chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a 18 year old male patient without pertinent medical history, drug reactions or allergies. On 12-JUL-2016, the patient was vaccinated with GARDASIL 9 (strength, dose, route and lot number were not reported). Other suspect therapies included TRUMENBA intramuscularly (dose and lot number were not reported). There was no concomitant therapies. On 12-JUL-2016, after vaccination the patient "started to pass out, did not lose consciousness, rested and revived". On that same day, the patient recovered. The patient did not received treatment for the event and did not sought medical attention. No lab diagnostics studies were performed. The even did not required intervention to prevent serious criteria, did not produce significant disability or incapacity, did not required hospitalization and it was not life threatening for the patient. No product quality complain was reported. Additional information has been requested.
Has swelling and redness on Lt. Arm. 70mm X 70mm lenght and width.
Vaccine administered 2/27/2023 with BUD on vial 2/28/23, however, later we realized the original vial box expiration date was 2/25/23. Called Moderna to notify and evaluate the case. They sent their email response indicating  "the vaccine administered on February 27, 2023 from lot number AR6965B maintained the activity necessary to protect against the SARS-CoV-2 (covid-19) virus at time of administration". We attempted communication with the patient but the phone number we have is not working. To this moment no adverse effects have been reported.
Extremely painful headache still ongoing 6 days later.  Difficulty in sleeping.    Cough developed and has not resolved
The patient fainted shortly after receiving his vaccination. He claimed to have a history of fainting after blood draws. He was fully recovered shortly after.
Flu shot at 11 a.m., on Dec. 4th. At 2:30 my throat started swelling, rapid heart beat, fever, face swelling and white thick fluid in eyes. Went to ER. I took BENADRYL thinking this would help before we called 911. Given methylprednisolone to take for 6 days.
no additional adverse events; temperature excursion with Rotateq which was administered to a patient; This spontaneous report was received from a medical assistance and refers to a patient of unknown age an gender. The patient's pertinent medical history, drug reaction, allergies and concomitant medications were not reported.  On 01-JUN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml, orally, lot # 1707408, expiration date 07-JAN-2022 for prophylaxis. The temperature excursion was 47.1 degrees Fahrenheit (F) for 15 minutes. There were no previous excursions reported. The digital data logger was non involved. No additional adverse events were reported.
Redness at site, Arm is severely itchy, had a reaction; Redness at site, Arm is severely itchy, had a reaction; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Redness at site, Arm is severely itchy, had a reaction) and INJECTION SITE ERYTHEMA (Redness at site, Arm is severely itchy, had a reaction) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history.). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (Redness at site, Arm is severely itchy, had a reaction) and INJECTION SITE ERYTHEMA (Redness at site, Arm is severely itchy, had a reaction). At the time of the report, INJECTION SITE PRURITUS (Redness at site, Arm is severely itchy, had a reaction) and INJECTION SITE ERYTHEMA (Redness at site, Arm is severely itchy, had a reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event was Benadryl cream.
The Pfizer vaccine was not properly diluted and resulting in more concentrated vaccine was administered to patient.
Took 1000mg Tylenol 1 hr prior to getting vaccine. Vaccine was given at work. About an hour after getting vaccinated I Suddenly felt lightheaded , dizzy and felt like I was going to pass. . Ate and drank water, did not help. Co workers notified of symptoms. About 1-2 hrs after symptoms started I Took 25 mg benedryl orally and laid down. Benedryl helped within next hour or so.  Then slept for 2 hrs and felt better. No symptoms since. Has not happened in past with flu vaccines or any vaccine.
101 fever, chills, body ache, headache, fatigue.  Treated with bufferin.  Incapacitating for about 24 hrs... Fever broke after that and severity of symptoms decreased over the next 24 hrs.  Day 3 back to 90% of normal.
18 weeks pregnant. Due august 27th. Symptoms are slight headache, chills, mild nausea and just an overall not feeling good after first dose.
