chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lot of pressure; Headache; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of STRESS (Lot of pressure), VACCINATION SITE PAIN (Pain at injection site) and HEADACHE (Headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 10-Mar-2021, the patient experienced HEADACHE (Headache). On 12-Mar-2021, the patient experienced STRESS (Lot of pressure). At the time of the report, STRESS (Lot of pressure) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown and HEADACHE (Headache) had not resolved.            No Concomitant medications were provided.  No treatment details were provided.    Reporter did not allow further contact
Leg swelling; This case was reported by a consumer via interactive digital media and described the occurrence of swelling of legs in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling of legs. On an unknown date, the outcome of the swelling of legs was unknown.   It was unknown if the reporter considered the swelling of legs to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-JUL-2022 Reporter's Comments: This case reported by the patient via interactive digital media. The patient had leg swelling after Shingrix. Follow-up would not be possible as no contact details available.
Information has been received from a physician's assistant concerning a 67 year old retired white female patient weighing 143 lbs. who on 04-OCT-2007 was vaccinated subcutaneously with the first dose of zoster vaccine live (Oka/Merck) (Lot # 657675/0618U). On 26-OCT-2007 the patient developed severe right facial pain and went to the emergency room on 29-Oct-2007. The patient was diagnosed with shingles however had no rash. The patient was called to come in for a visit on 01-Nov-2007 if there was no rash. The reporter indicated that they considered trigeminal neuralgia. Patient outcome is unknown. Additional information has been requested.
Had severe chills and body aches and fatigue about 12 hours after vaccine,  lasted about 8-10hrs fatigue and mild aches lasted another 8-10 hrs.  Then 2 days after the shot I got a herpes simplex virus in my eye.
Patient called on 8/31/2018 to report adverse event. She said about 1 hour after receiving vaccine, she began to feel aches, headache, chills, low grade fever (100.8). She called her primary provider and he advised her to go to emergency room. She did not provide treatment details from ER. Said she still ached on 8/31/2018, but her fever resolved.
Had yellow fever vaccine 7/7/07. On 7/10/07 developed soreness and pain from injection site up in Axilla
Throat closure (angioedema/anaphylaxis) requiring ambulance transport to Hospital emergency room and stay IV infusion of Benedryl, solumedrol, and Pepcid with excellent results. Observed twelve hours, then discharged.
TOOK VIVOTIF WITH DOXYCYCLINE; This spontaneous case (PVX2019-1419) was received from a nurse on 03-Jun-2019. It describes a 23-year-old female consumer who "took Vivotif with doxycycline". The consumer was receiving Vivotif for an unknown indication and doxycycline (100 mg; daily) for acne.  Case report: The consumer took Vivotif with doxycycline. She started doxycycline for acne before taking Vivotif and still she was taking it. However, she completed Vivotif course.  Action taken with Vivotif and doxycycline was not applicable.  The clinical outcome of the event "took Vivotif with doxycycline" was unknown.  Company's Comment: The causality of the event "took Vivotif with doxycycline" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif with doxycycline" was considered as not applicable.
Hearing loss in right ear; Blocking of both the ears; Sounds as of ocean in right ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Hearing loss in right ear) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-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 DEAFNESS UNILATERAL (Hearing loss in right ear) (seriousness criterion medically significant), EAR DISCOMFORT (Blocking of both the ears) and TINNITUS (Sounds as of ocean in right ear). At the time of the report, DEAFNESS UNILATERAL (Hearing loss in right ear) and TINNITUS (Sounds as of ocean in right ear) outcome was unknown and EAR DISCOMFORT (Blocking of both the ears) had resolved.            Treatment medications included flu nose, allergy pill, nasal spray and prednisone.  Company Comment: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-098399 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-098399:First Dose Case
I had a sore arm the next day after vaccination. The first week was the worse. I could not touch my left arm and I had to use my right hand to lift my left arm. This lasted for 2 weeks. I did take Tylenol for pain but did help. I did have long effects after getting COVID-19 in November 2020. I did have to get put on O2 for 3 months. Then, I caught COVID-19 again 06/16/2022. I takes me longer to test positive. My husband tested positive. It took me 8 days before I tested positive since symptoms. I had runny nose and sore throat. It took a total of 17 tests. I went to my doctor and was prescribed Paxlovid. I was showing abnormal bruising and blood vessels busting that looked like scratch marks. I went to the ER and had a chest x-ray, COVID-19 test, blood work, heart monitor which indicated bradycardia. Nothing was found on why my blood vessels were doing that and the doctor thinks that I could have something to do with COVID-19. My throat turned all white and moved from my uvula and lower part of my throat and even around my gums. My lips started peeling. I could not eat or drink. It went into my lungs. I used an oral mouth wash 4 times a day then Neosporin on my lips. I also went to my doctor and was tested for strep which was negative. I tested negative on 6/24/2022. Then on 7/2/2022, I tested positive with a rebound effect of COVID-19 and symptoms of headache and runny nose came back. My symptoms lasted for 2 weeks after the rebound.
