chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Friend got a shingles vx, got shingles the next month/Suspected vaccination failure; Got terrible shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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, less than 2 months 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 Information: GSK Receipt Date: 02-MAR-2023 Reporter's comment: This case was reported by a patient's friend via interactive digital media. The patient got a Shingles vaccine and then got terrible shingles the next month Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
took "two home pregnancy tests, and they both were positive"; her arm was sore at the injection site; her arm was sore at the injection site; This spontaneous prospective pregnancy report was received from a 27- year- old female patient, who was reporting on herself. The patient did not have any pertinent medical history, drug reactions or allergies. There were no concomitant medications.   On an unspecified date in July 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On 18-DEC-2019, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis.   The patient's arm was sore at the injection site after the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) administration in July 2019. On 18-DEC-2019, the patient's arm was sore at the injection site, after the second vaccination. The patient did not receive any treatment.  The patient became pregnant with last menstrual period (LMP ) of 20-NOV-2019 and estimated delivery date (EDD) of 26-AUG-2020 (dates calculated based on information, that at the moment of report gestation age was 4 weeks). The patient told the medical assistant, that she was one and a half weeks late on period, however the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was administered.  The pregnancy was confirmed by two home pregnancy tests performed on 18-DEC-2019, after the vaccination. Both showed positive result. No additional lab diagnostics were performed. The patient did not seek medical attention and was not hospitalized. The pregnancy outcome was pending. The fetal outcome was unknown. The outcome of injection site pain (onset date: July 2019) was not reported, the outcome of injection site pain (onset date: 18-DEC-2019) was recovering. The causality assessment between the events of injection site pain and the therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
sore arm; achyness; fever; exhaustion; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (achyness), PYREXIA (fever), FATIGUE (exhaustion) and HEADACHE (headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020. Concomitant products included LISINOPRIL for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (achyness), PYREXIA (fever), FATIGUE (exhaustion) and HEADACHE (headache). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. In March 2021, PAIN IN EXTREMITY (sore arm), PAIN (achyness), PYREXIA (fever), FATIGUE (exhaustion) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
On 1/3/20 Patient was brought in by mother for 2 immunizations. RN confirmed no contraindications or previous adverse reaction. Vaccines administered at 1343, patient observed to have loss of consciousness at 1345, episode lasted approximately 25 seconds. RN was able to catch patient in chair and hold upright. After patient regained consciousness, patient transferred to cot to lay down. At 1348 vitals were BP-80/50, P 75, R 18. Second assessment conducted at 1355-BP-95/75, P 78, R 18. Patient departed at 1430 Vital signs stable. Contact attempted on 1/6/20, unsuccessful due to phone number from another country.
p/vax pt exp lyme-like symptoms of lethargy & loss of balance; ER w/acute faintness; in ER had possible episode of arrhythmia;  persistent sore throats & variable back pain; pt currently seeing ENT; as of 8/9 pt condition unk;
This spontaneous retrospective pregnancy report was received from a 33 year old female patient with allergy to RONDEC. Without concurrent conditions and medical history. On 25-NOV-2014 the patient was vaccinated with a dose of GARDASIL, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). Concomitant therapies included cyanocobalamin (reported as B12). On an unknown date the patient became pregnant (also reported as pregnant "no"). The last menstrual period (LMP) and estimated date of delivery (EDD) were not reported. On 14-DEC-2014, the patient had a miscarriage after receiving GARDASIL. The patient stated that she was not aware that she was pregnant until she had the miscarriage, also she stated that she did not know that they could not be pregnant while getting the vaccine. She mentioned that no one at the office asked her to check and see if she was pregnant. The patient reported that the physician said the baby stopped growing at 6 weeks. He also said that the patient was further along with the pregnancy than 6 weeks but he was unsure of an actual gestation period. The physician took an estimated guess saying the patient may had been between 8-12 weeks. The patient went to the urgent care and was directed to the emergency room. Ultrasound and blood drawn (test unspecified) were performed, the results were not provided. The outcome of miscarriage was unknown. The relatedness between the miscarriage and therapy with GARDASIL was not reported. Additional information has been requested.
