chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: Dizziness; Weakness; Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Low grade fever; nausea; she did not feel well; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 67-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVI-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration on 22Feb2021 (Age a vaccination: 67-years-old) as single dose for covid-19 immunization. No medical history and no concomitant medications were not reported. historical vaccine included first dose of BNT162B2 (Lot/batch number: EL9262) for covid-19 immunization and got sick. patient and her husband received second injection on Monday afternoon. They have both been sick since then. He has been worse than her but getting better they did not expect it to take this long to get over it. She has had injection site pain, tiredness, headache, muscle pain, chills, joint pain, low grade fever, neither of them got a very high temperature but they checked both of their temperatures and they were right under 100, but she got chills, she was nauseated but she did not throw up, she did not feel well, they both felt unwell, she had dizziness and weakness. She still has the headache and the nausea is off and on. She still has dizziness, weakness all of that is still going on today but it is getting all getting better. She confirms ongoing but improved. She says the injection site pain, muscle pain, joint pain, and low grade fever have all resolved. The tiredness is ongoing, she groups that with the weakness. The outcome for the events chills, did not feel well was unknown, dizziness, weakness was resolving, Tiredness, Headache, nausea was not resolved and for remaining events outcome was reported as resolved on an unspecified date.  No follow up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: Dizziness; Weakness; Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Low grade fever; nausea; she did not feel well; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 67-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVI-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration on 22Feb2021 (Age a vaccination: 67-years-old) as single dose for covid-19 immunization. No medical history and no concomitant medications were not reported. historical vaccine included first dose of BNT162B2 (Lot/batch number: EL9262) for covid-19 immunization and got sick. patient and her husband received second injection on Monday afternoon. They have both been sick since then. He has been worse than her but getting better they did not expect it to take this long to get over it. She has had injection site pain, tiredness, headache, muscle pain, chills, joint pain, low grade fever, neither of them got a very high temperature but they checked both of their temperatures and they were right under 100, but she got chills, she was nauseated but she did not throw up, she did not feel well, they both felt unwell, she had dizziness and weakness. She still has the headache and the nausea is off and on. She still has dizziness, weakness all of that is still going on today but it is getting all getting better. She confirms ongoing but improved. She says the injection site pain, muscle pain, joint pain, and low grade fever have all resolved. The tiredness is ongoing, she groups that with the weakness. The outcome for the events chills, did not feel well was unknown, dizziness, weakness was resolving, Tiredness, Headache, nausea was not resolved and for remaining events outcome was reported as resolved on an unspecified date.  No follow up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Dizziness; Weakness; Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Low grade fever; nausea; she did not feel well; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 67-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVI-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration on 22Feb2021 (Age a vaccination: 67-years-old) as single dose for covid-19 immunization. No medical history and no concomitant medications were not reported. historical vaccine included first dose of BNT162B2 (Lot/batch number: EL9262) for covid-19 immunization and got sick. patient and her husband received second injection on Monday afternoon. They have both been sick since then. He has been worse than her but getting better they did not expect it to take this long to get over it. She has had injection site pain, tiredness, headache, muscle pain, chills, joint pain, low grade fever, neither of them got a very high temperature but they checked both of their temperatures and they were right under 100, but she got chills, she was nauseated but she did not throw up, she did not feel well, they both felt unwell, she had dizziness and weakness. She still has the headache and the nausea is off and on. She still has dizziness, weakness all of that is still going on today but it is getting all getting better. She confirms ongoing but improved. She says the injection site pain, muscle pain, joint pain, and low grade fever have all resolved. The tiredness is ongoing, she groups that with the weakness. The outcome for the events chills, did not feel well was unknown, dizziness, weakness was resolving, Tiredness, Headache, nausea was not resolved and for remaining events outcome was reported as resolved on an unspecified date.  