chrisvoncsefalvay/vaers-outcomes huggingface dataset:
POSSIBLE VACCINE ADMINISTRATION TO 16 YEAR OLD MALE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 16 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: 1822809, expiry: UNKNOWN) dose was not reported, administered on 27-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-OCT-2021, the patient experienced possible vaccine administration to 16 year old male. On 27-OCT-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the possible vaccine administration to 16 year old male and off label use was not reported. This report was non-serious.
administration of VARIVAX which was stored at -11.1 C for 4 hours and 30 minutes; This spontaneous report was received from a medical assistant (MA) and refers to a patient of an unknown age and gender. Information concerning the patient's past medical history, concurrent conditions, concomitant medications and historical drugs/allergies was not provided.   On 02-OCT-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 injection, lot # S003447, expiration date 04-FEB-2021 (dosage regimen and route of administration were not reported) as prophylaxis.  The improperly stored suspect vaccine experienced a temperature excursion of -14 Celsius degrees (C) to -10 C (average temperature was -11.1 C) for 4 hours and 53 minutes. No previous temperature excursion was reported.The call was due a digital data logger.  This is one of two cases recieved from the same reporter.; Sender's Comments:  US-009507513-2010USA001537:
having reaction to the vaccine./I really don't feel good; This is a spontaneous report from a contactable consumer reported for self. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Reason for no lot number: of COVID-19 Vaccine: Complainant hung up abruptly/transfer incomplete. The patient medical and concomitant medication history were reported. Patient stated, really did not feel good and really can not understand. Patient had reaction to the vaccine. Patient went to the emergency room and nobody can help patient. Patient was unwilling to share further information, hence, product details (LOT#, expiration date, NDC#, UPC#) and other details were unknown. The outcome of event was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a medical assistant and refers to three unspecified patients of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 03-NOV-2016, the patients were vaccinated with improperly stored doses of VARIVAX injection, subcutaneously, lot # M027886 with expiry date 03-JUN-2018 and lot # M028547 with expiry date 07-JUN-2018 (dose and anatomical location were not specified) for prophylaxis. The administered doses of VARIVAX underwent temperature excursion at -13 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
3 severe hot flashes from head to toes, like for a minute; rash; extreme fatigue; massive/severe headache; chills; fever:soaking wet; sweating; heat; swollen arm; itchy arm; redness/red arm; arm hot to the touch; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SWEATING FEVER (fever:soaking wet) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Menopause (when she was 40.).    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced SWEATING FEVER (fever:soaking wet) (seriousness criterion medically significant), HYPERHIDROSIS (sweating), FEELING HOT (heat), PERIPHERAL SWELLING (swollen arm), PRURITUS (itchy arm), ERYTHEMA (redness/red arm), VACCINATION SITE WARMTH (arm hot to the touch), PAIN IN EXTREMITY (sore arm), FATIGUE (extreme fatigue), HEADACHE (massive/severe headache) and CHILLS (chills). On 26-Oct-2021, the patient experienced RASH (rash). On 27-Oct-2021, the patient experienced HOT FLUSH (3 severe hot flashes from head to toes, like for a minute). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Adverse event, at an unspecified dose and frequency. On 26-Oct-2021, RASH (rash) had resolved. On 27-Oct-2021, HOT FLUSH (3 severe hot flashes from head to toes, like for a minute) had resolved. At the time of the report, SWEATING FEVER (fever:soaking wet), HYPERHIDROSIS (sweating), FEELING HOT (heat), PERIPHERAL SWELLING (swollen arm), PRURITUS (itchy arm), ERYTHEMA (redness/red arm), VACCINATION SITE WARMTH (arm hot to the touch), PAIN IN EXTREMITY (sore arm), FATIGUE (extreme fatigue), HEADACHE (massive/severe headache) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information included cold packs.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was Not applicable.   This case was linked to MOD-2021-366002, MOD-2021-366003 (Patient Link).
PT RECEIVED INFLUENZA VACCINE .25 ML ON 12/27/06 AT APPROXIMATELY 11AM. LATER PRESENTED TO THE ER WITH WHEEZING AND RASH. WAS TREATED WITH BENADRYL AND WATCHED. SYMPTOMS RESOLVED. PT HAS NOT PRIOR HISTORY OF AN ALLERGIC REACTION TO EGGS.   MR received for ER visit several hours after flu vax for c/o irritability and intermittant wheezing.  Fine, erythematous rash noted on upper chest. DX: Allergic reaction.
On 10/25/09 weakness, pain and numbness began in lower extremities. By 11/1/09 spread to entire body paralyzed with extreme pain. Initiated IVIG (5) days moved to rehab hospital on 11/9 and discharged on 11/19/09 in a walker. Numbness, fatigue, weakness. Remain while unstable on feet. Treatment continues.
neck ache (stiff) 20sec p/shot lasted 2 days;sore arm 4 days started first day;tired for 7-10 days or more;sore muscles in legs 3rd day-lasted 2 days or more;cramping in stomach-no appetite for at least 7 days;
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Medium, Additional Details: Patient fainted after covid vaccine administered.EMS was called.She was taken to hospital.
