chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Limb discomfort, Lymphocyte count, Off label use, SARS-CoV-2 antibody test
Clinical narrative: Sore arm; Little lightheaded; Tired; Got the Pfizer vaccines 1st dose-03/04/2021 and 2nd dose 03/24/2021 (less than 21 days in between doses).; Got the Pfizer vaccines 1st dose-03/04/2021 and 2nd dose 03/24/2021 (less than 21 days in between doses).; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (Patient). A 76-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 24Mar2021 as dose 2, single for COVID-19 immunisation. The patient medical history included chronic lymphocytic leukaemia (he was diagnosed 14-15 months ago with CLL, He had a spleen that was measuring 22cm and was pushing his stomach out. He has moved from Stage 2 to Stage 0), dental disorder nos, orthopaedic, heart issues from an unknown date and unknown if ongoing. The concomitant medications included ibrutinib (IMBRUVICA) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 04Mar2021 (at the age of 76-years-old) as dose 1, single for covid-19 immunisation. On unspecified date, the patient experienced sore arm, little lightheaded, tired and got the pfizer vaccines 1st dose-03/04/2021 and 2nd dose 03/24/2021 (less than 21 days in between doses). The patient asked that hopefully after the two initial doses and the booster I'm hoping to have some immunity. The patient also asked about data on patients with CLL or leukemia. He was confused, if there is a way to test for efficacy after the vaccine or not. On an unspecified date, the patient underwent lab tests and procedures which included blood immunoglobulin g: the first was an abigg, spike s (was a little arrow to the left less than 1), blood test: good (controlled by Imbruvica), investigation resulted negative (He had the immunity test to check if he gained immunity to the shots, like Corona IGG /Sars Covid 2 IGG spikes both came out negative), lymphocyte count resulted 50-60% lymphocytes, sars-cov-2 antibody test resulted negative (He had the immunity test to check if he gained immunity to the shots, like Corona IGG /Sars Covid 2 IGG spikes both came out negative and the little arrow read to the left of 1.4. and then later were 0.04 and 0.02 readings), sars-cov-2 antibody test: the first was an abigg, spike s (the reading was a little arrow to the left less than 1) and white blood cell count resulted 16k. The outcome of the events was reported as unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: Sore arm; Little lightheaded; Tired; Got the Pfizer vaccines 1st dose-03/04/2021 and 2nd dose 03/24/2021 (less than 21 days in between doses).; Got the Pfizer vaccines 1st dose-03/04/2021 and 2nd dose 03/24/2021 (less than 21 days in between doses).; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (Patient). A 76-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 24Mar2021 as dose 2, single for COVID-19 immunisation. The patient medical history included chronic lymphocytic leukaemia (he was diagnosed 14-15 months ago with CLL, He had a spleen that was measuring 22cm and was pushing his stomach out. He has moved from Stage 2 to Stage 0), dental disorder nos, orthopaedic, heart issues from an unknown date and unknown if ongoing. The concomitant medications included ibrutinib (IMBRUVICA) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 04Mar2021 (at the age of 76-years-old) as dose 1, single for covid-19 immunisation. On unspecified date, the patient experienced sore arm, little lightheaded, tired and got the pfizer vaccines 1st dose-03/04/2021 and 2nd dose 03/24/2021 (less than 21 days in between doses). The patient asked that hopefully after the two initial doses and the booster I'm hoping to have some immunity. The patient also asked about data on patients with CLL or leukemia. He was confused, if there is a way to test for efficacy after the vaccine or not. On an unspecified date, the patient underwent lab tests and procedures which included blood immunoglobulin g: the first was an abigg, spike s (was a little arrow to the left less than 1), blood test: good (controlled by Imbruvica), investigation resulted negative (He had the immunity test to check if he gained immunity to the shots, like Corona IGG /Sars Covid 2 IGG spikes both came out negative), lymphocyte count resulted 50-60% lymphocytes, sars-cov-2 antibody test resulted negative (He had the immunity test to check if he gained immunity to the shots, like Corona IGG /Sars Covid 2 IGG spikes both came out negative and the little arrow read to the left of 1.4. and then later were 0.04 and 0.02 readings), sars-cov-2 antibody test: the first was an abigg, spike s (the reading was a little arrow to the left less than 1) and white blood cell count resulted 16k. The outcome of the events was reported as unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash papular, Varicella
