chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Herpes zoster
Clinical narrative: Shingles/ it came on pretty severe all around her back, fore and front of the upper chest; Shingles/ it came on pretty severe all around her back, fore and front of the upper chest; This is a spontaneous report received from a contactable consumer (patient's child). An 87-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on an unspecified date (Lot: EN5318) as 1 st dose, single then on 27Feb2021 (Lot: EL9260) as 2 nd dose, single; both via an unspecified route of administration in left arm (at the age of 87-years-old) for covid-19 immunisation. Medical history included blood cholesterol, hypertension, heartburn and very small outbreak of shingles (35-40 years ago). Concomitant medications included amlodipine for hypertension; losartan for hypertension; omeprazole for heartburn and simvastatin for cholesterol. The patient had no investigation assessment. The patient had reaction after the second shot was shingles on 11Mar2021. The patient had shingles virus obviously in her system, viruses remain dormant, like that in the system. So her virus shingles was in her system. The patient's child guessed 35-40 years ago when she had a very small outbreak of shingles and then this time after the second shot it came on pretty severe all around her back, fore and front of the upper chest. The patient's child wanted to make sure that this was reported because he/she did think there was relation to it and think that people have them reporting the same thing. The patient's child stated, "She still has some facing from it I mean the shingles, I have not asked it anymore but she still has the after nerve sensation, you know that you get after shingles, yes; she still has some of the nerve sensation. That's common after shingles." On treatment for event, the patient's doctor called in a liquid medication that she took for a week for shingles, didn't have that name and bottle, also prescribed the pill that she could take in the evening if she need before bed called gabapentin was for when she had the nerve pain obviously standing on virus after shingle taken as needed prior to bed. Well the liquid was for to address the shingle that they were after shingle and the gabapentin was for her to take when she had that nerve pain obviously standing from the shingles virus, taken as needed prior to that. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nasal congestion
Clinical narrative: tested positive on  22Apr2021; a mild case with a stuffy nose; This is a spontaneous report from a contactable consumer (Patient) and received from a Pfizer sponsored program. A 52-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 12Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported tested positive on 22apr2021 and a mild case with a stuffy nose on Apr2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event tested positive on 22apr2021 was not recovered while for another event it was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: a steadily increase on his blood sugar; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. On an unspecified date after receiving the vaccine, the patient experienced a steadily increase on his blood sugar which arrived to glucose values nearing 575. The  patient would like to note there was no change in his diet or routine, and his conclusion was that it had to be a possible side effect from the vaccine. The outcome of the event a steadily increase on his blood sugar was not recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo, Vision blurred
Clinical narrative: Feeling dizzy; blurred vision; vertigo; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asked if the vaccine contains polyethylene glycol and sulfur. She also mentioned that she had an immediate response to the first dose. The patient experienced feeling dizzy, blurred vision and vertigo on an unspecified date. The events lasted for about 4 hours but got better. The patient said she is hesitant in getting the second. Outcome of the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid on 19Apr2021; This is a spontaneous report from a contactable Pharmacist. A 66-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tested positive for covid on 19apr2021. patient asked what is the acceptable time frame for the patient to receive the second dose or does he need to start the series over. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 19Apr2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives around the jaw and back; This is a spontaneous report from a Pfizer sponsored program . A contactable female consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 23Apr2021 at a single dose for COVID-19 immunization. Medical history included allergies to medication. The patient's concomitant medications were not reported.  The patient experienced hives around the jaw and back on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient experienced chills on 02May2021, 24hours after the second dose but then it went away. The outcome of the event was recovered in May2021.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021510504 Same reporter/drug, different patient/event.
