chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare professional (medical assistant) via company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not provided. On unspecified dates, the patient was vaccinated with 2 doses of GARDASIL (dose, strength, route, vaccination site not provided). On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, strength, route, vaccination site not provided) to complete the third dose of HPV vaccination series. After the administration of GARDASIL 9, the patient experienced an unspecified reaction. No further information was provided. Product quality complaint (PQC) was not reported. The outcome and causality of the adverse event was not provided. Additional information has been requested.
3/24/14 Lump in left upper arm. Onset approx 1 month post vaccine. ? abscess. Treated with BACTRIM 3/27/14 increased sx pt sent to ED and changed antibiotics to clindamycin 300mg QID.
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 66-year-old female patient who received SHINGRIX (batch number 9349T, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 7th July 2018 (please refer the case US2018GSK194710). On 19th September 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm, swelling arm, influenza-like symptoms, fatigue and weakness. In September 2018, the outcome of the pain in arm, swelling arm, influenza-like symptoms, fatigue and weakness were recovered/resolved. It was unknown if the reporter considered the pain in arm, swelling arm, influenza-like symptoms, fatigue and weakness to be related to SHINGRIX. Additional details were reported as follows: The patient experienced the same arm pain bad as she had after 1st dose, same symptoms as before but this time the pain radiated throughout the shoulder blade. She also had flulike symptoms feelings of fatigue, weakness but the symptoms subsided by the second day post administration. She did not seek any medical attention. The nurse did not agree to be followed up.
I have been experiencing extreme tinnitus ever since I received the vaccine and boosters. It has been slowly getting worse for about two years now, before the vaccines, I would experience slight cases of tinnitus maybe once every 3 to 6 months, now I experience it almost daily. it is all so much more extreme now, where I will lose all hearing in one of my ears for a short period of time with a very loud ringing , and it happens in both ears, but usually not at the same time. Before the vaccines I would never have 100% hearing loss  like this.
Patient presented to the ER with worsening dyspnea and productive cough over the past five days. He was given azithromycin outpatient by pcp without improvement. Per EMS patient had spo2 70% on RA. Work up in ED showed WBC 7.51, bicarb 17, agap 16, BUN 30, SCr 2.2, lactate 6.41 -- > 3.10. CXR with bilateral pneumonia. He was found to have COVID, had worsening respiratory failure required mechanical ventilation, had worsening AKI, ultimately requiring CRRT, had worsening 3 pressor shock, severe ARDS, Ongoing d/w family, and ultiatmley decision made for DNR. Family went to speak w/ the pt's wife (who has deferred decision to the children) and the family did decide to transition to end of life care.  Patient passed away 16 minutes after life support was withdrawn.
Fever; This is a spontaneous report from a contactable nurse reported for herself. A 56-year-old female nurse (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration, administered in left arm on 09Jul2021 (at age of 56-years-old) as dose 1, single for COVID-19 Immunization. Patient medical history includes Multiple sclerosis, Asthma, Hypothyroidism. Patient concomitant medications include formoterol fumarate dihydrate (4.5 ug) used for unspecified indication from unknown date and unknown ongoing, interferon beta-1b (BETASERON [INTERFERON BETA-1B]) used for multiple sclerosis from unknown date and unknown ongoing, budesonide, formoterol fumarate(SYMBICORT) used for asthma from unknown date and unknown ongoing, Levothyroxine used for Hypothyroidism from unknown date and unknown ongoing, Budesonide(160 microgram) used for unspecified indication from unknown date and unknown ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Jul2021 (one day after vaccination), patient experienced Fever. Nurse stated, she just have a quick question what is a normal fever that you can get, she stated that she called to local hospital, they do not give her any information. The fever she get the vaccine yesterday and her fever is at a 100 and she just want to make sure that its okay. Reason for no lot number was Nurse stated, PF12GR and then below that there is a R2W0181. The Reaction assessed for fever through source of assessment was primary source reporter and method of assessment was global Introspection as drug result was related. For Causality as Nurse stated, is it because of it, she believe so, yes. The patient underwent lab test and procedures include body temperature was 100 on 10Jul2021. The Outcome of event was Unknown.  Information on the lot/batch number has been requested.
