chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Upon awakening on 24Mar21, I experienced a charley horse in my left calf.; Muscle aches worsened slightly as the day went on; I started feeling moderate tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 14:15 (Lot number: EP6555) at the age of 56 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (product: COVID 19, brand: Pfizer BioNTech, lot number: EL3247, lot unknown: False, administration date: 04Mar2021, administration time: 10:30 AM, vaccine location: Left arm, dose number: 1), administration date: 04Mar2021, for covid-19 immunisation. The following information was reported: MUSCLE SPASMS (non-serious) with onset 24Mar2021 06:00, outcome "recovered", described as "Upon awakening on 24Mar21, I experienced a charley horse in my left calf."; MYALGIA (non-serious) with onset 24Mar2021 06:00, outcome "recovered", described as "Muscle aches worsened slightly as the day went on"; FATIGUE (non-serious) with onset 24Mar2021 06:00, outcome "recovered", described as "I started feeling moderate tiredness". Therapeutic measures were not taken as a result of muscle spasms, myalgia, fatigue.  Additional information: Upon awakening on 24Mar21, I experienced a charley horse in my left calf. Quadriceps and hamstrings were mildly sore in the morning. Muscle aches worsened slightly as the day went on and I started feeling moderate tiredness. I was able to continue with my work and daily activities. At 9:45 pm on the same day, symptoms remain the same. However, follow-up to the report submitted on 24Mar2021 it was reported, patient was recovered. Vaccine facility type was Workplace clinic. No other vaccine was administered in four weeks. Other medications in two weeks: Phillips Fiber Good Gummies, VSL #3 Probiotic Supp. No covid prior vaccination. covid was not tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
COVID-19 symptoms started on 07/05/22; tested positive on 07/06/22. I had a temperature of 99.8. July 4 I found out I was exposed and so I went home and took a self test and tested negative on the 4th and called the Doctor on the 5th. I went in the next day to a drive thru to get tested and was positive and Doctor prescribed me Paxlovid. Took the first dose at 4:30 PM and 2nd dose at 11:30 PM. Wednesday-Saturday I took the doses. By Tuesday I tested again and I was negative. I might have had a fever the next day July 5 but unsure.
Day of shot: Felt stoned  Day 2:  Fever developed overnight, high of 101, lasted for 24 hours. Shortness of breath, achy.  Day 3: Dizzy spells, achy, short of breath, mild headache developed into migraine by 7pm (behind right eye) Day 4: MIGRAINE has moved behind left eye. Dizzy spells, short of breath.  Day 5: Migraine, still behind left eye. Dizzy spells, short of breath.  Day 6: Mild headache, dizzy spells.  Day 7: ? That's tomorrow. Hopefully it'll be all over by then.
Developed shortness of breath, chest tightness on exertion while training cross country (run about 2 miles) - 3 days post second dose mRNA COVID-19 vaccine (Pfizer).  He had to stop, rest for the rest of training.  No palpitations, dizziness, or syncope.  He was seen by PCP 06/7/21, seen by Cardiology 06/08/21.
fever 2 minutes, tonic clonic seizure, lethargic 30 minutes post vax;
taste seemed off; morning smell seemed off; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (taste seemed off) and ANOSMIA (morning smell seemed off) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043LZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included VITAMINS;MINERALS;LYSINE for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (taste seemed off) and ANOSMIA (morning smell seemed off). At the time of the report, AGEUSIA (taste seemed off) and ANOSMIA (morning smell seemed off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient presents with hard oval shaped knot, red, radiation, heat, approximately 2 inches x 1 inch at the site of varicella injection. Also circular red spot 1 inch diameter at the site of TDAP injection.
11/13/11 Began with weakness exhaustion 11/18/11. Ataxic - confused - disoriented - weak. Choking episodes - hoarse. Without gag reflex. Hospitalized 11/26 overnight. Nystagmus. To ER 11/28 more choking stridor. Hospital 12/2/11 12/7/11. Temp paralyzed vocal cord.
