chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He was in a hospital now having an emergency due to complications that had something to do with a prostate procedure; he experienced having seizures; This is a spontaneous report received from the Pfizer sponsored program . A contactable consumer (patient himself) reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was unknown), via an unspecified route of administration on 10Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, initially, caller wants to cancel his second vaccine dose which according to him was today, 11Mar2021. He said that he was in a hospital now (on an unspecified date in 2021) having an emergency due to complications on an unspecified date in 2021 that had something to do with a prostate procedure he had 2 days ago. He had his first vaccine shot on 10Feb2021. That's more than 21 days if his next schedule was today, 11Mar2021. Consequently, during the call, he experienced having seizures on an unspecified date in 2021. The event "he was in a hospital now having an emergency due to complications that had something to do with a prostate procedure" was considered as serious (hospitalization) by the consumer. The outcome of the event he experienced having seizures was not recovered and unknown for the other event.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal relationship the causal relationship between BNT162B2 and event, post prostate procedural complications, seizures cannot be completely ruled out.
Vertigo; Felt not herself; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2021, several hours after receiving Shingrix, the patient experienced feeling abnormal. On an unknown date, the patient experienced vertigo. On an unknown date, the outcome of the vertigo and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the vertigo and feeling abnormal to be related to Shingrix.  Additional details were reported as follows: The patient received her first dose of Shingrix and after few hours experienced felt not herself that night until 3rd day then had vertigo both recovered. The patient declined follow up with her medical doctor. The reporter did not consent to follow-up.
After shots child left the office started sneezing and coughing went to grandmother's, vomited got weak, returned to office 10:20.  Child had erythematous rash all over his body. Pulse oximetry 99 percent, blood pressure 96/63, PULSE 149.  BENADRYL post mouth given, 1.5 tablespoon child vomited times two. 10:30 4mg intramuscular dexamethasone given, blood pressure 97/58, pulse 137 child examined in office till 11:45. remained stable.
Seizure that started in both legs then quickly progressed to full body. Limp limbs and body, eyes open and not focusing, quick tremors which lasted at least 10 minutes long and until paramedics administered an I.V. of medicine.
deep purple toes; elevated BP; her toes felt numb; cold and look like a deep purple color with blisters; This spontaneous case was reported by a consumer and describes the occurrence of BLUE TOE SYNDROME (deep purple toes), BLOOD PRESSURE INCREASED (elevated BP), HYPOAESTHESIA (her toes felt numb) and BLISTER (cold and look like a deep purple color with blisters) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported). Concomitant products included AMLODIPINE BESILATE (NORVASC) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLUE TOE SYNDROME (deep purple toes), BLOOD PRESSURE INCREASED (elevated BP), HYPOAESTHESIA (her toes felt numb) and BLISTER (cold and look like a deep purple color with blisters). At the time of the report, BLUE TOE SYNDROME (deep purple toes), BLOOD PRESSURE INCREASED (elevated BP), HYPOAESTHESIA (her toes felt numb) and BLISTER (cold and look like a deep purple color with blisters) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Hearing loss with tinnitus to right ear; Hearing loss with tinnitus to right ear; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jan2021 11:30 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included DM (diabetes mellitus) and HTN (hypertension) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Jan2021 11:30, the patient experienced hearing loss with tinnitus to right ear. The events resulted in doctor or other healthcare professional office/clinic visit and disability or permanent damage. The events was treated with hyperbaric oxygen therapy. The outcome of the events was not recovered.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the suspect drug and the event  hearing loss with tinnitus cannot be completely excluded.  This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
DOSE WAS ADMINISTERED AFTER BEING EXPIRED FOR AT LEAST 14 HOURS IN FRIDGE; VACCINE PLACED IN WRONG SHELF IN FRIDGE; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: 02-OCT-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-AUG-2021, the patient experienced dose was administered after being expired for at least 14 hours in fridge. On 27-AUG-2021, the patient experienced vaccine placed in wrong shelf in fridge. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dose was administered after being expired for at least 14 hours in fridge and vaccine placed in wrong shelf in fridge was not reported. This report was non-serious.
received an expired dose of Adacel/no AE; vaccine having been inappropriately stored/no AE; pregnant and received the vaccine several days ago/no AE; Initial pregnancy information received on 20-May-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a female patient who was exposed to vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] while she was pregnant.  The gestation period at onset and gestation period at exposure data needs to be populated, if available. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  It was of actual medication error due to incorrect product storage and expired vaccine used.  It was reported that no adverse event was experienced.  At time of reporting, the outcome of the pregnancy is unknown.   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.  There will be no information available on the batch number for this case, currently.
