chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got it again after the shot/suspected vaccination failure; got it again after the shot; pain/pain was no where's the level of pain before the shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got it again after the shot/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got it again after the shot) and pain (Verbatim: pain/pain was no where's the level of pain before the shot ). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-Apr-2023 The case was received from the patient via interactive digital media. The patient stated that true he or she got them again after the shot but the pain was no where's the level of pain before the shot. The shot definitely helped him or her. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
No adverse affect after 1st dose. After second dose, no arm pain was felt, but joint aches and a fevers were prevalent around hour 8 after injection. Around hour 10, a fever of 100° F set in and quickly rose to 102° before hour 12. Fever reached 103° by hour 12.5 and broke by hour 13. After fever broke, vomiting/dry heaving occurred for roughly 2 hours. Lethargy/ LOC set in around hour 16 and the former remained until around hour 48. After the course, I began to feel fine, I just wanted to report how adverse my side effects were compared to those of my coworkers.
On 10-03-23 pt called about currently experiencing swelling and redness from the flu shot.  She claims she can still see the "injection hole", but the area is not spreading, not warm to the touch, and does not hurt unless she lays on that side
a little bit of a headache; "real tiny" body aches; tired; sore arm; This is spontaneous report from a contactable nurse. A 28 1/2-years old male patient received first dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, solution for injection, batch/lot not reported) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was mentioned that with the first dose, patient experienced a little bit of headache (that was mild and lingering), real tiny body aches, tired-ness and a sore arm. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Born full term/healthy..Received shot during 2 month check up after told everything about her seemed fine..4 days later she started having seizures and we were hospitalized the next day..Diagnosed infantile spasms..All tests (MRI, blood work, spinal, genetic, chromosome etc...)were normal, doctors have no idea what is causing these sizures. The medical record received on 3/23/04 states irritable, rales and retractions. Discharge summary states focal seizure, respiratory distress. msv
The patient came into the office for a Influenza vaccine. Patient received the vaccine in the right arm, abut 8 minutes after the influenza vaccine, the child started saying that he could not breathe, his arms were red and he was clutching his throat. Patients primary care physician, requested for crash bag, and Epinephrine 0.3mg IM. Epinephrine given, per physician order. EMS was called to transport to Emergency Department. Patient was responding, smiling, conscious, and talking after Epinephrine was given.
On 2/2/08-Headache- 2/6/08-Had left side of face paralyzed, diagnosis Bell's Palsy- and continued to suffer symptoms (earache and paralysis, droopy eye).  03/19/2008 MR received for several OVs dated 2/11-28/2008 with DX:  Bell's Palsy. Upon PE L side of face noted to be drooping. Only R side of face moves when smiling. Cannot close L eye completely. Given prednisone in ER but not taking due to sleeplessness.
6/12/22- began feeling fatigued and weak. Cough, SOB, and fever began after.  Treatment includes: Dexamethasone, Remdesivir, oxygen, and IV fluids.
Numbness and tingling of hands/ completely numb hands; Numbness and tingling of hands; slight tingling in lips; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 13:30 (Batch/Lot Number: EW0164) as SINGLE DOSE for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patient received the first dose of vaccine in Arm Left on 24Mar2021 13:30 (Batch/Lot Number: ER8733), also at age of 64 years old for covid-19 immunization and experienced migraine. Medical history included, Brown- Sequard (cervical myelopathy), Common variable immunodeficiency (CVID), migraine, fibromyalgia, Chronic interstitial cystitis (IC), Complex regional pain syndrome (CRPS), multiple orthopedic issues. Patient allergy to Sulfa, cipro, reglan, IVIG , flu vaccine , macrobid, Suprax, tetracycline. Concomitant medications included levothyroxine sodium (SYNTHROID); gabapentin (NEURONTIN DAW); liothyronine sodium (CYTOMEL); pregabalin (LYRICA), all taken for an unspecified indication, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On the third day after the 2nd vaccine 17Apr2021 08:00, patient  awoke with completely numb hands.  It resolved within ten minute. Tingling / partial numbness have continued. Some slight tingling in lips. The outcome of events was not recovered. Patient didn't receive treatment for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious.  No follow-up attempts are needed. No further information is expected.
Hives reported 9/16/2020 10AM Benadryl 50mg po Every 6 hours
OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: Reynaud's (some circulatory issues), penicillin allergy, alcohol user (couple of times a week, moderate), and cigarette smoker (10 cigarettes a day, half a pack), and other pre-existing medical conditions included: The patient had no history of any drug abuse or illicit drug usage. Patient had been in good health at the time of vaccination. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: unknown) dose was not reported, 1 total administered on 03-APR-2021 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following first dose of vaccination (Dose number in series 1). The patient also received dose 2 (first booster) with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin not reported, batch number: 1855194, expiry: unknown) dose was not reported, 1 total administered on 12-NOV-2021 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first booster (Dose number in series 2). The patient received additional dose 3 (second booster) with covid-19 vaccine ad26.cov2.s (Dose number in series 3), (suspension for injection, route of admin not reported, batch number: 1855835 expiry: unknown) dose was not reported, 1 total administered on 08-APR-2022 to left arm for covid-19 prophylaxis which was an off label dosing frequency (Off label use) (Dose number in series 3). Age at time of vaccination 64 years old. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious.
