chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report from a contactable physician via a Pfizer sales representative. A 89-years-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on unspecified date in the fall of 2015 at 0.5 ml, single for immunisation. The patient medical history and concomitant medications were not reported. Within 24 hours of the injection in 2015 the patient experienced flu like symptoms with outcome of unknown. Follow-up (05May2016): Follow-up attempts completed. No further information expected.
reporting a pregnant patient inadvertently received 2 doses of adacel with no reported adverse event; pregnant patient received adacel with no reported adverse event; Initial information received on 13-Nov-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 16 years old female pregnant patient where patient inadvertently received 2 doses of diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported reporting a pregnant patient inadvertently received 2 doses of adacel with no reported adverse event occurred at 34 weeks of pregnancy and pregnant patient received adacel with no reported adverse event occurred at 34 weeks of pregnancy and the patient was exposed to vaccine at 29 weeks of pregnancy, during third pregnancy trimester for diphtheria-2/tetanus/5 ac pertussis vaccine.  The date of last menstrual period was reported as 23-Feb-2023. The estimated due date is 30-Nov-2023.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Sep-2023, the patient received a dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (lot U7869AA and expiration date- 18-Aug-2025) via intramuscular route in the right deltoid. On 17-Oct-2023 she also received a dose of the same vaccine lot U7869AA via intramuscular route in the right deltoid (dose, formulation, strength: not provided) for Immunisation (inappropriate schedule of product administration) and (exposure during pregnancy) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event and Additionally, at time of reporting, the pregnancy is still ongoing.  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.
Moderna COVID-19 vaccine was administered to patients past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.
This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a 4-month-old female patient who received ROTARIX (batch number A41CB512A, expiry date 10th February 2017). On 8th September 2015, the patient received ROTARIX (oral). On 8th September 2015, less than a day after receiving ROTARIX, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown. It was unknown if the reporter considered the vomiting to be related to ROTARIX. Additional details provided were as follows: The ROTARIX was administered to the patient, but she spitted it out and it splashed into the eyes and mouth of her mother (see case US2015128886 for accidental exposure to mother).
died; Initial information was received on 10-Dec-2021 regarding an unsolicited valid Social Media serious case received from a Consumer via social media.  This case involves an adult female patient (unknown age) who died (death) while receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient died (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  It is unknown if the patient experienced any additional symptoms/events.  Laboratory data and corrective treatment prior to death were not reported.  At the time of reporting, cause of death was not reported, it was unknown if autopsy was done.  Information on the batch number was requested.; Sender's Comments: This was a poorly documented social media case received from Facebook involves an adult female patient (unknown age) who died, after receiving INFLUENZA VACCINE. Time to onset is unknown. Additional information regarding patient's relevant medical history, health condition at time of vaccination, laboratory tests ruling out other alternate etiologies and autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Died
30 minutes after receiving the 2nd dose of covid vac I experienced a high pitched ringing in both ears, followed by a rhythmic pulsing whooshing sound in both ears. This pulsatile tinnitus ha s been going on for 6 month. Audio test revealed a significant hearing loss in both ears. Dr ordered a ct scan with contrast to rule out brain tumor. No tumors exist. The puise timmitus is most likely permenant resulting in significant hearing loss in both ears.  I willneed hearing aids.
This is a prospective pregnancy case. This 34-year-old female subject was enrolled in a study. The subject received BOOSTRIX (injection) .5 ml on 17th October 2014 11:32. Co-suspect products included FLUVIRIN. Concurrent medical conditions included epilepsy. Concomitant products included LAMICTAL and Prenatal Vitamins. The subject's last menstrual period was on 24th January 2014 and estimated date of delivery was 31st October 2014. The subject received BOOSTRIX at week 38 of the pregnancy and during the third trimester of pregnancy. On 18th October 2014, 1 days after receiving BOOSTRIX the subject developed muscle soreness (Non-serious). Additional event(s) included vaccine exposure during pregnancy and inappropriate preparation of medication. The outcome of muscle soreness was recovered/resolved. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown) and inappropriate preparation of medication (unknown). The pregnancy was ongoing. It was unknown if the investigator considered the muscle soreness to be related to BOOSTRIX. Additional information received on 09 October 2014: The patient received a dose of BOOSTRIX and FLUVIRIN mixed in the same syringe at clinic. The last menstrual period was not reported but was calculated with the due date of 31 October 2014.
