chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pain, Somnolence
Clinical narrative: had to go to sleep; Could not function correctly; They had headache; body aches; chills; He felt really exhausted and drained.; Pfizer Covid Vaccine first dose Date: 19 Apr 2021/Pfizer Covid Vaccine second dose Date: 03 May 2021; Pfizer Covid Vaccine first dose Date: 19 Apr 2021/Pfizer Covid Vaccine second dose Date: 03 May 2021; This is a spontaneous report from a Pfizer sponsored program COVAX US support.   A contactable 46-year-old male patient reported that who received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot Number and expiry date unknown) via an unspecified route of administration at left arm as a single dose for COVID-19 Immunisation. Past drugs included Lisinopril taken for quite some time, 3 or 4 years, Nifidipine for blood pressure. Historical vaccine BNT162B2 via an unspecified route of administration (Lot Number / Expiry Date was not reported) on 19-APR-2021 as a single dose at left arm for COVID-19 immunisation. On an unknown date patient could not function correctly the day after both shots. They had to go to sleep. He said that the headache, body aches and chills started the same day as the shot after both shots. He felt exhausted and drained. Patient did not visit physician office or emergency room visit due to the event. Outcome of the events were recovered on an unknown date.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain upper, Chest pain, Dyspepsia
Clinical narrative: GI Symptoms; EGD Mild Inflammation; 70 year old woman with these symptoms/ intermittent nausea, abdominal bloating, epigastric pain, indigestion, and chest pain; 70 year old woman with these symptoms/ intermittent nausea, abdominal bloating, epigastric pain, indigestion, and chest pain; 70 year old woman with these symptoms/ intermittent nausea, abdominal bloating, epigastric pain, indigestion, and chest pain; 70 year old woman with these symptoms/ intermittent nausea, abdominal bloating, epigastric pain, indigestion, and chest pain; 70 year old woman with these symptoms/ intermittent nausea, abdominal bloating, epigastric pain, indigestion, and chest pain; Menopause; This is a spontaneous report from a contactable other HCP. This is a report 4 of 5.   A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: Unknown, Expiration date: unknown) via unspecified route of administration on an unspecified date (at the age 70-year-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: Unknown, Expiration date: unknown) via unspecified route of administration on an unspecified date as first dose single for COVID-19 immunisation. Patient had no medical history. concomitant medications were not reported. On an unspecified date, patient experienced Gastrointestinal (GI) Symptoms, Esophago-Gastro Duodenoscopy (EGD) mild Inflammation, intermittent nausea, abdominal bloating, epigastric pain, indigestion, chest pain and menopause. Reporter wants to know what symptoms are being seen in the area of reflux and gastritis status post vaccine, 2-3 months out. Reporter states she started peri menopause and it through her into menopause and tested with waves of intermittent nausea, abdominal bloating, epigastric pain, indigestion, and chest pain. She was put on a PPI and she tried to do 20mg a day, but she has to do 20mg twice a day. Reporter states she thought maybe she developed a gluten sensitivity and that reacts to wheat protein, so she tried to cut that out. Reporter states she has reached out to her colleagues, and they reported a 70-year-old woman with these symptoms. The patient underwent lab test and procedure include Esophago-Gastro Duodenoscopy (EGD) endoscopy with mild inflammation on an unspecified date. Outcome of the events were unknown.  Follow-up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021623869 same reporter/drug/similar events, different patient;US-PFIZER INC-2021623328 same reporter/similar event, different patient
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Endoscopy, Gastrointestinal inflammation, Nausea
Clinical narrative: GI Symptoms; EGD Mild Inflammation; 70 year old woman with these symptoms/ intermittent nausea, abdominal bloating, epigastric pain, indigestion, and chest pain; 70 year old woman with these symptoms/ intermittent nausea, abdominal bloating, epigastric pain, indigestion, and chest pain; 70 year old woman with these symptoms/ intermittent nausea, abdominal bloating, epigastric pain, indigestion, and chest pain; 70 year old woman with these symptoms/ intermittent nausea, abdominal bloating, epigastric pain, indigestion, and chest pain; 70 year old woman with these symptoms/ intermittent nausea, abdominal bloating, epigastric pain, indigestion, and chest pain; Menopause; This is a spontaneous report from a contactable other HCP. This is a report 4 of 5.   