chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt presented to Emergency department with left arm pain after receiving the Moderna COVID-19 vaccine roughly 3 days ago.  Patient states she was injected, left shoulder Tuesday evening, 60 hours prior to evaluation.  She had pain in the left shoulder since then, relieved with ibuprofen but recurrent and intense when the medicine wears off.  She states that during injection she felt pain that went down to her middle digit.  She has normal neurologic function, normal motor function, no obvious infectious symptoms, and exam is benign.
Local swelling, redness at DTaP site-resolved with antihistamines orally.
Received booster shot on 10/7 and started feeling lethargic in the evening. I also experienced enlarged lymph nodes in my armpits as with the other two doses. 10/8 I felt generally lethargic all day but I had to work so I pushed through the symptoms. 10/9 I again had to work and was experiencing dizzy spells about mid afternoon. That evening, I went to bed about 9 PM. I woke up 10/10 at 2:30 AM in extreme pain from the lymph nodes. The pain that had originated in my left armpit/breast area had migrated to my right breast. I took advil and went to sleep. Woke up again at 6:30 in horrific pain and my husband drove me to the emergency room. ER took bloodwork and put me on toradol and zofran. ER told me that my pain was typical with the reaction my body was having to the booster. ER prescribed me dilauded and sent me home. Took two pills total through out the day. Spent 10/10 into 10/11 on the toilet with diarrhea and vomiting. I got in to see my PCP on 10/12 and my PCP inspected my breasts as I was still experiencing a lot of pain, redness, swelling in my right breast. My PCP diagnosed me with mastitis and prescribed me antibiotics. The paib, redness, swelling in my right breast has slowly lessened.
Pt called concerned about some "fluid-like" swelling under her armpit after having received the COVID booster from us.  She says she is nauseated and the pain runs across her back.  I told her that we do see some lymph node swelling occasionally with vaccines, but if it is concerning to her, she may consider having it looked at by her physician.  She said she wouldn't go to the doctor unless I recommended she do so.  I told her that I personally think that it should start resolving soon, but I can not make that decision for her and if she is concerned she should consider seeking treatment based on what she is seeing and what is normal for her.
sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient  was very sick after the Shingles shots. The follow up would not be possible as contact information was not available. For tolerance of another shot, refer linked case US2021AMR198765, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR198765:same reporter
This spontaneous report was received from a healthcare worker referring to an unspecified patients of unknown age and gender. On an unknown dates, the patient was vaccinated with improperly stored doses of GARDASIL 9 (dose, frequency and route of administration were not reported, lot # reported as L019297 with expiration date: 18-AUG-2017, L020015 with expiration date: 16-AUG-2017). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever 105, vomiting, weakness sore throat, pain everywhere,  hives on arms
After first shot (17 March 2021), soreness at injection site.  After second shot, soreness and pain at injection site; general symptoms were headache, body ache, joint pain, and fatigue.
This case was reported by a physician via sales representative and described the occurrence of Bell's palsy in an adult male subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included Bell's palsy 10 years ago. On an unspecified date in 2012 the subject received unspecified dose of FLUARIX (unknown). On an unspecified date in 2012, within 24 hours of vaccination with FLUARIX, the subject experienced Bell's palsy. An adult male subject developed Bell's Palsy within 24 hours of being vaccinated with FLUARIX (season was not specified). The physician associated the Bell's Palsy with the FLUARIX vaccine, lot number was not available. The sales representative reported that the healthcare professional wanted to remain anonymous. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the Bell's Palsy was unspecified. Approximately 10 years ago, the subject received influenza vaccination and experienced Bell's Palsy; brand name or manufacturer was unknown. For this case please see A1023598B.