Clinical narrative: he developed a rash from his chest to his arms and legs, and now it is on all of his face; he started to develop a rash and had a telehealth appointment with a doctor and they said it looked like chicken pox; and the doctor said in their opinion that the rash looks like Chicken Pox; This is a spontaneous report from a contactable pharmacist. A 21-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number and Expiry date: not reported) (age at the time of vaccination was 21 years), via unspecified route on 08May2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number and Expiry date: not reported), via unspecified route on an unspecified date, as dose 1, single for COVID-19 immunization. On 10May2021, the patient had developed rash from his chest to his arms and legs, had a telehealth appointment with a doctor and they said it looked like chicken pox. The outcome of the event was unknown.  No follow-up attempts were possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Myalgia
Clinical narrative: Muscle soreness; This is a spontaneous report based on the information received by facilitating company. (MCN#: 2021US000559) from a non-contactable consumer (Patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date (at age of 58-years-old) as dose number unknown, single for covid-19 immunization. Co-suspect included abaloparatide (TYMLOS, Formulation: injection, Batch/Lot number: not reported, Expiry date: not reported), 80 mcg once day subcutaneously on 11Sep2020 for age-related osteoporosis without current pathological fracture. The patient medical history and concomitant medication was not provided. Relevant surgical, social, or substance-usage history was not provided. On an unspecified date, the patient experienced had muscle soreness after she received the bnt162b2 vaccine. On unknown date, the patient had increased muscle- soreness. No relevant lab or diagnostic tests were reported. The action taken in response to the event for abaloparatide was dose not changed. No treatment was reported. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia, Body temperature, Fatigue, Malaise
Clinical narrative: These symptoms included fever, fatigue, malaise, and joint pain/Has had over a month of fever; These symptoms included fever, fatigue, malaise, and joint pain; These symptoms included fever, fatigue, malaise, and joint pain; These symptoms included fever, fatigue, malaise, and joint pain; This is a spontaneous report from a contactable physician reported for patient. This is 1 of 2 reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administered at unspecified anatomical location on 14Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fever/has had over a month of fever in Apr2021, these symptoms included fever, fatigue, malaise, and joint pain in 2021. The patient underwent lab tests and procedures which included antinuclear antibody: normal, polymerase chain reaction: normal, sars-cov-2 test normal. The reporter asked regarding two of his patients and seek any medical information to help him better make his decisions in providing treatment. HCP states that his first patient received the Pfizer COVID 19 vaccine on 14APR2021 and developed adverse effects beginning the following day and states that this has been ongoing with symptoms for a month and that he has seen the patient around 4 times since then which the last visit being 10MAY2021. The patient continues to have daily elevated temperatures throughout the day, but the other symptoms have started to decrease. Reporter have run tests to rule out other things such as ANA, PCR flu, covid, body temperature: daily elevated etc. and they have all resulted normal. The reporter asked are there been reports of ongoing fevers like this. The reporter wants to know is there any information on the efficacy of the Pfizer COVID 19 vaccine when the doses are given longer than 21 days apart. The reporter reported that he wanted to see if Pfizer has any information regarding patients running fevers for an extended period following the Covid-19 vaccine and declined to complete safety report. Report filed with minimal information provided. Reporter provided with phone number, and reportum reference number, JPVY58TK, prior to transfer. The outcome of the event was unknown  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Polymerase chain reaction, Pyrexia, SARS-CoV-2 test
Clinical narrative: These symptoms included fever, fatigue, malaise, and joint pain/Has had over a month of fever; These symptoms included fever, fatigue, malaise, and joint pain; These symptoms included fever, fatigue, malaise, and joint pain; These symptoms included fever, fatigue, malaise, and joint pain; This is a spontaneous report from a contactable physician reported for patient. This is 1 of 2 reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administered at unspecified anatomical location on 14Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fever/has had over a month of fever in Apr2021, these symptoms included fever, fatigue, malaise, and joint pain in 2021. The patient underwent lab tests and procedures which included antinuclear antibody: normal, polymerase chain reaction: normal, sars-cov-2 test normal. The reporter asked regarding two of his patients and seek any