chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up at 5am not feeling well at all, started having a massive anxiety attack, sore throat, shortness of breath, followed by headaches, nausea and a heavy pressure on my chest. After the 1st 24 hours the anxiety subsided, after 4-7 days the nausea and then the headaches went away. I still have the shortness of breath and the heavy pressure on my chest, along with the sore throat. I can't walk a flight of stairs without being "winded". I've been to the ER twice. I still have the shortness of breath and the heaviness on the chest today.
I always get a cough from the Covid vaccine and my asthma acts up, requiring albuterol at times and regular wexela doses for up to one month following vaccination. Although I seemed to be coughing less than with previous Covid vaccines, I seemed more out of breath than with the other doses. I received the vaccine on Monday 10/17, along with the FLU vaccine. On Friday 10/1 I was awoken by my heart racing , registering 140 on my Fitbit. This continued on throughout the day and night and into Saturday. I called the doctor on Saturday afternoon and was sent to urgent care. From there I was sent by ambulance to the hospital for Atrial Flutter.
10/27/2021 (2 days post vaccination) patient developed SOB /wheezing - saw health care provider and was given PRN Albuterol HFA inhaler. She also started experiencing intermittent dizziness, weakness and lightheadedness. this is ongoing since this time. she also c/o constant frontal headache that is mild, but unchanged.
10 MINUTES AFTER RECEIVING THE VACCINE, SHE FELT LIGHTHEADED AND VOMITED. ON SITE EMS RESPONDED. VITALS BELOW. NO HEADACHE. AFTER BEING MONITORED, SHE WAS RELEASED HOME. SHE CALLED SOMEONE WHO CAME AND PICKED HER UP.
Patient reports that on 01/24/2021 he woke up with a sore arm.  He reports that he has decreased range of motion and decreased strength in that arm. He denies redness, swelling or visible injury but feels like there is a bruise in his shoulder.
sleepy; little dizzy; lit headache; nauseate; felt heavy, want to go to sleep; This spontaneous case was reported by an other health care professional and describes the occurrence of SOMNOLENCE (sleepy), DIZZINESS (little dizzy), HEADACHE (lit headache), NAUSEA (nauseate) and FATIGUE (felt heavy, want to go to sleep) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced SOMNOLENCE (sleepy), DIZZINESS (little dizzy), HEADACHE (lit headache), NAUSEA (nauseate) and FATIGUE (felt heavy, want to go to sleep). At the time of the report, SOMNOLENCE (sleepy), DIZZINESS (little dizzy), HEADACHE (lit headache), NAUSEA (nauseate) and FATIGUE (felt heavy, want to go to sleep) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included a lot of medications. Treatment information was not provided.
Pt received 2 month vaccines today and per mom pt has been acting different since.  Per mom pt has been crying nonstop and if he is not crying he is eating or slepping.  per mom pt has been sleeping more than usual.  per mom pt appt was at 8am this morning  following appt pt has eaten at 1030 3oz and 1250 80ml and feeding while speaking.  per mom pt had episodes where teh R leg was twitching it was short episodes with several twitches pt temp is 99.5 no redness or swelling at site of immunization.  voiding WNL. mom concern is twitching is side effect to vaccines and should be reported and also febrile seizures
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 10:00 as dose 5 (booster), single (Lot number: Gj3277) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: En6204), in left arm, on 10Apr2021 as dose 2, single (Lot number: Er8731), in right arm, on 08Nov2021 as dose 3 (booster), single (Lot number: Ff2593), in left leg and on 25Apr2022 as dose 4 (booster), single (Lot number: Fj4989), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism"; "Sulpha allergy". The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with PF-07321332, ritonavir (PAXLOVID) from 24Feb2023 to 01Mar2023.
Inflammation; Anemia; Stiffness; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation), ANAEMIA (Anemia) and MUSCULOSKELETAL STIFFNESS (Stiffness) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced INFLAMMATION (Inflammation), ANAEMIA (Anemia) and MUSCULOSKELETAL STIFFNESS (Stiffness). At the time of the report, INFLAMMATION (Inflammation) and MUSCULOSKELETAL STIFFNESS (Stiffness) outcome was unknown and ANAEMIA (Anemia) was resolving.     The concomitant medication was not reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Large bulge in arm/swelling. Redness/itchiness/soreness in arm. Soreness in lymph nodes (under armpit). Drowsy/under the weather feeling.
