chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 22-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four months old male patient who was vaccinated with a 0.5 ml second dose of vaccine PENTACEL, (lot of Diluent Vial UJ108AA and Exp. Date 24-Apr-2020; lot number of HIB U1862AA and Exp. Date 11-Oct-2019) via intramuscular route in the right thigh on 15-Mar-2019. The patient's medical history not reported and concomitant medications included ROTATEQ and PREVENAR 13 both on 15-Mar-2019 for Immunisation. It was an actual medication error case due to inappropriate reconstitution technique. It was reported as diluent was administered without the powder being mixed in with ACTHIB, diluent was mixed with sterile water and given. There were no side effects. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder' 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. List of documents held by sender: none.
Rash on top of foot; Burning toes; Sore toes; Red toes; This is a spontaneous report from a contactable consumer, the patient. An 83-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737), via an unspecified route of administration in the left arm on 05Apr2021 at 10:30 (at the age of 83-year-old), as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (Afib). The patient did not have any allergies to food, medications, or other products. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the left arm on 13Mar2021 at 15:15 (at the age of 83-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the 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. On 05Apr2021 at 22:00 (same day after injection), the patient woke up with burning and sore red toes. On 06Apr2021 (second day after injection), the patient woke up with sore red toes on left foot and rash on top of foot. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events burning toes, sore toes, red toes and rash on top of foot was not resolved.  No follow-up attempts are needed. No further information is expected.
Incorrect vaccine for patient age administered - discovered on routine corporate audit - no known adverse effects or events occurred
Apprx. 24 hours following Influenza vaccination, pt experienced syncope and possible seizure activity (stiffness arms, thrashing, bit tongue and lip)
I recumbent vaccination on 1-14-21. A few couple later I had a lump at the injection site. Today, 1-28-21, I developed hives on and around the injection site. I read that it could be ?Covid arm?. Just reporting now, so I do not know what is to come.
Mom called 5/13/16 and reported that pt got 4 month old vaccines on 5-11-16 and the next morning had a fever until that evening. (Did not know what temp was). Also, the upper left leg was red and knot size of quarter.
Information has been received from a physician concerning an age approximately 19-20 year old male who "a couple of years ago" at approximately 17-18 years of age was vaccinated with a 0.5mL dose of varicella virus vaccine live (Oka/Merck). It was reported that "a couple weeks ago" on approximately April-2007, the patient developed shingles. The patient's status is recovering. No product quality complaint was involved. Additional information has been requested.
sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number H9LL4, expiry date 24th November 2023) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. 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 Shingrix.     Linked case(s) involving the same patient:  US2022AMR153021   Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's comment: The patient had stated that, she remembered having a sore arm after first dose, however received two vaccines that day and was not sure which vaccine caused the sore arm. The reporter consent to follow-up. Additional supportive information: For tolerance of second dose, refer case US2022AMR153021, reported by same patient. The batch number and expiry date were conservatively captured, as it was not clear for which dose it was reported. Clarification has been raised.; Sender's Comments:  GSK-US2022AMR153021:Same reporter
Within 12 hrs, mother noted lg area 4x4 of induration (lat). Inject site was red raised itchy. Fussy but no temp. Local reaction lasted 2-3 days.
No adverse symptoms reported; vaccinated wilh improperly stored VARIVAX; This spontaneous report was received from a physician referring to a 12 months old female patient. Information about pertinent medical history, concomitant medications and drug reactions or allergies was not provided.    On 30-DEC-2019, the patient was vaccinated with improperly stored dose(1 dosage form) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019581, expiration date 25-JUN-2021, route, anatomical location and strength were not provided) for prophylaxis (product storage error). No adverse effects were reported. Administered doses of vaccine experienced temperature excursion from -50 degrees Celsius (C) to -15 C (-14.67C) for 3 hours. Total time in the range from 6 degrees Fahrenheit (F) to 14 degree F (-14 degree C to -10 degree C) (-14.4C) for 3 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint (PQC) was involved with this report.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA006288:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer (on behalf of her son) concerned a male (works on a ship) of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (first shot) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total, vaccinated on left arm, administered on an unspecified date in AUG-2021 for prophylactic vaccination.  The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date in FEB-2022, the patient developed covid-19 infection, while on board of the ship. He experienced fever for 3 days with runny nose (suspected covid-19 infection and suspected clinical vaccination failure).  Laboratory data included: Body temperature (NR: not provided) 140 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on 2022, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0:20220528254-COVID-19 VACCINE Ad26.COV2.S-suspected   clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
I woke at 4 am with intense chills and nausea.  I looked at my watch at 5:24 waiting for my husband's alarm to go off. I thought to myself that I felt I was going to throw up. Next thing I know, my husband is yelling and the dogs are barking around me. I'm drowning in my vomit (laying on my back because the arm hurt). He sits me up and I throw up multiple times all over the bed. I had blacked out while vomiting and without him there, I could have died.
