chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt mental problem/my mind is not working properly; Feeling anonymous fear; Could not work almost four month; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single and administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID", start date: Feb2021 (unspecified if ongoing), notes: I am infected by COVID on Feb2021. The patient's concomitant medications were not reported. The following information was reported: MENTAL DISORDER (non-serious), outcome "unknown", described as "Felt mental problem/my mind is not working properly"; IMPAIRED WORK ABILITY (non-serious) with onset Apr2021, outcome "not recovered", described as "Could not work almost four month"; FEAR (non-serious), outcome "unknown", described as "Feeling anonymous fear".  Additional information: It was reported that patient took Pfizer vaccine of Covid 19 two times and moderna as booster and Pfizer on Apr2021 and booster on Dec of same year. Both time patient felt mental problem. In Apr could not work almost four month and after booster also patient could not work till now properly and feeling anonymous fear and mind is not working properly. Patient was infected by COVID on Feb2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
vomiting; This spontaneous case was reported by a patient and describes the occurrence of FOOD POISONING (vomiting, feels like food poisoning) 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 13-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced FOOD POISONING (vomiting, feels like food poisoning). At the time of the report, FOOD POISONING (vomiting, feels like food poisoning) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided. No treatment medications are provided.
Information has been received from a 25 year old female licensed practical nurse with sulfonamide allergy who on 31-MAY-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot # 657006/0188U). On 26-JUL-2007 the patient was vaccinated IM with a 0.5 ml second dose of Gardasil. Concomitant therapy included CELEBREX. On 07-AUG-2007 the patient developed genital warts. Unspecified medical attention was sought. The patient's genital warts persisted. Additional information has been requested.
woke up coughing; chest just did not feel right; extremely fatigued; tingling/ weird sensation in my mouth; Metally taste; vision didn't feel right; windpipe felt funny; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling/ weird sensation in my mouth), DYSGEUSIA (Metally taste), VISUAL IMPAIRMENT (vision didn't feel right), OROPHARYNGEAL DISCOMFORT (windpipe felt funny) and COUGH (woke up coughing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included CPAP (On CPAP machine for unknown history).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PARAESTHESIA ORAL (tingling/ weird sensation in my mouth), DYSGEUSIA (Metally taste), VISUAL IMPAIRMENT (vision didn't feel right), OROPHARYNGEAL DISCOMFORT (windpipe felt funny) and FATIGUE (extremely fatigued). On 07-Jan-2021 at 2:00 AM, the patient experienced COUGH (woke up coughing) and CHEST DISCOMFORT (chest just did not feel right). At the time of the report, PARAESTHESIA ORAL (tingling/ weird sensation in my mouth), DYSGEUSIA (Metally taste), VISUAL IMPAIRMENT (vision didn't feel right), OROPHARYNGEAL DISCOMFORT (windpipe felt funny), COUGH (woke up coughing), CHEST DISCOMFORT (chest just did not feel right) and FATIGUE (extremely fatigued) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 06 Jan 2021, within first few minutes after receiving the vaccine, the patient had a tingly/weird sensation in her mouth, a metally taste and was extremely fatigued.  After 15 minutes, her vision just didn't feel right and her windpipe felt funny.  She stated that she wasn't really short of breath and asked the person who gave the vaccine if she should use her inhaler. After 15 more minutes, she went home.  On 07 Jan 2021, at about 2:00am, the patient woke up coughing and felt something in her chest just did not feel right, but it wasn't her heart.  Treatment included one Benadryl (diphenhydramine) which did help.   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.; Reporter'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.
She had pain in left arm that radiated into left shoulder and back and ten into whole body x 48 hours after receiving the injection. She also had nausea, chills, and slight fever. The symptoms occurred 7 hours after receiving TDaP.
Within 1st few days, arm was warm, swollen and painful. Didn't subside after a week or two. 3 weeks after shot (a week ago), sx increased - more painful and swollen and decreased activity. Went to doctor 2-13-08 who said she had vaccine reaction with local infection in arm. Rx's Omnicef 300mg bid x 10d plus Medrol pack.
