chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had some tingling down my left arm into my thumb and hand.  Little bit of numbness in thumb; Had some tingling down my left arm into my thumb and hand.  Little bit of numbness in thumb; This is a spontaneous report from a contactable other hcp. A 65-years-old male patient received first dose of bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EL9267), via an unspecified route of administration, administered in Arm Left on 25Feb2021 15:30 as DOSE 2,SINGLE for covid-19 immunisation (Age at vaccination 65 years). The patient medical history and concomitant medications were not reported. On 25Feb2021 15:30 patient experienced had some tingling down my left arm into my thumb and hand. little bit of numbness in thumb. Therapeutic measures were taken as a result of events includes ice on hand. No other vaccine in four weeks. The outcome for both events was recovered on an unspecified date in 2021.  No follow up attempts are needed. Information on Lot/batch cannot be requested. No further information is expected.
Headache for less than 24 hours and elevated temperature - (low grade fever under 100*) for a duration of 24 hours  and persistently lowering day by day for the following three days
Painful, swelling and itching with reddened large hard bump entire deltoid area of right arm. Treatment with ice and Ibuprofen. Resolution of symptoms in 24h.
First a sore arm.  Then chills.  Then soreness down my entire body except feet.  Then fever.  Lasted for 3 days.  Arm was swollen and sore for about a week.
Felt dizzy, spacey and sick to stomach. Had headache for 24 hours, post vax.
Very painful, throbbing, aching pain all and up the left arm. burning pain on underside of left arm.
I had diarrhea to start and then it started with fever up to 101.7. And then I started having chills and pain in all the joints - general body pain and headache. ER visit they did a COVID test. The result was negative. They just told me take OTC Advil and Tylenol. I had my symptoms for three days. And then they all resolved. Right after the 2nd vaccine: I had chills, fever, and injection site was very sore and I had body pain (all the joints). Those lasted 2 days, I think. No treatment.
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 63-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 was reported. No treatment information was reported.
Redness in arm from shoulder to elbow. Was taking Benadryl but didn?t seem to help much. She then called pharmacy to seek advice. Was notified to seek medical assistance for possible steroid to reduce inflammation.
Information has been received from a physician concerning a 70 year old male patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck). It was reported that "soon after receiving the vaccine" the patient developed chickenpox. The patient sought medical attention with an office visit. At the time of the report the outcome of the patient was not reported. Additional information has been requested.
Falls asleep and sleeps for 4-5 hrs; sore arm felt like having a flu shot; Fatigue that is immense and overtakes her body, exhausted, tired; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Falls asleep and sleeps for 4-5 hrs), VACCINATION SITE PAIN (sore arm felt like having a flu shot) and FATIGUE (Fatigue that is immense and overtakes her body, exhausted, tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 020B21A) for COVID-19 vaccination.     The patient's past medical history included Lymph node excision (Ten lymph nodes were taken out due to cancer.). Concurrent medical conditions included Cancer.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Falls asleep and sleeps for 4-5 hrs), VACCINATION SITE PAIN (sore arm felt like having a flu shot) and FATIGUE (Fatigue that is immense and overtakes her body, exhausted, tired). At the time of the report, INSOMNIA (Falls asleep and sleeps for 4-5 hrs), VACCINATION SITE PAIN (sore arm felt like having a flu shot) and FATIGUE (Fatigue that is immense and overtakes her body, exhausted, tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient stated that after receiving both doses of COVID vaccine, every week the patient had a blow out day where she could not function. Concomitant medication and treatment drug were not reported. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.   This case was linked to MOD-2021-226976 (Patient Link).
received a 3nd dose, 2 months apart; 1st dose recieved in 2020 and 2nd dose in 10-Oct-2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 15-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 7TP53, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Fluarix (received fluarix 1st dose in 2020).   On 12th December 2022, the patient received the 3rd dose of Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 10th October 2022, the patient received the 2nd dose of Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 10th October 2022, not applicable after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device and unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On 12th December 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-DEC-2022. Reporter's Comment: The reporter stated that patient had received a dose of Fluarix on 10th October 2022 and a second dose on 12th December 2022. The reporter stated that patient did mention that the previous dose had been given in 2020 and did not specify further information. Reporter relayed information for adverse event report and agreed to be contacted further on via email, which was provided. Additional Supportive Information: The patient had received 1st dose of Fluarix in 2020 and 2nd dose of Fluarix in 10th October 2022 which led to lengthening of vaccination schedule. The patient received 3rd dose of Fluarix which led to extra dose administered.
