chrisvoncsefalvay/vaers-outcomes huggingface dataset:
41 year old patient received a dose of fluzone high dose, no AE; 41 year old patient received a dose of fluzone high dose, no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked with 2019SA295789, 2019SA295846, 2019SA295847, 2019SA295848, 2019SA295849 and 2019SA295851 (same reporter).  This case involves a 41 years old male patient who received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Prefilled Syringe, lot UJ285AA, expiry date: 02-Jun-2020) via intramuscular route in the left arm.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of reporting, 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 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.
This spontaneous report was received from a physician referring to an infant patient of unknown age. No medical history or concurrent conditions were reported. On 06-JAN-2016, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5mcg/0.5ml, with lot # reported as L025738 and expiry date of 14-AUG-2017, administered intramuscularly (dosage and dosage number were not reported). On the same day, the patient received a dose of PEDIARIX (dose number, dosage, route, lot # and expiration date not reported) as well. However, no adverse effects were reported. It was not reported whether the patient was vaccinated with any other Hepatitis B vaccine prior to 06-JAN-2016. Additional information has been requested.
Pt developed a rash that started on arms (worse on arm shot given) very itchy. Spread to neck, face - (more on side shot given) and then hands - few on torso. None on legs or feet. Saw PCP, then saw urgent care when spread to face - Prednisone, ATARAX given - on 11/7. Saw dermatologist - blood work and biopsy done. Saw dermatologist again - not much improvement, saw dermatologist a 3rd time - felt it was getting better.
DIARRHEA; CHILLS; COLD; This spontaneous report received from a consumer concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included itp (low platelet condition), and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206421A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced cold. On 10-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, diarrhea, and chills on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210427033.
About 2 hours after receiving the vaccination, I broke out in hives and had shortness of breath for several hours. I took a dose of Benadryl and used my Albuterol inhaler and the symptoms gradually subsided. I consulted the pharmacy where I received the vaccine and the pharmacist recommended taking the Benadryl and monitoring it carefully, which I did, using my peak flow meter. My peak flow remained at my average level. It did not seem serious enough to go to the ER. By about 10 PM, the symptoms were gone. I hope this was helpful!
No additional AEs; Caller reports expired vaccine administered; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medication was sterile diluent (manufacturer unknown).  On 10-JUN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type was rHA) subcutaneous injection, 0.5 milliliter, subcutaneously (SQ) for prophylaxis (lot #T018892, expiration date: 02-JUN-2022, strength was not provided) (expired product administered). No additional adverse event was reported (no adverse event).
Initially began with sore arm one day after vaccination (12/30),  The next Wednesday  (1/6), the vaccinated arm was sore, and later in the day developed small red areas near the vaccination area. The next morning the entire vaccination area was red, hot to the touch, swollen, and aching, and the redness had developed into an 11x7 cm area. The area continued to expand and later developed hives on chest, hips, legs in addition to joint pain (hips, left arm shoulder to wrist) and severe chills. Sought treatment and receive Keflex for cellulitis, since treatment the redness has improved but the area has continued to expand.
The patient reports not being able to walk for two days following the vaccine (the following Saturday and Sunday) as well as having uterine cramps, despite being post-menopausal. Patient also reports extreme thirst and flu-like symptoms after the vaccine.
This spontaneous report as received from a pharmacist refers to a 65 year old patient of an unknown gender. On an unknown date, the patient was vaccinated with VARIVAX (Merck) (dose, lot # and route of administration were not reported) when they were indicated for ZOSTAVAX. No adverse effect was reported. Additional information has been requested.
Patient's mother reported hives on chest 2-3 hours after vaccine was administered. Treated with BENADRYL.
Soreness at site of pneumonia vaccine 1st night, some itching noted-redness and swelling noted from shoulder to elbow. Lasted 2 weeks. 1st called 11/4/05-noted some improvement after five days 11/4/05. Follow up 12/1/05.
Itchy chest on evening of vaccine and noticed rash to chest day after. Applied cortisone cream.
A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD.) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD.).    No concomitant medicine were reported. A dose of Moderna COVID-19 vaccine, Bivalent vaccine was given 2 days beyond BUD. No treatment medicine were reported.
large area of erythema, tenderness & inc warmth skin 8x6 cm w/some induration of rt buttock surrounding area of immun; 2 days p/immun administered tx w/Augmentin for cellulitis;
fever and nausea at roughly hour 16 nausea and diarrhea by ~24 hours vomiting with intermittent fever at hour ~42 headache at hour ~50 fatigue beginning at about hour 36 arm soreness thru hour 72 significant brain fog from about hour 42-72 all but arm soreness resolved by hour 72.