bad case of diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (bad case of diarrhea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DIARRHOEA (bad case of diarrhea). On 29-Jan-2021, DIARRHOEA (bad case of diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not provided
Headache; neck pain; skin hurts; extreme fatigue; pain in arm where injection was given; extreme thirst; This is a spontaneous report from a contactable consumer or other non HCP (Patient).A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Lot number and Expiry date: Unknown), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccination the patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown) via an unspecified route of administration on an unspecified date as 1st dose, single dose for Covid-19 immunization. On an unspecified date, after vaccination, the patient experienced headache, neck pain, skin hurts, extreme fatigue, pain in arm where injection was given and extreme thirst. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
no adverse event; multiple temperature excursions for GARDASIL 9; This spontaneous report was received from a nurse prescriber referring to a patient of unspecified age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies was provided.  On 25-MAY-2022, the patient was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (dose at 0.5 milliliter, lot # T036444, expiration date: 09-APR-2023, strength, vaccination scheme frequency, and anatomical location were not reported) for prophylaxis after the excursion occurred (product storage error). Temperature and period of time of the temperature excursion were not provided. It was unknown if it had previous temperature excursion. No additional adverse event was reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA007630:
Day 8 after the vaccine (1/25/21) a large red hot itchy area appeared around the injection site, with headache.
I have developed shingles on my scalp & face; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0178), dose 2 via an unspecified route of administration, administered in Arm Left on 04Oct2021 16:00 (age at vaccination: 39 year) as dose 2, single for covid-19 immunisation. The patient medical history was not reported and past drug event was none. Concomitant medications included lorazepam (LORAZEPAM), lisdexamfetamine mesilate (VYVANSE), buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FF8839), dose 1 via an unspecified route of administration, administered in Arm Left on 13Sep2021 14:30 (age at vaccination: 39 year) as dose 1, single for covid-19 immunisation. Known allergies reported as none. If other vaccine in four weeks reported as No. Covid prior vaccination reported as unknown. Covid tested post vaccination reported as yes. On 02Nov2021 12:00 the patient experienced Shingles outbreak on my face. Patient never had shingles in life however 4 weeks after my 2nd dose of the pfizer vaccine patient have developed shingles on my scalp & face. The patient underwent lab tests and procedures which included PCR: negative, on 27Sep2021 Nasal Swab. Treatment received was valacyclovir 1gm tablet. The clinical outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
arm swelled little; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled little) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included TOCILIZUMAB (ACTEMRA) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (arm swelled little). At the time of the report, PERIPHERAL SWELLING (arm swelled little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Event occurred 7-10 days after getting the shot. No treatment information provided.
Headache, Myalgia, first was arm pain and hip pain; then 6pm myalgias, then nausea, by 9pm fatigue, skin hypersensitivity; 4am headache Narrative:
child patient gave an expired dose of IPOL with no reported adverse event; Initial information received on 16-Aug-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves child patient of an unknown age and gender who was vaccinated with the expired dose of suspect IPV (VERO) [IPOL] (expired product administered).  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 02-Aug-2021, the patient received a 0.5 ml fourth (one dosage form) dose of suspect IPV (VERO) (lot R1D97 and expiry date: 17-Jul-2021) (Frequency: once) (Suspension for injection) via an intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported "Patient age greater than one year enter as 2 month, 4 month, etc. Many pediatric vaccines need month for age. dose 0.25 mL to 2 mL for vaccines or 0.1 mL for TB (tuberculin) skin test-0.5ML, Strength: standard except for Fluzone HD-STANDARD, Pregnancy-not applicable, Last menstrual period, due date, AE (adverse event) symptoms or no AE, Vaccine presentation (for example specific flu vaccine), If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA (food and drug admiration) requirement. Reporter relationship: HCP (health care professional) Product used: used, first time product used: no, still using product: no HCP can be contacted Yes/No: No".  At time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
This is a spontaneous report from a contactable physician, via a sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation, PENTACEL, via an unspecified route of administration on an unspecified date at unknown dose for immunisation, rotavirus vaccine, via an unspecified route of administration on an unspecified date at unknown dose for immunisation. The patient medical history and concomitant medications were not reported. 1-2 days after vaccination the patient experienced irritable/fussy with outcome of recovered, had brief episodes (1-2 seconds at a time) of mouth movement/head jerking with outcome of recovered. The information on the batch number has been requested.
Started noticing  vision issues: stars and then fuzziness. Short term memory loss right after episode. Also blurry and spotty . Sunlight hurting eyes. Both arms started burning and slight tingling and some redness ( with the Doxycycline reaction I has severe loss of skin and it felt the same before arms peeled and I went to the hospital ( 3 times) .
pt recv vax around 230PM upon arriving @ home pt had 3hr of inconsolable crying, high pitched cry;no fever;pt was given APAP & is recovered this AM;
Stiff neck like symptoms; including pain/aches in neck, radiating to back of ear/inner ear, dull throbbing in jaw, pain in shoulder blade/back area towards left side--all of these symptoms progressively worsened and it is currently day 5 and still in a lot of pain, facial numbness/tingling for first two days on left side.