Malaise, muscle & joint aches, brain fog, unusual memory lapses, night sweats...the issues have been experienced since evening of the 2nd vaccination...the only side effects after 1st vaccination was a sore left arm.
joint pain; A spontaneous report was received from a consumer, concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced joint pain. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unspecified date, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis. And wants to know the effectiveness after the second dose. No treatment medication was reported. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event, joint pain was considered to be not resolved at the time of this report.  Based on MSA comment, joint pain is Listed in all RSIs
fever of 104; maybe Covid/suspected COVID; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In February 2021, unknown after receiving Shingles vaccine, the patient experienced fever and suspected covid-19. On an unknown date, the outcome of the fever and suspected covid-19 were unknown.   It was unknown if the reporter considered the fever and suspected covid-19 to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's daughter-in-law. Age at vaccination was not reported but the patient was in her early 70's. The patient received a shingles shot. The reporter was not 100% sure that the shot was Shingrix or Zostavax.  The patient experienced a fever of 104 degrees F. The reporter stated that It was a few days ago. That seems very high to me. The reporter asked if a high fever that normal? The reporter had two kids and bad lungs and was afraid and up at night worried it could not be a normal symptom of the shingles vaccine and might be Covid. No further information was provided.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 57-year-old male patient received BNT162b2 (BNT162B2, Vaccine brand unknown, vaccine lot unknown: False), on 11Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FMO698) at the age of 56 years, in left arm 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 had no relevant medical history. Known allergies: No. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Jul2022 at 13:30, outcome "not recovered" and all described as "COVID-19". Report about COVID treatment: Yes. If vaccine received: Yes. Other medication in 2weeks: Unknown. Anti viral details: product: COVID 19 Treatment, Brand: Pfizer, Treatment start date: 01Jul2022, Treatment stop date: 05Jul2022.Adverse event: Tested negative on 08Jul2022 and then positive again for Covid-19 again on 14Jul2022. Adverse event start date: 14Jul2022, 01:30 PM. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Report about COVID treatment: Yes; (08Jul2022) Negative, notes: Tested negative on 08Jul2022; (14Jul2022) Positive, notes: then positive again for Covid-19 again on 14Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Pt reports dizziness,sweating, Pt was transported to the clinic VS; BP 71/51 PULSE 78 O2 SAT 94% TEMP 98.5 Pt laid down, leg raised and water was offered. VITAL became better VS; BP 101/65 O2 SAT 97%
congestion in his chest; real deep coughing; hurting at the base of his neck/his shoulders were hurting from his neck down his arms to his elbow; dysentery; felt a little unwell; when he gets up, his back is giving him trouble; he can't stand up long because of the weakness; body also seemed to want to walk backward on his heels when he stands up and he is wanting to fall; he can't stand up that well; his head was hurting in the back of it; his shoulders were hurting from his neck down his arms to his elbow; his shoulders were hurting from his neck down his arms to his elbow; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 04Feb2021 (at the age of 84 years old) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported he came home after getting his shot, and he felt a little unwell but it was no too bad (04Feb2021). Then, on 11Feb2021, he started having dysentery. On 12Feb2021, he got congestion in his chest and a real deep coughing, and then he started hurting at the base of his neck. The patient used a chest rub which helped break up some of the congestion, but he is still coughing. On unspecified date in Feb2021, the patient also experienced his head was hurting in the back of it, and his shoulders were hurting from his neck down his arms to his elbow; his shoulders had been hurting so bad, he thought they would come off. Now (Feb2021), when he gets up, his back is giving him trouble, and he can't stand up long because of the weakness. His body also seemed to want to walk backward on his heels when he stands up and he is wanting to fall (Feb2021). The patient has been taking his dog out every morning, but it is hard to do that now because he can't stand up that well (Feb2021). Therapeutic measure was taken as a result of the event congestion in his chest. Outcome of the event real deep coughing was not recovered while outcome of all the other events was unknown.   Information on the lot/batch number has been requested.
Received flu vaccine on 12/5/16 at 530pm, on 12/6/16 at 3pm child developed hives on (R)deltoid, face, and buttocks. Child was picked up form daycare given BENADRYL, then at 1030 pm mom went to give BENADRYL again and hives were all over legs, trunk, stomach, back, hands, feet. Saw pediatrician on 12/7/16 at 9am diagnosed with erythema multiforme rash unknown etiology started on prednisone therapy 12/7/16. No fever.
Patient's arm is still sore, red, and swollen among his entire upper right extremity. His most concerned side effect is insomnia.
This case was reported by a physician and described the occurrence of pain in arm post vaccination in a 29-year-old female subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  Concurrent medical conditions included penicillin allergy.  Concurrent medications included CLARITIN D.  No other vaccines were given the same day as ENGERIX-B.  On 8 November 2007 the subject received 2nd dose of ENGERIX B (.5 unknown, left arm).  On 8 November 2007, less than one day after vaccination with ENGERIX B, the subject experienced pain in left arm post vaccination.  The following day she experienced difficulty moving arm without pain and was treated with hot packs.  The same days she had red spots and thought she was "burned" by the hot packs.  She was diagnosed with urticaria or rash from the injection.  One month later, she continues to have arm pain at the injection site.  The subject was seen in a physician's office.  At the time of reporting the outcome of the pain in the left arm and urticaria was unresolved and the other events were unspecified.  Follow-up received on 08 January 2008 via the physician.  She reported that on 09 November 2007, on day following vaccination with ENGERIX B, the subject experienced pain in arm post vaccination, urticaria, difficulty moving her arm, red spots, burn, rash and injection site pain.  She also noted that on the same day that the subject received ENGERIX B, treatment with CHANTIX for smoking cessation was started.  The subject was diagnosed with a possible allergic reaction.  It was reported that the red spots faded quickly to normal skin over four hours and the rash was gone completely in eight to twelve hours.  One month after the ENGERIX B injection the subject states that she needs to take eight MOTRIN daily to control pain which shoots up and down her arm from the injection site.  The physician indicated that she considered that the events could have been associated with the CHANTIX as it was started on the same day as the ENGERIX B was given.  The subject requested to discontinue the use of CHANTIX on 12 December 2007.  The physician reported that the subject was healthy, the vaccine was given by a qualified nurse in standard fashion and "no breech known."  The physician noted at this time that she did not know if the events were serious as they had not resolved and they could become serious.  She considered that the events were unresolved and possibly related to the use of ENGERIX B.
