chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Feeling hot, Flushing, Headache
Clinical narrative: Extremely thirsty I drank 3 times more water than normal and still couldn't seem to get enough; dry mouth; tired; slight muscle aches in my back and shoulders; headache; flushed/warm face; flushed/warm face; slight pain and a bruise at the spot of the injection.; slight pain and a bruise at the spot of the injection.; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP6955), via an unspecified route of administration, in left arm on 31Mar2021 09:45 (at the age of 38-years-old) as dose 2, single for COVID-19 immunization. Medical history included rosacea and seasonal allergies. Concomitant medications included xylometazoline hydrochloride (NASAL SPRAY II), metronidazole (METROGEL), loratadine (CLARITINE). The patient did not have any allergy to medications, food or other products.  No other vaccine was given in 4 weeks, Prior to vaccination, was the patient was not diagnosed with COVID-19 and since the vaccination, has the patient been tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ET3247), via an unspecified route of administration, in left arm on 10Mar2021 09:45 as dose 1, single for COVID-19 immunization. The patient did not have COVID-19 prior to vaccination and has not been tested since vaccination. The patient was extremely thirsty, he drank 3 times more water than normal and still couldn't seem to get enough, had dry mouth, tired, slight muscle aches in his back and shoulders, headache, flushed/warm face and slight pain and a bruise at the spot of the injection on 31Mar2021. Treatment of the event included Tylenol. The outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Thirst, Vaccination site bruising, Vaccination site pain
Clinical narrative: Extremely thirsty I drank 3 times more water than normal and still couldn't seem to get enough; dry mouth; tired; slight muscle aches in my back and shoulders; headache; flushed/warm face; flushed/warm face; slight pain and a bruise at the spot of the injection.; slight pain and a bruise at the spot of the injection.; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP6955), via an unspecified route of administration, in left arm on 31Mar2021 09:45 (at the age of 38-years-old) as dose 2, single for COVID-19 immunization. Medical history included rosacea and seasonal allergies. Concomitant medications included xylometazoline hydrochloride (NASAL SPRAY II), metronidazole (METROGEL), loratadine (CLARITINE). The patient did not have any allergy to medications, food or other products.  No other vaccine was given in 4 weeks, Prior to vaccination, was the patient was not diagnosed with COVID-19 and since the vaccination, has the patient been tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ET3247), via an unspecified route of administration, in left arm on 10Mar2021 09:45 as dose 1, single for COVID-19 immunization. The patient did not have COVID-19 prior to vaccination and has not been tested since vaccination. The patient was extremely thirsty, he drank 3 times more water than normal and still couldn't seem to get enough, had dry mouth, tired, slight muscle aches in his back and shoulders, headache, flushed/warm face and slight pain and a bruise at the spot of the injection on 31Mar2021. Treatment of the event included Tylenol. The outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Insomnia
Clinical narrative: felt tired; headaches; myalgia; chills; slightly elevated body temperature; Fall asleep around 13 hours and woke up around 16 hours; fever; not able to sleep all night; This is a spontaneous report from a contactable consumer(patient). A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP6955 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 31Mar2021 09:30 (at the age of 33-years-old) at dose 2, single for covid-19 immunization. Medical history included muscle aches. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have allergies to medications, food, or other products. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 10Mar2021 09:30 (at the age of 33-years-old) at dose 1, single for covid-19 immunization. The most recent COVID-19 vaccine was administered at workplace clinic. It was reported that patient was good in first 12 hours after vaccination. Later on 31Mar2021 22:00, patient experienced chills and slightly elevated body temperature, fall asleep around 13 hours and woke up around 16 hours and also had fever and myalgia, was not able to sleep all night and relived all muscle aches he had over last couple years. After 24 hours (01Apr2021 9:30), patient felt tired and had headaches. At 36 hours, chills came back but only stay around half an hour. At 48 hours, only leftover headache left. No treatment was given for the events. The outcome of the events was recovered on 02Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Sleep disorder
