chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was initially stored in refrigerator on 14Jun2023, expired on 18 Jun2023 and administered on 27Jun2023; No AEs were reported; HCP stated a patient was accidentally administered with an expired dose of Moderna COVID-19 Vaccine Bivalent on 27JUN2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated a patient was accidentally administered with an expired dose of Moderna COVID-19 Vaccine Bivalent on 27JUN2023), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14Jun2023, expired on 18 Jun2023 and administered on 27Jun2023) and NO ADVERSE EVENT (No AEs were reported) in a 35-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     Patient had recent bulb perforation.  Previously administered products included for Product used for unknown indication: VARICELLA VACCINE and MMR. Past adverse reactions to the above products included No adverse event with MMR and VARICELLA VACCINE. Concurrent medical conditions included Dust allergy (Allergy to dust particles) and Anemia.    On 27-Jun-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 27-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated a patient was accidentally administered with an expired dose of Moderna COVID-19 Vaccine Bivalent on 27JUN2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14Jun2023, expired on 18 Jun2023 and administered on 27Jun2023) and NO ADVERSE EVENT (No AEs were reported). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated a patient was accidentally administered with an expired dose of Moderna COVID-19 Vaccine Bivalent on 27JUN2023), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14Jun2023, expired on 18 Jun2023 and administered on 27Jun2023) and NO ADVERSE EVENT (No AEs were reported) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No AEs were reported) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP stated a patient was accidentally administered with an expired dose of Moderna COVID-19 Vaccine Bivalent on 27JUN2023) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14Jun2023, expired on 18 Jun2023 and administered on 27Jun2023).    No concomitant medication information was provided.  Patient had received Moderna monovalent dose 1 on 2Jun2021 and dose 2 on 30jun2021.  The vial size was reported as 2.5ml.  No treatment drug information was provided.
Patient  came  in  for  2nd  dose Moderna   vaccine  ( covid-19). After injection patient said  he got dizzy  and  loss  conciousness  for  about  10-15seconds.  Patient re cover after 30 minutes
Patient was given vaccine out of approved age range. Patient turned 7 and vaccine is approved until age 6. Patient had no adverse reaction, nurse was counseled on vaccine schedule.
Ear lobes very swollen, red and itchy.  Since then, I have full body hives.
11/26/2022 started feeling bad with headache and body aches about noon. Tested positive on an at home COVID-19 test. 11/27 PCR COVID-19 test positive at doctor's office. Prescribed PAXLOVID, and to treat symptomatically. After 4 days, symptoms improved 12/1. Then 12/5 there was a rebound case lasting until 12/13 before I recovered.
Started off as minor headaches, fatigue but has progressed to being diagnosed POTS, Orthostatic Hypotension, and Dysautonomia. He has continued headaches, light sensitivity, and can barely walk most days.
A little sore at the site" after receiving those previous doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization, reaction(s): ""a little sore at the site" after receiving those previous doses". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "A little sore at the site" after receiving those previous doses". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a registered nurse through the Merck Pregnancy Registry concerning a 16 year old female patient who on 28-MAR-2008 was vaccinated with the first dose of GARDASIL. On 22-MAY-2008 the patient was vaccinated with the second dose of GARDASIL. There was no concomitant medication. The patient was pregnant. The patient has not experienced any know symptoms. The patient sought medical attention seen by the physician. Follow-up information was received from a health professional. The patient delivered on 05-DEC-2008 via C-section due to breech presentation. The baby was 6 lb 5 oz and completely normal and healthy with no congenital anomalies. Upon internal review, C-section due to breech presentation were determined to be an other important medical event. Additional information has been requested.
Shoulder hurt after shot and continued.  Saw doctor on the 19th and was diagnosed with bursitis.  No symptoms before the vaccine.
Janssen COVID-19 Vaccine EUA Fever, body aches, headache, exhaustion
TIGHTNESS IN CHEST; LEGS SWELL; LEGS HURT MORE AS THE WEEKS GO BY; MUSCLE PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced muscle pain, tightness in chest, legs swell, and legs hurt more as the weeks go by. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pain, tightness in chest, legs swell and legs hurt more as the weeks go by was not reported. This report was non-serious.
