chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site swelling
Clinical narrative: skin itching/ skin itches; skin break out/ rash that spread in both arms; knot in the arm (hard ball) on the administration site; nauseous/sick to her stomach; upset stomach described as almost killing her; felt very Sleepy/ she is just in a sleepy mode; have to run back in forth popping all the time (diarrhea).; swollen administration site; felt very drain; got headaches like shot pain on the temporal on the right side; she has not been able to eat; Not feeling well/feel sick; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0182; Expiration Date: Jul2021), via an unspecified route of administration on 18May2021 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 27Apr2021 (patient provided the numbers 1887 but could not read rest) (at the age of 63-year-old) as a single dose for COVID-19 immunisation. It was reported that patient had skin itching/skin itches and skin break out on 18May2021, knot in the arm (hard ball) on the administration site, swollen administration site, nauseous, upset stomach described as almost killing her, felt very drain, felt very sleepy/she was just in a sleepy mode, have to run back in forth popping all the time (diarrhea) all in 2021. She also additionally mentioned that she got headaches like shot pain on the temporal on the right side and she even have a rash that spread in both arms in 2021. She added that she had used Cortisone but that didn't worked. she mentions her stomach was nauseous, she hasn't been able to eat, and her skin was all broke out from the 2nd vaccine and it itches in 2021. Her arms have been itching as soon as she got the vaccine. Her skin broke out after she had the shot on 18May2021, she states she was still itchy and still broken out. She started putting cortisone on her arms and it did not work. patient clarified that was was a maximum strength cortisone 10 cream with aloe. patient verifies that the itching has not improved and was persisting. While probing the caller for event details she stated that all these questions were making her feel sick and sick to her stomach in 2021. patient states that she really was not feeling well in 2021. The outcome of the events pruritus and rash was reported as not recovered. The outcome of all other events was reported as unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Myalgia, X-ray
Clinical narrative: Anxiety; Muscles aches this all over her body that started with her upper arms and now was all over her body even in her hands and fingers; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809), via an unspecified route of administration on 17Feb2021 as a single dose for COVID-19 immunization. The patient's medical and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3246), via an unspecified route of administration on 26Jan2021 as a single dose for COVID-19 immunization. Patient stated she was calling about the vaccination that she had in February. Patient clarified the vaccine she was referring to was the COVID-19 vaccine. Patient stated a friend of hers said if she called Pfizer, she may get some help. Patient stated she wanted to talk about this second shot that she had in February. Patient received the second dose of the Pfizer-BioNTech COVID-19 vaccine last February. Patient reported to have experienced "anxiety, muscle aches all over the body, and a queasy feeling or nausea" ever since the second shot on an unspecified date in 2021. Patient asked if these are possible side effects from the vaccine even though it has been months already. Explained to patient that there was no information found on "anxiety" as a possible side effect and that there are many factors to consider with regards to the duration of the possible side effects of the vaccine. Patient stated she had been to the emergency room several times, seen a cardiologist, general practitioner, gastrointestinal, and has had x-rays and blood tests down that have all come back negative. Patient stated she was having anxiety and muscles aches this all over her body that started with her upper arms and now was all over her body even in her hands and fingers. Patient asked if these symptoms have been reported. Patient stated also she did not mention queasy like nauseated. On an unspecified date, the patient underwent lab tests and procedures which included blood test: Negative, X-ray: Negative. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: I had a fever of 101F and this morning it was 97F; having " a little bit of muscle ache; 3 days after getting the vaccine I had bad rashes; I'm super lightheaded and spacy like I can't think.; I'm super lightheaded and spacy like I can't think.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 19May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her 1st dose last week Wednesday, 19May2021 and reported having " a little bit of muscle ache, but 3 days after getting the vaccine she had bad rashes, she was super lightheaded and spacy like she can't think. Last day (25May2021), the patient had a fever of 101F and this morning (26May2021) it was 97F. The patient saw her doctor last day (25May2021) but he didn't really tell her anything. The patient was not sure what to do. It was explained to the patient that explained in studies that the side effects did appear within 7 days but the duration might vary from one person to another. Referred to HCP if symptoms persist or gets worse. Outcome of the event fever was recovering and other events was unknown.  