chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever, chills, body aches, sore arm for 9 hours. treatment was rest and liquids, after 10 hours 2 pills of 500mg acetaminophen were given. all symptoms subsided.
Tinnitus in right ear.  I have no history of tinnitus, and it is quite disturbing.   I did feel quite ill the day after the vaccine. A general lethargy, headache, and just not feeling well have persisted. I honestly haven?t felt right since getting the vaccine, although I obviously can?t be sure the vaccine caused it.
Patient noted swelling and redness (Cellulitis) of L. arm on 2/18/2015.  He sought care on both 2/18/2015 & 2/19/2015.  Patient was treated with antibiotics without incident and has had no further problems. Routine f/u not recommended.
pt presented to ED with increasing SOB; positive for COVID; on NRB mask; had been dc'd from hosp 2 days before for treatment of COPD exacerbation, was negative for COVID @ that time; placed on BiPAP then Venturi mask; given remdisivir, Baricitinib, antibiotics, steroids; back on BiPAP; DNR/DNI; pt experienced V Tach and condition deteriorated; comfort measures put in place and pt died in the hospital
mom reports t104; cold chills approx 3PM recvd vax 130PM; upon awakening rt deltoid red & hot area 2"x2 1/2" in size; present t99R;
Felt electric shock down arm into a little finger immediately plus painful injection. Within the next hour felt product seep into left side of head and ear, and into left shoulder blade. Required Tylenol for the next 48 hours with 8/10 Pain scale. Five days later I still have arm pain, pain in the left side of my head and ear and left shoulder blade 2/10 pain scale. Mild fatigue for 48 hours.
Patient called back today 11/12/23 of severe arm pain. She's still able to move the arm.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). An 102-year-old male patient received BNT162b2 (BNT162B2), on 24Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 102 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown). The patient's relevant medical history was not reported. Concomitant medication(s) included: DIGOXIN, start date: 01Jan2021, stop date: 02Jun2022; LEXAPRO, start date: 01Jan2021, stop date: 02Jun2022; PRAVASTATIN, start date: 01Jan2021, stop date: 02Jun2022; ALPRAZOLAM, start date: 01Jan2021, stop date: 02Jun2022; METOPROLOL TARTRATE, start date: 01Jan2021, stop date: 02Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 28May2022, outcome "not recovered", COVID-19 (medically significant) with onset 28May2022 at 11:00, outcome "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Patient had no known allergies. Patient had received medication in 2 weeks. Anti-viral details: Product: COVID-19 Treatment, Treatment start date: 28May2022 and Treatment stop date:31May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a dental hygienist concerning a female patient ("one of their office employee's daughters), whose first dose of GARDASIL was well-tolerated. On an unspecified date she was vaccinated a second dose of GARDASIL (lot number, route and injection site not reported). Sometime after the vaccination, she had developed severe abdominal pain. It was stated that the patient was hospitalized for severe abdominal pain (duration unknown). The patient's outcome was unknown. Additional information has been requested.
Patient stated they woke up on the following day after vaccination with numbness in pinky, ring , and middle fingers of arm that was injected.  Patient also stated arm was cold.
mom states @ 11AM 24JUN93 that APAP was feverish, fussy p/shot, watery eyes, sensitive to light, redness around eyes, sleeping more; seemed sleepier than usual; diarrhea on 23JUN;
No additional AE reported; VARIVAX was administered again 9NOV2021; Patient had MMRII vaccine administered 7OCT2021. Pateient then had VARIVAX administered on 24OCT2021, before 28 days; This spontaneous information was received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 07-OCT-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided). On 24-OCT-2021 the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml for prophylaxis (lot number: U015688 with expiration date on 18-MAY-2023) (strength, frequency, route of administration and anatomical location were not provided) before 28 days (inappropriate schedule of product administration). Additionally, on 09-NOV-2021, the patient was vaccinated again with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) (inappropriate schedule of product administration).  No additional adverse event reported.
HCP called to report a temperature excursion (see case# 01766674) and reported that ROTATEQ was administered to 2 patients on l0/26/2020 after a temperature excursion and prior to having vaccines evaluated.; This spontaneous report was received from a physician, referring to a two patients of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 26-OCT-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered by oral route, as prophylaxis (formulation, strength, dose and vaccination scheme were not reported; lot number 1684163, which has been verified to be valid, expiration date reported and validated as 26-JUN-2021). The vaccine administered experienced a temperature excursion below 36 degrees Fahrenheit (F)/2 degrees Celsius (C) (0.9C to 1.9C) for 10 hours; above 47F/9C (9.1C) for 30 minutes, for a time frame of 10 hours and 30 minutes. There was no previous temperature excursion reported, and no data logger was involved in the report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA011171:
Pt did not have a reaction. The vaccine was administered after beyond use date of refrigeration for vaccine but lot number was not expired.
