chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the reporting healthcare professional on 02-JUL-2015, who informed that a patient was vaccinated on 15-JUN-2015 with a dose of ROTATEQ lot # K016313, expiration date not reported, (administration route was not provided). According to the reporter the vaccine dose that was administered underwent a temperature excursion for 87 hours. This is one of several reports from the same reporter. Additional information has been requested.
Flu-like symptoms: muscle aches, fatigue, mild nausea. Pain at injection site
Bruise on upper arm and very sore, also fatigue for following 24-48 hours , slight dizziness and headache.
Patient received vaccine on 9/11/2018. Came in to the office on 9/20/2018 with fever, rash. Parent gave Ibuprofen prior to coming into office. No other prescriptions given.
Subsequent to receiving on dose of varicella virus vaccine live the pt experienced a varicella rash.
A very 'heavy' left arm hard to lift above head; very tender nodes under arms; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 15Mar2021 at 13:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Feb2021 at 13:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 16Mar2021 at 06:00, the patient experienced a very heavy left arm which was hard to lift above head and very tender nodes under arms. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events a very heavy left arm which was hard to lift above head and very tender nodes under arms was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Nurse reported she administered VARIVAX (Merck) to a patient as directed (in approximately 2014), then she was supposed to administer M-M-R II. On 22-DEC-2014 nurse inadvertently administered PROQUAD (Merck) subcutaneously (dose and lot# were not reported) instead of the ordered dose of M-M-R II. Nurse stated the error occurred because the green color of the boxes of PROQUAD (Merck) and M-M-R II were similar. Nurse also reported she did not completely read the names on the product labels, specifically she did not notice the word "varicella" on the PROQUAD (Merck) box. No adverse effect reported. Additional information has been requested.
Patient reported swollen lower lip and tongue. Denied difficulty breathing. T 99.1. At 6:18 patient said tongue felt normal, right lower lip remained slightly swollen. Temp 98.8 with Tylenol. Difficulty breathing denied.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 70 years 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: "Mild hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "recurrent diverticulitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Aug2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Aug2023) Positive; (31Aug2023) Negative; (01Sep2023) Negative; (02Sep2023) Negative; (04Sep2023) Positive; (05Sep2023) Positive; (06Sep2023) Positive; (07Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
Described feeling funny after flu shot today weird, feeling all of her body parts, lightheaded. No SOB, swelling of tongue, chest tightness, rash.
Redness on right thigh, approx. 2" x 2", no fever, no reported pain.
Hoarse; Extremely dry throat; Fatigue/tiredness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8737), via an unspecified route of administration in the left arm on 02Apr2021 at 10:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient did not have a history of allergies to food, medications, or other products. Concomitant medications included estradiol (ESTROGEN), naloxone hydrochloride; buprenorphine hydrochloride (SUBOXONE) and venlafaxine hydrochloride (EFFEXOR) all from an unknown date and for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021, the patient experienced hoarse, extremely dry throat, and fatigue /tiredness. The patient did not know if having a hoarse and extremely dry throat was normal. Adverse events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events hoarse, extremely dry throat, and fatigue /tiredness was not recovered.   No follow-up attempts are needed. No further information is expected.
Patient received 0.3 ml of Pfizer bivalent for 6?11-year-old instead of 0.2 ml.  Talking with his dad 11/15/2022 at 9:05 am, he states patient is doing fine, complaining of a sore arm.  He states he is acting normal.
A report has been received from a Health Professional concerning a 2 year old, male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 15-Jan-2013. The reporter stated that the expired FLUMIST was administered which started on 15-Jan-2013. The outcome of the event of administered expired FLUMIST is unknown. The report was considered to be non-serious. Corrected report: Reporters, relation to patient for first reporter, event coding corrected. Associated case IDs added. Case was suppressed as Medication error with no adverse event. Follow-up of insignificant information received by AstraZeneca/MedImmune 04-Feb-2013 from consumer: The reporter's details updated. Corrected report 15-Feb-2013: Associate case ID entered.
Diagnosis of Orchitis of right testicle; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EWO158), via an unspecified route of administration, administered in Arm Left, on 01Jun2021 08:15 (received at the age of 32-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The most recent COVID-19 vaccine was administered at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and has not been tested for COVID-19 post vaccination. Medical history included ankle sprain in 2020 (1 year ago) and skull fracture in 1991 (30 years ago). Concomitant medication included acetaminophen (ACETAMINOPHEN) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, Lot Number: EWO158), administered in Arm Left, on an 11May2021 08:15 (received at the age of 32-years-old) for COVID-19 immunisation and had no reaction. The patient previously took ibuprofen and experienced drug allergy. The patient experienced diagnosis of orchitis of right testicle on Jun2021. The adverse event resulted into a doctor or other healthcare professional office/clinic visit, emergency room visit, and hospitalization. Therapeutic measures were taken as a result of the adverse event. Treatment included ROCEPHIN, VIBRAMYCIN, ULTRAM. Outcome of the event was not recovered.
Patient quickly developed hives about her face and a cough. Given an oral dose of Benadryl and within  25 minutes, epi pen administered into right thigh.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 24-APR-2018, the patient was vaccinated with an improperly stored PEDVAXHIB (strength, dose and route of administration were not reported) (lot # N003701 and expiration date: 01-NOV-2019) for prophylaxis. The vaccine was stored in between 0 degrees Celsius (C) to 1 C for 1 hour. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No additional information was provided. There was no product quality complaint (PQC) reported.
difficulty breathing; Extremely Fatigue; blood pressure ups and down; Ringing in the ears; Sometimes arm is red; Arm swells sometimes; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), FATIGUE (Extremely Fatigue), BLOOD PRESSURE ABNORMAL (blood pressure ups and down), TINNITUS (Ringing in the ears) and VACCINATION SITE ERYTHEMA (Sometimes arm is red) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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, the patient experienced DYSPNOEA (difficulty breathing), FATIGUE (Extremely Fatigue), BLOOD PRESSURE ABNORMAL (blood pressure ups and down), TINNITUS (Ringing in the ears), VACCINATION SITE ERYTHEMA (Sometimes arm is red) and VACCINATION SITE SWELLING (Arm swells sometimes). The patient was treated with PREDNISONE at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (difficulty breathing), FATIGUE (Extremely Fatigue), BLOOD PRESSURE ABNORMAL (blood pressure ups and down), TINNITUS (Ringing in the ears), VACCINATION SITE ERYTHEMA (Sometimes arm is red) and VACCINATION SITE SWELLING (Arm swells sometimes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: abnormal (Inconclusive) abnormal. On an unknown date, Oxygen saturation: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   This case was linked to MOD-2021-225038 (Patient Link).
Information has been received from a registered nurse concerning a 22 year old female who on 19-NOV-2007 was vaccinated intramuscularly in the left deltoid with her first dose of GARDASIL (Lot #658560/1062U). Concomitant therapy included vitamins (unspecified). On the evening of 19-NOV-2007 the patient experienced itching at injection site. The patient self-medicated with over-the-counter BENADRYL which provided good relief of the symptoms. Subsequently, the patient recovered from itching at injection site. On 21-NOV-2007, the patient was vaccinated with the influenza virus vaccine (unspecified). On 22-JAN-2008, patient reported the adverse symptoms during an office visit. Additional information has been requested. Information has been received from a registered nurse concerning a 22 year old female who on 19-NOV-2007 was vaccinated intramuscularly in the left deltoid with her first dose of HPV vaccine (lot # 658560/1062U). On the evening of 19-NOV-2007 the patient experienced itching at injection site. The patient self-medicated with over-the-counter BENADRYL which provided good relief of the symptoms. Subsequently, the patient recovered from itching at injection site. On 21-NOV-2007, the patient was vaccinated withthe influenza virus vaccine (unspecified). On 27-JAN-2008, patient reported the adverse symptoms during an office visit.
