chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received the Moderna vaccine to 17 years old patient; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the Moderna vaccine to 17 years old patient) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included No adverse event (No medical history reported).    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the Moderna vaccine to 17 years old patient). On 14-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the Moderna vaccine to 17 years old patient) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information on concomitant medication was provided.  No treatment information was provided.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Painful neuritis affecting bottoms of feet, palmar surface of hands, thoracic area, full length of both arms, neck, shoulders.
48-year-old male who received his Covid vaccine states that he waited the mandatory 15 minutes and actually stayed over a few extra minutes after the vaccine and felt fine got in his car and decided to attempt to drive home when he was driving he became somewhat sweaty diaphoretic and felt lightheaded states that he thought himself he should probably pull over but proceeded to continue driving for short distance until he states the last thing he remembers was thinking he needed to merge into this traffic and then the next thing he knows he woke up to the onstar representative asking if he is okay he noted that he had struck a tree when EMS arrived the patient was approximately quarter of a mile into a field and then struck a tree.  The patient states he was ambulatory at the scene he was having right-sided chest wall pain especially with movement or breathing he is noted to have seatbelt sign to that side.  The patient denies being on blood thinners denies any other complaints at this time. Restraints:  air bag deployed, lap and shoulder. Do to the severity of his syncope, he was admitted for observation overnight.
prescribed Paxlovid after vaccination; prescribed Paxlovid after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AZITHROMYCIN, start date: 03Jun2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "prescribed Paxlovid after vaccination". Clinical course: Patient had no known allergies. On 03Jun2022, patient had bad taste in mouth, diarrhea and stomach pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient was complaining of shortness of breath and was lightheaded 10 to 15 minutes after administration.   Patient observed and was fine after 30 minutes.
approximately 3 weeks   21 days after the first shot I developed a rash on my left thigh, knee and buttocks.   it looked like red pimples or measles.....extremely painful and itchy.....red....bled when I scratched ..awfully uncomfortable....only now is the rash subsiding with using over the counter cortizone cream...it took me this long to link the vaccine to the rash....
red spot on palm; itching; raised area; fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red spot on palm), PRURITUS (itching), SWELLING (raised area), FATIGUE (fatigue) and PAIN IN EXTREMITY (sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No patient history was reported by reporter. .  The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ESTROGEN NOS;PROGESTERONE for Hormone replacement therapy.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FATIGUE (fatigue) and PAIN IN EXTREMITY (sore arm). On 08-Mar-2021, the patient experienced ERYTHEMA (red spot on palm), PRURITUS (itching) and SWELLING (raised area). At the time of the report, ERYTHEMA (red spot on palm), PRURITUS (itching), SWELLING (raised area), FATIGUE (fatigue) and PAIN IN EXTREMITY (sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-081415 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received on 18-May-2021: outcome was updated to recovering On 19-May-2021: Follow up received on 19-MAY-2021 contained no new information.; Sender's Comments:  MOD-2021-081415:Dose 2 case
Arm pain, chest pain, had a mild stroke. weakness lasted about half hour, doctor wanted him to go to the hospital to get scans but scans were not done. just bloodwork  Extreme fatigue
Information has been received from a medical assistant, concerning her 13 year old daughter, who on 26-NOV-2007 was vaccinated IM with the second dose of Gardasil vaccine (lot # not reported). On 26-NOV-2007, while being vaccinated, the needle broke in her daughter's arm and less than a full dose was administered (details not provided). The MA's daughter sought unspecified medical attention. Additional information has been requested. Initial and follow-up information has been received from a medical assistant and a physician, concerning the physician's 13 year old daughter, a student, who on 26-NOV-2007 was vaccinated IM with the second dose of HPV vaccine (lot # not reported). On 26-NOV-2007, while being vaccinated, the needle broke in her daughter's arm, and less than a full dose was administered (details not provided). Follow-up informatiom form the physician indicated that it was not certain if any of dose was actually administered on 26-NOV-2007. On 10-NOV-2007, a full second dose was administered with no complications reported. Additional follow-up information received from a licensed practical nurse indicated that the needle did not break when the vaccine was being administered, but rather separated from the syringe when the vaccine was pushed through. The vaccine sprayed out into the room. The physician's daughter sought unspecified medical attention. Additional information is not expected.