suspected TIA or stroke vs seizure disorder; Suspected TIA or stroke vs seizure disorder; Suspected TIA or stroke vs seizure disorder; Encephalitis; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (suspected TIA or stroke vs seizure disorder), CEREBROVASCULAR ACCIDENT (Suspected TIA or stroke vs seizure disorder), SEIZURE (Suspected TIA or stroke vs seizure disorder) and ENCEPHALITIS (Encephalitis) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (suspected TIA or stroke vs seizure disorder) (seriousness criteria hospitalization and medically significant), CEREBROVASCULAR ACCIDENT (Suspected TIA or stroke vs seizure disorder) (seriousness criteria hospitalization and medically significant), SEIZURE (Suspected TIA or stroke vs seizure disorder) (seriousness criteria hospitalization and medically significant) and ENCEPHALITIS (Encephalitis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 08-Apr-2021 to 19-Apr-2021 due to CEREBROVASCULAR ACCIDENT, ENCEPHALITIS, SEIZURE and TRANSIENT ISCHAEMIC ATTACK. On 19-Apr-2021, TRANSIENT ISCHAEMIC ATTACK (suspected TIA or stroke vs seizure disorder), CEREBROVASCULAR ACCIDENT (Suspected TIA or stroke vs seizure disorder), SEIZURE (Suspected TIA or stroke vs seizure disorder) and ENCEPHALITIS (Encephalitis) had resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.  The patient received IVIG x5 doses and prednisone, along with seizure meds for treatment. Temporary pacemaker placed 13-Apr-2021 (HR=32). The patient was improved post-treatment and was discharged on 19-Apr-2021.  Company Comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Extreme swelling , redness and hard around  vaccine injection site. About 4 to 5 inches round.  Very sore and hurts, Benedryl does not help.   Note: same reaction I had from Humira injections on my thigh  years ago before Humira was changed.   I think it might be the preserves.
Headache, Fever, Diarrhea, NauseaVomiting, Fatigue Narrative:
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 64-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (For tolerance to the 1st dose refer case US2018GSK107320). On 4th June 2018, the patient received the 2nd dose of Shingrix. In June 2018, less than a week after receiving SHINGRIX, the patient experienced fever, pain in arm, vomiting, swelling arm, general body pain and nausea. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, pain in arm, vomiting, swelling arm, general body pain and nausea were recovered/resolved. The reporter considered the fever, pain in arm, vomiting, swelling arm, general body pain and nausea to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient experienced body aches, swelling in arm, and pain in arm. These symptoms resolved in 24 hours. The patient experienced the same symptoms after dose 1 but they were more severe with dose 2.
Patient had episode of syncope, passed out for about 10 seconds, became diaphoretic; patient also became hypotensive; patient monitored in clinic until BP returned to normal and was maintained. Patient left clinic with mother.
Information has been received from a medical assistant concerning a 32 year old female patient who on 23-JAN-2009 was vaccinated with the first dose of RECOMBIVAX HB and on 23-FEB-2009 received IM the second 0.5 mL dose of RECOMBIVAX HB (LOT # 662115/1263X thimerosal free).  Approximately two hours after receiving the second dose of hepatitis B vaccine, the patient experienced stomach upset.  The patient was seen by the physician.  It is unknown if the patient recovered.  It was also reported that on the same date two other patients were vaccinated and experienced the same adverse event.  Additional information has been requested.
Patient reported fever (101-102) starting 11 pm on 6/2/19 along with headache.  At approximately 9:00 AM on 6/3/19, patient developed muscle weakness in both legs and lost use of both legs.  This lasted until about 10 PM on 6/3/19.  Patient still complains of mild headache as of 6/6/19.
Information has been received from a Certified Medical Assistant referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ (lot # K023534, expiration date 22-MAY-2016, dose and route were unknown) (Incorrect product storage). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
After I got vaccinated I got brain fog and super fatigue really quickly and within two hours I got the chills. I had arm pain, body pain and I also felt like I had a fever. I took Tylenol and ibuprofen but it did not work. After I called off work the next day. I stayed in bed for 2 days because I was still having body pain and kept taking Tylenol for two days. The third day I felt much better.
Seven satellite papules on lower extremities, began 2/14/03. Itching.
Tingling in fingers on (L) arm, tingling to tongue, weakness to (L) arm.
