chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old patient received BNT162b2 (BNT162B2 NOS), on 14Sep2022 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hbp" (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. Clinical course: Other medication in 2 weeks: Unknown. Paxlovid, treatment start date: 03Jan2023, treatment stop date: 08Jan2023, indication: treatment of covid-19. Known allergies: None.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Body Ache, Head ache, Chills, Uncontrolled Bladder, Sore Red Eye
I could not sleep the night I had the vaccine.  The next morning after the vaccine I had chills, fatigue, body aches, a horrible headache, nausea, and stayed in bed all day feeling terrible.  I eventually took 2  acetaminophen  pills and felt better by the next day.
Received first COVID vaccine on 1/11/21. Pain in arm started three days post vaccine leading to arm swelling and now one week post vaccine armpit swelling in same are as vaccine given.
First symptoms were typical soreness in affected arm (left). The next day, she experienced stiffness and pain in the left arm and left hip. She stated that she was unable to extend her shoulder past a certain point. Hip pain was also painful to the extent where couldn't walk properly. Went to urgent care and the practitioner had found this was also an adverse effect previously reported by the vaccination. Patient had visited the pharmacy 6/24/19 and states that she is doing better and symptoms are resolving.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 65 year old female White and Not Hispanic/Latino. 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: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 09-MAR-2021, 1 in total administered on left arm for prophylactic vaccination. No concomitant medications were reported.  On 26-APR-2021, Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) Negative.  On an unspecified date, the patient experienced confirmed immunological vaccine failure, no antibodies present, no immunity and no protection against Covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210535317, 20210536064 and 20210536071.; Sender's Comments: V0: 20210534629-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
On 5/1/21 patient received Pfizer COVID vaccine after receiving Janssen COVID vaccine on 4/2/21.
Pt c/o tingling, swelling in right arm, distal edema noted (mild; no SOB, rash, or hives.  Benadryl 25 mg PO @1020; 1030 Edema improving, no other s/s.  Pt states B/P is normal for her.  Pt stayed 1 hour past injection.  Edema resolving.  Staqtes feeling much better.  Tingling resolved.  B/PP 100/60.
11/23/22 presents to ed for "chest pain" "COVID" "34 weeks pregnancy". PMHx of "graves' disease, anxiety disorder"
Increased severity of migraine following Pfizer shot #1. Dramatically increased severity of migraine pain and nausea following Pfizer shot #2 (beginning April 7). Severe migraine pain still persisting as of April 12. Usual medications are not managing pain adequately.
Vaccine was administered to 16 year old patient with no adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old (unknown gender) patient to whom influenza quadrivalent recombinant vaccine [Flublok] was administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administered with unknown dose of suspect influenza quadrivalent recombinant vaccine (lot QFAA2335 and Expiration Date: 30-June-2024; Dose, strength, formulation not reported) via unknown route in unknown administration site for Prophylactic vaccination to 16 year old patient with no adverse event (product administered to patient of inappropriate age) (latency on same day).  Action taken: not applicable.  Outcome : Unknown.   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.
SHINGLES; 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles was not reported. This report was non-serious.
Leg pain; Back pain; dizziness; warm; redness; pain at injection site right arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-May-2021 and was forwarded to Moderna on 05-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain), BACK PAIN (Back pain), DIZZINESS (dizziness), VACCINATION SITE WARMTH (warm) and VACCINATION SITE ERYTHEMA (redness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PAIN IN EXTREMITY (Leg pain), BACK PAIN (Back pain), DIZZINESS (dizziness), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (pain at injection site right arm). At the time of the report, DIZZINESS (dizziness), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (pain at injection site right arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
prominent lymph node in leftaxillary area, the same arm received vaccination.; This is a spontaneous report from a contactable other health care professional, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 23Feb2021, at 09:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included blepharitis and penicillin allergy. Concomitant medications included levonorgestrel (SKYLA), ciclosporin (RESTASIS), polyvinyl alcohol (REFRESH), OCCOSOFT PLUS, calcium carbonate/magnesium carbonate (TUMS) and calcium carbonate/magnesium hydroxide (MYLANTA); all for unknown indications from unknown dates and unknown if ongoing. 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. On 11Mar2021 at 10:30, the patient experienced prominent lymph node in left axillary area. It was reported that she had a breast magnetic resonance imaging (MRI) on 09Mar2021 as per regular check-up and her doctor (via a call on 11Mar2021) noted a prominent lymph node in her left axillary area, the same arm she received her vaccination. The doctor thought it might be vaccine related. She was advised to have a follow-up ultrasound/mammogram in about six weeks. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event prominent lymph node in left axillary area was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
