chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had Sore Arm (Expected), had high fever 102.5 Had fever all day 3/24/21 over 101.9-100.3, 3/25/21 had fever 100.1 -99.1 range dropped to normal for a while but went back up to 100.2 where it is at now 6:35pm. I started Tylenol before the shot and had Tylenol  before bed 03:00 am 3/24/21 and woke up at 08:00am with high fever 101.3 and it progress from there . I have been taking Tylenol the whole time. I had Coved19,  09/27/20 was sick for almost 2 weeks. I had high fever and persistent dry cough especially when laying down in bed. My wife caught it from me and ended up hospitalized for 5 days was oxygen deficient it was 85 when she was admitted.
The mother reported an apneic spell requiring stimulation. This happened twice. The pt experienced a hyporesponsive collapse. The pt is now on an apneic monitor and doing well with no further episodes and is scheduled to see a neurologist.
rash that is in he form of blotch , spinal lumbar, left knucle, right had, under left armpit, groin area, lip,
Fever to 103, redness and swelling LUE around site, leukocytosis, headache. ?(L) arm cellulitis vs vaccine reaction.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16May2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 16Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 23May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Nov2022 at 12:45 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2022 at 12:45, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with Paxlovid from 23Mar2023 to 27Mar2023. The patient did not received any other medication in last two weeks at the time of reporting. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300144562 same reporter/patient, different product/AE;
No adverse effects; two patients were administered an expired dose of properly stored PNEUMOV AX 23 (lot R012713 and expiration 03-AUG-2019); This spontaneous report has been received from a nurse referring to a 71 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not provided.         On 06-AUG-2019, the patient was vaccinated with an expired dose of properly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) (lot # R012713, expiration date was reported as 03-AUG-2019; dose and route were not reported) in the left deltoid for prophylaxis. No adverse effects reported. Post expiry memo vaccines and biologics administered did support the administration of expired vaccine. No additional information provided. The outcome of the event was unknown.     The causality between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.   This is one of 2 reports received from the same reporter.
Case died 9 months after completing primary Covid vaccine series. Case had no reported symptoms. He had a history of traumatic brain injury, and while cognitively impaired , did not display any increase of aggitation that normally indicates discomfort. Case died 11 days after testing positive on routine surveillance in his long-term care facility.
Left upper arm red and swollen and painful and warm 2 days after PNEUMOVAX - c/o pain and tenderness.
24 hours after injection the patient experienced swelling at site of injection and up to the base of neck. Also, full body rash.
Was around others who tested positive for COVID-19. Started feeling a cold come on, took a home COVID-19 test and it was positive. After reaching out to Telehealth doctor was prescribed PAXLOVID. Felt better after 5 days, then a week later I started feeling sick and tested positive for COVID-19 again.
FLU-LIKE SYMPTOMS (FEVER AND CHILLS); This spontaneous report received from a vaccine facility via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: 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 subject experienced flu-like symptoms (fever and chills). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms (fever and chills). This report was non-serious.
Large red knot at injection site & 2nd knot at elbow - tenderness & redness (4 in wide) between knots covered in red prickly rash on neck, back, chest & arms - even arm not injected. No fever. Rash area warm to the touch - itching - can still sleep well.
This case was reported by a consumer interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (1st dose received on an unknown date and also had flu-like symptoms, refer case US2021AMR241152).   On 29th November 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2nd dose of Shingles vaccine on Monday before reporting date and that made him/her very sick. The patient stated that he/she did not know what would be worse. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR241152:Same reporter.
Sore arm and lot of muscle soreness and weakness throughout my body! Also extreme tiredness.  This is different than what I  experienced after my 2nd shot.
Vaccine was administered on 5/11/2021 but expired on 5/6/2021 according to 30 day rule. Vaccine was received in clinic on 4/6/2021.
My COVID-19 symptoms started on 01/01/2023 in the evening. I had a bad cough and diarrhea. The cough was severe and  diarrhea was incontinence. I did a home COVID-19 test  on the same day which was positive. I called my doctor the next day and my doctor send in prescription  for Paxlovid. After 2 days of taking Paxlovid  I was feeling sicker and sicker I couldn't told anything down. everything I ate it would come out. So, I  went to the hospital on Friday . They took my temperature and gave me intravenous fluids through  out the night. The next morning they gave me food to eat I was able to eat it and had no problem.   I also had low sodium because I vomited so much.  I will going to my doctor's office next week to find out about my low sodium issue.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 11-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds .5 mLVIs 10 SDV, which had the lot # K008409, with expiration date 04-MAR-2016 (dosage number and route of administration were not reported). No adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced different temperature excursions of 184, 264, 152, 88, 152 and 344 hours. The lowest recorded temperature was 29 F (1.666666667 Celsius degree), 32 F (0 Celsius degree), 30 F (-1.1111111111 Celsius degree), 34 F (1.111111111 Celsius degree) 33 F (0.555555556) and 31 F (-0.555555556 Celsius degrees) respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator(R)". This is one of several reports received from the same reporter. Additional information has been requested.
