chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She got her vaccine, everything was fine that day.  24 hours later is when she started having pain in her arm.  As the day went by about noon it got worse and had a temp as well, which continued .  By Monday 4/22/21 she started getting migraines.  The arm pain had gone up her shoulder and into her neck which has been in agony and that set off the migraines.  She took Tripen for her migraines, and she knows when she goes blind she takes this medicine.  4 hours later she had to take another one and it was not working and took an Ibuprofen which sometimes helps.  Nothing helped and later that day she took a Norco which didn't help either.  Finally she went to sleep and woke up throughout the night and the headache kept coming back.  She didn't realize it may have been a side-effect of the vaccine and just took her regular migraine medicine, and a couple of days later finally got rid of her headache.  She had the migraine from the first one and a few days before the 2nd one she finally got rid of it, and then restarted again.   She is now 2 months post vaccine and is still having continuing headaches, not as much but still continuing.  She has been getting the headaches every few days and then they last a couple of days.  Normally her migraines she has one a week and last a couple of hours and then perhaps about 4 hours and they are bearable and sometimes she doesn't get any depending on the season, winter is worse and is a trigger.  The rainy season gets her, but it's not that season and they have been unexpected.  Her arm hurt and when she would lift it would go into spasms.  She said that it is getting better, but does not want to lift anything.   She had weakness due to the reaction and had to hire somebody to get her groceries and clean her house.  She did take Benadryl as well throughout her reaction.
shaking, chills, muscle aches, headache  over 12 hours. I have had similar reaction to previous Covid immunizations.
Information has been received from a representative concerning a 17 year old female who on 22-JAN-2008 was vaccinated with GARDASIL (lot# not reported).  On 23-JAN-2008 the patient experienced severe pains up her back and down her legs that lasted for two days.  She also had flu-like symptoms but no fever, congestion, or nausea.  Subsequently, the patient recovered from severe pains and flu-like symptoms.  No further information was provided.  Additional information has been requested.
The pt experienced a 3x4 cm area of swelling and erythema inferior to injection site vaccine reaction with cellulitis. treated with Augmentin and Benadryl.
Fever 101.1, irritability, vomiting within 24 hours of shot. 2mm area of erythema on abdomen. Observe closely. Alternate Tylenol, Ibuprophen for temp. Pedialyte x 12 m then 1/2 str formula.
Patient was inadvertently given the pediatric formulation of the vaccine instead of the age 12+ formulation  No adverse symptomatology occurred  reporting as vaccine administration error
Rash down (L) arm - starting at elbow Rash down (R) arm - starting at elbow Denies any respiratory issues or any other rash location. Refferd to Urgent Care For Further follow up and was prescribed Benadryl
Back pain,fever,chills,muscle aches, headache, diarrhea, upset stomach , nausea, severe head fog , Disiness, feels like electrical currents in head and ears.  These symptoms have been all 7 days.
pt recv vax 7AUG97 & 8AUG97 pt t103;18AUG97 went to MD 830AM & was sent  home w/DPH;mom gave DPH & pt vomited;19AUG97 had rash & swollen neck glands;dx measles;conjunctivitis eyes red, watery eyes;cough;coryza; koplik spots;
Physician 16 weeks pregnant; Administered at 7:45pm, went to observation area; experienced tachycardia; HR: 107; BP: 148/88 O2: 100% approximately 20 mins after injection; Appeared flush.  Water offered, transferred to room for isolation; drank 2 bottles of cold water; offered additional medical care; denied need; rested for 1 hr after vaccine; HR: 80s; O2: 100%. Spouse picked up for transfer home; referred to PCP for any additional needs.
Pt developed active varicella infection 3 days after vaccine was administered. Symptoms included fever, and multiple vesicular-papular erythematous lesions on scalp, face, abdomen, groin region.
Suspected Vaccination Failure; outbreaks; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter got vaccinated but still had outbreaks. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization schedule, time to onset for event and laboratory confirmation for shingles were not provided.
