chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site stinging in a female patient who received SHINGRIX. On 27th December 2017, the patient received SHINGRIX. On 27th December 2017, immediately after receiving SHINGRIX, the patient experienced injection site stinging and grimacing. On an unknown date, the outcome of the injection site stinging and grimacing were unknown. It was unknown if the reporter considered the injection site stinging and grimacing to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left deltoid. As per the pharmacist there was more wincing of the patient when SHINGRIX was being administered. This case was linked with the case US2017201546, reported by the same reporter.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, chills, change in taste Narrative:
Severe Headaches within 12 hours of the injection, with nausea, sweating, followed by severe vertigo and decreased cognitive abilities, followed by severe depression - hopelessness.  Symptoms of vertigo lasted 8 months, still having ongoing cognitive abilities.   Probable stroke given MRI findings below.   Depression became so severe, hospitalized for 39 days starting 13 October 2021.
Experienced mild vertigo for the first time one day after vaccination. Four days after vaccination was treated in the ER for severe vertigo including dizziness, vomiting and sweats. Resolved with 25mg Meclizine, but mild vertigo has returned twice, both times resolved with Meclizine.
Student received MMR vaccine on 9/4/14 for college entry. Last menses reported as 8/25-8/30/14 TC from pt 9/9/14 - (+) home preg test. Referred to medical group as intends to proceed with pregnancy.
At 2 am following the vaccines I woke up with chills, body aches and a fever. I had those symptoms plus, extreme fatigue, nausea and vomiting for the next 4 days
Patient described a maculopapular rash of the lower extremities first beginning  om 3/18 (2 days after vaccination). On day of first communication (3/19) with patient, he reported marked improvement in rash since day 1 with no treatment. Patient reported that significantly worsened with hot shower on first day. Continuing to follow.
Took the shingle shot and knock me off my feet; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: Took the shingle shot and knock me off my feet). The outcome of the feeling abnormal was not reported.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.   It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient took the shingles shot and knocked him/her off his/her feet. The follow up would not possible as no contact details were available.
rash on arm at injection site and elbow; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash on arm at injection site and elbow) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021A21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE RASH (rash on arm at injection site and elbow). At the time of the report, INJECTION SITE RASH (rash on arm at injection site and elbow) outcome was unknown. Not Provided
Patient felt lightheaded/faint after receiving vaccine. Gave patient juice box and had her sit for approximately 15 minutes. Patient and mom then said she felt better and was ok to go.
Subject dosed with 0.5mL of Covid 19 vaccine. Subject should have received 0.25 mL of the Covid 19 vaccine according to study protocol.
Narrative:  Covid +, Moderna #2, syncope, fall, fracture, no other covid symptoms, rehab s/p fall
got sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 52-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were reported as follows: The age at vaccination was not reported. In 2019, the patient received flu shot last fall and she came home, ate cereal then got sick and after that she felt better. The reporter did not consent to follow up.
the site had a welp and tender.  as the night went on, the welp is larger in size and red and hot to the touch.  it is tender and it is beginning to itch.
Information has been received from a physician concerning a 16 year old female who in October 2006, was vaccinated IM with the third dose of Gardasil vaccine. Subsequently, the patient was diagnosed with HPV. The specific type of HPV was not reported. The patient had received a pap test shortly after completing the series of vaccines and that test was negative. As of 25-OCT-2007, the patient had not recovered from HPV. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. Information has been received from a physician concerning a 16 year old female (119 lbs., 64 in.) who on 06-OCT-2006, was vaccinated IM with the first dose of GARDASIL vaccine (Lot #653650/0702F). The patient received the second dose of GARDASIL vaccine  (Lot #653736/0689F) on 07-DEC-2006 and the third dose of GARDASIL vaccine (Lot #656049/0187U) on 09-APR-2007. Subsequently the patient was diagnosed with HPV. The specific type of HPV was no treported. The patient had received a pap test shortly after completing the series of vaccines and that the test was negative. As of 25-OCT-2007, the patient had not recovered from HPV. No additional information is expected.
Nausea, diarrhea, vomiting, general malaise. Commenced within 12 hours following vaccination.  Treatment:  Saline Fluids (1l)Phenergan (25mg IV and Benadryl 50mg IV) Moderate resolution of signs and symptoms.
3/31/21 Two days after second Moderna Covid vaccine patient "woke up with raised, red, itchy hives head to toe" and "some swelling around her ears and wrists"  No oral/tongue or airway swelling, wheezing, shortness of breath or difficulty breathing. 3/31/21 Patient contacted her primary care provider 4/1/21 Patient reports that her hives / condition has improved
Flublok given to pediatric patients, with no reported adverse event; Initial information received on 14-Jan-2022 regarding an unsolicited valid non-serious case was received from a pharmacist.  This case involves a 5 year old pediatric female patient who was given INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Jan-2022, the patient received 0.5 ml, total dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2125, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid as prophylactic vaccination.  On 13-JAN-2022 the patient developed a non-serious "flublok given to pediatric patients, with no reported adverse event (off label use)" same day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Flublok given to pediatric patients, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event flublok given to pediatric patients, with no reported adverse event.
