chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No further AE; vaccine given during an excursion; This spontaneous report was received from an other health professional referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.    On 17-AUG-2023, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # W038815, expiration date was not reported, but upon internal validation established as 04-JUN-2024; strength, dose and route were not reported; one time) was given during an excursion to the patient for prophylaxis (product storage error).
Tuesday: headache and sore arm came around evening time then at night a fever of 102 kicked in. Wednesday: 102-101 fever took only ibuprofen Thursday: called doctor fever 99-101. Tyenelol and antibiotics and immune boosters  Friday: doctor oncall told me to continue meds and she will call me back on Saturday. Fever still 99-101 range.
Patient felt dizzy and fell down on the floor after receiving the vaccine about 5 minutes. Pt has needle phobia. He vomited a little bit after that.
Red bumpy rash developed on legs, fever of 101, rash continued to spread through next few days, even in mouth, fussy, irritable.
Employee states she felt bad two hours after receiving the vaccine. She has had trouble breathing and her body hurts but mainly her chest.
First dose Moderna given 1/3/2021 @ 1700 hrs. Developed acute headache with N/V ~ 12 hrs later prompting ED  E&M.  Since no past h/o headaches, imaging completed (mucous retention cyst of maxillary sinus) - labs & ECG unremarkable. Treated with IV fl,uids,
Very bad fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very bad fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Very bad fatigue). At the time of the report, FATIGUE (Very bad fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-036812, MOD-2021-036813, MOD-2021-036814 (E2B Linked Report).; Sender's Comments:  MOD-2021-036813:MOD21-046450:Same reporter,  Reporter's husband MOD-2021-036814:MOD21-046583:Same reporter, diferent patients MOD-2021-036812:MOD21-046584:Same reporter, invalid case
Information has been received from a physician assistant via company representative referring to a male patient in his "sixties". The patient's medical history and drug reaction/allergies were not reported. ON an unknown date of several years ago the patient was vaccinated with a dose of ZOSTAVAX (dose, strength and route unknown). Concomitant medication was not reported. Several years after the patient came down with a mild case of the shingles. The outcome of the event was recovered. Additional information is not expected as the reporter did not wish further contact.
Patient called stating he had a very severe reaction after receiving his flu vaccine.  He experienced flu like symptoms, lost control of bowels and bladder and was extremely dizzy.  He fell to the floor, needed help getting up. This was a Friday and had these symptoms until Sunday.  By Sunday, he had control of his bowels and bladder but still felt bad.  He called us Monday and states he is almost back to normal.
got COVID after all the jabs; got COVID after all the jabs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "got COVID after all the jabs". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Site: Pain at Injection Site-Medium, Systemic: numbness of left side of face.-Medium, Additional Details: The patient has a tumor that already affects the nerves on the left side of her face. After getting the shot the numbness have noticeably increased causing some droopiness. It has not resolved, gotten better/worse over the past month. Her physician told her it was because of the shot and signed a waiver to prevent the second for her workplace. At which time she called an reported to pharmacy.
Body aches, malaise, extreme fatigue x 4 days (no resolves as of yet)
redness and extensive swelling at vaccination site 20 cm X 13 cm wheal on top of right thigh
Soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Soreness in her arm). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided.   Treatment information was not  provided.   This case was linked to MOD-2021-293312 (Patient Link).
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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 13:00 as dose 1, single (Lot number: EN6198), in right arm and on 15Jul2022 at 11:00 as dose 2, single (Lot number: FP7139) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast Cancer" (unspecified if ongoing); "Type 2 Diabetes" (unspecified if ongoing), notes: Type 2 Diabetes. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jul2022) negative; (30Jul2022) positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Had extreme exhaustion that never improved. 4 days after I finished Paxlovid the sniffles and sneezing started again and feeling run down. Had a negative Covid test on 26Jul2022 and had another positive test on 30Jul2022.
Sore and tight throat. From ~15 minutes after shot until next morning at 7am.
Patient began having grand mal seizures as of 1/31/22, per mom, 4 days after second dose of vaccine. From that time, he started declining progressively, and for a time was catatonic, non-verbal and unable to walk. Consistent increase in seizure activity since 1/31/22 as well, per mom, and had a hospital stay related to this. Was transported from a medical facility to another medical facility.
