chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immunocompromised; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jan-2022 and was forwarded to Moderna on 28-Jan-2022.    This spontaneous case was reported by a physician and describes the occurrence of IMMUNODEFICIENCY (Immunocompromised) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNODEFICIENCY (Immunocompromised) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (Immunocompromised) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. It was reported that the patient received his first 2 primary doses without issue. He then received a 3rd dose of the vaccine 5 months later as a 0.25mL dosage and the patient was now immunocompromised and was asking about the 4th dose of the vaccine. Would it be possible to administer an additional booster dose although the 3rd primary series dose was administered at a different dosage. Treatment information was not provided.  Unknown dates of administration. No patient information available. No known symptoms or treatments. Colleague she has been discussing this with stated it was an "increasingly common question." She thinks this may indicate that this could have occurred with more than one patient.  This is a regulatory case concerning a male patient of unknown age with no medical history reported, who experienced the unexpected event of immunodeficiency. The event and the received dose of mRNA -1273 vaccine occurred on an unknown date. Immunodeficiency was reported as medically significant and at the time of report  the outcome was still unknown. The reporter's assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This is a regulatory case concerning a male patient of unknown age with no medical history reported, who experienced the unexpected event of immunodeficiency. The event and the received dose of mRNA -1273 vaccine occurred on an unknown date. Immunodeficiency was reported as medically significant and at the time of report  the outcome was still unknown. The reporter's assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.
Severe vertigo. Dizziness lasted several hours. Eventually went away after roughly 8 hours.
a terrible time sleeping; feet and hands were ice cold; chills; coughing; sneezing; blowing her nose; Felt like she wanted to vomit; Felt short shots in her heart and lungs; Felt short shots in her heart and lungs; Can't eat much food; Feels an erratic short pain on right side of head; Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people; Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people; very bizarre dreams; pains underneath her arms; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration on 01Feb2021 (at the age of 77-years-old) as 2nd dose single for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient experienced a, had to use tons of blankets to get warm, very bizarre dreams (bizarre experience), pains underneath her arms. On 01Feb2021 experienced terrible time sleeping, feet and hands were ice cold, chills, coughing, sneezing, blowing her nose, felt like she wanted to vomit, felt short shots in her heart and lungs, cannot eat much food, feels an erratic short pain on right side of head. Got the second Pfizer shot on Monday (01Feb2021). Patient was seeing dreams and wild things. Woke up yesterday (02Feb2021) morning and it seemed to dissipate by yesterday noon time. Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people. Clarified she is referring to the COVID-19 shot. The patient agreed that experienced these symptoms after receiving the second dose of the Pfizer COVID-19 vaccine and they lasted about 24 hours and today patient feels fine. The reporter was concerned that patient may have had COVID, possibly from the vaccine, and wants to know if she was contagious. It was queried if patient had a positive COVID test after receiving the second COVID-19 shot. Patient did not address question and stated she only received the first and second COVID-19 shot. The outcome of the events suspected COVID-19, drug ineffective, pain in extremity, abnormal dreams, sleeping disorder was unknown while for the other events was recovered on 02Feb2021.   Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts have been completed and no further information is expected.
Patient received the shot on Thursday 7/21/22 on Sunday 7/24/22  her arm from shoulder to elbow was tight and red. Her armpit was also sore. She said it was sore. She went to the doctor today 7/28/22 and was treated for suspected cellulitis. She was prescribed keflex 500mg 1 tid for 10 days.
Information was received 02 May 2008 from a health care professional. A 2-month-old male patient had received an injection of IPOL, lot number A0298-2 (date, route and site of administration not reported) and on 25 March 2008, he subsequently developed a black dot at the injection site. The reporter received a cluster of reports of black dots at the injection site from multiple satellite locations who were all affiliated with the reporter. This patient's case was one of four cases which were reported from the same satellite site. The information for the other three patients is contained in case numbers 2008-1338, 2008-01427, and 2008-1429. All facilities used McKesson alcohol wipes and syringes which included safety glide and vanish point with 25 gauge needles. Some of the black dots were reported to have appeared immediately with some present two months post immunization. This event had been noticed by all health care workers at the facilities and had not been noticed in the past. The reporter indicated follow-up information would be provided as it is obtained. The reporter for this case is the same as for case numbers 2008-01333 (IPOL and ActHIB), 2008-01334 (IPOL), 2008-01335 (IPOL), 2008-01336 (IPOL and DTaP), 2008-01338 (IPOL), 2008-01339 (Fluzone), 2008-01427 (IPOL), and 2008-01429 (IPOL).