Received vaccine on 12/28/2021. On 1/9/2022, I developed itching and a rash on my scalp and back. The itching and rash occurred spontaneously 5-7 times per day and the location began to spread to include all areas of body. I received a virtual urgent care visit where I was diagnosed with hives and give a steroid pack and instructed to continue taking antihistamines (Zyrtec, Prevacid, and Benadryl). After completing the series of steroids, the hives returned. Without oral administration of Zyrtec bid, hives would return. In early February I developed a thick, bumpy rash on the palm on my right hand. I visited a dermatologist who diagnosed this as eczema and prescribed a topical steroid cream. After continuing to experience hives when antihistamines were discontinued, I visited an allergist in April. He performed allergy tested and all tests were negative. He advised continued use of Zyrtec bid for 2-3 months and then to taper after. This regimen was followed and with tapering of Zyrtec, hives returned but with less frequency. As of today, 10/28/2022, I will develop hives if Zyrtec is not take every 24-36 hours.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 8:37 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 8:37 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 56.71.  Concomitant products were not provided.  On 22-Jun-2021, Excursion time was 08 AM, temperature was 35, total doses given for the day was 36, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 27-May-2021, vial was moved to clinic on 22-Jun-2021. 4 vials were sent to clinic. Vaccine BUD date was 26-Jun-2021.  Vial was stored on cooler 1, on 22-Jun-2021, Excursion duration At 8 AM: 35, 9 AM: 39, 10 AM: 47, 11 AM: 36, 12 AM: 42, 1PM: 43, 2 PM : 43, 3 PM: 43, 4 PM: 43   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
This spontaneous report as received from a Registered Nurse who reported that unknown number of patients were vaccinated on unknown date with improperly stored (32 degrees F for 24 hours) dose of oral ROTATEQ. (Batches # 0059AE, Expiry date 23-SEP-2013 and 1710AA, Expiry date 11-JUL-2013), (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. No treatment was reported. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
very fatigued; severe chills; headache; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (very fatigued), CHILLS (severe chills) and HEADACHE (headache) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Heart failure and Thyroid disorder. Concomitant products included OXYGEN for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced FATIGUE (very fatigued), CHILLS (severe chills) and HEADACHE (headache). On 23-Jan-2021, FATIGUE (very fatigued) and CHILLS (severe chills) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications included 5 blood pressure medications, heart failure medication and thyroid medicine.  Treatment information was not provided.
TOOK MY 1ST SHOT 3/25/21, 3/26 STARTED FEELING LAZY AND VERY TIRED AT THE END OF THE DAY, WENT HOME WENT TO BED. 3/27 WORK UP BREATHING HEAVY WENT TO WORK LEFT WORK AFTER 4 HOURS WENT HOME WENT TO BED. WOKE UP AROUND 2:00PM TRIED TO START MY WEED EATER AND COULDN'T CATCH MY BREATH. CHECKED MY OXYGEN LEVEL IT WAS 78  WENT TO THE HOSPITAL MY OXYGEN LEVEL WAS 84 ADMITTED TO HOSPITAL STAYED THERE TILL 4/2 WENT HOME WITH OXYGEN WENT TO UK HOSPITAL  ON 4/4 ADMITTED THAT DAY AND RELEASED 4/15.
PT NOTICED FEELING HOT APPROX 1/2 HOUR AFTER VACCINATION- PT THEN NOTICED HIVES ON LEFT ARM AND TRUNK AREA.
No additional AE reported; Improper storage of product in use; This spontaneous report was received from a medical assistant and refers to a 3-month-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 21-DEC-2022, the patient started therapy with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892784, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength was not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W006596, expiration date: 11-OCT-2024, administered intramuscularly for prophylaxis (strength was not provided). The administered doses of the vaccines experienced a temperature excursion of 47.9 degrees Fahrenheit (F) (storage in clinical practice) for 47 min on 01-DEC-2022. (product storage error). Data logger was involved. No information provided regarding a previous temperature excursion. No additional adverse event was reported (no adverse event).  This is one of several reports received from the same reporter.
9/26/21 patient presented to the ED hypoxic about 5 days after onset of URI symptoms, tested positive for covid-19 and was admitted to the hospital, currently hospitalized with covid-19 pneumonia
I had an egg shaped reddening in my left arm. By evening I started to have chills, fever, headache, and nausea. This lasted for three days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 20May2022 at 14:00 as dose 4 (booster), single (Lot number: IM9992) at the age of 60 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies : Penicillin" (unspecified if ongoing), notes: Known allergies : Penicillin; "Known allergies : Latex" (unspecified if ongoing), notes: Known allergies : Latex. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Sep2022) Negative; (20Sep2022) Positive, notes: Took Paxlovid from Sept 20-25 for positive COVID test with uri symptoms; (01Oct2022) Positive, notes: Symptoms returned on 01Oct2022 and retested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported event Drug ineffective and Covid-19  cannot be completely excluded.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. It was reported that the patient was vaccinated with ZOSTAVAX subcutaneously on 13-DEC-2012 and 25-SEP-2015 (extra dose administered). The patient had no known adverse effects. No product quality complaint (PQC) was filed. Additional information has been requested.
Body aches; Muscle ache; Chills; Extreme fatigue; High less fever; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN (Body aches), MYALGIA (Muscle ache), CHILLS (Chills), FATIGUE (Extreme fatigue) and PYREXIA (High less fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) for Depression, VITAMINS NOS for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 13-Jan-2021, the patient experienced PAIN (Body aches), MYALGIA (Muscle ache), CHILLS (Chills), FATIGUE (Extreme fatigue) and PYREXIA (High less fever). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL (TYLENOL PM, EXTRA STRENGTH) at an unspecified dose and frequency. On 14-Jan-2021, PAIN (Body aches), MYALGIA (Muscle ache), CHILLS (Chills), FATIGUE (Extreme fatigue) and PYREXIA (High less fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.