Assessment: Individual stated he was feeling lightheaded approximately four minutes after receiving his first dose of the Pfizer vaccine via IM injection in his upper arm. Individual was seated at the time and was about to move from the vaccination station to the check out desk.  PT attempted to stand and said, ?Oh, I don?t feel so good?, after which vaccinator inquired with PT on what was wrong. After a brief assessment, notified personnel of the situation. Individual remained with the vaccinator, who obtained a set of vital signs and continued an assessment.  Vitals: (as I recollect, I gave the post it to the check out staffers who monitored the individual prior to his departure) BP: 126/54, P: 78, RR: 18, pale and sweating across his brow area. Denied chest pain, difficulty breathing, nausea, tingling, headache, stated only symptom was lightheaded ness which was dissipating. Provided the individual with bottled water to sip on, which he did. Individual?s last oral intake was at ~0845 PTA at the clinic, a normal breakfast of eggs, toast and coffee. Individual stated he had several cups of coffee but had not had anything else to drink that morning. Individual receives dialysis three days per week. He had an appointment Wednesday, next appointment is Friday. Individual did not have anyone driving him to the clinic, stated he would be fine and did not have anyone to come pick him up. He stated he was feeling better already.  After approximately 8 additional minutes, individual stated he thought he could get up and move to the check out station.  Individual was able to stand an ambulate to the check out line. Upon arrival at check out, transferred the individual to the check out personnel and Exit workers to monitor the individual?s condition for the remainder of the 30 minutes.
2/13 Distinct moderate back pain along lower half of spine not at all resembling muscle aches. 2/14 Pain mostly only in lower back but intense and sustained enough to disrupt sleep. 2/15 Persistent lower back pain distinct from normal muscle aches.
Continuous Moderate Pain in left arm which radiates down forearm to wrist/hand, severe swelling, redness, tenderness, itching, warmth since 7/21/2018 @ 11:00 am. Area of redness and swelling  has increased in size. I have tried topical rubbing alcohol and witch hazel in hopes of providing some relief. Symptoms have progressively worsened since receiving SHINGRIX. Plan to return to  pharmacy today.
With the second dose her daughter's arm and stomach swelled up; With the second dose her daughter's arm and stomach swelled up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 26 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "oral allergy syndrome" (unspecified if ongoing); "allergy to birch trees" (unspecified if ongoing); "certain foods make her throat itch" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: Mar2021, for COVID-19 immunization, reaction(s): "stomach swelled up"; Bnt162b2 (1st dose, severe body pain and swelling at the injection site), administration date: Mar2021, for COVID-19 immunization, reaction(s): "Swelling at injection site", "Severe Body Pain". The following information was reported: PERIPHERAL SWELLING (non-serious), ABDOMINAL DISTENSION (non-serious), outcome "unknown" and all described as "With the second dose her daughter's arm and stomach swelled up". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, abdominal distension.  Additional information: This report was not related to a study or programme. Patient had been on Benadryl, Zyrtec, and Claritin and may have had a another and was still really suffering from this.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200463196 similar report from same reporter
Patient received 1st Moderna vaccine from facility according to mom and immunization card with patient. Patient is 17 yo. Moderna used for second dose; recommended by Pediatric Director after consultation.  No adverse reaction.
Patient's throat felt tight after returning to home. Called doctor patient taking BENADRYL has EPIPEN on hand.
pt. recvd. 3rd vax 21SEP90 & later devel urticaria. Tx w/ meds.
Acute transverse myelitis; This is a spontaneous report from a contactable physician (patient). A 42-year-old female patient not pregnant received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Deltoid Left on 18Mar2021 10:30 (Lot Number: Unknown) as single dose (at the age of 42-years-old) for covid-19 immunisation. Medical history included covid-19 (prior to vaccination, the patient was diagnosed with COVID-19). Patient had no allergies to medications, food, or other products. The patient did not receive any other medications within two weeks prior to the vaccination. Patient previously received influenza vaccine (INFLUENZA VACCINE) on unknown date for immunisation and experienced vertigo (Vertigo from flu vaccine). Patient did not receive other vaccine in four weeks prior to the COVID vaccine. The patient experienced acute transverse myelitis on 26Mar2021 19:45. Event resulted in Emergency room/department or urgent care, Prolongation of existing hospitalization (vaccine received during existing hospitalization) and Disability or permanent damage. Patient was treated with Prednisone. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) positive on 07Jan2021 and negative on 21Jan2021. It was reported that since the vaccination, the patient has been tested for COVID-19, date and results unknown. Therapeutic measures were taken as a result of acute transverse myelitis. Patient had not recovered from the event, at the time of the report.  Information about batch/lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Red spots/rash covering entire body, especially thick on face. Covered nearly every part of body, even scalp and ears.
Swelling around injection site; hardness around injection site; This spontaneous case was reported by a physician and describes the occurrence of SWELLING (Swelling around injection site) and INDURATION (hardness around injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 001B21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN (NEURONTIN) for Neuropathy, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced SWELLING (Swelling around injection site) and INDURATION (hardness around injection site). On 14-Feb-2021, SWELLING (Swelling around injection site) and INDURATION (hardness around injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Takes antihistamine mediation sometimes.   This case was linked to MOD-2021-073634 (E2B Linked Report).; Sender's Comments:  MOD-2021-073634:second dose case
Patient received PNEUMOVAX 23 in fall 2013. Patient administered PNEUMOVAX 23 again on Sept. 25, 2014. Patient states that arm is now sore and swollen. Started morning of Sept. 27.
