chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Overdose, Pain in extremity, Product preparation issue
Clinical narrative: nurse diluted vaccine with 0.8ml of diluent, and administered to 3 individuals. Patients inadvertently received a higher dose; nurse diluted vaccine with 0.8ml of diluent, and administered to 3 individuals. Patients inadvertently received a higher dose; Tender arm; redness; This is a spontaneous report from a contactable other hcp. This nurse reported for 3 patients (1 male and 2 female). This report is for a female patient (second female):  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Feb2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 12Feb2021, the patient experienced nurse diluted vaccine with 0.8ml of diluent, and administered to 3 individuals. patients inadvertently received a higher dose. On an unspecified date in 2021, patient experienced tender arm, redness. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021224135 same drug/ event, different patient;US-PFIZER INC-2021224939 same drug/ event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Pharyngeal swelling
Clinical narrative: I was driving and had double vision/ blurred vision in the evening; Swelling of throat; This is a spontaneous report from a contactable consumer or other non-HCP. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6198), via an unspecified route of administration on 19Feb2021 as DOSE 1, SINGLE (Age of vaccination: Unknown) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 19Feb2021 the patient experienced swelling of throat. On an unspecified date the patient was driving and had double vision/ blurred vision in the evening. The outcome of event swelling of throat was recovering while outcome of event was driving and had double vision/ blurred vision in the evening was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: soreness of the affect arm at the site of the vaccination; Fatigue; body aches; This is a spontaneous report from a contactable Nurse. A female patient (reporter's sister) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 18Feb2021 at 07:45 A.M as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced soreness of the affect arm at the site of the vaccination, fatigue, and body aches. The clinical outcome for the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Musculoskeletal stiffness, Swelling
Clinical narrative: soreness of right wrist; stiffness all fingers; swelling of area; discomfort level 7; This is a spontaneous report from a contactable consumer (patient). A 81-year-old male patient 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 23Feb2021 at 10:30 (at the age of 81-year-old) as dose 1, single for COVID-19 immunisation at public health clinic/veterans administration facility. Medical history included blood thinner from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had no known allergies. 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 25Feb2021 at 19:00, the patient experienced soreness of right wrist, stiffness all fingers, swelling of area, discomfort level 7, limited use of hand. The patient did not receive any treatment for the events. The outcome of the events was reported as not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: I got the chills; sore arm at injection site; general fatigue; aches; fever of 100.4; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 55-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in left arm on 25Feb2021 at 09:30 (at the age of 55-year-old) as dose 2, single for COVID-19 immunisation at clinic. Medical history included hypertension from an unknown date and unknown if ongoing, glucose tolerance impaired from an unknown date and unknown if ongoing, COVID-19 from an unknown date and unknown if ongoing. The concomitant medication within 2 weeks of COVID-19 vaccination included Prescription medication; diet supplements. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 04Feb2021 at 15:30 (at the age of 55-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. No Known allergies were reported. On 26Feb2021 at 12:30, the patient experienced I got the chills, sore arm at injection site, general fatigue, aches, fever of 100.4 units unspecified. Only lasted that one day. The patient underwent lab tests and procedures which included body temperature was 100.4 units unspecified. No treatment was received for the events. The outcome of the events was reported as resolved on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I got the chills; sore arm at injection site; general fatigue; aches; fever of 100.4; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 55-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in left arm on 25Feb2021 at 09:30 (at the age of 55-year-old) as dose 2, single for COVID-19 immunisation at clinic. Medical history included hypertension from an unknown date and unknown if ongoing, glucose tolerance impaired from an unknown date and unknown if ongoing, COVID-19 from an unknown date and unknown if ongoing. The concomitant medication within 2 weeks of COVID-19 vaccination included Prescription medication; diet supplements. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 04Feb2021 at 15:30 (at the age of 55-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. No Known allergies were reported. On 26Feb2021 at 12:30, the patient experienced I got the chills, sore arm at injection site, general fatigue, aches, fever of 100.4 units unspecified. Only lasted that one day. The patient underwent lab tests and procedures which included body temperature was 100.4 units unspecified. No treatment was received for the events. The outcome of the events was reported as resolved on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance, Vaccination site discolouration, Vaccination site haemorrhage, Vaccination site pain, Vaccination site swelling
