chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 100 degrees; Chills; Headache; Arm injection site pain; Stomach pain; This is a spontaneous report from a non-contactable consumer, the patient.   A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 16Apr2021 at 07:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included hypercoagulable blood. The patient had shellfish allergy. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Apr2021 at 12:00, the patient experienced fever 100 degrees, chills, headache, arm injection site pain and stomach pain. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events fever 100 degrees, chills, headache, arm injection site pain and stomach pain were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: vaccination facility type selected, lab data notes, batch number statement and final sentence were updated.
A spontaneous report was received from a consumer, concerning his wife, a 72-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe headache, body ache, chills, fever, nausea, and vomiting.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) in the left arm for prophylaxis of COVID-19 infection.  On 24 Jan 2021, after vaccination, the patient experienced severe headache, body ache and chills. On 26 Jan 2021, she also experienced fever of 104f. Additionally, on 27 Jan 2021 she developed severe nausea and vomiting. On an unknown date in 2021, she was bed ridden. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of event(s), severe headache, body ache, chills, fever of 104f, severe nausea, vomiting were not resolved and ongoing at the time of this report.; Reporter'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.; Sender's Comments:
Patient was given 0.5mL of the Moderna vaccine at 1503. She states that immediately after receiving the vaccine she started having tingling in her throat. She thought it was anxiety, so she waited awhile. She states it started getting worse and she notified the RN. Patient stated that in the past she has experienced a  tingling sensation in her throat, but it went away. Patient denied shortness of breath or rash.   BP 120/78, oxygen 97, pulse 46, respirations 20.   RN gave 50mg IM of Benadryl at 1530 per protocol. Patient stated after 5 minutes that her throat felt tight. Patient was taken over to convenient care to be evaluated.
Tdap (L) arm - not sore 5 pm area near collar bone to jugular vein know came up. She c/o tired. No fever. MD saw that weekly did CT scan to a MD seen specialist - 5 cm area he felt lymph node reaction to vaccine. She is to se him 11/19 for evaluation and possible removal. Denies previous Tdap. Uncertain Td date.
Have had hot flashes since the vaccine. Normally I am cold at work and home all the time. Hot flashes at random times throughout the month are VERY abnormal for me.... and increased clotting during periods. Feels like menopause set in after the vaccine. I was not having any of these symtoms before.
COVID-19; Feeling unwell/Not feeling well; Vaccination adverse reaction/Reaction to COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), MALAISE (Feeling unwell/Not feeling well) and IMMUNISATION REACTION (Vaccination adverse reaction/Reaction to COVID vaccine) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In December 2021, the patient experienced COVID-19 (COVID-19), MALAISE (Feeling unwell/Not feeling well) and IMMUNISATION REACTION (Vaccination adverse reaction/Reaction to COVID vaccine). At the time of the report, COVID-19 (COVID-19) had not resolved and MALAISE (Feeling unwell/Not feeling well) and IMMUNISATION REACTION (Vaccination adverse reaction/Reaction to COVID vaccine) outcome was unknown.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of COVID-19, Malaise and Vaccination complication was not provided with HUMIRA (ADALIMUMAB).  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Immediately after injection, wheal formed. Patient denied pain or feeling uneasy and waited about 10 minutes after injection.. Provider was notified and stated that urticaria characterized by wheals (hives) accompanied by an itching or burning sensation resolves generally within 24 hours and that she should monitor her arm for any issues and if she should have further issues to return to the clinic for further evaluation or go to ER. Patient refused repeat vitals because she had to leave for a meeting.  Will follow up with patient via phone call later today in the afternoon.
developed a rash in the right arm in the right arm that was red; swollen right arm; warm to the touch; developed a rash in the right arm in the right arm that was red; This spontaneous report was received from a consumer and refers to a 4-year-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-NOV-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, administered subcutaneously for prophylaxis (strength, lot #, and expiry date were not provided).  On an unknown date, the patient recovered from the events. On 07-NOV-2023 (also reported as 8 hours after vaccination), the patient experienced developed a rash in the right arm in the right arm that was red, swollen, and warm to the touch. The reporter states that the area was still red but the rash is gone and the "problem was resolved". There was no spread of the rash and the patient did not need any urgent care.  The causal relationship betweenall adverse events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was unknown.
Headache, Myalgia, INSOMNIA, ARM SORENESS., MALAISE NOTE- EMPLOYEE TESTED POSITIVE COVID 3/19/2020; HAD ANTIBODIES AT LEAST AS OF 10/22/2020
itching, redness, warm ("hot spot"), lump (size of egg) at injection site occurred 06/12/08; reported on 6/14/08, with improvement of all.
2/11/21- (Chills, excruciating headache, nausea, dry heaves, no appetite, muscle ache, fatigue, very weak)  2/12/21- (chills, weak, diarrhea)
27Sep90 pt vax 2nd hepta B; spent some time in tanning bed. Same day devel hives on arms, thighs, abdo, + back of neck also exp wheezing. Tx in ER + recv epi + Atarax.
I had the shot and still got shingles, 11 months to the day/Suspected vaccination failure; I had the shot and still got shingles, 11 months to the day; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in an adult 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient had the shingle shot and still got the shingles, 11 months to the day and believe me it was not fun said by the patient. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratoy test confirming shingles were not provided.
Body aches, fever, tired, injection site soreness, and slight breathing difficulty - these symptoms lasted around 24 hours. Injection site sorness lasted around 5 days.
Vaccine was stored in the fridge on 24Jan2023 and administered on 03Mar2023; no adverse event; Moderna Bivalent vaccine was administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023 and administered on 03Mar2023) and NO ADVERSE EVENT (no adverse event) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023 and administered on 03Mar2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023 and administered on 03Mar2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023 and administered on 03Mar2023).    No concomitant medications was provided. No treatment medications was provided.
Dizziness after injection, High fever (104), chills for approximate one and a half days, severe injection site pain followed by swelling, heat , swollen lymph node under arm, pain for a few days, insomnia, appetite loss. 2 days after injection asthma exacerbation with viral type symptoms, same as I experienced 2 days after last injection. It lasted about a week after the first injection.
Pt states that she felt a hot sensation immediately-became very painful-she could not sleep. The following day her arm was red from her shoulder to elbow-all the way around she put Neosporin on her arm x 2 days. Redness and pain went away.
Patient had 1 and 1/2 inch - diameter of red, deep spot on injection site (back of left arm). Rash around the spot, very itchy. Patient had diarrhea.
CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via another manufacturer (Pfizer) concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and amoxicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported and expiry: unknown) dose was not reported, 1 total administered on 13-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 31 years old. The patient additionally received Spikevax (elasomeran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported and expiry: unknown) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. Age at time of vaccination 31 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 symptoms (confirmed covid-19 infection) (dose number in series 2). On an unspecified date in JUN-2022,  tested positive (confirmed clinical vaccination failure) (dose number in series 1). On an unspecified date in JUN-2022, covid-19 symptoms and positive test recurred after 6 days of negative test following getting covid and taking paxlovid. Patient was treated with Paxlovid (Nirmatrelvir/ritonavir) on 01-JUN-2022 for treatment of covid-19 and last administration was on 05-JUN-2022. Laboratory data included: COVID-19 virus test Positive. Laboratory data (dates unspecified) included: COVID-19 virus test Negative. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000239139; Sender's Comments: V0: 20220658724-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. 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.
Received H1N1 vaccine 10/16/09 - On 10/22/09 URI H/A, glands swollen, aching sensation bilateral groin and legs. On 10/25 increased aching/pain - unable to walk up and down stairs, weakness in legs. Unable to raise leg off floor when lying flat - saw PCP neurologist rheumatologist. Rx NSAIDS, TYLENOL #4, MEDROL dose pack still ongoing.
Tingling legs, knee to toes, bilateral; tingling hands; poor balance.  Follow-up by neurologist; diagnosis: peripheral neuropathy.  Treatment: Vitamin B12 1000u every day.
I got the shot w/o any issues, was observed for 10 minutes at the Vaccine site w/o issues. On the drive home, I felt lite headed, lips, tongue and back of throat felt weird. I got home at 4:30, systems remained but lessened throughout the rest of the day. At 11:00 I went to be and felt fine, woke up today and took 2 Advil. No pain today and fell normal, but reporting just in case, concerned about 2nd dose and would like guidance.
Had a really bad headache; Still felt horrible; Slept most of that day; Suffer from BTV (vertigo) and it got very bad after the vaccine; Woke up feeling very agitated; Very dizzy; Had flu-like symptoms; Was not feeling well at all; Achy all over; Heart rate was higher, like 10 beats per minute higher; Started to shake; This spontaneous case was reported by a pharmacist and describes the occurrence of HEART RATE INCREASED (Heart rate was higher, like 10 beats per minute higher), TREMOR (Started to shake), VERTIGO (Suffer from BTV (vertigo) and it got very bad after the vaccine), AGITATION (Woke up feeling very agitated) and DIZZINESS (Very dizzy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Vertigo (BTV).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021 at 7:00 AM, the patient experienced HEART RATE INCREASED (Heart rate was higher, like 10 beats per minute higher) and TREMOR (Started to shake). On 24-Jan-2021, the patient experienced VERTIGO (Suffer from BTV (vertigo) and it got very bad after the vaccine), AGITATION (Woke up feeling very agitated), DIZZINESS (Very dizzy), INFLUENZA LIKE ILLNESS (Had flu-like symptoms), MALAISE (Was not feeling well at all), HYPERSOMNIA (Slept most of that day) and MYALGIA (Achy all over). On 25-Jan-2021, the patient experienced FEELING ABNORMAL (Still felt horrible). On 28-Jan-2021, the patient experienced HEADACHE (Had a really bad headache). At the time of the report, HEART RATE INCREASED (Heart rate was higher, like 10 beats per minute higher), TREMOR (Started to shake), VERTIGO (Suffer from BTV (vertigo) and it got very bad after the vaccine), AGITATION (Woke up feeling very agitated), DIZZINESS (Very dizzy), INFLUENZA LIKE ILLNESS (Had flu-like symptoms), MALAISE (Was not feeling well at all), FEELING ABNORMAL (Still felt horrible), HYPERSOMNIA (Slept most of that day), HEADACHE (Had a really bad headache) and MYALGIA (Achy all over) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. Treatment included Beta Blocker and Tylenol
Abdominal pain, allergies, balance problems, diarrhea, digestive problems, hear ringing in ears, pain back, pain knees and hips, rashes on face, skin with rash, pain stomach, pain ear, and for last sleep too much sleeping.
