chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Booster only.; Booster only. Had side effects .Pain in left arm , sore left arm injection site pain. Felt better in 2 days; Pain in left arm; sore left arm injection site pain; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  A 43 year-old female patient (pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Nov2021 (Lot number: Fh8027) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient is expected to deliver a baby(s) on 03Jul2022. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (previous dose product=COVID 19, previous dose brand=Pfizer, previous dose lot number=En6208, previous dose administrator route=Intra muscular, previous dose administration date=19Mar2021, previous Dose Number: 2, Previous Dose vaccine location : Left Arm), administration date: 19Mar2021, when the patient was 42 years old, for COVID-19 Immunization; Bnt162b2 (previous dose product=COVID 19, previous dose brand=Pfizer, previous dose lot number= En6205, previous dose administrator route=Intra muscular, previous dose administration date=26Feb2021, previous Dose Number: 1, Previous Dose vaccine location : Arm Left), administration date: 26Feb2021, when the patient was 42 years old, for COVID-19 Immunization.  The following information was reported: EXPOSURE DURING PREGNANCY (non-serious) with onset 18Nov2021, outcome "unknown", described as "Booster only. Had side effects .Pain in left arm , sore left arm injection site pain. Felt better in 2 days"; IMMUNISATION (non-serious) with onset 18Nov2021, outcome "unknown", described as "Booster only."; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Pain in left arm"; VACCINATION SITE PAIN (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "sore left arm injection site pain". Therapeutic measures were taken as a result of pain in extremity, vaccination site pain. The was patient was treated with Tylenol.  No follow-up attempts are possible. No further information is expected.
Adult INFLUENZA vaccine - FLUARIX - was mistakenly given instead of pediatric hepatitis B vaccine - ENGERIX B- to a newborn. The products both made by GlaxoSmithKline look almost identical. The very small lettering on the syringes and a small muted colored band - light gray for the FLUARIX and olive for the ENGERIX B- are the only identifiers of the products. The medications highly similar appearance made it very easy for these medications to be mistaken for each other and administered.
Felt sick/slightly feverish 12 hours after shot, hard to sleep. Day after shot was mostly normal, though a little under the weather.  After another day, all cold symptoms were gone.   Tinnitus in the right ear started 3 days after 2nd Pfizer COVID shot. Initially was only audible at night, when sleeping in a quiet room, but after 2 days became audible during day.  Tinnitus presented as a high pitched steady ringing in the ear. Triggered intense anxiety and perception of the tinnitus increased to almost debilitating levels. Mental health counseling and prescription of daily amitriptyline to help with sleep and lorazepam to take as needed for anxiety has helped cope with tinnitus and associated mental aspects. Ringing still persists after almost four weeks after it started, but is perceived to be less loud now.
Started with burning itching palms, fingers and hands on the first day of symptoms.  Itching elsewhere, hives and redness develop after scratching.  Resolves with Zyrtec.  Reoccurs every few days.  Always in the evening, frequently after activity.  Frequency has diminished some but persists.
This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired dose) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On 17-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (receiving expired dose). Vaccine was expired on the 13 and was given on the 17 Aug 2022. The vial was not exposed to a previous temperature excursion. didn't have information about the lot number of the used vial or the date that the vial was initially stored in the fridge as they discarded the vial No concomitant medication were given. No treatment information were given.
2 days after vaccination I suddenly came down with shaking chills, fever, severe aches, headache. Tapered off over a course of two weeks. Still fatigued, no appetite.
Case completed the 2 dose Covid vaccination series in April of 2021, and was admitted to hospital for treatment of Covid pneumonia on 7/28/21.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date in January 2015, the patients were vaccinated with GARDASIL (lot # K004204, 0.5 ml, intramuscular). It was reported that the vaccines which was administered were improperly stored. No adverse effects were reported. The outcome of the two reports from same reporter link (1507USA006655). Additional information has been requested.
Diffuse erythematous swelling on the inner side of the right arm around the vaccine site. Non tender . Mildly firm and warm to touch. Increased girth of the arm due to the swelling ( 22 cms proximally and  19.5 cms distally ) . Swelling is rectangular, 6 inches long and 2.5 inches wide.
Patient reports redness and tenderness at injection site.  She reports to have been diagnosed with cellulitis at injection site by doctor post vaccination.  Doctor states that injection was given in wrong site in left arm.
