chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Caller received 1st shot and went in for a routine physical. they ran blood work and found no antibodies.; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received first dose of bnt162b2 (Solution for injection), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced caller received 1st shot and went in for a routine physical, they ran blood work and found no antibodies. Caller received 1st shot and went in for a routine physical. they ran blood work and found no antibodies. she wants to know what is going on. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative. The patient did not receive any treatment for the event. The clinical outcome of the caller received 1st shot and went in for a routine physical, they ran blood work and found no antibodies was unknown. Information about lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a non-contactable consumer (patient) reporting for himself. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot no. and expiry date were not reported), via an unspecified route of administration on unspecified date in 2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first vaccine on the 14th (complete date not reported) and tested positive for Covid with a rapid results test (unspecified date in 2021). The patient wants to know about getting second shot. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer (Caregiver/wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included several underlying health conditions included type 1 diabetes mellitus, cancer survivor (2002), and he had a heart attack Jan2020. The patient's concomitant medications were not reported. The patient had his first Pfizer vaccine on 08Mar2021. He was scheduled for his second vaccine on 29Mar2021, but he tested positive for COVID on 28Mar2021, so he had to cancel. His primary care doctor sent him for monoclonal infusion therapy on Monday (29Mar2021). He was getting mixed messages as far as his second vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive for COVID on 28Mar2021. The outcome of the events was unknown.   Information about lot and batch number was requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on Dec2020 (Batch/Lot Number: e10140) as single dose and dose 2 via an unspecified route of administration on Jan2021 (Batch/Lot Number: e10140) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tested positive for COVID. The reporter wanted to know if there is any information on that specific lot number and any problems with that lot number. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on and unspecified date. The outcome of the events was unknown. The reporter considered the events to be non-serious.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021363888 Same reporter/drug, different patient/event.;US-PFIZER INC-2021363887 Same reporter/drug, different patient/event.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Just now coming out of having Covid; Just now coming out of having Covid; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 14Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The caller stated that the patient received the first dose of the vaccine on 14Mar2021 and scheduled for the second dose on 14Apr2021 but just now coming out of having Covid and was curious if they need to postpone her second dose. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on 24Feb2021, as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 17Mar2021, the patient was supposed to have the second dose. On 15Mar2021, 2 days before the 2nd vaccine, the patient went to the doctor and was tested positive for Covid so was told she could not get the vaccine. She did the quarantine and felt better but just had a little cough. She was still testing positive though. She questioned when would she get the second vaccine. The outcome of events drug ineffective and cough was unknown whereas of COVID-19 virus test positive it was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Feeling cold
Clinical narrative: Somewhere between 13th to 15th they go the covid virus./vaccine on 01 FEB 2021; Somewhere between 13th to 15th they go the covid virus./vaccine on 01 FEB 2021; my mom ended up with it(cold) as well; This is a spontaneous report received from a contactable consumer. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 01Feb2021 to 01Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that calling on behalf of his parents who received the first dose of the Pfizer covid vaccine on 01Feb2021. Somewhere between 13th to 15th they go the covid virus. His father felt like he had a cold, gave him the test and then his mom ended up with it as well on Feb2021. The efficacy of the first dose, feel like they were very well protected. Neither cases were bad, they did get the monoclonal antibodies, they were supposed to wait 90 days, it was not their recommendation, it was the CDC recommendation. I thought would call Pfizer since it was related to the Pfizer vaccine. The events "somewhere between 13th to 15th they go the covid virus./vaccine on 01 FEB 2021" were considered as medically significant. The outcome of the events was unknown.   Information about batch and lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Herpes zoster, Neuralgia, SARS-CoV-2 test
