chrisvoncsefalvay/vaers-outcomes huggingface dataset:
worse tinnitus, both their ears are ringing and fizzing.; little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (worse tinnitus, both their ears are ringing and fizzing.) and PAIN IN EXTREMITY (little sore arm) in a 72-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Tinnitus. Previously administered products included for an unreported indication: SHINGRIX. Concomitant products included VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced TINNITUS (worse tinnitus, both their ears are ringing and fizzing.) and PAIN IN EXTREMITY (little sore arm). On 10-Feb-2021, TINNITUS (worse tinnitus, both their ears are ringing and fizzing.) outcome was unknown and PAIN IN EXTREMITY (little sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown.       Concomitant medications cholesterol medication, vitamin C Treatment details were not provided.
Headache, Arthralgia, Fever, Fatigue, Weakness Narrative: Symptoms started evening of injection and persisted for a few days
Patient started experiencing pain, itchy at injection site (right deltoid) on 10-23-17 at 7 pm. Injection site is swollen and she experienced pain.
no adverse effects; Improperly stored doses administered; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 11-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally (strength and dose were not reported)  lot # R033252, expiry date 29-JUN-2020, for prophylaxis. The suspect vaccine was stored in a temperature below 36 Fahrenheit (F) degrees ( 34 F) for 24 hours. There were no previous temperature excursions. Digital data logger was involved. No adverse effects were reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA002834: US-009507513-1907USA003059: US-009507513-1907USA003060: US-009507513-1907USA003061: US-009507513-1907USA003062:
Per review of her vaccine record, she received an expired vaccine. This was several years ago. No known adverse effects. It is possible the wrong lot number/expiration date were entered as our EMR does auto-populate previously used lot numbers/dates.
Patient received Pfizer vaccine 7/15/2021 and developed headache, fever and backache. Came to urgent care, was assessed by dr. Tested for Covid and will follow-up via telehealth within 2-3 days.
11/05/2021 Vaccination. 11/08/2021 In the morning I was dizzy, light-headed. I took my BP 235/100. I called my son and he took me to the ER. Triaged and sent right away to stroke trauma center. CAT scan, blood panel. Diagnosed TIA. HX of TIA but haven't had in 3 years.
2nd dose of the Engerix-B (adult dose) vaccine today (9-December 2021; was administered pediatric dose; female patient was administered the pediatric dose of the first dose of Engerix; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 29-year-old female patient who received HBV (Engerix B adult) (batch number P4DJ5, expiry date 15th December 2022) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) for prophylaxis.   On 9th December 2021, the patient received the 2nd dose of Engerix B adult. On 21st October 2021, the patient received the 1st dose of Engerix B pediatric. On 21st October 2021, not applicable after receiving Engerix B adult and unknown after receiving Engerix B pediatric, the patient experienced accidental underdose and adult use of a child product. On 9th December 2021, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the accidental underdose, adult use of a child product and drug dose administration interval too long were unknown.  Additional details provided were as follows: Pharmacist called to report that a patient was administered the pediatric dose of the first dose of Engerix-B vaccine inadvertently which led to accidental underdose and adult use of a child product. The patient received the 2nd dose of the Engerix-B (adult dose) vaccine on the day of reporting which led to drug dose administration interval too long. No further details provided. The reporter consented to follow up.
Patient got her vaccine then the next day developed weakness and knee pain.  Later the daughter admitted that she had had increased weaknesss and confusion for a few weeks.  She was seen in her PCP's office and diagnosed with a UTI and gout.  The x-ray of her knee later showed a fracture of her proximal tibia.    A few days later she was brought to the emergency department with a wide complex tachycardia and acute coronary syndrome.  She had an 11 day stay complicated with congestive heart failure, hypoxia, aspiration pneumonia and metabolic encpehalopathy.    Her daughter thinks that this was brought on by the vaccine, and asked us to fill out a vaers.
Resident received the moderna covid vaccine  around 10 am.  Reported by Charge nurse Resident with nausea and large emesis around 530am and was given gingerale to sip on. Resident also c/o dizziness, FBS 211. Report by STNA Resident has rash and dizziness. Resident eval. hives noted on trunk and legs,c/o itchiness, dizziness. BP 101/42, P 96, P.O 91 % RA, R 16, Lungs clear but diminished. skin pale,cool,moist. Dr. notified. O2 2L NC, Zofran and Benadryl ordered. Approx 8am BP down to 80/50and MD ordered a liter of IV fluids. Benadryl effective for itching; Pt did not need sent out to the hospital; IV fluids given for 24 hours and all VS improved/normalized.
moderate sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), intramuscular, administration date 23Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Skin/Acne" (unspecified if ongoing), notes: Concomitant drug:, Drug name: Retin-A, Reason for use: Skin/Acne; "Low level" (unspecified if ongoing), notes: Drug name: Vitamin D, Reason for use: Low level. Concomitant medication(s) included: RETIN-A taken for acne (ongoing); VITAMIN D [COLECALCIFEROL] taken for vitamin d decreased (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "moderate sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had no reaction after my 1st dose on 23Feb, other than a moderate sore arm for a couple days. UP UNTIL the vaccine 2 dose, I was a completely healthy and happy 42 year old female. My life is blessed and even throughout the pandemic up until the vaccine 2nd dose  Follow-up attempts are completed. No further information is expected.