she developed itching and hives; SHe developed itching and hives on her neck, armpit, above the belly button, between her breasts, 21 bumps all over and very, very itchy.  She had one armpit with one bump and the other had 5 or 6 bumps; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 04Mar2021 02:00 at single dose for covid-19 immunisation. Medical history was not reported. Concomitant medication include fexofenadine hydrochloride (ALLEGRA, Strength: 180 mg). The patient reported, first dose on 4Mar2021 around 2 o'clock, right before the 24 hour mark she developed itching and hives. She developed itching and hives on her neck, armpit, above the belly button, between her breasts, 21 bumps all over and very, very itchy. She had one armpit with one bump and the other had 5 or 6 bumps. She put cream on them. She asked her doctor and suggested benadryl but she can't take benadryl. She started taking Allegra 180mg. She had bad hives for 4 days. The patient received treatment for the event. The seriousness was reported as non-serious. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Tachycardia. Started on Wednesday September 15. Testing heart rate at lowest was 95 up to 103. Consistent for 24 hours which prompted dr visit. Still occurring. Dizziness and fatigue as well
no adverse effect; EXPIRED VACCINE ADMINISTERED; This spontaneous report was received from a medical assistant refers to a 53 year old female patient. The patient's medical history, historical drugs, drug allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) (lot # R030120 and expiration date 15-NOV-2019) (strength, dose and frequency was not reported) for prophylaxis. On 06-DEC-2019, the patient was administered an expired hepatitis a vaccine, inactivated(VAQTA). No additional adverse event reported. Product quality complaint was not involved in the case.
Rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all over body) 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 RASH (Rash all over body). At the time of the report, RASH (Rash all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication is not provided by the reporter.  Treatment information was not reported.   Reporter did not allow further contact
Received Pediarix, Acthib, prevnar, rotateq on on 6/5/08 11:30 am. within 3 hours became excessively irritable.  6-8 hours post vaccination became pale, gray, and very lethargic. Irritability decreased and returned to normal state within 24 hours post immunization.  (Note: Older sib had irritability after each of his immunizations according to mom; he now has some developmental concerns that are not well defined)
Local reaction-3x2cm redness, 4x5cm swelling left thigh. Injection site -2 injection s 4-5mm apart. Unable to distinguish two separate sites.  Follow uP: Observatory/Tylenol.
This case was reported by a consumer via (Shingrix GSK) interactive digital media and described the occurrence of interchange of vaccine products in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (ZOSTAVAX) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of ZOSTAVAX. On an unknown date, unknown after receiving Shingrix, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received first dose of Shingrix vaccine and the second dosed Zostavax vaccine, which led to interchange of vaccine products.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 25-NOV-2014, the patient was vaccinated with a expired dose of GARDASIL lot # 0101AE, expiry date October 2014 (dose and route were not reported). There was no concomitant medication. The patient did not sought medical attention. The outcome of the event was unknown. Additional information has been requested.
Headache, Myalgia, Night Sweats Narrative:  Other Relevant History:
Swelling, itching, redness. Bump about 2 1/2 inches long, 2 inches wide. Noticed when I woke up.
This spontaneous report as received from a nurse refers to a female patient of unknown age. The patient has no pertinent medical history or drug reactions/allergies. The patient received three doses of M-M-R II (0.5 ml, subcutaneous. There were no concomitant medications. On an unknown date the patient had a titer done and was shown to have negative results for Rubella. The outcome was reported as not recovered. The patient sought medical attention by visiting the nurse's office. No treatment was received. Additional information is not expected.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's medical history and current condition were not reported. On 27-MAY-2015, the patient was vaccinated with an expired dose of VARIVAX (lot # H020601, expiry date: 13-NOV-2014, route of administration and dose number were not reported). No adverse effect was reported. Additional information has been requested.
awoke to not being able to breathe; coughing in my sleep most of the night; I ended up having to go sit up in a chair until my wheezing stopped; I was very fatigued; my insides hurt, my stomach was nauseated; my insides hurt, my stomach was nauseated; asthma; I had a headache; I felt sick; This is a spontaneous report from a contactable consumer, the patient. This 47- year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248),  dose  1 , single dose via an unspecified route of administration in the right arm on 21Jan2021 at 01:45 PM (at the age of 47- years-old) for COVID-19 vaccination.  Medical history included asthma, seasonal allergies, allergy to general anesthetic and melon and hiatal hernia. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included albuterol inhaler and pantoprazole. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 21Jan2021 at 07:00 PM the patient had a headache. She went to bed and the next day, (Friday 22Jan2021) was very fatigued, had a pounding headache,  insides hurt, stomach was nauseated and had trouble with asthma. In the early morning hours of Saturday, 23Jan2021 at 2:30am, she awoke to not being able to breathe. She  had to use her rescue inhaler 3 times & her husband said she was coughing in her sleep most of the night. She ended up having to go sit up in a chair until the wheezing stopped and she could breathe again. She had to drink a Tea to help clear her lungs. She felt sick until Saturday afternoon, 23Jan2021. Treatment received for asthma  and not being able to breathe included a rescue inhaler. The clinical outcome of  asthma, not able to breathe, headache, fatigued, insides hurt, stomach was nauseated,  wheezing and coughing was recovered on an unknown date in Jan2021 and recovered on 23Jan2021 for sick. Treatment was not received for events headache, fatigued, insides hurt, stomach was nauseated, sick, wheezing and coughing.  It was also reported that since the vaccination, the patient had not  been tested for COVID-19.