Clinical narrative: Tested positive on 25th of March; Nerve pain in her back; Shingles; This is a spontaneous report received from a Pfizer sponsored program and Pfizer COVID-19 Vaccine Call Center via medical information team. A contactable female consumer of an unspecified age reported for herself that received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 17Mar2021 to 17Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the caller had the 1st dose on 17Mar2021 and has been tested positive on 25Mar2021 (which was after the 1st dose). She also experienced nerve pain in her back the day after the 1st dose and it lasted for 5 days, she thought she had shingles on Mar2021. She would like to confirm if there was a time period before she can take the 2nd dose. Provided PMI phone and hours of operation, since she called outside of PMI operating hours. The Pfizer-BioNTech COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you COVID-19. The vaccine should be offered even if you had symptoms or no symptoms of COVID-19 infection. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 25Mar2021. The outcome of event "nerve pain in her back" was recovered and other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: fatigue; aches; chills; This is a spontaneous report from a contactable consumer (patient) reported for himself. A male patient of an unspecified age received bnt162b2 (Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced fatigue, aches, chills on an unspecified date. The patient was hospitalized for fatigue from Mar2020 to an unknown date. The patient was hospitalized for the events from an unknown date in Mar2020 to an unknown date. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the events was unknown.   Information on batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable consumer. A 64-year-old male patient (husband) received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included non-hodgkins lymphoma. Concomitant medications were not reported. Consumer stated her husband did not have any reactions to the vaccine except a sore arm. Outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Tested Positive for Covid 19; Tested Positive for Covid 19; This is a spontaneous report from a contactable nurse (patient). A 58-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date not reported), via an unspecified route of administration at left deltoid on 08Feb2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number; EL3249 and expiration date not reported), via an unspecified route of administration at left deltoid on 18Jan2021 as single dose for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced tested positive for covid 19 on 29Mar2021. Caller states that she just wanted to report that she received her second dose of the vaccine on 08Feb2021 and has tested positive on 29Mar2021. Lot difficult to read, assuming it starts with EL or EN, then states she thinks it may say V5318, states numbers are definitely 5318 but the beginning is what she cannot make out. The patient underwent lab tests and procedures which included sars-cov-1 test and resulted positive on 29Mar2021. The outcome of events was reported as unknown.  Information related Lot/Batch has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tested positive for COVID-19, which is considered failure of COVID-19 vaccine BNT162B2, and the administration of BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash
Clinical narrative: Another rash; EXHAUSTION; This is a spontaneous report. This report is regarding the second dose of bnt162b2. A contactable 52 years old female consumer (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization.  The medical history was not reported. Concomitant medication(s) included montelukast sodium (SINGULAIR), Metoprolol Succinate, Diltiazem Hcl, unspecified Multivitamin, pregabalin (LYRICA), levothyroxine sodium (SYNTHROID), Cyclobenzaprine Hcl, cyanocobalamin (VITAMIN B-12), Duloxetine Hcl, fluticasone propionate (FLOVENT), omeprazole (PROTONIX), cetirizine hydrochloride (ZYRTEC), calcium carbonate (TUMS), Meclizine hcl, fluticasone propionate (FLONASE ALLERGY RELIEF), salbutamol sulfate (ALBUTEROL SULFATE HFA), diclofenac sodium (VOLTAREN). Historical vaccine included the first dose of BNT162B2 for covid-19 immunization, and she had a rash on her face and scalp and had no energy. After the second vaccine dose, patient had another rash and felt extreme exhaustion on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: MNQ
Symptoms: Rash, Rash pruritic
Clinical narrative: an itchy rash on his arms, legs, and back; Initial information received on 16-Mar-2021 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 53 years old male patient who experienced an itchy rash on his arms, legs, and back (rash pruritic), after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication(s) was given to the patient.   On 08-Feb-2021, the patient received 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6827BB and expiration date :28-Feb-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  On an unknown date, 3 days later, the patient developed a non-serious an itchy rash on his arms, legs, and back (rash pruritic). The patient did not experience throat swelling or shortness of breath.   The pharmacist was asking that the reaction to be considered as an allergic reaction and if the patient was safe to take the next Menactra vaccine?  No laboratory data reported.  No treatment was received by the patient. The patient was going to see the Infectious disease Doctor on 16-Mar-2021.  At the time of reporting, the outcome was unknown for the reported event. As it was reported that, it was unknown if the rash was partially gone or all of the way gone.
