chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; body aches; This is a spontaneous report from a contactable consumer.  An adult female patient received second BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number not reported, via an unspecified route of administration from an unspecified date to an unspecified date at SINGLE DOSE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. On 13Jan2021, after receiving 2nd injection of COVID vaccine, the patient had a fever for 24 hours and body aches. The outcome of the event fever was recovered on 14Jan2021; while body aches was unknown. The patient is not pregnant at the time of vaccination. No treatment was received for the events.  Information on the lot/batch number has been requested.
headache, fever, eyes pain, chills, tiredness, muscle pain, pain in the injection site, swollen lymph node behind my left ear and necknone
Less than 24 hours of receiving the vaccine I started to experience my jaw locking. Later in the day it began to get worst. I could not blink my left eye and my face started to drop. I went to the ER and they stated that due to vaccine I have Bells Palsy. I was given medication. It is now 4 days in and the symptoms are getting worst. My left eye is now dry due to can  not blink. I have serve headaches behind my left eye. I can not eat or chew without having issues.
Moderna COVID-19 bivalent administered to patient instead of 1st primary dose of Moderna; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna COVID-19 bivalent administered to patient instead of 1st primary dose of Moderna) and NO ADVERSE EVENT (No Adverse Event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna COVID-19 bivalent administered to patient instead of 1st primary dose of Moderna) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna COVID-19 bivalent administered to patient instead of 1st primary dose of Moderna) 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 (Moderna COVID-19 bivalent administered to patient instead of 1st primary dose of Moderna).    No concomitant medications were reported.  No treatment information was provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 01Mar2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Negative, notes: Rebound of COVID 4 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Large, red, swollen, inflamed area around injection site approximately 4" x 2"
Patient called our onsite registered nurse on 18MAR21 to report an itchy, red raised rash at the injection site (left deltoid).  Patient also reports a headache.  Patient was advised to take Benadryl and Ibuprofen and will follow-up with onsite nurse as needed.
overdose; This case was reported by a other health professional via interactive digital media (Shingrix chatbot) and described the occurrence of accidental overdose in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient inadvertently received 2 doses of Shingrix, which led to accidental overdose.
SHINGLES - Woke early morning with pain in back; rash observed following day and confirmed by doctor; dr prescribed Valacyclovir; pain was non-relenting, day and nite; dr prescribed Gabapentin three times daily; pain did subside; dr increased Gabapentin to maximum dosage.  Shingles is ongoing.
Patient reported hot, red, swollen area where there was injection, no fever and was using a hot pack - advised cold pack and again on 11/3 to also include Benadryl.
Information has been received from a health professional concerning a 67 yr old male who on 04Oct05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot650453/0791P). On 05Oct05 the pt returned to the office complaining of significant tenderness of the right deltoid and swelling of the right shoulder. Cool compresses and acetaminophen (Tylenol) were ordered. There was no product quality complaint involved. The pts significant tenderness and swelling were considered to be other important medical events by the reporter (OMIC). Additional information has been requested.
A combination vaccine was given (Proquad) and so was a single dose of Varicella. Child received 2 doses of Varicella on day of vaccination.
Information has been received from a nurse and a practice manager concerning a 72 year old female who on an unspecified date was inadvertently vaccinated with VARIVAX (Merck) (lot number not provided) instead of ZOSTAVAX (Merck). No adverse event was reported. It was unknown if the patient sought medical attention. Follow-up information received from the nurse stated that this was a case of the wrong product was grabbed by mistake. The nurse explained that they do not usually have VARIVAX (Merck), and the nurse grabbed it by mistake. It was not a case of product confusion. This is one of the several reports received from the same source. Additional information is not expected.
Patients lip swelled and I told her to take benadryl.  If her condition did not improve, to go to the emergency room.
On 11/17/2021 I started getting an itchy throat. I felt like a cold was coming on. I had a lot of mucus build up and fatigue. It continued for a week before I went urgent care for the first time. Over the course of a month I would go to urgent and my doctor and they would prescribe me antibiotics and prednisone. I would get better for 7-14 days and then the symptoms would come back. Since November I had 3 urgent care, 1 emergency room, and 2 doctor visits. Then I was sent to a pulmonologist and was provided another antibiotic that as of today, after two weeks from finishing antibiotic seems to have killed the bacteria that was causing the issues.