Pain in arm similar to tetanus shot; Slight headache off and on for a day; Slight fatigue; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Apr2021 at 13:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to soy milk. The patient previously took amoxicillin on an unknown date for unknown indication and experienced drug allergy.  Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 14:30 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. On 25Apr2021 at 00:00, the patient experienced pain in arm similar to tetanus shot, slight headache off and on for a day and slight fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in arm, headache and fatigue were recovered on 25Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in 2016 (reported as after 29-JUL-2016), the patients received improperly stored (at 0.3 degrees Celsius for a total of five hours and five minutes) doses of M-M-R II lot number L036851, expiration date: 23-SEP-2017, therapy type rHA (recombinant human albumin) (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Bled a lot at injection site during administration (left arm); This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bled a lot at injection site during administration (left arm)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 024A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On 07-Apr-2021, the patient stated that after her 2nd dose, her left arm bled a lot at the injection site and blood ran down her arm and the patient was concerned if the vaccine came out through the blood and if she received the full dose?  On 07-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bled a lot at injection site during administration (left arm)) (seriousness criterion medically significant). At the time of the report, VACCINATION SITE HAEMORRHAGE (Bled a lot at injection site during administration (left arm)) outcome was unknown. Not Provided     No relevant concomitant medication were provided. No treatment information was provided.; Sender's Comments: This is a case or injection site bleeding during administration of mRNA-1273.  Based on the available information, a causal association between the product administration and the event cannot be excluded.
Very sore and tender breasts.  Started on my left side but now seems to be on both.  Had a breast exam last week and no lumps.  I have a mammogram scheduled for next week.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed a varicella type rash on the body, forehead, upper chest and scalp. The pt had 40 lesions.
First pain in whole arm and across my chest. Then chills and all over body aches. I also have fatigue. It began around 9 pm and is getting worse at 11:15pm.
Starting around 9am Tuesday 4/6/21 I began getting chills and my entire body hurt.  By 12 noon I had a splitting headache.  I left work and went home to sleep.  I was unable to sleep due to the headache. I took my temperature with a digital thermometer around 4PM.  I was running a 102 fever.  I took three 200 mg Advil around 6pm.  My headache got better over the next hour.  My fever broke around 9pm that night.  I soaked through a shirt.  That afternoon and evening I experience joint pain.  It felt like needles being jabbed into my joints.  Or like lightening strikes in my joints.  I got a full nights sleep and the next day I felt 95% better.  This was my second shot.  I got it at the pharmacy.
No appetite; Aching; Temperature of 100F; Chills; Sore arm (left arm); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm (left arm)) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm (left arm)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm (left arm)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Body temperature: 100 (High) 100 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient stated she was not taking other medications.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: No new information
10 minutes following vaccination patient had difficulty breathing. Pharmacist helped patient to the ground. Intern called 911. Patient had two seizures as well. Pharmacist attempted to administer epinephrine. Medics arrived and patient was doing better. Patient came back a few hours later to let us know she was ok and thanked us.
4 month old 24 week preemie with multiple medical problems, discharged from NICU 6 days ago received second set of immunizations today.  Initial immunizations were given at 2 months of age without adverse effect.  Baby was fine initially and went home.  Approximately one hour after the immunizations, while his parents were playing with him on the bed, he appeared to be straining.  (Parents initially thought he was trying to roll over.)  They describe his appearance as "stiff" but without clonic movements.  Parents state that his lips looked a little blue and he seemed to be "foaming at the mouth".  No change in level of consciousness was noted.  Parents considered calling 911 but the baby seemed better so they returned to the office.  On arrival at the office, baby was afebrile with normal vital signs, awake and alert.  Mother described him as normal.  Physical exam was benign.
