chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild chills; Moderate headache; Moderate fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 27Apr2021 at 13:00 at the age of 41-year-old as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737 via an unspecified route of administration in the left arm on 06Apr2021 at 20:00 at the age of 41-year-old as a single dose for COVID-19 immunisation. On 28Apr2021 at 01:00, the patient experienced mild chills, moderate headache, and moderate fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department, or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events mild chills, moderate headache, and moderate fatigue was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
pt recv vax & devel redness & itching @ inj site suggestive of an allergic rxn;
Information regarding PREVNAR 13 was received from a nurse regarding a 2 year old male patient who experienced wanted to be held and pain in leg that was injected. At 2 years of age, the patient received the first dose on 10 Aug 2010. MEDICAL HISTORY: The patient's concurrent illness includes therapy regimen changed. Past therapies included 4 injections of PREVNAR. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisation. Product was administered on 10 Aug 2010. Dose regimen was 1 dose 1 time per day. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced wanted to be held (irritability) and pain in leg that was injected (pain in extremity) in Aug 2010. Outcome was resolved in August 2010. No additional information was available at the time of this report.
Got GARDASIL shot in June got second shot on time. Have been having serious headaches and stomach ache since. Been to Dr. all they want to do is put her on more medication which does not help.
Rash started in groin, spread to other areas (face, trunk). Face slightly swollen. No itching. Face looks red. Lasted 7-10 days. No other associated symptoms
Woke up at 5am, walked to kitchen, started sweating and then fainted. Other symptoms include swollen red arm up to her neck, swollen glands, and hard to turn neck.
Information has been received from a physician concerning a 3 month old male who was vaccinated with a dose of PNEUMOVAX 23 by human error. No adverse effects were reported. Follow up information had been received from a medical assistant through a telephone call indicating that the patient should have been administered PREVNAR instead of PNEUMOVAX 23 (lot # 664871/1142Y). The employee pulled the wrong vaccine out of fridge. The patient was doing well and no adverse effects. No further information is available.
Flu Like Symptoms; Body ache; Fever; Cold; Headache; Fatigue; Shakiness; GI Symptoms; Drug dose administration interval too short; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 9th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain, fever, cold, headache, fatigue, tremor, gastrointestinal symptom nos and drug dose administration interval too short. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever, cold, headache, fatigue, tremor, gastrointestinal symptom nos and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, fever, cold, headache, fatigue, tremor and gastrointestinal symptom nos to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient stated he received the first dose of Shingrix vaccine about a month ago. The patient received his second dose of Shingrix vaccine. With the second dose of Shingrix he experienced flu like symptoms, body ache, fever, cold, headache, fatigue, shakiness and GI symptoms. The reporter did not described what kind of GI symptoms he experienced. No further details were provided.
Initial unsolicited report received from a nurse on 19-Oct-2017. This case involves a 33-year-old female patient was vaccinated with a dose of FLUZONE INTRADERMAL QUADRIVALENT) (dose, form, route, lot number, expiry date were unknown) on an unknown date. Patient medical history was no reported. Concomitant medications include DUPIXENT 600 mg subcutaneously on an unknown date and 300 mg SQ every other week since an unknown date for Atopic Dermatitis. On an unknown date, after the vaccination, the patient developed itchy and slightly dry eyes, getting really sick. Lab data and corrective treatment were not reported. The patient's outcome was recovered for the events itchy and slightly dry eyes and unknown for getting sick at the time of reporting. List of documents held by sender: none.
Became pale, light headed, closed eyes and became limp. Aroused immediately, by calling name and tapping cheek. While this was being done, she urinated onto chair and floor. Once aroused, became aware of surroundings. Became nauseated and threw up twice. Father was present through entire incident. B/P was 112/60. She was kept with the nurse for another 20 minutes, took sips of water, ate a sucker. She did mention that she had not eaten since the day before. She left the office ambulating independently, talking to father. I contacted dad at 5:05 pm. States she took a nap after eating and appeared to be fine.
unknown if patient had reaction. Someone under 60 was given RSV vaccine at vaccination clinic by mistake
Patient had J&J at different pharmacy back in May; didn't find out until after giving the shot she already received it before. Talked to her and she said her doctor recommended booster. Will follow-up in future with the patient. She did not have any adverse reaction. I just wanted to report invalid dose for admin error as a pharmacist. Thank you!
