chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient felt the flu afterward. It was awful. Lasted for days.; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient).  This case is linked to case 2020SA300039 and 2020SA300020 (same source).  This case involved a patient of unknown demographics who felt the flu afterward. It was awful and lasted for days (Influenza), while the patient received Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient felt the flu afterward. It was awful and lasted for days (Influenza) following the administration of influenza vaccine.  No laboratory test was reported.  It was not reported if the patient received any corrective treatment.  The event outcome was reported as unknown.  There will be no information available on the batch number for this case.
anaphylaxis 30mins-6hrs post-vaccination. Child was sweating, cold, pale, crying loudly for < 3 hrs.
Periodic headaches, suicidal ideation, inability to speak coherently for a few minutes, fatigue
Twitching during daytime naps only - per mom, dazed out, slight fever (warm to touch) per mom, vomiting. No symptoms observed in office. Mom reports frequency may be decreasing.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 02-Apr-2021. On 30-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 30-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Pt reports beginning to feel ill on 4/5/21 with flu-like symptoms (body aches, muscle pain, fatigue, and chest pain when deep breathing). Saw PCP on 4/6/21 and was sent to hospital for chest X-ray. Pt states that X-ray was normal but PCP treated for pneumonia with antibiotics  based on symptoms.
I began having fevers at the end of July. I usually have them in the afternoons. They went on for a while. I went to my PCP, and he diagnosed them as fever of unknown origin. He prescribed me to a infectious disease doctor. He orders at one time to have 35 labs done with nothing found. They have run an echocardiogram. They found nothing. They told me to see my PCP again. They have also refereed me to see a rheumatologist. I saw them on Tuesday the 18th of April. They ran a bunch of labs that I do not have the result for yet. I have now also been experiencing fatigue along with the fevers still.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 26 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "Got tonsillectomy+adenoidectomy", start date: 2004 (unspecified if ongoing), notes: Got tonsillectomy+adenoidectomy in 2004; "ad/hd" (unspecified if ongoing), notes: ad/hd. Concomitant medication(s) included: BUPROPION, start date: 01Nov2014; VENLAFAXINE, start date: 01Jan2017; ADDERALL, start date: 01May2021, stop date: 03May2022; VITAMIN D [COLECALCIFEROL], start date: 01Jun2014; CETIRIZINE, start date: 01Jun2019. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: At-home Antigen test for COVID was negative. Therapeutic measures were taken as a result of covid-19.anti viral details product COVID 19 Treatment, brand: Pfizer, treatment start date:03May2022, treatment stop date:08May2022, indication:Treatment of COVID-19.Adverse event: Symptoms returned on May 18: coughing, sore throat, sore lymph nodes, fatigue/tiredness, congestion. At-home Antigen test for COVID was negative.Adverse event start date and Time :18May2022;03:30 AM.Device timestamp: 18May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Autoimmune reaction resulting in painful PMR-like symptoms in legs, feet hands and arms. Treated with prednisone 20 mg daily.  By december 2021 developed painful neuropathy in both feet.  Neurological tests show small fiber peripheral neropathy which continues to worsen.  By January 2022 developed extreme fatigue and brain fog both of which continue as do all the above, although the PMR like smptoms and pain have lessened.
Complains of left upper arm pain of decreased movement secondary to pain two week after injection. Left tricep feels more firm and is tender touch.
Hit head on floor after passing out. passed out a minute or 2 later, after getting the shot. Acted lethargic, and he vomited about one hour later.
This spontaneous report was received from a healthcare worker refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent condition, drug reactions/allergies and concomitant medications were not provided. On 27-SEP-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M024702, expiry date: 18-MAY-2018). A data logger was involved. Healthcare worker reported that the vaccine underwent temperature excursion at 19.5F for 23 hours. They stated that the vaccine was previously exposed at 8.5F for 4 hours and 15 minutes. No adverse effect was reported. This is one of the four reports received from the same reporter. Additional information has been requested.
Body aches, joint pain, soreness at site, small red spot (size of a nickel) beginning around 8-10pm.  Temp of 100.1F next morning (11/10) at 8am.  Severe pain in arm in morning of 11/10 with continued body aches.  Redness at site approximately 2 inches in diameter.  Notified doctor and she told me what to be on the lookout for.  Still in severe pain all over body through the night.  Morning of 11/11, redness at site now covers the entire width of upper arm.  Fever of 102.5F at 8am.  Notified doctor.  She called in prescription for cephalexin 250mg and took first pill at 4pm.  Patient also had a previously scheduled CT Scan on 11/11 and pre medicates with Prednisone to combat a sensitivity to contrast dye.  The Prednisone taken at 12pm actually helped alleviate symptoms from vaccine reaction.  Cephalexin taken every 8 hrs along with Advil 600mg.  Still sore during 11/12.  Now it is 2:45pm on Saturday, 11/13.  Pain somewhat less. Site is still red across the width of upper arm.  Redness has been warm to the touch ever since symptoms began.
sharp pain in head, severe diarrhea, nausea, felt faint, ears ringing,
Patient would turn her head sharply to the right and be unresponsive for approximately 20 seconds. She also would turn in a circle to the right. This started the evening of 08/06/2015. She was taken to the Emergency Room and was admitted. After an EEG, she was diagnosed with having focal seizures.
