chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Heart rate, Loss of consciousness
Clinical narrative: He passed out; His blood sugar was 143; This is a spontaneous report from a contactable consumer (patient's parent). A 16-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3247) via an unspecified route of administration on the right arm on 17Jan2021 at single dose for COVID-19 immunisation. Medical history included hypopituitarism. Concomitant medication included somatropin (NORDITROPIN) taken for hypopituitarism. He passed out (emergency room visit needed) on 17Jan2021, his blood sugar was 143 in Jan2021. Caller stated that her son received his first dose of the Pfizer COVID vaccine on 17Jan2021, stated he passed out. Caller stated they had to drive 3 hours away to get the vaccine and wanted to know that if because he experienced this after the first dose if it would be possible to find somewhere closer to home to get the second vaccine. Caller stated she is in the trial as an adult, that she reached out to her trial coordinator and they told her that they can only administer to persons in the trial. Son feels like maybe there is a drug interaction, caller stated she was not sure about this. Stated after her son passed out, they called an ambulance, states the Medic watched him for about 45 minutes, stated they ran some tests in Jan2021, he did go home that day. His blood sugar was 143 in Jan2021. Heart Rate monitor in Jan2021 she couldn't see so is unsure of the readings. The outcome of the event passed out was recovered on 17Jan2021, of other remain event was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for self. A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: CDR00811854), via an unspecified route of administration on 19Jan2021 14:15 at single dose for COVID-19 immunization.  Medical history included depression, anxiety.  Concomitant medication included levothyroxine, atorvastatin calcium (ATORVA), hydrochlorothiazide; lisinopril. The patient experienced Nausea, throwing up 3 times on 19Jan2021 18:15. Outcome of events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got COVID-19.; got COVID-19.; This is a spontaneous report from a contactable nurse. This nurse reported for a female patient (daughter) with unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization.  Medical history and concomitant medications were not reported. The patient was also a nurse, she had the shot and the got COVID-19 on unspecified date. The outcome of event was unknown.   Information on the batch/lot number has been requested.; Sender's Comments: Based on the limited information available, a causal relationship between event "got COVID-19" (coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)cannot be completely excluded. The case will be reevaluated should additional information become available.
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Swollen tongue, Throat tightness
Clinical narrative: throat became constricted; anaphalactic reaction to flu vaccine; her tongue swollen; Initial information was received on 22-Jan-2021 regarding an unsolicited valid serious case from a consumer/non-hcp (healthcare professional).  This case involves an 84 years old female patient whose throat became constricted (throat tightness), anaphalactic reaction (anaphylactic reaction) and her tongue swollen (swollen tongue), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The medical history, medical treatments, past vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot U3604BA and expiration date was not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious throat became constricted (throat tightness), 10 years following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for this event.  On 22-Jan-2011, the patient developed a serious anaphalactic reaction (anaphylactic reaction) and her tongue was swollen (swollen tongue), 10 years following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for these events.  It was reported that she was told to find out the ingredients of that vaccine and then her doctor would compare it to the current Covid vaccines to determine if any of the ingredients are the same.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the events was unknown at the time of reporting.; Sender's Comments: This case involves an 84 years old female patient who experienced throat tightness, anaphylactic reaction and swollen tongue, after vaccination with FLUZONE HIGH DOSE. The time to onset is unclear. The patient's medical history, medical condition at time of vaccination, concomitant medication and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received first dose of GARDASIL 9 on 17-FEB-2016, second dose on 25-AUG-2016 and wanted to get his thrid dose; This spontaneous report as received from a physician refers to a 29 year old male patient. On 17-FEB-2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and lot # not reported) and on 25-AUG-2016, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and lot # not reported). The patient now wanted to get his third dose.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Heart rate increased, Injection site erythema, Nausea
