chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She felt like she was going to die; Getting very sick after receiving the second dose; Hives / itching like crazy with hives; Hives / itching like crazy with hives; 101°F fever/ high fever chills; 101°F fever/ high fever chills; Nausea; Headache; Lost sense of taste and smell; Lost sense of taste and smell; Her eyes were not good after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Glaucoma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization, reaction(s): "No adverse events". The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "recovered", described as "She felt like she was going to die"; ILLNESS (non-serious), outcome "recovered", described as "Getting very sick after receiving the second dose"; URTICARIA (non-serious), PRURITUS (non-serious), outcome "recovered" and all described as "Hives / itching like crazy with hives"; PYREXIA (non-serious), CHILLS (non-serious), outcome "recovered" and all described as "101°F fever/ high fever chills"; NAUSEA (non-serious), outcome "recovered", described as "Nausea"; HEADACHE (non-serious), outcome "recovered", described as "Headache"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "recovered" and all described as "Lost sense of taste and smell"; EYE DISORDER (non-serious), outcome "recovered", described as "Her eyes were not good after the vaccine". The patient underwent the following laboratory tests and procedures: body temperature: 101 Fahrenheit, notes: High. The patient wanted to know if she can get the Pfizer Covid Booster dose after getting very sick after receiving the second dose in the primary series. The patient had a history of glaucoma but says her eyes were not good after the vaccine. After he second dose she was fine initially. The patient stated 24 hours after her second dose she began to experience everything you can imagine happening. She had a 101F  fever, was itching like crazy with hives. Her husband had to help her and she felt like she was going to die. These symptoms lasted for 7 weeks.  The patient stated she spoke with several doctors, one who was a friend. She asked if she can take the Pfizer Covid Vaccine booster dose.   The lot number for bnt162b2 was not provided and will be requested during follow up.
severe pain/tenderness, swelling, and erythema of skin of right upper arm.  Treated with augmentin for presumed infection for 10 days.
Vaccinated 11/18/09. Cold symptoms/cough, runny nose started 11/22 apprx. Temp. on 11/22 at 95.2 degrees, dizzy upon walking to post office. General feeling of weakness for 3 weeks. Called rheumatologist on 12/3/09 to report symptoms. Ceased HUMIRA and methotrexate as of 12/3/09. Diarrhea started (moderate) 12-9-09. Saw primary Dr. on 12/11/09. Still have some runny nose and cough as of 12-14-09. Cold sx runny nose/cough began 11/22, temp 11/22 95.2 (pt reports subnormal temps are her norm) dizzy (walking to P.O.) general weakness x 3 wks pt called rheumatologist 12-3-09 he advised stop humera and methyltrexate inj & pt stopped 12-3-09. Pt saw PCP 12-11-09.
Small papule noted to buttocks 2/14/19. Numerous lesions started 2/17/19, erythematous papules, some progressing to vesicles and then crusting. Lesions to trunk, extremities, face, diaper area. Lesions at various stages when seen 2/18/19. Recommended symptomatic care. Returned 2/20/19 for VZV PCR for typing.
Got her shot, then waited for 15 minutes, and was able to leave.  She went immediately to dialysis around 1:00 PM.  She got in the chair for that and fell asleep for a few hours.  When she woke up her leg felt weird.  She lifted her leg to look at it and the dialysis tech said that he had noticed the leg rash.  The reaction is on the left leg, it is about the size of a softball.  The rash color is a dark red.  Then the rash is directly above the ankle and spread to just below the calf around the leg.  The doctor at dialysis looked at it, and he prescribed Keflex for her.   Put her feet up, told her to keep it elevated.  She has had cellulitis before in 2017 in both legs.   She said that this is a mild reaction.  The last time it went all the way up her calf.
I was told that the vaccine expired the day I was there; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I was told that the vaccine expired the day I was there) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (I was told that the vaccine expired the day I was there). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I was told that the vaccine expired the day I was there) outcome was unknown.            No Concomitant product use was reported.  The patient reported that they received Moderna booster vaccine yesterday on 02-May-2022, at a private pharmacy. While the patient was in the store the patient asked for how many months the booster vaccine was on the shelf. Reportedly, the patient was told that the vaccine expired the day the patient was there, and the vaccines lasts for six months and more.  No treatment information was provided.
Fainting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainting) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.  Company comment: 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.; 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.
COVID test negative. took couple of days and with fatigue, Tuesday had normal doctor's appt and had sore throat, by that evening I felt worse and lasted 2 weeks. I had a fever, stomach issues. Diarrhea and aches and pains and chills. The COVID swap 23 AUG2021 got lost and now I feel like I have allergies. I am better but I have bad allergies with Hay fever some it's better and some days it's bad.
This spontaneous report was received from a registered nurse refers to a 4 years old patient. The patient's medical history and concurrent conditions were not reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored VARIVAX (Merck) (lot # L008272, expiry date 11-MAR-2017). Concomitant medications were not reported. The outcome was unknown. This is one of the several reports received from the same reporter. Addiitonal information has been requested.