Follow-up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I had a fever of 101F and this morning it was 97F; having " a little bit of muscle ache; 3 days after getting the vaccine I had bad rashes; I'm super lightheaded and spacy like I can't think.; I'm super lightheaded and spacy like I can't think.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 19May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her 1st dose last week Wednesday, 19May2021 and reported having " a little bit of muscle ache, but 3 days after getting the vaccine she had bad rashes, she was super lightheaded and spacy like she can't think. Last day (25May2021), the patient had a fever of 101F and this morning (26May2021) it was 97F. The patient saw her doctor last day (25May2021) but he didn't really tell her anything. The patient was not sure what to do. It was explained to the patient that explained in studies that the side effects did appear within 7 days but the duration might vary from one person to another. Referred to HCP if symptoms persist or gets worse. Outcome of the event fever was recovering and other events was unknown.  Follow-up attempts are needed. Further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Bad leg pain in my knee joint; I'm in so much pain from this vaccine I can hardly think straight; his knee is going to hurt/is right knee has been on fire, and it hurts bad; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiry dates were not reported), via an unspecified route of administration, on 19Apr2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiry date was not reported), on unspecified date, as a single dose for COVID-19 Immunization. Patient stated that he had a bad leg pain in his knee joint from the COVID vaccination and "It's in his leg in knee joint and it was very painful. It's not the good time, he was in so much pain from this vaccine, he could hardly think straight. Patient also stated that he got his second shot last month on 19Apr2021, and for about the last 3 weeks, his right knee has been on fire, and it hurts bad and it was more painful, than burning. Stated that he needs to find out if the pain will go away or he needs to get his leg amputated, his knee really hurts. Stated that one of the vaccine side effects is joint pain and his knee was going to hurt: all events were occurred on an unknown date in Apr2021. He was in frustration and stated he is not getting his question answered. The outcome of the events was unknown.  Information about batch no/lot no has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph node; Tender Lymph node; This is a spontaneous report from contactable Pharmacist. An adult male patient in his late 40's (5 decades), received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not reported), via intramuscularly, in left deltoid on unspecified date as a single dose for covid-19 immunisation. Patient's medical history and concomitant medication were not reported. On an unspecified date, patient had a swollen lymph node for 19 days on his left side and was also tender. Reporter seriousness for swollen lymph node on the left side has been there for 19 days and was also tender was unspecified. The patient had several questions and caller referred him to his HCP however he did not know how to advised the patient on if he should get the second dose of the vaccine. The patient was hesitant to get the second dose with having a swollen lymph node. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia
Clinical narrative: He felt the numbness has advanced from his left arm to his left hand and left leg; He reported the numbness to be worse today; This is a spontaneous report received from a contactable consumer via medical information team. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, in Arm left, on 22May2021 (on Saturday) (at the age of 88 year) as 1st dose single dose for COVID-19 immunisation. The patient medical history included little numbness in his fingers every once in a while (before vaccination) and ongoing potassium low. Concomitant medication included ongoing potassium for low potassium. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no additional vaccines administered on same date of the Pfizer Suspect. Prior Vaccinations, there was no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 24May2021 (Monday), the patient reports that he felt numbness in his left arm. He stated that the numbness has advanced from his left arm to his left hand and left leg. Patient had received the injection on the left side. He stated that he is experiencing the occurring numbness off and on. He reported the numbness to be worse today and has noticed that it has progressed to his leg. He is on potassium medication and thinks the numbness could potentially be related to the potassium medication, but he is not sure. It was stated usually the numbness was only in his fingers, but lately it had been in his arm and leg. It was reported that he has an appointment with his doctor. Reporter asked if he should report this to his doctor. Reporter asked if the numbness was a side effect of the vaccine. Adverse events did not require a visit to emergency room and physician office. Outcome of the events was not recovered.  Information on lot/batch number has been requested.