chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; doses were administered following the excursion; This spontaneous report was received from a physician referring to a 13-month-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.     On 23-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) lot # T021642, expiration date 21-DEC-2021, at a dose of  0.5 milliliter for prophylaxis (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). No additional adverse event reported.   The vaccine was stored in a temperature of max 16.2  degree Fahrenheit (°F) for 2 hours 28 minutes as recorded by a data logger. There was no previous temperature excursion reported.
Small bruise appeared where the vaccine was administered. Pt does not take aspirin. Ice applied and everything ok on follow up next day.
Elevated heart rate; body feels cold; head, neck, and back pain; stomach discomfort.  Resting heart rate 90 bpm (I'm typically closer to 60), persistent for 12+ hours.
I woke up in the night with aches all over my body.  I have had zero energy for six weeks.  I have been unable to perform routine housekeeping chores.  I have been able to do some cooking and laundry but have not been able to keep my ironing done.  I have  a little energy in the morning but am totally exhausted by night. I basically have not had any treatment except Tylenol. I took the Pfizer vaccine.
COVID; COVID; joint pain; fatigue; loss of taste; shortness of breath; I don't have the energy; This is a spontaneous report from a non-contactable other healthcare professional reported for unknown female that: A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history included rheumatoid arthritis which has been diagnosed for greater than 10 years. Past drug included Xeljanz, Medrol Dosepak, LEFLUNOMIDE for Rheumatoid arthritis. The patient's concomitant medication was not reported. The patient experienced covid-19, drug ineffective which led to hospitalization on an unspecified date with outcome of unknown; joint pain, fatigue, loss of taste, shortness of breath, don't have the energy an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of shortness of breath.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and covid19 cannot be totally excluded.
it is hot, swollen, and painful and states that it "looks like a cloud" and is "getting less"; She reports that later on in the evening it started to burn; it is hot, swollen, and painful/arm was throbbing; it is hot, swollen, and painful and states that it "looks like a cloud" and is "getting less"/her arm was really big; as that night went on it got redder, hotter, and more panful/arm redness; hard to sleep; "large rash like area" in the same arm that she was injected in at the injection site; she has a large red welt on her arm; Rash; This is a spontaneous report from a contactable consumer (patient) from medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in left arm, on 27Mar2021 at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in left arm, on 27Feb2021 at dose 1, single for covid-19 immunization and had the throbbing for which she took Advil, achiness on her whole left side where she got the injection, change in taste where things tasted different; it went away, the middle of the night she started out of bed with a sensation that she equates to someone going off drugs cold turkey like on television or movies; she was just jumping around: but reports that little by little it dissipated (as reported) and she had a feeling like extreme anxiety, she couldn't lie in bed and had to jump up, and she had to wait it out; a frightening feeling, but little by a little it went away. The patient experienced the arm was throbbing/ painful, later on in the evening it started to burn and felt really hot and pretty painful on 27Mar2021, it is hot, swollen /it looks like a cloud and is getting less (as reported), as that night went on it got redder, hotter, and more painful/arm redness, large rash like area in the same arm that she was injected in at the injection site and she has a large red welt on her arm; though it is much less than it was two days ago, rash and hard to sleep on Mar2021. There were no investigational assessments. Therapeutic measures included Advil for all the events. The outcome of started to burn, erythema, hard to sleep, large rash at the injection site and rash was unknown and outcome of all other events were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no adverse effect; administered an expired dose; This spontaneous report was received from an other health professional (medical assistant) refers to a 41 year old patient.     The patient's medical history, concurrent conditions and concomitant medications were unknown. On 21-AUG-2019, the patient was inadvertently administered an expired dose (expired product administered) of hepatitis a vaccine, inactivated (VAQTA) (lot # R014952 exp.date: 09-AUG-2019) (strength, dose, frequency, anatomical location were unknown) for prophylaxis. No adverse events was reported. No product quality issue was reported. The outcome of expired product administered and no adverse event was unknown.
-2:30 - 5:30 p.m. Weakness, headache, lay down, had to lay down at 7:00 p.m. -sore neck  and shoulder mild headache, then she had to lay down-took 2 TYLENOL - at 2:30 a.m. acute problems began. Severe headache took aspirin and ice pack, took MAXALT. at 9 a.m. she took another MAXALT then continued sitting position until 5 a.m. then she was able to sleep until 8 a.m.
Received 0.5 ml dose instead of a 0.25 ml dose for their booster; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5 ml dose instead of a 0.25 ml dose for their booster) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 25-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Received 0.5 ml dose instead of a 0.25 ml dose for their booster). On 25-Oct-2021, ACCIDENTAL OVERDOSE (Received 0.5 ml dose instead of a 0.25 ml dose for their booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-363330 (Patient Link).
