chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Hepatic pain, Musculoskeletal chest pain
Clinical narrative: patient had kind of little bit dizzy or headache, little bit of headache; patient had kind of little bit dizzy or headache, little bit of headache; felt pain under right side rib might be it was rib, then these gone but the within a week her joint, her right joint, right leg joint a lot of pain; felt pain under right side rib might be it was rib, then these gone but the within a week her joint, her right joint, right leg joint a lot of pain; right side of finger got a little bit swollen and right leg joint pain most pain was over there; pain beginning from right under right liver; 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: EW0150, expiry date: Jul2021) via unspecified route of administration on 10Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medication were not reported. On an unspecified date in 2021, the patient experienced patient had kind of little bit dizzy or headache, little bit of headache something like that, felt pain under right side rib might be it was rib, then these gone but the within a week her joint, her right joint, right leg joint a lot of pain, right side of finger got a little bit swollen and right leg joint pain most pain was over there and pain beginning from right under right liver. Consumer stated that she got the Pfizer vaccine on 10April2021, 20 days ago, she got 2nd dose appointment tomorrow but she found, suspect side reaction, two. One thing was after the first dose the day and the next day, the patient had kind of little bit dizzy or headache, little bit of headache something like that. After that something come a week ago might be like 10 days ago. First thing she felt pain under right side rib might be it was rib, then these gone but the within a week her joint, her right joint, right leg joint a lot of pain, too pain. It was working too pain and she thought morning high in her finger always right side, right side of finger got a little bit swollen and right leg joint pain most pain was over there. The patient was going to appointment was tomorrow for the 2nd dose, she was not sure if she should go or not to go. The patient was wondering if this was a side effect reaction. Consumer stated that the first one or two day she got something the dizziness, headache, it was just feel like not before got the vaccine so after two days these things gone then after several days just like the pain beginning from right under right liver, this area was now starting having the pain, the right joint pain from right leg yes a lot of pain. At the time of this report the outcome of the events were unknown.   No follow-up attempts were needed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: patient had kind of little bit dizzy or headache, little bit of headache; patient had kind of little bit dizzy or headache, little bit of headache; felt pain under right side rib might be it was rib, then these gone but the within a week her joint, her right joint, right leg joint a lot of pain; felt pain under right side rib might be it was rib, then these gone but the within a week her joint, her right joint, right leg joint a lot of pain; right side of finger got a little bit swollen and right leg joint pain most pain was over there; pain beginning from right under right liver; 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: EW0150, expiry date: Jul2021) via unspecified route of administration on 10Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medication were not reported. On an unspecified date in 2021, the patient experienced patient had kind of little bit dizzy or headache, little bit of headache something like that, felt pain under right side rib might be it was rib, then these gone but the within a week her joint, her right joint, right leg joint a lot of pain, right side of finger got a little bit swollen and right leg joint pain most pain was over there and pain beginning from right under right liver. Consumer stated that she got the Pfizer vaccine on 10April2021, 20 days ago, she got 2nd dose appointment tomorrow but she found, suspect side reaction, two. One thing was after the first dose the day and the next day, the patient had kind of little bit dizzy or headache, little bit of headache something like that. After that something come a week ago might be like 10 days ago. First thing she felt pain under right side rib might be it was rib, then these gone but the within a week her joint, her right joint, right leg joint a lot of pain, too pain. It was working too pain and she thought morning high in her finger always right side, right side of finger got a little bit swollen and right leg joint pain most pain was over there. The patient was going to appointment was tomorrow for the 2nd dose, she was not sure if she should go or not to go. The patient was wondering if this was a side effect reaction. Consumer stated that the first one or two day she got something the dizziness, headache, it was just feel like not before got the vaccine so after two days these things gone then after several days just like the pain beginning from right under right liver, this area was now starting having the pain, the right joint pain from right leg yes a lot of pain. At the time of this report the outcome of the events were unknown.   No follow-up attempts were needed. No further information was expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Loss of personal independence in daily activities, Myalgia, Nausea
Clinical narrative: headache; generalized muscle pain/myalgia; injection arm soreness; intermittent nausea; intermittent nausea; pyrexia/fever (99.2°-99.6°F); interference with daily activities due to AEs; This is a spontaneous report from a contactable consumer or other non-HCP (patient reported for self). A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in left arm on 30Apr2021 13:00 (at the age of 46-years-old) as dose 2, single for COVID-19 immunization. Facility type Vaccine mentioned as Other. The patient did not receive any other medication in two weeks. The patient did not had COVID prior vaccination. Other medication reported as none. The patient medical history was not reported.  No known allergies per reporter's knowledge. The patient's concomitant medications were not reported. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0162), via an unspecified route of administration, administered in left arm on 09Apr2021 13:30 (at the age of 45-years-old) as dose 1, single for COVID-19 immunization. On 01May2021 10:00, the patient experienced pyrexia/fever (99.2 degree-99.6 degree F), headache, generalized muscle pain/myalgia, injection arm soreness, and intermittent nausea. All adverse events were mild in severity except for headache which was moderate. No concomitant use of antipyretic or pain medication taken. No prescription or OTC medications taken. There was interference with daily activities due to AEs (Adverse Events). Symptoms peaked around 01May 3PM and fully resolved around 10PM. The patient underwent lab tests and procedures which included body temperature: 99.2 degree-99.6 degree fahrenheit on 01May2021. Since the vaccination, patient has not been tested for COVID-19. No treatment was given for the reported events. The outcome of all events was reported as recovered on 01May2021 at 22:00 PM; interference with daily activities due to AEs was unknown. Device Date : 03May2021.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: headache; generalized muscle pain/myalgia; injection arm soreness; intermittent nausea; intermittent nausea; pyrexia/fever (99.2°-99.6°F); interference with daily activities due to AEs; This is a spontaneous report from a contactable consumer or other non-HCP (patient reported for self). A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in left arm on 30Apr2021 13:00 (at the age of 46-years-old) as dose 2, single for COVID-19 immunization. Facility type Vaccine mentioned as Other. The patient did not receive any other medication in two weeks. The patient did not had COVID prior vaccination. Other medication reported as none. The patient medical history was not reported.  No known allergies per reporter's knowledge. The patient's concomitant medications were not reported. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0162), via an unspecified route of administration, administered in left arm on 09Apr2021 13:30 (at the age of 45-years-old) as dose 1, single for COVID-19 immunization. On 01May2021 10:00, the patient experienced pyrexia/fever (99.2 degree-99.6 degree F), headache, generalized muscle pain/myalgia, injection arm soreness, and intermittent nausea. All adverse events were mild in severity except for headache which was moderate. No concomitant use of antipyretic or pain medication taken. No prescription or OTC medications taken. There was interference with daily activities due to AEs (Adverse Events). Symptoms peaked around 01May 3PM and fully resolved around 10PM. The patient underwent lab tests and procedures which included body temperature: 99.2 degree-99.6 degree fahrenheit on 01May2021. Since the vaccination, patient has not been tested for COVID-19. No treatment was given for the reported events. The outcome of all events was reported as recovered on 01May2021 at 22:00 PM; interference with daily activities due to AEs was unknown. Device Date : 03May2021.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Fatigue, Pyrexia, Vomiting
Clinical narrative: First shot: Fever (100.6), diarrhea, vomit, fatigue; First shot: Fever (100.6), diarrhea, vomit, fatigue; First shot: Fever (100.6), diarrhea, vomit, fatigue; First shot: Fever (100.6), diarrhea, vomit, fatigue; This is a spontaneous report from a contactable consumer. A 41-year-old female patient (non-pregnant) received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: ER8731 and expiration date: not reported), via an unspecified route of administration, administered in Arm Right on 10Apr2021 16:00 as a dose 1 single (age at vaccination: 41-year-old)for covid-19 immunisation. Medical history included no known allergies: No other medical history. The patient's concomitant medications were not reported. The patient is not pregnant at time of vaccination. The patient experienced first shot: fever (100.6), diarrhea, vomit, fatigue on 11Apr2021 16:00. The patient underwent lab tests and procedures which included body temperature: 100.6 on Fever (100.6). Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. no treatment was received for events. Events were reported as non- serious. The patient recovered from all the events.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling hot, Headache, Malaise, Nausea
