chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Intolerance to heat; Night sweats; Stomach upset; High blood pressure; Nausea; Chills; Slept all day; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: LAB-1451-0.7) via an unspecified route of administration in the left arm on 23Mar2021 at 14:30 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, prehypertension, anxiety, diverticulum, ulcers, vertigo, shingles, palpitations, herpes simplex type 1 and 2, gastroesophageal reflux disease (GERD) and hiatal hernia. The patient had received other unspecified medications within 2 weeks of vaccination. The patient previously took codeine (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. 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 23Mar2021, the day of vaccination the patient slept all day. On 30Mar2021 at 13:00, day 7 after vaccination, the patient experienced intolerance to heat, night sweats, nausea, stomach upset, chills and high blood pressure. The adverse events resulted in a visit to the doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome slept all day, intolerance to heat, night sweats, nausea, stomach upset, chills and high blood pressure were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
presenting today for Labs Only (covid test, symptoms, wants test only) .  pt vaccinated, has young child, weaning from breast feeding. No known exposure without ppe, symptoms x 2 days.
dose administered more that 24 hours after the vial was first punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered more that 24 hours after the vial was first punctured) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021 at 2:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021 at 2:40 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered more that 24 hours after the vial was first punctured). On 25-Aug-2021 at 2:40 PM, EXPIRED PRODUCT ADMINISTERED (dose administered more that 24 hours after the vial was first punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported by reporter Treatment information was not provided by reporter
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 29-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was reported that the data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter also stated that no adverse reactions were reported by any patients. Treatment information was not provided.
05/02/2022 I got back from traveling. I immediately went to another area, and I thought my asthma was acting up. They had a high pollen count, so I thought maybe I was having a reaction to the pollen. I was having trouble breathing, started coughing and was not sleeping that night. I thought I better get checked out. I went to the doctor. They gave me albuterol and prednisone for asthma. They did an x-ray and found a spot in my lower right long and treated that with an antibiotic. I had no fever or chills. I have recovered and can walk, breathe and chew at the same time. I received an email from the hotel, that guests at that hotel had been diagnosed with Legionnaire's Disease while I was there.
Pentacel was given and not mixed with ActHib lyophilized component and they just gave the liquid portion, no AE; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of unknown demography for whom it was reported that DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was given and not mixed with ACTHIB lyophilized component and they just gave the liquid portion, (lot number, expiry date, dose, route and site of administration not reported) on an unknown date.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate reconstitution technique.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC 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.  Information on the batch number was requested.  Documents held by sender: none.
Ministroke, TIA Numbness left hand, facial drooping Symptoms resolved within 5 minutes
2 days p/vax nauseated, body aches x 24 hrs, sore arm; one wk later head cold, chest cold, fever;
child received the DTap/ IPV portion only of the Pentacel vaccine; Initial information received on 20-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old patient who received 0.5 mL dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ123AAA, expiry date: 29-Sep-2020 via intramuscular route in the right thigh on 20-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was a case of actual medication error due to inappropriate reconstitution technique.  Office manager reports that today a child received the DTap/ IPV portion only of the Pentacel vaccine.  It was unknown if any adverse event was occurred.   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 2001/83/EC 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.
Body, ankles and feet swollen/my body has been swollen specially my ankles and my feet; Body, ankles and feet swollen/my body has been swollen specially my ankles and my feet; Body, ankles and feet swollen/my body has been swollen specially my ankles and my feet; This is a spontaneous report from a contactable consumer or other non hcp.   A patient of unspecified age and gender received bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single on an unspecified date for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, The patient experienced body, ankles and feet swollen/my body has been swollen specially my ankles and my feet. "patient was wondering, it was normal for your body to swell up after the vaccine. The patient got it on Monday and the next day patient body has been swollen specially the my ankles and my feet." Consumer was informed about Pfizer Medical Information Department. In response, consumer stated, "So will I be able to call now. I was just going to the "ER" (Further not clarified)." (Further call hung up) As consumer abruptly hung up the call. Product details (LOT#, expiration date, NDC# and UPC#), Pharmacy details and treatment could not be probed over the call. Limited information available over the call and appropriate response could not be provided. The outcome of the events were unknown.  Information on the lot/batch number has been requested.
