chrisvoncsefalvay/vaers-outcomes huggingface dataset:
little itchy injection site; swelling injection site; "reddish near 8cm size " on injection site; rash began small and increased for approximately 12 days, then subsided; This spontaneous case was reported by an other caregiver and describes the occurrence of VACCINATION SITE PRURITUS (little itchy injection site), VACCINATION SITE SWELLING (swelling injection site), VACCINATION SITE ERYTHEMA ("reddish near 8cm size " on injection site) and VACCINATION SITE RASH (rash began small and increased for approximately 12 days, then subsided) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Adhesive plaster sensitivity (Area of adhesive bandage becomes red, swollen, itchy) since 02-Feb-2021 and Hypersensitivity reaction (NOS). Concomitant products included FISH OIL, ASCORBIC ACID, COPPER GLUCONATE, TOCOPHERYL ACID SUCCINATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (AREDS 2 VISUAL ADVANTAGE) and CALCIUM, COLECALCIFEROL (CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]) for an unknown indication.    On 12-Mar-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (little itchy injection site), VACCINATION SITE SWELLING (swelling injection site), VACCINATION SITE ERYTHEMA ("reddish near 8cm size " on injection site) and VACCINATION SITE RASH (rash began small and increased for approximately 12 days, then subsided). On 11-Apr-2021, VACCINATION SITE PRURITUS (little itchy injection site), VACCINATION SITE SWELLING (swelling injection site), VACCINATION SITE ERYTHEMA ("reddish near 8cm size " on injection site) and VACCINATION SITE RASH (rash began small and increased for approximately 12 days, then subsided) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.  Concomitant medicines include Fish oil, AREDS-2, Calcium-D  Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received on 17-may-2021. Added reporters middle name, phone number. Updated reporter's mail id, patient initials, height, weight, race. Added other relevant history. Added event  vaccination site rash. Updated outcome of events and stop date of events, event assessment. Updated action taken in product tab and event product details tab.
Dizzy, lightheaded, cold chills, fever, vomiting, diarrhea, body aches, weakness, joint pain, severe headache
Rashes on Left forearm poss from IMMS PPD<Typhoid IPV> c  a procedure x1 mos ago for implantable from NEXPLANON.  .TX: HCTC  cream Apply TID; Ranitidine 150mg 1 tab bid; Benadry 25mg 1 capsule Q4H
Harden  and swollen skin between the area of the vaccine and armpit. Size as big as a "golfball." Was counseled to massage it and ice it to bring down the swelling. If it gets any worse, advised to go to emergency room.
Provider arrived for her Covid vaccine. After vaccine was administered she had an immediate localized reaction of tenderness and slight redness. No other symptoms. Provider was placed in the observation area and given and ice pack for the area and made aware that we do have oral Benadryl available. After about 2-3 min Genoveva alerted me that she was now having some itching/scratchiness to the back of her throat and requested Benadryl. 25 mg PO with water was administered and she was immediately escorted to the ED for evaluation with an RN, per protocol.
Breakthrough case admission after three vaccines Pfizer 4/27/21 Lot# EW0176;  Pfizer 5/18/21 Lot#EW0177;  Pfizer 12/14/21 Lot#330308D
Resident developed elevated temp of 101.2 with malaise, nausea and vomitting
? Reaction to Dtap to RA - after injection swollen, red and warm to touch - mom said 1/2 of arm - (8cm x 10cm).
Headache, Myalgia, chills, cold hands, muscle aches, constant headache Narrative:
experiencing a fever that is continually rising and is up to 101.1 degrees Fahrenheit; Feels bad; hard to talk because of the fever; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date: not reported), via an unspecified route of administration on 09Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced, a fever that was continually rising and is up to 101.1 degrees Fahrenheit, hard to talk because of fever, and feels bad on an unspecified date in 2021. She reported that, since 4 AM today, she had been experiencing a fever that was continually rising, and was up to 101.1 degrees Fahrenheit. She also reported it was hard to talk because of the fever. Referred caller to HCP (healthcare professional) for treatment. The patient was seeking information about this side effect. Yesterday she got her 1st injection of the Pfizer BioNtech Covid Vaccine (09Aug2021). Today (10Aug2021) her temperature kept going up and up, right now it was 101.1. Caller began to say something about her head but did not complete the sentence. Stated only that she felt bad. The patient underwent lab tests and procedures which included body temperature increased 101.1 on an unspecified date temperature keeps goes up and up, right now it is 101.1. Reason for no lot number of Pfizer BioNtech Covid Vaccine. Caller unwilling to complete the report. The outcome of the events was not recovered at the time of this report.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received SHINGRIX. Previously administered products included SHINGRIX (no adverse event). In April 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, influenza-like symptoms and swelling arm. On an unknown date, the outcome of the fever, influenza-like symptoms and swelling arm were recovered/resolved. The reporter considered the fever, influenza-like symptoms and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The patient experienced fever of 100.8 for 24 hours. She also experienced a swollen arm, with the swelling size of 3 inches by 2 inches, the patient also experienced overall flu like symptoms. She did not require hospitalization. She did not require hospitalization. The adverse event was filed as reported. No additional details provided by the representative.
Patient came in for a booster dose of Pfizer on 3/16/22.  The date of birth in the system (10/29/2008) did not match the date of birth on the consent form for the booster.  After reviewing the patient's passport, we confirmed the correct date of birth was 10/29/2008.  We reviewed the consent forms and vaccine dose card for the first 2 vaccines and confirmed the patient's parents purposely put an incorrect date of birth of 10/29/2008 so that the patient could receive a vaccine, however, our facility does not administer pediatric doses and as a result, the child was administered 2 adult doses of pfizer.
Red Spot; Itchiness; Achiness; Soreness in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red Spot), PRURITUS (Itchiness), PAIN (Achiness) and VACCINATION SITE PAIN (Soreness in injection arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 022M20A) for COVID-19 vaccination.     Concomitant products included RIVAROXABAN (XARELTO), FLECAINIDE, LEVOTHYROXINE, OMEPRAZOLE, METOPROLOL and AMLODIPINE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (Achiness) and VACCINATION SITE PAIN (Soreness in injection arm). On 27-Mar-2021, the patient experienced RASH MACULAR (Red Spot) and PRURITUS (Itchiness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Red Spot) had not resolved and PRURITUS (Itchiness), PAIN (Achiness) and VACCINATION SITE PAIN (Soreness in injection arm) outcome was unknown.            Action taken with mRNA-1273 in response to the events were not applicable.
Body aches; Chills; Headache; Fatigue; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Apr2021 at 18:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD), anxiety, depression and allergy to sulfa based medications. The patient had known allergies to pethidine hydrochloride (DEMEROL) and topiramate (TOPAMAX). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included duloxetine (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN) and linum usitatissimum seed oil (FLAX SEED OIL); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 18:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021 at 09:00, the patient experienced body aches, chills, headache, fatigue and nausea. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, chills, headache, fatigue and nausea was resolved on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started 8pm on the day after injection. Very sore arm. Decreased mobility. Warm. Swollen. Has taken TYLENOL, no relief yet. I recommend doing light arm lifts without weights. Start taking ibuprofen every 4-6 hours. Use cold pack to help decrease swelling.
Pt received Vaqta on 1/6/20.  Tuesday, 1/7/20, parents noticed a small rash on torso.  Throughout the day, the rash worsened, spreading.  Called doctor's office.  Instructed to give Benadryl.  Shortly after that, pt's foot started swelling.  Called doctor's office again and was instructed to go to Immediate Care.
Hives, welts, scratchy throat, shortness of breath. Started about 20 minutes after the injection. Did not resolve independently. Took medications and a course of steroids. Took 1+week to resolve with treatment.  Also significant arm pain, swelling and tenderness with warmth. Chills, body aches   Several months later I had a seizure walking into work. Had 3 separate doctors tell me they couldn't exclude the vaccine as a potential cause since no others were identified. I was hospitalized 3 days
Injection given on 08/20.  Approx 3" in diameter red rash.  Rash was hot, tender and swollen as presented on 08/22.  No other signs or symptoms.  No treatment give and no hospitalization required.  On 08/24 rash appeares to have impoved
anxiety; This is a spontaneous report from a contactable consumer. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE and Batch/Lot number was not reported) dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had anxiety. The patient wanted to know that, she was receiving her second dose of Pfizer's COVID vaccine tomorrow 13Feb2021 at 11 Am and was wondering if she could take Lorazepam (generic Ativan) today or a Tylenol after she gets the vaccine.  Follow-up attempts are completed. No further information is expected.  Follow-up (03Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
This spontaneous report as received from a Doctor of pharmacy refers to a patient of unknown age. The patient was vaccinated with an expired 0.65 ml dose of ZOSTAVAX (lot # 671021/0747AA, expiration date 18-AUG-2012) SQ on 18-OCT-2012. No adverse effect was reported. Additional information has been requested.
Pt devel episode of nausea w/vomiting 3 days w/ascending weakness w/dec respiratory effort; Dx GBS
had his shots and got shingles a year later/Suspected vaccination failure; had his shots and got shingles a year later; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The reporter stated that, her husband had shingles a year later administration of shingles shots. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles and laboratory confirmation for shingles were not provided.
A pharmacist reported that a patient missed her third dose of GARDASIL 9 according to the dosage schedule. No additional AE's and no PQC's were reported.; A pharmacist reported that a patient missed her third dose of GARDASIL 9 according to the dosage schedule. No additional AE's and no PQC's were reported.; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 25-FEB-2021, the patient missed her third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date were not provided) according to the dosage schedule (Product dose omission issue) as directed to prevent human papilloma virus infection. No additional adverse event (AE) reported.
Pt. started with small knot at injection site day after vaccine given - 2 days later with redness, swelling, warm to touch- treated with KEFLEX 500mg BID x 10d, prednisone 10 mg BID x 3d.
Pt was provided with covid vaccine, purple top vial. Incorrect amount of diluent 0.9mL instead of 1.8mL. Higher concentration of vaccine provided to patient. No adverse effects at this time. Normal side effects.
Hospitalization for COVID-19 symptoms on dates 6/7/2022-6/9/2022.  Treated with dexamethasone,  vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.?
Roof of mouth started to burn/burning mouth syndrome; gums bled; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 16Apr2021 (Batch/Lot Number: Ew0153) as DOSE 2, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient previously took Quinine, Sulfates and experienced the drug sensitivity. Prior to the 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 vaccines within four weeks prior to the vaccination. Historical vaccine via an unspecified route of administration, administered in Arm Right on 26Mar2021 (Batch/Lot number: Er8730) as DOSE 1, SINGLE for covid-19 immunisation. The patient reported on 16Apr2021, the patient experienced, Roof of moth started to burn, got worse over the next week like I ate hot chili peppers, gums bled, after about a mouth burning lessened, condition comes back without warning, never really goes away. She had been told it was Burning mouth syndrome. The events resulted in visit to Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events was not recovered at the time of the report. Device date was 20Aug2021.   Follow-up attempts are completed. No further information is expected.
Mother got shots at Dr office using 2 different last names of the child. She provided 1 copy that did show the need for a 4th set of immunizations. Immunizations were given. 2 days later, another copy of shots from Dr office were received showing the 4th series of immunizations with the other last name. This resulted in an extra series of immunizations that could have been avoided.
patient brought in by parents for second primary monovalent vaccine but all moderna monovalent 6m - 5y had expired and were discontinued unable to order more. so parents were aware the second vaccine would be pfizer monovalent 6m - 4y.  they were unhappy but agreed. while discussing checklist of patient with parents found out patient had a rash around the neck/shoulder area (circle) for 2 days post vaccination. this was after the patient got a fever of 100.4 and was given baby ibuprofen (never given product name) mom unsure if allergy to shot or medication.  father confirmed temp ranged from 99.6 - 100.4 at worst. baby was not sent to MD. advised mom if any rash after taking medication (Tylenol for babies instead of ibuprofen) go to ER for evaluation of allergy. parents stated understanding. patient waited 30m in waiting room post vaccine and no rash was noted on patient before they left. called mother today 4/14/2023. no reaction no rash no fever post vaccination with Pfizer vaccine. verified with father, also on the phone.  advised mother to not give child ibuprofen derived medication until allergy could be ruled out.
Herpes Zoster - Information has been received from a health care professional concerning a 4 year old female who in December, 1996 was vaccinated with one dose of varicella virus vaccine live (site unknown)  Subsequently the patient was diagnosed by physician with a small patch of zoster on the back of the upper arm.  Additional information has been requested.
4 yo male who received FLUMIST on 22 October and 1 -2 hrs post vaccination, pt developed itching of face/throat, as well as dyspnea and audible wheeze with increased work of breathing. He was taken to ER, received EPIPEN, nebs, BENADRYL, also given PRELONE. Dx with allergic reaction, he received FLUMIST once prior last year, tolerated it fine. He also had several injectable flu vaccines. He has fully recovered. Of note, tolerated egg without evidence of rxn. No other new foods, known bee stings just prior to the reaction.
Vaccinated 5/20/21.  Onset of chest pain 5/26/21.  Admitted to hospital 5/28/21.  Dx of myopericarditis. Treated with bedrest, analgesia, and telemetry monitoring to r/o ventricular arrhythmias.  Patient was recovered 5/30/21  and discharged.
11:30 AM, a few minutes after administering shots Tdap, MCV4 & varicella, she was sitting down waiting and she fainted. Fell to floor, had a seizure type jerking for about 10 seconds, we helped her up and she was alert & talking, had pallor to face & little dizziness. After sitting for about 10 min. Mom took her home.
Slept 8 hours after injection.  Awoke with chills, malaise & sore muscles.  Took self to ER.  Was evaluated & released after few hours assessment.
p/vax pt exp inj site pain, delirium, hallucinatory dreams, lethargy, mottled rash, nausea,high fever 103, sleepwalking, diff arousing from sleep, poss polysaccharide solvent rxn;
His back turned red hot, started running a fever of 101.7 it climbed to 104.0 at one point. Gave him infants Tylenol every 4 hours fever came down to 100.6 then finally broke at midnite on May 9, 2013.  On May 11, 2013 he woke up with a red rash all over his body.  During all of this he would scream like he was being hurt, would not let anyone comfort him.  He was given water and juice because he would not eat anything.
Information has been received from a medical assistant concerning a 27 year old male with no pertinent medical history and no drug allergies, who on 08-MAY-2009 was vaccinated with the first 0.5ml dose of VARIVAX (Merck) (lot # 659604/1743X) SC, and the second 0.5ml dose (lot # 659604/1743X) SC on 18-JUN-2009. There was no concomitant medication. After 2 doses of vaccination, the patient had failed to seroconvert. Titers were taken. The patient sought unspecified medical attention. At the time of the report, the patient did not seroconvert. Additional information has been requested.
Patient desribed tingling in one foot -- affecteing big toe and adjacent two toes [no numbness]
Patient here 1/19 for physical got MMR Dtap/Hib. A few hours after leaving office pt had hives on face and arms. During that night he woke with  vomiting and wheezing. Observed at home and fine in AM just hoarseness in voice and diarrhea.
got a flu shot and still got the flu; Initial information received on 07-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient).  This case involves a patient of an unknown demographic who got a flu shot and still got the flu (Influenza) after receiving INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (unknown latency) it was reported that patient got a flu shot and still got the flu.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown, at the time of reporting.  There will be no information available on the batch number for this case.