chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got 3 vaccinations; Sore; Sleepy; Chills; Temp of 99.6°F; Interchanged covid-19 products; A spontaneous report was received from a consumer concerning a 66-years-old female patient, who received 3 doses of the COVID-19 vaccine. After the 2nd Moderna shot her arm got sore she felt sleepy, got the chills and had an elevated temp of 99.6°F, Interchanged covid-19 products.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included Rosuvastatin 10mgxDay, Paroxetine 20mgxDay, Alendronate 70mg 1xWeek.     The patient received her first of two planned doses of mRNA-1273 (Lot # 027L20A) on 06 Jan 2021.  On 03 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot #013M20A) intramuscularly for prophylaxis of COVID-19 infection.    Caller states that she received 3 doses of the COVID-19 vaccine.  She received the Moderna vaccine on 06 Jan 2021 from a pharmacy.  Then on Monday 01 Feb 2021 she received the 1st dose of the Pfizer's vaccine (and had a sore arm). The Pfizer's dose is EL9265.  The pharmacy called for the 2nd Moderna dose on 03 Feb 2021. After the 2nd Moderna arm got sorer, she felt sleepy, got the chills and had a raised temperature of 99.6°F.  Treatment information was not provided/unknown.    The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the events, sore arm, she felt sleepy, got the chills and had an elevated temp of 99.6°F, Interchanged covid-19 products were unknown/not reported.; Reporter's Comments: This case concerns a 66-year-old female patient who received their second of two planned doses of mRNA-1273 (Lot: 013M20A), reporting Extra dose administered and Interchange of vaccine products, associated with Vaccination site pain, Somnolence, Chills and Pyrexia. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Information has been received from a registered nurse concerning an 87 year old female with no drug allergies who on 12-OCT-2007 was vaccinated SC with a single dose of zoster vaccine live (Oka/Merck) (lot # 658083/0885U). Secondary suspect therapy on 13-OCT-2007 included an IM dose of influenza virus vaccine  (unspecified) (lot # U2510A). There was no illness at the time of vaccination. The patient developed redness, swelling and warmth at injection site. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been received from a registered nurse who stated that the patient on 13-OCT-2007 had his left arm swollen, hot and painful. It was described it as "a size of baseball". The patient was reassured with heat of 2 hours. At the time of reporting the patient's condition was unknown. No further information is expected.
Hypotonia, decreased alertness, hyperglycemia for approximately 8 hours. Negative labs, head MRI, EEG normal. 11/18/05 Reviewed medical records from both hospitals. NW Med. Ctr. - reason for visit was noted as lethargy and a decreased level of consciousness was noted. 11/18/05 Reviewed medical records 2nd hospital and impression was noted as acute episode of encephalopathy lasting for a few hours and most likely a hypotensive-hyporesponsive episode. 3/15/06 D/C summary reviewed and final dx was HH episode as above.
"Covid arm" - red, itchy reaction about a week after injection date (dose 1). As of the date of this form submission, this has been present for 3 days
Rash on head and chest. Seen by doctor 4/9/03. No treatment.
Immediately my vision got blurry, then nausea that hasn't stopped with vomiting, the day of vaccine I was sleeping within an hour, I had a bubble where the shot was given,  I woke up on 8/1  with extreme itch at injection spot , a large Red rash  that has a fever juat in that area of 102. My whole left arm started to break out in hives and I'm missing work from the itch, blurred vision and nausea.
