chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 04Oct2021 09:40 (Lot number: 30155BA) at the age of 65 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot No: FC3183), administration date: 13Sep2021, when the patient was 65 years old, for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "recovering", described as "hair loss". No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101797400 same reporter/drug/event, different pt;US-PFIZER INC-202101799476 same reporter/drug/event, different pt
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Lip ulceration
Clinical narrative: lipschutz ulcer 10Dec2021, one day after second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 (Lot number: FK5618) at the age of 11 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5618, Location of injection: Arm Left), administration date: 18Nov2021, when the patient was 11 years old, for COVID-19 immunization. The following information was reported: LIP ULCERATION (non-serious) with onset 10Dec2021, outcome "recovering", described as "lipschutz ulcer 10Dec2021, one day after second vaccine". The event "lipschutz ulcer 10dec2021, one day after second vaccine" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of lip ulceration.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, patient not tested for COVID-19. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. Facility where the most recent COVID-19 vaccine was administered: withheld. Pain management treatment received for the adverse event. Device Date: 15Dec2021.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: It was sore at the injection site, like both other shots,; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 (Lot number: EN6206) at the age of 54 years as dose 2, single and administered in arm left, administration date 22Feb2021 (Lot number: EN6200) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Dupuytrens" (unspecified if ongoing), notes: Other medical history: Dupuytrens; seasonal allergies (hayfever); "seasonal allergies (hayfever)" (unspecified if ongoing), notes: Other medical history: Dupuytrens; seasonal allergies (hayfever); "seasonal allergies (hayfever)" (unspecified if ongoing), notes: Other medical history: Dupuytrens; seasonal allergies (hayfever). Concomitant medication(s) included: NATURE MADE VITAMIN D3; PROTANDIM; PB8 PROBIOTIC. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "It was sore at the injection site, like both other shots."  Additional information: If treatment AE: No, If covid prior vaccination: No, If covid tested post vaccination: No, If other vaccine in four weeks: No, Adverse event: "The third dose hurt a lot more than either, which surprised me. It was sore at the injection site, like both other shots, but this time it's been hot to the touch and a rash has developed about 3 inches below the injection. The site is still very warm to the touch and itchy."  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101803494 similar report from same reporter
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased
Clinical narrative: heart beat was real fast/heart rate going faster; it was 140 then I got it down like 126 but it does not seem going to the normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (COMIRNATY), administration date 15Dec2021 (Lot number: FT0809) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: Caller states he just went threw Covid and is still recovering. The patient's concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious) with onset 16Dec2021 06:30, outcome "recovered" (Dec2021), described as "heart beat was real fast/heart rate going faster; it was 140 then I got it down like 126 but it does not seem going to the normal". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated that he received his first shot of the Pfizer BioNTech Covid-19 vaccine yesterday. Reporter states this morning at 6:30-7:00 AM his heartbeat was fast and went up to between 144 and 130. He was worried and couldn't get his heartbeat down, so he did not go to his therapy appointment this morning. He checked his blood pressure, and the heartbeat was on there. He could not get it down, so he put his oxygen back and it helped bring his heart rate down. His heart rate was now okay, and it was down to 81. He just went through COVID and was still recovering as he was out of work for 3 months. He will be getting his second dose on 13Jan2022 which was 4 days before going back to work. Reporter would like to know if this was a normal side effect after getting the vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: she thought the side effects from the vaccine would be really bad but, in fat, they were really not bad at all; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (169752). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION COMPLICATION (non-serious), outcome "unknown", described as "she thought the side effects from the vaccine would be really bad but, in fat, they were really not bad at all". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased
Clinical narrative: increase of temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25Mar2021 (Lot number: EP6955) at the age of 61 years as dose 2, single and intramuscular, administered in arm left, administration date 04Mar2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing); "high cholesterol" (ongoing); "vitamin d deficiency" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE taken for hypertension (ongoing); ATORVASTATIN taken for blood cholesterol increased (ongoing); VITAMIN D [COLECALCIFEROL] taken for vitamin d deficiency (ongoing); MAGNESIUM (ongoing). The following information was reported: BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "increase of temperature". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior vaccinations (within 4 weeks), any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): included none. Relevant tests included none. Patient had increase of temperature after each vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Product administered to patient of inappropriate age
Clinical narrative: Diarrhea; Received their first dose of the Pfizer covid vaccine (adult dose from Gray cap); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 7 year-old female patient received bnt162b2 (BNT162B2), administration date 16Dec2021 (Lot number: FH8020) at the age of 7 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 16Dec2021, outcome "unknown", described as "Received their first dose of the Pfizer covid vaccine (adult dose)"; DIARRHOEA (non-serious) with onset 17Dec2021, outcome "not recovered", described as "Diarrhea". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: Reporter stated that 3 patients received their first dose of the Pfizer covid vaccine (adult dose). First patient: 7 years old female  experiencing diarrhea- lot number FH8020. Second patient: 10 years old male, lot number FH8020 (brother of the female). Third Patient :11 years male - lot number FL0007. Caller wanted to know any recommendation on what to tell the patient regarding what they need to look for. She stated she will be reaching out to disease control as well. Reporter stated the children were 11 and 10.5  and the third child was 7 and 60 pounds, she didn't know what weight pulls in to this. Caller states that she has talked to the parents and notified them. Caller states she is calling to report this and find out what else they should do and what guidelines they need to follow. Reporter stated she had the nurse check in with the patient's parents and they reported this morning she was having a lot of diarrhea but no vomiting and they were pumping her full of fluids.  No follow-up attempts are possible. No further information is expected. .; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101815734 same reporter/drug, different patients.;US-PFIZER INC-202101815735 same reporter/drug, different patients
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Muscle spasms, Vision blurred
Clinical narrative: cramp in left leg, pins and needles, cramping sensation; Her vision has been blurry/she cannot see anything close up anymore; worsened in intensity; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 05Oct2021 (Lot number: FF2538) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot: FC3683 or EC3683), administration date: 12Sep2021, when the patient was 60 years old, for COVID-19 Immunization, reaction(s): "Nothing happened after the first dose.". The following information was reported: MUSCLE SPASMS (non-serious) with onset Oct2021, outcome "not recovered", described as "cramp in left leg, pins and needles, cramping sensation"; VISION BLURRED (non-serious) with onset Oct2021, outcome "unknown", described as "Her vision has been blurry/she cannot see anything close up anymore"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "not recovered", described as "worsened in intensity".  Additional information:  Patient stated that after her second Pfizer covid vaccine, the second day she was in the car and had horrible cramp in her left leg. It was pins and needles, cramping sensation and electrical impulses like she has never felt, probably nerves.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (Lot number: EL8982) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "microvalve collapse" (unspecified if ongoing), notes: i have been a 22 years survivor. Concomitant medication(s) included: SENEX [SECNIDAZOLE] (ongoing); ZOLOFT taken for depression (ongoing); METOPROLOL taken for cardiac valve disease (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Arm hurt".  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Diarrhoea, Muscle spasms, Vaccination site pain, Vomiting
Clinical narrative: Injection site pain; Diarrhea; Vomiting; Cramps; Cold sweat; A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 (Lot number: F11620) at the age of 75 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Wears oxygen" (unspecified if ongoing), notes: States she has to wear oxygen because she smoked for a long time. The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Injection site pain"; DIARRHOEA (non-serious) with onset 16Dec2021, outcome "recovering", described as "Diarrhea"; VOMITING (non-serious) with onset 16Dec2021, outcome "recovering", described as "Vomiting"; MUSCLE SPASMS (non-serious) with onset 16Dec2021, outcome "recovered" (17Dec2021), described as "Cramps"; COLD SWEAT (non-serious) with onset 16Dec2021, outcome "recovered" (17Dec2021), described as "Cold sweat".  