chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable Registered medical assistant calling on behalf of a CRNP. A 67-year-old male patient received PREVNAR 13 lot R12276 Expiry Date 28Feb2018, intramuscular in Feb2017 at 0.5 ml, single for immunisation (health maintenance).  Medical history included ongoing hypertension, hyperlipidaemia, gastrooesophageal reflux disease.  Concomitant medication included ongoing acetylsalicylic acid (BABY ASPIRIN), atorvastatin calcium (ATORVASTATIN CALCIUM), ranitidine (RANITIDINE).  On 21Feb2017 within 4 hours after vaccination he started having fever, headache, shortness of breath, wheezing, and aching with outcome of unknown.  The patient underwent lab tests and procedures which included physical examination of unknown results.
80 year old male history significant for multiple cormorbities who presented to the ER with reports of shortness of breath and pleuritic pain. He reports sudden onset of back pain in his thoracolumbar spine which was associated with shortness of breath. He notes the pain was intermittent and sometimes positional but exacerbated with deep inspiration. Due to concern for aforementioned symptoms he presented to his PCP earlier who referred him to the ER. Subsequent workup with CT revealed right sided subsegmental PE. Etiology of PE remains elusive as patient denies recent trauma/immobilization, denies history of prior PE/VTE or coagulopathy
very bad sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in 2019, refer case US2020077722.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced sore arm but not as bad as after the first shot.  Sore arm has at the time of reporting resolved. The reporter did not consent to follow up.
no other adverse events reported; given an expired VARIVAX; temperature excursion/Temperature 46F; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 18-JUL-2022, the patient was vaccinated with one dose expired varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot #U020239 had verified to be a valid lot #, labeled  expiration date: 28-JUN-2023; route, strength and anatomical location was not provided) for prophylaxis (expired product administered). The vaccines varicella virus vaccine live (oka/merck) (VARIVAX) underwent temperature excursions of 46 Fahrenheit (F) for 264 hours (product storage error). The expiration date was short dated to 11-MAY-2022 after experiencing a temperature excursion. It was reported that the suspect vaccine was administered after short-dated expiry date but prior to labeled expiry date. There was no previous temperature excursion. And the reporter inquired about revaccination. No additional adverse event details were provided (no adverse event).
Left shoulder in rotator cup and under arm pit stay sore every since I received shot, pain everyday, have been to doctor two time and they had me to take Ibuprofen 3 time of day 300mg didn't help at all, still have the same pain.
RUE Cellulitis, approx 5x3cm. No drainage. Area warm to touch. Denies pain. KEFLEX 250/5ml one teaspoon Q12 hours x 10 d, antihistamine/BENADRYL, ice/warm compress.
Patient received vaccination on 01-13-2022 without complications; however, vaccine use-by-date was noted to be 01-09-2022. Patient did not report adverse events during 15 minute waiting period after vaccine was administered. A phone call will be made to patient and patient will be informed to come back for another dose if she wishes to receive.
Probable Guillain Barre onset 11 days after flu vaccine administered.  12/27/05 Received medical records 10/20-10/22/2005. Records state decreased reflexes, paresthesia, asthenia, headache, nausea, confusion, hand weakness progressing x 2 days approx 2 wks s/p flu shot. Weakness & difficulty walking progressed s/p d/c & was readmitted 10/24-10/26/2005.  Neuro consult done, demyelinating neuropathy per NCV..  Tx w/IVIG.  No LP done per pt refusal.
Flu-like symptoms - overactive bladder (night of) - neck rash (present 2 days after then 2 days).
Red rough skinned rash on  upper arm at the site of the shot down to the elbow , swollen, hard upper arm
ER records indicate that child had a possible febrile seizure on 4/26/18 the day after receiving Dtap and hep A vaccines. Upon arrival to the ER child's temp was 102.4.