Patient under recommended age at time of immunization. Patient returned for second dose and immunization was recommended for the patient to complete the series. Patient was 17 years. Patient did not experience unusual side effects.
Patient received  COVID-19 vaccine dose #2 on 1/17/21 one day too early. First dose given on 1/1/21, and second dose should have been given at the earliest on day 17 (i.e. 1/18/21) per CDC guideline. However, it was given 1 day too early on 1/17/21.  There was no adverse event associated with this incident.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 28-SEP-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (with an expiration date on 10-SEP-2016; dose and lot # were not provided), subcutaneously. There were no adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
improperly stored vaccine administered; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT STORAGE ERROR (improperly stored vaccine administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PRODUCT STORAGE ERROR (improperly stored vaccine administered). On 28-Jan-2021, PRODUCT STORAGE ERROR (improperly stored vaccine administered) had resolved. Not Provided      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.   Reporter did not allow further contact
From telephone contact with reporting physician, it was stated that a patient (2 of 2) received a YF-Vax vaccination, lot # UA373AB (date not specified). Five days later, the patient had 5cmx4.5cm area of local redness at the injection site. Also see case U2001-00976, same reporter.
Information has been received from a physician concerning a 17 year old female who was vaccinated with a dose of GARDASIL. Two years ago, the patient experienced headaches, paralysis, tremors which prevented her from participating in gymnastics. Therapy with GARDASIL was discontinued. The patient sought unspecified medical attention. At the time of this report the patient had not recovered. The reporting physician considered headaches, paralysis, and tremors to be disabling. Follow up information received on 02-SEP-2009 from a physician indicated that the patient had received only 2 doses of GARDASIL. The third dose of GARDASIL was being held because of the possible link between GARDASIL and the events. The physician also indicated that the patient had been referred to a neurologist. Additional Information was also received from the medical assistant of the patient's primary physician; the medical assistant stated that the patient did not had any medical history or known drugs allergies; the patient received a first dose of GARDASIL (lot # 655618/0186U) on 23-FEB-2007. No other vaccines received on this date. At an office visit on 01-JUN-2007 the patient complained of dizziness and tremors in right hand and right foot. The patient was referred to a neurologist. The patient received a second dose of GARDASIL (lot # 659655/1486U) on 06-MAR-2009. Concomitant vaccination given on 06-MAR-2009 included a dose of DTaP (lot# C2775AA) and a dose of MENACTRA (lot # U2549AA), sites of vaccination not recorded. The patient was not seen since 06-MAR-2008. Additional information has been requested.  12/29/09 Neurological consult received for DOS 06/17/07.  Pt c/o nonspecific visual problems and loss of complete vision. Pt was seen by ophthalmologist and diagnosed with migraine. Pt c/o bitemporal headache, tremors in legs, feeling of "pins and needles" in legs, feeling of paralysis, however Pt able to move legs. Neuro exam: wnl. Physician opinion was that Pt's symptoms were likely a psychological/emotional process. Pt r/o Lyme disease and MS.
Patient received 2nd dose of COVID vaccine (Pfizer) 24 hours before adverse reaction began. Patient was originally having fever, muscle aches, and fatigue. Patient began having sharp, non radiating pain to substernal area and began feeling short of breath which brought her to the hospital.
Pfizer-BioNTech COVID-19 Vaccine EUA Facial numbness and tingling. Excessive dry mouth and throat. Felt constriction of throat at one point. Heightened anxiety. Mild sweating. Milding tingling sensation throughout parts of the body
Headache; Pain on left side of body; This case was reported by a consumer via call center representative and described the occurrence of headache in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced headache and general body pain. On an unknown date, the outcome of the headache and general body pain were recovered/resolved.   It was unknown if the reporter considered the headache and general body pain to be related to Shingrix.  Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's Comments: The reporter was the patient herself. The reporter mentioned that, she received Shingrix and that night after vaccination, she experienced pain on the left side of her body as well as a headache. The symptoms lasted for 2 full days and resolved. The patient was worried about the second dose and she was looking for effectiveness information of one dose of Shingrix. The reporter did not consent to follow-up. The case US2022116932 was identified as duplicate of US2022116933. The case US2022116933 would be voided, and all the future correspondence would be added in this case US2022116932 which stands as a case of record for this patient.
