chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 12-JAN-2016, the patient was vaccinated with a dose of GARDASIL (lot # L020015 and expiration date August 2017, unknown route), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Metallic taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 10:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 09Apr2021, the patient experienced metallic taste in mouth for 8-10 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event metallic taste in mouth was resolved on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant product reported by reporter.  Nurses had no standing order other than what they had for second booster, when first administering bivalent boosters. So they assumed the same dose as the second booster and administered 0.25 ml instead of 0.5 ml to uncompromised adults. Patient received under dose of 0.25 ml of Moderna Bivalent Booster.  It was reported that CDC had recommended to re-vaccinate the patient with a full dose of 0.5mL.  No adverse events were reported.  No treatment medication reported by reporter.
When she got her 2nd dose she got some numbness on her leg for a few days and then it went away.  She was seeing things on social media regarding a magnet sticking to the injection site, and she tried it and it did the same thing with her and she also put it on her forehead and it stuck there as well.  She just want to find out why this is happening, is there a chip inside her body and is concerned as to why this can happen.   She did call her doctor, but they have not called her back yet.
pt recv vax & exp t100, mobility, problem arm, neck, shoulder & tingling & burning arm neck shoulder;weakness in both arms;joint problems;
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 07-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 07-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 07-Jul-2022).    No concomitant product use was reported.  Reportedly, Patient received half dose.  Date the vial was initially stored in the refrigerator was 04-Jun-2022.    Vial did not undergone any temperature excursions.  No treatment information was provided.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On 26-NOV-2018, the patient was administered an improperly stored dose of PROQUAD rHA lot number R017802 with expiration date of 19-DEC-2019 and lot number R020815 with expiration date of 16-JAN-2020 and VARIVAX lot number R019237 with expiration date of 04-JUL-2020, lot number R022116 with expiration date of 02-AUG-2020 and lot number N023963 with expiration date of 01-SEP-2019, subcutaneously for prophylaxis (dose, anatomical location, lot number and expiration date were not reported). No adverse effects were reported. The vaccines were exposed to a temperature excursions of 6°F to 14°F for 30 Minutes and 15°F to 46°F for 1 hour and 20 minutes while the sterile water diluent did not undergo a temperature excursion. Previous temperature excursions were reported as follows: VARIVAX: Lot number R019237: 6°F to 14°F 30 min, 15°F to 46°F 12 hours 45 minutes. Lot number R022116: 15°F to 46°F 6 hours 45 minutes. Lot number N023963: 15°F to 46°F 7 hours 45 minutes. PROQUAD: Lot number R020815: 15°F to 46°F 7 hours 45 minutes. Lot number R017802: 15°F to 46°F 9 hours 45 minutes. A "data logger" was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1901USA006165.
Breakthrough case admission after 2 vaccines; patient expired Moderna 1/12/21 Lot# 027L20A;   Moderna 2/9/21 Lot#010M20A
Normal labor and delivery on 10/27/2021. Hospital admission within 6 weeks of receiving the COVID-19 vaccine.
My daughter has H1N1 Vaccine November 2009 and 3 weeks later rashes with bump appeared on her body. She has flu vaccine 3 weeks before in Oct 2010  and 3 weeks later rashes with bump appeared on her body. I have not seen this rashes through out the year. She recovered from last year after a month this time she is not recovered yet as it happened 3 days ago and doctor is not sure what it is. As a mother knowing her closely and happened to her 2nd time so I suspect it's due to vaccine. It may be coincidence but I thought to share with you in-case if it's known issue.
VACCINE ADMINISTERED AFTER MORE THAN 12 HOURS OUTSIDE OF RECOMMENDED STORAGE AREA; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a male of unspecified age. 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 was not reported, administered on 30-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-JUL-2021, the subject experienced vaccine administered after more than 12 hours outside of recommended storage area. On 30-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and vaccine administered after more than 12 hours outside of recommended storage area was not reported. This report was non-serious.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 16-FEB-2018, the patient was inadvertently vaccinated with VARIVAX lot # N025932, expiration date on 19-SEP-2019, subcutaneously, for prophylaxis (strength and dose were not reported) instead of ZOSTAVAX for prophylaxis (strength, dose, route, lot # and expiration date were not reported). No adverse effects were reported in the patient.
