chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she was still having problems catching her breath until sometime in Jun2021.; Fever; Muscle aches; Joint aches; Headache; Sore arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 30Mar2021 at 11:15 (Batch/Lot Number: ER8732) as dose 2, single for covid-19 immunization (at the age of 53-years-old). Medical history included pre-diabetic (diagnosed about three years ago), tachycardia (she had this condition before she had covid 19 in Oct2020; it felt like she would pass out and she was nauseous) and overweight from an unknown date and unknown if ongoing and Covid-19 from Oct2020 (states she still has not regained her sense of smell that she lost during this illness) to an unknown date and high cholesterol (was diagnosed about 10 years ago) from 2011 to an unknown date. She also stated that before she had Covid 19 in Oct2020, she had the condition in which episodes became more frequent on day 4 of having Covid 19, from once a month, to weekly, daily, then multiple times a day; states it felt like she would pass out and she was nauseous. The concomitant medications included diabetes medication and a blood pressure pill for an unspecified indication and start and stop dates were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6199) via an unspecified route of administration, administered in Arm Left on 09Mar2021, as single dose for COVID-19 immunization (at the age of 52years old) and experienced trouble breathing, atelectasis, cardiac ablation and the patient was hospitalized on 12Mar2021 with pericardial effusion and mild bilateral atelectasis. The patient previously also received Shingles vaccine for prophylaxis around 3 years ago at the age of around 50-years-old and experienced flu like symptoms for about three days. It was reported that after receiving the second dose of vaccine the patient experienced mild symptoms such as fever, muscle aches, joint aches, headache, and sore arm on an unspecified date in 2021 and patient was still having problems catching her breath until sometime in Jun2021 from an unspecified date in Mar2021. She stated that after the second dose of the Covid 19 Vaccine her mild symptoms lasted for 2 days. The patient underwent lab tests and procedures which included blood test which showed inflammation and CT scan with die (computerised tomogram) which showed pericardial effusion; mild bilateral atelectasis and D-Dimer (fibrin d dimer) which result was elevated, all were in Mar2021 and echocardiogram which showed Aericarditis and atelectasis on an unspecified date in 2021. The outcome of the event breathing difficult was recovered on Jun2021 and was recovered from rest of the other events on an unspecified date in 2021.
This incident happened on 31May2012, @10:40 AM local time. Patient started jerking motion while she was sitting in waiting area after immunization, for approximately 10 seconds. Patient responded nurse after jerking motion and complained of nausea and dizziness, vomited X1, Vital signs @10:42 temp: 98, BP: 96/56, Pulse: 50, SPO2: 99. Placed Pt in supine position, elevated feet. Vital signs @10:47 Temp: 97.9, 110/67, Pulse: 74, SPO2: 97. Vital signs @10:52 are Temp: 98.3, BP 102/62, Pulse: 72, SPO2: 98. Vital sings @10:57 are temp: 98.6, BP: 100/62, Pulse: 80, SPO2: 98.  Patient says she's hungry, and feels better and eats spam rice ball at @11:00. Pt denies dizziness. Vital signs @11:02 are Temp: 98.6, BP: 121/72, Pulse: 69, SPO2:98. Patient talking with mother, and friend. Vital signs @11:17 are temp: 98.4, BP: 118/76, Pulse: 72, SPO2: 98. Patient denies dizziness, nor weakness. Pt was discharged at 11:25.
Pattient had second Pfizer vaccine yesterday evening and today has a temperature of 100.4. Boyfriend, who was caller stated she did not take anything for fever. RN reviewed she can take Tylenol or Advil. He asked for spelling as he stated he himself has never used either. RN reviewed increasing hydration, and using a cool compress on her head or behind her neck. RN stated if fever goes up or stays the same to call her provider. .
