chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Pain in extremity, Palpitations, Somnolence
Clinical narrative: Sore arm; felt weak; felt very sleepy; itchiness at injection site; heart palpitations; short of breath feeling like after running; This is a spontaneous report from a contactable consumer or other non-HCP. A 49-year-old female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration on 28Mar2021 as dose 2, single (at the age of 49-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Vaccination facility type was reported as School/Student Health Clinic. Patient medical history and concomitant medications were not reported. Patient allergies to food, or other products was reported as unknown. Prior to the 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 receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration on 07Mar2021 as dose 1, single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm, felt weak, felt very sleepy, itchiness at injection site, heart palpitations, short of breath feeling like after running on 28Mar2021. Therapeutic measures taken as a result of sore arm, felt weak, felt very sleepy, itchiness at injection site, heart palpitations, short of breath feeling like after running included Tylenol as treatment medication. The outcome of the events was resolved on an unspecified date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Sore arm; felt weak; felt very sleepy; itchiness at injection site; heart palpitations; short of breath feeling like after running; This is a spontaneous report from a contactable consumer or other non-HCP. A 49-year-old female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration on 28Mar2021 as dose 2, single (at the age of 49-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Vaccination facility type was reported as School/Student Health Clinic. Patient medical history and concomitant medications were not reported. Patient allergies to food, or other products was reported as unknown. Prior to the 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 receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration on 07Mar2021 as dose 1, single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm, felt weak, felt very sleepy, itchiness at injection site, heart palpitations, short of breath feeling like after running on 28Mar2021. Therapeutic measures taken as a result of sore arm, felt weak, felt very sleepy, itchiness at injection site, heart palpitations, short of breath feeling like after running included Tylenol as treatment medication. The outcome of the events was resolved on an unspecified date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: her injection site is still bruised; randomly started bleeding a bit/ bleeding at immunization site; This is a spontaneous report from a contactable consumer (Patient) via Regulatory Authority.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8730), via an unspecified route of administration in left arm on 24Mar2021 at 13:00 as dose 1, single for COVID-19 immunisation at clinic. The patient's medical history and concomitant medications were reported as none. The patient's past drug included vitamins. Patient's family medical history relevant to event was reported as none. Patient did not receive any other vaccine within four weeks prior to the first administration date of the suspect vaccine. On 26Mar2021, a couple of days after getting the immunization, the patient's injection site was still bruised. While it was getting better, the bruise persisted and on an unspecified date, in 2021, it randomly started bleeding a bit. Patient's arm did bleed when she got the shot, but then stopped right after. The patient received treatment for the events. The clinical outcome of the events was resolving.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Eyelid ptosis, Gait disturbance, Vision blurred
Clinical narrative: Vision started to get blurry; Double vision at long distances; Troubles trying to walk; Eyelids are drooping down and are almost closed all the way; This is a spontaneous report from a non-contactable consumer or other non hcp (patient).   A male patient of an unspecified age received BNT162b2 (CONMINTARY, Solution for injection, Lot No: was not reported), via an unspecified route of administration on Mar2021 as 1st dose, single for covid-19 immunisation.The patient medical history and concomitant medications were not reported.The patient experienced vision started to get blurry, double vision at long distances, troubles trying to walk, eyelids are drooping down and are almost closed all the way on an unspecified date. Patient wants to know if this is a side effect of the vaccine. The outcome of the events for vision started to get blurry, double vision at long distances was not recovered, troubles trying to walk, eyelids are drooping down and are almost closed all the way was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: She had arthritis in her knees; This is a spontaneous report received from Regulatory Authority via contactable female consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's second dose scheduled on 16Apr2021. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had arthritis in her knees and wanted to know if she could take Ibuprofen or advil. She just wanted to make sure that she would not mess up with the vaccine. The patient had arthritis in her knees on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: got her 1st dose on 18MAR2021, and after 2 weeks she has rashes; This is a spontaneous report received from contactable consumer (patient ) via Pfizer sponsor program . A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection batch/Lot number was not reported ,expiry date was not reported), dose 1 via an unspecified route of administration on 18Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced got her first dose on 18mar2021, and after 2 weeks she has rashes .Patient asked if it is associated with the covid-19 vaccine because her second dose schedule is on 08Apr2021.Outcome of the event was unknown.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained.No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Pain