Patient received additional (3rd) dose of pediatric Hep A. This dose was unnecessary. Patient's mother was notified that this dose was unnecessary.
Itching in hands and feet; Headache would come and go; A little bit of tiredness; Yeast infection; This spontaneous case was reported by a consumer and describes the occurrence of FUNGAL INFECTION (Yeast infection), PRURITUS (Itching in hands and feet), HEADACHE (Headache would come and go) and FATIGUE (A little bit of tiredness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Bell's palsy (5-6 years back.).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced FUNGAL INFECTION (Yeast infection). On 25-Feb-2021, the patient experienced PRURITUS (Itching in hands and feet), HEADACHE (Headache would come and go) and FATIGUE (A little bit of tiredness). The patient was treated with MICONAZOLE for Yeast infection, at an unspecified dose and frequency. On 01-Mar-2021, FUNGAL INFECTION (Yeast infection) had resolved. On 02-Mar-2021, PRURITUS (Itching in hands and feet), HEADACHE (Headache would come and go) and FATIGUE (A little bit of tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient states that her adverse reactions were minor and lasted for about 5 days. Patient concern is with the 2nd dose of the COVID-19 vaccine. She wants to know if there is a chance that she might have Bell's Palsy after receiving the 2nd dose.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up information received on 10-May-2021 and Reporter Contact information (E-mail) was added
Received bivalent booster on 10/7/22.  Pt called hospital call center to report Side effects on 10/10/22.  Reports rash on arm, fever, lymph node swelling under armpit, and injection site pain.  RN recommended for patient to go to ED but patient decline at the time. Pt will follow-up with their external PCP.
Headache  on first day.   Headache 2nd day.   Sore throat, tiredness 4th day. Sore throat,  post nasa drip, Headache,  tiredness 5th day.
Diuresis Went to urinate 7 times at night 13 hours after the second dose
Patient called on 12/17/2019 and stated that she recieved shingrix vaccine at the pharmacy on 09/29/19 and her arm has been hursting ever since.
sickness; Cough; Feeling hot; Flushing; fever; chills; headache; body aches; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (sickness), COUGH (Cough), FEELING HOT (Feeling hot), FLUSHING (Flushing) and PYREXIA (fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia in 1989. Concurrent medical conditions included Drug allergy (Seizures) since 1981 and Drug allergy (Rash,itching) since 2015. Concomitant products included Multi Vitamin Nos. (MULTI VITAMIN & MINERAL), ASCORBIC ACID (VITAMIN C ACID) and COLECALCIFEROL (D3).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ILLNESS (sickness), COUGH (Cough), FEELING HOT (Feeling hot), FLUSHING (Flushing), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (body aches). At the time of the report, ILLNESS (sickness), COUGH (Cough), FEELING HOT (Feeling hot), FLUSHING (Flushing), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (body aches) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took concomitant medications-COLO, Bilberry & Lutein once daily. No treatment medications were reported.   This case was linked to MOD-2021-170412.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow up received contains no new information. On 27-Sep-2021: Follow up received contains no new information.
Patient is having dizziness; Tired; This case was reported by a consumer via media and described the occurrence of dizziness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced dizziness and tiredness. On an unknown date, the outcome of the dizziness and tiredness were unknown.   It was unknown if the reporter considered the dizziness and tiredness to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient. The patient received Shingrix vaccine. After vaccination, the patient experienced dizziness and tired.
Initial unsolicited report received from a pharmacist on 28-Sep-2018. This case involves a 64 years female patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration as the patient receive the FLUZONE HIGH DOSE at age 64 years old. It was not reported if the patient experienced any adverse event or not. 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. List of documents held by sender: none.
BlurredVision, NauseaVomiting, Symptoms started eve of 12/28/2020 as above with marked generalized fatigue and pain on left deltoid. Feels better 12/29 with only left deltoid pain remaining.
Patient presented to pharmacy 2 days post vaccination with redness around the arm. He stated that he also had a fever for one day  post vaccination.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Immediately after Moderna vaccination, patient reported numbness in his hands and arms. He then began to feel lightheaded. Numbness did not spread. Patient recovered after about 5 minutes and left the store.
On 01/07/21, I woke up around 4 a.m. with a fever, headache, and severe body aches. I felt the same as I felt when I had COVID-19 on 11/01/20. I remained achy all day with a fever up to 103.4.  I was fever free by the morning of 01/08/21 and returned to work but still not feeling well, still a little achy.  On 01/10/21, I woke at around 5 a.m. with hives, a rash, and severe itching. The rash and hives were migrating from one part of my body to another. It started on my torso and buttocks and then migrated to my arms and legs.  I took Benadryl with some relief. My feet were itching most of the night even after taking more Benadryl. On 01/11/21, I went to work and continued to have itching with a rash and hives on my legs and arms and then on my neck and face.  My eyelids and lips began to swell. I was seen by provider and given Benadryl IM as well as a steroid IM (I think Depo-Medrol).  They also gave me a Rx for famotidine and loratadine.  I continued to have some itching all over and severe itching and swelling of my fingers that evening. I took Benadryl later that evening and loratadine and famotidine at bedtime I felt much better by the next morning with only slight swelling of my eyelids and slight itchiness. It took a couple of days for my eyelids to return to normal with no swelling.
