chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse event; received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 37-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) 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 ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose).    No concomitant information was reported. It was reported that the dosage was changed to 0.5 ml. For the past month, nurse had been given 0.25 ml to 19 patients who received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022, and 06-Oct-2022. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662961, US-MODERNATX, INC.-MOD-2022-662973 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662973:Same reporter US-MODERNATX, INC.-MOD-2022-662961:Same reporter
No actual symptoms or issues, Patient received a second Covid 19 Bivalent dose; the recommendation is just for 1 Covid 19 Bivalent vaccine.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild
Immune thrombocytopenia; A spontaneous report was received from a consumer concerning a 72-year-old, female patient, who experienced bruises on her arm, legs and blisters that bled inside her mouth and severe immune thrombocytopenia.  The patient's medical history was not provided.  Concomitant product used was not provided by the reporter.  On an unspecified date, one day prior to the onset of events, the patient received their first two planned doses of mRNA-1273 (Batch number: not provided) for the prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced bruises on her arm, legs and blisters that bled inside her mouth.  On 19 Jan 2021, the patient was admitted in the hospital with a severe case of immune thrombocytopenia. The patient was given platelet transfusions along with steroids and immunoglobulins.  On 02 Feb 2021, the patient's condition slightly improved and was sent home.  Treatment for the events included platelet transfusion, steroids and immunoglobulins.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events,  bruises on her arm, legs and blisters that bled inside her mouth and severe immune thrombocytopenia, were considered resolved on an unspecified date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time.
paralyzed from the waist down; Guillen Barre; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: PARALYSIS (medically significant), outcome "not recovered", described as "paralyzed from the waist down"; GUILLAIN-BARRE SYNDROME (medically significant), outcome "not recovered", described as "Guillen Barre". Clinical course: the reporter had 4 male patients, who have been paralyzed due to Guillen Barre from the Pfizer COVID 19 Vaccine. She states one of them is paralyzed from the neck down and the others from the waist down. The treatment has been different based on income. She reports one can't do anything financially due to income. The other is  getting neurological shots that work from the brain down to re-insulate his nerves to get more movement in the body. The shots are done in a series of shots and he has to be able to afford the shots to get better. If the patient doesn't have the money to pay for that, they are sitting in the hospital or at home. She states they do therapy with them to get them moving as much as possible but they still have a long road to recovery. One patient's Guillen Barre was in 2021 and he has recovered completely, but the other 3 never recovered. One is paralyzed from the neck down and the other 2 the waist down. One patient got his a month ago and nowhe is paralyzed from the waist down and he is working on the road to recovery. It is almost like a stroke. The reporter stated the most recent patient's seemed to be fine before the contracted Guillen Barre, they may have had arthritis or something but they were working full time and everything.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300110001 same reporter/drug/event, different patients;
Sore arm; A spontaneous report was received from a consumer concerning a 59-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 7 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 004M20A) in left arm for prophylaxis of COVID-19 infection.   On 7 Feb 2021, the patient experienced sore arm.  Treatment details were not provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of event, sore arm, was considered resolved after a couple of days.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a registered nurse concerning a 4 year old male with no known allergies who on 08/25/1997 was vaccinated with a dose of varicella vaccine in his right arm. There was no illness at the time of vaccination. On 06/21/2001, the pt presented to the doctor's office with a mild case of chicken pox, no fever, and about 20-30 vesicles. The nurse reported that the pt had no other complications. The vesicles were located on the pt's back and arms. The pt was treated with Benadryl and calamne lotion. After one week, the pt recovered. Additional info is not expected.
Entire body aches; joint aches; muscle aches; chills; exhaustion; headache; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 18Mar2021 at 13:15 (at the age of 61-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 at 13:45 (at the age of 61-year-old) both as a single dose for COVID-19 immunisation. Medical history included corneal ulcers. Concomitant medications included doxycycline (MANUFACTURER UNKNOWN), medroxyprogesterone (MANUFACTURER UNKNOWN) and progesterone (PROGESTIN) from an unknown date for an unknown indication. The patient previously took aspirin and experienced a drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 15:00 the patient experienced entire body aches, joint aches, muscle aches, chills, exhaustion and headache. The clinical course was as follows: Entire body aches (joints and muscles) and it began a week before the 2nd shot but had intensified the day after the 2nd shot. Chills, exhaustion and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills, exhaustion, headache, body aches, joint aches and muscle aches was not resolved at the time of the report.  No follow-up attempts are needed; information about the lot number cannot be obtained. No further information is expected.
