chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a office manager concerning a 12 year old female with no known pertinent medical history, and no known drug reactions/allergies, who on 15-AUG-2008 was vaccinated with the first dose of GARDASIL (Lot no 658558/1061U) in her right arm. Concomitant vaccine included VARIVAX. The office manager reported that on 24-AUG-2008 the patient called the office because she was having tingling and numbness in both of her legs. On 28-AUG-2008, the patient went to the doctor's office in which he ordered blood work, a urine test and he did a heavy metal screening and the patient was referred to the neurologist. On 11-SEP-2008, the test all came back normal. On 26-SEP-2008, the patient saw the neurologist whose impression was that the patient had paresthesia to the vaccine injection and he prescribed the patient NEURONTIN (Manufactured unknown) 100 mg twice daily and the patient was scheduled to see the doctor again in a month follow up. On 03-OCT-2008, the patient called the doctor because she was still having the tingling and numbness in both legs and he had diagnosed her with TA paresthesia and added ATAXIA CEREBELAR. On the same day, 03-OCT-2008, the patient had a MRI done of her brain and again was referred to see a neurologist for a second opinion and if it gets worse she may start LYRICA. The office manager stated that the end results of MRI seemed to be normal. The office manager reported that on 24-OCT-2008, the patient left a message which stated that she was now also having pain in her knee. On 27-OCT-2008, the patient saw the doctor again and he was diagnosed her with paresthesia. Then on 03-NOV-2008, the patient received her second opinion with a neurologist and said that she had a mild form of acute polyneuropathy (Guillain Barre) post vaccinating improving. Then on 17-NOV-2008, the patient saw the doctor again because she was stilled having tingling and numbness in both legs but now had worse symptoms in her feet and hand symptoms, and when the patient saw the physician on 17-OCT-2008 she stopped taking NEURONTIN (Manufactured unknown) on her own. Additional information has been requested.   12/2/08 MR received from PCP including 2 neuro consults. Final DX:  Mild form of Acute polyneuropathy (Guillain Barre) post vaccination-improving. Pt presented for neuro eval 9/26/08 with c/o worsening tingling sensation of both legs which began s/p Gardasil vax on 8/15/08.  Tingling is painful but able to continue with ADLs. Initial impression: Paresthesia 2' to vaccine injection. Started on Neurontin with some benefit.  2nd neurology opinion  11/5/08.  Now reporting some weakness of feet and difficulty with dorsiflexion of ankles and toes. Pt stable.  Additional studies will be obtained if worsening. Returned to PCP 11/17/08.  Missed November menses. Will observe.  Assessment:  paresthesias (Tingling or Numbness) related to Gardasil vax.  No further Gardasil vax.  Seen again by PCP with c/o painful lump near left breast.  On PE swelling and tenderness noted over L costosternal junction.  Assessment: costosternal inflammation.
Sharp head pains and red rash over several hours. Appears to be zoster, though no vesicles at time of exam.
Since leaving the clinic, with use of my left shoulder I have had excruciating pain in and around the shoulder to the point I have considered going to the hospital thinking I?m having another heart attack.  I have taken a boat load of Tylenol and it doesn?t touch it.    Only thing that helps is to prop my arm on a pillow  and not use it.
