chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Return of Covid symptoms; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Return of Covid symptoms) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Thyroid cancer and Kidney cancer.    On 08-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Nov-2022, the patient experienced COVID-19 (Return of Covid symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 03-Nov-2022 to 08-Nov-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Return of Covid symptoms) had not resolved.            Patient previously received a COVID-19 Vaccine. Patient took other medications/products within 2 weeks of starting COVID-19 treatment. Symptoms of COVID-19 reported as runny nose, coughing, headache, body aches, extreme fatigue and breathing difficultly. Hospitalization prolonged reported as no. Treatment received reported as no except using nebulizer for event breathing difficultly. Device date given as 18Nov2022.
Pt recvd vax 26OCT89 & exp staring & not moving much-tonic clonic movements, twitch, eyes rolled back in head, jerking motions, foaming @ mouth, blue/white; t104, vomit, sz, skin mottled, posturing movements, lethargic, diarrhea, viral,
my right hand, index finger is in pain. when I bend my finger my knuckle area is in pain.  now my right hand is swollen in index finger area. and pain in my right arm
injection of FLUZONE QUADRIVALENT was given to a 1 month old/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other-health care professional via agency (Reference number- 00455292) and transmitted to Sanofi on 01-Feb-2021.  This case involves a 1-month-old male patient who received 0.5 mL first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (injection, batch number: UT7081LA and expiry date: 30-Jun-2021 via an unknown route in left thigh) on 01-Feb-2021 (product administered to patient of inappropriate age) for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day).  Reporter want to know what to do now, and what they should look out for as well as information they need to give to the family. The caller wanted to talk to a doctor about recommendations. The product was used for first time.  No other vaccines or medications were given when FLUZONE QUADRIVALENT administered.  At the time of reporting, no adverse event was reported.  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 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.
@ 5:00pm on 103106, Patient noticed L arm painful upon movement, no swelling or redness, began to chill but did not take temp. arm so painful patient took a Lortab, and went to bed at 9:00pm. Slept well. This AM arm still sore upon movement and is slightly warm to touch. Still no redness or swelling. Patient took another Lortab this AM. Feels no need to see DR.
Migraine, nausea, vomiting, body aches, weakness, arm pain, redness at injection site
headache; intestinal burning; restlessness; rash; fever; the feeling of sunburnt skin; the feeling of sunburnt skin; Chills; loss of sleep; Restless legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Aug2021 15:00 (Lot number: FC3180) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot number: EW0196, Depression onset date: 22Jul2021., Recovered), administration date: 20Jul2021, for Covid-19 Immunization, reaction(s): "Depression", "Anxiety", "Dispair". The following information was reported: RESTLESS LEGS SYNDROME (non-serious) with onset 10Aug2021, outcome "recovered", described as "Restless legs"; SKIN DISCOMFORT (non-serious), SUNBURN (non-serious) all with onset 11Aug2021, outcome "recovered" and all described as "the feeling of sunburnt skin"; RASH (non-serious) with onset 12Aug2021, outcome "recovered", described as "rash"; PYREXIA (non-serious) with onset 11Aug2021, outcome "recovered", described as "fever"; HEADACHE (non-serious) with onset 15Aug2021, outcome "recovered", described as "headache"; CHILLS (non-serious) with onset 11Aug2021, outcome "recovered", described as "Chills"; INSOMNIA (non-serious) with onset 10Aug2021, outcome "recovered", described as "loss of sleep"; GASTROINTESTINAL DISORDER (non-serious) with onset 12Aug2021, outcome "recovered", described as "intestinal burning"; RESTLESSNESS (non-serious) with onset 12Aug2021, outcome "recovered", described as "restlessness". The events "restless legs", "the feeling of sunburnt skin", "the feeling of sunburnt skin", "rash", "fever" and "headache" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of restless legs syndrome, sunburn, rash, pyrexia, headache, chills, insomnia, gastrointestinal disorder, restlessness.  Additional Information: The patient not pregnant. The patient was not other vaccine in four weeks. The patient had not covid tested post vaccination. No known allergies reported. vaccination facility type: Pharmacy or Drug store.  No follow-up attempts are possible. No further information is expected.
Patient received vaccines and then fainted, turned very pale , vomited in one occasion, felt very hot to the touch.
36 after receiving seasonal flu shot and H1N1 at our clinic - client c/o achiness; chills, sore throat - punky feeling today Tuesday 4 days later feeling much better - some fatigue left - no thermometer -states this happened 10 years ago after receiving flu shot so hasn't had one since.
My body is itchy and turns red started the first day on my feet and ankles, after taking benadryl and sleeping it disappeared. Next day same thing but it was my arms and legs. Looked like hives had to take benadryl the next day the rash disappeared. But I still feel itchy everywhere but as long as its not being scratched no rash seems to appear.
Tightness in throat approx 30minutes after vaccine was administered (approx 10AM). At 4:00pm, patient felt faint and began shaking. At approx 4:30pm patient was seen by the attending physician. At 5pm, symptoms progressed into severe shaking (tremors), chills, nausea, and a fever of 101.6. Patient continued to have these symptoms until approx 11:30pm 11/09/09. Patient reported feeling "normal" the next morning.
At 11:30 am on 6/21/2000 pt called this nurse and informed her of reddened, quarter size are on right arm next to vaccinaton area. Pt stated she noticed it on 6/20/2000 at 7:30 am. Pt advised to apply ice pack, exercise arm and take Tylenol.
Continuous muscle pain at 30 days; This case was reported by a consumer and described the occurrence of muscle pain in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 2459T, expiry date unknown) for muscle pain.   On 14th December 2022, the patient received Shingrix. On 14th December 2022, less than a day after receiving Shingrix, the patient experienced muscle pain. In January 2023, the outcome of the muscle pain was recovered/resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-JAN-2023 Reporter's comments: This report was submitted via reporting system.  This report was submitted by site.  The patient had stated that, he had continuous muscle pain for 30 days after injection.  The symptoms were not treated. The reporter consented to follow-up.
SWELLING IN JOINTS OF HANDS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On an unspecified date, the subject experienced swelling in joints of hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of swelling in joints of hands was not reported. This report was non-serious.
Case number PHEH2016US006847, is an initial spontaneous report received from a health care professional on 11 Mar 2016. The report refers to a patient of unknown age and gender. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 01 Feb 2016. It was reported that FLUVIRIN pre filled syringe were out of temperature range from 12.3 Celsius and the low was -3.4 Celsius, there were a few excursions noted on the temperature log and was unsure the exact number and total time. Registered nurse stated that, there might be one patient who received the vaccine after one of the excursions. No adverse event was reported following this medication error.
Received Rabies #3, arm sore that evening (Feb 1 2017) fine next week. Wisdom teeth removed 2-10-17 and on pain med. Started pain medication after the next week about 2-17-17. Noticed pain and decreased movement. Went to MD 3-1-17. Told ligament and muscle damaged and started PT 3-6-17. MD thinks shot too high. Pt concerned.
Extremely dizzy; Face got very very hot; Couldn't breathe; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Extremely dizzy), FEELING HOT (Face got very very hot) and DYSPNOEA (Couldn't breathe) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 (First dose (lot EN6202)) on 07-Mar-2021 and Pfizer COVID-19 (Second dose (lot EN6208)) on 28-Mar-2021.    On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Oct-2021, the patient experienced DIZZINESS (Extremely dizzy), FEELING HOT (Face got very very hot) and DYSPNOEA (Couldn't breathe). On 31-Oct-2021, DIZZINESS (Extremely dizzy), FEELING HOT (Face got very very hot) and DYSPNOEA (Couldn't breathe) had resolved.            Concomitant product use was not provided by the reporter. No Treatment information was provided.
No ADEs- patient was given incorrect influenza vaccine based on age (high-dose fluzone administered in a 63 year-old)
contracted COVID; contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) 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 "contracted COVID".  Clinical course: Patient was fully vaccinated with your COVID vaccine. Patient was fortunate to be a very good health. Unfortunately, Patient still contracted COVID and had flu-like symptoms for a week and patient still have a dry, hacking cough over two weeks later. Patient was told had the Omicron variant. Patient was told by patient county's epidemiologist that there was significant spread this summer in where patient reside.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swollen axillary left lymph nodes developed  3 days after booster. Itchy, painful, rash developed 18 days after booster under left arm. Never had before.  No other symptoms.  I am a physician.
Myalgia, Arthralgia, Fever, SkinRash, injection site pain, bandage adhesive rash/vesicles Narrative:
No diluent used. Patient received the full concentration of 0.2mls without any diluent. No adverse reactions noted. Patient was in clinic upon realizing with happened. Patient and father notified of medication error and to monitor for any adverse reactions. Left clinic with no adverse reactions.
FEELS BAD; Initial information received on 03-MAR-2021 was processed with additional information received on 09-MAR-2021. The case was reassessed as serious based upon new information received on 09-MAR-2021. This spontaneous case was received from a patient and concerned a 76 year old female. The patient's weight was reported as 90 kilograms, and height was not reported. The patient's concurrent conditions included pulmonary arterial hypertension. The patient received treatment with COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported; the Company is unable to perform follow-up to request batch/lot numbers), dose was not reported for prophylactic vaccination on 02-MAR-2021. The concomitant medications included macitentan and apixaban.  On 03-MAR-2021, the patient reported feeling bad after taking the COVID shot and was considering going to the hospital. On an unspecified date in MAR-2021, the patient was hospitalized. No details were provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feels bad was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20210108619.; Sender's Comments: V0 A 76-year-old female patient reported feeling bad next day after receiving Janssen COVID-19 Vaccine Ad26.COV2.S (suspension for injection, route of administration not reported) for prophylactic vaccination. The patient's concurrent conditions included pulmonary arterial hypertension. concomitant medications, and details of the event were not reported. On an unspecified date the patient was hospitalized. This case has insufficient information to make a meaningful medical assessment.
Injection site bruise; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 19Mar2021 at 09:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and dysthymia. Concomitant medications included PROZAC, levothyroxine (MANUFACTURER UNKNOWN); both for unspecified indication from unknown dates. The patient did not have any allergies to food, medications, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient did not test for COVID-19. On 19Mar2021 at 17:00, the patient experienced injection site bruise and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the event vaccination site bruising and fatigue was resolved on unknown date of Mar2021.  No follow-up attempts are needed. No further information is expected.
Patient is not the appropriate age for the Janssen COVID vaccine at time of vaccination. She is currently 16 years old. No adverse reaction in the 15 minutes after administration. Pharmacist administering vaccine realized patient was underage when filling out vaccine card after administration.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and advised that this vaccine maintained activity necessary to protect against covid 19 on date vaccine was administered. Also patient did not call in to complain of adverse event.  This is administrative error without adverse event.
Within 2 weeks of my first injection I became experiencing diffuse muscle and joint pain through my shoulders, back, and leg.  The pain during the first several weeks was so extreme that I was unable to sleep.  I then began experiencing tinnitus.  Since that time the tinnitus has persisted and I have severe low back and hip pain.  All X-rays from an orthopedic consult have shown mild arthritic changes.  I had MRI?s of the hip and lumbar spine 3 days ago and am awaiting the results.  My activities have been significantly limited due to pain any the tinnitus has gotten worse.  A week of prednisone therapy provided temporary relief of the tinnitus and some relief of hip pain.  Both symptoms quickly returned within a day of prednisone being discontinued.  Although I have a history of mild hearing loss, I have never had tinnitus before and the low back pain, sciatica, and hip pain were non existent prior to the first dose of the Moderna vaccine.  I did have the second dose on April 6, but noticed no changes after that dose.
