chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effect reported; the patient was inadvertently administered a dose of VARIVAX that had been improperly stored; This spontaneous report was received from a vaccine coordinator (also reported as office manager), concerning a patient of unknown age and gender. The patient's pertinent medical history, and past drug reactions / allergies were not provided. The patient's concomitant therapies included sterile diluent.  On 24-SEP-2019, the patient was inadvertently administered a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylaxis (lot # S008692, date of expiration: 21-MAR-2021, lot # S019463, date of expiration reported as 24-JAN-2021, upon internal validation established as 24-JUN-2021, and lot number R035222, date of expiration: 04-DEC-2020; all lot number have been verified to be valid lot numbers) (strength, dose, route of administration, and anatomical location were not reported), that had been improperly stored (Product storage error). All lots of varicella virus vaccine live (Oka/Merck) (VARIVAX)  were reconstituted with properly stored sterile diluent. No adverse effects were reported.   The administered dose of the vaccine experienced a temperature excursion of 27.1 Fahrenheit degrees for 40 minutes, as recorded by a data logger. There was no previous temperature excursion. No product quality complaint was filed.
soreness at injection site, swollen lymph nodes in armpit (same arm as injection), fatigue, fever of 100.5, cough
peronality changes from placid, loving pt to temperamental, aggressive & disobedient one; nightmares lasting half the noc; clumsy & frequent falls; sometimes refused to stand; sx lasted more than a month & parents took back to MD;
soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248) via an unspecified route of administration at right arm on 27Feb2021 at 11:00 as a single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration at right arm on 24Feb2021 at 9:30 as a single dose, for COVID-19 immunisation. Patient is not enrolled in clinical trial. The patient was allergic to sulfa drugs. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021, the patient experienced soreness at injection site at 14:30. The clinical outcome for the events soreness at injection site was recovering at the time of report.  No follow-up attempts are possible. No further information is expected.
Initial report extracted from VAERS database via QSCAN FDA report on 11 March 2009 (VAERS identification number 247747). A 51-year-old female patient had received on 15 November 2005 at 10:30 am a dose of Fluzone SV 2005-2006 USP (lot number U1819AA). The route and site of administration were not reported. Approximately four hours later, at around 14:30 pm, the patient's eyes started to bother her and a co-worker told her that her eyes were very red. Her throat was also beginning to get sore. On the train ride to another doctor's office her mouth began to feel swollen and she had the chills and started to cough. It was not reported whether any relevant diagnostic tests or laboratory data were performed, or if any treatment was received at that time. By the time the patient returned home, her body ached, her eyes and mouth were swollen and her head hurt. The patient drank some tea with lemon and honey, ate some Lipton chicken soup and too two Aleve. The patient recovered (date not reported). Documents held by sender: None
Pt given injection in deltoid. developed over next 24 hours swelling, erythema, pain, and fever and general mailaise. this lasted for three days.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2017, the patient was treated by a physician/MD at a healthcare facility/office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Information has been received from a 28 year old female consumer concerning that female pt with no past medical history and no known drug allergies who on 02/09/2001 was vaccinated with a dose of varicella vaccine. She discovered she was pregnant on 03/09/2001. Her LMP was 05/28/1999, due to the fact she had been pregnant and nursing. On 03/12/2001, the pt developed vaginal bleeding for 8 hours. The pt's health care provider gave her two quantitative blood tests and confirmed that she is still pregnant. The pt is currently taking prenatal vitamins. No further info is available.
This is a 67 day old, HIV positive, male infant enrolled in protocols CIPRA SA 004, "Evaluation of quantitative and qualitative antibody response to streptococcus pneumoniae and haemophilus influenzae type B conjugate vaccines amongst HIV-1 exposed infected children that are receiving vs those not receiving antiretroviral therapy, as well as among HIV-1-exposed-uninfected children and HIV-1 unexposed-uninfected children," on 12/15/2005 who died of an unknown cause. The subject was also enrolled in the delayed antiretroviral therapy treatment arm of protocol CIPRA SA 002 "A Phase III, randomized, open-label trial to evaluate strategies for providing antiretroviral therapy to infants shortly after primary infection in a resource poor setting." The subject was born by vaginal breech delivery at 37 weeks gestation. Mother had apgar scores of 2 and 4 with no prenatal problems. The mother received zidovudine for an estimated 3 weeks prior to delivery and nevirapine at delivery. The subject received one dose of nevirapine at birth 7 days of zidovudine after birth. The subject has been solely formula fed since birth. The subject received one dose of Prevnar on 12/19/2005. He was evaluated on 01/03/2006 and his weight was in the 5th percentile, length just below 6th percentile, head circumference in the 10th percentile and his weight for height 1-score was 0.20. The subject had generalized lymphadenopathy (size 0-0 5cm), mild oral thrush, hepatosplenomegaly (4cm live span, 2cm palpable spleen), and no signs of respiratory distress. He was sent home on Vidaylin syrup, Ferro, drops, Bactrim, oral Mycostatin drops, and oral Daktarin gel. The mother reported no cough, no diarrhea or vomiting, no fever and no other complaints prior to 01/09/2006. At 18:00 on 01/09/2006 the mother noticed that the subject was breathing fast and at 22:00 the subject looked pale. The mother took the subject to the local hospital at 23:00. The subject was dead on arrival at 23:30 on 01/09/2006. Differential diagnoses of sepsis or pneumonia have been made. A post-mortem exam was performed on 01/17/2006 and results are pending. This site investigator believes this event is not related to study agent. The DAIDS medical officer believes this event is probably not related, but cannot rule out a relationship to study agent. 3/2/06 Received medical records which revealed UTI, oral thrush, hepatomegaly & splenomegaly. Received Autopsy Report 3/6/06 which revealed COD as pneumocystis carinii pneumonia & granulomatous hepatitis.
