chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Myalgia, Neck pain, Pain
Clinical narrative: having aches in my right shoulder, neck, and leg/shoulder pain/joint pain; having aches in my right shoulder, neck, and leg/neck pain; having aches in my right shoulder, neck, and leg/her right leg from her feet to her thigh, it feels like a muscle ache or a little pain; muscle aches; arthritis has gotten worse; muscle pain; This is a spontaneous report received from a contactable consumer. This consumer reported for herself (patient) that the 63-year-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2) for covid-19 immunization. The patient experienced having aches in my right shoulder, neck, and leg/shoulder pain on an unspecified date with outcome of unknown, having aches in my right shoulder, neck, and leg/neck pain on an unspecified date with outcome of unknown, having aches in my right shoulder, neck, and leg/her right leg from her feet to her thigh, it feels like a muscle ache or a little pain on an unspecified date with outcome of unknown, muscle aches on an unspecified date with outcome of unknown, arthritis has gotten worse on an unspecified date with outcome of unknown, joint pain on an unspecified date with outcome of unknown, muscle pain on an unspecified date with outcome of unknown.    The clinical course was reported as follows: I had the first shot either March 1st or the next Monday nd my last one was on the 29th of March. In between I didn't think nothing about it but I've been having aches in my right shoulder, neck, and leg. It's mostly at night. I put cream on it for muscle aches but this is not going away. It's not all the time just mostly at night. She was having symptoms after getting the Covid 19 vaccine and she is asking if anyone else is having these symptoms. She has neck pain and shoulder pain and her right leg from her feet to her thigh, it feels like a muscle ache or a little pain. She puts some cream on it and it goes away. It doesn't hurt all the time, mostly at night. She told the lady yesterday that she spoke with she had these symptoms. She does report she has arthritis but it has never affected her every day. She thinks maybe her arthritis has gotten worse. She was reading over the paper that has side effects from the Covid 19 vaccine and it talks about muscle pain and joint pain. She has questions. She reports the facility kept her vaccine card after she received her second dose. She thinks she received her first dose on 01Mar2021 or 08Mar2021 and she received her second dose on 29Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Vomiting
Clinical narrative: headache; vomiting/Throwing up; Nausea; pain throughout the body; This is a spontaneous report from a contactable Nurse report for self. This 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731), via an unspecified route of administration, administered in left arm on 14Apr2021 12:31 as single dose for covid-19 immunisation. Medical history included chronic pain (usually takes quarter to half a tablet Oxycodone 10mg). The patient's concomitant medications were not reported. On 19Apr2021 patient woke up with nausea at like 06:00 and throwing up from 12:00 to 18:00, 18:00 was the last time of vomiting/ threw up and then just nausea again. And major pain throughout the body. On 20Apr2021, she was experiencing a headache in the morning and the pain in the body is still residing, but the nausea and vomiting has ended. Patient has pain medicine, she had to take more pain medicine than usual (a full tablet) on 19APR2021. The outcome of nausea and vomiting was recovered on 19APR2021, pain throughout the body and headache was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: flu-like symptoms; Headache; fever / low grade fever after second dose; felt bad all over; face was red; This is a spontaneous report from a contactable consumer. A 60-years-old  male consumer (patient) reported for himself that he received second dose of second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW6170) via an unspecified route of administration in right arm on 19Apr2021 at 13:00 at single dose for COVID-19 immunization. The patient had Covid before Christmas. he was active and gets around. He had friends who had Covid (2020) and he had a bad run with it. The patient's concomitant medications were reported as no. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration in right arm on 29Mar2021 at 09:30 COVID-19 immunization and felt bad. The patient took second dose of Pfizer covid vaccine yesterday i.e. on 19Apr2021 at 13:00. He felt bad after the first. He felt great yesterday until he started feeling bad in the evening. He went to work today, he was feeling better, but now he was experiencing a low grade fever. Caller was asking if he was a slight risk to his coworkers or if he is a potential carrier of the COVID19 virus. He knows there was no live virus in the vaccine. He was just looking for clarification. He felt like he had the flu, felt like crap. He felt bad all over. Last night his wife told him his face was red. He had an infrared thermometer at his desk, he thinks his temperature is 99.5 to 100 tops. He did not take his temperature last night but thinks the fever started last night. He started feeling flu-like at 10:30 today. He was going home after he gets off the phone. Clarified his temperature was 98.8 degrees, but he felt hotter than it reads. His face was 101.8 degrees on his cheek and 100.4 or 101.2 degrees when checking on another area. He took 3 Excedrin this morning for a headache. The outcome of events was unknown.  