Clinical narrative: nausea; chills; increased urination; did not feel like eating; fast heartbeat; redness around injection site; fever; This case was reported by a consumer and described the occurrence of injection site erythema in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2020 16:30, the patient received the 1st dose of Shingrix (intramuscular). On 12th October 2020, 1 days after receiving Shingrix, the patient experienced increased urinary frequency and appetite absent. In October 2020, the patient experienced injection site erythema, fever and heartbeats increased. On an unknown date, the patient experienced nausea and chills. On 12th October 2020, the outcome of the increased urinary frequency was recovered/resolved. On 13th October 2020, the outcome of the appetite absent was recovered/resolved. On 14th October 2020, the outcome of the fever and heartbeats increased were recovered/resolved. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the nausea and chills were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, fever, nausea, chills, increased urinary frequency, appetite absent and heartbeats increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 53 or 54 years. On 11th October 2020 around 4:30 pm, the received 1st dose of Shingrix vaccine and under 24 hours after receiving the vaccine she had a fast heartbeat in the 150s, and this lasted about an hour and then decreased and returned to normal by 14th October 2020. On the morning of 12th October 2020, less than a day after receiving Shingrix, the patient had fever and redness around the injection site that went down from the injection site and kept expanding and patient stated that the red area around the injection site looked like the state of (unspecified) and she was unsure if the redness had resolved or not and the fever lasted until 14th October 2020 and then resolved. On 12th October 2020, the patient had an increase in urination, and this lasted until that evening and then resolved and on the same day, the patient did not feel like eating and this lasted until 13th October 2020 and then resolved  The patient reported that less than 2 months after receiving Shingrix, she had chills and nausea after receiving the vaccine but was not sure how long these lasted before resolving. The reporter did not consent to follow-up with her healthcare professional.
Sex: F
Vaccine: VARZOS
Symptoms: Pollakiuria, Pyrexia
Clinical narrative: nausea; chills; increased urination; did not feel like eating; fast heartbeat; redness around injection site; fever; This case was reported by a consumer and described the occurrence of injection site erythema in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2020 16:30, the patient received the 1st dose of Shingrix (intramuscular). On 12th October 2020, 1 days after receiving Shingrix, the patient experienced increased urinary frequency and appetite absent. In October 2020, the patient experienced injection site erythema, fever and heartbeats increased. On an unknown date, the patient experienced nausea and chills. On 12th October 2020, the outcome of the increased urinary frequency was recovered/resolved. On 13th October 2020, the outcome of the appetite absent was recovered/resolved. On 14th October 2020, the outcome of the fever and heartbeats increased were recovered/resolved. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the nausea and chills were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, fever, nausea, chills, increased urinary frequency, appetite absent and heartbeats increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 53 or 54 years. On 11th October 2020 around 4:30 pm, the received 1st dose of Shingrix vaccine and under 24 hours after receiving the vaccine she had a fast heartbeat in the 150s, and this lasted about an hour and then decreased and returned to normal by 14th October 2020. On the morning of 12th October 2020, less than a day after receiving Shingrix, the patient had fever and redness around the injection site that went down from the injection site and kept expanding and patient stated that the red area around the injection site looked like the state of (unspecified) and she was unsure if the redness had resolved or not and the fever lasted until 14th October 2020 and then resolved. On 12th October 2020, the patient had an increase in urination, and this lasted until that evening and then resolved and on the same day, the patient did not feel like eating and this lasted until 13th October 2020 and then resolved  The patient reported that less than 2 months after receiving Shingrix, she had chills and nausea after receiving the vaccine but was not sure how long these lasted before resolving. The reporter did not consent to follow-up with her healthcare professional.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Arthralgia, Blister, Influenza like illness, Malaise
Clinical narrative: little pimply /all over her body / the are increasing in number; itchy blisters all over her body / the are increasing in number; itchy blisters all over her body; felt like she had the flu; every joint in her body hurt; This case was reported by a consumer and described the occurrence of influenza like illness in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2020, no complications).   On 28th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 29th November 2020, 1 days after receiving Shingrix, the patient experienced influenza like illness and joint pain. On 2nd December 2020, the patient experienced pimples, blister and pruritus. The patient was treated with ibuprofen. On 30th November 2020, the outcome of the influenza like illness and joint pain were recovered/resolved. On an unknown date, the outcome of the pimples, blister and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the influenza like illness, joint pain, pimples, blister and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient received the 2nd dose of Shingrix and on the next day, she felt like she had the flu and every joint in her body hurt. The patient took ibuprofen and felt better on 30th November 2020. The patient started noticing 4 days after receiving Shingrix, little pimply, itchy blisters all over her body they were increasing in number as the days go on. The patient did not currently have a primary care physician. The reporter did not consent to follow-up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash pruritic, Rash vesicular
