chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information had been received on 19-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 11-OCT-2012 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 10-MAY-2013, the patient was seen by a physician at a dermatology facility for the onset of a blistering vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as Herpes Zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
prolonged high fever; Anatomical Location of Administration of Pfizer vaccine considered as suspect: Left Thigh; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team. The reporter is the parent.  A 13-month-old female patient received BNT162b2 (BNT162B2), on 23Jun2022 at 11:45 as dose 1, single (Lot number: FT9142) at the age of 13 months, in left thigh for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: mmr, administration date: 05May2022, when the patient was 12-month-old, for Immunisation, reaction(s): "Diarrhea". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 23Jun2022 at 11:45, outcome "unknown", described as "Anatomical Location of Administration of Pfizer vaccine considered as suspect: Left Thigh"; PYREXIA (medically significant) with onset 25Jun2022, outcome "not recovered", described as "prolonged high fever". The event "prolonged high fever" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (01Jul2022) gone down, notes: almost 105 degrees to 102 degrees. The patient did not receive any other vaccines within four weeks prior to the vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available)was none reported.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Everything was fine at first and I had the headache and normal stuff. I didn't have sensation I had with first vaccine because of the Benadryl (30 minutes prior to vaccine). The main problems started probably 2-3 weeks after (unsure of exact date/time). I started having headaches I used to get. I had an autoimmune disorder prior to being pregnant that they thought was maybe lupus but it wasn't definitive. I was fine after pregnancies until after this vaccine (not currently pregnant or at time of vaccine). I started getting the headaches and I could just tell it was the symptoms of fatigue. I started getting chest pain and shortness of breath and I could feel my heart pounding really fast. My doctor saw me and at that time it seemed more like it was costochondritis and not so much my heart but he went ahead and did a troponin blood test that came back slightly elevated and I was seen in ER because my chest pain was becoming more intense. After 1st test my troponin was normal. I did get an echo after 5 days and it came back stating I had left ventricular hypertrophy and there was swelling in left ventricular wall so now I'm waiting to see cardiologist to see how they want to go about doing that. I have had previous heart problems that went away with pregnancies. I still have chest pain off and on and shortness of breath.
10/6/04: one hour after received vaccine. Had severe headache: increased severity during day. Felt light-headed. Nausea by evening. Chills. 10/7: severe headaches, malaise , poor appetite. 10/8: no headaches, symptoms resolved next 24 hours.
Severe chest cold. Fever. Headache. Tired. Achy. Lasted approximately3 weeks.Got a steroid shot. Did mucinex and all vitamins.  Felt some better. Got 2nd shot  sick 2 days later. Sick with same symptoms for approximately3 weeks again. Did not go to dr. Took mucinex and all vitamins. Felt some better for about 2 weeks  sick again  same symptoms. Dr again. Got prednisone 40 mg and augmentin 875 mg. Feeling some better but my breathing is really heavy. Using my inhaler a lot more than normal.
After first shot started to hear blood pressure in ears; This is constant and became worse after the second dose; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0161, second dose) solution for injection intramuscular in the left arm on 05May2021 at 15:00 (at the age of 45-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included rheumatoid arthritis (RA). Concomitant medications included methotrexate sodium, adalimumab (HUMIRA), and folic acid. Historical vaccine included BNT162B2 (first dose, lot EW0161) for COVID-19 vaccination on 14Apr2021 and experienced hear blood pressure in ears. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. After first shot started to hear blood pressure in ears and this was constant and became worse after the second dose on 05May2021. No treatment was provided for the events. The outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up (20Jul2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021651464 same patient/drug and different dose, different/similar event
her post-herpetic neuralgia (PHN) pain became a lot worse, quite a bit worse, it went from 3-4-5 to 6-7-8; This spontaneous case was reported by a consumer and describes the occurrence of POST HERPETIC NEURALGIA (her post-herpetic neuralgia (PHN) pain became a lot worse, quite a bit worse, it went from 3-4-5 to 6-7-8) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Post herpetic neuralgia.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced POST HERPETIC NEURALGIA (her post-herpetic neuralgia (PHN) pain became a lot worse, quite a bit worse, it went from 3-4-5 to 6-7-8). At the time of the report, POST HERPETIC NEURALGIA (her post-herpetic neuralgia (PHN) pain became a lot worse, quite a bit worse, it went from 3-4-5 to 6-7-8) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.
