chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fibromyalgia; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4505151-00.  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jul2022, outcome "recovered" (31Jul2022) and all described as "COVID-19"; FIBROMYALGIA (non-serious), outcome "recovering". The action taken for upadacitinib was unknown. Clinical information: The patient had fibromyalgia and she was experiencing muscles pains. From 22Jul2022 to 31Jul2022, she had covid and went back to normal, covid amplified all the regular symptoms she had and also had a cough. It was unknown if she was enrolled in a Covid-19 Vaccine Trial. The reporter's causality for Rinvoq (Upadacitinib) for the event(s) of Fibromyalgia and Covid was not provided. The reporter's causality for Pfizer Biontech Covid-19 Vaccine (Tozinameran)  for the event(s) of Fibromyalgia and Covid was reported as Possible..  The reporter considered "covid-19" and "fibromyalgia" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid-19 ,Drug ineffective and fibromyalgia.
Severe headache, chills, nausea, lack of energy, no appetite, light headed
R thigh-11x9cm area of erythema, swelling and tenderness with 3 days of fever.
Swelling, redness, hardness, soreness 2 hours after vaccine. Lasted 2 days after vaccine then my arm went back to normal. 8 days after receiving vaccine, swelling, redness, big red oval almost 5 inches in length sideways, upper arm is very hard and injection site is very warm (102 degrees).  This is worse than it was right after I received the vaccine. Took 400mg of Advil today and it didn?t seem to do much.
Fever 103.0 F, Chills, Muscle Pain, Headache, Night Sweats, Dizziness/near-syncope, tachycardia (120's bpm), nausea, severe fatigue, severe soreness at injection site (but mild swelling, mild itching). Starting from 3:30 am on 02/21/21 until about 3 pm on 02/22/21. Milder headache and fatigue throughout rest of that week.  Back to normal now.
The morning of Sept. 20th pt was lethargic and burning up. I rushed him to the ER were he had a fever of 105.4. Once he was stable they transferred him by ambulance to Medical Center. There he was officially diagnosed with the rhinovirus and the adenovirus. I have discovered through his medical records, he possibly may have had RSV, which we were not made aware of. While in the hospital they did an ultrasound of his kidneys and checked his uric acid levels again, now they were at a 14.9. He was released on the 21st of September, and referred to a nephrologist. On the morning of the 27th, pt was in one of his spasms which were frequent with LNS, my husband was doing routine positioning taught by pt's physical therapist to us, to help him out of his fits. At this point, pt gasped and went limp. My husband ran into my room and we called 911. It took them 48 minutes to get pt heartbeat back, and by this point pt was brain dead. He was officially declared brain death at 1313 on September 29th. Almost instantly after arriving to the hospital, they started to accuse my husband of shaking our son. We know his is not true and believe this was cause from the brain injury due to lack of oxygen and vaccine injury.
paresthesias left face, left arm, tongue. Reoccurred with second vaccine on 01/30/2021 and has not resolved.
Pt recvd vax 7NOV91 & approx 1030 7NOV, pt felt lightheaded, nauseous, SOB; pt collapsed w/o LOC, & ambulance was called; pt was bradycardic (pulse 20's) atropine & epi given en route to ER; In ER had resp distress;
Returned to office approx. 2 hours after vaccine was given with  Urticarial rash on neck and periorbital edema. Benadryl 25 mg given by mouth. Rash and edema resolved within 20 minutes of taking medication.
Shingles- 14 days after second vaccine; Dead arm; Back pain; Fever; Chills; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Apr2021 at 17:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 17:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. On 27Apr2021, the patient experienced dead arm, back pain, fever, chills and nausea. On 10May2021, 14 days after second vaccine, the patient experienced shingles. The adverse events resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The patient received valacyclovir hydrochloride (VALTREX) as treatment for the reported events. The clinical outcome of the events dead arm, back pain, fever, chills, nausea and shingles was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
01/06/2021 developed a rash, redness, itching and is warm to touch at the injection site.
About one month after receiving the varicella vaccine, the pt developed a rash (non vesicular) at the site of the injection and spreading up to shoulder also a dime-sized patch on base of thumb. Rash does itch some.
woke up morning p/vax w/throbbing rt arm; felt like had flu, sx of extreme fatigue; temp afebrile; alternating chills & hot flashes; stomach cramps (thinks from oral erythromycin);
Unilateral angioedema of the left lip, lasting several hours. Over the course of the next 5 months I have had a total of 10 separate events, with the location changing, ie.,  upper lip, lower lip, left side or right side. The swelling  will last anywhere between 4- 18 hours. No lip swelling or throat tightening
Fever of over 103 lasting over 24 hours, nausea, chills, pain and redness at injection site, fatigue, muscle pain.
7/25/21: presents to the hospital via EMS by himself due to worsening flu-like symptoms since last visit on 7/22/2021. PHx intellectual disability. Patient does not answer any questions, but is alert and aware to his name. Patient is from a Group home and goes to a Center for Day Care. Due to very minimal history able to be obtained from patient, contacted (supervisor of the group home), who provided background history and HPI. She explains that patient had began to not act himself this past Thursday when he had come to the ED (7/22/21), subsequently testing positive for COVID.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender (no demographic details were provided). The patient medical history was unknown. On 04-JUN-2013 the patient was vaccinated with VARIVAX (Merck), lot number 0831AA. The medical assistant reported the administered dose of VARIVAX (Merck) was expired; the expiration date of the vaccine was reported to be 02-JUN-2013. No adverse event was reported. Additional information has been requested.
Narrative:  61 yo male h/o HIV+, h/o severe polysubstance use disorders in remission, colostomy creation February 2020 and take down October 2020. Patient had support from and much success with MH and substance abuse treatment program until February 2021.Patient had 2nd dose of Pfizer COVID-19 Vaccine on 29 March 2021. He had an Outpatient colorectal surgery appt in clinic on 31 March 2021. Chart says that he passed on 31 March 2021, the same day as that last appt. No pertinent information about the circumstances/cause of the death, but medical examiner was involved.
expired dose of DAPTACEL was administered to a patient with no reported adverse event; Initial information received on 27-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of unknown age and gender who was administered expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Jun-2023 the patient was administered expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot C5893AA; expiry date: 21-Jun-2023) with no reported adverse event (expired product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Case number PHEH2012US004170 is an initial spontaneous report received from nurse on 16 Feb 2012 with a follow up received on 07 Mar 2012. This report refers to 11 years old male patient with a follow up received on 12 Mar 2012. The patient was vaccinated with MENVEO (batch number: 114030AA) intramuscularly on to right deltoid on 15 Feb 2012. The nurse stated that the patient received less than 0.5 ml of MENVEO. During administration, the patient squirmed and only part of the vaccine entered into patient's arm. The patient received a redoes on 06 Mar 2012. In the follow up information it was reported that no adverse events were noted following administration error. Follow up received on 07 Mar 2012: Updated revaccination status of patient. Event recoded to vaccine underdose. Follow up received on 12 Mar 2012: Batch no and site of administration of vaccine updated, patient demographics updated, event recoded to drug administration error as the patient received a redose of MENVEO.
fever; body aches; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via unspecified route of administration, on 15Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included stress, cold sores, and birth control. Concomitant medications included valaciclovir hydrochloride (VALTREX) from 2009 and ongoing for cold sores, fluticasone propionate (FLONASE), and ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20) from 2006 and ongoing for birth control. The patient received the vaccine through work. The first time she got it, she had a fever on 16Dec2020 that lasted in 24 hours (until 17Dec2020). She also had body aches that lasted for 48 hours. Those were from the 16th to 18Dec2020. She received the first dose on the 15Dec2020. Then, the morning of the 16Dec2020, she noticed body aches. She didn't get a fever until later that afternoon. She got the vaccine because she works in a nursing home. She is an essential worker who is at high risk. The patient recovered from the fever on 17Dec2020 and recovered from body aches on 18Dec2020.
HIVES ON SKIN; This spontaneous report received from a patient concerned a female of unspecified age. 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the subject experienced hives on skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives on skin was not reported. This report was non-serious.
Vertigo that came on between 30-60 minutes post-injection and lasted for approximately 30 hours.
FEVER; chills; aches and pain all over; Tiredness; received second dose on 16Jan2021, first dose on 31Dec2020; This is a spontaneous report received from a non-contactable other healthcare professional. A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular in the right arm, on 16Jan2021 08:30, at single dose, for COVID-19 immunization. The patient has known allergies to latex, bananas and adhesive. The patient was not pregnant at the time of vaccination. There were no concomitant medications (no other medications in two weeks). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular in the right arm, on 31Dec2020 10:30, for COVID-19 immunization. The patient did not have other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient experienced fever, chills, aches and pain all over and tiredness on 16Jan2021 22:15. Treatment for the events was not given. The outcome of the events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cannot walk; Dizzy; Feeling off balance; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3246), via an unspecified route of administration in left arm, on 19Jan2021 (Tuesday), at a single dose, for COVID-19 immunization; and pregabalin (Unknown manufacturer), via an unspecified route of administration, on 22Jan2021, at 75 mg, twice daily, for an unspecified indication. The patient had no medical history and concomitant medications. The patient took her first dose of the BNT162B2 vaccine last Tuesday, 19Jan2021 (a week before the reporting). The patient felt fine as of Wednesday and Thursday (20Jan2021 and 21Jan2021) but started to feel dizzy and off balance on Friday (22Jan2021). The patient did start taking the generic medication, pregabalin on Friday (22Jan2021), took one pill that morning, then got extremely dizzy, has not taken any more since, still just feeling off balance. The patient was prescribed pregabalin twice a day but only took 1 pill, it is a new prescription. Medication (pregabalin) was started on the same day as the event but prior to onset of event. The patient had been dizzy ever since, it really feels more like she is just off balance. The patient can function, just an off-balance feeling. The patient read on the information sheet for BNT162B2 that dizziness could occur in the first 15 minutes. The patient was asking and wondering if this is a delayed reaction to the vaccine. This is why she thinks it could be a delayed reaction to the vaccine because she only took one pregabalin pill and it should be out of her system by now. The patient was just going back to the effect today (25Jan2021), the patient was not dizzy (as reported but also reported as not recovered), but she cannot walk, and she was little off balance. The patient was just wondering if that could be a side effect and if there was anything to be worried of. The action taken in response to the events for BNT162B2 was not applicable; and for pregabalin was temporarily withdrawn on 22Jan2021. The patient had not recovered from the events.  Pfizer is a marketing authorization holder of pregabalin in the country of incidence. This may be a duplicate report if another marketing authorization holder of pregabalin has submitted the same report to the regulatory authorities.
After the injection, went home. Laid down, woke up about, couldn't walk. The next day couldn't walk without holding on to things. Had headache, body aches, nerve pains. Everything from the belt upwards hurts. Today he can walk better but still has to hold on to things.
Fever. Left arm weakness and tingling. Injection site pain. Fatigue. Muscle aches. Headache.
Developed dizziness and nausea within 90minutes of vaccine; then developed tingling, and flushing of my skin. Then rapid heart rate and chest tightness by 2.5hrs post vaccine. I went to urgent Care and they thought it was an allergic reaction (BP 182/90, HR 82) and gave me 125mg solumedrol and Benadryl intramuscularly which caused worsened dizziness and a racing heart which caused me to collapse and they gave me a epi pen and called 911. I was transferred to ER and they completed EKG which was normal and monitored vitals for a few hours and I was released. I continue to remain extremely dizzy and nauseated 2days after the vaccine.
2/19/2023 Went to bed with headache, woke with fever peaking 102.  At Home COVID-19 test, positive.  Televisit with Doctor, who proscribed Paxlovid.  Periodically needed to use albuterol inhaler.  Symptoms cleared up, but had rebound on 22nd starting with nasal congestion and that lingers to time of reporting.
Lightheadedness - in a fog while walking around, muscle cramps throughout the body, and two rounds of having a fever. Temperature unknown
Received vaccine on the 14th, on the 17th, the redness began, and this morning, pt noticed a red ring around the redness.  C/o itching and pain at site.
Very bad pain in left shoulder. Could only move arm so far. Before pain ret. went to the doctor give me something pain. Tried to do exercise. Might have to have physical therapy.
mild headache,  ringing in ears (first day only) nausea, diarrhea, and mild vomiting ,
This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 83-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (experienced mild shingles 5 years before the date of reporting). On 14th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, 2 days after receiving SHINGRIX, the patient experienced allergic reaction and erythematous rash. On an unknown date, the outcome of the allergic reaction and erythematous rash were not recovered/not resolved. It was unknown if the reporter considered the allergic reaction and erythematous rash to be related to SHINGRIX. Additional details were received as follows: This case was reported by the patient's daughter. The patient received the SHINGRIX vaccine on the left arm. The reporter stated that initially the patient thought that she had Shingles. However, after physician visit, the physician told that she had an allergic reaction to the SHINGRIX. The patient had red lines on her skin that came and went. The red lines are located on her left armpit, on her right shoulder, the upper right arm, and half way down her back. The reporter stated that when the lines first appeared, the patient had them all over her abdomen as well. The lines on her abdomen have gone away. However, the red lines in the other locations continue to come and go. The physician's contact details were provided.
Achy all over; achy all over and joints; Very tired / felt tired, had to lay down; chills; headaches; Flushed; irritated; felt like dead weight / felt like an orgasm; 3 hours after short and through the night I urinated every 20 minutes; vaginal twitches, pulses, felt like an orgasm; sore arm / pain in left arm; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (Flushed), IRRITABILITY (irritated), FEELING ABNORMAL (felt like dead weight / felt like an orgasm), POLLAKIURIA (3 hours after short and through the night I urinated every 20 minutes) and MUSCLE TWITCHING (vaginal twitches, pulses, felt like an orgasm) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F221B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient had no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Penicillin allergy (Penicillin).    On 25-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Oct-2022, the patient experienced FLUSHING (Flushed), IRRITABILITY (irritated), FEELING ABNORMAL (felt like dead weight / felt like an orgasm), POLLAKIURIA (3 hours after short and through the night I urinated every 20 minutes), MUSCLE TWITCHING (vaginal twitches, pulses, felt like an orgasm), PAIN IN EXTREMITY (sore arm / pain in left arm), FATIGUE (Very tired / felt tired, had to lay down), CHILLS (chills) and HEADACHE (headaches). On 26-Oct-2022, the patient experienced PAIN (Achy all over) and ARTHRALGIA (achy all over and joints). At the time of the report, FLUSHING (Flushed), IRRITABILITY (irritated), FEELING ABNORMAL (felt like dead weight / felt like an orgasm), POLLAKIURIA (3 hours after short and through the night I urinated every 20 minutes), MUSCLE TWITCHING (vaginal twitches, pulses, felt like an orgasm), PAIN IN EXTREMITY (sore arm / pain in left arm), PAIN (Achy all over), FATIGUE (Very tired / felt tired, had to lay down), CHILLS (chills), HEADACHE (headaches) and ARTHRALGIA (achy all over and joints) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-1 test: (Positive) Positive.         No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-665347 (Patient Link).
Gave vaccines to pt while she was lying flat on the exam table.  Approximately 30 seconds later, she passed out and had several jerky upper body movements.  She then regained conciousness after about 30 seconds and was pale and slightly clammy.  Pulse and B/P were normal.
patient, who is pregnant, with no AE; Initial information regarding an unsolicited valid non-serious case received from a pharmacist on 21-Dec-2020.  This case involves a 27 years old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE in context of patient, who is pregnant, (exposure during pregnancy). Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was not reported. The estimated due date was not reported. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  On 18-Dec-2020, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7081NA) via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date, (unknown latency) after initiation of INFLUENZA QUADRIVAL A-B VACCINE, the patient was pregnant (exposure during pregnancy).  At the time of report, no adverse event was reported.  There will be no information available on the batch number for this case.