No follow-up attempts are possible; No further information expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: flu-like symptoms; Headache; fever / low grade fever after second dose; felt bad all over; face was red; This is a spontaneous report from a contactable consumer. A 60-years-old  male consumer (patient) reported for himself that he received second dose of second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW6170) via an unspecified route of administration in right arm on 19Apr2021 at 13:00 at single dose for COVID-19 immunization. The patient had Covid before Christmas. he was active and gets around. He had friends who had Covid (2020) and he had a bad run with it. The patient's concomitant medications were reported as no. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration in right arm on 29Mar2021 at 09:30 COVID-19 immunization and felt bad. The patient took second dose of Pfizer covid vaccine yesterday i.e. on 19Apr2021 at 13:00. He felt bad after the first. He felt great yesterday until he started feeling bad in the evening. He went to work today, he was feeling better, but now he was experiencing a low grade fever. Caller was asking if he was a slight risk to his coworkers or if he is a potential carrier of the COVID19 virus. He knows there was no live virus in the vaccine. He was just looking for clarification. He felt like he had the flu, felt like crap. He felt bad all over. Last night his wife told him his face was red. He had an infrared thermometer at his desk, he thinks his temperature is 99.5 to 100 tops. He did not take his temperature last night but thinks the fever started last night. He started feeling flu-like at 10:30 today. He was going home after he gets off the phone. Clarified his temperature was 98.8 degrees, but he felt hotter than it reads. His face was 101.8 degrees on his cheek and 100.4 or 101.2 degrees when checking on another area. He took 3 Excedrin this morning for a headache. The outcome of events was unknown.  No follow-up attempts are possible; No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is an initial spontaneous report from a Pfizer sponsored program from contactable consumer (patient). This 81-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose on 19Apr at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on an unspecified date at single dose for COVID-19 immunisation. The patient mentioned that he himself has received both doses of the vaccine and reported that the only side effect he experienced was yesterday, stating he had a sore arm that was "very slight" and "not that bad." He had his 2nd Pfizer shot on 19Apr and had a sore arm. Originating AE Request: REQ-258716. The outcome of the event was unknown.  No follow up attempts are possible. Information on lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: little nagging headache; a little tiredness; This is a spontaneous report from a Pfizer sponsored program  via a contactable consumer. This consumer (patient) reported that the female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 for covid-19 immunization. The patient experienced little nagging headache on an unspecified date with outcome of unknown, a little tiredness on an unspecified date with outcome of unknown. Consumer asking if she can take her Fluticasone. Consumer asking if she can take her Allegra. Consumer has a diagnosis of COPD. Consumer was advised by HCP to not take Prednisone at this time. Consumer curious as to why she shouldn't take the Prednisone. Consumer did voice during conversation of other concerns that she tolerated the Pfizer Covid 19 Vaccine well. She stated "I only experienced a little nagging headache enough to know it was there and a little tiredness". She has COPD and is taking predisone. her doctor told her not to take if getting the Covid vaccine. She has had both doses of the vaccine and wants to know how long she should wait to take her predizone again.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Dyspnoea
Clinical narrative: she had a problem breathing/out of breath; asthma; This is a spontaneous report from a contactable consumer (patient's mother). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for covid-19 immunisation. Reporter was calling on behalf of her daughter, she had both doses of Pfizer vaccine. She was in a clinical trial at (withheld), 6 hours after the second dose she had a problem breathing. She had been in and out of ICU ever since then. She had been going to Emergency Room, they were saying it was asthma, they didn't know how to treat it. She was scheduled to go to (withheld) clinic tomorrow. The insurance contacted her and said she can't go there, here Insurance won't cover it. She had been to several doctors in and around Toledo, doctors just didn't know what's wrong, she can't breath, she was on 4 different inhalers. She started CPAP machine, She had 2 sleep studies, got a CPAP, she was nurse with no breathing problems before this. She was on 10 different medications in the morning and not sure how many at night. She went to her family doctor, when she got out of ICU, they didn't know how to treat her. She did not respond, it felt like they didn't know what to do. Her primary care physician wanted her to go to (withheld) Clinic. She can't walk but a few steps, she was out of breath. Reporter just wondered if there was any place she could go and get help or see someone who might have experience in dealing with this. Reporter was going to reach out to the personal care physician. She just can't breathe. The final outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Gait inability, Impaired work ability, Intensive care, Lung disorder
