chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned multiple patients. 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: 1805031, and expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced administration of expired vaccine. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Info has been received from a physician concerning a 5 year old female with no allergies or medical conditions who in 2000, at 12 months of age, was vaccinated SC with a 1st dose of 0.5ml of varicella virus vaccine live. There was no illness at the time of vaccination. On 7/1/05, the pt presented with a rash which the reporter dx'd as a mild case of breakthrough. The pt was not febrile. A product quality complaint was not involved. Follow-up info was received from the physician who reported that on 6/24/05, the pt had a rash consistent with atypical varicella post/vax. Subsequently, the pt recovered. No diagnostic lab tests were performed. It was noted that neither the pt nor her sibling had any adverse events following prior vaccination. No further info is expected.
The first 3 days i had intermittent body aches, chills, and headaches.  I started developing sores under tongue, looked to be Plica Fimbriata- tongue tags, on day 4 after vaccine 2.  Called Primary care and sent photo on March 11th, 2021.   Could not get an appt to be seen until March 19th... until then i took L-Lysine - HCL, 600 mg amino acid  pills, which a neighbor recommended. Symptoms disappeared by day 13 after vaccine, when i had an appt with an otolaryngologist at Medical Center.  He saw no signs of any problems then.    i have stopped taking the amino acid now, but occassionally my tongue gets sore and i resume.  no long term condition at this time.
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer concerning an approximately 69 year old female patient There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2010, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a clinic. In 2016, the patient was treated by a physician at a clinic for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
1/8 vaccination HA went away after a week bleeding in between vaccinations ultra sounds weekly, blood work 1st went to ER, 2nd bleeding episode went to PCM for same day visit 2/2 miscarriage, D&C
reaction started 6AUG98 pt got a fever of 100 & was given APAP;mom noticed a large red knot the size of a nickel;the knot is red & hot to touch;
Initial report was received 20 August 2009 from a health care professional, who is also the patient's parent. A 17-year-old female patient with no concurrent illness and no pre-existing medical conditions had received a first dose intramuscular injection of MENACTRA (lot number unknown) on 18 August 2009, and one day later, she experienced a frontal and temporal headache with numbness of the forehead, upper palate and upper dental area, a dry cough and an axillary temperature of 100 degrees. MOTRIN and TYLENOL were administered every six hours as corrective treatment. The patient was scheduled for a physical evaluation on 20 August 2009 and per the reporter, laboratory testing (CBS and sed rate) was to be performed. The patient's recovery status was not reported. Document held by sender: None
Low grade fever (up to 99.9 degrees) & headache for approx 24 hours the day after vaccination
Patient received Covid -19 6m-4y 2023-2024 formulation that was diluted with 2.2ml instead of 1.1 ml.
Immediately, post vax, area felt painful. Very painful on 11/4/00 and 11/5/00. Continued to hurt. No redness or swelling visible but tender to touch. Difficulty lifting or reaching with left arm. Still painful today, 12/11/00 and was referred to MD.
A report has been received from a health professional concerning a 5 year old male patient. The patients concurrent disease(s) included PDD spectrum disorder, reactive airway disease and candidal skin rash. Concomitant medications included nystatin for rash. The patient had been received FLUMIST quadrivalent (intranasal) started on 27-Sep-2013. The patient was positive for flu type B and positive for RSV which started on 03-Oct-2013. The patient also had congestion. Patient presented with cough, nasal congestion, and fever of 100.3 on 01-Oct-2013. Diagnosed with fever and acute bronchitis. Patient presents with cough and wheezing on 04-Oct-2013. Diagnosed with acute bronchitis vs atypical pneumonia and purulent rhinitis. Patient presents with vomiting and loose stools on 09-Oct-2013. Diagnosed with vomiting and question of immunocompromised. Action taken with FLUMIST quadrivalent was not applicable. The outcome of the event of positive for flu type B, positive for RSV, cough, congestion, loose stools, nasal congestion and question of immunocompromised was unknown, at the time of reporting, the event of fever, acute bronchitis, wheezing, atypical pneumonia and purulent rhinitis was ongoing and the patient recovered from the event of vomiting on 11-Oct-2013. The reporter considered all the events to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 29-Oct-2013 from health professional: Added new events of acute bronchitis and wheezing and atypical pneumonia and purulent rhinitis and vomiting and loose stools and nasal congestion and question of immunocompromised. Added indication and concomitant medications. Added relevant history and lab details. Reporters detail updated.