Warm, red, oval that is slightly raised 4cm high and 5.5 cm wide.  Mildly itchy, but not bad.
Post vax, the LPN reported that on 12/11/2000 the patient presented with varicella, fever and blisters. Unspecified medical attention was sought. In follow up, the LPN nurse reported that on 12/11/2000 the patient developed a fever of 102F, congestion and lesions on his head, face and torso. The patient's outcome was unknown. Additional information is not available.
pneumonia; Upper respiratory infection; This spontaneous report was received from a consumer refers to a 32 year-old-female patient. The patient's current conditions, medical history, drug reactions/allergies, concomitant therapy were none. On an unknown date in1988 when the patient was 15-18 months old, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (1 dosage form (one shot), intramuscular in thigh, strength and lot number with expiration date was not reported) for routine immunisation. On an unknown date in 1988, within few days after receiving vaccine, the patient experienced upper respiratory tract infection. The patient sought medical attention and went back to doctor for respiratory infection. The patient was treated for the same. A week later ,the patient ended up in the emergency room for pneumonia. The patient had the one bout of pneumonia. The patient was treated for the events. It was unknown whether the patient underwent any lab diagnostics/studies. Product quality issue was not involved. The outcome of upper respiratory tract infection and pneumonia was reported as recovered. The reporter's causality assessment was not provided.  Upon internal review, the event of pneumonia was determined as medically significant.
Information has been received from a physician concerning a 71 year old female with hypertension 7/28/1999, hyperlipidaemia06/26/2001 and pneumoconiosis  1989 who on 1/7/2005 at approximately 11:00am, was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. Concomitant therapy included benidipine hydrochloride (Coniel), pravastatin NA (mevalotin), vitamin E nicotinate (juvela N) and Clotiazepam (Rize). 11/7/2005, in the evening, the patient developed injection site swelling, warmth and redness with dull pain. on 11/08/2005 (previously reported as 11/7/2005) the patient developed general malaise.  On 11/10/2005 the injection site swelling, warmth, redness and dull pain and malaise were relieved. On that same day, the patient developed itching. On 11/18/2005, the patient recovered from the itching. The reporter felt that the injection site swelling, injection site warmth, injection site redness, dull pain and malaise were considered to be other important medical events (OMIC). he reporter felt that the injection site swelling, injection site warmth, injection site redness, dull pain and malaise were related to therapy with pneumococcal 23v polysaccharide vaccine. Additional information has been requested. Other business partner numbers include E200600132.
ALWAYS FEEL HOT; CONSTANT ITCHING ALL OVER; BRAIN FOG DAILY; LOSS OF ENERGY; EXHAUSTED; INTENSE HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced always feel hot, constant itching all over, brain fog daily, loss of energy, exhausted, and intense headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the intense headache, loss of energy, exhausted, always feel hot, constant itching all over and brain fog daily was not reported. This report was non-serious.
pt reported a month p/vax has been sick w/diarrhea, nausea & h/a since inj;has not seen a MD;states there as few other @ office who were sick;encouraged pt to see MD;
On 5/2/11 pt was experiencing PMS. On 5/4/11 pt noticed 1 swollen lymph node on (R) groin. Tdap had been given in RUOQ - 5/2/11. Pt was seen by gyn 5/6/11. Menses started 5/7/11. Pt denied fever or rash, no symptoms.
covid-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (covid-19) 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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced COVID-19 (covid-19). At the time of the report, COVID-19 (covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
1st dose: 3/4/2021: a few days after ringing in both ears 2nd dose: 4/1/2021: a few days after ringing got much louder and is still present today.   Ringing in right ear more pronounced as well as occasional popping noise and the feeling of both ears being clogged or needing to be pressurized.   Second dose was Lot# EW0150