chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a sudden hearing loss in my right ear still present as of 4/12. I went to the ENT had hearing test which showed 90% loss, MRI(no tumors) and prescribed Prednisone.
Received the flu shot on Friday 10/16/15. Woke up Saturday morning 10/17/15 with numbness all around her mouth (teeth and tongue) and nose. Numbness then spread to her arms during the day 10/17. On call center directed her to ER for eval. Rule out stroke, Lymes and blood sugar levels. Numbness continued on the weekend. Saw neurologist on Tues 10/20. Eval done but no diagnostic testing. Numbness continued until 10/23/15. No loss of ROM or muscle strength; just numbness.
sweating, weakness, paresthesias, nervousness, swelling in lips; pt states that recvd vax 12:00PM while on the way home pt had to return to clinic because felt swelling around the lips & paresthesias; drank cup of coffee then felt better;
positive to COVID-19; positive to COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose:1), for COVID-19 immunization; Bnt162b2 (dose:2), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "positive to COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive. The course of the event: Caller states that one patient got the booster dose of the Pfizer-BioNTech COVID-19 Vaccine on monday 04Apr2022 and he tested positive to COVID-19 in the last couple of days. Caller would like to know if it's possible to test positive to COVID-19 as a result of being vaccinated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Breakthrough case admission after 3 vaccines Moderna 1/26/21 Lot# 012L20A; Moderna 2/6/21 LOt# 012L20A;  Moderna 1/15/22 Lot# 022J21A
Pt woke up middle of night the next day with significant r arm and axilla pain on side of vaccine despite adequate motrin. Pt cont to have pain and then 6.5cm red very swollen area size of golf ball just medial to vaccine site (not involving vaccine site). He was seen in my clinic 10/13 230pm but swelling had gone down during the day and light pink area of rash visible.
This spontaneous case, initially received from other non-health professional (consumer) on 03-Oct-2018, concerning a 41-year-old, adult female patient. The patient's historical condition included migraines, hemochromatosis, mast cell activation disease, endometriosis, postural orthostatic hypertension. The patient did not administer any concomitant medications. On 01-Oct-2018 (reported as night prior to vaccination), the vaccine was left in a freezer overnight and it had frozen. On 02-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported) which had been frozen. On the same day, after the vaccine administration, the patient experienced pain and soreness on the injection site. The patient did not take any treatment measures associated with the event. On 02-Oct-2018, the patient had recovered from the event pain on the injection. On an unspecified date, the patient was recovering from the event soreness on the injection site. The reporter assessed this case as non-serious. Follow up received from other non-health professional (consumer) on 01-Nov-2018: It was reported that the patient's soreness had subsided. Hence, the outcome of the event soreness on the injection site was updated from not-recovered to recovering. The reporter was unable to obtain the lot number and expiry date. Upon internal review, it was realised that the batch number and expiry date was captured in the narrative, though not provided in the source document. Hence the batch number and expiry date was removed from the product tab. The narrative was amended accordingly.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 at 12:15 as dose 1, single (Lot number: FJ5683), in left arm, on 15Feb2021 at 12:00 as dose 2, single (Lot number: EN5318), in left arm, on 07Aug2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 08Jan2022 as dose 4 (booster), single (Lot number: EL9262) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing). Concomitant medication(s) included: DEPAKOTE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08May2022 at 14:30, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound covid. Tested negative for three days then tested positive again; Positive, notes: Rebound covid. Tested negative for three days then tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took Other medication in 2weeks. Adverse event: Rebound covid. Tested negative for three days then tested positive again. Patient took Anti-viral Pfizer product for COVID 19 Treatment, Treatment start date was 27Apr2022 and Treatment stop date was 02May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
13 year-old female patient received FLUBLOK, no AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 13 year old female patient who received 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  Patient no other vaccines administered to the patient.   On 13-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2035 and expiry date: 30-Jun-2021) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to product administered to patient of inappropriate age (latency on same day).  At the time of report 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.
Lymph nodes on neck left side began to swell about 2 months after vaccine injection in left shoulder. No lymph node swelling on right side of neck. Waited 4 weeks to see if swelling  went down, It did not. Went to Urgent Care in May 17 2021 and they took blood samples for analysis. Based on blood analyisi report, referred to Cancer Center.. Additional blood tests 7 June 2021 and CT scans 14 June 2021 performed. Diagnosis of SLL/CLL. No treatmenet at this time as it is a watch and wait situation. January 2019 I had protate cancer requiring removal of the prostate. Follow up lood tests and PET scan did not reveal evidence of SLL/CLL in lymph system. No history of SLL/CLL in my family. The lymph node swelling.did not occur until after receiving  the 2nd covid vaccine in the left arm. I did have 4 inch diameter rash on my left arm after injection.