arm hurt; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via Pfizer Sponsored Program. A 95-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Her arm hurted for a few hours after the first shot. Patient got her second shot yesterday (17Feb2021). Patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 17Feb2021 as dose 2, single for COVID-19 immunization. She had no side effects at all with the second dose. She had heard if you have side effects it meant your immune system was working. She did not have any side effects and wanted to know if it was working. The outcome of the event was unknown.   Information about Lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
horrific reaction. Literally thought I was going to die; This case was reported by a consumer via interactive digital media and described the occurrence of impending doom in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced impending doom. On an unknown date, the outcome of the impending doom was unknown.   It was unknown if the reporter considered the impending doom to be related to Shingles vaccine.     Additional Information: GSK receipt date: 10-Jul-2022 Reporter's comment: The case was reported by the patient via interactive digital media. The patient had a horrific reaction to the shingles shot.  The patient literally thought that he/she was going to die and wanted to at one point. The patient never went back for second shot, no way and so beware and aware. Additional supportive information: Follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR105416 and US2022AMR105421, reported by same reporter for different patient. As per reported verbatim, ' I was going to die', event impending doom was coded as it was closed match event and for second dose there is a medical reason was reported for not receiving therefore it was coded as suspect with incomplete course of vaccination.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105416:same report, other patient US-GLAXOSMITHKLINE-US2022AMR105421:tag at post
Patient was given DTaP and should have been given Tdap.  The office contacted the mother and the patient has no adverse side effects as of 02-09-07.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 26-JUL-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (dose and route were unknown, lot # L044694, expiration date 04-FEB-2018), which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever; chills; body aches; headaches; malaise; chest pain in side-lying; cough; diminished appetite; This is a spontaneous report from a contactable healthcare professional. A 30-year-old male (also reported as female) patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EH9899), intramuscular in the left arm on 17Dec2020 at 15:45 at a single dose for immunization. The patient had no relevant medical history. The patient din not have Covid prior to the vaccination and had no known allergies to medications, food, or other products. The patient's concomitant medications were not reported. It was reported that the patient had no other medications in two weeks and did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient experienced fever, chills, body aches, headaches, malaise, chest pain in side-lying, cough, and diminished appetite starting at 11pm (23:00) on 17Dec2020 and gradually decreasing mild symptoms still present on 22Dec2020. The patient received no treatment for the adverse events and was not tested for COVID-19 after the vaccination. The facility where the most recent COVID-19 vaccine was administered was at the hospital. The outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause or require prolonged hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
Initial report received from a health care professional on 16 December 2013. 3 patients, whose gender, age, medical history and concomitant medications were not reported, had received a dose of ADACEL (Lot number U4612AA, site of vaccination was not reported) intramuscularly, on an unspecified date in December 2013. Patients reported the injection site became warm to touch, reddened, itchy, and a knot formed. Corrective treatment was not reported. At the time of this report the outcome of adverse event was unknown. Documents held by sender: none.
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional (Reference number- 00575182) and transmitted to Sanofi on 23-Apr-2021.  This case involves a male patient (age not reported) who received a 0.5 mL dose of expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6265AA and expiry date: 19-Apr-2021) via an unknown route in the deltoid for prophylactic vaccination on 23-Apr-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  The patient did not receive any other medications or vaccinations at the time of reporting.   This was a case of actual medication error case due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
This spontaneous report as received from a registered nurse refers to a 15 months old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (Merck) (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
blurry vision; This spontaneous case was reported by an other health care professional and describes the occurrence of VISION BLURRED (blurry vision) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced VISION BLURRED (blurry vision). At the time of the report, VISION BLURRED (blurry vision) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medicines were not reported
Immediately after receiving vaccines, patient put his head down, stiffened up and had syncopal episode. + loss of consciousness for a few seconds. Was confused after it happened. He laid down for 10 minutes and after that he sat up and was initially feeling better. 5 minutes after sitting up, he had a second syncopal episode where his head went back, he went stiff and then started falling towards the side. + loss of consciousness for a few seconds again. Vital signs at this time were BP 132/63, HR 51, O2 sat 99% in room air. 911 was called. Ambulance arrived within 5 min. Next set of vitals at 1004: BP 112/57, HR 61, O2 sat 99% in room air. Repeat at 1020: BP 115/77, HR 68. Pt continued to be alert and oriented, answering questions appropriately. Mild pallor. MDs and ambulance staff advised that patient be taken to the ER for further evaluation but family refused. Family did not give reason for refusal; only stated that they thought he "just needed to get home and eat something." Family was informed that ER visit should be covered by emergency insurance if no other insurance available. Ambulance staff called their supervisor, who also spoke to the family. Family still refused and signed form from ambulance staff stating their refusal. Pt remained seated, alert and oriented during conversation. Pt then walked without assistance out of the mobile clinic and into family's private vehicle.