Patient was given vaccine that was beyond use date. Stored properly but was beyond use on 2/28/2023
C/o burning and soreness at injection site 15min after injection-local reaction noted. BP 120/80 P 80 RR 14.
pt recv vax 20APR96 & lab eval on 26MAR97 revealed a lack of seroconversion;
No additional AE reported; VARIVAX expired on 8/18/2021 and was administered on 8/23/2021; This spontaneous report was received from a nurse, referring to a patient of unknown age and unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 23-AUG-2021, the patient was vaccinated with expired varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S025612, expiration date 18-AUG-2021; dose, strength and route were not provided) for prophylaxis (expired product administered). No previous temperature excursion. No additional adverse event reported.
This spontaneous reprot was received from a medical assistant and refers to an unspecified number of patient of unknown age and gender. No pertinent medical history or concurrent conditions were reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL, lot number not reported. No adverse effects reported. The outcome of incorrect product storage was unknown. Additional information has been requested.
3 hours after vaccination patient experienced nausea, diarrhea, chill, and headache.  Patient given 1000 mg of acetaminophen. Patient did not clear up symptoms after 6 hours and was sent home from work.
Mom brought child back to be looked at, developed a rash on his face shortly after had hepatitis A vaccine.
The patient received the flu shot first and then waited in consultation room and watched her sister and father also receive a flu shot.  After they were done and the whole family was  going to leave the consultation room the patient fainted and hit her head on the wall (occurred a few minutes after she had received the shot).  She seemed to lose consciousness for a few seconds. 911 was called but then canceled because her father said she was ok.  We also gave her a bottle of water which she took with her when she left the building.
Itching developed within 12 hours at the site of the vaccination.  This was followed by redness and swelling and pain the next morning.  Patient seen 64 hours after vaccination with 14.5 x 24cm area of erythema, mild induration, increased warmth and mild tenderness, moderate pruritis around the site of vaccination.  Fever of 100.5 at 48 hours after vaccination.  Missed work for 2 days.  Complained of some difficulty with short term memory.
After getting both shots on my left arm, the nurse said "okay you're good"  and allowed me to walk out. About 2 minutes of walking out the door, i sat on a post because i felt nauseous I then fainted on my right side. I was out for about 20-30 seconds and woke up in a pile of blood. The nurse who saw me on the floor denied to call 911 twice. After 30 minutes the doctor of the office called 911. The EMT took me to the hospital after 1 hour of the incident. I got 7 stitches inside and outside my mouth, a swollen, black eye, neck pain on my left side, constant migraines, and a messed up front right tooth . I got out of the hospital after 5 hours.
Patient called pharmacist approximately 24 hours after receiving the Fluad and Pneumovax23 vaccines. He reported that the left arm, the arm in which the Pneumovax23 was administered, was causing him a great deal of pain the night before. He said it was difficult to sleep that night. During the conversation with the pharmacist he reported that his pain had since significantly improved and that he was not experiencing any other complications such as redness, swelling, allergic reaction, or loss of arm function/mobility. He did not feel like he needed to follow up with his primary doctor as his arm pain was much improved.
Site of injection started to ache 3/5/09 pm. Unable to raise arm and fever. Recd. 1. Ibuprofen 600mg q 6-8 hours with food PRN discomfort 2. BENADRYL to reduce swelling.
Reported symptoms on 2/3/15: Extremely nauseous, heartburn, neck and back aches, diarrhea, sore chest, headache and fatigue. Reported symptoms on 2/6/15: Dizzy and weak. No treatment.
receiving an extra dose; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th September 2019) and Shingrix (received 2nd dose on 14th November 2019).   On 3rd March 2022, the patient received the 3rd dose of Shingrix. On 3rd March 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 04-APR-2022 Reporter's comments: Nurse reported that the patient received an extra dose of Shingrix. The reporter consented to follow-up. Additional Supportive Information:  The patient received 3rd dose of Shingrix, which led to extra dose administered. This case was linked with case US2022059684, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022059684:same reporter - 1st patient
I walked up the stairs to go to bed at 10:45pm and started feeling very dizzy, lightheaded, and nauseous. At the top of the stairs I passed out and fell backwards. Not sure exactly how long I was out, but no more than a few minutes. When I woke up I was disoriented and nauseous but didn't have the strength to get up. I rolled into my side and vomited 3 times. My fiance helped me get up slowly. He took my temp but I did NOT have a fever. The nausea, dizziness, and lightheadedness subsided after about 10 minutes, so I decided to NOT seek medical attention. This morning I have a headache and body aches in my lower back and left arm.
