chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Eye pain, Fatigue
Clinical narrative: Tiredness; Headache; Muscle pain; Joint pain; Fever; Nausea; Feeling unwell; Chills; Diarrhea; Sinus pain; Pain by my eye; This is a spontaneous report from a contactable consumer (patient). A 34-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration in left arm on 28Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On 30Jul2021, the patient experienced tiredness, headache, muscle pain, joint pain, fever, nausea, feeling unwell, chills, diarrhea, sinus pain, pain by eye. Consumer stated, on Wednesday had first shot. Consumer stated, it was still the same. It has not worsened or improved. Yes, it was still here it has not worsened or improved. Consumer stated I don't know that I have no idea about lot number and did not make an appointment it was just a walk in. The patient has been taking Sudafed (sinus medicine) because of sinus pain, pain by eye, headache, fever. The outcome of events was reported as not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: Tiredness; Headache; Muscle pain; Joint pain; Fever; Nausea; Feeling unwell; Chills; Diarrhea; Sinus pain; Pain by my eye; This is a spontaneous report from a contactable consumer (patient). A 34-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration in left arm on 28Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On 30Jul2021, the patient experienced tiredness, headache, muscle pain, joint pain, fever, nausea, feeling unwell, chills, diarrhea, sinus pain, pain by eye. Consumer stated, on Wednesday had first shot. Consumer stated, it was still the same. It has not worsened or improved. Yes, it was still here it has not worsened or improved. Consumer stated I don't know that I have no idea about lot number and did not make an appointment it was just a walk in. The patient has been taking Sudafed (sinus medicine) because of sinus pain, pain by eye, headache, fever. The outcome of events was reported as not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Sinus pain
Clinical narrative: Tiredness; Headache; Muscle pain; Joint pain; Fever; Nausea; Feeling unwell; Chills; Diarrhea; Sinus pain; Pain by my eye; This is a spontaneous report from a contactable consumer (patient). A 34-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration in left arm on 28Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On 30Jul2021, the patient experienced tiredness, headache, muscle pain, joint pain, fever, nausea, feeling unwell, chills, diarrhea, sinus pain, pain by eye. Consumer stated, on Wednesday had first shot. Consumer stated, it was still the same. It has not worsened or improved. Yes, it was still here it has not worsened or improved. Consumer stated I don't know that I have no idea about lot number and did not make an appointment it was just a walk in. The patient has been taking Sudafed (sinus medicine) because of sinus pain, pain by eye, headache, fever. The outcome of events was reported as not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Nasal congestion
Clinical narrative: feels terrible; congested; like he has the flu; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported.  It was reported that, patient stated he received the vaccine and he feels terrible. His first shot of the Pfizer on the 29. No further details on date provided. Patient clarified as the covid 19 vaccine. Should he get tested. He knew he was going to feel a little lousy and for four days he feels terrible, congested, and like he has the flu. Patient declined to complete a safety report, stating, he doesn't thinks its fault. He doesn't think it was from the vaccine. He doesn't have a primary physician. He doesn't go to doctors. He thinks something else is going on. The outcome of the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain
Clinical narrative: turned red and she was sore for 48 hours afterwards; she was sore for 48 hours afterwards; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a 28-year-old female patient that:  A 28 year old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was unknown. The patient's concomitant medications were not reported. On 12Jul2021, the patient experienced turned red and she was sore for 48 hours afterwards. It was ended two days after. Seriousness of event was reported as non-serious. The outcome of events were recovered on 14Jul2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Dyspnoea
Clinical narrative: Shortness of breath; COPD; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 71 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced shortness of breath leading to dyspnoea and COPD (chronic obstructive pulmonary disease) on Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included angiogram: his heart and arteries were in excellent shape.on Feb2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling abnormal, Headache, Hypersensitivity
Clinical narrative: I felt bad; Chills; Headache; Arms were like really hurting a lot and I can barely move it; Arms were like really hurting a lot and I can barely move it; Had little bit of nausea; Two three different areas were just like red, its looks like I would have an allergy or something; Two three different areas were just like red, its looks like I would have an allergy or something; My body feels weird like I have catch a cold or something; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FA7485, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 29Jul2021 08:15 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that, the patient went on Thursday like 08:15 for vaccination and then the next day on 30Jul2021 at 20:15 the patient got the reaction, "I felt bad", chills, the patient went to the bed and had headache. On the same day, the patient had little bit of nausea