patient came to the pharmacy while shopping in the store and informed me that he had developed a severe rash on his legs and back about 9 days after receiving the first dose of the Moderna vaccine. He has already contacted his doctor and had been treated with steroids. he still had the rash and it was not resolved. Patient stated he had not changed any other products and that the vaccine was the only new product/medication and that the rash was most likely due to the vaccine
no AE; Inappropriate dose of vaccine administered; it was documented that the patient received MMRlI, but the patient actually received PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.      It was documented that the patient received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, lot#, expiration date, strength, route and anatomical location were not reported) for prophylaxis, but the patient actually received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (1 dose, lot# t0050401 has been evaluated and changed to T005401, expiration date 12-AUG-2021, for prophylaxis; strength, route and anatomical location were not reported) on 22-JAN-2021(wrong vaccine administered). On 20-MAY-2021, prior to discovering the error in documentation, the physician ordered varicella virus vaccine live (oka/merck) (VARIVAX) (1 dose, lot# T016000, expiration date 08-MAY-2021, strength, route and anatomical location were not reported) for prophylaxis to be administered (inappropriate dose of vaccine administered). The patient did not experience any adverse events.
pt recv vax & had rash around ankles, hot sweats-took DPH almost gone in 5 days;
Started with symptoms of diverticulitis on 2/14/2021 (have never had diverticulitis previously)  Visited Facility on 2/19/21 at which time I began Augmentin for 7 days.  Scheduled a CT scan on 2/26/2021 which showed diverticulosis and growth on left ovary.  On further examination discovered a growth on my left ovary, and endometrial lining that is too thick for a postmenopausal women.  Need to have surgery to remove ovary and uterus. which has been put off due to other medical issues. Diveticulitis cleared up and have not had any further incidence in the last year.  However in June 2021 I began to have intense pains in shoulders, arms and hands.  Pain got worse at time went by and finally saw a doctor in July 2021.  Blood tests showed high inflammation factors at which point I saw a Rheumatologist in August 2021.  Was finally diagnosed with Polymyalgia Rheumatica on August 14, 2021.  Diagnosis by Dr. Have since been on prednisone starting at 15mg daily and now have weened down to 3mg daily.
Extremely severe yeast infection due to Gardasil injection shot 1; severe labia and vulva swelling; extreme itching and burning sensation at external vaginal site
She received her first Pfizer Covid vaccine dose on 11Mar2021 diagnosed with Covid-19 on 27Mar2021; She received her first Pfizer Covid vaccine dose on 11Mar2021 diagnosed with Covid-19 on 27Mar2021; This is a spontaneous report from a contactable consumer reporting on herself. A 39-years-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 11Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient was diagnosed with COVID-19 on 27Mar2021. She is due for her second dose on 01Apr2021. She wants to know if she can get her second dose of the vaccine or does she need to wait. The patient underwent lab test which included COVID-19: positive on 27Mar2021. Seriousness of the events was medically significant. Outcome of the events was unknown.  Information on the batch/lot number has been requested.
Fever; chills; enlarged lymph nodes in armpit; extreme soreness/pain in armpit; full body heat rash; hives; swelling of lips; tingly fingers; period/spotting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jan2022 17:00 (Lot number: 33130ba) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypothyroidism" (unspecified if ongoing); "skin cancer" (unspecified if ongoing); "Tree nuts" (unspecified if ongoing), notes: known allergies: Tree nuts. Concomitant medication(s) included: SERTRALINE; GIANVI; LYSINE; BUSPIRONE; SYNTHROID. Vaccination history included: Bnt162b2 (Dose 2, Product: COVID 19, Brand: Pfizer, Lot number: ew0158, Vaccine location: Left arm), administration date: 12Apr2021, when the patient was 33 years old, for Covid-19 immunization; Bnt162b2 (Dose: 1, Product: COVID 19 , Brand: Pfizer, Lot number: en6205, Dose administration time: 03:00 PM , Vaccine location: Left arm), administration date: 22Mar2021, when the patient was 33 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Fever"; CHILLS (non-serious), outcome "recovered", described as "chills"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "enlarged lymph nodes in armpit"; AXILLARY PAIN (non-serious), outcome "recovered", described as "extreme soreness/pain in armpit"; MILIARIA (non-serious), outcome "recovered", described as "full body heat rash"; URTICARIA (non-serious), outcome "recovered", described as "hives"; LIP SWELLING (non-serious), outcome "recovered", described as "swelling of lips"; PARAESTHESIA (non-serious), outcome "recovered", described as "tingly fingers"; INTERMENSTRUAL BLEEDING (non-serious), outcome "recovered", described as "period/spotting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, lymphadenopathy, axillary pain, miliaria, urticaria, lip swelling, paraesthesia, intermenstrual bleeding.  Additional Information: The patient had not received other vaccine in 4 weeks and covid prior vaccination. The patient had covid tested post vaccination. Covid test result was negative.  No follow-up attempts are possible. No further information is expected.
The patient received third/booster dose of BNT162b2; Moderate chill; Muscle pain; Joint pain whole night; Moderate injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received third/booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an intramuscular route of administration in the right arm on 06Nov2021 at 11:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an intramuscular route of administration in the right arm on 09Feb2021 (at the age of 58-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an intramuscular route of administration in the left arm on 10Mar2021 (at the age of 58-years-old) as single doses for COVID-19 immunisation and did not experience any reactions. On 06Nov2021, the night after receiving the booster dose, the patient experienced moderate chill, muscle pain and joint pain whole night. After taking paracetamol, the symptoms seemed to be under control. But it required continuous taking paracetamol every 6 hours for 2 days. On Day 4 (09Nov2021), these symptoms were gone. The other symptom was moderate injection site pain, started on Day 1 (06Nov2021) and lasted for 3 days. The patient did not experience such reactions after receiving the first 2 COVID vaccine doses. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with paracetamol (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events moderate chill, muscle pain and joint pain and moderate injection site pain which lasted for 3 days was resolved on 09Nov2021.