increase pain in most of joints Headaches nausea itching hives that come and go hangover symptoms fatigue chest pain over heart Rt arm pain that is still going on and decrease usage due to pain and muscle weakness
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2022 (Lot number: FJ6369) at the age of 49 years as dose 3 (booster), single and administration date 21Dec2020 (Lot number: EJ1685) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "an auto immune issue" (unspecified if ongoing). Concomitant medication(s) included: HYDROCODONE; CYMBALTA; NABUMETONE. Vaccination history included: Bnt162b2 (Dose: 2, Lot Number: EL1284, I know my last one was left), administration date: 19Jan2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "believed to have an auto immune issue but felt significantly better after my first and third Pfizer vaccine."; ELECTRIC SHOCK SENSATION (non-serious), outcome "unknown", described as "I am getting electric shocks with my muscles". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller is calling about the Pfizer COVID-19 Vaccine just to let you know she gave a call back regarding previous interaction. She has sent online but her main concern is that she was wondering if there are any studies for people who felt better after receiving the vaccine, so she already provided the medical information for her, and she is believed to have an autoimmune issue, but she felt significantly better after the first and the third Pfizer vaccine. Patient stated she actually has some long-term issues for like 20 years, it helped and feel better after her first one and third one and she do not know why but everybody else use to get sick to it, but she tends to get better patient really good for like 23-week. Patient also experienced getting electric shocks with her muscles and all those stuff. Follow-up attempts completed. No further information is expected. The lot/batch number is not available despite the follow-up attempts made.
Td given on 5/18/04.  Td site became reddened, itchy, and hard.  Benedryl and Hdro. creme to site
Mom called 1/9/03. Son woke up early this morning with extensively swollen upper left arm and hot to touch. Mom had called ER this morning and was told this was a common reaction and to apply cold compresses and give Ibuprofen. Reinforced these relief measures and informed mom that entire limb swelling has been reported more often after fourth or fifth dose of DTAP. Advised mom to monitor and to contact MD if no improvement over next several days. 1/10/03 talk to mom, state son doing better and arm swelling is decreasing.
This spontaneous report was received from an office manager refers to unspecified number of patients of unknown age and gender. The pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored (temperature 33F for 90 days) doses of ROTATEQ of lot # L039638 with expiry date 23-AUG-2017 (dose, strength, route, vaccination site unspecified). Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Left arm red and warm to the touch.  Started itching first and then became red in a circular diameter of about 4 inches.  Tender and warm when touched. Started the seventh day after vaccine and woke up on the eighth day and it was a lot worse. Also feels like a knot under the skin.
Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medication reported. No concomitant medication reported. The Rx number was (Privacy).
Pt presented to ER after receiving Tetanus/Diptheria injection.  There is a large area of tenderness and redness on the left deltoid area.
uncomfortable feeling on her arm; itchy arm; like a long rectangle 3-4 inches and 2,5-3 inches wide; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (uncomfortable feeling on her arm), VACCINATION SITE PRURITUS (itchy arm) and VACCINATION SITE SWELLING (like a long rectangle 3-4 inches and 2,5-3 inches wide) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-Feb-2021, the patient experienced VACCINATION SITE DISCOMFORT (uncomfortable feeling on her arm), VACCINATION SITE PRURITUS (itchy arm) and VACCINATION SITE SWELLING (like a long rectangle 3-4 inches and 2,5-3 inches wide). At the time of the report, VACCINATION SITE DISCOMFORT (uncomfortable feeling on her arm), VACCINATION SITE PRURITUS (itchy arm) and VACCINATION SITE SWELLING (like a long rectangle 3-4 inches and 2,5-3 inches wide) had not resolved.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by reporter  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received on 02 July 2021 ,Email address provided.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 12-JUN-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported). Lot # of the M-M-R II the patient received could be one of the following numbers: lot # K014832 with expiration date: 14-SEP-2016, K021152 with expiration date: 02-NOV-2016 and K015375 with expiration date: 18-SEP-2016. But it was not specified which lot # the patient received. All the lot # had been verified to be a valid lot number for M-M-R II. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Immediate soreness in arm after shot.  Some light headedness. Took 2 tylenol after and then again before bed. Felt fine until waking at 2am to muscle soreness. At 4:30am chills and horrible headache, horrible flatulence. 8:30am  stomach cramps, almost passed out. More chills, sweats and body shakes. Diarrhea and staved off vomiting. Could not eat most of the day until evening. Drank tons of fluids and Gatorade. Slept most of the day. Woke at 2am the morning of Feb 6th with continued muscle ache. Took more Tylenol. 9:15am as I write, I am feeling better, just exhausted.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information about concurrent medical conditions, concomitant medication and medical history was not provided. On 21-AUG-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # J009827, expiration date 10-AUG-2014, dose and frequency were not provided) intramuscularly. No known adverse effect was reported. All of the data was reconfirmed with the reporter. Additional information has been requested.