Clinical narrative: felt a burning sensation when the injection was administered to her arm.; felt something dripping down her arm; blood upon taking off the bandage; blot of black and blue color at the injection site.; injection site is still swollen; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration, administered in Arm on 02Mar2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date, the patient experienced felt a burning sensation when the injection was administered to her arm, felt something dripping down her arm, blood upon taking off the bandage, blot of black and blue color at the injection site, injection site is still swollen as it was already been 2 hours. The outcomes of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain, Pyrexia, Swelling
Clinical narrative: Pain; Fever; Chills; Swelling; An overall sense of malaise.; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247), via an unspecified route of administration left arm on 01Mar2021 at 13:00 (at the age of 44 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 01Mar2021 at 18:00 patient experienced pain, fever, chills, swelling and an overall sense of malaise. The seriousness was reported as non-serious. No hospitalization required. The patient did not received treatment due to the events. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Shortness of breath; fever; nausea; vomiting; diarrhea; arm soreness; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female (non- pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: En6198) via an unspecified route of administration, administered in right arm on 02Mar2021 08:30 (at the age of 39 years) as dose 2, single for covid-19 immunisation. The patient's medical history was none. No known allergies were reported. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9262) administrated in right arm on 28Jan2021 15:30 (at the age of 39 years) as dose 1, single for protection of Covid. The patient did not take any other vaccine in four weeks. No covid prior vaccination. Not tested for covid post vaccination. On 02Mar2021 09:00, the patient experienced shortness of breath, fever, nausea, vomiting, diarrhea, arm soreness. No treatment was given for events. Outcome of all the events were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Shortness of breath; fever; nausea; vomiting; diarrhea; arm soreness; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female (non- pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: En6198) via an unspecified route of administration, administered in right arm on 02Mar2021 08:30 (at the age of 39 years) as dose 2, single for covid-19 immunisation. The patient's medical history was none. No known allergies were reported. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9262) administrated in right arm on 28Jan2021 15:30 (at the age of 39 years) as dose 1, single for protection of Covid. The patient did not take any other vaccine in four weeks. No covid prior vaccination. Not tested for covid post vaccination. On 02Mar2021 09:00, the patient experienced shortness of breath, fever, nausea, vomiting, diarrhea, arm soreness. No treatment was given for events. Outcome of all the events were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Insomnia
Clinical narrative: Not sleeping; heart rate up; difficulty in breathing; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 82-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 13Feb2021 (Batch/Lot Number: El9269) as dose 2, single for covid-19 immunization (at the age of 82-years-old). Medical history included chronic CLL slight (lymphocytic leukaemia), A fib long time no effects (atrial fibrillation) and some COPD (chronic obstructive pulmonary disease) no effect till now all were from an unknown date and unknown if ongoing. The concomitant medications included blood pressure and blood thinner all new (other medications in two weeks). The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 20Jan2021 at 01:30 Pm (Batch/Lot Number: El3249) as single dose for covid-19 immunization (at the age of 82-years-old). Patient had not received any other vaccine in four weeks. Patient had no covid prior vaccination. Patient had not been tested for covid post vaccination. Patient had no known allergies. It was reported that after receiving the second dose of vaccine on 15Feb2021 at 12:00 am the patient was not sleeping, heart rate up difficulty in breathing about half his normal breaths have been to doctors they seem to think it is to do with heart. The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Lymphadenopathy, Musculoskeletal discomfort, Myalgia