Information has been received from a physician concerning a 14 year old female with allergy to metals (aluminum) who on 08-MAY-2009 was vaccinated intramuscularly with the first dose 0.5 mL of GARDASIL vaccine (yeast, LOT # was not provided).  On 11-MAY-2009 the patient experienced hives.  The outcome of the patient was unknown.  She sought unspecified medical attention.  Follow up information has been received from a physician concerning a 14 year old female who reported no allergies at the time of vaccination.  On approximately 11-MAY-2009 the patient experienced hives on her entire body.  On 27-MAY-2009 she saw ears, nose and throat doctor who prescribed BENADRYL, climetide and ATARAX.  On 4-JUN-2009 the patient made an appointment to see an allergist.  On 17-JUN-2009 she was referred by a physician to hospital and was placed on Steroids.  Hives was considered to be an other important medical event by the physician.  No further information is available.
Event is not being reported for adverse event. This is being reported because of vaccine administration error. The patient received the incorrect second dose of the covid-19 vaccine.  The patient verbally verified the incorrect vaccine brand to the vaccine administrator.
Within 4 hrs of receiving the vaccine (on Saturday), developed headache, fever, chills, sore throat, sore arm, fatigue. Symptoms faded during following day (Sunday) and by Monday left only with fatigue which resolved by Tuesday.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. 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 the vaccination was not reported, however patient could be either 65 or 66 years old. The patient experienced sore arm for about 4 days. The reporter consented to follow up. This case has been linked with case US2019001678 for the same patient reported by the same reporter.
BODY ACHES; TROUBLE EATING; EVERYTHING TASTES WEIRD; LIKE SHE HAD FLU; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced trouble eating. On 09-APR-2021, the subject experienced everything tastes weird. On 09-APR-2021, the subject experienced like she had flu. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body aches, trouble eating, everything tastes weird, and like she had flu. This report was non-serious.
Large localized reaction right upper thigh at 6 hours post, resolved by 48 hours.
No symptoms at this time.  Patient presented for appointment set up in state system.  Pharmacist administered second dose too soon without noting that patient had received first dose on 4/6/21.
Patient got a painful raised red bump on the arm roughly a week after the vaccine that required antibiotics. She went to the doctor 10 days later and is now taking cephalexin for cellulitis.
pt recvd vax; rxn at inject site; 7 maculo papular lesion on thigh;
On 12/24 I started having muscle twitching in my back, shoulders, eyes and my mouth are felt drawn up. It subsided after about 15 minutes. On 12/25 the same thing happened, bit twitching muscles also affected my arms and hands. It lasted about 35 minutes.
Hospitalized 6/8/2022 with increased dyspnea with exertion after testing positive for COVID on 6/4/2022, acute bilateral pulmonary emboli. NO covid directed therapies mild resp symptoms similar to allergies.
Continuous diarrhea ever since the day of the injection so three months so far. I have never had this issue prior.   Tennis elbow in injected arm. Never had condition prior
Bell's Palsy; Sharp headaches; cold; This is a spontaneous report from a non-contactable consumer. A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, on an unspecified date at 57 years old (Batch/Lot Number: EL9264) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced sharp headaches and cold then she went to ER, diagnosed with Bell's Palsy on an unspecified date. The events resulted in a Doctor or healthcare professional office/clinic visit and/or Emergency room/department or urgent care. Treatment was received for the events. The outcome of the events was unknown.