A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: Unknown, Expiration date: unknown) via unspecified route of administration on an unspecified date (at the age 70-year-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: Unknown, Expiration date: unknown) via unspecified route of administration on an unspecified date as first dose single for COVID-19 immunisation. Patient had no medical history. concomitant medications were not reported. On an unspecified date, patient experienced Gastrointestinal (GI) Symptoms, Esophago-Gastro Duodenoscopy (EGD) mild Inflammation, intermittent nausea, abdominal bloating, epigastric pain, indigestion, chest pain and menopause. Reporter wants to know what symptoms are being seen in the area of reflux and gastritis status post vaccine, 2-3 months out. Reporter states she started peri menopause and it through her into menopause and tested with waves of intermittent nausea, abdominal bloating, epigastric pain, indigestion, and chest pain. She was put on a PPI and she tried to do 20mg a day, but she has to do 20mg twice a day. Reporter states she thought maybe she developed a gluten sensitivity and that reacts to wheat protein, so she tried to cut that out. Reporter states she has reached out to her colleagues, and they reported a 70-year-old woman with these symptoms. The patient underwent lab test and procedure include Esophago-Gastro Duodenoscopy (EGD) endoscopy with mild inflammation on an unspecified date. Outcome of the events were unknown.  Follow-up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021623869 same reporter/drug/similar events, different patient;US-PFIZER INC-2021623328 same reporter/similar event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pt experienced sore arm after receiving Pfizer covid vaccination; This is a spontaneous report from a non-contactable consumer. A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as unknown single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient experienced sore arm after receiving Pfizer covid vaccination. Event took place after use of product. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.  Follow-up (31May2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included non-significant information regarding the Pfizer colleague confirming the reported if he was the primary reporter.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash that went over my entire body; This is a spontaneous report received from a contactable consumer, the patient. A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 08:30 (Batch/Lot Number: EW0167) (at the age of 54-year-old) as 2nd dose, single dose for covid-19 immunisation. Medical history included covid-19 (Prior to vaccination, was the patient was diagnosed with COVID-19). The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in Arm Left on 05Apr2021 (Batch/Lot Number: EW0153) for covid-19 immunisation and had no adverse effect. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021, the patient experienced rash that went over my entire body. Seriousness criteria was considered as non-serious. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of event and included treatment with oral steroid. The outcome of the event was not recovered.  Information on Lot/Batch number is available; Further information has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Urticaria
Clinical narrative: Allergic reaction/Anaphylactic shock; Hives; This is a spontaneous report from a contactable consumer. This consumer reported different events for two patients. This is 1 of 2 reports. A 21-year-old female patient (reporter's ((Name)colleague's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 04May2021 (Batch/Lot Number: EW0171) (at the age of 21-year-old) as 2nd dose, single dose for covid-19 immunization. Medical history included allergy with garlic. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unspecified date for covid-19 immunization. The reporter stated that on 04May2021 the patient got vaccinated with the second dose of vaccine and two days later i.e., on 06May2021 she had some hives, but she never had it before, and she developed an allergic reaction and was in an emergency room having anaphylactic shock and was hospitalized for 3 time and treated with Epinephrine (treatment). She went to an allergist and they checked, they said she did not have any allergy. The outcome of the events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). This is the first case out of the two cases. A 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8733), via an unspecified route of administration on 01Apr2021 as a 2nd dose, single for COVID-19 immunisation. The patient's medical history included arthritis, from an unspecified date and unknown if ongoing. Past drug event included prednisone for arthritis, the patient had been taking it for 25 years. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6206), via an unspecified route of administration on 10Mar2021 as a 1st dose, single for COVID-19 immunisation. The patient's age at vaccination was 81 years. The patient's concomitant medications were not reported. It was reported that, the patient and his wife, both had their shots which had been Pfizer. Stated that, the patient don't know the dates of when his wife had her list. Stated that, they have both come down with like Sciatica pain, both in their right knees both of them and they had been trying also pain medication. It seemed really strange of both of them, both of them had the same shots and both of them came down with the same pain. Stated that, he have had sciatica before that only way back when the patient was younger and driving long distances and sometimes after sitting in, the patient was having this problem and he actually have some homeopathic drops and stuff that he got from a natural doctor stuff (unspecified medication). He usually used that but he was feeling the affect in this they doesn't feel the affect in this sciatica. Stated that, he remember a Pfizer community and he told his doctor about that was happening. He was talking to a pharmacist the other day and he told the patient to call you guys and give you the information. He don't know email and stuff at all, he was not on internet and all that, so he don't know his wife's. Stated that, he just changed to a new medication that pharmacist told him about, it's a diclofenac something. Stated that, he had the container, he had been taking several different pain medication such as Lidocaine and this morning at 6 O'clock just a few hours ago, he started with this new medication that the pharmacist recommended that was diclofenac sodium topical gel 1%. It's for sciatica pain and arthritis. Stated that, when probed for any vaccination prior to the first shot was reported as no, nothing recently, he don't know. Stated that, weight, he don't weight himself fair enough, he think he was still pretty close to 155 pounds (further not clarified hence, not captured in tab). Stated that, it would just be a guess but he think it seemed like it was really close to when he had his second shot but he can't tell the exact date and unable to remember his wife's. Stated that, it doesn't show any expiration date. The investigation assessment was reported as no. The outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Influenza
Clinical narrative: having trouble breathing; After the first shot his symptoms were a little bit like the flu; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease and covid-19 in Jan2021. The patient's concomitant medications were not reported. On an unspecified date, after the first vaccination shot the patient experienced having trouble breathing and were a little bit like the flu. It was reported that, patient have had COVID in January, went out and had test done for blood, patient still had antibodies but they said he can still go ahead and had a shot, so patient had the first shot of Pfizer (Unspecified vaccine). Reporter stated that he got COPD and thought it was his medicine (unspecified medication), Patient thought it was inhalers. Patient realized today looking back that it was the medicine, honestly it was the medicine patient knew that. Patient went back into the doctor again this week and they have half his medicine, Patient was better the medicine seems to be working but that was what happened, and he went to the pharmacist, went to the pulmonary doctor today for his breathing and he could hardly go without anything and didn't know why this all happened. And his question was, was that going to came back. People that had this done since months ago had their help but all of this still came back. Patient was not upset with anybody, what he was upset with was said if his health was going to return okay that the question patient wanted to know. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Flushing, Headache, Heart rate increased
Clinical narrative: Throat swelling; Face swelling; Flush Face; headache; fast heart beat; difficult breathing; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) first dose and second dose both via an unspecified route of administration on an unknown date in right arm as single dose for COVID-19 immunization at Hospital. The patient had no medical history. He had no known allergies. The concomitant medications within 2 weeks of vaccination of the patient included tramadol and losartan. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine and if patient was diagnosed with COVID-19 prior to vaccination. On 08Apr2021 at 12:00 PM the patient experienced throat swelling, face swelling, flush face, headache, fast heartbeat, difficult breathing and chills. It was mentioned that 8 weeks after 2nd shot patient still had these side effects at night-time. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The seriousness for all the events was accessed as hospitalization. No treatment was received for the events. The patient underwent lab tests and procedures which included Nasal Swab: negative on 05May2021. The outcome of all the events was not recovered.  Follow up attempts were needed. Further information has been requested.; Sender's Comments: for serious hcp unlisted events  Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling, SARS-CoV-2 antibody test, Swelling face
