chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication of Janssen vaccine (first dose and the lot number was 1805022) on 15-Mar-2021 and Flu vaccine on 01-Nov-2021. Past adverse reactions to the above products included No adverse event with Flu vaccine and Janssen vaccine.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
Headaches began a week after the 2nd Pfizer dose. They have now persisted for a month and counting.
ringing in both of my ears got worse started slightly after the first dose and gotten worse after the second dose; ringing in both of my ears got worse started slightly after the first dose and gotten worse after the second dose; This is a spontaneous report from a non-contactable nurse.  A 32-year-old male patient receive d BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose , via an unspecified route of administration to Jan2021 at SINGLE DOSE for COVID-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  On an unknown date, the patient experienced ringing in both of ears got worse started slightly after the first dose and gotten worse after the second dose. Patient stated that it kind off went away toward right before the second dose, was ok for a day or two 5th or 6th getting worse again. Patient stopped two of her meds that could cause this. The vaccine was the only thing that has changed. The second dose was administered on unknown date in Jan2021 (5th or 6th of Jan2021). The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Redness, swelling of injection site, tingling sensation area injection, warm to touch, feverish.
Client c/o red rash with itching (generalized) after 7 minutes of injection. She was given Benadryl 50mg IM. After 3 hrs. of observation, client was ok.
Pt came to the pharmacy for Moderna 2nd booster (4th dose). The dosing should be 0.25ml.  However, 2.5ml of Moderna was giving to the patient by the Intern Pharmacist. Pt stayed in the pharmacy for about 2 hours after the administration and was asymptomatic. Follow up on the next day, Pt had mild fever and injection site pain. He was taking ibuprofen and felt better in the afternoon.
anaphylactic reaction; This is a spontaneous report from a non-contactable consumer received from other company, Mylan (Case ID: GI-2021-5625). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylactic reaction on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Got shot on Wed. 2/10/2021. Started feeling ill within a few hours. Next day, was "sick" and needed to vomit (but didn't).  Temperatures for 3 days was less than normal.  95.6 to 96.1.  FridayI I started vomiting and had incidents of a pain in my stomach area and by that night became sicker and dehydrated.  Was so sick I couldn't get out of bed to get water (I live alone).  By midnight Friday (12:00) Feb. 13 I was so sick I called daughter to take me to hospital.  Went to ER and then did blood work.  Blood work showed  liver enzymes were over 500 and eventually reached over 600, when normal is under 100.  Was admitted to hospital.  My electrolytes were out of "whack" too.  My doctor told me in 11 years practice she had never seen a liver enzymes reading over 600.  I am scared to take another vaccine shot at this point.  Note:  I had blood work done Friday, March 5, 2021 and my liver enzymes was 26 -- normal but I am not interested in getting that sick again and I have concerns about my liver.
Information has been received from a consumer concerning her daughter who was vaccinated with a second dose of Gardasil vaccine. Subsequently, the patient experienced "a lot of side effects". She had to have an "MRI" (illegible data) and her physician said "it was from the vaccine." At the time of this report the patient's outcome was unknown. Additional information is not expected.
Information has been received from a woman from a physician's office concerning an 8 year old female who on 20-MAY-1999 was vaccinated with a dose of Varivax (Oka/Merck). Concomitant vaccinations included a dose of MMR II. On 28-MAR-2006 the patient was diagnosed with varicella, "no problem with it, mild case". At the time of the report the patient had not yet recovered. Additional information has been requested.
No adverse effects reported; An expired dose of RECOMBIVAX HB was administered to a patient; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender.   The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 01-DEC-2022, the patient was vaccinated with an expired dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) syringe piston, 0.5 milliliters once, lot number U019135 has been verified to be a valid lot number with expiration date on 22-NOV-2022, administered as prophylaxis (strength, vaccination scheme, route of administration and anatomical location was not provided). No additional adverse events were reported.
Patient received Pfizer COVID vaccine on 4/7/21 and 5/3/21. On 10/6/21, patient was admitted to our facility with acute hypoxic respiratory failure, COPD exacerbation, and COVID infection (positive status). Patient was discharged home on 10/8/21 in good condition.
October 17, 2007 - Received flu shot in left arm.  Received pneumonia shot in right arm.  That evening, the injection site in my right arm was very red and the irritation was about the size of a quarter. October 18, 2007 - I woke up with a very small range of motion in my right arm without pain.  There was a orange size raised area around the injection area in the right arm.  I started having the chills.  About 1:00pm I was shaking with the chills.  I had 103.8 fever by 4pm.  I called clinic to let them know and I went to doctor.  The doctor took blood work for a CBC.  That was normal.  The raised red area had spread down and around my arm.  Still minimal range of motion without pain.  My muscles in my arm were burning.  The area was hard to the touch and hot.  The doctor concluded that my symptoms must be the result of the pneumonia inoculation.  That night my fever was 103.8-104 even though I was taking Tylenol and Motrin every 4 hours. October 19, 2007 - Irritation on my arm had spread further with pain moving down my muscles.  Fever 103.6 most of the day with 2 breaks of fever when it went down to +/-100.5 degrees.  Still very little range of motion in my arm without pain.  My arm was painful to the touch and was still raised and burning.  I tried warm compresses.  They did not help.  I was still taking Motrin and Tylenol. October 20, 2007 - Irritation on my arm was still spreading, still raised and hard.  I still had little range of motion.  My temperature was 103 in the morning and in the late afternoon.  Otherwise my temp was about 100. October 21, 2007 - Irritation on my arm looked better, some swelling had gone away.  My range of motion was increasing.  Still painful to the touch and there was a burning sensation in my muscles.  I woke up with no temperature but it went up to about 100.6 late in the afternoon.  My temp went back down after Tylenol.  My chest started feeling a little tight.  Started with a dry cough. October 22, 2007 - The raised irritation is gone on my arm.  Range of motion is almost normal.  There is a burning sensation in my muscles of my arm but the area is no longer hard and hot.  I had no fever.  I had to take some old asthma medication because of the tightness in my chest.  Blisters in mouth.
Patient is autistic. He was "stable" in behavior. He was given the Flu shot and became violent and defiant in behavior for 12 days. He was totally out of control in all surroundings (Home, School and Aftercare). Loss of appetite and sleep patterns also changed.
pt devel fever approx 6-7 hrs p/inject of 101 w/h/a; APAP given & fever dec; pt c/o eyes feeling funny;
She had the chills you know the whole gamut and so did her fiance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "She had the chills you know the whole gamut and so did her fiance".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021490064 same reporter/drug, different patients/AE;US-PFIZER INC-2021488779 same reporter/drug, different patients/AE
CLINET RECEIVED FIRST DOSE PFIZER ON 2/6/2021.  THEN ON 4/1/2021 RECEIVED MODERNA FIRST DOSE FOLLOWED BY SECOND DOSE.
Flu shot given 10/1 upper deltoid - discomfort and residual pain the bicep - seen by MD 11/6 Rx ice and antiinflammatories 4 day - still uncomfortable.  2 mos later with some residual weakness - Dx as tendinitis.
Patient was given TRUMENBA 9/28 and had small area of redness on arm. Possibly started to have some numbness that night. The next day she had increase in size of redness and it became quite warm. Also patient had loss of sensation to front and back of arm and hand below area of where shot was given (in a glove-like distribution). Patient was seen in office on 9/29 and had intact neurologic exam apart from endorsing a loss of sensation on exam. She was placed on KEFLEX for possible early cellulitis and was observed. Returned to care on 10/2 with persistent loss of sensation but improvement in erythema. A neurology referral was made.
This spontaneous report was received from a Medical Assistant concerning an unspecified number of patients. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The patients did not have drug reactions. On unknown dates, the patients were vaccinated with improperly store doses of VARIVAX (dose, route, lot number and expiration date were not reported) for prophylaxis. The temperature exposure was 47-77°F (49°F) for 30 hours. Previous temperature excursion was not reported, and a data logger was involved. This is one of the several reports received from the same source. Additional information has been requested; Sender's Comments: US-009507513-1704USA003069: Original Case : 1704USA003069 US-009507513-1704USA003210: Original Case : 1704USA003069 US-009507513-1704USA003211: Original Case : 1704USA003069.
