chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in Hand; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Pain in Hand) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB for Psoriasis.    No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for Gastroesophageal reflux disease, CLOBETASOL for Psoriasis, LISINOPRIL, IBUPROFEN and DICLOFENAC for an unknown indication.   In 2008, the patient started ADALIMUMAB (Subcutaneous) 40 mg. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in Hand). At the time of the report, PAIN IN EXTREMITY (Pain in Hand) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 19 May2021, received an update to event information, suspect drug and narrative description, The event of  PAIN WHEN CLOSING THE FIST  was amended to EXTREME PAIN ON RIGHT HAND WHEN CLOSING THE FIST.  No treatment information was provided.
Pt developed nausea and vomiting, fever, malaise the evening after immunizations were given 5-6 hours post injection. 4 days later cont. to recover, no fever, starting to take liquids without vomiting. Continues diarrhea, improved on 1/25/01.
Patient thought he received Pfizer for 1st dose, but after receiving vaccine and documenting he actually received Moderna for his first dose on 4/2. Contacted after vaccination and not experiencing any adverse events
Lot # 053E21A was administered outside the 30-day Use by Date.  A case was opened with Moderna ID Case ID CEA-1261.  "The vaccine administered maintained the activity necessary to protect against the SARS-CoV-2 (Covid-19) virus at time of administration."
Patient passed out unconscious about 3 minutes after getting vaccines. Dr. and staff went to check on the patient. Took blood pressure. Patient stayed in room to recover. He become conscious about 2 minutes after passing out.
pain underneat under the armpit; breast of the same side of the injection site; started getting pain, not too much pain, but felt something there.; then had a little shiver,; 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), administration date 10Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Received first two doses in Mar2021 of Pfizer COVID-19 Vaccine), administration date: Mar2021, for COVID-19 immunization, reaction(s): "pain in the arm where she got it"; Bnt162b2 (DOSE 2, SINGLE, Received first two doses in Mar2021 of Pfizer COVID-19 Vaccine), administration date: Mar2021, for COVID-19 immunization, reaction(s): "pain in the arm where she got it". The following information was reported: AXILLARY PAIN (non-serious) with onset 11Dec2021, outcome "unknown", described as "pain underneat under the armpit"; BREAST PAIN (non-serious) with onset 11Dec2021, outcome "unknown", described as "breast of the same side of the injection site"; VACCINATION SITE PAIN (non-serious) with onset 10Dec2021, outcome "unknown", described as "started getting pain, not too much pain, but felt something there."; CHILLS (non-serious) with onset 10Dec2021, outcome "unknown", described as "then had a little shiver,".  Additional information: The caller was a consumer she indicates that she received the booster dose of pfizer covid 19 on 10Dec and she presented pain underneat under the armpit and in the breast of the same side of the injection site. shot Received first two doses in Mar2021 of Pfizer COVID-19 Vaccine. Everything went fine, except she had some little pain in the arm where she got it. Now she received her booster shot at (Pharmacy name). Was fine for a couple hours In evening time, started getting pain, not too much pain, but felt something there. Then had a little shiver, which is something she knew she would probably get Then suddenly the next morning, felt like under her armpit started hurting her and the side of her breast was hurting. Now her arm was not hurting anymore, but the underarm and side of breast, she can still feel it. Hurts when she is moving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
WOKE UP MISERABLE IN MORNING; SLEEPING; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin, and batch number were not reported), 1 in total, dose was not reported (dose number in series was 1), for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced unspecified adverse event (dose number in series was 1). Seriousness criteria and outcome not reported for the event. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose was not reported (dose number in series was 2), 1 in total administered on 10-NOV-2021 at 16:00 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  As per the report, on 11-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient woke up miserable in the morning and was already feeling better after spending the day with fever and sleeping. The patient was stated that the first one was worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, sleeping, and woke up miserable in morning. (all events dose number in series 2) This report was non-serious. This case, involving the same patient is linked to 20211164612.
Extreme Fatigue (started 3 days after vaccine), 'skipped heart beats' at least 4 times during the date of report (6 days post injection), daily morning headaches (started 2 days after vaccine) with runny nose and sneezing (started 4 days after vaccine) and myalgias with chills  intermittently,
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-FEB-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K016966, expiration date 10-MAY_2017, dose and route not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion six times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 40, 34 and R; 112, 32 and R; 208, 31 and R; 136, 30 and R; 72, 29 and R; 104, 33 and R. The storage criteria was refrigerator. (R). This is one of several reports received from the same source. Additional information has been requested.
Area of injection was hot, erythematous, painful, itchy and swollen.  Patient went to PMD and received a cortisone injection.
