chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Tonic-Clonic seizures; Nausea; Vomiting; Severe body aches; Headache; Moderate - severe neurological events; Tics; Tremors; Confusion; Inability to speak or walk or use restroom on own; Inability to speak or walk or use restroom on own; Fine motor skills deficit; This is a spontaneous report from a contactable consumer (patient). A 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0876, Expiration Date: not reported), via an unspecified route of administration in left arm on 15May2021 at 15:00(Age at the of 14-years old)as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at time of Vaccination. Medical history was none. Known allergies was Nka. The patient received unspecified medications within 2 weeks of vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.On 17May2021,the patient experienced nausea, vomiting, severe body aches, headache, moderate - severe neurological events, tics, tremors, confusion, inability to speak or walk or use restroom on own, fine motor skills deficit and tonic-clonic seizures. Adverse events resulted in Emergency room/department or urgent care. The patient was hospitalized for 4 days. Hospitalization was not prolonged. The patient received treatment and stopped suspected interacting medicine. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0191, Expiration Date: not reported), via an unspecified route of administration in left arm on 06Jun202114:00 as dose 2, single for COVID-19 immunization. The outcome of the events was recovering. ~~ No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Altered state of consciousness, Feeling hot, Hyperhidrosis, Urticaria
Clinical narrative: I also felt like I was struggling to stay conscious./but I had to get up and move around.; I began to start sweating a lot; I felt a warm heat in my body almost like when you get hives. I also felt like I was struggling to stay conscious. I had to get up and use the bathroom and get a drink; I felt a warm heat in my body almost like when you get hives. I also felt like I was struggling to stay conscious. I had to get up and use the bathroom and get a drink; This is a spontaneous report from contactable consumer (Patient). A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection: Lot Number: EW1076) via an unspecified route of administration in left arm on 15Jun202 at 16:00 (at the age of 30-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included the patient had known penicillin allergies. Concomitant medications included methadone, ergocalciferol (VITADONE) both taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 15Jun2021 at 16:00, the patient experienced a little nervous because the Agency didn't approve it yet, so I did not know if that what messing with him. After i got the vaccine like 5 minutes after the shot i began to start sweating a lot and i felt a warm heat in my body almost like when you get hives. I also felt like i was struggling to stay conscious. I had to get up and used the bathroom and got a drink but if they would've made him sit in them chairs in the isles, I think I would've passed out. I knew they had them chairs there just in case someone passes out i thought, but i had to get up and move around. The patient did not receive any treatment for the event. The outcome of all events was recovered in 2021.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Fasting blood glucose elevated; This is a spontaneous report from a contactable consumer or other non hcp.     A 67-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that, The patient experienced fasting blood glucose elevated on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included blood glucose: elevated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus, ringing & buzzing in the ears.; This is a spontaneous report received from a non-contactable consumer (patient himself). A 67-year-old-male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6202) via an unspecified route of administration in left arm on 24Mar2021 13:00 as dose 2, single (at the age of 67-years-old) for COVID-19 immunization. Patient medical history included hypertension. Patient had no known allergies. The concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6203) via an unspecified route of administration in right arm on 01Mar2021 12:00 as dose 1, single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. Patient did not receive any other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination. Patient was not tested for COVID-19 post vaccination. On 20May2021, the patient experienced tinnitus, ringing and buzzing in the ears. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for the adverse events. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Eye disorder, Gait inability, Herpes zoster, Rash, Rash pustular
Clinical narrative: He actually woke up with vomiting/ he threw up; Couldn't walk for a week; The room was spinning and he threw up; Rash over the body and it's on one side of the body right now the inside they're little balls,  bubbles with some kind of puss inside, water or puss; Rash over the body and it's on one side of the body right now the inside they're little balls,  bubbles with some kind of puss inside, water or puss; Not sure, we look at pictures they look like shingles; He has side effects on his left eye; This is a spontaneous report from a contactable consumer (parent). A 17-year-old male patient (reporter's son) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 03Jul2021 at around 10 at night (at the age of 17-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as single dose for covid-19 immunization and did not experience any adverse event. Reporter stated, "my son had the Pfizer and he in the states right now and he went to play hockey, he took the second COVID on the next Saturday, he got it around 10 o clock in the night on 03Jul2021 and on 04Jul2021 he actually woke up with vomiting, could not walk for a week, the room was spinning and