14 year old received a "booster" vaccine. 1st Pfizer vaccine, lot number EW0182 was given in the left deltoid 0.3mL on 5/29/2021. 2nd dose of Pfizer vaccine, lot number FA6780 was given in the left deltoid 0.3mL on 6/24/2021. Patient is not old enough for a booster dose, however, a booster dose was given on 12/8/2021. No adverse events have been reported from patient or patient family at this time.
Super high Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Super high Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (got Pfizer in April) and PFIZER BIONTECH COVID-19 VACCINE (got Pfizer in March). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PYREXIA (Super high Fever). At the time of the report, PYREXIA (Super high Fever) had resolved.            Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient reported difficulty swallowing and feels as though his lips are swelling. Patient reports difficulty swallowing, redness, pain at injection site. Patient reported difficulty swallowing and feels as though his lips are swelling. BP rechecked manually 162/94. Prior to squad arriving patient reported he is started to experienced a headache and his heart was beginning to race. SOLU-MEDROL 40mg IV given one time.
Cough and heaviness in chest and tired all day on second day.  Around 3 pm starting feeling nauseous and having cramping in my stomach including a bad headache.  I took 2 Tylenol and laid down .  I could not keep food or drink down.  Next morning feel fine.
Diarrhea and stomach issues. They were resolved by 8pm. I took an Covid Test and it was negative
Information has been received from a physician concerning an 18 year old female with a history of Apgar score low and congenital hearing loss who in May 2007, was vaccinated with a first dose of GARDASIL 0.5 mL IM.  Concomitant therapy included LOESTRIN.  In June 2007, the patient experienced a grand mal seizure.  The patient received her second dose of GARDASIL in July 2007.  In July 2007 and August 2007 the patient experienced a seizure again and was hospitalized.  The patient was seen by a neurologist.  The neurologist prescribed the patient KLONOPIN.  Subsequently the patient experienced 15 pound weight loss and amenorrhea.  The patient was then seen by a psychiatrist who stated that he believed the seizures were due to physiological and prescribed additional medications (therapy unspecified).  At the time of reporting the patient was recovering.  No additional information was available.  The reporter considered the events of grand mal seizure, seizure, weight loss and amenorrhea to be other medical events.  Additional information has been requested. 7/9/08-records received-evaluation 1/4/08-fainting spells and seizures-Impression:conversion disorder with mixed presentation with symptoms of motor and sensory deficits as well as psychogenic seizures. Experiencing extreme psychological stress unable to deal with, derives secondary gain from the symptoms and gain attention. 7/10/08-records received for DOS 8/13/07- 8/17/07-Assessment:spells, these do not seem to be seizure with maintined consciousness during the spells. Consider psychosomatic etiology. Onset of syncope 2 years ago, circumstances of syncope burning sensation followed by altered sensorium, recalls the entire envents which last 10-12 minutes). Increasing in frequency, college entrance examination. Developed stuttering speech pattern, crying spells and jerking spell while in waiting room.  8/31/07-Condition improved.  7/10/08-records received for DOS 8/9-8/12/07-DC DX: epilepsy. Prolonged complex seizures. Somnolent due to phenobarital.