Patient received vaccine in right deltoid in February 2018. He received his second dose in Oct 2018 at pharmacy (they will submit their own form). He states that after his first vaccine, he had residual pain in the right deltoid, but it went away after a few months. He then received his second dose in the same arm. On todays date, the patient came in for his annual flu vaccine. He stated he still has pain in that arm (a year after receiving vaccine). When he was asked to show where the pain was, he pointed to the area where vaccines are normally given on the deltoid. He stated he had the typical flu-like symptoms after each vaccine which lingered for about two days, but the dull pain has never went away.
rec'd grey cap pfizer after being in freezer for 22 days- pt rec'd replacement dose on 6/3/22
pt devel high-pitched cry-1hr p/shots;vomited x 2-3 p/this;pt seen @ 330PM @ clinic- alert & playful bouts of crying;
None, pt was asked if pregnant told both MA and DO no HPV administered and then pt told provider she was 6 weeks pregnant.
acutely fatigued, yawning, dry mouth, BP dec to 80/0, dyspnea, weakness;tx w/IV DPH, Epi, IV fluids & hosp;
Pfizer Vaccine. A couple days after my second vaccination I started having front shoulder pain and stiffness in the left arm (arm I was vac in). I never had any shoulder pain or arthritis before the vaccination. I had an xray months later and was told it was AC Joint with small subchondral cysts and arthritis. Months later I started having right shoulder pain and stiffness. Now more than a year later I am having elbow pain and stiffness. I'm in a lot of pain. I truly believe this arthritis was brought on by the Pfizer vaccine. Blood work was completed and I did not have RA. RA is genetic in my family. Many doctors do not seem educated on the fact that its possible for a vaccine to cause arthritis. I think its possible I have ASIA. I will not be getting any more vaccines of this type due to the health issues this has caused me. My writing to you today to give you this information is so that you can know what reactions people are having. I believe you do not receive some symptoms because doctors are not listening to patients. I do want people to be informed that the Covid vaccine could cause arthritis. I never had this and its disabling. I'm struggling every day with this. I wish I had never received the vaccine. Please look into this further.
pt  woke up drenched in sweat.  She does not seem to have to have a temp but has sweat pouring off her face.  This is not typically normal for her.  She has had a few chills and is nauseated.  She has photo sensitivity and headache.  She is waiting for her PCP's medical assistant to give her a CB.
Moderna COVID19 Vaccine EUA Metallic taste appeared within 5 minutes of dose. Smell and other taste not affected. Very subtle metallic taste right after injection
Swollen face, lips and very itchy back with a rash 12 hours after vaccination on 01/05/2022.
PATIENT RECEIVED THE VACCINE FROM EITHER LOT # 024C21A OR # 007C21A. IT IS NOT KNOWN WHICH LOT. BOTH LOTS WERE OUT OF THE FREEZER FOR 4 TO 18 DAYS MORE THAN THE RECOMMENDED 30 DAYS.  MODERNA EXPECTS VACCINES TO HAVE REMAINED SUFFICIENTLY EFFICACIOUS.  PATIENTS DID NOT HAVE ANY NEGATIVE OUTCOMES SO FAR..
This is a spontaneous report from a contactable consumer or other non hcp. A adult female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via intramuscular route of administration on unknown date in Apr2021 as single dose for COVID-19 immunisation. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via intramuscular route of administration on unknown date in May2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On Jul2021, the patient experienced lack of efficacy tested positive for COVID after being fully vaccinated. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Jul2021 for COVID after being fully vaccinated. The outcome of the events was recovered on unknown date in 2021.  Information on lot/batch number has been requested.
