chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient describe itching of back. Red, slightly raised rash noted across shoulders. Administered 25 mg Benadryl PO. Patient waited additional 20 minutes.  Rash persists. Patient described sensation of slight itching  on legs. Denies and shortness of breath or itching of throat. Patient advised not to drive if she felt any sleepiness. She verbalized understanding.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 31-MAY-2012, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 29-JUL-2016, the patient was treated by the clinic, for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
positive COVID test; positive COVID test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient. 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovered", described as "positive COVID test"; COVID-19 (medically significant), outcome "recovered", described as "positive COVID test ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she had a positive COVID test last Wednesday; Negative, notes: home tests are now negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Details were as follows: patient noted that she took both Pfizer COVID vaccines and all available boosters, not otherwise specified then she had a positive COVID test. Her home tests are now negative.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Temp at 8pm 12/8/99 - 103.7, Tylenol reduced temp-101. Listless, fussy, poor appetite. Temp remained elevated. 12/10 temp at HD was 103.1. Child crying. RL Inj site has minimal erythema. As of 12/12 child still fever of 102.
Dizziness Seen by onsite EMT BP:135/94        Pulse:93        Po2: 99 Recorded by : RN Seen by: D.A. , EMTP  and A.P , EMTP
Bell's palsy; jaundice looking legs; inability to communicate clearly; Seems to be experiencing numerous seizures; This is a spontaneous report from a non-contactable consumer. A 20-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot and expiry unknown), via an unspecified route of administration on 26Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced Bell's palsy, jaundice looking legs, inability to communicate clearly and seems to be experiencing numerous seizures on 04Mar2021. The events were considered serious due to hospitalization. The patient was hospitalized on 04Mar2021. It was unknown if patient received treatment for the events. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
pt recv vax;refused to eat;mom could not give sz med or advil;lt sz & felt a little warm;took advil & phenobarbital p/ ate;pt had about 10 sz; to er; T 102;
A legal complaint was received from an attorney alleging that a male child received series of Hib-TITER, Tetramune, Tripedia, Engerix B, and Recombivax-HB vaccines from 1/18/96 though 8/14/97, and subsequently "suffered devastating injuries through mercury toxicity and associated complications and sequelae and the aggravation of other conditions directly through exposure, via IM injection of mercury" in the "thimerosal-containing vaccinations." The reporter indicated that the child's neurological injuries are "severe, devastating and permanent." According to the legal complaint, the child "was born a perfectly normal, healthy boy whose APGAR scores at birth were well within the normal range." It is alleged that at approximately 18 months of age, the child "was neurologically devastated by the accumulation of mercury in his body, having been exposed via IM vaccinations, and suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to becoming withdrawn, unresponsive to his environment, engaging in repetitive behavior and the loss of language skills." According to the legal complaint, the child "suffered severe and permanent injuries" and "sustained and will sustain in the future a mental, intellectual, developmental and neurological incapacity and associated learning disabilities, affect disorders and impairments."
Myalgias; Sore arm; This is a spontaneous report received from contactable reporter(s) (Physician).  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Lot number: EL3247) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "HTN" (ongoing); "DMZ" (ongoing); "BPH" (ongoing); "Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: ALFUZOSIN [ALFUZOSIN HYDROCHLORIDE] taken for benign prostatic hyperplasia (ongoing); LISINOPRIL taken for blood pressure abnormal (ongoing); METFORMIN XR taken for diabetes mellitus (ongoing). The following information was reported: MYALGIA (non-serious), outcome "recovered", described as "Myalgias"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm". Therapeutic measures were not taken as a result of myalgia, pain in extremity.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a registered  nurse and refers to a patient of unknown age and gender. On 09-DEC-2014, the patient was given ROTATEQ lot# K005273, expiration date: 23-FEB-2016, that was involved in temperature excursion on 18-NOV-2014. No adverse effects reported. This is one of several; reports received from the same source. Additional information has been requested.