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Nausea
Clinical narrative: Diarrhea; Nauseated; Tired; No appetite; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration in Apr2021 (3 weeks ago as reported) at a single dose for COVID-19 immunization. Other medications included treprostinil sodium (TYVASO), nasal from 09Mar2021 and ongoing, at 0.6 mg/ml, 4times a day via inhalation for pulmonary arterial hypertension and macitentan (OPSUMIT). Medical history included pulmonary arterial hypertension from 09Mar2020 and ongoing. Concomitant medications included warfarin sodium (COUMADIN SODIUM) and tadalafil (TADALAFIL). The patient experienced diarrhea, nauseated, tired and no appetite in Apr2021. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: it was painful where he was given the COVID vaccine but he had no symptoms; This is a spontaneous report from a contactable consumer (patient).   An adult male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient had received the first dose of vaccine on unknown date at the top of the arm and had minimal to no pain (only some swelling upon administration). The patient medical history and the patient's concomitant medications were not reported.  The patient experienced "it was painful where he was given the covid vaccine but he had no symptoms" (vaccination site pain) on an unspecified date with outcome of unknown.    The clinical course was as follows, "cold transfer from unknown department and caller says that he has symptoms but the whole thing started when he had his first COVID vaccine and he felt nothing. With his second shot he is not sure about it. The guy who gave the caller his second COVID vaccine did it on the side of his arm and the caller had doubts that it may of not gone in all the way into his muscle and let's just say it didn't- so put that question on the side. Then it was painful where he was given the COVID vaccine but he had no symptoms. Then a week or so later, and now, he has a little bit of pain there or a sensation."  No follow-up attempts are needed; Information related to batch/Lot number could not be requested.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: A  female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 26Apr2021 at 10:00 (Batch/Lot number was not reported)(at the age of 93-year-old) as single dose for COVID-19 immunisation.  Medical history included anaphylactic shock and blood cholesterol abnormal, both from an unknown date and unknown if ongoing and total knee replacement in 2009. Concomitant medications included simvastatin taken for blood cholesterol abnormal, start and stop date were not reported; furosemide (LASIX) taken for diuretic therapy, start and stop date were not reported and potassium taken for an unspecified indication, start and stop date were not reported.  The patient reported that around on 26Apr2021 at 21:00 she experienced diarrhea. She said that she has had it 8-10 times, and she was just a little bit nauseous. The patient outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Severe headache/His headache is severe it feels like he is being hit on one onside of his head; Fever; Fatigue; He feels like its shocking his body because of the pain all over, his body shakes because of the pain.; He feels like its shocking his body because of the pain all over, his body shakes because of the pain.; Diarrhea; This is a spontaneous report from a contactable consumer (patient).  A 44-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 22Apr2021 at 44 years old as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, fever, fatigue, shaking, pain and diarrhea in Apr2021 with outcome of not recovered. The patient reported severe headache, a fever and fatigue, not sure when he will get relief. The patient wanted to know when he will get some kind of relief. His headache was severe it feels like he was being hit on one onside of his head. He felt like it was shocking his body because of the pain all over, his body shaked because of the pain. He was surviving on Tylenol and Ibuprofen right now. The patient clarified having a maybe a little diarrhea along with the pain all over, fever, fatigue and severe headache.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Severe headache/His headache is severe it feels like he is being hit on one onside of his head; Fever; Fatigue; He feels like its shocking his body because of the pain all over, his body shakes because of the pain.; He feels like its shocking his body because of the pain all over, his body shakes because of the pain.; Diarrhea; This is a spontaneous report from a contactable consumer (patient).  A 44-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 22Apr2021 at 44 years old as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, fever, fatigue, shaking, pain and diarrhea in Apr2021 with outcome of not recovered. The patient reported severe headache, a fever and fatigue, not sure when he will get relief. The patient wanted to know when he will get some kind of relief. His headache was severe it feels like he was being hit on one onside of his head. He felt like it was shocking his body because of the pain all over, his body shaked because of the pain. He was surviving on Tylenol and Ibuprofen right now. The patient clarified having a maybe a little diarrhea along with the pain all over, fever, fatigue and severe headache.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: All of her body aches; Chills; This is a spontaneous report from a contactable consumer (patient's husband) reported for his wife.    A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included heart murmur, asthma. Concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation without adverse event. On an unspecified date, the patient experienced all of her body aches, chills. Therapeutic measures were taken as a result of the events included Tylenol. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness; Little swelling; Continuous itching; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation with no adverse effect. The patient experienced redness (non-serious) on an unspecified date with outcome of unknown, little swelling (non-serious) on an unspecified date with outcome of unknown, continuous itching (non-serious) on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myositis, Vaccination site inflammation, Vaccination site pain