Became paralyzed from waist down. It came on very suddenly. I was subsequently diagnosed with transverse myelitis.
Information has been received from a nurse practitioner concerning a 45 month old female with no pertinent medical history and no drug reactions/allergies who on 15-SEP-2010 was vaccinated with the first 0.5 mL dose of VARIVAX (Merck). There was no concomitant medication. On 16-SEP-2010, 24 hours after receiving VARIVAX (Merck), the patient experienced fever of 104.9 and had an onset of hallucination with the fever. The nurse practitioner reported that the patient came to the office and received a blood culture that came back negative. The nurse practitioner reported that the patient had had on therapy and recovered. Follow up information has been received concerning the patient with no brothers or sisters who was vaccinated the first dose of VARIVAX (Merck) via intramuscularly route at left thigh. There was no concomitant therapy. Within 24 hours the patient had fever onset post shot, 104.9 degree C, and episode of hallucination, complain of ST. The patient was no illness at time of vaccination. On an unspecified date, the patient recovered. No further information is available.
got Vaccine at abt 11 a.m. Hour and half after Injection sharp pain in left arm,  6 pm sharp pain from neck to left leg. Felling Fatigued
Very heavy menstrual cycles. Heavy flow for 3-4 days with clotting. Mild to moderate cramping on and off. First time in my life I've had heavy periods. Very apparent post vaccination of the change in my cycle that's still ongoing.
I had shingles the day after I got the vaccine; The initial case was missing the following minimum criteria: Invalid for Other-Info not qualifying for AE reporting-Medical Information. Upon receipt of follow-up information on 14Jun2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 24Feb2021 (Batch/Lot Number: EN6202) as single dose for COVID-19 immunisation. Medical history included Thyroid, glaucoma, pain back. Concomitant medication(s) included pravastatin (PRAVASTATIN) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for thyroid disorder, start and stop date were not reported; timolol maleate (TIMOPTIC) taken for glaucoma, start and stop date were not reported. The patient had no prior vaccinations. The patient got first Pfizer COVID shot on Wednesday (24Feb2021) night and she think she had shingles, she probably had them Wednesday night, she probably had then when she got the shot. She did laboratory test this week (Feb2021) and the results were normal. She was wondering how that effects it and if she had to go on to the anti-viral drug for shingles. The patient stated the next vaccination dose due date, maybe it's 19Mar2021. How that would affect her getting second COVID shot. When probed for start date, consumer stated, "she think it actually started before then but she just know she was just having some pain in her back but she didn't look at her back and she think there were probably some blisters that's there until recently when her, she told her husband that her back was sore, he looked and saw the blisters. But she think they were there before she got the shot." She think they were shingles. When probed for treatment for the problem, consumer stated, "For shingles, not yet. She was going to see a doctor." First covid vaccine. Now had shingles. Inquiring if there was any relations and if she could take the second dose. Upon follow up on 14Jun2021, the patient reported that she had no side effect from the COVID vaccine. She had shingles the day after she got the vaccine on 25Feb2021. Took antiviral 3days after the COVID shot. Outcome of the event was recovered on 25May2021.  Follow-up (14Jun2021): New information received from a contactable consumer (patient) included: Case considered valid with event shingles, onset date, end date, outcome, treatment received added for event shingles.  No follow-up attempts are possible. No further information is expected.  Follow-Up (02Jul2021): Follow-up attempts are completed. No further information is expected.
This spontaneous prospective pregnancy report was received from another health care professional, a practice manager concerning a 25 year old pregnant female patient. On 30-SEP-2014 the patient was vaccinated with a dose of GARDASIL lot # K001500 expiration date 06-NOV-2016, 0.5 ml, intramuscular in error as the patient was supposed to received Tdap at patient 36 weeks pregnant. The healthcare professional stated that the patient who administered the dose of GARDASIL did not confused this vaccine with Tdap. She stated that the error was not related to the product or labeling confusion; she just grabbed it. The patient's last menstrual period (LMP) was 19-JAN-2014, the estimated date of conception was 02-FEB-2014 and the approximate date of delivery (due date) was 26-OCT-2014. No adverse events were reported. Additional information has been requested.
Leg pain Shortness of breath , rapid heart rate , Dizziness , Nights sweat Symptoms started  March 24  .Went to Urgent care April 2, they referred me to the ER  . I went to the Hospital ER April 6 , They admitted me at noon after finding Blood Clot down my right Leg and Chest . 2 shots of Lovinox  for 3 to for days
She got her vaccine, it hurt right away.  The next day she had swelling, knot at the injection site, and it is red around it.  She still has this reaction.  She has not  taken anything for it.  It has not changed and staying the same as it was.