chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness on her arm/ Sore arm was in injection arm, clarified as left arm; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported; Expiration Date: 26Jun2021) via unspecified route of administration, administered in left arm on 26Jun2021 13:30 as dose 1, single for covid-19 immunization (at the age of 61 years). Patient medical history included bipolar and psoriasis. Patient concomitant medications included lamotrigine (LAMICTAL) 400 mg (Dose was increased from 300mg to 400mg) and ustekinumab (STELARA) taken for Psoriasis. No prior Vaccinations (within 4 weeks). On 27Jun2021 the patient experienced had soreness on her arm/ Sore arm was in injection arm, clarified as left arm. Patient did not any AE(s) require a visit to emergency room and physician office. Event outcome were recovered on Jun2021.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Productive cough
Clinical narrative: productive cough with mucus; nasal congestion; dry cough; This is a spontaneous report from a contactable other health care professional. A 44-year-old male patient received bnt162b2 (BNT162B2 BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date in Jul2021 as dose 1, single for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications was reported as none.On an unspecified date in 2021, the patient had a productive cough, last week from the day of report, symptoms of obstructive cough and nasal congestion and described it as mucus from his nose and throat from the cough and a dry cough as well. He did not have fever or fatigue or other symptoms besides productive cough and mucus. He did not have any experience when it comes to the vaccine and it did not come from the vaccine. The patient was due to get his second dose of the pfizer COVID-19 vaccine at 3 weeks, the next day from the day of report and the dates for will be 4 weeks tomorrow since first dose. He was supposed to take the vaccine last Friday from the day of report, but he did not as he was out of town and is looking to get this week. She just wanted to know if he could take the second dose. The clinical outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Decreased appetite, Nausea, Pyrexia
Clinical narrative: pains on her left heart; Fever; Nauseous; loss of appetite; This is a spontaneous report from a contactable consumer or other non hcp (parent). A female patient of an unspecified age 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 on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received 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 on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Consumer stated that, her daughter had the first shot she just had a sore arm that wasn't anything. The patient experienced pains on her left heart, fever, nauseous and loss of appetite on an unspecified date. The patient underwent lab tests and procedures which included body temperature: unknown results on unknown date. The outcome for the events was unknown.  Information about the Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100985810 similar report from same reporter
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Biopsy, Breast mass, Breast pain, Discomfort
Clinical narrative: soreness under my arm and below the arm pit; my breast got sorer; a lump that was sore and angry; low Vitamin B12; diagnosed a left knob on my left breast and then my right breast probably the same thing; uncomfortable; I had a breast issue with the Pfizer vaccine, with my lymph glands, I had the biopsy and then the other one my other breast is; it is not as severe as 1st one but my other breast I can feel that issue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 84-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number EL9269 and expiration date were not reported), via an unspecified route of administration on 10Feb2021 (Age at vaccination was 84 years) as dose 2, single for covid-19 immunization. Medical history included , hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included acetylsalicylic acid taken for an unspecified indication, start and stop date were not reported; estradiol taken for an unspecified indication, start and stop date were not reported; vitamin b12 nos taken for an unspecified indication, start and stop date were not reported; vitamin d nos taken for an unspecified indication, start and stop date were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number EL9261 and expiration date was not reported), via an unspecified route of administration, on 20Jan2021 as dose 1, single for COVID-19 immunization. On unspecified date in Apr 2021 patient reported that she had breast problems and she attribute it to that and she think her doctors do as well. Patient didn't have the reaction until Apr in her breast, she noticed soreness in under her arm down below her armpit and then in the breast itself soreness for a while and then all of sudden got really sore, patient put that on maybe she slept wrong, or exercised wrong or did something and she had visited Doctor and her Internal medicine Doctor, she sent her to have a monogram, sonogram and they started to do about, they did a biopsy. She was cancer free of course but in her other right breast she felt the same feeling in her right breast, in lower part of her breast right side at 7 o'clock. Patient was wondering and want to know how long this will go on, Do we have any knowledge on what to do, because of the vaccine. Now she had a question in her mind that it was because of reaction to that vaccine and they diagnosed a left knob on her left breast and then her right breast probably the same thing. Her question to Pfizer was how many people are experiencing this. The patient underwent lab tests and procedures which included biopsy with result on it is not as severe as 1st one but her other breast she can feel that issue. The patient did not receive any treatment for the events. The outcome of all the events was unknown.  No follow up attempts are needed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Vitamin B12 decreased