Clients reports numbness near the injection site (LA). That occurred 24 hrs post vaccination. The sensation of numbness and increased skin sensitivity spread to the L neck area and L calf area. No hx of similar rxn to other vaccines. No fever, no other notable symptoms.
inflammatory response; severe bruising at injection site. After 2 days, neck and lymph nodes were inflamed and visually noticeable. Nauswa and aching. GI cramping.
immediately post-vaccination pt experienced flushing/warm sensation L side of arm/neck/face.  Patient sat in chair x15min, given water.  Pt states continued flushing with dizziness and inability to focus vision/blurry vision. Had patient continue to sit and observed additional 30 min.  Pt reported no change in symptoms, moved pt back to vaccination room to reduce noise/traffic.  Checked BP 144/100,  pulse 77.  Pt given more water and observed.  No labored breathing or obvious distress noted.  Pt reported tingling of tongue/throat.  No signs of swelling of tongue/throat with examination but increased flushing of face/throat/ears.  Pt offered benadryl, she disclosed anaphylaxis to benadryl and refused antihistamine.  discussed concern of reaction and use of epipen/EMS services.  Patient declined, asked for continued observation.  observed x 15 min, no change in status.  observed additional 15min, offered loratadine (pt states taken safely in past) pt declined.  observed 15min, pt states continued tingling in mouth/throat with slight difficulty swallowing, no observed labored breathing, pt able to carry conversation without effort.  Recommended epipen and EMS, pt refused.  Pharmacist advised against driving and recommended seeking emergent care.  Patient refused EMS and left with friend with request from pharmacist to go to ER.  F/u with pt 2 hrs later, pt was at ER but no updated status. Phone call F/u with pt next day (5/13, 1pm). pt states given 1 medication (unknown) that reduced symptoms of tingling but HR/BP continued to fluctuate.  ER discharged pt home evening of 5/12 and pt has f/u with primary care 5/14/21.
Vaccine administration error - When administering vaccine, some of the vaccine leaked from the seal between needle and syringe barrel during administration.
Patient received 2 vaccines, nurse left room and 5 mins later heard loud noise. Nurse returned to room and found patient on floor, eyes open. Patient stiff not flaccid. Patient had mild tremoring in her extremities. Patient monitored for 20 min. Recheck BP 110/60, tremor had resolved. Patient was AxOx3, EDMI, PERLA. Patient advised to contact office with any problems.
1st dose on Oct2020, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in October 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: The pharmacist reported that the patient was late for the 2nd dose of Shingrix. No adverse event was reported. Only the first dose was administrated. No patient's identifiers was provided. No lot number and expiration date was provided. No vaccination date was provided. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
2 days of increasing number of dew drop vesicles with red base, some already scabbed. Low grade fever
Headache, Myalgia, Arthralgia, chills Narrative:  empl,taking 800mg mortin prn
Erythema down upper arm and on to left breast. Red and warm to touch. C/o pain all night.
Headache, Myalgia, NauseaVomtting, right arm sore, back pain,chills, sweating,  Narrative:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of ATTENUVAX (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, five days after vaccination with ATTENUVAX, the patient was vaccinated with a dose of M-M-R II, subcutaneously (dose, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported. Additional information is not expected, because there was no consent to contact physician.
Suspected vaccination failure; Shingles; burning throbbing pain in the right lower back radiating to the right abdomen; hypersensitivity of the skin in this area; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 69-year-old female patient who received Herpes zoster (Shingles vaccine) (batch number L63B4, expiry date 08-APR-2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) (batch number N3755) for prophylaxis.   Concurrent medical conditions included diabetes, hypertension, hyperlipidemia, hypothyroidism and peripheral vascular disease. Concomitant products included metformin, valsartan, bisoprolol fumarate, rosuvastatin, levothyroxine, cilostazol (Pletal) and clopidogrel bisulfate (Plavix).   On 26-JUN-2022, the patient received the 2nd dose of Shingles vaccine 50 ug. On 15-MAR-2022, the patient received the 1st dose of Shingles vaccine 50 ug. On 14-SEP-2023, 445 days after receiving Shingles vaccine and 548 days after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), pain (Verbatim: burning throbbing pain in the right lower back radiating to the right abdomen) and hypersensitivity (Verbatim: hypersensitivity of the skin in this area).  The patient was treated with methylprednisolone (Medrol) and valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and hypersensitivity were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and hypersensitivity to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and hypersensitivity to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 12-OCT-2023 This report was submitted via the online direct entry reporting system.  The patient was not pregnant. The patient self-reported this case. The patient received other products concomitantly. The patient received Shingrix and had burning throbbing pain in the right lower back radiating to the right abdomen with hypersensitivity of the skin in this area and shingles. The patient had no rash. The symptoms were treated with Medrol dosepack and currently on Valtrex for almost a week. The symptoms began from 14-SEP-2023 and still ongoing. The symptoms were treated. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
patient received vaccine 0818, in observation area  08:30 reported that she felt cold, sweaty palms and decreased sensation in hands, ate yogurt 2 hours prior to vaccine 08:32 bp: 124/85, o2sat 99%, hr 94, drinking pepsi, ate peanut butter crackers and granola bar 08:40 patient reports palms less sweaty, bp 141/63, hr 90, 1 glucose tablets administered 08:50 glucometer 130, bp 130/65, hr 83 9:10 T 98.0 oral, bp 125/78, hr 83, patient reports hands no longer cold, palms not sweaty, sensation normal in hands 9:22 patient left to go home, states she felt normal
About 24-30 hours after I got the shot, my arm got very itchy and a red spot formed that is warm to the touch and red and raised.  The spot is about 1.5 inches in diameter.  It?s itchy and sore.  I?ve put hydrocortisone cream on it and taken Tylenol. The whole arm hurts.