dad reported pt feeling sleepy 2-3 minutes p/vax; no disorientation pt talking & walking w/o difficulty; pt states felt okay approx 3 minutes later; father advised to bring pt to MD;
Febrile seizure - Rectal TYLENOL - Postictal symptoms: confusion
Patient did not have an adverse reaction after extra dose of moderna vaccine was administered on June 11th. Pt had previously received a J&J vaccine April 2nd. A follow up with patient was done on June 14th and pt did not state having any adverse reactions
Terrible reaction as far as taste/bad taste starts in far back of mouth; bad smell/ seems to hang in the nostrils and sinuses; feeling of heat traveling down nostrils; disgusting taste and smell forces to stop eating; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 03Mar2021 at 12:30 (at the age of 66-year-old) as a single dose and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 24Mar2021 at 12:45 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included neuropathy peripheral since unknown date and penicillin allergy. Concomitant medications included pregabalin (LYRICA) 300 mg daily and doxazosin (MANUFACTURER UNKNOWN) 8 mg daily, all received within two weeks of vaccination for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Mar2021, shortly after first dose, the patient started experiencing a terrible reaction as far as taste in the foods (never had a problem previously) bad taste starts in far back of mouth, then a bad smell became associated with it which seems to hang in the nostrils and sinuses. When the patient continues eating the bad taste and smell, intensify and a feel of heat travelled down to nostrils. The disgusting taste and smell forces patient to stop eating small quantities of food like peanut butter, peanuts and potato chips. After second dose the foods peanut, pretzels, popcorn and tostitos got added. The patient did not receive any treatment for the events. The clinical outcome of the event altered taste, altered smell, feeling of heat and stopped eating was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of low hepatitis b antibody level in a male subject of unspecified age who was vaccinated with ENGERIX B, manufacturer unspecified.  The subject completed the hepatitis B series in 1998 and in 2001.  A recent titer showed that the subjects hepatitis B antibody level was less than 9 (negative).  No additional information was provided.
in remission for 30 years and it came back within 3 months, he had Guillain Barre; in remission for 30 years and it came back within 3 months, he had Guillain Barre; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Guillain Barre which was in remission for 30 years. The patient's concomitant medications were not reported.  Patient was in remission for 30 years and it came back within 3 months, he had Guillain Barre. Outcome of the event was unknown.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
Received varivax on 7/3/97. Noted to break out with a few flea-bite size lesions on neck, chest, abdomen and legs. Approx. 15-20 lesions total. No complications. Dx: possible chickenpox modified because of vaccine.
After five days, the left side of my body (foot, arm, face) started going numb, my chest tightened, and my vision started to narrow. The numbness did not show noticeable drooping but the tingling lasted over two weeks. The pain in the left side of my chest lasted for over a month. My ears popped constantly for about over 2 months and had a headache impacting my right temple and the back right side of my head. I had some sharp pain to my chest that radiated to my jaw at about the 2+ month mark. I went in to the emergency clinic at the deployed hospital to get a heart reading. Results looked normal.
cannot get flu shot, allergic to them; Initial information was received on 26-Jan-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (patient) via social media. This case involves a patient (unknown demographics) who could not get INFLUENZA VACCINE as he/she was allergic to it (allergy to vaccine).  It was unknown if the patient had any concomitant disease or risk factor.  The patient's medical history, past medical treatment(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed allergy (allergy to vaccine) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.   The details medication and reason for taking the medicine were not provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.
This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.  No Medical History information was reported.On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No Concomitant medication details were provided. No Treatment medication details were provided.
slight headache first evening. During the night had to urininate but had problem getting out of bed due to dizziness, unable to move well. Had no control of body functions and urinated all over myself. Could not get strength to get off the toilet. Needed help with that and back to bed. Fell on the way there. Wife was able to help me crawl back to bed. A few hours later had to urinate again, but could not get out of bed. No control no strength. Was half on the toilet and could not get myself straight on due to literally no body strength. Fell off the toilet, could not move at all. Had to call my son over to get me up. I was sick all day long. Later in the day I was able to get up a bit and walk but not steadily. Tylenol helped. Later that night I was feeling better. By the next day I was pretty well back to mysllf
having a ruff time with sore throat; fever of 101.9 deg F; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (having a ruff time with sore throat) and PYREXIA (fever of 101.9 deg F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (having a ruff time with sore throat) and PYREXIA (fever of 101.9 deg F). At the time of the report, OROPHARYNGEAL PAIN (having a ruff time with sore throat) and PYREXIA (fever of 101.9 deg F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
DIZZINESS; CHILLS; FATIGUE; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not 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-APR-2021 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. On an unspecified date, the subject experienced dizziness, chills, fatigue, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, nausea, dizziness and chills was not reported. This report was non-serious.
Error occurred when administering a dose of Pediatric Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg.  Patient/caregiver unable to be reached for follow-up. Not known if any ADR occurred.