Clinical narrative: Site of injection really hurts; Site and muscle were all inflamed; Site and muscle were all inflamed; This is a spontaneous report from a contactable consumer (patient). A 55-years old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on 26Apr2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the site of injection really hurts and site and muscle were all inflamed. Caller stated that the site of the injection really hurts and she just wanted to know should she use a cold compress or warm compress. Clinical outcome of the events was unknown at time of this report.   No follow-up attempts are needed, information about batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeding disorder, Nausea, Vomiting
Clinical narrative: Shortness of breath; Can't eat; Lightheaded; Nauseated; Throwing up; This is a spontaneous report from a contactable consumer, the patient. This 57-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161; Expiration Date: 31Jul2021), via an unspecified route of administration in the right arm on 17Apr2021 14:30 (at the age of 57-year-old) as a single dose for COVID-19 immunization. The patient was not enrolled in any clinical study or program. Medical history included ongoing chronic obstructive pulmonary disease (COPD), ongoing Crohn's disease, ongoing diabetes mellitus, ongoing neuropathy peripheral, and ongoing liver disorder. The patient had allergic to a lot of antibiotics; she is allergies to metronidazole, Compazine, she is very highly allergic to Compazine, Penicillin, Augmentin, Bactrim, Iodine, Sulfa, IV contrast (iodine), Prozac and Avelox; the allergies to these medications occurred years ago with the same type of reactions with all these medications: Her throat closes up, she turns black and blue (bruising), or she vomits. Concomitantly, the patient takes medications but does not feel her medications are relevant. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730, Expiry Date: 31Jul2021); via an unspecified route of administration in the left arm on 27Mar2021 at 14:30 (at the age of 57-year-old) as a single dose for COVID-19 immunization. The patient reported she had her second Covid 19 vaccine on 17Apr2021, it seems like the next day on 18Apr2021, she didn't feel that good where she has been nauseated, lightheaded, throwing up, can't eat and has shortness of breath. Every day it seems worse. She doesn't know if she's sick with something else or if it's the vaccine. She called and spoke with her doctor and her doctor didn't know if her symptoms were related to the Covid 19 vaccine or maybe she had bronchitis or COPD (since she does have a history of COPD). No investigation assessment reported. The patient also called her liver doctor who told her to call and report her symptoms to Pfizer. Her symptoms are still persisting. The clinical outcomes of the events, nauseated, lightheaded, throwing up, can't eat and has shortness of breath were not resolved.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: They have had every symptom from COVID.; This is a spontaneous report from a contactable consumer. This consumer (husband) reported for a 53-year-old female patient (wife) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Right on 24Apr2021 (at the age of 53-year-old) as 1st, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller wanted to know what should he and his wife would do if they developed "every symptom on the list" of COVID-19 after receiving the first dose of the COVID-19 vaccine, as On 25Apr2021, they both had a "pretty severe" reaction, his reaction was "coming down quite a bit" but his wife´s reaction was not coming down as quick. Within 24 hours of after receiving the first dose of the Pfizer COVID-19 vaccine their symptoms started growing like if they got the shot and got the virus at the same time. During the call he mentioned that maybe the virus was on their systems for weeks or months but did not activate until they received the shot. Caller is trying to figure out the shot he got. On the 24Apr2021, Saturday, he and his wife went to an open vaccination clinic where they didn't have to have appointments. They both got the shot Saturday, and by Sunday afternoon, the next day, they were both getting sick. Now for the last week they have been sick as a dog. They have had every symptom from COVID. They were told that someone can't catch COVID from the vaccine. That is not true. What is he supposed to do Is it safe for them to go out after this sickness or cold? Pfizer needs to change the information that says people cannot get COVID. Him and his wife both have symptoms of COVID. Can they get the virus from the vaccine. It is unlikely both had it before the shot. He did not have diabetes, and he doesn't take medications. He has no health problems. He did not have a prescribing doctor. He went through the city's vaccination site. His COVID symptoms are improving. His wife's COVID symptoms are slowly improving. Caller has not received treatment. Him nor his wife have gone to the doctor or ER, not yet. He got the vaccine in his left arm. He had no diabetes, no heart problems, and no high blood pressure. They were feeling perfectly fine. They figured they may have to travel to Germany out of the blue to see family, so they better get vaccinated. The outcome for the event the patient experienced they have had every symptom from covid was recovering.  Follow up #1 (03May2021): This is a follow up-spontaneous report received from a contactable consumer reported for the patient via follow-up letter which included: event details and clinical information.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021494357 same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Hypoaesthesia, Pulmonary pain, Pyrexia