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient). A 24-years-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 22Mar2021 15:30 as second dose, single dose (at the age of 24-years-old); and previously took BNT162B2(Lot Number: EN6198), dose 1 via an unspecified route of administration, administered in Arm Left on 01Mar2021 15:30 as 1st dose, single dose for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to vaccination and not diagnosed with COVID-19 prior to vaccination. Medical history included chronic eczema. Concomitant medication included TACROLIMUS 0.1 ointment topical taken for an unspecified indication, start and stop date were not reported. On 26Mar2021, the patient experienced moderate/severe eczema flare-up. The patient underwent lab tests and procedures which included COVID19SS: negative (nasal swab) on 06Apr2021 after vaccination. No treatment received for event. Patient was not recovered from event. No follow-up attempts needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Hot flush, Nausea
Clinical narrative: Nausea; Diarrhea; Hot flashes; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number and Expiration date: unknown), via an unspecified route of administration in 2021, as first dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea on an unspecified date in May2021 and diarrhea, hot flashes on an unspecified date in 2021, about three weeks after the vaccination. It was reported that the patient was wondering, if anybody experiencing symptoms from the shot the first dose of the shot about three weeks after like nausea and diarrhea, hot flashes or the people are facing only in the first week. The outcome of the events was unknown. All the events were reported as non-serious.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: Changes in taste and smell after vaccination; Changes in taste and smell after vaccination; This is a spontaneous report from a non-contactable consumer. This consumer reported for a female patient (reporter's family member). A female patient unspecified age (Patient age/age group: 55-60) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient got her second shot more than 3 weeks ago and is complaining of changes in taste and smell after vaccination. Yes it was clarified that the adverse event took place after pfizer product use. 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: Arthralgia, Asthenia, Back pain, Blood pressure measurement, Dysphonia
Clinical narrative: weakness; shoulder and lower back pain; shoulder and lower back pain; fatigue; having shortness of breath; loosing her voiced; This is a spontaneous report from a contactable consumer, based on information received by Pfizer(manufacturer control number: EC-2021-089111), for BNT162B2. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date, as unknown, single dose for COVID-19 immunization ; lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 26Feb2021 (Batch/Lot number was not reported) to an unspecified date, at 20 mg, daily for endometrial cancer. Medical history included ongoing blood pressure increased , endometrial cancer from an unknown date and unknown if ongoing receiving radiation. The patient's concomitant medications were not reported. Patient reported that on08May2021, she has not been feeling lately and has been having shortness of breath, weakness, loosing her voiced and healthcare provider prescribed her with Steriod but patient was unsure of the name or dosage of the steriod as her daughter normally takes care of her medications. Patient previously reported continued increased blood pressure and patient went to the Emergency Room about a week ago (around 22Mar2021) for increased blood pressure as previously reported and patient had continued to have fatigue and headaches since starting Lenvima as well (symptom onset around 26Feb2021). Patient previously voiced that since starting Lenvima she has continued to have weakness, shoulder and lower back pain as well as fatigue, but patient was unsure if that was also due to receiving radiation and first COVID vaccine just prior to starting Lenvima. Diagnosis: Endometrial Cancer C54.1. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue
Clinical narrative: weakness; shoulder and lower back pain; shoulder and lower back pain; fatigue; having shortness of breath; loosing her voiced; This is a spontaneous report from a contactable consumer, based on information received by Pfizer(manufacturer control number: EC-2021-089111), for BNT162B2. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date, as unknown, single dose for COVID-19 immunization ; lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 26Feb2021 (Batch/Lot number was not reported) to an unspecified date, at 20 mg, daily for endometrial cancer. Medical history included ongoing blood pressure increased , endometrial cancer from an unknown date and unknown if ongoing receiving radiation. The patient's concomitant medications were not reported. Patient reported that on08May2021, she has not been feeling lately and has been having shortness of breath, weakness, loosing her voiced and healthcare provider prescribed her with Steriod but patient was unsure of the name or dosage of the steriod as her daughter normally takes care of her medications. Patient previously reported continued increased blood pressure and patient went to the Emergency Room about a week ago (around 22Mar2021) for increased blood pressure as previously reported and patient had continued to have fatigue and headaches since starting Lenvima as well (symptom onset around 26Feb2021). Patient previously voiced that since starting Lenvima she has continued to have weakness, shoulder and lower back pain as well as fatigue, but patient was unsure if that was also due to receiving radiation and first COVID vaccine just prior to starting Lenvima. Diagnosis: Endometrial Cancer C54.1. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased, Fatigue, Illness, Pain