Clinical narrative: Throat swelling; Face swelling; Flush Face; headache; fast heart beat; difficult breathing; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) first dose and second dose both via an unspecified route of administration on an unknown date in right arm as single dose for COVID-19 immunization at Hospital. The patient had no medical history. He had no known allergies. The concomitant medications within 2 weeks of vaccination of the patient included tramadol and losartan. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine and if patient was diagnosed with COVID-19 prior to vaccination. On 08Apr2021 at 12:00 PM the patient experienced throat swelling, face swelling, flush face, headache, fast heartbeat, difficult breathing and chills. It was mentioned that 8 weeks after 2nd shot patient still had these side effects at night-time. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The seriousness for all the events was accessed as hospitalization. No treatment was received for the events. The patient underwent lab tests and procedures which included Nasal Swab: negative on 05May2021. The outcome of all the events was not recovered.  Follow up attempts were needed. Further information has been requested.; Sender's Comments: for serious hcp unlisted events  Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombophlebitis superficial
Clinical narrative: Superficial vein thrombosis - right leg; This is a spontaneous report received from a contactable female consumer. A 34-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8737) via an unspecified route of administration, in right arm on 29Mar2021 09:15 as 1st dose, single for covid-19 immunisation. Medical history included the patient previously took bactrim for drug hypersensitivity. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Concomitant medications were not reported. Other vaccine details include second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0176) via an unspecified route of administration, in right arm on 29Mar2021 as 2nd dose, single for covid-19 immunisation. The patient did not receive any vaccines within four weeks prior to the vaccination. On 26May2021 18:00, the patient experienced superficial vein thrombosis on right leg. Adverse event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Outcome of event was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Haemoptysis, Pain, Pyrexia
Clinical narrative: Had Fever around 100; Coughing up small amount of blood and this is not good; Worst Pain; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 for COVID-19 immunisation on an unspecified date. When probed for the concern, consumer stated, patient got second vaccine (unspecified vaccine) yesterday and patient had fever around 100, patient woke up from sleeping today and temperature was 101.7, patient was coughing up small amount of blood, patient have heard this was not good, but nobody seems to agree with me. It's not about that patient just want to know, what was going on. This was the worst pain patient ever felt. Outcome of the events was unknown.  No follow-up attempts possible. No further information expected. Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site pain
Clinical narrative: had a dull achy sore pain where the shot was administered ever since I received the last shot; tingliess in my fingers on that arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-years-old non-pregnant female patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 18Mar2021 11:00 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation at pharmacy or drug store. Previously the patient had BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified) via unspecified route of administration on 25Feb2021 12:15PM, as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient did not receive any vaccination prior 4weeks of the vaccination. Medical history included anxiety. The patient's concomitant medications were not reported. On the same day, post vaccination the patient had a dull achy sore pain where the shot was administered ever since she received the last shot. The patient also had tingliess in fingers on that arm. The patient was treated with Zoloft 100mg and Vistaril 100mg at an unknown dose. The outcome of the events was reported as not recovered at the time of report.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Nervousness, Pain
Clinical narrative: Tired; Body was in pain; Felt shaky; A hard time breathing; She felt weak; This is a spontaneous report from a contactable consumer or other non hcp via a Pfizer-sponsored company. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24May2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, she got the 1st dose of the vaccine last 24May2021 and she had symptoms like heart rate, she felt weak and tired and her body was in pain and felt shaky and was having a hard time breathing on an unknown date. She would be getting the 2nd dose on the 17June. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pruritus, Insomnia, Pain
Clinical narrative: Body aches, after both vaccines; Very tired after both vaccines; Headache after first vaccine; Left arm soreness, after both vaccines; Swelling of arm, itching, and redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. Caller reports these events together.; Swelling of arm, itching, and redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. Caller reports these events together.; Swelling of arm, itching, and redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. Caller reports these events together.; Could not sleep on left side, after both vaccines; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for Injection Batch/Lot Number: EW0172), via an unspecified route of administration, administered in arm left on 03May2021 15:30 (at the age of 67-year-old), as single