chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Evening of 08May I tested positive via rapid; Evening of 08May I tested positive via rapid; 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 male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP7534 7/21), in right arm and on 12Apr2021 as dose 2 , single (Lot number: ER8731 7/21), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Nov2021 as dose 3 (booster), single (Lot number: 033F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high-blood pressure" (unspecified if ongoing); "Sulfa Allergy" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; ADVAIR. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), all with latency 10 days after the suspect product(s) administration, outcome "not recovered" and all described as "Evening of 08May I tested positive via rapid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Negative, notes: I tested negative via rapid test 03May, 04May, and 05May; (04May2022) Negative, notes: I tested negative via rapid test 03May, 04May, and 05May; (05May2022) Negative, notes: I tested negative via rapid test 03May, 04May, and 05May; (08May2022) Positive, notes: Evening of 08May I tested positive via rapid test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient had other medication in 2 weeks. Anti viral details: Product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 27Apr2022, treatment stop date 02May2022, indication: Treatment of COVID-19. Covid vaccine details : Vaccine brand: Other, vaccine brand other: Moderna, vaccine brand unknown: False, vaccine administration date: 18Nov2021, vaccine lot number: 033F21A, vaccine lot unknown: False, vaccine dose number: 3, vaccine dose number unknown: False, vaccine location: Right arm, vaccine brand: Pfizer / BioNTech, vaccine brand  unknown: False, vaccine administration date: 12Apr2021, vaccine lot number: ER8731 7/21, vaccine lot unknown: False, vaccine dose number: 2, vaccine dose number unknown False, vaccine location: Right arm, vaccine brand: Pfizer / BioNTech, vaccine brand unknown: False, vaccine administration date: 22Mar2021, vaccine lot number: EP7534 7/21, vaccine lot unknown: False, vaccine dose number: 1, vaccine dose number unknown: False, vaccine location: Right arm. Other medication details: Other medication in 2weeks product: Advair Diskus, other medication in 2weeks product: Lisinopril. Adverse event: Rebound case. The patient tested negative via rapid test 03May, 04May, and 05May. Did not test on 06May. On the evening of 07May he developed a sore throat and sinus congestion. Evening of 08May he tested positive via rapid test. The patient had sulfa allergy.
Had vaccine given around 15:00 on 10/17/00 and was fine that day and the next morning but that night, developed what was described as "band around arm". Went to MD that night as he had a fever of 101.5F. MD stated client had a sinus infection and he was placed on amoxicillin and he was instructed to take Advil for pain in arm. Arm started having spasms that night where band had developed. Condition improved over the next day and by the day after, had almost disappeared.
Chills and everything; Chills and everything; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Chills and everything) and CHILLS (Chills and everything) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Jan-2021, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 20-Feb-2021, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (Chills and everything) and CHILLS (Chills and everything). At the time of the report, IMMUNISATION REACTION (Chills and everything) and CHILLS (Chills and everything) outcome was unknown.            No relevant concomitant medications were reported. The patient received Pfizer BioNTech covid-19 Bivalent vaccine on 21-Oct-2022. Patient received Moderna vaccines and developed "Chills and everything" similar to that the patient experienced with the flu shot before receiving the Pfizer bivalent vaccine. No treatment medication reported.
The morning after my second shot, when I woke up, I felt stiff and achy through my shoulders, back, thighs, hips.  It felt like I had slept stiffly or in an awkward position.  I got ready and went to work as usual.  I didn't need tylenol or anything and I think it went away when I got to moving around.   I'm not really sure that it was because of the vaccination, but it wasn't usual for me.
BRUISING IN THE UPPER RIGHT ARM THAT IS PROMINENT,HAD TO GO TO ER TO GET IT CHECKED. THE DOCTOR HAD TO SOME TESTS ON 11/11/2018 AND CONFIRMING THATS A POSSIBLE CHANCE OF RUPTURE OF A BLOOD VESSEL. NO OTHER TREATMENTS RECOMMENDED.
Case number PHEH2014US024979, is an initial spontaneous report from a nurse received on 09 DEC 2014. This report refers to a 91 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145701) intramuscularly at a dose of 0.5 ml on 13 NOV 2014. The  nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 OCT 2014 and the temperature was between 46 to 49 degree F during the excursion.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 41 years 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "Asplenia" (unspecified if ongoing), notes: other medical history: Asplenia; "Depression" (unspecified if ongoing), notes: other medical history: Depression; "Left Nephrectomy" (unspecified if ongoing), notes: other medical history: Left Nephrectomy; "known allergies: PCN" (unspecified if ongoing), notes: known allergies: PCN; "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa; "Known allergies: Adhesive tape" (unspecified if ongoing), notes: known allergies: Adhesive tape. Concomitant medication(s) included: NEURONTIN; CYMBALTA; WELLBUTRIN; PRAZOSIN; TRAZODONE. Past drug history included: Keflex, reaction(s): "known allergies: Keflex", notes: known allergies: Keflex; Clindamycin, reaction(s): "known allergies: Clindamycin", notes: known allergies: Clindamycin; Oxycodone, reaction(s): "known allergies: Oxycodone", notes: known allergies: Oxycodone; Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was received other medication in 2 weeks. Patient received Treatment of COVID-19 as Paxlovid from 18Nov2022 (lot number: 2692438).; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, the pandemic and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Pt developed severe pain at injection site the day the vaccine was administered (8/18/15). Patient visited MD while visiting family and was prescribed methylprednisolone dose pak to treat this pain. Pt contacted pharmacy regarding pain approximately 10 days after vaccination. Pharmacist on duty believed pain she was describing was within normal expected discomfort for this particular vaccine.