Clinical narrative: my neck felt swollen and tender; my lymph nodes in my neck are swollen slightly; I had chills; injection site soreness; joint aches; muscle aches; This is a spontaneous report from a contactable Consumer reported for himself. A 35-year-old male patient received first dose of bnt162b2 (Pfizer COVID 19 vaccine, Solution for injection, Lot number: EN6203), via an unspecified route in the left arm on 25Feb2021 at 09:45 (age at vaccination: 35-year-old), as a single dose for covid-19 immunization. The patient medical history was reported as none. No concomitant medications were reported. No known allergies were reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 26Feb2021 at 10:00, patient experienced chills, injection site soreness, joint aches, and overall muscle aches within 12 hours. However, those subsided by the next day (27Feb2021). The next day (27Feb2021) his neck felt swollen and tender. It still is today. Patient cannot see it in the mirror, but it is tender to the touch and he believe his lymph nodes in his neck are swollen slightly. He read this happened with 1% of patients so it seems rare but still wanted to report it. Patient did not receive any treatment for the events. The clinical outcome of chills, injection site soreness, joint aches, and overall muscle aches was recovered the next day (27Feb2021), neck felt swollen and tender, lymph nodes in his neck are swollen was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: my neck felt swollen and tender; my lymph nodes in my neck are swollen slightly; I had chills; injection site soreness; joint aches; muscle aches; This is a spontaneous report from a contactable Consumer reported for himself. A 35-year-old male patient received first dose of bnt162b2 (Pfizer COVID 19 vaccine, Solution for injection, Lot number: EN6203), via an unspecified route in the left arm on 25Feb2021 at 09:45 (age at vaccination: 35-year-old), as a single dose for covid-19 immunization. The patient medical history was reported as none. No concomitant medications were reported. No known allergies were reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 26Feb2021 at 10:00, patient experienced chills, injection site soreness, joint aches, and overall muscle aches within 12 hours. However, those subsided by the next day (27Feb2021). The next day (27Feb2021) his neck felt swollen and tender. It still is today. Patient cannot see it in the mirror, but it is tender to the touch and he believe his lymph nodes in his neck are swollen slightly. He read this happened with 1% of patients so it seems rare but still wanted to report it. Patient did not receive any treatment for the events. The clinical outcome of chills, injection site soreness, joint aches, and overall muscle aches was recovered the next day (27Feb2021), neck felt swollen and tender, lymph nodes in his neck are swollen was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Headache, Oropharyngeal pain
Clinical narrative: Diarrhoea; Headache; Sore throat; Cough; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: El9264), dose 1 via an unspecified route of administration, administered in Arm Right on 23Feb2021 as a single dose for covid-19 immunization (at the age of 56-years-old). Medical history included Cancer (2 year's ago), Known allergies Penicillin, Codeine, ceph drugs, and Tamiflu. The patient's concomitant medications were not reported. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: El9264), dose 1 via an unspecified route of administration, administered in Right Arm on 02Feb2021 at 02:30 PM as a single dose for COVID-19 immunization (at the age of 56-years-old). Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. Patient visited to Physician Office. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Patient did not receive other vaccine within 4 weeks and 2 weeks prior to the COVID vaccine. The patient previously took codeine for drug hypersensitivity, tamiflu for drug hypersensitivity. Patient told to take Imodium and drink pedialite. On 03Feb2021 (at 10:00 PM), the patient experienced diarrhoea, headache, and sore throat, and cough. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity, Pollakiuria, Pyrexia