Clinical narrative: TSH levels were very elevated/TSH level thyroid are off the chart, they are like double; Tired and aching a lot; Tired and aching a lot; Sick for about a week; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via an unspecified route of administration on 05Apr2021 (Batch/Lot Number: ER8737; Expiration Date: 31Jul2021) as 2nd dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 on 08Mar2021 (Batch/Lot Number: EN6206). On an unspecified date in Apr2021 the patient felt tired and experienced aching a lot and sick for about a week. Patient was happy with the vaccination and on 26May2021 patient got blood report, and patient's TSH level thyroid was off the chart, they were like double, they were like 8, as patients TSH levels were very elevated, and all the other tests was perfect but patient's TSH was doubled and last TSH was done a year and half ago that was normal. The patient underwent lab tests which included blood thyroid stimulating hormone: normal on unknown date, blood thyroid stimulating hormone: 8.0 and it was elevated, Thyroxine and triiodothyronine: Perfect on 26May2021. Reporter could not specify the seriousness of events. The outcome of the events Tired and Aching a lot, Sick for about a week was recovered on an unspecified date in Apr2021, and the other event TSH level thyroid are off the chart, they are like double was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Thyroxine, Tri-iodothyronine
Clinical narrative: TSH levels were very elevated/TSH level thyroid are off the chart, they are like double; Tired and aching a lot; Tired and aching a lot; Sick for about a week; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via an unspecified route of administration on 05Apr2021 (Batch/Lot Number: ER8737; Expiration Date: 31Jul2021) as 2nd dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 on 08Mar2021 (Batch/Lot Number: EN6206). On an unspecified date in Apr2021 the patient felt tired and experienced aching a lot and sick for about a week. Patient was happy with the vaccination and on 26May2021 patient got blood report, and patient's TSH level thyroid was off the chart, they were like double, they were like 8, as patients TSH levels were very elevated, and all the other tests was perfect but patient's TSH was doubled and last TSH was done a year and half ago that was normal. The patient underwent lab tests which included blood thyroid stimulating hormone: normal on unknown date, blood thyroid stimulating hormone: 8.0 and it was elevated, Thyroxine and triiodothyronine: Perfect on 26May2021. Reporter could not specify the seriousness of events. The outcome of the events Tired and Aching a lot, Sick for about a week was recovered on an unspecified date in Apr2021, and the other event TSH level thyroid are off the chart, they are like double was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dyspnoea, Erythema, Fatigue
Clinical narrative: not feeling well; Headache; Rashes; feel weak; fatigued; Difficulty breathing, short of breath when she walks; Fever; swollen injection in the arm; muscle pain; redness; runny nose; sore throat; nausea; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: 11263) via an unspecified route of administration in left arm on 22May2021 at 14:30 as single dose for COVID-19 immunization. Medical history included known allergies (unspecified). Concomitant medication included in two weeks which included food supplement. Patient did not receive any other vaccine in four weeks. Patient did not had COVID before vaccination and was not tested for COVID post vaccination. Patient previously received first dose of BNT162B2 (Lot number: 11263) in left arm on 01May2021 at 14:15 as single dose for COVID-19 immunisation and experienced headache, rash. On 22May2021 (Saturday), at 16:00, patient experienced swollen injection in the arm, rashes, headache, fever, muscle pain, redness, runny nose, sore throat, nausea, shortness of breath. Reportedly, after second shot patient developed fatigue, fever, rash, headache, felt weak and fatigued and if walks, becomes short of breath and had difficulty breathing. Patient was supposed to go to work but since Monday (24May2021), she could not go to work, because she was not feeling well. States she still has a headache. Due to the events, patient visited doctor or other healthcare professional office/clinic visit. Therapeutic measures taken in response to the event included treatment with Tylenol. Outcome of the events were resolving.