Clinical narrative: felt tired; headaches; myalgia; chills; slightly elevated body temperature; Fall asleep around 13 hours and woke up around 16 hours; fever; not able to sleep all night; This is a spontaneous report from a contactable consumer(patient). A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP6955 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 31Mar2021 09:30 (at the age of 33-years-old) at dose 2, single for covid-19 immunization. Medical history included muscle aches. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have allergies to medications, food, or other products. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 10Mar2021 09:30 (at the age of 33-years-old) at dose 1, single for covid-19 immunization. The most recent COVID-19 vaccine was administered at workplace clinic. It was reported that patient was good in first 12 hours after vaccination. Later on 31Mar2021 22:00, patient experienced chills and slightly elevated body temperature, fall asleep around 13 hours and woke up around 16 hours and also had fever and myalgia, was not able to sleep all night and relived all muscle aches he had over last couple years. After 24 hours (01Apr2021 9:30), patient felt tired and had headaches. At 36 hours, chills came back but only stay around half an hour. At 48 hours, only leftover headache left. No treatment was given for the events. The outcome of the events was recovered on 02Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Swollen tongue
Clinical narrative: tongue really swollen; Sore throat; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: er8730), via an unspecified route of administration in the right arm on 01Apr2021 at 10:00 (at the age of 45-year-old), dose 1, single for COVID-19 immunisation. Medical history included hysterectomy in 2013 and her throat was closing up, and they think it was the pain medication in the hospital and had a reaction to Tramadol and Vicodin. The patient stated that she did not know if the vaccine and pain medications would have something similar in them. Family history included mother died of lung cancer. There were no concomitant medications. The patient previously took tramadol; hydrocodone bitartrate paracetamol (VICODIN) and had unspecified reaction. The patient had no history of previous immunisation with the COVID-19 vaccine. The patient did not administer additional vaccines on same date of the COVID-19 vaccine. The patient did not receive any vaccine within 4 weeks prior to COVID-19 vaccine. The patient stated she had the first shot on 01Apr2021 at pharmacy and on 02Apr2021, she woke up in the morning and her tongue was really swollen and she had sore throat. Nothing too severe, but she could feel it when she swallows. The patient called the pharmacy and they told her to take Benadryl. The patient had only been up for a couple hours and just took 25 mg of Benadryl at 09:00. They told her if she had trouble breathing then to go to the hospital. The reporter would like to know if there was anything else to do regarding their side effects other than what the pharmacist advised her, should she go to her primary care physician. The patient did not undergo lab tests and procedures. The patient did not visit emergency room or physician office for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: low-grade fever; achy body; chills; This is a spontaneous report from a contactable consumer (wife of the patient) via Pfizer-sponsored program  Support.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 25Mar2021 on last Thursday as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced low-grade fever, achy body and chills. The reporter would like to know if the side effects were taking that long before it would be experienced. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Itching at vaccination site; Swelling, the size of a chicken or goose egg; Injection site warm and red; Injection site warm and red; Tender, injection site, only when touched; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 02Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EP7534), via an unspecified route of administration on 21Mar2021 (at the age of 64-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient received unspecified medication as concomitant drug. The patient states that she did feel great for basically the first 8 and a half days, she had no side effects. On 30Mar2021, she decided to put rubbing alcohol and swab the area, as she hadn't done that before. She was in the car, with the sun on her shoulder and she noticed that it was starting to itch at the vaccination site, but she tried not to itch it. Later that night, she went to bed and it started itched again. She realized she had swelling the size of a chicken or goose egg. She got up and took her temperature, it was normal. She noted the site was warm and red, not alarmingly, but red with a 2.5-inch circumference, and it was swollen. She did not panic because she did not have a temperature. it remained swollen for the next day, but she still had no temperature, but it was itchy and warm. She stated she didn't do anything and tried to stay calm. She looked over the pamphlet that she got, and saw what it might be. The outcome was recovered for swelling, the size of a chicken or goose egg on 31Mar2021 and recovering for rest of the events.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dysgeusia, Erythema, Fatigue