stomach ache; vomiting; aches; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 13:00 (Lot number: EN6207) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 02Nov2020 (unspecified if ongoing), notes: The symptoms were not severe but did have fatigue, loss of taste and smell and a headache and pain; "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin; "Pituitary tumour" (unspecified if ongoing); "Brain aneurysm", start date: 2008 (unspecified if ongoing), notes: In 2008, I had a brain aneurysm rupture with coiling with a brain bleed effecting right side of body. The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Drug allergy", notes: Known allergies: Erithromycin. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EN6205, Anatomical location: Left arm, Vaccine administration time: 13:00 pm, Aches and headache that lasted 2 days), administration date: 12Mar2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "Headache", "Ache". The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 03Apr2021 12:00, outcome "recovered" (Apr2021), described as "stomach ache"; VOMITING (non-serious) with onset 03Apr2021 12:00, outcome "recovered" (Apr2021), described as "vomiting"; PAIN (non-serious) with onset 03Apr2021 12:00, outcome "recovered" (Apr2021), described as "aches"; HEADACHE (non-serious) with onset 03Apr2021 12:00, outcome "recovered" (Apr2021), described as "headache". Therapeutic measures were not taken as a result of abdominal pain upper, vomiting, pain, headache.  Additional information: The patient was not pregnant at the time of vaccination. The patient had COVID, diagnosed on 02Nov2020. The symptoms were not severe but did have fatigue, loss of taste and smell and a headache and pain. The patient felt like the virus attacked weakest parts of body (for instance) head hurt on left side, as if the patient was punched. It lasted two days. In 2008, the patient had a brain aneurysm rupture with a brain bleed affecting right side of body. That seemed to be where pain was from COVID. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 12:00 pm, the patient experienced stomach ache, vomiting for a full day 24 hours after second shot with aches and headache. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101067474 Same patient, different drug, different event (split)
PATIENT WAS 16 AT TIME OF VACCINE ADMINISTRATION INSTEAD OF RECOMMEND AGE OF 18 OR OLDER; PATIENT SHOWED NO REACTION AT CLINIC AND HAS YET TO ALERT US TO ANY SINCE.  CALLING PARENTS TO INFORM THEM.  THERE WAS A MISCOMMUNICATION BETWEEN PARENTS AND CHILD.
On 7/28/00, the pt was hospitalized for pancreatitis and pain control. She was discharged 5 days later and has recovered.
pt to hosp with c/o generalized weakness, cough, nausea, diarrhea, fever, abdominal pain; positive for COVID; DNR; pt does not want any aggressive treatment; stopped Decadron due to fluid overload; pt dc'd to home with hospice; pt died in her home 3 days later
fever, headache, fatigue, nausea acetaminaphine eased symptoms felt totally fine next day
Post vax, pt experienced an injection site reaction and flu-like symptoms. Unspecified medical attention was sought. The reporter also reported an additional pt (WAES 01010737). Addtl info has been requested.
having a flare-up of her migraines; chronic daily headaches/ other complicated headache syndrome; This is a spontaneous report from a contactable physician. A 75-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (at the age of 75-years-old) as a single dose for covid-19 immunization. Medical history included migraine and headache from an unknown date and unknown if ongoing. Concomitant medication included pregabalin (LYRICA) taken for prophylactic treatment, start and stop date were not reported. The physician previously talked to the patient at her last appointment on 24Mar2021 and asked if her headaches worsened over the summer monsoon season, so they could potentially go up on her Lyrica. The patient was diagnosed with other complicated headache syndrome. The physician spoke with the patient on 23Apr2021 and reported that she experienced flare-up of her migraines and had chronic daily headaches, especially after her recent covid vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pain @ the site of inj & it extended down the arm to the extensor side of the hand;20 days post vax 11DEC96 forearm was red, edematous & sore when moved;
she tested herself for COVID-19 as a requirement for a procedure at the hospital; This is a spontaneous report from a contactable consumer or other non HCP (patient herself).     A 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6207; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (at the age of 83-years-old) as dose 1, 0.3 ML single for Covid-19 immunisation. The patient's medical history included diabetic; she has been diagnosed more than 20 years. The patient was allergic to sulfa. The patient had no history of previous immunization with the Pfizer vaccine. The concomitant medications included she takes many unspecified medications and does not want to list them on this report. The patient previously took penicillin and experienced allergy. No additional vaccines administered on same date of the Pfizer suspect. The patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No adverse event following prior vaccinations. The patient got the first shot of the Pfizer COVID-19 vaccine on 19Mar2021 at (Facility name). She had no adverse events, and everything was fine. She had no problems with it, she was doing very well with it. She wanted to make an appointment for COVID-19 testing. She was scheduled to get an epidural done and had some testing she needed to get done and part of that testing was a COVID-19 test. On 27Mar2021, nasal swab taken, and she tested herself for COVID-19 as a requirement for a procedure at the hospital. The test went through her nose. She received a call saying that she tested positive for COVID-19. The patient stated  that currently, her husband, her son, her daughter, even her dog was in quarantine. She was isolated for 12 days. The adverse event not required emergency room and physician office visit. She was scheduled to take the second dose of the vaccine on 09Apr2021. She wanted to know if she can take the second dose of the vaccine as scheduled. She stated it has been 12 days and she want to get retested and schedule her next appointment if she has to reschedule. She wanted to know would they still give her the second shot on 09Apr2021, should she still take it. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
numbness in both feet.; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534), via an unspecified route of administration on 25Apr2021 (age at vaccination: 62 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, 4 days later, the patient experienced numbness in both feet. They are better but are still numb. She was supposed to get the second dose on Sunday. The outcome of the event was unknown. There was no product quality complaint (PQC) present.  No follow-up attempts are needed. No further information is expected.
