chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INTERMITTENT STOMACH PAIN/STOMACH PAIN ON AND OFF; DIARRHEA; SWEATING; GONE TO THE WORLD; CHILLS; FATIGUE; FEVER; This spontaneous report received from a consumer concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: stomach ulcer, and bee stings allergy. The patient experienced drug allergy when treated with cefaclor for bee stings allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: UNKNOWN) dose was not reported, administered on 12-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-NOV-2021, the patient experienced sweating. On 12-NOV-2021, the patient experienced gone to the world. On 12-NOV-2021, the patient experienced chills. On 12-NOV-2021, the patient experienced fatigue. On 12-NOV-2021, the patient experienced fever. On 15-NOV-2021, the patient experienced diarrhea. On 16-NOV-2021, the patient experienced intermittent stomach pain/stomach pain on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, gone to the world, chills, fatigue, and fever on 14-NOV-2021, was recovering from diarrhea, and had not recovered from intermittent stomach pain/stomach pain on and off. This report was non-serious.
Pt tested COVID positive on 3/24, less than 24 hrs post-vaccination #1.  Pt reported no associated COVID symptoms.  Presented to hospital w/ weakness r/t Afib (longtime diagnoses).
This spontaneous report was received from an unspecified reporter from the Department of Health, via company representative, referring to a child patient of unknown age and gender. The patient's concurrent conditions, past medical history, concomitant medications, and drug allergies or reactions were not reported. On an unknown date, the patient received a dose of M-M-R II (strength, dose, route of administration, lot # and expiration date were unknown), for prophylaxis. On an unknown date, the patient contracted measles-like symptoms after receiving the vaccine. On an unknown date, the child was swabbed for the virus and the test came back positive for vaccine-strain measles. It was unknown by the reporter if treatment was given for the events. The outcome of the events was unknown. A causal relationship between the events and M-M-R II was not provided.
Skin breakout; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Skin breakout) and FATIGUE (Fatigue) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free. On an unknown date, the patient experienced RASH (Skin breakout) and FATIGUE (Fatigue). At the time of the report, RASH (Skin breakout) had not resolved and FATIGUE (Fatigue) had resolved.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
This spontaneous report was received from a physician and a nurse and refers to a 66 year old female patient. The patient's pertinent medical history was skin cancer (2013), osteoporosis, hypercholesterolaemia and vaccination with PREVNAR 13 in 2016 (reported as last year). The patient had no drug reactions or allergies and no concomitant medications were reported. On 03-AUG-2017, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscularly for prophylaxis (exact dose, lot number and expiration date were not provided). On the same day, the patient experienced redness and tenderness at the site of the injection which traveled up her arm. On 04-AUG-2017, the patient was seen in the office and she had superclavicular lymph node enlarged (the size of a golf ball), tender and painful to the touch, also she experienced pain along the left side of her neck. The patient would be treated with paracetamol (TYLENOL), ibuprofen and cold compress, however no laboratory diagnostic studies were performed. The outcome of the events was not recovered/not resolved. The relatedness between the events and PNEUMOVAX 23 was not reported. There was no product quality complain involved in this case.
she received the second dose 14 days after her first dose; Pregnancy; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she received the second dose 14 days after her first dose) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she received the second dose 14 days after her first dose) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she received the second dose 14 days after her first dose) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 lot # L004014, expiration date - 04-MAR-2017. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Within 5 minutes of receiving GARDASIL the pt described a pressure sensation in the center of his back which made him want to move his arms for relief - he got the most relief by arching his back downward or putting pressure against his back. He was moving (twitching). Monitored BP & respiration and observed for 1 hr. Called Mom she stated he was back to normal by around 6:30 PM.
Suffered large MCA Ischemic stroke; facial droop; Memory loss; very lethargic; Sharp pain in head; vertigo; This serious case was reported by a consumer and described the occurrence of ischemic stroke in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included atrial fibrillation, anemia, cholesterol and blood pressure. Concomitant products included flecainide, irbesartan, rosuvastatin, folic acid and cyanocobalamin (Vitamin B12).   On 06-SEP-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced ischemic stroke (Verbatim: Suffered large MCA Ischemic stroke) (serious criteria hospitalization and GSK medically significant), facial droop (Verbatim: facial droop) (serious criteria hospitalization and GSK medically significant), memory loss (Verbatim: Memory loss) (serious criteria hospitalization), lethargy (Verbatim: very lethargic) (serious criteria hospitalization), headache (Verbatim: Sharp pain in head) (serious criteria hospitalization) and vertigo (Verbatim: vertigo) (serious criteria hospitalization).  The outcome of the ischemic stroke, facial droop, memory loss, lethargy, headache and vertigo were not resolved.   It was unknown if the reporter considered the ischemic stroke, facial droop, memory loss, lethargy, headache and vertigo to be related to Arexvy.     It was unknown if the company considered the ischemic stroke, facial droop, memory loss, lethargy, headache and vertigo to be related to Arexvy.   Additional Information: GSK receipt date: 2-Oct-2023 The patient suffered large MCA Ischemic stroke, went emergency room and hospitalized trying to recover.  The patient's wife had typed all this information into the computer for him. The patient also had memory loss and facial droop and ever since vaccine, the patient had have felt very lethargic since vaccine administration.  Sharp pain in head top right and severe vertigo. She too has had serious adverse events from this vaccine.  The reporter consented to follow-up.