Clinical narrative: soreness under my arm and below the arm pit; my breast got sorer; a lump that was sore and angry; low Vitamin B12; diagnosed a left knob on my left breast and then my right breast probably the same thing; uncomfortable; I had a breast issue with the Pfizer vaccine, with my lymph glands, I had the biopsy and then the other one my other breast is; it is not as severe as 1st one but my other breast I can feel that issue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 84-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number EL9269 and expiration date were not reported), via an unspecified route of administration on 10Feb2021 (Age at vaccination was 84 years) as dose 2, single for covid-19 immunization. Medical history included , hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included acetylsalicylic acid taken for an unspecified indication, start and stop date were not reported; estradiol taken for an unspecified indication, start and stop date were not reported; vitamin b12 nos taken for an unspecified indication, start and stop date were not reported; vitamin d nos taken for an unspecified indication, start and stop date were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number EL9261 and expiration date was not reported), via an unspecified route of administration, on 20Jan2021 as dose 1, single for COVID-19 immunization. On unspecified date in Apr 2021 patient reported that she had breast problems and she attribute it to that and she think her doctors do as well. Patient didn't have the reaction until Apr in her breast, she noticed soreness in under her arm down below her armpit and then in the breast itself soreness for a while and then all of sudden got really sore, patient put that on maybe she slept wrong, or exercised wrong or did something and she had visited Doctor and her Internal medicine Doctor, she sent her to have a monogram, sonogram and they started to do about, they did a biopsy. She was cancer free of course but in her other right breast she felt the same feeling in her right breast, in lower part of her breast right side at 7 o'clock. Patient was wondering and want to know how long this will go on, Do we have any knowledge on what to do, because of the vaccine. Now she had a question in her mind that it was because of reaction to that vaccine and they diagnosed a left knob on her left breast and then her right breast probably the same thing. Her question to Pfizer was how many people are experiencing this. The patient underwent lab tests and procedures which included biopsy with result on it is not as severe as 1st one but her other breast she can feel that issue. The patient did not receive any treatment for the events. The outcome of all the events was unknown.  No follow up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, White blood cell count
Clinical narrative: injection site pain; This is a spontaneous report received from contactable other healthcare professional and a contactable consumer (patient). A 66-year-old female patient reported that patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route of administration on 27Jul2021 (age at vaccination: 66-years) as dose 2, single for COVID-19 immunisation. The patient medical history included ongoing breast cancer from an unknown date. The patient's concomitant medications included (fulvestrant) FASLODEX for an unknown indication from 26Jul2021 and stop date was not reported and (denosumab) XGEVA for an unknown indication, start date and stop date was not reported. The patient received palbociclib (IBRANCE) via an oral route of administration from 28Jun2021 to current at dose of 100 mg daily for 14 days on and 14 days off for breast cancer (per md advise- prescription read 100 mg daily for 21 days and off 7 days with FASLODEX and XGEVA). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunisation. On an unspecified date in Jul2021, the patient experienced injection site pain. The patient underwent lab tests and procedures which included white blood cell count: 2.1 to 1.8 on an unspecified date in 2021 currently on break. The patient would have lab work on 05Aug2021 with XGEVA. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Amendment: This follow-up report is being submitted to amend previously reported information: This case is updated to be reflected as spontaneous report; IBRANCE was added as concomitant medication. This report is also being submitted to allow appropriate submission to health authorities.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Malaise
Clinical narrative: irregularities in BMs/Irregular digestive system, unspecified; it was bothering him; This is a spontaneous report from a contactable consumer.  A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on 29Jul2021 (at the age of 66-years), as dose 1, single for covid-19 immunization. The patient medical history. was not reported. The patient concomitant medications were not reported. It was reported that after 1st dose of vaccine, the patient had irregularities in BMs, multiple times per day and states that it had been easing up and that he did not had a perfect diet either likes mexican food, salsa, enchiladas, etc and that may be contributing to this. The patient wanted to know how common that side effect was and declined safety report. At the time of reporting, the outcome of the events were unknown.  No Follow-up attempts are possible. No information is expected further.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Fatigue, Interchange of vaccine products, Off label use, Pain in extremity