This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received FLUARIX. Concurrent medical conditions included iodine allergy, drug allergy and penicillin allergy. On an unknown date, the patient received FLUARIX 1 ml. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced pain in arm. Rechallenge with FLUARIX was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to FLUARIX. See case US2015GSK020072 for tolerance to next flu vaccination.
Seems like there may be some effect on my reproductive organs. Debilitating menstrual cramps which is very abnormal for me.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 2/4/21 and 2/25/21. Presented to ED 2/6/22 with SOB and sxs worsened over 3 weeks. Previous Friday to admission began having fevers, prescribed azithromycin and inhalers. Tested negative for covid 2-3 times. Admitted for A-fib and acute hypoxic resp failure 2/2 Covid. Required HFNC during admission, intubated 2/8. STEMI 2/9 c/b distributive shock and bil. pleural effusions. Transitioned to comfort care. Tx'd with decadron, solumedrol, baricitinib,cefepime and vancomycin. Expired 02/09/22.
Large red area surrounding injection site developed approximately 9 days (Janurary  following vaccination.  Area was red and hot to the touch.  Also felt somewhat lethargic  and not great.  Redness decreased over the next couple of days and felt better but has not disappeared and in fact has increased in size.
On 12/3/10 pt received vaccines at approximately 10AM and left clinic at 10:30. He states thru translator that at 1:30 he took 2 TYLENOL for arm soreness. At 1:40 he began to have itchy & teary eyes. At 2:30 he felt as if his throat was swelling and had shortness of breath. He went to ER and was given meds.
Patient is an 81-year-old veteran who received his second dose of Shingrix (recombinant zoster shingles vaccine) intramuscularly in his left deltoid on 9/25/19 complaining of fever, myalgia, weakness, and injection site reactions on his left arm. He noted that he took ibuprofen for symptomatic relief.
A report was received from a health care professional on 12/17/03 concerning a 6 year old female vaccinee who inadvertently received a sub-optimal dose of Fluvirin on 12/15/03. On 12/15/03, a vaccinee inadvertently received a dose of 0.25ml of Fluvirin. No adverse events had occurred as a result at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information was received from a health care professional indicating that the vaccinee did not experience any adverse reaction. The vaccinee did not contract influenza and she later received the full dosage of Fluvirin in mid January. No follow up pending. All information received.
approximately one week after the vaccination, the patient developed progressive edema around the injection site, with the arm swelling to about 1.5 times its original size with overlying errythema and painful skin
pt cried, screamed uncontrollably for little more than 24hr;had to be eval in ER;normally placid child hardly ever cries, p/vax inconsolable, no infect then 36hr later back to nl;
This spontaneous report was received from a medical assistant, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates since 10-FEB-2017, the patients were vaccinated with improperly stored doses of VAQTA injection (dose, frequency and route were not reported) lot # M009377 with expiration date of 17-JUN-2017, for prophylaxis. The temperature of the VAQTA was of 35 °F for a time frame of 72 hours. No previous temperature excursion occurred and no data logger was involved. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA000027:
shingles; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE: UNKNOWN, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200584328 same reporter/drug/event, different patient
A headache began the morning after vaccination (approximately 18 hours later). It lingered even with treatment and then got much worse by the following night (about 30 hours later). There was also mild arm pain. In the middle of the night, there were severe night sweats.  No treatment sought.
