chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Memory impairment
Clinical narrative: "I'm confused,  I believe it (vaccine )was yesterday".; does not remember getting a card from vaccination provider; This is a spontaneous report from a non-contactable consumer (patient). A male patient of age 72 (units unspecified) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on an unknown date in 2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included urinary flow. Concomitant medications included doxycycline calcium, atorvastatin calcium, doxazosin mesylate and finasteride taken for urinary flow. Patient received 1st dose of vaccine and became unsure if he received Pfizer or Moderna vaccine. He said he believes they told him they gave me Moderna. Patient said all his post vaccination paperwork says Pfizer and was sure he got the Pfizer drug. Patient continues to go back and forth about whether he received Pfizer or Moderna. He does not remember getting a card from vaccination provider and is asking for assistance with obtaining another card and confirming vaccination information (date received, manufacturing company). He is also confused about hand written date and time on top of paperwork, 10Mar2021 at 10 30am. Patient continues to voice he believes that was the date he got the 1st dose. Patient was confused about multiple topics and said maybe its medication he is taking, but this has been the most confusing day. Patient then repeats he was confused, he believed it (vaccine) was yesterday. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: Severe Headache; Dizziness; sore left arm; This is a spontaneous report from a contactable consumer or other non hcp. A 41-years-old female (non pregnant) patient received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200 and expiry date was not reported),via an unspecified route administered in Arm Left on 20Feb2021 09:00 ( age at vaccination 41 years old) as dose 1,single for COVID-19 immunisation.Medical history and concomitant medications were not reported.On 20Feb2021 12:00 patient experienced severe headache, dizziness, sore left arm.The outcome of the events was not recovered.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: el3247 and Batch no/Expiration date: not provided) via an unspecified route of administration in Arm Left on 18Feb2021 09:00 AM (age at vaccination 40-years-old) as dose 2, single for COVID-19 immunization at Workplace clinic. The patient medical history and concomitant medications were not reported. Patient had past drug codeine and experienced allergies. Historical vaccine included previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EL3247 and Batch no/Expiration date: not provided) via an unspecified route of administration in Arm Left on 28Jan2021 09:00 AM (age at vaccination 40-years-old) as dose 1, single for COVID-19 immunization. Patient did not receive other vaccines within four weeks and did not receive other medications within two weeks. Patient had no covid prior to vaccination and not tested post vaccination.Two days later on 20Feb2021, the patient experienced Sore arm, felt tired and headache most of the day. The patient received treatment for the reported events which included Tylenol. Outcome of all the events was recovering. Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Heart rate, Heart rate increased, Hypertension
Clinical narrative: high blood pressure; weakness; unable to stand; rapid heartbeat; This is a spontaneous report from a contactable consumer or other non hcp. A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number EN9581) via an unspecified route of administration, administered in Arm Right on 18Feb2021 10:00(Age at vaccination was 80 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, bronchitis chronic, asthma, covid-19 on 19Oct2020. The patient previously took percocet [oxycodone hydrochloride;oxycodone terephthalate;paracetamol] and experienced drug hypersensitivity. No other vaccine in was received in four weeks. Concomitant medication(s) included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]); ibuprofen (IBUPROFEN); esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) all taken at 12.5 mg for unspecified indication, start and stop date were not reported and the patient received within 2 weeks of vaccination. The patient had identical side effects after initial dose of vaccine.  On 19Feb2021 08:00 patient experienced high blood pressure, weakness, unable to stand, rapid heartbeat. Went to emergency room by ambulance on 19Feb, patient still experiencing weakness in legs and arms. No treatment was received for adverse events. 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 underwent lab tests and procedures which included blood pressure measurement: high on unspecified date, heart rate: rapid on unspecified date, sars-cov-2 test: unknown result on Oct2020. The report was non-serious. The outcome of events was recovered with Sequel.  Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, SARS-CoV-2 test