This spontaneous report as received from a physician refers to a multiple patients of unknown ages and genders. Pertinent medical history, concurrent conditions and drug reactions or allergies were not reported. On an unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB Lot # K023310, Expiration Date 15-APR-2017, and Pediatric/Adolescent Lot #L001456, Expiration Date 22-OCT-2016 (Dose, route and anatomical location were not provided). Other suspect product involved was sterile diluent lot # L041683 Expiration date 19-MAY-2018 and Lot # M002421 Expiration date 22-JUL-2018. Temperature: Lowest 25 Fahrenheit degrees (4 cycles) below. Time frame: 1 week. Previous: No. Digital data logger was involved. No product quality complain was involved. No other concomitant medication was reported. This is one of five reports received from the same reporter. Additional information has been requested.
Feels like I was punched in the left arm. Unable to raise my arm at or above shoulder level. I'm unable to sleep on my left side without pain. Lots of pain in the deltoid muscle.
Administration of expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  The vaccines was stored in freezer, they take out one to two vials and place in fridge each day as needed.
Information has been received from a consumer concerning her 4 month old relative who in approximately 2001 developed chicken pox after being exposed to his brother who had been vaccinated with varicella in 1998 who also developed chicken pox after recent varicella exposure. Subsequently, the pt recovered from chicken pox. It was not reported if the pt sought medical attention. No additional info was provided. Additional info has been requested.
A 14 month old was given an adult dose of Hep A vaccine. HAVARIX Hep A. No adverse event occured.
Paitent states she developed a moderate rash all over her  body about 1 hour after receiving her 1st dose on 2/10/21.  Patient  was seen for the rash but declined treatment except OTC  Benadryl capsules and rash resolved.  The Covid-19 vaccine medical provider was consulted and recommended to give her the 2nd dose today 3/10/21. Provider instructed patient to  stay in clinic 30 min after admin and if a  rash develops to return to medical clinic or the ER if emergent or ER after hours. Patient given the instructions and stated she understood them. Patient received COVID-19 immunization at this visit. Assessment after injection: 15 min after receiving the 2nd dose of Covid-19 vaccine the patient developed a rash all over her body and was anxious and itchy. She was taken to medical clinic and hand off was given to the Medical Provider and Registered Nurse Team.
On day of vaccine I had localized swelling , pain, and some itching.  This went away in about 3 days.  On 1/27/2021, I started experiencing , itching and redness on the spot of the injection.  Today is the 29th and I am still experiencing these symptoms.
Case number PHHY2011US52728, is an initial report from a nurse received on 09 Jun 201 with a follow up report from health care professional received on 28 Jun 2011. This report refers to an 11-year-old female patient. She had a current condition of allergic rhinitis and concomitantly received treatment with ALLEGRA and NASONEX. The patient was vaccinated with MENVEO (batch number M10034) reconstituted with on 02 Jun 2011. She did not receive MenCYW-135 component. No adverse event occurred. Follow up report received on 28 Jun 2011. Patient demographics, medical history and concomitant medications were updated.
Erythematous papular rash head, neck, trunk, diaper area and legs, days after varicella vaccine.
COVID 19; COVID 19; Moderna, Dose Number: 3, 4, 5 ; Pfizer/BioNTech, Dose Number: 1, 2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2021 at 12:00 as dose 1, single (Lot number: EW0164), in right arm and on 19May2021 at 15:00 as dose 2, single (Lot number: ER8736) at the age of 49 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Nov2021 at 15:00 as dose 3 (booster), single (Lot number: 65F21A), in right arm, on 14Apr2022 at 14:00 as dose 4 (booster), single (Lot number: x17L21A), in right arm and on 11Oct2022 at 14:00 as dose 5 (booster), single (Lot number: 05302244), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid disease" (unspecified if ongoing); "overweight" (unspecified if ongoing); "Known allergies: Amaranth, buckwheat" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Mar1996; LIOTHYRONINE SOD., start date: Feb2000; MONTELUKAST SODIUM, start date: 05Jan2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021 at 15:00, outcome "unknown", described as "Moderna, Dose Number: 3, 4, 5 ; Pfizer/BioNTech, Dose Number: 1, 2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of the covid-19 which included PAXLOVID taken from 03Feb2023 to 07Feb2023.
Narrative:  Day 1 - swelling, dizzy, fatigue; Day 2 - not walking, weakness, fatigue,; Day 3- Not walking well, stiff, fatigue; Day 4 - not walking well, fatigue; Day 5 - dull; Day 6 - not strong; Day 7 - legs don't work; Day 8 - not strong; Day 9 - leg better.
