chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Headache, Insomnia, Nausea
Clinical narrative: Violent shivering/shaking; Felt cold; Headache; a bit of nausea; had trouble sleeping; Shaking; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose of the vaccine with no reactions).   On 10th January 2021 11:00, the patient received the 2nd dose of Shingrix (intramuscular). On 10th January 2021 23:00, 12 hrs after receiving Shingrix, the patient experienced shivering, feeling cold, headache, nausea, difficulty sleeping and tremor. On an unknown date, the outcome of the shivering, feeling cold, headache, nausea, difficulty sleeping and tremor were recovered/resolved.   It was unknown if the reporter considered the shivering, feeling cold, headache, nausea, difficulty sleeping and tremor to be related to Shingrix.  Additional details were reported as follows: The patient  experienced shivering/shaking, felt cold, headache, a bit of nausea for 2-3 hours. The patient also stated that he had trouble sleeping last night. The patient received the vaccine at 11am yesterday morning in the upper left arm. The symptoms occurred 12 hours later at 11pm last night. .The reporter consented to follow up. No further information was available. Patient did give permission to follow-up with their HCP, and provided the following contact information.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Violent shivering/shaking; Felt cold; Headache; a bit of nausea; had trouble sleeping; Shaking; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose of the vaccine with no reactions).   On 10th January 2021 11:00, the patient received the 2nd dose of Shingrix (intramuscular). On 10th January 2021 23:00, 12 hrs after receiving Shingrix, the patient experienced shivering, feeling cold, headache, nausea, difficulty sleeping and tremor. On an unknown date, the outcome of the shivering, feeling cold, headache, nausea, difficulty sleeping and tremor were recovered/resolved.   It was unknown if the reporter considered the shivering, feeling cold, headache, nausea, difficulty sleeping and tremor to be related to Shingrix.  Additional details were reported as follows: The patient  experienced shivering/shaking, felt cold, headache, a bit of nausea for 2-3 hours. The patient also stated that he had trouble sleeping last night. The patient received the vaccine at 11am yesterday morning in the upper left arm. The symptoms occurred 12 hours later at 11pm last night. .The reporter consented to follow up. No further information was available. Patient did give permission to follow-up with their HCP, and provided the following contact information.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: "More reactions" than usual / reported a rash; This case was reported by a physician and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The reporter stated that, the patient received the dose of Shingrix and experienced Rash.as opposed to the usual muscle pain and fever The reporter asked information about Shingrix recall and mentioned that they had none to return and was not sure if she had any from the lots that were affected, she also asked what was the risk to the patient. The reporter was not certain though if the reaction was from the Shingrix nor if they were of the same batch of recalled Shingrix. The reporter did not consented to follow up. The reporter did not have any additional information regarding the events or the patients (demographics). This case was linked with US2021AMR057595 and US2021AMR057596 reported by the same reporter. Note- Since the reporter was just inquiring about recall of Shingrix and Hub also added comment about the same, no event about product recall has been coded.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR057595:Same reporter. Patient #2. US-GLAXOSMITHKLINE-US2021AMR057596:Master case. Several pts.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Electrocardiogram, Fatigue, Syncope, Throat tightness
Clinical narrative: Feelt very tired; loss of consciousness with fainting; Felt like her throat was closing; Chills; A spontaneous report was received from a consumer concerning a 25-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of consciousness, felt like her throat was closing, chills and felt very tired  The patient's medical history was not provided. No relevant concomitant medications were reported. Laboratory data was Prolong QT interval on ECG reported.  On 20 Jan 2021, approximately same day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 20 Jan 2021, 5 minutes after vaccination, the patient felt  like her throat was closing, chills, lightheaded and fainted. In the ER the work up for syncope revealed prolonged qt interval on ECG. Treatment included Benadryl, Magnesium, fluids. The patient was discharged on the same day but she still feels tired having brain fog.   Action taken with mRNA-1273 in response to the events was not reported.   The  outcome of events were not reported; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Dermatitis, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Cellulitis; Dermatitis; A reddish rash at the same spot of the vaccine; A reddish rash at the same spot of the vaccine; Itchy at the same spot of the vaccine; A lot of pain in the arm; A spontaneous report was received from a consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a lot of pain in the arm, itchy at the same spot of the vaccine, a reddish rash at the same spot of the vaccine, dermatitis and cellulitis.  The patient's medical history was not provided. Concomitant medications reported were Hydrochlorothiazide, Pepcid (Famotidine)  drug used for unknown indication.  On 13-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13-Jan-2021, the patient experienced a lot of pain in the arm . On 21-Jan-2021, the patient experienced itchy at the same spot of the vaccine . On an unknown date, the patient experienced the events a reddish rash at the same spot of the vaccine, dermatitis and cellulitis.  The patient received antibiotics and prednisone for dermatitis and cellulitis. No treatment information was other events.  Action taken with mRNA-1273 in response to the events were not reported.   On 18-Jan-2021 the outcome for a lot of pain in the arm was resolved. The outcome of other events were recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Cellulitis; Dermatitis; A reddish rash at the same spot of the vaccine; A reddish rash at the same spot of the vaccine; Itchy at the same spot of the vaccine; A lot of pain in the arm; A spontaneous report was received from a consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a lot of pain in the arm, itchy at the same spot of the vaccine, a reddish rash at the same spot of the vaccine, dermatitis and cellulitis.  The patient's medical history was not provided. Concomitant medications reported were Hydrochlorothiazide, Pepcid (Famotidine)  drug used for unknown indication.  On 13-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13-Jan-2021, the patient experienced a lot of pain in the arm . On 21-Jan-2021, the patient experienced itchy at the same spot of the vaccine . On an unknown date, the patient experienced the events a reddish rash at the same spot of the vaccine, dermatitis and cellulitis.  The patient received antibiotics and prednisone for dermatitis and cellulitis. No treatment information was other events.  Action taken with mRNA-1273 in response to the events were not reported.   On 18-Jan-2021 the outcome for a lot of pain in the arm was resolved. The outcome of other events were recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Underdose
Clinical narrative: Entire dose ran down her arm/didn't get the full dose; Entire dose ran down her arm/didn't get the full dose; A spontaneous report was received from a 61-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and entire dose ran down her arm/didn't get the full dose. (PT: Product administration error) (PT: Underdose)    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 011M20A/ 011W20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient reported she did not receive the entire dose of vaccine as it ran down her arm .   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The event entire dose ran down her arm/didn't get the full dose. (PT: Product administration error) (PT: Underdose), was considered resolved.  The reporter did not provide an assessment for the event entire dose ran down her arm/didn't get the full dose. (PT: Product administration error) (PT: Underdose); Reporter's Comments: This report refers to a case of Product administration error and. underdose for mRNA-1273 (lot # 011M20A/ 011W20A) with no associated AEs reported.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old recevied vaccine; A spontaneous report as received from a pharmacist concerning a 17-year-old, male patient, who received Moderna COVID-19 vaccine and considered as product administered to patient of inappropriate age .   The patient's had no known past medical history of drug addiction or an adverse reactions to vaccines. Concomitant medications were not provided.   On 22 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number:010M20A) through intramuscular route in the right deltoid for prophylaxis of COVID-19 infection.   No treatment information was provided.   Lab details were not provided.  Action taken with mRNA-1273 in response to the event was not applicable  The outcome of inappropriate age at vaccination administration was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Coronary artery stenosis, Dyspnoea, Fatigue
Clinical narrative: 90% blockage of her heart; shortness of breath; tired when she walks; A spontaneous report was received on 2 Feb 2021, from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 90% blockage of her heart, tired when she walks, and shortness of breath.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. The patient is scheduled for second dose.  On an unknown date, the patient experienced events, 90% blockage of her heart, tired when she walks, and shortness of breath.  Treatment details not provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include 90% blockage of her heart, tired when she walks, and shortness of breath were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac failure congestive, Extra dose administered
Clinical narrative: congestive heart failure; inadvertently administered another dose (3rd dose); tested positive for Covid-19; A spontaneous report was received from a nurse and other health care professional for a 91-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced congestive heart failure, tested positive for Covid-19 and inadvertently administered another dose (3rd dose).  The patient's medical history was not provided. No concomitant product use was reported.  On 22-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 23-JAN-2021, 1day after receiving the vaccine the patient was hospitalized due to congestive heart failure. The patient had difficulty of breathing at that time.   On 03-FEB-2021, the patient tested positive for covid-19. The patient was transferred to a rehabilitation facility on an unspecified date to recuperate.   On 25-FEB-2021 at around 11:30 in the morning, the patient was given second dose of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of covid-19 infection at a rehabilitation facility. On the same day at around 02:30 PM, a group of vaccine providers came and inadvertently administered another dose (third dose) of the vaccine mRNA-1273 (lot number: not provided) to the patient. Apparently, there was two patients with the same names, and they did not check the birthdays. The health care professional reported that at the time of this report, the patient was in the hospital and was on a ventilator. Treatment information included ventilation.  Action taken with mRNA-1273 was not applicable.  The outcome of the events, congestive heart failure and tested positive for Covid-19 was unknown and the outcome for the event inadvertently administered another dose (3rd dose) was recovered/resolved.  The reporter did not provide the assessment for the event's congestive heart failure, tested positive for Covid-19 and inadvertently administered another dose (3rd dose).; Reporter's Comments: COVID-19 in this patient is unlikely to be related to Moderna COVID-19 vaccine. Based on the current available information and temporal association, a causal relation between the product and congestive heart failure cannot be excluded. Medication error of extra dose administered for (mRNA-1273), lot # unknown  was reported, with no associated AEs reported after the additional dose.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Lymphadenopathy
Clinical narrative: Lightheaded; passed out; Lymph knot under armpit; A spontaneous report was received from a consumer for a 67-year-old female patient who experienced light headedness and passed out. She also had lymph knots under her armpit.  The patient's medical history was not reported. No concomitant product use was reported.  On 26 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 27 Feb 2021, next day after receiving the vaccine, the patient felt lightheaded and passed out and was hospitalized. She also experienced lymph knots under her armpit.  Action taken with mRNA-1273 with respect to the events was not reported.  The outcome of the events was not reported.  The reporter did not provide the causality assessment for the events.; Reporter's Comments: Based on the current available information which shows a strong temporal association between the use of the product and the start date of the reported event, a causal relationship with the event cannot be excluded. Axillary lymphadenopathy is consistent with the known safety profile of the mRNA-1273
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Dry mouth, Fatigue, Functional gastrointestinal disorder
Clinical narrative: bladder felt full, like they could not empty it; limited bowel function; vomiting that day; limited appetite; dry mouth; felt very dizzy; extreme tiredness for 3 weeks; A spontaneous report was received from a healthcare professional concerning a 65-year-old, female patient, who experienced urinary retention, dizziness, vomiting, fatigue, decreased appetite, dry mouth  and limited bowel function.  The patient's medical history, as provided by the reporter, included two time cancer survivor . Concomitant medications reported included Carvedilol for high blood pressure, acetamide for cholesterol, potassium, multivitamins, zinc, calcium, Vitamin D.  On 05 Feb,  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) in the left arm for prophylaxis of COVID-19 infection.   Patient was ok at midnight, but when they woke up, they felt very dizzy, were vomiting that day, and experienced extreme tiredness for 3 weeks, now they feel relatively recovered, like 90%, but still somewhat tired, probably related to not been able to eat on account of having very limited appetite. They mentioned they had limited bowel function, and their bladder felt full, like they could not empty it. Patient states they had a dry mouth from  the beginning of the symptoms.  After a week of these symptoms, on Saturday, the patient went to a clinic and they did some bloodwork and found that the liver enzymes were elevated and 5 more values were not normal and that their kidney function was not normal.  They consulted with their oncologist and they believed these could be an extreme immune response to the vaccine, since the lab work conducted on the 23Dec2020 was normal.  Last Friday they have some blood tests and the values were back to normal.  Treatment for the events included paracetamol and ibuprofen alternating; and  Prednisone.  Action taken with mRNA-1273 in response to the events was not reported.   The events, dizziness, vomiting, fatigue, dry mouth were relatively recovered, like 90%, but still somewhat tired.  The outcome events,  urinary retention,  decreased appetite,   and limited bowel function are unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Liver function test, Renal impairment, Urinary retention, Vomiting
