chrisvoncsefalvay/vaers-outcomes huggingface dataset:
positive home covid test 15Jan; positive home covid test 15Jan; awoke with 101.7 F fever; cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jan2022 (Lot number: FJ614) at the age of 15 years as dose 3 (booster), single, administered in arm left, administration date 05Jun2021 (Lot number: ew0178) as dose 2, single and administration date 13May2021 (Lot number: EW0169) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Patient had no known allergies. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "not recovered" and all described as "positive home covid test 15Jan"; PYREXIA (non-serious) with onset 15Jan2022, outcome "not recovered", described as "awoke with 101.7 F fever"; COUGH (non-serious) with onset 15Jan2022, outcome "not recovered", described as "cough". The patient underwent the following laboratory tests and procedures: body temperature: (15Jan2022) 101.7 Fahrenheit; sars-cov-2 test: (15Jan2022) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19, pyrexia, cough and included treatment with Tylenol.  Clinical Course: It was reported that facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid tested post vaccination.  Additional Information: On 18Jan2022, product quality complaint conclusion was reported as, the complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EW0169 and lot EW0178 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EW0169, fill lot EP8700, finished goods lot EW0178, fill lot EP8729 and the bulk formulated drug product EP8602. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A female patient of an unspecified age received PREVNAR 13 via an unspecified route of administration on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported. The pharmacist reported that the patient did not want subsequent PNEUMOVAX 23 shot because their first pneumococcal shot, the year before this report, of pneumococcal 13-val conj vac (dipht crm197 protein) was too painful. The pharmacist further specified that the patient received pneumococcal 13-val conj vac (dipht crm197 protein) the year before this report and her arm was uncomfortable and sore to sleep on. At the time of the report, the outcome of the events was unknown. The information on the batch number has been requested.
diarrhea; injection site warmth; Nausea; injection site pain; injection site swelling; injection site lump; itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), DIARRHOEA (diarrhea), VACCINATION SITE WARMTH (injection site warmth), NAUSEA (Nausea) and VACCINATION SITE PAIN (injection site pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PRURITUS (itching). On 01-Feb-2021, the patient experienced DIARRHOEA (diarrhea), VACCINATION SITE WARMTH (injection site warmth), NAUSEA (Nausea), VACCINATION SITE PAIN (injection site pain), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE INDURATION (injection site lump). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 01-Feb-2001, NAUSEA (Nausea) had resolved. On 27-Jan-2021, PRURITUS (itching) had resolved. On 01-Feb-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site warmth), VACCINATION SITE PAIN (injection site pain), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE INDURATION (injection site lump) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant treatment was not reported.
Developed severe pain in the area of left sacroiliac joint on May 3, 2021 and some small blisters on the back of the left leg.  It quickly became full blown shingles affecting entire left leg from waist to foot.  Family doctor gave be valtrex and gabapentin, but it progressed and within 2 weeks left leg was losing function.  Fell 3 times them realized it wasn't working.  It atrophied and developed deep vein thrombosis.  Taking eliquis.  Eventually regained some use of leg but after 8.5 months still can't walk without a walker.  I do have neuropathy from MS and chemo but not like the left leg.  Other than pain, almost no feeling.  It was a major life changing event since I was very active and now unable to walk freely.  Don't know if it is the vaccine or whether getting shingles was vaccine related but felt I should report as possible adverse effect.
Patients wife states he had a vomiting episode during the night of the shot.  Now is currently asymptomatic
Fever, body aches, chills, fatigue, nausea around 19 hours after vaccination.
I just have allergy; I do not feel good; I am feeling bad ever since I got that shot; Feeling horrible; This is a spontaneous report from a contactable consumer (patient herself). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW0198, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 17Jul2021 (at the age of 69-years-old) as a DOSE 1, SINGLE for covid-19 immunization at Pharmacy. The patient's medical history and concomitant medications were not reported. The patient reported that, I just have allergy and I do not feel good; I am feeling bad ever since I got that shot; feeling horrible, both on Jul2021. Reporter stated, I took the Pfizer shot last Saturday on the 17th and I don't have any face (Incomplete information), have any swell, do not have a fever and my body have been (Incomplete information) so far. So, I am just wondering, how long I am going to be like this? Further stated, No, I don't have a fever, I just have allergy. She stated, I do not feel good. Do I have Covid? and My first dose was 17Jul2021. Patient stated, No, no treatment I just got that vaccination shot, the first shot on 17Jul and I am feeling bad ever since I got that shot and I just want to know do I have Covid or not and how long I am going to be feeling horrible like this? Reporter seriousness for the events were unspecified. Outcome of the events was unknown.  Comment: Due to connectivity issue, consumer's voice was breaking over the call.
3 cm red & warmth area around vaccine site noted 5 days after vaccination of MMR.
