chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Finally urinated and it was dark in color; Induration of erythema about 3 inches; Acute renal failure; Felt so dry and realized I did not urinate; Disoriented; Sustained tachycardia for about 26 hours straight; Couldn't lay on left side; Induration of erythema about 3 inches; chills/rigors; Chills and sweats, back and forth; Severe tremor, rigors/Chills; Temperature was 104.1/ Fever persisted; Significant headache/Worst headache of her life; Body aches; Nausea; Vomiting; A spontaneous report was received from a consumer who is a physician's assistant) concerning 46 year old female patient.  Medical history included cystic fibrosis.  No relevant concomitant medication was reported.  On an unspecified date, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown)  for prophylaxis of COVID-19 infection. On 04Feb2021, the patient received the second dose of mRNA-1273 (lot number 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 05Feb2021, the patient experienced severe tremor, rigors, temperature of 104.1, significant headache (described as worst headache in her life), persistent fever, body aches, nausea vomiting, chills and sweats back and forth.  The patient was in bad all day 04Feb2021 (Thursday) through Saturday until 2pm.  She felt dry and did not urinate, until after a bag of unspecified intravenous fluids, when she finally urinated in was dark in color (the patient considered herself to have acute renal failure). The patient also experienced sustained tachycardia for 26 hours, was disoriented, had induration of erythema about three inches at the vaccination site, and could not lay on her left side.  The patient treated herself with ibuprofen and Tylenol for fever and body aches.  The patient reported she was fine on 08Feb2021.   Action taken with the mRNA-1273 in response to the events was not reported.  The outcome of the events of acute kidney injury, urinary retention, tremor, pyrexia, headache, pain, nausea, vomiting, hyperhidrosis, chromaturia, tachycardia, disorientation, vaccination site induration, vaccination site erythema, hypokinesia, and chills was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events , a causal relationship cannot be excluded.
Red soreness at time of vaccine, extreme fatigue, numbness tingling in hands & feet, severe nausea still to this date, lightheadedness, lack of premenstruation. Bowel issues possible blockage in March/2008. Healthy child is now so very ill!! 12/02/2008 Reviewed PCP office records which consisted only of lab reports & vaccine records w/o lot #s. 12/23/08 Reviewed additional PCP office records which are difficult to read but reveal patient experienced feeling unwell & being fatigued since 1/08. Started w/possible GERD, abdominal pain & throat tightness in 6/08. GI viral illness, ear pain, anxiety, dysuria.  GI clinic eval of 7/08 included  Endoscopy 9/08 for GI issues.  Seeing counselor for anxiety & depression. Per follow-up: October 8, 2008. To Whom It May Concern: I have enclosed the adverse reporting form with a copy of my daughters shot records. I am Very concerned about the HPV shots that she received this past year. She has always been a very healthy child until the first shot of HPV. I mean healthy!!! WE have been to several gastroenteritis's, counselors, specialists as well as frequently to our pediatrician looking for answers. I had asked my pediatrician months ago if it could be the HPV shots and always got "not possible" as an answer. I am very frustrated with all that my child is still going through and curious if there is anything else I should be doing or could be doing, or persons I should be in contact with. I am at a loss of what to do to help my daughter with these horrible side effects. Please contact me with any suggestions small or large. Thanking you in advance!!
1st dose Jul2021, 2nd March 2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in July 2021 ).   In MAR-2022, the patient received the 2nd dose of Shingrix. In MAR-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose Jul2021, 2nd March 2022). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 04-MAY-2023 The pharmacist reported that no exact vaccination dates or lot number for the vaccine were available because it was at a different facility. The reporter did not consent to follow up. The patient received 2nd dose of Shingrix vaccine later than the recommended interval, which led to lengthening of vaccine schedule.
18hrs after shot, fever 100.5, chills, body ache. I felt better 36hrs after shot. A few days following the shot, my taste and smell started to change. Certain things have a very distinct smell and matching taste. Most are liquids. For example Coke and Gatorade smell and taste exactly the same and it?s a terrible taste. Shampoo, tooth paste the same. Foods have recently started to taste the similar, there has been no improvement since it came on.