Clinical narrative: she had a problem breathing/out of breath; asthma; This is a spontaneous report from a contactable consumer (patient's mother). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for covid-19 immunisation. Reporter was calling on behalf of her daughter, she had both doses of Pfizer vaccine. She was in a clinical trial at (withheld), 6 hours after the second dose she had a problem breathing. She had been in and out of ICU ever since then. She had been going to Emergency Room, they were saying it was asthma, they didn't know how to treat it. She was scheduled to go to (withheld) clinic tomorrow. The insurance contacted her and said she can't go there, here Insurance won't cover it. She had been to several doctors in and around Toledo, doctors just didn't know what's wrong, she can't breath, she was on 4 different inhalers. She started CPAP machine, She had 2 sleep studies, got a CPAP, she was nurse with no breathing problems before this. She was on 10 different medications in the morning and not sure how many at night. She went to her family doctor, when she got out of ICU, they didn't know how to treat her. She did not respond, it felt like they didn't know what to do. Her primary care physician wanted her to go to (withheld) Clinic. She can't walk but a few steps, she was out of breath. Reporter just wondered if there was any place she could go and get help or see someone who might have experience in dealing with this. Reporter was going to reach out to the personal care physician. She just can't breathe. The final outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep study
Clinical narrative: she had a problem breathing/out of breath; asthma; This is a spontaneous report from a contactable consumer (patient's mother). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for covid-19 immunisation. Reporter was calling on behalf of her daughter, she had both doses of Pfizer vaccine. She was in a clinical trial at (withheld), 6 hours after the second dose she had a problem breathing. She had been in and out of ICU ever since then. She had been going to Emergency Room, they were saying it was asthma, they didn't know how to treat it. She was scheduled to go to (withheld) clinic tomorrow. The insurance contacted her and said she can't go there, here Insurance won't cover it. She had been to several doctors in and around Toledo, doctors just didn't know what's wrong, she can't breath, she was on 4 different inhalers. She started CPAP machine, She had 2 sleep studies, got a CPAP, she was nurse with no breathing problems before this. She was on 10 different medications in the morning and not sure how many at night. She went to her family doctor, when she got out of ICU, they didn't know how to treat her. She did not respond, it felt like they didn't know what to do. Her primary care physician wanted her to go to (withheld) Clinic. She can't walk but a few steps, she was out of breath. Reporter just wondered if there was any place she could go and get help or see someone who might have experience in dealing with this. Reporter was going to reach out to the personal care physician. She just can't breathe. The final outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: MI, symptoms started 2 hours after immunization; This is a spontaneous report from a contactable physician. A 64-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly, administered in the right arm on 14Apr2021 (Batch/Lot Number: EW0161) as a single dose for COVID-19 immunization. The vaccination facility type was reported. Relevant medical history included obstructive sleep apnea on CPAP; hypogonadism on bioTE; depression; history of (h/o) pneumonia; colon polyps; recurrent sinusitis; erectile dysfunction; MTHFR Mutation C677T Heterozygous; low high density lipoprotein (HDL); dyslipidemia; lumbar disc disease; and sciatica; all from an unknown date and unknown if ongoing. Concomitant medications included bupropion hydrochloride (WELLBUTRIN XL); anastrozole; celecoxib (CELEBREX); levothyroxine, liothyronine (NP THYROID); and escitalopram oxalate (LEXAPRO); all taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM), from which the patient had known allergies. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient experienced myocardial infarction (MI), symptoms started 2 hours after immunization on 14Apr2021. The adverse event (AE) resulted in a doctor or other healthcare professional office/clinic visit and an emergency room/department or urgent care, and hospitalization. The patient was hospitalized for the event "MI, symptoms started 2 hours after immunization" for 3 days. Therapeutic measures were taken as a result of the event, which included cardiac stent. The patient was recovering from the event.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of myocardial infarction.  The reported event likely represent intercurrent medical condition in this patient with history of dyslipidemia.   There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline, counteractive treatment measures and concomitant medications This case will be reassessed upon receipt of follow-up information.   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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Gingival disorder, Tooth disorder
