chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Cardiac infection
Clinical narrative: inflammation of the heart; This is a spontaneous report received from a non-contactable consumer (patient's sister). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose (dose number unknown) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced inflammation of the heart on an unspecified date with outcome of unknown. The patient was in the hospital after taking the COVID vaccine. He has inflammation of the heart. He didn't have any issues prior to the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Hypoaesthesia, Hypoaesthesia oral, Peripheral coldness
Clinical narrative: Anaphylactic shock; Numb lips; numb and cold hands; numb and cold hands; This is a spontaneous report from a contactable consumer (parent). A 35-year-old female patient received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at the age of 35 years old as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unspecified date. Immediately after the shot, the patient had numb and cold hands on an unspecified date. It improved and the patient was released. When the patient got home, she had anaphylactic shock and had numb lips, this started about 1.5 hours after the shot (unspecified date). The patient called and went to the hospital. The patient was treated with Benadryl. Outcome of numb and cold hands was recovering, while other events were unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer. This consumer reported similar event for 3 patients. This is one of 3 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on an unspecified date. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101473796 same reporter/drug/event, different patient;US-PFIZER INC-202101473797 same reporter/drug/event, different patient
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: The second vaccination itched and had a mark like a half dollar; The second vaccination itched and had a mark like a half dollar; This is a spontaneous report from a contactable consumer (patient reporting for herself). This consumer reported events for the second and third doses of the Pfizer vaccine. This is the second of the two reports, describing the events for the second dose.  A 78-year-old female patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm (reported as "injected in left arm and was in the shoulder part in the muscle") on 07Apr2021 (batch/lot number: NW6208) at the age of 78 years old, as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history included Grave's disease (is for thyroid) which she thinks she has had for years. She does not remember diagnosis date. Patient was allergic to antihistamines; she did not have a manufacturer, lot or expiration for the antihistamine she was allergic to. Patient was allergic to red, orange, and pink dye in any medication. She went to an allergy doctor and he could not give her the medications she was allergic to, just a list of things. He said she was allergic to Latex, Tape, Betadine, Penicillin, Reglan, Tramadol, Phenylephrine Topical, Metoclopramide, Low dose aspirin, Azithromycin, Toradol, Oxycodone/Acetaminophen. She can take Tylenol, but it raises her blood pressure. She does not take it and does not have information on the manufacturer, lot or expiration for any of the medications she is allergic to. She does not know the dates she was diagnosed. Concomitant medications included unspecified products which she takes early morning. She stated that she was not on anything that would interfere. She did not have any different medication with this one than the other two. They did not interfere with the other two. No further details were provided. The patient previously took the first dose of BNT162B2 injected in left arm and was in the shoulder part in the muscle on 04Mar2021 (batch/lot number: NW6200) at the age of 77 years old, as DOSE 1, SINGLE for COVID-19 immunization. There were no prior vaccinations within four weeks and no additional vaccines administered on same date of the Pfizer vaccine. The patient reported that her left arm itched terribly where it was real red at during the third (booster) vaccination. The second vaccination itched and had a mark like a half dollar, and it did not itch like the third one did and that was why she did not report it. No relevant tests were taken for the events. Patient reported that she has blood tests every 3 months. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101472577 same reporter/ patient/vaccine; different dose/ different events
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Fibromyalgia, Immunodeficiency
Clinical narrative: moderate or severe primary immunodeficiency; Fibromyalgia; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 14May2021 as DOSE 2, SINGLE (at the age of: 69-year-old) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date, the patient experienced fibromyalgia and moderate or severe primary immunodeficiency. The outcome of all events was unknown.   Follow-up activities closed. Batch/lot number not available for vaccine/BNT162B2.