ADACEL (TDAP) administered 2/9/2011. Patient c/o (L) arm (local) redness, pain and swelling on 2/12/11, with triage nurse. Used TYLENOL, heat for 3-4 days. Seen 2/14/11 for office visit. Area where injection given felt hard, warm to touch, area of inflammation 8.5 cm. Much improvement with Ibuprofen and ice also to area.
This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (Lot # not reported) dose, frequency and route not reported). No other co suspects were reported. No concomitant therapy was reported. On an unknown date the patient's experienced mild, zoster type rashes. The outcome of experienced mild, zoster type rashes was unknown. Additional information has been requested.
24 hours after administration of DTaP c/o right arm erythema and swelling at the site of vaccine's application.
shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 75-year-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2010, he was administered zoster vaccine live (ZOSTAVAX) by a pharmacist. On an unknown date, he was treated by physician for the following injuries resulting from patient's zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
invalid dose - administered to a patient under 18 years of age; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (invalid dose - administered to a patient under 18 years of age) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (invalid dose - administered to a patient under 18 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (invalid dose - administered to a patient under 18 years of age) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that The COVID-19 volunteers made a mistake on reading the date of birth for the consumer No concomitant medication reported.  No treatment medication reported
Mother states that child had a seizure and temperature of 103F on 10/17/01. The child was taken to the hospital and then transferred to a medical center .
This case was reported by a healthcare professional via a sales representative and described the occurrence of cellulitis in a subject of unspecified age and gender who was vaccinated with Infanrix, GlaxoSmithKline. On an unspecified date the subject received 5th dose of Infanrix (unknown). At an unspecified time after vaccination with Infanrix, on or before 30 August 2006, the subject experienced cellulitis from the shoulder to the elbow. The nurse was trying to determine if there is an issue with the lot or if the injections were given subcutaneously rather than intramuscularly. This case was assessed as medically serious by GSK. The subject was treated with antibiotics (Antibiotic). At the time of reporting the events were resolved.
Patient received Tdap on 6/26/07. On 6/27/07, patient noted right arm swelling, erythema, pruritus and mild warmth in right deltoid area at site of injection. No fever or pain reported. Swelling with erythema 7 cm x 8 cm in site.
Pt passed and approximately 15-30 sec after injection.  Was assisted to prone position.  No respiratory effort for approximately 30 seconds.  Color remained pink.  Pulse present , Chin - lift position to open airways and pt regained consciousness.  Monitored x 30 min.   Parents came to take pt home.  Incontinent of urine during syncope episode.
Subsequent to receiving vax, the pt developed a 4 X 8 cm wheal. She recovered.
headache; muscle aches; chills; feel nauseous; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (formulation: solution for injection), dose 2 via an unspecified route of administration on 09Feb2021 (NDC number, Lot number and expiry date was not reported) as dose 2, single for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient historical vaccine includes first dose bnt162b2 for covid-19 immunisation. The patient got her second COVID Vaccine Yesterday (unknown date). Last night and this morning she started to experience headache, muscle aches, chills, feel nauseous on an unknown date. Stated she can breathe and all but, she had side effects. She wanted to know if she can take Tylenol. When informed patient would have to transfer to Medical Information to potentially address her question, she got very upset. Stated she had waited for an hour and just wants her question answered. She declined to continue with safety report. She stated she just wanted to know if it was okay to take Tylenol after the second dose. She wanted to know if Tylenol will diminish the effectiveness of the vaccine. The outcome of the events was not recovered.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
1 week after injection, lump, redness at injection site. Cool compress, TYLENOL. Call if sx. change/worse.
After 5 minutes, she started shaking, hands for about 3 seconds, she became pallor, with dizziness. Blood pressure 90/52 with pulse of 60. After 20 minutes, she felt better and was able to leave with both parents present.
pt recv vax & started crying & screaming-it lasted for 1-1 1/2hr;unconsolable;had temp but not taken;appt w/MD for later & started vomiting;had diarrhea today 22JAN97 & unable to keep formula in;pt to have DT instead of DTP next time;
screaming almost constantly for 48hrs p/immun; t103 unresponsive to APAP x 48 hrs;
Swollen face, tingling lips, burning throat, stiff neck, headache, dizziness, nausea, fatigue and burning urination when first came home which only burned that one time.  Took Tylenol and by the next morning all the symptoms were gone except for some swelling still in my face and a headache.  Took another Tylenol and all symptoms were gone by noon.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 22Apr2022 as dose 4 (bosster), single (Lot number: FP4554) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; METFORMIN; TRAZODONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid (Lot number: GE8686) from 20Aug2022 to 25Aug2022. Patient took other medication in two weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt reported rash which developed after the first dose of covid but this improved over the days with otc hydrocortisone.  She then took the second dose and the rash recurred but this time did not resolve despite hydrocortisone.  No other symptoms.  No other new meds.