he threw up, I don't know if I said that and barely made a back to the bedroom, woke up had a rash over the body and it was on one side of the body right now the inside they were little balls, bubbles with some kind of puss inside, water or puss". The reporter also stated "not sure, we look at pictures they look like shingles, I see on the internet that in some rare cases it can be activate shingles in your body and I want to know how rare these side effects are and what to do about it". When confirmed that the vaccine son took was Pfizer COVID-19 Vaccine, reporter stated, yes, he was 17 and he had to take it. When probed anatomical site where vaccine was administered, reporter stated, I don't know that. I know that he has side effects on his left eye (on an unknown date in Jul2021). I don't know what side he got the injection. I would assume you got it in his left hand because he uses his right hand for lot of things". The outcome of the events was unknown.  Information regarding the lot/batch number has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: He actually woke up with vomiting/ he threw up; Couldn't walk for a week; The room was spinning and he threw up; Rash over the body and it's on one side of the body right now the inside they're little balls,  bubbles with some kind of puss inside, water or puss; Rash over the body and it's on one side of the body right now the inside they're little balls,  bubbles with some kind of puss inside, water or puss; Not sure, we look at pictures they look like shingles; He has side effects on his left eye; This is a spontaneous report from a contactable consumer (parent). A 17-year-old male patient (reporter's son) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 03Jul2021 at around 10 at night (at the age of 17-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as single dose for covid-19 immunization and did not experience any adverse event. Reporter stated, "my son had the Pfizer and he in the states right now and he went to play hockey, he took the second COVID on the next Saturday, he got it around 10 o clock in the night on 03Jul2021 and on 04Jul2021 he actually woke up with vomiting, could not walk for a week, the room was spinning and he threw up, I don't know if I said that and barely made a back to the bedroom, woke up had a rash over the body and it was on one side of the body right now the inside they were little balls, bubbles with some kind of puss inside, water or puss". The reporter also stated "not sure, we look at pictures they look like shingles, I see on the internet that in some rare cases it can be activate shingles in your body and I want to know how rare these side effects are and what to do about it". When confirmed that the vaccine son took was Pfizer COVID-19 Vaccine, reporter stated, yes, he was 17 and he had to take it. When probed anatomical site where vaccine was administered, reporter stated, I don't know that. I know that he has side effects on his left eye (on an unknown date in Jul2021). I don't know what side he got the injection. I would assume you got it in his left hand because he uses his right hand for lot of things". The outcome of the events was unknown.  Information regarding the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Lymphadenopathy
Clinical narrative: swollen lymph node; This is a spontaneous report from a lay media report reporting events for 3 patients. This is patient 1 of 3. This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced swollen lymph node on an unspecified date. She described one patient with a newly diagnosed breast tumor who had swollen lymph nodes on the same side and had recently received a Covid shot in the arm on that side. A biopsy was performed, an important step to determine whether there were malignant cells in the nodes that would then help decide a course of treatment. It was negative for cancer. The vaccine had most likely caused the swelling. The patient underwent lab tests and procedures which included biopsy: negative for cancer on unspecified date. Outcome of the event was unknown.; Sender's Comments: Linked Report(s) : Same article/same event/different patient
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Herpes zoster
Clinical narrative: "She had a shingles vaccine on 05/28/21; This is a spontaneous report from a Pfizer- sponsored program XELSOURCE. A contactable other HCP (nurse) reported that. A 67-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (age at vaccination 67-years) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation; tofacitinib citrate (XELJANZ, 5 mg tablets), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. Nurse stated, She had a shingles vaccine on 28May21. She would have a second vaccine done after July 28 up to September. The action taken in response to the events for xeljanz  was unknown. . The outcome of event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021846249 same reporter/patient/drug, diffent event/dose
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Received the first dose oft he Pfizer Covid vaccine on 13 Apr 2021. He then tested positive for Covid-19; Received the first dose oft he Pfizer Covid vaccine on 13 Apr 2021. He then tested positive for Covid-19; This is a spontaneous report from a contactable pharmacist from a Pfizer sponsored program. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 13Apr2021 as dose 1,single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reported as, patient who received the first dose of the Pfizer Covid vaccine on 13Apr2021. He then tested positive for Covid-19. Received 1st Pfizer Covid 19 vaccine on 13Apr and tested positive the end of Apr2021. Reporter would like to know when consumer can receive 2nd Pfizer Covid vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on an unspecified date on Apr2021. Outcome of the events were unknown.