chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Infanrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 15-month-old male patient who received DTPa (Infanrix) (batch number 23t73, expiry date 30-APR-2023) for prophylaxis.   On 04-MAY-2023, the patient received Infanrix. On 04-MAY-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired Infanrix administered). The outcome of the expired vaccine used 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-MAY-2023 Reporter's Comment: The medical office staff member reported that the patient received a dose of Infanrix, which was already expired on 30th April 2023 which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up by email.
While having blood drawn at 11:31 am, which was also after vaccine was given became nonresponsive with seizure like activity, agonal respirations and no pulse for less than a minute. Patient placed in supine position and quickly regained consciousness before further intervention was needed. He became alert and oriented while on the phone with 911. 911 was called at 11:32 am. 11:33 am vitals were BP 160/86 P 71 and R 20. 11:39 am vitals were BP 128/81, P 81, R 20, 11:44 am vitals BP113/75, P 79, R 24. EMS arrived recommended transport to hospital, patient declined and signed refusal with EMS.   11:51 am Sitting vitals BP 134/93, P 86 pulse ox 97%. Standing BP 146/95 P 90. Patient stayed for twenty more minutes without incident. Left with no acute distress.
3/07/06 Pt in clinic, states had soreness, aches and chills for a few days after flu shot, was given on 2/16/06, then 7-10 days later rash developed near injection site and that was spreading around arm to chest.  Said rash was painful but did not itch, Was seen by Dr and diagnosed with allergic dermititis on this date.  Was given Rx. for Diprolene 0.05% cream Bid, Pt calls on 8/15/06 and stats symptoms improve when uses diprolene cream but never go away.  Wife describes a "purple blotches".  Told to F/U with Primary Care Physician.  Pt is adament that he thinks symptoms due to flu shot.
APPROX 5-10 MINUTES AFTER VACCINES ADMINISTERED, CHILD BECAME LIGHTHEADED AND REPORTED NOT FEELING WELL.
Per Client on 4/13/2021 at 2:30 pm received second dose of Pfizer COVID 19 vaccine an experienced w mild discomfort at injection site in right arm same day. Three days later on 4/16/2021 noticed two bumps in  the right armpit area that morning and by 7:30 pm, started having itchiness on back of neck and a hive rash on neck. Per Client applied anti-itch ointment to the affected neck area and took Benadryl, which seem to be lessening the itchiness and rash. Per Client, no follow up with PCP or any visit to seek medical attention. PHN recommended for Client to follow up with PCP and continue to monitor signs/symptoms. Also, suggested that if symptoms worsened go to Urgent Care, ER or call  911 for medical emergency.
Headache, body aches, low temp, no energy, runny nose, sore throat, lack of appetite, red face. 1st flu shot.
Upper leg and knee of injection site became swollen (twice the size of the other leg) was red, hot and tender. Went to Urgent Care 10/7/17 when patient unable to bend knee after trying BENADRYL at home. Pt given prescription for Dexamethasone. Swelling and redness greatly decreased after second dose of steroid.
within 2 weeks I awoke with severe joint pain, muscle pain, scalp pain, headache I could not turn my neck, needed a walker it has now been almost 1.5 years since this and I still have autoimmune symptoms...they are better but prohibit me from many normal activities in my life. I needed to sell my dental practice as the limited range of motion and constant pain interfered with running a practice
Myalgia, Fever, CHILLS/FATIGUE Narrative:  Other Relevant History:
PATIENT REPORTED REACTION AS DEVELOPEMENT OF RASH IN MOUTH, UPPER PALATE AND TONGUE, PATIENT WAS ABLE SWALLOW AND NORMAL BREATHING AT  TIME OF REPORTING, HAD 2 TABELT OF BENADRYL 25 MG WAS TAKEN, AND WAS KEPT HERE UNDER SUPERVISION OF DAUGHTER AND DIRECTED TO SSEEK MEDICAL ADVICE BUT DENIED AND KEEP WATCHING.
Left arm and shoulder area got extremely sore and was unable to lift without pain. Could not lift above my head at all. Today, still somewhat sore and area of shot site discolored.