Got soreness from the first covid shot.; This is a spontaneous report from a contactable consumer or other non hcp (patient) via Pfizer-sponsored program. A male patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. The patient experienced soreness from the first covid shot. Reportedly, nurse put the needle in and said nothing was coming out, got soreness from the first covid shot. Patient did not feel any soreness from the second shot. No unaddressed medical questions referred or forwarded to Medical In-formation. The outcome of event was unknown on unspecified date.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv vax 9AM that eve MN pt felt feverish (i.e. chills) lt arm was hurting; cont to feel feverish during noc-temp 102; 23APR95 noticed localized redness & tender to touch; tender, hot, red; neck stiff;
Body ache, fatigue, mild headache up to the second day I had chills for the first day, then they went away and didn't happen again. I am on the 3rd day, and I feel tenderness in my legs and a tendency to numbness that still does not stop. It is not constant, it is every so often when I am pressing my feet on something for a long time.
Pt called 12/20/06 and reported that on the evening of 12/18/06 she developed generalized itching and hives, no other symptoms. She was instructed to take 25mg Benadryl Q 6H when needed. No further vaccinations will be administered per Dr.p report has been received from a registered nurse concernng a 31 year old female with drug allergies to DEPAKOTE, LORTAS, NEURONTIN, VALIUM and FIORICET. On 18-DEC-2006 (also reported as 18-DEC-1976) the patient was vaccinated with her first dose of GARDASIL (Lot number 65450/1161F) intramuscularly in the left deltoid. On 18-DEC-2006 in the eveneing, the patient experienced generalized itching and hives. The patient was instructed to take BENADRYL 25 mg every 6-8 hours until the itching subsided. The patient was informed that she will not be receiving the additional 2 vaccinations. Additional informationis not expected.
DTaP received at local hospital E.R. I suffered pain, soreness and decreased use of left arm for several months. I now believe it was Deltoid Bursitis. It is still not completely resolved and still bothers me some.
Received Menactra vaccine Saturday and developed headache, generalized abdominal pain, vomiting, diarrhea, chills 24 hours after vaccine.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11A21A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information reported.   This case was linked to MOD-2021-061031 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up received on 07-JUL-2021 ,event outcome updated and declined consent for follow up.
Fever 100.5; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.5) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    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 PYREXIA (Fever 100.5). At the time of the report, PYREXIA (Fever 100.5) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Med Info Agent AE Submitted  After 24 of 2nd shot I have a fever of 100.5 Yes, plus I had COVID 3 weeks ago
hearing loss; This is a spontaneous report received from non-contactable reporter(s) (Nurse), Program ID: (175794).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "hearing loss". The causality was reported as related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on the information currently available, a causal association between the reported event hearing loss and BNT162b2 cannot be excluded. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
Patient was given AFLURIA preservative free vaccine that only indicated for 18 years or older.
patient was given a booster dose of vaccine that expired on Jun2020, no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional (patient's mother). This case involves a 15 month old male patient was given a booster dose of HIB (PRP/T) VACCINE [ACT-HIB] (Batch number was not provided) (Expiry date: On an unknown date in June-2020) via unknown route in unknown administration site for prophylactic vaccination on an unknown date in Feb-2021 (expired product administered)  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported that the pediatrician's office called in the adverse event but the mother has more questions. Mother wanted to know if there are safety implications or dangers to children who received an expired dose. Mother asked for the shelf life of ActHIB.   She asked if there are safety implications or dangers for taking expired dose and expired product (system required document) SRD was discussed with her.   She also asked for the shelf life and it was discussed that expiration date given that vaccine is stored appropriately is considered. She asked if there are number of months or years indicated for the shelf life but call was disconnected before caller was assisted with this question.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
This spontaneous report as received from a nurse via other company, refers to herself, currently 72 years old female patient. The patient's concurrent conditions included drug allergy to gabapentin, unspecified nonsteroidal anti-inflammatory drug, tramadol, tetanus antitoxin, lactose intolerance. On an unknown date, the patient was vaccinated with a booster dose of PNEUMOVAX 23 in the left arm (dose, route, lot # and expiration date were not reported). On an unknown date, the patient experienced cellulitis of left upper arm. The outcome of the event was unknown. The relatedness between the event and the vaccination with PNEUMOVAX 23 was not provided. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a 69-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (a bad case of chickenpox as a child). Concurrent medical conditions included rheumatoid arthritis. On 8th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 10 hrs after receiving SHINGRIX, the patient experienced sinus infection, labyrinthitis, inner ear disorder, vomiting, cold sweat, diarrhea and difficulty in standing. On 20th August 2018, the patient experienced hearing loss (serious criteria GSK medically significant). The patient was treated with Antibiotic (Drug Name Unknown). On an unknown date, the outcome of the hearing loss, sinus infection, labyrinthitis, inner ear disorder, vomiting, cold sweat, diarrhea and difficulty in standing were unknown. It was unknown if the reporter considered the hearing loss, sinus infection, labyrinthitis, inner ear disorder, vomiting, cold sweat, diarrhea and difficulty in standing to be related to SHINGRIX. Additional details were provided as follows: The patient was a friend of the reporter. Ten hours after vaccination, the patient had vomiting and diarrhea. The patient had inner ear fluid imbalance. The patient went to the emergency room from 5 PM to 11:30 PM.  The patient had a computed tomography (CT) scan and was diagnosed with a sinus infection. The patient had been prescribed an antibiotic for treatment. The patient had a hearing test on the reporting date and had been diagnosed with hearing loss in her left ear (latency twelve day). This case has been linked with US2018151138 and US2018151143, reported by same reporter.
Patient was observed for 30 minutes. After that time, patient stated to the observer, RN her left arm "hurt all the way down" and "chest felts heavy". Encouraged patient to go to ED, but patient declined. Nurse assessed patient who then felt short of breath. Two RNs took patient, via wheelchair, to ED. Husband was with patient. ED triage took patient back and husband checked in patient.
Customer was unresponsive, clammy, pale. Customer received 0.3 mg of Epi IM in right thigh, 911 called and customer laid to floor with legs elevated. Customer became responsive after Epi. EMT arrived and vitals wnl. Customer and her mother declined hospital transfer.
Extreme discomfort at injection site, extreme tiredness, nausea, headache, painful to move
This case was reported by a nurse and described the occurrence of decreased antibody response in a 21 year old female pt who received Engerix-B injection for prophylaxis. The pt received immunizations with Engerix-B on 6/27/03, 8/11/03 and 12/19/03 (lots ENG5379A4, Eng5379A4 and ENG5456A4 respectively). The vaccine was administered on a 0, 2, and 6 month schedule rather than the recommended schedule of 0, 1, and 6 months. Approx. 2 months after receiving the 3rd vaccination with Engerix-B, on 2/18/04, a hepatitis B surface antibody titer measured 4.2 mIU/mL. The nurse consider the event to be related to vaccination with Engerix-B.
redness, firmness, and heat in upper arm around the injection site covering an area about 1.5" in diameter; slightly itchy; noticed 8 days after the injection; faded after 3 days
6 years and 10 month old child was given Tdap as a fourth dose series by mistake on 5/2/2023, instead of DTaP. There is no adverse effects so far. On the second dose series on 1/5/2023 the patient was given Tdap instead of DTaP.  We reported to the heath department and we are now reporting it here.
Back muscle aches; Abdominal Pain; Lower back pain; Nausea; Diarrhea; Upset stomach; Full body aches; This is a spontaneous report from a contactable nurse, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30125BA) via an unspecified route of administration in the left arm on 17Oct2021 at 12:00 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified medications (reported as "Too many to name") within 2 weeks of vaccination. The patient previously received amoxicillin; clavulanate potassium (AUGMENTIN) for unspecified indication from unknown date and experienced drug allergy and received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the left arm on 17Sep2021 at 12:00 (at the age of 35-year-old), as a single dose for COVID-19 immunisation. On 19Oct2021 at 16:00, the patient experienced back muscle aches, abdominal pain, lower back pain, nausea, diarrhea, upset stomach and full body aches. 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 back muscle aches, abdominal pain, lower back pain, nausea, diarrhea, upset stomach and full body aches was not resolved at the time of the report.
On 5/17/02, broke out with rash at 15:00 and Caladryl applied, Tylenol given for low-grade fever. On 5/18/02, rash gone in AM, then reappeared about 15:00 to 17:00; gave Aveno bath and Benadryl 25mg po and he slept all night. On 5/19/02, rash gone in AM, then reappeared about 15:00 to 17:00. Aveno bath and Benadryl given. To ER at 21:30 for complaint of itching and rash not improving. Treated with Solu-Medrol 40mg, given IM and Rx'd Orapred. On 5/20/02, rash gone. ER report describes urticaria with hives to trunk and extremities.
Myalgia, Fever & injection site redness/tenderness  IBUPROFEN
Had febrile seizure 3/5/16 - ER. Visit T-101.5 TYLENOL and ibuprofen given.