No additional AE; Expired dose of M-M-R II was administered; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 23-JUN-2022, the patient was administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type rHA) subcutaneous injection (lot # T018669 has been verified to be a valid lot number, expiration date: 29-MAY-2022; dose and route of administration not reported) administered for prophylaxis (Expired product administered). Additional product reported included sterile diluent (MERCK STERILE DILUENT) (reported as "DILUENT MRK") (lot # W009117, expiration date 16-JUL-2024). Measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the diluent used to reconstitute the vaccine were stored according to prescribing information through the date of administration. There were no additional adverse event (AE) details provided, there was no additional AE (No adverse event). There was no product quality complaint (PQC).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Other medical history: High Blood Pressure; "High BMI" (unspecified if ongoing), notes: Other medical history: High BMI; "High Triglycerides" (unspecified if ongoing), notes: Other medical history: High Triglycerides. Concomitant medication(s) included: DILTIAZEM HCL; FENOFIBRATE; LOSARTAN POTASSIUM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jul2022) Positive, notes: Tested positive again on 26Jul2022 via two different home antigen tests; (unspecified date) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  clinical course: the patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Approximately 1 week after Hepatitis B shot, devloped rash on arms - was itchy all over. Did not associate rash with shot - did not call MD. Contacted MD after 4/30/04 visit to Health Dept - shot refused her - Contacted MD - MD stated it was reaction to Hepatitis B vaccine.
Approximately three days after vaccine number two I experienced the following side effects that I have never experienced before: 1.) Bilateral knee pain more that was more prominent in the morning and approximately a 4 out of 10 on the pain scale.  This resolved within three days. 2.) Teeth sensitivity that was so severe it was difficult to brush my teeth. This has improved, but not completely resolved. 3.) Jaw pain and soreness after talking or eating.   This resolved without intervention within about three weeks. 4.) Very noticeable vertigo/dizziness directly related to activity.  If I rested the entire day and had minimal activity there was no vertigo.  This was severe days 3 - 10 post vaccine number two and took approximately three weeks to completely resolve. 5.) Brain fog - impaired memory, difficulty pronouncing more complex words, mild degree of expressive aphasia.  This has has improved, but not completely resolved. 6.) Period was delayed by approximately a week and developed acne.  I have not experienced acne or a delayed period in approximately 15  years and am normally very regular.
Severe chills at 11:30pm to 3am. Woke up at 4:30am and vomited several times. Felt weak and dizzy. The next morning, had severe headache and pain from behind my eyes to the back of my head.
9 days after shot developed fine full body itchy red rash, smooth spots, generalized body aches for 3 days, fever of 99.1 for 3 days.
Face got very warm, hands felt cool, slightly dizzy, a weird feeling.. I was in a store and took a Zrytec as it is what I had with me. Called my spouse to come and drive me. By the time I got home, approximately  1/2 hour to 45 min. later, I was starting to feel better.
When I got COVID-19 I woke up really congestion & sick. I was not able to taste or smell for a few days. I had a really bad headache & a few chills. I was also extremely tired for the first 2 days.
Received Menactra vaccine in the AM on 3/26/2007.  Around 7:30PM started to feel 'strange'.  Was brought to school's Health Center and was very disoriented and combative.  Was taken via ambulance to Medical Center ER.  At 0400 on 3/27/2007 he had a temp of 101.  He was discharged back to school around 5AM with diagnosis of viral syndrome with possible adverse reaction to Menactra.  I examined him in the AM of 3/27/2007 and he was afebrile and feeling well and his exam was normal.
Pt received dose of vaccine this arm. Returned to clinic approx 6hrs later with c/o "feeling hot and sweaty" lg raised area, warm to touch about size grape under skin. Patient received oral BENADRYL.
Temp 101.5 at 4AM 5-1-12, mom took baby to ER & discharged with instructions to monitor temp MOTRIN PRN, cool compresses to red, raised inj site.
