chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough case admission after 2 vaccines Pfizer 12/21/21 LOt# FJ8757;  Pfizer 6/13/22 Lot# FM0173
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore/Pain in arm) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In December 2021, the patient experienced VACCINATION SITE PAIN (Sore/Pain in arm). At the time of the report, VACCINATION SITE PAIN (Sore/Pain in arm) was resolving. No concomitant medication provided. No treatment information mentioned. In December 2021, patient experienced sore arm or pain in arm as a result of the COVID booster from Moderna. Reporters causality of events with Humira was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Within two hours developed severe headache and body aches. Urinary incontinence hit at the same time. Complete loss of bladder control continuing to this date.
Significant joint pain in extremities within 5 hours post injection. Pain worsened over 24/48 hours. Lessened between 48 -84 hours. About day 5 systemic joint pain began to occur which intensified in pain level over the next days/week. In addition some muscular pain accompanied surrounding joints. Overall malaise. Joint pain and inflammation persist 3 weeks after 1st dose. Physician recommended not taking 2nd dose.
My symptoms started on December 2, 2022. They included coughing and extreme fatigue. I tested for COVID-19 on December 2, 2022. My symptoms were worse the next day. I tested for COVID-19 again on December 3, 2022. The result was positive. I could not get out of bed on December 4, 2022, and I slept most of the day. My symptoms were at their worst. I called the doctor on Sunday, December 4, 2022. The doctor prescribed molnupiravir on December 5, 2022. The next day, I felt about 80% better. I continued to get better over time. I am about 90% better today.
Fever T 104 (R) after receiving Hep A #1 vaccine from 5 PM until AM. Seen in office 4/19 alert WBC 7.2 Hgb 11.5 Plat 196 as follow up. High fever 6 hours after receiving vaccine.
itching at vaccine site; Continued pain; redness; This non-serious case was reported by a consumer and described the occurrence of injection site itching in a 68-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included depression, anxiety, blood pressure high and herpes virus infection. Concomitant products included duloxetine hydrochloride (Cymbalta), bupropion hydrochloride (Wellbutrin), trazodone hydrochloride (Trazodone) and losartan potassium (Losartin).   On 08-NOV-2023, the patient received RSV vaccine. On 09-NOV-2023, 1 days after receiving RSV vaccine, the patient experienced injection site itching (Verbatim: itching at vaccine site), pain (Verbatim: Continued pain) and erythema (Verbatim: redness). The outcome of the injection site itching, pain and erythema were not resolved.   It was unknown if the reporter considered the injection site itching, pain and erythema to be related to RSV vaccine.   It was unknown if the company considered the injection site itching, pain and erythema to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 11-NOV-2023 The reporter was consumer. The patient received RSV vaccine and had continued pain, redness and itching at vaccination site. The reporter consent to follow up.
This spontaneous report as received from a consumer refers to a female patient of unknown age. On an unspecified date in 2014 the patient was vaccinated with GARDASIL lot number, expiration date and dose not provided. On an unkonwn date in 2014, reported as two weeks later, the patient found out she was pregnant. The gestation age was reported as 7 weeks on 23-SEP-2014. Last Menstrual Period (LMP) was estimated as of 05-AUG-2014 (by subtracting the Gestational Age from the date of this report). Due Date was estimate das 12-MAY-2015. The patient was exposed to GARDASIL during the first trimester of pregnancy. The pregnancy outcome was pending. No adverse effects were reported. No further adverse event information was provided. Additional information is not expected, because the patient did not wish to provide specific information and contact details.
The injection site became red, warm, and painful. 1-3 days after administration.  Then a welt grew, approximately the size of ½ golf ball several days later.  Pain, redness, and the welt persist 3 weeks after administration.
This spontaneous report was received from a nurse refers to a 21 month old patient of unknown gender. No medical history was reported. The patient received 3 doses of an unspecified Hib Vaccine on 04-DEC-2013, 04-MAR-2014 and 16-JUN-2014. On 30-APR-2015, the patient was then vaccinated with improperly stored PEDVAXHIB (lot # K019700, exp. 16-JUL-2017, intramuscular, dose not provided). No concomitant therapy was reported. No adverse effect was reported. The outcome of the events was unknown. The events were considered to be not related to PEDVAXHIB. Additional information has been requested.
Received 3rd dose on an Unknown reason; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (Received 3rd dose on an Unknown reason) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis.    On 18-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced OFF LABEL USE (Received 3rd dose on an Unknown reason). On 18-Aug-2021, OFF LABEL USE (Received 3rd dose on an Unknown reason) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient prescribed to take PROLEA shots as she took vaccine changed appointment for a PROLEA shot for osteoporosis. No treatment medications were provided by reporter. No concomitant medications were provided by reporter.   Reporter did not allow further contact
Initial and follow up information has been received from a registered nurse concerning a 25 month old female with no known allergies or pertinent medical history who on 16-AUG-2006 was vaccinated SC in the right thigh with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot#652874/0435F). The patient had no rash at the injection site or elsewhere within 42 days of vaccination. On 30-AUG-2007 (also reported as 29-AUG-2007) the patient developed shingles on her right thigh. There were 30-50 vesicular lesions. No other symptoms were noted. Unspecified medical attention was sought. There was no product quality complaint involved. The patient was enrolled in the VZVIP program: the Varicella Zoster Identification Program enables biological samples to be  analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type strain or with the Oka/Merck vaccine VZV strain. A specimen was obtained from a vesicle on the patient's right thigh on 31-AUG-2007. The results were pending. The patient had no recent exposure to chickenpox or herpes zoster, and has never had chickenpox. Subsequently the patient recovered. The sample of the lesion was collected on 31-AUG-2007. The sample was taken from a vesicle on the patient's right thigh. PCR results were provided: the isolated virus was Oka/Merck vaccine strain. Additional information is not expected.