9 days p/vax devel rt side face paralysis (Bell's Palsy);
I finished my last period right before my first dose of the Pfizer vaccine, got my first dose September 14th and my second dose October 5th at the pharmacy, and was supposed to start my period the 6th of October. I have never started my period since then and have never missed a period in my life. I am not pregnant and took many tests to confirm that. I also haven?t been sexually actively since my last period. I have had very regular periods since I was 13 and have never missed. I have no stress, have not lost weight, have not changed up my schedule, or done anything else that could possible change my cycle.  The only thing that has changed in my life from my last period to this one is the Pfizer vaccine.
Swollen face and eyes with deep redness and areas of purple coloring; nausea, multiple herpes zoster outbreak on lips, low grade fever.
Erythema Multiforme minor, was diagnosed at the office on October 28th 2019.
pt recv vax & was adm to hosp on 15SEP98 for inc SOB, cough;cough began right p/vax; ?allergy;no rash, no pharyngeal edema;
Covid-19 Treatment; Covid-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), on 11Jan2022 as dose 4 (booster), single (Lot number: FF8839) at the age of 34 years 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, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohns Disease" (unspecified if ongoing). Date of last menstrual period: 22Feb2022. The patient's concomitant medications were not reported. Last menstrual date: 22Feb2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Covid-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative, notes: Test was negative two and three days after completing treatment and was asymptomatic at that time; (17May2022) Positive, notes: experienced rebound symptoms and a positive COVID test 5 days after completing treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Product Quality Group provided investigational results on 19May2022 for BNT162b2:  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FF8839 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FF8839, fill lot FF8833, and the formulated drug product lot FA9148. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Drug ineffective, Covid 19 cannot be completely excluded.
DIABETES MELLITUS; REVACCINATION WITH DIFFERENT  COVID-19 VACCINE; ASTHMA; This spontaneous report received from a health care professional via other manufacturer (Moderna) concerned a 52 year old female. The patient's weight was 249 pounds, and height was 66 inches. The patient's concurrent conditions included: penicillin allergy, sulfa allergy, essential hypertension, obstructive sleep apnea, and dyslipidemia, and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 02-APR-2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) The patient received additional non-company suspect vaccine included: Pfizer (tozinameran) (Dose number in series 2) (form of admin was not reported, intramuscular, batch number: FJ1611 expiry: UNKNOWN) dose was not reported, administered at left deltoid on 23-DEC-2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with Pfizer (tozinameran) (Dose number in series 2)  The patient received additional non-company suspect vaccine included: Pfizer (tozinameran)  (Dose number in series 3) (form of admin was not reported, intramuscular, batch number: FM7553 expiry: UNKNOWN) dose was not reported, administered at right deltoid on 29-JUL-2022 for covid-19 prophylaxis.  On 02-AUG-2022, the patient experienced asthma (Dose number in series 3).  The patient received additional non-company suspect vaccine included Moderna (elasomeran) (Dose number in series 4) (form of admin was not reported, intramuscular, batch number: 069H22A expiry: UNKNOWN) 0.5 ml, administered on 01-JUN-2023 07:23 AM at right deltoid for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 4). Concomitant medications included simvastatin for dyslipidemia, and hydrochlorothiazide/lisinopril for essential hypertension.  On 06-JUN-2023, the patient experienced diabetes mellitus (Dose number in series 4). The action taken with covid-19 vaccine ad26.cov2.s, tozinameran, tozinameran, and elasomeran was not applicable. The outcome of the diabetes mellitus, asthma and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230652203-diabetes mellitus. The event 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. Specifically: MEDICAL HISTORY(Overweight). Therefore, this event is considered inconsistent with vaccine administration.
Pain in arm at injection site, headaches, dehydration, chest pains, muscle aches, diarreah
Patient given expired Pfizer. Bottle transferred from Ultra Frozen/freezer to fridge on 2/10/2022. Expired 03/13/2022. Vaccine given on day 36 after transferred to Fridge. Per call with Pfizer, dose does not need to be repeated as vial is considered stabile x 45 days after transfer.