Received pneumococcal vaccine 10/21/2003 9PM.  10/22/2003 6:30 AM: Noticed redness, pain and swelling to left arm injection site.  10/23/2003 12 noon: Presented to wellness center for evaluation.  Redness noted to left lateral arm (13 inch by 14 inch area).  Bicep with small blisters.  States has not seen improvement.  Recommended follow up with physician.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 87-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date 12th April 2021) for prophylaxis. On 14th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 16th December 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. The patient was treated with ANTIHISTAMINE and HYDROCORTISONE (CORTISONE (HYDROCORTISONE)). On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX.  Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced redness and pain at the injection site. The patient also described that the redness was 6 inches long, 2.5 inches wide at the bottom of the injection site and 4 inches wide at the injection site. The patient called the doctor but did not visit. The patient's sister was a doctor and stopped to look at the patient's arm. The reporter gave consent to follow up.
In MAY92, pt recvd (?) Engerix-B & 1st 48 hrs p/vax pt exp flu-like sx; fever; lousy feeling; 2nd 48 hrs post vax exp bladder dysfunction; back pain; numbness in genital area; pt is recovering;
On Friday, April 26th, started out slightly lethargic, but still had appetite. On Saturday, April 27th was quiet and lethargic, threw up three times starting at 12:00 AM Sunday, April 21st. Then had diarrhea Sunday and Monday, the 29nd. Threw up Tuesday, April 30th morning, 2:00 AM and again at 8:30 AM. He is sleeping a lot today. On Monday, April 29th administered Tylenol, had a 99.1 fever. I also noticed a about 5 welts around the injection site. I called Dr. this morning, April 30th who suggested a bland diet and to check him again if not better by the end of the week. He mentioned it could be unrelated to the vaccination and is rare to have a reaction like this occur later in the week, usually only a fever within first 24 hrs.
At 8:00 pm parent took child to Er as child was running  a high fever and having a seizure. Child was admitted to hospital for 23 hours where he recovered and was sent home. DGX per ER record is URI, febrile seizure. No further seizing during the observation period. Discharged to home w/out medication. CT scan of head was nl.
every time patient got one patient was sick for 3 months/ patient got the flu shot 3 years in a row and patient was SICK throu Nov Dec & Jan.; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 05-Dec-2020 and live follow up was received on 11-Dec-2020 (both processed together).  This case involved unknown demographic patient who every time got one , was sick for 3 months/ got the flu shot 3 years in a row and was SICK throu Nov Dec & Jan. (illness) while received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect Influenza Vaccine (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, unspecified time after receiving the vaccine, it was reported that patient every time got one and was sick for 3 months. Patient also reported the flu shot 3 years in a row and patient was SICK throu Nov Dec & Jan. Finaly got over it around valentines have not had a shot in 18 years and have not been sick will never get one again.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.
upper back ache; extreme tiredness; voice hoarse; pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 04Mar2021 at 15:00 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included A-Fib (Atrial fibrillation), high blood pressure and bee sting hypersensitivity (allergy to bee sting). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included diltiazem hydrochloride (DILTIZEM), bupropion (MANUFACTURER UNKNOWN), apixaban (ELIQUIS), lisinopril (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPRIN); all from an unknown date for unspecified indication and unknown if ongoing. The patient previously received dofetilide (TIKOSYN) and clindamycin (MANUFACTURER UNKNOWN); both for an unknown indication on an unknown date and experienced drug allergy. On 05Mar2021 at 06:00, the patient experienced extreme tiredness, voice horse and pain at injection site; Day 2, voice hoarse. On 08Mar2021, day 3, the patient experienced, upper back ache. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events extreme tiredness, voice horse, pain at injection site and upper back ache was recovered on an unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Pt recv vax on 10/29/98; on same day pt exp red/swollen/hard vax site; tx=cold compress, Tylenol
About a one & half inch itchy, red spot on my right arm where the anthrax vaccine was administrated.
7-25-12 7:00 pm (L) arm started to hurt 7-26-12 headache 7-27-12 fever - temp not taken 7-27 & 7-28-12 headache 7-29-12 rash in a band around arm (2") itched 7-30-12 redness upper arm 7-31-12 saw her physician - on antihistamine.
PATIENT MOVED DURING THE VACCINATION, THE NEEDLE CAME OUT BUT WENT RIGHT BACK IN ON ITS OWN. SHE HAS TWO POINTS OF INJECTION. LET MOM KNOW SHE IS AWARE