chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has herpes simplex II/five break outs since her first dose/she has had breakouts after the shot one right after the other; has herpes simplex II/five break outs since her first dose/she has had breakouts after the shot one right after the other; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Aug2021 at dose 1, single for covid-19 immunisation. Medical history included ongoing herpes simplex virus 2 (had herpes simplex II for 34 years. Stated that before she would have 6-8 breakouts a year). Concomitant medications were not reported. Reporter stated that she had received her first dose of the Pfizer vaccine shot 09Aug2021 and has herpes simplex II. Reporter has a medical history of herpes simplex virus 2 prior to the vaccine. Stated that she had breakouts after the shot one right after the other. Stated that she has had herpes simplex II for 34 years. Stated that before she would have 6-8 breakouts a year. Stated that since the first shot that she has had 5 breakouts. Stated that she is due for the second dose and is wondering if this is a long or short term effect. Is for Pfizer Covid vaccine. Is concerned about getting the second dose. Reporter details: Email address captured as provided. Outcome of the events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Received two dose primary series of Pfizer COVID vaccine 2/27/21 and 3/20/21, followed by Pfizer booster on 10/25/21.  On 6/25/22, became sick with COVID19.  Symptoms included 103 degree fever, severe chills, altered mental status, prolonged cough, and extreme fatigue.  Symptoms persisted 2 and a half weeks, and was prescribed an antibiotic for secondary lung infection.  Tested postive twice for COVID19 during this time frame.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 04-JAN-2018, the patient was vaccinated with an expired dose of ZOSTAVAX lot # M041085, expiration date 03-JAN-2018, subcutaneously for prophylaxis (strength and frequency were not provided).  Other suspect therapies included sterile diluent (MRK). No adverse effects reported.
Soreness of the site then was sick 6 days later positive for COVID -19.  Fatage
Stomach hurting; sore throat; fatigue; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach hurting), OROPHARYNGEAL PAIN (sore throat), FATIGUE (fatigue), NAUSEA (nausea) and VOMITING (vomiting) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Cholesterol.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach hurting), OROPHARYNGEAL PAIN (sore throat), FATIGUE (fatigue), NAUSEA (nausea) and VOMITING (vomiting). In February 2021, OROPHARYNGEAL PAIN (sore throat) and VOMITING (vomiting) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach hurting), FATIGUE (fatigue) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient take Tylenol and aspirin since 21Feb2021 as a Treatment medication    This case was linked to MOD-2021-022241, MOD-2021-022272.
1 day after receiving vaccine I experienced "brain fog".  Approximately 10 days afterwards (around 2/25), I experienced symptoms of a minor stroke - I experienced lack of coordination in typing and later that evening experienced difficulty with speaking and comprehension, but only for a few minutes. A few days later, that weekend, I had some issues playing songs on the piano I had played before, making a lot of mistakes.  About another 2 weeks afterwards, on 3/9/2021, I experienced more symptoms of stroke. For most of the day I had issues with typing, and later that evening I had some coordination issues with closing a soda bottle. On the morning of 3/10/2021, I continued to experience issues with typing and also had difficulty speaking and understanding my wife. At this point I went to the emergency room and was found/diagnosed to have experienced multiple TIA strokes.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored ZOSTAVAX, lot# reported as N009779, expiration date 12-MAR-2017 for prophylaxis. Concomitant therapies included sterile diluent. The excursion under temperature 15 to 46 degree Fahrenheit for 5 hours. The previously excursion was 15 to 46 degree Fahrenheit for 6 hours. Digital data logger involved. No adverse events reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA004439.
EXHAUSTED; ACHY; LOW GRADE FEVER; This spontaneous report received from a parent concerned a 27 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 30-APR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-APR-2021, the subject experienced achy. On 30-APR-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) Around 99.9. On 01-MAY-2021, the subject experienced exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, and low grade fever on 02-MAY-2021, and had not recovered from exhausted. This report was non-serious.
Localized reaction site of vaccine with pain involving arm. Ice, BENADRYL 25-50 mg PO every 4 hours as needed, MOTRIN 800 mg every 8 hours as needed.
Arm is graduating getting worse with pains and is tingling.  Moving to shoulder and neck.
Nausea, headache. T 96.8 degrees. Allergy-peanuts.
lightheadedness, migraine started. Waited extra 15 mins- Evaluated by EMS- Cleared
HYPOTENSION 1/13/2023 & 2/6/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SUBSEQ NEUROPATHY HYPOXIA
Moderna COVID-19 Vaccine EUA Muscle Soreness at Injection Site for 4-5 days.  Diarrhea on Day 3.
Bruise at injection site, few inches below red, swollen, hot that started out small but over 48 hours has grown big portion of upper arm, it also itches, muscle aches, fever, nausea, stomach cramps, cough, hard taking deep breath.