Severe chills started within 12 hours of the dose, no fever.    Fatigue, intermittent chills (which eased a little) and body aches throughout the next next 24 hours started.   By the end of 24 hours, and going into the next 48 hours, a mild cough, nasal drainage, and at the end of 72 hours chest burning started.   At the 72 hour mark, two rapid COVID tests were taken and I am now positive for COVID for the first time since the pandemic started.
Immediately got headache and that headache has been present for weeks (waxes and wanes in pain and intensity).  Also dizziness which has gotten worse.  Two days ago, she felt so dizzy and faint, she fell onto her husband in the kitchen, bruising herself.  She saw her MD for a checkup last week and did not mention the symptoms to him.
a 17 year old female patient received a 0.5 ml dose of Flublok Quadrivalent vaccine/No AE; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves a 17 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1917, expiry date: 30-Jun-2020 via intramuscular route in the right deltoid on 15-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  Doctor visit for flu vaccination on 15-Oct-2019.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient developed a fever within 6 hours of receiving GARDASIL 9 vaccination. He was lethargic and lost appetite. The fever was lingering around 101 to 102 degree range for several hours. ADVIL in 400 mg dose was given at bedtime. Upon awakening the next morning at approximately 7 AM, the patients temperature was lingering around 101 and additional 400 mg dose of ibuprofen was given. At approximately 11:45 patient's temperature was registering in the range of 103.2 to 104.3 and he was placed in a tepid bath. At approximately 12:15 he was given additional 400 mg ibuprofen and subsequently had a reduction of his temperature when measured again at the doctor's office. At approximately 1:45 his registered temperature was 99.4.
RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a health care professional concerned a 55 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: 14-DEC-2021) 2.5 ml, administered on 13-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-NOV-2021, the patient experienced received 2.5ml of the janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received 2.5ml of the janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211220948, 20211221158, 20211221439, 20211221529, 20211219731, 20211219686, 20211220537, 20211220233 and 20211219807.
Around 6 pm began acting lethargic. She didn't want to eat dinner and asked to go to bed. I gave her a warm bath and put her pajamas on her. By 7 pm I had to carry her to bed. She was "whiny" and didn't want to read stories or do any of her bedtime routine. I took her temperature via forehead temperature was 99.9. I also took her pulse and oxygen with a finger pulse oximeter. Her heart rate was 147. I went downstairs to talk to my husband about how she was feeling. Approximately 10 minutes later we heard her screaming. I went in her room and she was screaming that her legs, arms, neck, head hurt. I picked her up and help her and she quickly went back to sleep. I took her temperature again 100.9/pulse still in the 140s. I stayed with her to monitor her. Between 12-1 am she woke up screaming and saying "I don't know where I am" I turned on lights. She was laying looking up. I yelled her name and after 3 times she looked at me. I picked her up and held her. She fell back asleep. Approx 10 minutes after she fell asleep I took her temperature again which was normal and heart rate which was still in the 140s. No fever and elevated heart rate continued through morning.  Also it should be noted that her arms and legs jerked throughout the night and she would not stop moving her legs.
Fever of 104F w/vomiting; 5th DTP, no prior problems; No allergies; No family hx available;
Face and arms  were reddened. Pt reported feeling "a little  winded" when she ambulated to the bathroom. Pt states she has had this reaction previously with a shingles vaccine. Pt did not report previous reaction to administering nurse.