Clinical narrative: little pimply /all over her body / the are increasing in number; itchy blisters all over her body / the are increasing in number; itchy blisters all over her body; felt like she had the flu; every joint in her body hurt; This case was reported by a consumer and described the occurrence of influenza like illness in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2020, no complications).   On 28th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 29th November 2020, 1 days after receiving Shingrix, the patient experienced influenza like illness and joint pain. On 2nd December 2020, the patient experienced pimples, blister and pruritus. The patient was treated with ibuprofen. On 30th November 2020, the outcome of the influenza like illness and joint pain were recovered/resolved. On an unknown date, the outcome of the pimples, blister and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the influenza like illness, joint pain, pimples, blister and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient received the 2nd dose of Shingrix and on the next day, she felt like she had the flu and every joint in her body hurt. The patient took ibuprofen and felt better on 30th November 2020. The patient started noticing 4 days after receiving Shingrix, little pimply, itchy blisters all over her body they were increasing in number as the days go on. The patient did not currently have a primary care physician. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure abnormal, Pain
Clinical narrative: Soreness; had blood pressure; This case was reported by a consumer and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) (batch number ZM3D2, expiry date 3rd April 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and blood pressure abnormal. On an unknown date, the outcome of the pain and blood pressure abnormal were unknown.   It was unknown if the reporter considered the pain and blood pressure abnormal to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The Patient received Shingrix and had blood pressure and soreness. The Patient had blood pressure was coded blood pressure abnormal due to insufficient information. The reporter did not consent to follow-up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash erythematous, Rash papular
Clinical narrative: It is swollen at the injection site; It is a fine red rash around the injection site; It is a fine red rash around the injection site / they are little patches; it is starting to itch; It is raised only a little; they are little patches; This case was reported by a consumer and described the occurrence of injection site swelling in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included ibuprofen.   On 15th December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site rash, pruritus, raised rash and spot-like rash. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site rash, pruritus, raised rash and spot-like rash were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site rash, pruritus, raised rash and spot-like rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had swollen at the injection site. It was a fine red rash around the injection site, it was not big. The patient stated they are little patches was raised only a little and it was starting to itch.  The patient applied ice packs and took Ibuprofen. The reporter did not consent to follow up and did not provide consent. The agent failed to ask lot and exp date.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: It is swollen at the injection site; It is a fine red rash around the injection site; It is a fine red rash around the injection site / they are little patches; it is starting to itch; It is raised only a little; they are little patches; This case was reported by a consumer and described the occurrence of injection site swelling in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included ibuprofen.   On 15th December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site rash, pruritus, raised rash and spot-like rash. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site rash, pruritus, raised rash and spot-like rash were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site rash, pruritus, raised rash and spot-like rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had swollen at the injection site. It was a fine red rash around the injection site, it was not big. The patient stated they are little patches was raised only a little and it was starting to itch.  The patient applied ice packs and took Ibuprofen. The reporter did not consent to follow up and did not provide consent. The agent failed to ask lot and exp date.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry mouth