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: not feeling well; Headache; Rashes; feel weak; fatigued; Difficulty breathing, short of breath when she walks; Fever; swollen injection in the arm; muscle pain; redness; runny nose; sore throat; nausea; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: 11263) via an unspecified route of administration in left arm on 22May2021 at 14:30 as single dose for COVID-19 immunization. Medical history included known allergies (unspecified). Concomitant medication included in two weeks which included food supplement. Patient did not receive any other vaccine in four weeks. Patient did not had COVID before vaccination and was not tested for COVID post vaccination. Patient previously received first dose of BNT162B2 (Lot number: 11263) in left arm on 01May2021 at 14:15 as single dose for COVID-19 immunisation and experienced headache, rash. On 22May2021 (Saturday), at 16:00, patient experienced swollen injection in the arm, rashes, headache, fever, muscle pain, redness, runny nose, sore throat, nausea, shortness of breath. Reportedly, after second shot patient developed fatigue, fever, rash, headache, felt weak and fatigued and if walks, becomes short of breath and had difficulty breathing. Patient was supposed to go to work but since Monday (24May2021), she could not go to work, because she was not feeling well. States she still has a headache. Due to the events, patient visited doctor or other healthcare professional office/clinic visit. Therapeutic measures taken in response to the event included treatment with Tylenol. Outcome of the events were resolving.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rhinorrhoea, Vaccination site swelling
Clinical narrative: not feeling well; Headache; Rashes; feel weak; fatigued; Difficulty breathing, short of breath when she walks; Fever; swollen injection in the arm; muscle pain; redness; runny nose; sore throat; nausea; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: 11263) via an unspecified route of administration in left arm on 22May2021 at 14:30 as single dose for COVID-19 immunization. Medical history included known allergies (unspecified). Concomitant medication included in two weeks which included food supplement. Patient did not receive any other vaccine in four weeks. Patient did not had COVID before vaccination and was not tested for COVID post vaccination. Patient previously received first dose of BNT162B2 (Lot number: 11263) in left arm on 01May2021 at 14:15 as single dose for COVID-19 immunisation and experienced headache, rash. On 22May2021 (Saturday), at 16:00, patient experienced swollen injection in the arm, rashes, headache, fever, muscle pain, redness, runny nose, sore throat, nausea, shortness of breath. Reportedly, after second shot patient developed fatigue, fever, rash, headache, felt weak and fatigued and if walks, becomes short of breath and had difficulty breathing. Patient was supposed to go to work but since Monday (24May2021), she could not go to work, because she was not feeling well. States she still has a headache. Due to the events, patient visited doctor or other healthcare professional office/clinic visit. Therapeutic measures taken in response to the event included treatment with Tylenol. Outcome of the events were resolving.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Local reaction
Clinical narrative: local reaction after her first dose; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received (BNT162B2, Formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced local reaction after her first dose. The outcome of the event was unknown.  Information on the batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash
Clinical narrative: Headache after first vaccine; Rashes after first vaccine; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 11263), via an unspecified route of administration on the left arm on 01May2021 at 14:15 (at the age of 46-year-old) as 1st dose, single for COVID-19 immunization. The patient medical history included known allergies. The patient concomitant medications were not reported. The patient did not receive any other vaccines within two weeks prior to the vaccination. The patient took other medications like food supplement (unspecified) within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On unspecified date in May2021, the patient experienced headache for one day after first vaccine, and rashes after first vaccine. The outcome of the events was reported as unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: A little bit of achiness; This is a spontaneous report received from a non-contactable other hcp (Patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had first dose of BNT162B2 for COVID-19 immunization on unspecified date. On an unspecified date, the patient experienced a little bit of achiness. The patient got a little bit of achiness after the second dose, and took some Tylenol. The outcome of event was unknown. Causality was reported as related.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Back pain, Chest pain, Diarrhoea
Clinical narrative: Severe Chest pain; Back pain; I had side effect in stomach; Headache; Nausea; Diarrhea; stomach ache; I am concern and not feeling well/I have been taking Ibuprofen but it's not getting better; This is a spontaneous report received from a contactable consumer (patient). A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EW8173), via an unspecified route of administration in right arm on 18May2021 (at the age of 56 years) as 1st single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. On an unspecified date in May2021, patient had side effect. Patient had severe chest and back pain from last 2 days. Patient also had side effect in stomach, headache, nausea, diarrhea and last three days having severe chest and back pain. Patient was not feeling well and had stuff like that stomach ache, headache. It was reported that it's been a week and had "severe" (not clarified) chest pain and back pain. Patient had Ibuprofen 600 mg as treatment which was taken yesterday, took 2 today but events not getting better. Patient was waiting for urgent care because it was not getting better and wanted to know that what needs to be taken to get rid out of the events and just taken Ibuprofen (treatment). The chest pain hasn't been a week. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea
Clinical narrative: Severe Chest pain; Back pain; I had side effect in stomach; Headache; Nausea; Diarrhea; stomach ache; I am concern and not feeling well/I have been taking Ibuprofen but it's not getting better; This is a spontaneous report received from a contactable consumer (patient). A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EW8173), via an unspecified route of administration in right arm on 18May2021 (at the age of 56 years) as 1st single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. On an unspecified date in May2021, patient had side effect. Patient had severe chest and back pain from last 2 days. Patient also had side effect in stomach, headache, nausea, diarrhea and last three days having severe chest and back pain. Patient was not feeling well and had stuff like that stomach ache, headache. It was reported that it's been a week and had "severe" (not clarified) chest pain and back pain. Patient had Ibuprofen 600 mg as treatment which was taken yesterday, took 2 today but events not getting better. Patient was waiting for urgent care because it was not getting better and wanted to know that what needs to be taken to get rid out of the events and just taken Ibuprofen (treatment). The chest pain hasn't been a week. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Developed a rash on both arms that he still currently has; This is a spontaneous report from a contactable consumer (patient's wife). An adult male patient (age 57, units: not provided) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot Number and expiration date was unknown), via an unspecified route of administration on 15May2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number unknown and expiration date was unknown), via an unspecified route of administration on an unspecified date, as single dose for covid-19 immunization. On an unspecified date in May2021, after second dose of vaccine patient developed a rash on both arms that he still currently has. The outcome of the event was reported as not recovered.    Information about batch/Lot number has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid/got her 1st shot of the vaccine and tested positive for COVID ten days later; This is a spontaneous report from a contactable consumer (patient's mother). A 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 02Apr2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter (patient's mother) reported that the patient (reporter's daughter) received the first dose of the Pfizer-BioNTech COVID-19 Vaccine on 02Apr2021 and tested positive for COVID 10 days later, on 12Apr2021. She wanted to know the timeframe for when her daughter could receive her second dose. She said she did not have the vaccine card to provide the lot number and expiration date of the product. She also said that her daughter was already recovered and has been out of isolation within the past 2 weeks. The reporter referred to her HCP for further guidance. The reporter declined to complete a report as she had an appointment and did not have time right now, however consents to follow-up. No further information was provided or obtained as reporter requests a transfer to  to address her questions further. There was a product complaint. Outcome of the event was recovered on an unknown date in Apr2021.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Illness, Pyrexia, Tremor
Clinical narrative: her husband had a high temperature all night long and was shaking; her husband had a high temperature all night long and was shaking; sick; fever; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. The patient experienced a high temperature all night long and was shaking, sick and fever on an unspecified date. It was reported as, "Caller said she and her husband both had 2 doses of the Pfizer COVID-19 vaccine on the end of February. They were hanging out with two friends who were also completely vaccinated with the Pfizer COVID-19 vaccine the whole day yesterday. This morning, her girlfriend called saying that her husband had a high temperature all night long and was shaking. Her girlfriend's husband's doctor felt that it was highly unlikely that he has COVID-19. Caller wanted to know if it is possible that her girlfriend's husband has COVID-19. Caller said that they are still waiting for the results of her girlfriend's husband's COVID-19 test. She wanted to know what to do in the meantime. Reporter stated she is calling about the two doses of Pfizer COVID vaccine that her husband and she got. Reporter stated they are doing fine but she has a question about being with people that also got two doses of the COVID vaccine. Reporter stated her girlfriend just called her saying her husband was sick all last night and was shaking with a fever. Reporter stated although they are all vaccinated could they still get a mild case of COVID.Reporter confirmed that her husband, herself, and girlfriend is fine. Reporter confirmed that the girlfriend's husband is the one that is shaking with a fever. Reporter declined to complete report at this time wished to be transferred for her question. Reporter stated so she knows her husband and she was them yesterday and she was wanting to know how everything stands with if they could get mild COVID. Reporter confirmed that her girlfriend's husband got the Pfizer COVID vaccine but she is unsure when he got the doses. Reporter confirmed that everyone had the Pfizer COVID dose". The patient underwent lab tests and procedures which included body temperature increased: increased on an unspecified date. Outcome of the events were unknown.  Follow up attempts are needed. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Vaccination site pain