Information has been received from a registered nurse concerning multiple unspecified patients of unknown age or gender. No concurrent condition, medical history and concomitant therapies were reported. On unspecified dates, the patients received doses of improperly stored ROTATEQ (Lot # included: L027719 with expire date of 28-APR-2017 and L037574 with expire date of 01-JUL-2017, dosage and route not provided). The temperature/time frame was cumulative "-4.7 C" for 513 hours. It was reported because of a "date logger". There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
sore left arm injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm injection site arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 VACCINATION SITE PAIN (sore left arm injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left arm injection site arm) outcome was unknown.        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.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-438840 (Patient Link).
Severe vertigo started 48 hours after vaccine. Has lasted 9 days so far, currently treating with Meclizine. Symptoms ongoing.
Patient states she still has pain in her left arm. States difficulty with activities such as putting on seat belt. She says pain has progressed since the vaccine was administered.
Pulmonary Embolism in right lung; This is a spontaneous report from a contactable consumer (patient). A 92-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9267), via an unspecified route of administration, administered in right arm on 16Feb2021 at 12:45 PM at the age of 92-years-old as single dose for COVID-19 immunization. Facility type vaccine was reported as Other. The patient had no other vaccine in four weeks. The patient's medical history included known allergies to penicillin and sulfa drugs. Concomitant medications included fluoxetine, cyanocobalamin (B12-VITAMIN), and fish oil (OMEGA 3); all taken for unspecified indications, start and stop dates were not reported (reported as other medications in two weeks). The patient previously took potassium iodate and experienced allergies. The patient previously received the first dose of BNT162B2 in the right arm on 26Jan2021 at 12:45 PM (lot number: EL9261) at the age of 92-years-old for COVID-19 immunization. The patient experienced pulmonary embolism in right lung on 07Mar2021 at 09:00 AM. The event resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for pulmonary embolism in right lung for 2 days in 2021. The patient received treatment for the event which included heparin. The patient had no COVID prior the vaccination and was not tested for COVID post vaccination. The outcome of the event was recovering.
Swelling golf ball size, fever reached 102 F, nausea, vomiting and diarrhea.
1. Local erythema/swellings/tenderness. 2. Malaise/anorexia. 3. Low grade temp.
This spontaneous prospective pregnancy report as received from a physician refers to a 33 year old pregnant female patient. The patent had no pertinent medical history. No drug reactions or allergies were reported. On 27-FEB-2015, the patient was inadvertently vaccinated with a dose of M-M-R II (therapy type was not reported) (dose, frequency and route of administration were not provided, indication was reported as "vaccination") (lot # was reported as K007982 and expiration date: 03-JUN-2016) and a dose of VARIVAX (Merck) (dose, frequency and route of administration were not provided, indication was reported as "vaccination") (lot # was reported as K007982 and expiration date: 03-JUN-2016). Concomitant medication was not reported. The patient became pregnant with last menstrual period (LMP) reported as 12-FEB-2015 and estimated date of delivery (EDD) calculated as 19-NOV-2015. The patient did not know she was pregnant at the time of vaccination. Unspecified urine test was performed on an unknown date (results were not provided), The patent sought medical attention. She visited physician on an unknown date (approximately in 2015). No product quality complaint (PQC) was involved. The outcome of the events was reported as not recovered. Additional information has been requested.
vaccine associated measles pneumonitis in adult w/AIDS;approx 1yr p/vax pt w/cough, dyspnea & fever;exam revealed pulmonary rales & chest x-ray showed parenchymal nodules;analysis of lung biopsy showed multinucleated giant cells;
Flu like symptoms within 6 hours of being vaccinated, extreme fatigue lasting 4 days - 3 days bedridden, chest pain, cough, headache, neck ache, hard to breath, muscular aches, aches in armpits, sore back, stiff legs, face hurts, tingling in head,  Still feeling sick on day 4 from vaccine. Would have not gotten the vaccine if I knew I would be this sick
Information has been received from a consumer concerning her friend's son who in 2008 (also reported as 2001) was vaccinated with one dose of RECOMBIVAX HB (lot # not reported).  In 2008 the patient developed hives.  On an unspecified date, the patient recovered from hives.  The reporter noted that the patient did not receive the second dose of RECOMBIVAX HB.  No further information was available.  Additional information is not expected.
Breakthrough Chickenpox diagnosed 5/1/2008: pink, papulo-vesicular rash on face, chest, back; few with crusts.