Clinical narrative: This is a spontaneous report from a contactable physician (patient). This 62-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142), via an unknown route, on 30Dec2020 at single dose on the left arm for COVID-19 immunization, administered at hospital. Relevant medical history included glaucoma, hypercalciuria, osteoporosis and allergy to sulfa. Relevant concomitant medications included hydrochlorothiazide (HCTZ), diltiazem hydrochloride (DILTIAZEM CD) and brimonidine tartrate, timolol maleate (COMBIGAN). No other vaccine was received in four weeks. The patient developed xerostomia 18 days after receiving 1st dose of vaccine. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was not treated for the event. The patient had not recovered from the event. Amendment: This follow-up is being submitted to amend previously reported information: patient's age added.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Dyspnoea, Fatigue, Limb injury, Pain assessment
Clinical narrative: This is spontaneous report from a contactable consumer (patient). A 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included Blood pressure high, Cancer (Two or less years ago; In remission, Taking medication to follow through with remission period), Allergies and sinus issues, covid virus (in July). The patient reported soreness in the arm (15Jan2021), fatigue (15Jan2021) and  palpitations (16Jan2021) that he felt below the mouth and above the heart, calling it the esophagus area. He wanted to know if others had reported this same palpitation. The reporter further reported that he has a little bit of concern. He felt fine, had sore arm and fatigue that has gone away. Noticed lately, somewhere in his esophagus between his heart and mouth that he is feeling palpitations. Doesn't know if it's more indigestion. Stated it could be gas. Sometimes comes and goes, feels different than what he's already experienced. Wanted to double check if this has been heard of or anything similar to it. Clarified product as first dose of COVID-19 Vaccine. Received last Thursday. Received COVID-19 Vaccine in left arm on 14Jan2021 between 15:00 and 16:00. Both arms are sore, but only because other arm is injured. Pain level in injection arm was around 5-6 and he wasn't able to sleep on that side. Within the second day, 16Jan2021 in late afternoon soreness and fatigue was gone. Indigestion or Palpitations, feeling was happening again. They wanted to know if that is something he is experiencing from the COVID-19 Vaccine. Stated it doesn't appear to be related. It is around the esophagus. Stated it affects breathing. Stated maybe that has something to do with it. For the dose, they noticed it was a small amount of fluid in the tube that was injected into him. The outcome of the events soreness in the arm/sore arm and fatigue was recovered on 16Jan2021, while for other events was unknown. Information on the batch number/lot number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations
Clinical narrative: This is spontaneous report from a contactable consumer (patient). A 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included Blood pressure high, Cancer (Two or less years ago; In remission, Taking medication to follow through with remission period), Allergies and sinus issues, covid virus (in July). The patient reported soreness in the arm (15Jan2021), fatigue (15Jan2021) and  palpitations (16Jan2021) that he felt below the mouth and above the heart, calling it the esophagus area. He wanted to know if others had reported this same palpitation. The reporter further reported that he has a little bit of concern. He felt fine, had sore arm and fatigue that has gone away. Noticed lately, somewhere in his esophagus between his heart and mouth that he is feeling palpitations. Doesn't know if it's more indigestion. Stated it could be gas. Sometimes comes and goes, feels different than what he's already experienced. Wanted to double check if this has been heard of or anything similar to it. Clarified product as first dose of COVID-19 Vaccine. Received last Thursday. Received COVID-19 Vaccine in left arm on 14Jan2021 between 15:00 and 16:00. Both arms are sore, but only because other arm is injured. Pain level in injection arm was around 5-6 and he wasn't able to sleep on that side. Within the second day, 16Jan2021 in late afternoon soreness and fatigue was gone. Indigestion or Palpitations, feeling was happening again. They wanted to know if that is something he is experiencing from the COVID-19 Vaccine. Stated it doesn't appear to be related. It is around the esophagus. Stated it affects breathing. Stated maybe that has something to do with it. For the dose, they noticed it was a small amount of fluid in the tube that was injected into him. The outcome of the events soreness in the arm/sore arm and fatigue was recovered on 16Jan2021, while for other events was unknown. Information on the batch number/lot number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable other hcp (patient).  A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via unspecified route of administration on 19Jan2021 14:00 at a single dose on left arm for covid-19 immunization.  There was no medical history reported. Patient has no known allergies. Concomitant medication included Atenolol 25 mg, vitamin C 1000mg, vitamin D 5000mg; all on unspecified dates for unspecified indications.  