Clinical narrative: chills; temperature of 99.1; achiness/Achy the whole; tired; I was little like weak; This is spontaneous report received from Pfizer Sponsored Program. A contactable female consumer (Patient) reported herself. A female patient of an unspecified age received second 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 29Mar2021, 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-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization and had injection site pain. The patient received 2nd dose of Pfizer vaccine Sunday March 28th had reactions that lasted until Monday the 29th including: a temperature of 99.1 which lasted a few hours, chills, achiness, tired on an unspecified date in Mar2021. The side effects started quicker than when receiving the 1st dose, at which time she had injection site pain and muscle pain. Overall a feeling of being slightly unwell. The patient would like to know how long they should quarantine before seeing friends and family. The patient stated, "she just had her second dose of Pfizer she did have reaction 'actually' that after noon, she had it in the morning and it lasted until, she had it Sunday, Monday night, even yesterday she was little like weak and whatever but no fever no nothing. She had 98.9 which was really not a fever. Chills, achy the whole you know, not nauseous, no diarrhea but just very achy and chill. She had a really silly question on she had it obviously this week was there a quarantine. If the patient didn't stay at quarantine but it didn't say not to. So she was not sure what to do. Her husband and she both had the second dose. The patient underwent lab test and procedure included Body temperature with temperature of 99.1 (high) on 29Mar2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; temperature of 99.1; achiness/Achy the whole; tired; I was little like weak; This is spontaneous report received from Pfizer Sponsored Program. A contactable female consumer (Patient) reported herself. A female patient of an unspecified age received second 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 29Mar2021, 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-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization and had injection site pain. The patient received 2nd dose of Pfizer vaccine Sunday March 28th had reactions that lasted until Monday the 29th including: a temperature of 99.1 which lasted a few hours, chills, achiness, tired on an unspecified date in Mar2021. The side effects started quicker than when receiving the 1st dose, at which time she had injection site pain and muscle pain. Overall a feeling of being slightly unwell. The patient would like to know how long they should quarantine before seeing friends and family. The patient stated, "she just had her second dose of Pfizer she did have reaction 'actually' that after noon, she had it in the morning and it lasted until, she had it Sunday, Monday night, even yesterday she was little like weak and whatever but no fever no nothing. She had 98.9 which was really not a fever. Chills, achy the whole you know, not nauseous, no diarrhea but just very achy and chill. She had a really silly question on she had it obviously this week was there a quarantine. If the patient didn't stay at quarantine but it didn't say not to. So she was not sure what to do. Her husband and she both had the second dose. The patient underwent lab test and procedure included Body temperature with temperature of 99.1 (high) on 29Mar2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Malaise, Platelet count, Platelet count decreased
Clinical narrative: unwell; low platelets; fatigue; low grade fever; decreased appetite; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, 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; Lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 01Feb2021 (Batch/Lot number was not reported) to an unspecified date, at 24 mg for an unspecified indication. Medical history included thyroid cancer from an unknown date and unknown if ongoing, decreased appetite from an unknown date and unknown if ongoing, chemotherapy from an unknown date and unknown if ongoing, smoking cessation therapy from an unknown date to Sep2020 (quit 9/2020). The patient's concomitant medications were not reported. The patient experienced unwell on an unspecified date with outcome of unknown, low platelets on an unspecified date, fatigue on an unspecified date, low grade fever on an unspecified date, decreased appetite on an unspecified date. The patient underwent lab tests and procedures which included platelet count: low on. The action taken in response from Lenvatinib mesilate was unknown. The outcome of the events malaise, platelet count decreased, fatigue, pyrexia, decreased appetite was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: unwell; low