Information  has been received from a nurse concerning a 53 year old female who on an unknown date, was vaccinated with PNEUMOVAX (lot # not provided). Subsequently the patient developed a red and feverish arm. the patient was advised to use warm compresses, TYLENOL and BENADRYL. Subsequently, the patient's symptoms had resolved. the patient sought unspecified medical attention. This is one of several reports from the same source. Additional information has been requested.
Fever 10/24/05 vesicles/swelling at injection site 11/1/05
no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and from vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 09-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T041687 expiration date 10-DEC-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2110USA005066:
Lack of sleep, pain in arm, inability to lift any objects, redness and swelling around site. Pharmacist drew circle around location of site to monitor the swelling.
Two brief episodes of  vertigo  8 and 14 days after Pfizer booster. Resolved over 1-2 hours. No subsequent episodes. Had never  had vertigo episodes previously .   Increased volume of  chronic low volume tinnitus over past 2-3 months post booster.
Pt. stated he had shortness of breath, palpitations, and chest discomfort(sternum) that lasted 24 hrs. This started 3 days after receiving the Smallpox vaccine. It kept him awake and he thought it was indigestion at the time.
Patient received Sputnik Covid 19 Vaccine series 5/18/21 and 7/20/21.  This Moderna booster administered today should have been 0.25ml.  PATIENT RECEIVED 0.5ML INSTEAD
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Moderna product on 03/04/2021, 04/01/2021, and 09/20/2021. They tested positive for COVID-19 on 02/14/2022 and again on 02/21/2022. They were admitted to hospital 02/14/2022 and transferred to a different hospital on 02/19/2022 for a higher level of care. They experienced multiple complications, including ARDS, secondary bacterial pneumonia, dehydration due to acute diarrhea, acute ST elevation myocardial infarction of anterior wall, and acute stroke due to ischemia. The individual was transitioned to comfort care only on 03/04/2022 and they died later on the same day on 03/04/2022. This individual was immunosuppressed due to medication use.
Enlarged erythema at injection site. Warm to touch and hard over 3 day period
inflammation of lymph modes; inability to move arm; sore throat, fever of 101 for 1 day;
exposed to freezing temperatures; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 58-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received the vaccine after being exposed to freezing temperatures (-1 C for total amount of time of 25 min), which led to incorrect storage of drug. The reporter consented to follow up. This was 1 of 5 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021218245:same reporter US-GLAXOSMITHKLINE-US2021218244:same reporter US-GLAXOSMITHKLINE-US2021218239:same reporter US-GLAXOSMITHKLINE-US2021218238:same reporter
patient under 18 years old/17 years old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient under 18 years old/17 years old) in a 17-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 004M21A) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Drug allergy. Concomitant products included TESTOSTERONE for an unknown indication.    On 02-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 02-Jun-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient under 18 years old/17 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient under 18 years old/17 years old) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No other vaccines given within one month prior to Moderna COVID-19 vaccine. The patient was going through a gender change from female to male. An adult was considered 19 years old. Health care professional got parental consent from the patient's mom and administered the vaccine. Then health care professional found out that the patient was under 18 years old. Patient stayed for 30 minutes and had no reaction. Treatment details was not reported by the reporter.
pt recvd vax 19OCT92 & mom states had sz aobut 115PM; pt was taken to hosp & adm; t104; no APAP had been given since vax;
Patient came in for flu shot. Technician went to administer shot.Technician states verbally verified Covid shot with pt. Covid shot was given. Upon review with patient error was discovered. Patient was upset but no adverse effects were noted. Patient was consulted and asked if still wanted flu shot. Patient did and flu shot was given also.
immediately she felt dizzy, chills, nausea and fever by bedtime.  Left arm was painful. She took Tylenol then developed numbness down her arm.
SWELLING AND RAISED INJECTION SITE (ABOUT 2 INCHES IN DIAMETER)
Nurse drove the shot into my upper right arm.  12 hours later, I had a multiple symptoms. They were a headache, a fever, body ache, tenderness at the injection site.
the child moved during administration of the vaccine. they wanted dose in right arm, the needle was inserted but vaccine not administered before pulling her arm away.  the dose was administered in her left arm without incident.
Seven days after innoculation left arm in area of innoculation started to itch and a mild rash appeared.  Purchased hydrocortisone cream 1%  day after itching started (today).
GARDASIL 9 beginning at age 10 years old, and did not receive her second and third doses until she was 23 years old; The patient did not experience any symptoms.; This spontaneous report was received from a physician and refers to a 23-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, when the patient was 10 years old, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis. The patient did not receive her second and third dose until she was 23 years old. Physician noted that the second and third doses were spaced out by 3 months. The patient did not experience any symptoms.
discoloration of 3 toes (2 on one foot, one on the other). Occured 7 days after vaccination. non-painful. non-swollen. dusky red color. Gradually improving.