A legal complaint was received on 12/3/02 from an attorney alleging that a child received series of Hep B (manuf unk), Engerix B, Tripedia vaccines as well as Hib-TITER and Tri-Immunol vaccines from 10/16/96 through 10/19/98 and subsequently suffered "from the toxic neurological effects of mercury poisoning." According to the legal complaint, the child experienced "mental and intellectual incapacity, developmental incapacity, learning disabilities, and affect disorders and impairments." The pt's symptoms resulted in persistent or significant disability/incapacity. Vaccination info contained in the legal complaint indicated that the child received hep B, Engerix B, Tripedia, Hib-TITER, and Tri-Immunol vaccines during the first years of his life.
Arm pain.  Not from the injection site.  Deep within my arm. Extended from the shoulder down to my elbow.  Throbbing and constant.  Hurts to lift up, hurts when I lift an object. Throbbing pain when I sleep, and has woke me up if I lie on my arm too long.   It subsides when I take Bayer Back and Body, and BC powder, but they have to be taken around the clock.  The pain did not start until the 2nd dose.  It has been 3 months and the pain remains!!!!
Patient was 17 years old; younger than recommended 18 years old. No immediate symptoms or signs.
Onset of itchy bumps (lower back) 10 days following vax. Dx'd with zoster by one MD and impetigo by another MD. Took Augmentin 500 mg bid x 8 days, topical Benadryl. Rash resolved by 3/4/03.
6/3 immunization given started to favor leg that eve. 6/4 OK. 6/5 increased swelling twice the size, also around the knee. 6/6 playing but favor leg. 6/7 swollen rash on knee cap and behind knee
Tingling in left leg at 7:15pm. Tingling in left leg and arm; sleepiness at 8:15pm.
onset severe shingles 06/18/2021 , thyroid numbers worse than ever recorded, recurrence of excema not seen since childhood, onset of warts not seen since childhood,
he felt his head burning; body itching; his neck tendons are tense, his back tendons are tense; he feels tingling on his left feet, he feels tingling on his left leg; he can't sleep; he stands up and feels dizzy; he can't work; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (he felt his head burning), PRURITUS (body itching), TENDON DISCOMFORT (his neck tendons are tense, his back tendons are tense), PARAESTHESIA (he feels tingling on his left feet, he feels tingling on his left leg) and INSOMNIA (he can't sleep) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, the patient experienced BURNING SENSATION (he felt his head burning), PRURITUS (body itching), TENDON DISCOMFORT (his neck tendons are tense, his back tendons are tense), PARAESTHESIA (he feels tingling on his left feet, he feels tingling on his left leg), INSOMNIA (he can't sleep), DIZZINESS (he stands up and feels dizzy) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (he can't work). At the time of the report, BURNING SENSATION (he felt his head burning), PRURITUS (body itching), TENDON DISCOMFORT (his neck tendons are tense, his back tendons are tense), PARAESTHESIA (he feels tingling on his left feet, he feels tingling on his left leg), INSOMNIA (he can't sleep), DIZZINESS (he stands up and feels dizzy) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (he can't work) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. patient was tested, a CT scan and a MRI and nothing was found.
I got pregnant the month after that resulted in a miscarriage  (after having a normal pregnancy in the past). At week 6 the baby stopped developing and the pregnancy was lost at week 9. After having a D&C my Doctor, notified me of the amount of miscarriages he?s been seeing in vaccinated women just at his office and asked that I report it.
headache, lightheaded, dizziness; seen & cleared by EMS. Client said he had not eaten anything, blood glucose- 86, B/P-79/44, pulse ox- 100%
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 08-JUL-2011, the patient was inoculated with ZOSTAVAX at pharmacy / drug store as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-NOV-2015, the patient was treated at a physician's office for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
None stated 6/22/09 ZOSTAVAX was given instead of VARIVAX-client was notified 6/25/09-PHN inquired if he experienced any local or general SE/symptoms, he states no symptoms noted. Informed client that vaccine given counts as 2nd dose of VARIVAX. Informed client that this will be call clinic for documentation. Clinic was called to report in client's chart 10/26/09, 10:50 AM.
approx 7 hrs p/vax pt became limp, pale & slept for 14 hrs w/shallow resp, refused bottle & returned to sleep; has had APAP & did not have this response to APAP;
Information has been received from a licensed practical nurse concerning a patient who, on an undisclosed date, was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot # 657109/0444U), and subsequently developed a non vesicular welt. Additional information has been requested.
Had covid a few months ago; Had covid a few months ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Had covid a few months ago".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a physician via sales rep and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured adult as per vaccine indication. The patient experienced fever (body temperature: 103 F). It was unknown if the reporter agreed to be followed up. Medical Science Liaison (MSL) would follow up.