had crazy shakes later in the evening/her arms just started to shake like she had chills but no fever/couldn't control the shaking in her hands or body; had crazy shakes later in the evening/her arms just started to shake like she had chills but no fever/couldn't control the shaking in her hands or body; had crazy shakes later in the evening/her arms just started to shake like she had chills but no fever/couldn't control the shaking in her hands or body; fell asleep exhausted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (2nd dose, UNKNOWN MANUFACTURER), for Covid-19 immunization. The following information was reported: TREMOR (non-serious), CHILLS (non-serious), TREMOR (non-serious), outcome "unknown" and all described as "had crazy shakes later in the evening/her arms just started to shake like she had chills but no fever/couldn't control the shaking in her hands or body"; FATIGUE (non-serious), outcome "unknown", described as "fell asleep exhausted". Therapeutic measures were taken as a result of tremor, chills, tremor, fatigue.  Additional Information: Caller calling to report on herself and during report stated her older sister just her booster and she had crazy shakes later in the evening, her husband was in bed and she was cleaning up and her arms just started to shake like she had chills but no fever. Caller states she couldn't control the shaking in her hands or body. States her husband gave her Ibuprofen and she laid in bed and fell asleep exhausted. States she got her booster at the same place. Caller stated she got the Pfizer Covid booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a physician refers to a 25 year old female patient who was allergic to CIPLACTIN and clarithromycin. The patient was not pregnant. On 16-MAR-2013 the patient was vaccinated intramuscularly with 0.5 ml GARDASIL (lot # 0420AE, expiry date 01-DEC-2014). There was no other concomitant medication. The patient fainted after being administered GARDASIL on 16-MAR-2013 in the physician's office. Ammonia capsule and cold pack were given for treatment. The outcome of fainted was reported as recovered/resolved on 16-MAR-2013. Additional information is not expected.
This spontaneous report was received from a female patient of unknown age referring herself. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date in May 2011, the patient was subcutaneously vaccinated with a dose of ZOSTAVAX (dose, frequency, lot # and expiration date were not reported), for prevention of shingles. On an unknown date, the patient experienced swelling of her wrist (joint swelling) and her hands were "useless" (adverse event). She did not know if ZOSTAVAX "has caused her misery" (feeling abnormal). At the time of the report, she had not recovered from the adverse events. The causality between the adverse event and ZOSTAVAX was unknown. Upon internal review, the event of "her hands were useless" was considered to be serious due to disability. Additional information has been requested.
Vaccination adverse reaction; This spontaneous case was reported by a physician and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. It was reported that reporter accidentally submitted an adverse event report to pfizer instead of moderna. The patient actually received the moderna vaccine. No treatment medication were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
lip swelling, denies any SOB or difficulty swallowing. Adverse reaction treated with Benadryl 25mg IM with improvement within 30 minutes .  Disposition Home with VS stable.
After the fever/chills/aches from vaccine subsided, noticed ringing in both ears, none stop.   Now going on 7 months with constant ringing in ears
Woke up at 2am and felt dizzy, passed out, when I came to I was dizzy every time I opened my eyes I was spinning counter clockwise for the next 6hrs.  Now (2 weeks later) I get dizzy every time I move too fast and I have a constant ringing in my ears.
swelling and pain at the injection sites; pain at the injection sites; This is a spontaneous report from a non-contactable physician. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included lidocaine hcl (Solution for injection) taken for local anaesthesia, hyaluronic acid taken for an unspecified indication, start and stop date were not reported. The physician reported that the patient started to experience swelling and pain at the injection sites days after patient received their 2nd dose of the COVID 19 Pfizer vaccine. The patient was injected approx. 10 months prior with Juvederm VOLUMA with Lidocaine and Juvederm VOLBELLA with Lidocaine and 11 months prior with Juvederm VOLUMA with Lidocaine and Juvederme VOLITE. Treated with Telfast and betacorten steroidal ointment. Symtoms resolved. This record captures events relating to the first injection with Juvederm VOLUMA with Lidocaine. Outcome of the events is recovered on unspecified date.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Based on vaccine-event chronological association and known vaccine safety profile causality between event swelling and pain at the vaccination site and BNT162B2 vaccine cannot be excluded. 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.
(L) arm 9 1/4 cm red - swollen - warm - sl. tender - Sl. tender area - Rx AUGMENTIN.
Numbness, tingling in feet and hands for several days, numbness spread to legs and arms over 1 week, then numbness in face and eye lids with muscle pain in legs, arms, back and shoulders, plus headaches.  Still unresolved as of 11/29/09.12/3/2009 ED, MR for 11/22-11/23/2009, patient with c/o's numbness/tingling and weakness of extremities. Neuro exam wnl, Cardio w/up neg 12/11/2009 Neuro consult records for 11/17 and 12/2/2009. Patient with c/o's of persistent paresthesias and facial numbness, Neuro exams remain wnl, will order EMG/NCV studies then reassess  12/21/09 Neuro consult received for date 12/15/09. DX: RUE paresthesia CC: lower extremity sensory c/o resolved. Paresthesia RUE still present. r/t vaccination.
