chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adverse Events: Dizziness, Headache, Feeling of going to pass out around 9:00 PM, lack of appetite, very sore arm and small welps around injection site that spread all over body as weekend advanced Treatment: At home treatment of Tylenol (for head pain), Benadryl (for rash) and warm epsom salt bath (for rash)
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacture (pfizer) concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (not specified). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 13-MAR-2021 for prophylactic vaccination. Age at time of vaccination 40 years old. Concomitant medications included bupropion, cetirizine hydrochloride, lisdexamfetamine mesilate, and tadalafil. The patient additionally received non-company suspect Moderna (spikevax) vaccine (elasomeran) (dose number in series 2) (form of admin and route of admin were not reported, batch number: 939904 expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 23-OCT-2021 for prophylactic vaccination. Age at time of vaccination 40 years old. It was unknown whether patient had any adverse events following vaccination with first dose of non-company suspect Moderna (spikevax) vaccine (elasomeran) (dose number in series 2). The patient received second dose of non-company suspect Moderna (spikevax) vaccine (elasomeran) (dose number in series 3) (form of admin and route of admin were not reported, batch number: 026L21B expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 30-MAR-2022 for prophylactic vaccination. Age at time of vaccination 41 years old. On an unspecified date, the patient had Covid-19 symptoms (suspected covid-19 infection) (Dose number in series 3) which led to suspected clinical vaccination failure (Dose number in series 1).  The patient additionally received non company drug Paxlovid (form of admin, route of admin and batch number were not reported and expiry: unknown) dose was not reported, administered on 14-JUN-2022 for covid-19 treatment. Patient received last dose of Paxlovid on 19-JUN-2022. On 22-JUN-2022, the patient experienced rebound covid infection three days after completion of paxlovid. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and elasomeran was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000239917.; Sender's Comments: V0: 20220657382-Covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Received vaccine early morning of 9/29/10 & states feeling itchy with rash/hives by 9:00pm that evening. Reported on 10/1 to me & advised to call her primary doctor since she still has itching & hives.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history an drug reactions or allergies were not reported. On 22-JUL-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX23 (lot # M000592 and expiration date 12-OCT-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
A report has been received from a Health Professional concerning a 3 year old, Female subject, who had been receiving FLUMIST. FLUMIST started on 02-Jan-2013. The patient experienced administered three patient expired FLUMIST/received expired FLUMIST which started on 02-Jan-2013. The outcome of the event of administered three patient expired FLUMIST/received expired FLUMIST is unknown. The report was considered to be non-serious by the reporter. Summary follow-up information received by AstraZeneca/MedImmune 02-Jan-2013 from a Health Professional: Patient's detail was added.
no additional AEs were reported; 21 years old patient received a dose of PROQUAD on 28-SEP-2021; This spontaneous report was received from a medical assistance and refers to a 21-year-old patient of unknown gender. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications.   On 28-SEP-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: recombinant Human albumin (rHA)) (PROQUAD) lot # U009262, 19-SEP-2022, 1 dose for prophylaxis (exact dose, dose #, route and anatomical location were not reported) (inappropriate age at vaccine administration). No adverse events were reported.
Area started with redness 1.5 week after shots. Small head ruptured at injection site, never oozed but crusted over. Dark central crater like scale. Firmness in skin getting bigger, slightly tender, started on abx for presumed injection site infection.
No adverse event; Patient was inadvertently administered an expired vaccine/ Patient received an expired vaccine (two days after expiration); Patient received dose 1 on 26-Aug-2021 and dose 2 on 14-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administered an expired vaccine/ Patient received an expired vaccine (two days after expiration)), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 26-Aug-2021 and dose 2 on 14-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     It was reported that the acute illnesses at the time of vaccination and up to one month before or any chronic or long-standing health conditions were none.     On 14-Mar-2023 at 10:35 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 14-Mar-2023 at 10:35 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administered an expired vaccine/ Patient received an expired vaccine (two days after expiration)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 26-Aug-2021 and dose 2 on 14-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administered an expired vaccine/ Patient received an expired vaccine (two days after expiration)), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 26-Aug-2021 and dose 2 on 14-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administered an expired vaccine/ Patient received an expired vaccine (two days after expiration)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 26-Aug-2021 and dose 2 on 14-Mar-2023).    Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination or at the time of the adverse event were none.   It was reported that patient received an expired vaccine (two days after expiration). After checked with the vaccine manufacturer, it was deemed acceptable and valid. The vaccine administered was Moderna 12 plus Monovalent (Red Cap).   Treatment medication was not provided by the reporter.   This case was linked to GU-MODERNATX, INC.-MOD-2023-715414 (Linked Report). This case was linked to MOD-2023-718113 (Patient Link).; Sender's Comments:  GU-MODERNATX, INC.-MOD-2023-715414:Patient
Can there be a correlation between my second Hepatitis "A" shot and my frequent insect bites. I went to see my doctor at hospital 5 times in May for infection from insect bites and was prescribed antibiotics was never allergic to insect bites before.