too and patient reported "arms were like really hurting a lot and I can barely move it". Then the following day, on Sunday is when the patient was able to get up and felt little bit better but when the patient came to work (today in the morning, because the patient did vaccination in left hand and not in right hand), the patient did not realize and when someone sat next and they said, what's wrong. In the arm where they gave the shot not around it, like "two three different areas were just like red, its looks like I would have an allergy or something" on an unspecified date in 2021. The patient got to work yesterday feeling bad and just have to go home, "I really felt bad". "My body feels weird like I have catch a cold or something" on an unspecified date in 2021. The patient started to have a headache, the patient needed to go home and the patient went home and then started feeling really bad like in the afternoon may be like 2 o' clock or something like that. The patient did not know if it is normal. The patient was concerned and wanted to make sure that it was okay, that what the patient was seeing on arm. The patient took Tylenol (extra strength, maybe 500 or something) as treatment for the events. The patient reported that product details said that the patient had to go back on 19Aug2021. The little sticker was put at the site of vaccination. The call was hung up abruptly by the patient hence, limited information was available over the call. The outcome of the events was unknown.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased, Nasopharyngitis, Nausea, Pain in extremity
Clinical narrative: I felt bad; Chills; Headache; Arms were like really hurting a lot and I can barely move it; Arms were like really hurting a lot and I can barely move it; Had little bit of nausea; Two three different areas were just like red, its looks like I would have an allergy or something; Two three different areas were just like red, its looks like I would have an allergy or something; My body feels weird like I have catch a cold or something; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FA7485, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 29Jul2021 08:15 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that, the patient went on Thursday like 08:15 for vaccination and then the next day on 30Jul2021 at 20:15 the patient got the reaction, "I felt bad", chills, the patient went to the bed and had headache. On the same day, the patient had little bit of nausea too and patient reported "arms were like really hurting a lot and I can barely move it". Then the following day, on Sunday is when the patient was able to get up and felt little bit better but when the patient came to work (today in the morning, because the patient did vaccination in left hand and not in right hand), the patient did not realize and when someone sat next and they said, what's wrong. In the arm where they gave the shot not around it, like "two three different areas were just like red, its looks like I would have an allergy or something" on an unspecified date in 2021. The patient got to work yesterday feeling bad and just have to go home, "I really felt bad". "My body feels weird like I have catch a cold or something" on an unspecified date in 2021. The patient started to have a headache, the patient needed to go home and the patient went home and then started feeling really bad like in the afternoon may be like 2 o' clock or something like that. The patient did not know if it is normal. The patient was concerned and wanted to make sure that it was okay, that what the patient was seeing on arm. The patient took Tylenol (extra strength, maybe 500 or something) as treatment for the events. The patient reported that product details said that the patient had to go back on 19Aug2021. The little sticker was put at the site of vaccination. The call was hung up abruptly by the patient hence, limited information was available over the call. The outcome of the events was unknown.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary mass, Chest pain, Pain, Palpitations
Clinical narrative: Body and joint pain; lump under armpit; chest pain; heart racing; Body and joint pain; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number FC3180) via an unspecified route of administration in arm left on 01Aug2021 10:30 dose 2, single (age at vaccination: 48 years) for COVID-19 immunisation. Medical history included asthma, allergies: shellfish, both from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously took iodine and experienced allergy. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number FA7485) via an unspecified route of administration in arm left on 11Jul2021 12:00 dose 1, single for COVID-19 immunisation. No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination and covid was tested post vaccination. On 02Aug2021 at 02:00 PM, the patient experienced lump under armpit, had chest pain and heart racing, body and joint pain. No treatment was received. The patient underwent lab tests and procedures which included sars-cov-2 real time PCR test resulted as negative on 31Jul2021 nasal swab. The clinical outcome of the events was not resolved.  No follow attempts are possible; no further information is expected