NO ADVERSE EVENT; Doses were administered after the 30 day BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (NO ADVERSE EVENT) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In June 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (NO ADVERSE EVENT). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (NO ADVERSE EVENT) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (NO ADVERSE EVENT) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD).    No concomitant medication was reported.  Doses were administered after the 30 day BUD between 08-JUN-2023 -15-JUN-2023. No treatment information was reported. This case contains information for patient 7 out of 7.   This case was linked to US-MODERNATX, INC.-MOD-2023-729901.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729901:Master case
Very sore arm for 4 days after vaccine (expected); On day 5, woke up with extreme fatigue; muscle soreness; Headache; Dizziness; Brain fog; Nausea; Feeling feverish; This is a spontaneous report from a contactable consumer (patient). A 25-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: ER8731, expiration date was not reported), via an unspecified route of administration, administered in right arm on 21Apr2021 16:15 (at the age of 25-years-old) as dose 1, single for covid-19 immunization at hospital. The patient medical history included hashimoto's thyroiditis, ADHD, Strattera (allergies to  Strattera), covid-19 (I had COVID in early Feb and  this feels similar, but not as intense) , allergy. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), metformin, levothyroxine sodium (SYNTHROID), clarithromycin (CLARITAB), azelastine, all taken for unknown indications from an unknown date. List of any other medications the patient received within 2 weeks of vaccination included adderall, metformin, synthroid, azelastine, Clarit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 26Apr2021 at 07:00am the patient experienced very sore arm for 4 days after vaccine (expected). On day 5, woke up with extreme fatigue, muscle soreness, headache, dizziness, brain fog, nausea, and feeling feverish. Still ongoing as of today, but the headache, dizziness, and nausea are gone. I had COVID in early Feb and this feels similar, but not as intense. The patient underwent lab tests and procedures which included had COVID in early Feb (sars-cov-2 test): positive on Feb2021. The adverse events did not result in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating, congenital anomaly/birth defect. The reporter assessed the seriousness as non-serious. No treatment was received for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Janssen COVID-19 Vaccine EUA  -Onset of fever (101.9 F) approximately 9 hours after vaccine. Fever lasted for about 10 hours. After fever, severe muscle aches/tightness and lethargy for another 12 hours.   -Side effects resolved fully within 24 hours.  -On 9th day after vaccine, sudden onset of severe dizziness, lightheadedness, tiredness, diarrhea. Diarrhea lasted about 4 hours. Other symptoms continue.
Approximately 5 hours after receiving the injections I experienced shortness of breath, coughing, wheezing, chest tightness.  I took a claritin with relief immediately.  I received two doses of the COVID vaccine (Pfizer) originally, did not receive a third shot (I had covid) and had no prior reaction I have received the flu vaccine in the past without incident as well  Earlier in the day, prior to the vaccine, I noticed some tightness / shortness of breath-- but the response was significantly worse at 9PM.   This reaction may be a reaction to in-home air fresheners (there is significant aroma and I am sensitive, although never "allergic" I will follow up with my primary care provider on Monday
Patient received HEP B vaccine on 4/28/06 A few days later she had a severe nose bleed, blood pouring out of nose and mouth.  Coughing up blood with clots we got the bleeding to stop at home.  Held pressure.
FULL BODY HIVES; HEADACHE; EXTREME FATIGUE; NAUSEA; FEVER; BODYACHE; This spontaneous report received from a patient concerned a 30 year old female. The patient's weight was 110 (unit unspecified), and height was 5.1 (unit unspecified). The patient's concurrent conditions included asthma, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 10:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced bodyache. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced extreme fatigue. On 06-MAR-2021, the subject experienced nausea. On 06-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced full body hives. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bodyache, extreme fatigue, nausea, and fever on MAR-2021, recovered with sequelae from headache on MAR-2021, and was recovering from full body hives. This report was non-serious.
This spontaneous case reported by a consume, describes the occurrence of dry eye (eyes very dry/severe/even worse), headache (like a headache but it's not) and head discomfort (pressure) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 039K20A) for COVID-19 vaccination. Concurrent medical conditions included dry eye. On Mar 29, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced  dry eye (eyes very dry/severe/even worse), headache (like a headache but it's not) and head discomfort (pressure). The patient treated with physical therapy (compresses) for dry eye. At the time of the report, dry eye (eyes very dry/severe/even worse), headache (like a headache but it's not) and head discomfort (pressure) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Patient reported a hard time opening eyes. It's worse during the night; had been using compresses and eye drops as treatment. The unspecified treatment provided by the physician was ineffective too. No concomitant mediation reported. The reporter did not provide any causality assessments.
After receiving Zoster vaccine, patient experienced dizziness/room spinning that began 24 hours after vaccine and lasted about 1 week (same amount of time as local induration of arm).
Pt recv vax on 1/4/99; post vax pt exp erythema multiforme
I still have flareups 2 and 3 times a year/Suspected vaccination failure; I still have flareups 2 and 3 times a year; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had deal with shingles on and off since the patient was 30). Previously administered products included Shingles vaccine  (received original Shingles vaccine on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix and 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 hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Linked case(s) involving the same patient:  US2022AMR112219   Additional Information: GSK receipt date: 26-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had deal with shingles on and off since the patient was 30.  The patient was 70 years old. The patient have had the original shingle vaccine and the 2 part of Shingrix and still have had flare-ups 2 and 3 times a year. The patient takes 500 mg Valtrex every day. The case was linked with case US2022AMR112219, reported by same reporter for himself/herself. 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. The follow-up could not be possible as no contact details were available. As per reported narrative, the patient had received the original shingles vaccine but it was unknown whether it was of GSK or Non-GSK, in worst approach it was captured as historical product as shingles vaccine.