Rolling over in bed made it feel like the room was spinning. This continued until 8:00 AM. Slightly dehydrated after getting up. No fever.
about 2min p/vax pt felt hot & became lightheaded;started w/hyperventilation & passed out for 40-50 seconds;on exam sl pallor, cold skin;became responsive but looked tired;good pulsation;BP 118/78;
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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2022 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for COVID-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm for COVID-19 immunization. The patient's relevant medical history included: "History of thyroid issues, none currently" (unspecified if ongoing), notes: Other medical History: History of thyroid issues, none currently; "Interchange of vaccine products" (unspecified if ongoing), notes: Pfizer/BioNTech Dose number:1 and Johnson & Johsnon Dose Number:1. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Negative; (16May2022) Positive. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the events drug ineffective and covid19 cannot be totally excluded.
Began losing bladder control and developing thirst. 30 days after had lost a lot of weight had excessive thirst, no energy and no bladder control.
Reports being tired; Eyes were very irritated; I had a little diarrhea; Had a sore on my arm, it was hard; Had a sore on my arm, it was hard; The injection leaked a bit of liquid from the injection site; The injection leaked a bit of liquid from the injection site; A spontaneous report was received from a consumer who was also a 69-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced being a little bit tired, a little diarrhea, the injection leaked a bit of liquid from the injection site, dry eye irritation, and injection site sore and hard.  The patient's medical history included dry eyes. Products known to have been used by the patient were not provided.  On 11 Jan 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On 11 Jan 2021, as the mRNA-1273 vaccine was being given, the patient noted that the injection leaked a bit of liquid from the injection site. She denied a topical reaction. She reported that the side effects were mild, and she was fine that evening.  On 12 Jan 2021, she reports having a sore on her arm that was hard.   On 13 Jan 2021, she reported that she had a little diarrhea, and her eyes were very irritated, but she noted that she has dry eye to account for this.   On 15 Jan 2021, the diarrhea was almost resolved.   Treatment information was not provided.   Action taken with mRNA-1273 was not reported.  The outcome of the events, eye irritation and a little diarrhea, were resolving. The outcome of the events, being a little bit tired and injection site sore and hard, was not provided. The outcome of event, topical exposure at injection site, was resolved on 11 Jan 2021.; Reporter's Comments: The patient's medical history of dry eyes remains a contributor for the event of eye irritation. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt recvd vax 845AM & around 11AM pt began crying, was feverish; would not stop crying when rocked or held;
I initially started with allergy type symptoms sinus congestion, post nasal drip, itchy eyes, and runny nose. A few days later I felt extremely tired. I decided to take a COVID-19 test and it came back positive. For the next couple days on top of the other symptoms I had I also started to develop a headache, low grade fever, and body aches I used Flonase, and that helped relive my sinus congestion.  My symptoms lasted for about 8 days and I started to feel a lot better.
Swelling and redness in the tongue; redness in the tongue; eventually became generalized.; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021. The most recent information was received on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swelling and redness in the tongue), TONGUE ERYTHEMA (redness in the tongue) and ERYTHEMA (eventually became generalized.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (Swelling and redness in the tongue), TONGUE ERYTHEMA (redness in the tongue) and ERYTHEMA (eventually became generalized.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Swelling of tongue, Tongue redness and Redness, at an unspecified dose and frequency. At the time of the report, SWOLLEN TONGUE (Swelling and redness in the tongue), TONGUE ERYTHEMA (redness in the tongue) and ERYTHEMA (eventually became generalized.) 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 medicines were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant follow up received, added patient demographics, updated event outcome to recovered
low grade fever, arm redness and swelling at injection site, slept on and off all day
Sciatica pain; Chronic spinal stenosis; High blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (Sciatica pain), SPINAL STENOSIS (Chronic spinal stenosis) and HYPERTENSION (High blood pressure) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included ATENOLOL for Blood pressure high.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SCIATICA (Sciatica pain), SPINAL STENOSIS (Chronic spinal stenosis) and HYPERTENSION (High blood pressure). The patient was treated with TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) (epidural) for Spinal stenosis, at a dose of 80 milligram. At the time of the report, SCIATICA (Sciatica pain), SPINAL STENOSIS (Chronic spinal stenosis) and HYPERTENSION (High blood pressure) outcome was unknown.            The Patient had stated that a week ago on 15Oct2021, she had a spinal epidural for sciatica pain. She received the Kenalog 80mg epidural which is a high dose steroid, 80mg, per the patient for her chronic spinal stenosis with frequent sciatica pain. The patient had stated that the epidural infusion with the steroid is every 6 months and was taking this even before the first dose of the moderna vaccine for last couple of years.
This is a spontaneous report from a contactable consumer, reporting for her grandson.  A 16-month-old male patient of an unspecified ethnicity received the fifth dose of PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first to fourth doses of PREVNAR 13 for immunization, starting infancy through the toddler years as per the vaccination schedule. The reporter stated that her grandson (patient) received a total of 5 shots of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein). After the fifth vaccination she reported that immediately her grandson stopped talking or couldn't talk anymore. This happened in 2016 when the child was about 1 year old and 4 months between Dec2016 and Jan2017. Prior to this event, the child had already started talking but as she said on the fifth shot, the child was not able to talk anymore. Now the child is 2 years old and still unable to speak with continuous speech therapy as prescribed the doctor.