platelets; fatigue; low grade fever; decreased appetite; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, 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; Lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 01Feb2021 (Batch/Lot number was not reported) to an unspecified date, at 24 mg for an unspecified indication. Medical history included thyroid cancer from an unknown date and unknown if ongoing, decreased appetite from an unknown date and unknown if ongoing, chemotherapy from an unknown date and unknown if ongoing, smoking cessation therapy from an unknown date to Sep2020 (quit 9/2020). The patient's concomitant medications were not reported. The patient experienced unwell on an unspecified date with outcome of unknown, low platelets on an unspecified date, fatigue on an unspecified date, low grade fever on an unspecified date, decreased appetite on an unspecified date. The patient underwent lab tests and procedures which included platelet count: low on. The action taken in response from Lenvatinib mesilate was unknown. The outcome of the events malaise, platelet count decreased, fatigue, pyrexia, decreased appetite was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Diplopia, Dizziness, Dyspnoea
Clinical narrative: pain in the shoulder; constant headache; shortness of breath; Dizziness; I had the double vision; saw 2 images of the same; only in the left eye; I am not sure if could see; deep cough and then I expectorate or spit a very very medium brown material, very thick; Cough; Sore throat; I could not walk between chair and sofa; This is a spontaneous report from a contactable consumer. This 72-years-old male consumer (patient) reported for himself that: A 72-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL0142; Expiration Date: 20Mar2021), via an unspecified route of administration on 12Jan2021 (at the age of 72-year-old) as single dose for covid-19 immunisation. Medical history included Heart condition, diabetes mellitus, I had multiple strokes, I had a pacemaker, I had 4-way bypass and I had some MIs, TIAs and A-fib from an unknown date and unknown if ongoing and he is taking probably 8 to 10 different medication. Patient received unspecified concomitant medication. Patient stated, start with pain in the shoulder, that lasted about 3 days after the shot and then also pretty much the constant headache, shortness of breath, so dizzy that I could not walk between chair and sofa, I do not drive right now because of that, I had the double vision, I actually saw 2 images of the same about I guess we call theoretical maybe inch apart, and that is only in the left eye and it only occurred for about 25 minutes, I am not sure if could see. when I wake up in the morning I had very deep cough and then I expectorate or spit a very very medium brown material, very thick. patient stated still experiencing the events, I do not know because just really late specially the dizziness, and the cough and the sore throat. No lab test was performed. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9263; Expiration Date: 31May2021), via an unspecified route of administration on 02Feb2021 as single dose for covid-19 immunisation. The outcome of the events was reported as not recovered.   No Follow-up attempts are possible. No Further Information is expected. .
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Headache, Oropharyngeal pain, Productive cough, Visual impairment
Clinical narrative: pain in the shoulder; constant headache; shortness of breath; Dizziness; I had the double vision; saw 2 images of the same; only in the left eye; I am not sure if could see; deep cough and then I expectorate or spit a very very medium brown material, very thick; Cough; Sore throat; I could not walk between chair and sofa; This is a spontaneous report from a contactable consumer. This 72-years-old male consumer (patient) reported for himself that: A 72-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL0142; Expiration Date: 20Mar2021), via an unspecified route of administration on 12Jan2021 (at the age of 72-year-old) as single dose for covid-19 immunisation. Medical history included Heart condition, diabetes mellitus, I had multiple strokes, I had a pacemaker, I had 4-way bypass and I had some MIs, TIAs and A-fib from an unknown date and unknown if ongoing and he is taking probably 8 to 10 different medication. Patient received unspecified concomitant medication. Patient stated, start with pain in the shoulder, that lasted about 3 days after the shot and then also pretty much the constant headache, shortness of breath, so dizzy that I could not walk between chair and sofa, I do not drive right now because of that, I had the double vision, I actually saw 2 images of the same about I guess we call theoretical maybe inch apart, and that is only in the left eye and it only occurred for about 25 minutes, I am not sure if could see. when I wake up in the morning I had very deep cough and then I expectorate or spit a very very medium brown material, very thick. patient stated still experiencing the events, I do not know because just really late specially the dizziness, and the cough and the sore throat. No lab test was performed. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9263; Expiration Date: 31May2021), via an unspecified route of administration on 02Feb2021 as single dose for covid-19 immunisation. The outcome of the events was reported as not recovered.   No Follow-up attempts are possible. No Further Information is expected. .