Tightness of the chest, shortness of breath, Chest pain, Headaches. all started a week to a week and a half after shot was administered, and is on going.  Absolutely no previous issues.
COVID 19 Treatment; COVID 19 Treatment; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Dec2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension/high blood pressure" (unspecified if ongoing); "non insulin dependent type 2 diabetes" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Nausea vomiting rash fever body aches chills tiredness red spots again but day 4 this time
Soon after administration of ZOSTAVAX, pt. developed 4x6in redness and swelling around injection site, lasting 48 hrs.
Bright red area around injection site, feverish, tender, itching, headache, upset stomach sought treatment from primary care physician who advised BENADRYL and TYLENOL. Injection site is almost completely resolved in 5 days.
Symptom recurrence; Cyst; Sleep excessive; Headache; Vaccination related malaise; This spontaneous case was reported by a consumer and describes the occurrence of SYMPTOM RECURRENCE (Symptom recurrence), IMMUNISATION REACTION (Vaccination related malaise), CYST (Cyst), HYPERSOMNIA (Sleep excessive) and HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and Hidradenitis.    No Medical History information was reported.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Solution for injection in pre-filled pen, Citrate free. In September 2021, the patient experienced IMMUNISATION REACTION (Vaccination related malaise), HYPERSOMNIA (Sleep excessive) and HEADACHE (Headache). On an unknown date, the patient experienced SYMPTOM RECURRENCE (Symptom recurrence) and CYST (Cyst). In September 2021, IMMUNISATION REACTION (Vaccination related malaise), HYPERSOMNIA (Sleep excessive) and HEADACHE (Headache) had resolved. At the time of the report, SYMPTOM RECURRENCE (Symptom recurrence) was resolving and CYST (Cyst) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, Body temperature: The body temperature value was 102..         On unknown dates, the patient experienced felt symptoms returned and cysts on neck. In september 2021, the patient experienced reaction after covid 19 vaccine, not feel well, slept 14 hours and headache. On 10 sep 2021, the patient experienced had teamprature 102. In september 2021, the reaction after covid 19 vaccine,not feel well, slept 14 hours, headache and had teamprature 102 resolved.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.
On July 26, 2022, I had a runny nose and I decided to test for COVID-19.  The only symptom I had was the runny nose. I tested positive. My doctor prescribed Paxlovid over the phone, which I took.
Given vaccines DTaP, Hib, IPV (as PENTACEL), PREVNAR and ROTATEQ. Mom says that she cried alot more that day than previous vaccines. She used to vocalize (coo) but seemed to stop and she was not playful/smiling as usual starting immediately after the vaccines and continuing presently.
On Saturday felt fine On Sunday around 1pm started feeling (without any particular trigger) tightness in throat (like something stuck); chest pain in upper right chest.  Called nurse hotline. On Monday morning felt fine On Monday after biking home, felt chest pain which persisted for hours after biking.  Called nurse hotline, which advised to go to ER. ER determined nothing life threatening. Tuesday felt fine.
pt recv vax & exp induration of entire deltoid w/diffuse erythema of arm-not much tenderness;
Pt's rt deltoid - "palm sized indurated eyrthematous macule, moderate severity"
no aditional AE reported; vaccine administered after temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medication, drug reactions or allergies.  On 12-JUL-2021, the patient was administered a temperature excursion Hepatitis A Vaccine, Inactivated (VAQTA) (0.5ml, lot number T035720, with an expiration date 15-APR-2022) intramuscularly for prophylaxis (product storage error). The Hepatitis A Vaccine, Inactivated (VAQTA) were improperly stored at a temperature of 9.6 degrees Celsius for 11 minutes. There wasn't a previous temperature excursion, and this was called because of a data logger. No additional adverse events (AE) was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035720; expirationdate: 15-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Had 3rd capsule & got a fever; started shaking got cold & had stomache cramps; has a history of problems w/digestion of food;
Severe body aches, congestion,  fever, chills, cold sweats. Feel like death.
