chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Took a shingles shot an ended with neuropathy; This case was reported by a consumer via interactive digital media and described the occurrence of neuropathy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced neuropathy (serious criteria GSK medically significant). On an unknown date, the outcome of the neuropathy was unknown.   It was unknown if the reporter considered the neuropathy to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 02-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient took a shingles shot an ended with neuropathy. The patient further stated that, he/she would take shingles anytime. Additional Supportive Information: The follow up would not possible as no contact details were available.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION/LOSS OF SMELL/ MINOR COUGH; This spontaneous report received from a patient via a company representative concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-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 08-APR-2021, the patient experienced suspected clinical vaccination failure. On 08-APR-2021, the patient experienced suspected covid-19 infection/loss of smell/ minor cough. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection/loss of smell/ minor cough and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000175946.; Sender's Comments: V0: 20210420575-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
1 hour after receiving vaccine patient was eating and began to notice a few itchy red spots on body. No shortness of breath, swelling or lightheadedness. Pt had a few scattered red raised lesions c/w with mild urticaria.   No acute distress, Vitals normal including puse ox 98%.   Lungs clear, pharynx normal and no edema.  Advised IM Benadryl - refused.  Pt requested oral Benadryl which was not available at vax site.   Pt transported to medical facility in same building at the center for oral Benadryl and observation. - care transferred to physician at that site.
Didn't feel well; can't stop shaking and feels like something wrong; Fever being so high and temperature is 102.7; Didn't feel well; can't stop shaking and feels like something wrong; This is a spontaneous report from a contactable consumer (patient mother).  A 17-year-old Female patient received BNT162B2(PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0179), dose 2 via an unspecified route of administration, administered in Arm Left on 10May2021 03:00 (At the age of 17-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.The patient previously received BNT162B2(PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0179), dose 1 via an unspecified route of administration on 11Apr2021 (At the age of 17-year-old) as dose 1, single for covid-19 immunization.On 12May2021 the patient experienced didn't feel well; can't stop shaking and feels like something wrong, fever being so high and temperature is 102.7.The reporter stated, her daughter (consumer) who is a minor had her second dose (Covid) vaccine at 3-o-clock. She woke up this morning and did not feel well. She took two ibuprofen (treatment) and she came home from school in noon she did not feel good and went to bed. She texts me about 45 min ago and said she cannot stop shaking that she feels like something is wrong, so patient mother took her temperature it said 102.7, patient mother called her paediatrician and they said to call this number and very concerned about her fever being so high. If it was infant that is not high but she is (17 years) old an adult that is high. The patient mother would like a medical advice and she do not want to take her to the ER (not clarified) and expose her and I am very concerned about as we have a history of epilepsy in our family, so that is why patient mother worried about high fever. The patient underwent lab tests and procedures which included body temperature: 102.7 on Fever being so high and temperature is 102.7. Therapeutic measures were taken as a result with ibuprofen (400 mg) at 8 am in the morning and 400 mg at 5 PM in the evening after measuring the temperature. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Eczematous dermatitis; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczematous dermatitis) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (Eczematous dermatitis). At the time of the report, ECZEMA (Eczematous dermatitis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient called to report an adverse event and also had a concern: Received both the doses of Moderna vaccine. Received the 1st dose on 14FEB2021 and the 2nd dose on 14Mar2021. Short time before receiving the 2nd dose , developed eczema over patient's back and its persisting. The concern was, Is this symptom a reported side effect of Moderna vaccine and Did any other people reported similar symptoms after the Moderna vaccine? Patient did visited the Dermatologist who diagnosed the symptom as DERMATOGRAPHISIM and mentioned , it could be related to vaccine or due to Winter weather change. Dermatologist advised the patient to follow some treatment recommendation and follow up visit by month July if symptom persisting. Patient received both vaccine doses in the left arm. The lot # for 2nd dose vaccine vial mentioned as 013A21A and the expiration date as 20Aug2021. After receiving the 1st dose patient experienced the symptom of slight sore arm and the expiration date for the 1st dose vaccine vial mentioned as 01Jul2021. Gave consent for safety team and for HCP for follow up. Treatment Allegra, Cerave lotion for dry over, Dove soap   This case was linked to MOD-2021-069874 (Patient Link).