Fever; Coughing; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Consumer stated, "I got my COVID shot and I got fever for four days." "I've got fever for four days and coughing, yes. I am not saying it, I am feeling it." The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
metallic taste in mouth; metallic taste in mouth; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EK4176), via an unspecified route of administration on 19Jan2021 at single dose at right arm for covid-19 immunization. Medical history included T1DM (Type I diabetes mellitus) from 1974, AVR (aortic valve replacement) from 1990 (AVR 1990 and 1992). No known allergies. Concomitant medications included insulin, simvastatin, lisinopril. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Patient previously received first dose of bnt162b2 (lot number= EK5730) via an unspecified route of administration on 29Dec2020 11:00 AM at single dose at right arm for covid-19 immunization, and had metallic taste in mouth on 31Dec2020 for 3 days, chronic nausea began 07Jan2021, vomiting was explosive and unpredictable, and still occurring, splitting headaches. The patient experienced metallic taste in mouth on 19Jan (pending clarification) with outcome of not recovered. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient didn't receive any treatment.
pt recv vax 27SEP96 & 1OCT96 pt dx w/erythema mult;ER or MD visit was required;erythema mult resolved spontaneously on 3OCT96 shortly p/bottle feedings were bugun;
Arm hurt when getting shot and still hurts 2 weeks later when put on jacket, etc.
Patient asked to wait in lobby for at least 15 minutes due to previous reaction with needlestick (TB skin test, ear piercings). Just before 15 minutes up, pt told her friend she was filling dizzy, nauseous, lightheaded. By time RPH came out from behind the counter, pt had very briefly passed out (back in about 1 minute), was alert, talking, asking questions.  Her pulse started to decrease and the clamminess in her hands started to dissipate. 911 was contacted, patient decline ambulance to the hospital for further evaluation. After medics left patient waited for about 15 more minutes before leaving with her friend
DRY HEAT; NAUSEA; SORE ARM AT UPPER ARM AT SITE OF ADMINISTRATION; This spontaneous report received from a patient concerned a non patient of unspecified age and sex. 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: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination on Left Deltoid .No concomitant medications were reported. On 08-MAR-2021, the patient experienced sore arm at upper arm at site of administration. On 10-MAR-2021 02:00, the patient experienced dry heat, and nausea. Patient visited emergency room for severe nausea and dry heat which went on for 8-10 hours and ended up going to ER. In the ER patient received anti nausea medication and IV fluids.  Patient stated that they had no fever. Patient went to hospital around noon time and it was resolved soon after receiving fluids and medication in hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from dry heat, and nausea on 10-MAR-2021, and sore arm at upper arm at site of administration on MAR-2021. The reporter causality with covid-19 vaccine  ad26.cov2.s was related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210333680 - COVID-19 VACCINE Ad26.COV2.S -   Dry Heat . This event is considered un-assessable. The event has a compatible/suggestive temporal relationship, is un-labelled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. V0: 20210333680 - COVID-19 VACCINE Ad26.COV2.S -Nausea . This event is labelled and is therefore considered potentially related.
Rash and intense itching on arms and legs.    Persisting for over 3 weeks now Benedryl and cortizone 10 cream are needed to reduce the intensity.
Swollen leg, she wasn't able to walk for two days due to pain. The third day her leg was red an the bump started going away. She was fussy, you could tell she was not feeling well. It seemed to improve after five days.