This spontaneous report as received from a licensed practical nurse refers to a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2015, the patient was vaccinated with the dose of GARDASIL (lot # H021861, expiration date 09-OCT-2015; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
patient stated she had chest discomfort, NSR ON ecg NO SHORTNESS OF BREATHE blood pressure 150/87, 80, 16, 100 %
Piriformis syndrome; muscle spasms; both legs going numb to toes; Could barely move for weeks; This is a spontaneous report from a contactable consumer(patient). A 52-years-old-female patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number Ew0169), via an unspecified route of administration at Arm Left on 05Apr2021 at the 52 years old at single dose for COVID-19 immunization.  The medical history was none. The concomitant medications were not reported. There were no known allergies. The patient was not pregnant. The Historical Vaccine was first dose BNT162B2(lot number=Er8733) in 2021(08:30 AM) at 52 years old at Left arm for Covid-19 immunization. On 10Apr2021 08:30 the patient experienced Piriformis syndrome, muscle spasms and both legs going numb to toes, Could barely move for weeks. All of the events caused Emergency Room Visit and Physician Office Visit. The patient received Cortisone anti inflammatory and physical therapy as treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
FEVER; This spontaneous report received from a parent concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included down syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 15-MAR-2021 14:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.4 C, 98.9 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Developed pain and blistering rash on (L) lower extremity several days after ZOSTAVAX.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, PNEUMOVAX 23 and M-M-R II (doses, lot numbers, expiration dates, routes of administration were not provided for any vaccine). The vaccines were reconstituted with properly stored (reported as properly) sterile diluent. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 1.1 degrees Celsius for 37 minutes. Digital Data Logger was involved. There was no previous excursion.
REDNESS, SWELLING, REDNESS RADIATING ACROSS CHEST, ITCHING AT INJECTION SITE, BRUISING, BLEEDING, FEVER TO INJECTION SITE, HARD, FOLLOWING DAY BULLSEYE (RED RING).
rapid heartbeat; flushing; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced rapid heartbeat and flushing, 1.5 to 2 hours after the first dose on an unspecified date. And reported that events did not last for long, was fine the next morning. Patient stated that she read that rapid heartbeat was listed in fact sheet and she wanted to know that how to make an educated decision on getting the 2nd dose if experienced adverse reactions. Doctor told her as long if it did not last few days then it was ok. The events were assessed to be non-serious as per reporter. The clinical outcome for the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
parent reported to school nurse on 10/11/2005, child had vesicle like rash arms, legs bilaterally and trunk.
administered an expired Bexsero (exp:3/23/23) dose on 5/11/23; 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 18-year-old female patient who received Men B NVS (Bexsero) (expiry date 23-MAR-2023) for prophylaxis.   On 11-MAY-2023, the patient received Bexsero. On 11-MAY-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: administered an expired Bexsero (exp:3/23/23) dose on 5/11/23). 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-May-2023  Medical assistant reported an 18-year-old patient was inadvertently administered an expired Bexsero dose on 11th May 2023.  The reporter did not consent to follow-up. Medical assistant called to inquire if the patient should be revaccinated.
Ringing in ears after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears after vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Ringing in ears after vaccine). At the time of the report, TINNITUS (Ringing in ears after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Fever, chills, massive headache, sore and red arm, incredible fatigue and some body aches for 2 nights (like 60 hours)
vaccine administered 2pm Friday 5/7/21. Onset maculopapular pruritic rash bilateral forearms at 5pm Saturday 5/8/21.  +Penile pruritis 11pm Saturday. On morning of Sunday 5/9/21 rash had spread to pelvis/abdomen
Breast tenderness- Feels like I am going to have a period, which I have not had since June 2019.
Runny nose, congestion, cough, weakness in lower extremities 3-4 days after Hepatitis B injection #2 given on 3/10/2003.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 03-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M000996, expiry date 07-JAN-2018, dose, strength, vaccination site, route unspecified). the vaccine was exposed to a temperature of 6.5 Fahrenheit (F) for 80 hours. Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
LEFT ARM ITCHING AT INJECTION SITE; LEFT ARM PAIN AT INJECTION SITE; HARD KNOT AT INJECTION SITE UNDER THE SKIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 260 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced hard knot at injection site under the skin. On 11-JUN-2021, the subject experienced left arm pain at injection site. On 13-JUN-2021, the subject experienced left arm itching at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hard knot at injection site under the skin, left arm pain at injection site, and left arm itching at injection site. This report was non-serious.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. The physician reported for two patient. This is the first of two reports. A patient of unspecified age, ethnicity and gender started to receive TRUMENBA, via an unspecified route of administration on an unspecified date at single dose. Relevant medical history and concomitant medications were not reported. The patient experienced a lot of vomiting on an unspecified date. The outcome of the event was unknown. Follow-up (19-MAY-2016): Follow-up attempts are completed. No further information expected.