Clinical narrative: arm was sore; Not feeling 100%, not feeling well; feverish/Feeling a little feverish; tired; increase urination; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient (Age: 66, unit: unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 23Feb2021 at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient experienced arm was sore, not feeling 100%, not feeling well, feverish/feeling a little feverish, tired, increase urination. Reporter got 1st dose on Tuesday. Reporter says her arm was sore for 2 days. May be the 3rd day I started noticing I didn't feel well. Reporter says on Sunday, she felt Feverish, thermometer showed normal range. On Monday, she felt like the same off and on. Reporter says today, She is feeling tired and possibly increase urination. Reporter says, I know people complained about arm soreness. Reporter says she heard symptoms increase after the 2nd dose. Reporter is asking if it is normal to feel unwell or uncomfortable a week later. Reporter asking if she should I get the 2nd dose after this experience with the 1st dose. Reporter asking for recommendation to do before next dose to Lessen effects of 2nd dose. Reporter gives examples: like drinking more fluids. Reporter says, I saw you shouldn't take Tylenol before. Reporter stated she is calling regarding the Pfizer Covid Vaccine that she had last Tuesday 23Feb2021 and she is feeling a little feverish and not feeling 100%, not feeling well. She states that her doctor appointment is not until after second shot is scheduled. She is wanting to know if this is a normal side effect. Reporter refused to answer any further questions and just wants to be transferred to someone that can answer her question. She states that she has been on hold for an hour already and is already behind. 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: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable consumer. This female consumer reported for herself that: who received bnt162b2 (BNT162B2), dose 2 (Lot number and expiry date was not reported) via an unspecified route of administration on 02Mar2021 as a single for covid-19 immunisation. Historical vaccine BNT162B2 dose 1 (lot number and expiry date unknown) administration unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. the patient medical history and concomitant medications were not reported. Patient got her 2nd dose this morning 02Mar2021. She was having a breakout with hives. Patient had the hives and wants to know if she can take Benadryl without negating the effects of the vaccine. Outcome of the event was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Malaise
Clinical narrative: Not feeling well; headache; tired; cough; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), unknown dose via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced not feeling well, headache, tired, and cough. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: injection site pain; tiredness; headache; muscle pain; chills; fever; joint pain; This is a spontaneous report received from a Pfizer-sponsored program via Regulatory Authority support. This is a contactable consumer or other non HCP (patient) reported for himself. A 78-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 16Feb2021 as single dose for covid-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date the patient experienced injection site pain, tiredness, headache, muscle pain, chills, fever, joint pain. Clinical course was reported as male consumer received the first dose of the COVID vaccine on 16Feb2021. His symptoms began 12 hours after the first dose, all similar to when he had COVID in November. He did not have an anaphylactic reaction, however, he had side effects of injection site pain, tiredness, headache, muscle pain, chills, fever, and joint pain. He did not have injection site swelling or redness. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: injection site pain; tiredness; headache; muscle pain; chills; fever; joint pain; This is a spontaneous report received from a Pfizer-sponsored program via Regulatory Authority support. This is a contactable consumer or other non HCP (patient) reported for himself. A 78-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 16Feb2021 as single dose for covid-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date the patient experienced injection site pain, tiredness, headache, muscle pain, chills, fever, joint pain. Clinical course was reported as male consumer received the first dose of the COVID vaccine on 16Feb2021. His symptoms began 12 hours after the first dose, all similar to when he had COVID in November. He did not have an anaphylactic reaction, however, he had side effects of injection site pain, tiredness, headache, muscle pain, chills, fever, and joint pain. He did not have injection site swelling or redness. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: stomach cramps with diarrhea; stomach cramps with diarrhea; mild headache; Achiness; mild fever (100.4),; fatigue; nausea; injection site pain.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 66-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3248 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 01Mar2021 at 15:30 as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination: 66-years-old). Medical history included drug hypersensitivity (known allergies: Penicillin). Concomitant medication included omeprazole (OMEPRAZOLE). The patient experienced stomach cramps with diarrhea, mild headache, achiness, mild fever, fatigue, nausea and injection site pain on 01Mar2021 at 16:00. No treatment was received for the events. Outcome of all the events was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot been obtained].