Clinical narrative: Chills; shakiness; headache; joint pain; tiredness; nausea; metallic taste in mouth; injection site pain; redness; This is a spontaneous report from a contactable other health professional (patient). A 47-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration, administered in Arm Right on 24Mar2021 at 15:00 (at the age of 47-year-old) as dose 2, single for COVID-19 immunisation. Medical history included rhinitis allergic, hypertension, diverticulum and Penicillin allergy. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. 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. Historical vaccine included bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, administered in Arm Right on 03Mar2021 at 15:00 (at the age of 47-year-old) as dose 1, single for COVID-19 immunisation. On 25Mar2021 at 02:00 the patient experienced Chills, shakiness, headache, joint pain, tiredness, nausea, metallic taste in mouth, injection site pain, redness. Patient visited emergency room for the events. Patient was treated with antibiotics. The patient underwent lab tests and procedures which included sars-cov-2 (Nasal swab): negative on 28Mar2021. Since the vaccination the patient been tested for COVID-19 and results were negative. Outcome of the events was recovered on unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, SARS-CoV-2 test, Tremor, Vaccination site pain
Clinical narrative: Chills; shakiness; headache; joint pain; tiredness; nausea; metallic taste in mouth; injection site pain; redness; This is a spontaneous report from a contactable other health professional (patient). A 47-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration, administered in Arm Right on 24Mar2021 at 15:00 (at the age of 47-year-old) as dose 2, single for COVID-19 immunisation. Medical history included rhinitis allergic, hypertension, diverticulum and Penicillin allergy. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. 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. Historical vaccine included bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, administered in Arm Right on 03Mar2021 at 15:00 (at the age of 47-year-old) as dose 1, single for COVID-19 immunisation. On 25Mar2021 at 02:00 the patient experienced Chills, shakiness, headache, joint pain, tiredness, nausea, metallic taste in mouth, injection site pain, redness. Patient visited emergency room for the events. Patient was treated with antibiotics. The patient underwent lab tests and procedures which included sars-cov-2 (Nasal swab): negative on 28Mar2021. Since the vaccination the patient been tested for COVID-19 and results were negative. Outcome of the events was recovered on unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Oropharyngeal discomfort, Pruritus, Swollen tongue
Clinical narrative: Swollen tongue; throat; itching; dizzy; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 37-year-old non pregnant female patient received first dose of BNT162B2 (solution for injection, Batch/Lot Number: Ew0150, Expiry date: not reported) via an unspecified route of administration, administered in Left Arm on 31Mar2021 (at the age of 37 years old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was reported as none and concomitant medications were not reported. The patient has no other medical history. The patient had no allergies to medications, food or other products. The patient had not received any other vaccine within 4 weeks and other medication in 2 weeks. Patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. On 31Mar2021, the patient experienced swelling tongue, throat, itching, dizzy. Therapeutic measures were taken as a result of events at Medical help at vaccine injection facility, Benadr. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Some reason after vaccine side effects of joint pain, muscle soreness went away so did my hip pain; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program ]. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hip pain and inflammation in my right hip, muscle soreness and joint pain. The patient's concomitant medications were not reported. On an unspecified date, patient experienced some reason after vaccine side effects of joint pain, muscle soreness went away so did my hip pain. Patient inquired if vaccine boost her immune system. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Illness, Pain, Pyrexia, Tremor
