chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High fever; sweats; chills; Heart racing/Palpitations; Rash; hives over the entire upper torso; This is a spontaneous report received from contactable reporter consumer or other non HCP. The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2022 10:45 (Lot number: FK9896) at the age of 54 years as dose 4 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 3, Batch/Lot No: FH8020, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 24Oct2021, when the patient was 54 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8731, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 23Apr2021, when the patient was 53 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 31Mar2021, when the patient was 53 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 02Apr2022 22:00, outcome "not recovered", described as "High fever"; HYPERHIDROSIS (non-serious) with onset 02Apr2022 22:00, outcome "not recovered", described as "sweats"; CHILLS (non-serious) with onset 02Apr2022 22:00, outcome "not recovered", described as "chills"; PALPITATIONS (non-serious) with onset 02Apr2022 22:00, outcome "not recovered", described as "Heart racing/Palpitations"; RASH (non-serious) with onset 02Apr2022 22:00, outcome "not recovered", described as "Rash"; URTICARIA (non-serious) with onset 02Apr2022 22:00, outcome "not recovered", described as "hives over the entire upper torso". The events "high fever", "sweats", "chills", "heart racing/palpitations", "rash" and "hives over the entire upper torso" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pyrexia, hyperhidrosis, chills, palpitations, rash, urticaria.  Additional information:-Patient had no known allergies. patient had no seriousness criteria like death, life threatening, disabling/Incapacitating, and congenital anomaly/birth defect. The patient had no other medications in two weeks. Patient does not had any other vaccine in four weeks. The patient does not had covid prior to vaccination. the patient did not taken covid test post vaccination.  No follow-up attempts are possible. No further information is expected.
syncopy. Patient received Pfizer Covid Bivalent in office today at 11:22 AM, at 11:28 AM patient was at Check-Out and began to appear sluggish. At that time, the patient service representative (PSR) requested assistance with patient. Reporter, the RMA arrived to patient and observed patient as patient began to pass out. Reporter was able to reach patient and help her to the ground. Patient was not injured and was softly laid to the ground. At which time, reported called for the NP who was availble to help with patient and patient began to come to. Patient recovered by 11:29 AM. The NP held patients legs up with patient flat on ground, patient was talking and did not remember fainting. Reporter supported NP staff with providing a cold paper towel to patients forehead. Patient regained color and was set up against the wall at 11:31 AM. At 11:33, patient was assisted in moving to the chair, being monitored. Patient then called family/friend to pick them up. Patient was given bagel and water. Patient denied ever fainting from previous vaccines or blood draws.
Day after injection: painful injection site/ upper arm, body aches. Three days later: diarrhea lasting about 6 hours, until anti-diarrheal pills took effect.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ROTATEQ lot # M042169, oral for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. Sender's Comments: US-009507513-1709USA003145: US-009507513-1709USA003455: US-009507513-1709USA003453.
sore; achy; fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore), PAIN (achy), FATIGUE (fatigue) and PYREXIA (fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for an unknown indication.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced FATIGUE (fatigue) and PYREXIA (fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore) and PAIN (achy). On 07-Mar-2021, FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (sore) and PAIN (achy) outcome was unknown. Not Provided          treatment: Tylenol   This case was linked to US-MODERNATX, INC.-MOD-2021-060667 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060667:dose 1(husband case)
Face and ears are hot; This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9262), via an unspecified route of administration in left arm on 28Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history included high blood pressure. Concomitant medications included none. She didn't know what to take and therefore has taken nothing. Patient states that she got the vaccine yesterday. She was calling about the COVID vaccine. She was fine, but then last night the skin on her face got hot on 28Jan2021. The rest of body did not. She did have a blanket on. Her face and ears are hot on 28Jan2021, the rest of her body was not hot. She wanted to know, she has called the doctor and has had no answer, she wants to know was she could she take aspirin or Tylenol. Her first dose was on 28Jan2021. Her face being hot started last night. It was just the skin on the face and ears that got hot starting 28Jan2021. She was going to be switching. Investigation assessment was none. She has had no issues with vaccines in the past. She has had 5 COVID test in total and all were negative. The last one was 2 weeks ago on an unspecified date in Jan2021. She last had an antibody test that was negative back probably on an unspecified date in Jul2020. The outcome of the event was recovering.
Low grade temperature 100 degrees F, red local site left thigh with blisters.  Seen by MD 05/27/2003.  Assessment: possible attenated virus infection.  Keep covered from other children.  Call if any distal lesions or symptomatic.
Mother states child is having unusual behavior, such as rubbing arms on chairs repetitively, repetitively touching and tapping objects.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ oral liquid (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, exact dose was unspecified). There were no concomitant medications provided. The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Fainted moments after receiving the flu shot,  revived and had a meal. No further effects.
Feeling warm, fatigue, dizzy, light headed, cramps in abdomen, headache
24yo F with hx of sulfa allergy received the Moderna Covid vaccine on 1/4.   Day 1 felt chills, feverish.  Reports edema in limbs, face, hands and whole body ("swollen to twice it's size).  Tingly lips, extreme headache, nausea and body aches.  Reddish urine for 4 days following.  Swelling subsided after a few days.
Face went numb and red (flushed); Face went numb and red (flushed); This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0178, Expiration date: unknown) via an unspecified route of administration, administered in left leg on 27May2021 at 12:30 pm (age at vaccination was 48 years) as dose 1, single for COVID-19 immunization. The patient's medical history included COVID-19. The patient had known allergies to one cough medicine. The patient did not receive any concomitant medications or other medications in two weeks. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 27May2021 at 17:30 pm, the patient's face went numb and red (flushed) about 5 hours after the shot. Lasted a few hours. No treatment was received for the adverse events. The outcome of the events was resolved on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
severe headache; chills; fever; stomach pain; This is a spontaneous report from a contactable Nurse via the Regulatory Authority. This 52-year-old male Consumer reported himself.  A 52-years-old female patient received second dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration, on 05Oct2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date on Oct2021, the patient experienced chills, fever, stomach pain, and a severe headache. It was reported that patient had the second dose of the Pfizer covid vaccine yesterday, and it was okay until I was going to bed. I started having chills, fever, stomach pain, and a severe headache. She asked How long are these supposed to last. The Centers for Disease Control and Prevention provides information regarding Possible Side Effects After Getting a COVID-19 Vaccine. Side effects after your second shot may be more intense than the ones you experienced after your first shot. These side effects are normal signs that your body is building protection and should go away within a few days. Beyond what is described in the <Pfizer-Biontech Covid Vaccine> Prescribing Information, Pfizer does not have information on how long what you are experiencing may last. There may be many factors to consider including your medical history and medical condition. We all react differently to medicine, and therefore we are unable to specifically say when your symptoms may be relieved. The outcome of the events were unknown.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
5 x 4 cm. Erythema and induration and pain left thigh.
The bi-valent vaccine was given when the single dose should have been given for the primary series.  The vaccine was billed for the correct dose, but mixed and given a s a bi-valent when it was not approved yet.
itching; hives; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included dupilumab (DUPIXENT) taken for pruritus, start and stop dates were not reported. A few days after having the patient's 1st COVID vaccine, she started itching and then one night she woke up and had hives, her skin is pink, and she took diphenhydramine (BENADRYL). She feels better now but she has her 2nd COVID vaccine on 22Apr2021. She has been on dupilumab for about 2 years and never had any itching till a few a days after her COVID vaccine. Per pharmacist notes, patient reported itching and hives about 2 weeks after receiving 1st dose of Pfizer COVID vaccine (unspecified date). Therapeutic measures were taken as a result of itching and hives. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
vaccine dose 1 on 6/1/21 and dose 2 on 6/28/21 at pharmacy. arrived at hospital on 7/17/21 - in ER found to have bilateral pulmonary embolisms especially on the right side with possible right pulmonary infarct as of 7/18/21 currently being treated with heparin drip and admitted as inpatient IV dilaudid required to manage pain outcome unsure at this time - remains in hospital receiving acute treatment at time of report
The needle was not fully connected to the syringe, so when the syringe plunger was depressed, the dose spilled onto the patient's arm. Another 0.5 ml dose from the same vial was drawn up using a different syringe, as it did not appear that any of the initial dose was actually injected.
Patient received Pfizer vaccine 4/22/2021.    She developed severe headaches 48 hours later.  She has loss of balance and difficulty with fine motor skills.  She presented to an ED.   Neuroimaging detected significant central venous thrombosis. Admitted to  hospital and started on anticoagulation therapy.    Neurology and Hematology/Oncology consulted.
Around 6 am,( day after vaccine- approximately18 hrs after vaccine) achy legs, fever, sore arm(left arm), fatigue, headache.  Lasted approximately 12 hours
Over the course of 8 hours the headache has gotten gradually worse. It is keeping me awake and I'm unable to sleep. The injection site burns and is slightly swollen.
Tdap administered 8/20/07, 10:45 am.  Pt began c/o severe headache at 7:30 pm followed by body aches, fever of 102F.  Began vomiting at 11:30 pm.  PMD notified at 12:00 am, 8/21/2007 by phone.  Vomiting continued until 8 am 8/21/2007.  Con't to have 102 fever with chills 8/21/2007.
my legs swelled up, especially my ankles.  so much that i had difficulty getting my shoes on, and I had an ankle bracelet that broke because my ankles got so big. this lasted from August  5 until approximately September 9 or 10.
Pt went to hospital by ambulance because at around 6pm she had indigestion after dinner and it went to severe pain after that. She had a severe migraine as well, her blood pressure went low too, they lowered dose. Patient is still recovering, is very weak and dizzy.
Adult patient was given pediatric dose of 0.5mL.  Merck & Co safety report
she was admitted to the hospital on an unespecified date for surgery on a torn meniscus; she had shingles in either on her back or near her pupic area/she developed shingles twice that month; This spontaneous report has been received from a female patient of currently 75 years old reporting on herself. The patient's has asthma as concurrent condition. There were no drug or allergy history, or concomitant medications to be reported. She stated that she had shingles as historical condition.  On an unspecified date in June 2015, the patient was vaccinated with 1 dose of zoster vaccine live(ZOSTAVAX) (strength, frequency, route of administration, lot# and expiration date were not provided) as prevention of shingles.  The reporter stated that after she received zoster vaccine live (ZOSTAVAX) she got shingle monthly since an unspecified date (herpes zoster), in either on her back or "near her pupic area". She stated that she did not have shingles that frequently prior zoster vaccine live (ZOSTAVAX).  Furthermore, she stated that she believed she was admitted to the hospital on an unknown date for surgery on a torn meniscus (meniscus operation). Moreover, on an unspecified date in August 2019, the patient developed shingles twice that month. The patient sought medical attention and she received Valacyclovir as treatment, and unspecified laboratory test were performed.  The outcome of meniscus operation and herpes zoster was reported as not recovered. At the reporting time, the casual relationship between the aforementioned events and zoster vaccine live (ZOSTAVAX) was not reported.
Developed a 4cmX6cm oblong shape pink/red rash, not cellulitic. Pt said it was hot to the touch as well.
Chills, dizziness, tiredness, not feeling well from 1/12/21 to 1/17/21.. From 1/15/21 one side of head headache for 3 days
This spontaneous report was received from a consumer and refers to herself, a 71 years old, female patient. The patient's medical history included Klebsiella pneumonia and the concomitant's medication included NITROFURANTOIN MONOHYD MACRO, also reported as NITROFURANTOIN MCR. The patient did not have pertinent drug reactions or allergies. On 20-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 for prevent pneumonia, single 0.5 ml dose, intramuscularly (anatomical site of injection, lot # and expiration date were not reported). On the same date, the patient started experienced joint pain and swelling down past her elbow and the area was warm to the touch. Also the patient reported that she had developed a hard lump size of a marble in the area between her neck and shoulder. The patient did not received treatment for the adverse events. The laboratory test of urine for bladder infection was performed (no results were provided). The patient did not seek medical attention. The outcome for the events was reported as not recovered. The causality assessment between PNEUMOVAX 23 and the events were not reported.
bad seizure/it was horrible; fell on the floor; all muscles gone; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (bad seizure/it was horrible) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 146A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Drug allergy (cortisone type steroids).   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced SEIZURE (bad seizure/it was horrible) (seriousness criterion medically significant), FALL (fell on the floor) and MUSCLE DISORDER (all muscles gone). At the time of the report, SEIZURE (bad seizure/it was horrible), FALL (fell on the floor) and MUSCLE DISORDER (all muscles gone) outcome was unknown.            No concomitant medication information was provided. No treatment medication were provided.  Company Comment: This spontaneous case concerns an 89-year-old, female patient with no relevant medical history reported, who experienced the unexpected, serious AESI of seizure and the unexpected, non-serious events of fall and muscle disorder. The events occurred 1 day after administration of the booster dose of the Moderna mRNA-1273 vaccine. The report stated that the patient had a seizure which was described as 'horrible'. She also fell on the floor and 'all muscles gone'. Treatment information was not provided. The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.   This case was linked to MOD-2022-467243 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2022: Follow-up contains no new information.; Sender's Comments: This spontaneous case concerns an 89-year-old, female patient with no relevant medical history reported, who experienced the unexpected, serious AESI of seizure and the unexpected, non-serious events of fall and muscle disorder. The events occurred 1 day after administration of the booster dose of the Moderna mRNA-1273 vaccine. The report stated that the patient had a seizure which was described as 'horrible'. She also fell on the floor and 'all muscles gone'. Treatment information was not provided. The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.
Patient expereinced pain at vaccination site 2 hours after administration.  in 20 hours it had become red and swollen.  Swelling and redness have steadily decreased to time of individual reporting today at 13:00 (Jan 22, 2020 reported)
Erythema 6 1/2 inch local reaction. No anaphylaxis.
Shortness of breath/trouble breathing with minor exertion; headaches, waves of severe fatigue; digestive discomfort; difficulty focusing ("mind fog"); some dizziness. Unable to conduct levels of activity I easily participated in prior to the vaccine--a significant drop off. When I do exercise (prior to the vaccine, I was training to complete two 100 mile bike rides and was able to easily complete 50+ miles in a little less than 4 hours with no problems. I also was in a formal training program that had me riding hard 4-5 times a week and completing `100+ miles per week. Since receiving the vaccine, I can only ride 1-2 time per week and for a couple ff days after (days 2 and 3 in particular) I am extremely fatigued. This is 180 degrees from where I was prior to the vaccine. Nights and early morning are particularly bad for digestive issues and fatigue, though the fatigue can come anytime, without warning. All of this has made it hard to work. July was a brutal month with high levels of chronic fatigues most everyday. Things improved in August, but have plateaued the past couple of months--not getting better or worse.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 24-AUG-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursion (date unspecified): lasting for 16 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.55 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient stated she experienced headache, nausea, diarrhea, fatigue, and muscle pain.