chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DEAFNESS FOR ABOUT 2 DAYS; PSYCHOTIC EPISODES; COULD NOT WALK; KICKING LEGS AND HANDS; MUMBLING; CARRYING ON; SHAKING; GOT REAL HOT, DIDN'T WANT FAN ON; THOUGHT HUSBAND WAS STILL ALIVE; COULD NOT GET UP; GONE BACK IN TIME ONE MINUTE AND IN RIGHT MIND THE NEXT; NO STRENGTH; This spontaneous report received from a consumer concerned an unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date in SEP-2021, about 2 weeks after vaccination, patient experienced ringing in ears and deafness for about 2 days.  According to the reporter, it was an epileptic seizure but this was not diagnosed. The patient did not know what she was doing: kicking legs and hands, mumbling, carrying on, shaking, she got real hot and did not want the fan on. Then she had psychotic episodes that lasted about 2 days after the ringing in ears and hearing/ deafness stopped. She did not have a fever. After that patient did not have any more episodes. She thought her husband was still alive. On an unspecified date, patient was hospitalised for about 5-6 days and then she was sent to a behavioral center for 8-9 days. As per the reporter, patient was still in the hospital. Patient had been having effects like back in time one minute and in right mind the next. Patient stayed in bed 4 days after she got the shot. She could not get up and walk and did not have the strength. Reporter advised the patient to contact her HCP for advise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deafness for about 2 days, psychotic episodes, kicking legs and hands, mumbling, carrying on, shaking, and got real hot, didn't want fan on, and the outcome of could not get up, could not walk, thought husband was still alive, gone back in time one minute and in right mind the next and no strength was not reported This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211006204-covid-19 vaccine ad26.cov2.s -Deafness for about 2 days, psychotic episodes, could not walk,  kicking legs and hands, mumbling, carrying on, shaking, got real hot, didn't want fan on, thought husband was still alive, could not get up, gone back in time one minute and in right mind the next. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211006204-covid-19 vaccine ad26.cov2.s -No strength. This event(s) is labeled per RSI and is therefore considered potentially related.
This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (miss her second dose), MALAISE (feeling sick), COVID-19 (results were positive for Covid), DECREASED APPETITE (no appetite) and MYALGIA (body aches) 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. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced MALAISE (feeling sick). On 14-Apr-2021, the patient experienced COVID-19 (results were positive for Covid). On 28-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (miss her second dose). On an unknown date, the patient experienced DECREASED APPETITE (no appetite), MYALGIA (body aches), CHILLS (chills), FATIGUE (feeling very tired) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) for Headache, Tired out, Chills, Ache and Feeling sick, at an unspecified dose and frequency. At the time of the report, PRODUCT DOSE OMISSION ISSUE (miss her second dose), MALAISE (feeling sick), COVID-19 (results were positive for Covid), DECREASED APPETITE (no appetite), MYALGIA (body aches), CHILLS (chills), FATIGUE (feeling very tired) and HEADACHE (headaches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, SARS-CoV-2 test positive: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided.
10/26/11. Abrupt onset of facial droop. Increasing 10/27/11. Seen at E.R., dx. w/ Bells Palsy. Rx'd Prednisone 20mg. F/u neurology.
pts husband called and said pt was having tremors yesterday that have stoped today, and nausea, body aches, head pressure, cant eat and feels like her organs are swollen. she says she feels worse than when she had chemo. requested that it be reported to vaers.