medical information to help him better make his decisions in providing treatment. HCP states that his first patient received the Pfizer COVID 19 vaccine on 14APR2021 and developed adverse effects beginning the following day and states that this has been ongoing with symptoms for a month and that he has seen the patient around 4 times since then which the last visit being 10MAY2021. The patient continues to have daily elevated temperatures throughout the day, but the other symptoms have started to decrease. Reporter have run tests to rule out other things such as ANA, PCR flu, covid, body temperature: daily elevated etc. and they have all resulted normal. The reporter asked are there been reports of ongoing fevers like this. The reporter wants to know is there any information on the efficacy of the Pfizer COVID 19 vaccine when the doses are given longer than 21 days apart. The reporter reported that he wanted to see if Pfizer has any information regarding patients running fevers for an extended period following the Covid-19 vaccine and declined to complete safety report. Report filed with minimal information provided. Reporter provided with phone number, and reportum reference number, JPVY58TK, prior to transfer. The outcome of the event was unknown  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Rash
Clinical narrative: feels tiredness; back ache; Rash and Itches, broke out, wrist going away; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was ER8733 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 27Apr2021 at 10:30 (Age at vaccination was 67 years) as dose 2, single for covid-19 immunisation. Medical history included ongoing seasonal allergy (patient states had sneezing but that is going away), herpes zoster from an unknown date and unknown if ongoing (he has had the shingles shot before, and he was supposed to be due for the second one, but they said to wait a month after the last Covid vaccine. Patient states his first shot from the shingles vaccine, he noticed that it wore him out too because they gave him the virus and he was tired for a few days). The patient's concomitant medications were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0150 and expiration date were not reported), via an unspecified route of administration, on 01Apr2021 as dose 1, single for COVID-19 immunization. The patient experienced rash and itches, broke out, wrist going away on 29Apr2021. Patient noticed that he developed some rash in right hand, left wrist and behind his knee in right leg about 3-4. On 30Apr2021, the patient experienced feels tiredness, back ache. He says about the tiredness that he could be in bed all day and he does not feel like doing some morning exercise and about the back pain, he feels like a back spasm that has given him problems in his golf (he missed yesterday course) and washing his car. Patient also states he doesn't remember injuring his back. Patient states it was severe last night, but it comes and goes. States when he was sitting still it goes away but it was still there when he bends over to the left and right, he had muscle soreness. States he was lethargic and could sit in the chair all day and not move. Patient states he was hoping it didn't effect his kidneys, it was on the lower right side. The patient did not perform any relevant test. Patient had Laser treatment on his back because he thought it was a muscle, but they don't seem to be doing much and Aleve was also took. Therapeutic measures were taken as a result of back ache (back pain). The outcome of all the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Discomfort, Dyspnoea, Erythema, Pruritus
Clinical narrative: she started itching everywhere; had hives; she also had massive diarrhea.; Her injection site was also extremely painful/Injection site really sore and hurtful; She also had vision blurriness/Vision affected a little; shortness of breath; redness and spots; quite uncomfortable; This is a spontaneous report received from a contactable consumer (patient, self-reported) via medical information team. A 67-year-old female patient BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: EW0183 and expiry date was not reported), via an unspecified route of administration in arm right, on 11May2021 at 12:45 PM (age at vaccination: 67 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 11May2021, the patient experienced she started itching everywhere, had hives, she also had massive diarrhoea, her injection site was also extremely painful/injection site really sore and hurtful, she also had vision blurriness/vision affected a little, shortness of breath, redness and spots, quite uncomfortable. Clinical course was reported as female patient who received her 1st dose of the vaccine yesterday. within 2 hours after the injection the patient had itching everywhere and had hives. This proceeded to continue to the night, where she also had massive diarrhoea. Reportedly the patient injection site was also extremely painful, which made her quite uncomfortable. She also had vision blurriness and shortness of breath. The patient