Sex: U
Vaccine: HIBV
Symptoms: Medication error, Product preparation issue
Clinical narrative: found a leftover saline diluent that was supposed to be mixed in with the HIB with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from a other health care professional via Medical Information (Reference number- 00522974) and transmitted to Sanofi on 17-Mar-2021.  This case involves a patient of unknown age for whom it was reported found a leftover saline diluent that was supposed to be mixed in with the HIB (PRP/T) VACCINE [ACT-HIB] (product preparation error) (lot number: UJ266AA and expiration date: unknown] via an unknown route at an unknown administration site for prophylactic vaccination.  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  It was also reported that that it was probably another sterile diluent that they use for their other vaccines. Caller asking if the dose needs to be repeated. Caller asking if the dose can be repeated at any time.  It was an actual medication error due to wrong diluent used (latency: unknown).  At the time of report, no adverse event was reported.  It was not reported if the patient received a corrective treatment.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, Product preparation issue
Clinical narrative: A patient received only the Dtap and polio portion of the vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00524890) and transmitted to Sanofi on 18-Mar-2021.  This case involves a four-month-old female patient who received only the dtap and polio portion of a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [lot UJ319AA and expiry date: 04-Jun-2021) via an intramuscular route in the right thigh for prophylactic vaccination on 16-Mar-2021 (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  This was a case of actual medication error case due to inappropriate reconstitution technique (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error
Clinical narrative: expired dose of ActHIB was administered 25MAR2021 with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Other Health Care Professional (HCP) via Medical Information (Reference number- 00539720) and transmitted to Sanofi on 29-Mar-2021.  This case involves a patient with unknown demographics who received expired dose of HIB (PRP/T) VACCINE [ACT-HIB] lot number not reported, expiry date 23-Mar-2021 via unknown route in unknown administration site for prophylactic vaccination on 25-Mar-2021.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   It was a case of an actual medication error due to expired vaccine used (latency same day).  Health Care Professional (HCP) reported expired dose of ActHIB dated 23-MAR-2021 was administered 25-MAR-2021. No further information available. HCP stated it has been reported already on 25-MAR-2021  At the time of report there was no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: injection site, left arm, / itchy; the injection site, left arm, is swollen / size of a soft ball / on the upper half of the left upper arm; injection site, left arm, / red; fever; This case was reported by a other health professional via call center representative and described the occurrence of injection site itching in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number F93YS, expiry date 8th October 2022) for prophylaxis.   On 3rd March 2021, the patient received the 1st dose of Shingrix. In March 2021, less than a week after receiving Shingrix, the patient experienced injection site itching, injection site swelling, injection site erythema and fever. On an unknown date, the outcome of the injection site itching and injection site swelling were not recovered/not resolved and the outcome of the injection site erythema was unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the injection site itching, injection site swelling, injection site erythema and fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination not reported. Health care professional from Pharmacy called and stated that, the patient received the first dose of the Shingrix vaccine at this pharmacy. But the reporter stated they did not have information of when and where the patient got the Shingrix vaccine. The patient received Shingrix vaccine in her left arm and after receiving the vaccine, the injection site, left arm, wasw swollen the size of a soft ball, was red and itchy. The swelling was on the upper half of the left upper arm. The patient also had fever, which she did have till yesterday, but on the day of reporting there was no fever. The reporter consented to follow up   Follow up information was received from the other healthcare professional on 7th April 2021: The patient's age was updated.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Sleep disorder
Clinical narrative: CHILLS; BODY ACHES; DISTURBED SLEEP; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 29-JUN-2023) once a total dose, start therapy date were not reported, vaccinated on arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced chills, body aches, disturbed sleep, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, body aches, and headache, and the outcome of disturbed sleep was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and same has been requested. No concomitant medications were reported. On APR-2021, the subject experienced shivering chills all night. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shivering chills all night and fever was not reported. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Contusion, Dehydration, Emotional distress, Fall