On 19Jan2021 at 14:15, the patient stated that "after the injection I went to the waiting area. I started to feel tingling on my left side of my face and then my nose and a little on the right cheek. I got the injection at 2 pm and now is 8:28 and I still have the tingling." Patient has not received any treatment. There were no other vaccine administered in four weeks. Patient has no COVID prior vaccination and has not tested post vaccination. The outcome of the event was not recovered.  Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Her pulse was 146 and 45 minutes later, her pulse was 136/her pulse was 105/6 hours later her pulse continued to come down; Her pulse was 146 and 45 minutes later, her pulse was 136/her pulse was 105/6 hours later her pulse continued to come down; Throwing PVCs like crazy; Hard to take a deep breathe; This is a spontaneous report from a contactable Nurse (patient). A (Age: 64, Unit: Unknown) female patient received BNT162B2 first dose on 14Jan2021 at single dose for covid-19 immunization. Medical history included thyroidectomy and concomitant medications were not reported. Patient wanted to know if tachycardia had been reported as an adverse reaction following administration of the Covid vaccine 12 hours later. Caller stated that she received her first dose of the Covid vaccine last Thursday (14Jan2021). Twelve and a half hours after administration of the vaccine (14Jan2021), her pulse was 146 and 45 minutes later, her pulse was 136. Caller's husband took her to the ER and in the 5.5 hours she was there, she received IV saline and had been "throwing PVCs like crazy." She was released from the ER around 3 a.m 15Jan2021., in which her pulse was 105 and she was throwing PVCs periodically at this time. 6 hours later her pulse continued to come down. Caller stated that it is still hard to take a deep breathe, but her oxygen saturations have been fine, ranging in the 70s to 105, then back down to 80s. Caller stated that she has no comorbidities and has only had a thyroidectomy in which her TSH is normal on 14Jan2021. She has no cardiac problems, in which a cardiologist did an EKG and found it to be normal on 14Jan2021. The cardiologist advises her to "absolutely take the second dose." Caller stated that she is scheduled for a stress test and echo on the 28Jan2021. Caller is also scheduled to receive the second dose on 04Feb2021. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of tachycardia, premature ventricular contractions and abnormal pulse  due to temporal relationship. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, cardiac enzymes, electrolytes, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Chills, Diarrhoea, Feeling abnormal, Heart rate increased
Clinical narrative: heart rate 160 (elevated); she had an allergic reaction to the vaccine; fever of 102; chills; irritation in throat; Diarrhea; felt funny; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (BNT162B2 reported as Pfizer COVID 19 vaccine; lot number: EL3302; expiration date: unknown), via an unspecified route of administration left arm on 15Jan2021 09:30 at a single dose (reported as unknown dosage with a needle to left arm one time) to prevent Covid 19 and build up antibodies to Covid 19 (COVID-19 immunization). The patient has no medical history and concomitant medications. The patient reported that last Friday (15Jan2021) at 9:30 she took the first dose of vaccine and felt funny, so she waited for 15 minutes. She mentioned that she had not eaten before so they gave her glucose tablets. She then mentioned that later on that night (15Jan2021) that she had a fever of 102 [unit unspecified], elevated heart rate of 160 [unit unspecified], had chills and felt like she had Covid. She further stated that she had irritation in her throat that started after the vaccine. She stated that her doctor mentioned that she may be positive for Covid 19 and did not know it before she had the vaccine. The patient mentioned that she had the nasal swab for Covid and they drew her blood on an unspecified date, but all came back negative. She was told that she had an allergic reaction to the vaccine. She added that she had no symptoms prior to the vaccine. The patient reported that she has to go back for the second Pfizer Covid 19 vaccine on 05Feb2021. The patient received treatment included prednisone, diphenhydramine (BENADRYL) and was given an epinephrine injection (EPIPEN) to bring home. She also was given acetaminophen (TYLENOL) for fever. She was given fluids to try to bring everything down. She added that she was given famotidine (PEPCID) for her stomach due to diarrhea on 15Jan2021 that she is still taking. The outcome of the events allergic reaction and felt funny were unknown, as for diarrhea was not recovered, for the event irritation in throat was recovered on 15Jan2021 while the outcome of the other events was recovered on 17Jan2021.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Throat irritation