Clinical narrative: high blood pressure; weakness; unable to stand; rapid heartbeat; This is a spontaneous report from a contactable consumer or other non hcp. A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number EN9581) via an unspecified route of administration, administered in Arm Right on 18Feb2021 10:00(Age at vaccination was 80 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, bronchitis chronic, asthma, covid-19 on 19Oct2020. The patient previously took percocet [oxycodone hydrochloride;oxycodone terephthalate;paracetamol] and experienced drug hypersensitivity. No other vaccine in was received in four weeks. Concomitant medication(s) included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]); ibuprofen (IBUPROFEN); esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) all taken at 12.5 mg for unspecified indication, start and stop date were not reported and the patient received within 2 weeks of vaccination. The patient had identical side effects after initial dose of vaccine.  On 19Feb2021 08:00 patient experienced high blood pressure, weakness, unable to stand, rapid heartbeat. Went to emergency room by ambulance on 19Feb, patient still experiencing weakness in legs and arms. No treatment was received for adverse events. 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 underwent lab tests and procedures which included blood pressure measurement: high on unspecified date, heart rate: rapid on unspecified date, sars-cov-2 test: unknown result on Oct2020. The report was non-serious. The outcome of events was recovered with Sequel.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Transient global amnesia
Clinical narrative: Received her first dose on 28Jan and patient was diagnosed with transient global amnesia; This is a spontaneous report from a contactable Nurse (Patient). A 68-year-old female (Non pregnant) patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered anatomical location not reported on 28Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient wanted to know if a patient can have IV contrast Iohexol 75 ml/350 solution due to a neurological event happened on 16Feb (year not reported), can the patient receive the second dose of the vaccine which will due tomorrow (4 days later of IV contrast) and is it safe to give COVID-19 vaccine 4 days later. Patient wanted to know what arm patient should get their second dose of the bnt162b2 vaccine (opposite arm or same arm). On unspecified date, patient experienced transient global amnesia. Treatment received for the event was unknown. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021183970 similar report from same reporter
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, SARS-CoV-2 test
Clinical narrative: 36 hrs after injection extreme fatigue began. while improving slightly it has continued for 18 days. went to ER but they could not find a reason to admit me. Still very weak. Need help but no one can; Still very weak.; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administrated in left arm on 12Feb2021 13:30 (age at the time of vaccination 75-years-old), as a single dose for COVID-19 immunization at Hospital. The patient's medical history included copd, and coronary artery disease. The patient's concomitant medications included spiriva, plavix, avodart, atorvastatin, lipitor, linzess, breo, and levoxly. Patient did not have known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Feb2021, the patient experienced 36 hrs after injection extreme fatigue began. while improving slightly it has continued for 18 days. went to ER but they could not find a reason to admit me. Still very weak. Need help but no one can provide, and Still very weak. On 18Feb2021, the patient underwent lab tests and procedures which included Nasal Swab, COVID-19: Negative. The adverse event result in Emergency room/department or urgent care. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Upon follow-up (26Feb2021), age of the patient at the time of vaccination, lot number, date and time of vaccination, date of lab test and result, concomitant drugs, adverse event, and outcome was updated. The outcome of the event was not recovered. Information on the lot/batch number has been requested.  Follow-up#1 (26Feb2021): This is a spontaneous report from a contactable consumer. This consumer (patient) reported that, which included: age of the patient at the time of vaccination, lot number, date and time of vaccination, date of lab test and result, concomitant drugs, adverse event, and outcome was updated in narrative.  Follow-up#2 (06Mar2021): This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: no new information was added.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Headache; Severely swollen lymph node in left armpit; Pain radiating down inside of left arm; Pain radiating down inside of left arm; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 51-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5381) via an unspecified route of administration in left arm on 16Feb2021 07:30 as dose 2, single (at the age of 51-years-old) for COVID-19 immunization. Vaccination facility type was reported as Workplace Clinic. Patient medical history was not reported. Patient received unknown concomitant medications in two weeks. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- EN5381) via an unspecified route of administration in left arm on 26Jan2021 07:00 as dose 1, single for COVID-19 immunization and experienced sore arm and diarrhea. Patient did not receive other vaccine in four weeks. Patient had not COVID prior vaccination and was not tested post COVID vaccination. On 18Feb2021, the patient experienced headache, severely swollen lymph node in left armpit and pain radiating down inside of left arm. Patient did not receive any treatment for the reported events. The outcome of the events was not recovered.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: arm started hurting; body aches/aches are increasing; Headache; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 intramuscular, administered in Arm Left on 18Feb2021 14:00 (at the age of 56-years-old) (Batch/Lot Number: EL3302; Expiration Date: May2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included blood pressure high from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that on an unspecified date, she had headache, body aches, her arm started hurting first when she got the vaccine. Through the evening, she started getting achy. Through the night, she had like feverish body aches that kept waking her up. Reporter clarified she was not experiencing any fever at this time. The aches was increasing. It was reported that patient did not receive any additional vaccines on same date of the Pfizer Suspect. Patient did not receive any prior vaccinations within 4 weeks. Reporter stated she hasn't had a vaccine in over 50 years. Patient did not have medical history including any illness at time of vaccination and did not underwent any relevant tests. Patient stated she was feeling achy and she had a headache. Is it okay to take Tylenol (reporter question). It was reported that they didn't have anything on the pamphlet that was given out about taking Tylenol. Outcome of all events were unknown.  Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Heavy fatigue starting 4 hours after vaccine and lasting about 8 hours; This is a spontaneous report from a non-contactable consumer (patient herself). A 43-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN6200, expiration date was not reported), via an unspecified route of administration, administered in left arm on 18Feb2021 (age at vaccination; 43-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. After 4 hours of vaccination on 18Feb2021, the patient had experienced heavy fatigue which lasted for about 8 hours. The patient received treatment for the event. The outcome of the event was recovered.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Affective ambivalence, Asthenia, Dizziness
Clinical narrative: Dizziness; Weakness; I experienced eight of the twelve affect you could have; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and Lot number was not reported), via an unspecified route of administration on 07Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced eight of the twelve affect you could have plus lot of the severe one it is dizziness and weakness. The outcome of the events was unknown.  Information on lot/ batch has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Altered taste/ eat a cookie everyday to test it, and it tasted terrible/ now its just bad; This is a spontaneous case received from a contactable consumer (patient herself). A female patient (age:83, Units: unknown) received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 19Feb2021 at approximately 08:00 as SINGLE for COVID-19 immunization. The patient medical history included immunocompromised. The patient concomitant medications was not reported. The patient historical vaccine included first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 22Jan2021 at approximately 08:00 for COVID-19 immunization and experienced altered taste/ metallic taste, also very hungry and tired. The following morning after second vaccination on 20Feb2021, the patient experienced altered taste.  Also stated, I eat a cookie everyday to test it, and it tasted terrible. After second dose she ate a lot and slept. It was stated it was more metallic first time (after 1st dose), now its just bad (after 2nd dose). Caller stated she did rinse mouth with Listerine in the morning, and asking if that could affect the taste.  Asking if this was a side effect from the vaccine. Made caller aware there is currently no information to provide on altered taste post vaccination. The outcome of the event was unknown.  Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: boiling blisters; This is a spontaneous report from a contactable consumer (Patient) based on the information reported to Pfizer by company, (Mfr. Report Number: LRN4255056). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on an unspecified date, as dose number unknown, single for COVID-19 immunization. The patient's medica history and concomitant medications were not reported. On an unspecified date, after vaccination, the patient experienced boiling blisters. The clinical outcome of the event was reported as unknown.   No further information was reported. Information on lot/ batch has been requested.   Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Muscle spasms