Clinical narrative: No memory; Passed out; Hallucination; lost feeling in her legs; incontinent of urine and feces; Had a terrible fall; Never able to walk, she crawled; Bruises all over body; urinary tract infection; Severely dehydrated; Legs felt weak; emotionally distraught; A Spontaneous report received from a physician concerning a 80-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced weakness in legs/muscular weakness , legs felt weak / hypoaesthasia , fall , never able to walk so she scrawled /gait inability , hallucination ,passed out / loss of consciousness , bruising / contusion ,urinary tract infection , dehydration , emotionally distraught/emotional distress, memory loss /amnesia.    The patient's medical history was not provided. concomitant product used not provided by reporter.   On 14-feb-2021, the patient received their first of two planned doses of mRNA-1273 (batch no: 031L21A) via unknown route for prophylaxis of COVID-19 infection. On 01-mar-2021, the patient experienced muscular weakness (legs felt weak).  On 03-mar-2021, the patient experienced fall (had a terrible fall), gait inability (never able to walk, she crawled) and contusion (bruises all over body).  On 05-mar-2021, the patient experienced loss of consciousness (passed out) (seriousness criteria hospitalization and medically significant) and hallucination (hallucination) (seriousness criteria hospitalization and medically significant).  On an unknown date, the patient experienced urinary tract infection (urinary tract infection), dehydration (severely dehydrated), amnesia (no memory) and hypoaesthesia (lost feeling in her legs).  The patient was hospitalized on 05-Mar-2021 due to hallucination and loss of consciousness. No treatment information was provided. The outcome for the events, loss of consciousness (passed out), hallucination (hallucination), fall (had a terrible fall), gait inability (never able to walk, she crawled), contusion (bruises all over body), urinary tract infection (urinary tract infection), dehydration (severely dehydrated), emotionally distraught/emotional distress, amnesia (no memory) and hypoaesthesia (lost feeling in her legs) was not reported.   The action taken with mRNA-1273 in response to the event was not reported.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Hallucination, Hypoaesthesia, Incontinence, Loss of consciousness
Clinical narrative: No memory; Passed out; Hallucination; lost feeling in her legs; incontinent of urine and feces; Had a terrible fall; Never able to walk, she crawled; Bruises all over body; urinary tract infection; Severely dehydrated; Legs felt weak; emotionally distraught; A Spontaneous report received from a physician concerning a 80-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced weakness in legs/muscular weakness , legs felt weak / hypoaesthasia , fall , never able to walk so she scrawled /gait inability , hallucination ,passed out / loss of consciousness , bruising / contusion ,urinary tract infection , dehydration , emotionally distraught/emotional distress, memory loss /amnesia.    The patient's medical history was not provided. concomitant product used not provided by reporter.   On 14-feb-2021, the patient received their first of two planned doses of mRNA-1273 (batch no: 031L21A) via unknown route for prophylaxis of COVID-19 infection. On 01-mar-2021, the patient experienced muscular weakness (legs felt weak).  On 03-mar-2021, the patient experienced fall (had a terrible fall), gait inability (never able to walk, she crawled) and contusion (bruises all over body).  On 05-mar-2021, the patient experienced loss of consciousness (passed out) (seriousness criteria hospitalization and medically significant) and hallucination (hallucination) (seriousness criteria hospitalization and medically significant).  On an unknown date, the patient experienced urinary tract infection (urinary tract infection), dehydration (severely dehydrated), amnesia (no memory) and hypoaesthesia (lost feeling in her legs).  The patient was hospitalized on 05-Mar-2021 due to hallucination and loss of consciousness. No treatment information was provided. The outcome for the events, loss of consciousness (passed out), hallucination (hallucination), fall (had a terrible fall), gait inability (never able to walk, she crawled), contusion (bruises all over body), urinary tract infection (urinary tract infection), dehydration (severely dehydrated), emotionally distraught/emotional distress, amnesia (no memory) and hypoaesthesia (lost feeling in her legs) was not reported.   The action taken with mRNA-1273 in response to the event was not reported.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Urinary tract infection
