chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First reaction was very sore arm (injection site), about 2 hours after injection. Then very sleepy but not fatigued. Over the next couple hours: muscle aches, nausea, sharp pain in joints, headache, chills, fatigue. Unable to sleep that night due to all-over muscle pain, like having the flu. Very uncomfortable. Severe chills overnight. Next morning, same symptoms plus cough. Nausea worsened. I was unable to work at my computer or care for my 6-year-old son. I was camped out on the couch all day, in and out of naps, covered in blankets. Around dinner time, all symptoms started lifting. A bit of nausea remained, plus cough. I slept VERY well that night -- best I've slept in years. The next morning, I was completely normal and felt better than I did before the vaccine.
This spontaneous report as received from a nurse, refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/ allergies or were reported. On 27-AUG-2018, the patient was vaccinated with an improperly stored dose of (Wistar RA 27-3) M-M-R II (which had a lot # of N027780 and an expiration date of 08-AUG-2019; however, dosage number and route of administration were not reported), for prophylaxis. The diluent used to reconstitute the vaccine was properly stored. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursions: 47 F degrees to 77 F degrees for 20 minutes. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA011769: US-009507513-1808USA011662.
Numbness; Tingling / Tingling down his legs; Painful calves; incomplete course of vaccination; Drug dose interval too long; This case was reported by a consumer via call center representative and described the occurrence of numbness in a 27-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included Rabies NVS (RabAvert) for prophylaxis.   Previously administered products included RabAvert (For 1st dose refer caseUS2020AMR153824 ) and RabAvert (for 2nd dose refer case US2020152664).   On an unknown date, the patient received the 3rd dose of RabAvert and the 4th dose of RabAvert. On an unknown date, less than 2 weeks after receiving RabAvert and not applicable after receiving RabAvert, the patient experienced numbness, tingling, pain in calf, incomplete course of vaccination and drug dose administration interval too long. On an unknown date, the outcome of the numbness, tingling, pain in calf, incomplete course of vaccination and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the numbness, tingling and pain in calf to be related to RabAvert.  Additional details were reported as follows: The reporter was patient's the mother. The patient received Rabavert for post-exposure prophylaxis. The patient received 3rd dose one week later after 2nd dose on right arm which led to drug dose administration interval too long and he experinced tingling, numbness, tingling down his legs and painful calves. At the time of reporting the was due for 4th dose  but till the time was not received which led to incomplete course of vaccination.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR153824:same patient
This spontaneous case, received from a pharmacist on 15-Oct-2018, (initial and follow-up 1 combinedly processed), concerns a 56-year-old, adult female patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56 F for 8 hours following a power outage (explicitly coded as incorrect product storage). On 14-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019) which underwent temperature excursion (coded as drug administration error). No adverse event was reported. The reporter assessed the case as non-serious. This case 201804544 was cross-linked to the case 201804533 (original case) reported by the same reporter.
Patient felt a burning sensation. Left shoulder is sore, pain down the arm and neck, pricking sensation on the skin. Pt is experiencing this discomfort from 8-12 until this day (8-19). He took ADVIL and it's not getting better.
Large red area approximately 4 " long 1 1/2" wide oval, hot to the touch, painful. Injected SC into back Left arm (upper) on 9/15 Rx'd ->cephalexin 500 mg bid 7 days to treat possible infection.
pt recv vax 22FEB99 230PM & started having trouble swallowing around 7PM;required hosp for dehydration x 24hr;UGI/laryngoscopy WNL;still on zantac for persistent reflux sx;
2/7/21  2:00pm - Mild Headache, fatigue and mild muscle aches 11:30pm - Fever and chills, along with above symptoms 2/8/21 (Midnight - Midnight ) High Fever (101 with Motrin on board) Chills Headache Fatigue Nausea Muscle Aches 2/9/21 (Midnight - Midnight) Headache Mild Fever Fatigue 2/10/21 (Midnight - Midnight) Headache Fatigue 2/11/21 Headache 2/12/21 Headache
congestion intermittently through the night; Headcahe; Earache; Nausea; Lymph node pain; General body pain; Pain from injection site; Joint pain /pain radiating to elbow; Chills; Fever; Cough; hard time breathing; This is a spontaneous report received from a contactable consumer, the patient . A 42-year-old female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in an unspecified arm on 22Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. On 22Mar2021, the patient experienced pain from injection site (vaccination site pain) which radiated to elbow, chills and fever, cough developed, hard time breathing (breathing difficulty), congestion intermittently through the night (nasal congestion) headache developed, ear ache developed, nausea, pain in lymph nodes (lymph node pain), body aches (general body pain) and join pain especially along the back (joint pain). No treatment was received for the adverse events. The clinical outcome of the events vaccination site pain, chills, fever, cough, breathing difficulty, headache, ear ache, nausea, nasal congestion lymph node pain, general body pain and joint pain was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt devel a rash 2 to 3 wks p/receiving Engerix-B; tx w/DPH; reporter indicated questionable attribution to Engerix-B since rash onset was 2 to 3 wks post vax;
I had a stable pancreatic pseudocyst long predating the shot.  I do not drink alcohol and haven't in any time relevant to this.  A week and a half after the shot, I had sudden debilitating pain at work, went to ER. The pseudocyst increased in size between double and triple what it was at visit 2 weeks before vaccine.  The cyst ruptured.  Never had a blood clot, didn't have any risk factors for one, yet developed multiple blood clots in the spleen and led to multiple splenal infarction.  I almost died a day after arriving at hospital when blood pressure suddenly dropped to 75/35.  I lost consciousness.  Two blood transfusions stabilized me.