Additional Information: She received her 1st dose of the Covid 19 Vaccine on 16Dec2021 between 10:30-11:30am. Caller states that if she knew all this was going to happen, she wouldn't have taken it. She knows that everyone is different and will have different reactions, and her reactions weren't severe, but they were pretty bad. States it was hard because she was sitting on the toilet with the diarrhea and she didn't know what was going to happen, but she was able to make it to the sink. She threw up twice. States that she is feeling better this morning. Caller laughs and states that she thought she would leave a permanent ring on the toilet from sitting there for so long. States that she has a thing that she breathes in everyday so she doesn't get osteoporosis. Clarifies that this is a medication that she takes everyday. She doesn't remember the name of it, but it starts with withheld. No prior vaccinations within 4 weeks. Time the Vaccination Was Given: 10:30-11:30am This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Platelet count, Platelet count decreased, Ultrasound abdomen
Clinical narrative: After dose two, platelet count was much lower than normal; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Apr2021 09:30 (Lot number: EW0162) at the age of 60 years as dose 2, single and intramuscular, administered in arm left, administration date 27Mar2021 09:00 (Lot number: ER8734) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing), notes: Hypothyroidism; "arthritis" (unspecified if ongoing); "obesity" (ongoing), notes: Obesity: Yes, Onset date: ongoing, Treatment required: No. Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing); EXCEDRIN PM; EUTHYROX taken for hypothyroidism (ongoing). The following information was reported: PLATELET COUNT DECREASED (non-serious) with onset 18May2021, outcome "not recovered", described as "After dose two, platelet count was much lower than normal". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of platelet count decreased.  Additional information: If other vaccine in four weeks: No. if covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: Sensitivities only - not allergic. Vaccine facility type: Pharmacy or Drug store. Patient received 1st Pfizer vaccine on 27Mar2021, had received 2nd Pfizer covid vaccine on 17Apr2021; had annual blood work completed on 18May2021 and noted to have a low platelet count; recheck of platelet count on 18Jun2021 and result was lower than previous. Patient contributed this to prior Covid-19 vaccination; but was not a publicized side effect. After dose two, platelet count was much lower than normal on routine lab draw. I suspected vaccine may be contributing factor. ABD ultrasound was done & negative. Platelets eventually returned to my baseline. I had platelets drawn right before dose 3 and they were 150K (ref range 150k-399k and where I usually run). 3 weeks later platelets down to 126k.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: With the first two vaccines, she felt a lot of fatigue; tiredness, just the regular sort of side effects.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 (Lot number: ER8734) at the age of 44 years as dose 1, single and administered in arm left, administration date 19Apr2021 (Lot number: ER8737) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "With the first two vaccines, she felt a lot of fatigue"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tiredness, just the regular sort of side effects.".  No follow-up attempts are possible. No further information is expected.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: he had just a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A 8 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 (Lot number: FK5127) at the age of 8 years as dose 1, single and administered in arm left, administration date 15Dec2021 (Lot number: FL0007) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "he had just a sore arm". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: Large, silver dollar sized area of swelling and redness.; redness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 47-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (Lot number: FJ8762) as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: "CIU" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "known allergies: Compazine", notes: known allergies: Compazine; Cephalosporins, reaction(s): "known allergies: Cephalosporins", notes: known allergies: Cephalosporins; Clindamycin, reaction(s): "known allergies: Clindamycin", notes: known allergies: Clindamycin. The following information was reported: SWELLING (non-serious) with onset 20Dec2021, outcome "not recovered", described as "Large, silver coin piece sized area of swelling and redness."; ERYTHEMA (non-serious) with onset 20Dec2021, outcome "not recovered", described as "redness". The events "large, silver coin piece sized area of swelling and redness." and "redness" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of swelling, erythema.  Additional Information: The patient had known allergies: Compazine, Cephalosporins, Clindamycin. Other medical history: CIU. The patient had no other vaccines within 4 weeks. She did not have COVID-19 prior to vaccination and was not tested for COVID-19 post the vaccination.  No follow-up attempts are possible. No further information is expected. .