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: stomach cramps with diarrhea; stomach cramps with diarrhea; mild headache; Achiness; mild fever (100.4),; fatigue; nausea; injection site pain.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 66-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3248 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 01Mar2021 at 15:30 as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination: 66-years-old). Medical history included drug hypersensitivity (known allergies: Penicillin). Concomitant medication included omeprazole (OMEPRAZOLE). The patient experienced stomach cramps with diarrhea, mild headache, achiness, mild fever, fatigue, nausea and injection site pain on 01Mar2021 at 16:00. No treatment was received for the events. Outcome of all the events was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot been obtained].
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Diarrhoea, Fatigue, Malaise, Rash
Clinical narrative: she went to receive her 2nd vaccine dose and the head person at the vaccination site said they would not vaccinate me without clearance from an allergist due to her reactions following her first Pfizer vaccine dose; rashes on my legs; malaise; fatigue; diarrhea; This is a spontaneous report from a contactable consumer. This female consumer reported that a female patient with unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not provided), dose 1 via an unspecified route of administration on 03Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Consumer states she reported her side effects. She received first Pfizer vaccine one month ago, 03Feb2021 and 30 hours later developed rashes on my legs every evening x 3-4 times. Consumer also states she experienced malaise, fatigue and diarrhea. Consumer states she went to receive her second vaccine dose and the head person at the vaccination site said they would not vaccinate me without clearance from an allergist due to her reactions following her first Pfizer vaccine dose. She questioned if other people had rashes too after being vaccinated. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dizziness postural, Fatigue, Pyrexia
Clinical narrative: extreme dizziness; Fever; Chills; Fatigue; still dizzy upon standing or laying; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 05Feb2021 12:00 (62-year-old at vaccination) as Dose number unknown, Single for COVID-19 immunization. The patient's Medical history included Haemochromatosis. No known allergies were reported. No concomitant medications received by the patient in two weeks after vaccination. Vaccination facility type was reported as Other. The patient had not received any other vaccine four weeks prior to vaccination. T The patient tested for covid prior vaccination. On 05Feb2021 at 15:00, the reporter stated that, his adverse event most have subsided, except extreme dizziness, had fever, chills, fatigue and dizziness, still dizzy upon standing or laying, very dizzy on day 5. These ae resulted in Doctor or other healthcare professional office/clinic visit. The patient not tested for covid post vaccination. No treatment received for the resulted events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Chills, Fatigue
Clinical narrative: Tiredness; Headache; chills; joint pain; fever; nausea; feeling unwell; weakness; stomach upset; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EM9809) via an unspecified route of administration on 26Feb2021 (at the age of 73-year-old) as single dose for COVID-19 immunization. Patient had no medical history and was not taking any other products (concomitant). On 28Feb2021, two days after vaccination patient experienced tiredness, headache, chills, joint pain, fever, nausea, feeling unwell, weakness, upset stomach. Patient stated she had no injection site reactions but had all the other ones. She used 1 Tylenol 2 days after the shot that was because she was trying to lessen the severity of the symptoms. Patient asked why she had so many symptoms that were very severe. She mentioned that they gave a list after the shot of things you might have, and she had them all. The only she didn't have was pain in her arm, which she did ice her arm, but she has had all the other symptoms on the whole list. She clarified she has had tiredness, headache, chills, joint pain, fever, nausea, feeling unwell, weakness, all of that. She said everything began 2 days later, she was fine for 2 days on Sunday 28Feb2021. She said she still has an upset stomach which was not listed as one of things that could happen. The nausea part was but not upset stomach, she still has bits of the nausea and upset stomach. The other symptoms have gone away. She clarified the tiredness, headache, chills, joint pain, fever have gone away. She said the chills was more like shivers through the night like if someone was hypothermic but all of that has subsided. Patient asked if other people reported things like this where they have had a lot of symptoms. Treatment included Tylenol. Outcome of the event nausea and stomach upset was not resolved, for unwell and weakness was unknown and for all other events were resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Pyrexia