dose for COVID-19 immunisation. Medical history included covid-19 from an unspecified date in Jan2021. The patient concomitant medications were not reported. On 03May2021, the patient experienced left arm soreness, after both vaccines, swelling of arm, itching, and redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. caller reports these events together, could not sleep on left side, after both vaccines, on 04May2021 body aches, after both vaccines, very tired after both vaccines, headache after first vaccine. Patient was not administered with Additional Vaccines on Same Date of the Pfizer Suspect. The patient under-went lab tests and procedures which included sars-cov-2 test positive: positive on Jan2021. Out-come of the events Swelling of arm, itching, and redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. Caller reports these events together, Left arm soreness, after both vaccines was resolved on an unspecified date in 2021, Headache after first vaccine was resolved on 04May2021, Body aches, after both vaccines, very tired after both vaccines was resolved on 24May2021, could not sleep on left side, after both vaccines was resolved on 26May2021.  Agency Communication: Multiple reclarifications made with patient in adverse event section, to clarify if events occurred after the first or second vaccine, or with both vaccines.  For events occurring with both vaccines, patient reports start date as when event occurred after first vaccine and end date, as the date event ended after the second vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Body aches, after both vaccines; Very tired after both vaccines; Headache after first vaccine; Left arm soreness, after both vaccines; Swelling of arm, itching, and redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. Caller reports these events together.; Swelling of arm, itching, and redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. Caller reports these events together.; Swelling of arm, itching, and redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. Caller reports these events together.; Could not sleep on left side, after both vaccines; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for Injection Batch/Lot Number: EW0172), via an unspecified route of administration, administered in arm left on 03May2021 15:30 (at the age of 67-year-old), as single dose for COVID-19 immunisation. Medical history included covid-19 from an unspecified date in Jan2021. The patient concomitant medications were not reported. On 03May2021, the patient experienced left arm soreness, after both vaccines, swelling of arm, itching, and redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. caller reports these events together, could not sleep on left side, after both vaccines, on 04May2021 body aches, after both vaccines, very tired after both vaccines, headache after first vaccine. Patient was not administered with Additional Vaccines on Same Date of the Pfizer Suspect. The patient under-went lab tests and procedures which included sars-cov-2 test positive: positive on Jan2021. Out-come of the events Swelling of arm, itching, and redness at injection site, left arm, first vaccine, and swelling and itching only after the second vaccine. Caller reports these events together, Left arm soreness, after both vaccines was resolved on an unspecified date in 2021, Headache after first vaccine was resolved on 04May2021, Body aches, after both vaccines, very tired after both vaccines was resolved on 24May2021, could not sleep on left side, after both vaccines was resolved on 26May2021.  Agency Communication: Multiple reclarifications made with patient in adverse event section, to clarify if events occurred after the first or second vaccine, or with both vaccines.  For events occurring with both vaccines, patient reports start date as when event occurred after first vaccine and end date, as the date event ended after the second vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: I started menstruating one week following the first dose of my vaccine.; This is a spontaneous report from a contactable consumer (Patient). A 40-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0186) via an unspecified route of administration, administered in Arm Right on 17May2021 (at the age of 40-years-old and not pregnant at the time of vaccination) at 12:45 PM as 1st dose, single dose for COVID-19 immunisation. The patient's medical history included Subglottic stenosis, start and stop date not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received birth control medications within 2 weeks of vaccination with no drug name. Relevant past drug history was reported as None known. On 26May2021 at 06:30, the patient had started menstruating one week following the first dose of my vaccine. She was taking her birth control correctly and had no physical symptoms leading up to the breakthrough bleeding. Patient was not on prolonged hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for event caused. The outcome of event at the time of last observation was Recovering/Resolving.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Pyrexia