Nausea, Chills, Fever (101.3), Weakness, loss of appetite
Pain on the right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on the right arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ALBUTEROL [SALBUTAMOL], CARVEDILOL, LISINOPRIL and FUROSEMIDE for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain on the right arm). At the time of the report, PAIN IN EXTREMITY (Pain on the right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included Nebulizer (4 treatments per day) and Hydroziline. No treatment medications were reported.   This case was linked to MOD-2021-307454, MOD-2021-307468 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up received contains no new information On 08-Sep-2021: Follow up received contains no new information On 08-Sep-2021: Non significant follow up received on 08-Sep-2021
Stool was continuous several times a day, green, thick, unusual foul odor, hot.  Baby cried and said "hot".
A pharmacy student administered an expired dose of Bexsero to a patient. It was the patient's second dose and the vaccine expired 8/2022. Patient was called and informed of situation - reported no SE/AE's and declined revaccination.
dizzy; chills; fever; fatigue; Tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid-19), DIZZINESS (dizzy), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 39K20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), ASCORBIC ACID (VITAMIN C ACID), VITAMIN D [VITAMIN D NOS] and CYANOCOBALAMIN (VITAMIN B12 AMINO) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced COVID-19 (Tested positive for Covid-19), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue). On 17-Jan-2021, the patient experienced DIZZINESS (dizzy). At the time of the report, COVID-19 (Tested positive for Covid-19), DIZZINESS (dizzy), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Motrin 400 mg Saturday when diagnosed by rapid test used twice an inhaler Mucinex Lorazepam because the tightness in the chest was causing a lot of anxiety   Reporter did not allow further contact
High pitched crying Initial report received from health care professional in the USA on 08-Jul-2005. A 2 month old female patient presented with high pitched crying one day after receiving a number of vaccinations on 06-Jul-2005. The patient received the following injections: 1. Daptacel lot number C2120AA intra muscularly in the right leg; 2 IPOL lot number Y0240 subcutaneously in the right leg; 3. Comvax MSD, lot number 0123R intra muscularly in the left leg; 4. Prevnar Wyeth lot number A9444OA intra muscularly in the left leg. The patient's parents administered acetaminophen and the patient's symptoms resolved. Follow up information received on 11-August-2005. The patient recovered from the adverse event on 07/Jul-2005. The patient did not have any concurrent conditions or concurrent medications and was not on any concurrent medications. The patient did not have any illness at the time of vaccination.
LEGS GIVING A LOT OF TROUBLE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported.  On an unspecified date, the patient experienced legs giving a lot of trouble. The action taken with covid-19 vaccine was not applicable. The outcome of legs giving a lot of trouble was not reported. This report was non-serious.
On 3/26/21, I got the vaccine. 2 days later, I started general itchiness. 2 days after that, starting at upper torso red spots began to show and then the red raised spots continued to go all over the body, I began taking OTC benadryl. On 4/2/21,  I saw my family MD who instructed me to continue taking benadryl OTC & gave a prescription for topical steroid. On 4/9/21, I saw my family MD for the continued itchy whole body rash who asked me to continue taking OTC benadryl and the prescription topical steroid, he was hesitant to start something else that might interfere with the vaccine's course. I am to follow up with my family MD 4/16/21 with the thought that enough time will have passed to give something else..
I received the Flublock Quad 2021-2022 (PF) 180 mcg (45mcgx4)/0.5ml IM dose yesterday in my left arm. Within an hour I had a rash begin that continued to expand over the next 12 hours. It has started to fade in color from deep red to lighter pink almost 24 hours later. I have had the flu shot annually for at least 20 years and never had this side effect before. The only other time I had a rash post vaccination was after my 2 covid vaccinations earlier this year, also given in the left arm.
Moderna Covid-19 Vaccine EUA   Where I received the shot on my arm- it's red and when I touch it, it feels warm
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were received totally 8 doses of improperly stored GARDASIL (lot number, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Redness, swelling within 24 hrs of vax. Confirmed swelling 42 hrs later in R upper arm.
Since admin. of flu shot I have been experiencing shoulder issues. I am unable to raise my left shoulder fully over my head. I have decreased ROM with 8/10 when trying to raise arm. At rest pain is 2-3/10 in bicep shoulder area. This has been on going x 1 month.