Clinical narrative: heart rate 160 (elevated); she had an allergic reaction to the vaccine; fever of 102; chills; irritation in throat; Diarrhea; felt funny; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (BNT162B2 reported as Pfizer COVID 19 vaccine; lot number: EL3302; expiration date: unknown), via an unspecified route of administration left arm on 15Jan2021 09:30 at a single dose (reported as unknown dosage with a needle to left arm one time) to prevent Covid 19 and build up antibodies to Covid 19 (COVID-19 immunization). The patient has no medical history and concomitant medications. The patient reported that last Friday (15Jan2021) at 9:30 she took the first dose of vaccine and felt funny, so she waited for 15 minutes. She mentioned that she had not eaten before so they gave her glucose tablets. She then mentioned that later on that night (15Jan2021) that she had a fever of 102 [unit unspecified], elevated heart rate of 160 [unit unspecified], had chills and felt like she had Covid. She further stated that she had irritation in her throat that started after the vaccine. She stated that her doctor mentioned that she may be positive for Covid 19 and did not know it before she had the vaccine. The patient mentioned that she had the nasal swab for Covid and they drew her blood on an unspecified date, but all came back negative. She was told that she had an allergic reaction to the vaccine. She added that she had no symptoms prior to the vaccine. The patient reported that she has to go back for the second Pfizer Covid 19 vaccine on 05Feb2021. The patient received treatment included prednisone, diphenhydramine (BENADRYL) and was given an epinephrine injection (EPIPEN) to bring home. She also was given acetaminophen (TYLENOL) for fever. She was given fluids to try to bring everything down. She added that she was given famotidine (PEPCID) for her stomach due to diarrhea on 15Jan2021 that she is still taking. The outcome of the events allergic reaction and felt funny were unknown, as for diarrhea was not recovered, for the event irritation in throat was recovered on 15Jan2021 while the outcome of the other events was recovered on 17Jan2021.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Scattered dizziness and nausea; Scattered dizziness and nausea; This is a spontaneous report from a contactable nurse, the patient.  A non-pregnant 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK4176), via an unspecified route of administration in the right arm, on 13Jan2021 at 07:00 AM (at the age of 63-year-old) as a single dose for COVID-19 immunization. Medical history included high  cholesterol, regurgitation.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication taken within two weeks of vaccination included sertraline hydrochloride (ZOLOFT), rosuvastatin calcium (CRESTOR), omeprazole (PRILOSEC).  The patient previously took erythromycin and experienced drug hypersensitivity. The patient has allergy to penicillin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EH9899), right arm  on 23Dec2020 for COVID-19 immunization.  On 15Jan2021, the patient experienced scattered dizziness and nausea. The patient did not receive any treatment for the events. The clinical outcome of the scattered dizziness and nausea was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at the left arm on 13Jan2021 at a single dose to protect against COVID.  Medical history included under active thyroid in Jul2019. There were no concomitant medications. The patient woke during the night feeling like she was on fire feeling prickly throughout her body/her whole body got really hot and she had to cool with a rag on 19Jan2021 03:00. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dysentery, Fatigue, Pain in extremity
Clinical narrative: stomach bug; had history of 2 radioactive ablations; had history of 2 radioactive ablations; like a dysentery; constant diarrhea; completely exhausted/tired; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EH9899, expiration: 31Mar2021), via an unspecified route of administration in left arm on an unspecified date at a single dose for COVID-19 prophylaxis.  Medical history included ongoing Barrett's esophagus, ongoing esophageal hernia, 2 radioactive ablations, ulcer, ongoing high cholesterol, ongoing arthritis, and ongoing esophageal problems.  She has had a lot of esophageal issues, had history of 2 radioactive ablations. Concomitant medications included ongoing omeprazole for esophageal problems, ongoing atorvastatin to prevent high cholesterol, and ongoing paracetamol (TYLENOL) for arthritis. The patient reported that she received the vaccine on Saturday morning at 0900 (unspecified date). The patient's arm hurt on 16Jan2021. On 17Jan2021, she has had constant diarrhea. She is not panicked. She wants to know if this is from the vaccine or if she has a stomach bug. She was completely exhausted on 17Jan2021, and her arm hurt so bad. She stayed in bed. She is not as tired now.  She said that her arm hurt with the flu shot and other shots too (unspecified date). She said that she was not worried about it. With regards to diarrhea, she said that Sunday was like a dysentery, but it is a little bit better today. She is not going out or exercising because she is tired. Her second dose supposed to be on 06Feb2021. She said that she does not like medication or shots. The patient is recovering from events constant diarrhea (like a dysentery) and completely exhausted/tired; recovered from arm hurt on 18Jan2021; while unknown outcome for the remaining event.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Myalgia, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunisation, ibuprofen sodium (IBUPROFEN [IBUPROFEN SODIUM]), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dosage for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient was in bed now and he has got aches and pains like muscle pain throughout his body. Outcome of events was unknown. MInformation about Lot/Batch number is requested.