pt recv vax 10APR97 & 21APR97 pt to ER w/morbilliform rash that was all over body including hands, chest, & cheeks;pt cheeks were very red & inflamed;fingers had a pin-point dot w/redness all around it;measles-like rash instead allergy ATB
Initial case received from a nurse on 27 June 2011. It pertains to 1 of 2 patients who experienced an adverse event following ADACEL administration. The event for the other patient is captured in case number 2011-03811. A 12-year-old female patient, with no reported medical history, was diagnosed with pertussis 16 months after receiving an intramuscular left arm injection of ADACEL (sanofi pasteur Ltd. lot number C3257, sanofi pasteur Inc. lot number U3042AA) on 03 February 2010. The patient also received a left arm intramuscular injection of MENACTRA (lot number U3333AA) on the same date. The patient presented to her physician on 09 June 2011 with a 3-week history of dry cough, headache, and occasional emesis. She had no complaints of fever. She underwent a pertussis smear, which was negative; subsequent PCR culture on 15 June 2011 was positive for pertussis. She was treated with 2 rounds of ZITHROMAX. Outcome was not reported. Of note, the reporting nurse stated that she was aware of 3 patients who had been diagnosed with pertussis; however, only 2 of the 3 were identified as having received ADACEL. Documents held by sender: None.
This spontaneous report was received from a medical assistant and refers to an unspecified patient of unknown demographics. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date, the patient received an improperly stored dose of PEDVAXHIB injection (involved lot numbers: L051124 with expiration date at 14-OCT-2018 and L014426 with expiration date at 08-MAR-2018; dose and route of administration were not reported) for prophylaxis. The administered dose of vaccine was exposed to a temperature of 32 Fahrenheit (F) degrees for 20 hours. There was no previous temperature excursion reported. Data logger was used to track the temperature. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010622: US-009507513-1612USA013776.
Pt recv vax on unknown day; within 1 month post vax pt dx=Bell's Palsy
Vaccine administration error.  It is suspected that a 1/2" needle syringe was used instead of a 1" needle syringe
by 11PM on 13MAY96 devel temp of 100;14MAY96 early AM fever of 103;mom kept on tempra;t100-101;sl OM & cold;15MAY96 by 6PM t104.5;gave motrin;didn't sleep well & was fussy but consolable;16MAY(6 t100 in AM;
Large, red, warm, painful bump on administration arm at and around site of injection.  Started later in the day after her dose.  This happened on the first dose too and lasted several days.  Also experienced fatigue, body aches.
Developed fever 102.5, abd pain and vomiting for 3 days. Returned to office 7/7/16 for worsening abd pain, dehydration and sent to ED for IVF and to R/o appendicitis.
found unresponsive in crib, unresponsive to resuscitation. deceased. autopsy pending
redness around site of injection; felt weak; no motivation to eat.; swelling around the site of injection; area was hard; it was painful for her to lift her arm; hot area around injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness around site of injection), ASTHENIA (felt weak), FOOD REFUSAL (no motivation to eat.), VACCINATION SITE SWELLING (swelling around the site of injection) and VACCINATION SITE INDURATION (area was hard) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness around site of injection), ASTHENIA (felt weak), FOOD REFUSAL (no motivation to eat.), VACCINATION SITE SWELLING (swelling around the site of injection), VACCINATION SITE INDURATION (area was hard), PAIN IN EXTREMITY (it was painful for her to lift her arm) and VACCINATION SITE WARMTH (hot area around injection). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE ERYTHEMA (redness around site of injection), ASTHENIA (felt weak), FOOD REFUSAL (no motivation to eat.), VACCINATION SITE SWELLING (swelling around the site of injection), VACCINATION SITE INDURATION (area was hard), PAIN IN EXTREMITY (it was painful for her to lift her arm) and VACCINATION SITE WARMTH (hot area around injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
Vaccine coordinator reporting the administration of improperly stored VARIVAX. See Temperature Excursion case 02298756. No PQC reported.   ?    Names of vaccines involved: VARIVAX (W018830 06/14/2024)         ?    Temperature: -5C         ?; This spontaneous report has been received from a vaccine coordinator, concerning 12-month-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On an unknown date, the varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # W018830 experienced a temperature excursion of -5 grades Celsius (C) for a time frame of 12 hours, 0 minutes and 0 seconds. No previous temperature excursion reported, if a digital data logger was involved was not reported (product storage error).   Consequently, on 01-DEC-2022, the patient was vaccinated with one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, (lot# W018830 confirmed to be valid, expiration date reported and stablished as 14-JUN-2024) administered as prophylaxis (strength, exact dose, vaccination scheme, route of administration and anatomical location were not provided) (product storage error).
Breakthrough case admission after three vaccines Pfizer 1/18/21 Lot# EK4176;  Pfizer 2/8/21 Lot# EL9264;  Pfizer 12/17/21 Lot# FD7218
t102-103 AX Friday 18OCT & Saturday 19OCT, rash from top of head down into groin area started Sun 20OCT PM;
Itchy raised vessicles on back; Itchy raised vessicles on back; This spontaneous case was reported by a nurse and describes the occurrence of BLISTER (Itchy raised vessicles on back) and PRURITUS (Itchy raised vessicles on back) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced BLISTER (Itchy raised vessicles on back) and PRURITUS (Itchy raised vessicles on back). At the time of the report, BLISTER (Itchy raised vessicles on back) outcome was unknown and PRURITUS (Itchy raised vessicles on back) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator. Patient used cortisone cream over the counter for redness and it went away.