Flu symptoms 1 hour after getting home . Fatigue, runny nose, red eyes, tired eyes, body aches, diarrhea . Sore arm, swelling, painful to move arm
pt stated was having trouble w/vision in summer, school nurse identified @ start of school & further testing resulted;14MAY98 MD felt it was viral in nature & is looking @ all possibilities;vision is lost in rt eye;
This spontaneous report was received from a licensed practical nurse referring to a 53 year old patient of unknown gender with allergy to naproxen and penicillin (drug hypersensitivity). On 03-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M041085, subcutaneous for prophylaxis in the lower abdominal quadrant for an unspecified reason. Concomitant therapies included escitalopram oxalate (LEXAPRO). On 03-AUG-2017, 1 day after onset of therapy the patient experienced injection site erythema, and injection site swelling. The outcome of injection site erythema and injection site swelling was reported as recovered/resolved.
pt recvd vax & 1 days post vax reported neck stiffness;therapist suggested neck massage;during massage pt exp tingling down rt arm & flexion contractions of 3rd & 4th fingers;seen by MD who prescribed Xanax;weakness & tingling cont;
This spontaneous report has been received from a consumer concerning her daughter of unknown age with cardiac arrhythmia, epilepsy and sensitive to yeast. On an unknown date the patient was vaccinated with the first dose of GARDASIL, (dose, route and lot# not reported). Concomitant therapy was not reported. On an unknown date the patient experienced pain in her arm that moved down to her lower back in the base of the spine. The outcome of pain in her arm that moved down to her lower back in the base of the spine was unknown. Additional information is not expected.
pt found in bed unresponsive on morning of 9/6/99 by mom; paramedics performed resuscitation; pt taken to ER; pronounced dead p/failed resuscitation;
Employee tested positive for COVID-19 at facility via rapid test; reports symptoms of congestion and runny nose.
Started feeling extreme fatigue 3/5/21 about 2 hours after shot was given. Woke up 3/6/21 with extreme body aches, bad headache, mild sore throat and chills which lasted until late evening 3/8/21. Swollen lymph nodes in right under pit and neck. Alternated 1000mg of Tylenol and 800mg of ibuprofen, I was hurting a lot when either wore off.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 19-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2022 as dose 1, single (Batch/Lot number: unknown) and on 27Apr2022 as dose 2, single (Batch/Lot number: unknown) at the age of 19 years for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: CLONAZEPAM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: being asymptomatic and initially testing negative; Positive, notes: Became symptomatic on day 12 with new symptoms and positive rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication details included Clonazepam medication in 2weeks product. Adverse event included patient had rebound COVID within 2 days after completing 10 day quarantine, being asymptomatic and initially testing negative. Became symptomatic on day 12 with new symptoms and positive rapid test. There was no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Diarrhea; This spontaneous case was received on 03-Nov-2020 from other non-health professional via agency (reference number: SEQW20-04730) and concerned a 68-year-old, female patient.  The patient's concurrent condition included alpha gal syndrome. The patient's concomitant included Zocor (simvastatin), simvastatin and Venlafaxin (venlafaxine hydrochloride), all for unreported indications.   On 21-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, route of administration and anatomical location: not reported) for flu prevention.The batch number was not reported.  On the same day, the patient was vaccinated with non-company co-suspect Shingrix (varicella zoster vaccine rge (cho); dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On 22-Sep-2020, one day after receiving Fluad Quadrivalent and Shingrix, the patient got diarrhea. No corrective treatment was applied.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The reporter assessed the event as non-serious.  Company comment: The event of diarrhea is considered as related to Fluad Quadrivalent.; Sender's Comments: The event of diarrhea is considered as related to Fluad Quadrivalent.
7 cm x 7 cm erythematous, well - demarcated lesion on right upper arm. Slight warmth and tenderness. Advised cold compresses, MOTRIN of 6-8 hr prn pain. BENADRYL and steroid cream.
Vaccine administration error, Moderna is licensed for 18 and up and this person is 16 years old.