2 Dec 2022: Got Covid. Fever, lethargy, Cough, Congestion, Chills.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 10-OCT-2013 the patient was vaccinated with an expired dose of VARIVAX (Merck) injection (lot # 671232/1272AA, expiry date: AUG-2013 as reported), (dose, route and location unspecified). No adverse effects reported. Additional information has been requested.
received the Covid-19 vaccine. She reports symptoms of Other: Pt daughter reported her mother had a rash on her cheeks, tip of the nose and chin that wasn't there prior to the vaccine administration.   .. I have observed patient sitting comfortably in recliner, no c/o dizziness, sob, itchiness, chest pain, HA , vision  or swallowing difficulties. Note redness on checks , tip of nose, chin and noted red rash on forehead. Pt and daughter state pt has history of whitecoat syndrome. After last set of VS taken- bumps on forehead skin were noted. Pt transferred to ED  via wheelchair daughter present. Treatment/intervention upon noting redness by daughter, pt monitored VS were: 1452: B/P 193/88, P80, R16, O2Sat 96% 1502: B/P 179/75, P76, R16, O2Sat 97% 1515: B/P 174/71, P73, R16, O2Sat 97% Bumps noted on forehead, patient transferred to ED via wheelchair. Daughter at side
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Patient's pertinent medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored M-M-R II (lot # M045392, expiry date: 14-NOV-2018) (dosing regimen and frequency unknown) which was reconstituted with properly stored sterile diluent for prophylaxis. No adverse effects were reported. The temperature excursion was 9 degree C to 25 degree C for 1 hour 35 minutes. The temperature excursion was detected by digital data logger. No previous temperature excursions were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000705: US-009507513-1709USA000706: US-009507513-1709USA000707: US-009507513-1709USA000709: US-009507513-1709USA000667.
29 weeks pregnant, due date 6/16/2021. Healthy pregnancy. No reactions to 1st dose other than sore arm. With this 2nd dose, I experienced chills, fatigue, nausea/vomiting and painful muscle aches from the hips down until about 24 hours post injection. No fever. 100% improved into the 2nd day and no further symptoms.
painful arm; vaccination site movement impairment; Strange headache on the left side of head; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (painful arm), VACCINATION SITE MOVEMENT IMPAIRMENT (vaccination site movement impairment) and HEADACHE (Strange headache on the left side of head) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PAIN IN EXTREMITY (painful arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (vaccination site movement impairment). 06-May-2021, the patient experienced HEADACHE (Strange headache on the left side of head). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (painful arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (vaccination site movement impairment) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant drugs were not reported
chills; body aches; stomach issues; A Spontaneous case was received from consumer, concerning a female patient and age 53, who received Moderna's COVID-19 vaccine experienced Chills, Myalgia/ body aches, Abdominal discomfort/ stomach issues.  The patient's medical history was not provided. The Patient's concomitant medications were singulair, Pepcid, Claritin, fish, oil, zinc, collagen.  On 11Jan2021 , prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (Batch number : 012L20A) via unspecified route for COVID-19 infection prophylaxis.  On 09Feb2021 , prior to the onset of events, the patient received her second of two planned doses of mRNA-1273 (Batch number : 029L20A) via unspecified route for COVID-19 infection prophylaxis.   On an unknown date, she experienced severe chills, body aches, stomach issues and severe congestion.  Since the patient had already taken both the scheduled doses of vaccine, the action taken in response to the events, Chills, Myalgia, Abdominal discomfort was not applicable.  The outcome of the event, Chills, Myalgia, Abdominal discomfort Vaccination site rash was considered to be unknown.  The treatment medications reported to be taken by the patient was Voltaren.
Arm is extremely sore; nausea; headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm is extremely sore), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INJECTION SITE PAIN (Arm is extremely sore), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body aches). The patient was treated with BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) at an unspecified dose and frequency and anti-nausea medication at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Arm is extremely sore), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact