chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very tired; A little upset stomach; Neuropathy returned in my hands, feet and lower legs; Neuropathy returned in my hands, feet and lower legs; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (BNT162B2, Lot number: EN6199; Expiration date was not reported) on the left arm on 04Mar2021 (16:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the public health clinic. Medical history included rectal cancer from 2018 to an unspecified date; chemo from 2019 to an unspecified date; and neuropathy that was left from the chemotherapy. The patient had unspecified concomitant medications. The patient previously took aspirin (acetylsalicylic acid), and had drug allergy. The patient was not pregnant at the time of vaccination. On 04Mar2021 (17:30), the patient's neuropathy had returned in the hands, feet and lower legs; and had sore arm. On 05Mar2021 (10:30), the patient was very tired, and had a little upset stomach. The patient did not receive treatment for the events. The outcome of the events, 'neuropathy had returned in the hands, feet and lower legs', 'sore arm', 'very tired' and 'little upset stomach', was recovering. The patient has not had COVID-19 prior to vaccination; and was not tested for COVID-19 post-vaccination.
One week and one day post second vaccination developed left sided teeth pain both upper and lower. Worsened over past few days, today, 2/16, have what seems like trigeminal neuralgia which I never had before. Intense facial and tooth pain and burning  left side of face.  Will report to MD tomorrow.
The pt developed red papular lesions on abdomen and chest 5-10 with whitish center, fever and pruritis.
Headache started at 6:30 pm, chills started at 8:15, woke up with body aches and headache at 5:50am
Pt vaccinated with MMR developed insulin dependent diabetes mellitus 6 wks following MMR immunation.
Severe body pain; Severe body cramps; Headache; Chills; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 10Apr2021 at 15:00(at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included adhd (Attention deficit hyperactivity disorder).The patient did not have any allergies to medications, food, or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) from an unknown date for unknown indication taken within 2 weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 at 15:00(at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 11Apr2021 at 10:00 the patient experienced Severe body pains/cramps, headache, chills and vomiting. No therapeutic measures were taken as a result of the events. The clinical outcome of the events Severe body pains/cramps, headache, chills and vomiting were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
the pain is so severe that she feels excruciating pain all over her back and on her chest now/ Rated pain as more than 10, 10 being the highest.; the pain is so severe that she feels excruciating pain all over her back and on her chest now/ Rated pain as more than 10, 10 being the highest.; felt soreness of her left arm (injection site), across her back to her right arm and into her right breast.; Taken to the emergency room for pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (the pain is so severe that she feels excruciating pain all over her back and on her chest now/ Rated pain as more than 10, 10 being the highest.), BREAST PAIN (the pain is so severe that she feels excruciating pain all over her back and on her chest now/ Rated pain as more than 10, 10 being the highest.), PAIN (Taken to the emergency room for pain) and VACCINATION SITE PAIN (felt soreness of her left arm (injection site), across her back to her right arm and into her right breast.) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jul-2021, the patient experienced PAIN (Taken to the emergency room for pain). On an unknown date, the patient experienced BACK PAIN (the pain is so severe that she feels excruciating pain all over her back and on her chest now/ Rated pain as more than 10, 10 being the highest.), BREAST PAIN (the pain is so severe that she feels excruciating pain all over her back and on her chest now/ Rated pain as more than 10, 10 being the highest.) and VACCINATION SITE PAIN (felt soreness of her left arm (injection site), across her back to her right arm and into her right breast.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (the pain is so severe that she feels excruciating pain all over her back and on her chest now/ Rated pain as more than 10, 10 being the highest.), BREAST PAIN (the pain is so severe that she feels excruciating pain all over her back and on her chest now/ Rated pain as more than 10, 10 being the highest.), PAIN (Taken to the emergency room for pain) and VACCINATION SITE PAIN (felt soreness of her left arm (injection site), across her back to her right arm and into her right breast.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication includes Muscle Relaxers and Pain killers.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow Up received on 12 july 2021 , updated with new treatment medications( pain killers and muscle relaxants). information about event were updated..
side effects; arm to swell after second shot; Very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects), VACCINATION SITE SWELLING (arm to swell after second shot) and VACCINATION SITE PAIN (Very sore arm) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects), VACCINATION SITE SWELLING (arm to swell after second shot) and VACCINATION SITE PAIN (Very sore arm). At the time of the report, VACCINATION COMPLICATION (side effects), VACCINATION SITE SWELLING (arm to swell after second shot) and VACCINATION SITE PAIN (Very sore arm) outcome was unknown.            No concomitant information provided by the reporter No treatment information provided by the reporter; 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
Chest pain, shortness of breath.  Patient presented to the ER for evaluation of symptoms.  Noted to have tachycardia upon arrival
Pneumonia of left lower lobe due to infectious organism - He had a stroke code on the day of death because of change in mental status and flailing arms and possible weakness. MRI was not obtainable as it was down and not functional. CT scan did not show any acute ischemia. Showed progression of lacunar infarcts in the basal ganglia in cardiac region. He was found to have arterial blood gases elevated CO2 97. He continued to deteriorate during the stroke code. At this time, had been after his palliative care consult, full code. After discussion with his spouse, over the past days, he transitioned to DNR/DNI. He did not want intubation. Ultimately transitioned this morning to comfort measures. He received morphine and Ativan as needed for his tachypnea and struggling with his breathing. He passed away at 1324, comfortable. Hospitalization and passing within 6 weeks of receiving the COVID vaccine.