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report from a contactable consumer (parent). A 24-year-old male patient received the second dose of bnt162b2 (BNT162B2, batch/lot number was not reported), via an unspecified route of administration, administered in Arm Left on 2021 (in May2021 or beginning of Jun2021, administered around 17: 00 or 18:00) (at the age of 24-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The vaccine was administered at a hospital. The patient did not receive any vaccine within four weeks prior to receiving bnt162b2. There patient had no relevant medical history or concomitant medications to report. The reporter stated that the patient has been a healthy kid. The patient previously received the first dose of bnt162b2 (BNT162B2), on May2021 (administered around 17: 00 or 18:00) (at the age of 24-years-old) as DOSE 1, SINGLE for COVID-19 immunisation; he had no reaction to first dose aside from sore arm. The reporter stated that her son had the second vaccine in May2021 or beginning of Jun2021 and experienced myocarditis after the second vaccine dose. He was in the hospital and he is fine for right now. The reporter stated that the patient is stuck with a (currency amount) bill. The reporter was asking about compensation. Two days after his second dose of the vaccine is when he was diagnosed with myocarditis on an unspecified date in 2021. When querying treatment, she reported that he went to the doctor that morning since he was having chest pain, shortness of breath, and dizziness and the doctor gave him a nitro spray in his mouth and sent him off by ambulance. He was given something in the hospital to relax the heart muscle and he was monitored closely. She does not think he was given a lot of medications in the hospital. The patient had EKG (electrocardiogram), echo, and blood draws. The doctors were watching levels in the blood draws, and knows one blood level was high, she is not sure what the name of the blood level for the heart that was high. She stated that the patient had an unusual spike in EKG. The adverse events required a visit to the emergency room and physician office. The patient was followed-up with regular GP (general practitioner) and he had a few follow-ups with the cardiologist. The patient was also hospitalized for 2 days. Outcome of the event myocarditis was recovered on an unspecified date in 2021.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Defaecation disorder, Dysuria, Erectile dysfunction
Clinical narrative: Started taking Nyquil just so he could sleep; Feet and lower body started to get numb; Penis and anus doesn't work, can't control how much he urinates or defecates; Penis and anus doesn't work, can't control how much he urinates or defecates; Hasn't been able to get an erection at all; Had the sweats; Chills; Fever; Cough; Aches and pains; It was just like the flu; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: FC3182), via an unspecified route of administration, administered in the left deltoid on 20Sep2021 13:00 (at the age of 66-years-old) as dose 1, single for COVID-19 immunization. Medical history included allergy to shellfish (he swells up and his throat closes). The patient has no concomitant medications. The patient did not receive any other vaccines prior to the COVID-19 vaccine. he has never gotten the flu shot. He always makes sure to wash his hands and is pretty clean. He doesn't drink and he doesn't smoke. On 20Sep2021 13:00, the patient was off work so he got the COVID-19 vaccine. The patient reported that due to peer pressure, he got the COVID shot and thought it was not a problem. On 21Sep2021, he went back to work and he started feeling bad, had the sweats, chills, fever, cough, and aches and pains. It was just like the flu and he hasn't had that for 20 years. He has never gotten the flu shot. The patient was feverish and it was terrible according to him, he was having to go to be at 19:00. In Oct2021 (3 weeks after the vaccination), the patient's feet and lower body started to get numb. Also, his penis doesn't work and his anus doesn't work (as reported). He hasn't been able to get an erection at all. He never had problems with that before. The patient clarified that these symptoms (sweats, chills, fever, cough, aches and pains) all occurred on 21Sep2021 and that it all lasted for 3 weeks. He has completely recovered completely from all of these symptoms except for the cough. He still has the numbness and it has stayed the same. Then, the urine just drops out and he can't control it at all, he can't control how much he urinates or defecates, that started 3 weeks prior to the report (Oct2021). The patient thought that it would only last maybe a week. That is why he went to the pharmacy and he was told to report these events to Pfizer. The patient started taking Nyquil just so he could sleep. The patient did not visit the emergency room or physician's office since he didn't think the doctor could do anything about a reaction (what was he going to give him). The patient reported that he had gone for a physical and everything was fine and really good for his age. He is a pretty healthy guy. The outcome of events Sweating, Chills, Fever, Pain, Flu-like illness was recovered in Oct2021 (3 weeks after the vaccination) while the outcome of events cough and numbness of lower extremities was not recovered. The outcome of the remaining events was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Influenza like illness, Pain, Pyrexia