2 X 1 1/2 cm Swollen area at site of vaccine (Varivax)
Patient reported  experiencing  chest tightness and coughing. she experienced pruritus to the chest that quickly subsided. she also reported a hoarse voice and was slightly shortness of breath.  she was also light headed for few seconds. she denies  throat tightness , difficulty breathing and any other cutaneous symptoms. her symptoms subsided after approximately 10 minutes. she was instructed to wait full 30 minutesand the is free to leave if symptoms resolved
This spontaneous report as received from a nurse practitioner refers to a 5 year old female patient with asthma, seasonal allergies and no past drug history. On 05-AUG-2014 the patient was in error vaccinated with ZOSTAVAX (dose, units, route of administration, anatomical location, lot number, expiration date were not reported). Concomitant therapies included ALBJTEROL nebulizer as needed. It was unknown if any relevant tests were performed. The reporter stated that the patient received ZOSTAVAX instead of (Oka/Merck) VARIVAX.  Additional information has been requested.
Headache / experienced headache; Body aches; Tiredness; has been having to take a nap during the day since the vaccination; This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received on an unknown date and experienced headache and fatigue, tolerance of 1st dose refer case US2021094725). Concomitant products included COVID 19 VACCINE.   On 13th April 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 13th April 2021, less than a day after receiving Shingrix, the patient experienced headache, general body pain, tiredness and daytime sleepiness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, general body pain and tiredness were not recovered/not resolved and the outcome of the daytime sleepiness was unknown.   The reporter considered the headache, general body pain, tiredness and daytime sleepiness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and later that same day, she experienced headache, body aches and tiredness.  She stated, she had been taking a nap during the day since the vaccination. These symptoms were ongoing and had not yet resolved. She followed up with her health care provider (HCP). The physician also reported about this patient as she experienced headaches and fatigue after receiving Shingrix.  The HCP did not have lot number or expiration date of doses of Shingrix. The HCP described the headaches and fatigue had not gotten any better or worse since they began.  The HCP noted that, 14 days before dose two of Shingrix, the patient had received Covid vaccine.  No additional information was provided. The reporter consented to follow up. This is 1 of 4 cases reported by the the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094723:same reporter (husband case) US-GLAXOSMITHKLINE-US2021AMR095072:husband case US-GLAXOSMITHKLINE-US2021094725:same reporter
Lump the size of a softball, pain, soreness, red rash, swollen, hot to the touch. Has been on my arm for nearly 48 hours.
49 yo Female had a vasovagal syncope likely associated anxiety.  Patient received her 1st Moderna IM  dose at 12 n and was asked to to move to the next chair to allow her 19 yo son  to receive his vaccine.  While patient was watching son get vaccinated, she Felt dizzy and the vaccinator noted her closing her eyes, slowly lost tone, and fainted,  was guided to the floor preventing head trauma .  She was positioned supine with feet up . She did not appear pale, and opened her eyes within 5 minutes of Fainting , looked for her son, oriented to place and person. No focal weakness or deficits.  Initial vital signs showed mild hypotension 86/50 mmHg ( MAnual BP) , HR 99/min SpO2 98%, RR18/min not in distress but had shallow breathing.  After 5 minutes repeat BP was 100/70mmHg, HR mid to high 80?s , RR 18-20/min , improved tidal volume , able to take deeper breaths, not in respiratory distress .  Distal extremities warm and well perfumes  She was moved to a Gurney, HOB  45 degrees.  BP eventually increased to 140?s to 70? mmHg ( highest was 147/77 mmHg.  Sp02 consistently stable 98-98% on room air , HR high 80?s/min. She had no stridor , appeared comfortable , with clear speech , chest  clear breath sounds to auscultation, Heart RR,no murmur , good and equal radial and dorsal is pedis pulses.  Distal extremities warm and well perfused.   She  was kept under close observation until full recovery. She was able to sit up, allowed to rest , able to stand up, observed to have normal gait , was escorted to her car with no further incident.  Follow up phone call done 7 hours after the incident , she answered her cell phone, normal voice tone without stridor and verbalized she is feeling better , no recurrence of symptoms , no focal weakness. She has no primary care provider.  She was encouraged to find a primary care provider to monitor her BP and for health supervision. She verbalized understanding .
NAUSEA AND VOMITING APROX. 4 HOURS AFTER VACCINATION THAT LASTED THROUGH THE NIGHT. FULL RECOVERY MADE IN 24 HOURS. PROMETHAZINE ADMINISTERED.
pt became limp, not interactive & grayish for 1min as per mom;no cyanosis/apnea;limpness & non responsiveness resolved w/in 5min;hypotonic hyporesponsive episode;