Patient tested positive for Covid19 after being vaccinated with the moderna vaccine EUA 03/07/2021-04/01/2021
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 05Oct2023 at 12:00 as dose 1, single (Lot number: MG4629) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild, intermittent asthma" (unspecified if ongoing); "mild hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ancef, reaction(s): "known allergies: Ancef". Vaccination history included: bnt162b2 (vaccine lot number: 10006, vaccine dose number: 5, ), administration date: 12Sep2022, when the patient was 58-year-old, for COVID-19 immunization; bnt162b2 (vaccine lot number: FP4554, vaccine dose number: 4, ), administration date: 12Apr2022, when the patient was 57-year-old, for COVID-19 immunization; bnt162b2 (vaccine lot number: FH8027, vaccine dose number: 3, ), administration date: 22Nov2021, when the patient was 57-year-old, for COVID-19 immunization; bnt162b2 (vaccine lot number: ER8736, vaccine dose number: 2), administration date: 26Apr2021, when the patient was 57-year-old, for COVID-19 immunization; bnt162b2 (vaccine lot number: ER8737, vaccine dose number: 1, ), administration date: 05Apr2021, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Oct2023, outcome "unknown" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Oct2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Tested positive for Covid on 6May2022 via at home test; Tested positive for Covid on 6May2022 via at home test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 at 16:30 as dose 1, single (Lot number: EJ1685), in left arm, on 25Mar2021 at 16:00 as dose 2, single (Lot number: EK5730), in left arm and on 02Dec2021 at 14:30 as dose 3 (booster), single (Lot number: FJ1620) at the age of 31 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AIMOVIG; BEYAZ; VYVANSE. Vaccination history included: afluria (Other vaccine 4weeks product: Afluria Quad 2021-2022 3yr Up Syringe), administration date: 22Nov2021, when the patient was 31-year-old, for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06May2022 at 10:00, outcome "recovering" and all described as "Tested positive for Covid on 6May2022 via at home test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course- Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient receive Afluria Quad 2021-2022 3yr Up Syringe vaccines within 4 weeks prior to the COVID vaccine. There was list of any other medications Aimovig, Beyaz Birthcontrol pill, Vyvanse the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Patient could not be aroused from his cot by others. In presence of dependent lividity, his core body temperature was 108oF. Temperatures in the area at the time were at or above 120oF. Wet-bulb globe temperatures were "pegged" (at max recordable temp), but were typically at least 92oF. Final autopsy report: Cause of death--heat-related death. Autopsy diagnoses: Micro pulmonary findings suggestive of heat injury. Mild right ventricular hypertrophy. Mild coronary atherosclerosis.
Chills, shaking, hot flashes, headache body aches for 24 hours
Swelling, redness, warm to touch and pain - started 7/27/07 - Rx Levaquin 500mg N 2 tab x8d
1st shot 3/8/02, HEB 1, congested, irritable, fussy. 2nd shot 5/1/02, IPV/OPV, DTaP, DTP, DT/TD, HIB, PPV, very congested, irritable, high pitch cry, fever, hot and cold flashes, cold sores-thrash, sleepy, no eating well. No solutions. Doctors say baby has "SBS." Subdural heamtoma, non-accidental trauma, multiple rib fractures.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA277418 and 2018SA282124. (Same Reporter) This case involves a 73-year-old female patient who received a partial dose of vaccine FLUZONE QUADRIVALENT which was leaked out from hub of syringe. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. Reported as no other vaccines given. On 04-Oct-2018, the patient received a 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6301NA expiry date: 30-Jun-2019 via unknown route. It was reported that do not know the site of the vaccination was given. It was a case of actual medication error due to vaccine under dose. It was reported that vaccine leaked out from hub of syringe during administration to patient, reported partial dose was given to patient. It was also a case of syringe issue. It was not reported that if any adverse event was experienced or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive  and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none
three months later feels exactly same symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (three months later feels exactly same symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION COMPLICATION (three months later feels exactly same symptoms). At the time of the report, VACCINATION COMPLICATION (three months later feels exactly same symptoms) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Upper chest pain; stronger and faster heartbeat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Nov-2021 and was forwarded to Moderna on 08-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Upper chest pain) and PALPITATIONS (stronger and faster heartbeat) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced CHEST PAIN (Upper chest pain) and PALPITATIONS (stronger and faster heartbeat). At the time of the report, CHEST PAIN (Upper chest pain) and PALPITATIONS (stronger and faster heartbeat) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2021, Heart rate: fast (High) stronger and faster heartbeat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment medications were reported.  It was reported that the patient had experienced stronger heartbeat which come and goes. It went away after  while on 06-Nov-2021 and came back on 07-Nov-2021.   Reporter did not allow further contact
Patient received a possible 4th dose of Pfizer on 10/13/21. Patient received 1st dose of Pfizer on 1/21/21 and 2nd dose of Pfizer on 2/13/21 and then a historical dose of Pfizer was added on 8/4/21 as a booster dose.
