chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a male physician refers to a 19 years old female patient with none drug reactions or allergies and none pertinent medical history. The patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscularly in April 2011 and with the second dose of GARDASIL, 0.5 ml, intramuscularly in July 2011. No other co-suspects were reported. There was no concomitant medications. The patient left for college in August 2011 and shortly after started to complain of pain in her "shins", swelling of the knees and difficulty walking. It was also reported that the patient had developed debilitating muscle weakness and pain after being administered GARDASIL. The physician reported she was getting worse. The "bone pain" had continued, the weakness had progressed (she was in a wheelchair), and there were signs of tremor/clonus. The patient was hospitalized due to adverse events. The patient had undergone an extensive work-up at several major medical centers. She had been tentatively diagnosed with RSD (reflex sympathetic dystrophy) by some physicians. The patient was a champion horseback rider prior to the onset of that illness. Because of her exposure to horses and farms, the physician's current evaluation would be looking for evidence of Eastern Equine Encephalitis and organophosphate exposure. KEPPRA, fentanyl, PAXIL and LYRICA were given as a treatment for the adverse events. Treatment with LYRICA and KEPPRA had been unsuccessful. Multiple MRIs (brain, spinal cord, extremities), EMGs and bone scans had been negative. It was also reported that CT scan, blood labs were performed with no results provided. She might undergo muscle and biopsies. At the time of the report the patient had not recovered. The relatedness for the adverse events was not reported for GARDASIL. Pain in her "shins", swelling of the knees, difficulty walking, debilitating muscle weakness, signs of tremor/clonus and RSD (reflex sympathetic dystrophy) were considered to be disabling by the reporting physician. Additional information has been requested.
SORE THROATS; SCRATCHY THROAT; Eczema; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema), OROPHARYNGEAL PAIN (SORE THROATS) and THROAT IRRITATION (SCRATCHY THROAT) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriatic arthritis and Plaque psoriasis.    Concurrent medical conditions included Psoriatic arthritis and Plaque psoriasis (MODERATE TO SEVERE).   On 15-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced ECZEMA (Eczema). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (SORE THROATS) and THROAT IRRITATION (SCRATCHY THROAT). At the time of the report, ECZEMA (Eczema) was resolving and OROPHARYNGEAL PAIN (SORE THROATS) and THROAT IRRITATION (SCRATCHY THROAT) outcome was unknown.            No concomitant medication were provided  It was reported that In 2022, the patient was diagnosed with eczema and Skyrizi helped tremendously, but still it was itchy and red sometimes. Also patient had arthritis and Skyrizi seemed to be helping that as well. Although feet have turned but seemed to be slowing. Patient was not sure for sure if it was caused by Skyrizi, but patient has had to use epipen a couple of times since, which patient had never had to do before.  Further it was reported that it seemed to get sore and scratchy throats more often.  It was also reported that therapy with Skyrizi was still going.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality of Skyrizi for the event of Eczema, sore throat's and scratchy throats was not provided.  No treatment details were provided.
Large rash on entire back (both sides), developed 16 hours post-administration. Does not hurt.
6 days after vaccination left arm swelled, painful at site, bruised from site to left elbow.
In a little over 12 hours after receiving vaccine, I had a temperature over 104.3, a severe pounding headache, stiff joints, no energy, extreme lethargy and back and neck pain.  The injection site was also extremely tender, red and swollen about the size of a half of a baseball.  I took over the counter acetaminophen and ibuprofen around the clock for the whole day.  I did not go see my doctor, as I had no energy or will to move out of the bed.  By Thursday,  1/23, only a day and a half after receiving vaccine, I woke up and felt 85% better.  Only issues were I still had a low grade fever fluctuating between 99-100.7 and of course the arm swelling and pain.  All other symptoms have dissipated.  Now it's Saturday, 1/25, I have no other symptoms except the arm swelling (which doesn't seem to be improving) and pain.  I have been taking ibuprofen and applying cold packs to the site.
Initial report was received from a healthcare professional on 17 August 2013, who is also the patient's parent. A female patient (age and date of birth not reported) received an intramuscular injection of Influenza Vaccine (manufacturer unknown) on an unreported date during the shortage a few years ago (lot number, site, and side of administration not reported). The patient was exposed to flu. She ended up with bronchitis, sinusitis, and flu for 6 weeks. The patient's outcome was not reported. The reporter is the same for cases 2013-08969 and 2013-09059. Documents held by sender: none.
This spontaneous report was received from a certified Medical Assistant regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 25-FEB-2015, the patient was vaccinated with improperly stored VARIVAX (Merck) lot # L030160, expiration date- 11-AUG-2017. No adverse event reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient began to feel light headed and like her head was spinning.  She proceeded to move to the chair and fainted.  She quickly recovered ( less  than 30 seconds).  She was able to walk to the chair, she felt back to normal after a few more minutes.  She was observed for about 20 minutes.  When she left she was feeling back to herself.
