chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects were reported; Multiple patients were administered improperly stored PROQUAD. Temperature -3 C; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions/allergies, concurrent conditions and concomitant medication were not reported.      On 12-JUN-2019, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030805, expiration date: 22-APR-2020, albumin status: rha) (dose number, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot #, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA010323: US-009507513-1906USA010324: US-009507513-1906USA010325: US-009507513-1906USA010328: US-009507513-1906USA010329: US-009507513-1906USA010327: US-009507513-1906USA008695: US-009507513-1906USA010326: US-009507513-1906USA010331: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662:
neuropathy; Palpitation; tachycardia; dysesthesias; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Oct2021 (Lot number: FF2589) at the age of 43 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL1284, Location of injection: Arm Left, Route of Administration: Intramuscular), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EJ1685, Location of injection: Arm Left, Route of Administration: Intramuscular), for COVID-19 Immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 11Oct2021, outcome "not recovered", described as "neuropathy"; PALPITATIONS (non-serious) with onset 11Oct2021, outcome "not recovered", described as "Palpitation"; TACHYCARDIA (non-serious) with onset 11Oct2021, outcome "not recovered", described as "tachycardia"; DYSAESTHESIA (non-serious) with onset 11Oct2021, outcome "not recovered", described as "dysesthesias". The events "neuropathy", "palpitation", "tachycardia" and "dysesthesias" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of neuropathy peripheral, palpitations, tachycardia, dysaesthesia.The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications for events. Prior to vaccination, the patient was not diagnosed as COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
stomach a little bit upset/ stomach was a little upset for a little bit.; soreness in the arm; little bit of fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach a little bit upset/ stomach was a little upset for a little bit.), PAIN IN EXTREMITY (soreness in the arm) and PYREXIA (little bit of fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach a little bit upset/ stomach was a little upset for a little bit.), PAIN IN EXTREMITY (soreness in the arm) and PYREXIA (little bit of fever). At the time of the report, ABDOMINAL DISCOMFORT (stomach a little bit upset/ stomach was a little upset for a little bit.), PAIN IN EXTREMITY (soreness in the arm) and PYREXIA (little bit of fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-341167, MOD-2021-341203 (Patient Link).
p/vax felt like throwing up became pale & fainted;mom held child;BP 92/50, P96, R18;
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 01-AUG-2014, the patient was vaccinated with dose of ZOSTAVAX (dose number, lot number and expiration date was not reported), 0.65 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The pharmacist reports that on 01-AUG-2014 a dose ZOSTAVAX that underwent a temperature excursion was administered to five patients. (MARRS 1408USA006489, 1408USA006490, 1408USA006491, 1408USA006492 and 1408USA001809). This case is one (1) of five (5) reports from the same source. Additional information has been requested.
Approximately 1031, client stated feeling light headed with blurred vision and stated her ears felt muffled. Client visibly pale. Client was immediately transferred from the chair down to the floor and her feet were elevated on a chair. Vital sign was taken BP 114/68, Pulse 73, Resp 20, Temp 97.9, SaO2 99%. Client was monitored closely. At 1040, client stated they were no longer feeling dizzy or feeling discomfort with cold compress given. Client was transferred from the floor to sitting on a chair. Client stated she felt better and wanted to leave because her aunt was waiting for her outside. Staff encouraged client to stay longer for observation but client declined. Risk and benefits to waiting longer in observation was explained but patient declined strongly. Vital sign was taken t 1050, BP 113/73, pulse 75, Resp 20, Temp 98.2, SaO2 99%. Patient was discharged and escorted to her car where her aunt was waiting to drive her home.
On 1/5/21 pm sore arm . On 1/5/21 noontime 1000 mg Tylenol. On 1/6/21 5 am body aches during early am got up at 5 am. Took Tylenol 1000mg. Went to work. Around 9am of 1/6/21 chills more pronounced body aches.  Temp 99.3. Continued to feel poorly, rechecked temp 1.00 pm. Now 99.9. Sent home. At 2:15 pm temp 104.00. More severe chills and body pain, nauseous.  Toast for dinner, Tylenol again at 6 pm , recheck temp 100.8. Went to bed. 1/7/22 am  some body aches, not as severe, nauseous and migrai. Type headache. Did no take temp, because didn't feel one. Call to nurse at covid vaccine holiness. Check temp while on phone  97.4.
Day of had low grade fever, muscle fatigue, and soreness at injection site. 5 days later, left shoulder itching, hard, red and swollen
Tingling in legs and arms and back of neck, feeling of needles in legs and arms, headache, frequent urination every 15 minutes that started 3 hours after vaccination and continues now which it has been 8 hours now since the vaccine, numbness in checks, burning soar throat, mucus feeling in throat making it hard to swallon, depression, difficulty breathing upon minor exertion such as walking about 500 square feet.
they inadvertently administered an expired Fluarix (exp:6/30/23) vaccine this morning on 10/16/23 to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 42-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 9XL7N, expiry date 30-JUN-2023) for prophylaxis.   On 16-OCT-2023, the patient received Fluarix Quadrivalent 2022-2023 season (right deltoid). On 16-OCT-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: they inadvertently administered an expired Fluarix (exp:6/30/23) vaccine this morning on 10/16/23 to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-OCT-2023 The reporter was medical assistant. The reporter called to inquire that how to proceed and would the patient need to be revaccinated. The reporter reported that they inadvertently administered an expired Fluarix vaccine this morning to a patient in the right deltoid, which led to expired vaccine used. The reporter did not consent to follow-up.