generalized pruritus evening of 20JUL93 no treatment obtained; swollen MCP joint rt index finger w/pain, 22JUL93 given Motrin & DPH;
This spontaneous report as received from a medical assistant refers to multiple patients of unknown demographics. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L029615, expiry date: 15-MAY-2017). No adverse effects were reported. Excursion information: Time: 30 minutes, Temperature: 9C and Time: 30 minutes, Temperature: 11C. The call was because of a data logger. The improperly stored doses were administered. There were no previous excursions. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt is a 13 y/o male who presented to COVID-19 vaccine pop up to receive  1st Pfizer booster dose. Pt was checked in at front registration for an Pfizer dose, however name and DOB were written on the wrong color coated form.     The vaccinator after confirming name and DOB did not catch that the patient was 13 instead of 11 as presumed from the color coordinated form.    The patient received 0.2mg of Pfizer vaccine (1.3ml dilution) and was therefore mistakinglybundervaccinated. After consulting the COVID-19 vaccination program provider support line the recommendation was made to vaccinate the 13 y/0 with the correct dose and dilution.    The option was given to wait 8 weeks to reduce risk of myocarditis, though family decided to proceed to correct vaccine today.    This was discussed with our whole team to clarify what happened and what recommendations are in this situation.
swelling in upper arm between elbow & shoulder;hard to move arm;red, sore, warm to touch;swelled 2-3x nl size;skin taut, anything touching it hurt;saw MD 1-2wk later suggested Ibuprofen;said not to repeat;
Patient developed hives all over his body and was very itchy within 48 hours.  Benadryl given, itching subsided, hives resolved.  Slept next am, had few residual hives on abdomen and back.  Around 8-9 pm next night, developed hives again which were worse, Benadryl given, same occurance the following night.  No shortness of breath or difficulty breathing, MD notified.
Info has been received from a nurse concerning an 80 year old female with allergies to iodine, codeine, epinephrine and mycins who on 11/15/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent in the right deltoid (lot #641530/1351L). The pt was well at the time of vaccination. On 11/15/2002 the pt developed a severe site reaction. The pt reported that her right arm was hot, red, swollen in a 3 inch diameter, and painful to the touch. On 11/16/2002 the pt went to the ER where she was diagnosed with cellulitis. She was treated with cephalexin, 500 mg, and was told to use moist heat on the area. On 11/21/2002 the pt reported that the cephalexin was giving her diarrhea. The area was still painful but not as red. The physician instructed the pt to discontinue the cephalexin. The health professional reported that they had not heard back from the pt since 11/21/2002, so they were assuming that she recovered. The reporter expressed a concern regarding the lot number. The health professional also provided info regarding other pts (WAES #0211USA01894 and 0211USA02405). The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The pt sough unspecified medical attention. Additional info has been requested.
Shot sight was red and knotted after day one. Day 5 it had disappeared only to come back on day 10 worse then after shot. Have fever headaches and chills.
Maculopappular pruritic non-blanchable rash on abdominal/ pelvic region, spreading to extremities. Most consistent with IgA vasculitis.
Second time having them, and I had the vaccine; Second time having them, shingles; painful; This 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.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-Aug-2022 Reporter's Comments: The reporter reported the case via interactive digital media. The patient stated that he/she had them second time, so painful, and he/she had the Shingles vaccine. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Left upper arm red, swollen and warm to touch.  Keflex 375mg two times a day for 10 days.  Benadryl, Ice pack.
a 55 years old patient got Fluzone High Dose with no adverse event; a 55 years old patient got Fluzone High Dose with no adverse event; Initial information regarding this unsolicited valid non-serious case received from a pharmacist via The Angency (reference number: 00339992)on 30-Oct-2020.  This case involved a 55 years old male patient for whom it was reported that the patient received a 0.7 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ536AA, expiration date 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination on 29-Oct-2020 (product administered to patient of inappropriate age and overdose).  Medical history, medical treatments, vaccinations and family history were not provided.  No concomitant medication was reported.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).   It was a case of overdose (latency: same day).  At the time of report no adverse event was reported.  Pharmacist stated FLUZONE HIGH DOSE (HD) was given to a patient per their request, but when they checked the patients chart after administering the vaccine, they realized he was only 55 years old, she wants to know if there are any adverse effects to worry about and requested urgent call back. Caller asked if there is any data on what to expect if a 55 years old patient got Fluzone HD has this happened before. Are there any studies using it in under 65 years old. Caller said yesterday a patient came in and asked for the Fluzone HD vaccine and said he was 65.5 years old. She said he confirmed his age for her too and the technician and asked for the HD vaccine by name too. After she had given it to him, she entered his information in the system and that is when she realized he was 55 and not 65 years old. She called the patient and he said he is doing fine.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Gave the injection and 1/2 of dose squirted out of the syringe at the hub of the needle.