No follow up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: congestion; coughing; sore throat; had a little soreness; This is a spontaneous report from a contactable consumer. This consumer reported for herself and another one patient (Mother). This is 1st of 2 reports and consumer reported for herself. A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EN6200), dose 1 via an unspecified route of administration, administered in right arm on 18Feb2021 (at the age of 74-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included COVID-19 (Additional information for other conditions: had COVID previously in Oct2020) from Oct2020 to an unknown date. Other products reported as unknown. Investigation assessment reported as no. Concomitant medications, history and investigations: Patient stated that there was nothing relevant. Caller states that she has been on the same medications for years now, there was nothing new. No further details were provided. Patient woke up on 22Feb2021 with a little sore throat and not feeling good, and then it went into chest, congestion, coughing up, so patient had the side effects more than a week now. Patient stated that she took Nyquil and Mucinex and stuff to help. Patient heard from other people that the second dose of the Pfizer vaccine has worse side effects than the first dose. Patient would like to know if this was accurate and percentage of efficacy after one dose. The outcome of the events were recovering.   No follow up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Influenza like illness, Lethargy
Clinical narrative: Slight fever; Felt weak, tired, lethargic; Felt weak, tired, lethargic; he administered the Pfizer-BioNTech COVID-19 Vaccine second dose to 3 Patients but he has drawn more than the required volume (0.5mL instead of 0.3mL).; Felt weak, tired, lethargic; typical soreness; flu like symptoms; This is a spontaneous report from contactable pharmacists. This Pharmacist reported similar events for 3 patients. This report is for 3rd of 3 patients. A 26-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EL3302; Expiration Date: 28May2021) as DOSE 2, 0.5 ML SINGLE (at the age of 26-year-old) for covid-19 immunisation. The patient medical history was unknown. Historical vaccine included BNT162B2 dose 1 on 05Feb2021 Batch/Lot number: EL3302 exp 28Mar2021 for COVID-19 immunisation. The patient's concomitant medications were none. The patient did not take other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient received the 2nd dose of the vaccine with overdose (administered .5 mg instead of .3mg to patient) on 26Feb2021 and felt weak and tired the next day. Slight fever next day after vaccination which did subside after using Tylenol. Felt weak, tired, lethargic. Has since resolved. Properly diluted vial so only slight overdose, not full vial overdose. Pharmacist monitored patient for a week and she has been fine after her symptoms resolved. She had the expected typical soreness and flu like symptoms for 24-48 hours. Therapeutic measures were taken as a result of slight fever. The outcome of the events Slight fever, Felt weak, tired, lethargic, typical soreness, flu like symptoms was recovered in 2021.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) :PFIZER INC-2021223835 Same reporter/drug/event, different patient. PFIZER INC-2021216069 Same reporter/drug/event, different patient.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Pain, Pyrexia
Clinical narrative: Slight fever; Felt weak, tired, lethargic; Felt weak, tired, lethargic; he administered the Pfizer-BioNTech COVID-19 Vaccine second dose to 3 Patients but he has drawn more than the required volume (0.5mL instead of 0.3mL).; Felt weak, tired, lethargic; typical soreness; flu like symptoms; This is a spontaneous report from contactable pharmacists. This Pharmacist reported similar events for 3 patients. This report is for 3rd of 3 patients. A 26-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EL3302; Expiration Date: 28May2021) as DOSE 2, 0.5 ML SINGLE (at the age of 26-year-old) for covid-19 immunisation. The patient medical history was unknown. Historical vaccine included BNT162B2 dose 1 on 05Feb2021 Batch/Lot number: EL3302 exp 28Mar2021 for COVID-19 immunisation. The patient's concomitant medications were none. The patient did not take other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient received the 2nd dose of the vaccine with overdose (administered .5 mg instead of .3mg to patient) on 26Feb2021 and felt weak and tired the next day. Slight fever next day after vaccination which did subside after using Tylenol. Felt weak, tired, lethargic. Has since resolved. Properly diluted vial so only slight overdose, not full vial overdose. Pharmacist monitored patient for a week and she has been fine after her symptoms resolved. She had the expected typical soreness and flu like symptoms for 24-48 hours. Therapeutic measures were taken as a result of slight fever. The outcome of the events Slight fever, Felt weak, tired, lethargic, typical soreness, flu like symptoms was recovered in 2021.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) :PFIZER INC-2021223835 Same reporter/drug/event, different patient. PFIZER INC-2021216069 Same reporter/drug/event, different patient.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blunted affect, Chills, Cough, Diarrhoea