Rash started 3 days after the vaccine was given, mild rash that waxes and wanes. Hives on forearms
This spontaneous report was received from a medical assistant referring to patient of unspecified gender and age. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 21-SEP-2017, an improperly stored dose of ROTATEQ 2 ml, once, lot number M045544, expiration date 23-JUN-2018 (dose, route of administration and were not reported) was administered to the patient. The dose was stored in temperature 33.8 degrees Fahrenheit for 20 minutes and in temperature 35.8 degrees Fahrenheit for 2 minutes. No previous temperature excursions were reported. No adverse effects have been reported. Data logger was involved. Product quality complaint was not involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA012899: US-009507513-1709USA012898: US-009507513-1709USA011805: US-009507513-1709USA012897.
lymph node swelling, same arm as injection; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant and treatment provided   This case was linked to US-MODERNATX, INC.-MOD-2021-015627, US-MODERNATX, INC.-MOD-2021-015727 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-015627: US-MODERNATX, INC.-MOD-2021-015727:
Associate received the vaccine and was sitting in waiting area. Approximately 20 minutes after she received the vaccine she stated she was having Chest tightness and mild SOB. A MET call was started and the team arrived. BP 160/102, no known history of  HBP.  Associate was taken to the ED  per MD at the scene.
Beginning day following vaccination, patient began experiencing shooting pain down his right arm. Pain comes & goes. Location of pain is from left shoulder to elbow and hand. Occasional pain in armpit and chest. Some bruising at vaccine administration site. No redness or swelling reported.
Had it twice/shots don't work/suspected vaccination failure; Had it twice; Awful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had it twice/shots don't work/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Had it twice) and feels awful (Verbatim: Awful). The outcome of the vaccination failure was unknown and the outcome of the shingles and feels awful were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 Reporter's comment: The case was reported by a consumer via interactive digital media. The patient had it twice which was awful, and those shots did not work. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. Note: As per narrative it is seems that patient had twice shingle episode which was awful so only one suspect coded without dose number.
Rash/heat/Redness/Swelling/itching Left side of face. Emergency Room visit due to list above, Doctor believes to be shingles.
pt comes to ED after LOC (2-3min) during dialysis; c/o generalized weakness x1 wk; positive for COVID; placed on O2; given steroids, ABX; respiratory status worsened; DNR/DNI; during dialysis pt passed away in the hospital
I recorded the Vaccines and was rushing, I had seen the Number 2 on the expiration date of the Dtap and it did not register to me that it was expired earlier this month I had thought it would be the end of the month, After admistering the vaccine I tried to record it but realized it was expired, I went out to the waiting room and explained to Mom I had given patient and expired vaccine, I spoke with our pharmacist to see how soon I can give another Dtap vaccine he explained right away but our clinic was out of stock, I spoke with Mom and she is ok with coming back in for an up to date vaccine of Dtap for her Child
The day after vaccination, my left armpit became mildly sore. By day 2 (post-vaccine), still moderately sore and developed a diffuse moderate puffiness/edema in the anterior axilla.
Patient reported having history of  having ? vasovagal episodes? Patient reported feeling dizzy and anxious Patient provided water and seen by medical team Patient refused medical transport and signed AMA form Patient?s symptoms resolved
CHILD had general malaise, abdominal pain 1 wk post completion of series. Child bitten by racoon about 1 mo ago. Had a GI series. Pain has continued intermittantly for 2 wks now. Has been off school periodically as a result.
Woke up with chills at 2 am Had a fever at the same time Body aches present at same time
Patient arrived at pharmacy on 10/5/17 to pick up antibiotics being sent in from dr. Pt had flu and pneumonia vaccinations given on 10/3/17, and said that her arm steadily kept turning red over the next days. The red part kept getting bigger and bigger until she went to the dr. Dr says it is an infection, rather than a reaction and gave her antibiotics.
Breakthrough case admission after 4 vaccines Moderna 3/4/21 Lot# 030A21A;  Moderna 4/1/21 Lot# 025B21A;   Moderna 11/3/21 Lot# 051F21A;  Moderna 6/1/22 Lot# 049L21A
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unspecified date the patient was vaccinated with ZOSTAVAX (lot number not provided). On an unknown date, the patient experienced tenderness and pain around the injection site. The patient was given an unspecified antibiotic on an unspecified date by an unspecified healthcare provider. The outcome of tenderness and pain around the injection site was unknown. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same reporter. Additional information is not expected.
Pain and redness injection site.  Tired. 2 days later developped tingling/itchy and pain feet/hands, tingling lips and throat, severe neck pain, lumps inner thighs and wrists.  Treatment: benadril, ibuprofen, zyrtec