Clinical narrative: diarrhea; Severe cramping; This is a spontaneous report from a contactable consumer (patient). A 47-Years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6200) via unknown route of administration in Left arm, on 20Feb2021 03:30 PM (at the age of 47 years old), as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history included MCTD, endometriosis and patient were allergic to Quetiapine. The patient's concomitant medications included hydroxychloroquine sulfate (PLAQUENIL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), ibuprofen and trazodone. On 20Feb2021 at 07:00 PM, the patient experienced severe cramping and diarrhea. The patient did not receive treatment for the event. The patient did not have COVID prior vaccination and not tested COVID post vaccination. At the time of this report the outcome of the event was reported as recovering.  Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Body aches; hand plus thumb ache even stronger; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported, Expiry date: not reported, age at of 70-year-old), via an unspecified route of administration, administered in left arm on 15Feb2021 13:00 as dose 2, single for covid-19 immunisation. Medical history included arthritis (diagnoses in the affected thumb and wrist). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiry date: unknown, at age of 70-year-old), via an unspecified route of administration in left arm on 25Jan2021 16:00 as dose 1, single for covid-19 immunisation. The patient concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks to vaccine. It was unknown if patient received other medication in two weeks. On 16Feb2021, the patient experienced body aches, and hand plus thumb ache even stronger than body ache. The outcome of event was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Back pain, Fatigue, Headache
Clinical narrative: Injection site pain; Tiredness/is just wiped out; Headache; has not been able to put anything in her stomach, as she runs straight to the bathroom; hurts so bad, her stomach and back; hurts so bad, her stomach and back; This is a spontaneous report from a contactable consumer (patient, self-reported). A 69-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EM9810 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 16Feb2021 (age at vaccination: 69 years), as a single dose for COVID-19 immunization. The patient's medical history included high blood pressure. Concomitant medication included unspecified blood pressure medication. Historical vaccine included first 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 and she was fine. The patient stated that on 16Feb2021, she received the second dose of the COVID vaccine. After this dose, about two hours after, she started feel ingtired. The patient stated that she hasn't been able to get straight. The patient was having injection site pain, tiredness, headache, all of these things were going on. The patient was wondering how long these side effects were supposed to last. She has not been able to put anything in her stomach, as she runs straight to the bathroom. The patient tried to eat twice, but she didn't like the feeling of diarrhea and it was constant. The patient stated that she tried to get up and move around, but she was just wiped out. The patient was wondering if these were normal side effects, like she hurts so bad, her stomach and back and she has not had food in a long time. The patient was wondering if she was supposed to be in this situation. The patient reported that all events were still ongoing. When queried for outcome, patient stated that she would feel like her symptoms have improved but then they come back with a vengeance. She gets up and tries to function, and her symptoms shoot her back down. The patient confirmed that she had no other vaccines on the same day as her COVID vaccine. The patient took an unspecified blood pressure medication, she confirms she took it the same day as her COVID vaccine, but she was unwell the next day and the day after, and she didn't get out of bed, so she forgot to take this medicine on those days. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; Tiredness/is just wiped out; Headache; has not been able to put anything in her stomach, as she runs straight to the bathroom; hurts so bad, her stomach and back; hurts so bad, her stomach and back; This is a spontaneous report from a contactable consumer (patient, self-reported). A 69-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EM9810 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 16Feb2021 (age at vaccination: 69 years), as a single dose for COVID-19 immunization. The patient's medical history included high blood pressure. Concomitant medication included unspecified blood pressure medication. Historical vaccine included first 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 and she was fine. The patient stated that on 16Feb2021, she received the second dose of the COVID vaccine. After this dose, about two hours after, she started feel ingtired. The patient stated that she hasn't been able to get straight. The patient was having injection site pain, tiredness, headache, all of these things were going on. The patient was wondering how long these side effects were supposed to last. She has not been able to put anything in her stomach, as she runs straight to the bathroom. The patient tried to eat twice, but she didn't like the feeling of diarrhea and it was constant. The patient stated that she tried to get up and move