Clinical narrative: feel kind of little bit of pain in my heart, I feel like in my lung; feel kind of little bit of pain in my heart, I feel like in my lung; got huge swelling under my neck on the left side/ swelling in the back; some pain in my chest; left arm has got kind of also very numb I cannot hold stuff with my left arm; Fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 07Apr2021 (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated, "I took second shot of Pfizer vaccine COVID 19, for COVID it was almost 07Apr2021 and right after that a period later I got huge swelling under my neck on the left side and I took the vaccine on the left arm also and then I had huge fever also for basically 24 hours and recently I have been experiencing swelling in the back and also some pain in my chest and today my left arm has got kind of also very numb I cannot hold stuff with my left arm and sometimes I also feel kind of little bit of pain in my heart, I feel like in my lung. So, I don't know whom I should go visit to show me. Do these symptoms make sense is it dangerous or not?" The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: feel kind of little bit of pain in my heart, I feel like in my lung; feel kind of little bit of pain in my heart, I feel like in my lung; got huge swelling under my neck on the left side/ swelling in the back; some pain in my chest; left arm has got kind of also very numb I cannot hold stuff with my left arm; Fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 07Apr2021 (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated, "I took second shot of Pfizer vaccine COVID 19, for COVID it was almost 07Apr2021 and right after that a period later I got huge swelling under my neck on the left side and I took the vaccine on the left arm also and then I had huge fever also for basically 24 hours and recently I have been experiencing swelling in the back and also some pain in my chest and today my left arm has got kind of also very numb I cannot hold stuff with my left arm and sometimes I also feel kind of little bit of pain in my heart, I feel like in my lung. So, I don't know whom I should go visit to show me. Do these symptoms make sense is it dangerous or not?" The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: heart rate elevated really bad; This is a spontaneous report from a contactable consumer(patient). A 33-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date unknown), via an unspecified route of administration, in right arm on 12Apr2021 (at the age of 33-years-old), at a single dose for COVID-19 immunization. The patient did not have any medical history or concomitant medications. The patient's heart rate elevated really bad 3 hours after vaccination on 12Apr2021. The event resulted in emergency room visit on 14Apr2021. The outcome of the event was recovered after a week in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: The patient medical history and concomitant medications were not reported. Patient was asked that, "I got my first vaccine on March 26th and then the following, on April 6th I tested positive for Covid. my second dose was supposed to be on April 16th but I was still positive. I was positive through April 23rd. I am no longer positive, What do I do with the second shot". The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Mobility decreased, Myalgia, Pain
Clinical narrative: the muscle aches and pain; felt horrible; could not get out of bed; the muscle aches and pain; This is a follow up-spontaneous report from a contactable patient who reported that a patient of 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unspecified route of administration on 21Apr2021 09:00 at single dose for COVID-19 immunization. Medical history reported was ongoing high cholesterol and it is controlled by medication. Concomitant medication reported was cholesterol for high cholesterol. Anatomical location was reported as left. History of all previous immunization with the Pfizer vaccine considered as suspect, Prior Vaccinations (within 4 weeks) and additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as None. Caller received the first dose of the Pfizer-BioNTech COVID-19 Vaccine last 21Apr2021, at 9AM and mentioned by 9PM, she felt horrible. Caller mentioned she could not get out of bed, as if somebody beat her up. Caller took Tylenol for the pain. Two weeks later, the muscle aches and pain still persisted. Caller mentioned she will be receiving the next dose pretty soon, on 12May2021. She stated also that she was taking medications for high cholesterol. Offered to transfer to Safety, but Caller declined because she is busy. Consumer called regarding the Pfizer COVID 19 vaccine. Stated she got the first dose of the vaccine last week, when ask to provide the exact date and time she states she doesn't remember and does not have this information. Caller stated after the shot for three days she was in so much pain she can't get up; every morning that she wakes up she was in pain; all her muscles are hurting like someone hit her with a baseball bat and this in not normal. She was asking what if she get the second one and it gets worse. Regarding Muscle Pain patient stated she got the shot two weeks ago at about 0900AM and by 2100PM at that night it was horrible. It has continued to hurt; it is the same and sometimes worse especially when she wakes up in the morning. It was reported treatment was two weeks ago and caller does not have vaccination card with her to provide NDC, lot or expiration date. Caller mentioned the only thing she has high cholesterol, and it was controlled by medication. Caller attempts to provide a name of a product but was unsure of the spelling or pronunciation and stated it was cholesterol medication. Outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: she had COVID-19; Tested positive COVID; Fever; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Left on 03Apr2021 11:30 (Batch/Lot Number: EW0150) as SINGLE DOSE for covid-19 immunisation. Patient medical history was not reported. Concomitant medications included influenza vaccine (FLU). The patient experienced fever on 11Apr2021. Patient stated, she received the first