chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed fatigue, fell. admitted to hospital after fall on 10/15 and tested (+) with COVID. Also some slight shortness of breath was briefly put on oxygen but is now on room air. About to transferred to skilled nursing facility
Severe radicular pain at injection site and traveling down arm, causing significant weakness of left arm.  Developed over several hours following injection.  No associated redness, warmth, discharge at injection site.  No systemic symptoms.
Chills; Fever 100F; Soreness; A spontaneous report was received from a 49-years old, female patient (health care professional) concerning herself who experienced the events soreness/pain, chills and fever of 100F.   The patient's medical history was not provided.  Concomitant product use includes multivitamins for immunity.  On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.    On 04 Jan 2021, the patient experienced soreness.   On 09 Jan 2021, the patient had chills and fever of 100F up until at the time of this report.   Treatment details included Paracetamol and Naproxen for pain.   Action taken with mRNA-1273 in response to the events  was not provided.  The outcome of the events soreness was unknown, chills and fever was not recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a nurse concerning a 9 month old patient who on an unspecified date was vaccinated with a dose of VARICELLA (Merck) (lot # unspecified). The nurse mentioned that on 21-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Additional information has been requested.
Patient is a refugee and had incorrect date of birth charted - was presumed to be 18 year old and received adult dose of Pfizer vaccine. When she returned for her second dose on 2/5/2022, she had documentation of her birthday being (privacy). She received the adult Pfizer vaccine at 11 years old.
itchiness; allergy issues; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness) and HYPERSENSITIVITY (allergy issues) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Brain tumor and Depression. Concomitant products included TAMSULOSINE [TAMSULOSIN], ATORVASTATIN, SERTRALINE, FISH OIL (OMEGA 3 FISH OIL [FISH OIL]), VITAMIN D3 and PARACETAMOL (TYLENOL) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PRURITUS (itchiness) and HYPERSENSITIVITY (allergy issues). At the time of the report, PRURITUS (itchiness) and HYPERSENSITIVITY (allergy issues) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medications also included riveltectim (sic). No treatment information was provided.   This case was linked to MOD-2021-101600 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 15:00 as dose 4 (booster), single (Lot number: GT2524) at the age of 36 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) 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), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive for covid; Negative, notes: Positive for covid then tested negative on mornings of day 8 and day 10 of isolation; Negative, notes: Positive for covid then tested negative on mornings of day 8 and day 10 of isolation; Positive, notes: tested positive again on day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Positive for covid then tested negative on mornings of day 8 and day 10 of isolation. Started to feel symptoms (congestion, coughing, sore throat) on day 10 and tested positive again on day 11.  No follow-up attempts are possible. No further information is expected.
Vaccine was received during the second day of period cycle, vaccine resulted in an abrupt end to menses. Following cycle was half as long as normal, occuring again in 23 days instead of 42 (as is normal for patient).
Noticed that I was feeling a bit more fatigued beginning in early spring, thought it was just "again" process. Also noticed that my head felt a "little swimmy", slight dizziness at times and blamed it on allergies. Had some dental issues going on and thought that my fatigue might be due to the infection the tooth, as the feelings continued to increase, I took my blood pressure (at home, I'm a retired RN) and it was 160/92. Checked it again later, it remained high, checked it the next morning and it was still high so called my MD and went right in to see him. He started me on Lisinopril 10mg daily. It took a few weeks for my BP to come down but seems steady presently.
Covid monitoring documentation. PT admitted 1/18/22 documented to have positive covid. PT received Moderna 07/6/21 Lot 8077702739 for dose 1. Dose 2 was Moderna given on 08/4/21 Lot 036C21A.
Fever of 103.3 Degrees Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 103.3 Degrees Farenheight) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PYREXIA (Fever of 103.3 Degrees Farenheight). At the time of the report, PYREXIA (Fever of 103.3 Degrees Farenheight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: 103.3 degrees fahrenheit (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient self-treated with ibuprofen 200mg.
1. It started with a severe headache, which is now a daily occurrence. 2. In the last few weeks, I started feeling numbness (primarily arms and legs). I measured my pulse - it was 51 yesterday . Numbness is getting worse. 3. I have been experiencing severe fatigue since the vaccine. It never went away.