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Chills, Dizziness, Dyspnoea
Clinical narrative: mild difficulty breathing; localized rash; itching at injection site; Soreness in arm progressively worse right after injection; muscle pain all over; chills; fever; debilitating weakness; numbness in my arm; stiffness in my neck; dizziness; balance difficulty; This is a spontaneous report from a contactable consumer (patient). A 66-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 10Apr2021 at 10:00 (at the age of 66-years-old), in right arm as dose 2, single for COVID-19 immunization in other facility. Medical history included latex (known allergies: latex) and shellfish (known allergies: shellfish). Concomitant medications were not reported. Historical Vaccination reported as BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 20Mar2021 (at the age of 66-years-old), in right arm as dose 1, single for COVID-19 immunization in other facility. COVID prior vaccination reported as no and COVID tested post vaccination reported as no. Other medications in two weeks reported as no. On 11Apr2021 13:00 the patient experienced mild difficulty breathing, localized rash, itching at injection site, soreness in arm progressively worse right after injection, muscle pain all over, chills, fever, debilitating weakness, numbness in my arm, stiffness in my neck, dizziness, balance difficulty. Treatment was not taken for the events. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: mild difficulty breathing; localized rash; itching at injection site; Soreness in arm progressively worse right after injection; muscle pain all over; chills; fever; debilitating weakness; numbness in my arm; stiffness in my neck; dizziness; balance difficulty; This is a spontaneous report from a contactable consumer (patient). A 66-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 10Apr2021 at 10:00 (at the age of 66-years-old), in right arm as dose 2, single for COVID-19 immunization in other facility. Medical history included latex (known allergies: latex) and shellfish (known allergies: shellfish). Concomitant medications were not reported. Historical Vaccination reported as BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 20Mar2021 (at the age of 66-years-old), in right arm as dose 1, single for COVID-19 immunization in other facility. COVID prior vaccination reported as no and COVID tested post vaccination reported as no. Other medications in two weeks reported as no. On 11Apr2021 13:00 the patient experienced mild difficulty breathing, localized rash, itching at injection site, soreness in arm progressively worse right after injection, muscle pain all over, chills, fever, debilitating weakness, numbness in my arm, stiffness in my neck, dizziness, balance difficulty. Treatment was not taken for the events. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pruritus
Clinical narrative: mild difficulty breathing; localized rash; itching at injection site; Soreness in arm progressively worse right after injection; muscle pain all over; chills; fever; debilitating weakness; numbness in my arm; stiffness in my neck; dizziness; balance difficulty; This is a spontaneous report from a contactable consumer (patient). A 66-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 10Apr2021 at 10:00 (at the age of 66-years-old), in right arm as dose 2, single for COVID-19 immunization in other facility. Medical history included latex (known allergies: latex) and shellfish (known allergies: shellfish). Concomitant medications were not reported. Historical Vaccination reported as BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 20Mar2021 (at the age of 66-years-old), in right arm as dose 1, single for COVID-19 immunization in other facility. COVID prior vaccination reported as no and COVID tested post vaccination reported as no. Other medications in two weeks reported as no. On 11Apr2021 13:00 the patient experienced mild difficulty breathing, localized rash, itching at injection site, soreness in arm progressively worse right after injection, muscle pain all over, chills, fever, debilitating weakness, numbness in my arm, stiffness in my neck, dizziness, balance difficulty. Treatment was not taken for the events. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Off label use, Product use issue, Suppressed lactation
