chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller stated that on 8/19/2020, the patient was administered improperly stored VARlVAX; This spontaneous report was received from a registered nurse, referring a female patient. The patients' pertinent medical history, current conditions, previous drug reactions or allergies were not reported.   On 19-AUG-2020, at the age of 4-year-old, the patient was administered improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T002848, which has been verified to be valid, expiration date reported and validated as 23-JAN-2022), as prophylaxis (product storage error). As concomitant therapy, a properly stored sterile diluent (MERCK STERILE DILUENT) (lot number S008566, which has been verified to be valid, expiration date reported and validated as 16-NOV-2021) was used to reconstitute the vaccine (medication dilution). The vaccine administered was stored at temperatures that went, from -14 degrees Celsius (C) to -10C (-12.1C) for a time frame of 3 hours, and from -9C to 8C (-7.5C) for 8 hours 30 minutes, as recorded by a data logger. There was no previous temperature excursion.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014014:
Information has been received from a parent of a 20 year old daughter with no medical history, drug reactions or allergies who in February 2010, was vaccinated with a dose of GARDASIL (dose and lot number not reported). Concomitant therapy included LOESTRIN. Consumer reported that her daughter had a really bad rash 9 to 10 days after getting the vaccine shot from the waist up, mainly in her arms and her belly. It was reported that was "welty and swollen". On an unknown date, a blood work was performed (results not provided). The outcome was not reported. Patient sought unspecified medical attention. No further information is available.
6 hours after vaccination in left arm deltoid muscle: Nausea/vomiting, 100 degrees temp (norm body temp is 97.5), severe all over body aches, chills, headache, fatigue, stomach cramps, loose stools. All reactions lasted 3-4 days
Patient isn't sure which HPV vaccine she got from her OBGYN today but her appt was at 845 am and it is not 324 pm and she still has severe nausea, stomach pain, and fatigue. I am concerned about this.
HPV #2 vax given. 10" later pt displays pallor & c/o nausea, diaphoresis & feeling like she "may pass out" pt given 6oz water to drink, a sweet cereal snack & a peppermint hard candy. Phys exam was WNL. Pt laid down supine & felt better in 15" & went home.
Not sure which flu vaccine I was given so the above could be wrong. I became very tired but could not fall into a deep sleep for two nights. It was like a twilight sleep. Beginning on the 28th I began having off and on ear pain . EAr pain continued off and on until the 9th of Oct when it became strong and mostly in left ear continuously. On the 15th Oct I began symptoms of bronchitis (disoriented, loss of balance, loss of energy, cough)
Date of Admission: 10/16/2022   Date of Discharge: 10/19/2022   Admission Diagnosis: Chest pain, unspecified type   Hospital Principal Problem (Discharge Diagnoses): Type 2 MI (myocardial infarction)
Nausea; Headache; Fatigue; This is a spontaneous report from a contactable nurse, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via intramuscular route of administration in the left arm on 30Apr2021 at 15:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, ocular dysmetria, irritable bowel syndrome (IBS), all tapes (adhesive tape) allergy and sulfonamide allergy. Prior to the vaccination, it was unknown if the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included doxylamine succinate (UNISOM), nigella sativa (BLACK SEED OIL), ibuprofen (ADVIL), magnesium (MANUFACTURER UNKNOWN), fish oil (OMEGA 3), vitamin d nos (VIT D) and cyanocobalamin (VIT B12); all taken from an unknown date for an unknown indication and unknown if ongoing. The patient previously received cefprozil (MANUFACTURER UNKNOWN), levofloxacin (LEVAQUIN), doxycycline (MANUFACTURER UNKNOWN), angelica sinensis (DONG QUAI), cetrimonium bromide (ELASTOPLAST) and panax ginseng root (GINSENG) and experienced drug allergy. On 05May2021 at 06:00, the patient experienced nausea, headache and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nausea, headache and fatigue was recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Presented to PCP office c/o dizziness and feeling that tongue was swelling. Had received shingles vaccine at Pharmacy approx. 4 hrs prior. No SOB. EPIPEN administered. 911 called, transported to ER.
