chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/09/13 (day shift) 1330 Complained of right upper arm pain after having received pneumovax injection. She was given Motrin for pain at 1330 and a cool pack. Patient stated much relief after the cool pack. She was seen by internist. She was given Benadryl 50mg at 1430 for arm discomfort. 10/10/13 (night shift) Patient has redness and induration to right arm. Was c/o pain to her right upper arm and headache. 10/10/13 (day shift) Patient stated she couldn't sleep last night due to pain on her right arm from the pneumonia shot. 10/11/13 (Night shift) Her right arm (place injection was administered) is now slightly swollen with redness throughout her inner bicep and now spreading to her lower arm. Dr. was notified and ordered Motrin 400 mg PO x1, which was administered at 2430 (Motrin PRN was already administered at 2036 and another dose was not within time range), along with Benadryl 50mg PO PRN. 10/11/13 (Day Shift) Patient shows some cellulitis on her right upper arm. She has some redness, warmth and tenderness noted. Patient denied pain. V/S: 126/80, 97.6, 76, 18. 10/12/13 (Night Shift) She denied pain to arms bilaterally.
RIGHT SIDED NECK PAIN, TINGLING AT FINGERTIPS 2ND THROUGH 5TH FINGER AND PAIN AND STIFFNESS IN RIGHT FINGERS.
I got extremely light-headed, almost funny feeling in the head.  Very dizzy feeling and as if my head was very heavy. On 9/10/10, I developed several very painful canker sores on my gums between my top and bottom teeth.  I treated them with salt, baking soda and warm water, and they finally disappeared today, 9/13/10.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II injection (lot #, expiration date, albumin status, dose and route of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 49 degrees Fahrenheit (also reported as more than 46 but less than 77 degrees Fahrenheit) for 4 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005340:
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 01/22/2021, 02/19/2021, and 11/15/2021. They tested positive for COVID-19 on 09/19/2022. They were also seen in emergency department on 09/19/2022 and admitted to hospital until 09/21/2022. During this hospital stay, they were diagnosed with COVID-19 pneumonia. They were hospitalized again a few weeks later, when they were under evaluation for UTI. They were hospitalized from 11/08/2022 until their death on 11/15/2022.
Can't move her left arm; Extreme joint pain; Fatigue; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move her left arm), ARTHRALGIA (Extreme joint pain), FATIGUE (Fatigue) and MYALGIA (Muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy, Allergy (Sensitive on Ozone days), Allergy (Depakote) and Drug allergy (Augmentin). Concomitant products included LEVOTHYROXINE and PROPRANOLOL (PROPANOLOL [PROPRANOLOL]) for Product used for unknown indication, ALPRAZOLAM, AMLODIPINE, OLMESARTAN, CLONIDINE, ESTRADIOL, PILOCARPINE NITRATE (PILOCARPINE EYE DROPS), ROSUVASTATIN, MONTELUKAST SODIUM (SINGULAIR), OXCARBAZEPINE (TRILEPTAL) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication, SEROTONIN and ESZOPICLONE.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move her left arm), ARTHRALGIA (Extreme joint pain), FATIGUE (Fatigue) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 26-Jul-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move her left arm), ARTHRALGIA (Extreme joint pain), FATIGUE (Fatigue) and MYALGIA (Muscle pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included  Dymysta,, Ritlin and Zedia.   This case was linked to MOD-2021-045952 (Patient Link).
p/vax pt exp dizziness & nausea;today has pain in stomach & retching, feeling tired;had some nausea p/1st vax;pt reports dizzy spell 7 sweating;some nausea cont;
4/29/09 Pt. given Tdap injection during an OV to be seen due to a cat bite. 5/7/09 Pt. returned to office with symptoms of left upper arm pain which became red on 5/5/07. Pt. relates arm pain since receiving injections but redness did not start-until 5/5/09. Could not abduct arm past 15 degrees. Referred to a neuro specialist who diagnosed with post-vaccination brachial plexitis (due to toxin). Prognosis guarded but fair. Pt. is in rehab. and ROM improving - no further pain, just weakness.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN, SINGLE, vaccine location: Right arm), administration date: 21Jun2023, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid treatment from 31Oct2023 to 04Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300381441 same patient, different event/ drug (Paxlovid case);
Itching at the site; injection site hives; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis.   On an unknown date, the patient received Fluarix Tetra at an unknown dose. On an unknown date, unknown after receiving Fluarix Tetra, the patient experienced injection site itching and injection site hives. On an unknown date, the outcome of the injection site itching and injection site hives were unknown.   It was unknown if the reporter considered the injection site itching and injection site hives to be related to Fluarix Tetra.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Fluarix quadrivalent and had hives and itching at the site and extending away from the site as well. The reporter asked was fluarix quadrivalent hypoallergenic.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 28th September 2018, the patient received the 1st dose of SHINGRIX. On 28th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 29th September 2018, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were recovering/resolving. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced substantial swelling that was noticed in the morning of 29th October 2018. The swelling was the size of her palm and had been improving. The vaccine was not administered at the same location of report.