Patient received both immunizations on 8/15/17. According to patient her arm started getting red 'a couple of hours after immunization'. Did not seek medical attention until 8/17/17 when her right arm was red from the armpit to her wrist. At that time she went Medical Center Emergency Department. Patient states she was diagnosed with cellulitis. Was not admitted to the hospital was released from the ED on 8/18/17 with a prescription for Bactrim DS. This pharmacy provided her with the generic. Redness had subsided and was clearly visible on the inside of her arm from the armpit to just above the elbow.
Painful cervical adenopathy; overlying erythema of skin; Painful swallowing on side of vaccine; This is a spontaneous report from a contactable physician.  A 59-year-old female patient received first dose of intramuscular (PFIZER-BIONTECH COVID-19 VACCINE) on 17Jan2021 at 14:45 at a single dose in left arm for Covid-19 immunisation at the age of 59-year-old. Lot number was EL0142. Medical history included Hashimoto's thyroiditis, Gastrooesophageal reflux disease (GERD), obesity, anxiety, Known allergies (Seasonal pollen, dust, dander). The patient was not pregnant. Historical vaccination included influenza vaccine on 21Dce2020 for immunization. Concomitant medications included aluminium hydroxide gel, dried, magnesium carbonate (PEPCID), sertraline hydrochloride (Zoloft) and lorazepam. On 18Jan2021, the patient experienced painful cervical adenopathy, overlying erythema of skin, painful swallowing on side of vaccine with onset day 1 post vaccine, start of improvement on day 5, the patient was still with adenopathy on day 10. The patient was treated with ibuprofen and acetaminophen. The patient recovered from the events with lasting effects. Prior to vaccination the patient did not have Covid-19; since vaccination the patient was not tested for Covid-19.
Patient was scheduled to for a Pediatric Pfizer Booster instead was given Pfizer Booster Adult dose on his left arm.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 20Nov2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Additional information: patient received COVID 19 Treatment (Paxlovid) from 30Jun2022 to 04Jul2022 for Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Blisters in roof of mouth 48 hrs. after taking first dose of oral Typhoid. Blisters became slightly worse after second and third dose. Client intends to continue to take fourth dose.
Started feeling poorly around 9:30 PM on 1/30. By 10 PM I had fever, chills, anxiety, dry mouth, headache, body aches, and I had a hard time staying asleep. I rarely wake during the night to pee but I woke 4 times for water and to use the bathroom.  I woke more than that, but 4 times specifically for that reason. My fever broke the next morning (1/31) around 6 or 7 AM. I still had a mild headache and felt tired and not like myself. I took ibuprofen and the headache subsided. Around 2 the headache came back as did the anxiety. I am not a typically anxious person. I took another dose of ibuprofen. Around 10 that evening (1/31) I felt back to normal.
A few minutes after administration of Covid 19 Vaccine made by Pfizer, patient went into a seizure like adverse event.  Patient fell out of chair onto the floor and was unresponsive.  Pt had labored breathing, clenched, shaking  arms, and pale skin color.  Pt's eyes were open and emergency services were called.  Pharmacy team made sure pt was still breathing and in a safe position until help could arrive.  Pt remained unsresponsive for a few minutes with his eyes open and then suddenly came to as if nothing happened.  Pt was experiencing some dizziness, nausea, light headed ness and fatigue.  Was given water and allowed to remaining sitting on the floor.  EMT arrived and started to evalaute vitals.  BP, HR was elevated.  ECG was performed and vitals continued to be monitored.  EMTs described the event as a vagal response which may have been due to the process of vaccination rather than the vaccine itself.  EMT reccomended Pt to go to  the hospital but pt was feeling better and refused and after feeling better was able to leave on his accord with family.