Clinical narrative: Tiredness; Headache; chills; joint pain; fever; nausea; feeling unwell; weakness; stomach upset; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EM9809) via an unspecified route of administration on 26Feb2021 (at the age of 73-year-old) as single dose for COVID-19 immunization. Patient had no medical history and was not taking any other products (concomitant). On 28Feb2021, two days after vaccination patient experienced tiredness, headache, chills, joint pain, fever, nausea, feeling unwell, weakness, upset stomach. Patient stated she had no injection site reactions but had all the other ones. She used 1 Tylenol 2 days after the shot that was because she was trying to lessen the severity of the symptoms. Patient asked why she had so many symptoms that were very severe. She mentioned that they gave a list after the shot of things you might have, and she had them all. The only she didn't have was pain in her arm, which she did ice her arm, but she has had all the other symptoms on the whole list. She clarified she has had tiredness, headache, chills, joint pain, fever, nausea, feeling unwell, weakness, all of that. She said everything began 2 days later, she was fine for 2 days on Sunday 28Feb2021. She said she still has an upset stomach which was not listed as one of things that could happen. The nausea part was but not upset stomach, she still has bits of the nausea and upset stomach. The other symptoms have gone away. She clarified the tiredness, headache, chills, joint pain, fever have gone away. She said the chills was more like shivers through the night like if someone was hypothermic but all of that has subsided. Patient asked if other people reported things like this where they have had a lot of symptoms. Treatment included Tylenol. Outcome of the event nausea and stomach upset was not resolved, for unwell and weakness was unknown and for all other events were resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Neck pain, Nuchal rigidity
Clinical narrative: Her shoulders and neck hurt to move or lay down; Her shoulders and neck hurt to move or lay down; Neck feels like it is more fused than it was before; Chills; Back pain; This is a spontaneous report from a contactable consumer (patient) via Support. A 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. Medical history included ongoing fused spine. The patient's concomitant medications were not reported. The patient reported that shoulders and neck hurt to move or lay down and her neck felt like it was more fused than it was before. The patient received paracetamol (TYLENOL). After a week, the patient had lessened flexibility, and reported that chills come and go and she did not feel like doing much for a week. The patient also had back pain. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Flushing, Pain
Clinical narrative: Cough; body aches; shortness of breath; tired; felt flushed; not ever red but tingly; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 72-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205), via an unspecified route of administration in left arm on 25Feb2021 10:00 (at the age of 72-years-old) as dose 1, single for COVID-19 immunization. Medical history included Sick from 30Jan2021, fever and COVID-19 from 02Feb2021 (started getting sick on 30Jan2021, health department cleared her on 14Feb2021, she was still dealing with the residual lingering effects). Prior to vaccination, the patient did not receive any vaccines within four weeks nor any other medications within two weeks prior. The patient experienced cough, body aches, shortness of breath, tired, felt flushed and not ever red but tingly on 25Feb2021. It was reported that patient had shortness of breath dealing with oxygen, more body aches than she had with COVID. The patient heard that people react to the second dose more than first, asked how long she should wait to get the second dose of the vaccine. Events started later the evening of vaccination. She can get up out of the chair, still has a cough, residual breathing, and tiredness. She was trying to build up stamina by doing more around the house. After a day and half, she started feeling better and she was much better at the time of this report. Patient stated that she thinks she shrunk a little bit. Outcome of events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Cough; body aches; shortness of breath; tired; felt flushed; not ever red but tingly; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 72-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205), via an unspecified route of administration in left arm on 25Feb2021 10:00 (at the age of 72-years-old) as dose 1, single for COVID-19 immunization. Medical history included Sick from 30Jan2021, fever and COVID-19 from 02Feb2021 (started getting sick on 30Jan2021, health department cleared her on 14Feb2021, she was still dealing with the residual lingering effects). Prior to vaccination, the patient did not receive any vaccines