Clinical narrative: Nausea; diarrhea; dizziness; fatigue; joint and muscle pain; joint and muscle pain; chills; sinus and ear congestion; sinus and ear congestion; runny nose; sneezing; cognitive blunting; injection site inflammation and pain; injection site inflammation and pain; cough; This is a spontaneous report from a contactable other HCP (patient). A 69-year-old non-pregnant female patient (consumer) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL9261; Expiration Date: 22Feb2021), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 14:00 (age 69-year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. Facility type vaccine was in Hospital. The medical history included, Meiges disease; Seropositive RA; severe Osteoarthritis/4 joint replacements; ADHD; allergies and TIA (Transient ischaemic attack) all from an unknown date and unknown if ongoing. The patient had known allergies of Codeine; Bupropion; Lidocaine; and Cortisone preservatives. The concomitant medications included certolizumab pegol (CIMZIA); hydroxychloroquine sulfate (PLAQUENIL); Prednisone; acetylsalicylic acid (ASPIRIN); and venlafaxine hydrochloride (EffexorXR) all taken for an unspecified indication, start and stop date were not reported. The did not had covid prior vaccination and covid was not tested post vaccination. The patient did not receive any other vaccine in four weeks. The patient experienced nausea, diarrhoea, dizziness, fatigue, joint and muscle pain, chills, sinus and ear congestion, runny nose, sneezing, cognitive blunting, injection site inflammation and pain, cough all events on 22Feb2021 12:00 AM. The diagnosis were mod-severe and present 1-7 days post injection. No treatment was received for all the adverse events. The outcome of the events was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear congestion, Fatigue, Myalgia, Nausea
Clinical narrative: Nausea; diarrhea; dizziness; fatigue; joint and muscle pain; joint and muscle pain; chills; sinus and ear congestion; sinus and ear congestion; runny nose; sneezing; cognitive blunting; injection site inflammation and pain; injection site inflammation and pain; cough; This is a spontaneous report from a contactable other HCP (patient). A 69-year-old non-pregnant female patient (consumer) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL9261; Expiration Date: 22Feb2021), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 14:00 (age 69-year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. Facility type vaccine was in Hospital. The medical history included, Meiges disease; Seropositive RA; severe Osteoarthritis/4 joint replacements; ADHD; allergies and TIA (Transient ischaemic attack) all from an unknown date and unknown if ongoing. The patient had known allergies of Codeine; Bupropion; Lidocaine; and Cortisone preservatives. The concomitant medications included certolizumab pegol (CIMZIA); hydroxychloroquine sulfate (PLAQUENIL); Prednisone; acetylsalicylic acid (ASPIRIN); and venlafaxine hydrochloride (EffexorXR) all taken for an unspecified indication, start and stop date were not reported. The did not had covid prior vaccination and covid was not tested post vaccination. The patient did not receive any other vaccine in four weeks. The patient experienced nausea, diarrhoea, dizziness, fatigue, joint and muscle pain, chills, sinus and ear congestion, runny nose, sneezing, cognitive blunting, injection site inflammation and pain, cough all events on 22Feb2021 12:00 AM. The diagnosis were mod-severe and present 1-7 days post injection. No treatment was received for all the adverse events. The outcome of the events was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sinus congestion, Sneezing, Vaccination site inflammation, Vaccination site pain
Clinical narrative: Nausea; diarrhea; dizziness; fatigue; joint and muscle pain; joint and muscle pain; chills; sinus and ear congestion; sinus and ear congestion; runny nose; sneezing; cognitive blunting; injection site inflammation and pain; injection site inflammation and pain; cough; This is a spontaneous report from a contactable other HCP (patient). A 69-year-old non-pregnant female patient (consumer) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL9261; Expiration Date: 22Feb2021), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 14:00 (age 69-year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. Facility type vaccine was in Hospital. The medical history included, Meiges disease; Seropositive RA; severe Osteoarthritis/4 joint replacements; ADHD; allergies