chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Onset Date: ??-???-2021      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details were not provided.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-029064 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
5 minutes post vaccination, pt reported the roof of her mouth swelling and then swelling to her throat and tightness to her face and neck.  Benadryl 50mg IM given to R arm.
1 week after vaccine extreme vertigo, had nausea, diaphoresis - seen in ER, adm.
Experienced an allergic reaction of hives, facial swelling, lip swelling "lips were bouncy" and inflamed hives.; Experienced an allergic reaction of hives, facial swelling, lip swelling "lips were bouncy" and inflamed hives.; Experienced an allergic reaction of hives, facial swelling, lip swelling "lips were bouncy" and inflamed hives.; This is a spontaneous report received from a contactable consumer or other non hcp. A 57-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 14Apr2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced an allergic reaction of hives, facial swelling, lip swelling "lips were bouncy" and inflamed hives. The events assessed as non-serious. She reports that her doctor wants to her to have an allergy test where they inject vaccine to see if she is allergic to components to investigate what she is allergic to. She reports concern and asks, what are the risks of doing that and is anaphylaxis a potential risk. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Pt complained of nausea, light-headedness, post vax, (onset about 30 minutes). Pt had 3 episodes of "blackout" while playing basketball. Pt complained of SOB, cough, scratchy throat on 5/11/01, seen in clinic and received Solu-Medrol 125mg, IM and Albuterol treatment.
pt recvd vax 26OCT95 & on evening of 6NOV95 noted to have staggering & falling-ataxia, mild unsteadiness also had mild macular papular rash on trunk;
Rash located on legs. The rush is purple. Palpable purpuric papules distributed on the left anterior medial distal thigh and legs. The rash has been present for 6 weeks after the first vaccine injection, and got significantly worse after the second injection. Dermatologist diagnosed LCV related to COVID vaccination.  Besides purpura, internal bleeding (vaginal and urinal) has occurred right after the 2nd dose and persisted for for 6 days.
At 1:30 pm on 4/20/21 pt. began having involuntary contractions and movement of her shoulders, neck and head.  This continued in a rhythmic pattern.  Unable to reach pt. neurologist.  Had video visit with pediatrician at Pediatrics. Went to hospital emergency department for evaluation.  Diagnosed with Dystonia by ER doctor Dr. Received iv benadryl and discharged home with prescription for benztropine.  On 4/21/21, had video visit with neurologist, who also prescribed Baclofen.  Involuntary movements of neck continues, as well as feet, legs, hands, and eyes.
5/13 Sore throat and coughing started. 5/14 Sore throat and very bad cough. Fever 100.6, ears and head felt fuzzy, took Tylenol and Tussin DM to treat symptoms. Fever lasted all day. 5/15 No fever, but symptoms continued otherwise. 5/16, No fever, but cough improved, though sounded wet. All other symptoms same. 5/17 No change in symptoms. Took at home Covid test, which was positive. 5/18 Headache all day, metallic taste in mouth. 5/19 No change. 5/20 produced dark yellow sputum.
pt was given APAP at midnight, day of vax & pt was alert & awake, but felt warm; pt found 6am-615am on 7/16 & time of death was estimated to be 2hrs. earlier
Approx 15 minutes after receiving vaccines, Tdap, MMR and Hepatitis A vaccines, pt c/o fine red rash on R arm. Cortisone cream was applied to arm. After another 3-5 minutes, pt c/o mild lightheadedness and perhaps a numb mouth. 1.0 cc Epi administered IM to R thigh. B/P 160/60. After 5 minutes B/P 155/60 and pt states he feels shaky and heart pounding. After 10 more minutes pt states shakiness is subsiding. Rash is gone. Mouth feels normal and heart is still pounding. Dr. in to see pt. Heart was ascultated and is regular, although pounding slightly. Pt assessed for history of allergic reactions and relevant history. Mouth examined and is normal. No rash apparent on arm. Pt instructed about the possibility of rebound reaction and instructed carefully to call 911 is any signs of rash, mouth itchiness or numbness or difficulty breathing occur. Instructed to call 911- not to ask friends to drive him to the emergency room. B/P 140/70. Pt dismissed 40 minutes after Epi and 70 minutes after vaccines. Pt was advised to avoid further doses of Hepatitis A vaccine and MMR vaccine in the future.