headache; wasn't able to lift up his head, feels like he has a weight on his brain; This is a spontaneous report from a contactable consumer or other non hcp.A 74-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/lot number: EM9810 and expiry date: 30Jun2021) via intramuscular route administered in the region of left arm on 10Feb2021 at 13:42 as SINGLE DOSE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing diagnosed about 3 years ago.The patient's concomitant medications were not reported. Prior Vaccinations (within 4 weeks) were reported as none. On 15FEB2021 07:30, the patient  woke up in the  morning with a headache. He took some migraine headache pills. Within 3 hours, he wasn't able to lift up his head. He clarifies he couldn't even lean up on his elbows. The caller clarifies further it feels like he has a weight on his brain. Therapeutic measure was taken. When probed for product information for the migraine pills he took, he explains the bottle just says migraine relief purchased from pharmacy. It says pain reliever/ pain reliever aid. There was a number on the pill, but it does not say the strength. He makes the comment that it is all small print. When he took the vaccine, he was told the headaches would come, but he didn't understand the headaches would result in him laying down and actually not being able to function. The outcome of the events was unknown.  Therapeutic measures were taken as a result of headache.  No follow -up attempts possible. No further information is expected.
1 vial of undiluted Pfizer-BioNTech Covid-19 Vaccine was administered to the patient. Patient was assess 30 minutes later, denies allergic reaction. A follow up call an hour later, to inform the patient of 1 vial  undiluted vaccine given to the patient, pt c/o of body malaise, Patient was told to go to the Hospital, patient don't want to go. Another follow up call 2x in the afternoon and patient starts having headache, patient said will go to Hospital if condition worsen.  Another follow up call 4/7/21 AM and PM,  patient went to work , feel better, no more headache and body malaise or allergic reaction to the Covid vaccine but sour to the injected site.
Approximately 10 days after receiving first dose, noticed soreness in left armpit (presumably swollen lymph nodes), however at the same time, noticed that left lower forearm muscle (flexor capri ulnaris) also sore all the way up to the lateral aspect of the left elbow joint. Felt so sore and tender that unable to strongly  grasp anything with that arm.   This continues until today 1/25.
"Information regarding possible side effects I found to be odd. I experienced heart palpitations the day after the injection until today. This continued in episodes for 48 hours. I also experienced an increase in HR. I usually have a pulse of around 70-74. Post injection it stayed at 94-95 for an entire day with the palpitations."
Second dose administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose administered after temperature excursion) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose administered after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter.
Administration error, Patient received a booster dose on 0.25ml, instead of a full 2nd dose of 0.5ml.
Information has been received from a pharmacist concerning a 50 year old female with hypertension and no history of drug reactions/allergies, who on 1-OCT-2008, was vaccinated with HEPTAVAX. Concomitant therapy included influenza virus vaccine (unspecified), BENICAR, furosemide and ATIVAN. On 2-OCT-2008 the patient developed an itchy rash from her neck to her knees. The patient had been treated with unspecified steroids and antihistamines but the rash persisted. A skin biopsy, performed by an unspecified dermatologist, revealed "possible drug reaction". The patient also developed numbness of the fingers of her left hand. At the time of reporting, the patient has not yet recovered. The patient sought medical attention with an office visit. No product quality complaint involved. Additional information has been requested.
Patient administered second dose of the Moderna COVID-19 vaccine more than 35 days after the first dose; Patient administered second dose of the Moderna COVID-19 vaccine from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered second dose of the Moderna COVID-19 vaccine more than 35 days after the first dose) and EXPIRED PRODUCT ADMINISTERED (Patient administered second dose of the Moderna COVID-19 vaccine from an expired vial) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 054C21A) for COVID-19 vaccination.     Concomitant products included CLONAZEPAM, BUPROPION HYDROCHLORIDE (WELLBUTRIN) and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered second dose of the Moderna COVID-19 vaccine more than 35 days after the first dose) and EXPIRED PRODUCT ADMINISTERED (Patient administered second dose of the Moderna COVID-19 vaccine from an expired vial). On 24-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered second dose of the Moderna COVID-19 vaccine more than 35 days after the first dose) and EXPIRED PRODUCT ADMINISTERED (Patient administered second dose of the Moderna COVID-19 vaccine from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist reported that they had two vials of the Moderna COVID-19 vaccine which were received and refrigerated since 23JUN2021 . The vials did not experience a temperature excursion and were stored at the appropriate refrigerated temperatures through 30 days. The pharmacist wanted to know if the vials can be used beyond 30 days of storage in a refrigerator.The pharmacist asked whether the patient will have to be given the dose again, given that the dose administered was from an expired vial.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up received contains, Mail Id and contact number updated, events outcome updated to recovered.
Normal chills, weakness, sore body, dry mouth. Had a seizure around 7PM
Fever, aches, chills, swollen lymph nodes under left arm, muscle pain and muscle weakness, hives across abdomen, severe headache, brain fog
patient states that after she received the two vaccines, she developed redness/puffiness/swollen/painful to touch  from the injection site down to the elbow.