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Body and joint pain; lump under armpit; chest pain; heart racing; Body and joint pain; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number FC3180) via an unspecified route of administration in arm left on 01Aug2021 10:30 dose 2, single (age at vaccination: 48 years) for COVID-19 immunisation. Medical history included asthma, allergies: shellfish, both from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously took iodine and experienced allergy. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number FA7485) via an unspecified route of administration in arm left on 11Jul2021 12:00 dose 1, single for COVID-19 immunisation. No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination and covid was tested post vaccination. On 02Aug2021 at 02:00 PM, the patient experienced lump under armpit, had chest pain and heart racing, body and joint pain. No treatment was received. The patient underwent lab tests and procedures which included sars-cov-2 real time PCR test resulted as negative on 31Jul2021 nasal swab. The clinical outcome of the events was not resolved.  No follow attempts are possible; no further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Shoulder hurts; muscle pain; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 25Mar2021 as a dose 1, single and the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 15Apr2021 as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the caller named (withheld), already got the first and second dose of the Pfizer vaccine. Stated that, she received the first dose last on 25Mar2021 and got the second dose last on 15Apr2021. (Withheld) told that, she lost her vaccination card and wanted to get a copy of it. (Withheld) also mentioned that, on an unspecified date in 2021, her shoulder hurts after getting the first and second dose, she cannot straight her arm up and whenever she's trying to straighten her arm she's having muscle pain on an unspecified date in 2021. Stated that, the call was not transferred as the call got disconnected. Any medical questions addressed by this program forwarded/referred to Medical Information (live operators only) was reported as no: customer and/or medical inquiry was not forwarded or referred to MI. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Pyrexia, X-ray
Clinical narrative: She had an on and off fever after that up until May.; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 67-year-old at the time of vaccination), via an unspecified route of administration on 23Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced she had an on and off fever after that up until May. Reported that she went to infectious disease doctors and ran test, CT scan, blood works, X-rays. She already discussed this concern with her HCP and said she might need to get the 1st shot again, then she also spoke with her Pharmacist and said she needs to get the 2nd dose. The patient underwent lab tests and procedures which included blood test, CT Scan, x-ray all with unknown results. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: his 2 adolescent daughters became ill with covid-like sxs/reported same illness days there after; This is a spontaneous report from a contactable other hcp. A adult male (age appx 40-year-old) patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 intramuscular on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. Medical history included moderately obese/apparent high BMI from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Not known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 via intramuscular route on an unspecified date for covid-19 immunisation. Consumer stated his 2 adolescent daughters became ill with covid-like SXS, patient reported same illness days thereafter, since recovered. Unknown sequalae. Appeared healthy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received treatment. The outcome of the events was recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: A lot of rash; Itching; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 26Jul2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient had Pfizer vaccine done on last Monday and patient getting a lot of rash and itching and patient wanted to see, Is that something normal. The outcome of the events was unknown.  Follow-up activities closed. Batch/lot number not available for [vaccine/BNT162B2].
Sex: U
Vaccine: COVID19
Symptoms: Cough, Illness, Insomnia
Clinical narrative: Sick; Coughing; I can't sleep; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A 81-years-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration on 05Mar2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269) via an unknown route of administration on 15Feb2021 as dose 1, single for COVID-19 immunisation. Patient stated, I need to talk to somebody in Pfizer who knows about the vaccine and what kind of ingredients they use. Consumer stated, patient received first injected in February 15 and then I had the second one, and that was injected on 05Mar2021 and since then, on unknown date I have been very sick. I need to call before but I did not and I am coughing and I can't sleep its 3 o clock in the morning its 6 o clock in the morning and I am still up. I went to doctor, my pulmonary doctor and they did all kinds of test and gave all kinds of medicines (Unspecified Medications) and I am not getting better. So, I would like to talk to somebody who will be able to tell me something. I am not coughing in this 3 minutes because patient received codeine treatment and I had taken a lot of stuff since then. Consumer sated, patient heard that they were giving the third shot. Is that true. Do you think I can get it. The outcome of the events was reported as unknown.  Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Glucose tolerance impaired