This spontaneous report as received from a physician and from a support director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 07-JUL-2016 , the patient was vaccinated with an improperly stored dose of GARDASIL lot # L033347 , 0.5 ml - 10 Pk SD PFS-Luer-Lok, expiry date 23-JUL-2017; route of administration was not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (date unspecified): lasting for 48 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.1 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT DID NOT MEET THE RECOMMENDED REQUIREMENTS TO RECIEVE THE 4TH DOSE VACCINE. PT REPORTS NO SIGNS OF ADVERSE EFFECTS
Tinnitus, has increased after each vaccination (original and boosters), occured within a day of shot. Has worsened after getting covid
This spontaneous report has been received from a office manager and refers to a 58 year old male patient. The concurrent conditions included high cholesterol and concomitant therapies included atorvastatin calcium (LIPITOR). The patient did not have any known drug reactions or allergies. On 14-FEB-2017, the patient was vaccinated with ZOSTAVAX 19400 Plaque-Forming Units (PFU), 0.65 ml, subcutaneously, lot # M001745 expiration date 07-APR-2017. On unknown date in February 2017, the patient experienced a large welt in the injection site. No treatment was given for the adverse event. There were no lab diagnostic studies performed. The patient sought medical attention by calling to the office. No product quality complaint was involved. The outcome of a large welt in the injection site was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Injection site soreness (8/10) Rash (6-8 inches across) Fever (peak at 103 degrees F) Loss of Appetite Lethargy Very tired
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 03Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 04Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 04May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfur drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300093113 same patient/product, different dose/event;
Started about 6 hrs after injection, chills, headache, sore muscles, low grade fever, accompanied by chest tightness and rapid heart rate.  Resting heart rate was 115, when I stood from bed shot up to 135. Lasted for about 6 hrs. Woke up the next next day and day after just exhausted.
pt recvd vax; pt was crying grandma states sudden onset of flaccid & pallor; pt given sugar & H2O & pt perked up; pt taken to ER;
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Severe, Additional Details: pt passed out in observation chair bp was low 11:47a 101/56 pilse 48, 11:52a 98/59 pulse 74, pt was put on back with feet elevated bp was unstable and continued to stay low even while on back, called emergency at 12:05pm arrived at 12:15pm and parmedics took patient outside to monitor
Swelling, warmth, induration, itchy. All about 2" lower than where the injection was given.
HCP stated they have seen other similar cases after the vaccines; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (HCP stated they have seen other similar cases after the vaccines) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (HCP stated they have seen other similar cases after the vaccines). At the time of the report, VACCINATION COMPLICATION (HCP stated they have seen other similar cases after the vaccines) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were reported.
She got her vaccine, about 6:00 PM she was hot and she felt like she had been hit by a truck.  She kept getting hotter, her arm hurt but not horribly.  She was so hot that she realized that she had a fever, it got to 105 throughout the night.  Her arms and legs were paralyzed and her jaw, she could not talk as it was jaw.  Her teeth mashed down to far that she could not open her mouth.  The fever was unbearable as well as her arms and legs until they became paralyzed and she could not walk or get to the bathroom.  By the next morning it seemed that the paralysis was gone, but the fever was still there, not as high, not as dizzy and she could talk and could move her jaws.  She felt like she had been hurt in a car accident as she was hurting everywhere.  By the next day on Saturday 10/14/23  everything was about over.  She thought was going to die.  She cannot take aspirin or any of those products as she has only one kidney and could not take anything for her fever.  She was not able to get dressed or get out of the house due to the paralysis.  She was not able to eat or drink anything at this time as she could not unclench her draw, possibly like lock-jaw.    She talked to the pharmacist and explained to her what happened, and she gave her our phone # to call and report it.    She is feeling better, she is still tired and has CHF, and does not know if that's any reaction.
rash  on injection site; redness at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a female 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 injection site rash and injection site erythema. On an unknown date, the outcome of the injection site rash and injection site erythema were unknown.   It was unknown if the reporter considered the injection site rash and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced rash and redness on injection site  The patient was not received second dose because after the first dose experienced rash and redness on injection site which led to   The reporter consented to follow up.
Patient was administered vaccine on right arm on 2-5-19. The following day, Mom called the office stating swollen and red arm. Patient was told to come in, and was seen by Dr. Dr. prescribed ATARAX and prednisone.
Pain started in (L) shoulder on 3-29-18, went into (L) neck for 4 days, very stiff neck. 4-7-18 had all over body aches and weakness, (L) side facial droop and dysphagia and dysarthria. Acyclovir, SOLU-MEDROL given, 4-12-18. (L) sided weakness in arm and legs and trouble breathing. Was in ICU for 4 days receiving plasmapheresis treatments x  5, SOLU-MEDROL. Inflammatory polyneuropathy. Discharge from hospital.
she began having diarrhea and still has diarrhea to this day.; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (she began having diarrhea and still has diarrhea to this day.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included OXYCODONE for an unknown indication.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced DIARRHOEA (she began having diarrhea and still has diarrhea to this day.). At the time of the report, DIARRHOEA (she began having diarrhea and still has diarrhea to this day.) had not resolved.            Treatment medication include over the counter anti-diarrhea pills.  Action taken with mRNA-1273 in response to event was not applicable.
The patient developed a rash on abdomen and behind knees. This was not seen by physician. It resolved in a few days. On 5/21/2009 The patient received another immunization (Prevnar) and had another episode of rash that according to mother was the same. This was seen be me, and was noted to be rough red plaques in popliteal fossae and on abdomen. No urticaria or target lesions. This rash also resolved after a few days. He had it again when he received his next Prevnar, 11/11/09. He has had allergy testing which was negative. He has also had some episodes of eczema without vaccine trigger. The allergist suggested that it was possible that aluminum adjuvant might have triggered the eczema-like rash, but did not consider this to be a contraindication for further immunizations. I am submitting this report at parents' request.
Information has been received from a Healthcare worker referring to a patient of unknown age and gender. Patient's concurrent conditions, concomitant medication and medical history were not provided. On 12-JAN-2015 the patient was vaccinated with a dose of improperly stored VAQTA injection 25/0.5 (0.5 ml, lot3 was not provided) intramuscularly. No adverse events were reported after improperly stored VAQTA was administered. Additional information has been requested.
4 days after receiving Covid shot  in left arm, shingles appeared on right scapula area, 3 days later shingles appeared on right upper lateral arm form shoulder to forearm
Patient developed a supraclavicular nodule in lymph node 7 days post vaccination (same side as vaccination).  Oncologist ordered a CT scan and biopsy.  Biopsy and lymph node removal completed on day 8 post-vaccination was normal (non-cancerous).
This report is only in response to the request from the agency to submit all patients into VAERS that received the COVID19 vaccine and subsequently tested positive for COVID19.  No other adverse reactions to the vaccine were reported. The patient reported a COVID19 positive test on 12/23/20.
Information has been received from a nurse concerning a 16 year old female student, with asthma and an allergy to cefaclor (Ceclor), per her parents she had hypoglycemia with dizziness and syncope, a recent history of lightheadedness in school, who on 30-OCT-2006 was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Zyrtec, Singulair and hormonal contraceptives (unspecified). On 21-DEC-2006, the second vaccination with Gardasil was administered. The patient had no adverse event with the first or second vaccination. On 26-APR-2007, late PM, the patient's vitals were taken (results not reported) and then she was vaccinated IM into the deltoid with a third dose of GARDASIL (lot # 657006/0188U). Concomitant therapy included ZYRTEC, SINGULAIR and hormonal contraceptives (unspecified) Ten minutes later, the patient fainted in the waiting room. Her blood pressure was 90/50. She had not eaten that afternoon before the vaccination. Subsequently, the patient recovered. Additional information has been requested.  Additional information is not expected.
rosacea rash; This is a spontaneous report from a contactable consumer. This pharmacist reported for a 13-year-old female consumer(patient).   A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1ST dose, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On an unspecified date, the reporter stated that the patient received the first dose of the Pfizer COVID-19 vaccine 3 weeks ago and 3 days later developed rosacea rash that she still has, and HCP recommended that the patient does not get the 2nd dose by HCP. HCP was asking how effective was the first dose. A total of 514 took part in the study (age 19 to 77 years). The first dose of the vaccine was immunogenic in 92% of the participants 21 days after administration. The IgG levels elicited by the vaccination in individuals with previous evidence of COVID-19 infection were at least one order of magnitude higher than those with no evidence of previous infection. Outcome of the event was reported as unknown.   Follow-up attempts are needed. Further information is expected.
Pt recv vax on 3/23/99; on same day pt exp red swelling at vax site-lt leg
her arms are hurting; my area my arm I am still experiencing a lot of pain and lot of swelling; I am still very very lethargic and dragging around; no energy; her arms are swelled up; it was painful; she had fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 (Lot number: ER2613) as dose 1, single and administered in arm right, administration date 21Apr2021 (Lot number: EN6204) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious), outcome "unknown", described as "her arms are hurting"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "my area my arm I am still experiencing a lot of pain and lot of swelling"; LETHARGY (non-serious), outcome "unknown", described as "I am still very very lethargic and dragging around"; ASTHENIA (non-serious), outcome "unknown", described as "no energy"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "her arms are swelled up"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "it was painful"; FATIGUE (non-serious), outcome "unknown", described as "she had fatigue".  Additional information: The patient arms are hurting and still swelling after receiving the 2nd dose of Covid vaccine on 21Apr2021. Also experienced the same problem after receiving the 1st shot on 31Mar2021. She mentioned that on the 1st dose her arms swelled up about 4 inches in round and the whole area was swelling and it was painful, she had fatigue and she dragged herself around 2 to 4 days saying she had no energy. 5 to 7 days later, she figured out it was the side effect of the vaccine and it happened the same thing with the 2nd shot.  No follow-up attempts are possible. No further information is expected.