Information has been received from a nurse concerning a 26 month old patient who on 24-FEB-2011 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot# 667920/0860Z). the nurse mentioned that on 23-APR-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports form the same source. Follow up information has been received from the registered nurse concerning the male patient with no illness at the time of the vaccination. The patient's medical history included bronchiolitis, croup and eczema. The patient was vaccinated subcutaneously in the left leg with lot # (667920/0860Z) dose 1 of VARIVAX (oka/merck) (VARIVAX) on 24-FEB-2011 at 15:30hrs. No other co-suspects and no concomitant medications were reported. On 23-APR-2012 the patient went to the clinic with rash described as "scattered small papules and vesicles; some intact, others with scabs-bilat arms, back "s/ of abdomen and s/ of legs, lots of excoriation. No edema, scaling or petechial". The patient was diagnosed with varicella. No treatment information was reported. No lab diagnostic testing was performed. The patient was seen on 11-JUN-2012 and had no rash, the outcome of the patient's events was reported as recovered. The relatedness for the reported events was not provided for VARIVAX (Oka/Merck). Alot check has been initiated. Additional information is not expected.
About midnight, early morning of June 26th, I had fever, nausea, fatigue and light headed and body aches primarily in the joints. After about 4 days I didn't have any fever but still had the joint aches and extreme fatigue for about a week. I began PAXLOVID on June 30 after testing positive at home and speaking with doctor. As of today, July 25th, I still have low energy.
4 years old kid, would have received Moderna vaccine vial for adults but in her age appropriate dosage; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 years old kid, would have received Moderna vaccine vial for adults but in her age appropriate dosage) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 years old kid, would have received Moderna vaccine vial for adults but in her age appropriate dosage). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 years old kid, would have received Moderna vaccine vial for adults but in her age appropriate dosage) outcome was unknown.            No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Patient c/o "severe" headache that began immediately after receiving vaccine. She stated that yesterday she was at her neurologist's office and had an induction of a seizure, which resulted in a severe headache. She said she did not have a headache prior to the injection.  VS 1120 130/70bp 98% 78HR 98.7t 16RR 5/10pain 1130 115/85bp 99% 75HR 98.7t 1140 99% 71HR 1/10pain  1145-patient left with her husband and little boy  we educated her to inform her md about her symptoms today and to discuss measures to take regarding future vaccines.
This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 60-year-old female patient who received SHINGRIX (batch number 97H2?, the reported lot number does not match with any GSK lot number, expiry date 8th February 2021) for prophylaxis. On 30th August 2018, the patient received the 1st dose of SHINGRIX. On 31st August 2018, 1 days after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported via chat. The patient experienced a full body rash.
Friday night I felt extremely tired, sat morning I felt like I never slept. Around 5:30am I started feeling extremely nauseous and had diarrhea. My head hurt something horrible. The nausea lasted all day Saturday. Sunday I still had a pretty major headache
No additional adverse event reported.; Nurse calling to report an adverse event on improperly stored administered PROQUAD; This spontaneous report was received from a registered nurse referring to a 12-month-old patient of unknown gender. Information regarding the patient's pertinent medical history, current condition, previous drug reaction or allergy and concomitant medication was not reported.  On 25-FEB-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (0.5 ml, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot # T023919, expiration date 09-JAN-2022) for prophylaxis. The vaccine administered experienced temperature excursions of 5.2 degrees Celsius for 15 minutes as recorded by a data logger. No additional adverse event reported.
pt recvd vax on 4MAR93 & devel tenderness & erythema @ & below site toward elbow aprpox 2" x 2" area;
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.
Bloodshot eyes; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Bloodshot eyes) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced OCULAR HYPERAEMIA (Bloodshot eyes). At the time of the report, OCULAR HYPERAEMIA (Bloodshot eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medications were not reported.
pharmacist who reported patient got an expired dose of ipol with no reported adverse event; Initial information was received on 06-Jul-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age/gender patient who got an expired dose of ipv (vero) [Ipol] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of expired suspect ipv (vero) Suspension for injection (lot number: U1C571M, expired date: 17-Jun-2023) (dose, route, administration site, strength: Unknown) Immunization (immunisation) with no reported adverse event (expired product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  Outcome was Unknown for the event pharmacist who reported patient got an expired dose of ipol with no reported adverse event.  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 the guidelines. 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.
