chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Ear discomfort, Hypoaesthesia, Pain in extremity
Clinical narrative: Left ear and left side of face from my eye toward ear went numb/Numbness; Left ear and left side of face from my eye toward ear went numb/Numbness; hands swelled/Hands are still showing swelling on day 7; terribly sore arm; light headed; chills(but no fever); This is a spontaneous report from a contactable consumer or other non health care professional(Patient herself) of 54-year-old (non-pregnant) female patient received the first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in Left arm on 09Apr2021 08:15 (at the age of 54-years-old) at a single dose for covid-19 immunisation at Pharmacy or Drug Store. Medical history included none and Concomitant medications were not reported. No Known allergies reported. No Allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, patient had not been tested for COVID-19. On 09Apr2021, the patient experienced Left ear and left side of face from my eye toward ear went numb, hands swelled, had to take jewelry off. Numbness went away by next morning. Hands were still showed swelling on day 7, still not able to put jewelry on. She had some Normal side effects earlier in the day, terribly sore arm, light headed, chills (but no fever). No treatment was received for the events caused. The outcome of events was recovering.   Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Left ear and left side of face from my eye toward ear went numb/Numbness; Left ear and left side of face from my eye toward ear went numb/Numbness; hands swelled/Hands are still showing swelling on day 7; terribly sore arm; light headed; chills(but no fever); This is a spontaneous report from a contactable consumer or other non health care professional(Patient herself) of 54-year-old (non-pregnant) female patient received the first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in Left arm on 09Apr2021 08:15 (at the age of 54-years-old) at a single dose for covid-19 immunisation at Pharmacy or Drug Store. Medical history included none and Concomitant medications were not reported. No Known allergies reported. No Allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, patient had not been tested for COVID-19. On 09Apr2021, the patient experienced Left ear and left side of face from my eye toward ear went numb, hands swelled, had to take jewelry off. Numbness went away by next morning. Hands were still showed swelling on day 7, still not able to put jewelry on. She had some Normal side effects earlier in the day, terribly sore arm, light headed, chills (but no fever). No treatment was received for the events caused. The outcome of events was recovering.   Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; hives; nausea; headache; body ache; This is a spontaneous report from a contactable consumer or other non hcp.   A 32-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 08:00 (at the age of 32-years-old) as dose 2, single for covid-19 immunisation. The patient was allergic to Avocado, herbal medicine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included acetaminophen; vitamin c [ascorbic acid]; cordyceps sinensis, ganoderma lucidum, lentinus edodes, trametes versicolor, tremella fuciformis (MUSHROOM 5 COMPLEX). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8732) dose 1 via an unspecified route of administration, administered in Arm Left on Mar2021 for covid-19 immunisation. On 14Apr2021, the patient experienced body ache in unspecified time, hives at 20:00, headache at 02:00, fever at 20:00 and nausea at 20:00. It was reported that after receiving the second vaccine, from 12 hours after, the patient experienced general body ache and headache. Between 24-36 hours, symtoms (high fever, headache, general body ache, nausea etc.) became severe. 5 days after the second vaccination, sudden hives (inflammatory hives) occurred and the hives area continued to become wider and also, after the first dose, the patient had high fever, general body ache, nausea and headache. Since the vaccination, the patient has been tested for COVID-19. The adverse event resulted in Emergency room/department or urgent care. Upon follow up on 21Apr2021, details with pregnancy information, lot number date and time of vaccination was updated. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Apr2021. Treatment was given for the adverse event with Benadryl and hydrocortisone cream. Outcome of the events were not recovered.  Follow-up (21Jun2021): Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: fever; hives; nausea; headache; body ache; This is a spontaneous report from a contactable consumer or other non hcp.   A 32-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 08:00 (at the age of 32-years-old) as dose 2, single for covid-19 immunisation. The patient was allergic to Avocado, herbal medicine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included acetaminophen; vitamin c [ascorbic acid]; cordyceps sinensis, ganoderma lucidum, lentinus edodes, trametes versicolor, tremella fuciformis (MUSHROOM 5 COMPLEX). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8732) dose 1 via an unspecified route of administration, administered in Arm Left on Mar2021 for covid-19 immunisation. On 14Apr2021, the patient experienced body ache in unspecified time, hives at 20:00, headache at 02:00, fever at 20:00 and nausea at 20:00. It was reported that after receiving the second vaccine, from 12 hours after, the patient experienced general body ache and headache. Between 24-36 hours, symtoms (high fever, headache, general body ache, nausea etc.) became severe. 5 days after the second vaccination, sudden hives (inflammatory hives) occurred and the hives area continued to become wider and also, after the first dose, the patient had high fever, general body ache, nausea and headache. Since the vaccination, the patient has been tested for COVID-19. The adverse event resulted in Emergency room/department or urgent care. Upon follow up on 21Apr2021, details with pregnancy information, lot number date and time of vaccination was updated. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Apr2021. Treatment was given for the adverse event with Benadryl and hydrocortisone cream. Outcome of the events were not recovered.  Follow-up (21Jun2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested COVID-19 positive/had your first Pfizer shot and then week and half later contracted covid; This is a spontaneous report from a contactable consumer.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient tested COVID-19 positive a week and a half after receiving the 1st dose so his 2nd dose schedule was moved on 20Apr from 13Apr. Consumer (Patient's wife) was asking on behalf of patient if this was okay confirming that patient already recovered from the virus. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in 2021. The outcome of event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she got tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. This consumer reported similar events for 2 patients. This is the 1st of 2 reports. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unknown route of administration on 07Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 16Apr2021, she got tested positive for covid. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Apr2021. She wanted to ask that what would happen and should she receive the second dose of the vaccine. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021438248 same reporter/drug/event, different patient
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Blood test normal, Chest pain, Feeling hot
Clinical narrative: Blood pressure was elevated; having daily mild chest pain; mild left neck tension/warm sensations; mild left neck tension/warm sensations; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 12:00 (at the age of 47-years-old) (Batch/Lot Number: ER8737) as single dose for COVID-19 immunisation. Medical history included Allergies to medications, food, or other products: Yeast intolerance. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. 10 days after 1st dose vaccination, on 10Apr2021, the patient started having daily mild chest pain and mild left neck tension/warm sensations. This was still continuing at this date. Blood pressure was elevated and saw physician and had blood work. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event was Unknown. Outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness
Clinical narrative: Blood pressure was elevated; having daily mild chest pain; mild left neck tension/warm sensations; mild left neck tension/warm sensations; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 12:00 (at the age of 47-years-old) (Batch/Lot Number: ER8737) as single dose for COVID-19 immunisation. Medical history included Allergies to medications, food, or other products: Yeast intolerance. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. 10 days after 1st dose vaccination, on 10Apr2021, the patient started having daily mild chest pain and mild left neck tension/warm sensations. This was still continuing at this date. Blood pressure was elevated and saw physician and had blood work. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event was Unknown. Outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Carpal tunnel syndrome, Hormone level abnormal, Menstrual discomfort, Migraine, Panic attack
Clinical narrative: panic attacks; believe that vaccine has negatively effected my hormones; have had a huge increase in migraines; unusually intense period symptoms; carpel tunnel in my hands and wrists; This is a spontaneous report from a contactable consumer or other health professional (patient) of 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 17:00pm (at the age of 35 years old) (Batch/Lot number was not reported) as dose 1, single and dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 15:45 pm (Batch/Lot Number: EW0162) as dose 2, single both for covid-19 immunization at Pharmacy or Drug Store. The patient's medical history included covid-19 from unknown date and unknown if ongoing and concomitant medications were not reported. No known allergies. No allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that on 01Apr2021, she believed that vaccine had negatively affected her hormones. The patient had a huge increase in migraines, unusually intense period symptoms, carpel tunnel in her hands and wrists, and panic attacks. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient receive treatment for the adverse events. and Prescription for migraines. The clinical outcome of the events was not recovered.  Information about lot/batch number is available. Follow-up attempts are needed.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Colonoscopy, Large intestinal haemorrhage, Pain in extremity, Polyp