Clinical narrative: asthma; pre-diabetes; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old patient of an unspecified gender received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported.patient previously received first dose bnt162b2 (BNT162B2, Solution for injection,Batch/Lot Number: not reported)via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation.On an unspecified date the patient experienced asthma, pre-diabetes. The outcome of the events asthma, glucose tolerance impaired was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be re-quested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: on my legs I am getting really itchy and like red, I want to say like small red bumps; on my legs I am getting really itchy and like red, I want to say like small red bumps; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: FA7484) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient's legs getting really itchy and red like small red bumps. Consumer was informed safety report will be filed and contact the doctor for emergency. The outcome of the events was unknown.  No further information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Since getting the vaccine is having trouble breathing; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 29Jul2021 as a dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the patient received Pfizer Covid vaccine last week on Thursday and since getting the vaccine was having trouble breathing on an unspecified date in 2021. The reporter seriousness for the event was reported as unspecified. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood blister, Burning sensation, Erythema, Peripheral swelling, Rash
Clinical narrative: arm ballooned up the size of a small apple; arm turned bright red / got three dark red like something between a rash and blood blister; arm was burning hot to the touch; got three dark red like something between a rash and blood blister; got three dark red like something between a rash and blood blister; At the beginning it was light brown dots on her arm; This is a spontaneous report from a contactable consumer.This female consumer (patient) reported for herself that:  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm ballooned up the size of a small apple, arm turned bright red / got three dark red like something between a rash and blood blister, arm was burning hot to the touch, got three dark red like something between a rash and blood blister, got three dark red like something between a rash and blood blister, at the beginning it was light brown dots on her arm. The clinical outcome of events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: arm ballooned up the size of a small apple; arm turned bright red / got three dark red like something between a rash and blood blister; arm was burning hot to the touch; got three dark red like something between a rash and blood blister; got three dark red like something between a rash and blood blister; At the beginning it was light brown dots on her arm; This is a spontaneous report from a contactable consumer.This female consumer (patient) reported for herself that:  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm ballooned up the size of a small apple, arm turned bright red / got three dark red like something between a rash and blood blister, arm was burning hot to the touch, got three dark red like something between a rash and blood blister, got three dark red like something between a rash and blood blister, at the beginning it was light brown dots on her arm. The clinical outcome of events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever; Ache; This is a spontaneous report from a contactable consumer (patient's friend). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as DOSE 1, SINGLE for covid-19 immunisation. No reactions, with the second time. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced fever, ache. The outcomes of events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported for herself. A female patient, of an unspecified age, received 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. The patient medical history and concomitant medications not reported. Patient had severe anxiety on an unspecified date. She wanted to know more information on getting the booster shot for the COVID-19 vaccine and the availability. The outcome of the event reported as unknown. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, 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 Aug 2, 2021, at 10:00, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. She stated she had every side effect listed and more. She was okay after getting the shot, but at night in bed, (Aug 2021) she experienced chills, fever, aches until midnight. Repeatedly, she tried to get up yesterday (Aug 3, 2021) and she had vertigo, dizziness, nausea and diarrhea. She took Tylenol and left her feel so weak. She experienced shortness of breath and she had chills again yesterday. All day, she wondered if the shortness of breath was related to the vaccine. Therapeutic measures were taken as a result of chills, fever, aches, vertigo, dizziness, nausea and diarrhea. At the time of this report, the outcome of shortness of breath and felt so weak: unknown; other events: recovering. The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vertigo
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, 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 Aug 2, 2021, at 10:00, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. She stated she had every side effect listed and more. She was okay after getting the shot, but at night in bed, (Aug 2021) she experienced chills, fever, aches until midnight. Repeatedly, she tried to get up yesterday (Aug 3, 2021) and she had vertigo, dizziness, nausea and diarrhea. She took Tylenol and left her feel so weak. She experienced shortness of breath and she had chills again yesterday. All day, she wondered if the shortness of breath was related to the vaccine. Therapeutic measures were taken as a result of chills, fever, aches, vertigo, dizziness, nausea and diarrhea. At the time of this report, the outcome of shortness of breath and felt so weak: unknown; other events: recovering. The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up. Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fear, Pain in extremity