Clinical narrative: headache; arm pain; arm was really hot; nauseous/nausea; diarrhea; body aches; feel bad/she wasn't feeling well; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0171, Expiration date: unknown) intramuscular, administered in left arm on 04May2021 in the morning around 10:00 am (age at vaccination was 48 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history. The patient did not receive any concomitant medications and she hasn't been on any medicines. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8732, Expiration date: unknown) intramuscular, administered in left arm on 01Apr2021 in the evening between 15:30-16:00 pm (age at vaccination was 48 years) as dose 1, single for COVID-19 immunization and experienced headache, arm pain and her arm was warm at the site, her body was aching and she was really tired. No additional vaccines were administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that after the first dose, the symptoms lasted 3 days and on the 4th day, she started to feel better. For the second dose, it seems like it was doing the same thing and she was feeling the same way. The patient received the second dose of Pfizer COVID vaccine on Tuesday, 04May2021 and she was okay on Tuesday. On 05May2021, Wednesday night around 22:00 pm, the patient experienced headache, arm pain, her arm was really hot, nauseous/nausea, had diarrhea and body aches/her body was achy. The patient was at work and she started to feel bad and she wasn't feeling well. She confirmed those symptoms were still ongoing and persisting. She clarified she just felt her arm and it felt not as hot as it was. She mentioned she started taking some Tylenol and it seems like the hotness went down, her arm was just warm. She clarified that she referred to her left arm. The patient asked how long those symptoms typically last and if anyone had reported that. The adverse events did not require a visit to Emergency Room or Physician Office. No relevant tests were done. There was a Product Complaint. The outcome of the events arm pain and arm was really hot was resolving. The outcome of the other events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: headache; arm pain; arm was really hot; nauseous/nausea; diarrhea; body aches; feel bad/she wasn't feeling well; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0171, Expiration date: unknown) intramuscular, administered in left arm on 04May2021 in the morning around 10:00 am (age at vaccination was 48 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history. The patient did not receive any concomitant medications and she hasn't been on any medicines. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8732, Expiration date: unknown) intramuscular, administered in left arm on 01Apr2021 in the evening between 15:30-16:00 pm (age at vaccination was 48 years) as dose 1, single for COVID-19 immunization and experienced headache, arm pain and her arm was warm at the site, her body was aching and she was really tired. No additional vaccines were administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that after the first dose, the symptoms lasted 3 days and on the 4th day, she started to feel better. For the second dose, it seems like it was doing the same thing and she was feeling the same way. The patient received the second dose of Pfizer COVID vaccine on Tuesday, 04May2021 and she was okay on Tuesday. On 05May2021, Wednesday night around 22:00 pm, the patient experienced headache, arm pain, her arm was really hot, nauseous/nausea, had diarrhea and body aches/her body was achy. The patient was at work and she started to feel bad and she wasn't feeling well. She confirmed those symptoms were still ongoing and persisting. She clarified she just felt her arm and it felt not as hot as it was. She mentioned she started taking some Tylenol and it seems like the hotness went down, her arm was just warm. She clarified that she referred to her left arm. The patient asked how long those symptoms typically last and if anyone had reported that. The adverse events did not require a visit to Emergency Room or Physician Office. No relevant tests were done. There was a Product Complaint. The outcome of the events arm pain and arm was really hot was resolving. The outcome of the other events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymph node pain, Myalgia
Clinical narrative: prolonged muscle soreness in left arm (first and second dose); pain at the injection site; redness at injection site; itching at injection site; tenderness in underarm lymph node; Fever; chills; body aches; headache; fatigue; This is a spontaneous report from a non-contactable consumer or other non-HCP (patient reported for self). A 33-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0164), via an unspecified route of administration, administered in left arm on 15Apr2021 08:30 (at the age of 33-years-old) as dose 2, single for COVID-19 immunization. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8737), via an unspecified route of administration, administered in left arm on 25Mar2021 at 08:30 (at the age of 33-years-old) as dose 1, single for COVID-19 immunization and experienced muscle soreness and disruption of menstrual cycle. Facility where the most recent COVID-19 vaccine was administered mentioned as Other. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination. Medical history included known allergies to Sulfa. Concomitant medications (received within 2 weeks of vaccination) included loratadine (CLARITIN [LORATADINE]); naproxen sodium (ALEVE) and Olly Women's Multi-Vitamin. On 15Apr2021 20:30 the patient experienced Fever, chills, body aches, headache, fatigue, prolonged muscle soreness in left arm (first and second dose), pain at the injection site, redness at injection site, itching at injection site, tenderness in underarm lymph node for 36 hours following vaccination. Post vaccination, patient was not tested with covid 19. No treatment was given for the reported events. The outcome of event prolonged muscle soreness in left arm and tenderness in underarm lymph node was recovered on an unspecified date of Apr2021. The outcome of rest all events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: prolonged muscle soreness in left arm (first and second dose); pain at the injection site; redness at injection site; itching at injection site; tenderness in underarm lymph node; Fever; chills; body aches; headache; fatigue; This is a spontaneous report from a non-contactable consumer or other non-HCP (patient reported for self). A 33-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0164), via an unspecified route of administration, administered in left arm on 15Apr2021 08:30 (at the age of 33-years-old) as dose 2, single for COVID-19 immunization. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8737), via an unspecified route of administration, administered in left arm on 25Mar2021 at 08:30 (at the age of 33-years-old) as dose 1, single for COVID-19 immunization and experienced muscle soreness and disruption of menstrual cycle. Facility where the most recent COVID-19 vaccine was administered mentioned as Other. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination. Medical history included known allergies to Sulfa. Concomitant medications (received within 2 weeks of vaccination) included loratadine (CLARITIN [LORATADINE]); naproxen sodium (ALEVE) and Olly Women's Multi-Vitamin. On 15Apr2021 20:30 the patient experienced Fever, chills, body aches, headache, fatigue, prolonged muscle soreness in left arm (first and second dose), pain at the injection site, redness at injection site, itching at injection site, tenderness in underarm lymph node for 36 hours following vaccination. Post vaccination, patient was not tested with covid 19. No treatment was given for the reported events. The outcome of event prolonged muscle soreness in left arm and tenderness in underarm lymph node was recovered on an unspecified date of Apr2021. The outcome of rest all events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Urticaria
Clinical narrative: body pain; chills; welts; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 06May2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on unspecified date of 2021 as dose 1, single for covid-19 immunization leading to tiredness, body pain and allergy that was removed on the second day. On unspecified date of 2021 the patient experienced body pain, chills, welts had come out of it that are removed and returned to it and further added that this time the welt thing hasn't been taken away from him and he wants to know what to do to get them removed. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Respiratory disorder
Clinical narrative: respiratory issue; Diarrhea; headache; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 30Apr2021 as DOSE NUMBER UNKNOWN SINGLE for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced respiratory issue, diarrhea and headache on an unspecified date. It was further stated that "He developed headache and respiratory issue during the 1st day - Diarrhea for 3 days now - He wants to know how long the symptoms usually last - Patient was in a hurry, he was not able to specify if the Pfizer shot that he got was the 1st or the 2nd dose - While confirming the spelling of his name he stopped and mentioned that he will just call again because he needs to answer another phone call". The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Rhinorrhoea, Sneezing
Clinical narrative: right eye continues to jump/jerk, sticks when I blink.; runny nose; sneezing; This is a spontaneous report from a contactable consumer (Patient). A 61-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 07May2021 at 16:15 (at the age of 61-years-old) as dose 2, single for covid-19 immunisation. Medical history included high blood pressure, obesity, arthritis. Patient had no known allergies. Other vaccine in four weeks was none. Concomitant medications included hydrochlorothiazide, valsartan (DIOVAN HCT); potassium; simvastatin; metoprolol. Historical Vaccine included BNT162B2 (Lot number: ER8731) on 16Apr2021 at 06:15 pm as dose 1 for COVID-19 immunization and experienced discoloration at injection site. On 09May2021 at 07:30, the patient experienced "right eye continues to jump/jerk, sticks when i blink", runny nose and sneezing. Patient was not covid prior vaccination and not tested for covid post vaccination. Discoloration at injection site after first dose of vaccine that is still there after 3 weeks. No treatment was given for the events. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pharyngitis, Throat irritation
Clinical narrative: coughs with the irritation; his throat burns; he has had a lot of throat infection kind of feeling, like something is pressing on his throat; This is a spontaneous report from a contactable consumer (patient).   A 41-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection Batch/Lot Number: ER8730; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in arm left on 28Apr2021 at noon (age at vaccination 41 years) as dose 1, 0.3 ml single for covid-19 immunisation. There was no patient's Medical History (including any illness at time of vaccination). Family Medical History included his mother has low blood pressure issues. She had open heart surgery 25 years ago and that is it, there is nothing else that he can think of. The patient's concomitant medication were not reported. To get prevention from COVID the patient taking Pfizer COVID vaccine. He doesn't have any medical conditions which are serious. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. There was no prior Vaccinations (within 4 weeks). There was no AE following prior vaccinations. He received the vaccination 28 Apr 2021, that was his first dose. He noticed he has had a lot of throat infection kind of feeling, like something was pressing on his throat. The feeling with his throat from the second day. He did not really pay attention. He clarifies he took it on a Wednesday and he noticed it on Friday but since it has been going on for a week or something he did not know if it was some kind of condition. He had 2 friends that also had the Pfizer vaccination and they just were feeling tired, nothing of such like he was having, they had like flu-like symptoms, no further information provided. His side effect has been more than a week so he was thinking was this something that has to be considered, should he go see a physician. He confirms the feeling in his throat began 30 Apr 2021. It was ongoing. When asked if it has improved persisted or worsened, he says if he drinks hot water it was okay but then after that it becomes worse and a more constant condition and he coughs with the irritation. He says it was a lot of irritation and it causes cough and the his throat burns, it was that kind of situation. He just wanted to know whether he should be concerned or if he should go to his family doctor to report this or take any medicine. The outcome of events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Tremor, Urticaria
Clinical narrative: hives; Tremors; Swollen face; This is a spontaneous Pfizer product safety information report form from a contactable consumer (patient's mother). A 16-year-old female patient received second dose of 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 30Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included prednisone (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of 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 05Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation. After the second shot, on an unspecified date in 2021, the patient had severe hives has went to the urgent care, her primary doctor and also, the emergency room as this has been so severe. She has hives all over her body, her face was swollen, and she has tremors. She was not responding to the usual course of an Antihistamine and Prednisone. The reporter thought the tremors might be form the Prednisone but was not sure. The patient was miserable and would like someone to call her back with some suggestions to help. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthma, Bedridden, Chills, Dizziness
Clinical narrative: I became nauseated; Had a headache that wouldn't let up; Fatigue; Muscle and joint pain; Muscle and joint pain; chills; Hot flashes; I was ill and bedridden for 26 hours; I was ill and bedridden for 26 hours; I am asthmatic; had trouble breathing in; vaccine location:Left leg; Dizzy spells; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-years-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0167) via an unspecified route of administration in leg left on 01May2021 at 09:45 (at the age of 31 years-old) as dose 2, single for COVID-19 immunization. The patient was not a pregnant at the time of vaccination. Patient medical history included covid-19 (covid prior vaccination: Yes), asthma, hypoglycaemia, hypothyroidism, irritable bowel syndrome, endometriosis, known extensive allergies, Fruit allergy, nature allergy. The concomitant medications included levothyroxine (LEVOTHYROXINE) taken as 50 mcg 1x daily for an unspecified indication. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0161) via an unspecified route of administration in right arm on 10Apr2021 at 09:45 (at the age of 31 years-old) as dose 1, single for COVID-19 immunization and reported that minutes after dose 1 she became severely nauseated and had a bad headache. On 01May2021 at 22:00, the patient experienced "i became nauseated", had a headache that wouldn't let up, fatigue, muscle and joint pain, chills, hot flashes, i was ill and bedridden for 26 hours, I am asthmatic, had trouble breathing in, dizzy spells on 2021, vaccine location:left leg (product administered at inappropriate site) on 01May2021 09:45. The patient was was put on watch for an hour before being released. The patient previously taken NSAIDS and experienced allergy. The vaccination facility type was reported as hospital. No other vaccine in four weeks. The covid was not tested for post vaccination. The patient experienced 10 hours after dose 2 she became nauseated, had a headache that wouldn't let up, fatigue, muscle and joint pain, chills and hot flashes. she was ill and bedridden for 26 hours. She was asthmatic and also had trouble breathing in with second dose. A week after she was beginning to get dizzy spells and those are still occurring. The vaccine was administered at left leg. No treatment received for the adverse events. The clinical outcome of all events was not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Hot flush, Illness