Took 2 doses of Moderna COVID-19 vaccine and IGG antibodies test 1 month later came nonreactive; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANTIBODY TEST NEGATIVE (Took 2 doses of Moderna COVID-19 vaccine and IGG antibodies test 1 month later came nonreactive) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Kidney polycystic in 1978 and Kidney transplant (Kidney transplant in November 2006.) in November 2006. Concurrent medical conditions included Allergy to antibiotic (Amoxycillin), Allergy to antibiotic (Doxycycline), Drug allergy (Percocet), Drug allergy (Allipurinol) and Drug allergy (Zestril). Concomitant products included EZETIMIBE, SIMVASTATIN (VYTORIN) for Cholesterol, MYCOPHENOLATE MOFETIL (MYCOPHENOLATE), SIROLIMUS and PREDNISONE for Kidney transplant, SITAGLIPTIN PHOSPHATE (JANUVIA) for Sugar blood increased, ACETYLSALICYLIC ACID (BABY ASPIRIN), COLCHICINE (COLCRYS), DOCUSATE, FAMOTIDINE, TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), METOPROLOL and NICOTINAMIDE for an unknown indication.   On 12-Jan-2021 at 10:29 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021 at 11:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021 at 4:14 PM, the patient experienced ANTIBODY TEST NEGATIVE (Took 2 doses of Moderna COVID-19 vaccine and IGG antibodies test 1 month later came nonreactive). At the time of the report, ANTIBODY TEST NEGATIVE (Took 2 doses of Moderna COVID-19 vaccine and IGG antibodies test 1 month later came nonreactive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, SARS-CoV-2 antibody test: negative (Negative) Negative and unreactive.         No treatment medication was provided.  Description: The patient's doctor told him that these results mean he had not developed immunity to the COVID-19 virus.  Company Comment  Some immunosuppressants drug have been found to reduce the effectiveness of COVID vaccines as such causal relationship cannot be excluded   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up received updated patient demographics, medical history, concomitant medications.; Sender's Comments: Some immunosuppressants drug have been found to reduce the effectiveness of COVID vaccines as such causal relationship cannot be excluded.
Pain started on right side of lower back. By the second day after receiving shot, I could not walk without excruciating pain. Pain then walked down the front of my right leg. Saw doctor twice over it, trip to ER, and was placed in physical therapy and pain is still continuing. Pain is causing my right leg to give out/ buckle underneath of me with every step I take. This has drastically changed my life and my mobility. I can barely walk.
Began noticing shortness of breath and anxiety in January 2022. During colonoscopy my blood pressure bottomed out and heart rate shot up. Ran a lot of lab work and ordered stress test, and heart monitor. October I was put on ELIQUIS 5mg twice a day. Diltiazem to take twice a day and take an extra one if I felt atrial flutter. I was scheduled to see a heart surgeon and was scheduled for an ablation in both upper chambers of heart. Heart surgeon increased diltiazem.
itchiness from head to toes; Stomach cramping; had 8 bowel movements; This is a spontaneous report from a contactable consumer (patient) received via the Medical Information Team. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 12Mar2021 (Batch/Lot number was not reported) (at the age of 62 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 12Mar2021, the patient experienced itchiness from head to toes (at 07:00 PM), stomach cramping, and had 8 bowel movements. Clinical course of events was as follows: The patient had the first shot of Pfizer COVID vaccine on 12Mar2021 and supposed to have the second dose on 06Apr2021, Tuesday. The patient received the first dose from 02:30 to 03:00 PM on 12Mar2021, and the night at 07:00 PM, had developed itchiness from head to toes. The patient took loratadine (CLARITIN) that night, and the next morning on 13Mar2021, the itchiness resolved. The patient also experienced stomach cramping which eased with a bowel movement. Stated that she had 8 bowel movements that day. The patient was wondering whether she should receive the second dose. The patient would like to know if she should take loratadine (CLARITIN) before her second shot if she decided to get the second shot. The outcome of event itchiness from head to toes was recovered on 13Mar2021; the event stomach cramping was recovering; the event had 8 bowel movements was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started on her right side and that numbness going up to her breast, went up into shoulders and down arms and whole side was numb, on the right-side, starting at hip and and going directly to toes; Fell down after losing her balance and thought she had a blood clot or stroke; Fell down after losing her balance and thought she had a blood clot or stroke; She was tingly; This is a spontaneous report from a contactable consumer via Pfizer Sales Representative. This female consumer (patient) reported that.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry was not reported) via an unspecified route of administration on 29Jun2021 as a dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date was not reported) via unspecified route of administration on unspecified date as a dose 1, single for covid-19 immunisation. It was reported that on an unspecified date, the patient had numbness in her hip that went directly to her toes and immediately, after that it started on her right side and that numbness going up to her breast, went up into her shoulders and down her arms and her whole side was numb again on the right side. She fell down after losing her balance and thought she had a blood clot or stroke and then she was tingly after that and she went to the emergency room, they did a CAT scan, and they did CAT scan with contrast and they were looking for the blood clot and then they did ultrasound of her right leg and found nothing. She never had anything like this happened before and she believe that could possibly be a side effect of the vaccine and that was why she called and left me that message today. The reporter was asking what happens after that and will she get contacted or what happens. Caller stated She went to the hospital and I do not know what they gave her at the hospital. (further clarification about hospitalization was unknown). The patient underwent lab tests and procedures which included computerised tomogram was unknown result, CAT scan with contrast'they were looking for the blood clot, ultrasound scan was found nothing ultrasound of her right leg on an unspecified date. Outcome of the events was unknown.  Information on lot/ batch number has been requested.