p/vax pt c/o of sore throat & top lip swollen; by time seen by MD eye swollen; MD dx allergic react & prescribed benadryl;
tired, weak ,body ache, sore shoulder, chills, strange dreams,  5 hrs after shot
I received the shot on 22 April 2022. I think got severe bronchitis - that went away with antibiotics. Then I went on vacation and traveled and returned with Covid 19 for the first two weeks in June. Over the summer I had several serious bouts with "I cannot breathe bronchitis." I got a second round of Covid 19 in the second and third weeks of September that lasted for nine days. I have not had the latest booster.
Product administration interrupted; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if the patient was ever been diagnosed with or tested positive for COVID-19. It was unknown if the patient had any acute illnesses at the time of vaccination and up to one month before. It was also unknown whether the patient had any chronic or long standing health conditions.     On 24-Aug-2021 at 1:33 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted).    No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-716566 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716566:Patient 2: Case for Bivalent
Monovalent vaccine was given instead of Bivalent Pfizer.  Patient is experiencing no adverse events
16 year old patient was inadvertently given Janssen Covid 19 vaccine by PA. This was discovered by Regional Director, who has not been able to reach the patient or guardian, but is awaiting a call back.
Arm Pain (injection side) ...Within 5 minutes of injection. Mild neck and torso stiffness...Began 2 hours and 40 minutes after injection. Wheezing...Began about 4 and a half hours after injection. Shortness of breath occurred overnight.   8 hours after injection. ...checked oxygen level  at 93  Moderate widespread aching...8 hours after injection. 15 hours after injection...oxygen level at 88 15 hours after injection...Temperature of 99
This is a spontaneous report from a contactable nurse. A 4-month-old female patient (weighting 15 pounds and 9 ounces) received the 2nd shot of PREVNAR 13, (Lot # N05076, exp date Sep2017, NDC #  0005197102, UPC # N300051971022) intramuscular at 0.5 ml, single dose at right thigh on 26Oct2016 at 9:30 am for immunization at Doctor's office. Medical history were none. Concomitant medication included the 2nd shot of ROTAVIRUS VACCINE, (Merck, Lot # M004542) oral and the 2nd shot PENTACEL (Sanofi, Lot # C5233AA) IM at left thigh, both on 26Oct2016 for immunization with no adverse events occurred. The patient previously ROTAVIRUS VACCINE and PENTACEL in 2016. The patient received PREVNAR 13 shot 1st time when she was of 2 months old in 2016 for immunisation and this was her 2nd shot at 4 months. No other vaccines were given 4 weeks prior to the day of suspected vaccine. Patient did not have any siblings. The patient started experiencing redness and swelling in one of her legs probably after 3 or 5 minutes after she was given the shot on 26Oct2016.  Treatment received: Benadryl. Patient was kept in clinic for one and half hours and she was fine (recovered completely). Nurse mentioned that they were going to do a follow up with the allergist doctor to make sure that patient was not allergic to the Prevnar 13. The reporter assessed redness and swelling in one of her legs were Unrelated to Prevnar 13.
The Pharmacist injected the vaccine slowly into the subcutaneous tissue, not the IM. Shortly after the vaccine, the site became hard and raised with pain. I now have a large red ring on my skin with a bump where the vaccine was injected. The red ring is getting larger. I spoke with the Pharmacist and was told to "massage the area and it will absorb."