dose of the vaccine on 03Apr2021 and on 09Apr2021 she was tested for COVID and on 11Apr2021 she got the results for being positive for COVID. The COVID 19 vaccine lot number is EW0150 and unknown expiry date and NDC number. Patient clarified that herself and family mem-bers tested positive for COVID 1 week after getting the first dose of the COVID 19 vaccine and then tested negative 2 weeks after that. Patient stated the appointments had to be rescheduled for the second dose of the vaccine. Patient asked what was the best time to get the second dose of the COVID 19 vaccine or does it matter. Patient stated people keep asking her why she was getting the second shot since she had the antibodies already that the second shot would be giving her. Patient asked should she try to get the second dose at all. Therapeutic measures were taken as a result of events. Patient stated she took Advil for fever and also got an albuterol inhaler. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Apr2021 positive. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizzy; Nauseous; This is a spontaneous report received from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported that a 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unspecified route of administration on 04May2021 13:00 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received BNT162B2 for covid-19 immunization. It was reported that caller and her husband received the second dose of the Pfizer Covid-19 vaccine around 1 p.m. today. Caller stated that her husband started feeling dizzy and nauseous around 7-7:30 p.m. Caller stated the onset of these symptoms occurred very quickly. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Depression, Feeling abnormal, Irritability, Neuropathy peripheral
Clinical narrative: Neuropathy; Feel crazy; Irritable; Depression; Feel extremely agitated and unstable; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 23Apr2021 (10:00) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included type 1 diabetes; peripheral neuropathy; autonomic neuropathy; and clinical depression. The patient was not pregnant at the time of vaccination. Concomitant medications included propranolol, gabapentin, metformin and duloxetine hydrochloride (CYMBALTA). On 23Apr2021 (18:00), the patient had neuropathy; had felt crazy; was irritable; had depression; and had felt extremely agitated and unstable. The outcome of the events was not recovered. The patient had no COVID-19 prior to vaccination, and had not been tested post-vaccination.  Information on lot/batch number was available. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination
Clinical narrative: Hallucinations; This is a spontaneous report from a contactable consumer, reporting for herself. A 65-year-old non-pregnant female patient received the second dose of the bnt162b2 (BNT162B2), via an unspecified route of administration in Apr2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (Lot Number: ER8729) at 65 years of age on 06Apr2021 at 9:30AM for covid-19 immunization and experienced slurred speech and confusion for a week starting 07Apr2021 12:00AM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In Apr2021, the patient experienced hallucinations. Prior to and since the vaccination, the patient was not diagnosed with COVID-19. The clinical outcome of the event was unknown.    The batch/lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heavy menstrual bleeding, Lethargy, Menstruation irregular, Nausea
Clinical narrative: breakthrough bleeding/Bleeding heavily with large clots; period started 1 day later with breakthrough bleeding; nausea; headache; lethargic; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ew0169), via an unspecified route of administration, administered in Left arm on 17Apr2021 at 13:45 (at the age of 45-year-old) at single dose for COVID-19 immunisation. Medical history reported as no. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included probiotic (probiotics nos); daily vitamins; birth control pills. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: er8730), administered in left arm on 27Mar2021 at 10:00 AM (at the age of 45-year-old) at single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, headache and lethargic, all on 17Apr2021; and period started 1 day later (18Apr2021) with breakthrough bleeding. Bleeding heavily with large clots beginning 25Apr2021 and still happening 4 days later. Normal period lasts 6 days with 2 heavy days, 3 regular days and one light day. Since the vaccination, patient had not been tested for COVID-19. The outcome of the events was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Facial spasm, Palpitations
Clinical narrative: Facial spasms left side of forehead starting 72 hours; Heart palpitations around 80 hours after second dose; This is a spontaneous report from a non-contactable consumer (patient). A 47-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0169), via an unspecified route of administration, administered in Left arm on 17Apr2021 at 15:00 (at the age of 47-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient previously received sulfa; first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Mar2021 at 03:15 PM (at the age of 46-year-old) at single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced heart palpitations around 80 hours after second dose on 20Apr2021. Lasted only 20 minutes. Facial spasms left side of forehead starting 72 hours after second dose on 20Apr2021 at 15:00 and lasted 5 days. Since the vaccination, patient had not been tested for COVID-19. The outcome of the event facial spasms was recovered in Apr2021 for 5 days, outcome of event palpitation was recovered on 20Apr2021 for 20 minutes.