Clinical narrative: Caller seeking information when she should retest for anitbodies against the covid 19 infection? Caller also wanted to report "I got three shots and it didn't kill me"; Caller seeking information when she should retest for anitbodies against the covid 19 infection? Caller also wanted to report "I got three shots and it didn't kill me"; Caller seeking information when she should retest for anitbodies against the covid 19 infection? Caller also wanted to report "I got three shots and it didn't kill me"; Felt tired; arm was sore; This is a spontaneous report from a contactable consumer (Patient).   A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 3, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Caller states that she received two doses of the Moderna covid 19 vaccination series. She then tested negative for antibodies and received a Pfizer BioNtech  covid 19 vaccine. She was seeking information when she should retest for anti bodies against the covid 19 infection and she also wanted to report she got three shots and it didn't kill her she reported she heard a news story that this fall everyone is going to start dying from the shots.  She reported that she received both Moderna Covid 19 vaccines and she tested negative for antibodies, after both Moderna vaccines. Then she went and got one Pfizer Covid 19 vaccine she felt tired, after the vaccine, but otherwise felt alright. She was asking how long should she wait to retest for antibodies she is calling about the Pfizer Covid 19 vaccine and she did receive both Moderna Covid  19 vaccines and did test negative for antibodies she did get one Pfizer Covid 19 vaccine, and re-ports feeling tired, and her arm was sore after the vaccine. She was asking how soon can she be tested for antibodies again. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative tested negative for Covid antibodies after both Moderna Covid 19 vaccines. The outcome for the event felt tired and sore arm was unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: Caller seeking information when she should retest for anitbodies against the covid 19 infection? Caller also wanted to report "I got three shots and it didn't kill me"; Caller seeking information when she should retest for anitbodies against the covid 19 infection? Caller also wanted to report "I got three shots and it didn't kill me"; Caller seeking information when she should retest for anitbodies against the covid 19 infection? Caller also wanted to report "I got three shots and it didn't kill me"; Felt tired; arm was sore; This is a spontaneous report from a contactable consumer (Patient).   A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 3, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Caller states that she received two doses of the Moderna covid 19 vaccination series. She then tested negative for antibodies and received a Pfizer BioNtech  covid 19 vaccine. She was seeking information when she should retest for anti bodies against the covid 19 infection and she also wanted to report she got three shots and it didn't kill her she reported she heard a news story that this fall everyone is going to start dying from the shots.  She reported that she received both Moderna Covid 19 vaccines and she tested negative for antibodies, after both Moderna vaccines. Then she went and got one Pfizer Covid 19 vaccine she felt tired, after the vaccine, but otherwise felt alright. She was asking how long should she wait to retest for antibodies she is calling about the Pfizer Covid 19 vaccine and she did receive both Moderna Covid  19 vaccines and did test negative for antibodies she did get one Pfizer Covid 19 vaccine, and re-ports feeling tired, and her arm was sore after the vaccine. She was asking how soon can she be tested for antibodies again. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative tested negative for Covid antibodies after both Moderna Covid 19 vaccines. The outcome for the event felt tired and sore arm was unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, Red blood cell sedimentation rate increased
Clinical narrative: the vaccine is not working; high sedimentation rate; high CRP levels; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, batch/Lot number was not reported) via an unspecified route of administration on 24Mar2021 as dose 2, single for covid-19 immunization. (Age at the time of vaccination 60 years). Patient medical history and concomitant medications were not reported. On 03Mar2021 patient had first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunization (at the age of 60-year-old). On an unspecified date he explained that he went to see his HCP for a Covid-19 antibody test results were given back with a value of 1.13 and indicated a titer result of 1.14 or higher would indicate a positive result. He reported his interpretation of his results as negative and a drop off of the IgG antibodies. No further AE details provided post vaccination. He voices his concern that his interpretation is the vaccine is not working and that within a period of 4 months he expected his antibodies to be higher. Patient reported annual physical examination and his laboratory result came with high sedimentation rate - He mentioned that he never had high CRP levels. Patient visited to physician's office for the event. The patient underwent lab tests and procedures which included CRP level: high, annual physical examination: high sedimentation rate, sedimentation rate: high (all on unspecified date), and COVID-19 antibody test were negative on 28Jul2021, 1.13. If the value is 1.14 or higher, then it is considered positive. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Fatigue, Feeling abnormal, Listless, Tinnitus