Extreme high fever Chills Headache Muscle pain Weakness Short of breath Chest pain Rapid heart rate  Fever and chills went away after 4 days, all other symptoms  continue  I have had pulmonary function testing, and more appointments scheduled
Pt received first dose COVID 19 vaccine 3:07pm on left arm and left to pharmacy after 15 minutes observation.  Pt came back to vaccine site after pharmacy c/o weakness and numbness in left arm 3:40pm.   BP 127/92 HR 77 O2 98 BS83, last meal at around 1pm. NP was on site to evaluate pt.  Pt is A&O but lethargic.  Pt was able to move his right arm, right leg, and left leg weakly but not able to move his left arm.  Both arm appeared to be pale.  Sensation intact for all extremities, no facial droop.  Pt then c/o SOB.  Called ambulance, wife left with pt to medical center.
9-11-07 C/O not feeling well, headache and stiff neck. 9-12-07 330 itching 700pm broke out in hives. Had eaten a peanut snack bar that afternoon. Took OTC Benadryl as needed. hives continued 9-13 relieved by Benadryl. Resolved by 9-16-07.
Patient received pediatric Pfizer Dose 1 on 11/03/2021.  Dose 2 of pediatric Pfizer administered 16 days later on 11/19/2021, which was too early.  Patient has had no negative effects, no symptoms or adverse reactions.  Patient's mother was notified on 11/23/2021 that he must be re-vaccinated with Dose 2 on 12/10/2021 (21 days after early dose 2 administration) per Immunization Consultant.
Shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash zosteriform in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number BP57E, expiry date 7th December 2021) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix. In September 2019, couple of days after receiving Shingrix, the patient experienced rash zosteriform. On an unknown date, the outcome of the rash zosteriform was unknown.   It was unknown if the reporter considered the rash zosteriform to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient developed rash after receiving vaccine. The rash was on one side of his body including his arm and trunk and looks like a shingles rash.
When patient came in for their second dose of Pfizer toddler primary dose series, I was filling out the CDC card for the patient. I noticed that the lot number for the first dose was a pediatric Pfizer lot number. Initially I was not sure if it was a clerical error or an incorrect vaccine was given. I notified the parent that the child received Pediatric Pfizer vaccine instead of toddler upon speaking to the pharmacist on duty on 6/26/22. The pharmacist was not aware that there was a separate vial for toddler Pfizer vaccine (maroon color). The parent stated that the child did not experience any side effects as a result of the first dose (pediatric dose- orange cap). Error was discovered on 7/17/22.
fever as high as 102.2F; rash on the cheeks; This case was reported by a nurse via call center representative and described the occurrence of fever in a 18-month-old female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received 1st dose on an unknown date).   On 3rd August 2020, the patient received Havrix. In August 2020, 48 hrs after receiving Havrix, the patient experienced fever and rash. On an unknown date, the outcome of the fever and rash were not recovered/not resolved.   It was unknown if the reporter considered the fever and rash to be related to Havrix.  Additional details were provided as follows: After receiving booster dose Havrix, the patient experienced fever as high as 102.2 degree F and it continued. The patient also had rash on the cheeks. The reporter was consented to follow up.
Above vac. given 845AM 9/1/21 and vac. expired 8/31/21 Reported to Moderna awaiting further instruction.
tested positive for covid 19 infection; tested positive for covid 19 infection; This is a spontaneous report from a contactable pharmacist via a 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 at single dose for COVID-19 immunisation at the age of 43-year-old. Lot number was EN6208. Medical history and concomitant medications were unknown. On 31Mar2021, the patient resulted positive to Covid-19 test. The outcome of the event was unknown.; Sender's Comments: The contributory role of the suspect product  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE to reported events cannot be excluded. This case will be reassessed if follow-up information is received.