Severe tinnitus in both ears.  Loud electronic ringing/buzzing in both ears non-stop 24 hours a day, 7 days a week. Same loud volume, does not fluctuate, does not change pitch or noise level.  Severe. Daily occurrence since second Covid-19 vaccine shot #2 received. Nothing relieves symptoms.   Patient has an audiology appointment on April 19, 2021 at 8:30am with Clinic
58 y/o woman with obesity with BMI of 34, HTN, T2DM (A1c: 6.6%), HLD, vaccinated against COVID x2 (no booster), who presented to the ED on 12/13 with fever, dizziness, cough and nausea, vomiting found to have covid pneumonia with acute hypoxemic respiratory failure.    Hospital course:    COVID Pneumonia with acute hypoxemic Respiratory failure: Symptom onset on 12/6, COVID positive on 12/13. Last fever on 12/12. There was a documentation of O2 sat of 88% during sleep in ED so she was started on steroids and remdesivir and HBS was consulted. However, she has remained 96-97% at rest and 95% on exertion. Her fatigue and dizziness has resolved. She received 3 days of decadron and remdesivir. Given she has no hypoxemia and decadron worsened her blood glucose levels, will not Discharge on decadron. Her liver enzymes remains within normal limit. CRP trending down. She was on lovenox for DVT PPx. She will be discharged with covid kit. Booster within a month when feeling better.    HTN/HLD:  PTA Norvasc 10 mg daily, Losartan 100 mg daily, Atorvastatin 40   T2DM: resume PTA metformin and glipizide on discharge.      Primary Procedures:  none   Secondary Procedures: None   Reason for Hospital Admission (Admitting Diagnosis):  Dizziness and covid PNA
Information was received on 28-NOV-2016 from a pharmacist via Pfizer (manufacturer # 2016528115) concerning a 65 year old female.  No medical history or concomitant medications were reported. It was reported that the patient had received a dose of PREVNAR 13 (dose, lot,  site and exact date received was not reported) one year ago for prophylaxis. She received a dose of PNEUMOVAX (lot, dose, site not reported) a week ago for prophylaxis and experienced shooting pain down arm. The outcome of shooting pain down the arm was not reported. The causality was not reported. No other information was provided. Additional information has been requested.
This spontaneous report was received from a 79 year old female patient, who was reporting on herself. The patient did not have medical history, concurrent conditions, concomitant medications, drug reactions or allergies. In November 2012, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) (lot #, expiration date, anatomical location or route of administration were not provided), one injection was administered to avoid shingles. In January 2017, the patient had shingles in her right eye (ophthalmic herpes zoster) and in her scalp (herpes zoster). The patient said shingles started in her right eye with her eye getting very swollen within a week. She also developed post herpetic neuralgia (PHN) which caused a headache in her scalp every day; so she had used creams, shampoos and conditioners on her scalp but they all burn. Therefore, she had try acupuncture and cold laser therapy to relieve the pain; the last one seemed to help relieve some of the PHN pain, but the pain persists. The patient said she might consider seeing a neurologist. Her physician was treating her shingles with a 300 mg of gabapentin tablet, which the patient was told to take 4-5 times a day, but she only takes 3 times a day. The patient said the medication did not seem to be working. At the time of this report, the patient had not recovered yet from the ophthalmic herpes zoster, shingles and PHN. The causal relationship between the ophthalmic herpes zoster, shingles and PHN with ZOSTAVAX was not provided. Upon internal review, the ophthalmic herpes zoster was determined to be a medically significant event.
Pt received moderna vaccines on 04/24/21 and 05/24/21. Pt presented to the hospital on 11/18/21 after testing positive for COVID outpatient on 11/12/21. Pt noted to have flu like symptoms. Pt developed hypoxia
Information has been received from a RN concerning a house wife who in approx. MArch 2003, was vaccinated SC in the arm with a first dose of varicella virus vaccine live. On 07Apr2003, the pt developed a rash on her forehead and body. Unspecified medical attention was sought. Subsequently the pt recovered. Additional information is not expected.
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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 4:26 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 4:26 PM, 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 53.11  Concomitant products were not provided. On 13-Feb-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021. 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 in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
dehydrated; headache; fever; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (dehydrated), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.  Concurrent medical conditions included Latex allergy and Diabetes since 2010.Concomitant products included METFORMIN and PRAVASTATIN from 2021 to an unknown date for an unknown indication.On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEHYDRATION (dehydrated), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). The patient was treated with MELOXICAM ongoing from October 2021 at a dose of 15 mg once a day; LOSARTAN ongoing from June 2021 at a dose of 50 mg once a day and PROPRANOLOL ongoing from June 2021 at a dose of 10 mg four times per day. In May 2021, DEHYDRATION (dehydrated), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) had resolved.DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):In May 2020, SARS-CoV-2 test: positive (Positive) Positive.mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.Treatment information was not provided.This case was linked to MOD-2021-272486 (Patient Link).