Clinical narrative: gum/teeth are bothering her; gum/teeth are bothering her; gum/teeth are bothering her; This is a spontaneous report from a contactable consumer (patient's husband) from a Pfizer sponsored program. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient's medical history included her gum/teeth were bothering her. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date at 66 years old for covid-19 immunisation. The patient received the second dose of the Pfizer covid vaccine a week prior to the report and her gum/teeth were bothering her, the dentist prescribed antibiotic penicillin and caller wanted to know if it was ok to take it after the week of the vaccine. He was asking if this would be okay even if his wife received the second dose of the vaccine five days prior to the report, 15Apr2021. She had this problem before the vaccine also, same spot. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Mobility decreased, Neuralgic amyotrophy, Neuritis
Clinical narrative: weakness under his shoulder; pain under his shoulder; Parson Turner Syndrome  (neuritis); Parson Turner Syndrome  (neuritis); experience arm pain; difficulty moving his arm; This is a spontaneous report received from a contactable physician. The physician reported similar events for two patients, this is the first of two reports.   A 20-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at 20 years old on 17Apr2021 (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for covid-19 immunization. Caller reported that he had a patient who received his Pfizer vaccine, second dose last Saturday (17Apr2021). He reported that on Monday (19Apr2021) he continued to experience arm pain followed by difficulty moving his arm. Now he was requiring a sling, had been prescribed Toradol and Steroids but was not doing any better. He was having continued weakness and pain under his shoulder. Caller was asking for documentation or studies that have been done to determine if the vaccine has any relationship with Parson Turner Syndrome (neuritis) and recommendations for management. He asked to speak with a Pfizer Neurologist. Caller reported that the patient was being seen by an orthopedist, MD. Caller was requesting urgent escalation of his inquiry for further investigation into a relationship between the covid vaccine and Parson Turner Syndrome (neuritis). The outcome of the events was unknown.  No Follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021441207 Same reporter/drug/AE, different patient
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: weakness under his shoulder; pain under his shoulder; Parson Turner Syndrome  (neuritis); Parson Turner Syndrome  (neuritis); experience arm pain; difficulty moving his arm; This is a spontaneous report received from a contactable physician. The physician reported similar events for two patients, this is the first of two reports.   A 20-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at 20 years old on 17Apr2021 (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for covid-19 immunization. Caller reported that he had a patient who received his Pfizer vaccine, second dose last Saturday (17Apr2021). He reported that on Monday (19Apr2021) he continued to experience arm pain followed by difficulty moving his arm. Now he was requiring a sling, had been prescribed Toradol and Steroids but was not doing any better. He was having continued weakness and pain under his shoulder. Caller was asking for documentation or studies that have been done to determine if the vaccine has any relationship with Parson Turner Syndrome (neuritis) and recommendations for management. He asked to speak with a Pfizer Neurologist. Caller reported that the patient was being seen by an orthopedist, MD. Caller was requesting urgent escalation of his inquiry for further investigation into a relationship between the covid vaccine and Parson Turner Syndrome (neuritis). The outcome of the events was unknown.  No Follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021441207 Same reporter/drug/AE, different patient
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Vaccination site pain, Vomiting
Clinical narrative: vomiting; pain at injection site; headache/throbbing; migraine; This is a spontaneous report received from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in left upper arm on 17Apr2021 at 52 years old at 08:52 (Lot Number: EW0161; Expiration Date: Jul2021) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were none. There was no history of all previous immunization with the Pfizer vaccine considered as suspect, no vaccine was administered within 4 weeks Prior Vaccinations, no events followed prior to vaccination. Patient got connected with you after doing a report for her side effects from the Pfizer Covid 19 vaccine. She was concerned about the second round, if this was considered a severe reaction or normal. She had little pain at injection site and headache at first on 17Apr2021 that turned into a 36 hours migraine with vomiting. Migraine started from 17Apr2021 and Vomiting started from 18Apr2021. Caller stated she had a reaction and was just curious if this was still considered one of the more normal side effects. Caller stated she experienced a migraine that lasted almost 36 hours with vomiting. Caller stated she was a little hesitant to receive the second dose. Caller stated she received the vaccine Saturday 17Apr2021 in the morning and she developed a headache the throughout day and it was throbbing. Caller stated she still had a little bit of a headache when she woke up on Monday but it was much better and reduced down to a mild head-ache. Caller stated she definitely had this all night Saturday, then all day Sunday and most of the night, and then the severity was much less Monday morning where it was manageable. Caller stated the migraine stopped later on Monday (19Apr2021). About treatment, patient stated just before she vomited she took an Advil so she did not know if it was in her system long enough. Caller stated and so later on since she was not sure she took two Advils the equivalent of like an Ibuprofen it was generic. There was no Relevant Tests. The patient had recovered from headache and migraine on 19Apr2021, and recovered from Vomiting on 18Apr2021. Outcome of pain at injection site was unknown. Serious criteria was non-serious.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pruritus, Throat irritation
Clinical narrative: I started to get excessively itching in my both ears and throat; I started to get excessively itching in my both ears and throat; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Apr2021 09:58 at 61 years old (Lot Number: EW0164; Expiration Date: 31Aug2021) at single dose for covid-19 immunisation. Medical history included she had to get her glasses to read the handwritten information. The patient's concomitant medications were none. No other vaccines were administered on the same date or within 4 weeks prior to vaccination. Patient received it at 9:58am and stayed there for 15 minutes and went about her day. Everything went fine. Sometimes many hours later, say 6:00 in the evening, she started to get excessively itching in her both ears and throat on 19Apr2021. She didn't even think about getting the vaccine that day or if the reported event had something to do with that. She was talking with someone and they said maybe she shouldn't get the 2nd dose, would the 2nd reaction be more severe? And by the time she went to bed at 11pm it had subsided. The symptoms had subsisted by then. She spoke with her PCP and at first she said maybe she should hold off. Let her call you back and said the more she looked into it was not a severe reaction it wasn't within the first hour and she recommended do get the 2nd one but before she did that, she had 21 days, to refer her to an allergist just in case. Patient asked if there was any information on changing vaccines, like getting the Moderna one for her 2nd dose. She would follow up with an allergist. Stated somebody told her to call her primary care physician and she was wondering if she should get the 2nd dose of the Pfizer COVID Vaccine. The events didn't require a visit to ER or MD office. Caller stated she did not require treatment and the itching in her throat and ears is better. There were no relevant tests. The outcome of the events was recovering. Serious criteria was non-serious.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: UNK
Symptoms: Blood glucose decreased
Clinical narrative: patient already had problems with interaction; he noticed his sugar level went way down after he had the vaccine; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support. A contactable consumer (patient's friend) reported that a 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunization. Co-suspect drug included insulin pen from an unspecified date for Diabetes. The patient's medical history included he had a stroke a year and a half prior to the report and had trouble talking; had Diabetes and used an insulin pen. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for covid-19 immunization. Reporter would like to know if there were any problems with diabetes medicine and covid vaccine. Clarified that the patient already had problems with interaction. Reporter was calling in regards to her friend, she is the healthcare power of attorney for. She stated patient had a stroke a year and a half prior to the report and had trouble talking so she called for him. He had Diabetes and uses an insulin pen. He had received both doses of the vaccine. He did not bring anything up until after the second shot but he noticed his sugar level went way down after he had the vaccine. However, he had also improved his diet and through more fruits and vegetables. She stated he had been using an insulin pen for awhile and now all of the sudden he was having lower blood sugar levels. He still had to take some insulin but not as much. She stated he was thankful to get the vaccine so this was minor to him. She asked if there was an interaction between the vaccine and insulin. Action taken for insulin was dose reduced. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Balance disorder, Body temperature fluctuation, Feeling of body temperature change, Head discomfort