and TIA (Transient ischaemic attack) all from an unknown date and unknown if ongoing. The patient had known allergies of Codeine; Bupropion; Lidocaine; and Cortisone preservatives. The concomitant medications included certolizumab pegol (CIMZIA); hydroxychloroquine sulfate (PLAQUENIL); Prednisone; acetylsalicylic acid (ASPIRIN); and venlafaxine hydrochloride (EffexorXR) all taken for an unspecified indication, start and stop date were not reported. The did not had covid prior vaccination and covid was not tested post vaccination. The patient did not receive any other vaccine in four weeks. The patient experienced nausea, diarrhoea, dizziness, fatigue, joint and muscle pain, chills, sinus and ear congestion, runny nose, sneezing, cognitive blunting, injection site inflammation and pain, cough all events on 22Feb2021 12:00 AM. The diagnosis were mod-severe and present 1-7 days post injection. No treatment was received for all the adverse events. The outcome of the events was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: flu like symptoms; flushed in her face; body aches; nausea; A really bad headache; This is a spontaneous report from a contactable consumer or other non hcp. An 81-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 15Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The medical history and concomitant medications were not reported. On an unknown date the patient experienced flu like symptoms, flushed in her face, body aches, nausea and a really bad headache. It was reported that the reporter asked if the symptoms her mother is experiencing were side effects of the vaccine. The reporter stated that her 81yo mother (name) had her second vaccine dose on 15Feb and yesterday she began having flu like symptoms including being flushed in her face, body aches, nausea and a really bad headache. She asks if this is from the vaccine and is that normal for symptoms to start so long after getting the vaccine, reporting that she didnt have any symptoms following her first dose. The outcome of all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Pain in extremity, Swelling, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Sharp pain under breast; swelling just below neck area; Redness and itching just below injection site; Redness and itching just below injection site; Sharp pain under left arm; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200), dose 1 via an unspecified route of administration, administered in Arm Left on 18Feb2021 at 13:00 (age at vaccination: 67 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Patient did not receive any other vaccines in 4 weeks. Patient did not receive other medications in 2 weeks. The patient experienced sharp pain under breast, swelling just below neck area, redness and itching just below injection site, sharp pain under left arm on 20Feb2021. swelling just below neck area (still there after 10 days) Redness and itching just below injection site, appearing after a week. Sharp pain under left arm and breast. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Treatment received was unknown. The outcome of the swelling just below neck area was not recovered. The outcome of the rest of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Dizziness, Fatigue, Nausea
Clinical narrative: experiencing nausea (pretty intense); feels dizzy (she's getting a "spinning feeling, which comes and goes); fatigue; chills; couldn't sleep last night; bruise on her second toe; This is a spontaneous report from a contactable consumer or other non hcp. A female consumer (Patient) of 69 (unit: unknown) age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Thursday 25Feb2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient experienced experiencing nausea (pretty intense), feels dizzy (she's getting a "spinning feeling, which comes and goes"), fatigue, chills and could not sleep last night until 05:00AM. She added that she had a bruise on her second toe, but had not dropped anything on it. The outcome of all the events was reported as unknown.   No follow-up attempts were possible; information about lot/batch number could not been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Sleep deficit
Clinical narrative: experiencing nausea (pretty intense); feels dizzy (she's getting a "spinning feeling, which comes and goes); fatigue; chills; couldn't sleep last night; bruise on her second toe; This is a spontaneous report from a contactable consumer or other non hcp. A female consumer (Patient) of 69 (unit: unknown) age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Thursday 25Feb2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient experienced experiencing nausea (pretty intense), feels dizzy (she's getting a "spinning feeling, which comes and goes"), fatigue, chills and could not sleep last night until 05:00AM. She added that she had a bruise on her second toe, but had not dropped anything on it. The outcome of all the events was reported as unknown.   No follow-up attempts were possible; information about lot/batch number could not been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Nasal oedema, Pain in jaw, Sensitive skin
