chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a consumer received 2 Fluzone High Dose vaccines in one day/No AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves patient of an unknown demographics who received two doses of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number not reported via unknown route in unknown administration site on an unknown date.  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 extra dose administered.  It was given in a nursing home. Pharmacist do have a note saying that some guy was given two doses of Fluzone High-Dose vaccine in the same day.  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.  Information on the batch number was requested.
This spontaneous report was received from nurse prescriber and refers to a 4 year old male patient. The patient had none pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies. On 27-MAR-2015, the patient was vaccinated with a dose of M-M-R II (lot # reported as L021950, expiration date was not reported) and with a sterile diluent (lot # and expiration date were not reported) (dose and route were not reported for both medications) both administered for prophylaxis. On 25-APR-2016, the patient was vaccinated with a dose of VARIVAX (lot # L048467, and expiration date was not reported) and with a sterile diluent (lot # and expiration date were not reported) (dose and anatomical location were not reported for both medications) both administered subcutaneously for immunization. On an unknown date, after receiving both vaccines, the patient experienced lesions around eyes (face injury). Then, on an unknown date, the patient was seen at an urgent care by an unspecified eye doctor and he received an unspecified treatment. None laboratory diagnostic tests were performed. The outcome of face injury was unknown. The causality between face injury and both suspect therapies were not reported. Additional information has been requested.
This spontaneous report as received from a field representative via a physician refers to a 71 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# and route not provided). On an unknown date the patient developed shingles two years later. The physician reported that the case of shingles was "mild" and in the T12 dermatome. By the time the patient came into the physician's office on an unspecified date, the patient had shingles for two weeks. The outcome of shingles was unknown. No PQC (product quality complaint) involved. Additional information has been requested.
Within 10 minute of  injection I got nauseous  and dizzy. I have now develop a rash that appears all over my body every 5 to 10 ten as if they are flare ups. The area gets tight and swallow with pumps itching and tingling  this happen thru out the day.I had 21 flare up  events yesterday.
12/2: Prevnar inj right thigh 11/30/04 right thigh 7x9cm, red swelling 12/2/04. 12/3: area greatly reduced. Treatment with Benadryl
Headache, tiredness, fever, chills, nausea, diarrhea (feels like the flu)
This spontaneous report was received from a Doctor of Pharmacy refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiration date and route were unspecified). Concomitant medications were unspecified. On an unknown date, the patient developed rash around the injection site after receiving ZOSTAVAX. The rash went away after an unspecified amount of time. The outcome of the event was unknown. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Low grade temperature) and NAUSEA (Nausea) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 032L20A) for COVID-19 vaccination. The patient's past medical history included Migraine. Concurrent medical conditions included Diabetes and High cholesterol. Concomitant products included IBUPROFEN for Pyrexia and Nausea, FOLIC ACID for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PYREXIA (Low grade temperature) and NAUSEA (Nausea). At the time of the report, PYREXIA (Low grade temperature) and NAUSEA (Nausea) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concurrent product included medication for cholesterol. The action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD21-084754, MOD21-040476 (E2B Linked Report). This case was linked to MOD-2021-028092. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow-up document was received. Reporter's address and email id were added. It contains non significant information.; Sender's Comments:  MOD21-084754:follow up - contact information updated - last name , email , address of the reporter MOD21-040476:cross linked id
Was notified around 1750 that an ambulance was called because patient started having convulsions. Mother called and reports that about 4 minutes after leaving the clinic patient started having convulsions, decreased respiratory rate, and had urinary incontinence. The mother called the ambulance and had patient was taken to hospital and is now in stable condition.
PT SAID EXTREME FATIGUE 24 HOURS AFTER ADMINSTRATION,  48 HOURS AFTER ADMINISTRATION RASH/HIVE OVER MUCH OF UPPER BODY
Patient is experiencing ongoing joint pain and swollen lymph nodes in groin area, also has not felt well in general since second vaccination.
No additional adverse events; the patient was inadvertently administered PREVNAR 13 and PNEUMOVAX 23; This spontaneous report was received from a pharmacist technician, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant medication were not reported.     On an unknown date, the patient was inadbertently vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)  for prophylaxis (strength, dose, frequency, route of administration, and anatomical location was not reported) (lot number S012244 had been verified to be a valid number; expiration date 09-FEB-2021), and pneumococcal 13v conj vaccine (crm197) (PREVENAR 13) (duplicate therapy error).  No additional adverse event.