states she cant sleep; cant concentrate; tinnitus, ringing of ears; Ear fullness; Tingling in right side of face, around eye and cheeks and everything; This is a spontaneous report from /Medical Information received from a contactable nurse  reporting for herself  A 46 year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6206) on 21Mar2021 at single dose via an unspecified route of administration  on right deltoid for COVID-19 immunization. Relevant medical history included ongoing autoimmune disease from 2016 (diagnosed about 5 years ago). Concomitant medications were not reported. On 21Mar2021 the patient experienced Tingling in right side of face, around eye and cheeks and everything, started little bit the day of vaccination  and then just kept going and got gradually a little bit worse. The events was considered as medically significant. On 23Mar2021 the patient started complaining ear fullness, started to get full like feeling in ear, like plugged under water kind of thing described as ongoing as improved slightly but  it comes and goes (as such). The event was considered medically significant. On 27Mar2021 the patient also started experiencing tinnitus, clogged/plugged  ears and ringing in the ears. The event was considered medically significant. This was not going away, she also mentioned can' t sleep and  can' t concentrate. Patient also informed that she is part of a huge online Support group (1500-2000) for people who have developed tinnitus after covid vaccination with either of Pfizer, Moderna or Jansen and Jansen Covid vaccine. Patient declined to provide information on the persons other people who were experiencing the same symptoms, hopefully, those persons call Pfizer on their own. She also informed that was not be getting her second dose (as such). The patient recovered from 'Tingling in right side of face, around eye and cheeks and everything' on an unspecified date in Mar2021, was recovering from ear fullness, while have not yet recovered from tinnitus, ringing of ears. At the time of the reporting outcome of other events was unknown.; Sender's Comments: Based on the close temporal relationship, the association between the event "tingling in right side of face" with BNT162b2 can not be fully excluded. The association between the events "ear fullness" and "tinnitus" with BNT162b2 can not be fully excluded based on the temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Diarrhea; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and PAIN (Soreness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced DIARRHOEA (Diarrhea) and PAIN (Soreness). At the time of the report, DIARRHOEA (Diarrhea) and PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
No adverse event; Nurse stated that doses were given in their facility >12(US) hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse stated that doses were given in their facility >12(US) hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 6-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse stated that doses were given in their facility >12(US) hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse stated that doses were given in their facility >12(US) hours post puncture) 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 (Nurse stated that doses were given in their facility >12(US) hours post puncture).    Concomitant medication details not reported by the reporter. Vial was initially stored in refrigerator on 01-JUN-2023. Vial size was reported as 2.5 ml. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 26hs and 30 minutes. The vial exposed to room temperature for >24 hour 09-Jun-2023. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728775 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728775:Same reporter
No adverse events until today 2/26/21 (10 days after injection.) Hot red rash 2" x 2.5", slightly swollen, and itchy; discovered about an hour after waking at 9:45 a.m.
Headache, nausea, low grade fever. Large Area Of redness (approx. Softball size) Golf Ball size hard area at Center of redness very warm to touch
I contracted COVID-19 in October 2022. I had a headache, nausea, diarrhea, breathing problems, and a fever. I felt like I wanted to vomit. I always felt thirsty and was craving for something cold. I spoke to my doctor and I was prescribed Paxlovid. The symptoms lasted for about 4 days. I do currently have a hearing problem.
Complained of pain 9-25-09 but no redness, firmness of area, or swelling; no warmth noted at site, no other symptoms noted or reported  on 9-29-09 redness of area approximately 3 inches in diameter - firm to touch and warm with slight swelling physician ordered Rocephin 500 mg IM, Kenalog 40mg IM and Bactrim OS BID x 7.
Pt screamed continuously from 130PM 2AUG91 until 8PM 2AUG91; Slept 8PM-10PM, then screamed during noc, all day & noc 3AUG91; limp & clammy mom states, had low fever but did not measure; Fussy 4AUG91;
swelling, erythema, induration, blister formation, 7 days after vaccine Vaccine given by Health Department on 2/17, presented by video visit 2/25 due to symptom onset on 2/24, referred to Allergy on 2/25, recommended anti-histamine and otc analgesic
Patient received  Moderna vaccine, 1st dose, on 9/16/21 after expiration time of 1:00 am on 9/14/21.  Moderna has been contacted.  Awaiting to hear further guidance.
RN did not dilute this Pfizer Bivalent vaccine.  Pt received higher than normal dose since it was not reconstituted.
Patient reported swelling, inflammation and pain to injection. Patient was diagnosed and given antibiotics by MD. Patient reports cellulitis.
This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received a mixed series) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    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 and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received a mixed series). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received a mixed series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.
Felt like he was going to pass out. Dizziness. Diarrhea x 5 days. Rash, forehead only. (R) arm numbness. Fingers (R) hand tingling. All started 7-10 days after vaccine was administered each time.
This initial spontaneous case, was received on 24-Oct-2014, from a pharmacist, concerning a male patient of unspecified age. On an unspecified date, the patient was administered with FLUAD (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date, the patient was administered with non-company product PNEUMOVAX 23 (dose, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that, the patient was given PNEUMOVAX 23 as booster dose along with FLUAD high dose. After vaccination the patient felt ill because of flu. Outcome of the event flu was not reported.
Period came almost two weeks early, lasted for 1.5 weeks. Usual period is at the same time each month and only 4 days.
The evening of the vax, the pt developed pain and swelling at the injection site so severe that she could not lift her arm. The next day she developed nausea and a headache.
Client was vaccinated with Moderna vaccine for Covid on 3/29 and 4/20 at Hospital.  Symptomatic with runny nose, fever x 2 days, headache, and loss of taste/smell starting on 8/26.  Tested rapid positive for Covid 8/27.  Reported as a case of breakthrough Covid in a fully vaccinated person.