"awaken" the Guillain-Barre syndrome (GBS) in his body; "awaken" the Guillain-Barre syndrome (GBS) in his body; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 65-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Guillain-Barre syndrome (GBS)" (ongoing), notes: he explained having GBS at the age of 16, which "damaged" his body and for which he was hospitalized. The patient's concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as ""awaken" the Guillain-Barre syndrome (GBS) in his body".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Written by husband, observer of episode in question. Times are approximate. Patient reported discomfort starting soon after injection that worsened as the day proceeded. By midafternoon she was feeling quite poorly in general and began to have gastric upset. She lay down by 1600 and as evening progressed her condition worsened. Stomach upset and overall discomfort worsened into evening. At about 2000 she went to the commode where she sat for 15 or more minutes. After this approximate length of time observer noticed her head hanging down and drool emitting from mouth. She was cleaned up and assisted to bed, walking being very difficult and mental function definitely impaired. She was still communicative but was showing signs of an impending seizure.   After 10 or so minutes she was dressed as observer intended to take her via personal vehicle to local emergency room. Within minutes of deciding of course of action, it became apparent that she was no longer capable of walking or assisting in movement to car. She lay down in bed and remained for another 30 minutes est.   During this period communication was attempted to assess the seriousness of the situation. She had experienced a small number of seizures in the recent past which had been quite mild and short in duration. As this was hoped for and possible, she was observed in anticipation of the event passing on its own. After possibly an hour it was determined that this was going to be a more serious event and an ambulance was called. It took some time to arrive, by which time she was apparently under the effects of a full seizure.   She was intubated by medics as she was experiencing breathing difficulties. I believe that with much more delay in calling for ambulance she could have died due to failure of breathing.
Red swelling raised area 3?x2? at site of injection. Area is hot to the touch, sore and itchy. Had initial redness of the injection site. That?s subsided and this began 7days later.
Extreme Myalgia, Myositis, hypotension, vertigo, "pins and needles", uncontrolled yawning, low heartrate.
Patient had been administered with Pediatric Pfizer Vaccine(5 to 11yrs). Pediatric vaccine is not strong enough to get protection Patient has been contacted to revaccinated but he has not come back to pharmacy yet.
Three hours after the vaccine, the patient experienced nausea, vomiting and had syncope at home. She notice a petechial rash along her neck and chin.
I got shingles eventhough i had both vaccines/suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got shingles eventhough i had both vaccines/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 12-Jun-2023 The case was received from the patient via interactive digital media. The patient got shingles even though he or she had both vaccines. The patient stated that however it was a very very mild case. The patient was glad he or she got the vaccine. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Experienced diarrhea after believed food poisoning; Experienced diarrhea after believed food poisoning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: they did have covid prior to being vaccinated, just as a note.; "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "high BP" (unspecified if ongoing); "scoliosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE,Lot number: UNKNOWN.), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious), FOOD POISONING (non-serious) all with onset 2021, outcome "recovered" and all described as "Experienced diarrhea after believed food poisoning".  The reporter considered "experienced diarrhea after believed food poisoning" not related to bnt162b2.  Additional information: The patient was fully vaccinated and got a second shot several months ago. They waited the allotted time before vaccination and two doses vaccinated summer 2021. Precise vaccination date, Jun2021 reporter believed was the 2nd dose.  Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the event and the suspect BNT162B2 can be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Diarrhea for 2 weeks; Headache; Nausea for a day; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea for 2 weeks), HEADACHE (Headache) and NAUSEA (Nausea for a day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Diabetes and Blood pressure reading high.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea for 2 weeks), HEADACHE (Headache) and NAUSEA (Nausea for a day). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Upset stomach, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea for 2 weeks) and NAUSEA (Nausea for a day) had resolved and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    This case was linked to MOD-2021-037125 (Patient Link).
fainting spell & became listless lasted 5 mins;eyes red, swollen, squinting eyes;eyes looked glazed & looked tired, no sz activity;rash on chest, no fever;MD called;welts on entire body, face swollen, t100.2, papular rash w/ecchymosis;
I received the first dose of the Covid Pfizer vaccine on Wednesday, June 16 at around 6:45pm.  By 9:30 pm I started to notice my feet felt very cold and numbing sensation that felt as though my feet were in a puddle of water.  I then had a low-grade fever and the numbing tingling sensation started to travel up my legs.  By 2am my tongue and mouth started to tingle.  by morning my feet still felt cold/numb, my tongue/mouth tingled and then my hands started to feel the same.  As the day progressed I noticed the same sensation on my forearms and occasional sharp pokes across my face.   It has been 4 days since the vaccine and I continue to feel the tingling sensation throughout my body.  The cold numbing feeling I had in my feet has subsided some but I still feel in other parts of my body like legs, chest, mouth, face and hands.  I have made my primary care dr, rheumatologist and pharmacy where I received the vaccine aware.  I had not experienced this prior to the vaccine.