Sex: U
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: Chronic dental infection; This is a spontaneous report from other health professional (dentist) from a Pfizer-sponsored program Pfizer First Connect.  A patient of unspecified age and gender received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced chronic dental infection (non-serious) on an unspecified date with outcome of unknown.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood creatinine increased, Blood glucose normal, Blood potassium decreased, COVID-19
Clinical narrative: presented to ED 3 days post injection with c/o palpatations and some SOB,. Patient was found to be in AFib with RVR.  Labs showed severe hypokalemia.  Three doses of potassium chloride were administered with improvement of potassium.  Patient underwent a DC cardioversion   Patient also reported positive COVID 19 test on 1/15/2021
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cardioversion, Differential white blood cell count abnormal, Dyspnoea, Full blood count abnormal, Hypokalaemia
Clinical narrative: presented to ED 3 days post injection with c/o palpatations and some SOB,. Patient was found to be in AFib with RVR.  Labs showed severe hypokalemia.  Three doses of potassium chloride were administered with improvement of potassium.  Patient underwent a DC cardioversion   Patient also reported positive COVID 19 test on 1/15/2021
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Mean cell haemoglobin increased, Palpitations, SARS-CoV-2 test positive, White blood cell count increased
Clinical narrative: presented to ED 3 days post injection with c/o palpatations and some SOB,. Patient was found to be in AFib with RVR.  Labs showed severe hypokalemia.  Three doses of potassium chloride were administered with improvement of potassium.  Patient underwent a DC cardioversion   Patient also reported positive COVID 19 test on 1/15/2021
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Oral discomfort, Pruritus
Clinical narrative: Patient received her vaccine and waiting for 30 minutes following vaccine with no issues reported.  About 2 hours after patient returned home, patient's outside of her mouth started to burn.  She continued to wait to see if it resolved and when it didn't, she returned to vaccine clinic.  Nurse practitioner at vaccine clinic administered 25mg PO Benadryl and had her wait another hour.  Patient was able to be discharged but continued to have itchiness and burning.  She was seen by her PCP the next day and was given a steroid shot and instructed to continue Benadryl every 6 hours.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip blister, Lip swelling, Oral pruritus, Pruritus, Throat irritation
Clinical narrative: Patient received her vaccine and waiting for 30 minutes following vaccine with no issues reported.  About 2 hours after patient returned home, patient's outside of her mouth started to burn.  She continued to wait to see if it resolved and when it didn't, she returned to vaccine clinic.  Nurse practitioner at vaccine clinic administered 25mg PO Benadryl and had her wait another hour.  Patient was able to be discharged but continued to have itchiness and burning.  She was seen by her PCP the next day and was given a steroid shot and instructed to continue Benadryl every 6 hours.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: left lymph node tenderness noted in axilla the morning after the injection. That evening, I noticed marked swelling to the left axilla as the tenderness continued. Both resolved after 3 days. Injection was in left arm.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Underneath area of shot, it was red hard and painful.  Lasted 3 days. Then in turned pink and has been pink for two more days.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient received 1st COVID Pfizer vaccine at a drive through offered by Public Health on 01/23/21 at 2:20 pm. At approx. 2:00 pm on 01/24/21, patient developed hives to hips, groin, and bilateral forearms. Later that evening, patient took benadryl 50 mg PO and then went to bed. Never took any more medication. Hives faded away within 2 days.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 8 days after receiving the COVID vaccine, pt developed a local site reaction of redness, swelling and itching.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Peripheral swelling, Pruritus, Skin exfoliation