Tylenol every morning for her arthritis; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (Pfizer Covid 19 Vaccine, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as first dose single, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as second dose single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient just finished the two doses of the vaccine but has been taking Tylenol every morning for her arthritis on an unspecified date. patient read somewhere that you should not take Tylenol which patient is not aware of. Therapeutic measures were taken as a result of tylenol every morning for her arthritis. The outcome of the event was unknown.  Information about the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
At approximately 9 pm evening of shot left shoulder became extremely pain movement, lack of mobility. Inability to lift and reach. Hard to sleep. Pain radiates down arm to elbow and from shoulder to neck. Slightly better after the weekend but still wakes me up. A week later still painful reduced range of movement.
Patient is an 80 yo female with a history of breast CA, s/p right mastectomy and reconstruction, GIST with recurrence s/p re-excision, currently on Gleevac 200 mg, prior tuberculosis infection s/p right lobectomy, HLD, HTN, osteoporosis, who presented initially to ED complaining of fever as high as 101.9 degrees F and right pleuritic chest pain. She called her oncologist who recommended that she come to the ED for a COVID test. COVID PCR was positive on 1/7/22. The patient is fully vaccinated against COVID. She denies sick contact nor recent travel. She complains of cough, sneeze, but denies SOB, loss of sense of taste or smell, abdominal pain, bowel habit changes. She had been on RA.   Upon presentation, TMAx 101.1 degrees F. She was satting 100% on RA. CXR showed no consolidative process in the right lung. Scattered reticular opacities in the right lung suggestive of parenchymal scarring. CTA chest showed no acute thoracic findings. No evidence of pulmonary embolus. Chronic nodular densities in the right upper and lower lobes compatible with indolent atypical infection or scarring. EKG unremarkable. Laboratory values showed flat trending slightly elevated troponins x 3. Patient was admitted to for further evaluation and management.
severe rash on breasts, neck, back and abdomen. No hives. No itching.
Headache; Blood Nose; This is a spontaneous report from a contactable consumer (Patient) and a contactable physician. A 12-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0180, patient was not pregnant at the time of vaccination), via an unspecified route of administration, administered in Deltoid Left on 24May2021 at 12:00 PM (at the age of 12-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were reported as none. It was reported that patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0202, patient was not pregnant at the time of vaccination), via an unspecified route of administration, administered in Deltoid Left on 14Jun2021 (at the age of 12-year-old) as DOSE 2, SINGLE for covid-19 immunisation. 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 was not tested for COVID-19. On 24May2021 at 09:00 PM (Evening), the patient experienced blood nose, on 25May2021 (AM unspecified) patient experienced headache. It was reported that physician did not consider the Pfizer product had a causal effect to the adverse event. No seriousness criteria were reported. No treatment was received for events. The outcomes of events were recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
I had a pain going into my breast area at the bone underneath the left side, numb of left side of body, headache was pounding, blurry vision, dizzy, unstable balance.
Not an adverse event but patient received a pneumonia vaccination on 3/29/2021 and was not truthful about the date. Told us it was 2 weeks ago. So interval between shots was not the recommended 14 days.
No additional AE reported; Customer called and reported that a dose of PROQUAD expired on 2/2/2023 and was administered to a patient on 3/3/2023.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 03-MAR-2023, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) recombinant human albumin (PROQUAD) subcutaneous injection, lot #W029554, expiration date reported as 02-FEB-2023 but upon internal validation discrepantly established as 14-MAR-2024 (dose, route of administration and anatomical location were not provided) administered for prophylaxis (expired product administered).  The suspect vaccine underwent no temperature excursions. No additional adverse event was reported. No additional information provided.
Onset of severe generalized headache and fever 6/21/04 at 12:00 AM. Also complained of eyes hurting, some cervical tenderness. Referred to ER and subsequently hospitalized with meningitis for 8 days. Medical diagnosis: Aseptic meningitis.  Nurse follow up on 08/31/04 states: "Nausea, back stiffness, muscle pain, nuchal rigidity."
Patient described feeling very hot all of a sudden and then they passed out.  Patient was lowered to the ground and was responsive within seconds.  Patient had a history of passing out once before after a vaccine administration.  They had received other vaccines since without issue.  Patient was given a cool compress and felt better within a few minutes.  Patient waited for extra time once they were able to stand up and felt good.