Neurological issues, migraines, fatigue, muscle twitching, numbness and tingling in limbs, vertigo, muscle weakness, nausea, Gi issues, heart palpitations, shaking limbs, hot flashes, tinnitus, head pressure, ear pressure. Throat tightness, muscle tightness in neck back and shoulders. Muscle spasms throughout body,  dry eyes, lightheadedness, brain fog, anxiety, insomnia. Seeing auras, light sensitivity, constipation, stomach cramping, nerve pain, joint pain.
Chills, Headache, arm soreness at injection site and sleeplessness at 12 hour mark, single episode of loose bowels at 24 hour mark, general malaise  at 12-24 hours post injection
I began to experience vertigo symptoms and muscle tightness in my left forearm. I visited my primary care physician and they confirmed that I have vertigo symptoms. My left forearm tightness and soreness was not discussed during my physician visit because I was unaware of reporting potential adverse events related to the vaccine.
No adverse event; 5 patients were administered an expired vaccine on 12 JUNE 2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients were administered an expired vaccine on 12 JUNE 2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients were administered an expired vaccine on 12 JUNE 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 patients were administered an expired vaccine on 12 JUNE 2023) 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 EXPIRED PRODUCT ADMINISTERED (5 patients were administered an expired vaccine on 12 JUNE 2023).    This case contain information of 4th patient out of 5th reported by reporter. Concomitant Medication use information was not provided by reporter. A day ago, checking on the viability of a vaccine that was expired. Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728837 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728837:Master case patient no. 01
Chills with moderate sweats, that increase after 6 hrs and lasted  for 24+ hrs.  Moderate abdominal pain, starting after 24 hrs and lasting for 14+ hrs, with cramping, diarrhea, nausea.  Full body soreness, with weakness, dizziness, and fatigue.
A 45 year old female patient, born on 3/27/1960, received a RabAvert pre exposure series 1 ml, IM in 2005. First dose was given in Sept 2005 and last dose was given on 10/4/2005. On 10/11/2005 the patient experienced numbness on right side of face and right side of body, She was treated with steroids and developed steroid psychosis. She was hospitalised. At the time of hospitalisation she began having seizures. One MRI showed an abnormal lesion in the brain. A follow up MRI was normal. An EEG was normal as well. She was diagnosed with pseudo seizures. The symptoms were persisting at time of report (2/16/2005). Seriousness criterion hospitalisation. Causality not related.
Pericarditis; This is a spontaneous report received from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982) via unspecified route of administration in left arm on 02Feb2021 01:00 PM as 2nd dose, single dose for COVID-19 immunization. The most recent COVID-19 vaccine was administered at hospital (facility type). The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior vaccination. The patient's concomitant medications received within two weeks of vaccination included simvastatin and telmisartan both from unspecified date. The patient previously took levofloxacin (LEVAQUIN) and it was reported as known allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via unspecified route of administration in left arm on 12Jan2021 12:00 PM (at the age of 73-year-old) for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On unspecified date in Mar2021 the patient experienced pericarditis treated with unspecified medication and resulted in doctor or other healthcare professional office/clinic visit. The had patient been tested for COVID-19 on unspecified date in May2021 with nasal swab test and a negative result was reported. The outcome of the event was not resolved.
pt recvd vax; had bumpy "rash on face & trunk,irritable;to er;20dec rash worse,on legs,arms & ears;;T nl;taken to MD & dx as side effect to MMR; 6jan95 PC to pt, recovered;
feel something wrong with my fluids retentions; leg gets swallow in the morning and keep going during the day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 (Lot number: 30135BA) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gastritis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3184, Location of injection: Arm Left), administration date: 07Sep2021, when the patient was 34 years old, for COVID-19 immunization; Mmr (Dose-2, Lot Number: T013003, Anatomical location: LD), administration date: 26Aug2021, when the patient was 34 years old. The following information was reported: FLUID RETENTION (non-serious) with onset Oct2021, outcome "not recovered", described as "feel something wrong with my fluids retentions"; PERIPHERAL SWELLING (non-serious) with onset Oct2021, outcome "not recovered", described as "leg gets swallow in the morning and keep going during the day". The events "feel something wrong with my fluids retentions" and "leg gets swallow in the morning and keep going during the day" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of fluid retention, peripheral swelling.  Additional information: Patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID since the vaccination. Patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.