inconsolable crying spells for five hrs or more @ a time intermittently for 48 hrs p/vax;
Itchy; large rash; hot at the upper arm; upper arm sore; This is a spontaneous report from a contactable consumer. A 81-years-old female patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EL9261), dose 1 via an unspecified route of administration, administered in Arm Left on 23Jan2021 07:59 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure, Cardiac, Cholesterol from an unknown date and unknown if ongoing. Concomitant medication included lisinopril (LISINOPRIL) taken for hypertension; rivaroxaban (XARELTO) taken for cardiac disorder; carvedilol (CARVIDOL) taken for cardiac disorder;  ezetimibe (ZETIA) taken for blood cholesterol; rosuvastatin (ROSUVASTATIN) taken for blood cholesterol, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first dose of the Pfizer COVID 19 vaccine on 23Jan2021 at 07:59AM in the left arm. States she had upper sore arm a short while later in the day. Yesterday on 02Feb2021 she first noticed her arm was itching and so she took off her clothes to look and saw she had a large rash on her upper arm, 4-5 inches long, that was hot, located at the injection site and below. Adds she thought that only happens with Moderna and not Pfizer. Mentions this occurred ten days after the vaccine. She has spoken with her HCP who did not provide any advice. Mentions all these effects cleared up by the evening of 02Feb2021 except her arm is still a little sore. She is scheduled for the second dose 13Feb2021. The outcome of the event upper arm sore was recovering and the outcome of events Itchy, large rash, hot at the upper arm was recovered on 02Feb2021.  Follow-up attempts are completed. No further information is expected.
He had severe vision issues and feeling weak and strange. Also had fever and ended up going to the hospital for 4 days.
This is a spontaneous report received from a non-contactable reporter(s) (Nurse). A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EL3247), on 06Apr2021 as dose 2, single (Lot number: EL3247) and on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 45 years for Covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jun2022, outcome "unknown" and all described as "PCR"; DYSPNOEA (non-serious), HEADACHE (non-serious), SNEEZING (non-serious), COUGH (non-serious) all with onset 10Jun2022, outcome "unknown" and all described as "SX of SOB HA sneezing and coughing". The events "PCR" and "SX of SOB has sneezing and coughing" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jun2022) Positive, notes: COVID test type post vaccination: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, Covid-19, dyspnoea, headache, sneezing, cough. Device timestamp: 13Jun2022. No follow-up attempts are possible. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the event, vaccination failure and Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Developed a severe rash on my torso, extreme on the back and moderate in the chest/stomach. My first two vaccines were from Moderna to which I had no reaction, so I wonder if having the Pfizer booster was the problem.  Photo of the rash is available which I will send if I find a way to do that. Otherwise let me know if you would like it.
No adverse effects; patient was administered an improperly stored varivax; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions, historical drugs and drug reactions/ allergies were not reported. On 11-JUL-2019 the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S000132 and expiry date 02-JAN-2021 (dose, frequency and route of administration not reported) for prophylaxis. Concomitant therapies included sterile diluent which was used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored properly. The storage temperature and time frame was reported as 15 degree Fahrenheit to 46 degree Fahrenheit (29.1 degree Fahrenheit) for 3 hours. There was no previous temperature excursion. No adverse effect was observed. Digital data logger was not involved. No Product Quality Complaint (PQC) was present.
This spontaneous report as received from a Healthcare worker refers to a patient of unknown age. On 15-AUG-2014, the patient was vaccinated with experienced ZOSTAVAX (lot # J001700, expiry date: 08-MAY-2014) vial .65 ml, subcutaneously. Concomitant medication was unspecified. There was no PQC. Outcome of the reported event was unknown. Additional information has been requested.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 05-FEB-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Child's mother reports that son has been complaining of chills, warm to touch, and lower back pain of vaccinations 02/23/2017. Only continues with back pain now; taking medication that helps. Mother states she has not taking the child to the doctor yet. The mother is encourage to take child to a provider for further evolution.
Breasts extremely sore and enlarged.; Breasts extremely sore and enlarged.; This is a spontaneous report from a contactable consumer (patient). An 18-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number and expiration date: Not reported), via an unspecified route of administration on 15Jun2021 (age at vaccination: 18-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unknown date in Jun2021, the patient breasts extremely sore and enlarged. It was going on day 7 of pain and treated with Ice packs and Tylenol. Outcome of the events was recovering.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Serious erythema and soft tissue swelling occurred within 1 hour, got worse, went to ER 2/4/03 7 PM. Rx IM Benadryl.
Few hours after receiving vaccines patient developed headache, red itchy rash about the body, bruising to the left thigh and swelling to  face  ( both sides.)  Denied difficulty breathing. Pt did not go to the Emergency Room. She took Benadryl beginning the next day.
Started to sweat profusely immediately, felt weak, blood pressure dropped, a little dizzy,
This is a spontaneous report from a contactable consumer (patient). A 41-year-old (non-pregnant)  female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# EW0161), at the age of 41, via an unspecified route of administration, left arm, on Apr 17, 2021, at 11:15, single dose, for COVID-19 immunisation. Medical history included genital herpes. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline for unknown indication on unknown date and unknown if ongoing. The patient has no known allergies. On Apr 18, 2021, at 08:00, patient experienced muscle pain, stiff neck, joint pain, tiredness, nausea and feeling overall unwell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of muscle pain, stiff neck, joint pain, tiredness, nausea and feeling overall unwell: not recovered (at the time of this report). No follow-up attempts needed. No further information expected.
Client received MCV4 vaccine in AM and had small rash by PM. The next AM, client went to doctor and received antibiotics for infection. Rash was gone next AM.
After 2nd injection: severe rash and itching lasting 3 weeks. Received 3 steroid injections and 1 Benadryl injection. After 3rd injection, severe rash and itching lasting 2 weeks. Took over the counter Benedryl.
Patient presented to the pharmacy wanting an updated Covid Moderna Booster, however she received the flucelvax 2022-2023 influenza vaccine instead. Patient did not compain about any adverse events.
she is reluctant to get second dose as she is afraid that she might have bleeding or bruising after vaccination; bruising on the opposite arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising on the opposite arm of injection) and ANXIETY (she is reluctant to get second dose as she is afraid that she might have bleeding or bruising after vaccination) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic reaction (She has experienced a severe anaphylactic reaction in the past to ASA.). Concomitant products included MULTIVITAMINS [VITAMINS NOS] and CALCIUM CARBONATE (TUMS 500 CALCIUM) for an unknown indication.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced CONTUSION (bruising on the opposite arm of injection). On 17-Jun-2021, the patient experienced ANXIETY (she is reluctant to get second dose as she is afraid that she might have bleeding or bruising after vaccination). At the time of the report, CONTUSION (bruising on the opposite arm of injection) and ANXIETY (she is reluctant to get second dose as she is afraid that she might have bleeding or bruising after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, White blood cell count: increase (High) WBC Increase. On an unknown date, Clotting factor transfusion: normal (normal) Normal. On an unknown date, Platelet count: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were used.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Added new lab tests clotting factors and platelet counts. Added new event anxiety.
dizziness; aches; nausea; been in bed; This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number T9KE4, expiry date 25th September 2021) for prophylaxis.   On 23rd June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 23rd June 2019, less than a day after receiving Shingrix, the patient experienced dizziness, pain, nausea and bedridden. On an unknown date, the outcome of the dizziness, pain, nausea and bedridden were not recovered/not resolved.   It was unknown if the reporter considered the dizziness, pain, nausea and bedridden to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in his left arm. Ever since then, the patient had been in bed.   The patient was experiencing dizziness, aches and nausea which started within 24 hours after the injection. The patient consented to follow up.
Nasal congestion in 31 year old male with complaint of headache for 96 hours, post vax.
back pain,can not straighten up; body pain; shaking chills; Felt cold; her right arm hurts as much as her left arm ( the one who was vaccinated); the right it is a little swollen but the left arm is more swollen; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain,can not straighten up), MYALGIA (body pain), CHILLS (shaking chills), FEELING COLD (Felt cold) and PAIN IN EXTREMITY (her right arm hurts as much as her left arm ( the one who was vaccinated)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced BACK PAIN (back pain,can not straighten up), MYALGIA (body pain), CHILLS (shaking chills), FEELING COLD (Felt cold), PAIN IN EXTREMITY (her right arm hurts as much as her left arm ( the one who was vaccinated)) and PERIPHERAL SWELLING (the right it is a little swollen but the left arm is more swollen). At the time of the report, BACK PAIN (back pain,can not straighten up), MYALGIA (body pain), CHILLS (shaking chills), FEELING COLD (Felt cold), PAIN IN EXTREMITY (her right arm hurts as much as her left arm ( the one who was vaccinated)) and PERIPHERAL SWELLING (the right it is a little swollen but the left arm is more swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
fatigue; high fever; nausea; This case was reported by a consumer and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, fever and nausea. On an unknown date, the outcome of the fatigue, fever and nausea were recovered/resolved.   It was unknown if the reporter considered the fatigue, fever and nausea to be related to Shingrix.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per the vaccine indication. The patient had fever, nausea, fatigue for a couple days. The patient stated would take that over the Shingles any day. The follow-up would not possible as no contact details were available.
Severe itching and hives/welts over my body; Severe itching and hives/welts over my body; This is a spontaneous report from a contactable consumer (patient). A 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0175) via an unspecified route of administration, administered in Arm Left on 29May2021 (at the age of 32-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history not reported. Concomitant medication(s) included metronidazole (METRONIDAZOLE). No known allergies reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine/ No other vaccine in four weeks. The patient experienced severe itching and hives/welts over my body on 29May2021. Patient did not receive any treatment for the event. No covid prior vaccination. No covid tested post vaccination. Reporter assessed case as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Approximately 1 hour after injection I developed chest tightness, burning eyes, scratchy throat and hives. No anaphylaxis. If Benadryl was not taken regularly the hives would return for the first  48 hours.