Rash appeared covering body after flu vaccine was administered. No respiratory distress. O2 sat 97%. BENADRYL given. Directed to give BENADRYL Q 6 hours PRN. Mom to call allergist and consult regarding future flu vaccines.
A high number of heartbeats/a fast heart beat; A very mild fever/ Mild temperature, fever; This is a spontaneous report from a contactable consumer. A 17-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 12May2021 15:15 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing acne from an unknown date. Concomitant medications included doxycycline hyclate taken for acne, start and stop date were not reported.  Patient previously took first dose of BNT162B2 on 21Apr2021 03:15 PM in left shoulder for covid-19 Immunization. It was reported that patient experienced Fast heart beat, and Mild temperature after second vaccine on 13May2021. During the course of todays (reporting date) morning the patient has experienced a high number of heartbeats, she mentioned that the patient had a very mild fever. Additional Information for Concomitant Products Doxycycline Hyclate was he started the medication, maybe about 5 months ago, and stopped probably a week prior to the second vaccine. Regarding Fast heart beat time caller answers as it started last night and has been incrementing, according to his watch. Caller reports that the highest point, clarified as fastest heart rate, was at 9:40 am or 10 am. Caller states he thinks it happened in his sleep. caller answers as the heart rate has gone down, it has improved, but not very much. Caller states he wants to protect himself while he was out and about at work and at school. Patient took a Tylenol, 2 hours after he had the rapid heart beat. He took the Tylenol for his temperature, and the medication had a good effect. Outcome of the event A very mild fever/ Mild temperature, fever was recovered on 13May2021 and Outcome of the other event was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Incorrect injection cause severe arm pain, inability to raise arm , lift, sleep. Constant arm pain, ache all night, heaviness, fatigue
4 wks cluster h/a then multiple strokes HTN; 4 wks cluster h/a then multiple strokes HTN; 4 wks cluster h/a then multiple strokes HTN; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable physician. A 36-year-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 12Apr2021 10:45 (Batch/Lot Number: en6206) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 12Apr2021 (Batch/Lot Number: er8729) as single dose for covid-19 immunisation at the age of 36-year-old. Medical history included HTN (hypertension, ongoing) and migraine with aura. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced 4 weeks cluster h/a (Heart attack) then multiple strokes HTN on 13Apr2021 03:00 with outcome of recovered with sequelae on unspecified date in 2021. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included COVID-19 test via Nasal Swab: negative on 17Jul2021. Therapeutic measures were taken as a result of 4 wks cluster h/a then multiple strokes HTN. The event result in visit of Emergency room/department or urgent care, Hospitalization, Life threatening. Prior to vaccination, the patient was not diagnosed with COVID-19.; Sender's Comments: A causal relationship between BNT162B2 and the reported serious events cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate .
At 46 hours pt report extreme pain at injection site, making her cry. Injection site was swollen and warm. At 53 hrs post injection, patient said slightly better.
Vaccine given beyond 30 days refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days refrigeration period) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Penicillin), Drug allergy (Vicodin.) and Drug allergy (Lexapro).   On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days refrigeration period). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days refrigeration period) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days refrigeration period) to be possibly related.    No concomitant medication information was provided. No treatment medication information was provided.  This case was linked to MOD-2021-353124 (Patient Link).
Given to patient under the age of 18. Monitored for 15 minutes post injection without any adverse events.
Employee received the 1st dose of Merck recomb Hep B vaccine.  The next moring she woke uo with minor swelling at left ebow and scattered rash upper/lower lt. arm (site of injection)..also noted some red spots on right arm.  Not itchy...no other symptoms.
a week after the shot, started using a wrist ECG and it displayed over many unusual rhythms. At the time, there were so many oddities, I couldn't make sense of them. This continued until May, when it was bad enough I  went to above hospital for 'palpatations'. They recorded  many PAC, PVC and  some triplets. They wanted to admit me, but I'd had enough, so we agreed on HOLTER monitor.  Symptoms resolved without additional meds, over a period of several more months.
Rash on trunk area found the next day. The rash is getting better and patient wants to get 2nd shot.