This case was reported by a pharmacist and described the occurrence of wrong vaccine administered in a male patient who received ENGERIX B adult (batch number FB3A3, expiry date 28th January 2016. Concomitant products included TWINRIX. On an unknown date, the patient received ENGERIX B adult. On an unknown date, an unknown time after receiving ENGERIX B adult, the patient experienced wrong vaccine administered and drug dose administration interval too long. On an unknown date, the outcome of the wrong vaccine administered and drug dose administration interval too long were unknown. Additional information: TWINRIX was started on 0, 1 and 6 month schedule. The patient received TWINRIX at dose 1 but was inadvertently given ENGERIX-B for dose 2. The patient was also late on the schedule. He received the ENGERIX-B dose 2 months after dose 1 of TWINRIX.
Migraines with dizziness, eye pain, light sensitivity, room spinning, fever, chills, very ill feeling, high and low blood pressure events, severe fatigue, trouble walking due to dizziness, hoarse throat, body aches like a flu.
fever; trouble sleeping; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (did not had any adverse reaction).   On 16th July 2020 04:00, the patient received the 2nd dose of Shingrix. In July 2020, 17 hrs after receiving Shingrix, the patient experienced fever and difficulty sleeping. The patient was treated with melatonin and paracetamol (Tylenol). On 18th July 2020, the outcome of the fever and difficulty sleeping were recovered/resolved.   It was unknown if the reporter considered the fever and difficulty sleeping to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix about 4 PM and had trouble sleeping so she took Melatonin at 2 AM, but it did not work so they took Tylenol. The patient temperature at 9 AM was 100.5 degrees F and it increased to 101.6 so she contacted her doctor. She was instructed to take Tylenol every 6 to 8 hours instead of every 12 hours. She went to the Urgent Care at 5 PM and her temperature had decreased to 99.7 degrees F. The reporter consented to follow up. Emergency room visit was required.
Patient 1st dose on june 2019, second dose on january 2021.; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in June 2019, Lot number: 2yn4s).   In January 2021, the patient received the 2nd dose of Shingrix. In January 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix, later than the recommended schedule, which led to lengthening of vaccination schedule.  The reporter consented to follow up.
HPV vaccine to beef up his T cells; This spontaneous report has been received from  a 63 year old male patient regarding himself. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 25-MAY-2021, the patient was vaccinated with an unspecified HPV vaccine (lot #, expiration date, dose and route were not reported) to "beef uo his T cells" (Drug use for unapproved indication).  It was further mentioned that the patient started therapy with pembrolizumab (KEYTRUDA) on the same date, and experienced several adverse events (captured into MARRS # 2105USA006345).    This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2105USA006345:
This is a spontaneous report from a contactable consumer. A 64-year-old male patient received the second dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number unknown, Expiration Date: unknown),via an unspecified route of administration on Arm Right On 02Feb2021 01:00 at single dose for COVID-19 immunization. The patient historic vaccine include second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number unknown, Expiration Date: unknown), via an unspecified route of administration, On Jan2021at single dose for COVID-19 immunization. concomitant medication was not reported. On 04Feb2021 patient experienced swelling under armpit a little larger than an egg, fluid went into his chest and back, red blotches on chest and back, event recovered on 06Feb2021. On 07Feb2021 patient experienced swelling in face primarily around the eyes(ongoing), face was as red as a beet as if he had a sunburn (ongoing). Patient took treatment Benadryl. The first dose was 21 days exactly prior to the second Vaccination. Vaccination Facility Type at Hospital. The outcome of swelling under armpit a little larger than an egg, fluid went into his chest and back, red blotches on chest and back, event was recovered on 06Feb2021 and red as a beet as if he had a sunburn, event eye swelling, erythema Recovering. Information on the lot/batch number has been requested.