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 31-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's medical history included pregnancies - gravida 2 para 2. On 13 May 2014 the subject received unspecified dose of BOOSTRIX (0.5 ml, intramuscular). Her last menstruation period was on 19 October 2013 and her estimated date of delivery was on 26 July 2014. The subject was exposed to the vaccine during the 3rd trimester (29 weeks of gestation). At the time of reporting, the pregnancy was ongoing. Follow-up information received on 22 July 2014: Subject details were reported. Vaccine responsible physician details were provided. Follow-up information received on 01 October 2014 from nurse: The subject received Tdap vaccine at week 29 of the pregnancy and during the third trimester of pregnancy. The VAERS details were provided. Some of the patient's details were updated. This has a normal conception pregnancy. Follow-up information received on 6 November 2014 from nurse: At 39 weeks and 4 days, the subject gave birth to a male neonate via vaginal delivery. The pregnancy resulted in a live neonate with no apparent congential anomaly. The neonate weighed (8lbs 5oz) at birth. APGAR scores was 9 and 9.
NARRATIVE: Patient that was anxious prior to injection of second dose of Pfizer covid vaccine developed nausea and lightheadedness was brought to ED for evaluation. Patient had no complaints in ED, was stable and walking around without issue and was able to go home requiring no intervention.
light headed; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIZZINESS (light headed) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033E21-2A, 002A21A, 006B21A and 939906) for COVID-19 prophylaxis.     Concurrent medical conditions included Prostate cancer stage IV (using Lupron Injection every 6 months and casodex twice daily.) since 2005, Hypertension (taking Metoprolol , Lisinopril, Norvasc, and Eliquis) since 2010, High cholesterol (taking Simvastatin) since 2010 and Gastroesophageal reflux (taking Famotidine) since 2010. Concomitant products included FAMOTIDINE for Gastroesophageal reflux, SIMVASTATIN for High cholesterol, METOPROLOL, LISINOPRIL, AMLODIPINE BESILATE (NORVASC) and APIXABAN (ELIQUIS) for Hypertension, LEUPRORELIN ACETATE (LUPRON) and BICALUTAMIDE (CASODEX) for Prostate cancer stage IV.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (light headed). At the time of the report, DIZZINESS (light headed) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that about 10 days after the 2nd primary dose, patient started feeling very very light headed. About 10 days after the 3rd shot, and 10 days after the 4th shot. Patient did not had any other vaccines within 4 weeks of any of his COVID shots.   Treatment medications were not reported.   This case was linked to MOD-2023-707708 (Patient Link).
vomiting the next day which persisted for 5 days;hosp w/dehydration;dx w/lobular pneumonia;on nebulizer tx & ATB;
Day of vaccine = nothing Day 2 = sore arm + small, red, raised bump at injection site (1/2? x 1/2?) Day 3 = sore arm + same small red, raised bump  Day 4 = swelling gone, red mark very faint ????? Day 8 = VERY itchy, large raised red mark at site of injection (1? x 1?). Began taking Benadryl + ibuprofen, + topical Cortizone-10 cream for itch Day 9 = same; red mark is now  (1.5? x 2?) Day 10 = same; red mark is now (2.25? x 3?). Mark is now slightly faded in center with a red outline.
opened IPOL was exposed to temperature of 47.7F for 47.25 mins due to the door was left open and was administered to patient with no reported adverse event; opened IPOL was exposed to temperature of 47.7F for 47.25 mins due to the door was left open and was administered to patient with no reported adverse event; Initial information received on 31-May-2023 regarding an unsolicited valid non-serious case received from nurse.  This case involves a 4 months old male patient who was administered opened IPV (VERO) [IPOL] which was exposed to temperature of 47.7F for 47.25 mins due to the door was left open with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-May-2023, the patient received a dose of 0.5 ml of suspect IPV (VERO) (Suspension for injection) (lot: V1B902M; expiry date: 02-Jun-2024; strength: standard) via intramuscular route in the right thigh for Immunization.  On 23-May-2023 the patient was administered opened IPV (VERO) [IPOL] which was exposed to temperature of 47.7F for 47.25 mins due to the door was left open with no reported adverse event (product storage error) (unknown latency) (poor quality product administered) (latency: same day).   It was reported, "A Nurse called and wants to know if their vaccines are still suitable to use after it had a temperature excursion. Caller asked also if revaccination is needed because they administered the IPOL vaccine after it had excursion."   Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   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 the 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 interpreted 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.