Itchy hives widespread over body (armpits, groin, neck, abdomen, scalp, hands, feet, elbows). Began 11 days after booster and continuing now for 10 days and counting. Worsens with sweat, heat and activity. Very painful lymph nodes right after booster also noted.
Hard knot, swelling, and redness at injection site/ it felt hard in that spot; hard knot, swelling, and redness at injection site; hard knot, swelling, and redness at injection site; hurt a little more, she has more soreness; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that:  A female patient of unspecified age had received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178, Expiration date ??-AUG-2021), via an unspecified route of administration, administered on left arm on 03AUG2021 at single dose for COVID-19 immunisation. Patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178) via an unspecified route of administration on 13Jul2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. After first dose patient had didn't have too much of a reaction maybe a little soreness on Jul2021. After 2nd dose on 03Aug2021, patient had experienced did hurt a little more, she has more soreness but throughout the day she noticed a knot, it felt hard in that spot it felt hard in that spot. Yesterday she noticed that in the area it looks like it was getting swollen like a big mosquito bite that spreads when you scratch it. She iced it yesterday and it still is like that today. She didn't have a reaction the 1st time but she did with the 2nd. Do they put something different in there the 2nd time She was concerned. At the time of reporting, the outcome of the events were not recovered.  Description of complaint:  Caller reporting AEs following the 1st and 2nd dose of the Pfizer COVID vaccine asked if they put something different in there the 2nd time? She is concerned since she did not have this side effect with the 1st dose.  Probed for NDC, lot number and expiry date and caller does not see the NDC or expiry date on the COVID vaccination record card for the 1st dose and doesn't see an NDC for the 2nd dose. Therapy start date populated as the date for the caller's first COVID vaccine and the therapy stop date populated as the date for the caller's second COVID vaccine. Populated 2nd dose lot and expiry date within formal fields since caller's main concern was after the 2nd dose.  Caller confirms that both doses have the same lot number.
Covid-19 treatment; Covid-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Lot number: EL9264), in left arm and in 2021 as dose 2, single (Lot number: EL 9266), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Dec2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Allergic to bee stings" (unspecified if ongoing); "Allergic to poison ivy" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "Cough" (unspecified if ongoing); "Pain" (unspecified if ongoing). Concomitant medication(s) included: DAYQUIL taken for cough, start date: 18May2022, stop date: 21May2022; ADVIL [IBUPROFEN] taken for pain, start date: 24May2022, stop date: 30May2022. Past drug history included: Tylenol, reaction(s): "known allergies: Tylenol"; Codeine, reaction(s): "known allergies: Codeine"; Erythromycin, reaction(s): "known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course of the events: Other medication in 2weeks product: Vitamins. other medication in 2 weeks brand: Vitafusion. Other medication in 2 weeks start date: 01May2022. Patient had a persistent terrible taste in my mouth, especially the roof of my mouth. More importantly, patient started coughing again (enough to wake me up), joint pain, and having nasal congestion on day 4 out of 5 on Paxlovid. I had no coughing for two days and my nose was fine. Patient allso had only a little joint pain, which was normal since she have rheumatoid arthritis. Essentially she felt really good and now I'm sick again. Adverse event start date: 31May2022. Vaccine administration date of dose 2: 02Feb2021. Vaccine administration time: 03:00PM. Vaccine administration date of dose 1: 04Feb2021. Vaccine administration time: 03:00PM.  No follow-up attempts are possible. No further information is expected.
First vaccine - side effects lymph nodes in right armpit, lasted 5 days Second vaccine side effects - lymph nodes swollen and very sore in left armpit started 2-18-21 and still uncomfortable  today 2-21-21.
I had a stroke. Dizziness, numbness on left side. Numbness went away after I sat and shook my arm, but my vision was affected in my left eye.
Patient was sick when on vaccation with headache, dizziness and being nauseated.  Once she had the second shot almost a month later the dizziness came immediately and has continued to be present on and off depending on how she is feeling  (tired, illness, etc)
experience excruciating stomach pain that feels like a knot. He says it radiates to his back; experience excruciating stomach pain that feels like a knot. He says it radiates to his back; "a little bit" of nausea; This is a spontaneous report received from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported) via an unspecified route of administration on 22May2021, as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 22May2021, that evening patient experienced excruciating stomach pain that feels like a knot, it radiated to his back and had a little bit of nausea. Asking that this was normal. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
My second vaccine was in my left arm.  A few days later I had sever pain in my left shoulder, neck , back and an eye twitch in my left eye. The pain tuned in to severe nerve pain in my left shoulder, neck and back.  It lasted a few weeks. I went to a chiropractor twice with little relief. On the third visit he used electric stimulation and that started to relieve some of the nerve pain. Next,  I saw an acupuncturist and was needled for those issues. I got much relief and returned  one more time for acupuncture and I am now pain free. She also prescribed an all natural anti inflammatory herb which I am still taking.