Clinical narrative: shingles; Decreased breast milk supply; Decreased breast milk supply; Decreased breast milk supply; This is a spontaneous report from a contactable consumer. A 28-year-old female patient (non-pregnant) received BNT162B2 (BNT162B2, PFIZER BIONTECH, COVID-19 Vaccine, Solution for injection: Batch/Lot number: EN6203, and expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on 07Mar2021 as DOSE 2, SINGLE (age at vaccination 28-year-old) for covid-19 immunisation. The patient medical history included hypothyroidism, Tree Nuts allergy. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]) taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient historical vaccine includes BNT162B2 (BNT162B2, PFIZER BIONTECH, COVID-19 Vaccine, Solution for injection: Batch/Lot number: EL9266, and expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on 14Feb2021 at 11.30AM as DOSE 1, SINGLE for covid-19 immunisation. other vaccine in four weeks: No. covid prior vaccination was No. covid tested post vaccination was No. It was reported that happen only after my second dose of the vaccine. I have a few close friends (2-3) who are also breastfeeding, and they also reported changes in breastmilk supply to the point that they switched to formula. Thankfully, I was able to pick up my supply again through pumping a ton, but they reported not being able to get back to their normal supply after the vaccine, also was diagnosed with shingles on 01Apr2021, 3.5 weeks after my second vaccine. I'm not sure if this has been reported by anyone else, but I think it's pretty bizarre that I got the shingles at such a young age and in less than 4 weeks from getting the vaccine. Therapeutic measures were taken as a result of shingles, decreased milk supply. The outcome of the event was suppressed lactation and herpes zoster was recovering.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021423510 same reporter/drug, different event/Patient  (baby case)
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Headache, Movement disorder, Muscle discomfort
Clinical narrative: Started with a pulled muscle sensation next day; chest pain on right upper chest; Very difficult to breath or move; Very difficult to breath or move; Pain became very severe; felt like what sounded like a snap in neck and was unable to move head; feeling slight pain in chest and behind neck and back of head; feeling slight pain in chest and behind neck and back of head; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration administered in Left arm on 02Apr2021 at 02:45 pm (48-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included Hay Fever, Hashimotos and Graves Disease from an unknown date and unknown if ongoing. The patient had no known allergies. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. The patient had no other medications in two weeks. On 03Apr2021 at 12:00 PM, the patient experienced a pulled muscle sensation, chest pain on right upper chest, very difficult to breath or move, severe pain, a snap in neck, was unable to move head, slight pain in chest and behind neck and back of head. It started with a pulled muscle sensation next day after the vaccine which lasted 2 days. On 3rd day, the patient began having chest pain on right upper chest. Pain became very severe. On 6th day, the patient felt like what sounded like a snap in neck and was unable to move head. Pain was also very severe. Now almost a week after symptoms began the patient was still feeling slight pain in chest and behind neck and back of head. The patient was not sure if it was vaccine driven but cannot think of anything else. The outcome of events were not recovered.  Information about Lot/Batch number has been requested.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Neck pain, Pain
Clinical narrative: Started with a pulled muscle sensation next day; chest pain on right upper chest; Very difficult to breath or move; Very difficult to breath or move; Pain became very severe; felt like what sounded like a snap in neck and was unable to move head; feeling slight pain in chest and behind neck and back of head; feeling slight pain in chest and behind neck and back of head; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration administered in Left arm on 02Apr2021 at 02:45 pm (48-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included Hay Fever, Hashimotos and Graves Disease from an unknown date and unknown if ongoing. The patient had no known allergies. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. The patient had no other medications in two weeks. On 03Apr2021 at 12:00 PM, the patient experienced a pulled muscle sensation, chest pain on right upper chest, very difficult to breath or move, severe pain, a snap in neck, was unable to move head, slight pain in chest and behind neck and back of head. It started with a pulled muscle sensation next day after the vaccine which lasted 2 days. On 3rd day, the patient began having chest pain on right upper chest. Pain became very severe. On 6th day, the patient felt like what sounded like a snap in neck and was unable to move head. Pain was also very severe. Now almost a week after symptoms began the patient was still feeling slight pain in chest and behind neck and back of head. The patient was not sure if it was vaccine driven but cannot think of anything else. The outcome of events were not recovered.  Information about Lot/Batch number has been requested.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue
Clinical narrative: Tiredness; cough; difficulty breathing; This is a spontaneous report from a contactable consumer or other non hcp. A 24-years-old non pregnant female patient received (BNT162B2, formulation: Solution for injection, Lot Number: unknown), 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 was not reported Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. and concomitant medications were not reported. The patient experienced tiredness, cough and difficulty breathing on an unspecified date. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No follow-up attempts are possible.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased, Palpitations
Clinical narrative: High heart rate while at rest, over 100 beats per minute with palpitations; High heart rate while at rest, over 100 beats per minute with palpitations; shortness for breath.; This is a spontaneous report from a contactable consumer (Patient). A 36-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown), dose 2 via an unspecified route of administration in arm left on 14Apr2021 at 10:30 (age at vaccination was 36 years) as single dose for COVID-19 immunization. The patient's medical history included COVID-19 from an unknown date. The patient did not have any known allergies. Concomitant medication included loratadine, pseudoephedrine sulfate (CLARITIN D 12 HOUR) in two weeks. The facility where the most recent COVID-19 vaccine was administered was unknown county. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Apr2021 at 11:00, after first dose the patient experienced high heart rate while at rest, over 100 beats per minute with palpitations and shortness for breath. No treatment was received for the adverse events. The patient underwent lab tests and procedures which included heart rate: high/over 100 beats per minute on 15Apr2021. Patient visits healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment received for the adverse events. The outcome of the events was resolving.   Information about Lot/Batch number is requested.  Follow-up (17Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection, Lethargy, Muscular weakness, Pyrexia
Clinical narrative: Herpes; fever; lethargy; muscle weakness; This is a spontaneous report from a contactable consumer (patient herself). A 42-years-old non pregnant 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 left arm on 14Apr2021 10:00 (age at vaccination: 42 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history were not reported. There were no concomitant medications. The patient had no known allergies. The patient did not have any other vaccine in four weeks not received ant medications in 2 weeks. On 15Apr2021, the patient experienced herpes, fever, lethargy and muscle weakness. The adverse event resulted in physician's office visit. The patient received Advil as treatment for the adverse event was advised to rest. The patient had no prior vaccination for covid nor was tested post vaccination. The outcome of all the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Rash, Skin discolouration
Clinical narrative: full blown torso front and back; body rash; shingles; very achy; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in right arm on 16Apr2021 at 03:30 AM (at the age of 48 years old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included post-traumatic stress disorder, neoplasm malignant, anxiety. The patient did not have any known allergies. Concomitant medications in two weeks included ciprofloxacin (CIPROFLOXACIN) for herpes zoster; ethinylestradiol, norgestimate (SPRINTEC); oxcarbazepine (OXCARBAZEPINE); lorazepam (LORAZEPAM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of unspecified vaccine on 16Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 18Apr2021 at 21:30 patient experienced very achy sat. Sun. She woke up with a questionable patch on her abdomen sat. She didn't think related. Sore rash like. She had a full blown torso front and back body rash on sun night. She got cream. Later in the week diagnosed with shingles. She have cancer so not sure what to attribute the shingles to. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of very achy, cream for body rash, valacyclovir for shingles. The outcome of events was recovering.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus
Clinical narrative: Golf ball sized lump developed at injection site about 24 hours/Lump is raised about 1 cm and itchy; Golf ball sized lump developed at injection site about 24 hours/Lump is raised about 1 cm and itchy; This is a spontaneous report from a contactable consumer. This 33-year-old male consumer (Patient) reported that.  A 33-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Ew0162), dose 1 via an unspecified route of administration, administered in Arm Left on 17Apr2021 12:30 as (At the age of 33-years) dose 1, single for covid-19 immunisation. Nonmedical history was not reported. There were no concomitant medications. No other vaccine in four weeks. No Other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies ware reported. On 18Apr2021 12:30 patient experienced Golf ball sized lump developed at injection site about 24 hours. Lump is raised about 1 cm and itchy. Has been present for 10 days and counting. Patient was not received any treatment for events. The outcome events was not recovered at the time of report.    No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Headache, SARS-CoV-2 test