Clinical narrative: nose got swollen; very sensitive on the bridge of my nose.; red; Bottom of my jaw was painful as well.; This is a spontaneous report from a contactable consumer or other non-HCP. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (COMIRNATY, Solution injection, Lot number/Expiration date: Unknown) on an unspecified date for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced nose got swollen, very sensitive on the bridge of his nose, red and bottom of his jaw was painful as well. The outcome of event was unknown. No follow-up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dizziness, Dizziness postural, Headache
Clinical narrative: headache; stood up really fast and got dizzy; light headed; noticed a bruise on her left thigh; This is a spontaneous report from a contactable consumer (patient herself). A 45-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 27Feb2021 15:30 (at age of 45-years-old) as DOSE 1, SINGLE for COVID-19 immunization. No medical history and concomitant medications were reported. Patient had not history and other products. Caller reported that yesterday on 28Feb2021 around 6:30 she was sitting down and stood up really fast and got dizzy and light headed which did not happen often with her. Caller also reported that when she got home she noticed a bruise on her left thigh and stated she have not done anything to bruise herself but she reported that a friend told her that the side effect of getting the vaccine was low platelets and she asked did she have thromcytopia or not. She did not realize that bruising was a side effect of the product. Last night, called noticed a small bruise on her left thigh, the size of a fist. Caller stated that earlier in the day, she had gotten dizzy as well. Caller stated that she was sitting down and stood up too quickly, and she got dizzy, and at first she just thought it was because she got up too quick, but she was a little out of it. Then, caller went away about her day and that evening, when she went to take a shower, she noticed the bruise on her thigh. Caller said that she was talking to a friend who said that the caller needed to go get it checked because unexplained bruising can be a sign of platelet levels going down, because the friend had the same thing. Caller stated that today, she has not been up very long because she works 2nd shift, so it has only been a couple of hours, but she does not feel bad today, and she has no other bruising anywhere else. Caller states that she drank some water, and she not feeling super dizzy or anything, but maybe just has a tad bit of a slight headache on 01Mar2021. But nothing was crazy. Caller was concerned about the bruising though because she does not recall hitting herself or getting hit in that spot. Caller was seeking more information about bruising with the product because she was trying to decide what her next steps should be. The outcome of event headache and noticed a bruise on her left thigh was not resolved while the events light headed and stood up really fast and got dizzy was resolved on 01Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Erythema, Pain in extremity, Wrong technique in product usage process
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for three patients (male, 2 female). This is the first of three reports. A 70-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on Feb 12, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On Feb 12, 2021, nurse diluted vaccine with 0.8mL of diluent and administered to 3 individuals. Patients inadvertently received a higher dose. On an unknown date in 2021, patient had post vaccination  tenderness in arm and redness. 7-day post vaccination follow-up for these individuals. The outcome of the events: unknown. No follow-up attempts possible. information about lot/batch number cannot be obtained. Sender's comments: Linked report(s): US-PFIZER INC-2021224940 same drug/event, different patient: US-PFIZER INC-2021224939 same drug/event, different patient.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Body temperature, Diarrhoea, Myalgia
Clinical narrative: joint pain; stomach cramps; tremors; 100.4 Fever; sore arm; pain in muscle; Severe diarrhea; Nausea; This is a spontaneous report from a contactable Consumer. This 73-Year-old male Consumer (patient) reported that: A 73-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number were not reported), via unspecified route administration on an unspecified date (at the age of 73-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient had medical history included heart disease, multiple strokes and known allergies: penicillin all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had not received other vaccine within four weeks, Prior to vaccination. The patient did not receive other medications in two weeks prior vaccination. The patient hat not covid prior vaccination. Patient had not covid tested post vaccination. On an unspecified date after the first dose of vaccination, the patient experienced joint pain, stomach cramps, tremors, 100.4 fever, sore arm, pain in muscle, severe diarrhea and nausea. It was reported that first three days a sore arm only. Woke at 03:00 day four with fever of 100.4, tremors, nausea pain in muscles and joints. Severe diarrhea. This lasted for approximate 4 hours. The only symptom remaining was joint pain and stomach cramps. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via unspecified route administration, administered in left arm on 22Feb2021 15:00 (at the age of 73-years-old) as DOSE 2, SINGLE for COVID-19 immunization. On an unspecified date, the patient underwent lab tests and procedures which included body temperature: 100.4 (day four with fever of 100.4.) The patient did not receive any treatment for the adverse events. The outcome of event severe diarrhea was recovered on an unspecified date and joints pain and stomach cramps was not recovered, while outcome of other events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Tremor
Clinical narrative: joint pain; stomach cramps; tremors; 100.4 Fever; sore arm; pain in muscle; Severe diarrhea; Nausea; This is a spontaneous report from a contactable Consumer. This 73-Year-old male Consumer (patient) reported that: A 73-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number were not reported), via unspecified route administration on an unspecified date (at the age of 73-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient had medical history included heart disease, multiple strokes and known allergies: penicillin all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had not received other vaccine within four weeks, Prior to vaccination. The patient did not receive other medications in two weeks prior vaccination. The patient hat not covid prior vaccination. Patient had not covid tested post vaccination. On an unspecified date after the first dose of vaccination, the patient experienced joint pain, stomach cramps, tremors, 100.4 fever, sore arm, pain in muscle, severe diarrhea and nausea. It was reported that first three days a sore arm only. Woke at 03:00 day four with fever of 100.4, tremors, nausea pain in muscles and joints. Severe diarrhea. This lasted for approximate 4 hours. The only symptom remaining was joint pain and stomach cramps. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via unspecified route administration, administered in left arm on 22Feb2021 15:00 (at the age of 73-years-old) as DOSE 2, SINGLE for COVID-19 immunization. On an unspecified date, the patient underwent lab tests and procedures which included body temperature: 100.4 (day four with fever of 100.4.) The patient did not receive any treatment for the adverse events. The outcome of event severe diarrhea was recovered on an unspecified date and joints pain and stomach cramps was not recovered, while outcome of other events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chest pain, Diarrhoea, Dyspnoea, Nausea
Clinical narrative: shortness of breath; Chest pain; severe abdominal pain; nausea; frequent diarrhea; This is a spontaneous report from a contactable nurse (patient).   A 38-years-old non pregnant adult female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EK4176) administered in left arm via an unknown route of administration (at the age of 38 years old) on 15Jan2021 as dose 2, single for covid-19 immunisation.  Medical history included depression, obesity and known allergies to Hydrocodone, sulfa, Trintellix, Nickel, Amitriptyline. The patient previously received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EH9899) administered in left arm via an unknown route of administration (at the age of 38 years old) on 28Dec2020 at 03:30 pm as dose 1, single for covid-19 immunisation and experienced no adverse event. It was reported that there was no covid prior vaccination. There was no covid tested post vaccination. It was reported that no other vaccine received in four weeks. Other concomitant medications in two weeks medications included Cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), Colecalciferol (VIT D3), Lamotrigine (LAMICTAL), Omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]), Propranolol (PROPRANOLOL). On 16Jan2021 at 09:00, the patient experienced shortness of breath, chest pain, severe abdominal pain, nausea and frequent diarrhea. The adverse events resulted in emergency room/department or urgent care. No treatment was received for the events. The outcome of all the events was reported as recovered with lasting effects on an unknown date in Jan2021. No follow up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: the arm I had received the vaccine in was generally sore from elbow to shoulder; cold; headache; Muscle soreness; Fever; I had the chills; I had an elevated Temp 99.2F; unusual fatigue; This is a spontaneous report from a contactable consumer. This 70yearsold male consumer reported for himself that:  A 70-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Arm Left on 09Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included none. There were no concomitant medications. On 26Feb2021, the patient experienced i had the chills, i had an elevated temp 99.2f, unusual fatigue, fever. On 27Feb2021, headache, muscle soreness. On an unspecified date, the arm i had received the vaccine in was generally sore from elbow to shoulder, cold.  