Clinical narrative: bladder felt full, like they could not empty it; limited bowel function; vomiting that day; limited appetite; dry mouth; felt very dizzy; extreme tiredness for 3 weeks; A spontaneous report was received from a healthcare professional concerning a 65-year-old, female patient, who experienced urinary retention, dizziness, vomiting, fatigue, decreased appetite, dry mouth  and limited bowel function.  The patient's medical history, as provided by the reporter, included two time cancer survivor . Concomitant medications reported included Carvedilol for high blood pressure, acetamide for cholesterol, potassium, multivitamins, zinc, calcium, Vitamin D.  On 05 Feb,  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) in the left arm for prophylaxis of COVID-19 infection.   Patient was ok at midnight, but when they woke up, they felt very dizzy, were vomiting that day, and experienced extreme tiredness for 3 weeks, now they feel relatively recovered, like 90%, but still somewhat tired, probably related to not been able to eat on account of having very limited appetite. They mentioned they had limited bowel function, and their bladder felt full, like they could not empty it. Patient states they had a dry mouth from  the beginning of the symptoms.  After a week of these symptoms, on Saturday, the patient went to a clinic and they did some bloodwork and found that the liver enzymes were elevated and 5 more values were not normal and that their kidney function was not normal.  They consulted with their oncologist and they believed these could be an extreme immune response to the vaccine, since the lab work conducted on the 23Dec2020 was normal.  Last Friday they have some blood tests and the values were back to normal.  Treatment for the events included paracetamol and ibuprofen alternating; and  Prednisone.  Action taken with mRNA-1273 in response to the events was not reported.   The events, dizziness, vomiting, fatigue, dry mouth were relatively recovered, like 90%, but still somewhat tired.  The outcome events,  urinary retention,  decreased appetite,   and limited bowel function are unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Cellulitis; Hot at the injection site; Itchiness at the injection site; Redness at the injection site; Pain at the injection site; A spontaneous report was received from a 67 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed cellulitis, redness at the injection site, itchiness at the injection site, hot at the injection site, and pain at the injection site.  The patient's medical history and concomitant medications were not provided.  On 18-FEB-2021, 8 days prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (batch number: 010M20A) intramuscularly in the left arm for the prophylaxis of COVID-19 infection.  On 26-FEB-2021, the patient developed cellulitis, redness at the injection site, itchiness at the injection site, hot at the injection site, and pain at the injection site. Treatment included administration of antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, cellulitis, redness at the injection site, itchiness at the injection site, hot at the injection site, and pain at the injection site, were reported as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Pneumonia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: reveled mild pneumonia; I tested positive for Covid19 19Feb (3 weeks +2days) after 2nd dose of vaccine; I tested positive for Covid19 19Feb (3 weeks +2days) after 2nd dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262; expiry date: unknown) via an unspecified route of administration in the left arm, on 28Jan2021 at 15:00, at a single dose, for COVID-19 immunisation. Medical history included known allergies to penicillins. Concomitant medication included acyclovir (ACICLOVIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284) in the left arm, on 06Jan2021 at 13:00, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID-19 vaccination. The patient had dry cough and difficulty getting deep satisfying breath about 12Feb2021 (2 weeks + 2 days) after 2nd dose of Pfizer vaccine. The patient tested positive for COVID-19 nasal swab on 19Feb2021 (3 weeks +2days) after 2nd dose of vaccine. On 24Feb2021, patient was seen in a physician office for symptoms of cough and shortness of breath (SOB). On the same day (24Feb2021), chest X-ray revealed mild pneumonia. Patient was now on prednisone, azithromycin and albuterol inhaler. Patient was a little better and was now on 3rd day of taking 3 medications. Outcome of the events was recovering.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Dyspnoea, Headache, Hypertension
Clinical narrative: dizzy; blood pressure, it was "high", around 129/88; shortness of breath; urge to vomit (nausea); faint; body aches; headache; her arm hurt; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 11Feb2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Pfizer's vaccine on Thursday, morning (11Feb2021), at the time her arm hurt. She had body aches the entire Friday (12Feb2021) and headache; she stayed in bed all day and the next day, she took Tylenol. On Saturday (13Feb2021), she had shortness of breath and the urge to vomit (nausea), she was about to faint. She was also dizzy and checked her blood pressure, it was "high", around 129/88, but she can't recall the values exactly. She doesn't know if she should get the second dose because she's scared. The patient wanted to know if these are symptoms from the vaccine or could it have been a reaction or allergy. She is scheduled for the second dose on 04Mar2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Syncope