around, but she was just wiped out. The patient was wondering if these were normal side effects, like she hurts so bad, her stomach and back and she has not had food in a long time. The patient was wondering if she was supposed to be in this situation. The patient reported that all events were still ongoing. When queried for outcome, patient stated that she would feel like her symptoms have improved but then they come back with a vengeance. She gets up and tries to function, and her symptoms shoot her back down. The patient confirmed that she had no other vaccines on the same day as her COVID vaccine. The patient took an unspecified blood pressure medication, she confirms she took it the same day as her COVID vaccine, but she was unwell the next day and the day after, and she didn't get out of bed, so she forgot to take this medicine on those days. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: arms are aching; woke up yesterday and from his shoulder to his elbow on his left arm is sore; This is a spontaneous report from a contactable consumer.   A 79-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 13Feb2021 13:15 (at the age of 79-years-old) as dose 1, single for covid-19 immunisation. Patient received second dose of BNT162B2 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation on 06Mar2021. Family Medical History Relevant to AE was none, but patient stated that he had 2 sisters who died from cancer on an unspecified date. Patient stated he had blood work done prior to getting the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated that he takes blood pressure medication, cholesterol medication, and fish oil and he wears a patch for his blood pressure (names of the products unknown).Vaccine administered at clinic. None of the vaccines was administered on same date of the Pfizer suspect vaccine. On 18Feb2021, patient stated that when he woke up yesterday morning his arms are aching and the left is the sorest, said he received the vaccine in the left arm also said that his right arm is sore at the elbow. Patient had no visit to emergency room or physician office. Outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache/ Tylenol (Treatment) back and forth, back and forth/ I get relief when I have it and then it come back again; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported, Expiration date was unknown), via an unspecified route of administration on an unknown date in Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Feb2021, the patient received COVID vaccine, given last week Monday. So, from then I have been having this headache. So, I have taken Tylenol (Treatment) back and forth, back and forth. Is like I get relief when I have it and then it come back again. The outcome of event was unknown.  Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. This consumer (husband) reported for a female patient (wife) that a female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number-Not reported) via an unspecified route of administration, administered on unspecified date as Dose 1, single for covid immunization. Patient medical history include Type 1 diabetic. Just wondering if there is a survey I could help with after receiving the first dose of the Pfizer vaccine for COVID. I had arm soreness for about a day, but that is it. The patient concomitant medication were not reported. Patient experienced arm soreness on unknown date. The outcome of event was unknown.  Information about lot/batch number has been requested. Follow-up attempts completed. No further information expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021213472 Same reporter/ drug/ event for different patients
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer or other non hcp.   A 20-year-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number-Unknown),via an unspecified route of administration, administered in arm left on12Jan2021 19:30 (age at vaccination 20 years) as dose 1, single for COVID-19 immunization. The patient medical history was reported as none. The patient's concomitant medications were not reported. The patient experienced sore arm on an unspecified date in 2021. The outcome of event was recovered on an unspecified date in 2021.  Information about lot/ batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: she had a slight headache after the first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age 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. The patient's medical history and concomitant medications were not reported. The patient wants to know how she can reschedule her second dose and mentioned she had a slight headache after the first dose on an unspecified date. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Muscle fatigue, Muscle tightness