Information has been received from a physician concerning a 61 year old female patient with endometrial cancer (last chemotherapy in May 2008) and penicillin allergy who on 19-NOV-2009 was vaccinated SC with a dose of ZOSTAVAX (Merck) (lot number not reported) from a pharmacy. Concomitant therapy included PRAVACHOL, monthly B12 injections and FLUOXETIN 3-4 days later, on approximately 22-NOV-2009 the patient developed shingle lesions on both of her legs. The patient was seen by the physician on 25-NOV-2009. It was unknown if lab studies performed. At the time of the report on 25-NOV-2009, the patient had not recovered. Follow-up information has been received from a completed questionnaire by a physician. The physician indicated that the patient had an unknown history of chickenpox and it was unknown if the patient had been recently exposed to chickenpox or herpes zoster received her first dose of ZOSTAVAX (Merck). On 19-NOV-2009 (also reported as 23-NOV-2009, four days after receiving ZOSTAVAX (Merck) the patient developed herpes zoster. The physician reported that the patient developed a classic vesicular rash at the right calf, 1 centimeter long, with smaller lesions at the left calf and left upper thigh. The patient also developed itching. The rash also occurred at the neck. The physician classified the pain as 1 in a scale of 1 to 10. The patient was given FAMVIR 500 oral, twice in a day for seven days. On 05-DEC-2009 the patient recovered. The reporter considered shingle lesions to be other important medical event. Additional information is not expected.
In October in 2022 I noticed I had a rash on my breastbone.  It was raised, red, itchy bumps.  It appears different on my chest than on my face.  On my face it looks more like acne with white heads and would become dry and scaly.  It started to appear on my face in February 2023.  It got worse as I got emotionally stressed.  I finally went to the doctor in April 2023 and diagnosed with dandruff on chest and face in addition to rosacea on my face.  I received prescriptions for Doxycycline, face wash, Sodium Fulsacetamide Wash, Ketoconazole cream for my face.  I began noticing symptoms for COVID-19 on February 4, 2023, and tested positive on the 6th. My symptoms were severe fatigue, joint pain, back pain, coughing and a runny nose.  The symptoms progressed within 36 hours, and I had a bad cough and sore throat.  I had a telehealth appointment and was prescribed Paxlovid.  I felt better within the first day.  I just remained fatigued and had brain fog for about another week.
3/17/09 - developed numbness/tingling/headache - found to have CIDP as of 9/19/11 - still with symptoms of CIDP - got better with treatment - IVIG.
41yo consumer reports exp swelling @ inject site (size of 1/2 grapefruit) w/in 24 hrs of vax (mid FEB) nodule just disappeared @ time of this report 8APR92; also had exaccerbation of underlying liver disease-hep C & rt quad pain;
administered an expired dose of Boostrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 70-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number HF2YA, expiry date 20-JUL-2023) for prophylaxis.   On 15-SEP-2023, the patient received Boostrix. On 15-SEP-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administered an expired dose of Boostrix).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 18-SEP-2023 The vaccine administration facility was the same as primary reporter The pharmacist reporting having administered an expired dose of Boostrix on 15 September 2023 which was expired on 20th July 2023, which led to expired dose used. The reporter consented to follow up.
Employee has sore throat, diarrhea, dizziness and rash at injection site and on legs. 9/20/12.
Pt experiencing pain/achiness in the legs since the day after the second dose was administered. No treatment at this time. Patient is going to PMD today (day 11 after dose).
After receiving my second shot, the next day my menstrual cycle started. I was two weeks early and I had horrible cramping. My lower back became inflamed and couldn't get out of bed. I still have lower back pain and I spot on a regular bases. I have blurred vision during the late afternoons and I'm so tired.
High heart rate, low fever, chest tightness. Felt it a week after the vaccine, went to the hospital on the 10th of october, result was Pulmonary embolism, small blood clots in my lungs.