also stated that the itchiness was still there, but it was nothing like it was be-fore. The redness and spots have diminished but she was still itching to death. The patient also stated that they are better than last night but still ongoing. Reportedly the patient did not want to get the injection, but her family suggested it. The patient also stated that she has some health problems. No further information provided by the patient. Reportedly the patient just wanted to report her information that she was concerned about getting the second shot. States that she has multiple allergies, does not specify. Reported that that she spoke with her allergist before the first shot, and they told her to get the injection. Reportedly the patient was wondering if she should get the second injection. The clinical outcome of the event she started itching everywhere was not recovered, and other event redness and spots was recovered, and other events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pain, Visual impairment
Clinical narrative: she started itching everywhere; had hives; she also had massive diarrhea.; Her injection site was also extremely painful/Injection site really sore and hurtful; She also had vision blurriness/Vision affected a little; shortness of breath; redness and spots; quite uncomfortable; This is a spontaneous report received from a contactable consumer (patient, self-reported) via medical information team. A 67-year-old female patient BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: EW0183 and expiry date was not reported), via an unspecified route of administration in arm right, on 11May2021 at 12:45 PM (age at vaccination: 67 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 11May2021, the patient experienced she started itching everywhere, had hives, she also had massive diarrhoea, her injection site was also extremely painful/injection site really sore and hurtful, she also had vision blurriness/vision affected a little, shortness of breath, redness and spots, quite uncomfortable. Clinical course was reported as female patient who received her 1st dose of the vaccine yesterday. within 2 hours after the injection the patient had itching everywhere and had hives. This proceeded to continue to the night, where she also had massive diarrhoea. Reportedly the patient injection site was also extremely painful, which made her quite uncomfortable. She also had vision blurriness and shortness of breath. The patient also stated that the itchiness was still there, but it was nothing like it was be-fore. The redness and spots have diminished but she was still itching to death. The patient also stated that they are better than last night but still ongoing. Reportedly the patient did not want to get the injection, but her family suggested it. The patient also stated that she has some health problems. No further information provided by the patient. Reportedly the patient just wanted to report her information that she was concerned about getting the second shot. States that she has multiple allergies, does not specify. Reported that that she spoke with her allergist before the first shot, and they told her to get the injection. Reportedly the patient was wondering if she should get the second injection. The clinical outcome of the event she started itching everywhere was not recovered, and other event redness and spots was recovered, and other events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash, Skin lesion
Clinical narrative: face was red, scaly, and itchy; face was red, scaly, and itchy; face was red, scaly, and itchy; terrible rash with an allergy in his face it was dry, it was itchy, red; his face was swollen too; rash/it started on his face, it goes to his nose/below his belly button, like 4 inches to the right; terrible rash with an allergy in his face it was dry, it was itchy, red; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8732) via an unspecified route of administration, administered in right arm on 02Apr2021 at 15:00 (at the age of 79-year-old) as DOSE 1, SINGLE, for COVID-19 immunization. Medical history included throat cancer from 2000 to an unknown date. Patient's concomitant medications were not reported. On 06Apr2021 after vaccination, the patient's face was red, scaly, and itchy. The patient also experienced terrible rash with an allergy in his face it was dry, it was itchy, red; face was swollen, and rash/it started on his face, it goes to his nose/below his belly button, like 4 inches to the right on 06Apr2021. It was reported that the patient's face was red, scaly, and itchy. He had a terrible rash with an allergy in his face. His face was swollen too. Rash/it started on his face, it goes to his nose/it started getting red and dry and then when he got up in the morning it was full blast completely/below his belly button, like 4 inches to the right/like a rash of the same type/rash on the face. He called his primary doctor and his doctor told him to rush to the emergency room; so he did not have any problem with his throat. He had throat cancer in 2000 and so now he had problems swallowing because of the radiation and so his doctor told him to rush to the emergency room before he has any more problems with his throat or with swallowing, so that's what he did. He went to the emergency room on 07Apr2021 because he had a terrible allergy. He did not go to the physician office. At the emergency room, they took his vitals and asked him questions and they gave him medicine and in one hour, he was out. They gave him 2 different medicines that he took for 14 days. The medicine they gave him worked and then 14 days later he was okay, he was back in good shape and the medicine worked. No investigation assessment was performed. His face was back to its normal. He has recovered completely from the rash.  