Pt present self to ER with central chest pain with hx of vaccination on 5 AUG 2019 of Smallpox. Onset of symptoms was. Approximately 3 hrs in ER he became hypotensive. Labs remarkable for Troponin to 0.50.  He was eventually admitted to ICU at Medical Center for concern of myopericarditis.
This spontaneous report was received from a register nurse concerning a 47 year old female patient with a medical history of stem cell transplant and her immune system had been wiped out, who on 07-JUN-2012. was vaccinated with dose 1, 40 Microgram hepatitis b vaccine (manufacturer unknown) (route, lot number and expiration date were not provided). No other co-suspects were reported. Concomitant therapy included unspecified immune suppressive therapy. After the vaccination, at some unknown point after the administration, the patient developed muscle soreness. No treatment information was reported. The outcome of muscle soreness was reported as recovered/resolved. Additional information has been requested.
Via phone mother reports "hives all over body this a.m. (12/3/09)" States having having chill in school. Also there is itching.
Heart monitors, full cardiac work up due to VT, SVT, tachycardia. Placed on beta blockers. Fatigue, tachycardia, high  resting heart rate, dysautonomia  symptoms
This non-serious initial spontaneous case, was received from other Non-health professional on 13-Nov-2017, concerning a 54-year-old, adult, female patient. On an unspecified date in Oct-2017, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch number and expiry date: not reported). On 15-Oct-2017, the patient experienced pain in whole arms down to her wrists. It was reported that the pain lasted for 20 minutes. On the following day, her arms were little bit itchy. The outcome of the events was not reported.
10 min had fast heart beat/Had spells of rapid heart rate on and off. Ended up going to ER 4 days after due to rapid heart rate; rush of heat to head; her face stayed red 45 min; This is a spontaneous report from a contactable Consumer. A 75-year-old female Consumer (patient) reported that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on 02Mar2021 at (at the age of 75-years-old) at single dose for COVID-19 immunization.Medical history included single kidney, hypo thyroid, cancer to both previous, childhood illnesses, acid reflux. Known allergies to Sulfa, Levaquin, seasonal allergies, adheasive, neosporin. Concomitant drugs included Levothyroxin 50 micograms, Qnoll 100mgs, Zertec 10mgs, melatonin 5mlgs, colase 100 mgs, folodadine 20mgs. After the vaccine administration on 02Mar2021 the patient had rush of heat to head - 10 min had fast heart beat maybe 30 sec then felt ok. She waited another 7 min. She told nurse she was ok nurse said they could leave. After home her face stayed red 45 min after. Had spells of rapid heart rate on and off. Ended up going to ER 4 days after due to rapid heart rate. At the ER received tests and will have to wear halter monitor for 24 hrs. The outcome of the events was unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Tested positive for COVID-19 virus after the first vaccine dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 virus after the first vaccine dose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025AZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 virus after the first vaccine dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 virus after the first vaccine dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.       No treatment were listed in the source document.
Initial BP 90/60, P 60 sitting. Pt had gone unconcious and fell out of her chair in observation area and fell down. Upon falling to ground pt regained consciousness, AOx4. Subsequent BP of 118/71, P 60. Pt hit head on concrete and has a contusion. Pt denies trouble breathing or seeing. FAST exam negative. Pt reports not eating much for breakfast and did not drink any water today.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm). On 19-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-071431, US-MODERNATX, INC.-MOD-2021-071492 (E2B Linked Report). This case was linked to MOD-2021-052937, MOD-2021-052928 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071492: US-MODERNATX, INC.-MOD-2021-071431:
Reddish bumps on forearms and legs, (R) shoulder immunization site weeping, also a rash on the skin portion where bandages were used to cover the vaccination site.
anaphylaxis reaction; they think it was due to the polyethylene glycol in the vaccine; This is a spontaneous report received from a contactable reporter Physician from medical information team.  A 17 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: lamictal, reactions: "reacted", notes: in the past that contained polyethylene glycol. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis reaction"; REACTION TO EXCIPIENT (medically significant), outcome "unknown", described as "they think it was due to the polyethylene glycol in the vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.
got a cold for the day; This is a spontaneous report from a contactable consumer   A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unspecified date at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. It was informed that patient experienced got a cold for the day on an unspecified date. At the time of the reporting event outcome was unknown.   The information on the lot/batch number has been requested.