Clinical narrative: tinnitus; vertigo; balance problems; brain fog; listlessness; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on 18Mar2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6198), via an unspecified route of administration for Covid-19 immunisation. On 18Mar2021 patient received second dose of Pfizer vaccine and suffered with severe tinnitus, vertigo, balance problems, brain fog, listlessness, and extreme fatigue on an unspecified date. It has been 19 weeks with little relief. The outcome events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: tinnitus; vertigo; balance problems; brain fog; listlessness; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on 18Mar2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6198), via an unspecified route of administration for Covid-19 immunisation. On 18Mar2021 patient received second dose of Pfizer vaccine and suffered with severe tinnitus, vertigo, balance problems, brain fog, listlessness, and extreme fatigue on an unspecified date. It has been 19 weeks with little relief. The outcome events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vomiting
Clinical narrative: dizziness; throwing up; This is a spontaneous report from a contactable consumer or other non-health care professional reporting for her mother.  A 95-years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 03Aug2020 09:30 as dose 2, single (at the age of 94-years) for COVID-19 immunisation. Medical history included COPD, Congestive Heart Failure, Pulmonary Problems, is on oxygen and asthmatic from an unknown date and unknown if ongoing. Other than that, she cannot think of everything else. She also has Neuropathy in legs. She had all prior to getting first dose. She has been with these conditions for years. She uses inhalers for respiratory problems. No further details provided. Historical vaccine included first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: was not reported), via an unspecified route of administration, on an unspecified date as dose1, single for COVID-19 immunization. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks. Family Medical History Relevant to AE(s) was reported as None. The patient's concomitant medications were not reported. Other products reported as unknown. On 03Aug2021 01:00 the patient experienced dizziness, throwing up. Caller stated side effects began several hours after vaccination. She was not at her home and needs to find out what to do. Patient received her second dose today. First was three weeks ago on Thursday. Doctor said very little muscle but patient did get it in the muscle. The outcome of the events was not resolved.  Follow-up attempts are needed. Information on the lot/batch number is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: feeling like he has a cold like he's been outside; Fever; Congestion with running nose; Congestion with running nose/nose is running; This is a spontaneous report from a contactable consumer (patient) reported for himself. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch / Lot Number: not reported, Expiry date, NDC: Not Provided), via an unspecified route of administration on 31Jul2021 as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in 2021. the patient feels like he had a cold like he's been outside. On an unspecified date in 2021 complaints of fever and congestion with running nose. The patient was asking if these side effects are normal with the administration of the Pfizer Covid-19 vaccine. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Headache, Malaise
Clinical narrative: I felt tired and had a slight headache.  The next day, I felt more tired; headache; felt un-well with slight achy feeling.; felt un-well with slight achy feeling.; next day I was extremely exhausted with stuffy; with stuffy nose with no drainage; I was extremely tired/weak; problem was diarrhea; This is a spontaneous report from a contactable Consumer.   A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration, administered in right arm on 29Jul2021 11:00 Am (at the age of 66-years), as dose 1, single for covid-19 immunization. Patient known allergies includes mefoxin. The patient relevant medical history includes cancer in remission and fibromyalgia. The patient concomitant medications includes lexapro, vitamin D-3 and prolia on two week. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the next day after to shot, the patient felt tired and had a slight headache. The next day, the patient felt more tired and just felt unwell with slight achy feeling. The next day the patient  was extremely exhausted with stuffy nose with no drainage and upon slight physical exertion (specifically walking up stairs) she was extremely tired/weak and had to sit down with breathlessness that improved with rest but reoccurred throughout the day with slight exertion. A more troublesome problem was diarrhea that started at 2 am two days after the shot and continued for two more days. This diarrhea occurred after every time she ate something and was uncontrollable. Finally the third day after taking an over the counter antidiarrheal drug the constant diarrhea stopped and extreme fatigue was improving each day. The patient had no treatment for adverse event. The patient did not had vaccination prior to covid and  also did not tested for covid post vaccination. The outcome of the events was recovering.   No Follow-up attempts are possible. No information is expected further.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain
Clinical narrative: I felt tired and had a slight headache.  The next day, I felt more tired; headache; felt un-well with slight achy feeling.; felt un-well with slight achy feeling.; next day I was extremely exhausted with stuffy; with stuffy nose with no drainage; I was extremely tired/weak; problem was diarrhea; This is a spontaneous report from a contactable Consumer.   A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration, administered in right arm on 29Jul2021 11:00 Am (at the age of 66-years), as dose 1, single for covid-19 immunization. Patient known allergies includes mefoxin. The patient relevant medical history includes cancer in remission and fibromyalgia. The patient concomitant medications includes lexapro, vitamin D-3 and prolia on two week. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the next day after to shot, the patient felt tired and had a slight headache. The next day, the patient felt more tired and just felt unwell with slight achy feeling. The next day the patient  was extremely exhausted with stuffy nose with no drainage and upon slight physical exertion (specifically walking up stairs) she was extremely tired/weak and had to sit down with breathlessness that improved with rest but reoccurred throughout the day with slight exertion. A more troublesome problem was diarrhea that started at 2 am two days after the shot and continued for two more days. This diarrhea occurred after every time she ate something and was uncontrollable. Finally the third day after taking an over the counter antidiarrheal drug the constant diarrhea stopped and extreme fatigue was improving each day. The patient had no treatment for adverse event. The patient did not had vaccination prior to covid and  also did not tested for covid post vaccination. The outcome of the events was recovering.   No Follow-up attempts are possible. No information is expected further.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea
Clinical narrative: Difficulty breathing/she has had other people tell her that they have had the same type of symptoms; Cough/she has had other people tell her that they have had the same type of symptoms; This is a spontaneous report from a contactable consume or other non-health care professional. Report 2 of 2. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were 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. On unspecified date patient had Difficulty breathing/she has had other people tell her that they have had the same type of symptoms and Cough/she has had other people tell her that they have had the same type of symptoms. It was reported that, when the patient got the Pfizer vaccine, she had a cough that lasted a long time and she had difficulty breathing. The woman said her cough lasted a month. Outcome of the event difficulty breathing was unknown, and outcome of the event cough was recovered on unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoacusis, Somnolence
Clinical narrative: hearing was seriously impaired; felt groggy; Felt tired; This is a spontaneous report from contactable consumer (patient) via Pfizer-sponsored program COVAX US SUPPORT. A female patient that received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported) via an unspecified route on an unknown date as DOSE 1, SINGLE for COVID-19 immunization. The patients medical history and concomitant medication(s) are not reported. On an unknown date the Caller stated she had the first dose of the Pfizer vaccine late in the afternoon. She got home and felt tired. Took a nap and when she woke up her hearing was seriously impaired. She felt groggy and went back to bed. By the morning everything was fine. This has happened 5 times in a 3 week period. She saw a doctor and they did some tests and did agree her hearing was impaired. She really wants to get the second dose but she is afraid. She wanted to know what caused this to happen. relayed number to PMI. read ISI, declined drug and safety because she already reported this to VEARS. Transferred to (Withheld) in PMI. The outcome of the event was unknown  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up(16Sep2021):  Information about lot/batch number cannot be obtained. No further information expected
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: injection site pain which is swelling, red, and hot; injection site pain which is swelling, red, and hot; injection site pain which is swelling, red, and hot; injection site pain which is swelling, red, and hot; just wants to itch; caller's arm is itchy; they both don't have energy to cook or anything and sleeping a lot.