Clinical narrative: double vision; Lots of headaches; This is a spontaneous report from a contactable consumer. This 56-year-old male consumer (patient) reported that: Who received bnt162b2 (BNT162B2) formulation solution for injection, dose 2 (Lot Number: Ep7534 expiry date was unknown) via an unspecified route of administration at arm right on 11Mar2021 as a single dose for covid-19 immunisation. Medical history included hypertension, High blood pressure and diabetes, diabetes mellitus from an unknown date and unknown if ongoing other medical history: High blood pressure and diabetes. There were no concomitant medications. Historical Vaccine dose 1 (Lot number: En6203 expiry date was unknown) via unspecified route of administration at right arm on 11Mar2021 08:45 AM as a single dose for COVID-19 immunisation. Prior to the 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 receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 01:00 Lots of headaches after his second shot then last Wednesday 21Apr2021 double vision. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Mar2021.    No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Eye irritation, Eye swelling, Ocular hyperaemia, Vision blurred
Clinical narrative: blurry / double vision; double vision; Bloodshot eyes; my eyes were burning and felt swollen; my eyes were burning and felt swollen; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-years-old non-female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 21Apr2021 09:15 (Batch/Lot Number: ER8729) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included Major depression disorder, bipolar disorder, erythromelalgia, surgical hysterectomy, chronic endometriosis from an unknown date and unknown if ongoing. Prior to the 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 receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021,10:15 A.M. (Batch/Lot Number: ER8730) as DOSE 1, SINGLE for covid-19 immunisation. Concomitant medications included oxcarbazepine; imipramine; hydroxyzine hydrochloride (HYDROXIZINE); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. On 26Apr2021 06:30, On day 5 post-2nd vaccination, the patient experienced, I woke up with blurry / double vision and bloodshot eyes. Within 12 hours of getting the second dose, my eyes were burning and felt swollen. The patient did not receive any treatment for the events. The clinical outcome of the events was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Herpes virus infection
Clinical narrative: Herpes outbreak on left butt cheek.  3 days after 1st dose. and 2nd Herpes outbreak in similar location 13 days after 2nd dose; Herpes outbreak on left butt cheek.  3 days after 1st dose. and 2nd Herpes outbreak in similar location 13 days after 2nd dose; This is a spontaneous report from a contactable consumer (patient). A 52-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0150), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 22:00 (at the age of 52-years-old) as dose 2, single for covid-19 immunisation. Medical history included none and had no known allergies. Concomitant medication included progesterone; estradiol (ESTROGEN); testosterone and multivitamins. Historical Vaccine included BNT162B2 (Batch/Lot Number: ER2613) on 23Apr2021 at 02:00 (at the age of 52-years-old) pm for covid-19 immunisation and experienced Herpes outbreak on left butt cheek. 3 days after 1st dose. On 26Apr2021 at 09:00, the patient experienced herpes outbreak on left butt cheek.  3 days after 1st dose. and 2nd herpes outbreak in similar location 13 days after 2nd dose. Treatment was provided with Valtrex medication & Abreva topical ointment. The patient received no other vaccine in four weeks. The patient was not COVID prior vaccination and did not test for COVID post vaccination.Outcome of the events were recovering.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes virus infection, Product use issue
Clinical narrative: other vaccine same date on 21Apr2021; after the second shot, I had a herpes cold soar flare up; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 21Apr2021 12:00 (age at the time of vaccination 52-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. On 21Apr2021, the patient took other vaccine same date (name unspecified). Patient previously received first dose of BNT162B2 vaccine, on an unspecified date, as a single dose for COVID-19 immunization. On 22Apr2021 12:00, the patient experienced after the second shot, I had a herpes cold soar flare up, and on an unspecified date other vaccine same date on 21Apr2021. Patient received treatment as a result of adverse event which included Valtrex pill. No covid prior vaccination. No covid tested post vaccination. The outcome of the event after the second shot, I had a herpes cold soar flare up was recovered on an unspecified date; and other was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.