Patient sent a message to the practice on February 11, 2022. Reporting the following, " Two days later, I had decreased range of motion in my shoulder, a big knot right above the joint and continued muscle soreness and joint pain and I was only able to lift the arm approximately 45 degrees above horizontal above my head. I was able to schedule an appointment with my sports doctor, last week to assess. He put me on over the counter anti-inflammatory drugs for a week and gave me PT exercises to do each day which I have been doing. "
This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a male patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. This case was reported via vaccine inside sales representative at time of report of reaction to second dose. No lot number or expiration date or further details were reported. The physician was expected to call with a more detailed report. This case has been linked with case US2017109009, reported by the same patient.
Patient reported developing rash and hot flashes couple hours after receiving  Moderna Covid19  vaccine. No known sick contacts. Denied N/V, dizzy sensation, SOB, difficulty breathing, scratchy throat, cough.
pt states that afternoon after she got the covid vax that she developed fever, body aches, chills, loss of appetite, headache.  Feels just like she did when she had the Covid Virus.  Her urine is dark yellow and she is sweating profusely.  Pt still has all of these symptoms and has a phone visit w/ her PCP today 3/10/2021.
This spontaneous report was received from a registered nurse referring to a female physician of unknown age, who is the patient. No pertinent medical history or concurrent conditions were reported. The patient's allergies included reactions to unspecified allergens. On 13-AUG-2015 the patient was vaccinated with ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not provided). No concomitant medications were reported. On 15-AUG-2015, the patient experienced an anaphylactic reaction. No description of anaphylactic reaction was provided. As treatment, the patient administered herself epinephrine with an epi-pen. Then, the patient sought medical attention at the emergency room of an unspecified hospital. There the patient received unspecified treatment and was released to home. Also, on an unknown date, after the administration of ZOSTAVAX, the patient experienced a rash at the site of administration. The treatment for rash was unspecified. No product quality complaint was reported. The outcome of the anaphylactic reaction and administration site rash was reported as recovered, on an unspecified date in August 2015. The reporter did not assess the relationship between the events and the ZOSTAVAX. Upon internal review, the anaphylactic reaction was considered medically significant. Additional information is not expected because there is no permission to contact the physician.
pea sized lump (non red) noted @ site of both inj same day as given;seemed nl to parents but did not go away;then almost 3wk later lump became red, then scab formed;now 4wk later both sites are healed;
I almost died.  I contracted ITP.  My body started attacking it's own white blood cells.    My white platelet count went to zero.  I could not fight off infections.  I was covered with bruises.  Any where I got injured, my cuts would not coagulate and I almost bled to death on multiple occasions.  I could not do anything for risk of opening my flesh or having internal bleeding.  Internal bleeding would result in certain death.   They tested for leukemia.  They took marrow out of my spine.  I was in Hospital for 3 days.  They took blood every week for a year until levels returned to normal.  Too this day I have a deathly fear of hospitals, needles, blood, iodine, bandages, bruising, injury etc.
Patient presented to clinic today to receive dose #2 of vaccine.  She neglected to tell us that she had previously received her first dose at another facility and that it was the Pfizer vaccine. She was out of town and received an email that she was able to register for first dose of vaccine - she did this and received her first dose of vaccine at Medical Center.  She received Pfizer's COVID vaccine on 12/28/2020 - Lot ELO140 She subsequently received the Vaccine at Medical Center on 1/22/2021 - Lot 030L20A No adverse reaction has occurred to date
1 week AFTER my immunization I had intense discomfort in the upper arm. Upon inspection I found my arm with swelling and redness, 8 inches by 5 inches. The area seemed to be increasing! I had no unusual reaction the week prior. It was located around the injection site and was the area that had been "a little sore" after the vaccination.   I had no fever, but did have some body ache.. I had been working a ten hour night shift, so I could have just been tired? I took Benadryl and ibuprofin and the inflammation decreased.
dizziness; headache; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (dizziness), HEADACHE (headache) and FATIGUE (fatigue) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced DIZZINESS (dizziness), HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) on 02-Apr-2021 at a dose of 25 milligram. At the time of the report, DIZZINESS (dizziness), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure measurement: 130/82 mmHg (High) Blood pressure Increased. On 02-Apr-2021, Heart rate: 72 (Inconclusive) 72 per minute. On 02-Apr-2021, Oxygen saturation: 97 (normal) 97 Percent.     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.   No relevant concomitant medications were reported
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 25-SEP-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date-10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
After 09/12/2022 after my vaccine my arm hurt for weeks. It was tender sore and warm to the touch. I tested positive on 12/28/2022. I had a runny nose like a facet and a stuffy head.  I really felt congested and tired. On the 28th I had really tightness in my chest, it was painful. I had developed a cough and I didn?t run a fever until at the doctor office. I was prescribed Paxlovid, and it worked fine, I started feeling better after the 2nd day. I was completely well on the 3rd day. It was nasty though, it worked and quickly. . I did go to the doctor last week with this cold, but everything looked clear and well. I took over the counter medication to get pass the cold.