Moderna vaccine given to patient under the age of 18. Mom notified. Pharmacist explained Moderna was not approved for 17 and younger. Patient already received 2 doses of Pfizer. Mom was aware patient received Moderna vaccine. Mom was not concerned, but appreciated being notified.
several hours after immunization, patient developed bruising, warmth to the touch and swelling of the left arm.  Patient came to pharmacy 3 days later to check with pharmacist on duty
URTICARIA. I have broken out in hives from head to toe. The exact location varies day to day. This started 10 days after my Moderna booster and continues today, almost 7 days. No other symptoms. I didn't have similar reactions to my first 2 doses of Moderna vaccine.
Narrative:  A 68yo male with PMH of Extrinsic Asthma, Urithral Stricture, Rectal Bleeding, Cataract, Subjective Tinnitus, Sensorineural hearing loss, Opioid Depe. Remission, Diverticulitis, late Effects of Motor Vehicle Accident,  Esophageal Varices, Hepatitis C, Hepatic Cirrhosis, Chronic Postatitis He received Covid-19 on the right arm on March 6,2021 per protocol and was reported with post vaccine shot reactions of Chills, Muscle aches and head aches which started the following day after the vaccination
This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. On 29-DEC-2012, the patient was vaccinated with a dose of GARDASIL (lot number reported as 667194/1271Z, dose and route unspecified) that had expired on 11-DEC-2012. No adverse effect was reported. This is one of the two reports from the same reporter. Additional information has been requested.
Swelling, redness, raised, warm Rt upper out arm. Fever, chills, joint pain, fatigue.
c/o rt arm numbness & painful c/o pain in rt upper & lower arm & paresthesias in rt middle finger; pain in shoulder joint when uses it also seem to have sl pain on palp of rt deltoid muscle grip strength in rt arm questionable sl diminished
My first menstrual cycle after the first dose was very short and very light,  which is very abnormal for me. My second menstrual after the second dose is even more abnormal. My cramps this month were the worst I?ve ever felt, and I?ve currently been bleeding for 26 days. Long periods are nothing new to me, my usual period is about 12-14 days, but I?ve never gone longer.
Narrative: Patient reported symptoms following vaccination. Self administered diphenhydramine orally and symptoms resolved without further medical intervention. Patient declined 2nd dose of Pfizer COVID 19 vaccine and elected to received JOHNSON and Johnson COVID 19 vaccine on 8/30/21. No reaction reported to that vaccination.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2021-395985 (Patient Link).
Systemic: Lymph Node Swelling-Mild, Additional Details: Patient had lymph node swelling in upper left chest quadrant that started just a few days after vaccine admin and has continued all the way to the second dose on 6/19/21. Patient still wanted to get second dose.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients. Medical history and concurrent conditions were not reported. On unspecified dates the patients were vaccinated with ZOSTAVAX (route, dosage, dose number and lot number unknown). The pharmacist reported that "injection site reactions are common" with ZOSTAVAX, and he observed many injection site reactions that he did not report as AEs. He did not recall any specific details about any of these other injections site reactions at the time of this report. The outcome of the injection site reactions was unknown. This is one of three reports on the same source. Follow up information was received on 16-DEC-2014 from the pharmacist. The pharmacist states he had no access to the Lot number for the ZOSTAVAX vaccine he and wife received. The pharmacist also stated he had no patient identifiers, Lots numbers or dates of vaccinations for the other patients he referred to in the original report. The pharmacist had no information to share at this time. Additional information has been requested.
HIGH BLOOD PRESSURE; LOW GRADE FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was a pretty healthy till now. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced high blood pressure, and low grade fever. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, and had not recovered from high blood pressure. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Began with fatigue around 3PM progressing into chills, muscle aches, and cramps. The chills and muscle pains prevented sleep.
Pt was given second PNEUMOVAX in same calendar year. Developed swelling, pain et baseball/softball size redness at site. Was instructed to apply ice et take ibuprofen. By 11-11-11 improvement to site noted. Voiced no other complaints.
Received dose on 01/12/2021 - left arm - muscle soreness.  however on 01/14/2021 developed left axillary lymph node became very swollen and very painful -discomfort.  Also became very fatigued and temperature not stable bouncing down to 97.4 - 99.9.  these all lasted for about 3 days and then completely went away
Dizzy , Light headed,  next day 6 to 8 times  that last about 8 minutes.    Dizzy only one time, third day so far.