Clinical narrative: She has 102 fever; she is felling worried; This is a spontaneous report from a contactable consumer (patient's son). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 29May2021 as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 for COVID-19 immunisation. On 30May2021, the patient experienced she has 102 fever and she is felling worried. She was getting worried because she has 102 fever. So she want to know if she need to go to the doctor or she need to do something. The consumer further asked that was it normal, he need to know everything because the patient was feeling worried about all that. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine: Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for covid-19 immunization. On an unspecified date the patient experienced ringing in his ears  4-5 days after the Pfizer covid vaccine. The patient knew people in his area that had the same complaints. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pain, Oral herpes
Clinical narrative: Oral herpes sore on lip (small) after 10 years of not getting one. Started the very night I got the second dose.; Oral herpes sore on lip (small) after 10 years of not getting one. Started the very night I got the second dose.; This is a spontaneous report from a non-contactable consumer (reporting on herself). A 43-years-old Non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number and Expiration Date was not reported), via an unspecified route of administration in Arm Left on 29May2021 14:00, as 2nd dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported.  Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number and Expiration Date was not reported), via an unspecified route of administration in Arm Left on 08May2021 14:30, as 1st dose, single for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Patient did not have any known allergies. On29May2021 17:00, patient experienced oral herpes sore on lip (small) after 10 years of not getting one. started the very night i got the second dose. Patient did not receive any treatment for adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. Event occurred in a country different from that of the reporter.  This may be a duplicate if the reporter also submitted directly to his/her local agency.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Not feeling good; This is a spontaneous report from contactable consumer (for daughter 16-year-old) via Pfizer sponsored program.   A 14-year-old female patient received first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 27May2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller wants to check if her daughter can take the Pfizer vaccine. Her daughter is only 14yo and she had taken the 1st dose yesterday on 27May2021. on an unspecified date in May2021, Her daughter is not feeling good and she's not sure of the symptoms yet since her daughter is sleeping. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Pain, Sleep disorder
Clinical narrative: Cough; Body aches; I am tired because I have been sleeping a lot; Injection site pain; Chills; I am tired because all I do I have been sleeping a lot; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0187) via an unspecified route of administration on 29May2021 in upper right arm as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 30May2021, the patient experienced cough, some body aches, she was tired, she got the pain at the injection site which she knew was common anyway, little bit of chills but nothing major. She was tired because all she did was sleeping a lot. She just wanted to know if she could take amphetamines (treatment), if it could help alleviate some of those side effects. She wanted to know if it was safe to do that or not. The outcome of all events was unknown.  Consumer was informed about Pfizer Medical Information Department.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Cough; Body aches; I am tired because I have been sleeping a lot; Injection site pain; Chills; I am tired because all I do I have been sleeping a lot; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0187) via an unspecified route of administration on 29May2021 in upper right arm as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 30May2021, the patient experienced cough, some body aches, she was tired, she got the pain at the injection site which she knew was common anyway, little bit of chills but nothing major. She was tired because all she did was sleeping a lot. She just wanted to know if she could take amphetamines (treatment), if it could help alleviate some of those side effects. She wanted to know if it was safe to do that or not. The outcome of all events was unknown.  Consumer was informed about Pfizer Medical Information Department.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: chills/pyrexia/myalgia (2nd dose); chills/pyrexia/myalgia (2nd dose); chills/pyrexia/myalgia (2nd dose); Vaccination site pain (1st dose and 2nd dose); This is a spontaneous report from a contactable consumer (patient). A 58-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0168) via an unspecified route of administration in Arm Left on 11May2021 at 10:00(at the age of 58 years old) as 2nd dose, single dose for COVID-19 immunisation at pharmacy or drug store.  