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient) reported himself. A 32-year-old male patient received bnt162b2 (Pfizer- Biontech COVID-19 Vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 17Apr2021 19:00 at 32 years old (Lot number: EW0170) at single dose for covid-19 immunization. Medical history was none, his mom had high blood pressure. The patient's concomitant medications were none. No vaccines were administered on the same date or within 4 weeks prior to vaccination. Caller stated he received the first dose of the Pfizer covid 19 vaccine on Saturday, 17Apr2021. Caller reported that 24 hours later on 18Apr2021 around 1830 to 1900, he felt pressure in the back of his head saying it was very subtle and short lived. He had pressure on back of his head behind his left ear that got progressively worse. The pressure started Sunday evening and progressed a little on Monday. It is the worst today. Caller stated that on Monday (19Apr2021) it progressed to throbbing shooting pains. Caller stated that today (20Apr2021) it is pressure or shooting pains and trouble controlling his temperature stating he went from freezing to hot to freezing to hot and headaches. Caller stated it was not consistent. If it is no pain it is just pressure. Caller stated it was on the left side in the back and occasionally came to the front noting nothing on the right side. Caller reported the injection was on the left side. Caller asked has this been reported before, is this normal, should he get it checked out. Caller also stated that he was not feeling well, mentioned his stomach and flu like symptoms on20Apr2021. It threw off his equilibrium. He felt better sitting or laying. About treatment, he just took an ibuprofen yesterday one time for pain. Caller indicated that the pain had worsened.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Malaise, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient) reported himself. A 32-year-old male patient received bnt162b2 (Pfizer- Biontech COVID-19 Vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 17Apr2021 19:00 at 32 years old (Lot number: EW0170) at single dose for covid-19 immunization. Medical history was none, his mom had high blood pressure. The patient's concomitant medications were none. No vaccines were administered on the same date or within 4 weeks prior to vaccination. Caller stated he received the first dose of the Pfizer covid 19 vaccine on Saturday, 17Apr2021. Caller reported that 24 hours later on 18Apr2021 around 1830 to 1900, he felt pressure in the back of his head saying it was very subtle and short lived. He had pressure on back of his head behind his left ear that got progressively worse. The pressure started Sunday evening and progressed a little on Monday. It is the worst today. Caller stated that on Monday (19Apr2021) it progressed to throbbing shooting pains. Caller stated that today (20Apr2021) it is pressure or shooting pains and trouble controlling his temperature stating he went from freezing to hot to freezing to hot and headaches. Caller stated it was not consistent. If it is no pain it is just pressure. Caller stated it was on the left side in the back and occasionally came to the front noting nothing on the right side. Caller reported the injection was on the left side. Caller asked has this been reported before, is this normal, should he get it checked out. Caller also stated that he was not feeling well, mentioned his stomach and flu like symptoms on20Apr2021. It threw off his equilibrium. He felt better sitting or laying. About treatment, he just took an ibuprofen yesterday one time for pain. Caller indicated that the pain had worsened.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Received both doses of vaccine then 2.5 weeks later got covid; Received both doses of vaccine then 2.5 weeks later got covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable physician (patient) reported that a male patient of an unspecified age (reported as Age: 80; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose via an unspecified route of administration on an unspecified date in Jan2021 (Batch/Lot number was not reported) as a single dose; then second dose via an unspecified route of administration on an unspecified date in Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received both of the Pfizer COVID 19 Vaccines back in Jan2021. About 2.5 weeks later the patient was diagnosed with COVID on an unspecified date. He received the "Bamlan" back in January. He was asking if he will need to take another COVID vaccine. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Vaccination failure and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte count, Lymphocyte count decreased
Clinical narrative: ; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported that a 60-year-old female patient received the Second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 13Apr2021 for COVID-19 immunisation. Relevant history included benign mild hypertension and lower back pain. Relevant concomitant included benazepril hydrochloride (LOTENSIN) 10 mg daily for benign mild hypertension, naproxen 500mg daily for lower back pain.  The patient received the first dose of BNT162B2 on 23Mar2021 for COVID-19 immunisation. The patient had labs drawn which showed low lymphocytes and she was wondering if related to the vaccine. Outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling abnormal, Intranasal paraesthesia, Sneezing
Clinical narrative: nose started tingling; funny taste in her mouth; It almost felt like she was sneezing; felt like a wush going through system and around neck when give the vaccine; This is a spontaneous report received from a contactable consumer (patient). A female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine) via unspecified route of administration on 20Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she felt like a wush going through system and around neck when give the vaccine. Her nose started tingling and she felt a funny taste in her mouth. It almost felt like she was sneezing. The patient asked if this considered an allergic reaction. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Rash, Urticaria, Vaccination site pain