Patient has developed biopsy-proven MMF (macrophage myofascitis) with diffuse weakness and muscle atrophy causing his to be wheelchair-bound. Another concern is that I am aware of a second case of MMF in a 6 year old diagnosed earlier this year at hospital.
RECEIVED THE 2ND DOSE OF COVID VACCINE ON 06/09/2021, AND BY 06/10/2021 MY SON HAD DEVELOPED A SWOLLEN LYMPHNODE IN HIS ARMPIT THE SIZE OF A GOLF BALL IN AN OVAL SHAPE.
55 Year Old Patient was administered Gardasil 9; No additional AE reported; This spontaneous report has been received from a nurse via a field employee referring to a 55-year-old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  On an unknown date, on referral from the patient's gynecologist, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot number and expiration date were not provided) for prophylaxis at her primary care physician's office (product administered to patient of inappropriate age). No additional adverse event (AE) or product quality complaint (PQC) was reported. No further information was provided.
Pediatric patient given pediatric Pfizer COVID-19 vaccine 0.2mL without diluent. Patient and mother stayed for 15-minute observation time. No adverse reaction reported during 15-minute wait time. The mother was aware of administration error after vaccine was given.
Very Tired around 3pm December 30th, High Blood Pressure 190/140, chills, fever 99.9  After Rest and Tylenol, started to feel better 2 days later
Pt. (patient) tested + for Covid-19. Pt (patient) asymptomatic; Pt. (patient) tested + for Covid-19. Pt (patient) asymptomatic; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 79 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AZITHROMYCIN oral, start date: 05May2022, stop date: 12May2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 14May2022, outcome "unknown", ASYMPTOMATIC COVID-19 (medically significant) with onset 14May2022, outcome "recovering" and all described as "Pt. (patient) tested + for Covid-19. Pt (patient) asymptomatic". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) positive. Therapeutic measures were not taken as a result of drug ineffective, asymptomatic covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Drug ineffective and Asymptomatic COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Psychotic break down; Became very depressed; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOTIC DISORDER (Psychotic break down) and DEPRESSION (Became very depressed) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PSYCHOTIC DISORDER (Psychotic break down) and DEPRESSION (Became very depressed). At the time of the report, PSYCHOTIC DISORDER (Psychotic break down) and DEPRESSION (Became very depressed) outcome was unknown.        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.   No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2021-064043 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: NNI On 03-Jul-2021: Followup received and reporter information was added.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is not expected.
Itchiness in her body; Feel like a swollen node on the left side of the throat; Felt the nose dried; Felt the nose congested; A pain on the stomach; Throat went numb, like if she would have got sick from sick throat; Tongue also went numb; Nose went numb; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021. The most recent information was received on 24-May-2021 and was forwarded to Moderna on 24-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NASAL DRYNESS (Felt the nose dried), NASAL CONGESTION (Felt the nose congested), ABDOMINAL PAIN UPPER (A pain on the stomach), PHARYNGEAL HYPOAESTHESIA (Throat went numb, like if she would have got sick from sick throat) and HYPOAESTHESIA ORAL (Tongue also went numb) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced NASAL DRYNESS (Felt the nose dried), NASAL CONGESTION (Felt the nose congested), ABDOMINAL PAIN UPPER (A pain on the stomach), PHARYNGEAL HYPOAESTHESIA (Throat went numb, like if she would have got sick from sick throat), HYPOAESTHESIA ORAL (Tongue also went numb), HYPOAESTHESIA (Nose went numb) and LYMPHADENOPATHY (Feel like a swollen node on the left side of the throat). On 21-Apr-2021, the patient experienced PRURITUS (Itchiness in her body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, at a dose of 0.25 mg and LORATADINE at an unspecified dose and frequency. At the time of the report, NASAL DRYNESS (Felt the nose dried), NASAL CONGESTION (Felt the nose congested), ABDOMINAL PAIN UPPER (A pain on the stomach), PHARYNGEAL HYPOAESTHESIA (Throat went numb, like if she would have got sick from sick throat), HYPOAESTHESIA ORAL (Tongue also went numb), HYPOAESTHESIA (Nose went numb) and PRURITUS (Itchiness in her body) outcome was unknown and LYMPHADENOPATHY (Feel like a swollen node on the left side of the throat) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Blood pressure measurement: 138 (abnormal) 138 BP. On 31-Mar-2021, Oxygen saturation: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Case created for 2nd dose. New events (Throat went numb, Would have got sick from sick throat, Tongue also went numb, Nose went numb) added. On 21-APR-2021, new event (Itchiness in her body) added. On 02-Jun-2021: follow up received on 2-jun-2021:batch number of vaccine was given wrong that was updated