Clinical narrative: joint pain; pain; I got very sick; Shaking; Fever; This is a spontaneous report from Pfizer-Sponsored program. This contactable 28-year-old female consumer(patient) reported which includes that :  A 28 years female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247) dose 1 on 04Feb2021 and dose 2 (Lot number: EN5318) on 20Feb2021 via an unspecified route of administration administered on left arm (At the age of 28 years) at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. On an unspecified date in Mar2021, Patient had stated I got very sick, I had pain all over my body specially my joint, Shaking and Fever. Treatment They just gave me medication for pain, I stopped it so I am not taking any medication now. I just use only Aleve Every time I have pain I take 2 pills. I did use Meloxicam but I stopped using it." At the time of reporting, the outcome of the events were unknown.  Additional Context:  Consumer stated, "I wanted to tell you my experience about the vaccine Covid vaccine Pfizer. After few weeks I got some symptoms that I never had in my life. I got very sick and it stated pain like I had pain all over my body specially my joints and other symptoms like I have shaking, sometimes fever not all the times. I went to ER and I went to another doctor they sent me to neurologist and he write I didn't had any problem before and he thought it might be from the vaccine because sometimes what happen that chemical can attack our joints and he did some test. My test number was so high which means my immune system has antibody. I want to know if somebody called you and had some history about that because it is so strange and I never had joint problem and the test result is showing I have joint problem. And is this possible from the vaccine is somebody has these symptoms?"      No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Wheezing
Clinical narrative: coughing; wheezing; This is a spontaneous report from a non-contactable consumer, patient's friend.   A female patient of an unspecified age received unknown dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the covax and was coughing and wheezing. It was suggested that she get tested to rule out if she had the virus but this could also a side effect. It was reported that the patient did not have on a mask. The outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: 2nd Pfizer vaccine on 27Mar, and on 29Mar woke up with rash and hives on both legs the entire legs.; 2nd Pfizer vaccine on 27Mar, and on 29Mar woke up with rash and hives on both legs the entire legs.; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer reporter for a male patient of unknown age who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 27Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. On 29Mar2021, two days after vaccination the patient woke up with rash and hives on both legs the entire legs. The event outcome was unknown.  No follow-up attempts were needed. Information about lot/batch number could not be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin burning sensation
Clinical narrative: itchy; Burning skin; This is a spontaneous report from a contactable other HCP (nurse). A 39-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular route, administered in left arm (Left Deltoid) on 30Jan2021 at 10:15 (Batch/Lot Number: EL3246) as SINGLE (age at vaccination was 39-years-old) for covid-19 immunization. Medical history included seasonal allergies and urticaria. The patient's concomitant medications were not reported. On 31Jan2021, at 06:00, the patient was itchy. On an unspecified date in 2021, the patient experienced burning skin. On 23Feb2021, at 12:30, patient received second dose of bnt162b2 via intramuscular route, administered in left arm (Batch/Lot Number: EL3302) as SINGLE for covid-19 immunization. Therapeutic measures were taken for both the events (Benedryl/ topical steroid). The outcome of pruritis was unknown whereas, burning skin was recovered on an unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot number: EN6208, expiration date: 30Jun2021) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included high blood pressure she has had this condition for 3 or 4 years and arthritis. Concomitant products included patient has been on Celebrex at a dose of 200 mg twice a day for about 2 weeks. Patient was taking Celebrex for arthritis and lisinopril with HCTZ 20mg/25mg 1x/day for high blood pressure, she has been taking this for 3 or 4 years. It was reported that after the first shot the patient experienced sore arm. The outcome of event was unknown.  No follow-up attempts are needed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling face
Clinical narrative: swelling of the hands and arms and more recently swelling in his face; swelling of the hands and arms and more recently swelling in his face; swelling of the hands and arms and more recently swelling in his face; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient experienced swelling of the hands and arms and more recently swelling in his face. The outcome of the events was unknown.  No follow up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Nausea, Rash pruritic