Mother reported patient had fever (unsure how high, no working Thermometer) with hallucinations (everything in room spinning, moving fast, flashing, hands shaking, moaning in sleep. The night following vaccinations
He had pfizer COVID vaccine on Friday 9/16 and then got the rash on 9/17/22. It was tiny pink bumps on arms, legs and trunk as well. It did not bother him. The rash is flat. It was never bumpy. They were very small spots, like 1 mm. There were not migratory.  It seemed to appear everywhere at once, and has not changed location since. No blistering nor sloughing of skin.  No change in skin products nor soaps.   On 9/17 he woke up with some gunk in the eyes and then it cleared up over that weekend.  His eyes were not appreciably pink. He was not sick in any other way at that time. He was sick the week prior but was definitely on the mend for many days and then the eye symptoms happened somewhat out of the blue. No runny nose nor seeming in pain/sore throat nor cough at that time. The eyes were better within a few days.  They were dabbing some tea bags on the eyes which helped.  No tongue swelling nor lip swelling. No abnormal breathing nor funny noises with breathing. No vomiting.  Rash is about the same since (this visit was 5 days from vaccination)
Dx with eosinophilic pneumonitis; Breathing problems; cough; thick phlegm, waxing and waning; This is a spontaneous report from a contactable physician. This physician reported for a 59-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 26Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation at the age of 59 years old.  Medical history included known allergies: Penicillins. No COVID prior vaccination. There were no concomitant medications.  The patient previously took doxycycline and experienced allergies. On 30Aug2021, the patient experienced Breathing problems with cough and thick phlegm, waxing and waning infiltrates not responsive to several rounds of antibiotics. Dx with eosinophilic pneumonitis 20Oct by bronchoscopy. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment included: prednisone prolonged Rx course. Patient had Nasal Swab Covid tested post on 18Oct2021 with unknown results. The outcome of events was Recovering.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: As per available information in the case provided, the causal association between the event pneumonitis and the suspect drug cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
I could not drive; severe reaction/ it was ugly; It was horrible; hardly any sleep; I was unfunctional for two weeks. I couldn't do anything.; tired; This spontaneous case was reported by a patient and describes the occurrence of IMPAIRED DRIVING ABILITY (I could not drive), IMMUNISATION REACTION (severe reaction/ it was ugly), FEELING ABNORMAL (It was horrible), SLEEP DISORDER (hardly any sleep) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I was unfunctional for two weeks. I couldn't do anything.) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (I could not drive), IMMUNISATION REACTION (severe reaction/ it was ugly), FEELING ABNORMAL (It was horrible), SLEEP DISORDER (hardly any sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I was unfunctional for two weeks. I couldn't do anything.) and FATIGUE (tired). At the time of the report, IMPAIRED DRIVING ABILITY (I could not drive), IMMUNISATION REACTION (severe reaction/ it was ugly), FEELING ABNORMAL (It was horrible), SLEEP DISORDER (hardly any sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I was unfunctional for two weeks. I couldn't do anything.) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   No concomitant medications were reported.  Patient was enrolled in a FLU vaccine trial and patient got a severe reaction.  It was reported you receive any other vaccines in the 4 weeks prior to COVID-19 vaccine as unknown. It was reported patient not happy with what happened. patient went nine days with hardly any sleep patient was literally fit to be tied. patient went another couple of days before patient could start. Getting some sleep. I mean, it took like two weeks out of my life with this vaccine. It was horrible and patient only did this because patient had been very happy with Moderna. Patient protected with the Moderna Flu vaccine trial. And patient had been never had a reaction to a flu shot. And it was ugly. It was reported the care was Horrendous. And patient mean over the weekend, and then by Monday.  No treatment medications were reported.
Received vaccine on 1/25/21. On 2/04/21 started getting itchy at 10:45pm around injection site. Broken out in welts/hives approx 11:10pm around injection site as well as area being slightly warm. Welts/hives gone by morning on 2/05/21.
