chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had a little weakness; Very mild fever; This is a spontaneous report from a contactable consumer (Patient's daughter). This is report 3 of 4, caller reporting on her mother. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 22Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. No known allergies, medical history and concomitant medications were reported. The patient experienced had a little weakness and very mild fever after the first vaccine on an unspecified date. Caller stated her family all took the vaccine together, and some of her family had slight weakness. Caller confirmed herself, her father, her mother and her husband, took the vaccine together, on 22Apr2021. The patient was scheduled second vaccine 25 days after the first vaccine. Due to get second vaccine on 17May2021. The clinical outcome of the events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
she is COVID positive right now and had received Pfizer's COVID vaccines; she is COVID positive right now and had received Pfizer's COVID vaccines; This is a spontaneous report from a Pfizer-sponsored program via contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced COVID positive right now and had received Pfizer's COVID vaccines. On an unspecified date, the patient underwent lab tests and procedures which included COVID-19 test: positive. The events was medically significant. The outcome of the events was unknown.  DSU: AE discovered after call, thus, e-transmitted with limited demographics. Caller stated she is COVID positive right now and had received Pfizer's COVID vaccines but has not gotten her booster dose yet. PAXLOVID (ritonavir) was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101551011 Same patient, same drug, different event (split)
Hives that come and go. She reports the day after vaccine when her cloths touch or she scratches her face she develops welts
Approx. five minutes after series of three vaccinations, child was sitting in a chair and appeared to be bending over to pick up an item on the floor, which she had just dropped.  She slumped to the right and and fell into the table which she was sitting by and landed on the floor, hitting the right side of her on the way out of the chair on the table.   MOC and I were standing right beside her and she never fully lost consciousness.  She was able to respond and talk right away upon bending down to her.  She was cool, clammy and dazed with her gaze and slow to speak.  She did rouse and speak normally within 2-3 minutes.  No apparent injuries noted, other than the mark by the right eye, where she hit it.  Positioned child flat on back with feet elevated.  Cold washcloth applied to back of neck and forehead.  Kept child approx 30 minutes after incidence to make sure she was acting and responding appropriately for a normal 3 year old.  Did discuss s/s of concussion with MOC and appropriateness to seek medical attention.  Encouraged if any new developing issues to see  ASAP.  Called MOC on 7-26-2021 to provide follow up.  MOC reports that child seemed to not have any lasting effects from that day.  States that she did have some redness and puffiness to Left eye that afternoon of incidence, but felt that it was related to holding the cat, which she believes that child may have an allergy to.
heard a hissing sound on her left ear which then became a ringing sound; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 01Mar2021, outcome "unknown", described as "heard a hissing sound on her left ear which then became a ringing sound". The event "heard a hissing sound on her left ear which then became a ringing sound" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional information: Caller mentioned that she received her first dose of the vaccine on 27Feb2021 and about 2 days later heard a hissing sound on her left ear which then became a ringing sound. She has had tinnitus in her left ear since she got the first dose, and it has been ringing for 24 hours a day. She consulted with her primary which stated that there was nothing wrong and that her ears were clear. She then consulted with an ENT who again said that there was nothing wrong with her after examination. She was prescribed Prednisone for 5 days, but she held off on it because she received her 2nd dose last Saturday on 20Mar2021. The doctor told her to take it 24 hours later. She was asking if there have reports of tinnitus after getting vaccinated because her doctors cannot confirm that but she has read on articles that it may be plausible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported throat and mouth tingling approximately 10 minutes after vaccination. She identified herself to staff. She stated that she usually takes Benadryl when she has these symptoms. She had an elevated blood pressure at the time (BP= 180s/110s. She proceed to take 50mg Benadryl. Approximately 20 minute later,  she developed  coughing and continued tingling of her perioral area and that the tingling was extending to her nose and forehead. At which time, she said that she would use her Epipen at such a time. She self administered an Adult Epipen. Approximately 10 minutes, her symptoms improved. She continued to cough and have elevated BP. She was transported via EMS to the nearest ER in stable condition.