developed heart palpitations/PVCs. Multiple cardiologist appointments, testing, heart monitors and EKGS. Happened within 3 months of the shot. Followed by an autoimmune disease, hashimotos.
Vaccine DTaP+IPV not indicated for patient age. Should have received the DTaP and IPV separately.
I started experiencing "fullness" and pressure inside my head and ears, slight dizziness,  tinnitus, and trouble focusing.  This started approximately 60 hours after 2nd vaccine dose, after the normal side effects such as fever and weakness had passed.  I have waited 24 hours for the symptoms to subside, but they are the same as of today.
This spontaneous report was received from a License practitioner nurse regarding a 18 month old female patient with no known allergies.   On 17-NOV-2016 at 12:58 P.M  the patient was vaccinated with  expired dose of VARIVAX (lot# K006134, expiry: 29-APR-2016) dose 1, subcutaneous route in the right arm for prophylaxis and expired dose of hepatitis A vaccine, inactivated(Manufacturer unknown)(Lot# L015460) dose 1, intramuscular route in left arm for prophylaxis. Concomitantly the patient was also vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (Manufacturer unknown) and influenza virus vaccine (unspecified) (Manufacturer unknown) on the same day. The reporter was checking for efficacy. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1611USA010737: US-009507513-1612USA005160: US-009507513-1612USA005161: US-009507513-1612USA005162: US-009507513-1612USA005163: US-009507513-1612USA005164: US-009507513-1612USA005165: US-009507513-1612USA005166: US-009507513-1612USA005167: US-009507513-1612USA005168: US-009507513-1612USA005169:
redness, swelling, fever starting 24hrs p/vax;rt arm;rx cold compresses, APAP & DPH
This spontaneous report was received from a pharmacist, referring to a female patient at a nursing home facility, with no pertinent medical history reported. On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot # H013581, expiration date not reported)(no dose, route or anatomical location were specified). No other co-suspects or concomitant medications were specified. On an unknown date the patient developed cellulitis at the injection site that required antibiotic therapy. The patient sought unspecified medical attention, she is in a nursing home. At the time of the report the outcome for cellulitis at the injection site was unknown. Additional information has been requested. This is one of the several reports of the same source.
I had a 102.5 degree fever off and on for two days; severe body aches; chills; headaches; injection site soreness; redness; skin sensitivity; brain fog; hot flashes; fatigue; swollen lymph nodes (left armpit); This is a spontaneous report from a contactable other hcp. A 44-year-old male patient reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9268), via an unspecified route of administration, administered in Arm Left on 12Feb2021 14:00 (at the age of 44-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included migraines. Patient had no known allergies. Patient had not covid prior and post vaccination. Concomitant medication(s) included ibuprofen (ADVIL LIQUI GELS); acetaminophen (ACETAMINOPHEN). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 26Jan2021 02:45 (at the age of 44-year-old) as 1st dose, single for COVID-19 immunization. The patient stated that on 13Feb2021 02:00, he had a 102.5 degree fever off and on for two days, severe body aches, chills, headaches, injection site soreness, redness, skin sensitivity, brain fog, hot flashes, fatigue, and swollen lymph nodes (left armpit). Patient did not received any treatment for the events. The outcome of the events was reported as recovering.  Follow-up attempts have been completed and no further information is expected.
General malaise at onset of symptoms and at 4:00 PM chills began. Full fever of 102.5 began ~4:45 PM. Took Advil for fever. Fever broke at ~4:00 AM on 01/15/2015. Incredibly sore, swollen, ichy and red rash at vaccination location (left upper arm) that began ~3 hours after vaccination. Arm is still slightly sore, itchy and a small bump is present now (01/25/2015).
Seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In October 2021, the patient experienced SEIZURE (Seizure) (seriousness criteria hospitalization and medically significant). In 2021, SEIZURE (Seizure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.  No concomitant medication information was  provided.  It was reported that In Oct 2021, the patient had a seizure, 3 days after covid injection and was not on Rinvoq.  Patient was admitted for one week. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication information was provided.  Company comment: This spontaneous case concerns a 73-year-old female patient, with no reported medical history, who experienced the unexpected serious (hospitalization and medically significant) AESI of Seizure after receiving a dose of mRNA-1273 vaccine and co-suspect drug Upadacitinib (unknown indication). The event occurred within a year of administration of mRNA-1273 vaccine. It was reported that patient had seizure, 3 days after vaccination and was hospitalized for one week. Clinical course and treatment details were not reported. The outcome of event was reported as resolved. The co-suspect Upadacitinib could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a 73-year-old female patient, with no reported medical history, who experienced the unexpected serious (hospitalization and medically significant) AESI of Seizure after receiving a dose of mRNA-1273 vaccine and co-suspect drug Upadacitinib (unknown indication). The event occurred within a year of administration of mRNA-1273 vaccine. It was reported that patient had seizure, 3 days after vaccination and was hospitalized for one week. Clinical course and treatment details were not reported. The outcome of event was reported as resolved. The co-suspect Upadacitinib could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.
dizziness/lightheaded; brain fog; kind of head pressure not being there; This is a spontaneous report from a non-contactable consumer (Patient). A 57-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 27Jul2021 (age at vaccination 57 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 2021 the patient experienced dizziness/lightheaded, brain fog, kind of head pressure not being there. Patient reported that symptoms have improved some not completely and asking if the second Pfizer Covid 19 Vaccine will cause "worst vertigo?" also asking if the vaccine will cause Central Nervous System issues, if any have been reported? The outcome of event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event has been reported.  It was realized after the patient received the Abrysvo vaccine that he did not meet CDC guidelines to receive the vaccine.  The patient is 54 and guidelines state that he should be >/=60 years old.  We have been unble to reach the patient to ask how he did with the vaccines and when we attempted to reach his listed primary care provider, we were told that he is no longer a patient since they had not seen him in over a year.
21 y/o client complains of nausea and dizziness. Head-to-toe assessment done. All within normal limits except skin color was pale. BP: 94/62. Client appears to be tachypneic but states she has no trouble breathing. She is no acute distress. Client vomited 30-40 ml of brownish emesis. After client vomited, she stated she felt better. She refused ambulance assistance and preferred to go home. Co-worker was with her at the time and stated she will drive her home. At the end of monitoring time, client stated she felt better and left facility, accompanied by her co-worker, ambulatory. At the end of monitoring time, client?s color was normal and she was in no acute distress, breathing was even and unlabored. Her departure time was 1019.
headache; dizziness/dizzy at work; chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIZZINESS (dizziness/dizzy at work), CHILLS (chills) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Feb-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 02-Feb-2023, the patient experienced DIZZINESS (dizziness/dizzy at work) and CHILLS (chills). On 08-Feb-2023, the patient experienced HEADACHE (headache). At the time of the report, DIZZINESS (dizziness/dizzy at work), CHILLS (chills) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2023, Blood pressure measurement: 145/90, increased.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. The patient experienced Chills and Dizziness after her bivalent booster dose that was administered on 2Feb2023. On wednesday 8FEB2023 the patient became dizzy at work.  No treatment information was reported.   This case was linked to MOD-2023-709251 (Patient Link).
The vaccine was administered and the patient said they were starting to feel lightheaded within 2 minutes of receiving it. The patient then fainted in the chair with their head back and their tongue out of their mouth. I was trying to wake the patient up to clarify whether the patient was having trouble breathing or if any part of her mouth or throat was swelling, but I could not wake the patient. Both arms were very red. It sounded like labored breathing for about 30 seconds once I got in the room and then the patient stopped making noise. I could not hear any breaths so I administered one dose of 0.3 mg epinephrine in an Epipen.
redness and heat to forearm with swelling and bogginess of the elbow. treated for poss cellulitis.  more inflamed than a typoical pneumovax local injection site rxn.
Administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 72t95, expiry date 9th August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th August 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 18th August 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 22-AUG-2022 Reporter's Comment: The reporter reported that, a patient was administered an expired dose of Havrix. The reporter declined to provide more information due to not having the patient's permission. The reporter did not consent to follow-up. Additional Supportive Information: The reporter reported that, a patient was administered an expired dose of Havrix, which led to expired vaccine used.
Swollen lump at injection site appeared on 7th day, itchy and sore.  Continues to swell on 8th day.  On 6th-8th day neck is very stiff and sore, probably unrealated and how I slept but thought I'd mention it
606 doses were given after expiration date; Vial which was expired on 03-Oct-2021 was placed in refrigerator on 03-Nov-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial which was expired on 03-Oct-2021 was placed in refrigerator on 03-Nov-2021) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Vial which was expired on 03-Oct-2021 was placed in refrigerator on 03-Nov-2021). On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial which was expired on 03-Oct-2021 was placed in refrigerator on 03-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported.  Vial did not undergo any temperature excursion.  It was reported that patient did not experience any adverse event.
Patient has red, inflamed, and tender rash about 3 to 4 inch diameter around the injection site. Md diagnosed as an infection.
Pt was given the wrong vaccine while in office today; she was supposed to get Hep A and not Hep B. No adverse event occurred.