Clinical narrative: Pain in Arm; Polyps; Hemorrhage of colon (Large intestinal hemorrhage); This is a spontaneous report based on the information received by Pfizer from AbbVie (Mfr. Control No: 21K-163-3835479-00). A contactable consumer (patient) reported for herself that A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8732), via intramuscular on 25Mar2021 (vaccinated at the age of 63 years) as DOSE 2, SINGLE for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous from an unspecified date in 2020 (Batch/Lot number was not reported) and ongoing, at 40 mg, 1 in 2 week for ulcerative colitis. Medical history included ex-tobacco user from an unknown date to 2014, former tobacco use: a pack of cigarette for two days or more (stopped 2014), started smoking in her early twenty's and alcohol use from an unknown date and unknown if ongoing, she started to drink on her late twenty's and a glass of wine four times a week. Concomitant medications included hydrochlorothiazide, valsartan (DIOVAN HCT) taken for hypertension; lamotrigine (LAMICTAL), ziprasidone hcl (ZIPRASIDONE HCL), both were taken for bipolar; trazodone taken for sleeping; clonazepam (KLONOPIN) taken for anxiety; multiviti (TS NOS) and potassium taken as supplement; tocopherol (VITAMIN E [TOCOPHEROL]) taken for product used for unknown indication and for all Concomitants no start and stop date were reported. Historical vaccine includes first dose of BNT162B2 (Lot Number: EN6204) via Intra-muscular route of administration on 04Mar2021 for covid-19 immunisation. The patient experienced hemorrhage of colon (large intestinal hemorrhage) on an unspecified date in 2021, polyps on an unspecified date Mar2021 and pain in arm on 25Mar2021. On 17Mar2021, the patient underwent lab tests and procedures which included colonoscopy: several polyps, 6 polyps removed, humira helped her colon. The report received as, the patient stated that she had a colon bleeding for two weeks and stated that she did not take any medications for it and it just so happened that she already scheduled for routine colonoscopy. The patient stated that she did not missed or stop HUMIRA and just took it three days later after the colonoscopy as per her doctor instruction. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The report assessed as other medically important condition. Causality for event hemorrhage of colon (large intestinal hemorrhage) was not related, for polyps was as per reporter (drug/vaccine) and for pain in arm causality was probable. Outcome of the event pain in arm was unknown, event hemorrhage of colon (large intestinal hemorrhage) recovered on an unspecified date 2021 and polyps was recovered on unspecified date Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Eye contusion, Hypoaesthesia, Migraine, SARS-CoV-2 test, Vertigo
Clinical narrative: experienced black eyes; continuous numbness in left arm; continuous migraine; vertigo; This is a spontaneous report from a contactable consumer or other non-HCP. A 30-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EC0142) via an unspecified route of administration, administered in arm left on 13Jan2021 as single dose (at the age of 30-year-old, non-pregnant at the time of vaccination) for COVID-19 immunization. The patient's medical history included arthritis. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730) administered in arm left on 22Dec2020 for COVID-19 immunization and experienced no reaction on previous exposure to drug. The patient took albuterol [salbutamol] for product used for unknown indication and experienced drug hypersensitivity. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had not diagnosed with COVID prior vaccination. And post vaccination, patient had not tested with COVID 19. On 01Apr2021, at 15:30 the patient experienced black eyes, continuous numbness in left arm, continuous migraine, vertigo. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 05Apr2021. Therapeutic measures were taken as a result of experienced black eyes, continuous numbness in left arm, continuous migraine, vertigo. The outcome of event was not recovered.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Fatigue, Headache, Hyperventilation, Monoplegia