Clinical narrative: No memory; Passed out; Hallucination; lost feeling in her legs; incontinent of urine and feces; Had a terrible fall; Never able to walk, she crawled; Bruises all over body; urinary tract infection; Severely dehydrated; Legs felt weak; emotionally distraught; A Spontaneous report received from a physician concerning a 80-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced weakness in legs/muscular weakness , legs felt weak / hypoaesthasia , fall , never able to walk so she scrawled /gait inability , hallucination ,passed out / loss of consciousness , bruising / contusion ,urinary tract infection , dehydration , emotionally distraught/emotional distress, memory loss /amnesia.    The patient's medical history was not provided. concomitant product used not provided by reporter.   On 14-feb-2021, the patient received their first of two planned doses of mRNA-1273 (batch no: 031L21A) via unknown route for prophylaxis of COVID-19 infection. On 01-mar-2021, the patient experienced muscular weakness (legs felt weak).  On 03-mar-2021, the patient experienced fall (had a terrible fall), gait inability (never able to walk, she crawled) and contusion (bruises all over body).  On 05-mar-2021, the patient experienced loss of consciousness (passed out) (seriousness criteria hospitalization and medically significant) and hallucination (hallucination) (seriousness criteria hospitalization and medically significant).  On an unknown date, the patient experienced urinary tract infection (urinary tract infection), dehydration (severely dehydrated), amnesia (no memory) and hypoaesthesia (lost feeling in her legs).  The patient was hospitalized on 05-Mar-2021 due to hallucination and loss of consciousness. No treatment information was provided. The outcome for the events, loss of consciousness (passed out), hallucination (hallucination), fall (had a terrible fall), gait inability (never able to walk, she crawled), contusion (bruises all over body), urinary tract infection (urinary tract infection), dehydration (severely dehydrated), emotionally distraught/emotional distress, amnesia (no memory) and hypoaesthesia (lost feeling in her legs) was not reported.   The action taken with mRNA-1273 in response to the event was not reported.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: felt a lump under her arm, it was really painful and kind of swollen under the arm where had the injection; felt a lump under her arm, it was really painful and kind of swollen under the arm where had the injection; felt a lump under her arm, it was really painful and kind of swollen under the arm where had the injection; a little bit of soreness in the arm; This is a spontaneous report from a contactable nurse, the patient. This 66-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration on 05Mar2021 (at the age of 66-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265), via an unspecified route of administration on 12Feb2021 (at the age of 66-year-old) as single dose for COVID-19 immunization. On 05Mar2021, the patient actually didn't feel anything until she showered that night, she experienced a little bit of soreness in the arm, she had forgotten that she had gotten a shot but she didn't take anything for it at the time. On 07Mar2021, she felt a lump under her arm, it was really painful and kind of swollen under the arm where had the injection, so she took two ADVIL on the same day. As of 08Mar2021, she had recovered from the injection site pain but her swelling and pain under her arm is ongoing but had improved a little bit with just the two Advil she took yesterday. Therapeutic measures were taken as a result of the events included two doses of ibuprofen (ADVIL). The clinical outcome of the vaccination site pain was resolved on 08Mar2021 while the pain in arm, vaccination site lump and vaccination site swelling was resolving.  No follow-up attempts needed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: paralysis of right side of face (Bell's Palsy); This is a spontaneous report received from a contactable consumer (patient himself). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EMe205) via an unspecified route of administration in left arm on 09Mar2021 at 17:15 (at the age of 76-year-old) as a single dose for COVID-19 immunization. The patient's medical history included ADM II. The patient did not have allergies to medications, food, or other products. Concomitant medications included insulin, carvedilol, furosemide, clopidogrel, simvastatin (SIMVAS); All received within two weeks of vaccination. 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 has not been tested for COVID-19 since the vaccination. The patient experienced paralysis of right side of face (Bell's Palsy) on 11Mar2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The event was considered as serious (disability or permanent damage) by the consumer. The patient was treated with physical therapy - heat, vibration for the adverse event. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash erythematous, Rash papular, Rash pruritic, Urticaria
Clinical narrative: Red, raised itchy tender rash/welt at injection site
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Monoplegia
Clinical narrative: Severe pain at injection site beginning 1 hour post injection.   General loss of motor function in entire arm.    Symptoms worse after 24 hours.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Insomnia, Nausea, Pain
Clinical narrative: 4/7 6pm  arm very sore fevered, caused sleepless night, 4/8 headache, body aches, low grade fever, chills, nausea
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 4/7 6pm  arm very sore fevered, caused sleepless night, 4/8 headache, body aches, low grade fever, chills, nausea