A non-serious spontaneous report of "we gave expired H1N1 to several patients" was received from a registered nurse/health professional in concerning a 36-month-old male out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date was 12-Feb-2010, that had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
Shingrix : shorter than recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19th January 2023, batch number:z9ad5 and expiry date:4th February 2023).   On 27-FEB-2023, the patient received the 2nd dose of Shingrix. On 27-FEB-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Shingrix : shorter than recommended interval). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 05-JUL-2023 The reporter reported that a immunocompetent adult received a shingrix it showed that the patient got a 2nd dose of Shingrix 40 days later from another pharmacy but patient said that he did not receive a 2nd dose and needed a 2nd dose. The reporter consented to follow up. The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Menveo reconstituted with non-approved diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 2-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA689A, expiry date 20th October 2022) for prophylaxis.   On 24th November 2021, the patient received the 1st dose of Menveo. On 24th November 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.  Additional details were provided as follows: The nurse reported that the patient received dose of Menveo vaccine that was reconstituted with a non-approved diluent, which led to wrong solution used in drug reconstitution. No further information reported. The reporter consented to follow-up.
erythema, pain and bruising at site of injection. Symptoms began with in 6 hrs of injection. Cool compress and analysis.
chills; fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever of 101) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Parkinson's disease since an unknown date.   On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever of 101). At the time of the report, CHILLS (chills) and PYREXIA (fever of 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101 High.         No relevant concomitant medications were reported  No treatment information was provided This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever of 101) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Parkinson's disease since an unknown date.   On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever of 101). At the time of the report, CHILLS (chills) and PYREXIA (fever of 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101 High.         No relevant concomitant medications were reported  No treatment information was provided
No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 30-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # 1621929, expiration date: 06-DEC-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. 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: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:same reporter
April 7, or around this time, I noticed an area around me under arm and back. Little red irritations spots 6-7 hives. I tried to use creams daily to reduce the irritation. I have eczema but I haven't had any issues for years until the very first one. I did reach out at a point to ask my doctor for triamcinolone actinodin cream to reduce the irritation.
Acute on chronic respiratory failure with hypoxia; pneumonia due to COVID-19; chest pain; elevated troponin
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Moderna product on 07/16/2021 and 08/13/2021. It is not known if the individual had a specific symptom onset, but tested positive via antigen test on 01/03/2022 at the skilled nursing facility at which they were a resident. The individual died on 01/07/2022.
6 mins after receiving pfizer vaccine. The Patient experienced light-headedness, a warm flushing sensation around her neck, dry mouth. Vital signs were taken and were within normal limits. Patient was given water to sip on. patient was seated for 30 mins, until she felt better. She stood up slowly and was standing for several minutes before she was permitted to leave.
Resident was found unresponsive with absence of vital signs. Resident was a full code and code was initiated, but resident did not recover and expired.  No prior signs nor symptoms of adverse reactions to vaccine were present between the time of vaccine being given and this event.
Developed rash, warm, red, itchy, got a lump near injection; got a lump near injection site; itchy; Developed rash; red; injection site is still sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Developed rash, warm, red, itchy, got a lump near injection), VACCINATION SITE MASS (got a lump near injection site), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE RASH (Developed rash) and VACCINATION SITE ERYTHEMA (red) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012LD0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE WARMTH (Developed rash, warm, red, itchy, got a lump near injection), VACCINATION SITE MASS (got a lump near injection site), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE RASH (Developed rash), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (injection site is still sore). At the time of the report, VACCINATION SITE WARMTH (Developed rash, warm, red, itchy, got a lump near injection), VACCINATION SITE MASS (got a lump near injection site), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE RASH (Developed rash) and VACCINATION SITE ERYTHEMA (red) outcome was unknown and VACCINATION SITE PAIN (injection site is still sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Patient's physician advised to get an ultrasound for the lump developed at the injection site.  Patient did not take any treatment medications for the symptoms.
General aches and pains all over body; Waves of chills like never before; Headache; Vomiting; vomited on empty stomach; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (General aches and pains all over body), CHILLS (Waves of chills like never before), HEADACHE (Headache) and VOMITING (Vomiting; vomited on empty stomach) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced MYALGIA (General aches and pains all over body), CHILLS (Waves of chills like never before), HEADACHE (Headache) and VOMITING (Vomiting; vomited on empty stomach). At the time of the report, MYALGIA (General aches and pains all over body), CHILLS (Waves of chills like never before), HEADACHE (Headache) and VOMITING (Vomiting; vomited on empty stomach) outcome was unknown.            The patient did not receive any treatment medications.
ADVERSE EVENT NOT SPECIFIED (NOS); This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received j and j baby shampoo (shampoo, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication; and j and j baby powder (powder, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number is not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced adverse event not specified (nos). The action taken with covid-19 vaccine ad26.cov2.s, j and j baby shampoo, and j and j baby powder was not applicable. The outcome of adverse event not specified (nos) was not reported. This report was non-serious.
vaccine administered 11 days after first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered 11 days after first puncture) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered 11 days after first puncture). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered 11 days after first puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-332745.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up information received contain No new information (NNI).
Blood clots-1. 4/14/21 @ 1:35 pm on right side of mouth where the tooth was pulled. Tooth on the right was pulled on 4/9/21 @ 10:00 am.  This is the side the abscess was on & 10 day amoxicillin was prescribed.  2. 4/17/21 @ 12:31 am woke up blood on pillow went to bathroom rinsed mouth out blood cloth came out just like the same as 4/14/21. Prior to vaccine no problems.