Shortness of breath for 5 days, dizziness when standing up for 5 days, and stabbing chest pain for 10 days.
pt recv vax 3MAY96 & on 27JAN97 pt devel a mild chicken pox rash described as disseminated 50-75 lesions;
A report was received from a health professional on 10/21/02, concerning a 69 year old female vaccinee who was administered expired Fluvirin vaccine on 10/21/02. The vaccinee did not experienced any adverse effects. The reporter has assessed the relationship of the vaccine to the event as unclassifiable. Update (1) 12/12/02: A follow up report was received from a health care professional. The vaccinee received Fluvirin subcutaneously on 10/21/02. The vaccinee received the 2002-2003 formulation of influenza vaccine (brand unspecified) on 11/15/02.
The site of injection is red and looks like a rash. It feels hot and before I noticed the rash I had trouble breathing.
No Adverse Event; Dose 1: 22-Apr-2023 and Dose 2: 16-Jun-2023; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 22-Apr-2023 and Dose 2: 16-Jun-2023) and NO ADVERSE EVENT (No Adverse Event) in an infant male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 17-Jun-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 10 microgram. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On 16-Jun-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 22-Apr-2023 and Dose 2: 16-Jun-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 22-Apr-2023 and Dose 2: 16-Jun-2023) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      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 assessments were provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 22-Apr-2023 and Dose 2: 16-Jun-2023).    Concomitant product use was not provided by the reporter.  The route of administration of suspect Moderna bivalent was reported as BI.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
03Jan96 Pt recv 1 dose vax. 03Feb98 Pt exp lesions over back & chest. 1 of the Pt's siblings exp chickenpox.
CDC reports: 15 mo child rec'd DTP/OPV/MMR on 19DEC89. 25DEC89 had temp of 102 x 2 days, then rash started. Rash was on face, neck, arms & body, duration of illness 4 days, child asymptomatic on 2JAN90.
Fever 99.6,  headache (similar to sinus headache) body aches, chills all day, next day headache remains took Tylenol
No adverse effects reported; patient missed the following second dose. No additional doses administered; patient missed the following second dose. No additional doses administered; This spontaneous report as received from a pharmacist refers to a 13 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.    In May 2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL) for prophylaxis.         On 12-AUG-2019, the patient missed the following second dose and no additional doses were administered neither adverse effects were reported.
Patient developed palpitations and went into Atrial Fibrillation with RVR requiring medications and later cardioversion. This also led to a drop in his kidney function.
MMR given 05/24/05. Onset erythema multiforme 06/03/05.
Itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 29L29 and 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History reported).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced PRURITUS (Itchy). On 05-Apr-2021, PRURITUS (Itchy) had resolved.            This case was linked to US-MODERNATX, INC.-MOD-2021-067209 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067209:1st dose
Tired, congestion fever. Took paxlovid, improved quickly. I was not that sick, but had a vacation trip scheduled, would have lost a lot of money if I cancelled. So" wanted to get welk quickly.
Information has been received from a registered nurse concerning a 51 year old female patient who on 09/21/01 was vaccinated SC in the left arm with the first dose of MMRII. On 10/01/01, the patient developed a diffuse,fine, pinpoint,red rash. Unspecified medical attention was sought. FOLLOW-UP information from a registered  nurse reported that per phone conversation with the patient, she described the rash as fine, pinpoint and located all over the body. When she was seen in the clinic "later the same day", the rash was not as it was described by the patient but rather clusters of 3-4 papules (mosquito bite size) all over her body. The patient also complained of intense itching. The patient recovered approximately 2 weeks later. No further information is available.
Legs felt as if they were 200lbs, was unable to walk, burning eyes, faint feeling, severe headache.
Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures; Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures; There were also 10 underage recipients.; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) in a 15-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 16-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that reporter discovered this in April 2022.  Storage condition at the time of the excursion was Refrigerated. Excursion duration: Unknown (12Jan2021- 22Apr2022). No treatment medications were reported.
This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 6-month-old patient who received KINRIX (batch number 99A7M, expiry date 3rd September 2016). On an unknown date, the patient received KINRIX .5 ml. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.
Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient came in 3 days after vaccination complaining of numbness in left thumb and index finger. She is still able to ambulate all her fingers. Patient stated that she is going to follow up with her Dr if numbness does not improve but wanted to bring situation to our attention.
Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. On unspecified dates, the patients were administered an unspecified number of improperly stored doses of RECOMBIVAX HB (Lot# J005078, expiration date: 20-SEP-2015 and lot# J006511, expiration date: 28-JAN-2016, route, strength and dose were unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Intense ringing in ears(tinnitus), unable to sleep-nightmarish flash images during rest- first 2 nights,  joints swollen and aching (over 1 week),  onset of seasonal allergies for 1st time( sneezing 20x row,  sinus pressure-over 1 week).
mom recv vax w/child in utero;child was born w/severe eye problems & md were attempting to figure out exactly what was wrong;it was reported that the MD who gave shot stated nothing to worry about;another MD counseled on getting an abortion
Swelling, redness at injection site that was prolonged in nature for 3 days past the injection. Was treated at clinic. Limited documentation from health care provider. Did not indicate which provider seen.
Mild cellulitis (R) arm low grade fever. Tx with cephalexin and BACTRIM.
Reaction induration: 45x40cm. Mother noticed induration on right deltoid 4 days after shot given 6/7/04. Noticed 6/10/04.
alopecia-pt had moderate loss of hair starting 1-2wk following 2nd vax;lost approx 1/2 of hair on head;
The evening after vaccine complained of nausea, sore arm at injection site. The next day about 22 hours after vaccine came home from school with 102 F fever. Fever persisted for 48 hours then resolved.
Yesterday the patient tested positive using a rapid/"instant" test for COVID-19 as well as again today using an "instant" test resulting as positive.; Yesterday the patient tested positive using a rapid/"instant" test for COVID-19 as well as again today using an "instant" test resulting as positive.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer(patient) reported that a 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH covid-19 vaccine, formulation: solution for injection) via an unspecified route of administration (batch number/lot number: FC3182), in left arm on 30Aug2021 12:00 PM (at the age of 69-years-old) as dose 3, single, via an unspecified route of administration (batch number/lot number: EL9262), in left arm on 02Feb2021 12:00 PM (at the age of 68-years-old) as dose 2, single and via an unspecified route of administration (batch number/lot number: EH9859), in left arm on 12Jan2021 12:00 PM (at the age of 68-years-old) as dose 1, single and all for covid-19 immunization . Medical history included ongoing high cholesterol from ten years. Ongoing concomitant medication included rosuvastatin for high cholesterol from ten years. The patient received his 1st dose of the Pfizer COVID vaccine on 12Jan2021, 2nd dose 02Feb2021, & 3rd dose received on 30Aug2021. On 15Sep2021 the patient tested positive using a rapid/"instant" test for COVID-19 as well as again on 16Sep2021 using an "instant" test resulting as positive. The patient was waiting on the PCR testing results. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Sep2021 and sars-cov-2 test: positive on 16Sep2021. The outcome of the events was unknown.
FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 11-MAR-2021 13:00 in right deltoid for prophylactic vaccination. The batch Number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 102-103 Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Nodular rash red indurated 1 1/2 inch round red mildly tender area  1/2 inch above injections ; injection site.
June 15 and 16 weakness, unsteadiness - June 17 weakness, falling, fever, fast heartbeat, confusion - June 18 same as above and difficulty breathing (on June 18 20:00 AM put in ICU in critical condition).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 18-OCT-2013, the patient was inoculated with ZOSTAVAX at Pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 05-DEC-2014, the patient was treated a physician office for the onset of Rash, which was diagnosed as herpes zoster. She was prescribed Val Acyclovir and VICODIN (acetaminophen, hydrocodone bitartrate) for management of her painful symptoms and excruciating pain. As a direct and proximate result of the defective zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Information has been received from a certified medical assistant concerning a 66 year old male patient who in February 2009 was vaccinated with his first dose of PNEUMOVAX 23. On 08-Sep-2009 was vaccinated with a second dose of PNEUMOVAX. A few hours later he developed localized redness and swelling at the injection site. It is unknown which arm was involved. On 10-SEP-2009, the patient sought medical attention by a phone call. No treatment was recommended. No lab diagnostic studies were performed. Follow up information was received on 11-SEP-2009 from a pharmacy intern, reporting that the patient was recovering and also reported that the patient experienced fever and extreme tiredness along with the injection site reaction. According to the pharmacy intern, the patient was "getting better" but was not yet recovered. This is one of several reports received from the same source. Additional information has been requested.