Clinical narrative: Started taking Nyquil just so he could sleep; Feet and lower body started to get numb; Penis and anus doesn't work, can't control how much he urinates or defecates; Penis and anus doesn't work, can't control how much he urinates or defecates; Hasn't been able to get an erection at all; Had the sweats; Chills; Fever; Cough; Aches and pains; It was just like the flu; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: FC3182), via an unspecified route of administration, administered in the left deltoid on 20Sep2021 13:00 (at the age of 66-years-old) as dose 1, single for COVID-19 immunization. Medical history included allergy to shellfish (he swells up and his throat closes). The patient has no concomitant medications. The patient did not receive any other vaccines prior to the COVID-19 vaccine. he has never gotten the flu shot. He always makes sure to wash his hands and is pretty clean. He doesn't drink and he doesn't smoke. On 20Sep2021 13:00, the patient was off work so he got the COVID-19 vaccine. The patient reported that due to peer pressure, he got the COVID shot and thought it was not a problem. On 21Sep2021, he went back to work and he started feeling bad, had the sweats, chills, fever, cough, and aches and pains. It was just like the flu and he hasn't had that for 20 years. He has never gotten the flu shot. The patient was feverish and it was terrible according to him, he was having to go to be at 19:00. In Oct2021 (3 weeks after the vaccination), the patient's feet and lower body started to get numb. Also, his penis doesn't work and his anus doesn't work (as reported). He hasn't been able to get an erection at all. He never had problems with that before. The patient clarified that these symptoms (sweats, chills, fever, cough, aches and pains) all occurred on 21Sep2021 and that it all lasted for 3 weeks. He has completely recovered completely from all of these symptoms except for the cough. He still has the numbness and it has stayed the same. Then, the urine just drops out and he can't control it at all, he can't control how much he urinates or defecates, that started 3 weeks prior to the report (Oct2021). The patient thought that it would only last maybe a week. That is why he went to the pharmacy and he was told to report these events to Pfizer. The patient started taking Nyquil just so he could sleep. The patient did not visit the emergency room or physician's office since he didn't think the doctor could do anything about a reaction (what was he going to give him). The patient reported that he had gone for a physical and everything was fine and really good for his age. He is a pretty healthy guy. The outcome of events Sweating, Chills, Fever, Pain, Flu-like illness was recovered in Oct2021 (3 weeks after the vaccination) while the outcome of events cough and numbness of lower extremities was not recovered. The outcome of the remaining events was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Started taking Nyquil just so he could sleep; Feet and lower body started to get numb; Penis and anus doesn't work, can't control how much he urinates or defecates; Penis and anus doesn't work, can't control how much he urinates or defecates; Hasn't been able to get an erection at all; Had the sweats; Chills; Fever; Cough; Aches and pains; It was just like the flu; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: FC3182), via an unspecified route of administration, administered in the left deltoid on 20Sep2021 13:00 (at the age of 66-years-old) as dose 1, single for COVID-19 immunization. Medical history included allergy to shellfish (he swells up and his throat closes). The patient has no concomitant medications. The patient did not receive any other vaccines prior to the COVID-19 vaccine. he has never gotten the flu shot. He always makes sure to wash his hands and is pretty clean. He doesn't drink and he doesn't smoke. On 20Sep2021 13:00, the patient was off work so he got the COVID-19 vaccine. The patient reported that due to peer pressure, he got the COVID shot and thought it was not a problem. On 21Sep2021, he went back to work and he started feeling bad, had the sweats, chills, fever, cough, and aches and pains. It was just like the flu and he hasn't had that for 20 years. He has never gotten the flu shot. The patient was feverish and it was terrible according to him, he was having to go to be at 19:00. In Oct2021 (3 weeks after the vaccination), the patient's feet and lower body started to get numb. Also, his penis doesn't work and his anus doesn't work (as reported). He hasn't been able to get an erection at all. He never had problems with that before. The patient clarified that these symptoms (sweats, chills, fever, cough, aches and pains) all occurred on 21Sep2021 and that it all lasted for 3 weeks. He has completely recovered completely from all of these symptoms except for the cough. He still has the numbness and it has stayed the same. Then, the urine just drops out and he can't control it at all, he can't control how much he urinates or defecates, that started 3 weeks prior to the report (Oct2021). The patient thought that it would only last maybe a week. That is why he went to the pharmacy and he was told to report these events to Pfizer. The patient started taking Nyquil just so he could sleep. The patient did not visit the emergency room or physician's office since he didn't think the doctor could do anything about a reaction (what was he going to give him). The patient reported that he had gone for a physical and everything was fine and really good for his age. He is a pretty healthy guy. The outcome of events Sweating, Chills, Fever, Pain, Flu-like illness was recovered in Oct2021 (3 weeks after the vaccination) while the outcome of events cough and numbness of lower extremities was not recovered. The outcome of the remaining events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Interchange of vaccine products, Off label use, Pyrexia, Vomiting
