chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were provided as follows: This case was reported via chat. The age at vaccination was not reported. The patient enquired regarding symtoms of fever and shivering would show up within 1 day or later. The patient refered symtoms of fever and shivering related to vaccine, but did not experinced it. About a week or so later the patient had fever and aches.
Information has been received from a physician assistant concerning a female patient who on unspecified dates was vaccinated with all three 0.5 ml doses of GARDASIL. At the time of vaccination the patient was not yet sexually active. Subsequently, after all 3 doses of GARDASIL the patient became sexually active and developed genital herpes. Unspecified medical attention was sought. It was noted that after the treatment the patient had two Papanicolaou (PAP) tests done. The first test came back atypical squamous cells of undetermined significance (ASCUS) and the second test came back high risk human papilloma viral (HPV). At the time of the report, the patient's status was unknown. Additional information has been requested.
Information has been received from a nurse practitioner and an office manager concerning a 34 year old female who on 13-Nov-2006 was inadvertently vaccinated SC with a 0.65 ml dose of varicella-zoster virus vaccine live instead of a dose of varicella virus vaccine live. The office manger noted that the person giving the injections hadn't seen the new varicella-zoster virus vaccine live and "just reached in grabbed that one". The varicella virus vaccine live was hidden from view. Additional information was received from a consumer concerning his 35 (also reported as 34) year old wife with no allergies or medical history who on 10-Nov-2006 (also reported as 13-Nov-2006) was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. The reporter did not known why the vaccine was given in error. She also developed a red, warm injection site reaction which has resolved. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. Additional information has been requested.
Friday April 2, 2021 ? Got Phizer COVID shot at noon.  No reactions that day  Saturday 4/3 ? Woke up to body aches, fatigue, and sweats.  Fever of 100.4 most of the day. ? Stayed in bed and slept until 6:00.  Did not eat or drink much today. ? Felt dizzy when I got up.  Drank water and had 2 bananas and ½ a bowl of chicken soup. ? Felt the same all day.    Easter Sunday 4/4  ? Felt better but still fatigued.  Body aches were not as bad, and temp was normal. ? Drank a lot more water and had a little to eat in the morning. ? Kids came over for Easter Brunch.  We ate about 11:00. ? Whenever I stood up quickly, I got very dizzy.  Happened quite a few times throughout the day (I never had this problem before). ? When walking into the kitchen from outside, I got very dizzy and could not get up the steps on my own, I just kind of stopped.  Did not black out but felt close.  The kids helped me in, and I sat down.   ? Drank more water and took it easy. ? The kids left about 2:00.  Before they left, friend told me to go to a fire station and have my blood pressure checked. ? 2nd friend took me to 3 fire stations before we found one open, south of hardware store? They were nice, took my blood pressure, oxygen level and an EKG. ? They thought I was experiencing A-FIB.  Told me to go to the emergency room right away.  Wanted me to go by ambulance but I told them 2 friend could take me.  They recommended medical center , which was better equipped for this.   ? Got to the emergency room about 4:30 and checked in. ? Nurse checked me out and asked a lot of questions.  I gave her the EKG print out from the fire station.   ? She had us go back to the waiting area and was going to talk with the doctor.  ? After a while they took us back to emergency ward and plugged in a saline bag and monitor.   ? They hooked me up to an EKG machine again and took a reading. ? The doctor. came in and diagnosed me with A-FIB and discussed what it is, what can happen and how to treat it. She said that this could be a temporary episode of A-FIB or it could be permanent. ? She put me on a blood thinner and had me make an appointment with my cardiologist, Dr.    Monday 4/5: ? Felt better got dizzy a couple of times but drank a lot of water and ate. ? Finally got the blood thinner prescription at about 4:00.  Tuesday - Friday: ? Kept drinking a lot of water.  No real issues with dizziness.
A nurse reported a non-serious case of vaccination from last year's FluMist involving a six-year-old female. No medical or drug history information has been reported for this patient. The patient received a dose of FluMist on 15-Nov-2007. The nurse reported that a coworker gave last year's FluMist vaccine to the patient. The nurse was familiar with the frozen product and did not noted the vaccine expiration date. The product was hand awaiting return permission from the VFC agency. No ill effects were observed as of 27-Nov-2007. No additional information available. The child was also vaccinated with the 2007-2008 FluMist vaccine on 15-Nov-2007. The reporter did not provide a causality assessment for this medication error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Linked case MDBI-0006197 report for a sibling.