Very painful to lift vaccinated arm.  Onset about 5 hours after receiving vaccine.  Shooting pain going in both directions.  Has to take pain medicine to keep pain from being unbearable.
patient received ACT-HIB with wrong diluent; mixed with diluent used for MMR with no reported adverse event; Initial information received on 27-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health professional via Medical Information (MI) (Reference number- 00787088).  This case involves patient (unknown demographics) who was vaccinated with HIB (PRP/T) VACCINE [ACT-HIB], which was mixed with MMR (measles, mumps, and rubella) wrong diluent (Product preparation error).  The patient's medical history, past medical treatment, concomitant medication, vaccination and family history were not provided.  On 24-Sep-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ404AAB and expiry date: 04-Oct-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to Wrong solution used in drug reconstitution (latency on same day).  At the time of report no adverse reactions were reported.  It was reported "Caller stated that they mixed ACTHIB with wrong diluent before administration. ACTHIB was mixed with diluent used for MMR. Caller wanting to know what they should do.Caller states that on Friday, 24 Sep 2021, an ACTHIB vaccine was given that had been improperly reconstituted. The ACTHIB was reconstituted with the diluent from an MMR vaccine. Caller does not have patient information at this time, she states that she could obtain it".   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.
PT received incorrect 2nd vaccine dose. First dose was MODERNA and indicated on his vaccine card as well as his EMR. No adverse reactions noted within 45 minutes. This HCW is an advance practice RN and was briefed on potential adverse events and will respond if needed.
diluted with sterile water instead of the provided diluent with no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via phone at call center via Medical Information (Reference number- 00319980) and transmitted to Sanofi on 16-Oct-2020.   This case involved a 4 months old female patient who received HIB (PRP/T) VACCINE [ACT-HIB] (lot number-UJ355AA, expiry date: 24-Jul-2021) via unknown route in the left thigh for prophylactic vaccination on 16-Oct-2020, which was diluted with sterile water instead of the provided diluent with no adverse event (Product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  It was an actual medication error due to Wrong solution used in drug reconstitution (latency- same day).   At the time of reporting, the patient had no adverse event.  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.
Onset shingles 13 days after receiving Covid vaccine (updated vaccine for 2023-2024). Have received 7 Covid vaccinations starting January 2021, all Pfizer.  Shingles in T 7 distribution, onset 10/8/2023.  Have had Zostavax on 2015 and two doses of Shingrix vaccine in March and June 2018. Curious if this has been reported as a known consequence of the Covid vaccine. Or simply a coincidence.
Fever, body aches and night sweats and arm infection went to the doctor and the doctor gave me catflax.
Case number PHEH2015US021519, is an initial spontaneous report from a physician received on 21 Oct 2015. This report refers to 2-year-old patient of unknown gender. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: not reported) intramuscularly on 20 Oct 2015. No adverse event was reported.
RIGHT AFTER GIVING THE FIRST DOSE OF MODERNA (LOT 052E21A), PATIENT FELT LIGHT-HEADED AND BECOME PALE.  PATIENT FAINTED AND WAS UNCONSCIOUS FOR 1 MINUTE.  9-1-1 WAS CALLED AND AMBULANCE ARRIVED.  HE REGAINED CONSCIOUS AND SAID HE WAS FINE BUT STILL FEEL LIGHT-HEADED.  AMBULANCE TOOK HIM TO THE HOSPITAL FOR FULL CHECK UP. PATIENT CALLED 2 HOURS LATER TO REPORT THAT HE IS DOING FINE NOW.  HE DID MENTIONED THAT HE DIDN'T EAT OR DRINK ANYTHING IN THE MORNING PRIOR TO COMING FOR THE VACCINE.
No adverse event occurred. Patient incidentally received 2nd dose 1 week earlier than scheduled  (she presented to the community clinic earlier than scheduled). Documented "error" per requirements.
hot to touch around injection site; arm was sore; arm became red  around injection site; arm became swollen; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (hot to touch around injection site), VACCINATION SITE SWELLING (arm became swollen), VACCINATION SITE PAIN (arm was sore) and VACCINATION SITE ERYTHEMA (arm became red  around injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (esophageal) and Anxiety. Concurrent medical conditions included Hypersensitivity. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Acid reflux (oesophageal), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, CELECOXIB (CELEXA [CELECOXIB]) for Anxiety, IBUPROFEN.    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE SWELLING (arm became swollen). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch around injection site), VACCINATION SITE PAIN (arm was sore) and VACCINATION SITE ERYTHEMA (arm became red  around injection site). On 07-Jan-2021, VACCINATION SITE SWELLING (arm became swollen) outcome was unknown. At the time of the report, VACCINATION SITE WARMTH (hot to touch around injection site), VACCINATION SITE PAIN (arm was sore) and VACCINATION SITE ERYTHEMA (arm became red  around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.