chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Aug2021 11:30 (Lot number: 5234) at the age of 12 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Product=COVID 19, lot number=5234, lot unknown=False, administration date=04Aug2021, administration time=08:30 AM, dose number=1, vaccine location=Right arm), administration date: 04Aug2021, when the patient was 12 years old, for Covid-19 Immunisation. The following information was reported: PAIN (non-serious) with onset 28Aug2021, outcome "recovering", described as "Body aches"; CHILLS (non-serious) with onset 28Aug2021, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 28Aug2021, outcome "recovering", described as "fever"; PAIN IN EXTREMITY (non-serious) with onset 28Aug2021, outcome "recovering", described as "sore arm". Therapeutic measures were not taken as a result of pain, chills, pyrexia, pain in extremity. Additional information: The patient did not have Covid prior vaccination. The patient did not test for Covid tested post vaccination. The patient did not have other medical history. The patient did not receive, other vaccine in four weeks. The patient did not receive, other medications in two weeks. No follow-up attempts are possible. No further information is expected.
HEART HURTS; FAST HEART BEAT; REALLY DIZZY; REALLY SICK; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. 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 administration not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported 1 total for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient had fast heart beat and like the patient's heart hurts and stuff. The patient knew should have gone to the doctor but patient did not. Patient was wondering if it would be like safe to get the booster then based on that like patient did not get like any permanent side effects but other than like the heart beat the patient was like really really dizzy and felt like really sick. The patient had a question about getting the booster shot. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) fast.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fast heart beat, heart hurts, really dizzy and really sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220123758-COVID-19 VACCINE AD26.COV2.S-heart hurts. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt experienced an area of firmness at injection site 7 x 8 cm area of splotchy redness around injection site. Saw an MD on 4/3/00.
Developed fever and headache then later developed hives, itching, and bruising. Already taking Zyrtec daily. Began taking famotidine daily. Required Benadryl on 1/11/21 but still has hives as of 1/11/21.
Extreme fatigue, temperature, shivering, diarrhea, pain in the left arm way below injection site.
Phone call from pt's mother reporting "rash, red, itchy all over her body" not present @ bedtime 05/26/08, but present this morning. Temperature @ 99 F, no other symptoms @ this time.  Pt spent weekend with father, mother doesn't know child's activities over weekend. Taken to ER, diagnosed with chicken pox @ 9:30 AM.
Swelling and red rash just below vaccination site. Swollen lymph node left axilla. Red area 2.5 in x 1 in on 4/15/21, approximately 3 in x 2 in at present time (4/16/21) No itching noted. No tenderness at sight of rash. Tenderness in axilla area. Was instructed by PA to take Pepcid 20mg BID and apply warm compress several times a day.
Red hives around DTP site-leg red & warm tender to touch; hives noticed about 24 hrs p/given; mom reports felt warm @ bedtime but did not take temp;
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 06-AUG-2018, the patient received a dose of PROQUAD (lot # N010246), expiration date 25-SEP-2018, for prophylaxis (exact dose and route of administration was not provided) and sterile diluent (lot # N030173, expiration date 02-JUL-2020). The dose of PROQUAD was intended for the patient's brother. No adverse effects reported. The outcome of the event was unknown.
Since 9/23/2017, I have had severe L arm pain which affected upper body dressing and sleep. Today 10/9 pain is significantly less but still present during L arm movement.
This initial spontaneous case, was received on 11-Oct-2017, by other non-health professional, concerning a 41-year-old, adult, female patient. The patient's historical conditions included disc bulging, anxiety disorder, COPD (chronic obstructive pulmonary disease), migraine, depression, seizures. The patient's current condition included latex allergy. The patient's concomitant medications included KEPPRA, hydroxyzine, PROVENTIL, SEROQUEL, KLONOPIN, omeprazole, FLONASE, oxycodone, promethazine. On 14-Sep-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid of left arm, batch number: 195216, expiry date: Apr-2018). On 15-Sep-2017, next day of vaccination, the patient woke up with blisters all over body, with skin felt as if it were on fire. In the meantime, of her healing, all the color has come out of her tattoos. It was reported that, the patient received FLUCELVAX QUADRIVALENT for the first time, but had other products in past with no issues. The patient was in treatment with lidocaine cream for pain. The patient recovered from the events blister (but it left scars) and burning sensation of the skin. It was reported that, the color had drained from tattoos. The reporter assessed the event as non-serious. Follow-up received on 24-Oct-2017: The outcome of the event was changed from not recovered to recovered, but was left with scars. It was reported that, the color had drained from tattoos. Narrative was amended accordingly. Follow-up received on 08-Nov-2017: Outcome for the event 'burning sensation skin' was updated from not recovered to recovered. Amended narrative accordingly.