He would like to know if he should get the second dose due to the first reaction. The outcome of the events was resolved on an unspecified date in Apr2021.  No follow-up attempts were needed. No further information was expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: face was red, scaly, and itchy; face was red, scaly, and itchy; face was red, scaly, and itchy; terrible rash with an allergy in his face it was dry, it was itchy, red; his face was swollen too; rash/it started on his face, it goes to his nose/below his belly button, like 4 inches to the right; terrible rash with an allergy in his face it was dry, it was itchy, red; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8732) via an unspecified route of administration, administered in right arm on 02Apr2021 at 15:00 (at the age of 79-year-old) as DOSE 1, SINGLE, for COVID-19 immunization. Medical history included throat cancer from 2000 to an unknown date. Patient's concomitant medications were not reported. On 06Apr2021 after vaccination, the patient's face was red, scaly, and itchy. The patient also experienced terrible rash with an allergy in his face it was dry, it was itchy, red; face was swollen, and rash/it started on his face, it goes to his nose/below his belly button, like 4 inches to the right on 06Apr2021. It was reported that the patient's face was red, scaly, and itchy. He had a terrible rash with an allergy in his face. His face was swollen too. Rash/it started on his face, it goes to his nose/it started getting red and dry and then when he got up in the morning it was full blast completely/below his belly button, like 4 inches to the right/like a rash of the same type/rash on the face. He called his primary doctor and his doctor told him to rush to the emergency room; so he did not have any problem with his throat. He had throat cancer in 2000 and so now he had problems swallowing because of the radiation and so his doctor told him to rush to the emergency room before he has any more problems with his throat or with swallowing, so that's what he did. He went to the emergency room on 07Apr2021 because he had a terrible allergy. He did not go to the physician office. At the emergency room, they took his vitals and asked him questions and they gave him medicine and in one hour, he was out. They gave him 2 different medicines that he took for 14 days. The medicine they gave him worked and then 14 days later he was okay, he was back in good shape and the medicine worked. No investigation assessment was performed. His face was back to its normal. He has recovered completely from the rash.  He would like to know if he should get the second dose due to the first reaction. The outcome of the events was resolved on an unspecified date in Apr2021.  No follow-up attempts were needed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Condition aggravated, Gingival pain, Lip dry, Lip swelling
Clinical narrative: the chapped/dryness is moving outside the lips and into nose area; it's getting worse; chapped/swollen lips; chapped/swollen lips; the gums on left side of mouth were tender/The tenderness in the gums; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 54-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8734, 8733), via an unspecified route of administration on 19Apr2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Two days after second dose on 21Apr2021 the patient experienced chapped/ swollen lips/ blown up lips, the gums on left side of mouth were tender. The tenderness in the gums had resolved but her lips were swollen, and the chapped/dryness was moving outside the lips and into nose area. She states it was getting worse and wanted to know if this had been reported before. The outcome of event tenderness in the gums was resolved on an unspecified date in 2021. For the rest of the events the outcome was not resolved.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Confusional state, Fatigue, Hypertension, Thyroid disorder