Clinical narrative: dizzy; blood pressure, it was "high", around 129/88; shortness of breath; urge to vomit (nausea); faint; body aches; headache; her arm hurt; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 11Feb2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Pfizer's vaccine on Thursday, morning (11Feb2021), at the time her arm hurt. She had body aches the entire Friday (12Feb2021) and headache; she stayed in bed all day and the next day, she took Tylenol. On Saturday (13Feb2021), she had shortness of breath and the urge to vomit (nausea), she was about to faint. She was also dizzy and checked her blood pressure, it was "high", around 129/88, but she can't recall the values exactly. She doesn't know if she should get the second dose because she's scared. The patient wanted to know if these are symptoms from the vaccine or could it have been a reaction or allergy. She is scheduled for the second dose on 04Mar2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin, Blister, Pemphigus
Clinical narrative: Pemphigus; blisters over upper body; This is a spontaneous report from a contactable physician. An 82-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration on left arm on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included glaucoma, AMD and arrhythmia. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), rosuvastatin calcium (CRESTOR) and timolol. The patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: lot number: EL 1284 on left arm) on 30Dec2020 for covid-19 immunisation and experienced hives in the back. The patient experienced pemphigus and blisters over upper body on 18Feb2021 12:00. The patient underwent lab tests and procedures which included Skin Bx: confirm pemphigus on an unspecified date. Therapeutic measures were taken as a result of pemphigus and blisters included prednisone. Outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events "Pemphigus and blisters over upper body" cannot be completely excluded based on temporal association.   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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Spinal cord disorder
Clinical narrative: spinal cord modulation pain; This is a spontaneous report via a Pfizer-sponsored program, from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer said she received the 1st dose of the Pfizer-BioNTech Covid19 Vaccine on Wednesday. She said that she has not had any pain related to the vaccine. However, she has the condition, spinal cord modulation pain (unspecified date in Feb2021). She said she was prescribed to take hydrocodone/paracetamol (VICODIN) once every other night. She wants to know if this is okay and wants to know how long she has to wait to take the medication after receiving her 2nd dose. She is asking if she can already take the medicine VICODIN before the 2nd dose or she can take the medicine after she got the 2nd dose instead. The outcome of the event was unknown.  Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dysgeusia, Hypertension, Hypoaesthesia, Paraesthesia
Clinical narrative: blood pressure was high 210/106; facial tongue tingling; facial tongue tingling; numb; metallic taste in mouth; This is a spontaneous report from a contactable nurse.  A 75-year-old female patient received her first dose of BNT62b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no. and expiry date were not reported), via an unspecified route of administration on 25Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After getting her first dose on unspecified date in Feb2021, the patient experienced facial tongue tingling and numb, blood pressure was high 210/106 and had a metallic taste in mouth. Paramedics gave her Benadryl and monitored for an hour. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Due to a positive drug-event temporal association and lacking identified alternative explanations, the company, despite no patient's medical history, concomitant medication and baseline and follow-up values of blood pressure have been provided, cannot completely exclude that the reported high value of blood pressure is related to BNT162b2 administration. The impacts 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.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: blood pressure was high 210/106; facial tongue tingling; facial tongue tingling; numb; metallic taste in mouth; This is a spontaneous report from a contactable nurse.  A 75-year-old female patient received her first dose of BNT62b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no. and expiry date were not reported), via an unspecified route of administration on 25Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After getting her first dose on unspecified date in Feb2021, the patient experienced facial tongue tingling and numb, blood pressure was high 210/106 and had a metallic taste in mouth. Paramedics gave her Benadryl and monitored for an hour. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Due to a positive drug-event temporal association and lacking identified alternative explanations, the company, despite no patient's medical history, concomitant medication and baseline and follow-up values of blood pressure have been provided, cannot completely exclude that the reported high value of blood pressure is related to BNT162b2 administration. The impacts 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: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis, SARS-CoV-2 test