Awoke morning of 01/26/2021 with fever, chills, muscle aches, sore throat; dizzy and lightheaded on standing. Able to maintain fluid good intake and output. Symptoms persisted throughout the day - could not stand for more than 1-2 minutes without becoming profoundly lightheaded, resolving on lying flat in bed - passed out collapsed on floor returning from bathroom at approx. 10pm that evening. B/P by home machine 60/40;  EMS called - unable to record standing B/P d/t dizzyness on standing, heart rate 122.. transported to ER. Normal saline 2L IV bolus given. Symptoms resolved and discharged home.
woke up swollen, ears were very large, very itchy. He had urticaria/hives; woke up swollen, ears were very large, very itchy. He had urticaria/hives/he is still a bit itchy and red; woke up swollen, ears were very large, very itchy. He had urticaria/hives/he is still a bit itchy and red; woke up swollen, ears were very large, very itchy. He had urticaria/hives; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (woke up swollen, ears were very large, very itchy. He had urticaria/hives), PRURITUS (woke up swollen, ears were very large, very itchy. He had urticaria/hives/he is still a bit itchy and red), ERYTHEMA (woke up swollen, ears were very large, very itchy. He had urticaria/hives/he is still a bit itchy and red) and URTICARIA (woke up swollen, ears were very large, very itchy. He had urticaria/hives) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 021B21A and 003A21A) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included Pain (Constant pain). Concurrent medical conditions included Disability and Nervous system injury.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (woke up swollen, ears were very large, very itchy. He had urticaria/hives), PRURITUS (woke up swollen, ears were very large, very itchy. He had urticaria/hives/he is still a bit itchy and red), ERYTHEMA (woke up swollen, ears were very large, very itchy. He had urticaria/hives/he is still a bit itchy and red) and URTICARIA (woke up swollen, ears were very large, very itchy. He had urticaria/hives). The patient was treated with FAMOTIDINE for Swelling, Itching and Urticaria, at an unspecified dose and frequency. At the time of the report, SWELLING (woke up swollen, ears were very large, very itchy. He had urticaria/hives), PRURITUS (woke up swollen, ears were very large, very itchy. He had urticaria/hives/he is still a bit itchy and red), ERYTHEMA (woke up swollen, ears were very large, very itchy. He had urticaria/hives/he is still a bit itchy and red) and URTICARIA (woke up swollen, ears were very large, very itchy. He had urticaria/hives) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Patient was also taking allergy pills.
swelling of lt upper arm, redness, hot sensitive to touch, hard lump in arm;flu like sx, arm, legs, back, aches, weakness of limbs for 2 days;
General pain; Headache without fever; Persistent pain in the left arm; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0177) via an unspecified route of administration in the arm left on 19May2021 at 13:15(at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and penicillin allergy. Concomitant medications included hpv vaccine vlp rl1 9v (yeast) (GARDASIL 9) on left arm and levothyroxine sodium 50ug (EUTHYROX), all from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8735) via an unspecified route of administration in the arm left on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in May2021, the patient experienced persistent pain in the left arm. On 20May2021 at 03:00 in the night of second shot of vaccine, the patient experienced general pain and headache without fever. However, the headache and persistent pain in the left arm had not been improved and it was very painful. The patient took pain killers and Tylenol as treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event persistent pain in the left arm, general pain and headache without fever was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Right flank pain 5 days after administration of Zostavax, right deltoid. Office evaluation 12/13/06, 12/17/06 and 12/22/06 required pain medication.
A patient was given Fluzone High Dose vaccine and less than a quarter of the vaccine was left in the prefilled syringe/No AE; Initial information received on 29-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of an unknown demographic who was given a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] vaccine and less than a quarter of the vaccine was left in the prefilled syringe (batch number and expiry date not reported) via unknown route in unknown administration site on an unknown date for prophylactic vaccination (Underdose).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was the case of vaccine underdose (latency at the time of vaccination).   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
sore arm; Body ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (Body ache) and HEADACHE (Headache) in a male 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 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (Body ache) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (Body ache) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported ,No treatment medication was reported .
approx 2hr p/vax pt had 2 episodes of eyes rolling up, limp & unresponsive;pt was brought in & adm for observation;PO intake was dec or 15hr more & then was back to nl;no further episodes devel;