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Eye irritation, Eye pain, Ocular hyperaemia, Underdose
Clinical narrative: solution got on her eye.; solution got on her eye. It was irritated/patient's eye was irritated; patient's eye was irritated and stinging; solution got on her eye. It was irritated, "not super red" and stinging pain; Adult Dose; Not a full dose--some sprayed into eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 23 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Dec2021 (Lot number: FD7218, Expiration Date: 28Feb2022) at the age of 23 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: ACCIDENTAL EXPOSURE TO PRODUCT (non-serious) with onset 23Dec2021, outcome "unknown", described as "solution got on her eye."; EYE IRRITATION (non-serious) with onset 23Dec2021, outcome "unknown", described as "solution got on her eye. It was irritated/patient's eye was irritated"; EYE PAIN (non-serious) with onset 23Dec2021, outcome "unknown", described as "patient's eye was irritated and stinging"; OCULAR HYPERAEMIA (non-serious) with onset 23Dec2021, outcome "unknown", described as "solution got on her eye. It was irritated, "not super red" and stinging pain"; UNDERDOSE (non-serious) with onset 23Dec2021, outcome "unknown", described as "Adult Dose; Not a full dose--some sprayed into eye". Therapeutic measures were taken as a result of eye irritation, eye pain, ocular hyperaemia.  Additional information: Caller asked about the Pfizer COVID-19 Vaccine Purple Cap presentation. No other products. No investigation assessment. Caller stated that she is calling about the Pfizer Covid 19 Vaccine Adult Dose. Caller stated that one of the pharmacy interns was drawing up a dose from the vial and the air pressure must have been too high because when she pulled the syringe out, the product sprayed, and it got in her eye. Caller stated that the patient's eye was irritated, "not super red" and stinging pain. Caller stated they rinsed it out in the sink and with eye wash. She washed it with saline. Eye contact: Rinsed thoroughly with plenty of water for at least 15 minutes, lifting lower and upper eyelids. Consulted a physician. Caller wanted to know if there are any further instructions for this. Caller was asking is there anything else they should do or any procedures to follow. Treatment received was eye rinse.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Lip pruritus, Lip swelling, Swelling, Swollen tongue, Tongue pruritus
Clinical narrative: My tongue and lips have being itching; Swelling a little bit my lips and tongue; my 'place' is swell little bit.; My tongue and lips have being itching; Swelling a little bit my lips and tongue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: CVS6738, Expiration Date: 22Dec2021, Batch number: Unknown) at the age of 48 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE :1), for Covid-19 immunization. The following information was reported: LIP PRURITUS (non-serious), TONGUE PRURITUS (non-serious), outcome "unknown" and all described as "My tongue and lips have being itching"; SWOLLEN TONGUE (non-serious), LIP SWELLING (non-serious), outcome "unknown" and all described as "Swelling a little bit my lips and tongue"; SWELLING (non-serious), outcome "unknown", described as "my 'place' is swell little bit.".  Additional Information: Consumer stated, "Since I taken the Pfizer, my tongue and lips have being itching and my 'place' is swell little bit." No other medical conditions.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Severe pain and swelling under arm (same arm as vaccine); Severe pain and swelling under arm (same arm as vaccine); chills; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Lot number: EP6955) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies: Sulfa antibiotis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1 , Batch/Lot No: EN6204 , Location of injection: Arm Left), administration date: 21Mar2021, when the patient was 60 years old, for COVID-19 immunization, reaction(s): "No events after first vaccine". The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2021, outcome "unknown" and all described as "Severe pain and swelling under arm (same arm as vaccine)"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient did not received within 2 weeks of vaccination. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient did not have been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: Allergic reaction; Rashes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergic reaction"; RASH (non-serious), outcome "unknown", described as "Rashes".  Additional information: This reporter was not related to study or programme. The reporter stated that his son (patient) had an allergic reaction to the shot and he had the rashes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchy skin; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Jan2021 12:00 (Lot number: EL9263) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL1283, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 08Jan2021, when the patient was 75 years old, for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious) with onset 01Feb2021 12:00, outcome "not recovered", described as "itchy skin". The event "itchy skin" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pruritus.  Additional information: No other vaccine was taken in four weeks. Doctor suggested allergy and for 6 month follow up scan. Treatment was given with Steroid ointment and OTC antihistamines. Patient was not tested COVID prior and post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Rash
Clinical narrative: Rash; Arthritis pain after first two injections; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Lot number: EN6205) as dose 2, single and administered in arm left, administration date 11Feb2021 (Lot number: EM9810) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart Problems" (unspecified if ongoing), notes: other medical history: Heart Problems; "Known allergies: Contrast Dye" (unspecified if ongoing), notes: Known allergies: Contrast Dye. The patient took concomitant medications. The following information was reported: RASH (non-serious) with onset 2021, outcome "unknown", described as "Rash"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "Arthritis pain after first two injections".  Additional information: No other vaccines received in four weeks. The patient received hypertension medication in 2weeks. On 26-Nov-2021, the patient received third dose of Pfizer covid-19 vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rash; Arthritis pain after first two injections; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Lot number: EN6205) as dose 2, single and administered in arm left, administration date 11Feb2021 (Lot number: EM9810) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart Problems" (unspecified if ongoing), notes: other medical history: Heart Problems; "Known allergies: Contrast Dye" (unspecified if ongoing), notes: Known allergies: Contrast Dye. The patient took concomitant medications. The following information was reported: RASH (non-serious) with onset 2021, outcome "unknown", described as "Rash"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "Arthritis pain after first two injections".  Additional information: No other vaccines received in four weeks. The patient received hypertension medication in 2weeks. On 26-Nov-2021, the patient received third dose of Pfizer covid-19 vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: experiencing longer and more painful menstruation; experiencing longer and more painful menstruation; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 33 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization.  The following information was reported: DYSMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown" and all described as "experiencing longer and more painful menstruation".  Additional information: Caller is just curious. His girlfriend got the Adult COVID vaccine. She got the two-shot series. Since, her menstrual cycle has been altered. She said she has talked to her friends who got the vaccine and experienced the same thing. Her periods are longer and more painful. It is concerning to him because she is in childbearing age, and this is her menstrual cycle. He is just curious. He doesn't know if she wants to do a report. He will tell her to report it online or call in if she wants to report. He is a doctor, but he isn't her doctor. She is 33 years old.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101883401 same reporter/drug/event, different patients
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: experiencing longer and more painful menstruation/Her friend is experiencing the same thing period; experiencing longer and more painful menstruation/Her friend is experiencing the same thing period; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 33 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown" and all described as "experiencing longer and more painful menstruation/Her friend is experiencing the same thing period".  Additional Context: Caller is just curious. His girlfriend got the Adult COVID vaccine . She got the two shot series. Since, her menstrual cycle has been altered. She said she had talked to her friends who got the vaccine and experienced the same thing. Her periods are longer and more painful. It was concerning to him because she was in child bearing age, and this was her menstrual cycle. He was just curious. He had not know if she wants to do a report. He will tell her to report it online or call in if she wants to report. He was a doctor, but he wasn't her doctor. She was 33 years old.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101882983 same reporter/drug/event, different patients
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: mild fever; My left arm felt, including my fingers and arm pits feel swollen; My left arm felt, including my fingers and arm pits feel swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Dec2021 15:30 (Lot number: FJ8757) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "bee stings allergy" (unspecified if ongoing); "sting rays allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0173, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 14May2021, when the patient was 48 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 23Apr2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 29Dec2021 09:00, outcome "recovered", described as "mild fever"; PERIPHERAL SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 29Dec2021 09:00, outcome "not recovered" and all described as "My left arm felt, including my fingers and arm pits feel swollen". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, peripheral swelling, peripheral swelling.  