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 47-year-old male patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose 2 (initial pfizer dose), single (Lot number: FJ8762) at the age of 46 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Feb2021 as dose 1, single (Lot number: 030M20A), in left arm and on 12Mar2022 as dose 3, single (Lot number: 032M20A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (06Oct2022) Negative, notes: I was tested negative using an in-home kit on 06Oct and 07Oct, respectively; (07Oct2022) Negative, notes: I was tested negative using an in-home kit on 06Oct and 07Oct, respectively; (12Oct2022) Positive, notes: I was tested positive again on 12Oct. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive any other medication in 2weeks. The patient received Paxlovid for the treatment of COVID-19 from 02Oct2022 to 07Oct2022.   Follow-up attempts are completed. No further information is expected.
Muscle and joint pain in upper left arm; Muscle and joint pain in upper left arm; unable to raise left arm as high as my right arm since second vaccine; numbness in left arm while lying on my left side; extreme fatigue; frequent headaches; This is a spontaneous report from a contactable nurse (patient) reported herself that a 36-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/ lot number: unknown), via an unknown route of administration in left arm on 11Jan2021 at 13:15 (at the age of 36-years-old) as single for COVID-19 immunization at hospital. The patient's medical history included ADHD (Attention deficit hyperactivity disorder) and depression; both were from an unknown date to unknown if ongoing. She had no known allergies. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and lisdexamfetamine mesylate (VYVANSE); both were taken for an unknown indication from an unknown date. No other vaccine in four weeks. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/ lot number: unknown), via an unknown route of administration in left arm on 16Dec2020 at 13:00 (at the age of 36-years-old) as single for COVID-19 immunization. On 11Jan2021 at 20:00, the patient experienced muscle and joint pain in upper left arm, unable to raise left arm as high as my right arm since second vaccine, numbness in left arm while lying on my left side, extreme fatigue and frequent headaches. The events resulted in doctor or other healthcare professional office/clinic visit. No COVID prior vaccination. No COVID tested post vaccination. No treatment received. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Hair fall out; This case was reported by a consumer via interactive digital media and described the occurrence of hair loss in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was unknown.   The reporter considered the hair loss to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that the flu vaccine made hair fall out and no way anymore.
Pt reports that she developed fever 100.7, cough, aches and a rash on her abdomen that responded to cortisone cream. Symptoms lasted approximately 2 days.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown date, the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L017997 with expired date 04-FEB-2017, lot# L013827 with expired date 21-APR-2017, lot# L017145 with expired date 13-MAY-2017, lot# L17997 with expired date 19-MAY-2017, dose and route were unknown. No concomitant medication was reported. The nurse could not tell how many of each lot number of this vaccine had been administered. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected since the reporter refused to be contacted.
onset of rash on 8/15/99 duration of rash was 5 days;no fever at all;pt has croup;no complications;no meds given;
This spontaneous report was received from a physician and refers to a 12 month old patient. No information about the patient's medical history, concurrent conditions, drug reaction or allergies and concomitant therapies was provided. On 30-JAN-2017, the patient was vaccinated with ZOSTAVAX injection, lot # reported as M042503, expiration date: 18-AUG-2017 (dose and route of administration were not reported) instead of VARIVAX. Medical assistant, who made an error, was in hurry and grabbed the wrong vaccine. The patient did not experience any adverse effect. Product quality complaint was not involved. Additional information has been requested.
Chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Chronic fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.  No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Chronic fatigue). At the time of the report, FATIGUE (Chronic fatigue) outcome was unknown. Not Provided          This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   Patient reported had a chronic fatigue since vaccinated. But I also must disclose that I did have COVID months before vaccinated. So, I have been attributing my fatigue symptoms to so called long COVID. The LONG COVID just taxing our bodys resources or something. Its been nearly 6 months since my booster (4th dose). Fist two series were Moderna, booster was Pfizer, but both are same mRNA protein building vax. I am seriously considering skipping the 2nd booster 4th) short. Especially since active substance coun-19Just might be taking our system. I don't mean hurting or harming us like cancer or anything. But t numbers are down and relatively pretty low.  No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. PAtient was revaccinated on 03/19/21 and has since received dose 2 on 04/09/21
Narrative:  Pt was a 97 YO female with PMH of DM2, HTN, diverticulosis, HLD, and hypothyroidism. Documented in records that she received a dose of the Pfizer COVID-19 vaccine; unclear which dose in series or exactly where it was administered. Death was reported by agency to another agency; no indication that the COVID-19 vaccine contributed to the death.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Jun2023 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 49 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". 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 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300336618 same patient, different dose/event;
Shortly after (~10 minutes) receiving flucelvax vaccine had hives on chest, face reddening, increased blood pressure & headache. Patient self-administered cetirizine and diphenhydramine with no relief. ~20 to 30 minutes after vaccine had ongoing symptoms with reports of itchiness in throat and coughing and throat clearing. Administered epipen 0.3mg x 1 dose in left upper thigh with rapid resolution of itchiness in throat/coughing. Patient then went to closest urgent care where she was immediately assessed for further intervention at the time of last update, anticipated to receive a steroid injection with another hour of observation.