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 59-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 02Aug2021 (at the age of 59-years-old) (Batch/Lot Number: FA7484; Expiration Date: 30Sep2021) as dose 2, 0.3ml single for covid-19 immunisation. Medical history included heart murmur, laryngitis and had shoulder surgery from an unknown date and unknown if ongoing The patient stated she had shoulder surgery and she was scratching and trying to pull the tape off. The patient previously experienced known allergies: Penicillin and Tape. The patient stated she is usually allergic to a lot. The patient's concomitant medications was not reported. Patient previously took first dose of BNT162B2 (at the age of 59-years-old) (lot number: EW0181, expiration date: 30Aug2021) on 12Jun2021 for covid-19 immunisation and experienced Choking, Sluggish, Worn out, Tiredness, Coughing, Feeling abnormal and Hoarse voice. The patient experienced injection site pain which is swelling, red, and hot on 02Aug2021. The patient stated that she just wants to itch and scratch it, it's red and swollen. She also stated that arm was itchy and she wanted to scratch it so bad. The patient and her mother had nothing with the first one they were just tired and sluggish and worn out all a week. This improved then they got second dose and now they feel they've been run over by a car. They both don't have energy to cook or anything and sleeping a lot. The patient received treatment regarding the events. The outcome of the event just wants to itch, caller's arm is itchy and they both don't have energy to cook or anything and sleeping a lot was unknown. The outcome of all the other events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101002323 Same reporter/product, similar event, different patient
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site pain which is swelling, red, and hot; injection site pain which is swelling, red, and hot; injection site pain which is swelling, red, and hot; injection site pain which is swelling, red, and hot; just wants to itch; caller's arm is itchy; they both don't have energy to cook or anything and sleeping a lot.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 59-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 02Aug2021 (at the age of 59-years-old) (Batch/Lot Number: FA7484; Expiration Date: 30Sep2021) as dose 2, 0.3ml single for covid-19 immunisation. Medical history included heart murmur, laryngitis and had shoulder surgery from an unknown date and unknown if ongoing The patient stated she had shoulder surgery and she was scratching and trying to pull the tape off. The patient previously experienced known allergies: Penicillin and Tape. The patient stated she is usually allergic to a lot. The patient's concomitant medications was not reported. Patient previously took first dose of BNT162B2 (at the age of 59-years-old) (lot number: EW0181, expiration date: 30Aug2021) on 12Jun2021 for covid-19 immunisation and experienced Choking, Sluggish, Worn out, Tiredness, Coughing, Feeling abnormal and Hoarse voice. The patient experienced injection site pain which is swelling, red, and hot on 02Aug2021. The patient stated that she just wants to itch and scratch it, it's red and swollen. She also stated that arm was itchy and she wanted to scratch it so bad. The patient and her mother had nothing with the first one they were just tired and sluggish and worn out all a week. This improved then they got second dose and now they feel they've been run over by a car. They both don't have energy to cook or anything and sleeping a lot. The patient received treatment regarding the events. The outcome of the event just wants to itch, caller's arm is itchy and they both don't have energy to cook or anything and sleeping a lot was unknown. The outcome of all the other events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101002323 Same reporter/product, similar event, different patient
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: Upper arm is very sore; His wife's left upper arm, injection site, was very sore and painful.; can't raise her arm.; Caller explained the symptoms are getting worst; This is a spontaneous report from a contactable consumer or other non hcp (patient's husband) via medical information team. A 41-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 27Apr2021 as DOSE 1, SINGLE, and second dose via an unspecified route of administration, administered in Arm Left on 18May2021 (at the age of 41-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient's left upper arm was very sore and she cannot raise her arm. It was not getting better despite a few treatments. The reporter explained the symptoms are getting worst on an unspecified date in Apr2021. It was also reported that after the vaccines, his wife left upper arm, injection site, was very sore and painful. The patient has been going to the acupuncturist for a few weeks, and it has not improved, and was getting worse. The patient received treatment for all the events experienced by her. The outcome of the events was not recovered.     The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Was sick/ She got sick; This is a spontaneous report from a contactable consumer or other non HCP reports for herself. A female patient of an unspecified age received bnt162b2 ((PFIZER-BIONTECH COVID -19 VACCINE, Injection for injection, (Batch/Lot Number is not reported expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported she was sick/ she got sick (illness) on an unspecified date. States she got her 1st shot ;no problem but in between, she was supposed to go back in 3 weeks and she got sick so she couldn't make it to her next appointment for her second shot. She said her doctor told the nurse to go get her a shot, well the nurse told the doctor that the shots weren't any good as they had been sitting out for some time and the doctor says they are fine to get it anyway and she got the shot and then she got extremely ill for a long time, over a month.  