Pt recvd vax & devel a mild rash; On approx 3MAR92 pt recvd 2nd dose of Hep  B vax & devel a bad rash;
p/vax approx 3hrs pt had difficulty breathing & was pale & weak. in AM broke out w/hives on trunk of body. 24hrs later only c/o severe itch, but felt better
LOSS OF EFFECT; COVID-19 PCR TEST POSITIVE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. Initial information was processed along with additional information received on 04-MAY-2022. 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: 1802068 and expiry: Unknown) dose was not reported, 1 total administered at left arm on an unspecified date in JAN-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in JAN-2022, the patient tested positive for COVID-19 on PCR, and experienced loss of effect. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the COVID-19 PCR test positive and loss of effect was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000229106.; Sender's Comments: V0:20220502894-Covid-19 vaccine ad26.cov2.s-Loss of effect. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
lightheaded, sweaty, and nausea. Past hx of vasovagal reactions to needles
Contractor presented for Dose 2 of Moderna Covid Vaccine.  Immediately following vaccination, contractor reported feeling hot and nausea.  0927 VS 132/56 HR 69 02SAT 98% RA.  Contractor placed in w/c and delivered to observation area and seated in a recliner.  Given ice pack for comfort.  Immediately, contractor reported symptoms resolved.  VS@0935 BP 121/66 HR 75 02sat 99% RA. T 97.1.  Contractor remained in observation area until 1020 and ambulated from area without incident.
When you received the vaccination your left arm did not hurt while shot was going in but had pain afterwards. The site was really sore and broke out in big red splotches. If anyone touched her arm it would be in a lot of pain. She laid in her chair for 4 days very fatigued, no appetite, and light headed. She had adverse reactions for about 4 days and then she was fine. She did not receive medical attention.
Tingling from elbow to fingertip, muscle pain and spasms, joint ache, flu like symptoms 2 days later. Treated with anti inflammatories and Benadryl
Vaccine expired on 24-Apr-2022 and removed from the fridge on 25-Apr-2022 and administred on 25-Apr-2022; administered vaccines past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered vaccines past the expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 24-Apr-2022 and removed from the fridge on 25-Apr-2022 and administred on 25-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered vaccines past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 24-Apr-2022 and removed from the fridge on 25-Apr-2022 and administred on 25-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered vaccines past the expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 24-Apr-2022 and removed from the fridge on 25-Apr-2022 and administred on 25-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Reportedly, by used date was mentioned as 24-Apr-2022. The vaccines were stored in the freezer and only removed as needed to thaw and then administered. It was mentioned that vials were taken out at a time and thawed as they did not thawed an entire box.  Treatment details were not reported by the reporter.
Pfizer-BioNTech COVID19 Vaccine EUA The muscles in my arm where the vaccine was objected started hurting about 5 hours after the vaccine. Two hours later the pain had gotten so intense I could not move my arm more than in inch from my body and had to get help performing simple tasks. The next morning, the pain is less intense and I can move my arm, but there is no pain in my elbow and wrist joints on the same arm.
Patient, who is an OB/GYN, reported severe "flu-like" symptoms over the next 48 hours after receiving booster (3rd) dose of the vaccine.  Patient had fever/chills, muscle and joint pain, extreme fatigue to where she could not walk with her family for more than 15 minutes without requiring a 4 hour nap.  Patient also alternated ibuprofen and acetaminophen doses every 4 hours to combat symptoms.  Patient reports today at 10:00am EST she is still fatigued, but other symptoms have gone.