Color lose, Lips turned blue, felt faint, placed cool rag on forehead, laid down on exam table. Recovered in about 10 minutes.
Hives; Complex (Hemiplegic ) Migraine; This is a spontaneous report from a contactable consumer, the patient. A 36-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included asthmatic, acid reflux, endometriosis, collapsed lung and allergy to steroids. The patient previously received acetylsalicylic acid (ASPIRIN) on an unspecified date for an unknown indication and experienced drug allergy. Concomitant medications were not reported.  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 vaccination. On 05Apr2021, the patient experienced hives and complex (Hemiplegic) migraine. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with Benadryl. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hives and complex (Hemiplegic) migraine was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
8 days after injection developed 2 inc diameter raised bump as in dome like. Kept spreading every 12 hours an inch. At 7x5" it started to loose bright red, itchiness and heat with help of oral antihistamine and hydrocortisone creme. RN stated not uncommon and report to this site.
Itching on the hands and face 15 minutes after the shot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on the hands and face 15 minutes after the shot) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to animals. Concomitant products included OXCARBAZEPINE (TRILEPTAL), CLONAZEPAM (KLONOPIN), OLANZAPINE (ZYPREXA) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced PRURITUS (Itching on the hands and face 15 minutes after the shot). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching on the hands and face 15 minutes after the shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
11/17/2012: Initial symptom was more pain at injection site (right upper arm) following day.  Pain, swelling increased.  11/19/2012: fever of 101.5 F.  Due to underlying leukemia, patient went to hospital.  Dx rhinovirus, sent home w oral antibiotic levofloxacin.  11/20/2012 2PM fever increased to 102.5, so patient returned to hospital, admitted for IV anti-biotics; swelling in right upper arm very pronounced, skin hot & red, deltoid muscle very swollen & firm to the touch.   11/28/2012: patient remains admitted to hospital, receiving IV vancomycin, Zosyn, Unasyn, but swelling not resolved, still experiencing intermittent fevers; now receiving IV steroids to treat inflammation.  MRI imagining (11/21 and 11/25) showed myositis but no abscess or collection.  Blood work identified no bacterial infection, but elevated CPK was found.  Best to request records from the hospital.  The patient will grant access upon request.  Patient has had flu shot many times in past year without problem, no other allergies
I was closing down the pharmacy and I wasn't feeling well or seeing well. I called my wife to come get me and taken to the hospital. The doctor did some diagnostic test and let me go after a few hours but I couldn't see well still. Two days later I went to my eye doctor to get my eyes checked and he said he thought my stroke was still active. I got admitted to a ER and they diagnosed that I had a stroke after they did an MRI. They're currently treating me for the after effect of the stroke. I still can't see well and I'm on medication to prevent any other strokes.
I had rectal bleeding about 3-5 days after the vaccine. It persisted so I went to the doctor and was prescribed prednisone for 10-12 days and it cleared up unusually easy and fast. It never clears up that fast. Usually flare ups take at least a couple months to clear up. It cleared up in time to get my second dose on time.
Lump formed in armpit day of, extreme chills and shaking, high fever, heart palpitations and tachycardia night of vaccination, joint paint, extreme sweating
Patient felt light headed and clammy. Registered pharmacist got cold water and an ice pack and instructed the patient to put head down between knees. The light headedness passed but the patient became nauseous and vomited. Patient felt better after vomiting. Registered pharmacist gave the patient a cold Gatorade and an apple and stayed with the patient for 20 more minutes until feeling well enough to leave. Patient left oriented and able to walk without assistance. Patient left the store at 1:50pm.