The patient historical vaccine included first dose of BNT162B2 (Batch/Lot number: EW0171) administered in Arm left on 20Apr2021 at 10:00 for COVID-19 immunisation and experienced vaccination site pain. The patient medical history and concomitant medication were not reported. The patient did not received any other vaccine within four weeks of vaccination. The patient did not tested for COVID prior to vaccination. On 11May2021 at 22:00 the patient experienced chills/pyrexia/myalgia and vaccination site pain. The patient did not tested for COVID post vaccination. Outcome of all the events were recovered.  Follow-up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Is it normal to get a rash around the breasts after the COVID Vaccine; itchiness; This is a spontaneous report from a Pfizer sponsored program COVAX US Support from contactable consumer (patient). An unspecified age of female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: not reported), via an unspecified route of administration on an unspecified date as a Unknown, single dose for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash around the breasts after the COVID Vaccine and itchiness. The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia, Swelling, Urticaria
Clinical narrative: swelling, numbness in arm, allergies, and hives around breast; swelling, numbness in arm, allergies, and hives around breast; swelling, numbness in arm, allergies, and hives around breast; swelling, numbness in arm, allergies, and hives around breast; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer reported for her wife. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: not reported), dose 1 via an unspecified route of administration, on an unspecified date, as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced swelling, numbness in arm, allergies, and hives around breast. The reporter confirmed that the side effects took place after the first dose of the Pfizer vaccine. The reported enquired to know that if the patient was okay to get the second dose of vaccine. The reporter has firsthand knowledge of the patient and was reporting on a specific patient. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Then a week after my second shot, I had severe nausea.; This is a spontaneous report received from a contactable consumer (patient) via medical information team.   A male patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization and the patient had had no side effects after first dose. On an unknown date, the patient experienced severe nausea. The patient reported that He got the 1st dose of the Pfizer COVID vaccine, and had no side effects. Then a week after my second shot, patient had severe nausea. The patient asked how long will this last. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Pyrexia
Clinical narrative: It left her with migraines; A slight fever; Severe fatigue; This is a spontaneous report from a contactable consumer (caregiver) via a Pfizer sponsored program and medical information team. A 15-year-old female patient (reporter's daughter) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date in May2021 (at the age of 15-year-old) as a single dose for COVID-19 immunization. The patient's medical history included few immunity issues which were currently being treated. Concomitant medications were not reported. It was reported that patient has a few immunity issues which we are currently treating. Patient had her first vaccine last week, it left her with migraines, a slight fever with severe fatigue on an unspecified date in 2021. Reporter was concerned that the second would be more harsh. Please advise on your research if think that we should proceed or wait. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: excessive mucus; feeling feverish; little difficulty breathing; she woke up with excessive coughing; she has experienced nasal & chest congestion; she has experienced nasal & chest congestion; loss of appetite; headache; muscle aches and fatigue; muscle aches and fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 43-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on 30Apr2021 (at the age of 43-years-old) (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 via an unspecified route of administration on unknown date for covid-19 immunization. On 30Apr2021, after the second vaccine the same day caller experienced muscle aches and fatigue that lasted for about 3 days. She took Tylenol Extra Strength that seemed to help. Within the last week on an unspecified date in May 2021, she had experienced nasal & chest congestion, loss of appetite, and headache. Yesterday, 30May2021 she woke up with excessive coughing. She took cough drop & increased her fluid intake. Caller reports waking up today with congestion worse. Also patient experienced excessive mucus, feeling feverish & a little difficulty breathing on 30May2021. Around 9 am she took some Tussin for mucous & congestion relief. The caller reports the medication seems to be helping some. Therapeutic measures were taken as a result of muscle aches and fatigue, she woke up with excessive coughing and excessive mucus. The outcome of event muscle aches and fatigue was recovered on 03May2021. The outcome of the rest events was unknown.  Information about batch/Lot number has been requested.