adult patient received a pediatric dose.; adult patient received a pediatric dose.; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 53-year-old female patient who received HBV (Engerix B pediatric) (batch number FB9RH, expiry date 21st January 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st October 2022, the patient received the 3rd dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 31st October 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 1-Nov-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. Additional supportive information: The patient received a pediatric Engerix B dose, which led to underdose and adult use of child product.
Had fever, chills, body aches and shortness of breath from 5am the next day (11/03) through 11/10.
dose was not reconstituted with the lyophilized powder; administered the liquid diluent portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 92F7F, expiry date 9th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 28th July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 28th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Jul-2022 Reporter's comment: The nurse reported that a patient was administered the liquid diluent portion of Rotarix on the day of reporting. The dose was not reconstituted with the lyophilized powder. At the time of reporting, the dose had not been repeated. The reporter consented to follow-up. This case is for 2 of 2 patients. Additional supportive information: The patient was administered the liquid diluent portion of Rotarix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022112352:same reporter, other patient
Contracted COVID; Contracted COVID; This is spontaneous report from a contactable consume (patient son). An 84-year-old female patient (mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization, the first dose was on an unspecified date, the second dose was on 26Mar2021. Medical history and concomitant medication were not reported. Patient recently had her second vaccine for COVID. She had no side effects and was in good spirits. In late April, she was hospitalized, discharged on 26Apr2021, reason for hospitalization was unspecified. Currently she was in Hospice care and contracted COVID. The outcome of events was unknown.  The information on the lot/batch number has been requested.
Diarrhea, chills, myalgias, malaise; Tmax 99.8. Diarrhea about twice/day.
My mother received her vaccine at 12:40 on 2/2. She waited longer than the fifteen minutes and she seemed fine. We left the facility and on the way home, approximately 45 after she received the vaccine, she began slurring her words ands was confused. The slurring lasted for 2-3 minutes The confusion continued. I brought her the ER where she was immediately taken in for  a CT Scan. She later had an MRI, and met with a Cardiologist. She later had an EEG at the request of a Neurologist. She spent three nights in the hospital.  All tests showed no acute signs of stroke, etc.
her feet get swollen; her feet get swollen and hot, a little bit painful, sometimes it goes up her legs; they're kind of itchy and red; they're kind of itchy and red; feet get swollen and hot; a rash on her arm for a week; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING (her feet get swollen), PAIN IN EXTREMITY (her feet get swollen and hot, a little bit painful, sometimes it goes up her legs), PRURITUS (they're kind of itchy and red), ERYTHEMA (they're kind of itchy and red) and FEELING HOT (feet get swollen and hot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and LISINOPRIL for an unknown indication.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced RASH (a rash on her arm for a week). On an unknown date, the patient experienced SWELLING (her feet get swollen), PAIN IN EXTREMITY (her feet get swollen and hot, a little bit painful, sometimes it goes up her legs), PRURITUS (they're kind of itchy and red), ERYTHEMA (they're kind of itchy and red) and FEELING HOT (feet get swollen and hot). On 10-Mar-2021, RASH (a rash on her arm for a week) had resolved. At the time of the report, SWELLING (her feet get swollen), PAIN IN EXTREMITY (her feet get swollen and hot, a little bit painful, sometimes it goes up her legs), PRURITUS (they're kind of itchy and red), ERYTHEMA (they're kind of itchy and red) and FEELING HOT (feet get swollen and hot) outcome was unknown.            The patient had to keep them out of covers at night, they wake her up in the night and she has to be in the cold tile. The patient did not receive any treatment medications.
This spontaneous report was received from a registered nurse refers to a child patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PEDVAXHIB (dose, units, frequency and route not reported) (lot# and expiration date not reported). Reporter stated that, on an unknown date, dose of PEDVAXHIB was administered too soon to an unspecified child. No adverse effects were reported. No product quality complaint was involved.
Small lump developed under the skin immediately following injection, feels very hard like pebble and itches. Continues to itch and cause pain as of this reporting date. Same reaction as the last injection. This one in the left or right hip. Doctor states it could be ARTHUS reaction.