Extreme nausea and vomiting about 9 hours after injection. Lasted about 5-6 hours
Fever, cough, shortness of breath, aches and pain, headache,   Hoarseness, Presented as asthma.    Diagnosed with pericarditis after a hospital stay. Went to ED because of shortness of breath and chest pain.  Was admitted for observation and heart and lung tests.
Patient stated that she developed many problems due to receiving the vaccination. Postural Orthostatic Pachycargra syndrome. Hypertension, QT
Member received vaccine, was observed for 15 mins and then left clinic.  Member came back to clinic at 2:25 pm to report bleeding under the skin on some of her finger tips .  thinks it is a reaction to the vaccine.  denies any itching or pain at the site;  no swelling noted, not warm to touch.   Member denies any other symptoms.  Member sent to be evaluated in Urgent care.
Pt reports a localized rash above and below the vaccination site. Offered Benadryl PO. Patient refused. Notified and here at table. Patient will be observed for 30 mins in Observation . Patient remained in observation for 30 min with no other complaints. Rash seems to be subsiding @ 1645. At 0510 - patient walks out. No further complaints.
This spontaneous report as received from a physician refers to a patient of unknown gender and unknown age. The patient was vaccinated with a first dose of VARIVAX (Merck) injection (lot#, dose and route not provided) on 14-MAY-2014 and a second dose of VARIVAX (Merck) injection (lot#, dose and route not provided) on 21-JUL-2014. No adverse symptoms reported. Additional information has been requested.
exhausted; arm hurts; muscle aches; This case was reported by a consumer via call center representative and described the occurrence of exhaustion in a 76-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 2nd dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced exhaustion, pain in arm and muscle pain. On an unknown date, the outcome of the exhaustion, pain in arm and muscle pain were unknown.   It was unknown if the reporter considered the exhaustion, pain in arm and muscle pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for themselves. The patient had the shingles shot in the week of reporting and felt exhausted, their arm hurt and had muscle aches.
Pt received a high dose flu shot on 12/04/15. Later that day he experienced increased blood pressure (163/102) and increased heart rate (91). He felt very weak, feverish, sluggish, had chest pain, and felt like he was about to have heart attack or stroke. He continued to feel worse through the evening. He came into the pharmacy the next day, feeling better, but he wanted to report his experience.
Patient started experiencing right neck and upper back pain radiating to the right arm starting the morning of 8/24/2016.  She also noticed some sores in the upper palate of her mouth which persisted for about 3-4 days. She used warm compress and took some tylenol to relieve the discomfort.
swelling in right armpit; tissue in right armpit seems to be hard and hurts to touch; This is a spontaneous report from a contactable consumer or other non-HCP reported about herself.    A 49-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration, administered in right arm as dose 2, single on 12Jun2021 (at the age of 49-year-old) for covid-19 immunisation. The patient's medical history included allergies with amoxicillin, vicodin drugs and with pollen extracts. Historical vaccine included first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: EW0186), via an unspecified route of administration, administered in right arm as dose 1, single on 22May2021 09:15 AM (at the age of 49-year-old) for covid-19 immunisation. And the patient took another second dose of unspecified Pfizer vaccine (Lot number: EW0167) via unspecified route of administration, administered in right arm on 22May2021. Concomitant medications included labetalol, losartan and hydrochloorthiazide all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medications labetalol, losartan and hydrochlorothiazide within 2 weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 13Jun2021, the next day after the second dose of vaccine patient experienced there was swelling and tissue in right armpit seemed to be hard and hurts to touch. At the time of this report, outcome of events was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Constant headache beginning a week after the second dose; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the arm left on 08May2021 at 11:00 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm left on 17Apr2021 at 09:00 (at the age of 21-year-old) 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 been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16May2021 at 13:00, the patient experienced constant headache beginning a week after the second dose received on 08May2021, headache beginning 16May2021. The patient took a visit to the emergency room, no abnormal blood work, normal neurological test. The event resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as a result of the event constant headache and included treatment with NSAID. On 22May2021, the patient underwent COVID-19 blood test and the result was pending. The clinical outcome of the event constant headache beginning a week after the second dose was not resolved at the time of reporting.   No follow-up attempts are possible. No further information is expected.
reaction to pneumovax & flu vax;pt recv vax 19OCT98 in lt arm;used Ibuprofen & moist heat;lt arm swollen above elbow approx 7cm red, hot to touch;cellulitis  to PMD:
On 2/4/04 developed a raised red area midway L side of back. On 2/7/04 developed another area to the left of 1st area. Approx 2cm x 6cm of raised red bumps. Itchy but no pain. Saw MD on 2/4/04 and diagnosed as herpes zoster treated with Famuir 500mg po tid x 7 days. Currently being treated.