This spontaneous report as received from a other health professional refers to a 13 year old patient.    On 08-JUL-2015 the patient was vaccinated with GARDASIL lot # K016966 dose 3, 1 DF for prophylaxis. On 08-JUL-2015, 4 months after onset of therapy the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event.
Irregular periods and heavy spotting which is still continuing 3 months later. I?ve never had issues with either of these things before. I expected my period as normal one day after my vaccination and it arrived two weeks later. I also randomly bleed heavily for a day or so and then it just stops.
Very painful; no taste and appetite; no taste and appetite; no energy; sores were big and oozing; sores were big and oozing; Rash; sick; Got shingles June 6th (after both vaccine shots).\ suspected vaccination failure; shingles; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On 6th June 2021, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain, appetite absent, taste absent, loss of energy, skin ulcer, discharge, rash and sickness. On an unknown date, the outcome of the vaccination failure, shingles, pain, appetite absent, taste absent, loss of energy, skin ulcer, discharge and sickness were unknown and the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, pain, appetite absent, taste absent, loss of energy, skin ulcer, discharge, rash and sickness to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got shingles after both Shingles vaccine shots. The patient stated he/she very painful, no taste and appetite, no energy and sores were big and oozing. The rash was just leaving and starting to feel normal. It was told vaccine could had aggravated the shingles as had the virus in our body. Had been so sick. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Has bumpy irritated rash at each lateral thigh, not hot, not apparently tender, not indurated. Pt had a little fever the night of her vaccines on 1/24 up to 100, then she had a mild rash on both injection sites developed about three hours after the injections. The rash is itchy. Per mother this is the 2nd time this occurred after vaccinations. The mother reports, the first time it lasted for a couple of days, this time it has been over a week. Mother feels it has improved today, although yesterday it had peaked. We are uncertain if this is related to rubbing alcohol used to clean injection site. We applied rubbing alcohol to top of foot at visit today, mother to call if Pt. develops a rash.
Flu-like symptoms; muscle aches; chills; more soreness at administration site than a normal injection
started having allergies like sneezing; started having allergies like sneezing and coughing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SNEEZING (started having allergies like sneezing) and COUGH (started having allergies like sneezing and coughing) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No historical conditions were reported.  Concomitant products included COLESEVELAM HYDROCHLORIDE (WELCHOL) for Acid reflux (oesophageal), MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced SNEEZING (started having allergies like sneezing) and COUGH (started having allergies like sneezing and coughing). At the time of the report, SNEEZING (started having allergies like sneezing) and COUGH (started having allergies like sneezing and coughing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were reported as blood pressure medication, cholesterol medication, anxiety medication and acid reflux medication. No treatment information was reported.  Patient was concerned if she can take her second dose with respect to the events occurred after first dose. Her physician directed her to take her second dose.
Fever to 105.2 (R) s/p 72 hrs vaccinations. Ibuprofen with TYLENOL given for fever. Fever lasted 4 days.
pt recvd flu vax & devel pain described as neuralgia/tendonitis like in the arm of inject; pt exp this pain when moving arm; seen by orthopedist who prescribed PT; pt recovered;
Severe chest pains the night following vaccination.   We thought they would get better, but continued to get worse.   Vaccine was on Friday afternoon at 4:00.   Went to primary doctor on Monday afternoon.   Referred to Heart facility for further testing.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken with Paxlovid as a result of drug ineffective, covid-19.  Clinical information: Reported seriousness was No. Patient received treatment with Paxlovid from 06Sep2022 to 12Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a nurse practitioner refers to a patient (gender and age not reporter) which was vaccinated with PNEUMOVAX23 (lot# reported as H021941; exp. date: 11-JUL-2014) (dose and route not provided) which was exposed to 11C for 56 hours. No adverse effect reported. Lot number H022281 is an invalid lot number for PNEUMOVAX23. This is one of several reports received from same source. Additional information is not expected.
Initial report received on 22 September 2008 from a consumer, who is the patient. A 54 year old female, with no medical history, received on 16 September 2008 a left deltoid intramuscular injection of ADACEL (lot number C2997AA). The patient had no illness at the time of vaccination. She had received her last Td vaccination 20 years ago and had no adverse events following prior vaccinations. On 17 September 2008, one day post vaccination, the patient had developed a six inch rash around the left deltoid injection site. The area was red, hot, and itchy and there was a lump which measured approximately one inch. Corrective treatment was not reported. At the time of the report, 22 September 2008, the patient's symptoms showed some improvement, but she had not recovered. Follow-up information was received 09 October 2008 from a consumer, who is the patient. Laboratory and diagnostic testing was reported to have been not applicable (N/R). No additional medically significant information was provided at the time of the report. Documents held by sender: None.