They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) 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 adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case contains information for the 13th of 24 patients described by the reporter.  No concomitant medications were reported. The patient's were between 6 months to 5 years. The vaccination clinic received incorrect guidance from the Department of Health in regards to the vaccination, who instructed to order and administer the vials with pink top to 6month-5year previously unvaccinated patients when the switch from monovalent to bivalent happened. This resulted in 24 patients being under vaccinated. It was reported that 24 patients were administered underdose bivalent vaccine doses for either their first or second doses. They received 0.2 ml dose from the pink vial instead of the 0.25 ml dose from the blue cap vial. The patients were being contacted and revaccinated with the correct dose. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
7 days after my first vaccination, the vaccination site was hot, itchy, slightly painful, and had several raised red welts.  I did not contact my doctor.  I choose to take Benadryl that day and two days after.  It took three full days for the symptoms to clear.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling and injection site induration. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and injection site induration were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller stated that she received SHINGRIX vaccine between her elbow and her shoulder last Tuesday or Wednesday. The patient experienced arm was sore, red, hard and big as a grapefruit at the injection site. The patient noted that she received the vaccine and was concerned the vaccine was given too low. The caller refused any other questions. The caller was referred to her physician, but declined, so she was then referred back to the pharmacy where product was received. The caller was seeking to know if the reaction was normal and due to the vaccine. The prescribing information was reviewed with the caller on the reactions seen in clinical trials. The health care professional declined and did not want to report.
This spontaneous report was received from a nurse concerning a 4 years old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions and concomitant therapies. On 11-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot number M035688 with expiration date of 10-AUG-2018 (strength, anatomical location and route of administration were not provided) for prophylaxis. The administered dose with lot number M035688 was exposed to a temperature higher than -10°C but lower than 8°C for 9.7 hours measured with digital data logger and the lot had no previous temperature excursion. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA009503: US-009507513-1701USA009504.
Patient was given the wrong vaccine supposed to receive HPV9 but accidently got PREVNAR 13.
Patient given 0.5mL of vaccine instead of 0.3mL. No adverse reaction occurred.
Herpes outbreaks. Before vaccination outbreaks have always been very rare. I had outbreaks immediately following vaccination and boosters. Now outbreaks occur at least once a month.
12/19 I had coughing and wheezing so called my doctor on Monday 12/27 and went in the afternoon. First thing we did was  Flu and Covid tests and found nothing. Advised to continue taking OTC and rest for the week and was advised that if I got worse to come back. Cough is persistent but feeling much better.
Patient fainted roughly 5 minutes after vaccine. He was nervous and stated he had fainted in the past from vaccines.  He asked to have his partner with him during the shot and after to help prevent fainting. She was there when he asked to put his head down, then fainted. We moved him to floor. By the time we were able to get him to floor, he was waking.
Adverse event: Vomiting, diarrhea, chills, sweating, headache, body aches, heavy feeling in legs, heart racing, arm pain Treatment: rest, pain medicine, liquids Outcome: side effects subsided by Monday afternoon (1/25/2021)
This spontaneous report as received from a 77-year-old female patient refers to herself. The patient's pertinent medical history included shoulder surgery on both shoulders, foot surgery on both feet, and pneumonia vaccination in 2008. She was sensitive to an unspecified pain medicine. On 29-MAR-2010, the patient was vaccinated with ZOSTAVAX subcutaneously (dose, lot# and expiration date were not provided), for prevention of shingles. Her concomitant therapies included omeprazole (PRILOSEC), estrogens, conjugated (PREMARIN) and levothyroxine sodium (LEVOXYL). On about 20-APR-2010, the patient experienced fructose malabsorption, stomach cramps, and stinky gas. Additionally, she had headache and gastrooesophageal reflux disease (GERD). The patient sought medical attention and she had the "office visit". No treatment was given for the adverse events and and no diagnostic studies were performed. At the time of the report, the patient did not recover from the adverse events. Additional information is not expected, as there was no consent to contact the nurse.
pt recvd vax & felt stinging & burning at inject site as soon as inj given;pt called RPH & instructed to use cortisone cream; rest;elev arm; use apap; swelling & red around inject site monday;size of 50 cent piece & became bigger;imp w/ tx
Dizzy sick for 2 days; Dizzy sick for 2 days; chills; nausea; fever; sore muscles; upset stomach; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 07Aug2021 10:00 (Batch/Lot number: FC318D) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of vaccine, lot number: FA6780, left arm), when the patient was 64 years old, for COVID-19 Immunisation. The following information was reported: CHILLS (non-serious) with onset 07Aug2021 21:00, outcome "recovered" (09Aug2021), described as "chills"; NAUSEA (non-serious) with onset 07Aug2021 21:00, outcome "recovered" (09Aug2021), described as "nausea"; PYREXIA (non-serious) with onset 07Aug2021 21:00, outcome "recovered" (09Aug2021), described as "fever"; MYALGIA (non-serious) with onset 07Aug2021 21:00, outcome "recovered" (09Aug2021), described as "sore muscles"; ABDOMINAL DISCOMFORT (non-serious) with onset 07Aug2021 21:00, outcome "recovered" (09Aug2021), described as "upset stomach"; DIZZINESS (non-serious), ILLNESS (non-serious), outcome "recovering" and all described as "Dizzy sick for 2 days". Therapeutic measures were not taken as a result of chills, nausea, pyrexia, myalgia, abdominal discomfort.  Additional information: Facility type vaccine was pharmacy or drug store. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid prior vaccination. Not tested for covid post vaccination. No known allergies. Chills, Fever, upset stomach, dizzy sick for 2 days felt better on 3rd day but did not do anything, walked around hoose. No problem with first shot.  No follow-up attempts are possible. No further information is expected.
He got his Pfizer booster in October. He signed up for the Moderna booster because he thought he only got the first two. After he got the Moderna booster he then presented his card to the pharmacist which showed all three Pfizer shots on it.
Patient states she developed hives bilaterally on face Saturday morning after receiving both flu and pneumonia on Friday, 9/29/17. Patient states she has several allergies and is not positive that the reaction could be due to either vaccine. Patient will follow up with PCP as soon as possible.
pt recvd vax; devel sore throat, muscle aches, & swelling & induration at inject site; 2 days later, pt c/o upper resp congestion;
I had been off my period for 2 days when I got the vaccine and started my period again 3 days later (day 5 of my cycle). The period lasted for 13 full days and was the heaviest period I?ve ever had with thick clotting and blood. After that period I went 2 full months with no period. This has NEVER happened to me before.
Information has been received from a registered nurse concerning her approximately 30 day old (currently 8 weeks) infant son with no pertinent medical history and no known drug reactions or allergies who in August 2011, was inadvertently vaccinated intramuscularly with 1 ml of RECOMBIVAX HB (lot # not reported). There was no concomitant medication. Her son experienced slight tenderness at the injection site which did not require treatment (date unspecified). No treatment for the adverse event was given. Laboratory and diagnostics studies were not performed. At the time of the report, the patient had recovered on an unspecified date. No further information is available.
inadvertently injected a second (duplicate) moderna covid booster (0.25mL) instead of a flu shot. Subsequently administered IM flu shot to offer flu protection as requested. No know adverse event associated.
Pt states awoke next morning after 1st HPV injection and could not abduct (R) arm. States area sore & had trouble lifting it x 1-1 1/2 wks then symptoms subsided. Pain & difficulty lifting (R) arm recurred 10/27/10. Pt states muscle soreness prevents full function.
I did not have an adverse reaction to the vaccine. I developed a bad cold in 05/2023. I tested for COVID-19 was negative in 05/2023. I had a telehealth visit with my doctor, and it was determined that a bad cold. I had a sore throat, runny nose and a bad cough. The symptoms lasted for about 14 days. I stayed hydrated and I took antihistamine, but it really didn't help. I tried too just tough it out.
15FEB95 pt exp rectal bleeding, bilat leg pain & tightness,muscle weakness,myopathy,non-necrotizing granuloma,dx non-necrotizing lymphocytic vasculitis;edema-hands/feet;7lb wt gain;synovitis bilat wrist;high CD4 # & % lymph & low # & %CD8
Information has been received from a physician assistant concerning a 20 year old female with unspecified pertinent medical history and no drug reactions/allergies reported, and no concomitant medications who on 20-MAY-2008 was vaccinated with the first dose of GARDASIL, IM to the left arm.  The patient contacted the office on 27-MAY-2008, because of a rash that covered both arms, stomach, and back.  There was also a "mark" at the injection site which was the left arm.  The rash started on the left arm and then spread to the stomach, back and right arm.  The rash is itchy and there are little white bumps everywhere that cannot be seen unless the skin is stretched and can be detected by touch.  No further information is available.  Additional information has been requested.
Pain in spine; Stiffness in neck and shoulder; Have a red circle in my arm; Ran very high fever next day and for two days; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (Pain in spine), MUSCULOSKELETAL STIFFNESS (Stiffness in neck and shoulder), ERYTHEMA (Have a red circle in my arm) and PYREXIA (Ran very high fever next day and for two days) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   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 an unknown date, the patient experienced SPINAL PAIN (Pain in spine), MUSCULOSKELETAL STIFFNESS (Stiffness in neck and shoulder), ERYTHEMA (Have a red circle in my arm) and PYREXIA (Ran very high fever next day and for two days). At the time of the report, SPINAL PAIN (Pain in spine), MUSCULOSKELETAL STIFFNESS (Stiffness in neck and shoulder), ERYTHEMA (Have a red circle in my arm) and PYREXIA (Ran very high fever next day and for two days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-061143 (Patient Link).
Cellulitis right thigh 10x12.5 cm induration, warmness and erythema.