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events of COVID-19  and Drug ineffective and the suspect product BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID monday, 14Jun2021 after completing Pfizer vaccine series.; diagnosed with COVID monday, 14Jun2021 after completing Pfizer vaccine series.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Jun2021, the patient experienced diagnosed with COVID Monday, 14Jun2021 after completing Pfizer vaccine series. On unspecified date, voice was raspy, she said she felt very tired. But hope to return to work on Wednesday (unspecified date). The patient underwent lab tests and procedures which included COVID-19: positive on 14Jun2021. The clinical outcome of events was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: The caller reports she tested positive for Covid illness about a week ago, and she then passed it on to her daughter; The caller reports she tested positive for Covid illness about a week ago, and she then passed it on to her daughter; This is a spontaneous report from a contactable consumer. This consumer reported for a 53-year-old female patient (reporter's daughter).   A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single and Dose 1, single on an unspecified date for covid-19 immunization. The patient medical history and concomitant medications was not reported. The caller was a consumer who reported that she is 74-year-old female and her daughter 53-year-old had both been fully vaccinated with the Pfizer-Biontech COVID-19 vaccine. The caller reported she tested positive for Covid illness about a week ago (on an unspecified date), and she then passed it on to her daughter (on an unspecified date). She indicated that they had followed CDC recommendations that stated fully vaccinated patients can be around each other and need not wear a mask. She asked for how many people in the population who were fully vaccinated had tested positive for Covid19, the percentages, and the percent of the cases which were the new delta variant. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on an unspecified date. Outcome of the events was reported as Unknown.   No follow up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021846613 same reporter/drug/event, different patient
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: Blood clots both lungs; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: not reported) via an unspecified route of administration, administered in right arm on 30Mar2021 12:00, as DOSE 2, SINGLE for COVID-19 immunisation in pharmacy. Medical history included sulphate drugs allergy. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: not reported), administered in right arm on 09Mar2021 02:00, as DOSE 1, SINGLE for COVID-19 immunisation. On 22Jun2021, the patient had blood clots both lungs. The event reported as serious. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care hospitalization. Therapeutic measures were taken as a result of blood clots both lungs and treatment with heparin. Outcome of the event was not resolved.  Information about lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid 19 contagion. Muscle aches, fever, sore throat, cough; This is a spontaneous report from contactable consumer (patient, self-reported). A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0186 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 30Jun2021 at 14:30 PM (age at vaccination: 22 years), as a single dose for COVID-19 immunization at Pharmacy or Drug store. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient did not have any known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. The patient reported that on 02Jul2021 at 23:30 PM, she experienced Covid 19 contagion. muscle aches, fever, sore throat, cough. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 03Jul2021 and sars-cov-2 test: positive on 05Jul2021. The patient received treatment for the event. Outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive; Tested positive; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE and as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated I am vaccinated with the 2 doses against COVID-19 and I and my wife tested positive. The patient underwent lab test and procedure which included: SARS-CoV-2 test which was positive on an unspecified date. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Cerebrovascular accident, Corneal reflex decreased, Eye disorder
Clinical narrative: On Friday I was dianogosed with Bell's Palsy.; On Thursday night i started showing signs of a full-blown stroke; June 22nd I started having issues with my eye. It would look like it was cloudly and I couldn't blink.; June 22nd I started having issues with my eye. It would look like it was cloudly and I couldn't blink.; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 34-years-old male patient received bnt162b2 (Pfizer covid vaccine, formulation: solution for injection, tch/Lot Number: EW0185), via an unspecified route of administration, administered in Arm Right on 11Jun2021 12:00 (at the of 34-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to the vaccination the patient was not diagnosed with covid. The patient had no allergies. Since the vaccination, the patient had not been tested for covid 19. The patient previously took BNT162B2(Pfizer covid vaccine, formulation: solution for injection, lot number=EW0168) via unspecified route of administration, administered in Arm right on 19May2021 12:00 as DOSE1, SINGLE for covid 19 immunisation. On 22Jun2021 at 19:00, the patient experienced  having issues with his eye. It would look like it was cloudly and he could not blink and eye disorder. On 23Jun2021 , Wednesday, the patient experienced issue with his eye and got worse. On 24Jun2021 Thursday night, the patient started showing signs of a full-blown stroke. On 25Jun2021 Friday, patient was diagnosed with bell's palsy and on Wednesday the issue with eye got worse. The outcome of the events was not recovered.  Follow-Up (09Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Multisystem inflammatory syndrome in children, Splenomegaly