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive COVID; Tested positive COVID; This is a spontaneous report received from a contactable consumer (mother) reported for a 16-year-old (reporter's daughter). A 16-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration, administered in left upper arm like shoulder on 03Apr2021 11:30 (Batch/Lot Number: EW0150) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that 4 of the family members after getting the first dose of the COVID 19 vaccine tested positive for COVID and then tested negative 7 weeks after the vaccine and wondering if they should still get the second dose of the vaccine. Reporter clarified that herself and family members tested positive for COVID 1 week after getting the first dose of the COVID 19 vaccine and then tested negative 2 weeks after that. Reporter stated herself and daughter was scheduled for the second 6 weeks and 4 days from the first dose. Reporter stated her daughter was tested positive for COVID on 11Apr2021. Reporter stated no her daughter might have taken Advil one day but she does not think so. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021498996 same drug/similar event, different patients;US-PFIZER INC-2021502035 same drug/similar event, different patients;US-PFIZER INC-2021502099 same drug/similar event, different patients
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive on 25Apr2021, her 1st dose on 15Apr2021; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 15Apr2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 25Apr2021, the patient experienced tested positive on 25Apr2021, her 1st dose on 15Apr2021. Caller called to say that she tested positive on 25APR2021. She wants to know if this will affect her second dose of the vaccine which is scheduled on 06MAY2021. Were any unaddressed medical questions referred or forwarded to Medical Information? Yes: Customer and/or medical inquiry forwarded or referred to MI. On 25Apr2021, the patient underwent lab test which included covid test: positive. The patient did not receive any treatment for the events. The clinical outcome of the tested positive on 25Apr2021, her 1st dose on 15Apr2021 was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: she experiencing side effects (fatigue, a little bit nausea and achiness); she experiencing side effects (fatigue, a little bit nausea and achiness); she experiencing side effects (fatigue, a little bit nausea and achiness); This is a spontaneous report from a Pfizer sponsored program. The contactable female consumer reported for herself. A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and expiration date unknown) via unspecified route on 30Apr2021, at 2:00 pm as 2nd dose single for COVID-19 immunisation. The patient received first dose of BNT162b2 on PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and expiration date unknown) via unspecified route on 07Apr2021, as 1st single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 01May2021, the patient experienced side effects (fatigue, a little bit nausea and achiness). The patient wanted to know and asked for over the counter medications for side effects. Cold transfer due to longer than normal wait time. Unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive a week after receiving first dose; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of BNT162B2 (solution for injection) via an unspecified route of administration on an unspecified date in Apr2021 at singled dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date it was reported that patient received 1st Pfizer dosage 3 weeks ago, tested positive a week after receiving first dose and was scheduled to receive 2nd dose on 04May2021. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on an unspecified date in Apr2021. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: The patient's medical history and concomitant medications were not reported. It was reported that the patient got the first dose last 06Apr2021 and tested positive of Covid 19 last 18Apr2021. Second dose was on 16May (more than 21 days). The outcome of event was unknown.  No follow-up attempts are needed. Information related to batch/lot number could not be requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Periarthritis
Clinical narrative: Usual sore arm; Frozen shoulder.  Hurts just to touch; Frozen shoulder.  Hurts just to touch; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 18Mar2021 as second dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated second dose on 18Mar2021. It was reported that usual sore arm for a week following vaccine getting more sore. Also frozen shoulder, hurts just to touch on Mar2021. It was advised that mention it to family doctor. The patient inquired as it was safe getting another vaccine in the future. The outcome of event usual sore arm was not recovered and other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: first dose of the vaccine was on 2Apr2021, after a week, she tested positive for the Covid virus and has not gotten her second dose; This is a spontaneous report from a contactable consumer(patient). A 60-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6208), via an unspecified route of administration, administered in arm left on 02Apr2021 12:00 (at an age of 60-years-old) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Apr2021, the patient experienced first dose of the vaccine was on 2Apr2021, after a week, she tested positive for the covid virus and has not gotten her second dose. Caller states her symptoms started on 09Apr2021 but she tested positive for Covid on 10Apr2021, after receiving her first dose of the Covid Vaccine on 2Apr2021. On 10Apr2021, the patient underwent lab test which included covid-19 test: positive. On 19Apr2021, the patient underwent lab test which included covid-19 test: negative. The clinical outcomes of the first dose of the vaccine was on 2Apr2021, after a week, she tested positive for the covid virus and has not gotten her second dose was recovered on 19Apr2021.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive from covid-19 virus; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date it was reported that she got her 1st dose and about a week later she tested positive from covid-19 virus. She was done with the quarantine and already surpassed the covid-19 virus. she had to start over or wait for weeks or months to take her 2nd dose of vaccine. The outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.