24 hours of not feeling good after the first shot; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (24 hours of not feeling good after the first shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE, GLYCOPYRRONIUM BROMIDE (BREZTRI AEROSPHERE) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (24 hours of not feeling good after the first shot). At the time of the report, VACCINATION COMPLICATION (24 hours of not feeling good after the first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-348894 (Patient Link).
chills; fatigue; stomach pain; dehydration; nausea; muscle pain; sweating; This case was reported by a consumer and described the occurrence of chills in a 50-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 4th September 2020 17:30, the patient received the 1st dose of Shingles vaccine. On 4th September 2020, 12 hrs after receiving Shingles vaccine, the patient experienced chills, fatigue, stomach pain, dehydration, nausea, muscle pain and sweating. On an unknown date, the outcome of the chills, fatigue, stomach pain, dehydration, nausea, muscle pain and sweating were recovered/resolved.   It was unknown if the reporter considered the chills, fatigue, stomach pain, dehydration, nausea, muscle pain and sweating to be related to Shingles vaccine.  Additional details were reported as follows: The patient received 1st dose of Shingrix on 4th September 2020 5:30 pm and she experienced chills, fatigue, stomach pain, nausea, a lot of muscle pain, sweating, and dehydration these adverse events occurred after 12 hours  She was not taking any other medications at time of vaccination.  All adverse events subsided within a couple of hours she thinks the adverse events may have been due to dehydration. The patient asked should expect the same with the second dose  The reporter did not consent to follow-up.
16 y/o with needle phobia. 7 minutes after administering vaccine the patient fainted. the patient bit into his tongue and chipped 1 of his front teeth.
The evening of the vaccination I experienced a fever of 100 degrees F, sweating, and chills, and shivering so violent I woke up about four times that night.  I experienced moderate fatigue the next day due to lack of sleep.   Approximately 36 hours after the injection I began getting a cold sore in the right corner of my mouth.  The following day I began to get a second cold sore in the center of my top lip.  Later that day I began to develop numerous cold sores on my pallet, something I've never experienced before.   Six days after the injection I was awake at 2:00 AM because of a new baby in our home.  at 2:19 AM on 10/11/21 my tinnitus began ringing in my left ear louder than I had ever heard it before.  20 minuets later my right ear began ringing as well.  (I have never experienced tinnitus in both ears at the same time before.)  My left ear lasted the entire rest of the night.  I was able to fall asleep, and my right ear had stopped ringing but I woke up another 2 times that night and icy left ear continued ringing until approximately 7:00 AM.
This is a spontaneous report from a contactable consumer for a patient enrolled in a Pfizer-sponsored program, this report regards an event part of the medical history of the patient. An adult female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history included pneumonia when she was a baby. Concomitant medications were not reported. The patient experienced pneumonia on an unspecified date with outcome of unknown. Pfizer is a marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the country of incidence. This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities. The information on the lot number has been requested.
Body ache (day after vaccine shot); Headache (day after vaccine shot); Chills (night of vaccine shot); Slight fever (night of vaccine shot); Soreness in chest (night of vaccineshot); Tiredness (night of vaccine shot and day after vaccine shot); This is a spontaneous report from a contactable other healthcare professional, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 3248) via an unspecified route of administration in the left arm on 14Apr2021 at 10:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19.The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications in two weeks reported as not applicable (N/A). On 14Apr2021, on the night of vaccination shot, the patient experienced chills, slight fever and soreness in chest. On 15Apr2021, day after vaccination shot, the patient experienced body ache, and headache. On 14Apr2021 and 15Apr2021, both the days on the night of vaccine shot and also day after vaccine shot, the patient experienced tiredness. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or 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 the events chills, slight fever, soreness in chest, tiredness, body aches and headache were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
sweaty, pale, dizzy. PB 117/75, PO2 97%, HR 86. After laying down, drinking water, felt better (so symptoms)
Immunizations on 06/07/2004 Right arm and had fever up to 102 F x4days. Mod. Swelling and erythema right arm with pain and rash.