Welts on face, itching, chest rash later onset, followed by legs.  Lips swollen.  Some difficulty breathing.
pt recv vax 15OCT97 & 7 days later pt devel deafness in lt ear;pt was seen by ENT specialist;multiple tests, including MRI were performed;results were not provided;reporter indicated event resulted in permanent disability;
Approximately 5 minutes after injection pt became dizzy, reported double vision, and left sided weakness. VSS.  Pt was sent to on-site ER for further evaluation. ER workup was "unremarkable" per ER notes and "likely due to low blood pressure or some form of anxiety." Symptoms had resolved by end of ER visit and she was sent home with general
This spontaneous report as received from a 16 year old female consumer reporting on herself, with "pre-diabetes", but never diagnosed as diabetic and without drug reactions or allergies. On unspecified dates, the patient was vaccinated with dose 1 and 2 GARDASIL, 0.5 ml doses (0,2 and 6 months), intramuscular (lot number was not reported). In 2013, the patient received dose 3 GARDASIL. Secondary therapies were not reported. There was not concomitant medication. The consumer stated that on an unspecified date after her "second or third" GARDASIL dose, she stopped getting her period for 5-6 months. The gynecologist prescribed unspecified "pills" to induce menstruation after using for 10 days, which it did. The patient stated that "not too long ago", on an unspecified date she became unable to sleep at night. A week or two ago, in approximately 27-DEC-2013 the patient began having extreme fatigue during the day, leading to sleep for extended periods of time. In addition, the patient stated that recently she "shake" or tremble for short periods of time despite not being cold. At the time of the report, outcome for stopped getting her period was recovered. The outcome for the other events was not reported. On an unknown date, the patient performed a blood work and test urine (results not provided). The causality of the event was not reported. Additional information has been requested.
About 3 weeks after patient had the second dose of Moderna Covid-19 vaccine He started with extreme fatigue, diarrhea, high blood pressure, join pain, muscle pain, join swelling, restricted motion or stiffness, headache syndrome.
A few hours after vaccination I had headache body aches and no energy. On 4/13/2021  had sever headache and anything I took only helped for a few hours, body aches were in my legs with sharp pain. On 04/14/2021 same symptoms as day before, also tired, no energy and stay in bed all day so I don?t feel the pain as much
swollen lymph nodes in armpit; 100.8 °F fever; chills; body aches mostly legs and hips; body aches mostly legs and hips; sore arm at vaccine site; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6202), administered in right arm on 24Feb2021 03:00 PM (at the age of 72-year-old) as 2nd dose, single for COVID-19 immunisation. Vaccine facility type was reported as hospital. The patient's medical history included high blood pressure, premature ventricular contractions (pvc's), mitral valve (as reported), thyroid nodules, hemangioma's in liver. No known allergies reported. No COVID prior vaccination was reported. The patient's concomitant medications in two weeks included atenolol (TENORMIN) 50 mg, enalapril maleate (VASOTEC) 10 mg, rosuvastatin calcium (CRESTOR) 5 mg, colecalciferol (VITAMIN D), ascorbic acid (VITAMINS C). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262), administered in right arm on 04Feb2021 09:30 (at the age of 72-year-old) for COVID-19 immunisation. No other vaccine was received in four weeks. On 25Feb2021 03:00 AM the patient experienced 100.8 °F fever, chills, body aches mostly legs and hips, swollen lymph nodes in Armpit same arm as vaccine, sore arm at vaccine site. No treatment was received due to the events. Patient was not tested for COVID post-vaccination. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.