Jynneos vaccine administered intramuscularly; Case reference number US-BN-2022-003510 is a spontaneous case report initially received on 23-Sep-2022 from a nurse via Communication (reference number: USBAV22-1515) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at unknown dose, administered intramuscularly at unknown site, for monkeypox prophylaxis (explicitly coded as 'inappropriate route of vaccination').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos  Additional information received on 23-Sep-2022 from Communication included Jynneos indication and a dose number.; Reporter's Comments: A patient of unknown demographics was vaccinated with the first dose of Jynneos vaccine at unknown dose, administered intramuscularly at unknown site, for monkeypox prophylaxis, which is considered as inappropriate route of vaccination. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the first dose of Jynneos vaccine at unknown dose, administered intramuscularly at unknown site, for monkeypox prophylaxis, which is considered as inappropriate route of vaccination. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
pt became ill w/acute lymphocytic leukemia on 23OCT93 soon p/flu vax; pt exp flu like sx & acted tired; pt had little red dots all over body; dx acute lymphoblastic leukemia;
Red pruritic urticarial rash at injection site. Few papules showed up within 24 hours of vaccine, faded away, and then large rash broke out 7 days after vaccine.  Also developed mild Id reaction rash on bilateral forearms approximately 3 days prior to rash at injection site (4 days after vaccine).
swelling on the inside of her knee that was big like a hand; rash on both legs, from her knees up; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on both legs, from her knees up) and JOINT SWELLING (swelling on the inside of her knee that was big like a hand) in a 79-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 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced RASH (rash on both legs, from her knees up). On 03-Feb-2021, the patient experienced JOINT SWELLING (swelling on the inside of her knee that was big like a hand). On 04-Feb-2021, RASH (rash on both legs, from her knees up) and JOINT SWELLING (swelling on the inside of her knee that was big like a hand) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included For the symptoms: cream on her skin., Other: blood pressure medicine.   Reporter did not allow further contact
Tested positive for IgG; Tested positive for IgM; This case was reported by a physician via call center representative and described the occurrence of igg in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, between 1 and 2 months after receiving Shingrix, the patient experienced igg and igm. On an unknown date, the outcome of the igg and igm were unknown.   It was unknown if the reporter considered the igg and igm to be related to Shingrix.  Additional case details were reported as follows: The patient tested positive for both IgG and IgM approximately one to two months post receipt of Shingrix doses. The reporter did not have lot or expiry date for either dose of shingrix as it was given at a pharmacy.      Lab Comments: lab test performed on unknown date
Patient RECIEVED T-DAP VACCINE 2/29/2008, WAS IN 3/5/2008 AND SAID SHE HAD DEVELOPED FEVER AND CHILLS FOR TWO DAYS AFTER RECIEVED VACCINE.
expired dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   On 7th February 2023, the patient received Havrix. On 7th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The pharmacist reported that an unknown patient received an expired dose of Havrix.  The vaccine was expired on 16th December 2022. The HCP (health care professional) did not had any patient details at the time of report. The reporter consent to follow up via email. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sore armpit; Felt unwell; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 12:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. 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 vaccines within four weeks prior to the COVID vaccine. On an unknown date in Apr2021, the patient experienced sore armpit and felt unwell. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events, The clinical outcome of the event sore armpit and felt unwell were recovered on an unknown date in Apr2021, at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. Concurrent or historical condition was not provided. On unknown dates the patients were vaccinated with inappropriately stored PROQUAD (therapy type, dose and route were unknown). Concomitant therapy was not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Varicella vaccine administered 08/26/2002 as part of routine 12 month checkup, Child presented 09/10/02 with chicken pox lesions.
I was poked twice, the vaccine was administered on the second poke. After the first time he put the needle into my shoulder, he said that he "hit something hard" and didn't "want to just stab through it." He immediately poked me again and gave me the vaccine. Both pokes were much higher than usual. The morning after I had received the vaccine, my arm was in excruciating pain and my range of motion was almost nonexistent. I expected this side effect, but I did not expect it to last this long. It has been 3 days and my arm is still nearly immobile and testing the mobility is very painful. I haven't taken any medication since the adverse event. I visited an urgent care facility today and was told to fill out this form during the consultation.
couldn't sleep; warm; swollen at the injection; Patient experiencing soreness; redness; feverish; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep), VACCINATION SITE WARMTH (warm), VACCINATION SITE SWELLING (swollen at the injection), VACCINATION SITE PAIN (Patient experiencing soreness) and VACCINATION SITE ERYTHEMA (redness) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-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 INSOMNIA (couldn't sleep), VACCINATION SITE WARMTH (warm), VACCINATION SITE SWELLING (swollen at the injection), VACCINATION SITE PAIN (Patient experiencing soreness), VACCINATION SITE ERYTHEMA (redness), PYREXIA (feverish) and MYALGIA (muscle pain). At the time of the report, INSOMNIA (couldn't sleep), VACCINATION SITE WARMTH (warm), VACCINATION SITE SWELLING (swollen at the injection), VACCINATION SITE PAIN (Patient experiencing soreness), VACCINATION SITE ERYTHEMA (redness), PYREXIA (feverish) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported No treatment medications were reported
Swelling, red and arm to touch at injection site. Benadryl given with success per pt's mother.