Within 5 minutes after shot my lips were feeling tingly. at 15 minutes out a co-worker sat by me and I told her about my lips and she commented that I had a large red mark/rash on my neck. I went to the nurse and she asked if I was nervous - which I was. She told me that I should take a Benadryl. I took a single Benadryl.  I went home and was still feeling the tingling sensation and had the rash which had spread onto my chest.  I took another Benadryl about one hour after the initial shot. This reduced the rash and tingling sensation. as it wore off about 4.5 hours later the rash, tingling lips and facial swelling started to appear. I took two more Benadryl and called the on call doctor at my physicians office.  He advised me to continue taking Benadryl until 48 hours after the vaccine, I did this every 4-5 hours including waking during the night to keep up on it. I was also taking Advil at this point to try to help with the swelling and a dull headache that had set in. I should note that I have never had any facial injections or anything like unto it. For 40 hours post vaccine I did this. After 48  hours the symptoms seemed to go away. I did start feeling a metallic taste in my mouth that night and the following night so I took a single Benadryl at bedtime those nights and that seemed to resolve it. I have had a slight cough and congestion on days 3-6 when I woke up in the morning, but that would resolve itself within an hour of being up. The doctor on call that I spoke with the first night did advise me to still get the second dose, but to take some Benadryl ahead of time and to make sure that the clinic has a current EpiPen on site.
Pins tingly sensation in mouth and arms, face begin to feel strange. Blood pressure 200/180. Hearing and vision became affected. I am now still currently seeing my cardiologist for hypertension I have never had high blood pressure until now. I am currently undergoing test for my heart also.
tingling-itching on his face; dry mouth; Dehydrated; Shaky legs; Lower eyelids really red; Lower eyelids really red and swollen; Tingling, itching on face, hands; Exhausted, depleted of energy; Chills; Feeling weird, feeling medicine moving in the arm, felt rushes; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling weird, feeling medicine moving in the arm, felt rushes), DRY MOUTH (dry mouth), DEHYDRATION (Dehydrated), TREMOR (Shaky legs) and EYELID DISORDER (Lower eyelids really red) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes (Medical history reported as diabetes) and Asthma (Medical history reported as asthma) since January 2021. Concomitant products included PREDNISONE from 04-Jan-2021 to an unknown date for Asthma, METFORMIN for Diabetes.    On 17-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced FEELING ABNORMAL (Feeling weird, feeling medicine moving in the arm, felt rushes). On 18-Jan-2021, the patient experienced DRY MOUTH (dry mouth), DEHYDRATION (Dehydrated), TREMOR (Shaky legs), EYELID DISORDER (Lower eyelids really red), EYELID OEDEMA (Lower eyelids really red and swollen), PARAESTHESIA (Tingling, itching on face, hands), FATIGUE (Exhausted, depleted of energy) and CHILLS (Chills). On an unknown date, the patient experienced PRURITUS (tingling-itching on his face). At the time of the report, FEELING ABNORMAL (Feeling weird, feeling medicine moving in the arm, felt rushes), DRY MOUTH (dry mouth), DEHYDRATION (Dehydrated), TREMOR (Shaky legs), EYELID DISORDER (Lower eyelids really red), EYELID OEDEMA (Lower eyelids really red and swollen), PARAESTHESIA (Tingling, itching on face, hands), FATIGUE (Exhausted, depleted of energy), CHILLS (Chills) and PRURITUS (tingling-itching on his face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information has been reported.; Sender'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.
Initial unsolicited report received from a consumer on 11-March-2015. A 19-year-old male patient, whose medical history and concomitant medications were not reported, had received a dose of FLU VACCINE (batch number, expiry date, dose number, route and site of administration were not reported) on an unspecified date. On an unspecified date since vaccination, the patient experienced ear infection and hearing difficulty. Laboratory investigation and corrective treatment were not provided. At the time of report, outcome of the event was unknown. Documents held by sender: none.