chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Apr2021 at 12:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included obsessive compulsive disorder (OCD) and chronic urticaria (not current). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) and norethisterone acetate/ethinylestradiol/ferrous fumarate (LOMEDIA 24 FE), both taken for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 12:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 23:00, the patient experienced overall strong body achiness, headache and skin sensitivity. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events overall strong body achiness, headache and skin sensitivity was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
WOKE THIS MORNING ARM WAS SORE AND SWOLLEN AND WARM TO THE TOUCH AND A RED SPOT A SIZE OF A FIFTY CENT PIECE.
Swollen lips and tongue   Prednisone  Pepcid.  Zyrtek
Began with a 3"x4" itchy red patch just below injection site. Continued to grow down the arm past the elbow - 4"x9 1/2"
vaccination adverse reaction; little headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (vaccination adverse reaction) and HEADACHE (little headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (vaccination adverse reaction) and HEADACHE (little headache). At the time of the report, VACCINATION COMPLICATION (vaccination adverse reaction) and HEADACHE (little headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment information was provided.   No relevant concomitant medications were reported.
After the second dose, her arm has a rash at the site she got the shot.; This is a spontaneous report from a contactable consumer. A contactable reporter reported that a 70-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, lot: EW0179, expiry date: Aug2021) via unspecified route of administered on 02Jun2021 at 11:00 as single dose in left arm for COVID-19 immunization. Medical history and concomitant medication s were not reported. the patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) intramuscularly administered in arm left on 12May2021 11:00 (Batch/Lot Number: EW01735; Expiration Date: unknown date on Aug2021) as single dose for covid-19 immunisation. No Prior Vaccinations (within 4 weeks) was reported. Caller remarked that the only time she had a reaction to a vaccine was in grade school, back in the 50's. She got a rash. Back then they did with not just one needle, they poked her, and she got a scab and rash. Caller reported on the Pfizer Covid 19 shot and who explained she had a reaction to the product. With the first dose she did fine. After the second dose, her arm has a rash at the site she got the shot. It started out the size of a nickel but was now about the size of the top of a soup can. The rash started 07Jun2021 and has gotten worse. Caller confirmed it has increased in size. It was noted she went to emergency care and wasn't given anything for treatment, this was last night 09Jun2021. Outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
I experienced short-lived but painful cramps and cold sweats (phase 1), followed by chills, aches and pains (phase 2).  The first phase lasted only about an hour; the second was much longer (around 4 hours).  Started around 10 that evening.  I was pretty weak the rest of that next day (Saturday).
Full body swelling started an hour after the shot was administered. Face, scalp, neck, chest, abdomen, hips, labia, thighs, calves, ankles, feet, toes, arms, wrists, hands and fingers continued to swell until my skin stretched over the swelling. Swelling has not gone down.