Pfizer BioNTech COIVD  19 vaccine EUA- Pt. was given pfizer vaccine that was not properly diluted. Should have been diluted with 1.8 cc diluent was actually diluted with 0.8 by mistake. Pt notified of incident  and to watch for reactions, No reactions at time of vaccination or within 15 minutes afterward.
Pleurisy/Pleuritis; A spontaneous report was received from a Consumer concerning a 51 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pleurisy.  The patient's medical history was not provided. Relevant concomitant medications were not reported.   On 08 JAN 2021, approximately 4 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the Left Deltoid for prophylaxis of COVID-19 infection.  He received the vaccine on 08 JAN 2021 and the pain developed 3 days after the vaccination. He received this first dose in his left deltoid. The chest cavity pain was on his left side. The pain lasted for 6-7 days.  On 11 JAN 2021, the patient diagnosed with Pleurisy which is a medically important event and intervention was required. Laboratory details were provided as Chest X-ray, Echocardiogram, Electrocardiogram, Troponin normal and the results were reported as normal. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.   On 11 JAN 2021, the outcome of the event Pleurisy was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Narrative: COVID infection following completion of COVID vaccine series 04/07/21 COVID vaccine dose #1 (J&J) 08/02/21 Pt presents to ED reporting 4 days of fever (100.1), chills, cough, myalgia, headache; CXR normal; discharged home with azithromycin, prednisone; COVID POSITIVE 08/05/21 Pt calls reporting moderate shortness of breath, wheezing, diaphoresis-advised to go to ER; went to ER but left without being seen 08/06/21 Pt reports cough and shortness of breath but is improving 08/09/21 Pt reports improved dry cough and improved SOB
fever, spike in temp; chills; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever, spike in temp) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, the patient experienced PYREXIA (fever, spike in temp) and CHILLS (chills). At the time of the report, PYREXIA (fever, spike in temp) and CHILLS (chills) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient received Moderna vaccines Initial doses in 2021 and Boosters in 2022.  Patient stated that she was scheduled to take her Spikevax on the reporting day. She stated that the doctor told them that there was a new vaccine. Patient reported that with the previous doses they both had, they experienced a fever, spike in temp, and chills with all doses which lasted a short while but did not last.  The patient did not have lot number information for their Moderna vaccines: initial doses and all boosters.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-745394 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745394:husband case (Same reporter diferrent patients)
Severe nausea x 2 days, body aches x 1 day, fatigue, tiredness, moderate soreness at injection site.  All symptoms started the day after the vaccination. Was administered
4-5 days after vaccine,  I awoke in the middle of the night with a fever, aches, chills.  The following several days I had fever that would come and go, ongoing headache, achey.  Today is 2 weeks that I've had the vaccine and I still cannot leave the house due to intermittent sudden headaches and severe exhaustion and an overall thick/swimmy feeling in my head, with loose stool.
Mother called 20 minutes past flu shot stating that child had raised red rash.  Counseled mother to take to pmd.  pt saw Dr at Clinic.  Denies problems with previous vaccine or flu shot
No patient reaction has been noted.; patient received second dose of GARD ASIL 9-1 month and 9 days after first dose instead of recommended 2 month interval/ Vaccine Administered earlier than recommended; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On an unknown date in approximately January 2021, 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) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis.  On 01-MAR-2021 (also reported as 1 month and 9 days after first dose), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe injection, 0.5 milliliter, lot # S028738, expiration date 30-APR-2022 (injection site and route of administration were not reported) for prophylaxis. The vaccine was administered earlier than recommended 2 month interval. No patient reaction has been noted. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S028738; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
1 of 3 nonresponders reported who recvd Engerix-B; reporter stated 1 recvd in buttock; clarification is being sought;
the adverse event its a error on administration. Patient comes to the clinic for her 4th dose (2nd booster) but patient was injected with the monovalent moderna vaccine instead of the bivalent moderna vaccine (0.25 ml administered), the administered vaccine doesn't present any previous temperature excursion or any related problems. We are waiting responses of the immunization system of virginia to see how proceed with the patient, if we need to revaccinate the patient(s) or what else we can do.
No additional AE reported; Improperly stored VARIVAX administered to patient; This spontaneous report was received from a healthcare business professional and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 04-MAR-2022, there was a temperature excursion of -14 up to -10 degrees Celsius (-10.77°C) for 30 minutes, registered for varicella virus vaccine live (oka/merck) (VARIVAX).  On 18-APR-2022, there was another temperature excursion of -11.45 degrees Celsius for 1 hour. On the same date, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot #U022320 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date: 15-JUL-2023 (strength, dose, route of administration, and anatomical location were not provided) administered for prophylaxis (product storage error). There was no additional adverse event reported (no adverse event).; Sender's Comments:  US-009507513-2206USA000626: US-009507513-2205USA007031:
Heart Palpitations the night of and pressure began building on the heart area which has continued for a week.. difficulty breathing. Went to an emergency room and ekg was normal. going back to a doctor today. I believe this is myocarditis or pericarditis.
Mother states 24 hrs after shots were given child's arm became red, firm and warm to touch, was seen by PMD and given tylenol and benadryl 1/27/03 - Mom states arm is normal.
pt recv vax 25JUN96 & 26JUN96 began to exp arthralgias;
RA well controlled until after Moderna Covid vaccine injection #1.  RA flares began several days after the vaccine.  My doctor doesn't believe it's the vaccine but it seems worth reporting as I had not had any flares in 18 months until I received the vaccine.
12/08/2004 Prevnar given. That night he ran fever that ended on 12/9. On 12/9 He also developed iridespread varicorial rash along with target lesions. Consistent with erythema multiforme.
Severe chorinic migraines, 6-16 a month, consuming life; In bed all the time, always in bed; Life has been ruined, can't clean the house; This non-serious case was reported by a other health professional via call center representative and described the occurrence of migraine aggravated in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included migraine (since patient was a young adult, amounting anywhere from 0 to 6 a month).   In SEP-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced migraine aggravated (Verbatim: Severe chorinic migraines, 6-16 a month, consuming life), bedridden (Verbatim: In bed all the time, always in bed) and activities of daily living impaired (Verbatim: Life has been ruined, can't clean the house). The patient was treated with sumatriptan. The outcome of the migraine aggravated, bedridden and activities of daily living impaired were not resolved.   It was unknown if the reporter considered the migraine aggravated, bedridden and activities of daily living impaired to be related to Shingrix.     It was unknown if the company considered the migraine aggravated, bedridden and activities of daily living impaired to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR047301, US2023AMR047842   Additional Information: GSK receipt date: 28-MAR-2023 The patient self-reported this case. The patient had severe chronic migraines and after the 1st injection it was been anywhere from 6 to 16. The reporter had been in bed with migraines for most of the time.  The reporter and the doctors had been trying to ease them up but to no avail.  They were trying all the new medications to get under control, but nothing was working. Since the vaccine the patient's life had been ruined. The reporter was an Artist, he/she was doing shows, and painting all the time but now he/she was just a sick person in bed all the time. The reporter was always in pre-migraine, migraine, or post migraine. The reporter had one good day a week, where he/she might feel good enough to take a shower or cook. The reporter could not do cleaning of the house. He/she was always in bed with the blinds, curtains closed and underneath the blankets pulled over his/her head praying for relief. Sumatriptan helped him/her for some time but not for long time. Pain killer did not helped. It had been 3 years of nightmare migraines consuming his/her life. The reporter did not consent to follow up. For tolerance of 2nd dose, refer case US2023AMR047301 and for tolerance of Sumatriptan, refer case US2023AMR047842, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR047301:Same reporter US-GSK-US2023AMR047842:same patient