pt started wheezing @ about 530PM-seen @ ER 630PM;pt seems to be cranky & having some difficulty breathing per mom;pt recv DTAP & HIB in MD office about 4hr earlier;some rash note by mom;in ER pt not observed to be wheezing or SOB;
right side weakness; tingling/ numbness in limbs; muscle twitches/ spasms; palpitations; dizziness; nerve, muscle & joint pain; nerve, muscle & joint pain; nerve, muscle & joint pain; altered sensations; heat & humidity intolerance; heat & humidity intolerance; difficulty concentrating/ finding words; balance and gait issues; balance and gait issues; fine muscle movement issues- hands; blurring vision; muscle spasms; tingling in limbs; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, administered in right arm on 14May2021 10:45 (Age at vaccination: 22 year) as DOSE 2, SINGLE for covid-19 immunization. The patient past Medical history included hypothyroidism from an unknown date and unknown if ongoing and migraine from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE) taken for an unspecified indication, levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication and topiramate (TOPIRAMATE) taken for an unspecified indication. The allergies include Azithromycin. The patient previously took bnt162b2 dose 1 via an unspecified route of administration, administered in right arm on 23Apr2021, 10:45 AM   dose 1, single (lot number: ER8732) for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On an unspecified date in May2021, the patient experienced right side weakness, tingling/ numbness in limbs, muscle twitches/ spasms, palpitations, dizziness, nerve, muscle & joint pain, altered sensations, heat & humidity intolerance, difficulty concentrating/ finding words, balance and gait issues, fine muscle movement issues-hands and blurring vision. AE resulted in: Doctor or other healthcare professional office/clinic visit. The event outcome was not recovered.  No further information is expected.  Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected
patient received dose of Moderna vaccine post excursion; patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion).    No concomitant medications were reported.  It was reported that the patient received a dose of Moderna vaccine post excursion.  Treatment information was not provided by the reporter.  This case contains information for 2nd of the 19 patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-706941 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-706941: Master case
Vertigo I have 2 cochlear implants and suffered severe vertigo with the second that lasted for weeks.   This is the first day after but I feel pretty bad.  Too sick to get up and move around.
A 16 year old patient was administered the first dose of the Moderna COVID-19 vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient was administered the first dose of the Moderna COVID-19 vaccine.) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient was administered the first dose of the Moderna COVID-19 vaccine.). On 08-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient was administered the first dose of the Moderna COVID-19 vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: followup received: Second dose details, patient demographics were added
Asthma exacerbation (wheezing, cough ,short of breath) that necessitated an urgent care visit. Treated with decadron injection and medrol dose pack.
Information has been received from a nurse practitioner for the Pregnancy Registry for GARDASIL concerning a 22 year old female who on 27-NOV-2007 was vaccinated with her first dose of GARDASIL (lot # 659437/1266U) and is pregnant.  The patient's LMP was reported as 18-NOV-2007.  The patient had routine prenatal labs.  Subsequently the patient experienced no known symptoms.  Follow-up information was received from a nurse practitioner which reported that the 22 year old female with a history of 2 pregnancies and 1 live birth and a history of cervical intraepithelial neoplasia II-III in 2006, atypical cells of undermined significance (ASCUS)/negative HPV and loop electrosurgical excision procedure (LEEP) and sepsis (February 2006) delivered a normal, healthy male baby weighting 8 pounds on 22-AUG-2008 (weeks from LXP: 39).  On 08-APR-2008.  09-JUN-2008 and 07-AUG-2008 ultrasound indicated there were no anomalies.  On 28-APR-2008, maternal serum alpha-fetoprotein (MSAFP) was negative.  Prenatal vitamins were taken from 22-JAN-2008.  There were no complication during pregnancy and labor/delivery.  There were no infections or illnesses during pregnancy.  Additional information is not expected.
Tingling in hands & feet 36 hours after getting ZOSTAVAX, resolved within a few days.
This spontaneous report as received from a patient's friend refers to his 27 year old female friend. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017 at the age of 27 years old, the patient began GARDASIL 9 series (first and second dose administered on day 0 and 2 months respectively) (dose, lot #, expiration date and route were not reported). No adverse reaction reported. For the third dose of GARDASIL 9, the patient was schedule for an appointment "next month" which has been more than a 6 month interval from the time she received the second dose and the patient was a bit concerned for this timeframe.
A report has been received from a Health Professional concerning a 18 year old, male subject, who had been received nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 25-NOV-2014. The patient was given expired FLUMIST Quadrivalent on 25-NOV-2014. The outcome of the event of expired FLUMIST Quadrivalent given to patient is unknown. The report was considered to be non-serious.
Crying since visit 5 hours ago. Shaking and tremors of arms/legs since appox 2 1/2 hours ago. Not eating well since vaccine. Did start to breast feed better tonight at office.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022; No adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022).    No concomitant product use was reported.  Patient had received half dose.  Vial did not undergo any temperature excursions.  No treatment information was provided.