Clinical narrative: high blood pressure; confusion; memory loss; thyroid issues/  thyroid was out of wack.; fatigue; This is a spontaneous report from a contactable consumer (patient's husband) from a sponsored program.   A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on 04Feb2021as 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 high blood pressure, confusion, memory loss, thyroid issues/ her thyroid was out of wack and fatigue. Patient had been on medication for thyroid for more than 30 years now. Amlodipine for 1 week was taken for high blood pressure as a therapeutic measure. Patient received second dose of BNT162B2 on 25Feb2021 for COVID-19 immunisation. Outcome of high blood pressure was not recovered and rest all events was unknown at the time of reporting.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, Pruritus, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer reported for patient (reporters' son). A 23-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at the age of 23, via an unspecified route of administration, in  left arm, on May 11, 2021, at 10:00, single dose, for COVID-19 immunisation. Medical history included allergy to peanut, egg and typically almonds from an unknown date and unknown if ongoing. The patient's concomitant medications not reported. The patient previously received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. On an unspecified date (a couple of hours after the patient got his second dose), patient experienced twitching in different parts of the body. Second shot was reaction was a little different than first shot. He noticed he got slight twitching here and there. He gets twitch here and there in his foot, his shin muscles and his arm. It was not a constant twitching the whole entire time, but it was definitely twitching. The twitching was intermittent going from 10 minutes to an hour. The twitching was still there but not as bad. The patient also developed a couple of rashes. It's actually a dot and happens differently on different part of his body. He also had itchy spots in different areas but was particularly concerned with the twitching. Therapeutic measures taken as a result of the events: Tylenol. The outcome of twitching: not resolved. The outcome of the other events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Eye discharge, Eye swelling, Musculoskeletal stiffness, Myalgia
Clinical narrative: 2nd dose is due today but the technician and the pharmacist advised her not to take it as her experience might indicate mild anaphylaxis; stiff neck; both shoulders were stiff; in pain; eyes were red; swollen from her eyes extending to where her cheeks start; one eye had discharge; muscle pain; This is a follow-up spontaneous report received from a contactable consumer(patient). This female consumer (patient) reported for herself stating that.  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, expiry date: unknown) via an unspecified route of administration on 21Apr2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecific date in Apr2021the patient experienced stiff neck, both shoulders were stiff, in pain, eyes were red, swollen from her eyes extending to where her cheeks start, one eye had discharge and muscle pain. On an unspecified date, 2nd dose was due today but the technician and the pharmacist advised her not to take it as her experience might indicate mild anaphylaxis. It was reported that, patient didn't seek medical attention because she didn't think it was that bad. She went to the pharmacy to receive her second dose and the pharmacist and technician refused to give the second dose because they believed that her side effects may have been an anaphylactic reaction. She was advised to check first with her own physician about her symptoms. Stated she heard that the vaccine was 75% effective after the first dose. The patient had not received treatment for all the events. The outcome of the events stiff neck, both shoulders were stiff, and swollen from her eyes extending to where her cheeks start was recovering. The outcome of the event eyes were red, and one eye had discharge was recovered on unspecific date in Apr2021. The outcome of other events was unknown.  No follow-up attempts are needed; information about lot/batch no. cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Pain
Clinical narrative: 2nd dose is due today but the technician and the pharmacist advised her not to take it as her experience might indicate mild anaphylaxis; stiff neck; both shoulders were stiff; in pain; eyes were red; swollen from her eyes extending to where her cheeks start; one eye had discharge; muscle pain; This is a follow-up spontaneous report received from a contactable consumer(patient). This female consumer (patient) reported for herself stating that.  