On July 3rd I had a sore throat and my fever was 101.  I was very tired and had a terrible headache.  I began to feel a foggy brain on day 2.  I had a metallic taste in my mouth.  I called my doctor's office on July 5th and was prescribed Paxlovid.  I did not take this medication because I was advised by the doctor's office that it may react adversely to my current medication.  On day 3 I had sore throat and bad taste in my mouth and fever.   By day 4 I still had a fever and very fatigued.  The sore throat didn't go away until about the 8th of July.  Saturday the 9th my sore throat was gone.  As of today, my symptoms are just a head cold with a nasal congestion.  The nasal congestion has been continuous throughout.
No additional adverse event; the patient was inadvertently administered a dose of PROQUAD on 6/16/2020, that had been improperly stored.; This spontaneous report was received from a licensed practical nurse referring to a 13 years old male patient. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided.  On 16-JUN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA (recombinant Human albumin)) (lot # S030215, expiration date 25-MAR-2021; vaccine dosage detail and route of administration not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent (STERILE DILUENT) (product storage error). The storage temperature was 7.2 Fahrenheit degrees for 30 minutes. Previous temperature excursion included:  On 05-JUN-2020, 6 Fahrenheit degrees to 14 Fahrenheit degrees for 1 hour and 15 Fahrenheit degrees to 46 Fahrenheit degrees for 4 hours; On 08-JUN-2020, 6 Fahrenheit degrees to 14 Fahrenheit degrees for 1 hour 50 minutes; On 15-JUN-2020, 6 Fahrenheit degrees to 14 Fahrenheit degrees for 20 minutes. No additional adverse event. Data logger was involved.
This spontaneous report as received from a consumer refers to a patient of unknown gender aged 17 (details unspecified) (reported as family member of the reporter). No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with M-M-R II (dosing details, lot#, expiry date and route were not reported) for prophylaxis. On an unknown date, the patient experienced autism. The outcome of autism was unknown. The relatedness of the event to the therapy with M-M-R II was unknown. There were no product quality complaints (PQC) involved. Upon internal review autism was determined to be medically significant. This case is related to case number 1702USA011531 and 1702USA011535 via same reporter link. Additional information is not expected as the reporter did not wish further contact. Sender's Comments: US-009507513-1702USA011535: US-009507513-1702USA011531.
Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022 /Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022 /Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration) in an 83-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022 /Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022 /Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Reportedly, 173 doses or vials were initially stored in the refrigerator on an unknown date. It was reported that vials had not undergone any temperature excursion. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up was received with non-significant information.
Headache, Myalgia, fatigue, pain, reddness and swe,lling at vaccine site Narrative:  Other Relevant History:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8733), in left arm, on 04Apr2021 as dose 2, single (Lot number: ER8731), in left arm and on 19Dec2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 33 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SEASONIQUE taken for contraception, start date: 01May2019; LEXAPRO taken for depression, start date: 02Jan2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
itchiness (like something crawling in my face and extremities) all over intermittently lasted 2 days; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration, at the left arm on 23Dec2020 09:30 at single dose for COVID-19 immunization at a hospital.  Medical history included dry eyes, carcinoma in situ, and procedure of complete hysterectomy. The patient was not pregnant at the time of vaccination. Concomitant medications included camellia sinensis extract (GREEN TEA), ciclosporin (RESTASIS), estradiol (VIVELLE DOT). The patient previously took augmentin and experienced allergies.  The patient experienced itchiness (like something crawling in my face and extremities) all over intermittently lasted 2 days on 23Dec2020 09:30 and was treated with cetirizine hydrochloride (ZYRTEC)  x1 on the second day. The patient recovered from  the event on 25Dec2020.
3" round itchy  rash on arm injected 8 days after receiving vaccine.  Pain in arm at site of injection. Lasted 2 days.
My left arm has been numb from the area around the injection site down to the tips of my fingers on my left hand; My left arm has been numb from the area around the injection site down to the tips of my fingers on my left hand; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 11:00 (Lot number: EWO183) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EWO183, Dose Administration Time: 11:00 AM, vaccine location=Left arm), administration date: 24Aug2021, when the patient was 63 years old, for COVID-19 immunization.  The following information was reported: VACCINATION SITE HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 29Sep2021 06:00, outcome "not recovered" and all described as "My left arm has been numb from the area around the injection site down to the tips of my fingers on my left hand". Therapeutic measures were taken as a result of vaccination site hypoaesthesia, hypoaesthesia.  Additional information: The patient was not pregnant at the time of vaccination. No known allergies. No other medical history. Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. Other medications in two weeks included vitamins. Treatment for event included lymphatic massage. No covid prior vaccination. Patient not tested for covid post vaccination.   Follow-up attempts are completed. No further information is expected.