Clinical narrative: Took Johnson & Johnson vaccine on March 13th 2021, took Pfizer booster on 10/22/21; Took Johnson & Johnson vaccine on March 13th 2021, took Pfizer booster on 10/22/21; Fever; Vomiting; Very sick for four days; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCIN), via an unspecified route of administration on 22Oct2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN (BOOSTER), SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Patient took Johnson & Johnson vaccine on 13Mar2021. The patient experienced took johnson & johnson vaccine on march 13th 2021, took pfizer booster on 22Oct2021, fever in Oct2021, vomiting in Oct2021, very sick for four days in Oct2021.Outcome of fever vomiting very sick was recovered in Oct2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Immunisation
Clinical narrative: Noticed bump underneath armpit; A lot of pain under armpit; Booster; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Oct2021 as dose 3 (booster), single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration on an unspecified date as dose 1, single and via an unspecified route of administration on an unspecified date as dose 2, single both doses for COVID-19 immunization. It was reported that she received a booster dose of the Pfizer COVID vaccine on Wednesday 27Oct2021 and yesterday on 28Oct2021 noticed a bump under her armpit that she never had until she got the vaccine and a lot of pain in that area. She would like to know if this was a side effect from the vaccine and how long it might last. She stated to them that the top of her arm where the shot was given it hurts as well. She stated yesterday on 28Oct2021 it was a big bump under her armpit and she noticed that it was still but not as big as yesterday. She stated she just wanted to know if she should be alarmed or if it was normal and would go away as she has not had this before. She declined to provide age but was a female. She stated she had to leave to go to the dentist. Response received as Read from attached documents. According to Section 6 overall safety summary In a clinical study of participants 18 through 55 years of age, the most commonly reported adverse reactions (>10%) following administration of a booster dose were pain at the injection site. In clinical studies of participants 16 years of age and older, adverse reactions following administration of the primary series included pain at the injection site and lymphadenopathy. Informed caller no specific information in regarding how long a bump under arm may last. The outcome of the events was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further in-formation is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Hypersensitivity, Pruritus
Clinical narrative: Anaphylaxis; allergic reactions; She began feeling an itching sensation all over; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist (patient) reported that a 49-old-year female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Oct2021 between 5:30 and 6:00 PM (Batch/Lot Number: EW0178) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced anaphylaxis and allergic reactions on an unspecified date. On 28Oct2021, she began feeling an itching sensation all over, declined hives. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Immunisation, Off label use
Clinical narrative: I got my booster yesterday; I got my booster yesterday; arm started to hurt from the injection site; I woke up with trouble chills;  there were lot of chills; Headache; I had a pain on my lower right side by my waist going towards the back; still have that pain on my right side in the back; Fever; first this was 99 and then it was 100; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on 28Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on unspecified date as DOSE 1, SINGLE for covid-19. immunisation. Also, patient has received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on unspecified date as DOSE 2, SINGLE for covid-19. The patient medical history and concomitant medications were not reported. On an unspecified date in Oct2021, the consumer stated, okay it is not urgent or anything. I got my booster yesterday my Pfizer booster and I seem to be fine and then last night my arm started to hurt from the injection site but then in the middle of the night, I woke up with trouble chills and I had a headache. I got a headache. I am not sure if that was just from the weather but yeah there were lot of chills are very (Incomplete Sentence). That my pain and stuff. I had a pain on my lower right side by my waist going towards the back not revolving the back. So at 2 o clock in the morning, I took the sheet of medicine (Further clarification unknown) and not seems to help (Further not clarified) so I still have that pain on my right side in the back. Consumer further stated, I also had a fever this morning. Well first this was 99 and then it was 100 but I was not going to take it again (Not clarified) but I thought I take an Ibuprofen. The patient underwent lab tests and procedures which included body temperature: 99 and 100 Fahrenheit on an unspecified date. The outcome for the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: I got my booster yesterday; I got my booster yesterday; arm started to hurt from the injection site; I woke up with trouble chills;  there were lot of chills; Headache; I had a pain on my lower right side by my waist going towards the back; still have that pain on my right side in the back; Fever; first this was 99 and then it was 100; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on 28Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on unspecified date as DOSE 1, SINGLE for covid-19. immunisation. Also, patient has received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on unspecified date as DOSE 2, SINGLE for covid-19. The patient medical history and concomitant medications were not reported. On an unspecified date in Oct2021, the consumer stated, okay it is not urgent or anything. I got my booster yesterday my Pfizer booster and I seem to be fine and then last night my arm started to hurt from the injection site but then in the middle of the night, I woke up with trouble chills and I had a headache. I got a headache. I am not sure if that was just from the weather but yeah there were lot of chills are very (Incomplete Sentence). That my pain and stuff. I had a pain on my lower right side by my waist going towards the back not revolving the back. So at 2 o clock in the morning, I took the sheet of medicine (Further clarification unknown) and not seems to help (Further not clarified) so I still have that pain on my right side in the back. Consumer further stated, I also had a fever this morning. Well first this was 99 and then it was 100 but I was not going to take it again (Not clarified) but I thought I take an Ibuprofen. The patient underwent lab tests and procedures which included body temperature: 99 and 100 Fahrenheit on an unspecified date. The outcome for the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Pyrexia, Tremor
Clinical narrative: Blood pressure gone sky high; Shaking like a leaf on a tree; Got a high temperature and high fever; This is a spontaneous report from a contactable consumer (Patient).   A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date, the patient experienced blood pressure gone sky high, shaking like a leaf on a tree and got a high temperature and high fever. She stated, she never had problem with her first dose but the second dose threw her up a loop because she was shaking bad all over and got a high fever and blood pressure gone sky high. The events were non-serious. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Had a sore arm for a couple of days; This is a spontaneous report from a contactable consumer (patient).   A 75-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose 1, single and received BNT162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. Patient relevant medical history includes allergic to penicillin and allergic to sulfa. The patient concomitant medications were not reported. The patient received the first and second dose of the vaccine and was scheduled to get the booster. Patient asked if the ingredients was the same in the booster as the first two doses. The patient was allergic to Penicillin and Sulfa so the patient wants to make sure it was the exact same thing. The patient had a sore arm for a couple of days with the first two doses. The outcome of the event was unknown.   No follow-up attempts are possible. No further information expected
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: had a stroke; This is a spontaneous case from a contactable consumer (patient). This 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via unspecified route in left arm on Apr2021 at 11:00 AM at patient age of 60-year-old, as single dose (Lot Number: ER8735) for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient medical history was none. The patient had none known allergies. The patient concomitant medications included hydrochlorothiazide, acetylsalicylic acid (ASPIRIN), cetirizine hydrochloride (ZYRTEC). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via unspecified route in left arm on Mar2021 at 11:00 AM at patient age of 60-year-old, as single dose (Lot Number: EP7533) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had a stroke on 25Apr2021 17:00 PM. He had no idea whether this was a coincidence or was connected to the shot. However, due to the proximity in time to the second covid shot, the patient thought that this event might be related. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 3 days. The patient did not receive treatment. COVID not tested post vaccination. The patient recovered from the event in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Receiving a "Cortizone" shot on her foot.; This is a spontaneous report from an agency. This is a spontaneous report from an agency. A 77-year-old consumer female received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number -not reported) via unspecified route of administration as dose 2, single and first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number -not reported) via unspecified route of administration (age at vaccination 77 years) for covid 19 immunization. The patient medical history and concomitant's medications were not reported. Patient was scheduled to take her booster shot on Monday 01Nov2021 as well as receiving a Cortizone shot on her foot. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Psoriasis, SARS-CoV-2 test