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, expiry date: unknown) via an unspecified route of administration on 21Apr2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecific date in Apr2021the patient experienced stiff neck, both shoulders were stiff, in pain, eyes were red, swollen from her eyes extending to where her cheeks start, one eye had discharge and muscle pain. On an unspecified date, 2nd dose was due today but the technician and the pharmacist advised her not to take it as her experience might indicate mild anaphylaxis. It was reported that, patient didn't seek medical attention because she didn't think it was that bad. She went to the pharmacy to receive her second dose and the pharmacist and technician refused to give the second dose because they believed that her side effects may have been an anaphylactic reaction. She was advised to check first with her own physician about her symptoms. Stated she heard that the vaccine was 75% effective after the first dose. The patient had not received treatment for all the events. The outcome of the events stiff neck, both shoulders were stiff, and swollen from her eyes extending to where her cheeks start was recovering. The outcome of the event eyes were red, and one eye had discharge was recovered on unspecific date in Apr2021. The outcome of other events was unknown.  No follow-up attempts are needed; information about lot/batch no. cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm got sore; This is a spontaneous report from a contactable nurse (wife). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 21Feb2021 as dose number 2, single for COVID-19 immunisation. Medical history included anemic from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 as dose 1, single for COVID-19 immunisation and experienced rashes all over/ shingles/all red, vomiting, headache, stomach upset, looking really sickly and scar was a little bit deep and brown. The patient experienced his arm got sore on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity, Vaccination site haemorrhage
Clinical narrative: afterward, normal marginally sore arm; left armpit became tender and started hurting (there was no lymph-node type lump that could palpate; The injection site bled at the time of injection; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 intramuscular, administered in Arm Left on 09May2021 13:30 (at the age of 45-years-old) (Batch/Lot Number: EW0182) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was none. Concomitant medication included multivitamin (within 2 weeks of vaccination). Patient had no allergies. 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. Patient previously took first dose of bnt162b2 (Lot number: EW0164) administered in Arm right on 18Apr2021 at 12:30PM (at the age of 45-years-old), Intramuscular for covid-19 immunisation. On 09May2021, the patient experienced the injection site bled at the time of injection, afterward, on 10May2021 16:00, normal marginally sore arm, around 24h after the injection and left armpit became tender and started hurting (there was no lymph-node type lump that could palpate). Patient received no treatment for the events. It was reported that the patient was not hospitalized. Seriousness of events were reported as non serious by the reporter. Outcome of events were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Blood glucose, Thyroid function test
Clinical narrative: The first dose caused a slight arthritis flare with the first shot; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6199, Expiry date: Unknown), via an unspecified route of administration, administered in left arm (reported as left upper arm) on 06Mar2021 (reported as in the afternoon) (at the age of 46-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing crohn's disease (had this for pretty much her whole life) and ongoing arthritis inflammatory (reported as this is related to the Crohns disease). Patient was allergic to several antibiotics: Tetracycline, Penicillin, Cipro, and Bactrim (this was 20+ years ago). Concomitant medications were not reported. The patient previously received flu vaccine and experienced a sore arm, and she even had the pneumonia vaccine 5 years ago with no issues. No history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. It was reported that patient had blood work before the first dose and it was normal. Reported that the original lab works was done at the end of Feb2021. On an unspecified date in Mar2021, after first dose of vaccination, patient experienced slight arthritis flare. Reported that, It was expected and the doctor told her it would go away and it did. It lasted 48 hours, started a few days after the first dose. Adverse event required a visit to Physician Office. No relevant Family Medical History related to Adverse event. The patient underwent lab tests and procedures which included blood glucose resulted in 80's and thyroid function test resulted 2.0 on an unspecified date in Feb2021; blood glucose resulted 108 and thyroid function test resulted 6.2 on 10May2021. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Throat irritation
Clinical narrative: a slight cough/ dry cough; scratchy throat; This is a spontaneous report from a contactable female consumer (patient) reported for herself via Medical Information Team. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 15Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She stated that she was due for her second dose of the Pfizer Covid 19 vaccine today but she has a slight cough/dry cough and scratchy throat; she have like a little tickling. She was due to get her second one. She was due to take it today that's why she was calling to ask should she still take it as her throat was scratchy and she have a slight cough. Asking if she should take her second dose of the vaccine. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Hyperhidrosis, Influenza like illness, Pain