Site: Pain at Injection Site-Medium, Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Fainting / Unresponsive-Mild, Additional Details: constant pain down spine (midback to lower back).
1 day after vaccination, I noticed I was itchy on my butt and ankles but was out and didn?t see under my clothes. Then this morning, 2 days after vaccination, I developed urticaria. It started on my butt, feet, and hands and got progressively worse over a period of 15 minutes.
Vaccinated at approximately 9:10 am. Telephone call from mother around noon. Mother reported that he had vomited a couple of times and seemed tired & weak. Father had carried him into home upon arrival home due to reported weakness. They live in another county. Nurse advised go to ER. Telephone call from ER physician, who inquired about any previous doses of influenza vaccine. Dr stated "I don't think he is having a reaction to the vaccine". Mother also reported child felt "hot to the touch". No actual temperature taken.
A report has been received from a Health Professional concerning a 33 year old Female patient, who had been received Nasal FLUMIST (INTRANASAL), 0.2 Milliltres, Once/Single administration for INFLUENZA PREVENTION. FLUMIST, INTRANASAL started on an unknown date for INFLUENZA PREVENTION. It was reported that FLUMIST was inadvertently administration to pregnant female patient. The outcome of the event of FLUMIST ADMINISTERED TO PREGNANT WOMAN is unknown. The report was considered to be non-serious by the company physician.
Information has been received from a nurse practitioner concerning a 26 year old female who was vaccinated intramuscularly with a 0.5 ml dose of Gardasil.  Subsequently the patient developed shortness of breath, dizziness, a drop in blood pressure and pulse rate.  The patient reported that she hadn't eaten for about 8 hours.  Subsequently, the patient recovered.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow-up information has been received from a nurse practitioner concerning a 26 year old female who was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL. Subsequently the patient developed shortness of breath, dizziness, a drop in blood pressure and pulse rate. The patient reported that she hadn't eaten for about 8 hours. Subsequently, the patient recovered. Additional information has been requested. In follow-up, she reported stated that there was "no adverse reaction".
Intense pain into shoulder, neck and arm. Prescribed pain meds, muscle relaxants when went to urgent care.
Approximately 12 hours after the injection I started to get chills headache dizziness and was not able to sleep, it is the next day now and I?m still feeling pretty bad and body aches all over
Chest pressure, shortness of breath, numbness of lips, throat tight/ache. Red splotchiness on arms. Lasted about 20 minutes then slowly improved. Breathing back to normal after 45 minutes.
Patient was on observation having a conversation with her father when suddenly she started passing out and exhibiting twitching like having Petit mal convulsions and not able to arouse, and later in 2 minutes she recovered eyes open appears pale in face and lips, not aware that she had passed out, and became responsive.  Father claims that HR is always running on low side because she is an athlete. On around 4:40pm she was released under the care of her parent and recommended to get an appointment with her PCP for further evaluation Patient status was checked the following day 4/22 and Pediatrician said that it must be a vasovagal Syncope per Neurologist he consulted no further appointment will be needed at this time
Itchyness, redness, and warmth to injection site; BENADRYL OTC PRN.
10 hours, post vax, pt's left leg swelled up from his hip to below the knee and became red and very hard. He cried inconsolably for 2 hours and would not walk on it or let anyone touch his leg for an hour, his left foot was dusky from lack of circulation due to the swelling. We took him to the ER, where his regular doctor was on call (he knows about his previous reaction to the DTAP). He was given Tylenol with codeine and ibuprofen and observed until circulation in his lower leg was fully re-established. He was sent home. The swelling took a week to go down.
Was seen in the office 10/11/05 at approximately 1500 for a well child exam.  He was in good health at the time of the exam without any symptoms of illness.  He was given Hepatitis A vaccine and Menactra.  Approximately 12 hours later he presented to the Emergency Department with fever (103.1), chills and shaking.  His CBC was slightly elevated in the ER to 11.4.  His ALT was 129, however this was a known medical problem.  He was discharged to home, and followed up in the PCP office in the am with mild URI symptoms and afebrile.
patient states her arm that got the flu shot starting puffing up and was super red at the site. she said it was as big as a golf ball. no other symptoms and it wasn't hurting.
muscle pain; joint pain; left shoulder mobility decreased; left shoulder mobility decreased; Inappropriate route of vaccination; This case was reported by a physician via sales rep and described the occurrence of muscle pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On 5th December 2019, the patient received the 1st dose of Shingrix and INFLUENZA VACCINE (intramuscular). On 5th December 2019, less than a day after receiving Shingrix, the patient experienced muscle pain, joint pain, injected limb mobility decreased, joint range of motion decreased and inappropriate route of vaccination. On an unknown date, the outcome of the muscle pain, joint pain, injected limb mobility decreased and joint range of motion decreased were not recovered/not resolved and the outcome of the inappropriate route of vaccination was unknown.   It was unknown if the reporter considered the muscle pain, joint pain, injected limb mobility decreased and joint range of motion decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and INFLUENZA VACCINE (unknown name by Sanofi) in right arm. The patient experienced joint pain and muscle pain that started in both shoulders, and moved to only the right shoulder. Also, the physician reported that the patient stated that the Shingrix was given higher up into the deltoid muscle, this led to inappropriate route of vaccination. The physician reported that the patient refused treatment and the issues were still unresolved. Consented to follow up.
Prolonged swelling with erythema lasting longer than a week and headaches that turn into migraines daily. Icing and or heating pad to aid in pain and swelling at injection site. Tylenol and Ibuprofen to treat the head aches that don't turn into migranes and migraine medicine (OTC- acetaminophen/caffeine tablets) and sleep to treat migraines.
AFTER ADMINISTERING THE VACCINE THE PATIENT WALKED OUT AND WITHIN MINUTES HE PASSED OUT FELL DOWN HIT HIS HEAD AND DIDN'T KNOW WHERE HE WAS  HE WAS CONFUSED SWEATING WE CALLED EMS THEY WERE HERE WITHIN FEW MINUTES AND WORKED ON HIM  THE PATIENT REFUSED TO GO TO ER AFTER A WHILE 1/2 HOURS OR SO HE CLAIMED HE WAS GETTING BETTER AND HE WENT TO HIS CAR WAITING FOR HIS FATHER TO GIVE HIM  A RIDE
Approximately 24 hours following my vaccine I developed urinary frequency. In a 12 hour period, I urinated somewhere between 40-50 minutes. Approximately once every 10-15 minutes. I have never had frequency in my life. By the following morning, it was completely gone. I have spoken to friends, and two friends developed similar symptoms. One female. One male. Same age group. I do not see this reported in any literature.
Pt recvd vax 1JUL92 & devel t103 & a rash on 4JUL92; no further details were provided;
PATIENT CALLED PHARMACY ON 2/19/21 WITH BODY ACHES, NAUSEA, HEADACHE,AND FEVER OF GREATER THAN 100
Left upper arm swelling, warmth, tenderness since vaccine administration on 7/3/2017.
On Monday, February 13, 2023, around 430pm, MA administered an orange top Pfizer 1st dose vaccine. She states she noticed on Tuesday, 2/14/2023.
Patient was inadvertently given vaccine that was 1 day past the 10 weeks expiration date.
99.0 temp 8 hrs after lasting for one day. Body aches joint pains, fatigue, crohn abdominal pain.  These symptoms improved with normalizing temp.  Occasional oxygen  desaturations. 88-91 Continued.  Prednisone, inhalers, modify activity as needed.
a shingles outbreak after receiving the vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (a shingles outbreak after receiving the vaccine) 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 reported adverse event).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HERPES ZOSTER (a shingles outbreak after receiving the vaccine). At the time of the report, HERPES ZOSTER (a shingles outbreak after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   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. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: 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. Further information has been requested.
I received my second dose of the shingles shot along with my annual flu shot. The following day I had an adverse reaction: chills, arm pain rising up into my neck, nausea, headache and fatigue. The second day, I felt much improved.