Start of fever of 102 on 11/20/15, shaky movements in arms started on 11/22/15 and mother noticed he was having difficulty walking (looked drunk), was fully alert, worse when he would wake up from sleeping, would get better as day progressed, fever continued Mon-Thurs, decreased appetite. Parents noticed hands were shaking with feeding himself.  Went to ER 11/28/15, CT brain negative, dx with probable acute cerebellar ataxia.
got 2 vaccines, sore arm; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles Vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date refer case US2021AMR186321).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the 2nd vaccines of shingles and experienced reaction was a sore arm. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186321:1st dose
Itching left side within 4 hours of vaccine; subsided after few hours with no further incident
Seizures, meningoencephalitis developed symptoms 09/02/2005, required ventilator support. Hypertension 2 ARY to autonomic instability, CT showed Bilateral frontal lobe infarcts. 28 day stay on Rehab unit 2 ARY to impaired mobility contractures left lower extremity, residual weakness and pain left lower extremity. Information from 60 day follow-up report states: residual left leg weakness;lower extermities contractions left > right continued anti epileptic drugs, abnornal EEG. 1/01/2010 Seizure disorder.
no adverse event; vaccine used which were beyond the 30-Day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date) and NO ADVERSE EVENT (no adverse event) in a 46-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date).    Concomitant products were not reported.  It was reported that patient received monovalent dose that was administered beyond 30 day beyond use date. The use by date of lot 042J21A was reported as 17-Feb-2022.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Significant Live Follow up received narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Family noticed baby was blue and called 911.  Baby was coded and pronounced at approx 1755.  At this time I do not have exact times.
She could even barely make it to give herself to go pee, she was completely immobilized.; Migraine/light sensitive/nausea/headache; Extremely dizzy; Painful and scary; scary; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for herself and her husband. This is the 1st of 2 reports.  A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) (at the age of 42-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported that she woke up at 6:00 in the morning (on 17Apr2021), there were on migraine, light sensitive, extremely nauseous and extremely dizzy. She could even barely make it to give herself to go pee, she was completely immobilized. She was that nauseous and that dizzy, she was staying in the bed she could not do anything else; she could not get in the kitchen or get something to drink. She took a MOTRIN (as a treatment) around 3 after, she was still felling the symptoms, migraine got disappeared, she was able to move around but eventually got better headache. She was painful and scary. The patient outcome of migraine was recovered and the outcome of the other events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) :PFIZER INC-2021479302 same reporter, drug, different patient and event
she reports a headache only on her right side of her head; weakness; This is a spontaneous report from a contactable consumer (patient).   A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), on 09Mar2021 (at 73 years) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced weakness on 09Mar2021 and next night (10Mar2021) she reported a headache only on her right side of her head. She wanted to know if she can still have the second dose of the vaccine as scheduled on 29Mar2021, the day before at night time a headache in the right side of head. The final outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot been obtained.
FLUZONE HD QIV was administered to a patient to 57 years old with no reported adverse event; Initial information was received on 24-Oct-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 57 years old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Oct-2023, the 57 year old patient received 0.7 ml of dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UT8094BA and expiry 30-JUN-2024) (formulation and strength: not reported) (product administered to patient of inappropriate age, latency same day) via intramuscular route in the right deltoid for prophylactic immunization (immunization).  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.
Received flu shot - 9-26-16 - In right arm. Day after shot - started having pain in right arm and proceeded to shoulder joint. Several days later developed numbness in right side of neck and in back of head. Symptoms stopped in neck and back of head and started having headaches in forehead and then became lightheaded and confused and real nervous (jitters) and unable to think clearly. Followed by irritable and been very very tired. Had to lay down several hours everyday, feeling very very bad. Consulted physicians - 10-7-16 - for aches and pains. Received medications for six days. After six days - returned to physicians again - 10-12-16. Medications for six more days. Symptoms still there. Contacted physician by phone and was instructed to take TYLENOL and rest. Symptoms are still continuing. We are concerned about our health and long term effects.
Extreme pain left arm, headache, fever chills, muscle and joint aches, exhaustion. Symptoms for 48 hours slowly reducing by day 3.
(L) arm pain, swelling, erythema, headache, joint pain all over body, fatigue, generalized weakness, decreased appetite.
At the time of vaccination, booster doses were not approved for pts aged <18yrs.  NO adverse reaction noted.