Clinical narrative: Chills; Itching rash on arms, back, neck and chest; Diarrhea; nauseated; stomach started turning like she had a strong laxative and cramping real bad; stomach started turning like she had a strong laxative and cramping real bad / Stomach pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number), via intramuscular route of administration in arm left on 01Apr2021 (at the age of 67-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included compromised immune status, gentic/ chromosomal abnormalities, endocrine abnormalities, obesity, asthma and respiratory illness all from an unknown date and unknown if ongoing. The patient is allergic to Codeine, Penicillin, Sulfa, Iodine, Epinephrine, Morphine, Clindamycin, Food allergies to Gluten, dairy, artificial sweeteners including Sorbitol and Xylitol, Broccoli, Cauliflower, Cabbage, Brussel Sprouts, Asparagus, all percifirous (transcribed as provided) vegetables, allergic to pollen, trees, grass, ragweed, mold, mildew, dust and allergic to cats. The concomitant medications of the patient were not reported. The Family medical history was reported as none. On 01Apr2021, the patient experienced chills, itching rash on arms, back, neck and chest, diarrhea, nauseated, stomach started turning like she had a strong laxative and cramping real bad. The patient reported that she got second shot on 01 Apr 2021, and felt good and was excited. She did not feel the weakness previous day, but what she did feel was the stomach started turning like she had a strong laxative and cramping real bad. She ended up with diarrhea like she never had before and it was persistent. She was having very bad stomach pains and on the sides of stomach where large intestines are on left side. She was also nauseated but can't seem to throw up. The nausea had been from previous night. It was hard to eat when you are nauseated and the diarrhea was still going on. She had been taking the same prescription medications for years. She did not felt they were relevant. She wanted to know what to do to help her feel better and with the stomach thing, what would they recommend for severe pain and diarrhea. Therapeutic measures were taken as a result of diarrhea, stomach started turning like she had a strong laxative and cramping real bad / stomach pain that included Tylenol and Pepto Bismol. The outcome of the events chills, diarrhea, nauseated, stomach started turning like she had a strong laxative and cramping real bad was reported as not recovered and the outcome of the event itching rash on arms, back, neck and chest was reported as resolving.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Oropharyngeal pain, Pain
Clinical narrative: some allergies; body ache; a kind of sore throat but not that bad; feeling tired / fatigue; This is a spontaneous report received from a contactable consumer (patient reported for herself) from Pfizer sponsored program COVAX US Support A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration, on 18Mar2021 (at the age of 69-years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had her first dose on 18Mar2021. Just this morning (01Apr2021), the patient had experienced body ache, a kind of sore throat but not that bad and feeling tired. The patient stated, it lasted for that short period of time, some allergies too that could be in the mix here. She had been fine since. Their next shot was on Thursday and knew they will be fine. Patient and her husband (age 73) both experienced fatigue the next day. They were relaxing. Patient wants to know if it was just side effects of the vaccine or if she was having a reaction to the vaccine. Outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Sore muscles/ Muscle aches; Chills; Headache; Little bit of fever; This is a spontaneous report from a contactable consumer (patient) reported himself.A 38-Year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on 31Mar2021 ( at the age of 38-Year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE; Lot Number and expiry date: not reported) via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunization.The patient reported that events experienced on next day. On 01Apr2021, he had chills, a little bit of fever, muscle aches, headache and he got sore muscles. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hives all over body; rash; itching; This is a spontaneous report received from a from a contactable consumer (wife) reported for a 65-year-old male patient (husband). A 65-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not provided), via an unspecified route on 09Mar2021 at 12:00, as a single dose for covid-19 immunization. Medical history included diabetes. The patient concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies were reported. On 10Mar2021 at 00:00, patient had hives all over body, rash and itching the day after his second dose of the Pfizer Covid vaccine. He still has it and it has been a month since he had vaccine. Doctors seem to be clueless on what to do. Pfizer is not able to make any treatment recommendations for individual patients. During the clinical trials, systemic symptoms (symptoms throughout your body) were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. However, everyone's body is different, and some symptoms may last longer in certain individuals. Please continue to discuss this with his HCP so they can evaluate his symptoms to determine the best treatment recommendations. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures taken as a result of the events included steroid shot. The clinical outcome of the events was reported as it has been a month with no relief from itching.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Dizzy; Tired; Headache; Nauseaus; Constipation; Swollen face; This is a spontaneous report received from a Pfizer sponsored program COVAX US support. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizzy, tired, headache, nauseaus, constipation, swollen face. The outcomes of events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Dizzy; Tired; Headache; Nauseaus; Constipation; Swollen face; This is a spontaneous report received from a Pfizer sponsored program COVAX US support. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizzy, tired, headache, nauseaus, constipation, swollen face. The outcomes of events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Heart rate increased, Hypoaesthesia
Clinical narrative: red like a rash; heart rate for 1 minute or 1.5 minutes went up to 209 bpm; dizzy; extremely exhausted; nauseous; lack of appetite; had a little bit of fever, a 99.3°F~99.4°F fever; Pain in left jaw -pretty intense; Lips and cheeks were numb; Lips and cheeks were numb; Numb mouth; This is a spontaneous report from a contactable consumer (patient herself). A 44-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number ER8732, Expiry date: 31Jul2021, Age at vaccination: 44years) via an unspecified route of administration on 27Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced pain in left jaw -pretty intense, red like a rash, heart rate for 1 minute or 1.5 minutes went up to 209 bpm, dizzy, extremely exhausted, nauseous, lack of appetite, had a little bit of fever, a 99.3 degree F 99.4 degree F fever. On 27Mar2021 it was reported that patient lips and cheeks were numb, numb mouth. She got received the vaccine on Saturday and 20 mins after received it my mouth, cheeks and lips got numb little numb, pretty strong jaw king in my left jaw joints, her face when she looked into the mirror was blushy and red. It was weird, she don't know. Seems like she was fine, after that, after a while, 2 days later, she felt extremely high heart rate of about 209 or some around 200 for she don't know exactly about the whole time but for a minute or minute and a half and I got completely exhausted and nauseous she did have very mild temperature like 99.4 or something like that and she have read on the internet that If you have any reaction then you should probably get allergy tested and also perhaps not receive the second vaccine but she really would like to receive it but she need to check that there is something considered as allergic reaction. The outcome of the events was unknown.  Follow-up (PRD 02Apr2021/ SRD 09Apr2021) New information was received from a contactable consumer includes: lot number, expiry date, events onset date.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Nausea, Pain in jaw, Pyrexia, Rash erythematous
Clinical narrative: red like a rash; heart rate for 1 minute or 1.5 minutes went up to 209 bpm; dizzy; extremely exhausted; nauseous; lack of appetite; had a little bit of fever, a 99.3°F~99.4°F fever; Pain in left jaw -pretty intense; Lips and cheeks were numb; Lips and cheeks were numb; Numb mouth; This is a spontaneous report from a contactable consumer (patient herself). A 44-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number ER8732, Expiry date: 31Jul2021, Age at vaccination: 44years) via an unspecified route of administration on 27Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced pain in left jaw -pretty intense, red like a rash, heart rate for 1 minute or 1.5 minutes went up to 209 bpm, dizzy, extremely exhausted, nauseous, lack of appetite, had a little bit of fever, a 99.3 degree F 99.4 degree F fever. On 27Mar2021 it was reported that patient lips and cheeks were numb, numb mouth. She got received the vaccine on Saturday and 20 mins after received it my mouth, cheeks and lips got numb little numb, pretty strong jaw king in my left jaw joints, her face when she looked into the mirror was blushy and red. It was weird, she don't know. Seems like she was fine, after that, after a while, 2 days later, she felt extremely high heart rate of about 209 or some around 200 for she don't know exactly about the whole time but for a minute or minute and a half and I got completely exhausted and nauseous she did have very mild temperature like 99.4 or something like that and she have read on the internet that If you have any reaction then you should probably get allergy tested and also perhaps not receive the second vaccine but she really would like to receive it but she need to check that there is something considered as allergic reaction. The outcome of the events was unknown.  Follow-up (PRD 02Apr2021/ SRD 09Apr2021) New information was received from a contactable consumer includes: lot number, expiry date, events onset date.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itchy; skin rash; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 49-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date was not reported) (at the age of 49-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced itchy and skin rash. Events took place after use of product. It was reported that following first Covid vaccination dose, patient felt itchy and experienced a skin rash and after the second dose, felt symptoms similar to pneumonia for one day. The clinical outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021377013