Information has been received from a physician concerning a 24 week old female, with no medical history and no allergies, who, "2 months ago", on approximately 12-AUG-2006, was vaccinated with a first oral 2 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#653755/0319F).  Concomitant vaccines administered on the same day included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR), a dose of diphtheria toxoid (+) Pertussis acellular 5-component vaccine (+) tetanus toxoid (DAPTACEL), a dose of Hib conj-hepatitis B vaccine and a dose of poliovirus vaccine inactivated (IPOL).  "Three weeks ago", on approximately 21-SEP-2006, the patient developed spasms, described as a "jumping" type movement.  The patient was evaluated in the hospital and released.  It was reported that the patient recovered.  Unspecified medical attention was sought.  No product quality complaint was involved. No other information was provided.  Follow up information from a physician indicated that on 02-OCT-2006 the patient was seen in the office and was observed for 15 minutes and had four episodes of spasms and "jumping-type" movements which looked seizure-like.  On that same day the patient was admitted to the hospital.  While hospitalized, the patient underwent an MRI and a 24 hour EEG both of which were negative for any seizure activity.  The patient was subsequently discharged from the hospital ( date not known).  The patient was seen by the physician on 11-OCT-2006 and was noted to be recovered, as she had not had any additional episodes of spasms and "jumping-type" movements.  Additional information has been requested.
Within 20 minutes of having the injection, bright white lights overtook my vision in my left eye.  At first, it was not fully overtaking vision but just blurring it. Within the first 5-10 minutes of the episode, the bright/white light basically overtook all my vision in my left eye. There also was at one point a bit of jagged light shapes in the upper corner of my left eye vision. After roughly 15 minutes of this, my vision seemed to return to mostly normal though was slightly blurry at the edges. I also had a small headache. I think maybe after 30 minutes total my vision fully returned to normal. I have not suffered anything else since then. My right eye vision was not affected.
This is a spontaneous report from a Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A contactable pharmacist reported that a 68 year old female patient received the first single dose of  PREVNAR 13 on 21Sep2016, for immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced extensive heart problems. It was reported that extensive heart problems occurred after the first pneumococcal 13-val conj vac (dipht crm197 protein). Hospitalization was required on an unspecified date, at the beginning of Oct2017. Clinical outcome was unknown at time of this report. Sender's Comments: There is no plausible mechanism to implicate the suspect vaccine to the occurrence of the serious event "extensive heart problems" due to insufficient information. More information such as medical history and concomitant medications, and even term details including diagnostic workup (EKG, Echocardiography and myocardia enzymes) and the time lag between the vaccination date and the onset of the event are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-2017524137 same patient, same product, different event.
4 of the patients ended up with a rash near the injection site and down the arm; The other 3 patients it almost felt like an infection. The injection site was swollen for almost 2 weeks; The other 3 patients it almost felt like an infection. The injection site was warm for almost 2 weeks; Initial information was received on 14-Dec-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves 10 patients of unknown age and among 4 of the patients ended up with a rash near the injection site and down the arm (vaccination site rash) and the other 3 patients it almost felt like an infection. the injection site was swollen and warm for almost 2 weeks (vaccination site swelling and vaccination site warmth), while patients was treated with influenza quadrivalent recombinant vaccine [Flublok QIV].  Medical history, medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza quadrivalent recombinant vaccine [lot number: QFAA2016 and expiration date: 30-Jun-2021] at a dose of 0.5 ml once via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, 4 of the patients ended up with a rash near the injection site and down the arm (vaccination site rash) and the other 3 patients it almost felt like an infection. the injection site was swollen and warm for almost 2 weeks (vaccination site swelling and vaccination site warmth).  The patient was treated with hydrocortisone for vaccination site rash and antibiotics for vaccination site swelling and vaccination site warmth.  At the time of reporting, outcome of the events was resolved on an unknown date.
Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.            No concomitant medications were provided by the reporter.   Treatment information was not provided.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 47 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Had very sore arm". Clinical course stated by patient was "16 hours after 1st dose, had very severe sore arm. About 18 hours after 2nd dose, felt extreme dizziness, severe headache, confusion, and body aches. I started feeling better about 12 hours later and all those symptoms completely went away by the time I woke up the next morning. About 18 hours after getting the booster, my arm was very sore and started feeling the same way I did after the 2nd shot. I was dizzy, headache, body aches, I took 600mg ibuprofen and within 4 hours I felt completely normal. About 2 months after getting the booster, the arms got all 3 shots in (right) the muscle thirst when I felt weights. It was never hurt before getting these shots. The lot number for bnt162b2 was not provided and will be requested during follow up.
Myalgia, Rash, Rash started back of neck/warm to touch. Neck muscle above shoulders pain Narrative:  Employee went to Employee Health and was sent home 12/30/2020. No medications taken.
This case was reported by a nurse via call center representative and described the occurrence of muscle pain in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain, joint pain, nausea and chills. On an unknown date, the outcome of the muscle pain, joint pain, nausea and chills were recovered/resolved. It was unknown if the reporter considered the muscle pain, joint pain, nausea and chills to be related to SHINGRIX. Additional information was received as follows: The health care professional was the retired nurse who was self reporting this adverse event via health care professional chat to the Agency. The age at vaccination was not reported, however, it could be 61 or 62 years. The health care professional reported that the patient had 48 hours of muscle pain, joint pain, chills and nausea after receiving the dose of SHINGRIX. No other information was available, the health care professional did not have vaccine information.