Bloody nose; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 21Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and expiration date were not reported) via an unspecified route of administration on 31Mar2021 at single dose for COVID-19 immunization. The patient experienced bloody nose on 22Apr2021 in the morning in moderate amounts, but had lightened up throughout the day. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Redness and knot at site of injection Hot and tender, approx. 3 1/2 in diameter. Mostly gone by day 5.
Breakthrough case admission after 2 vaccines Moderna 12/6/21 lot# 031H21A;  Moderna 1/3/22 lot# 041J21A
Narrative:  Patient is a 88y M. Died on 06/26/2021. Received COVID vaccines on 1/19/2021 and 3/26/2021. Death likely not related to vaccinations. No other information provided.
Into office with mother. Mother stated the next night after child receives his shots she noticed his left upper arm was very red, swollen and warm to touch. Child has not ran fever or had any other signs and symptoms. Has went to see childs nurse
A large knot with blisters and a large reddened hot area at injection site. Given DT instead of TB.
On the afternoon of March 2, 2021, the baby breastfed and then was being held in a sling worn by her mother. Mother notes she was on a video call for work and thought the baby had fallen asleep. A short time later (unsure of exact timing) she noticed that the baby was not breathing, appeared blue, and was bleeding from her nose. Mother called 911 and began CPR that was continued by EMS and then hospital emergency department personnel. Baby was found by EMS to be apneic, cyanotic, and severely bradycardic. Baby was brought to the hospital and treated with multiple rounds of epinephrine, IV fluids, dextrose. She was intubated. She developed seizure activity and was started on Keppra. Baby subsequently transported to Hospital PICU.
Bell's palsy; This is a literature report.  A 57 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "3 previous episodes of Bell's palsy ageusia Facial weakness" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 Immunisation. The following information was reported: BELL'S PALSY (medically significant), outcome "recovering", described as "Bell's palsy". Therapeutic measures were taken as a result of bell's palsy included prednisone. No neuroimaging was taken.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal association, a causal relationship between the event Bell's palsy and BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Swelling, fever, bruised, hot to touch, warm compress per ER MD per mom on Saturday.
Diarrhea (8+ liquid bowel movements) - 3 days after 1st Moderna COVID-19 vaccination.  Immodium AD tablets x4 (2 tablets after 1st loose bowel movement, 1 tablet taken 2 addtl times after subsequent liquid bowel movements - max. of 4 tablets in 4hr period, which is max. dosage recommended for 24hr period).
Unexplained Infertility. I started experiencing it in 2016 when trying to conceive but was not diagnosed until 2017. Please note that the first vaccine and date given were the first of a series of 3. The other two shots were given on 2/22/2007 and 6/15/2007.
vaccine from expired vial has been administered to five patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine from expired vial has been administered to five patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine from expired vial has been administered to five patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine from expired vial has been administered to five patients) 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.   No concomitant details were provided No treatment details were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-154363, US-MODERNATX, INC.-MOD-2021-153743, US-MODERNATX, INC.-MOD-2021-154462, US-MODERNATX, INC.-MOD-2021-155107, US-MODERNATX, INC.-MOD-2021-155523 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-154363: US-MODERNATX, INC.-MOD-2021-153743: US-MODERNATX, INC.-MOD-2021-154462: US-MODERNATX, INC.-MOD-2021-155107: US-MODERNATX, INC.-MOD-2021-155523:
Pt developed rash that started the following her vaccination.  It started in the arm where the vaccine was administered. I continued to spread the following day.  She came in to the pharmacy on 9/23/2022 and notified the pharmacy of her reaction.  She informed us that a doctor would prescribe a medication for her.
Pain behind her eyes; Headache on top of her head; Little tired; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Pain behind her eyes), HEADACHE (Headache on top of her head) and FATIGUE (Little tired) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01832A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ASCORBIC ACID, BIOFLAVONOIDS NOS (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS]) and MANUKA HONEY for an unknown indication.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 25-Mar-2021, the patient experienced EYE PAIN (Pain behind her eyes), HEADACHE (Headache on top of her head) and FATIGUE (Little tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EYE PAIN (Pain behind her eyes), HEADACHE (Headache on top of her head) and FATIGUE (Little tired) outcome was unknown.
-Urticarial rash Pt received 2 Epinephrine .3 S/C dose + Benadryl 50 IM
Chronic spontaneous urticaria  Hives and itchy rashes all over body that come and go
Within 5 minutes after injection sudden onset of sneezing.  Mom left office with child.  Child then with eye/mouth swelling, hives, no responsive distress.  Once back at office, patient given 1 1/2 tsp po Benadryl.  Administered 1 1/2 tsp po Benadryl twice a day for 24 hours then three times a day for 1 day.  Patient discharged to home.  Swelling/hives improved.
Breathing heart problems (palpitations), painful lumps, heart burn, sore throat, nausea, headaches, fatigue, memory loss, arm felt like it was on fire.