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Swollen lymph node in left armpit; pain in armpit; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL3247 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 01Apr2021 11:15 (at the age of 52-year-old), as dose 2, single, for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Patient had no allergies to medications, food, or other products. Medical history included lupus. Concomitant medications included hydroxychloroquine phosphate (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]); sumatriptan and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL3247 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 09Mar2021 13:15 (at the age of 52-year-old), as dose 1, single, for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced pain in armpit on 02Apr2021 and swollen lymph node in left armpit on 02Apr2021 at 20:00. Patient received no treatment for swollen lymph nodes. The outcome of swollen lymph node in left armpit was not recovered and the outcome of pain in armpit was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypersensitivity, Paraesthesia, Paraesthesia oral
Clinical narrative: Dizzy; Tingling around my mouth and tongue, specially lips; Tingling around mouth and the roof of the mouth, specially the face; she was starting to have an allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: ER8733), via an unspecified route of administration administered in left arm on 25Mar2021 around 14:00 (60-year-old at the time of vaccination) as single for covid-19 immunisation. The patient medical history was reported as none. The patient's concomitant medications were not reported. The patient had no additional vaccines administered on same date of BNT162B2. The patient usually does not even get the flu shot. The patient had not received any vaccine within four weeks. The patient had no adverse event prior to vaccination. On an unspecified date in Mar2021, the patient experienced starting to have an allergic reaction. On 25Mar2021, the patient got really dizzy and had tingling around her mouth and tongue, around mouth and the roof of the mouth, specially the face and lips. These were not listed as one of the side effects. The dizziness calmed down fairly quickly, it lasted maybe 45 minutes. The patient would say the tingling lasted about 24 hours. The patient asked who she would talk to if she was concerned about getting the second dose. The patient has also seen online where it said even if it was not life threatening that she may not want to get the second dose. The patient had not visited emergency room and stated she had gotten worse she would have gone to the ER. The outcome of the event dizzy was recovered on 25Mar2021, while events tingling around my mouth and tongue, around mouth and the roof of the mouth, specially lips and face were recovered on 26Mar2021 and event starting to have an allergic reaction was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Body temperature, Body temperature increased, Cardiac function test
Clinical narrative: right upper quadrant pain; upper quadrant discomfort; Broke out in a rash; she developed a rash; Cardiac numbers are elevated; After she did her injection she started feeling bad; nausea; vomited; feeling sweaty; chest discomfort; diarrhea; gas; burping; She feels feverish; achy; Her temperature is 100.9ºF; chest pain; Numbness around mouth; Difficulty swallowing; This is a spontaneous report from a non-contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch no/Lot number: not reported) via an unspecified route of administration on 24Feb2021 as dose 2, single for COVID-19 immunization. Patient also received Inotersen sodium (TEGSEDI, injection) ongoing via subcutaneously on 29Aug2019 for hereditary neuropathic amyloidosis and diphenhydramine hydrochloride (BENADRYL ALLERGY) on an unspecified date for right upper quadrant pain and upper quadrant pain. ISSD (Integrated Syringe Safety Device) for unknown Indication from unknown therapy dates. Patient's medical history included as hereditary neuropathic amyloidosis. Concomitant medications were not reported. On 05Mar2021, patient experienced right upper quadrant pain, upper quadrant discomfort, broke out in a rash; she developed a rash, cardiac numbers are elevated, after she did her injection and she started feeling bad, had nausea, vomited, feeling sweaty, chest discomfort, developed diarrhea, gas, was also burping, she feels feverish, achy, her temperature is 100.9 F, chest pain, numbness around mouth and difficulty swallowing. Patient under lab tests and procedures which included cardiac function test and results noted elevated on 11Feb2021 and on 05Mar2021, body temperature increased results 100.9F. Outcome of the events Abdominal pain upper and Rash was not recovered, and other events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained. No further information is expected.