Clinical narrative: he developed multisystem inflammatory syndrome; Big spleen; This is a spontaneous report from a contactable consumer (patient's parent) via a Pfizer-sponsored program.  A male patient (age not provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration, on 18May2021 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 22May2021, the patient developed multisystem inflammatory syndrome and big spleen. The outcome of the events was unknown.   Information about Batch/Lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test was positive after both doses; covid test was positive after both doses; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7534) via an unspecified route of administration on 19Mar2021 as dose 1, single; and later received second dose of BNT162B2 (Lot number: ER8734) on 09Apr2021 as dose 2, single; both for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient received the two parts of Pfizer vaccine on 19Mar2021 and 09Apr2021 and experienced a week of symptoms, losing taste and smell was the clincher in Jun2021. After that patient went to a local urgent care and had a nasal swab covid test that was positive on 05Jul2021. Patient was told that many vaccinated people were testing positive in his/her area. On 05Jul2021, the patient underwent lab tests and procedures which included sars-cov-2 test which result was positive. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Finger deformity, Immune system disorder, Pain in extremity, Peripheral swelling, Rheumatoid arthritis
Clinical narrative: I am worried that the vaccine has messed up my immune system and caused my RA to come back; I am worried that the vaccine has messed up my immune system; My fingers started swelling; The pain and swelling in my hands is now excruciating and it is starting in my feet; My fingers are starting to twist and curl; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting). A 57-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6203 and expiration date was not reported), via an unspecified route of administration in arm left on 04Mar2021 at 12:30 as dose 2, single (age at vaccination 57-year-old) for COVID-19 immunisation. Medical history included rheumatoid arthritis from an unknown date, Thyroid Disease from an unknown, Hashimotos from an unknown date. The patient previously took levaquin and experienced hypersensitivity. Historical vaccine information included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number EL9261), via an unspecified route of administration in arm left on 12Feb2021 at 12:15 PM for COVID-19 Immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications within 2 weeks of vaccination includes compounded Thyroid med, compounded est/test cream. The patient reported that worried that the vaccine has messed up her immune system and caused RA to come back, her fingers started swelling, the pain and swelling in her hands was now excruciating and it was starting in her feet, her fingers were starting to twist and curl on 10Apr2021. Patient had RA in the past but had been in remission for over a year and a half. About a month after getting the 2nd COVID vaccination her fingers started swelling and hurting. The pain and swelling in her hands was excruciating and it was starting in her feet. Her fingers were starting to twist and curl. She was worried that the vaccine has messed up her immune system and caused her RA to come back way worse than it ever was. This was coming on fast and very severe. She won't be able to work much longer if something wasn't done to reverse the pain and damage. The patient underwent lab tests and procedures which included x-ray: unknown on an unknown date. Therapeutic measures were taken as a result of events includes medication for the pain and inflammation, x rays. The outcome of the events were not resolved.  Follow-up actions are needed. Further information has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: I am worried that the vaccine has messed up my immune system and caused my RA to come back; I am worried that the vaccine has messed up my immune system; My fingers started swelling; The pain and swelling in my hands is now excruciating and it is starting in my feet; My fingers are starting to twist and curl; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting). A 57-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6203 and expiration date was not reported), via an unspecified route of administration in arm left on 04Mar2021 at 12:30 as dose 2, single (age at vaccination 57-year-old) for COVID-19 immunisation. Medical history included rheumatoid arthritis from an unknown date, Thyroid Disease from an unknown, Hashimotos from an unknown date. The patient previously took levaquin and experienced hypersensitivity. Historical vaccine information included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number EL9261), via an unspecified route of administration in arm left on 12Feb2021 at 12:15 PM for COVID-19 Immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications within 2 weeks of vaccination includes compounded Thyroid med, compounded est/test cream. The patient reported that worried that the vaccine has messed up her immune system and caused RA to come back, her fingers started swelling, the pain and swelling in her hands was now excruciating and it was starting in her feet, her fingers were starting to twist and curl on 10Apr2021. Patient had RA in the past but had been in remission for over a year and a half. About a month after getting the 2nd COVID vaccination her fingers started swelling and hurting. The pain and swelling in her hands was excruciating and it was starting in her feet. Her fingers were starting to twist and curl. She was worried that the vaccine has messed up her immune system and caused her RA to come back way worse than it ever was. This was coming on fast and very severe. She won't be able to work much longer if something wasn't done to reverse the pain and damage. The patient underwent lab tests and procedures which included x-ray: unknown on an unknown date. Therapeutic measures were taken as a result of events includes medication for the pain and inflammation, x rays. The outcome of the events were not resolved.  