Information has been received from a physician concerning an 8 week old male patient, who on 22-FEB-2010 was vaccinated orally with the first 2 mL dose of ROTATEQ (lot number not reported). On 22-FEB-2010, one hour later of the vaccine administration, the patient experienced "liquidy" stool and later on bloody stool. The patient sought unspecified medical attention. At the time of reporting the patient had not recovered. Upon internal review, bloody stool was considered to be an other important medical event. Additional information has been requested.
LEFT ARM-SWELLING, SWELLING UP THE LEFT SIDE OF THE NECK AND LEFT SIDE OF HEAD, FEVER, CHILLS, SWEATS, ARM FELT WARM AND TINGLY, WENT TO ER AROUND MIDNIGHT AND WAS GIVEN STEROIDS AND PAIN REDUCERS.
Heart palpitations every couple of hours. After the patient drink 16oz of water or more it calms down after 30 minutes but will start back up again.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 09Apr2021 at 15:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and endometriosis. The patient did not have any allergies to food, medications, or other products. Concomitant medications included iron (MANUFACTURER UNKNOWN), potassium (MANUFACTURER UNKNOWN), thyroid (ARMOUR THYROID), ibuprofen (MANUFACTURER UNKNOWN) and biotin (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 18:30, the patient experienced heart palpitations every couple of hours. After the patient drank 16oz of water or more it calmed down after 30 minutes but would start back up again. The patient did not receive treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event heart palpitations every couple of hours. After the patient drink 16oz of water or more it calms down after 30 minutes but will start back up again was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
At 10:15 p.m. on Nov 16, 2019, I woke up with severe muscle spasams, especially around my abdomen, everytime that I moved, lasted almost 24 hours, relieved by ipufrphen, but still painful.
Child had 2 complex febrile seizures on 10/28/18.  She was admitted to the hospital from 10/28/18 to 10/30/18.  She developed mild cold symptoms.  She had a full recovery.
Shingles vaccine 9/14. 9/16 red swollen hot area baseball sized around injection site itchy hot & red x 7 days. Took 2.5 - 3 weeks to resolve completely.
can?t get rid of muscle aches and headaches which affect eyes. feeling really tired and feeling achy all over.
oral thrush; I am severely ill but both times taking the bivalent booster has resulted in mild to severe fungal infections for me; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history included: "POTS" (unspecified if ongoing); "IST" (unspecified if ongoing); "MCAS" (unspecified if ongoing); "hEDS" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "asthma" (unspecified if ongoing); "IBS" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "Known allergies: peanuts" (unspecified if ongoing); "Known allergies: cashews" (unspecified if ongoing); "immune compromised" (unspecified if ongoing); "oral thrush, which I have had before" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: morphine, reaction(s): "Known allergies: morphine"; Known allergies: fluoroquinolones, reaction(s): "Known allergies: fluoroquinolones". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ORAL CANDIDIASIS (non-serious), outcome "unknown", described as "oral thrush"; FUNGAL INFECTION (non-serious), outcome "unknown", described as "I am severely ill but both times taking the bivalent booster has resulted in mild to severe fungal infections for me". The events "oral thrush" and "i am severely ill but both times taking the bivalent booster has resulted in mild to severe fungal infections for me" required physician office visit. Therapeutic measures were taken as a result of fungal infection.  Additional information: After her first bivalent does last Sep2022 she noticed that she had developed a case of oral thrush, which se had before so she thought nothing of that. she did not normally had fungus reactions like that unless she was severely ill but both times taking the bivalent booster had resulted in mild to severe fungal infections for her. she contacted her Dr. both times and she offered to prescribe fluconazole for the yeast infection but she had already taken Monistat over the counter and that started to recede by the time she offered. Patient had no covid prior vaccination. Patient had not covid tested post vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300262392 same reporter/patient/drug, different dose/event;
Patient reports the inside side of her left arm having a large red sore area. The same arm as the injection but on the opposite side to the deltoid. It was painful and patient was having trouble even raising her arm up. By 9-15-17 the swelling and pain had subsided and the area appeared a tanner color than the rest of her arm. She reported having no signs of the reaction on 9-17-17. I told the patient to put ice on the reaction and instructed her to take ibuprofen the day she reported the reaction to me (9-13-17).
very red scar; strange rashes; rash on her neck that was so painful; This is a spontaneous report from a contactable healthcare professional (patient). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 13Jan2021 (Batch/Lot number was not reported), at the age of 34 years old, as dose 2, single for covid-19 immunisation The patient was not pregnant at the time of vaccination. There were no relevant medical history and concomitant medications. The patient previously received dose 1 of BNT162B2 intramuscular in left arm on 25Dec2020 15:00, at the age of 34 years old, for COVID-19 immunization. No COVID prior to vaccination, underwent COVID test (nasal swab) on 16Jan2021 with negative result. On 27Jan2021, about 2-3 weeks after her 2nd vaccine, she became covered in strange rashes. She had a rash on her neck that was so painful and unidentifiable that it had to be biopsied. She was having another strange unidentifiable rash in her groin area, which also had to be biopsied. She had a rash between her eyes as well that has heal but was so deep that it left a very red scar. The event rash resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment unknown. The patient was recovering from rash, while unknown for scar.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patient had breakthrough rash developed/ rash appeared approximately 2 minutes after the injection; This spontaneous report as received from a nurse via company representative refers to a patient of unknown demographics. The patient' medical history, concurrent conditions and concomitant medications were not reported. On 01-JUL-2019, the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) one dose (1 dosage form) (strength, lot number and expiration date were not reported) through an unknown route for prophylaxis. On an unknown date in 2019, after receiving the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) the patient experienced a breakthrough rash (varicella). The outcome of varicella was unknown. The reporter's causality assessment was not reported. No product quality complaints were involved. The reporter also inquired when the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) should be administered.   This is a non-valid case due to lack of patient identifier.  Follow-up information was received from the nurse on 28-AUG-2019 referred to a 53-year-old female patient. The patient was not pregnant. On 01-JUL-2019, the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose was reported as "5 g"). Approximately 2 minutes after the injection the patient had rash. The outcome of the event was unknown. Causality assessment was not provided.
I was vaccinated from shingles but got them anyway / suspected vaccination failure; I was vaccinated from shingles but got them anyway; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingles vaccine and got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
sore arm; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information: The patient's second dose was scheduled for 28 days and was asking if it was ok.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366660 Same reporter, drug and event; Different patient
Patient had previously rec. vaccine on 11/11/15 - forgot called patient on 2/26/16 - said fine and no problems. Patient stated called in sick to work day after vaccine.
Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID-19 vaccine.
Our son began to lose speech around the time of vaccinations and being treated for a croupe cough. He was given ORAPRED and clyndomycin. His eating became extremely restrictive. He then began to seclude himself frequently throughout the day and avoid eye contact and all forms of communication. Prior to this time, he ate a varied healthy diet and was a happy, verbal baby with no issues of any kind. He was diagnosed with speech delay to start.
no additional adverse event; syringe broke off; the patient did miss today's dose; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 08-APR-2021, the patient was about to be vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, 0.5 milliliter, once (lot # T009743, expiry date 27-JAN-2022) for prophylaxis.   The reporter stated that during the preparation, when she went to screw the needle onto the syringe, "it just broke of'. She stated the location of where the break occurred was in the luer lock where the needle was screwed onto the syringe. She believed there was a small piece that was completely broken off from the syringe and the piece was in the needle which has been discarded as of now. She stated the syringe/needle did not touch the patient, however the patient did miss the dose due to this quality issue, because they did not have another pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) available to administer on that day. The patient was going to return tomorrow to receive the dose. No additional adverse event or product quality concern were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T009743; expirationdate: 27-JAN-2022; deviceage and unit: 0 ; serialnumber: 100810826130; operatorofdevice: Pharmacist; malfunction: Unknown; productavailableforevaluation: Yes; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient felt light headed and was dehydrated and need to sit down.  Lost color and  we elevated her feet.
2 hours after getting vaccines, she woke up from nap with fevers 101.9 crying with projectile vomiting 5 times.  8 hours later she was back to normal and eating well.
Rash approximately 1" square on upper back near left arm. Smaller rash near injection site.
Extreme rt arm pain/aches  (5 days) Full body aches (4 days) Extreme chills (1.5 days) Diarrhea (ongoing)