Clinical narrative: His arm where he got it has a nagging annoying pain that comes and goes and won't go away; He experienced a "rotating cup (shoulder)" on the same extremity; This is a spontaneous report from a contactable consumer (patient) via medical information team. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 10Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 for COVID-19 immunization. Patient stated that his arm where he got it has "nagging and annoying pain" on the extremity that got the vaccine shot and that comes and goes and won't go away in Mar2021. He also stated that he experienced a "rotating cup (shoulder)" on the same extremity that received the vaccine shot in 2021. The outcome of vaccination site pain was not recovered and for shoulder discomfort was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Peripheral swelling, Skin discolouration, Vaccination site discolouration, Vaccination site swelling
Clinical narrative: Around the injection site was now swollen, like a ping pong ball, black and blue and  blistered; Around the injection site was now swollen, like a ping pong ball, black and blue and  blistered; Around the injection site was now swollen, like a ping pong ball, black and blue and  blistered; Arm was swollen black and blue and there was a blister the size of a table tennis ball; Arm was swollen black and blue and there was a blister the size of a table tennis ball; Arm was swollen black and blue and there was a blister the size of a table tennis ball; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0183), via an unspecified route of administration in right arm on 26May2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7533), via an unspecified route of administration on 05May2021 (at the age of 58-year-old) as a single dose for COVID-19 immunization. Patient stated she was calling about the Pfizer vaccine, COVID 19 vaccine. Patient states she received her 2nd Pfizer vaccine dose yesterday, 26May2021. The patient received the injection in her right arm and the area "around the injection site was now swollen, like a ping pong ball, black and blue and blistered on an unspecified date in May2021. Patient states they are "a lot of little blisters, the size of pen tip, all around the area also on an unspecified date in May2021." She denies pain and itching. She states it was starting to "drain and it looks gross." Enquired has this side effect been reported before and could you recommend any treatment for it. Patient asked was this was a common side effect. It was reported that, her arm was swollen black and blue and there was a blister the size of a table tennis ball on an unspecified date in May2021. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site vesicles
Clinical narrative: Around the injection site was now swollen, like a ping pong ball, black and blue and  blistered; Around the injection site was now swollen, like a ping pong ball, black and blue and  blistered; Around the injection site was now swollen, like a ping pong ball, black and blue and  blistered; Arm was swollen black and blue and there was a blister the size of a table tennis ball; Arm was swollen black and blue and there was a blister the size of a table tennis ball; Arm was swollen black and blue and there was a blister the size of a table tennis ball; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0183), via an unspecified route of administration in right arm on 26May2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7533), via an unspecified route of administration on 05May2021 (at the age of 58-year-old) as a single dose for COVID-19 immunization. Patient stated she was calling about the Pfizer vaccine, COVID 19 vaccine. Patient states she received her 2nd Pfizer vaccine dose yesterday, 26May2021. The patient received the injection in her right arm and the area "around the injection site was now swollen, like a ping pong ball, black and blue and blistered on an unspecified date in May2021. Patient states they are "a lot of little blisters, the size of pen tip, all around the area also on an unspecified date in May2021." She denies pain and itching. She states it was starting to "drain and it looks gross." Enquired has this side effect been reported before and could you recommend any treatment for it. Patient asked was this was a common side effect. It was reported that, her arm was swollen black and blue and there was a blister the size of a table tennis ball on an unspecified date in May2021. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Multiple allergies
Clinical narrative: coughing; allergies; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER COVID 19 VACCINE; formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21May2021 as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 26May2021 the patient experienced coughing and allergies. She wants to know if she can take over-the-counter medication for allergies. The outcome of the events was not recovered.  Follow-up attempts are needed; information about lot/batch number cannot be obtained.