Fever, nausea, chills, headache, extremely sore arm, shooting pains in arm, sensitivity to light
each of them feeling sick; aching all over for a day or two; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An elderly female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "each of them feeling sick", "aching all over for a day or two"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "each of them feeling sick", "aching all over for a day or two"; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "each of them feeling sick", "aching all over for a day or two"; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "each of them feeling sick", "aching all over for a day or two". The following information was reported: MALAISE (non-serious), outcome "recovered", described as "each of them feeling sick"; PAIN (non-serious), outcome "recovered", described as "aching all over for a day or two".  Additional information: Caller reported receiving 6 Pfizer COVID-19 vaccine injections in the past (dates and formulations not provided) and after each of them feeling sick and aching all over for a day or two. Caller's last Pfizer COVID-19 injection was in May.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312955 Same patient/vaccine/event, different dose;
Red, swollen, inflamed deltoid at the site of injection. Delayed reaction after 48 hrs. No blister no fever.
pt began fever, unk origin >102 approx 72hr p/vax; adm to hosp subsequently devel vomiting & diarrhea;
Patient called to report severe weakness, vertigo, intermittent chest cramps, difficulty breathing, severe body aches,  constant headache, extreme fatigue, chills, loss of appetite, nausea, and vomiting. Patient received her 1st dose of moderna covid vaccine 4-1-21 at pharmacy at 5:15 PM and started experiencing symptoms at 5:30 PM. Patient states her vertigo comes on when she is sitting up or standing, to the point where she is no longer able to stand up without feeling like she is going to fall. Patient also states her weakness is so severe she can "barely lift" her arms up. Patient states she is unable to touch her chin to her chest due to her experiencing neck stiffness stating "my neck feels locked up". Patient does have a history of "POTS" and explained that she will occasionally have "chest cramps" but notice it has been becoming more frequent since receiving the vaccine with each cramp occurring every 3 hours and lasting from 2-10 minutes. Patient states she has "vocal cord dysfunction" and at baseline always has difficulty breathing but has had more difficulty breathing since last night.  Patient states she has used cyclobenzaprine with mild response.
Received the Pfizer vaccine around 3:00 PM. After shot took Benadryl just incase I had a reaction (history of allergic/ anaphylactic reaction to bee stings). Felt fine the first 6 six hours; experienced some fatigue but nothing serious. Then after the six hour mark, I believe the Benadryl went away and I started to itch and grow a rash on my right side. I then looked in the mirror and my chest, stomach, back, and behind my ears were red and covered in hives.  I went to the ER incase the reaction would turn anaphylactic and they said I was alright. They prescribed me Benadryl and prednisone  to help with the reaction.
103 degree fever, migraine, severe joint pain, GI got significantly worse (pain in stomach); went to ER; admitted overnight to hospital since they could not get the fever and migraine resolved; spent two days in the hospital treated with various medications including Tylenol and magnesium
PRIMARY MEMBRANOUS NEPHROPATHY SHORTLY AFTER COVID-19 VACCINATION; This is a literature report.  A 56-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: GLOMERULONEPHRITIS MEMBRANOUS (hospitalization, medically significant, life threatening), 2 weeks after the suspect product(s) administration, outcome "recovering", described as "PRIMARY MEMBRANOUS NEPHROPATHY SHORTLY AFTER COVID-19 VACCINATION". Therapeutic measures were taken as a result of glomerulonephritis membranous.  Clinical course: As COVID- 19 vaccinations have increased worldwide, there has been a rise in associations between the COVID- 19 vaccine and various glomerular diseases. This case displays the onset of PLA2R-positive primary MN occurring shortly after an episode of COVID -19 vaccination. A 56 year old female was admitted with hypertensive urgency, nephrotic syndrome and anasarca. She had developed generalized edema two weeks after receiving the Pfizer-BioNTech COVID-19 vaccine series. Patient reported no prior history of COVID-19 Infection. Labs showed elevated proteinuria (urine protein creatinine ratio 19g/g), serum hypoalbuminemia (1.7 gm/dL) stable serum Cr of 1.3 -1.5, normal complements and unremarkable SPEP. Serum PLA2R Antibody was positive. Renal biopsy findings: By LM, diffuse and global capillary wall thickening in most of the glomeruli. By IF, diffuse 3+ positivity for IgG (3+) and light chains, along with variable moderate to weak positivity for C3 (2+), C1q (1-2+) and IgM (trace). By EM, rows of subepithelial electron dense deposits and near-diffuse effacement of podocyte foot processes in sampled glomeruli, Tubuloreticular inclusions were absent. Findings are consistent with PLA2R-positive Primary Membranous Nephropathy. Patient was treated with tacrolimus with good clinical remission This case suggests possible association between the Covid-19 vaccine and loss of self-tolerance to the PLA2-R antigen.; Sender's Comments: Based on provided information and temporal association reported event causal relationship to the suspect drug methylprednisolone cannot be excluded. Case to be re-assessed upon receipt of new information. The 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 notified to RAs, Ethics Committees, and Investigators, as appropriate.