Clinical narrative: hives on multiple areas of her body which worsened and began to blister and ooze; hives on multiple areas of her body which worsened and began to blister and ooze; rash on her neck; soreness on her left/injection arm; This is a spontaneous report received from a contactable nurse. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On 16Apr2021, she developed a rash on her neck and had expected soreness on her left/injection arm. She stated the next morning (17Apr2021) she had hives on multiple areas of her body which worsened and began to blister and ooze. She reported they were similar to a shingles rash. She started a methylprednisolone (MEDROL) dose pack on 19Apr2021 and stated the rash continued but had not worsened. Outcome of neck rash was not resolved. Outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cough, Fatigue, Nausea, Pulmonary pain
Clinical narrative: tiredness; cough; pain in my lungs, in the back and in the chest; pain in my lungs, in the back and in the chest; nausea; This is a spontaneous report from a contactable consumer (patient). The patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). This is the case for dose 2. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation on an unspecified date, after the first dose patient had a headache and chest pain, but it went away quickly. Patient received the second dose of the Pfizer COVID 19 vaccine yesterday (19Apr2021). Since then, she's been feeling with a bad headache, tiredness, cough, pain in her lungs, in the back and in the chest and nausea in Apr2021. Patient is wondering whether this has been reported before. Outcome of the events was unknown.   No follow-up attempts are needed; Information related to batch/Lot number could not be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Ear infection, Ear pain, Headache, Hypoaesthesia
Clinical narrative: Bell's Palsy; Headache; jaw ache; ear ache; numbness in face; Assuming ear infection; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 27Mar2021 12:45 (Lot Number: EP6955) as single dose (at 56 years old) for COVID-19 immunisation.  Medical history included none. Concomitant medications included atorvastatin, cetirizine hydrochloride (ZIRTEC), Forces of Nature Skin Tag. On 13Apr2021, the patient experienced Bell's Palsy (medically significant), headache, jaw ache, ear ache, numbness in face, assuming ear infection. Therapeutic measures were taken as a result of the events included Prednisone. The outcome of the events was recovering. The patient required a visit to the emergency room and diagnosed with Bell's Palsy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: Bell's Palsy; Headache; jaw ache; ear ache; numbness in face; Assuming ear infection; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 27Mar2021 12:45 (Lot Number: EP6955) as single dose (at 56 years old) for COVID-19 immunisation.  Medical history included none. Concomitant medications included atorvastatin, cetirizine hydrochloride (ZIRTEC), Forces of Nature Skin Tag. On 13Apr2021, the patient experienced Bell's Palsy (medically significant), headache, jaw ache, ear ache, numbness in face, assuming ear infection. Therapeutic measures were taken as a result of the events included Prednisone. The outcome of the events was recovering. The patient required a visit to the emergency room and diagnosed with Bell's Palsy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body height, Chills, Condition aggravated, Drug ineffective
Clinical narrative: sweats; Chills; feeling horrible; it was progression of the disease; tired; energy level was gone/wasn't strong; low fever; tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patients mother).   A 98-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right Arm on 17Jan2021 (Batch/Lot Number: EL9261) as SINGLE DOSE for covid-19 immunisation. Medical history included cholesterol, blood pressure, synthetic thyroid replacement, kidney and breast cancer survivor. Concomitant medication(s) included levothyroxine sodium (LEVOXYL) taken for thyroid therapy, start and stop date were not reported, vitamins,  Cholesterol medication, Blood Pressure medication. The patient previously had a flu shot.  The reporter said her 99-year-old mother received the 1st dose of the Pfizer-; had mild symptoms. Her mom is 99 and in good health. Her dad lived until 110. Her mom had first Pfizer shot through the assisted living facility on 17Jan2021. During routine testing her mom tested positive for COVID 25Jan2021. She had mild symptoms that started on the 26Jan2021. She was tired. Her energy level was gone and she had low fever. For prevention and to stay safe she had monoclonal antibodies infused on 29Jan2021. After that, she got really bad with fever and sweats. She never had trouble breathing. When taking her back from receiving the monoclonal antibodies, her mom had chills and was feeling horrible. They said it was progression of the disease. It took a month for her to get her strength back, but now she is great. She wasn't strong when she was due for second shot on 07Feb2021 and she didn't get it because they didn't want to stress her. She didn't have any stamina at that point. Now caller has been reading that some people say wait 90 days after monoclonal antibodies for the second dose. Her mom's thyroid doctor said not to give it. Her mom got better within the month, but would tire easily. She would be spent and couldn't do anymore. Now she is back to normal. She is up all day and stays up until 11PM.The outcome of the events was not reported.