Difficulty breathing; swelling; rash; dizzy; This is a spontaneous report from a contactable consumer (patient him/herself). A 30-years-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200) via an unspecified route of administration, administered in right arm on 14Feb2021 15:00 (age at vaccination: 30 years) as first dose, single dose for COVID-19 immunization. The patient medical history included epilepsy and diabetes. The patient received other unspecified vaccine in two weeks. There was patient known allergies. On 14Feb2021 16:00, the patient had difficulty breathing, swelling, rash and dizzy. The adverse events resulted in emergency room visit requiring treatment of IV with meds (unspecified). The patient did not receive any other vaccine in four weeks. The patient did not receive any prior covid vaccination nor was tested positive for covid post vaccination. The outcome of all the events was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Janssen COVID-19 Vaccine EUA  Events: 6 hours post injection: --general tiredness/exhaustion set in but with restlessness, not able to sleep --sweating begins --light headache set in  12 hours post injection: very rough night and morning --Elevated resting heart rate: 101 --Fever: 101.1 --Chills/shivers  --Heavy Sweats --Restless but very fatigued --Body aches, especially back. --Mental Confusion --Severe headache  36 hours post injection: --fever reduced to almost normal --headache persists but not as strong --body aches persist but not as strong --chills come and go --some mental fog persists but improved
Vaccine stored in refrigerator on 30-Jun-2022/Vaccine administered on 01-Aug-2022; No adverse event; Patient received vaccine last week beyond its use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 30-Jun-2022/Vaccine administered on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine last week beyond its use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 30-Jun-2022/Vaccine administered on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 30-Jun-2022/Vaccine administered on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine last week beyond its use by date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 30-Jun-2022/Vaccine administered on 01-Aug-2022).  No concomitant medications were reported. Number of doses or vials were unknown.  The vial was initially stored in the refrigerator on 30-Jun-2022.  The vial did not undergo any temperature excursions.  No treatment medications were reported.
This patient was supposed to receive the Pfizer-adult dose since they are 13 years old. Instead, they had received the pediatric dose by mistake. Patient did not report any symptoms or adverse effect.
Pt recv vax on 4/5/99; 8 hr post vax pt exp sneezing, fever, full body rash w/ flu-like sx, first 2 wk of life pt exp matted eyes, agitation, unconsolable
Moderna booster given to a 16 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster given to a 16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (2nd dose - 15May2021 lot number EW087) and Pfizer (1st dose - 24Apr2021 lot number EW0171). Past adverse reactions to the above products included No adverse reaction with Pfizer and Pfizer.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 22-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster given to a 16 year old). On 22-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster given to a 16 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Woke up Sunday, 10/29, in the morning with fever of 101.7 and vomited.  Felt achy.  Parent gave TYLENOL/ADVIL.
redness between the elbow and the shoulder; wheals between the elbow and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness between the elbow and the shoulder) and URTICARIA (wheals between the elbow and shoulder) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness between the elbow and the shoulder) and URTICARIA (wheals between the elbow and shoulder). At the time of the report, ERYTHEMA (redness between the elbow and the shoulder) and URTICARIA (wheals between the elbow and shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment history was not provided.
Hives and minor lip swelling 1/24/21 throughout the day. Took two Atarax after waking up. Took multiple Benadryl throughout the day. Did not help. Took 50mg Benadryl at bedtime along with Claritin. Woke up 1/25/21 with swelling of both lips and swelling in throat what felt like around tonsil and lymph area (have had tonsillectomy). Went to ER was given additional Benadryl  PO, IV Decadron and  IV Pepcid. Was discharged home with a prednisone taper prescription, Benadryl and Pepcid. My full biological sister also had minor hives after her second dose of Pfizer , but has never had an anaphylactic reaction in the past and her onset was within the first day after vaccination.
On Nov 13 both my husband and myself broke out in very itchy rash on our chest and spread to arms and legs.  Spoke with Dr., he suggested allergist.  Made apt. with Dr.   Tested showed husband was allergy to grass and dust mites only... we saw Dermatology,  prescription for topical relief.  It did not work and then he did a biopsy and it showed eczema.  Our question was how and why would we get  eczema exact same time.  We purged our home and anything that would start something like this... no relief.  I believe it was the covid booster from Nov 9. We got it at the same time.  We both still have the rash. And getting some relief with OTC creams....