This spontaneous report as received from a nurse refers to an 13 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 10-APR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot #K004204, exp. date: 12-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Fibromyalgia flare after 12 years of remission. Extreme myalgia, brain fog , malaise x  4 weeks post 1st dose.
Initial misuse report received from a healthcare professional on 15 May 2013. A 01-month-old patient was administered DAPTACEL vaccine instead of Hepatitis B vaccine. No adverse event was reported. List of documents held by sender: none.
100 degree fever evolving into 103 degree fever which lasted for 5 days. Then developed into all over body rash resembling measles which has so far lasted 4 days. Loss of appetite for total of 6 days. Headache, stomach ache, constant crying for all days symptoms were present.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced CHILLS (Chills). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Chills, at an unspecified dose and frequency. At the time of the report, CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was taking concomitant medication but did not provided.
4/17/2009: SM contacted VHC reporting receipt AVA #2 on 4/8/2009 (lot# unknown). The next day he had numbness to right 4th/5th digits. 4/10/09 this numbness had progressed to his 3rd/middle finger with pain in his right forearm. He stated his palm tingles after lifting/moving boxes and his wrist aches. His AVA site is sore w/o redness or swelling.  He reported past history of right shoulder/neck problems with normal x-rays. Prior to vaccination and after he helped load-packed gear in preparation for deployment, continued training, and was wearing 50 lb ''IBA'' packs. He advised moving his right arm/shoulder caused the forearm to hurt. He was given Ibuprofen 400mg every 6 hr by medical with minimal relief.
Patient received 1st dose of Moderna Vaccine. While patient was being interview by MD. Patient was complaining of migraine headache and nausea. Patient states she was feeling okay before the vaccine was administer. 5 minutes later after receiving the moderna vaccine. This trigger her symptoms as per patient . Patient denies numbness, weakness. Patient is able to move all extremities. No deficit noted. No Shortness of breath noted as well. Decision to call 911 was made by MD.  BP 147/118 HR 103 Sat 98 % on RA   09:55 Fire Department Rescue. Patient was able to walked to the rescue cot without any difficulty. Patient will be transported emergency room.
Around 9 am 11/24/11 she started itching on her head and then her body. She thought it was dry skin and started to put lotion on and found bumps on her groin area, mid-drift and from her shoulders down to ther wrist.  She then took hydroxyzine 25 mg about 12:30 pm and this helped the itching and the bumps decreased in size and color.
ACHES; CHILLS; LOW GRADE FEVER; NASTY HEADACHES; NAUSEA; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced aches. On MAR-2021, the subject experienced low grade fever. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced nasty headaches. On MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nasty headaches, chills, low grade fever, aches, and nausea. This report was non-serious.
Day 0 and Day 3 had no side effects; Day 7 injection is when the side effects began. Side effects of Day 7 (third series of the rabies vaccine) were flu-like symptoms. Rash from third series of injection started on 10/02/2022. Side effects had elevated on 10/03/2022.
This spontaneous report was received from a registered nurse referring to a patient of unknown age. On 13-JAN-2016 the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (lot # L022447, exp date: 26-JUN-2017) orally. The product was exposed in temperature of 49.3 F degrees for 40 minutes. The temperature excursion was recorded by a data logger. The product had previously exposed to 50.2 F degrees for 1 hour 10 minutes. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
I realized that the bottom half from my knee to my foot, was swollen and tender. I realized that I had to think of the possibility of a blood clot, since I am a doctor. I called a doctor to go and get a doppler ultrasound. It was a tibuial vein blood clot. So it was in a good place. So I went in the next week, since I was not in pain. I took medication to reduce it and put on tight socks and it was a lot better in the week. It was still red but no where near what it was. The doctors ruled it as caused by the Lupis. But it is nothing to be concerned. I am reporting this as it is unknown if it came from the vaccine or from lupis or a mixture of both. If I keep the compression socks on, it clears up and does not give me any problems, however like every patient, if I do not follow the orders of using the socks, it begins to swell again
Received MMR, and Varivax on 9/27/04. Develops fever on 10/5/04 and chicken pox type rash on 10/7/04.
Consent sheet was filled out by mother and listed child's age as 12.  Dose was administered.  Did not realize patient was, in fact, was 3 months shy of 12 years old unti trying to enter vaccine into computer system.
7-Mar 2pm received 1st Moderna vaccine shot 8-Mar 7am woke up with sore arm headache (3 out of 10) 2pm body aches, headache (5 out of 10)" 4pm upset stomach, headache (7 out of 10), Fatigue 8pm Chills, Fever ( 101 ), Nausea, Body ache, headache (10 out of 10) 11pm Fever ( 103), Chills, Sweating 9-Mar 7am headache (4 out of 10), Fatigue/Tired, Body ache