Follow-up actions are needed. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: developed pneumonia 12 days ago; This is a spontaneous report from a contactable consumer (patient).  This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unspecified route of administration, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. In Jun2021 (12 days ago, as reported), the patient developed pneumonia for which he took antibiotics. The outcome of the event was unknown.  Information about Batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report from a contactable other hcp. The other hcp reported for both the husband and wife, this is the case for husband. A male patient of an unspecified age received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced stroke on unspecified date.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021856673 Same reporter/ drug/event, different patients
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report from a contactable other hcp. The other hcp reported for both the husband and wife, this is the case for wife. A female patient of an unspecified age received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced stroke on unspecified date and died. It was not reported if an autopsy was performed.  Information about batch/lot number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Cerebrovascular accident and the suspect drug bnt162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021856461 Same reporter/ drug/event, different patients; Reported Cause(s) of Death: stroke
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired healing, Vaccination site bruising
Clinical narrative: to notice a set bruises on her left arm(injection site) a few days after the first dose; she is not healing as fast as she used to; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0182; expiration date: 31Aug2021), via an unspecified route of administration in the left arm on 18May2021 (at the age of 67-year-old) as single dose for COVID-19 immunization. Patient had no medical history. Patient did not receive any other products (no concomitant medication). On an unspecified date in May2021, few days after the first dose of vaccination, patient started to notice a set bruises on her left arm (injection site). Patient reported that, "instead of a couple of days, it's taken longer or about 3 weeks to heal" and was not healing as fast as she used to on an unspecified date in May2021. Patient noticed this up to 3-4 weeks to the first shot. Patient had been rough housing with her grand-children, and the bruises are not disappearing as fast as before, like up to 2-3 weeks before the shot. It was taking her longer to heal. Patient looks like an abused woman right now. She used to work at Pfizer. She keeps seeing more and more of the bruising. Patient clarified that she first noticed it a couple of days after the first shot happened. It took her bruises about 3 weeks to disappear. She then was rough housing with her grandchild again, and she had black and blues on her arms again. This recurs because of something. The bruises are not popping up on their own. Usually if she has a bruise, they go away in 3 days or so. This was like multiplying it by 7. Patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0183; expiration date: 31Aug2021) in left arm on 08Jun2021 as single dose for COVID-19 immunization. Patient was wondering if this was because the vaccine was traveling through her system and asked if there has been reports of this as a side effect and how long will this side effect last. Outcome of both the events were not resolved.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ischaemic stroke, Thrombosis
Clinical narrative: Acute Ischemic stroke caused by blood clot.; Acute Ischemic stroke caused by blood clot.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-year-old non-pregnant female patient received bnt162b2 dose 2 via an unspecified route of administration, administered in Arm Right on 11Apr2021 (Batch/Lot Number: ER8730) as single dose for covid-19 immunisation at the age of 66-year-old. The patient medical history and concomitant medications were not reported.  The patient previously took bnt162b2 dose 1 administered in Arm Right on 21Mar2021 (Batch/Lot Number: EP6958) as single dose at the age of 66-year-old. On 27Jun2021, the patient experienced acute Ischemic stroke caused by blood clot. The event resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the event and the patient was still under medical care. The event was reported as serious with seriousness criteria of life threatening. The outcome of the event was unknown. The patient was not diagnosed with COVID-19 prior to vaccination and hasn't been tested for COVID-19 since the vaccination.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: My son woke up on thursday 01Jul2021 the day after he received the 2nd dose of the covid 19 vaccine with partial facial paralysis and was diagnosed with bells palsy; My son woke up on thursday 01Jul2021 the day after he received the 2nd dose of the covid 19 vaccine with partial facial paralysis and was diagnosed with bells palsy; This is a spontaneous report from a contactable consumer or other non hcp. A 14-year-old male patient received second dose of BNT162b2 (CONMINTARY, Solution for injection, Lot No: EW0196), via an unspecified route of administration, administered in Arm Left on 30Jun2021 17:45 (at the age of 14-year-old), as 2nd dose single for COVID-19 immunization (Administered at Pharmacy or Drug Store). The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2(CONMINTARY, Solution for injection, Lot No: EW0191), via Left arm on 23May2021, 01:00 PM (at the age of 14-year-old), for 1st dose, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no known allergies. No other medical history was reported. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The reporter stated that their son woke up on Thursday 01Jul2021 the day after he received the 2nd dose of the covid 19 vaccine with partial facial paralysis and was diagnosed with bell's palsy. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of facial paralysis and bell's palsy. Treatment received included prednisolone. No seriousness criteria was reported. Outcome of the events was not recovered at the time of reporting.  Device Date was 09Jul2021.  No follow-up attempts needed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Arthralgia, Influenza like illness, Myalgia