Clinical narrative: Guillian Barre syndrome; numbing in hands and feet; psoriasis to legs; This is a spontaneous report from a contactable consumer (patient). A 35-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 15Sep2021 (Batch/Lot Number: 301308A) as dose 2, single (at the age of 35-years-old) for Covid-19 immunisation. There were no medical history and no concomitant medications. The patient had no known allergies. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 25Aug2021 (Batch/Lot Number: FC3184) as dose 1, single (at the age of 35-years-old) for Covid-19 immunisation. 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. The patient experienced numbing in hands and feet - progressed to psoriasis to legs - currently in hospital being treated for Guillian Barre syndrome, on 07Oct2021. The patient's hospitalization was prolonged as a result of guillian barre syndrome, numbing in hands and feet and psoriasis to legs. The patient underwent lab tests and procedures which included SARS-COV-2 test via nasal swab: negative on 23Oct2021. Therapeutic measures were taken as a result of the events which included IVIG - and therapy. The outcome of the events was not resolved. This report is serious (caused/prolonged hospitalization). The events resulted in: Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Lacunar infarction, SARS-CoV-2 test, Transient ischaemic attack
Clinical narrative: Acute lacunar infarction; suffered a mini stroke; This is a spontaneous report from a contactable consumer (patient).   A 62-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm Left on 10Apr2021 13:00 (Batch/Lot Number: EW0151) at the age of 61-years-old as DOSE 2, SINGLE for COVID-19 immunization at the Pharmacy or Drug Store.  Medical history included asthma and arthritis. Concomitant medications included gliclazide (CLARITIN); mometasone furoate (ASMANEX); and assorted vitamin Cs all taken for unspecified indications and therapy dates. The patient received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) on 20Mar2021 at 03:00 PM (Batch/Lot No: ED6955) at the age of 61-years-old administered on the Arm Left for COVID-19 immunization. Then, received the 2nd dose on 10Apr2021 13:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Aug2021 10:30, the patient suffered a mini stroke as he had acute lacunar infarction. The event required Emergency room/department or urgent care visit and later admitted in the hospital in 2021. The patient received metoprolol and atorvastatin as treatment. The patient also had negative nasal swab on 08Aug2021.  The patient was discharged and recovered from the event in 2021  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Immunisation, Insomnia
Clinical narrative: This is a spontaneous report received from a contactable consumer (Patient). A 40-years-old male patient received third booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in Arm right on 28Oct2021 13:15 (at the age of 40-years-old) as dose 3 (booster), single for covid-19 immunisation and also received covid-19 vaccine (mrna 1273) (MODERNA COVID-19 VACCINE, Batch/Lot number: Unknown), via an unspecified route of administration, administered in Arm left on 28Oct2021 as dose 3 (booster), single for covid-19 immunisation. Medical history included colitis ulcerative, allergy from kiwi, penicillin from an unknown date, and unknown if ongoing. Concomitant medications received within two weeks included MESALAMINE and POLYETHYLENE GLYCOL both taken for an unspecified indication, start and stop date were not reported for any. The patient previously received first dose of moderna covid-19 vaccine on 17Mar2021 (at the age of 39-years-old) for covid-19 immunisation and received second dose of moderna covid-19 vaccine administered in arm right on 07Apr2021 (at the age of 40-years-old) for covid-19 immunisation and also received Cefdinir and experienced drug hypersensitivity. Patient received vaccine facility in public health clinic/veterans. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient denied for any other vaccine in four weeks. On 29Oct2021 01:00, the patient had severe diarrhea, similar to colonoscopy prep for which patient drank plenty of water but still was weak, lightheaded and could not sleep the entire night due to complications. The reporter considered the event as non-serious. It was reported that ae resulted in emergency room/department or urgent care for examination. The patient did not received any treatment for the events. The patient underwent lab tests and procedures which included examination with unknown results on an unspecified date. The outcome of the events was reported as recovering. Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Investigation, Off label use, Product use issue
Clinical narrative: This is a spontaneous report received from a contactable consumer (Patient). A 40-years-old male patient received third booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in Arm right on 28Oct2021 13:15 (at the age of 40-years-old) as dose 3 (booster), single for covid-19 immunisation and also received covid-19 vaccine (mrna 1273) (MODERNA COVID-19 VACCINE, Batch/Lot number: Unknown), via an unspecified route of administration, administered in Arm left on 28Oct2021 as dose 3 (booster), single for covid-19 immunisation. Medical history included colitis ulcerative, allergy from kiwi, penicillin from an unknown date, and unknown if ongoing. Concomitant medications received within two weeks included MESALAMINE and POLYETHYLENE GLYCOL both taken for an unspecified indication, start and stop date were not reported for any. The patient previously received first dose of moderna covid-19 vaccine on 17Mar2021 (at the age of 39-years-old) for covid-19 immunisation and received second dose of moderna covid-19 vaccine administered in arm right on 07Apr2021 (at the age of 40-years-old) for covid-19 immunisation and also received Cefdinir and experienced drug hypersensitivity. Patient received vaccine facility in public health clinic/veterans. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient denied for any other vaccine in four weeks. On 29Oct2021 01:00, the patient had severe diarrhea, similar to colonoscopy prep for which patient drank plenty of water but still was weak, lightheaded and could not sleep the entire night due to complications. The reporter considered the event as non-serious. It was reported that ae resulted in emergency room/department or urgent care for examination. The patient did not received any treatment for the events. The patient underwent lab tests and procedures which included examination with unknown results on an unspecified date. The outcome of the events was reported as recovering. Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeding disorder, Gastrooesophageal reflux disease, Investigation, Oesophagoscopy