Vaccine leaked from the injection site. No adverse event occured. The dose was reattempted intradermally and was succssful.
Body hives/rash starting 8 days post vaccine shot to upper thighs, stomach, chest, back, upper arms and neck.  No itchiness or pain.  Raised red bumps.   Rash has still not subsided after a few days.
After testing positive I had a mild but persistent headache; joint tenderness in knees; mild cough; slight chest congestion; 2 days with 101.0 fever. Emailed my physician with the test results and was prescribed PAXLOVID for 5 days.
Breakthrough case admission after 2 vaccines Pfizer 9/20/21 lot# FC2184;  Pfizer 10/20/21 lot# FF2590
J&J vaccine for C19 per pt 4/2021 w/o actual date knowledge 8/8/2021- onset symptoms- GI and fever at home 8/14/2021- came to ED and admit same day- pt came in with body aches, cough, fatigue, progressive weakness,  8/10/2021- had C19 testing at pharmacy and reported as Covid positive
Moderna Covid Bivalent vaccine received 5 weeks after primary series, instead of the recommended 2 months.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included ZOSTAVAX with an associated reaction of herpes zoster (received ZOSTAVAX previously on an unknown date and had shingles 5 times since receiving ZOSTAVAX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 12 hrs after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in January or February 2018. About 12 hours after receiving the vaccine, she experienced flu-like symptoms that lasted for 2 to 3 days. This case has been linked with US2018151143 and US2018151144, reported by same reporter.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna, Vaccine administration date: Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 Vaccine - Manufacturer Unknown, as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "High Blood pressure (BP)" (unspecified if ongoing); "Known allergies: Statins" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Victoza, reaction(s): "known allergies: Victoza". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Sep2022, outcome "unknown", described as "Vaccine brand other: Moderna, Vaccine administration date: Sep2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested negative; (23Dec2022) Positive, notes: Then on 23Dec tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I was given the injection and about 4 hours later I started feeling feverish and achy and weak and nauseous. It got worse at about 6 o'clock at night. I was vomiting, during the night that stopped. It took about 2 days to finally get to feeling better again. Shortly after that I started experiencing hair loss, lots of aches. I was diagnosed with Afib in December.
Pt recvd DTP/MMR/OPV 17JUN92 & next morning awoke w/arm swollen from shoulder to antecubital fossa on lateral aspect; area erythematous, hard & warm; area marked w/ink @ margins to watch for further spread & treated w/prelone, cool compress
1st dose, after 10 minutes the staff member started shaking, increased heart rate, and throat swelling. Gave 25mg of Benadryl and an Epi-pen and then took them straight to the ER. Staff member is still at the ER (as of 11/24/21) but is doing better.
Patient had pale pink macular rash on the inner aspects of both arms.  No evidence of rash, redness, swelling, or itching at site of injection which was Right upper arm.Loradamed was given.
I injected the needle into the left muscle and there was some resistance, but I pushed the needle into the muscle as far as I could. The needle was in the muscle, but after depressing the plunger, the vaccine seemed to drip out of the arm. The needle tip stayed secure on the plunger, so I do not think the needle tip was loose, at least from what I could tell. Probably more than half of the dose seemed leaked out onto the patient's arm. I do not know for sure why this happened. This is the first time this has happened to me. This is being reported as an administration event, not as a vaccine adverse event. Patient appeared to be fine, and I did not see anything unusual with his left arm.
TIREDNESS; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included no medical history. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported on left arm, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021, the patient experienced tiredness. On 12-MAR-2021, the patient experienced slight headache. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness, and slight headache. This report was non-serious.
Confusion and disoriented.  Not able to remember names, or past events.  Symptoms have lasted 5 days and just now starting to clear up.
Arm pain,  next day fatigued, body aches and joint pain , headache, lightheaded, itching across chest and neck.  day 3 prickly rash on chest . Day 4 rash on chest
pt recvd vax; c/o ear ache when got home from clinic;to hosp er 22sep94 9:30pm; t 101 at that time; tx w/ amoxicillin & motrin;
This case was reported by a nurse via call center representative and described the occurrence of erythematous rash in a 11-year-old female patient who received BOOSTRIX (batch number 7B222, expiry date 23rd April 2017). Concurrent medical conditions included latex allergy. On 4th August 2016, the patient received BOOSTRIX .5 ml. On 9th August 2016, 5 days after receiving BOOSTRIX, the patient experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was recovering/resolving. It was unknown if the reporter considered the erythematous rash to be related to BOOSTRIX. Additional details were provided as follows: The healthcare professional reported that the patient experienced a red rash on her shoulders and back. On 10th August 2016, the symptoms were subsided. The reporter stated that the patient was allergic to late but administered the single dose vial.
Approximately 40 mins mouth/tongue started tingling. Then an hour I developed a rash lower part of my face and hives on chest. I'm still exp symptoms taking Benadryl.