Clinical narrative: States that it was worse the second day; States that her wife is afraid to take the second dose of the Pfizer Covid 19 Vaccine; Experiencing pain in her arm after receiving the 1st dose; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a female (patient). A 28-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot number: Unknown, Expiry date: Unknown, NDC number: Unknown) dose 1 via an unspecified route of administration, administered in the left arm on 17Jul2021 16:45 (at the age of 28 years old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing oesophageal achalasia, ongoing cardiac murmur functional, diabetes (aunt with diabetes). The patient concomitant medication was not reported. No PQC was present. Vaccine was not administered at facility. No other vaccines were given 4 weeks. Additional vaccines were not administered on same date of the pfizer suspect. On 17Jul2021 the patient experienced experiencing pain in her arm after receiving the 1st dose. On an unspecified date Patient states that it was worse the second day, states that her wife is afraid to take the second dose of the pfizer covid 19 vaccine. Reporter states that the caller's wife's second dose of the vaccine is scheduled for 07Aug2021. The caller would like to know if this side effect was normal and if her wife can still take the second dose when she is still having pain; mentions the pain is not as bad now as it was in the first days. Caller comes onto the line and verifies information received from the transferring agent. States that her wife is afraid to take the second dose of the Pfizer Covid 19 Vaccine. Says her wife has heard that sometimes the second dose was worse than the first one. State's wife was worried because she was still feeling the arm pain from the first one. Caller mentions that her wife has a condition called Achalasia. States that are causes difficulty swallowing and was a rare disease with no cure. Caller states her wife was diagnosed with this about 2 months ago. States her wife was diagnosed before she received the first dose of the vaccine. Caller mentions that the vaccine was the same for her. She also had pain in her arm. States she had this with her first and second dose. With the second dose she states she also had fever and pain all over her body. Caller states she knew this was normal. Caller states that she is good and declines to complete a safety report for herself currently. Caller states she has no questions regarding her own experience. AE had not result to emergency and physician room visit. The clinical outcome of the event experiencing pain in her arm after receiving the 1st dose was reported as not recovered and states that it was worse the second day, states that her wife is afraid to take the second dose of the pfizer covid 19 vaccine was reported as unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphonia, Lip swelling, Nausea, Palpitations
Clinical narrative: lip swelling; heart racing; raspy voice; panic; dizzy; nauseous; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in right arm on 11Mar2021 (at the age of 54-year-old) as dose 1, single for covid-19 immunisation. Medical history included known allergy to mosquito bites from an unknown date and unknown if ongoing, she knows of mosquito bites she gets a big reaction on her skin sets her off. The patient's concomitant medications were not reported. On 11Mar2021 within 90 seconds felt an impending doom with complaints that she had lip swelling, heart racing, raspy voice, Her vaccination provider kept her at the site for 30 minutes then let her go afterwards. For five days after received the first dose of the Pfizer Covid-19 vaccine, till had complaints and on an unspecified date in Mar2021 she was panic, dizzy, nauseous. She read on Medscape that a small study was done with subjects who had side effects with the first dose of the Pfizer Covid-19 vaccine and did well with the second dose. Patient asked that if there was any information about receiving the second dose after having side effects with the first dose of the Pfizer Covid-19 vaccine. Agent relays that the callers healthcare provider advised her not to get the 2nd dose. Stated that yesterday she read an article that says it's ok to get the 2nd dose. she didn't took anything as she didn't want to mask anything and left it at that. Stated she was fine after 5 days, it went away. She tried to went for the 2nd shot and they asked her how did it go with the 1st shot and told her no for the 2nd. Has spoken to her immunology clinic, health department, and two pharmacist who have told her not to receive the second dose of the Pfizer Covid-19 vaccine. Outcome of the events were unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Panic reaction
Clinical narrative: lip swelling; heart racing; raspy voice; panic; dizzy; nauseous; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in right arm on 11Mar2021 (at the age of 54-year-old) as dose 1, single for covid-19 immunisation. Medical history included known allergy to mosquito bites from an unknown date and unknown if ongoing, she knows of mosquito bites she gets a big reaction on her skin sets her off. The patient's concomitant medications were not reported. On 11Mar2021 within 90 seconds felt an impending doom with complaints that she had lip swelling, heart racing, raspy voice, Her vaccination provider kept her at the site for 30 minutes then let her go afterwards. For five days after received the first dose of the Pfizer Covid-19 vaccine, till had complaints and on an unspecified date in Mar2021 she was panic, dizzy, nauseous. She read on Medscape that a small study was done with subjects who had side effects with the first dose of the Pfizer Covid-19 vaccine and did