Patient had no symptoms or adverse effects following the dose; VARIVAX was administered following a temperature excursion; This spontaneous report was received from a business professional and refers to a 26-year-old patient. The patient's concurrent conditions and medical history were not provided.    On 23-SEP-2022,the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml once, lot # W012164, expiration date 12-APR-2024 (route of administration was not provided) for prophylaxis. The vaccine was stored at a temperature of 25 Fahrenheit (F) degrees for 1 hour 30 minutes. There was no previous excursion. The patient had no symptoms or adverse effects following the dose. The patient concomitantly received diluent (DILUENT MRK), which was properly stored.
Guardian called on 3/29/23 to report that redness and knot at injection site. Stated site was warm to touch
pt recvd vax; pt devel measles-like rash on back, neck, hairline area & upper arms; pt devel also pruritus in ears & felt hot; pt was itchy; pt exp'd flu-like symptoms w/ generalized achiness, a feverish feeling & nausea;
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 16-OCT-2015, the patient was vaccinated with a dose of improperly store (incorrect product storage) RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route and anatomical location were not provided). No adverse effects reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a physician via lawyer concerning a 16 year old female student with no known drug allergies a family history of thyroid disease and a history of headache who on 26-MAR-2007 was vaccinated with the first dose of GARDASIL IM into her left deltoid. On 29-MAY-2007, the patient received the second GARDASIL. On 01-OCT-2007, the patient received the third dose of GARDASIL IM into her left deltoid. There were no illness at the time of vaccination. In June 2008, the patient experienced bitemporal headache with phonophobia and photophobia lasting 24 hrs every 2-3 days. The patient was treated with TOPAMAX for the headache. In July 2008, the patient experienced sudden hair loss. Lab tests included a serum antinuclear antibodies test (ANA) serum thyroid-stimulating hormone test (TSH) and erythrocyte sedimentation rate (RSR) with normal results. Additional information is not expected.  12/31/08 Reviewed PCP medical records. FINAL DX: alopecia, HA Records reveal that on 11/27/08 office visit patient experienced sudden severe alopecia x 1 week, HA w/nausea, photo/phonophobia intermittently x 1 mo.
Severe vertigo, nausea. Had to keep my head totally still. Stayed in bed first day. Symptoms lessened over time. A week later I can function fairly normally, but am slightly dizzy, not hungry, and tire easily. I am afraid to get my 2nd dose.
Feel bad; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling bad (Verbatim: Feel bad). The outcome of the feeling bad was resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.     It was unknown if the company considered the feeling bad to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-MAY-2023 The case was self reported by the patient. The patient received second dose of Shingrix and simply made her felt bad. The reporter did not elaborate on side effects. The reporter did not consent to follow up.
hard to fall asleep; felt like she was going to pass out/vasovagal reaction; heartbeat was high; Fatigue; Woozy/Dizzy; hard to concentrate; feeling hot; he also felt as though was on the verge of a headache but never got one/she felt like the blood was rushing to her head; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3249), via an unspecified route of administration on 16Jan2021 09:00 at SINGLE DOSE for covid-19 immunisation. The patient medical history was none. No prior vaccinations within 4 weeks. No family history relevant to adverse events. Patient has no concomitant medications. On 16Jan2021 09:20, 20 minutes after vaccination, the patient felt like she was going to pass out reported as vasovagal reaction, and experienced heart beat was high, fatigue, woozy/dizzy, hard to concentrate, feeling hot, and felt as though she was on the verge of a headache but never got one/she felt like the blood was rushing to her head. On 16Jan2021 10:00, 1 hour after vaccination, the patient experienced had to fall asleep. On the day she got the shot she sat for a full hour with the nurse to be monitored. Then she went home. The events lasted from 09:20 until 18:00 on that day. 13 days after vaccination on 29Jan2021, 12:00 and ongoing until reporting time, the symptoms recurred about the same when they started. The patient was wondering if this could be a side effect 2 weeks after getting the shot or if she should look elsewhere on what could be causing these events. She is supposed to get the second dose on Friday and was wondering about getting the second dose after her experience. Patient wanted to know it is safer for her to have the 2nd dose. No physician office visit and emergency room visit. No prior vaccinations within 4 weeks. Outcome of the events was recovered on 16Jan2021 18:00.