Clinical narrative: Gastrointestinal esophagus flare; pain; chest pain; unable to eat; This is a spontaneous report from a contactable consumer. A 41-year-old female consumer (patient) reported for herself that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9269) via an unspecified route of administration in arm left on 25Feb2021 (at the age of 41-year-old) at single dose for COVID-19 immunisation. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL8982) in arm left on 04Feb2021 for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Relevant medical history included allergy to iodine and sulfa medicine. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 17Mar2021 the patient experienced gastrointestinal oesophagus flare, pain, chest pain, unable to eat. All started two weeks after last shot and while severed from March through July, still going on. The events were serious due to disability and resulted in Doctor or other healthcare professional office/clinic visit and Emergency Room visit. The patient underwent heart tests, esophagus scope and other tests (unspecified). The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The events were not resolved at the time of report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Gastrointestinal esophagus flare; pain; chest pain; unable to eat; This is a spontaneous report from a contactable consumer. A 41-year-old female consumer (patient) reported for herself that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9269) via an unspecified route of administration in arm left on 25Feb2021 (at the age of 41-year-old) at single dose for COVID-19 immunisation. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL8982) in arm left on 04Feb2021 for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Relevant medical history included allergy to iodine and sulfa medicine. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 17Mar2021 the patient experienced gastrointestinal oesophagus flare, pain, chest pain, unable to eat. All started two weeks after last shot and while severed from March through July, still going on. The events were serious due to disability and resulted in Doctor or other healthcare professional office/clinic visit and Emergency Room visit. The patient underwent heart tests, esophagus scope and other tests (unspecified). The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The events were not resolved at the time of report.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast pain, Chest pain, Nausea
Clinical narrative: Pain in chest; Nauseous; Pain under the breast; Back ache; This is a spontaneous report from a non-contactable consumer. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 25Oct2021 18:00 (at 27 years old) as dose 2, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date. Concomitant medications were not reported. Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received the first dose o of BNT162B2 on 13Sep2021 (at 27 years old) for COVID-19 immunization. On 25Oct2021, the patient experienced pain in chest, nauseous, pain under the breast, and back ache. The adverse events resulted in a doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included Robaxin.   No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Nasal congestion
Clinical narrative: Covid 19 virus; Covid 19 virus; tired; feels like she has some congestion; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 2021 (at the age of 61 years old) (Batch/Lot number was not reported) as dose 2, single, the first dose via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included influenza vaccine (FLU) taken for an unspecified indication in Sep2021.  Patient received the shots in the spring (unspecified date in 2021) and at the beginning of Sep2021 she was hospitalized with the COVID virus for 15 days. Regarding the COVID virus, even though she was hospitalized, she mentioned it wasn't that severe. The patient clarified that she was actually hospitalized 2 separate times for 7 days each, once at the beginning of Sep2021 and once at the end of Sep2021. She was discharged on 01Oct2021. During this hospitalization she lost her vaccination card and mentioned she can't get her booster without her card. On an unspecified date in 2021, when the patient was asked if she has completely recovered from COVID she said she was real tired and feels like she has some congestion but is feeling much better. She will be going to her doctor next week regarding this. The event COVID virus resulted in an emergency room and physician office visit, the rest of the events resulted in a physician office visit. The outcome of the events was recovering.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.