Clinical narrative: slightly more tired than normal; the area of the area of the arm where administered was sore to touch/arm was extremely sore and couldn't lift above shoulder level; muscles were fatigued; muscles were fatigued and tightening considerably in shoulders and back, way beyond normal soreness; muscles were fatigued and tightening considerably in shoulders and back, way beyond normal soreness; muscles were fatigued and tightening considerably in shoulders and back, way beyond normal soreness; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 24Feb2021 at 14:45 (at the age of 47-year-old), dose 1, single for COVID-19 immunisation. The patient had no medical history and there were no concomitant medications. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 24Feb2021, the day of vaccination, the patient's area of the arm where vaccine administered was sore to touch. On 25Feb2021, next day, the arm was extremely sore and could not lift above shoulder level and she needed to rest and was slightly more tired than normal. On 26Feb2021, the patient resumed activities, and arm could raise to normal. From an unspecified date in Feb2021 (by the weekend and even the entire following week), the patient's muscles were fatigued and tightening considerably in shoulders and back, way beyond normal soreness. The patient received chiropractic care for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slightly more tired than normal; the area of the area of the arm where administered was sore to touch/arm was extremely sore and couldn't lift above shoulder level; muscles were fatigued; muscles were fatigued and tightening considerably in shoulders and back, way beyond normal soreness; muscles were fatigued and tightening considerably in shoulders and back, way beyond normal soreness; muscles were fatigued and tightening considerably in shoulders and back, way beyond normal soreness; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 24Feb2021 at 14:45 (at the age of 47-year-old), dose 1, single for COVID-19 immunisation. The patient had no medical history and there were no concomitant medications. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 24Feb2021, the day of vaccination, the patient's area of the arm where vaccine administered was sore to touch. On 25Feb2021, next day, the arm was extremely sore and could not lift above shoulder level and she needed to rest and was slightly more tired than normal. On 26Feb2021, the patient resumed activities, and arm could raise to normal. From an unspecified date in Feb2021 (by the weekend and even the entire following week), the patient's muscles were fatigued and tightening considerably in shoulders and back, way beyond normal soreness. The patient received chiropractic care for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain, Pyrexia
Clinical narrative: her back was bothering her/Back ache; Fever; Achiness; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 04Feb2021 as dose 2, single for COVID-19 immunization. Medical history included Shingles. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was stated that patient realized, she came down with shingles probably the day before or the day of that she took the first shot. The patient's concomitant medications were not reported. The patient experienced her back was bothering her/back ache, fever, and achiness on 05Feb2021. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid ptosis, Hypoaesthesia, Paraesthesia, Paraesthesia oral
Clinical narrative: Left eye drooping; numbness; tingling of nose and upper lip area and left side of face began about 30 post vaccine; tingling of nose and upper lip area and left side of face began about 30 post vaccine; tingling of nose and upper lip area and left side of face began about 30 post vaccine; This is a spontaneous report received from a contactable consumer or other non hcp. A 60-years-old female patient received 2nd dose of bnt162b2 (COMIRNATY,Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 27Feb2021 15:45,at the age of 60 years old,as Dose 2,single for covid-19 immunization. Medical history included interstitial cystitis and drug hypersensitivity from an unknown date and unknown if ongoing.     There were no concomitant medications.The patient previously took tigan and experienced drug hypersensitivity, bnt162b2 for covid-19 immunization.The patient experienced left eye drooping, numbness, tingling of nose and upper lip area and left side of face began about 30 post vaccine on 27Feb2021 16:15.The outcome of the event was recovering.The patient had not received any other vaccine within 4 weeks.The patient was not diagnosed with covid prior vaccination and not tested post vaccination.  Follow-up (12May2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash macular, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: it was blotchy and turned red; it was blotchy and turned red; the area started to itch; soreness and warmth at the injections site; soreness and warmth at the injections site; This is a spontaneous report from a contactable nurse (patient) via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 20Feb2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced soreness and warmth at the injections site on 20Feb2021, the area started to itch on 22Feb2021, and it was blotchy and turned red on 01Mar2021. Patient reported that she experienced soreness and warmth at the injections site. Two days later the area started to itch, but she didn't bother with it, 9 days in and she rubbed the area but still didn't itch it, the whole are became red. And when it subsided, it left a blotch, with off and on itching. Patient reported that the blotch is really mild, it was fading, but it leaves her feeling uncertain. Outcome of event soreness and