She got the vaccine, she was itching and scratching and when she took her clothes off noticed that she was breaking out and itching with blotches all over her body.  She called and talked to the pharmacist who gave her Benadryl.  She saw her PCP and he was supposed to call her some medicine.  Saw her cardiologist yesterday and he told her to take the Benadryl and to use the Calamine and if not gone by Monday to go the ER.  She is going to try some Calamine lotion and oatmeal baths and see if that helps.
t104 & high, crying, fussy, AM temp 99 then elevated again APAP very little;pt uncomfortable & fussy, nursing very little for 3 days; MD informed;
I started with symptoms 24hrs later with chills, fever, body aches and headaches and extreme fatigue.
Fever, Left middle cerebral artery infarct, seizure, R. sided weaknedd (resolved) Symptoms occurred 1 day after vaccine administration, started on phenobarbital and aspirin.
Pt received BEXSERO on 04/03/17, developed increasing redness and warmth to touch on 04/04/17 at site (left deltoid). Pt seen at Urgent Care on 4/05-Imm Reaction vs. Cellulitis, then seen in PCP office on 4/6/17 for same. Started on Cephalexin course 4/6/17.
Excessive crying since vaccines. No fever, vomiting, diarrhea, or rash.
Only diluent administered; Only diluent administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA771A, expiry date 31-OCT-2024) for prophylaxis.   On 17-MAY-2023, the patient received Menveo. On 17-MAY-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only diluent administered) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-MAY-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The reporter called to inform that only the diluent portion of Menveo was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Information has been received from a consumer concerning her 5 yr old male son who in Jun 2002, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and it was vaccine and it was not effective per titer performed on her son. Unspecified medical attention was sought. It was noted that the pt had not recovered. There was no product quality complaint involved. Additional information has been requested.
Patient called the pharmacy the following day (10/15/14) and also notified her primary doctor of these adverse events: around 7pm on 10/14/14 she started experiencing a sore arm, throat and ears, and swelling. She felt like her throat was closing. When she called her primary doctor he didn't make any recommendations and stated the symptoms should go away. I (pharmacist) recommended using Benadryl for the allergic reaction. Patient took Tylenol for the pain and soreness. Today 10/16/14 I called the patient and she is getting better only soreness in arm.
Patient had generalized weakness that started the next day and gradually progressed over the next 36 hours to result in marked lower extremity weakness, such that patient could not appropriately ambulate. She was admitted to the hospital for evaluation. Her Na was low on admission, attributed to SIADH and HCTZ. Her HCTZ was discontinued and Na gradually corrected to the 130s. However, patient's lower extremity weakness persisted and EMG was done showed severe demyelinating polyneuropathy of sensorimotor type.  LP was done and CSF findings revealed elevated glucose and protein. She received 4 doses of IVIG with marked improvement in symptoms.   The concern is that her GBS was possible vaccine induced given the sequence of events and patient being completely mobile, ambulatory before the vaccine was administered
Noted pain right deltoid area where Pneumovax vaccine injected on 10/14/2005am. Client states discomfort right deltoid is not relieved with ibuprofen or heat area. Reported to nurse on 10/25/2005 talked with client 10/26/2005 states pain persists with small bruised area at injection site approx 11 " in diameter.
05/09/2022 I woke up with a mild cold. As the day progressed I knew I was sick. The next day I still felt pretty sick and stayed home from work and took a home test and it was positive for Covid. I was in bed for two days with bad congestion and dry cough. I went to doc for dry cough was prescribed cough medicine.
Lightheaded, dizzy, nauseus and very short of breath immediately after the vaccine for 48 hours
patient received a pediatric dose of Havrix on 04Oct2022; This was a 3rd dose of the vaccine; This case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 72-year-old male patient who received HAV (Havrix pediatric) (batch number 4CY9H, expiry date 28th April 2023) for prophylaxis.   On 4th October 2022, the patient received the 3rd dose of Havrix pediatric .5 ml. On 4th October 2022, unknown after receiving Havrix pediatric, the patient experienced adult use of a child product and extra dose administered. On an unknown date, the outcome of the adult use of a child product and extra dose administered were unknown.      Additional Information: GSK receipt date: 04-OCT-2022 Reporters comment: The patient received a pediatric dose of Havrix and this was a 3rd dose of the vaccine. The reporter consent to follow-up. Additional Supportive information: The patient received a pediatric dose of Havrix and was a 3rd dose of the vaccine, which led to extra dose administered and adult use of child product.
I got my annual flu shot like I do every year. I did not have any previous illness, signs or symptoms previous to being injected. My arm was unusually swollen and tender at the injection site. About 3 hours after receiving the vaccine, I started getting severe dizziness, photosensitivity and my heart was beating  rapidly like I had just run 5 miles. The dizziness was relentless and I could barely stand up. I decided to lay in bed in hopes that the dizziness would subside. After about 8 hours the dizziness finally went away and my heart had calmed down. My eyes were still extremely sensitive to light for about 24 hours. I did not report this to my doctor because the dizziness went away and I didn't feel as though I needed to bug my doctor about it. I now understand that I should have reported it ASAP because it is important public health information.