Clinical narrative: Acute pericarditis; This is a spontaneous report from a contactable Physician reporting for himself   A 37-year-old Male Physician received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EZ3248) on 11Jan2020 at single dose, via an unspecified route of administration,  on left arm  for COVID-19 immunization. Relevant medical history included hypothyroidism and hyperlipidemia. The patient received first dose of BNT162B2 on Dec2020 via an unspecified route of administration  on left arm for COVID-19 immunization.  Concomitant medications included atorvastatin and levothyroxine sodium (SYNTHROID). On 21Feb2021 at 17:00, the patient experienced acute pericarditis resulted in doctor office/clinic visit. Treatment received included Ibuprofen, Colchicine and Pantoprazole. At the time of the reporting, the patient was recovering from the event.; Sender's Comments: Based on the limited information currently available, a possible association of the suspect drug administration with the reported event cannot be excluded, due to a plausible temporal relationship. This case will be reassessed when additional information becomes 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Headache, Loss of consciousness, Urticaria
Clinical narrative: dizziness on the verge of passing out; welts all over midsection from upper legs through hips and onto torso lasting for weeks; Intense headache; dizziness on the verge of passing out; flushed face and ears; This is a spontaneous report from a non-contactable other healthcare professional. This 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1283),  dose  1, single dose via an intramuscular route of administration in the left arm on 10Feb2021 at 10:30 AM (at the age of 44- years-old) for COVID-19 vaccination.  Medical history included complete thyroidectomy with neck dissection (removed lymph) for papillary thyroid cancer with neck dissection (removed lymph) for papillary thyroid cancer- otherwise healthy and penicillin allergy. The patient was tested for COVID-19 on 14Aug2020 by nasal swab and was negative. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 10Feb2021 at 10:30 AM, the patient experienced intense headache within 5 minutes, dizziness on the verge of passing out (waited in the lobby for 1 hour before leaving), flushed face and ears, headache for several days, welts all over midsection from upper legs through hips and onto torso lasting for weeks. The clinical outcome of headache, dizziness on the verge of passing out, flushed face and ears, headache and welts was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Body temperature, Chills, Diarrhoea, Dizziness
Clinical narrative: I fell and must have passed out; I fell and must have passed out; painful, large red swollen arm at injection site (size of half a baseball in height and about 6 inches down my arm); painful, large red swollen arm at injection site (size of half a baseball in height and about 6 inches down my arm); Body pain; severe headache; fever (100/sweating); chills (shaking with temp drop- 97.2; normal 97.6); vomiting; loose stools; Lost 6 lbs; abrasion on her right side forehead; dizzy; weak; fever (100/sweating); nausea; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation, at 68 years old. Medical history included Metastatic breast cancer, thyroid, glaucoma, osteo  arthritis, neuropathy, sulfa allergy, Fish/shellfish allergy, penicillin allergy, MS (Multiple sclerosis), and Phenothiazines allergy. No other vaccines in four weeks were received. The patient is not pregnant at the time of vaccination. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included amlodipine, levothyroxine sodium (SYNTHROID), gabapentin, timolol, and cyanocobalamin (B12), therapy dates and indications unspecified, in two weeks. The patient previously took Cytoxan, cipro, Demerol and experienced allergies. On 28Jan2021 20:00 (also reported as about 8 hours), the patient experienced body pain; severe headache; fever (100/sweating); chills (shaking with temp drop- 97.2; normal 97.6); Nausea; vomiting; loose stools; painful, large red swollen arm at injection site (investigation: size of half a baseball in height and about 6 inches down her arm); dizzy; weak; and she fell and must have passed out. Woke up on floor with abrasion on her right-side forehead. The patient also reported she lost 6 lbs. The events lasted from Thursday evening to Sunday morning. Treatment for the adverse events included BENARDRYL. Outcome of the events was recovered on 29Jan2021. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9267) via an unspecified route of administration (right arm) on 18Feb2021 09:30 for COVID-19 immunisation.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Headache, Hyperhidrosis, Investigation, Loss of consciousness
Clinical narrative: I fell and must have passed out; I fell and must have passed out; painful, large red swollen arm at injection site (size of half a baseball in height and about 6 inches down my arm); painful, large red swollen arm at injection site (size of half a baseball in height and about 6 inches down my arm); Body pain; severe headache; fever (100/sweating); chills (shaking with temp drop- 97.2; normal 97.6); vomiting; loose stools; Lost 6 lbs; abrasion on her right side forehead; dizzy; weak; fever (100/sweating); nausea; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation, at 68 years old. Medical history included Metastatic breast cancer, thyroid, glaucoma, osteo  arthritis, neuropathy, sulfa allergy, Fish/shellfish allergy, penicillin allergy, MS (Multiple sclerosis), and Phenothiazines allergy. No other vaccines in four weeks were received. The patient is not pregnant at the time of vaccination. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included amlodipine, levothyroxine sodium (SYNTHROID), gabapentin, timolol, and cyanocobalamin (B12), therapy dates and indications unspecified, in two weeks. The patient previously took Cytoxan, cipro, Demerol and experienced allergies. On 28Jan2021 20:00 (also reported as about 8 hours), the patient experienced body pain; severe headache; fever (100/sweating); chills (shaking with temp drop- 97.2; normal 97.6); Nausea; vomiting; loose stools; painful, large red swollen arm at injection site (investigation: size of half a baseball in height and about 6 inches down her arm); dizzy; weak; and she fell and must have passed out. Woke up on floor with abrasion on her right-side forehead. The patient also reported she lost 6 lbs. The events lasted from Thursday evening to Sunday morning. Treatment for the adverse events included BENARDRYL. Outcome of the events was recovered on 29Jan2021. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9267) via an unspecified route of administration (right arm) on 18Feb2021 09:30 for COVID-19 immunisation.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pyrexia, Skin abrasion, Vaccination site pain
Clinical narrative: I fell and must have passed out; I fell and must have passed out; painful, large red swollen arm at injection site (size of half a baseball in height and about 6 inches down my arm); painful, large red swollen arm at injection site (size of half a baseball in height and about 6 inches down my arm); Body pain; severe headache; fever (100/sweating); chills (shaking with temp drop- 97.2; normal 97.6); vomiting; loose stools; Lost 6 lbs; abrasion on her right side forehead; dizzy; weak; fever (100/sweating); nausea; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation, at 68 years old. Medical history included Metastatic breast cancer, thyroid, glaucoma, osteo  arthritis, neuropathy, sulfa allergy, Fish/shellfish allergy, penicillin allergy, MS (Multiple sclerosis), and Phenothiazines allergy. No other vaccines in four weeks were received. The patient is not pregnant at the time of vaccination. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included amlodipine, levothyroxine sodium (SYNTHROID), gabapentin, timolol, and cyanocobalamin (B12), therapy dates and indications unspecified, in two weeks. The patient previously took Cytoxan, cipro, Demerol and experienced allergies. On 28Jan2021 20:00 (also reported as about 8 hours), the patient experienced body pain; severe headache; fever (100/sweating); chills (shaking with temp drop- 97.2; normal 97.6); Nausea; vomiting; loose stools; painful, large red swollen arm at injection site (investigation: size of half a baseball in height and about 6 inches down her arm); dizzy; weak; and she fell and must have passed out. Woke up on floor with abrasion on her right-side forehead. The patient also reported she lost 6 lbs. The events lasted from Thursday evening to Sunday morning. Treatment for the adverse events included BENARDRYL. Outcome of the events was recovered on 29Jan2021. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9267) via an unspecified route of administration (right arm) on 18Feb2021 09:30 for COVID-19 immunisation.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling, Vomiting, Weight, Weight decreased
Clinical narrative: I fell and must have passed out; I fell and must have passed out; painful, large red swollen arm at injection site (size of half a baseball in height and about 6 inches down my arm); painful, large red swollen arm at injection site (size of half a baseball in height and about 6 inches down my arm); Body pain; severe headache; fever (100/sweating); chills (shaking with temp drop- 97.2; normal 97.6); vomiting; loose stools; Lost 6 lbs; abrasion on her right side forehead; dizzy; weak; fever (100/sweating); nausea; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation, at 68 years old. Medical history included Metastatic breast cancer, thyroid, glaucoma, osteo  arthritis, neuropathy, sulfa allergy, Fish/shellfish allergy, penicillin allergy, MS (Multiple sclerosis), and Phenothiazines allergy. No other vaccines in four weeks were received. The patient is not pregnant at the time of vaccination. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included amlodipine, levothyroxine sodium (SYNTHROID), gabapentin, timolol, and cyanocobalamin (B12), therapy dates and indications unspecified, in two weeks. The patient previously took Cytoxan, cipro, Demerol and experienced allergies. On 28Jan2021 20:00 (also reported as about 8 hours), the patient experienced body pain; severe headache; fever (100/sweating); chills (shaking with temp drop- 97.2; normal 97.6); Nausea; vomiting; loose stools; painful, large red swollen arm at injection site (investigation: size of half a baseball in height and about 6 inches down her arm); dizzy; weak; and she fell and must have passed out. Woke up on floor with abrasion on her right-side forehead. The patient also reported she lost 6 lbs. The events lasted from Thursday evening to Sunday morning. Treatment for the adverse events included BENARDRYL. Outcome of the events was recovered on 29Jan2021. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9267) via an unspecified route of administration (right arm) on 18Feb2021 09:30 for COVID-19 immunisation.  Information on the lot/batch number has been requested.