Calls with complaint of a red slightly raised rash on his back and legs. This rash started after he had the shingles shot a month ago. The rash on his legs has formed small blister like areas, then scabs that are now falling off. They are not painful or itchy. he has not run a fever.
pt was vax approx 10AM & arrived @ 11AM started screaming unconsolably until 3PM; local redness around inject site;
p/vax pt rt upper arm & shoulder started hurting;became worse 2mo later;saw MD dx bursitis & given naprosyn & took for 2mo;rt arm hurts to reach upward or behind;rt arm shoulder hurts very badly;dx tendonitis;given med;
pyrexia; weakness; Tiredness; Muscle pain; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (weakness), FATIGUE (Tiredness), MYALGIA (Muscle pain), HEADACHE (Headache) and PYREXIA (pyrexia) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 26-Jan-2021, the patient experienced ASTHENIA (weakness), FATIGUE (Tiredness), MYALGIA (Muscle pain) and HEADACHE (Headache). On an unknown date, the patient experienced PYREXIA (pyrexia). At the time of the report, ASTHENIA (weakness), FATIGUE (Tiredness), MYALGIA (Muscle pain) and HEADACHE (Headache) was resolving and PYREXIA (pyrexia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information was provided.  No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
VACCINE ADMINISTERED AFTER THE 31 DAY BEYOND USEDATE BUT BEFORE THE 45 DAY EXCURSION DATE.
Information has been received on 10-MAR-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 10-MAR-2017 the patient was vaccinated with an expired dose of ZOSTAVAX lot # L032399 expiration 26-NOV-2016, unknown route for prophylaxis. No side effects reported. No further information was provided. Additional information has been requested.
COVID+ 12/31/2022.  Vaccination status - Moderna x2 + Pfizer x1 Discharge Physician: PRIVATE MD, MPH Primary Care Physician: PRIVATE, MD  Date of Admission: 12/31/2022 Discharge Date: 1/1/2023 Room Number: 2021/2021-1   BRIEF OVERVIEW:   Active Hospital Problems   Diagnosis Date Noted POA ? COVID-19 01/01/2023 Yes ? Pulmonary emphysema (HCC) 01/01/2023 Yes ? Chronic systolic heart failure (HCC) 10/26/2022 Yes ? Amiodarone pulmonary toxicity 10/07/2022 Yes ? Hypertension   Yes ? Biventricular automatic implantable cardioverter defibrillator in situ 01/15/2014 Yes ? Cardiomyopathy (HCC)   DETAILS OF HOSPITAL STAY:   PRESENTING PROBLEM: Hypoxia [R09.02] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 80 y.o. male who presents today with shortness of breath. He has a history of dilated cardiomyopathy with an EF of 29%, ICD, chronic systolic heart failure, HTN, CAD, and pulmonary toxicity from amiodarone.   In the ER the patient was initially 93% on room air, but oxygen desaturation to 87% occurred with ambulation with prolonged recovery.  He was placed on 2 Liters NC.  He tested positive for COVID.  Labs included BNP 3,540, procalcitonin 0.08, normal WBC of 8.49.  CXR showed emphysema.  Hospitalist service consulted for admission further evaluation.  He was initiated on dexamethasone and was outside window therapeutic benefit for Remdesivir.  He was quickly weaned to room air with stable oxygenation.  Patient was advised to follow-up outpatient pulmonology and obtain PFTs which are currently scheduled for 1/27 with local Medical Group pulmonology. Patient clinically improved and hemodynamically stable for discharge. Discussed plan of care discharge with patient including outpatient follow-up PCP within 7 days. Patient voiced understanding was agreeable with plan of care discharge.
high pitched crying 24 to 48 hrs p/vax; treated w/APAP;
Next day, arm aching 10/22/22.  Then upper back aching on left.  Over the next few days pain began to radiate to front of chest wall predominantly on left.  Face and head on left hurting. Tingling on side of left breast.  Raised red bumps in clusters starting near spine moving in a horizontal line towards left breast.  Malaise. Went to ER 11/1/22.  XR CHEST 2 VW, BASIC METABOLIC PANEL, TROPONIN I, CBC W/ AUTO DIFFERENTIAL, ECG 12-LEAD, various tests.  Given zofran for nausea, torodol by iv. Prescribed ibruprofen for pain and methocarbamol.  Zofran did not help.  Torodol did very little to alleviate pain.  Methocarbamol prescription caused anxiety, no relief and was disposed of.