Gave a HEPLISAV-B Vaccine on 05/17/2023 But Wrote Expiration Date in January 2023; Initial Report Received on 19-Jun-2023  A retail pharmacist reported that a 22-year-old female patient (race and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and allergies at the time of vaccination were reported as unknown. Medications at the time of vaccination were not reported.  On 17-May-2023, the patient received an expired dose of HEPLISAV-B vaccine (Lot # 941389, expiration date Jan-2023 and NDC # 43528000305) intramuscularly (injection site not reported) at a retail pharmacy. The actual expiration date was unknown. The reporter denied any adverse effects.  No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Post vax, the pt experienced pain and then a grand mal seizure for 5 seconds. Unspecified medical attention was sought.
Fever of 104, severe nausea, malaise, chills, body aches/pain.
Itching on R side of neck started 23 hours after injection.   Applying OTC steroid cream to itching area 30 minutes after the onset made skin burn.   Progressed to large hives and very painful/burning skin along R side of neck over 1.5 hours.   25 mg Benadryl stopped spread of hives but pain persisted.   Benadryl taken over the next 24 hours.  Hives and skin pain resolved after 24 hours, redness over neck resolved after 2 days,  a single scab like lesion remained for one week.
10 minutes after received GARDAIL 9 a headache came on; This spontaneous report was received from a medical assistant and refers to a 11 year old female patient. No information was given reagarding the patietn's concomitant medications, concurrent conditions or medical history.  On 24-JUN-2019 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R009614, intramuscular for prophylaxis. 10 minutes after patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) a headache came on. Acetaminophen (TYLENOL) was given for treatment, however it was unknown how long the headache lasted for.  No lab diagnostics were performed, no medical attention sought or hospitalization.  The outcome of headache and the causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Patient came to pharmacy to report/show a red, warm, and tender circle approx, 2 inches in diameter.  Area was located several inches below actual injection site.  We recommended that she seek further attention at her doctor's office/urgent for a second opinion and antibiotics (if deemed necessary).
The patient received her second Pfizer covid vaccine, then moved on to observation.  When a nurse went to fill out the second dose on the child's card, all the personal information was already filled out, including her birthday of 12/06/2012.  The patient and her brother (13) had both been vaccinated and were sitting in the second row with the windows up.  When asked, the father rolled down the windows so the nurse could observe them and the younger child was clearly wearing a brown, bob wig.  The nurse asked her age;  when she did not answer, the mother and father both stated clearly that she was 8 years old.  The mother then stated that she had signed a consent form for her daughter to receive the first dose, knew that the Pfizer vaccine was not yet approved for EUA for her daughter's age group, and took "full responsibility".  On the site's program, the child's birthdate and age had both been entered correctly for both doses.  The parents were asked if they would allow us to observe the patient for a total of 30 minutes and they agreed.  The patient was released after that time to be driven home by her father with no adverse events noted.
full body generalized rash itchy, antihistamines not helpful, nor topical steroids, trying PO steroids and referring to allergy
Left side of my face was numb.  It happened last time as well.   Doctor suggested I should not have a booster in the future.