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus started approximately 5 hours after vaccination and continues unabated.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Eye pain, Headache, Pain in extremity, Retching
Clinical narrative: Received shot at 11am. Around 9:30pm that evening  started having the  chills and  a slight headache. Around 1:30am  woke up with severe chills and a very bad headache where even my eyes were hurting. Also my arm was hurting from my upper shoulder down  to  my elbow and was warm. Around 2:00 am I started to throw up and had dry heaves for about 30 minutes. Once that stopped I took 2 Tylenol and fell back to sleep about an hour later. Woke up around  6am with a slight headache, took 2 more Tylenol and by noon time I felt completely fine and not even tired
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Skin warm, Vomiting
Clinical narrative: Received shot at 11am. Around 9:30pm that evening  started having the  chills and  a slight headache. Around 1:30am  woke up with severe chills and a very bad headache where even my eyes were hurting. Also my arm was hurting from my upper shoulder down  to  my elbow and was warm. Around 2:00 am I started to throw up and had dry heaves for about 30 minutes. Once that stopped I took 2 Tylenol and fell back to sleep about an hour later. Woke up around  6am with a slight headache, took 2 more Tylenol and by noon time I felt completely fine and not even tired
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Flushing, Hyperhidrosis, Hyperventilation
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium, Additional Details: Patient had a vasovagal reaction.  He was \"not a big fan of shots\".  Hadn't eaten well the day before nor breakfast.  Didn't sleep well.  Called 911.  They did EKG and it was fine.  Spoke with patient the next morning and he was good.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality sleep, Presyncope, Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium, Additional Details: Patient had a vasovagal reaction.  He was \"not a big fan of shots\".  Hadn't eaten well the day before nor breakfast.  Didn't sleep well.  Called 911.  They did EKG and it was fine.  Spoke with patient the next morning and he was good.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Lethargy
Clinical narrative: Lethargy, dizziness, chills, fuzzy head
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Urticaria
Clinical narrative: Broke out in hives on my upper neck/under chin area shortly after drinking a small glass of wine with my evening meal. (White Zinfandel)  This has never happened before.  The next evening I had another small glass of wine with my meal and the same thing occurred and this time my lower lipped swelled some also.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dysphonia, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: Patient waiting recommended 30 minutes and came back after she went to her car.  She needed 50mg of Benedryl given IM to the right deltoid.  Called patient that evening and her voice was still scratchy.  Haven't had update
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Pain
Clinical narrative: Faster than normal heartbeat, dizziness, aches all over
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Dizziness, Feeling cold, Headache
Clinical narrative: Constant runny nose in beginning, dizzy, stomach ache, achey joints muscles, irritability, feeling water swooshing ears, feelings of cold sensation on inner thigh, some headache
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Myalgia, Rhinorrhoea, Tinnitus
Clinical narrative: Constant runny nose in beginning, dizzy, stomach ache, achey joints muscles, irritability, feeling water swooshing ears, feelings of cold sensation on inner thigh, some headache
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Hyperhidrosis, Myalgia
Clinical narrative: About 2 hours after the vaccine until 6:00 pm the symptoms were slowly increasing in intensity (chills, 101.2 fever, fogginess, sinus pressure, muscle soreness, headache, sweating). This continued until I took theraflu around 10:00 pm and then mild symptoms persisted.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Pyrexia
Clinical narrative: About 2 hours after the vaccine until 6:00 pm the symptoms were slowly increasing in intensity (chills, 101.2 fever, fogginess, sinus pressure, muscle soreness, headache, sweating). This continued until I took theraflu around 10:00 pm and then mild symptoms persisted.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Systemic: Seizure-Severe, Additional Details: Patient was taken to the ER via ambulance after having a seizure in the pharmacy.  She was given Benedryl as she was thinking she was having allergic reaction.  She has been on Tegretol to control her seizures.  She didn't let us know she had seizures in her past.  She did not let the pharmacist know until the next day that she is not allowed to be given the Flu or Pneumonia shot.  She will not be getting her second dose even though her doctor at the ER told her not to be scared to.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient had her dose and was fine.  She then watched her husband get his shot and got light headed.  She was taken to lay down and put her feet up on the chair.  After drinking a water bottle and just resting, she left with her husband