Pt with tightness and palpitation of chest, sudden onset this AM 0815 seen by Medical Clinic. Pt given Chest X-ray then sent to another facility to follow up for xanthym.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 88-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.   No treatment medication reported.  The vaccines was  stored in freezer, out one to two vials were taken out and placed in fridge each day as needed.
lot of pain; joint swelling worse; joint pain worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (lot of pain), JOINT SWELLING (joint swelling worse) and ARTHRALGIA (joint pain worse) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (moderate to severe rheumatoid arthritis). Concomitant products included UPADACITINIB (RINVOQ) for Rheumatoid arthritis.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-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) at an unspecified dose. In 2021, the patient experienced JOINT SWELLING (joint swelling worse) and ARTHRALGIA (joint pain worse). On an unknown date, the patient experienced PAIN (lot of pain). At the time of the report, PAIN (lot of pain) outcome was unknown and JOINT SWELLING (joint swelling worse) and ARTHRALGIA (joint pain worse) was resolving.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Information received on 30 Mar 2022: It was determined that this case was considered a duplicate of AER 22K-163-4340390-00. All information from both cases were merged into this case and retained. AER 22K-163-4340390-00 was invalidated. Treatment drug was not reported.  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.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2022: Concomitant medication and current condition added. Pain added as new event.
PT DEVELOPED REDNESS, SWELLING, PAIN, AND FEVER ON INJECTION AND AROUND THE SITE.
a patient who had seizures after receiving GARDASIL 9.; This spontaneous report was received from a Company Representative who reported on behalf of pharmacist, and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), (strength, dose, dose#, lot #, expiry date, route of administration, and anatomical site of vaccination were not provided) for prophylaxis.  The pharmacist stated that the patient came to her pharmacy to fill a prescription for an unspecified seizure medication, and the patient stated that on an unknown date,  she getting seizure after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), at her doctor's office. Due to the event, she received an unspecified seizure medications. At the time of reporting, the outcome of the event was unknown.  The causal relationship between seizures and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.   Upon internal review, the event of seizure was determined to be medically significant.
Patient admitted for STEMI. November. She does reports associated diaphoresis and nausea, worse with exertion.  ECG showed sinus rhythm with inferior ST elevations and she was taken emergently to cath lab which revealed distal RCA occlusion which was treated with thrombectomy and placement of a 3.0 x 48 mm DES. She did require pressor support for a short period post procedure, resolved. Discharged home. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Began with sensitivity on the left side (same side vaccine was given) just below breast to the bottom of rib cage. By 10/24/2014, rash began to develop only in the area of sensitivity. Called doctor and began valacyclovir for shingles on 10/25/14. Symptoms persist at time of this report.
Very tired all of the time; Headache; Fingers Shaking; brain fog and can''t concentrate; problems with both arms hurting; sleeps a lot; brain fog and can''t concentrate; feeling of swelling; This is a spontaneous report from a contactable consumer or other non-health care professional.   A 73-year-old male patient (reporter's husband) received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FC3183) via an unspecified route of administration, administered in left arm on 02Oct2021 (at the age of 73-year-old) as dose 3 (booster), single for covid-19 immunization. Medical history included bone cancer 10 years ago and they took out his pubic bone on the left side and his pelvis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (solution for injection, Lot Number: EL9264) via an unspecified route of administration administered on 03Feb2021 (at the age of 73-year-old), as dose 1 single and BNT162B2 (solution for injection, Lot Number: EN6200) via an unspecified route of administration administered on 24Feb2021 (at the age of 73-year-old) as dose 2, single for COVID-19 immunization. On 02Oct2021 the patient was very tired all of the time, headache, fingers shaking, brain fog and can't concentrate, problems with both arms hurting, sleeps a lot, booster has been really rough on them, really hard on the body. On an unknown date in 2021, the patient had feeling of swelling. Treatment received with Ibuprofen to get rid of that. Outcome of the events were not resolved.  Follow-up attempts are completed. No further information is expected.
DTaP given 6/8/04; mother noted 6/10/04 when patient awoke: left thigh/ upper calf edema: otherwise normal. On exam, left thigh circumference 2.5cm >right, left calf circumference 1cm > R; on 6/17/04 resolving edema: Left thigh 1.25cm > R, Left calf 0.5cm >R
Patient lost consciousness approximately 10 minutes after flu vaccination was administered. She gained consciousness in less than 3 minutes.