Red, swelling, and itching. Spreading since onset. No fevers, bleeding, or discharge. Seen in office 4/26/17 for the issue and will start antibiotics due to concern for cellulitis. Plan for close follow up.
I cannot confirm the type of vaccine the pt received as it didn't occur in our health system.  Pt experienced out of hospital cardiac arrest a few days after vaccination.  Pt resuscitated; however never regained consciousness.  Coronary angiogram revealed normal coronary arteries.
pt recvd vax & exp t103 had grand mal sz @ home; observed @ ER & released;
Patient had either lot # 032L20A or  lot # 013L20A -  Were unable to provide provider with the lot number patient received at the time of the VAERS vaccine report. Patient said she felt like she was having panic feeling and that her breathing was shallow.  Patient denied nausea, vomiting, dizziness, chest pain, headache, itching, rash, throat swelling, troubles swallowing or talking.  Patient said she did not take her medications. Vitals were done , normal SaO2, initial pulse 102 that then resolved and in 90's and then 86.  BP elevated 173/103, then 172/99, then 167/98.
euphoria; little dizziness; felt pain in my side; sacroiliitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "mini-stroke" (unspecified if ongoing), notes: I had a mini-stroke behind my eye years ago. The patient's concomitant medications were not reported. The following information was reported: EUPHORIC MOOD (non-serious), outcome "recovered" (2021), described as "euphoria"; DIZZINESS (non-serious), outcome "recovered" (2021), described as "little dizziness"; PAIN (non-serious) with onset 14Mar2021, outcome "unknown", described as "felt pain in my side"; SACROILIITIS (non-serious) with onset Mar2021, outcome "unknown", described as "sacroiliitis". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient had received the first dose of the Pfizer COVID vaccine. After getting the first dose patient experienced euphoria and a little dizziness, and felt great after about 2 hours. On Sunday, patient felt pain in her side. she went to the walk-in clinic about it, they did x-rays but thought it was probably a muscle spasm. The x-ray showed sacroiliitis which is inflammation of the joint between my spine and pelvis on the back.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The pt slept for 24-36 hours post vax, had a low grade fever, then had normal behavior during the daytime but fitful, wakeful sleep at night. This persisted through the evening of 6/10.
DEAD; This spontaneous report received from a consumer via Social media concerned a male of unspecified age, race and ethnic origin. 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, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reported stated "my brother was injected on Thursday and was dead by Sunday. Don't go thinking its all good. You have been duped". On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220141974-COVID-19 VACCINE AD26.COV2.S- Dead. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
SORE THROAT; FATIGUE; HEADACHE; PAIN IN ARM; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure, ulcerative colitis, insulin resistance, latex allergy, dust allergy, seasonal allergies, non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with naproxen sodium, acetylsalicylic acid, ibuprofen, and levofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced pain in arm. On 08-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced fatigue. On 11-MAR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat on 13-MAR-2021, pain in arm on 01-APR-2021, headache on 11-MAR-2021, and fatigue on 12-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210328999.
Sore arm; This is a spontaneous report from a contactable consumer. A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL9262), via an unspecified route of administration on 20Jan2021 19:00 at SINGLE DOSE at right arm for covid-19 immunisation. Medical history included Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included tamsulosin hydrochloride (FLOMAX), atorvastatin (LIPITOR), duloxetine hydrochloride (CYMBALTA), varicella zoster vaccine rge (cho) (SHINGRIX). On 21Jan2021 02:00, the patient experienced sore arm, normal effect with most shots. The patient did not receive treatment for the adverse event. The outcome of the event was recovering.
Throat constriction over 3 hours, DX epinephrine, Solumedrol, prednisone 60 mg at home, 20mg TID.
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 70-year-old male patient received BNT162b2 (BNT162B2), on 09Feb2021 at 16:30 as dose 1, single (Lot number: EL9261), in left arm, on 09Mar2021 as dose 2, single (Lot number: EON9810), in left arm, on 11Sep2021 at 13:00 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 01Apr2022 at 15:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart Disease" (unspecified if ongoing); "Diabeties" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: 15Jul2017; EZETIMIBE, start date: 15Jul2017; LOSARTAN, start date: 15Jul2017; DILTIAZEM HCL, start date: 16Nov2021; ATORVASTATIN, start date: 15May2013; METFORMIN, start date: 15Jul2017; METOPROLOL TARTRATE, start date: 14Jul2012. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient received nirmatrelvir/ ritonavir (PAXLOVID) for the event (refers to AER#202201045334).
Vaccine leaked from the injection site resulting in insufficient vaccine administration. The dose was repeated approximately 2 inches away from the original injection site. The repeated dose was successful.