FEELING BAD; This spontaneous report received from a health care professional via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included idiopathic thrombocytopenic purpura. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced feeling bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling bad was not reported. This report was non-serious.
Body Aches , Chills, 100.9 Temp , Fatigue , nausea , Skin hurt
arm is sore; 3 inch red rash around injection site; rash is warm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is sore), INJECTION SITE ERYTHEMA (3 inch red rash around injection site) and INJECTION SITE RASH (rash is warm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm is sore), INJECTION SITE ERYTHEMA (3 inch red rash around injection site) and INJECTION SITE RASH (rash is warm). At the time of the report, PAIN IN EXTREMITY (arm is sore), INJECTION SITE ERYTHEMA (3 inch red rash around injection site) and INJECTION SITE RASH (rash is warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.    Reporter did not allow further contact
Patient complaining of muscle aches and weakness of muscles since vaccination. She can no longer walk the distance she used to, while exercising she gets fatigued easily.
Pt developed a larg wheal and flare lesion over injection site and within 24 hours, had multiple diffuse hives. Received Benadryl with no further effects.
Patient stated that the day following the vaccination she experienced redness that traveled and became hot and painful.  She went to the urgent care on sunday and the md prescribed cephalexin w/ a suspected indication of cellulitis.
sudden onset projectile vomiting, sudden diarrhea, weakness, nausea, loose cough
This spontaneous report was received from a certified medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. It was stated by the medical assistant that on unspecified dates since 02-JUN-2015, the patients were administered with an unspecified number of improperly stored doses of PROQUAD (Merck) (lot #, expiration date and frequency were not reported), subcutaneous injection. No adverse effects were reported. Concomitant therapies were unknown. This is one of two reports from the same source. Additional information has been requested.
DIZZINESS, NUMBNESS IN FOREHEAD, NOSE AND UPPER LIP, THE NEXT DAY A CLOT ON THE LOWER LIP
I week and 1 day after getting the vaccine, my arm started to swell at the injection site, turned red, became very itchy, and hot to the touch.
Severely bruised left arm (dark purple and warm to touch) from shoulder to elbow; Complaining of pain and not being to sleep on the left side; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp (Healthcare professional).  This case involves an 89 years old male patient who experienced severely bruised left arm (dark purple and warm to touch) from shoulder to elbow (contusion) and complaining of pain and not being to sleep on the left side (pain in extremity), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatments, vaccinations, and family history were not provided.   Concomitant medications included WARFARIN (WARFARIN) 5 mg.  On 06-Oct-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiration date were not reported) via intramuscular route at an unknown administration site for prophylactic vaccination.  On 06-Oct-2020, the patient developed a non-serious severely bruised left arm (dark purple and warm to touch) from shoulder to elbow (contusion) and complaining of pain and not being to sleep on the left side (pain in extremity), on same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The intensity for the event contusion was severe.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The patient was recovering from the events at the time of reporting.  There will be no information on the batch number for this case.
Administered Moderna vaccine around 0915 after reviewing health form with patient. Verified prior to giving vaccine that Moderna was being given. After administering vaccine patient related she had received the Pfizer vaccine at Coliseum. Monitored patient. No reactions noted. Nurse manager notified.
Started with fever at 1530hrs and was treated every 4 hours with Tylenol as prescribed by Dr. Around 1600 mother observed baby looking off at nothing and not responding to name for a few minutes. This was followed by the baby's hands and legs having seizure like movement. This was repeated 3 times over the night. Baby was taken to ER following 3rd incident and admitted. Child's temp never exceeded 101.8.
After 4 1/2 days, I developed retching and diarrhea.  Day 2, the retching stopped, but, I had mild nausea for 26 days.  Still, after 31 days, I continue to have mild diarrhea and intestinal mucus,  and enough intestinal flatulence to fill a hot air balloon.
This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age. It was reported that the RECOMBIVAX HB of unknown dose, have undergone a second temperature excursion dated 2-JUL-2014 and have been administered post initial excursion reported as 16-JAN-2014. Excursion supported. It was reported that no adverse events and no concerns are reported by any patients. RECOMBIVAX HB have been administered since date of last excursion of 27-JAN-2014 is with Lot number reported as J001836 and expiry date reported as 01-FEB-2015. This is one of the several reports from the same source: different patients same reporter. Additional information has been requested.
15may89 pt vax w/ 3rd Hepa B. 14 hrs after vax experienced h/a n/v/d & pain @ inject site. w/in 24 hrs sx resolved. 89aug pt developed viral resp synd followed by dermititis.  Described as vasculitis and joint pain ..see worm
2 days after vaccine (MENACTRA) in left deltoid, c/o "twitching"/muscle spasm in left arm. Having frequent muscle spasm in left arm for past 3 days. Still occurring at office visit today (2/24/16).