Information was received from a physician on 07-SEP-2010 concerning a 69 year old male patient. The patient's medical history included hypertension, hypercholesterolemia and an unspecified psychiatric disorder. Concomitant medications included unspecified medications for hypertension, hypercholesterolemia and the psychiatric disorder. On 01-SEP-2010, the patient received a flu vaccine (manufacturer unspecified) and 0.5ml PNEUMOVAX 23 (batch number: 1339Y) via intramuscular injection. Both vaccines were given in the left arm. On 02-SEP-2010, a day after receiving the suspect drugs, the patient developed cellulitis of the left arm at the injection site and extending to the patient's elbow. The patient was admitted to hospital and was treated with intravenous antibiotics. Laboratory diagnostic studies performed revealed a white blood cell count of 19000. Blood cultures, unspecified CT (Computed Tomography) scan and xrays were negative. The patient's outcome was recovering at the time of reporting. No further information is available at this time. This case was originally reported to Merck & Co., Inc. (case # 1009USA00781). The case was reported as serious due to hospitalisation and significant disability or incapacity. No causality assessment was reported. The company considered events possibly related to the suspect drugs; flu vaccine and PNEUMOVAX 23. Information derived from this AE report does not change the current safety profile of the product.
My left ear lobe is swelling.  Woke up with it.  Took Allegra and it's held steady so far. This happened on my Dose # 1 as well, except it got out of hand and both ears swelled.  Dose No. 1 was 00ZC21A (cannot tell if Z or 2 as written on card) given on 5/5/2021.  I also had mysterious swellings in my eyelids, nose area, and face (but not moon shaped).  I also got a four inch rash 7 days after the first dose that took several days to disappear.  Went to urgent care a week before dose two was due, doctor said my ear drum was swollen but no evidence of infection.  Got a primary care physician to get checked out.  She noted I was inflamed looking in my mouth/throat.  We did blood tests.  She suggested Flonase and Allegra and referred me to Allergists for the face swellings.  I went and the idea so far was contact dermatitis; they didn't think it the vaccine and it's okay to get dose two.  Which I did, last Monday morning.  However, this newest swelling seems very unlikely to be contact dermatitis because I haven't used any products, purposely trying to avoid what happened last time.  However the date range is one day faster than last time-- where four days later my ear swelled; today is three days and wah la-  Swelling again.  If I'm on track like last time (Dose 1) I will get a four inch (I hope no larger) rash at day 7 at the site of the injection.
"COVID Arm".  Red-ish, swollen area around shot location on arm. Approximately 3" x 2" in size. Slightly blotchy pink color. Slightly itchy but not much. Taught to the touch. Occurred 9 days after shot.   Currently still persists after 24 hours since onset.
Swollen tongue, lips; Swollen tongue, lips; Swallowing, choking feeling in throat; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 74-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265), via an unspecified route of administration (at the age of 74-years), administered in arm right on 02Feb2021 11:00 as dose 1, single for COVID-19 immunization. Medical history included thyroid removed and known allergies numerous from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken as 125mcg tablet for an unspecified indication, start and stop date were not reported. The patient did not have covid prior vaccination and had not been tested for covid post vaccination. The patient did not receive and any other vaccine in four weeks. On 02Feb2021 at 11:15, the patient experienced swollen tongue, lips and swallowing, choking feeling in throat. The treatment was not received for the event. The facility type of vaccine was reported as other. The clinical outcome of the event swollen tongue, lips and swallowing, choking feeling in throat was reported as recovered in 2021.  Follow-up attempts completed. No further information expected.