At the time had minor soreness. But then 2 1/2 weeks later he had a delayed reaction to the shot. He had an elevated Temp 99.2F, on Saturday morning (27Feb2021), the arm he had received the vaccine in was generally sore from elbow to shoulder and also he had the chills. Should he still got his second dose. On 26Feb2021, pretty bad reaction. The is supposed to get the second dose tomorrow. Is there any concern about getting the second shot tomorrow. This past weekend, he had a delayed reaction to the first shot. After the first shot he had a minor sore arm, then this weekend all of the sudden Friday the caller got really tired, his temperature was somewhat elevated from normal base. Saturday morning his temperature was 99.2, his normal base is 96.5, this was a fever for him. The caller had a headache, the muscle in the same arm from the shot was really bothering him, it was generic muscle pain, not very site directed. The caller also got chills, was very cold and could not warm up and has been quarantining and stying within his family bubble. The caller wanted to know if this was a very delayed reaction, 2.5 weeks later, was a known thing. The patient underwent lab tests and procedures which included temp: 99.2 fahrenheit on 27Feb2021, covid test: negative on 27Feb2021. The clinical outcome of events chills, i had an elevated temp 99.2f, unusual fatigue, fever were recovering and other events were unknown.  No follow-up attempts are possible; No further information are expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngitis, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: the arm I had received the vaccine in was generally sore from elbow to shoulder; cold; headache; Muscle soreness; Fever; I had the chills; I had an elevated Temp 99.2F; unusual fatigue; This is a spontaneous report from a contactable consumer. This 70yearsold male consumer reported for himself that:  A 70-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Arm Left on 09Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included none. There were no concomitant medications. On 26Feb2021, the patient experienced i had the chills, i had an elevated temp 99.2f, unusual fatigue, fever. On 27Feb2021, headache, muscle soreness. On an unspecified date, the arm i had received the vaccine in was generally sore from elbow to shoulder, cold.  At the time had minor soreness. But then 2 1/2 weeks later he had a delayed reaction to the shot. He had an elevated Temp 99.2F, on Saturday morning (27Feb2021), the arm he had received the vaccine in was generally sore from elbow to shoulder and also he had the chills. Should he still got his second dose. On 26Feb2021, pretty bad reaction. The is supposed to get the second dose tomorrow. Is there any concern about getting the second shot tomorrow. This past weekend, he had a delayed reaction to the first shot. After the first shot he had a minor sore arm, then this weekend all of the sudden Friday the caller got really tired, his temperature was somewhat elevated from normal base. Saturday morning his temperature was 99.2, his normal base is 96.5, this was a fever for him. The caller had a headache, the muscle in the same arm from the shot was really bothering him, it was generic muscle pain, not very site directed. The caller also got chills, was very cold and could not warm up and has been quarantining and stying within his family bubble. The caller wanted to know if this was a very delayed reaction, 2.5 weeks later, was a known thing. The patient underwent lab tests and procedures which included temp: 99.2 fahrenheit on 27Feb2021, covid test: negative on 27Feb2021. The clinical outcome of events chills, i had an elevated temp 99.2f, unusual fatigue, fever were recovering and other events were unknown.  No follow-up attempts are possible; No further information are expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Chills, Pyrexia, Sneezing
Clinical narrative: Sneezing; Low grade fever; arthritis; chills; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6203; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in Arm Left on 27Feb2021 at 14:15 as DOSE 1, SINGLE (at the age of 76-year-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported that in the past she had a flu shot and afterwards contracted the flu. Patient received Pfizer vaccine on Saturday (27Feb2021) and then Sunday (28Feb2021) patient was sneezing, it was uncontrollable, then this morning patient was sneezing and had a fever, a low grade temperature. Patient has chills, describing it as feeling chilly. Patient heard that the second dose was when someone would have a reaction. Patient has a doctor appointment on Wednesday and they are a hematologist, if patient has a fever they won't let her in. Therapeutic measures were taken as a result of events. Patient took Tylenol for her arthritis, but nothing helped her low grade fever and sneezing. Patient also took a fizzle tablet of Vitamin C also, and her vitamins. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Tiredness; Fever; Chills; aches; Headache; This is a spontaneous report from a contactable consumer (Patient). A 46-years-old non-pregnant female patient received second dose BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EL3247) via unspecified route of administration and administered in left arm on 22Feb2021 at 11:30AM for COVID-19 Immunization (at the age of 46 years). Medical history and Concomitant medications were not reported. The patient previously took first dose BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EL3247) via unspecified route of administration and administered in left arm on 08Feb2021 at 11:00AM for COVID-19 Immunization. It was reported patient did not received no other vaccine in four weeks and also no other medications in two weeks. No Known allergies. On 23Feb2021 at 03:00 PM the patient had experienced tiredness, fever, chills, aches, headache. It was reported that no covid prior to vaccination and also not tested covid post vaccination. The patient did not received any treatment for the events. The clinical outcome of the events were recovered.      No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Culture stool, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: Extreme fatigue / weakness; Foggy disposition; Intermittent chills; muscle aches; Diarrhea for roughly 3 weeks; This is a spontaneous report from a contactable consumer (patient herself) via COVAES. A 62-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL 1284), via an unspecified route of administration, administered in arm left on 05Jan2021 10:00 as dose 1, single for COVID-19 immunisation (at the age of 62-year-old). Medical history included penn.allergy and ongoing controlled hypertension. There were no concomitant medications. The patient did not took any other vaccine in four weeks. The patient did not had COVID prior vaccination and not tested for COVID post vaccination. On 07Jun2021, the patient experienced extreme fatigue / weakness, foggy disposition, intermittent chills, muscle aches and diarrhea for roughly 3 weeks. Timeframe between vaccination and starting of symptoms was 1 day 14 Hours. The patient did not received any treatment for adverse events. On an unspecified date, the patient underwent lab tests and procedures which included stool test: negative and CBC test: negative. The outcome of the events was not recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Myalgia
Clinical narrative: Extreme fatigue / weakness; Foggy disposition; Intermittent chills; muscle aches; Diarrhea for roughly 3 weeks; This is a spontaneous report from a contactable consumer (patient herself) via COVAES. A 62-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL 1284), via an unspecified route of administration, administered in arm left on 05Jan2021 10:00 as dose 1, single for COVID-19 immunisation (at the age of 62-year-old). Medical history included penn.allergy and ongoing controlled hypertension. There were no concomitant medications. The patient did not took any other vaccine in four weeks. The patient did not had COVID prior vaccination and not tested for COVID post vaccination. On 07Jun2021, the patient experienced extreme fatigue / weakness, foggy disposition, intermittent chills, muscle aches and diarrhea for roughly 3 weeks. Timeframe between vaccination and starting of symptoms was 1 day 14 Hours. The patient did not received any treatment for adverse events. On an unspecified date, the patient underwent lab tests and procedures which included stool test: negative and CBC test: negative. The outcome of the events was not recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Heart rate increased, Oesophageal spasm
Clinical narrative: chest heaviness; throat spasms; racing heart; dizziness; This is a spontaneous report from a contactable consumer. This 70-years-old female consumer(patient) reported that:  A 70-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration in Arm Left on 01Mar2021 14:45 as dose 2, single for covid-19 immunisation. Medical history included 6 autoimmune, asthma, diabetes 2 celiac, environmental, genetic extra histamine production. Concomitant medications included certolizumab pegol (CIMZIA) taken for an unspecified indication, start and stop date were not reported. Patient known allergies: genetic extra histamine production. The patient receive other medications within 2 weeks of vaccination are cimzia (not enough space for all). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration in Arm Left on 08Feb2021 as dose 1, single for covid-19 immunisation. On 01Mar2021 at 15:00 patient experienced much milder with chest heaviness, throat spasm, dizziness, racing heart but no swelling of lips and jaw. Treatment patient received 20mg prednisone day before and day off vaccine and also took 50 mg benadryl 1 hour after vaccine. The clinical outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.