Pt recvd vax & exp rt-sided Bell's Palsy; pt was seen by MD & prescribed Pred; As of 4SEp92 treating MD inidcated felt there would be no residual neurologic abnormality;
He had fever of 104, headache, chills, body aches. The reason we went to ER started having chest pain they did  Chest X-ray, EKG monitored few hours and then he was discharged,
Patient reported that she is still experiencing aching pain at injection site. It wakes her up at night all she can take is ibuprofen/Naproxen. No insurance can not see Dr.
Petechiae, aplastic anemia. Vaccination 3 weeks prior to symptoms. Appropriate response unknown. Attempts to contact reporter failed to produce additional patient information.
New onset ankle, knee, elbow, shoulder, back pain, no fever. Diagnosed arthralgia vs arthritis symptoms thus labs drawn.
feet were tingling at bottom of sole of the feet; numbness has moved up to the calf and then it it continued moving up to her thigh and pelvic area; difficulty using the restroom; This case was reported by a nurse via sales rep and described the occurrence of tingling in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 3425X, expiry date 18th December 2021) for prophylaxis.   On 21st November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced numbness in leg and activities of daily living impaired. On 21st November 2019, the patient experienced tingling. On an unknown date, the outcome of the tingling was unknown and the outcome of the numbness in leg and activities of daily living impaired were recovering/resolving.   It was unknown if the reporter considered the tingling, numbness in leg and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 21st November 2019, late morning, the patient received the 1st dose of Shingrix vaccine and later that evening, patient reported that her feets were tingling at bottom of sole of the feet. The patient also reported that the numbness has moved up to the calf and then it it continued moving up to her thigh and pelvic area. The patient said that based on where the numbness was located, she had difficulty using the restroom..
Rash occurred around injection site in an approx. 2 1/2 x 2 1/2 area. Fine macular papular rash. Itchy observed day after injection.
No adverse event; 0.5 ml of bivalent given as first dose of primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (0.5 ml of bivalent given as first dose of primary series) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 30-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (0.5 ml of bivalent given as first dose of primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (0.5 ml of bivalent given as first dose of primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (0.5 ml of bivalent given as first dose of primary series).    No concomitant medication information provided.  The pharmacist states they had a vaccine error. They administered 0.5 ml of a Moderna bivalent vaccine to someone who had not yet received a primary dose yet on 30Sep2022. No treatment information provided.
I saw a doctor at an urgent care for an irritation in my throat that was painful and tasted metallic. This was identified as an oral mucosal lesion. No test or labs but was advised to continue warm salt solution for treatment that I was already taking. I got rid of the irritation but I have a residual metallic taste from time to time. No other conditions since.
The day after injection the area was a little red and sore - it progressively has gotten bigger.
Approximately 10 hrs after injection, woke-up with significant aching muscle pain in hips/groin, shoulders, elbows and wrists. Was unable to go back to sleep until after 1000mg tylenol  took effect. Muscle aches continued throughout the day on 11/4, and continue now on 11/5. Pain is managed alternating 1000mg tylenol and 500mg ibuprofen. Continuing ADLs, but with some discomfort.
Swollen lymph node under left arm pit; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 14Apr2021 at 16:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), esomeprazole magnesium (NEXIUM), escitalopram oxalate (LEXAPRO) and alprazolam (XANAX); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 at 16:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 16Apr2021 at 10:00, after 2 days of second dose,  the patient experienced swollen lymph node under the left arm pit. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event of swollen lymph node under left the arm pit was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 21-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211164584.
Violently ill, Threw up for 2  Days. Felt like food poisoning.  Low grade fever for  2  days.
On AM of 6/13/01, could not bend or put weight on knees. Pain down shin and up back of thigh and was unable to walk. Doctor visit on 6/14/01 and was referred to Orthopedists. Pt stated Orthopedist dx'd her with Guillain-Barre Syndrome. The annual follow up states that, "pt states that she has permanent disability. Extent of disability is unknown." 60-day and Annual Follow up on 11/17/2003: "It is unknown whether the vaccine recipient recovered from the adverse events that was reported for this vaccination."
Patient received ZOSTAVAX on 9/8/12 and reported to the pharmacy on 9/12/12 complaining of rash around the injection site. Rash was localized to the back of the arm, about 2 inches wide by 4 inches in length.
Reporter indicated that several pts c/o inject site pain described as inject site stinging; tx & outcome of the events is unk;
I have a major side sore arm, soreness has gotten better, it has developed into a bump on the site of the injection; I have a major side sore arm, soreness has gotten better, it has developed into a bump on the site of the injection; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on an unspecified date at a single dose as a COVID-19 vaccine. The patient's medical history and concomitant medications were not reported. The patient stated that she had a major side sore arm, but the soreness has gotten better. It had developed into a bump on the site of the injection. She was not sure if it's swelling. Stated that it's still there. The patient was asking if this was normal and how long it will take. Outcome of the event pain in arm was recovering, while for the event vaccination site mass was not recovered.  Information about the batch/lot number has been requested.
Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; This is a spontaneous report from a contactable nurse (patient herself). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) intramuscular (left arm), on 03Dec2020 at 16:00, at a single dose, for COVID-19 immunization. Medical history included hypertension (HTN). The patient has no known allergies. Concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a facility. On 04Dec2020, at 05:00 a.m., the patient initially experienced soreness at the injection site. Over the next 4 days (today is day 4), patient experienced pain in left shoulder, back, and up the back of head/neck which was getting progressively worse - now excruciating. Ibuprofen managed the pain for the first two days, but the soreness/pain was no longer managed with NSAID's and other comfort measures. Patient was hoping that these are normal and was hoping they will get better. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
she was only able to receive two doses of GARDASIL 9; No additional AEs or PQC reported; This spontaneous report has been received from a 45 years old female patient referring to herself. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not provided.  In February 2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, route, lot# and expiration date were not provided). In April 2023, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, route, lot# and expiration date were not provided). The operator was unknown. The patient reported she was only able to receive two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) due to turning 46 (years old) before 3rd dose was due (inappropriate schedule of product administration). No additional adverse events (AEs) or product quality complaint (PQC) reported.
6:38pm received vaccine 6:55pm alerted observer staff to feeling of throat being tender/swollen.  Given water and observed closely. 7:00pm patient became more agitated/fearful, having difficulty swallowing and speaking but not choking/gagging and was fully alert.  7:03pm attached to monitor BP 150/101  and NP alerted to situation.  Patient steadily increasing hoarseness to voice.  States she really has to push to swallow.  Given 2 tabs Benadryl 25mg.  O2sat 100% 7:10pm Husband called to be with patient.  Transported patient back to private room in clinic by wheel chair.  Red rash to upper chest area. Voice very faint. NP assessed patient and noted expiratory wheezing (mild) with non-obstructed posterior oropharynx and 02% sat still 100%.  Patient was kept on continuous 02 sat and HR monitor with BP checks every 3 minutes. 7:13pm After moving to private room with safer surroundings, epi injection procedure explained to patient.  Then Epi  pen 0.3mg given to left lateral thigh per NP.  O2sat 100%  HR 92  BP 162/90  Hospital rapid response team called (per facility protocol) for transfer to main hospital facility ER per  NP.   7:14pm Hoarseness improving.  Patient states neck and swallowing feel about the same although visible swelling was receding as was the rash on her upper chest. 7:17pm O2 sat 100  HR97  feeling shakey and cold. 7:19pm BP 144/95 HR97 O2 sat 100 7:26pm Patient cold and shakey.  Throat still difficult to swallow but not any worse than before.  BP 151/97. HR 101, O2 sat 100% Instructed patient that she will be transported to ED by ambulance.  Husband will move car and meet her in ED.   7:30pmTransported to front entrance to meet first responders.   7:36pm Transferred to ambulance. 7:38pm Called  ED
After administering the second shot (Shingrix), the patient started shaking. Patient said she needed to lie down. Pt then lied down, put her legs up on the chair. Then the patient fainted, had a seizure for about approximately 1-2 minutes. We called 911. The patient then woke up, threw up and continued to be nauseous and throwing up. The patient started feeling better. We gave her ice pack, three small cups of water, and mint as the patient requested.
thirsty a lot; feel a little bad; headaches; tiredness; inflammation to her hands and feet; chest pain; This is a spontaneous report from a contactable consumer (patient, reporting on herself) via medical information team. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0187 and expire Date: Unknown), via unspecified route of administration, in Arm Left, on 23July2021 (age at vaccination: 45 years), as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. patient did not provided family medical history relevant to adverse events. The patient did not receive any vaccines administered on same date with the Pfizer vaccine considered as suspect. The patient did not receive any vaccines within four weeks prior to the first administration date of the suspect vaccine. patient did not have any relevant tests results.On 23July2021 patient experienced headaches, tiredness, inflammation to her hands and feet, chest pain. on unspecified date she was thirsty a lot. she wants to know if her symptoms were normal, what she could do about the side effect and how long will they last. she felt a little bad and her primary healthcare professional is not available until september. The seriousness of the events was Unspecified. Outcome of the events headaches, tiredness, inflammation to her hands and feet, chest pain was not resolved and outcome of the event thirsty a lot, felt a little bad was unknown  Follow-up attempts are completed. No further information is expected.