Clinical narrative: I became nauseated; Had a headache that wouldn't let up; Fatigue; Muscle and joint pain; Muscle and joint pain; chills; Hot flashes; I was ill and bedridden for 26 hours; I was ill and bedridden for 26 hours; I am asthmatic; had trouble breathing in; vaccine location:Left leg; Dizzy spells; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-years-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0167) via an unspecified route of administration in leg left on 01May2021 at 09:45 (at the age of 31 years-old) as dose 2, single for COVID-19 immunization. The patient was not a pregnant at the time of vaccination. Patient medical history included covid-19 (covid prior vaccination: Yes), asthma, hypoglycaemia, hypothyroidism, irritable bowel syndrome, endometriosis, known extensive allergies, Fruit allergy, nature allergy. The concomitant medications included levothyroxine (LEVOTHYROXINE) taken as 50 mcg 1x daily for an unspecified indication. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0161) via an unspecified route of administration in right arm on 10Apr2021 at 09:45 (at the age of 31 years-old) as dose 1, single for COVID-19 immunization and reported that minutes after dose 1 she became severely nauseated and had a bad headache. On 01May2021 at 22:00, the patient experienced "i became nauseated", had a headache that wouldn't let up, fatigue, muscle and joint pain, chills, hot flashes, i was ill and bedridden for 26 hours, I am asthmatic, had trouble breathing in, dizzy spells on 2021, vaccine location:left leg (product administered at inappropriate site) on 01May2021 09:45. The patient was was put on watch for an hour before being released. The patient previously taken NSAIDS and experienced allergy. The vaccination facility type was reported as hospital. No other vaccine in four weeks. The covid was not tested for post vaccination. The patient experienced 10 hours after dose 2 she became nauseated, had a headache that wouldn't let up, fatigue, muscle and joint pain, chills and hot flashes. she was ill and bedridden for 26 hours. She was asthmatic and also had trouble breathing in with second dose. A week after she was beginning to get dizzy spells and those are still occurring. The vaccine was administered at left leg. No treatment received for the adverse events. The clinical outcome of all events was not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Product administered at inappropriate site
Clinical narrative: I became nauseated; Had a headache that wouldn't let up; Fatigue; Muscle and joint pain; Muscle and joint pain; chills; Hot flashes; I was ill and bedridden for 26 hours; I was ill and bedridden for 26 hours; I am asthmatic; had trouble breathing in; vaccine location:Left leg; Dizzy spells; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-years-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0167) via an unspecified route of administration in leg left on 01May2021 at 09:45 (at the age of 31 years-old) as dose 2, single for COVID-19 immunization. The patient was not a pregnant at the time of vaccination. Patient medical history included covid-19 (covid prior vaccination: Yes), asthma, hypoglycaemia, hypothyroidism, irritable bowel syndrome, endometriosis, known extensive allergies, Fruit allergy, nature allergy. The concomitant medications included levothyroxine (LEVOTHYROXINE) taken as 50 mcg 1x daily for an unspecified indication. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0161) via an unspecified route of administration in right arm on 10Apr2021 at 09:45 (at the age of 31 years-old) as dose 1, single for COVID-19 immunization and reported that minutes after dose 1 she became severely nauseated and had a bad headache. On 01May2021 at 22:00, the patient experienced "i became nauseated", had a headache that wouldn't let up, fatigue, muscle and joint pain, chills, hot flashes, i was ill and bedridden for 26 hours, I am asthmatic, had trouble breathing in, dizzy spells on 2021, vaccine location:left leg (product administered at inappropriate site) on 01May2021 09:45. The patient was was put on watch for an hour before being released. The patient previously taken NSAIDS and experienced allergy. The vaccination facility type was reported as hospital. No other vaccine in four weeks. The covid was not tested for post vaccination. The patient experienced 10 hours after dose 2 she became nauseated, had a headache that wouldn't let up, fatigue, muscle and joint pain, chills and hot flashes. she was ill and bedridden for 26 hours. She was asthmatic and also had trouble breathing in with second dose. A week after she was beginning to get dizzy spells and those are still occurring. The vaccine was administered at left leg. No treatment received for the adverse events. The clinical outcome of all events was not recovered.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Night sweats, Pyrexia, Vaccination site pain
Clinical narrative: Night sweats; Fatigue; Chills/fever; Terrible headaches; Injection site hurt worse with the first shot than the 2nd dose; This is a spontaneous report from a non-contactable consumer or other non-health care professional. A 82-years-old female patient received BNT162B2 (BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient historical previously received BNT162B2 as dose 1, single for COVID-19 immunization and experienced injection site hurt worse with the first shot than the second dose. On an unknown date, the patient experienced night sweats, fatigue, chills/fever, terrible headaches, injection site hurt worse with the first shot than the second dose. The reporter wanted to know the efficacy after one dose, are the side effects in the second dose worse than the first dose, is the second dose the same medication, is there any research about giving different doses to smaller people, who weigh less as the reporter had COVID-19 in Mar2020, only weighs 108, since the patient had COVID-19, is that side effects were just like COVID, maybe only one dose is enough instead of two and was it too late to get the second dose. The clinical outcome of all the events was unknown.   No follow-up attempts are needed; Information related to batch/Lot number could not be requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis
Clinical narrative: her legs turned blue for a few days; This is a spontaneous report from a contactable Nurse or other health professional. This nurse reported for herself that a 40 year-old female patient received bnt162b2 (COMIRNATY formulation; solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date (at the age of 40 -year-old) dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications was not reported. On an unknown date, the patient's legs turned blue for few days and then returned to normal color. No other side effects observed. Event took place after use of product. Outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: Severe headache; lightheadedness; extreme fatigue; soreness at injection site; slight fever; This is a spontaneous report from a contactable consumer or other non hcp. This report was received via a sales representative.  A 59-years-old male patient received bnt162b2 (BNT162B2, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No underlying conditions, I felt fine prior to vaccination. On an unspecified date, The patient experienced severe headache, light headedness, extreme fatigue, soreness at injection site, slight fever. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Pyrexia
Clinical narrative: Chills; Fever; Nausea; Dizziness; This is a spontaneous report from a contactable consumer (patient). This report was received via a sales representative. A 15-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number: EIH0183), dose 1 via an unspecified route of administration on 17May2021 at 14:00 as dose 1, single for covid-19 immunization. It was reported that patient had no underlying conditions. The patient medical history and concomitant medications were not reported. On 18May2021 at 11:30, the patient developed chills, fever, nausea and dizziness. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea, Rash
Clinical narrative: she has a rash from head to toe; Broke out body wide pityriasis rosea; This is a spontaneous report from a contactable consumer (patient's mother). An 18-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0161) via unspecified route of administration on 29Apr2021 (age at vaccination was 18 years) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient also received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via unspecified route of administration on an unknown date (age at vaccination was 18 years) as DOSE 1, SINGLE for COVID-19 immunisation. It was reported that the patient received her 2nd dose at Pfizer vaccine on 29Apr2021 and about a week ago in May2021, the patient broke out body wide pityriasis rosea. So, she has a rash from head to toe and she has no history of it. I do not know if its related. Reporter stated, I am not reporting this for help. We have been to a pediatrician. I am doing this because I think it might be concern to Pfizer and her doctor said that she saw another case of same age fully vaccinated with the same rash. I thought maybe you all should know about it. I do not even know if its related. I just thought it is in the public interest to let you know that there's been a reaction. The outcome of the events was unknown.    No Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Drug ineffective
Clinical narrative: Breakthrough COVID; Breakthrough COVID; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 21Oct2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he took Pfizer vaccine few weeks prior to the initial report on 20May2021. He had no immunity for COVID in his blood wok on an unspecified date. On 21Oct2021, the patient reported that it (vaccine) does offer protection. If you get a breakthrough COVID you are expected to experience only mild symptoms. The patient had seen this first hand already. It (vaccine) beats death and long COVID. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Hands like purplish; This is a spontaneous report from a contactable consumer (patient's father).  A 15-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0187), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date, patient experienced hands like purplish. The outcome was unknown.  No follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Peripheral swelling
Clinical narrative: experienced "arthritic pain in her shoulders and hands" and was not able to be "functional".; hand was swollen; was not able to be functional; This is a spontaneous report from a contactable consumer or other non hcp. A 6-decade-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (9 days after getting cortisone shots in each of her arms) as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication(s) included cortisone shots taken for an unspecified indication, start and stop date were not reported. The patient experienced arthritic pain in her shoulders and hands and was not able to be functional and hand was swollen for 3 days then as it subsided, her other hand got swollen for 3 days also on an unspecified date. It was reported that, she was unable to open a water bottle/cap in the morning but was capable at night. She had 2 steroid treatment and finished her second one. She was a tennis player and still could not do any of that. Therapeutic measures were taken as a result of events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.