Someone we know got both doses of the Moderna Covid-19 vaccine & died from Covid.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Someone we know got both doses of the Moderna Covid-19 vaccine & died from Covid.) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced COVID-19 (Someone we know got both doses of the Moderna Covid-19 vaccine & died from Covid.) (seriousness criterion death). The patient died on 23-Nov-2021. The reported cause of death was covid-19. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported It was reported that patient took both doses of the Moderna Covid-19 vaccine and died from Covid.  Company Comment: This is a fatal case that concerns a patient of an unknown age and gender, with no relevant medical history reported, who experienced the unexpected fatal AESI event of COVID-19. The event occurred after an unknown time interval after both doses of the mRNA-1273. The rechallenge was not applicable as no additional dose is going to be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a fatal case that concerns a patient of an unknown age and gender, with no relevant medical history reported, who experienced the unexpected fatal AESI event of COVID-19. The event occurred after an unknown time interval after both doses of the mRNA-1273. The rechallenge was not applicable as no additional dose is going to be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: COVID-19
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-FEB-2019, the patient was vaccinated with an improperly stored doses of VARIVAX lot R018933, expiration date 02-JUL-2020 and lot R017641, expiration date 20-JUN-2020 subcutaneously (dose was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of - 6 degrees Celsius for 2 hours. Sterile diluent used was properly stored. Data logger was involved. There were no previous excursions reported.
Coughing at night and off/on during day. Headache is main complaint (off and on). No fever noted. No vomiting currently. Did have "upset" stomach after vaccination.
2 doses of Hep B vaccine given (Pediarix and Energix-B). No adverse reactions noted or reported.
This spontaneous report was received from an office manager and refers to a 15 months old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 30-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA0044667: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004477:  US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
headache; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 18Aug2021 (Lot number: EW0169) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Anatomical site of injection:  Right Arm, Route of administration: Intramuscular, Batch/Lot number: EW0161, Expiry date: Jul2021), administration date: 28Jul2021, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 19Aug2021, outcome "unknown", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 19Aug2021, outcome "unknown", described as "Sore arm".  Additional information: No new side effects noted with second shot only had a sore arm and a headache the next day.  No follow-up attempts are possible. No further information is expected.
injection site pain, extreme tiredness over 12 hours of sleep and still felt groggy and fatigued. Headache, muscle pain, chills, joint pain, fever, feeling unwell, swollen lymph nodes and arm pain.
FATIGUE; LIGHT HEADACHE; This spontaneous report received from a consumer concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced fatigue, and light headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and light headache. This report was non-serious.
I was exposed on 08/18/22, I started feeling achy, sore throat, hot but no fever, cough, runny nose, stuffy head, headache. I would describe it as the worse flu or cold I ever had. On 08/25/22, I used a home COVID-19 test that came back positive. I called my doctor's office we discussed my symptoms and decided not to prescribe medication. The symptoms were gone within two to three weeks with the exception of the cough and fatigue. They lasted for six weeks.
32 y/o patient approximately 1 Mar 10. Myopericarditis. Airlifted out of the country. Tx 18 days at medical center.
Follow up information provided birthweight, name if additional suspect vaccine and country where vaccines administered. Information regarding Prevnar was received from a healthcare professional regarding a 2-month-old male patient who experienced a temperature greater than 101^F. At 2 months of age, the patient received the first dose Jan-2006. The patient also received a dose of Act-Hib in Jan-2006. The patient experienced temperature greater than 101^F in Jan-2006. In Jan-2006, the patient developed a temperature of greater than 101^F after receiving his first dose of Prevnar and Act-Hib. The patient's outcome is unknown. See related case: HQWYE221314JUN06 (adverse event, non-expedited).
ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPERCAPNIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY
This case was reported by a nurse via sales rep and described the occurrence of taste metallic in a 51-year-old female patient who received FLULAVAL QUADRIVALENT. On 19th October 2017, the patient received FLULAVAL QUADRIVALENT. In October 2017, less than a week after recovering FLULAVAL QUADRIVALENT, the patient experienced taste metallic. On an unknown date, the outcome of the taste metallic was unknown. It was unknown if the reporter considered the taste metallic to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The reporter was immunization coordinator. The lot number was different for both patients. The patient experienced metallic taste for 10 minutes. This case has been linked with case US2017GSK163230, as reported by same reporter for same event.
Hospitalized 11/12/21 for septic thrombophlebitis of left internal jugular vein. PICC line removed from right arm 11/27/21 and 3 days later had acute DVT of right arm.
Subsequent to receiving one dose of varicella virus vaccine live on 7/2/98, the pt discovered she was pregnant on 7/27/98 (LMP 6/12/98). Follow-up information reported that in November of 1997, the pt had a miscarriage. Additional follow-up from a physician reported that on 11/5/98, the pt experienced sinusitis and on 11/9/98 an ultrasound revealed bilateral choroid plexus cysts which subsequently resolved. The ultrasound also showed the fetus to be small for gestational age. The pt gave birth to a healthy, normal live born male infant on 3/1/99.
On or about June 15th, patient first noticed minor eruption associated with itching sensation.  At annual physical on June 22nd, Nurse Practitioner observed that the eruption had multiple sites, non-bilateral, and diagnosed shingles, potentially associated with the patient's recent 2nd dose of the COVID-19 vaccine.  The patient was prescribed a 7-day course of Valtrex, completed on June 29th, during which period the symptoms abated, with no recurrence since the anti-viral course was completed.
Patient seen in retail health clinic 6 days after vaccine. Mother states has seen PCP twice for vaccine reaction and coming to clinic for strep test to rule out strep throat. Reports after receiving vaccine patient had fever, chills, fatigue, ear pain, rash, heart palpitations, abdominal pain, and mucus in stools. Has been giving acetaminophen for fever and benadryl for itching as directed by PCP. Afebrile at time of visit,  fine papular rash observed, slight erythema to throat. Strep test negative at visit.
she started experiencing an ache/heaviness in her arm / I have a pain in my bicep when I try and pick up a cup of coffee; she started experiencing an ache/heaviness in her arm; a "drippy nose."; the needle punctured a nerve in her arm; This spontaneous report was received from a 71-year-old female patient who referred to herself and a licensed practical nurse (LPN). She had no concomitant medication and no pertinent medical history. Her historical drugs included levofloxacin (LEVAQUIN), to which she reported allergy. Her historical vaccines included pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) and pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). The patient reported to have contracted pneumonia after being vaccinated with unspecified pneumonia vaccine (captured in case 2202USA004709).  On 14-JAN-2022, the patient was vaccinated with one dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection (site of administration, lot# and expiry date were not provided) intramuscularly for pneumonia prevention.   On 21-JAN-2022, the patient experienced ache and heaviness in her arm, and a drippy nose. She stated she had pain in her bicep when she tried and picked up a cup of coffee. The patient was informed by a pharmacist the pain she was experiencing could have been caused if the needle punctured a nerve in her arm, however it was unconfirmed. The patient was treated with ibuprofen (ADVIL) for events (also reported as "for inflammation"). The LPN advised she did not have additional information regarding the reported adverse events post the vaccine administration, as the patient was not vaccinated at their's office. The patient sought medical attention form a healthcare professional. The outcome of events was reported as not recovered.  The causal relationship between Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and the events was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA004709:
About 10 days after the shot I could not breath.  It came on over the course of a few hours to the point that my doctor told me to go to the ER.  There they administered a nebulizer and a prescription for prednisone for 4 days which helped.   24 hours after the prednisone prescription was complete, the breathing difficulty resurfaced and I was back in the ER again.  This time they gave me a longer course of prednisone (10 days) that reduced over that time.  Once that course was complete the breathing difficulty started again, but not to the point of an ER visit.  My GP then prescribed a smaller dose of Prednisone over 6 days combined with an inhaler.  That has helped.  I don't really know if this is related to the vaccine.  My suspicion is that the vaccine may have revved up my immune system and because of my autoimmune disease it attached my airway.  But that is just a guess.
fatigue, low grade fever, nausea, dizziness, muscle & joint pain, weakness; sx began on 11NOV94 & worsened till 27DEC94- when pt able to get out of bed; since then they have improved sl, but still unable to work;
Itching; COVID arm; Radiating; Feeling hot; Looks like a softball; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), INJECTION SITE REACTION (COVID arm), PAIN (Radiating), FEELING HOT (Feeling hot) and INJECTION SITE MASS (Looks like a softball) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes (PME includes diabetes.) since an unknown date. Concurrent medical conditions included Penicillin allergy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METFORMIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PRURITUS (Itching), INJECTION SITE REACTION (COVID arm), PAIN (Radiating), FEELING HOT (Feeling hot) and INJECTION SITE MASS (Looks like a softball). At the time of the report, PRURITUS (Itching), INJECTION SITE REACTION (COVID arm), PAIN (Radiating), FEELING HOT (Feeling hot) and INJECTION SITE MASS (Looks like a softball) outcome was unknown.            No treatment information was reported.    This case was linked to MOD-2021-032770 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Feb-2021 and was forwarded to Moderna on 16-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), INJECTION SITE REACTION (COVID arm), PAIN (Radiating), FEELING HOT (Feeling hot) and INJECTION SITE MASS (Looks like a softball) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes (PME includes diabetes.) since an unknown date. Concurrent medical conditions included Penicillin allergy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METFORMIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PRURITUS (Itching), INJECTION SITE REACTION (COVID arm), PAIN (Radiating), FEELING HOT (Feeling hot) and INJECTION SITE MASS (Looks like a softball). At the time of the report, PRURITUS (Itching), INJECTION SITE REACTION (COVID arm), PAIN (Radiating), FEELING HOT (Feeling hot) and INJECTION SITE MASS (Looks like a softball) outcome was unknown.            No treatment information was reported.    This case was linked to MOD-2021-032770 (Patient Link).