Clinical narrative: Left arm fell asleep; uncontrollable nausea and vomiting; gradually got more nauseous; I was hyperventilating; Woke up with a headache; Had extreme vertigo with headache; body aches; disorientation; very tired; This is a spontaneous report received from a contactable consumer (Patient). A 38-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: WAG6975), via an unspecified route of administration, administered in Arm Right on 08Apr2021 14:00 (at the age of 38-years-old) as single dose for covid-19 immunisation. Medical history included anxiety and DVT in lower leg 7 years ago from surgery. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC DUO). Patient had no known allergies. Patient did not receive any other vaccines in four weeks. Patient was not diagnosed with covid-19 prior to vaccination, and she was not diagnosed with covid -19 since vaccination. On 18Apr2021 08:00, patient experienced left arm fell asleep, was hyperventilating, woke up with a headache, gradually got more nauseous, had extreme vertigo with headache, uncontrollable nausea and vomiting, body aches, disorientation and very tired. It was reported that she ended up in the ER 10 days after vaccine. Woke up with a headache then gradually got more nauseous. Had extreme vertigo with headache and uncontrollable nausea and vomiting. Left arm felt asleep, and she was hyperventilating. Couldn't stop vomiting until the Er gave her an injection and pills. Had body aches later that day and the next day and disorientation and very tired. No fever. Patient received Iv fluids, injection for nausea RX for vertigo as a therapeutic measure to treat adverse events. The events were recovered with sequel.  Follow-up attempts are possible. Further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vertigo, Vomiting
Clinical narrative: Left arm fell asleep; uncontrollable nausea and vomiting; gradually got more nauseous; I was hyperventilating; Woke up with a headache; Had extreme vertigo with headache; body aches; disorientation; very tired; This is a spontaneous report received from a contactable consumer (Patient). A 38-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: WAG6975), via an unspecified route of administration, administered in Arm Right on 08Apr2021 14:00 (at the age of 38-years-old) as single dose for covid-19 immunisation. Medical history included anxiety and DVT in lower leg 7 years ago from surgery. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC DUO). Patient had no known allergies. Patient did not receive any other vaccines in four weeks. Patient was not diagnosed with covid-19 prior to vaccination, and she was not diagnosed with covid -19 since vaccination. On 18Apr2021 08:00, patient experienced left arm fell asleep, was hyperventilating, woke up with a headache, gradually got more nauseous, had extreme vertigo with headache, uncontrollable nausea and vomiting, body aches, disorientation and very tired. It was reported that she ended up in the ER 10 days after vaccine. Woke up with a headache then gradually got more nauseous. Had extreme vertigo with headache and uncontrollable nausea and vomiting. Left arm felt asleep, and she was hyperventilating. Couldn't stop vomiting until the Er gave her an injection and pills. Had body aches later that day and the next day and disorientation and very tired. No fever. Patient received Iv fluids, injection for nausea RX for vertigo as a therapeutic measure to treat adverse events. The events were recovered with sequel.  Follow-up attempts are possible. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 08Apr2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 21Apr2021, the patient experienced tested positive for COVID-19. It was reported that the patient received first dose of Pfizer-BioNTech COVID-19 Vaccine on 08Apr2021 and had a small family gathering with fully vaccinated people, with not fully vaccinated people, and everyone managed to get sick. The patient tested positive for COVID-19 on 21Apr2021. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling face
Clinical narrative: rash on cheeks, jawline and neck; facial swelling; itch skin around jawline, some welting.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8731), via an unspecified route of administration in left arm on 21Apr2021 at 14:45 (at the age of 56 years old) as single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8734), via an unspecified route of administration in left arm on 29Mar2021 at 05:45 PM (at the age of 56 years old) for covid-19 immunisation. The patient's medical history was not reported. The patient had known allergies to sulfa based meds, chlorine, latex, wasp sting, seasonal environmental allergy (spring). Concomitant medications received within 2 weeks of vaccination included gummy multi-vitamin, fish oil, calcium, magnesium. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. No symptoms for 1st dose. 2nd dose received around 2:45 pm and on 21Apr2021, around 8:45 pm patient experienced itch skin around jawline, some welting. Woke up following day with rash on cheeks, jawline and neck, took 2 Benedryl before bedtime, following day some facial swelling rash lower back. Emailed Dr. instructed to take Zyrtec day, and Pepcid then Benedryl at night. Followed instructions, following morning woke up to even more facial swelling once oval face was square. Went to walk-in clinic for steroid shot. The event resulted in: Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event: injection of dexamethasone and dexamethasone. Reporter considered events as non-serious. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Malaise
Clinical narrative: shortness of breath; dizzy; felt very unwell; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in right arm on 22Apr2021 at 10:00 as a single dose for COVID-19 immunization. Medical history included Lupus and Hypothyroidism from an unknown date and unknown if ongoing. Patient had known allergies to Suprex and Septra. Concomitant medications included methylprednisolone acetate (MEDROL [METHYLPREDNISOLONE ACETATE]); naltrexone for lupus, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient had received a DePo medrol Steroid Shot and is on Low Does Naltrexone for lupus. On 22Apr2021, at 04:00, 5 hours after the shot she became very dizzy and shortness of breath. She also felt very unwell. Day two, she felt worse and could not breath alerting me to go to the ER to get checked out. The event resulted in: Emergency room/department or urgent care. The patient received treatment due to the events with ativan shot. The clinical outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Haematochezia, Mucous stools, Vomiting
Clinical narrative: severe abdominal pain; diarrhea and vomiting; diarrhea and vomiting; mucous and bloody stool; bloody stool; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EZ736), via an unspecified route of administration, administered in left arm on 23Apr2021 at 10:45 (at the age of 49-years-old) as dose 2, single for COVID-19 immunization. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0151), via an unspecified route of administration, administered in left arm on 02Apr2021 at 10:45 as dose 1, single for COVID-19 immunisation. Medical history included childhood asthma, tonsillitis and benignant ovarian cystoma. There were no known allergies. The concomitant medications included unspecified over-the-counter medicines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 24Apr2021 at 01:15 AM (at the midnight of the next date of vaccination), the patient experienced severe abdominal pain, diarrhea and vomiting. In the next morning, severe abdominal pain and bloody stool were present. Although three days passed after vaccination, mucous and bloody stool were currently present. No treatment was received for the adverse events. Patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Seizure
Clinical narrative: New onset seizure. Total of 4; This is a spontaneous report from a contactable consumer (patient).   A 32-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 02Apr2021 07:00, at the age of 32-years-old, (Lot Number: ER8737) as DOSE 1, SINGLE; and via an unspecified route of administration, administered in right arm on 23Apr2021 07:00 (Lot Number: EW0171) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included seizure on 01Apr2021 05:00AM. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  On unspecified date on Apr2021, after receiving the vaccine, patient had new onset seizure, total of 4. The event required ER visit, and the patient was hospitalized for 2 days due to this.  Post vaccination, the patient been tested for COVID-19, tested with nasal swab with negative result on 24Apr2021. The outcome of the event was recovering.    Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: diagnosed with a COVID-19 active infection; This is a spontaneous report from a non-contactable consumer or other non hcp(Patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization .The patient medical history and concomitant medications were not reported. she received the first dose of the Pfizer's COVID-19 vaccine on 08Apr and a week later she was diagnosed with a COVID-19 active infection that required a visit to the Emergency Room.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unknown date in Apr2021.The Consumer had an appointment for the administration of the second dose of the vaccine on May the 1st. AE for the COVID-19 active infection of the Patient and the visit to the ER. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Compression fracture
Clinical narrative: Compression fracture in her back.; This is a spontaneous report from a contactable consumer(patient). A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/batch number: not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported.  Patient stated that she had recently taken Flexeril, a muscle relaxant, for a compression fracture in her back. She did not specify if it was prescribed to her before vaccination or in between vaccine doses. Patient received Pfizer Covid19 vaccine and asked if there was a contraindication with taking Flexeril because she was due for second dose tomorrow. The outcome of the event was unknown.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Swollen tongue, Tongue discomfort, Tongue disorder
Clinical narrative: My tongue has been burning, covered in swollen taste buds, and been swollen since the 4th day after the first shot on 24Mar; My tongue has been burning, covered in swollen taste buds, and been swollen since the 4th day after the first shot on 24Mar; My tongue has been burning, covered in swollen taste buds, and been swollen since the 4th day after the first shot on 24Mar; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Mar2021 as single dose, for second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 14Apr2021 as single dose for covid-19 immunization. Medical history and concomitant medications were not reported. It was reported that I want to make you aware of my reaction to the Covid 19 vaccine. My tongue has been burning, covered in swollen taste buds, and been swollen since the 4th day (28Mar2021) after the first shot on 24Mar It started to subside a couple of days before the season shot so my Dr told me to go ahead with the second shot on 14Apr. Again, on Day 4 my tongue went crazy again and remains that way today. I am now in fear of a booster and do not know where to go from here. Treated w/ max doses of Benadryl, steroids, Pepcid. The outcome of the events recovered with sequelae.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Mass
Clinical narrative: a knot appeared just to the right of the bruise about the size of a silver dollar/about a size of a nickel; bruise on my inner elbow; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 50 years old via an unspecified route of administration, administered in Arm Left on 18Mar2021 11:00 (Batch/Lot Number: EN 6207) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; liothyronine taken for an unspecified indication, start and stop date were not reported; and varenicline tartrate (CHANTIX) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, (lot number: EL 9266), at the age of 50 years old, dose 1, single on 25Feb2021 11:00AM in the left arm for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was in the doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 24 hours 19Mar2021 11:00 AM after the injection, the patient stated, "I woke up with a bruise on my inner elbow, 24 hrs after that on 20Mar2021 a knot appeared just to the right of the bruise about the size of a silver dollar. 24 hours after that on 21Mar2021 another knot appeared just below the bruise about the size of a nickel. Still have the large knot as of 28Apr2021." The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was given steroid shot and antibiotics as treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The events did not result in death and was not life threatening. The event did not cause hospitalization and was not disabling and was not a congenital anomaly. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Cardiac flutter, Headache, Migraine
Clinical narrative: Heart started fluttering; his asthma has been worse; headache or migraine; headache or migraine; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient's wife) reported that a male patient of unspecified age received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot/batch number, expiry date and NDC number: not provided) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history includes ongoing asthma. Concomitant medications were not reported. Reporter stated that since her husband received the covid vaccine, his asthma has been worse, and his heart started fluttering and also has had a headache or migraine on an unspecified date. Reporter and her husband both received the Pfizer covid vaccine on an unspecified date. Reporter does not know right now if patient's symptoms are related to the covid vaccine. Reporter does not know all the details about patient's symptoms to report about them. Outcome of the events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Hypersomnia, Illness, Neuropathy peripheral, Productive cough
Clinical narrative: Neuropathy; Vomiting; Severe coughing; Sick; Sputum; since the pfizer covid vaccine shot, all her pains have completely disappeared; sleeping for 2 days afterwards; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection) via unknown route of administration on 13Apr2021 as dose 1 single for COVID-19 immunization. Medical history included diabetic, neuropathy in her left hand and shoulder (gabapentin), pain was constant felt like a stabbing pain, prevented her from sleeping at night, she could not lift her left hand, slipped disc, pain in her neck (prednisone and another medication). Concomitant medications were none. It was reported that patient received 1st dose of pfizer covid vaccine on 13apr and was due for her second shot on the 4May. After the vaccination in 2021, stated she became very sick with vomiting, severe coughing with a lot of sputum and was sleeping for 2 days afterwards. States she was really concerned about her symptoms she went to urgent care on april 25th. stated the symptoms she experienced were all the symptoms of covid. She had a covid test done which was negative in 2021. Adds that prior to the vaccination, she had a history of neuropathy in her left hand and shoulder; pain was constant felt like a stabbing pain and prevented her from sleeping at night and she couldnt lift her left hand. She took gabapentin for the neuropathy and had been on disability since last year. Prior to the vaccination, she also had pain in her neck from a slipped disc and was given prednisone and another medication. since the pfizer covid vaccine shot, all her pains have completely disappeared in 2021, she has stopped taking her gabapentin and can lift her left hand. States I have 'felt so different since the shot'. patient was also diabetic. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapeutic response unexpected, Vomiting