This spontaneous report was received from a registered nurse regarding 3 patients of unknown demographics. There was no information about concurrent condition and historical medication. On approximately 10-MAR-2016, 5 weeks ago, the patient was vaccinated with GARDASIL 9 dose 1. Since the patients were in the office she stated that they would like to administer the second dose today that was on 14-APR-2016. No adverse event was reported. The outcome of the event was unknown. Additional information is not expected because patient does not wants to get contacted.
Information has been received from a 25 year old female office manager who on 13-DEC-2006 was vaccinated with a first 0.5 mL dose of GARDASIL vaccine. On 13-DEC-2006, the patient developed a small bump under the skin that was tender after receiving the vaccination.  The patient sought unspecified medical attention. At the time of this report, the patient's small, tender bump under the skin persisted.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FF2587) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "heart desease" (unspecified if ongoing); "Benign prostatic hyperplasia" (unspecified if ongoing); "Aortic valve stenosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Xeralto, reaction(s): "Known allergies: Xeralto". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19: treated with Paxlovid from 29Jan2023 to 02Feb2023.
pt recv vax 28MAY97 & same day exp pain @ inj site which persisted for 3wk;
patient did not have adverse event. However, she does have allergy to latex, which vaccine would be contraindicated.  pt did not have a reaction after receiving vaccine on 8/29/22.
night of injection chills lasted about an hr. this morning when i woke up i felt very weak and went to the bathroom and tried to sit down and i passed out.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that there have been no power outages that would have impacted the Moderna vaccine. However, reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download for the months of DEC2021, JAN2022, and FEB2022. Reporter said that they are filling out a temperature excursion assessment with the State at this time and she was calling in to report the same to Moderna.  Reporter confirmed that patients have been administered doses while the temperature excursion assessment has been ongoing. It was reported that no adverse reactions were reported by any patients.
Caught COVID less than 3 months ago; Less than a week after first dose lost sense of smell, still can't smell anything; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Less than a week after first dose lost sense of smell, still can't smell anything) and COVID-19 (Caught COVID less than 3 months ago) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091DZA) for COVID-19 vaccination.     Patient had no Medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No allergies.     On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced ANOSMIA (Less than a week after first dose lost sense of smell, still can't smell anything). On an unknown date, the patient experienced COVID-19 (Caught COVID less than 3 months ago). At the time of the report, ANOSMIA (Less than a week after first dose lost sense of smell, still can't smell anything) had not resolved and COVID-19 (Caught COVID less than 3 months ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided. No treatment medication was provided.  COMPANY COMMNET: This spontaneous case concerns a 53-year-old, male patient with no medical history reported, who experienced unexpected non serious AESI events of anosmia, Covid-19 (reported as Caught COVID less than 3 months ago), which occurred unspecified days after first dose of mRNA-1273 vaccine. The patient received the second dose 9 months after the first dose, which is not in accordance with the recommended vaccine interval. Lack of efficacy is not concluded. Anosmia can be secondary to COVID 19. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected.   This case was linked to MOD-2022-546723 (Patient Link).; Sender's Comments: This spontaneous case concerns a 53-year-old, male patient with no medical history reported, who experienced unexpected non serious AESI events of anosmia, Covid-19 (reported as Caught COVID less than 3 months ago), which occurred unspecified days after first dose of mRNA-1273 vaccine. The patient received the second dose 9 months after the first dose, which is not in accordance with the recommended vaccine interval.Lack of efficacy is not concluded. Anosmia can be secondary to COVID 19.Current ongoing pandemia remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected.
pounding h/a, unsettled stomach (butterfly's), tired, body aches (no soreness @ inj site), & medicine taste in mouth;took 3 regular strength APAP;
Optic Neuritis, later diagnosed with MOG Antibody Disease. No similar incidents had occurred prior to receiving the vaccine.
Was 13 weeks pregnant at time of vaccine dose. Due date 6/23/22. At 16 week appointment no fetal heartbeat on ultrasound and doctors said baby stopped growing around 14.5 weeks.