Received Pfizer Covid shots already. I had Covid in Feb2021; Received Pfizer Covid shots already. I had Covid in Feb2021; pneumonia; Went home on oxygen for 3 months; Feel terrible every day/ so miserable; have to take naps everyday; No energy; Not get back to normal every day things; This is a spontaneous report from a contactable consumer (the patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as a single dose, dose 1 via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date in Feb2021, the patient experienced pneumonia and stated that received Pfizer COVID shots already and had COVID in Feb2021. Hospitalized for a week. On an unknown date, the patient went home on oxygen for 3 months and experienced feel terrible every day/ so miserable, have to take naps everyday, no energy, not get back to normal every day things. On an unspecified date in Feb2021, the patient underwent lab tests and procedures which included SARS-COV-2 antibody test: positive. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
COVID symptoms on 04Jan2023 (Wednesday night)/ positive Ag Nasal Swab on 06Jan2023; COVID symptoms on 04Jan2023 (Wednesday night)/ positive Ag Nasal Swab on 06Jan2023; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: CJ6742) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE], on 28Sep2022 as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2023, outcome "recovering" and all described as "COVID symptoms on 04Jan2023 (Wednesday night)/ positive Ag Nasal Swab on 06Jan2023". COVID symptoms on 04Jan2023 (Wednesday night) and tested Negative; then on 06Jan2023 (also reported as 06Jan2022): positive Ag. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (04Jan2023) Negative, notes: Nasal Swab; (06Jan2023) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
was given it during a surgery, came down with whooping cough/ suspected vaccination failure; whooping cough; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Concurrent medical conditions included surgery.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown.   It was unknown if the reporter considered the vaccination failure and whooping cough to be related to Tdap Vaccine.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient received Tdap vaccine during a surgery and he came down with whooping cough. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for whooping cough and time to onset was unknown. This case was linked with the case US2021AMR214222 (wife's case), reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR214222:Same reporter
Fever, body aches, chills, diarrhea, joint swelling, leg swelling, skin tenderness, extreme joint pain, nausea, upper back and neck pain, headache, skin redness not at injection site.
Received HPV #2, VARIVAX #2 and flu vaccine at routine PE. By report 15 minutes post visit developed urticaria. Treated with BENADRYL, DECADRON and SOLUMEDROL. Had been observed for > 15 minutes post HPV dose prior to discharge.
Patient pulled away as vaccine was being injected causing  a weal at injection site. Although  it is not known with certainty, the possibility exists that allot part of the dose may have been injected subcutaneously.
Erythema, cough, SOB, tenderness swelling and pain to injection site.
Lethargic; Chills; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), CHILLS (Chills) and MYALGIA (Sore Arm) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced LETHARGY (Lethargic), CHILLS (Chills) and MYALGIA (Sore Arm). At the time of the report, LETHARGY (Lethargic), CHILLS (Chills) and MYALGIA (Sore Arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-239018 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; GABAPENTIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient did not have any allergies. Patient received Paxlovid from (27Jun2022 to 01Jul2022) as a result of treatment for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to  all the reported events Drug ineffective , COVID-19 cannot be completely excluded based on temporal association and known drug safety profile
I DON'T THINK THIS IS ACTUALLY AN "ADVERSE EVENT" BUT I'M REPORTING IT SO IT CAN BE EVALUATED BY SOMEONE MORE INFORMED THAN ME. On about Dec. 1 I started to have some nose and throat congestion, mostly coughing, and increasing stiffness and and discomfort at the base of my neck. I thought is was a cold but at the suggestion of family took an at home Covid test on Dec. 2 which was negative, then another on Dec. 4, which was positive. I went to an immediate care clinic and discussed my condition and treatment options. The NP I talked to agreed that I was likely a little late to get the most out of treatment with Paxlovid, and said my vital signs were quite good, indicating I was pretty unlikely to get much worse and would likely get better pretty quickly. She gave me a prescription for Paxlovid with directions about other medications if I decided to use it, but told me it was my decision to take Paxlovid or not. I decided not to and I got better pretty quickly and was back pretty much to normal by Dec. 9-10. Negative at home Covid tests Dec. 5 and 6.
Information has been received from a health care worker concerning a 12 year old female patient with no pertinent medical history and no drug reactions who on 21-JUL-2010 was intramuscularly vaccinated with the first dose of 0.5ml GARDASIL (lot# not reported), the second dose (lot# not reported) on 29-OCT-2010 and the third dose (lot# 666597/0768Z) on 15-MAR-2011. There was no concomitant medication. On 18-MAR-2011, the patient developed purpura type rash on both arms. It started as a small bruising and the area got bigger and turned to rash. Then the rash spread to the other arm. The patient did not have any problems with the first and second dose of GARDASIL. Base line complete blood cell count (CBC) was performed with no results reported. The patient sought unspecified medical attention. There was no treatment given for the event. At the time of reporting, the patient had not recovered and would be seeing an infectious disease specialist. Additional information was received from a physician and medical records regarding a 12 year old female. On 15-MAR-11, the patient received a GARDASIL (lot# 666597/0768Z) injection intramuscularly in her left deltoid. The patient had received two previous doses on 21-JUL-10 and 29-OCT-10. No other illnesses were documented at the time of vaccination. On 18-MAR-11, the patient started to experience left deltoid bruising. On 19-MAR-11, the patient experienced a petechial type rash on her left upper arm/ deltoid region. A complete blood count (CBC) test revealed white blood cell count (WBC) 4.5 and mean platelet volume (MPV) was 10.5 fl. All other values were within normal range. On 21-MAR-11, the patient experienced purpura/ ecchymosis on her left arm to wrist and she developed a rash on her right deltoid. On 23-MAR-11, the patient was taken to the emergency department where additional labs were drawn (results were not provided). On 24-MAR-11, the rash on the patient's right arm had spread to her wrist and continued on the other side. On 31-MAR-11, urinalysis revealed trace leukocyte esterase. The patient's rash had almost resolved. The patient had an appointment with an infectious disease specialist on 25-APR-11 for follow-up. Additional information has been requested. All available medical records will be provided upon request.