Clinical narrative: Neuropathy; Vomiting; Severe coughing; Sick; Sputum; since the pfizer covid vaccine shot, all her pains have completely disappeared; sleeping for 2 days afterwards; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection) via unknown route of administration on 13Apr2021 as dose 1 single for COVID-19 immunization. Medical history included diabetic, neuropathy in her left hand and shoulder (gabapentin), pain was constant felt like a stabbing pain, prevented her from sleeping at night, she could not lift her left hand, slipped disc, pain in her neck (prednisone and another medication). Concomitant medications were none. It was reported that patient received 1st dose of pfizer covid vaccine on 13apr and was due for her second shot on the 4May. After the vaccination in 2021, stated she became very sick with vomiting, severe coughing with a lot of sputum and was sleeping for 2 days afterwards. States she was really concerned about her symptoms she went to urgent care on april 25th. stated the symptoms she experienced were all the symptoms of covid. She had a covid test done which was negative in 2021. Adds that prior to the vaccination, she had a history of neuropathy in her left hand and shoulder; pain was constant felt like a stabbing pain and prevented her from sleeping at night and she couldnt lift her left hand. She took gabapentin for the neuropathy and had been on disability since last year. Prior to the vaccination, she also had pain in her neck from a slipped disc and was given prednisone and another medication. since the pfizer covid vaccine shot, all her pains have completely disappeared in 2021, she has stopped taking her gabapentin and can lift her left hand. States I have 'felt so different since the shot'. patient was also diabetic. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 46.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective
Clinical narrative: Lack of drug effect; This is a solicited report Facilitated Collect based on the information received by Pfizer (MFR Control No. # 21K-163-3870248-00). A contactable 46-year-old female consumer (patient) reported for herself that. A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular on an unspecified date (age at vaccination 46-years) (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; adalimumab (HUMIRA, Suspension for injection in pre-filled pen) , subcutaneous from an unspecified date (Batch/Lot Number: 1138527) to an unspecified date, at unspecified dose for Psoriatic arthritis.  The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced lack of drug effect (drug ineffective) (medically significant). On an unknown date, the patient experienced Humira did not work. COVID-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the event for adalimumab was unknown. Outcome of the event was not recovered.  The reporter's assessment of the causal relationship of the event with the suspect product was not reported at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event Drug ineffective and suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid on 17Apr2021; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable male consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN), via unspecified route of administration on 10Apr2021, as 1st dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 17Apr2021, the patient was tested positive for COVID-19. The caller wanted to know when he will be able to get second covid vaccine. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be required. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Ocular hyperaemia, Periorbital swelling, Staphylococcal infection
Clinical narrative: a staph infection; her eye was red, watery, puffy/The puffiness under her eye is hard; her eye was red, watery, puffy/The puffiness under her eye is hard; her eye was red, watery, puffy/The puffiness under her eye is hard; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative. A 6-decade-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration on 25Apr2021, as 2nd dose, single for Covid-19 immunisation. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration on an unspecified date, as 1st dose, single for Covid-19 immunisation. Medical history and concomitant medications were not reported. On Wednesday, 28Apr2021, her eye was red, watery, puffy and felt like she had or was getting a staph infection. The puffiness under her eye was hard. Patient was a female, age not sure but think mid 50's. The outcome of the events was unknown.   Information on batch/lot number was requested.