Bad reaction around the injection area/itching, redness, hot, and it's swollen, it also started to spread at the injection site; Bad reaction around the injection area/itching, redness, hot, and it's swollen, it also started to spread at the injection site; Bad reaction around the injection area/itching, redness, hot, and it's swollen, it also started to spread at the injection site; Bad reaction around the injection area/itching, redness, hot, and it's swollen, it also started to spread at the injection site; This is a spontaneous case initially received from other non-health professional via agency (reference number: SEQ19-07417) on 12-Dec-2019 concerning a 69-year-old, male patient.   The patient's medical history included diabetes, heart disease, high cholesterol, high blood pressure, sleep apnea, the patient had a history of a heart attack and a stroke.  The patient's past medications included flu vaccine every year without any adverse events. The patient's concomitant medications included pasmetformin, Plavix (clopidogrel bisulfate), Aspirin (acetylsalicylic acid), Coreg (carvedilol), digoxin, simvastatin, Multivitamin (vitamins nos), Humalog (insulin lispro), Lantus (insulin glargine) and Jardiance (empagliflozin), all used for unknown indications.  On 10-Dec-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 261233, expiry date: 30-Jun-2020] for influenza prophylaxis.   On the same day, an unknown amount of time after vaccination, the patient experienced bad reaction around the injection area. He experienced itching, redness, hot, and it was swollen. It had also started to spread at the injection site.   On an unspecified date in Dec-2019, the patient started treatment with Benadryl (diphenhydramine hydrochloride) and put some Cortisol (hydrocortisone) cream at the site and ice pack on it.   At the time of initial report, the patient did not recover from the events.   The reporter assessed this case as non-serious.  The reported did not provided causality to Flucelvax QIV.  Company comment: Temporal relationship is suggestive for the causal role of Flucelvax. Causality assessment is confounded by use of concomitant drugs. Based on the available information, all events are assessed as related to Flucelvax.; Sender's Comments: Temporal relationship is suggestive for the causal role of Flucelvax. Causality assessment is confounded by use of concomitant drugs. Based on the available information, all events are assessed as related to Flucelvax.
Approximately 10 minutes after vaccination, patient vomited. Patient does have a history of vomiting so it is not clear if it was related to vaccination.
Gave 0.5ml third full dose instead of half shot booster.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.). On 02-Nov-2021, ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported.  No treatments medications was reported.   This case was linked to MOD-2021-374517 (Patient Link).
SIRVA - shoulder pain, weakness, nerve pain under the scapula, starting on the 3rd day after the vaccine, and worsening. Persisting at over 2 weeks after the injection. Injection site looks too low and suspect the belly of the muscle was missed. She gets temporary relief from Aleve.
rash; itchy rash; bump; soreness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number J225D, expiry date 22nd October 2021) for prophylaxis.   On 12th September 2019, the patient received the 1st dose of Shingrix. On 12th September 2019, less than a day after receiving Shingrix, the patient experienced pain. On 18th September 2019, the patient experienced red rash, itchy rash and local swelling. On an unknown date, the outcome of the pain, red rash, itchy rash and local swelling were unknown.   It was unknown if the reporter considered the pain, red rash, itchy rash and local swelling to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced soreness after receiving the first Shingrix vaccination.  The patient also experienced  red, bumpy and itchy rash. The reporter consented to follow up.
Vial was initially stored in refrigerator on 09-AUG-2023 and administration on 11-SEP-2023; No adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 09-AUG-2023 and administration on 11-SEP-2023) and NO ADVERSE EVENT (No adverse event) in a 24-month-old male patient who received mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (batch no. 201L22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1- Lot  AS1414B) on 29-Jun-2022 and Moderna COVID-19 Vaccine (Dose 2- Lot AS1412B) on 27-Jul-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 11-Sep-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (unknown route) .2 milliliter. On 11-Sep-2023,  after starting mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 09-AUG-2023 and administration on 11-SEP-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 09-AUG-2023 and administration on 11-SEP-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 09-AUG-2023 and administration on 11-SEP-2023).    Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Vial was initially stored in refrigerator on 09-AUG-2023. Vial did not undergo any temperature excursion. Treatment details was not reported by the reporter.
This vaccine was administered 1 day past it's expiration date. No adverse events occurred. Pfizer was called and their suggestion was to repeat the vaccine due to there being no information on the vaccine's effectiveness when given after it's expiration date.
4 yr old child presented with redness and swelling on eyelids, sneezing and runny nose. Mild local reaction on (R) leg. BENADRYL 1 tsp given PO per provider.