-15 hours after the vaccine I had extreme chills, sweating, fever and myalgias until 6pm the next day. (symptoms lasted about 14 hours from 4am to 6pm). took 500mg of acetaminophen at 6pm the day of vaccination, 8am and 8pm the next day. -Cold sore occured 3 days after. went to urgent care and was given 2 valacyclovir 2000mg BID PO.
Pt. received two doses of Anthrax vaccine.  First dose given 3 November 2007 without reaction.  The second dose given 8 December 2007.  Pt reported C/O SOB, chest tightness, and generalized itchiness.  SX began aprox. 6 Hrs after immunization.  Pt stated she took Benadryl for SX with relief of SX.
patient received an extra dose of MENQUADFI with no reported adverse event; Initial information received on 28-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old female patient where patient received an extra dose of menquadfi with no reported adverse event while receiving vaccine meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hpv vaccine vlp rl1 4v (yeast) (gardasil) and meningococcal vaccine b rfhbpa/fhbpb (trumenba) for Immunisation.  On 28-Apr-2023, the patient received 0.5 ml dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection (frequency- daily) (batch number- U7447AC and expiration date-20-Sep-2024) via intramuscular route in the right arm (strength: not provided).  On 28-Apr-2023 the patient received an extra dose of menquadfi with no reported adverse event (extra dose administered) (latency- same day) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the 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 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.
Two swollen eyelids, lips, and lining of nose.  Eyelid edema. Very painful arm at injection site. Still present from 11/14/2021- 11/15/2021. Taken two claritin after onset of swelling.
I was diagnosed with shingles. Nerve and muscle pain on right side of neck and rash on upper back,   below the neck pain area. Was taking steroids and muscle relaxant. Had persisted for about 3 weeks before Covid vaccine 2/18/2021. At time of vaccine I thought I was essentially over the shingles because pain and rash essentially gone. That late afternoon and night after the vaccine and all the next day I was in excruciating pain in the same location as my shingles. I attribute it to the Covid vaccine reinflaming the nerves that were inflicted with the shingles virus. I have not had Shingrix. I am currently taking an antiviral, Gabapentin, Methocarbomol, Tramadol, Ibuprofen, Acetaminophen, all for the neck pain.
Infant fell sleep around 7pm in parents bed. Parents noted her making noise around 9:45pm and then saw arm move in jerking motion.  Child stiff and obviously seizing (general, tonic clonic). Pale, "burning up", then lips turned blue/not breathing. EMS responded. T=105.4 rectal in ER. Seizure activity for at least 30min per parent. Fever took 1-2hrs to come down. Patient with decreased level of response/dazed/sleepy for same amount of time.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Feb2021 as dose 2, single (Lot number: EL1283) at the age of 39 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Jan2022 as dose 3 (booster), single (Lot number: 028k21a), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune disease" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jun2022) positive, notes: Positive antigen test 10Jun2022 after symptoms for 1 day,; (14Jun2022) negative, notes: negative test on 14Jun2022 symptoms resolved; (21Jun2022) positive, notes: HA developed and tested positive on 21Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 16-JAN-2012 at 7:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 28-FEB-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671141/1267AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
The pt experienced cellulitis with induration, a 4 x 6 cm posterior lateral aspect of left thigh.
LUE cellulitis with erythema, induration 18 cm in length on left lateral deltoid. Pt admitted to hospital x2 days with IV antibiotic administration.
This case was reported by a consumer and described the occurrence of Guillain-Barre syndrome in a 76-year-old female subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). A physician or other health care professional has not verified this report. On 28 October 2013 the subject received a dose of Influenza vaccine unspecified (details unknown). It was reported that "two vaccines in the flu shot mixed". On 19 January 2014, 83 days after vaccination with Influenza vaccine unspecified, the subject experienced fell. The patient's symptoms began on 19 January 2014 when she fell three times. On 20 January 2014, 84 days after vaccination with Influenza vaccine unspecified, the patient went to the emergency room and was first treated for low sodium. On an unknown date in 2014, months after vaccination with Influenza vaccine unspecified, the subject experienced "numbness of hands, feet and arms", "paralysis of whole body", arm paralysis and Guillain-Barre syndrome. The subject was hospitalised. The subject was discharged from the hospital on 10 February 2014 when transferred to transitional rehab facility. The patient was treated with plasmapheresis five times. The patient underwent acute physical therapy. Relevant test results included sodium of 117 on 20 January 2014 and spinal tap in 2014 that "confirmed it" [diagnosis]. At the time of reporting the arm paralysis and Guillain-Barre syndrome were unresolved, but the whole body paralysis was considered resolved; the fell was resolved and the outcome for the low sodium and numbness was unknown. At the time of the report, the patient was still at the rehab facility because she was "not able to function on own".
Throbbing pain, body aches, body chills.  Tylenol helped.  Lasted 18 hours.