MMR 1/26/11, four days later began having bilateral leg pain from hips to feet with numb /prickly needle sensation bilaterally from behind knees to feet. First onset was fourth day after vaccination at night while sleeping and continuous for three days and nights. No fever injection site red not painful. Bladder over active urinating frequently. Stopped when leg symptoms stopped.
Information had been received from a female for GARDASIL (MARRS# 1410USA006736). The patient reported that in January 2014, she went in for her six-week checkup after giving birth to her son (actual date of birth not reported). This is one of two reports concerning the same patient. No further information is anticipated.
contracted with Covid-19 (confirmed diagnosis) from vaccinated parents; contracted with Covid-19 (confirmed diagnosis) from vaccinated parents; 7-year-old male received BNT162B2; This is a spontaneous report from a non-contactable consumer via a Representative. A 07-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date, dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient contracted with COVID-19 (confirmed diagnosis) from vaccinated parents. The patient was on inhalers and steroids to overcome respiratory symptoms. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Date of refrigeration was on 7-may-2021. Concomitant medication use was unknown. Treatment information was unknown
Vax area became red and swollen, a 'bump' appeared in vax area (approximately size of golf-ball); itching, swelling lasted 1.5 weeks; however bump is still present.
2-3-4 TC from mother stating child has dime size red area on left thigh and a spot where you can see where the needle went in-denies other reactions or symptoms.
The expiration date was mislabeled by the pharmacy, and the patient received an expired vaccine dose.
facial swelling; swelling around both of her eyes/ facial swelling around the eyes/ she could barely open her eyes; uncomfortable/ discomfort; her face felt itchy; This non-serious case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-AUG-2021 09:30, the patient received the 1st dose of Shingrix. On 28-AUG-2021, 1 days after receiving Shingrix, the patient experienced facial swelling (Verbatim: facial swelling), periorbital swelling (Verbatim: swelling around both of her eyes/ facial swelling around the eyes/ she could barely open her eyes), discomfort (Verbatim: uncomfortable/ discomfort) and pruritus facial (Verbatim: her face felt itchy). The outcome of the facial swelling, periorbital swelling and discomfort were resolved and the outcome of the pruritus facial was not reported.   It was unknown if the reporter considered the facial swelling, periorbital swelling, discomfort and pruritus facial to be related to Shingrix.     It was unknown if the company considered the facial swelling, periorbital swelling, discomfort and pruritus facial to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-OCT-2023 The patient self-reported this case. The consumer (patient) stated she experienced a reaction after Shingrix, adding it was the first reaction she has ever had to a vaccine, despite receiving all recommended vaccinations.  She further clarified the reaction as facial swelling around the eyes after receiving dose one of Shingrix at 9:30 in the morning at her doctor's office. She stated the swelling was initially noted the next morning.  The next morning, her face felt itchy, and when she looked into the mirror, she had swelling around both of her eyes, in which she could barely open her eyes. Since the patient experienced discomfort and swelling. She had placed a bag of peas on her face the whole day and kept the area cool for a day and a half. The patient iced the area with a bag of peas and the swelling resolved after about one and a half days in Aug 2021.  She reported it was uncomfortable, but never felt hot. The patient gave consent to follow up with HCP (health care professional).
rapid progressive dementia ventilation for respiratory failure, t105; family states confusion started about 16 hrs p/vax; post flu vax encephalitis;
Fever 99.6; Pain in the injection site (left); Activated nerve in left arm to fingers; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Activated nerve in left arm to fingers), PYREXIA (Fever 99.6) and VACCINATION SITE PAIN (Pain in the injection site (left)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for an unknown indication.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced NEURALGIA (Activated nerve in left arm to fingers) and VACCINATION SITE PAIN (Pain in the injection site (left)). On 24-Mar-2021, the patient experienced PYREXIA (Fever 99.6). On 25-Mar-2021, PYREXIA (Fever 99.6) had resolved. At the time of the report, NEURALGIA (Activated nerve in left arm to fingers) and VACCINATION SITE PAIN (Pain in the injection site (left)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 99.6 (Inconclusive) 99.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  concomitant medical  provided by the reporter. Patient took Excedrin (1) dose on 24-Mar-2021 and (1) dose on 25-Mar-2021 as treatment medication.