Reported feeling flushed, some swelling at the injection site, stated "I just don't feel right" Patient was stable, was being monitored. BP checked 147 systolic. Pt reported feeling worse "I just don't feel myself" Paramedics were called and transported patent from the hospital
Temp 100.5, vertigo, headache, generalized body aches, chills/sweats.
Product storage error; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in a 39-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 05-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was placed in the refrigerator was 31-Oct-2021. There was no temperature excursion. The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Mild tingling and numbness symptoms started on her right side of face then later radiating to right arm and right lower extremity. Denies any weakness Narrative:  will be seeing her PCP
Information has been received from a physician concerning a 10 year old male with allergy to OMNICEF who on 22-APR-1999 was vaccinated with a first dose of VARIVAX vaccine (Merck). On 10-AUG-2008 the patient experienced break-through chickenpox after infant dose of vaccine and had at least 50 lesions. The patient sought medical attention of the physician. Outcome was unknown. The patient did not receive other vaccines within 4 weeks. Additional information was received from a medical assistant. On 20-AUG-2008, the patient recovered. No further information is available.
1 cm circle of redness around injection site of right deltoid. Redness 15 1/2 inch away from injection site and is 4x5 - 4.25 inches wide, wrapping around bicep and 4 inches vertically. Warm to touch. Noticed this morning when child woke up, but was a little swollen around injection site last night.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "high LDL" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: sulfa. Concomitant medication(s) included: LOSARTAN, start date: Apr2022; GEMTESA, start date: May2022; PANTOPRAZOLE, start date: Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Lot number of suspect vaccine was not available/ provided to reporter at the time of report completion. Anti-viral details stated as COVID 19 Treatment with Paxlovid (lot number=GD9502) from 05Sep2022 till 09Sep2022. Recurrence of symptoms 2 days after stopping Paxlovid from 11Sep2022 07:00 hr. No other treatment was provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received regarding a case in litigation concerning a female minor child who was exposed to thimerosal by virtue of the hepatitis B virus vaccine on 11/29/95 (lot # 129LA) and 1/30/96 (lot # 613800/1291A). It is believed that as a result of the child's exposure to thimerosal, and the mercury contained in the thimerosal from the above vaccinations, she sustained neurological injuries and as a result of those injuries has been diagnosed with autism spectrum disorder. Upon internal review, neurological injuries and autism spectrum disorder were considered to be other important medical events (OMIC).
He began breaking out with measles-like rash, followed by fever. The doctor said this was normal to give Tylenol/Motrin. Over the next 3 months he regressed and lost all language, eye contact, interest in people, stopped eating, etc.
Heart palpitations/ fluttering several times a day for two weeks. Intermittently since then
Information has been received from a registered nurse referring to a 5 year old female patient. The patient's medical history was not reported. On 04-MAY-2015 the patient was vaccinated with improperly stored PROQUAD (Merck) injection lot # K022447, exp 13-MAY-2016, 0.5 ml, subcutaneously in the left leg. No adverse effects reported at this time. No concomitant medication was reported. Action taken and outcome were not provided. This is one of several reports from the same source. Additional information has been requested.
the day of and the following days there was normal soreness on arms, a bit more tired than usual, on the 8th the arm, where the vaccine was given, was getting red with a small lump, and the lump began to grow and it is now small, swollen, red, a little itchy, hurts,  on the 9th she began to take advil and Benadryl, not doctor recommended but patient thought it would help.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 20-MAR-2018, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M041184, expiry date: 31-MAY-2018) orally for prophylaxis (product storage error). The vaccine was stored at a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit (59.6 degree Fahrenheit) for a time frame of 8 hours. No adverse effects reported. Previous temperature excursions was reported as "yes". There was a digital data logger involved. No product quality complaint involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1804USA004718.
Redness and heat at injection site 9.22.18 to 9.25.18. Pain and soreness at injection site. Hard to raise arm. 9.21.18 to 9.25.18. Stomach pain (stabbing) 9.27.18 to 9.29.18. Headache and chills 9.28.18 to 9.29.18.
pt recv vax 25SEP95 & 20min post vax pt exp aching arm, neck & head felt thick;30min post vax pt lay down @ end of bed & had a body ache;1hr post vax pt exp h/a a sizzle in head;became dizzy, fainted;flu-like sx;
Bell's palsy; chest pains; high blood pressure; This is a spontaneous report from a contactable consumer (patient).  A female consumer of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. On 05Feb2021, the patient had bad chest pains (she was not sure if she was having a heart attack, as reported), high blood pressure, and Bell's palsy. She was scheduled to have her second dose on 14Feb2021. On unknown date, blood pressure resulted high. The outcome of the events. Information on the LOT/Batch number has been requested.