Reports  she developed an itchy arm, then noticed it was also red and warm to the touch on 11/12/2021 course of Cephalexin 500 mg  tablet(s) 3 times a day by oral route for 7 days
Information has been received from a doctor's office concerning a female patient who on approximately 08-NOV-2010 or 09-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # not provided). It was reported that the patient unfortunately got two PNEUMOVAX 23 vaccines within a 7 day period. She experienced a localized reaction, including redness and swelling. What happened was she came back to get the flu vaccine (the reporter supposed the doctor did not want her to receive both the same day) but when she returned, she said she was supposed to get PNEUMOVAX 23. The office employees took her by her word, instead of reading from the chart, and proceeded to give her the PNEUMOVAX 23. At the time of this report, the patient's outcome was unknown. Follow up information was received from a doctor of osteopathy concerning a 80 year old female with chronic obstructive pulmonary disease (COPD), allergy to codeine and morphine, coronary artery disease (CAD), breast cancer and hypertension who on 01-NOV-2010, was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml (Lot No 667271/0680Z). The patient returned to office on 09-NOV-2010 for flu vaccine and was given erroneously an other dose of PNEUMOVAX 23. The physician spoke with the patient on 09-NOV-2010 due to swelling and redness on the right arm, which alerted them to mistaken dose. At the time of the report the patient had recovered. No further information is available.
Patient reported headache, clamminess, feeling of being "hot inside" but no fever, increased pulse and heart rate.
Initial report received from a non-health professional calling for a consumer on 06 April 2011. A 31-year-old female patient received on an unspecified date an intradermal injection of 0.1 milliliters (ml) of Tetanus Toxoid Adsorbed Preservative-free, sanofi pasteur lot number U3349BA. The patient was inadvertently administered 0.1 ml of Tetanus Toxoid Adsorbed Preservative-free instead of TUBERSOL. The patient experienced skin irritation at the site and red, hardened area at the site. The reported declined further information and identification. The outcome was reported as unknown. Documents held by sender: None.
About 4 weeks, 37 days later, my daughter was paralyzed from the neck down. Due to her age, we were unable to determine how long this had been progressing to a condition of transverse myelitis. As per annual follow up report: She is a quadriplegic, Although making progress she is still in a wheel chair, limited hand function, limited leg ability. Weakened respiratory function, neurogenic bladder. It is unfortunate that there is no accurate method to prove causation.
This spontaneous report as received from a female consumer of unknown age refers to herself. On an unknown date the patient was vaccinated with ZOSTAVAX, vial (dose, route, lot # and expired date were not reported). Concomitant therapy was not reported. On an unknown date the patient experienced a red-hot, blistering rash at the injection site after receiving ZOSTAVAX. The outcome of adverse events was not reported. The relationship between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Some oval shaped redness in upper arm and shoulder near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Some oval shaped redness in upper arm and shoulder near injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concomitant products included BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (ZIAC [BISOPROLOL FUMARATE;HYDROCHLOROTHIAZIDE]), SIMVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), FISH OIL and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Some oval shaped redness in upper arm and shoulder near injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Some oval shaped redness in upper arm and shoulder near injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided.
She claims she developed itching after a few hours after receiving the vaccination earlier that morning and it progressively got worse on her back and both arms. She did not seek medical treatment until 12/15/17 for a rash covering her whole body from Dr. At that appointment she had a red and inflamed rash with scars on her back from itching and marks on her arms from constantly itching. The doctors office gave her a kenalog injection and triamcinolone cream to use twice daily as needed. The doctor's office informed the pharmacy on 12/20/17 about the potential that she could have had a reaction to the PREVNAR 13 injection and that they were doing additional allergy tests to rule out other causes. On 12/21/17 the pharmacy felt they should report the incident in the event that it was indeed an allergic reaction to the vaccination.
For about 24 hours after receiving the vaccine, I was tired and had a sore arm. I started not feeling well on 12/08/2022 with congestion and sneezing. I tested positive for COVID-19 on 12/12/2022. By the time I tested positive for COVID-19 I was passed the recommended time to start the medication. I also tested positive for COVID-19 on 12/27/2021.
She took him to the ER last night since he was throwing up to the point where he had nothing in his stomach. He was prescribed antinausea medication and discharged home. Today he is still throwing up but not as frequently. The medication seems to help. Temp now 99, nothing over 100. He still eating and able to keep down most feeds. Has the normal amount of wet diapers.   Vomited 4x, decreased appetite, decreased fluid intake, was given ondansetron 4mg/5ml
Hives localized to injection site showed up suddenly, about 1 week after vaccination. Redness, welting about 3 inches in diameter. Took benadryl. Hives began decreasing by the next morning. Completely resolved 3 days later.
This spontaneous report received from a patient via other company (RA) concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriasis. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 40 mg, 1 time every 2 weeks, from an unspecified date to JAN-2022 for psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced sinus issues, and headache. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the sinus issues and headache was not reported. This report was non-serious.