Serious breathing problem; Feeling lousy all over; Upset stomach; Spitting up; Not interested in eating; Started having memory issue; Soreness at the injection; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Serious breathing problem), FEELING ABNORMAL (Feeling lousy all over), ABDOMINAL DISCOMFORT (Upset stomach), VOMITING (Spitting up), DECREASED APPETITE (Not interested in eating) and MEMORY IMPAIRMENT (Started having memory issue) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Serious breathing problem) (seriousness criterion hospitalization), FEELING ABNORMAL (Feeling lousy all over) (seriousness criterion hospitalization), ABDOMINAL DISCOMFORT (Upset stomach) (seriousness criterion hospitalization), VOMITING (Spitting up) (seriousness criterion hospitalization), DECREASED APPETITE (Not interested in eating) (seriousness criterion hospitalization), MEMORY IMPAIRMENT (Started having memory issue) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Soreness at the injection) and FATIGUE (Tired). At the time of the report, DYSPNOEA (Serious breathing problem), FEELING ABNORMAL (Feeling lousy all over), ABDOMINAL DISCOMFORT (Upset stomach), VOMITING (Spitting up), DECREASED APPETITE (Not interested in eating), MEMORY IMPAIRMENT (Started having memory issue), PAIN IN EXTREMITY (Soreness at the injection) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not reported. The treatment information was not provided.  The patient went to hospital 7 times in the past 2 months. The smallest time spent in hospital was three days and the longest time was nine days. The patient was scheduled for second dose on 28-FEB-2021.  Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
have had all vaccines and boosters for Covid. We had Covid in July; have had all vaccines and boosters for Covid. We had Covid in July; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "have had all vaccines and boosters for Covid. We had Covid in July". Clinical course: Patient's wife and him have had all vaccines and boosters for Covid. They had Covid in Jul and patient had concern that how long they could wait to get new boosters vaccine.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300151917 Same event, vaccine and different patient;
This case was reported by a physician via call center representative and described the occurrence of shingles in a 65-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included IMMUNOSUPPRESSIVE THERAPY (NOS) (unspecified immunosuppressive therapy). On 10th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a month after receiving SHINGRIX, the patient experienced shingles, numbness in leg and tingling of extremity. On 3rd October 2018, the patient experienced vesicles. On an unknown date, the outcome of the shingles, numbness in leg, tingling of extremity and vesicles were unknown. It was unknown if the reporter considered the shingles, numbness in leg, tingling of extremity and vesicles to be related to SHINGRIX. Additional details were provided as follows: About 1 week back, from the date of reporting, the patient had numbness and tingling in the legs. Two days back, from the date of reporting, the shingles vesicles appeared and the diagnosis of shingles was made.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid taken from 17Sep2023 to 22Sep2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nausea immediately after injection which calmed down. Light nausea until 1430 when I vomited. Left work and when I arrived home 15 minutes later o started vomiting again. Additionally, body can?t decide if it?s warm or has the chills.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Obesity" (unspecified if ongoing), notes: Other medical history included Obesity. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19".  Clinical course: Patient had received Anti-viral Product for COVID 19 Treatment, Brand Paxlovid, Treatment started on date02Jul2022 and was stopped on date 06Jul2022, It was reported covid symptoms returned 5 days after finishing paxlovid and tested negative 2 days after finishing paxlovid. Also tested positive for covid 6 days after finishing paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received the Moderna COVID-19 vaccine 1/6/2021 at approximately 11 AM. Pt stated she does not have any history of allergy or anaphylaxis. Pt reported about 5 minutes after vaccine administration a runny nose. Pt reported she did not have a runny nose prior to administration of the vaccine. Pt notes a history of nasal problems. Pt denies difficulty swallowing, swelling of airway, difficulty breathing, itching, rash, flushing, swelling of lips, face, throat, or eyes, sensation of throat closing, change in voice, wheeze, cough, n/v/d, abd pain, dizziness, weakness.  Pt confirmed she felt well other than her runny nose.  Pt was observed in our observation area for 45 minutes with no progression of symptoms. Epinephrine not administered. RN consulted with medical advisor Dr. over the phone as he was off site.   EMS on site. VS done by paramedic patient signed refusal with paramedic as she did not want to go to the ED. Pt was advised by RN about delayed anaphylaxis, to continue to monitor her symptoms, call 911 if additional symptoms arise. Pt declined recommendation to go the ED. Advised pt to call her PCP asap for further guidance. Advised pt there is a local urgent care she should be checked out in if she cannot get in with her PCP today.  Pt verbalized understanding and agrees to the POC.   2:26 PM RN called patient to check on her and obtain additional information for VAERS form. Pt reports she is feeling well, no other symptoms developed. Pt called her doctor and is waiting for a call back.
Raised, firm, itchy red rash at injection site appeared at Day 7 after injection and is still present at day 8.  Rash is approximately 2 inches in diameter.  Swollen, tender lymph in left armpit started on day 4 and has continued through today, day 8 post injection.
Patient called pharmacy stating that she felt pain in her left arm about 3 days after the flu shot.  Per pt, she did not think anything of it until her husband pointed out a red rash.  Per pt, the rash was near the injection site on the left arm and it was red and warm to the touch.  Pt was advise to take benadryl and to contact primary doctor if the pain persisted or got more severe or if she developed fever.  Attempted to call pt twice to determine if she reached out to provider and to determine the outcome, but received no response from the pt.
Painful red rash appeared on both arms( under arm near glands),  lower back, and under both breast.
Patient was administered the incorrect dose required to complete the series. Patient received Pfizer 6 month to 4 years old vaccine instead of 5-11yr vaccine. Patient had no adverse reaction to the vaccine administered after waiting in office for 15 minutes.
Mom states pt collapsed in car seat; was unresponsive & eyes were rolled back in head; Taken to clinic; Was also pale, but alert; P86, R22; Pt fainted again @ home;
I started getting symptoms of sore throat and a cough. That progressed to a worse cough, fever, and, tiredness. The next day, I took an at home COVID-19 test that was negative. On 6/25/2022, I went to a drive thru and received a positive COVID-19 test. I contacted my doctor and received a prescription for a cough medicine and PAXLOVID. I feel like the PAXLOVID is helping. I still have a cough but it is not as bad as it was.
Extreme soreness at injection site started after removing the bandage 10 hours after the injection (removed bandage at 10 pm).  Insomnia, could not sleep all night; extreme pain in upper right arm.  Body hot and mildly nauseas.
Infant developed generalized urticarial 24 hours after vaccinations. Lesions resolved with 3 doses of fexofenadine.
Within a few hrs of vax administration, vomiting, rash, description consistant with hives on lower extremity/face, followed by a 2" "white bump" rash on trunk. No fever. Had pruritus, resolved by next am and remained asymptomatic.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 10:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 10:57 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 79.75. No concomitant medications were reported. On 15-Apr-2021 at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and vial was initially moved to the fridge on 06-Apr-2021 and beyond use date was 09-May-2021. Product moved to clinic on 15-Apr-2021    Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
No additional AE's; inquire if an expired dose of PNEUMOVAX 23 was considered a valid dose; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.   On 23-SEP-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) as prophylaxis (dose and frequency reported as: one time as instructed) (route of administration and anatomical site of vaccination were not reported; lot number S006777 has been verified to be valid, expiration date reported and established as 28-NOV-2020) (expired product administered). The reporter inquired if an expired dose of the vaccine was considered a valid dose. No additional expired vaccines were administered, and no adverse events were reported (no adverse event). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S006777; expirationdate: 28-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
about 10 minutes after the shot his fingers felt "strange".  Soon after his chest felt tight and he felt weak.  No SOB.  No tongue or month swelling.  He felt faint, but did not have a syncope episode.  Vitals were taken x 2 )201/106 pulse 117 pulse ox 97%.  Patient was A&Ox3 and laid down on a cot.  He was sent to hospital via ambulance.  EMS called at 1202 and arrived at 1215.  left facility at 1220.
After the first, the arm was sore for a day or two; This is a spontaneous report from a non-contactable physician (the patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that after the first (dose), the arm was sore for a day or two. The outcome of the event was unknown.      No Follow-up attempts are possible; information about lot number cannot be obtained.
Information has been received from a registered nurse concerning a 23 year old female patient with allergy to VICODIN who on 21-JAN-2009 was vaccinated with the first dose of GARDASIL (lot # 660616/0570X), 0.5 mL, intramuscularly.  Concomitant therapy included NECON.  The nurse reported that on 21-JAN-2009 the patient developed itchy, watery eyes with sensitivity to light, a few hours after receiving GARDASIL vaccine.  The patient contacted the office by phone and was prescribed BENADRYL.  The practitioner suggested that the patient not complete the vaccine series.  At the tome of reporting, the patient had recovered.  Additional information has been requested.