The pharmacy received Moderna vaccine (lot number 069H21A, expiration 4/6/22) on 12/6/21 at 3:23 PM. The pharmacy miscalculated the beyond use date as 1/6/22, when it should have been 1/5/22 (30 days from the date received). It appears the pharmacy did not account for December having 31 days, which lead to the miscalculation. Patients administered vaccine after 3:23 PM on 1/5/22 received product that was past its beyond use date.
Pulsatile tinnitus onset in right ear. Can feel/hear a rhythmic thumping/heartbeat sound in my right ear at all times.
According to customers father on 10/09/2020 Patient started having high temperature 5 hours after receiving vaccine and is currently in ICU diagnosed with bacteria meningitis
DEVELOPED FEVER, ACHES, HEADACHE, COUGH, HOARSENESS, CHILLS, FATIQUE, 0 ENERGY. TIMEFRAME WITHIN 12 HOURS. CALLED MY DR AND THEY TOLD ME TO TAKE TYLENOL AND ETC AND IF I FELT WORSE GO TO THE EMERGENCY ROOM. NEVER GOT ANY BETTER CALLED MY DR AGAIN-NO HELP. i WOUND UP GOING TO CLINIC AND GOT EXAMINED AND THEY PUT ME ON ANTIBIOTIC LEVAQUIN --TOOK SEVERAL TESTS NEGATIVE FOR FLU--CHEST XRAY NEGATIVE FOR PNEUMONIA. I WAS FINE UNTIL I TOOK THE FLU SHOT.
Severe soreness at injection site area from day after until present. Sometimes very painful to move or lift right arm. Sometimes pain goes to right elbow as well.
Covid; still was sick as a dog with Covid twice. Stinks; Initial information received on 01-Jan-2023 regarding an unsolicited valid social media non-serious case received from a consumer/non-HCP.  This case involves an unknown age and unknown gender patient who experienced covid; still was sick as a dog with covid twice. stinks after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor The patient's medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination (strength, formulation, dose expiry date: unknown).  On an unknown date the patient developed covid; still was sick as a dog with covid twice. stinks (covid-19) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Not Recovered / Not Resolved for the event covid; still was sick as a dog with covid twice. stinks.
Immediately upon injection, the patient experienced "immediate sensitivity to vaccination at the site of the injection". The patient experienced a large welt, swelling and redness.
1st dose:  Slight ringing in ears after 1st vaccine dose. 2nd dose:  10 hours after shot; severe tiredness, arm soreness.  16 hours after shot; 101 fever, headache, body aches, ringing in ears (tinnitus), loss of appetite,  These symptoms lasted approximately 48 hours except the tinnitus has remained.
I felt fine initially just so soreness of my arm. The next day I started with the chills and a little bit of the headache, I just kinda figured it was a response to the vaccine and did not think much of it. Through the night I had fever (100.8F), chills and headache. I took some Excedrin and Wednesday morning I felt ok. I decided to go to work but the screening told me because I had fever in less than 24 hrs I could not go to work I had to report to the COVID hotline. They sent me to get tested because of the fever. I got tested at hospital and was tired the rest of the day but no fever and the next day I was ready to go to work but I had to wait for the test results that would come 24hrs later. The test came back positive. So I could not return to work until yesterday.
Information had been received from a nurse who reported that an unspecified number of patients were administered improperly stored doses of MMR II and GARDASIL on unspecified dates. No adverse events were reported. No further information was provided. Additional information had been requested.
PT with full body vesicular rash with scabbing and erythema, itching, pain and swelling with open sores from itching. PT rash started within 48 hours of 15 month vaccinations. Per mother PT on normal CDC schedule as far as she knows so she believes PT received Hep B, HIB, PCV, IPV, MMR, Varicela, DTAP and possibly hep A. Per mother will get complete list from pediatrician.
Rash comes and goes but is persistent. Rash started on arms moved to torso and then to thighs.  Looks somewhat like German measles rash but not very red.  I took Benadryl 25mg by mouth each night for several nights when it first started.  Seemed to subside then started up again and spread.  Started taking Benadryl again.  For the most part the rash has not been itchy.  See my primary care doctor in the morning before my second shot.  I did email information to my doctor along with pictures of the rash.
Approximately 20 minutes after getting vaccine started having numbness in arms and legs, ringing in ears, severe headache, and profuse sweating. Works in a pharmacy, BP was checked by staff was very increased.  Went to nearby ER and was seen.  Bloodwork, CT and exam was normal and patient was sent home.  States she slept 22 of the next 38 hours but numbness resolved later that evening and all symptoms left completely on 04/30/2021 around 11:45 p.m.