Severe headache lasting 4 days.  Pain in left arm and limited motion without pain.  Body felt like someone took a baseball bat to my body. 3 day fever.  Upset stomach, Dizziness and feeling out of body for five days. Onset of hot flashes.  Insomnia lasting 5 nights and daytime exhaustion. Ringing in ears and blurred vision.
Insomnia for 2 nights following vaccine administration. I am currently 18 weeks pregnant, after IUI treatment. I am due 07/06/2021. I have had hyperemesis and severe nausea throughout my pregnancy so far.
No additional AE reported; PROQUAD was administered on 08/25/2021 following a temperature excursion; This spontaneous report has been received from an office manager referring to an unknown age and gender patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported.  On 25-AUG-2021, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant Human albumin (rHA)) (PROQUAD) (dose, strength, route of administration and anatomical location were not provided; lot # U009260, expiration date reported as 19-SEP-2022) for prophylaxis (product storage error). The vaccine underwent temperature excursion of -10.7 degree Celsius for total 192 hours. It was reported that there were no previous temperature excursions. At the time of report, there was no additional adverse event (AE).
I woke up after I had worked the 3 PM to 11 PM shift. My muscles starting aching and I was almost ready to go to the ER as I couldn't eat or didn't have an appetite. I had a tight chest and sore throat as well as a fever of 101.8 and cough.
Patient was given Prevnar 13 instead of Pneumococcal 23 as ordered.
I experienced a cough that will not go away on 02/28/2023 and it has yet to go away. I also have been experiencing tiredness and a lack of sleep as of 03/20/2023 and it has yet to go away as well, I have an appointment 04/14/2023 to see my PCP about the symptoms that I've been experiencing.
Cellulitis in my left arm 11 days after injection. Was started on Keflex
Flushed face; Rash was so inflamed and itchy; Rash on her neck and arms that she said may be hives, huge hives; so itchy she was going crazy; Bad rash all over her upper body: shoulders, neck, chest and arms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Rash on her neck and arms that she said may be hives, huge hives), FLUSHING (Flushed face), PRURITUS (so itchy she was going crazy), RASH PRURITIC (Rash was so inflamed and itchy) and RASH (Bad rash all over her upper body: shoulders, neck, chest and arms) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031mzoa) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced RASH (Bad rash all over her upper body: shoulders, neck, chest and arms). On 22-Feb-2021, the patient experienced PRURITUS (so itchy she was going crazy). On 24-Feb-2021, the patient experienced URTICARIA (Rash on her neck and arms that she said may be hives, huge hives) and RASH PRURITIC (Rash was so inflamed and itchy). On 25-Feb-2021, the patient experienced FLUSHING (Flushed face). On 23-Feb-2021, PRURITUS (so itchy she was going crazy) had resolved. At the time of the report, URTICARIA (Rash on her neck and arms that she said may be hives, huge hives), FLUSHING (Flushed face), RASH PRURITIC (Rash was so inflamed and itchy) and RASH (Bad rash all over her upper body: shoulders, neck, chest and arms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment was a combination of hydrocortisone cream and tea tree oil on the rash which maybe helped.   This case was linked to MOD-2021-054414 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Significant Follow up received- The event Pruritus was added. Medical was added. Event outcome was changed to recovered. On 24-Jul-2021: Non Significant Follow up
Pain and swelling of the right eyelid. Started about 48 hours after the first dose was administered and had been getting progressively worse over the next 48 hours. Talked to my PCP and a nurse over the phone and through one chart. Treating the symptoms as a stye seem to be helping. Ibuprofen, eye drops, and a product called stye have been helping reduce the symptoms, especially the pain. A hot, wet washcloth is even more helpful. Used it for almost an hour this evening and the swelling is way down.   My eyes themselves are actually starting to itch and look red tonight. This is the first time this has happened lately. I have seasonal allergies, but this whole thing experience has felt entirely different from that kind of swelling.   I've never had swelling of this nature before. Or any adverse reactions to vaccines (aside from minimal soreness near the injection site).
Patient needed 3rd dose of Pfizer COVID vaccine. Medical assistant drew up full vial without diluting. Double checked with another medical assistant who did not realize that only one syringe was drawn up instead of 6 (as it would be had it been diluted). Medical assistant administered this syringe and realized shortly after she had not diluted it, so patient received the equivalent of 6 vaccines. Immediately clinical supervisor and NP present in clinic. Clinical supervisor called Pfizer, which did not recommend hospitalization if no symptoms. NP called patient to come to clinic for q15m vitals until next steps decided. Patient was stable, only symptom was "feeling clammy." NP advised patient to be seen in ER and he declined, preferring to be home and calling family if symptoms occurred. Clinic will reach out daily for the next 3 days.
Within 10 minutes lips started tingling. Pt did not tell anyone. After her 15 minute wait, by the time she got in her car, her lips were swelling and got tight. Her throat got scratching but did not cause any breathing discomfort. All subsided by the time she got home. She has not had any more symptoms. Has contacted her family Dr. and reported.