Patient sat in our waiting area for 15 minutes and no obvious signs/symptoms of reaction to vaccine were reported or noted.  Per patient, after she left our office, at 12:20 pm, she experienced "chest tightness, racing heart rate, could not feel her tongue and throat was tight." She went home, took Benadryl (25 mg) and she was "ok" after that - symptoms subsided.  She followed up with her primary care provider, who advised her not to receive the second vaccination due to this adverse reaction.  Patient informed our office, of her adverse reaction on 2/15/21 - we are reporting today because she was able to provide more information regarding the event.
On 12/21/21 I had severe abdominal pain, nausea, vomiting, fever and chills. Also reduction of smell, taste, and also had diarrhea. Minor cough and nasal congestion.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 27-MAY-2014, the patient was vaccinated with the third dose of VARIVAX, intramuscularly, 0.5 ml (lot # and expiration date were not provided). Nurse stated that on 27-MAY-2014, she had administered the third dose of VARIVAX via the intramuscular route. No adverse effect was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Throat became dry and scratchy during 30 minute wait period in clinic. Patient was kept for an additional 15 minutes, throat felt liek it was closing.  The next day, patient had angioedema surrounding bilateral eyes, with more swelling in the Left upper eyelid
headache; sore joints; arm hurts; felt like hit by a truck; This case was reported by a consumer via call center representative and described the occurrence of headache in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019 16:00, the patient received the 2nd dose of Shingrix. In September 2019, less than a day after receiving Shingrix, the patient experienced headache, soreness of joint, pain in arm and feeling abnormal. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the headache, soreness of joint, pain in arm and feeling abnormal were unknown.   The reporter considered the headache, soreness of joint and pain in arm to be related to Shingrix. It was unknown if the reporter considered the feeling abnormal to be related to Shingrix.  Additional details were provided as follows: On 10th September 2019 at 9:50 AM, the patient reported that, the patient felt like hit by a truck, headache, sore joints and arm hurts as expected. The patient took Tylenol. The patient asked if there was anything else to do regarding these events.
after the first shot I got COVID shortly thereafter; after the first shot I got COVID shortly thereafter; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A 58-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) intramuscular, in left arm for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "after the first shot I got COVID shortly thereafter". Therapeutic measures were taken as a result of drug ineffective and suspected COVID-19. Clinical information: It was reported that the patient was currently being treated in mental health department for major depression. He also had post-traumatic stress disorder (PTSD) prior to the shot he had. It was also mentioned that he had normal (no increased blood pressure, high cholesterol and triglyceride). It was stated that the after the first shot, he got COVID immediately. He received an unspecified treatment for the event.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300100040 same product, patient, different AEs and  dose number;
I didn't have any side affects except for pain and stinging my arm and a really hard lump that lasted for about four weeks. It's tiny now - I can still feel it but for the most part it's down to just a little lump. Went to   Urgent Care - about two weeks after the vaccine. Topical ointment was given to me and was told to take Benadryl. I took it for two days and then went to see the other doctor and he said that the ointment wouldn't do anything and it hadn't so I stopped taking the Benadryl and using the ointment. That doctor wrote down how big the lump was. It was a few cm around. His
Fussy and feverish. Information from 60 day follow-up report states: He still scores as autistic in every assessment. Per follow up report-is still autistic. Is in PPCD classes. We had to move to a new town to a school districk who would give him the services he needed. What is going to be done to help us?
Kinrix vaccine to a 16 month old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-APR-2022 Reporter's Comments:  The reporter stated that Kinrix vaccine was administered to a 16 months old patient. The reporter was upset about the mistake and wanted to be transferred to Medical information. No other demographics or information shared.The reporter was consented to follow up. Additional Supportive Information: The patient received Kinrix at 16 months age, which led to Inappropriate age at vaccine administration