Continuous screaming (shrieking cry) over 3 hours. only on that day. Resolved without intervention.
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: PATIENT REPORTED ARM PAIN AND PASSED OUT BRIEFLY (ABOUT 15-20 SECONDS) - GAVE WATER AND MONITORED FOR 30 MINS. TOOK BP 105/78 WHICH MOM REPORTS AS NORMAL FOR PT. FULL RECOVERY EXPECTED
MENQUADFI underwent temperature excursion was administered to patient with no reported adverse event; Menquadfi reached a low temperature of 32.9F with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 18 years old patient of unknown gender who was administered the Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] that underwent temperature excursion and reached a low temperature of 32.9 F with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-May-2023, the patient received dose 2 dose 0.5 ml of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection of lot U7576AB and expiry: 28-Feb-2025 via intramuscular route in the left arm for prophylactic vaccination (immunization).  On an unknown date, it was reported that Meningococcal A-C-Y-W135 (T CONJ) vaccine reached a low temperature of 32.9 F with no reported adverse event (product storage error) (unknown latency).  On 01-May-2023, the patient was administered Meningococcal A-C-Y-W135 (T CONJ) vaccine that underwent temperature excursion with no reported adverse event (poor quality product administered) (latency: same day).   No lab data was reported.   Action taken was not applicable.   At time of reporting, the outcome was Unknown for both events.  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.
Patient got 2 doses of the J&J vaccine (1st: Lot 1802072 on 3/8/21 at pharmacy. 2nd: Lot 1822811 on 12/8/21 at pharmacy). Patient came in today here at pharmacy asking for the Pfizer booster 3rd dose.  There was a language barrier between the patient and staff. The patient was given the adult pfizer vaccine today 12/29/21 without the technician checking the vaccination card and vaccination screening/questionnaire form. The technician realized after administering the vaccine that the patient shouldn't have gotten this type of shot. Patient kept saying everybody told them to get the pfizer 3rd dose but didn't understand that the j&j booster suffices. The pharmacist was notified after the vaccine was administered. Patient was told to wait the entire 15 minutes. Pt had no reaction during the wait time.
on 18JAN94 immun given 130PM very fussy all day high pitched cry few hrs; next day 19JAN94 very fussy all day; cried 3 hrs; 5PM to 9PM;
arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little sore) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. DIZAZIA) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-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 PAIN IN EXTREMITY (arm was a little sore). At the time of the report, PAIN IN EXTREMITY (arm was a little sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication reported. No treatment information was provided.    This case was linked to MOD-2021-363679, MOD-2021-363695 (Patient Link).
Initial reaction (after this second dose) was fatigue and muscle soreness like a mild flu. It took a couple of days to resolve.  I am reporting because of the 6 day hospital stay 45 days later, which may possibly be related.
12 years old patient given 1st dose of moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 years old patient given 1st dose of moderna vaccine) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 years old patient given 1st dose of moderna vaccine). On 24-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 years old patient given 1st dose of moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.
possible that only the diluent was delivered/no AE; Initial information received on 08-Jan-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] by incorrect reconstituation.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via intramuscular route in the thigh.  It was of actual medication error due to Inappropriate reconstitution technique.  It was unknown whether adverse event was noticed or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  The information on the batch number was requested.
Exactly one week after getting the Covid vaccine due to a mandate by the Governor in order to keep my job I lost vision in the top part of my left eye.  I first went to the Clinic to the eye dr.  She stated I had an optic nerve stroke.  I was referred to a neuro ophthamologist at Hospital.  I don't remember his name. He stated the same thing - but called it an ischemic Optic neuropathy.  He stated that it could have been caused by the vaccine or by my diabetes. However, since I have been diabetic for 14 plus years it is more likely from the vaccine.  He would not put that in writing however.
This spontaneous report was received from a medical assistant and refers to a 54 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 16-JUN-2017, the patient was vaccinated subcutaneously with an expired dose of M-M-R II injection (lot # K009956, expiration date: 14-JUL-2016; therapy type, exact dose were not reported). Concomitant therapy included properly stored MERCK STERILE DILUENT. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
** flu vaccine administered; informed via fax (after the fact) that patient received vaccine one day prior at another pharmacy**