Clinical narrative: chills; achy; flu-like symptoms; fever; sweating; weakness/Very Weak; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6206, Expiration date: not reported) via an unspecified route of administration, administered in left arm on 11May2021 at 13:55 (at the age of 61-years-old) as dose 1, single for covid-19 immunization. Medical history included covid-19, He had a history of covid infection 6-7 weeks ago for which he was hospitalized for rehab and quarantine, Verbatim: Covid 19 Virus. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient did not receive any other vaccines within four weeks prior. No adverse events following prior vaccinations. There were no concomitant medications. On 12May2021, patient experienced chills, flu-like symptoms, achy, fever, sweating and weakness/Very Weak. It was reported that last night (12May2021) was rough and he is still chilling today and sweating. Therapeutic measures were taken as a result of fever included acetaminophen. The events did not result in emergency room or physician office visit. The outcome of event weakness was not recovered and rest all events was recovering.  No follow-up activities are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; achy; flu-like symptoms; fever; sweating; weakness/Very Weak; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6206, Expiration date: not reported) via an unspecified route of administration, administered in left arm on 11May2021 at 13:55 (at the age of 61-years-old) as dose 1, single for covid-19 immunization. Medical history included covid-19, He had a history of covid infection 6-7 weeks ago for which he was hospitalized for rehab and quarantine, Verbatim: Covid 19 Virus. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient did not receive any other vaccines within four weeks prior. No adverse events following prior vaccinations. There were no concomitant medications. On 12May2021, patient experienced chills, flu-like symptoms, achy, fever, sweating and weakness/Very Weak. It was reported that last night (12May2021) was rough and he is still chilling today and sweating. Therapeutic measures were taken as a result of fever included acetaminophen. The events did not result in emergency room or physician office visit. The outcome of event weakness was not recovered and rest all events was recovering.  No follow-up activities are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Palpitations, Pruritus, Rash erythematous, Vaccination site mass
Clinical narrative: having a rashy bump/whitish bumps where he was jabbed; Over the last few weeks he's had palpitations; a little bit of discomfort in his arm; red rashy bump; its itchy; some whitish bumps where he was jabbed.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8734), via an unspecified route of administration on 07Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration on 16Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date in 2021, the patient experienced having a rashy bump/whitish bumps where he was jabbed, over the last few weeks he's had palpitations, a little bit of discomfort in his arm, red rashy bump, its itchy, some whitish bumps where he was jabbed. Therapeutic measures were taken as a result of having a rashy bump/whitish bumps where he was jabbed, a little bit of discomfort in his arm, red rashy bump, its itchy, some whitish bumps where he was jabbed. It was reported that after taking the second dose of Pfizer vaccine patient experienced a rashy bump and kind of having a reaction. The doctor said it was a possible reaction due to the preservatives used in the lot number. The doctor thought it would go away in a couple months. Patient heard that there was some kind of fat in the vaccine and wondered if the vaccination provider may have thought she pushed it all it but pulled back some and maybe didn't get it all in the muscle. Reported that patient thought it was natural to have a little bit of discomfort in his arm but several weeks after he realized he was developing a red rashy bump, some whitish bumps where he was jabbed. He thought it was strange. He usually puts on moisturizer and thought it would help he used antibiotic cream and started to get concerned. Its been maybe 5 weeks since the Covid vaccine and he still has the bump and all that, its itchy at times. Patient asked if there have been other reports of palpitations or tachycardia as a reaction to the vaccine or preservative. Patient did not specify having tachycardia, only asked that as part of his question. The outcome of event (some whitish bumps where he was jabbed.) was not recovered; the outcomes of events (having a rashy bump/whitish bumps where he was jabbed, Over the last few weeks he's had palpitations, a little bit of discomfort in his arm, red rashy bump, its itchy) were unknown.   No follow-up attempts are needed. No further information is expected.