well with the second dose. Patient asked that if there was any information about receiving the second dose after having side effects with the first dose of the Pfizer Covid-19 vaccine. Agent relays that the callers healthcare provider advised her not to get the 2nd dose. Stated that yesterday she read an article that says it's ok to get the 2nd dose. she didn't took anything as she didn't want to mask anything and left it at that. Stated she was fine after 5 days, it went away. She tried to went for the 2nd shot and they asked her how did it go with the 1st shot and told her no for the 2nd. Has spoken to her immunology clinic, health department, and two pharmacist who have told her not to receive the second dose of the Pfizer Covid-19 vaccine. Outcome of the events were unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Diarrhoea, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Bad case of diarrhea for one day; Sore arm; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported, expiry date: not reported) via an unspecified route of administration on 19Jul2021 as dose 1, single for COVID-19 immunization. The patient's medical history included COVID from Dec2020, constipation. He has taken medicine before and after but he has never had that happen before. One of the medications that he is taking causes constipation and he has to usually take prunes or something to keep going, but this was the opposite. Concomitant medications were not reported. On 23Jul2021, patient experienced a bad case of diarrhea for one day and on 20Jul2021, experienced, sore arm. Patient also stated he experienced a bad case of diarrhea for one day that occurred two days after receiving the vaccine. Caller states he did not experience anything else with the first dose other than a sore arm. Sore arm wasn't severe, it was just sore. He could use it but it was just sore. It wasn't bad, it was just there. But two days later he had a severe case of diarrhea that lasted one day and then it was gone. He had the COVID vaccine on 19Jul2021 and he had a sore arm for about 2 1/2 to 3 days and then it was gone and he had diarrhea on the second day afterwards. His arm was sore starting on 20Jul2021 and it was gone by 23Jul2021 probably. The diarrhea started on 23Jul2021 and lasted all day and then it was gone. He confirms he has recovered completely from both side effects. He had to drink a lot of water to stay hydrated.  Lab test included antibody test: had antibodies on an unspecified date in Jun2021, Covid test: negative on an unspecified date. The outcome of events was recovered on 23Jul2021.  Follow up (04Aug2021): New follow-up information received from a contactable consumer (patient) included: event information, vaccine information, outcome of event added.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported with the first dose of the Pfizer Covid 19 vaccine he initially thought he had bruising but then clarified he did not experience bruising and only just a sore arm. Consumer clarified that he was mistaken, there was no bruising noted. Caller explained that his second dose was early in the morning and he experienced this "burst of energy" as if he had drunk caffeinated beverage or a energy drink. It was unusual, felt totally energetic but did not have any weird side effects of being over caffeinated. This lasted from 7-8 hours. It was amazing and a nice feeling. He did house and yard chores. Then at 7pm he just "petered out" no more energy and was tired. He did not feel sick and felt normal the next day and that was it. Patient questioned, Any data on autoimmune disorders in regard to long term efficacy of Pfizer Covid 19 vaccine? Consumer further explains he has read from multiple sources 39-59% efficacy rate. What does that percentage mean? Any further conclusions? "Six Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine." In closing call, consumer stated to agent, "Thanks a lot (Withheld) I had to say you did a great job in helping us and giving us info and Kudos to you and Pfizer what you were doing, I really appreciate that." The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: blazing headache; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself. A female patient with an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: unknown), via unknown route of administration on 25Mar2021 as DOSE 1 SINGLE for covid-19 immunisation. The patient medical history and concomitant medication were not reported. On an unknown date, the patient experienced blazing headache. she had her first dose 25Mar2021, about 4 months ago, a little over that. She said she hasn't had her second dose yet so she wanted to see if it was still recommended or ok to get it. At the time of this report the outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pruritus, Rash, Vaccination site pain
Clinical narrative: chest pain; rash on his neck and all over the body; itchiness/ rash developing on his skin and is itchy; pain in the injection site (right upper arm); This is a spontaneous report from a contactable Nurse. This Nurse reported for 12-year-old male patient (Reporter's son). A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in right arm on Aug2021 (at the age of 12-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient has side effects of chest pain, rash on his neck and all over the body, itchiness/ rash developing on his skin and is itchy, pain in the injection site (right upper arm). The reporter wants to know what to do to alleviate itching and how long will it take to go away. The reporter questioned whether the Pfizer was like neurotoxins, like any of the chemicals that go inside the brain and was asking whether the vaccine was tested on animals, like mice. The clinical outcome for the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.