The left side of her face became swollen; Booster; Her first two doses were Moderna; Her first two doses were Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 15:50 (Lot number: FF8841) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Moderna (1st dose: , lot number 002B21A,), administration date: 31Mar2021, when the patient was 41 years old, for Immunization; Moderna (2nd dose:, lot :039A21A,), administration date: 28Apr2021, when the patient was 41 years old, for Immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 15Dec2021, outcome "unknown" and all described as "Her first two doses were Moderna"; IMMUNISATION (non-serious) with onset 15Dec2021 15:50, outcome "unknown", described as "Booster"; SWELLING FACE (non-serious) with onset 17Dec2021 01:00, outcome "recovering", described as "The left side of her face became swollen".  Additional information: The patient stated sometime over night last night the left side of her face became swollen. She knows this is a possible side effect and is seeking recommendations on what to do about it and to ensure it is reported. She got the vaccine at the Patent trade office. She doesn't know the address. The swelling has improved a little. She did not receive any other vaccines. AE(s) didn't require a visit to Emergency Room or Physician Office. Any prior vaccination within 4 weeks was not reported.  No follow-up attempts are possible. No further information is expected.
Nausea, exhaustion, dizziness, headache, tinnitus the day after the vaccine. Rested all day. Day 2 after the shot, feeling better but intermittent dizziness and tinnitus have continued.  2 weeks after shot, full day of being very dizzy, brain fog, and tinnitus. Tinnitus not overbearing but bothersome as I have never had this before.
This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced going downhill fast within a day or two of getting it. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unspecified adverse event. This report was non-serious. This case, from the same reporter is linked to 20220200358.
None yet. My problems didn?t start until later after about 8 months after my shots.
Uncontrolled shaking; Malaise; Extremely tired; Chills; This spontaneous case was reported by a nurse and describes the occurrence of TREMOR (Uncontrolled shaking), MALAISE (Malaise), FATIGUE (Extremely tired) and CHILLS (Chills) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy, Type 2 diabetes mellitus and Dyslipidemia. Concomitant products included METFORMIN, ROSUVASTATIN CALCIUM (CRESTOR OD) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 19-Jan-2021 at 10:50 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced TREMOR (Uncontrolled shaking), MALAISE (Malaise), FATIGUE (Extremely tired) and CHILLS (Chills). At the time of the report, TREMOR (Uncontrolled shaking), MALAISE (Malaise), FATIGUE (Extremely tired) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Scattered papules, sl, vesicular, few excoriated, thick on back, few on legs, face, thighs.
Pt states on the evening of the pneumo vaccine, inj. site very red, size of apple. 10-9-07 size of grapefruit, lighter in color. 10-10-07 area getting smaller. Treatment - rest, elevate arm, ice 5 min, TID, Claritin 10mg PO QD x 10 days. patient to call if not better 10-11-07.
Sharp tight pain in the middle of my chest with right jaw burning radiating from chin to right ear. First the nerve pain started about 1-2 mins after injection and then immediately after the nerve burning in my face was the chest tightness and sharp pain. Like it hurt to take a deep breath as well. The burning pain in my right side of my face passed after 20-30 mins and then the chest tightness and sharp pain passed a little longer about an hour.
Symptoms of mild headache, body ache, fatigue, cold sweat, and nausea and diarrhea began on Saturday afternoon.
extreme muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) 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 included: "extreme muscle pain" (unspecified if ongoing), notes: patient had symptoms similar to those (extreme muscle pain) when taking statin. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series complete, manufacturer unknown), for Covid-19 Immunisation. The following information was reported: MYALGIA (non-serious), outcome "not recovered", described as "extreme muscle pain".  Additional information: It was reported that patient had symptoms similar to those when taking statin - extreme muscle pain - since receiving new COVID booster. Patient inquired what to do to relieve pain.  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.
This spontaneous report as received from the consumer's mother refers to her daughter of unknown age. The patient's medical history included chickenpox in childhood. On 16-JUN-2013 and on 15-JUL-2013 the patient's sister was vaccinated with first and second doses of VARIVAX (merck) respectively (dose, route and lot number not provided). A couple days later, on approximately July 2013 the patient experienced rash with itchiness, lesions like red "bug bites" and pustules the same rash as her sister had. The patient went to a doctor who prescribed halobetasol propionate cream (manufacturer unknown) which helped itch only. The patient's rash was beginning to scab over. The causal relationship was not provided. This is one of several reports from the same source. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 78-year-old male patient who received Shingrix for prophylaxis. Concurrent medical conditions included rheumatoid arthritis, prostate cancer, brachytherapy to prostate (prostate cancer radioactive seed implantation therpay) and radiation therapy (for treating prostate cancer for 28 days, ending on 3rd August 2018). On 20th March 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced headache, tiredness and muscle pain. On an unknown date, the outcome of the headache, tiredness and muscle pain were recovered/resolved. It was unknown if the reporter considered the headache, tiredness and muscle pain to be related to Shingrix. Additional information was reported as follows: The case was reported by the patients's wife. The patient received the vaccine in left deltoid. The contact details of the physician was provided. For tolerance to next dose, refer case US2018GSK175636.