PATIENT REPORTED SIGNIFICANT SWELLING (DESCRIBED AS 1/2 A BASEBALL SIZE) AT INJECTION SITE, BRIGHT RED, SORE AND ACHY AT INJECTION SITE. ALSO ACHY JOINTS AND MUSCLE FOR 2-3 DAYS FOLLOWING THE VACCINATION.
About 24 hours after the vaccine, I started to have itchiness, redness, warm to the touch, and the swollen. It was about 1.5 inches below the injection site. It was like an allergic reaction. This lasted about 1 week and then stopped. I am concerned that if I get my 4th injection that I might get an allergic reaction.
Myocarditis. Patient presented with chest pain, troponin leak, and EKG findings consistent with myocarditis. Symptoms stabilized and troponins were down trending. Was able to discharge safely home.
This spontaneous report was received from a healthcare worker regarding her son, a 16 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were reported. On an unknown date, the patient began the vaccination series with GARADSIL. On 24-AUG-2015, the patient also received GARDASIL 9 as the second dose, in the vaccination series. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Initially the whole shoulder/deltoid swelled.  It then became painful, and a black bruise formed around the injection site.  Today, as the swelling subsided, it feels like there is a hard capsule inside the injection site.
Patient was administered an "un-reconstituted" dose. 0.2mL of concentrate
IRREGULAR REDNESS ACROSS THE SKIN AND REDNESS ON ARM; SORE ARM; MILD HEADACHE; SWOLLEN AROUND THE INJECTION SITE IN UPPER ARM ABOUT THE WIDTH OF FINGER; HARDNESS AROUND THE INJECTION SITE IN UPPER ARM ABOUT THE WIDTH OF FINGER; DIARRHEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, once a total administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced swollen around the injection site in upper arm about the width of finger. On MAR-2021, the subject experienced hardness around the injection site in upper arm about the width of finger. On 13-MAR-2021, the subject experienced sore arm. On 13-MAR-2021, the subject experienced mild headache. On 15-MAR-2021, the subject experienced irregular redness across the skin and redness on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild headache, sore arm, irregular redness across the skin and redness on arm, swollen around the injection site in upper arm about the width of finger, diarrhea, and hardness around the injection site in upper arm about the width of finger. This report was non-serious.
pt recvd vax & 5NOV93 devel h/a & was hospitalized for 1 wk; MD reported that pt fell & was adm to hosp w/cerebral contusion; discharged but cont to have h/a; readmitted twice 2nd time p/hit head on open drawer; found subdural hematoma;
Rash developed on thigh about 2 weeks after the 1st Pfizer vaccine; NOTHING else in life is novel, ie, no new foods, detergents, soaps; no traveling, no guests, and the patient abhors the outdoors so insect involvement is extremely unlikely. Rash was reported to me (Mom) on Thursday, April 1st. There was one spot/lesion that was oval and larger than the others, with a somewhat blanched center.  No itch or pain. Friday the 2nd, patient reported around 5:00 p.m. that it had spread to his sides, so I called the nurse healthline.. Saturday a.m. per recommendation I took him to Urgent Care; it had by then also spread to his stomach. The doctor there didn't have any "A-HA!!" moment, but sent us off with a prescription for a clotrimazole/betamethasone topical cream. The rash is now heavily populating his stomach, is on his back and there are a couple spots on his arm. I contacted his primary care manager this morning as we are to receive our 2nd Pfizer vaccines day after tomorrow (Wed, 4/7) and I'm wondering if he should get his as planned or whether that might be a bad idea.
Headache, nausea, chills, body aches, low-grade fever everything started by 1630 on Thursday afternoon
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On multiple unspecified dates, improperly stored oral ROTATEQ (lot # L006184, expiration date 13-DEC-2016) (dosage and strength unknown) (temperature: low 32.2 degree F, time frame: 53 hours 25 minutes) were administered to the patients. There was no concomitant medication reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse (R.N.) concerning a 17 year old female patient who on 05-MAY-2010 was vaccinated with the second 0.5mL dose of VARIVAX (Merck) (Lot number 666695/1706Y). Concomitant therapy included a dose of VAQTA (Lot number unknown), a dose of MENACTRA and BOOSTRIX. The nurse stated that the patient had a local reaction to the VARIVAX (Merck) vaccination. Between 05-MAY-2010 and 07-MAY-2010, the injection site was hot, red and raised. At the time of report the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Fever and rash developed 2 days after vaccination.  The rash is located over trunk and is described as erythematous.  Patient was prescribed BENADRYL.
Pt recvd Engerix-B on 30APR90, 29MAY90, & 25OCT90 & subsequently found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
This spontaneous report as received from a registered nurse via field representative refers to a child patient of unknown age and gender. On an unspecified date, the patient was vaccinated with a dose of GARDASIL (dose, frequency, route and lot # unknown). On an unknown date in 2013, (also reported as "in the last year") the patient fainted after receiving the dose of GARDASIL. It was unspecified if patient sought medical attention. The outcome of the event was reported as recovered/resolved on an unspecified date. The causality was not reported. This is one of several reports received from the same source. Additional information has been requested.