3rd dose administered instead of flu vaccine,Patient is not considered as immunocompromised per HCP's knowledge; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (3rd dose administered instead of flu vaccine,Patient is not considered as immunocompromised per HCP's knowledge) in a 70-year-old patient of an unknown gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (3rd dose administered instead of flu vaccine,Patient is not considered as immunocompromised per HCP's knowledge). At the time of the report, OFF LABEL USE (3rd dose administered instead of flu vaccine,Patient is not considered as immunocompromised per HCP's knowledge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that The patient got the 2nd dose less than 1 month ago. No concomitant product information was provided. No treatment information was provided.
This 82 year old female received the Moderna Covid shot on  1/28/21    and went to the ED on  2/24/21     and was admitted  on 2/24/21 with the following diagnoses listed below. CVA (cerebral vascular accident)  Cerebral infarction, unspecified Facial weakness
Back pain (9/1/2021) Rash - Week later Bruising in legs Numbness/tingling of toes Split toenail Concern if affected her cognition
Patient was supposed to get the bivalent vaccine and was administered the monovalent vaccine. No adverse events took place. Patient is recommended to get vaccinated with the bivalent vaccine in 2 months time. The vaccine product also expired on 11/30/2022, therefore making it expired before being administered to the patient.
shingles outbreaks/shingles is currently recurring; Lack of effect; This spontaneous report was received from a consumer (patient) via GSK referring to herself, a female patient of unknown age. Concomitant medication and drug reactions/allergies were unknown. Prior to any doses of either shingles vaccines, the patient had recurrent shingles and she routinely took acyclovir for outbreaks.  In December 2014 (reported as 7 years ago), the patient took the single dose of zoster vaccine live (ZOSTAVAX) (strength, route, lot# and expiration date were unknown) for prophylaxis.   Approximately 4 years ago, the patient received both doses of varicella zoster vaccine rge (SHINGRIX) (strengths, routes, lot # and expiration dates were unknown) in her right arm. She stated the first dose was given in December and the second dose was given 15th-February of the following year. She thought it was February 2018.  She stated after the 2 doses of varicella zoster vaccine rge (SHINGRIX), she was symptom free of shingles for 4 years but her shingles was currently recurring now about once a month (lack of effect) (herpes zoster and vaccination failure). She described her shingles outbreaks were small clumps of a 5-6 blisters that itch and then burn and last a month before healing, before another patch pops up on a different location. Currently she had a patch on the palm of her hand and on her lower back near her tailbone.   The outcome of herpes zoster and vaccination failure was unknown.  The causality assessments between herpes zoster and zoster vaccine live (ZOSTAVAX) and varicella zoster vaccine rge (SHINGRIX) were not reported. The causality assessment between vaccination failure and zoster vaccine live (ZOSTAVAX) and varicella zoster vaccine rge (SHINGRIX) were related.
Patient husband reported patient (wife) experiencing rash at injection site and lower leg pain. Advised to alternate tylenol/motrin for pain management and to see PCP for further evaluation.
Hypopigmented area just above the knee with fat necrosis under the skin causing dimpling.
Increased heart rate from shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of HEART RATE INCREASED (Increased heart rate from shot) in a  patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Increased heart rate from shot). At the time of the report, HEART RATE INCREASED (Increased heart rate from shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) Increased heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
Woke up next morning with fever and severe right lower back pain that keeps coming back despite steroid round x 2 and chiropractic care. Also experiencing muscle twitching and swelling/pain in right foot/toes.
Instant swelling and bubbling of skin (approximately 1/2" high) at injection site, induration >3"; ice applied within 1 minute of injection. Swelling continued to expand to 4" diameter induration over the next 15minutes while continuously applying ice to site. No other ADEs noted.
Patient was given pediatric dose of Hepatitis A in place of adult dose: Lot ## 4B299 on 11/10/14 around 2:40 pm. Manufacturer - GSK.
Temperature spike of 102.3 about 4 hours after injection uncontrolled  shaking for 20 minutes. High fever lasted for 2 days before dropping to 100.7 and then to 99.3.
About 12 hours after I receive my second vaccine I woke up with a severe migraine and neck pain. I had slight muscle aches and injection site pain but they were not bothersome. The migraine however lasted two days.
Pt was given Hep-A vaccine at 18:00-18:15. He was a chaplain with the Police Dept and was riding with a Police Officer. The Police Officer took the pt home at 23:30. States that the pt had no complaints at that time. At 02:15, the Police Dept was informed by the pt's wife that he had been sent to the hospital and died. Autopsy states cause of death as atherosclerotic cardiovascular disease. Other significant conditions: diabetes, hypertension, obesity.
Numbness in tougne; Cancker sores; Tiredness; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA ORAL (Numbness in tougne), APHTHOUS ULCER (Cancker sores) and FATIGUE (Tiredness) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (she does has drugs allergies.).   On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jun-2023, the patient experienced HYPOAESTHESIA ORAL (Numbness in tougne) (seriousness criterion medically significant), APHTHOUS ULCER (Cancker sores) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). At the time of the report, HYPOAESTHESIA ORAL (Numbness in tougne), APHTHOUS ULCER (Cancker sores) and FATIGUE (Tiredness) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had taken three vaccinations and received side affects as numbness in tougne, cancker sores and tiredness. Patient had concern about taking fourth vaccination.   Treatment information was not reported.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 29-APR-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot number and expiration date were not reported). The patient was inadvertently administered a second dose of GARDASIL 9 (dose, route of administration, lot number and expiration date were not reported) on 16-MAY-2016. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
pt recvd vax 23MAR93 & reports swelling & redness @ site x 2 days on 29MAR93 & 30MAR93; also skin warm to touch; approx 2in round; instructed to take DPH;
ACHE OR PAIN; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (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 2021, the subject experienced ache or pain. On 2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The outcome of the fever and ache or pain was not reported. This report was non-serious.
HEADACHE; NAUSEA; FATIGUE; FEELING HOT; CHILLS; SORE ARM; MINOR COLD; This spontaneous report received from a consumer concerned a 2 decade old male. 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 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced minor cold. On APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced feeling hot. On 10-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling hot, and chills on 11-APR-2021, and minor cold on APR-2021, and had not recovered from headache, nausea, sore arm, and fatigue. This report was non-serious. This case, from the same reporter is linked to 20210420912.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 70 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), BREATH SOUNDS (non-serious), outcome "unknown" and all described as "squeaky noise I have coming from my body, sometimes from ears, lungs, or head"; NASOPHARYNGITIS (non-serious), HYPERSENSITIVITY (non-serious), outcome "unknown" and all described as "he has a cold or allergies right now".  Additional information: Caller was a 70 year old male consumer who stated that he has received the first two doses of the Pfizer COVID 19 vaccine - Comirnaty. He wanted to receive the third dose but he has been having a issue and does not know if it was related to the vaccine. He has spoken to his doctors office and tried to schedule an appointment for a check up but when telling them about his problem they suggested calling Pfizer to see if we had any information on this being a side effect from the vaccine before scheduling him an appointment. He stated that he has been experiencing a squeaking noise coming form inside his body. He states that it sounds like its coming from different places at different times. He describes that while he was sleeping it sounds like it was coming from his lungs and other times it comes from his head or his ears. He also stated that he has a cold or allergies right now. He declines to be transferred at this time. Response included Relayed to caller that upon searching through my data there was no information found on this being a side effects from the vaccine. Referred to speak with HCP. Patient was asking can he schedule his second dose. Response received included referred caller to speak with his vaccination site or HCP to schedule the appointment. This consumer reported in response to non HCP telephonic follow up activity which included telephonic conversation to consumer to obtain mailing information. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from the physician office manager concerning a healthy 17 year old female who on an unspecified date was vaccinated with Gardasil (lot number unknown). Concomitant therapy included DTAP-IPV (Sanofi Pasteur). On an unspecified date the patient was sitting and fell to the floor after receiving a dose of DTAP-IPV (Sanofi Pasteur) followed by a dose of Gardasil. The patient came to approximately a minute after she fainted. Medical attention was sought in the physician's office and "left the office smiling". Additional information has been requested.
16 year old female had both Covid booster (Pfizer Bivalent) and the flu shot administered in one sitting on Sun., Oct. 30th at approximately 12:30 pm. This was her fourth overall Pfizer Covid shot; she has never had any issues with the past three shots except for some soreness at the site of the injection. She also has had her flu shots and also did not have any adverse reactions. This time, she reported arm pain throughout the day, nothing more serious. In the evening at dinnertime, around 7 pm, she said her stomach didn't feel great and she ate very lightly. She continued with a series of tasks, including homework and doing laundry with no complaint. At around 11 pm, as she went to bed, she said she felt very tired and "was done for the day," She fell asleep and had no issues throughout the night. At 6:15 am, she awoke to get ready for school and said she felt groggy. That is not unusual- as a teenager, she wakes up sleepy a bit. About 20 minutes later, at around 6:35 am, as she's brushing her teeth and we are reviewing what is ahead , she said "I don't feel well." I went to touch her forehead, stepped one foot closer, and she went to embrace me.  I heard her mumble something into my shoulder, and when I lifted my head, I heard her say more clearly, "I feel like I'm going to pass out." She then went fully limp in my arms, her eyes rolled back into her head and she collapsed on the floor, her body weight leaning against me. She was unresponsive and fully unconscious for about 1 minute but she would not respond and her eyes alternated between closed and open without her responding. I yelled her name, shook her lightly applied pressure with my palms to either side of her face but she did not respond. As I held her up off the floor, I tried to reach the phone to call 911. After about 1 minute, she came to, still very dazed, completely unable to stand on her own and with no balance. She was confused, out of it, unaware of what was happening.  I helped her move to the couch where she has been resting. I have called her doctor and she said to keep an eye on her. This has only happened in the last two hours so not sure what the day will bring. She has NEVER had any adverse reactions to any vaccines or medicines before and has no chronic or ongoing health issues. She has never passe d out before.