Flu like symptoms; After the first dose he ran low grade temperature of 101 for 24 hours; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-May-2021 and was forwarded to Moderna on 26-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (After the first dose he ran low grade temperature of 101 for 24 hours) and HEADACHE (Headache) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 pneumonia on 03-Nov-2020. Concomitant products included FINASTERIDE for an unknown indication.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (After the first dose he ran low grade temperature of 101 for 24 hours) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (After the first dose he ran low grade temperature of 101 for 24 hours) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 101 (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was Hospitalized, was admitted in the  intensive Care Unit for 5 days, critical care unit for 1 day.  Other Procedures: Blood and fluid drainage from the brain, physical therapy, MRI, Scan.    Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: From TCR Report: Patient denied for the further follow-up
(+) rash, hoarse throat within 10 min of vaccine (FLUBLOK).
severe skin reactions lt upper arm rasied red rough area (app size 10-12mm x 3-4mm) w/irregular white cream colored small blisters pinpoint; lt upper arm swollen, red painful to touch (knot under skin) pvt MD told mom pt probably allergic ;
Last night (04/10/2021) at around 8:30, I began having a dry cough, which I have now at 8:45 am on 04/11/2021. I also had a small fever last night, with my temperature up to 100 degrees F. I feel pretty weak.
Information has been received from a nurse practitioner concerning a 9 week old male with no pertinent medical history, drug reactions or allergies who on 14-APR-2008 was vaccinated orally with "one pouch", a first dose, of ROTATEQ (lot # 659855/1692U).  Concomitant therapy included POLY-VI-SOL.  On 15-APR-2008 the patient developed diarrhea.  At the time of reporting the stools were described as "mucousy and browner than before".  On 26 APR 2008 the patient began vomiting.  There was no fever.  It was noted that there were no signs of dehydration, and that the child "was still happy".  At the time of reporting the patient was recovering.  Unspecified medical attention was sought.  There were no lab diagnostic studies performed.  There was no product quality complaint.  Additional information has been requested.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 12-APR-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL (strength: 0.5 ml) lot # L020162 and expiration date: 23-JUL-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 240 hours, with the highest recorded temperature of 1 degrees Fahrenheit (1 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Flu-like symptoms for 2 days, fever of 101.3 (hard to bring down with OTC IBU/APAP-- took several doses), arm swelling and tenderness, small knot in arm at site of injection, warmth at site of injection.
This spontaneous report was received from a physician concerning a 2 month old patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ROTATEQ (dose, strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The physician reported that on an unknown date, the 2 month old child had bloody stools for 9 days. At the time of the report the outcome was unknown. Additional information has been requested.
Mild Herpetic Keratitis relapse; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HERPES OPHTHALMIC (Mild Herpetic Keratitis relapse) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Herpetic keratitis.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES OPHTHALMIC (Mild Herpetic Keratitis relapse) (seriousness criterion medically significant). At the time of the report, HERPES OPHTHALMIC (Mild Herpetic Keratitis relapse) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided.
got one shot / got shingles in between but was so mild; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingles vaccine and got shingles in between but was so mild went back after shingles and got second shot worth it.
on 4/2 the day after the vaccine a large rash with hives developed around my neck   I took benadryl 50mg and it subsided .  Then on 4/4 (sunday) I went to sleep early around 8pm  Wasnt feeling well. I woke up around 2 hours later   I had a bad rash with hives in my groin, on my torso, again on my neck, scalp and palms of my hands.  My hands were covered in hives.   I took 125mg of Benadryl at 10pm and had a prednisone prescription at home similar to a medrol dose pak   So I took 6 prednisone 5mg at 10pm and 5 prednisone 5mg early the next morning around 5am 4/5. I also added more benadryl around 2am (50mg) and 6am (50mg) By the morning  tho the rash was very visible and still raised on my palms, neck and groin.  I went to the doctor and he examined me and he felt in the absence of any other factors like new deodorant, shampoo , or new laundry soap that it was likely the vaccine.   I finished a five day course of the steroid and im completely back to normal.