During the night of vaccination noticed swelling of his eyes and an irritated like rash on his arms. Non itching. Reported that his throat felt tight. With IM vaccination in Oct 08 he reported a heart rash like bumps on both arms. With IM vaccination in Oct 09 he was just recovering from pneumonia and he noticed little red non irritating bumps on injection arm only. Bumps lasted a couple of days.
This spontaneous report received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of ZOSTAVAX (lot # M042504, Expiry date: 30-NOV-2017; lot # M038863, expiry date: 12-DEC-2017; lot # M035692, expiry date: 07-NOV-2017). On an unknown date, the vaccine was exposed to temperature of 6 degree F to 14 degree F for 1 hour 5 minutes. No adverse effects reported. Previous temperature excursions occurred on unknown dates between temperatures of 6 degrees F to 14 degrees F (6F) for 15 hours and 6 degrees F to 14 degrees F (6F) for 26 minutes. This case was reported because of a data logger. No product quality complaint (PQC) was reported. No further information to report.
Suspected vaccination failure/1st dose on 01Mar2020, 2nd on 04Jun2020, had shingles 3x since then; Shingles 3x; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 4th June 2020, the patient received the 2nd dose of Shingrix. On 1st March 2020, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 2-Feb-2023 Reporter's comment: The patient stated he received his 2 doses of Shingrix and since then, the patient had experienced 3 recurrences of shingles.  Each time he was treated with Valacyclovir. The patient provided limited information.   The patient needed to end the call as he needed to leave for an appointment. Did not consent to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Burning sensation in his feet; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 06Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced burning sensation in his feet on 17Mar2021. The outcome of the event was unknown. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 27Mar2021 at single dose for COVID-19 immunization.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Patient described feeling lightheaded and dizzy. Passed out for a moment and recovered. Patient received 2 bags of saline
Increased (L) thigh red, warm & tender (L) 4in x (W) 2in.
Pt called and stated  he was having sob, and chest discomfort tightness, stated started at 7:00am and has not improved or changed nothing that he dose changes this discomfort stated 6/10 scale I told him I felted that he should be seen by the ED, he also had bone pain and Diff breathing
his head feels clogged up; lack of energy; ear feels plugged; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (his head feels clogged up), ASTHENIA (lack of energy) and EAR DISCOMFORT (ear feels plugged) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced HEAD DISCOMFORT (his head feels clogged up), ASTHENIA (lack of energy) and EAR DISCOMFORT (ear feels plugged). At the time of the report, HEAD DISCOMFORT (his head feels clogged up), ASTHENIA (lack of energy) and EAR DISCOMFORT (ear feels plugged) outcome was unknown.            No concomitant medications were reported.  It was reported that patient was on unspecified research trial drug.  Patient was waiting to get Covid test done.  No treatment medications were reported.
Developed fever to 103, vomiting, abdominal and leg pain.  She was in so much distress that she was evaluated in the Emergency Room.  I just spoke with Mom and she said that patient is doing much better.
Patient called today to state that he had a reaction to the Arexvy vaccine he reveived on 9/10/23.  Yesterday, his arm was sore  but this morning after showering he noticed that about 3 inches around the administration area of the vaccine  that it was very red. He saw his physician and was prescribed Augmentin 875mg bid for 7 days
Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were inadvertently vaccinated with GARDASIL 9 (lot # L011846 with expiration date 16-JUN-2017; strength, dose, dose number and route were not reported), which had been improperly stored. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
for 48 hours following the shot the patient reported diarrhea, extreme nausea and no appetite then it went away.
Patient is a 93 y.o. female patient of MD with PMH of COPD, CAD presented to the ED due to SOB and weakness. Treated for COPD/Covid.  Discharged to hospice care    Acute on chronic hypoxemic respiratory failure COPD Secondary to COVID pneumonia, COPD Required Bipap in ED, but was weaned down to NC. Home requirement is 2L Tachypnea slowly improved during admission  Pulm toilet Scheduled bronchodilators.   Covid-19 Virus Infection Date of onset of symptoms: 2 days(7/28/23) Symptoms present on admission: SOB, cough, weakness. Date of covid positive test: 7/30/23 Vaccination status: vaccinated Imaging: CXR no consolidation  Current oxygen requirements: 2L NC Medical therapy: steroids Anticipated special isolation end date: 8/8/23 CAD Non-ischemic cardiomyopathy LHC 7/10/23 with severe multi vessel disease, not amenable to PCI nor a surgical candidate, recommending medical management. EF 7/2023 EF 60%, pulm HTN 48 mmHg Resume home plavix, imdur, metoprolol, ranexa, statin.  Depression Lexapro   GERD Omeprazole, pepcid.     HTN Cozaar   Goals of Care Discussed code status, in agreement for DNRCCA-DNI Palliative consulted, family prefers home with hospice