Severe body & joint aches. Runny nose. Slight cough. Headache. Severe body aches started at 0900 on 4/6. Hurts to move.
Red, raised, painful right deltoid swollen. Revaccination due to storage of vaccine to cold.
This literature marketed report as received from the authors of the published article, concerns an infant baby girl. The patient's mother, who had chronic hepatitis B, delivered her at age 28. During her first pregnancy, she was recommended to schedule standard active and passive immunoprophylaxis with hepatitis B immune globulin and hepatitis b vaccine (recombinant) (manufacturer unknown)  vaccination for her, to be administered within 12 hours of birth, followed by additional two doses to complete the vaccination series. An infant was born via a caesarean section. On an unknown date, she was noted to have the presence of hepatitis B surface antigen (HBsAg) and high levels of hepatitis B virus deoxyribonucleic acid (HBV) DNA (vaccination failure). The outcome of the event was unknown. The authors considered the event to be related to Hepatitis B Vaccine (Recombinant) (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On unknown dates, the patient was vaccinated with series of GARDASIL (dose and route unknown). On an unspecified date, the patient had positive herpes simplex virus (HSV) titers that lasted an unspecified amount of time. The outcome of the event was unknown. The causal relationship between the event and GARDASIL was unknown. Additional information is not expected as the reporter did wish to be contacted.
Pt recvd 2nd dose of Engerix-B vax on 16MAY91 @ 4PM & reported "burning" feeling @ inject site which traveled down arm & hand; Pt also exp very tight feeling (like a BP cuff) in the upper rt arm became diaphoretic, nausea, vomiting, h/a;
Patient was administered a booster dose of Moderna on 4/5/22 but the vial had expired on 4/4/22. Incident was reported to Moderna and a lot analysis was completed. Results showed the vaccine "maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration".
LEFT DELTIOD AREA RED, FEVER, MINIMAL TENDERNESS, SPLOCHY AT LEFT DELTOID.
SOB, Tingling Hands, Heavy chest  Vitals 1005-HR 85 BP-108/90, RR-20  Vitals 1030-HR 70 BP-110/76, RR 20  Provided juice, and monitored, spoke with her until she was well enough to leave.  Follow up phone call attempted that evening, reach her the next day and she was well.
Woke up 10 hours post shot feeling weak and aches in body. Entire body aches but mostly legs and arms. weakness, chills & sweats overnight. Next morning around 7AM very cold. Temperature around 6am 99.7. Later in the afternoon about 99.9. Took ibuprofen overnight. Symptoms lasted until 6AM the next day (about 36 hours after shot). Shortness of breath when having conversation. Lack of desire to eat or drink anything. Was unable to work, called in sick.
Only local mild pain only on the day.  5 days later dizziness, kind of vertigo.  I do not know if it is related to the vaccine.
receiver an earlier 3rd dose of Engerix-b. the third dose was given at 2 months instead of the sixth month; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-Oct-2022 Reporter's comment: The pharmacist reported on 4th October 2022 that an adult patient received an earlier 3rd dose of Engerix B. The third dose was given at 2 months instead of the sixth month. There was no adverse event reported. There were no patient's identifiers provided. There was no lot number and expiration date provided. There was no vaccination date provided The consent to follow-up was granted. Additional supportive information: The patient received the 3rd dose earlier than the recommended interval, which led to shortening of vaccination schedule.
Pain from injection site to tips of my fingers for over 40 days now. Unable to perform my profession of jewelry designer.
On 12/22/2021, I woke up with my whole body covered in a red rash with raised welts. Face, torso, legs, arms, chest, abdomen, etc. Everywhere on my body itched. That night, I was seen via telehealth by an Urgent Care healthcare professional, who prescribed me a lotion and Benadryl to help with the rash and itching. I'm continuing to use the medications, but the rash persists. The rash gets worse the more I scratch. Any slight touch on any part of my skin (brushing against a piece of furniture, my clothing moving against my skin, holding a fork, etc.) results in a red, itchy mark forming wherever there was skin contact, resulting in a constant rash that goes and comes based on what I touch and when. The rash is itchy, red, and if I scratch, the rash gets redder and raised welts form all over again.
8/25 six hours after flu shot received in right deltoid she became hot and her skin was flushed red. She vomited x 1 then went home. She was dizzy and aching across her arms and shoulders. That night she had diarrhea and said to ache, 9/27 she is still feeling achy.
BODY FELT HOT; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced body felt hot. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fever, and body felt hot. This report was non-serious.