Clinical narrative: My heart was like killing me; heart still hurts and I never had problem with my heart; Flu like symptoms; Severe muscle ache; Joint ache; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received second dose of bnt162b2 (Pfizer BioNTech Covid 19 vaccine, formulation: solution for injection, Batch/Lot Number: ER8734) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported.The patient previously received first dose of bnt162b2 (Pfizer BioNTech Covid 19 vaccine, formulation: solution for injection, Batch/Lot Number: EN6202) via unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. It was reported the patient was little freaked out, received second dose Pfizer (Covid) vaccine and 12 hours after started having flu like symptoms, severe muscle ache, joint ache and muscle ache and like heart was killing him like. Patient did not know whether need to go to Emergency room or not. Patient was healthy individual, and only go to the Doctor once a year and if it was just a side effect and he will be ok but, heart still hurts. Do patient need to go see a cardiologist. The patient never had problem with his/her heart. The patient was not recovered from heart was like killing me; heart still hurts and unknown for the flu like symptoms, severe muscle ache, joint ache.   Follow-up attempt are not possible. No expected further information.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhoea; Vomiting; This is a spontaneous report from a contactable consumer (Patient). A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date (Saturday) in Jun2021 (at the age of 25-year-old), as DOSE 1, SINGLE for Covid-19 immunization and took it from the facility. The patient past medical history and concomitant medication was not reported. On 01Jul2021, the patient experienced Diarrhea and vomiting, a week ago when took Pfizer vaccine. The patient stated that the schedule date for second dose was "22 or 21 days after". When probed if the patient was still experiencing adverse event to which he responded that he was still experiencing, everyday like, two times a day, diarrhea. The patient did not take any treatment for the reported events. The patient stated "Did you poop? This makes me happy. I watched videos women pooping." The patient hung up the call hence limited information was available over the call. The event outcome Diarrhea was not resolved while the outcome of the other 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: soreness in his left arm at the injection site; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 28Jan2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient states that he received the first dose of the Pfizer Covid-19 vaccine on 28Jan2021 and had complaints of soreness in his left arm at the injection site on unspecified date in Jan2021 and the next day the soreness was pretty much gone. Patient received the second dose of the vaccine on 18Feb2021 and reported that he had no reactions. He was happy with the results of getting the Pfizer Covid-19 vaccine and "the first two seem to be working well". Patient was asking if it would be okay for him to get another dose of the Pfizer Covid-19 vaccine. Patient was asking if anyone has received the third dose of the Pfizer Covid-19 vaccine, are there any results for the third dose, and, if someone has received the third dose, has there been any side effects. The outcome of the event was recovering.  Information on Lot/Batch information has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Feeling abnormal, Headache, Rash, Vaccination site mass
Clinical narrative: Vertigo/room spinning; Blurry vision; General "fuzzy" head feeling; Headache going from back of head (left side) to the front.; Had a small rash that has since turned into the bruise; Had a small rash that has since turned into the bruise; Bruised knot at injection site still hasn't cleared; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0196) via an unspecified route of administration, in the left arm on 01Jul2021 (at the age of 28-years-old) as dose 1, single for COVID-19 immunization at pharmacy or drug store. The patient medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medication within 2 weeks of vaccination included ESTRADIOL, 0.5mg once daily taken for an unspecified indication, start and stop date were not reported. Allergies to medications, food, or other products included dilaudid and lortab. Prior to vaccination patient was diagnosed with COVID-19 and did not received any other vaccines within 4 weeks. Since the vaccination, the patient had not been tested for COVID-19. On 01Jul2021, the patient experienced headache going from back of head (left side) to the front started within an hour of receiving the vaccine and hadn't stopped since, and Still ongoing; and also had Bruised knot at injection site still hadn't cleared and had a small rash that has since turned into the bruise. On 03Jul2021, on day 3 after vaccine patient had Vertigo including blurry vision, room spinning, and general fuzzy head feeling started and lasted until day 7. The reporter assessed the events as non-serious The patient did not receive any treatment for the event. Outcome of the events vertigo, blurry vision and general fuzzy head feeling was recovered on 07Jul2021 and outcome of other events was not recovered.