Clinical narrative: Gradual onset of erythema, pruritus, swelling of my right fourth toe which evolved to swelling of and the same symptoms on my left fourth toe and my left third toe. Additionally some blisters and peeling of the skin. It appears that there is starting to be resolution of my right fourth toe and I assume that I will have resolution of my left toe soon. Visited a podiatrist and the etiology was not known. Awaiting appointment with derm.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Dizziness, Erythema, Nausea, Pain in extremity
Clinical narrative: redness, pain to right arm, hive like rash on right side of neck and right cheek 2 days after vaccination without dyspnea, angioedema, other rash location, nausea, lightheadedness. prescribed cetirizine and famotidine
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: redness, pain to right arm, hive like rash on right side of neck and right cheek 2 days after vaccination without dyspnea, angioedema, other rash location, nausea, lightheadedness. prescribed cetirizine and famotidine
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Fatigue, Injection site induration, Injection site pruritus
Clinical narrative: At 5:00 AM on 1/29/2021 I began having chills, fatigue, earache  and was nauseated. On 1/31/2021 I began having a rash which was about 3 inches in length and 2 1/2 inches in width around the injection site.  There was a hard spot in the center of the rash.  It was extremely itchy.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Nausea
Clinical narrative: At 5:00 AM on 1/29/2021 I began having chills, fatigue, earache  and was nauseated. On 1/31/2021 I began having a rash which was about 3 inches in length and 2 1/2 inches in width around the injection site.  There was a hard spot in the center of the rash.  It was extremely itchy.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site swelling
Clinical narrative: Red area at vaccination site on arm. Slightly swollen and itchy
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue
Clinical narrative: fatigued, tired, worsening of a baseline cough
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Full blood count, Purpura, Rash maculo-papular
Clinical narrative: PURPURA, ALL OVER ERYTHEMAPOUA, MACULOPAPULAR,  STERIOD INJECTION DEXAMNTHASONE AND DEPOMEDROL, RX FAMOTIDINE 20 MG BID PRN FOR ITCHING
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Erythema, Pruritus, Rash, Rash erythematous
Clinical narrative: PURPURA, ALL OVER ERYTHEMAPOUA, MACULOPAPULAR,  STERIOD INJECTION DEXAMNTHASONE AND DEPOMEDROL, RX FAMOTIDINE 20 MG BID PRN FOR ITCHING
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling, White blood cell count normal
Clinical narrative: PURPURA, ALL OVER ERYTHEMAPOUA, MACULOPAPULAR,  STERIOD INJECTION DEXAMNTHASONE AND DEPOMEDROL, RX FAMOTIDINE 20 MG BID PRN FOR ITCHING
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Body aches and chills
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Inappropriate schedule of product administration, Injection site pain, Pain in extremity
Clinical narrative: I received the first dose on 12-29-2020. i was exposed to Covid on 12-31-2020. I experienced chills, left arm was incredibly sore at the site and radiated down my arm up to four inches. I tested positive for Covid on 01-05-2021.  I received my second dose on 01-29-2021.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I received the first dose on 12-29-2020. i was exposed to Covid on 12-31-2020. I experienced chills, left arm was incredibly sore at the site and radiated down my arm up to four inches. I tested positive for Covid on 01-05-2021.  I received my second dose on 01-29-2021.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Pyrexia
Clinical narrative: Fever, anxious.  Tylenol given.  Symptoms resolved after 24 hours.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dehydration, Diarrhoea, Nasal congestion, Nausea
Clinical narrative: Pt started having nausea, vomiting, diarrhea, cough and congestion on 1/22/2021.  Pt went to ER on 1/24/2021 where she had a negative Rapid COVID test.  Pt was seen on 2/1/2021 still complaining of above symptoms along with dehydration.  Pt was sent back to ER via EMS.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Vomiting
Clinical narrative: Pt started having nausea, vomiting, diarrhea, cough and congestion on 1/22/2021.  Pt went to ER on 1/24/2021 where she had a negative Rapid COVID test.  Pt was seen on 2/1/2021 still complaining of above symptoms along with dehydration.  Pt was sent back to ER via EMS.