Systemic: Chills-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient reported chills and sweat
PATIENT CAME TO OFFICE COMPLAINING OF FEVER FOR A COUPLE DAYS AND DOTS ALL OVER BODY. RECIEVED ONE YEAR SHOTS ON 12-10-03. DIAGNOSED AS REACTION TO VARIVAX. NO TREATMENT NECESSARY.
Symptoms - ? Patient reports at 02:00 + fever of 106 (1000 mg Tylenol taken at 03:00) and + fever of 104 at 08:00 (1000 mg Tylenol taken at 08:15), + chills. Last day of work and shift - unknown Home remedies? -   see ?symptoms? for narrative Any improvement? - mild Recommendation? Patient educated to continue to monitor her symptoms and to contact EH vaccine support line with further questions and concerns.  Patient educated to continue to rotate Tylenol and motrin as indicated in the Medical Directive provided by employer and to notify her manager she will be unable to report to work until she is fever free for 24 hours without the use of an antipyretic.  Patient educated to continue to manage per Employer Illness in the Workplace Policy.  Patient verbalized back understanding and denied further questions at this time.
Medication administration error: Patient received his first dose of Pfizer COVID-19 mRNA vaccine on 12/13/2021 prior to discharging from the hospital. After discharge, the administering nurse realized the vaccine was past the 6 hr beyond-use-date/time (BUD). Follow-up investigation revealed that a complicated and delayed discharge process with the patient transferred between several primary nurses most likely resulted in the vaccine not being given prior to expiring. Vaccine was only past the BUD by ~1 hr. Patient was not reached after discharge to notify of the administration error as he lives in his vehicle and is difficult to contact.
pt recv vax 1996 & 11JUN97 pt devel chickenpox that consisted of less than 50 lesions;
3 days after vaccination he developed temp of 101 and diffuse petechiae on body.   He was seen in the emergency room and had a normal CBC and CRP.  The fever only lasted a few hours and petechiae self-resolved
ALLERGIC REACTION ON THE WHOLE BODY, MORE INTENSIVE ON THE HANDS AND FOOTS/SKIN FEELS ITCHES; FEVER; This spontaneous report received from a patient via a company representative concerned a 23 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced allergic reaction on the whole body, more intensive on the hands and foots/skin feels itches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 11-MAR-2021, and had not recovered from allergic reaction on the whole body, more intensive on the hands and foots/skin feels itches. This report was non-serious.
Approximately 2 weeks after the second shot, my left arm started hurting at the injection site.  A few weeks later, the pain had migrated into my shoulder joint.  THe pain continued migrating through the shoulder joint and began causing numbness in the arm that comes and goes randomly.  I spoke to a doctor at the Clinic about it and he diagnosed a rotator cuff injury and recommended PT.  I had no injury during this time to the shoulder, and told the doctor that the pain only started after the Covid shot was administered.  I've had a rotator cuff injury to my right shoulder, and the pain did not migrate around the shoulder or joint.    Additionally, The pain is not muscular, as massageing the area does not relieve the pain.  I have tried Motrin, Aleve and Aspirin to del with the pain, the pain level remains constant, but it varies throught the weeks and months.
Fatigue. Out of body (not thinking clearly).  Muscle  and joint aching.
Vertigo; Dizziness; Tinnitus/ loud buzzing in right ear/ Ringing would not stop sounded like morse code; sharp pain in right ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus/ loud buzzing in right ear/ Ringing would not stop sounded like morse code), EAR PAIN (sharp pain in right ear), VERTIGO (Vertigo) and DIZZINESS (Dizziness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (Poison IVY). Concomitant products included PREDNISONE from 22-Apr-2021 to 02-May-2021 for Allergy to plants.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced EAR PAIN (sharp pain in right ear). On 23-Apr-2021, the patient experienced TINNITUS (Tinnitus/ loud buzzing in right ear/ Ringing would not stop sounded like morse code). On an unknown date, the patient experienced VERTIGO (Vertigo) and DIZZINESS (Dizziness). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) on 15-Jul-2021 for Tinnitus, at an unspecified dose and frequency; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) on 03-Aug-2021 at an unspecified dose and frequency and IVERMECTIN on 26-Sep-2021 at an unspecified dose and frequency. On 12-Apr-2021, EAR PAIN (sharp pain in right ear) had resolved. At the time of the report, TINNITUS (Tinnitus/ loud buzzing in right ear/ Ringing would not stop sounded like morse code) had not resolved and VERTIGO (Vertigo) and DIZZINESS (Dizziness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2021, Acoustic stimulation tests: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that  on 08-Nov-2021 she had diagnosis of middle ear muscle myoclonus and results were unknown and ENT advised her to take calcium and potassium. Also stated that she had auditory nerve inflammation which was improving after 7 months.   Most recent FOLLOW-UP information incorporated above includes: On 20-Nov-2021: Patient demographics, Events start date, concomitant and Treatment medications, Reporters causality were updated.