Myalgia fatigue, myalgias, throat tightness with mild dyspnea, lightheadedness Narrative:
My arm was sore for 2-3 days after shot, took one advil.  A week later it was itchy in the morning and starting to get uncomfortable throughout the day.  By 8:00 pm it was very painful ,swollen and hot.  I applied ice and took 1 Advil .  It did not help.  It continued to hurt throughout the night, and I couldn't put pressure on it at all.  It is still hurting now and the swelling area has noticeably wider.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/07/22. When error discovered facility contacted CDC for course of action. At direction of the CDC, patient outreached regarding occurrence to offer re-vaccination of dose. No adverse side effects or event as result of dose.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 25-FEB-2014 the patient was vaccinated with GARDASIL. Lot number, dose, route and frequency were not provided. The vaccine was exposed to 56F for 10 days, an excursion that was found to be unsupported by in-house stability data. No adverse event was reported. Additional information has been requested.
Headache; body aches; chills; stomach mildly upset; unable to sleep due to foregoing; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in left arm on 06Aug2021 at 09:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food, or other products. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in left arm on 15Jul2021 at 15:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 06Aug2021 at 18:00, the patient experienced headache, body aches, chills, stomach mildly upset and was unable to sleep due to foregoing. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, body aches, chills, stomach mildly upset and was unable to sleep due to foregoing were recovering at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
RASH SPREAD OVER ENTIRE LEFT ARM, SUBSIDED AFTER 2 DAYS
No adverse event; patient received a regular booster instead of a bivalent booster; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a regular booster instead of a bivalent booster) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient received a regular booster instead of a bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received a regular booster instead of a bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant information provided No treatment information provided
ANXIETY OVERWHELMING; ARM SORENESS; FATIGUE; MUSCLE PAIN; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On SEP-2021, the patient experienced anxiety overwhelming. On SEP-2021, the patient experienced arm soreness. On SEP-2021, the patient experienced fatigue. On SEP-2021, the patient experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, muscle pain, arm soreness, and anxiety overwhelming. This report was non-serious.
3 mo old infant received multiple vaccines to include PEDIARIX, HIB, PREVNAR, and ROTARIX during well child visit on September 2nd. On September 3rd. he was brought to Pediatric Clinic by his mother with c/o "trouble breathing". When the physician came into the room, the infant was noted to be seizing. A CBC, CMP, ABG and urine samples were also collected. He was diagnosed with Status Epilepticus and taken to a Hospital where he was admitted to PICU. A CT and brain MRI were completed. EEG demonstrated left temporal focus; HSV PCS & culture were negative; the initial infant screen was insufficient, repeat infant screen, ID & genetic consults are pending.
Chest pains  an hour after shot , lasted 15-20 minutes Shortness of breath  4  1/2 hours after shot, lasted 10 minutes  Both symptoms have not recurred since
Sore throat started within 4 hours.  Became very lethargic.  Became very congested within 12 hours.  Various aches and flu-like symptoms within 18 hours.  Had trouble staying hydrated.  Bedridden since the day after vaccine received.  Called doctor and was prescribed Amoxicillin (1000mg 2 x per day)and Sudafed and Tylenol 1000mg 2 x per day.  And drinking plenty of fluids.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: GIVEN IM DIPHENHYDRAMINE 50MG/ML 1ML- S/P 15 MINS GAVE 1 EPIPEPN 0.3MG EVERY 5 MINS- 1ST SHOT PATIENT ADMINSTERED. NO IMPROVEMENT-CALLED EMERGENCY NUMBER- PARAMEDICS CAME IN AND TOOK IT AFTER THAT
LLL pneumonia (fever 101-102 x 3 days, started 3 days after vaccination; productive cough).  PNA diagnosed by PCP 6 days after vaccination after CXR.  Treated by pt with Aleve only, by PCP with Zithromax, Asmanex inhaler.
Chills, diarrhea, lung pain, stabbing pain, headache, weakness and very tired for several days.
Severe migraine after first and second dose of Modern COVID-19 vaccine. Increase in frequency in migraines following the Moderna vaccine. Pre-vaccine, frequency was 1 migraine approximately every 2-4 months and since the vaccine, frequency is 2-4 migraines per month.
Pt. states after receiving the vaccine that evening she had fever of 103, body aches and arm very sore. Did not seek medical care at that time. Pt. went to her PCP for clearance for #2 Hepatitis B vaccine and the MD determined it was an allergic reaction.    ***Don't know if the MD fllled out a VAERS form***
My son has only ever has vasovagal syncope (vvs) when he was sick and throwing up. He had a vvs episode 4 days after his first covid vaccine, and the day after his second covid vaccine. I can only find the paperwork for his first hospital visit. We ended up in the ER both times. You may follow up with the childrens ER. He was in the ER 5/24/21, and 6/16/21 follow up with Cardiology with a 14 day zio patch and all lookede and he was cleared for .