She had received her first Pfizer covid 19 vaccine, was sick in between the two doses, received her second dose of the vaccine six weeks or more after the first dose. The nurse at her doctor's office told the doctor the doses aren't good because they were out for too long, the nurse didn't want to give it out. She was informed by her doctor to get the vaccine. She said the vaccines were left out for a couple of days. She had the following side effects after the second dose: chills, diarrhea, headache, joint pain, fever, sweating, hot, it was like I was drained of all my energy, the site where I got injected was swollen, red, and hurt for a long time, and had to wear air all the time, loss her sense of smell, didn't eat, and had to drink Gatorade by the gallons because I was lethargic. She did not want to file a safety report because she doesn't want the information to be relayed to her doctor and to make a report. She had asked what does Pfizer recommend, for storage of the vaccine at room temperature. Is it suppose to be refrigerated. States she got the Pfizer shot. She doesn't know, she hasn't been well for a year and a half since this whole stuff started. She was wondering what could happen if that shot was left out. She wants to know why she got sick like that, should she have not been given that shot since it was left out of refrigeration. She was asking if it is supposed to be refrigerated. she does not know how long it was left out, just that nurse said it wasn't good and they weren't giving it out to anybody. The outcome of the event is recovered on an unspecified date.  The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: axillary lymph node swelling; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history included COVID (had Covid back in Jan). Concomitant medications were not reported. On an unspecified date, the patient experienced axillary lymph node swelling. The patient wanted to know if axillary lymph node swelling was common coming up on 5 months since her second Pfizer dose. PS she also had Covid back in Jan her provider might be ordering a biopsy of her node if she didn't clear up soon any advice or information would be greatly appreciated. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Terrible stomach pains really sharp pains; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's daughter). A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration on Jan2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Jan2021, the patient experienced terrible stomach pains really sharp pains. The reporter states ever since her mom has been experiencing terrible stomach pains really sharp pains. The reporter would like to know if this could be related to the vaccine.The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Diarrhoea
Clinical narrative: experiencing severe diarrhea and today it is worse; her daughter also had diarrhea at 10pm the day she received the 1st dose, 13Jul2021/experiencing severe diarrhea and today it is worse; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a 20-year-old female patient (reporter's daughter) that: A 20-years-old Female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number and Expiration date were not provided), via an unspecified route of administration in Arm Left on 13Jul2021 as dose 1, single and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number and Expiration date were not provided), via an unspecified route of administration in Arm Left on 03Aug2021 as dose2, single for COVID-19 immunization. Medical history included ongoing coeliac disease Diagnosed in 2015 or 2016 , arthritis from 2019 and ongoing. The patient's concomitant medications were not reported. Previously patient received Tdap and experienced Injection site erythema (red arm after getting a booster shot for TDap, when she was 13 or 14 years old, was in 2013. They gave her a topical steroid to put on it). Reporter on behalf of daughter, aged 20, received her second dose of the Pfizer BioNTech Covid 19 vaccine on 03Aug2021. Yesterday she started experiencing severe diarrhea and on 04Aug2021 (today) it was worse.  In the clinical trials how long did the side effect of diarrhea last. She noticed that her daughter also had diarrhea at 10pm the day she received the 1st dose, 13Jul2021, but it wasn't as bad as it was now. Stated that she called because she just wanted to find out from the people who experienced diarrhea in the clinical trials, how long did it last. States that her daughter was a college student, so she was 20 years old, and caller doesn't have her card to be able to provide her Lot numbers. States that the diarrhea started yesterday, 04Aug2021; she had it all day. Today the diarrhea was worse. States that she hasn't even eaten anything, so there isn't anything left to come out, so it's just like water; she is in the bathroom like every 30 minutes. She took Imodium yesterday but it didn't help. The outcome of the events was not recovered.     No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity, Tendonitis
Clinical narrative: Tendonitis pain in both arms; Tendonitis pain in both arms; muscle/joint pain; muscle/joint pain; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient).  A 44-year-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no: not reported /Lot Number: unknown) via unspecified route of administration, administered in Arm Left on 28Apr2021 14:30 (age at vaccination was 44 years) as dose number unknown, single for covid-19 immunization at Pharmacy or Drug Store. The patient medical history was none, and concomitant medication were not reported. No known allergies were reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks and no other medication taken prior to the COVID vaccine. On 01Jul2021, the patient experienced tendonitis pain in both arms, significantly worse in left arm, began feeling this pain about a month ago. It was not getting better despite resting it. Patient have never experienced this type of muscle/joint pain prior to the vaccine. Treatment was taken for the event which included rest, OTC pain relievers. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.