6 days after getting the covid vaccine I developed painful urination, frequency and significant pelvic pain. I was diagnosed with Interstitial Cystitis 5 years ago and haven?t had any problems or flares for 4 years. Since I received the covid vaccine, I have been in a constant flare with the worst pain I have ever felt. Nothing seems to help.
PATIENT STATES THAT 1 DAY AFTER THE SECOND INJECTION SHE STARTED HAVING FEVER, CHILLS, HEADACHE, AND BODY ACHES.  A DAY LATER SHE HAD ABDOMINAL CRAMPING AND DIARRHEA THAT LASTED 4 DAYS.  SHE HAD ALL S/S FROM ABOVE LASTED 5 DAYS.  PATIENT DID NOT SEEK MEDICAL TREATMENT AND ONLY USED OTC MEDICATIONS IE..TYLENOL FOR ISSUES.  SHE DID NOT REPORT TO HER PCP.
Not been able to sleep, started insomnia; he try to go to sleep and within an hour or 2 hours his body jerks and wake him back up; Not been able to sleep, started insomnia; he try to go to sleep and within an hour or 2 hours his body jerks and wake him back up; Started developing a cough; This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 03May2021, as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 03May2021, right after his first vaccine, the patient started to have a cough. As time went on, the patient was not able to sleep and started insomnia. Patient tried to sleep and within an hour or 2 hours, his body started to jerk and woke him up. Patient never experienced this before. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Initial report received on 07 December 2009 from a consumer, who is the patient's parent. A 33 month old female patient, with allergies to OMNICET, BACTRIM, and formaldehyde, received a first left thigh intramuscular injection of Influenza A (H1N1) 2009 Monovalent Vaccine - No Preservative (lot number UT014FA) on 23 October 2009. Two hours post-vaccination, the patient developed itching and broke out in hives. She was given ZYRTEC, which resolved the symptoms. However, for the following two weeks, the hives continued to return after the ZYRTEC wore off. The patient's pediatrician felt that this was a possible allergy to something else. The patient was seen by an ENT the week previous to the report. The patient had not been evaluated by an allergist, but she was to have allergy testing on 08 December 2009. At the time of the report, the patient had not recovered. Follow-up information received on 14 December 2009 from a consumer, who is the patient's parent. At the time of the report, the patient still had hives.
On February 23, 2021 I received the second Pfizer vaccine at 10 AM. Upon awaking at 7 AM the next day I had severe constant high pitch hissing in both ears. The left ear was worse. The left arm was the vaccine injection site.  On March 1st the level intensity decreased about half.  It has been over three months, since the symptom started, with no additional improvement.  I have not experienced any tinnitus symptoms before the vaccine.  I was examined by ENT and my hearing tested. I have no hearing loss.   I have no health issues nor do I take any medicines.
This spontaneous report was received from a pharmacist and refers to a 28 year old female patient. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 04-FEB-20156, the patient was vaccinated with an expired dose of M-M-R II (lot # J011332, expiration date 19-SEP-2015 (dose and route of administration were not reported). No adverse effects reported. Additional information has been requested.
56/M presented with abdominal pain found to have thrombocytopenia, CT showed splenic infarct, non-occlusive thrombi in the left common and external iliacs.  2 days after he developed R sided weakness, found to have thrombi in L vertebral, proximal L ICA, RE common carotid.  PF4  antibody positive at 2.323 (normal <0.399).
After receiving my shot around 4:00 pm on April 13, 2021, I was restless and did not sleep well that night. When I woke up on April 14, I was tired but otherwise felt fine except my arm was a bit sore.  However, after working at home for a couple of hours, shortly before 10:00 am I began to feel nauseous. I rushed to the bathroom thinking I was going to throw up, and almost immediately fainted. My wife and sons found me on the floor and woke me up. I threw up shortly after and felt pretty lousy the rest of the day with low grade fever, chills, body aches, fatigue, and a headache. I began to feel better at night and had a good night of sleep. Today (April 15), I feel fine except I'm a little tired.
Systemic: Headache-Severe, Additional Details: Stated she had a mild headaache for several days post injection but then began experiancing severe migraines. Stated that CT scan run by doctor returned with normal results. States she has never had migraines before receiving covid vaccination.