within four weeks nor any other medications within two weeks prior. The patient experienced cough, body aches, shortness of breath, tired, felt flushed and not ever red but tingly on 25Feb2021. It was reported that patient had shortness of breath dealing with oxygen, more body aches than she had with COVID. The patient heard that people react to the second dose more than first, asked how long she should wait to get the second dose of the vaccine. Events started later the evening of vaccination. She can get up out of the chair, still has a cough, residual breathing, and tiredness. She was trying to build up stamina by doing more around the house. After a day and half, she started feeling better and she was much better at the time of this report. Patient stated that she thinks she shrunk a little bit. Outcome of events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Rash
Clinical narrative: a rash forming on her chest; mild chest tightness; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female unknown pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3246, Expiration date: not reported), via intramuscular in arm left on 28Jan2021 at 14:15 (at the age of 36-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included Chiari I malformation, Ehlers-Danlos syndrome, Mast cell activation syndrome, other food allergy. Past drug event included codeine (CODEINE) and experienced known allergies: codeine (unknown reaction). The patient's concomitant medications in two weeks included alprazolam (XANAX), 3x/day, oral, gabapentin (cap/tab), oral, tizanidine, oral, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), all were taken for an unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL0142, Expiration date: not reported), via intramuscular in arm left on 07Jan2021 at 14:45 (at the age of 36-year-old) as a dose 1, single for COVID-19 immunization. Other vaccine in four weeks was reported as unknown. Covid prior vaccination and covid tested post vaccination was reported as unknown. It was reported that, the patient received her vaccine, 20 minutes later reported a rash forming on her chest and mild chest tightness on 28Jan2021 at 14:15. Stated that, she has a history of Mast Cell Activation Syndrome and had pre-medicated with Zyrtec. At 14:20, the nurse administered 25mg PO Benadryl, at 14:50, she felt her symptoms decreased and went home with her spouse. Treatment medication included 25mg PO Benadryl. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria, Vaccination site pain
Clinical narrative: tenderness at the site of injection; itching; hives; rash that covered my entire abdomen, my back, legs, arms, and neck; This is a spontaneous report from a contactable consumer (Patient herself). A 62-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on 27Feb2021 at 10:45 (at the age of 62-years-old) as single dose for covid-19 immunisation. Medical history included hypertension, tooth infection and had hives a few times in her life. She has had hives before and had allergic reactions twice in her life. One time she had no idea why and the other time was after cutting grass. Concomitant medications included amoxicillin and hydrochlorothiazide, losartan potassium (LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS). She had a flu shot probably three months ago and she had shingles vaccination six months ago. She did not have any prior vaccination within 4 weeks. Patient reported that she had the first COVID19 Vaccination. Everything was fine. She didn't have any reaction except tenderness at the sight. Nothing bothersome. She waited 15 to 30 minutes after the vaccine and no adverse reaction. She was not sure if the reaction could happen later. At 4:00 AM Sunday she started to get hives They woke her up because they were itchy. She took two Benadryl and they went away. She woke up Monday morning exhausted because she had taken Benadryl. Yesterday afternoon the hives came back again. Benadryl dissipated the hives. Last night about 1:00AM she had a rash that covered the entire abdomen and partial back. She had spots on her arms and neck. When it happened the first time she thought who knows. Now she has gotten them three times. Today at noon she got them again under her breast, waist, neck, and abdomen. She knows not to wear anything too restrictive or tight. She questioned if Pfizer heard of people having a reaction several days later. She feels terrible. She knows four people that have had the vaccination and no one has had a reaction. Everything she reads says hives happen right after the reaction. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pyrexia, Somnolence
Clinical narrative: tired; Fever; headache; he goes to sleep very quickly; nausea; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 27Feb2021 at 11:00 as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 01Mar2021 at 06:00, the patient experienced nausea and tired, fever, headache, he goes to sleep very quickly on an unspecified date. The outcome of nausea was recovered on an unspecified date in 2021. The outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.