Sore at test site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 86 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Jan2021 15:00 (Lot number: EL3249) at the age of 85 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "many cancers" (unspecified if ongoing), notes: Illness/ AE: Many cancers; "Marrow (illegible) disease", start date: 2012 (ongoing), notes: illness/AE: marrow (illegible disease); "Chronic UTI", start date: 1970 (unspecified if ongoing), notes: illness/AE: chronic UTI, Stop date: Now Under control. Concomitant medication(s) included: BROVANA; AZITHROMYCIN; PULMICORT; DILTIAZEM HCL A; ESTRADIOL; FLONASE ALLERGY RELIEF; HYDRODIURIL; LIDOCAINE 5% EXTRA; COZAAR; HIPREX [METHENAMINE HIPPURATE]; SINGULAIR; THYROID; NYSTATIN; PREDNISONE; PREVIDENT; RESTASIS MULTIDOSE; SODIUM CHLORIDE; TIOTROPIUM; KENALOG [TRIAMCINOLONE ACETONIDE]; CALCIUM; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; ADVIL [IBUPROFEN] taken for pain, inflammation; MOTRIN [IBUPROFEN] taken for pain, inflammation; KY taken for nasal dryness; LOPERAMIDE HCL FLX taken for diarrhoea; LUTEIN ZEAXANTHIN; MULTI VITAMINS & MINERALS; RETAINE FLAX; VIT C; FOSAMAX taken for osteoporosis. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Sore at test site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: 2nd shot moderately sore at test site plus upper arm sore after 8 hrs. 3rd shot same, but entire arm sore and stiff-especially stiff, took ibuprofen 14 hrs later and that solved the problem site was reddish for a couple of days.  No follow-up attempts are possible. No further information is expected.
she received one dose ofGARDASIL-9 on both 8/30/2019 and on 12/3/2019, not in accordance with the prescribing information; No additional adverse effects; This spontaneous report was received from a female physical therapist refering to herself. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 30-AUG-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 1 dosage form for prophylaxis (dose number, strength, frequency, route of administration, lot# and expiration date were not provided). The patient reported she received another dose of  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) on 03-DEC-2019, 1 dosage form for prophylaxis (dose number, strength, frequency, route of administration, lot# and expiration date were not provided), not in accordance with the prescribing information (inappropriate schedule of product administration).  No additional adverse effects were reported in the patient.
I had swelling and Grammy arms, like it just flapped, like bat wings. It was very hot to touch at the swelling, at first it was just where the shot was given and then it wrapped around the whole arm. It lasted about 3 weeks.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on her left arm close to where the injection/spreading on the same arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 031A21A and 021M20A) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and SOLIFENACIN SUCCINATE (VESICARE) for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, the patient experienced VACCINATION SITE RASH (rash on her left arm close to where the injection/spreading on the same arm). At the time of the report, VACCINATION SITE RASH (rash on her left arm close to where the injection/spreading on the same arm) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No medical history information was reported. No Treatment information was reported.
Patient received Moderna vaccine initial dose at clinic on 4/2/21. Patient presented to the Emergency Department on 4/14/21 with complaints of dizziness and mild nausea.  CT angio chest w& wout contrast identified pulmonary embolus within the intermediate pulmonary arteries bilaterally. Treatment started 4/14/21 with Eliquis (apixaban) patient admitted for observation overnight and discharged in stable condition on 4/15/21.
pt recv vax 29SEP98 & slept 20hr, h/a 24hr, muscle-nausea, runny nose;
09/05/2021 09:15 dizziness and headache; later evening had severe dizziness, nausea and neck and back pain; ambulance to ER; discharged with vertigo diagnosis  09/12/2021 22:30? severe dizziness and nausea; called for ambulance; began vomiting when moved;   09/13/2021 admitted to hospital to monitor vertigo
Patient was walking around the store after the shot. He wasn't feeling well within about 10 minutes  so sat down and then fainted. He came to quickly, but then kept fainting maybe 3 times. He was extremely pale/gray and sweating profusely.  He was very groggy whenever he came to.  We called the paramedics with in a few minutes of him fainting initially.