This spontaneous report was received from a registered Nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On multiple unspecified dates, the patients were vaccinated with improperly stored of PROQUAD (Merck), (Lot numbers L005297; expiration date 17-AUG-2016 and lot number reported as L023112; expiration date 24-DEC-2016) dose, route, frequency and anatomical location were not provided. No concomitant medications were specified. No adverse effect was reported. This is one of two cases from the same source. Additional information has been requested.
raised, red, itchy scaly rash on arm after first dose worsening rash on both forearms, arm, back, legs after second dose, progressively getting worse over the past week
Pt recvd Hep B vax in JUL91 & exp burning & pain @ inject site; lot# of Hep B vax was changed & sx did not recur;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unspecified date in 2013, the patient was inoculated with ZOSTAVAX for routine adult health maintenance for the prevention of shingles (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2013, the patient was treated at the hospital for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering (emotional distress), and other damages. The outcome of the events was unknown. Causality assessment was related.
Patient complained of their throat feeling swollen roughly 30 minutes after administration of the vaccine. RN collected patient from the front of clinic and performed an examination, collected vital signs, and administered PO benadryl 25mg per protocol.  Patient able to swallow pill and water fine. Patient denied swelling of tongue or difficulty breathing. Patient then examined by provider who advised patient to monitor symptoms and if swelling does not go down or if they have difficulty catching their breath or sudden drooling to notify one of the staff immediately. Patient verbalized understanding and returned to work at front of clinic. RN checked on patient again after an hour from when benadryl was given and patient verbalized swelling had decreased and they were feeling fine.
Pt called on 7/12/01 to report that she has had left arm pain since her hepatitis A injection. She describes the pain as continuous like a toothache. It's zapping me. Pt has not sough any medical follow up. PHN recommended she see a physician asap.
Severe polymyalgias; CPKs very high at 80,000; This is a spontaneous report from a contactable physician. A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Not Provided, second dose) solution for injection intramuscular on an unknown date (at the age of 30-years-old) as a single dose for COVID-19 vaccination. Medical history included Cystic Fibrosis and Autoimmune Necrotizing Myositis. Concomitant medications were unknown. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on an unknown date with no adverse effect reported (tolerated first COVID-19 vaccine). The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Less than 24 hours after second COVID-19 vaccine injection, the patient had severe polymyalgia. CPKs checked very high at 80,000. The patient was currently admitted to the hospital. Unspecified treatment was provided for the events severe polymyalgias and CPKs very high. The outcome of the events severe polymyalgias and CPKs very high was unknown. Since the vaccination, the patient has not been tested for COVID-19. The patient was supposed to get RITUXAN as a regimen for his muscle disorder and was interested in Pfizer checking his neutralizing antibody level both pre and post Rituxan. The patient will receive RITUXAN shortly in the next week.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on chronological connection to the vaccine causality between events severe polymyalgia and CPKs checked very high and  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE0 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
dizziness, overall weakness, heavy limbs, sore muscles, fever, vomiting, diarrhea
This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.  Sender's Comments: US-009507513-1804USA005153.
Trouble breathing for 4 months after the booster shot. (3rd shot) Also coughing a lot. Coughing up a lot of mucus. Dizzy, light headed, heart racing at times, low heart rate at other times, and irregular heart beat. 4 months of this. Finely my doctor gave me anti biotics for a week, and I started feeling better. Still not right though. I have no lung capacity. I walk 20 feet, and I'm out of breath. I've never been like this in my life until I took the vaccine. Same thing happened after the second shot. That lasted 2 months before I started feeling normal again.
Patient was administed expired Covid-19 Moderna Vaccine. Notified Moderna when we were made on 11/17/21. Patient has been called and informed of incident and advised to come in and be given an additional full dose of Covid-19 Moderna Vaccine per the instructions of both Moderna and Public Health.
Patient was administered vaccine on 7/21/22 with use before date of 7/16/22
No adverse event; Half dose; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Half dose) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer on 12-Mar-2021 and Pfizer on 02-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Immunocompromised.    On 28-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 28-Oct-2022, the patient experienced UNDERDOSE (Half dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Half dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Half dose).    The concomitant medication was not reported by reporter.  On 03-Jun-2022, patient received intramuscular Moderna vaccine injection (lot number 037A22B, expiration date 31-Aug-2022). The dose given on the day of the report by intramuscular injection was a 0.25mL dose. The patient requested this dose because patient was immunocompromised. No reported symptoms. No additional doses, medications, or treatments reported.  The treatment medication was not reported by reporter.