I was 7 weeks pregnant and received 2nd Pfizer vaccine, on the same day started having virginal bleeding and crumping, had miscarriage next day.
welt at the injection site; big red circle at the injection site; itching at the injection site; hives at injection site; arm being kind of sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE URTICARIA (welt at the injection site), MYALGIA (arm being kind of sore), INJECTION SITE ERYTHEMA (big red circle at the injection site), INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE URTICARIA (hives at injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high, METFORMIN for Diabetes, SIMVASTATIN, VITAMIN C [ASCORBIC ACID], VITAMIN D [VITAMIN D NOS] and FISH OIL for an unknown indication.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced MYALGIA (arm being kind of sore). On 27-Sep-2021, the patient experienced INJECTION SITE URTICARIA (welt at the injection site), INJECTION SITE ERYTHEMA (big red circle at the injection site), INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE URTICARIA (hives at injection site). The patient was treated with HYDROCORTISONE (topical) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE URTICARIA (welt at the injection site), MYALGIA (arm being kind of sore), INJECTION SITE ERYTHEMA (big red circle at the injection site), INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE URTICARIA (hives at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Patient reported that she won't get the second shot. Patient also reported that  she has an appointment with her doctor on 16October2021. treatment medication include antibiotic,vaseline
Raised, red, hard (knot like) area the size of a dime that still appears when the vaccine was given by a pharmajet device on the right upper deltoid.
mild sleepiness; malaise; right upper arm pain developed; This is a spontaneous report from a contactable consumer (patient). A adult patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and from the night of the vaccination, right upper arm pain was developed. After the 2nd dose: On an unspecified date in Feb2021, a few hours after the vaccination, right upper arm pain developed. The pain was little stronger than the 1st dose. On the second day of the vaccination, in the afternoon, there were mild sleepiness and malaise. The outcome of the events was recovering as on the third day.  No follow-up attempts are possible. No further information is expected.
Shingles; This is a spontaneous report from Pfizer-sponsored program, COVAX Support. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had been diagnosed with Shingles on 06Apr2021 and her second dose schedule is this coming Friday. She also confirmed that she has not taken any medication. Second dose appointment is on 09Apr2021 and she received her first dose on 19Mar2021. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
rashes; throat and glands have been extremely swollen; throat and glands have been extremely swollen; had allergic reactions to things that I have never had reactions to in my life, such as dogs and horses; sore throat; plugged ears; had a fever multiple times a day; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient (non-pregnant at time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose via an unspecified route of administration on an unspecified date as single dose; the second dose via an unspecified route of administration in the arm left on unspecified date as single dose for COVID-19 immunization. Medical history included allergy to Sulfa. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient reported that since vaccines, especially the second, patient throat and glands had been extremely swollen. Patient had had allergic reactions to things that she had never had reactions to in her life, such as dogs and horses. Patient had an insanely sore throat and plugged ears, which she had two rounds of antibiotics for and has done nothing. Adverse events start date/time was 25Apr2021 12:00. Patient also had rashes and every day since the first shot on unspecified date, she had a fever multiple times a day on 25Apr2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Lab data included Binax was negative (Nasal Swab) on 11May2021 and PCR was negative on 11May2021. Treatment received for events. The outcome of the event rashes was unknown, while of the other events was not recovered. This report was assessed by the reporting consumer as non-serious; no results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating or congenital anomaly/birth defect.  Information on the lot/batch number has been requested.
Information has been received from a licensed practical nurse referring to 6 patient of unknown age and gender. On an unknown date the patients were inadvertently administered with a dose of (Oka/Merck) VARIVAX (injection, lot#, dose route were unspecified) respectively, that had been improperly stored. No adverse effects were reported. Additional information has been requested.
Patient experienced a low-grade fever, headache, chills and arm swelling (including area under the arm as well as lymph nodes). Blistering under the arm. Patient seen by their pediatrician who directed them to the pharmacy for reporting. No treatment given from the pediatrician or pharmacy. Symptoms resolved as of 02/03/2022.
Patient came to the pharmacy for her 2nd COVID Pfizer dose and marked YES on question #5 section B which led to an inquiry in which we discovered that she experienced a widespread body rash (not just localized to the injection site) roughly 4 days after the vaccination; no difficulty breathing/shortness of breath. Patient has notified her PCP of reaction.