This spontaneous report was received from a consumer via Pfizer refers to her daughter of unknown age. The patient concurrent condition, concomitant medication and medical history were unknown. On an unknown date, the patient was vaccinated with GARDASIL (strength, dose, frequency, route of administration, lot # and expiry date unspecified) for prophylaxis. On an unknown date, the patient died (death). The consumer also reported about 354 deaths due to GARDASIL. The consumer reported that her daughter's information was on goggle. It was unable to clarify if reporter was referring to her daughter  as one of the 354 deaths. The cause of death was not reported. It was unknown if autopsy was done. Causality assessment was also not reported.; Reported Cause(s) of Death: unknown.
4 months old patient received a kinrix dose by mistake; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 4 months old patient received a kinrix dose by mistake). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-JUL-2023 A physician reported that a 4 months old patient received a kinrix dose by mistake, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
This spontaneous report has been received via a company employee from a consumer referring to two unspecified patients. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the two patients were vaccinated with the GARDASIL 9 (dose, route, lot number and expiration data were not reported) for prophylaxis. On an unknown date, the two patients passed out after vaccination. The outcome of the event was unknown. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA011284.
Felt a little tired; Sore arm; This is a spontaneous report from a contactable consumer reported for herself.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient reported that she felt a little tired on 18Apr2021 after receiving the second dose of the Covid-19 vaccine on 17Apr2021. She reported that she experienced less than 24 hours of arm soreness and feeling tired.  She reported that she didn't experience anything severe or unexpected following the Covid-19 vaccine.  She reported that she did not experience anything more than the side effects that were listed as expected. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
At 07:00 on 1/18/01, pt started vomiting and seemed dizzy. Seen MD at 08:30 with disorientation and nystagmus. Sent via EMS to medical center. Dx'd with acute cerebral ataxia. Was discharged on 1/19/01.F/U altered LOC ,refusing to stand,IV started, blood drawn. Pt vomiting, dizzy, reaction to Prevanar. Pt was admitted for observation.
I developed a little soreness in the arm at the injection site which only lasted a couple day. I suffer from Hypertension that has been under control for years but on 10/12 when I went to see my PCP my BP was elevated a little above normal. My PCP increased my Lisinopril dosage to 20mg day and night and an additional BP med to take if it goes over 140 on top.  The other night it got so terribly high of about 205/101 which made me reach out to my PCP who advised I take the additional metoprolol med, which did lower it along with a Xanax because I was freaking out and scared.
Constant thirst from 4/18/21 until present, headache  from 4/18/21 until 5/29/2021, fatigue 4/18/21 to 5/29/21( I was falling asleep at work and driving)  insomnia,  4/18/21 to present,  Inability to walk more then 10 minutes without feeling fatigue 4/18/21 to present. I now carry bottled water with me at all times. I no longer go for strolls.
Systemic: GI discomfort and discolored stools-Medium, Additional Details: pt's husband called pharmacy 7/9 to report that the pt was experiencing stomach discomfort with black, grainy, sandy stools. Pharmacist advised that the patient should seek medical care to make sure pt does not have a GI bleed. Unsure whether this is an adverse reaction to COVID vaccine. wanted to report since it initiated after vaccine administration and is continuing for 4 days after.
REDNESS  AND SWELLING NOTED ON LEFT DELTOID.  PTS MOTHER DENIED HAVING ANY FEVER OR PAIN ASSOCIATED WITH REDNESS.  PLACED ICE PACK AND PRESCRIBED HYDROCORTISONE FOR SIGHT
The pt had Lyme disease from 1987-1990. The Lyme vaccine has picked up where the Lymes left off, destroying my immune system, severely increase my neurological damage, causing pain to return and all other symptoms of Lyme disease. It has also messed with my mind and energy level so bad that I don't know if I can complete my rehabilitation schooling. 60 day follow-up states the pt experienced exhaustiion, pain, neurological damage, brain fog and lack of energy.
pt recv vax & stated felt faint then fainted & had sz;arms & legs stiffened, color pale for few seconds;oriented to time, place, had no breakfast;stated hungry amb inhaler;