warmth at the injections site was unknown, the area started to itch was not resolved, Blotchy was resolving and Redness was resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on her sides which speared through her entire body/broke out in a rash; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6198), via an unspecified route of administration in the left arm on 25Feb2021 at 14:15 (at the age of 65-year-old), dose 1, single for COVID-19 immunisation. The patient had no medical history and there were no concomitant medications. The patient had no family history. The patient did not receive other vaccines four weeks prior. The patient did not underwent lab tests and procedures The event was reported as non-serious and resulted in emergency room visit and doctor or other healthcare professional office/clinic visit. On 28Feb2021, the patient noticed rash on her sides which speared through her entire body. The patient went to emergency and consulted a dermatologist. It was reported the patient broke out in a rash. Ended up going to the emergency room. Was only told to get on Benadryl. The rash spread all over her body and went to a dermatologist and was told it was definitely a reaction from the COVID-19 Shot. The rash appeared initially as long scratch marks or long stretch marks. Noticed it in the morning and thought it was strange. In the evening, the rash was all over her chest, neck, and top parts of arms. The rash was spreading all over her body as of the report. On 28Feb2021, the patient was discharged from emergency room. Stated it was after 23:00 and there was no urgent care open at that time. As of the reporting day, the rash on her sides still resembles scratch or stretch marks. On the rest of her body, it is just a blotchy rash. The patient had been taking Benadryl (lot number: SPF061, expiration date: Aug2022) three times a day (25mg in the morning, 25mg in the afternoon, 50mg at night) for five days. Dosing instructions provided by emergency room. The dermatologist advised to complete five days of Benadryl. Afterwards, begin taking Zyrtec in the morning and Benadryl at night. Would begin this regimen on Saturday (as reported). The patient's next dose was supposed to be 18Mar2021. The patient wanted to know if she was eligible to receive the second dose of the vaccine. The patient read on the fact sheet that one does not get the second dose if they had a severe allergic reaction to the first vaccine. The reporter also asked how long does rash last post vaccination. The patient stated she would see her physician and dermatologist a couple days before her second dose. The outcome of the event was not recovered.  No follow-up attempts are possible; No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Mobility decreased, Pain in extremity
Clinical narrative: ache in my shoulder that goes down my arm; ache in my shoulder that goes down my arm; can't lift my arm past my shoulder; wiped out/very tired; like have no energy; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302), via an unspecified route of administration on 27Feb2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced ache in my shoulder that goes down my arm, can't lift my arm past my shoulder, wiped out/very tired and like have no energy on 01Mar2021. It was asked long will these side effects last. Outcome of events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Frustration tolerance decreased, Nasopharyngitis
Clinical narrative: colds; She is very frustrated; The initial case was missing the following minimum criteria: unspecified event. Upon receipt of follow-up information on 13May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 84-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch / Lot Number: EN5318, Expiry date not reported), via an unspecified route of administration in left arm on 23Feb2021 (age at vaccination was 84 years) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced colds and, she was very frustrated. It was reported that called to ask whether she should pursue going to the facility for her second vaccine dose, 16Mar2021. She first received it last 23Feb2021. However, she developed colds in-between doses (started a few days before her second vaccine schedule). She was very frustrated because she has been trying to reach someone whom she can speak to, asking whether she should pursue taking her second dose of the vaccine scheduled tomorrow, but was only being put on hold for 3 hours. She was on the verge of giving up and not having the second vaccine tomorrow if and when she still did not feel good. The outcome of the events was unknown.     Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dyspnoea, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Breathing difficulty when standing; chest pain; sore throat; swollen gland; back ache; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6198), via an unspecified route of administration in the left arm on 26Feb2021 at 10:15 (at the age of 75-year-old), dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at hospital. On 04Mar2021 at 00:00, the patient experienced breathing difficulty when standing, chest pain, sore throat, swollen glands, back ache. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; No further information is expected.