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 at 14:15 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Apr2021 at 14:15 as dose 2, single (Batch/Lot number: unknown), in left arm, in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 09Jun2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholestorol" (unspecified if ongoing); "depression" (unspecified if ongoing); "Known allergy: Raw eggs" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, stop date: 16Sep2022; LEXAPRO. Past drug history included: Amoxycillin, reaction(s): "Known allergy: amoxycillin". The following information was reported: VACCINATION FAILURE (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: (unspecified date) Positive, notes: Return of symptoms and positive test; (unspecified date) Positive, notes: Treatment of COVID-19; (23Sep2022) Negative, notes: Tested negative on Friday; (27Sep2022) Positive, notes: Tested positive Tuesday morning, September 27. Therapeutic measures were taken as a result of vaccination failure, covid-19 including PAXLOVID given on 17Sep2022 to 21Sep2022.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Developed a dry cough after receiving the second Pfizer vaccine shot. The cough has persisted with varying frequency and intensity for 4 months.  The cough is not specific to a time such as morning or evening.  It lingers throughout the day.  The voice sounds hoarse and crackles with a feeling of something in the throat.  Constant feeling of needing to clear the throat. There was a three week period in June where the cough was accompanied by extreme fatigue.  Benzonatate was prescribed for the cough. Root cause has not been determined by DR.
a flare of her Rheumatoid Arthritis; This is a spontaneous report from a contactable consumer. A 38-year-old female patient received third dose of BNT162B2 (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient's medical history and medications were not reported. The patient experienced a flare of her rheumatoid arthritis on an unspecified date. Patient reported that she did hold her Xeljanz 11mg for 5 days after she received her Covid booster as advised.  Patient reported a flare of her Rheumatoid Arthritis but is back on track. No further questions or concerns. Outcome of the event was unknown. The patient received first and second dose of BNT162B2 on unspecified dates.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
maculopapular, red, itchy patches on back and abdomen.   Benadryl, unscented lotions, cool baths- return in 1 week if no improvements
A report has been received from a Health Professional concerning a patient, female subject, who had been receiving intramuscular FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 28-Oct-2014. The administration to wrong patient population was reported. The outcome of the event of administration to wrong population is unknown. The reporter's description of the event(s) was as follows: Not provided. The report was considered to be non-serious.
delayed Injection site reaction began 9 days after vaccination presenting as blotchy red rash approximately 6 square inches with no pain or fever.
Caller's husband called the call center on the morning of 4/26 to ask about symptoms that his wife (the patient), who was 24 days post vaccination with Johnson & Johnson COVID-19 vaccine,  had experienced the evening of 4/25.  He reported that she had developed a severe headache and vomited.  She c/o leg and chest pain as well and he reports that she has a history of blood clots but no h/o migraine headaches.  At the time of the call his wife was feeling fine.  I advised that they discuss with PCP. Having none I advised that she discuss with Urgent Care.  I called him back about 6 hours later.  They had decided that since since she continued asymptomatic they were not going to seek clinical evaluation.  They believe that the symptoms were musculo-skeletal after "spending the whole weekend laying a patio".
G1P0 28 week and 3 day OB EDC OCT/10/2017. Left deltoid Erythema Swelling 4x5cm.
9/2/2020 ? Visit to Pediatric Dr. for 3 year old Wellness Exam & 1st dose of MMR. No neurological or behavioral issues/concerns by parents or doctor.  9/9/2020 ? Drastic neurological/behavioral changes ? throwing things, flipping chairs, shoving little sister, hitting, screaming, constantly rubbing elbows, and chewing on cheeks. 9/14/2020 ?Visit to Pediatric Dr. ? concluded ?adverse neurological reaction to vaccine?. Dr. reports reaction to Department of Health. 9/14/2020 ? Visit to the ER at Hospital ? admitted for neurological/behavioral changes. Stayed at the hospital for 4 days: 9/14-9/17. 9/15/2020 ? Saw neurologist at hospital and ordered MRI and LP (Lumbar Puncture/"spinal tap"). 9/16/2020 ? Saw psychiatrist at hospital and gave two doses of Risperidone (one dose on 9/16 & 9/17) to help with rages. 9/16/2020 ? Sedated MRI and LP were completed. 9/17/2020 ? EEG was completed. All results from MRI, LP, and EEG came back normal. All preliminary blood work came back normal. Still awaiting results from more extensive blood work as well as from titer testing for MMR.
patient had 101.5 degree fever and reported to urgent care day after vaccination.  They tested for uti and sent home.  PAtient takes routine Tylenol, so fever could have been suppressed.  Had low grade fever 2 days after vaccination.  Woke up 3 days after vaccination with large red patch greater than 4x6inches on arm, looked to be spreading across bicept.  Pharmacist determined it was warm and hard to the touch.  Referred patient to urgent care in case of infection or injection site reaction that needed further treatment.