Additional information: My left arm felt, including my fingers and arm pits feel swollen starting about 12 hours after the injection and has been getting worse, still not gone after 48 hours. I did also have a mild fever on the day after the injection, but the fever is gone now. Patient had no other medical history. Patient was not received other vaccine in four weeks and was not received other medications in two weeks. No covid prior vaccination and no covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: some soreness in the right arm shoulder; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14May2021 (Lot number: EW0173, Expiration Date: 31Aug2021) at the age of 55 years as dose 2, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL 12 HOUR; TYLENOL. Vaccination history included: Bnt162b2 (Dose no: 1, Lot Number: ER8731, Expiry Date: 31Jul2021, Route, Anatomical Location: Right arm shoulder), administration date: 23Apr2021, when the patient was 55 years old, for Covid-19 immunization, reaction(s): "mild soreness". The following information was reported: ARTHRALGIA (non-serious) with onset 15May2021, outcome "recovered" (16May2021), described as "some soreness in the right arm shoulder"; PAIN (non-serious) with onset 15May2021, outcome "recovered" (16May2021), described as "body aches". Therapeutic measures were taken as a result of arthralgia, pain.  Additional information: The patient did not receive any with 4 weeks prior to the suspect vaccine. No additional Vaccines were Administered on Same Date of the Pfizer Suspect.  There were no relevant tests. Is report related to a study or programme- No. The patient took 1 Advil for these events and the Advil cured her, patient was back to normal, and recovered completely. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101886115 similar report from same reporter
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives started on left cheek; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2021 14:45 (Lot number: 330368D) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergic to Vscan dye" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "hiatal hernia" (unspecified if ongoing); "Chronic sinusitis" (unspecified if ongoing); "torn meniscus" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE. Past drug history included: Omeprazole, reaction(s): "Drug Allergy"; Tamiflu, reaction(s): "Drug Allergy". The following information was reported: URTICARIA (non-serious) with onset 30Dec2021 21:15, outcome "recovering", described as "hives started on left cheek". The event "hives started on left cheek" was evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin test
Clinical narrative: sore arm; The initial case was missing the following minimum criteria: there is no indication that the patient experienced an event under suspect product. Upon receipt of follow-up information on [26Oct2021], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. Relevant medical history included: "allergy to propylene glycol" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She says she has never had a reaction to it. She knows that polyethylene glycol is contained in the Pfizer Covid vaccine and wants to know what the difference is between the two compounds. Caller is asking for guidance on how to get the vaccine in her area. She only got a sore arm from the vaccine and does not want to be contacted any further.  Follow-up (26Oct2021): This is a follow up spontaneous report from a contactable consumer. Upon receipt of follow-up information this case now contains all required information to be considered valid. This consumer reported in response to Non HCP letter sent via telephonic follow-up activity which included that: new adverse event and other information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Malaise
Clinical narrative: Feeling unwell; Diarrhea; Tired; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old female patient received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 02Mar2021 at 14:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included losartan (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), levomilnacipran hydrochloride (FETZIMA) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and multivitamins (MANUFACTURER UNKNOWN); all from an unknown date taken for an unknown indication. On an unknown date in Mar2021, the patient experienced feeling unwell, diarrhea and tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feeling unwell, diarrhea and tired was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment(12Oct2021): This follow-up report is being submitted to amend previously reported information: Product name updated from conmirnaty to BNT162B2. In narrative, BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) updated to BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN)  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site reaction
Clinical narrative: arm continues to itch at the injection location.; arm continues to itch at the injection location; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Batch/Lot number: unknown) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Prev dose details, Prev dose product=COVID 19, prev dose brand unknown=True, Prev dose brand name unknown: Covid 19 vaccine, prev dose lot unknown= True, Prev dose lot  unknown reason: Misplaced/Discarded, Prev dose administration Date: 21Dec2021, prev dose dose number=1, Prev dose vaccine location: Right arm), administration date: 2021, when the patient was 61 years old, for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "recovered" (2022), described as "arm continues to itch at the injection location."; VACCINATION SITE REACTION (non-serious) with onset 2021, outcome "recovered" (2022), described as "arm continues to itch at the injection location". Therapeutic measures were not taken as a result of pruritus, vaccination site reaction.  Additional information: If other vaccine in four weeks: No.other medications in two weeks: Yes.My right hand was itchy and raised bumps appeared after first dose. It continues to itch to this date. After the second dose my arm continues to itch at the injection location.AE resulted in: None of the above.If treatment ae: No.If Covid prior vaccination: No.If Covid tested post vaccination: No. known allergies: Yes.other medical history: Yes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.