Vaccine side effects.  Pt c/o muscle spasms and pain in lower back and abd x4 hours. Pt recieved J&J vaccine at 0845, began having discomfort at 0930, fell asleep until 1500 and symptoms began around 1600. Pt is dry heaving and has not been able to eat or drink since AM. Pt notes ''fuzzy'' vision.Re-Assessment@ 2330: pt calm and feeling much better. no abdominal pain per pt; abdomen soft, NT, w/o guarding.  no neuro deficit and able to ambulate in ER.  no source of focal infection identified and symptoms likely due to J&J vaccine.  will d/c with mother.
Started as a couple small spots of rash/hives. Later in the evening he was covered in hives/rash from neck to toe. Were itchy. Had slight fever.
Patient received Tdap vaccine to (R) deltoid on 10-7-14. Received call from patient on 12-4-14 reporting pain and decreased mobility to (R) arm since receiving injection. Has seen primary MD, advised to use ibuprofen. Reports no better, mobility is decreasing.
Johnson & Johnson Janssen COVID-19 EUA Patient not 18 years of age (17) Identified during record audit; called client to advise.
Pt states "Right after I was given the PNEUMOVAX, the whole muscle begin to hurt".  Later in the afternoon the inj site was "swollen, painful & hot" No redness, later in day the back of upper arm became painful & hot.  By the evening, pt's whole arm from elbow to shoulder was very painful.  She was unable to lift her arm or really use it due to the pain.  No fever, N,V.  Pt called on 10-22-08.  We had her come in to be seen.  The pain at injection site was less but the pain on the tricep area still was very painful.  It was hot to the touch + very painful even with a light touch.  There was a lump in that area also.  Pt was seen by Dr + sent home with dx of 'adverse reaction to drugs.  NOS.'  Pt was told to take BENADRYL 1-2 tabs every 6 hrs + a recheck visit was made for the next day.  Pt seen again on 10-23-08.  The site of the injection was less painful out continued to be more painful then inj.  site, Pt was able to use her arm + lift.  At the tricep area, it was still warm with the lump.  The lump at the inj. site was gone.  Dr said for pt to continue with BENADRYL and call if it got worse or not better.
congestion, fever, cough; nasal & chest congestion-lasting 2-3 wks-tx w/fluids-ATB;
Information was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On 06-JUN-2018, the patient was inadvertently vaccinated with VAQTA of lot # N002921 and expiration date of 08-APR-2018 for prophylaxis (expired vaccine used). No adverse effects were reported.
Patient received Moderna Bivalent Booster one month after receiving Pfizer Bivalent Booster
KINRIX, PROQUAD, Flu vaccine and TYLENOL (generic) given at 1155 am on 11/14/16. At 12:10 pm the family came back in with patient who was itching and covered in hives head to toe. Swelling in face and bottom lip. No respiratory distress. BENADRYL (generic) given at 12:20. Pt monitored for 1 hour. Vitals taken every 15 min and were stable. Swelling and hive decreased at D/C. Instructed to monitor for increased SX. BENADRYL rec. q 6 hours and follow up call in am. 11/15/16 8:38 (follow up call) 100% recovery.
Patient described severe pain day after vaccine.  She said she was unable to lift arms over head and did not trust holding anything in each hand because unable to lift item up.  She explained that she thinks vaccine was given too high and close to shoulder.  Two days later she is still sore but slowly getting better
At 1:30 I noticed a pain in my arm like the day after shot. After a while it became itchy and red and swollen.  Been putting ice pack on site.
Pain in arm; Night sweats worse at night; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), NIGHT SWEATS (Night sweats worse at night) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, LISINOPRIL and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), NIGHT SWEATS (Night sweats worse at night) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Pain in arm), NIGHT SWEATS (Night sweats worse at night) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) Negative.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-086114, US-MODERNATX, INC.-MOD-2021-085994, US-MODERNATX, INC.-MOD-2021-086095 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086114:Case for dose 1 US-MODERNATX, INC.-MOD-2021-085994:Case for husband US-MODERNATX, INC.-MOD-2021-086095:Case for husband