Headache, mild. Muscle pain, severe fatigue.  Started in June of 2021 and has been getting progressively worse to the point I called the primary care physician.
Pt has a history of allergy to hand sanitizer(unknown) and sesame Oil (hives). The patient has been under care for chronic cough and is being evaluated by an allergist. There was a reported sensation of tightness in the throat and upper chest, respiratory distress, itchy throat and difficulty swallowing 5mins after vaccination.  There was no stridor or wheeze though a persist upper airway cough throughout the observation period.  BP 113/81, HR 100, RR 18, 100% RA -- > 105/87, 108, 16, 100% RA.  Pt given 50mg PO benadryl and Albuterol 2puffs inhaled. The albuterol inhaler did seem to relax the cough effort and approximately 15 minutes after the p.o. benadryl the patient reported no further itching of the throat and was able to take water without difficulty.  NP recommended J&J vaccine if booster is needed at a later date.  Pt stable and released from the vaccination site.  Recommended that the pt f/u with healthcare provider, f/u instructions provided.
Rebound positive Ag test on day 13/Treatment of COVID-19; Rebound positive Ag test on day 13/Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 53 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 was not pregnant at the time of vaccination. The patient's relevant medical history included: "Type 2 DM" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE, start date: 14May2022, stop date: 20May2022 (other medication in 2 weeks product). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "recovering" and all described as "Rebound positive Ag test on day 13/Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive, notes: on day 13. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with Paxlovid.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Experienced balance problems within 24 hours of injection. Was significant for 7 days (more frequently wanting to fall to the right).; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown; NDC number: NDC 59267-1000-1) via an unspecified route of administration in the right arm on 03Apr2021 at 11:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, bradycardia, hypermobility syndrome, history of deep vein thrombosis with pulmonary embolism (history of DVTs with PEs), cyst surgies and infection, squamous cell carcinoma, known slight allergy to latex allergy and milk products. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN), abatacept (ORENCIA), hydroxychloroquine sulfate (PLAQUENIL) and rivaroxaban (XARELTO) and etc (unspecified medications); all for unspecified indication from unknown date and unknown if ongoing. The patient previously took pioglitazone hydrochloride (ACTOS) and metformin (MANUFACTURER UNKNOWN) both for unknown indication from unknown date and experienced drug allergy to pioglitazone hydrochloride and metformin. 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 04Apr2021 at 07:00, the patient experienced balance problems within 24 hours of injection which was significant for 7 days (more frequently wanting to fall to the right). Critical point: The patient did not take methotrexate or orencia for 12 days after vaccination. Once back on methotrexate and orencia, balance had nearly returned to normal. The patient was not certain if this was a vaccine or unknown reaction to suddenly stopping medications. 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 event. The clinical outcome of the event balance problems was recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever, vomiting, severe headache, pain at injection site, body aches, body soreness. Symptoms began Tuesday morning and lasted until Wednesday night.
6 days after administration pt had a burning sensation in skin on chest and next day broke out in a shingles rash.
Postural orthostatic tachycardia syndrome (POTS); Fatigue; Dizziness; Headache; Orthostatic intolerence; Autonomic Nervous System Imbalance; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to female patient (pt) of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome (POTS), autonomic nervous system imbalance, orthostatic intolerance, headache, dizziness and fatigue.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007593: US-009507513-2301USA007498: US-009507513-2301USA007595: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007522: US-009507513-2301USA007521: US-009507513-2301USA007594:
twelve-year-old patient got vaccinated with Moderna Vaccine for COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (twelve-year-old patient got vaccinated with Moderna Vaccine for COVID-19) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (twelve-year-old patient got vaccinated with Moderna Vaccine for COVID-19). On 01-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (twelve-year-old patient got vaccinated with Moderna Vaccine for COVID-19) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.
This spontaneous report as received from a registered nurse refers to a 66 year old patient (gender unknown). On 12-FEB-2013 the patient was vaccinated with live (Merck) VARIVAX, 0.5 ml, subcutaneous. There was no concomitant medication reported. On 12-FEB-2013 the patient received VARIVAX when he was supposed to receive ZOSTAVAX. There was no adverse event reported. No further information was provided. Additional information has been requested.