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Nausea, Nightmare
Clinical narrative: Hives on my arms and stomach developed within 15 minutes of receiving the vaccine at 2:16. I left the facility after 30 minutes because the hives did not get any worse and I did not experience any other symptoms. At home about 8 hours later, I started feeling exhausted, weak, and my body was literally shaking whenever I stood. Overnight, I felt feverish, I had the worst nightmares, and woke up every few hours. On Friday (next day) I felt dizzy whenever I moved, nauseous whenever I stood, and once when I was standing too long I started vomiting.  On Friday evening I went to a local ER (all the urgent cares were closed) at my primary care Dr?s suggestion to ensure that I wasn?t having an allergic reaction to the vaccine. The ER determined that the hives were likely an allergic reaction but all other symptoms were reactions due to the vaccine.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder, Tremor, Urticaria, Vomiting
Clinical narrative: Hives on my arms and stomach developed within 15 minutes of receiving the vaccine at 2:16. I left the facility after 30 minutes because the hives did not get any worse and I did not experience any other symptoms. At home about 8 hours later, I started feeling exhausted, weak, and my body was literally shaking whenever I stood. Overnight, I felt feverish, I had the worst nightmares, and woke up every few hours. On Friday (next day) I felt dizzy whenever I moved, nauseous whenever I stood, and once when I was standing too long I started vomiting.  On Friday evening I went to a local ER (all the urgent cares were closed) at my primary care Dr?s suggestion to ensure that I wasn?t having an allergic reaction to the vaccine. The ER determined that the hives were likely an allergic reaction but all other symptoms were reactions due to the vaccine.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site reaction, Pain in extremity, Skin reaction, Skin warm
Clinical narrative: COVID arm; redness, soreness, warmth
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Headache, Injection site pain, Nausea
Clinical narrative: Fever and chills, nausea, headache, pain at injection site, brief chest pain
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever and chills, nausea, headache, pain at injection site, brief chest pain
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Systemic: Headache-Mild, Additional Details: Patient reports slight headache post vaccination, also indicated that he had not eatan all day. Provided patient with 7Up, patinet reported that he headache went away, and was due to not eating in the morning. Follow up call to the patient at the end of my shift, patient reported no headache and flet back to normal.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chest discomfort, Chills, Gait disturbance
Clinical narrative: Janssen COVID-19 Vaccine EUA About 8 hours after the vaccine, I developed a fever and chills. Then when I went to bed at 9:30 pm I had extreme thirst. I tried falling asleep but my fever got worse, chills worsened, I developed body aches, and I got a massive headache. I ended up not being able to get any sleep at all during the entire night because I was in so much pain. I felt tightness in my chest, stomach pains, super sore joints, and my body aches and headache kept getting worse and worse. When I got up to go use the bathroom I could barely walk because I felt so weak and was super dizzy. Later into the night my legs felt like pins and needles as if they were starting to go numb. I still have a fever, body aches, and a headache.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Paraesthesia, Pyrexia, Sleep disorder
Clinical narrative: Janssen COVID-19 Vaccine EUA About 8 hours after the vaccine, I developed a fever and chills. Then when I went to bed at 9:30 pm I had extreme thirst. I tried falling asleep but my fever got worse, chills worsened, I developed body aches, and I got a massive headache. I ended up not being able to get any sleep at all during the entire night because I was in so much pain. I felt tightness in my chest, stomach pains, super sore joints, and my body aches and headache kept getting worse and worse. When I got up to go use the bathroom I could barely walk because I felt so weak and was super dizzy. Later into the night my legs felt like pins and needles as if they were starting to go numb. I still have a fever, body aches, and a headache.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: Janssen COVID-19 Vaccine EUA About 8 hours after the vaccine, I developed a fever and chills. Then when I went to bed at 9:30 pm I had extreme thirst. I tried falling asleep but my fever got worse, chills worsened, I developed body aches, and I got a massive headache. I ended up not being able to get any sleep at all during the entire night because I was in so much pain. I felt tightness in my chest, stomach pains, super sore joints, and my body aches and headache kept getting worse and worse. When I got up to go use the bathroom I could barely walk because I felt so weak and was super dizzy. Later into the night my legs felt like pins and needles as if they were starting to go numb. I still have a fever, body aches, and a headache.