Started with fever and vomting within 24 hours of getting vaccine and then started with sore throat. At 48 hours, temp 102.6 fever did not resolve until 10/21/14.
pt recvd vax t100 on 24MAR93 & cont the same on 25MAR93; then on 27MAR93 pt started w/ a temp of 104 -105; also broke out in a general rash which is still getting worse; MD saw the pt on 29MAR93 stated had case of Measles from the vax;
vaccine past its expiration date administered to 11 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine past its expiration date administered to 11 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine past its expiration date administered to 11 patients). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (vaccine past its expiration date administered to 11 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided. On 29 OCT 2021, one first dose was given to a patient which had expiry date on 27 OCT 2021.   This case was linked to MOD-2021-371244, MOD-2021-371236 (Patient Link).
shingles; rash over their neck and upper back on the opposite side; with a little rash; was swollen on the bicep area; arm was sore immediately; A spontaneous report was received from a caregiver concerning a 67-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was sore immediately/pain in extremity, and was swollen on the bicep area/swelling, with a little rash/rash, rash over their neck and upper back on the opposite side/rash, shingles /herpes zoster.  The patient's medical history was not provided. Concomitant medications reported were 0.5 mg lorazepam, 10mg amitriptyline, 5mg Lisinopril for drug use for unknown indication.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 038K20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) arm was sore immediately, and was swollen on the bicep area, with a little rash. On 12 Feb 2021, the patient experienced the event(s) rash over their neck and upper back on the opposite side.  Treatment details included Topical treatment  for the initial rash., Valacyclovir for the shingles.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm was sore immediately, and was swollen on the bicep area, with a little rash, rash over their neck and upper back on the opposite side,shingles was unknown.
Patient was given adult TD instead of DTaP. No signs or symptoms. Patient's mother instructed to bring child back within 72 hours to get correct injection.
Patient was very dizzy and lightheaded. Non-verbal when spoke too and unable to follow commands.
Pt experienced heart palpitations after 30 mins from vaccination. Pt examined by Dr. and advise to take 200-400mg of ibuprofen. Also advised to limit activity for today. Pt vitals @ 1501 124/78 77 bpm @ 1511 124/76 81 bpm and @ 1528 114/74 86 bpm. Pt by 1530 felt well and went home.
RECEIVED MODERNA COVID-19 VACCINE AS A SECOND DOSE; This spontaneous report received from a health care professional concerned a 32 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 31-DEC-2069) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. Concomitant medications included mrna 2416 for prophylactic vaccination.  On 03-SEP-2021, the patient experienced received moderna covid-19 vaccine as a second dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received moderna covid-19 vaccine as a second dose was not reported. This report was non-serious. This case, from the same reporter is linked to 20211006533.
Dizziness, Headache, NauseaVomiting,  "anxious" "lightheaded", shaking, "migraine" ice pack  Narrative:  at1133: BP-125/79, HR-90, SPO2-99% RA, employee reported  feeling anxious, lightheaded, with headache, dizziness, nausea, and shaking.  at1148: BP-138/84, HR-79, SPO2-100% RA, stated having migraines that is  more intense than usual, ice pack was given, and at1200: employee taken to ER  via wheelchair for further observation of migraine, escorted by individual. Employee  stated after 1st dose experienced night sweats and headache same day as injected  that went away the next day, also reported fatigue the following day after injection  and is still experiencing some fatigue today.
Hours after the administration of the covid vaccine inmate reported chills and body aches.  Ibuprofen and Tylenol was given to treat symptoms. Next morning, inmate had no other complaints, symptoms had resolved.
Case number PHEH2013US019053 is an initial spontaneous report received from a pharmacist on 09 Sep 2013 and a follow up report from the pharmacist received on 16 Oct 2013. This report refers to a 69-year-old female patient. Her medical history included fall and trauma to head or eyes. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1308401) at a dose of 0.5ml intramuscularly in the arm on 06 Sep 2013 (11:00 AM). On the same day after vaccination, she experienced redness and swelling at the injection site and disturbances with vision, such as depth perception and dizziness. Her ophthalmic examination determined that her recent fall caused visual issues. She also had blurred vision and double vision. Injection site reactions had improved since initial presentation but the visual disturbances still persisted. Seriousness and causality of the events were not reported. Follow up report from the pharmacist received on 16 Oct 2013: Medical history, vaccination site and dose of FLUVIRIN, events (double vision and blurred vision) and lab data were updated.
STARTED 8/5/2023, WITH REDNESS, SWEELING AND HOT TO THE TOUCH