The next day I felt a stone in my arm pit area, with some pain. The pain lasted about 2-3 weeks and I had to visit my doctor. Doctor felt something in my breast and did an ultrasound and mammogram. About a month later I went for another ultrasound. Still feel something in my armpit. Did my flu shot 2 months after in my right arm and felt the same symptoms. Has not resolved.
Vaginal bleeding lasting longer and heavier than usual with clots larger than a quarter. Bleeding mid-cycle.
I had congestions on my throat and back of my throat; very severe body aches. My body temperature remained normal throughout the disease. I had a lot of sweating. I was extremely tired. 07/19/2022 I went to the doctors office  where he did a COVID-19 test. On the 07/21/2022 I got the result which was positive and along with a prescription with PAXLOVID for 5 days. I started taking the medication on 07/22/2022. I also drank plenty of fluid including soups with fresh garlic. I had to quarantine for 10 days. I did a rapid test at a local country clinic after 10 day which was negative.
I had the symptoms on 12/27/2022 which were headache, fatigue, tiredness and a little bit of chills and sore throat. I slept all night at took an at home test on 12/28/2022. I had a televisit with a physician's assistant 12/28/2022. I still have a little bit of fatigue.
suddenly began shaking horribly from head to feet/shaking of his hands; freezing; My walking is not as good as before; This is spontaneous report received from a contactable consumer (patient). A 79-year-old male patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration on 01Mar2021 at 12:45 (at the age of 79 years) at a single dose in the left arm for COVID-19 immunization. Medical history included stem cell transplant; then soon after GBS from an unknown date and was diagnosed with COVID-19 from an unknown date. No allergies to medications, food, or other products. Concomitant medications included levothyroxine; rosuvastatin; telmisartan; and metformin. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269) on 08Feb2021 at 12:45 pm in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Mar2021 at 21:30, patient was getting ready for bed but suddenly began shaking horribly from head to feet and was freezing. His wife put him in bed with six blankets but he was still freezing. His wife brought him to the ER. Upon arrival at the ER, it was noted that the shaking was gone but the shaking of his hands remain that he could not put a spoon of sugar in his coffee cup without spilling it and stated that his walking is not as good as before. The patient was hospitalized due to the events for 2 days. The events were considered serious for disability. Therapeutic measures were taken as a result of the events (needles were placed on both legs as reported) and MRI was performed. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequel on an unspecified date.
Itching around belly; Rash around belly; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching around belly) and RASH (Rash around belly) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O24M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PRURITUS (Itching around belly) and RASH (Rash around belly). At the time of the report, PRURITUS (Itching around belly) and RASH (Rash around belly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.    Reporter did not allow further contact
Muscle pain in left arm, a dull continuous pain, a feeling of weakness in left hand. Treatments-10 days of prednisone, 10 days of PT. Some better-still a soreness in shoulder.
Patient experienced a tonic clonic seizure less than 24 hours after receiving vaccine. He has a history of epilepsy which is well controlled and no seizure activity in over a year.  Seizure started at approximately 10:00am and lasted 5 minutes or so... Pulse and breathing were lost for 2 minutes while CPR was started. EMT arrived and did a full work up. Patient woke up and was in a postictal state for an hour or so. ECG, BP, pulse, were all fine when patient was released from EMTs care to wife to go home.
Patient immediately felt dizzy after injection. He then passed out in his chair and we put him down on the floor.  He then had a seizure lasting a couple seconds. The entire episode lasted less than a minute and he then regained consciousness and was responsive.  Emergency services was contacted at the first sign of the seizure and upon arrival, they checked that he was alert and oriented x4. Patient did not go to the hospital but he did go home with a family member.
Patient in 30 minute observation area developed hives on back, chest and arms. Evaluated by EMS.  No shortness of breath; lung sounds were clear. Monitored for 30+ minutes. Negative change. Refused treatment and transport.
Patients husband phoned at 5:54 pm on 12-27-15 stating that his wife was experiencing vomiting and headache. They wanted to know if these were adverse side effects of the vaccine.
Sick; felt under the weather; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Sick) and MALAISE (felt under the weather) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     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 ILLNESS (Sick) and MALAISE (felt under the weather). At the time of the report, ILLNESS (Sick) and MALAISE (felt under the weather) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-660539 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660539:case for another patient-male
This spontaneous report as received from a physician refers to an unspecified number of patients. On an unknown date the patients might have been vaccinated with PEDVAXHIB (lot #, expiration date, route and route unspecified) that was exposed to temperature conditions that Merck cannot support. NO PQC. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Left 6th cranial nerve palsy. Patient's mother called into the office for advice/input, and was put on the schedule to be seen. After Dr. (PCP) assessed the patient, he was then referred to Dr. (Pediatric Ophthalmology), as well as Dr. (Pediatric Neurology).
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose 5 (booster), single (Lot number: G73277) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 15Apr2021 as dose 2, single (Lot number: EW0162), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: DF10F), in left arm and on 07Jun2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive, notes: Still testing positive on day 12. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: the patient was treated with PAXLOVID.