Headache, Sedation, Myalgia, Fever, NauseaVomiting, Sore Arm Narrative:  Received 2nd dose on 1/20/21. Noted sore arm and increased fatigue that evening. Awoke at 1 am on 1/21/21 with fever (102F), myalgias, chills, HA and nausea. Headache continued into 1/22/21, with improvements in other symptoms. Missed one day of work. No known prior COVID infection   Other Relevant History:
Patient received Pfizer 12yr and up vaccine instead of 5-11yr old.  Dose was 0.3mg  patient did not have any adverse effects patient was discharged home after receiving vaccination
Information has been received from an attorney alleging that a male received Orimune (number of doses not specified) between 3/1968 and 10/1970. In September or October/1970, the pt was dx'd with a brain tumor and as a result "sustained numerous injuries". Tumors and tissues from the pt were tested and were positive for SV40. As of the date of this report, no further information was available. Brain neoplasm is considered "Medically Important".  Follow up on 08/25/2003: "Follow up information received on 08/13/2003 provided medical records.  Information has been received from an attorney alleging that a male received Orimune (number of doses not specified) between March 1968 and October 1970.  On 09/28/1970, he was hospitalized with a 3 week history of vomiting following a fall from his crib.  An echo encephalogram revealed a large echo-free area in the right hemisphere.  An angiogram revealed a large avascular cystic mass in right temporal-occipital area with a large amount of surrounding edema.  A brain scan revealed a large right occipital mass.  He was diagnosed with a right temporal-parietal-occipital mixed astrocytoma.  On 08/30/1970, he underwent surgery for removal of the neoplasm.  Pathological sectino of the neoplasm showed ependymal, astrocytic, and cystic features.  On 10/05/1970, he was discharged.  The results of a psychometric evaluation performed on 07/03/1972 placed his functining in the category of mild to moderate retardation.  The legal complaint states that tumors and tissues from the patient were tested and were positive for SV40."
Transient tachycardia, transient difficulty swallowing, three separate short duration occurrences at 10:00, 11:00, and 5:00 p.m.  no treatment
Heart palpitations, dizziness, fatigue, stomachache, chest pressure/tightness, headache, chills
Information has been received from a physician concerning a 64 year old female who in approximately January 2008, was vaccinated SC with a dose of zoster vaccine live (Oka/Merck). Two months later, in approximately March 2008, the patient developed zoster opthalmicus. Unspecified medical attention was sought. The patient's zoster opthalmicus persisted. A product complaint was not involved. No further information is available.
Summary:66-yof with past medical history of ESRD HDD Monday Wednesday Friday, COPD not on home oxygen, hypertension, depression, hyperlipidemia, who comes to the ED with 4 weeks duration of generalized malaise, fatigue, and loose stool.  Incidentally she reports her daughter tested positive for Covid on Sunday and she was exposed at that time, but sx pres for several wks .  She was noted have a fever of 102.3.  Ferritin 1086.  Her O2 sats declined to 92 percent the emergency room.  She also tested positive for Covid 19.
Approximately 18 hours after vaccination with Hep B and MMR, pt developed an uticarial rash.  No respiratory or systemic symptoms.
Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Recipient ID was 8620019.   No concomitant medication were reported.  It was reported that vials had not undergone any temperature excursion. Total of 102 doses/vials were given for LOT 026C21A.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non significant information.
Received Pfizer vaccines on  11/18/21, 12/9/21 admitted to hospital on 3/11/22 for workup of "Dizziness" and prolonged QT interval, found to be COVID positive by PCR on 3/11/22.
Low grade temperature, minor runny nose and sore throat, not a big deal. Major gastrointestinal stuff; 12 hours of vomiting and I'm on day 7 of diarrhea. I started to feel it in my chest yesterday and called my doctor, it feels like the Valley Fever. I was given PAXLOVID last night.
Patient felt dizziness, pulse was 48, legs felt tingly, laid her down for 15 minutes.  Then her pulse returned to normal.  Had her set for 10 minutes pulse continued to remain normal legs felt fine.  Then had her stand and pulse was normal.  When she went to take a step she felt dizzy, legs gave out.  Immediately we laid her back down.  Pulse was thready and skipping every 4th to 5th beat.  Immediately we called 911.  Took her blood pressure which was in normal range.  EMS showed up and took over.
chills, body aches, mild low grade fever of 101. Dull headache.
rash appeared on back & legs, itching, t103 to ER given DPH; t97 in ER:20OCT92 tc to g'ma no temp rash persists: refer to md; dx of reaction to DTP made in ER: