chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 69-year-old male patient received BNT162b2 (BNT162B2), on 28May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 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's relevant medical history included: "COPD" (unspecified if ongoing). 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 treated with Paxlovid, Orally stopped on 25Jul2022.  Clinical course: Reinfection after Paxlovid regimen started on 01Aug2022 and not recovered. Known allergies: NKDA (No known drug allergy)  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis. On an unknown date, a week after receiving the ZOSTAVAX, the patient developed shingles. The outcome of shingles was unknown. The relatedness between the event and ZOSTAVAX was not reported.
headache; Dizziness; Swollen arm; tired; sweaty; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired), HYPERHIDROSIS (sweaty), PERIPHERAL SWELLING (Swollen arm), HEADACHE (headache) and DIZZINESS (Dizziness) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in May 2020.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced FATIGUE (tired) and HYPERHIDROSIS (sweaty). On 10-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm). On an unknown date, the patient experienced HEADACHE (headache) and DIZZINESS (Dizziness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency; KETOROLAC TROMETHAMINE (TORADOL) at an unspecified dose and frequency and CHLORPROMAZINE (MEDIZINE [CHLORPROMAZINE]) at an unspecified dose and frequency. On 27-Mar-2021, FATIGUE (tired) and HYPERHIDROSIS (sweaty) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm) and HEADACHE (headache) outcome was unknown. Not Provided          No relevant concomitant medication was reported.  Treatment information was not provided.
From initial information received on 10/31/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that an 8 year old female patient received FLUZONE, lot number U1090AA, administered in the left thigh at 3:30 PM on 10/20/03. The next day, on 10/21/03, at 7:15 AM, the mother noticed that the patient, who was lying in bed, suddenly started shaking (upper torso), rolling her eyes and had a clicking noise from the mouth. The patient was taken to the ER immediately and she was hospitalized for one day. The patient recovered from these events. No other information was reported.  Follow up on 09/28/2004: "Despite continued attempts to obtain follow-up, no further information was provided. No further information is anticipated, this case is considered closed."
The child developed urticarial looking rash around the injection site. Pt developed about 2 days after and lasted 1 week. Mom did not tell us about it until 2/25/14 when she came in with child's siblings.
Soreness in left arm and fatigue on day 1. Fatigue persisted. Woke up with blurry vision in left eye on 1/14/2021. There was pain in left eyebrow, tingling in left jaw region, pain in left temporal and parietal region
Her blood sugar went high to over 300; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number not reported), via an unspecified route of administration on 09Feb2021 as single dose for COVID-19 immunization. The patient's medical history included type 1 diabetic. The patient's concomitant medications were not reported. On 09Feb2021, the patient's blood sugar went high to over 300 last night after receiving the vaccine and it has never happened before. Is there something in the shot that raises my blood sugar. The patient has been continuing to take her insulin, but it was not going down. Caller asking there to have been any reports of this. Information responded that all agents were busy when attempting warm transfer (13 callers ahead) and caller did not want to hold, thus, AE transmitted. Caller was ok with someone calling her if additional information was required. Consumer was unwilling to further answer the questions. Hence, Limited information was available over the call. The outcome of the event was unknown.  Information about Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Myalgia; Fatigue; Chills; Nausea; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Myalgia), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and HYPERHIDROSIS (Sweating) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 MYALGIA (Myalgia), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and HYPERHIDROSIS (Sweating). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia, Fatigue, Chills, Nausea and Sweating, at an unspecified dose and frequency. At the time of the report, MYALGIA (Myalgia), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and HYPERHIDROSIS (Sweating) outcome was unknown.            No concomitant medication provided.
Mom check in patient and sibling appointment for influenza and Pfizer Bivalent Pediatric Booster, at time of check in, Pharmacist mentioned to mom apologetically that we did not currently have Pediatric Bivalent in stock, that next door at local Clinic, we were made aware that vaccine was in stock and family could inquire in wanted.  Mom insisted that we go ahead to administer influenza vaccine to both children and she would look into bivalent booster at a later time.  After the vaccines were typed and claims were processed with that influenza vaccine in bin with consent forms, I got the attention of the administrator, and Graduate Intern, and mentioned that she had checked earlier that day, that we did indeed newly have the Pediatric Bivalent in stock. I suggested if willing she could administer if she would like.  She asked mom, and mom gratefully agreed.  A few hours later, when I relieved Graduate Intern for her break, she briefly mentioned that that Bivalent Pediatric vaccine needed to be typed with the specific NDC.  In passing I asked if the vaccine was diluted. Graduate Intern's face went ghost white to break.    After doing a little research, I called mom to notify her of the error that was made.  I mentioned to look for possible side effects, usual to covid vaccines and to report to us anything out of the usual, but not alarmingly that she needed to rush to the ER, that initial studies were made with higher doses.  I did assure her that VAERs would be reported and we would also have an internal reporting and to please notify us of any unusual adverse reactions so we can update patient's  file and VAERS.  We discussed what I would do as a mom, and what I suggest as a clinician and she felt, better relieved.  She only asked that any additional information if we get any to please let her know and she appreciated that we called to let her know.
15 minutes after flu shot I was on the freeway when I started to get a weird feeling. I was hot and sweating, breathing hard, felt like I was going to pass out, vision was darkened, lips and face were pale.
Started period that day, only 4 days after ending last one. Spotting the day of, very heavy starting day after. Horrible cramping and achy right leg.
Chest tightness; Bone pain; Ear pain; Pain in the face; Neck pain; Diarrhea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest tightness), BONE PAIN (Bone pain), EAR PAIN (Ear pain), FACIAL PAIN (Pain in the face) and NECK PAIN (Neck pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced CHEST DISCOMFORT (Chest tightness), BONE PAIN (Bone pain), EAR PAIN (Ear pain), FACIAL PAIN (Pain in the face), NECK PAIN (Neck pain), DIARRHOEA (Diarrhea) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) in February 2021 for Adverse reaction, at an unspecified dose and frequency. On 01-Mar-2021, CHEST DISCOMFORT (Chest tightness), BONE PAIN (Bone pain), EAR PAIN (Ear pain), FACIAL PAIN (Pain in the face), NECK PAIN (Neck pain), DIARRHOEA (Diarrhea) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow-up received and reporter contact information was updated.
Her arm began hurting after injection on Friday, but on Saturday, she began to have localized swelling.  On Sunday 03/29/15, the circumference of her whole upper arm was edematous, hot to touch and erythematous.  She was seen in clinic followed by the emergency room.  She was treated with Keflex.
4/4/02 Patient received 3 vaccinated noted in #13. 4/11/02 noted left foot/leg drag. 4/30/02 Left arm and left leg weak; sensation intact. 5/6/02 Admitted to hospital; stroke ruled out. In hospital 2 weeks. Diagnosed with probable acute disseminated encephalomyelitis. 60 day follow up informations states the status of the patient as unknown.  Annual follow up on 01/06/04: "It is unknown whether the vaccine recipient has recovered from the adverse events that was reported for this vaccination.  I received a call from a CDC staff member in late 2002.  She stated CDC was following up directly with pt.  I have not received any information since then (says the RN).
received a DTaP/IPV from a Pentacel without the HIB/ no side effects; Initial information received on 25-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old male patient received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) on 24-Apr-2019  On 24-Apr-2019, the patient received a second dose 0.5ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ100AB, expiry date 13-Jun-2020 via unknown route in unknown administration site.  It was an actual medication error due to inappropriate reconstitution technique.  It was reported that the patient received a DTaP/IPV from a Pentacel without the HIB.  The patient did not experience any adverse reaction after the injection.   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.  List of documents held by sender- none.
I got a UTI in June (like 2 months after the second shot) and am reporting it just in case. I went to the doctor so I could get antibiotics to treat it. It was resolved within a week of taking antibiotics.
12/28/2020, Pharmacy staff administered Moderna COVID Vaccine.  12/29/2020,  he had not eaten breakfast or lunch but did consume fluids and take his medications. BP =150/70, Temp. = 101.6, Pulse= 102,  Respirations= 18 and  Oxygen saturation= 97%. Tylenol 650 mg given.   It was difficult for him to swallow.   Also had no use of right upper extremity and unable to move lower extremity, mouth was drooping and was drooling.  Physician in attendance and ordered to send to ER.   1/1/2021, received information from nurse at hospital that patient received a Peg Tube this afternoon and Clinical indication of a stroke.
pt recvd vax 13APR93 & on 20APR93 pt devel hives; 4 days later devel a fever; pt MD stated that there were other possible causes of the fever besides the vax;
This case was reported by a consumer and described the occurrence of sick in a female subject of unspecified age who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). A physician or other health care professional has not verified this report. In 2003, "about 10 years ago" the subject received a dose of Influenza vaccine unspecified (unknown details). In 2003, "about 10 years ago" and at an unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced sick. The subject stated that "when the companies started adding mercury to the vaccine, she has been sick for a week after getting a flu vaccine, so she stopped having them." At the time of reporting the event was resolved.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patients were administered a dose of RECOMBIVAX HB (dose, route, lot number and expiration date not reported) that was exposed to a temperature outside the prescribing information. The temperature excursions were not reported. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 24-NOV-2014, the patient was vaccinated with a dose of M-M-R II (subcutaneous, dose, frequency, lot number and expiration date were not reported) which had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recvd series of 3 Engerix-B vax on 21SEP90 01NOV90 & 20MAR91; when tested @ completion of series was a non-responder & not protected;
This is a spontaneous report from a contactable physician, reported for his son, via a Pfizer sales representative. A 17-year-old male patient of an unspecified ethnicity received first dose of TRUMENBA, intramuscular on an unspecified date at 0.5ml single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced tenderness at site of injection and generally achy, both assessed as non-serious on an unspecified date with outcome of recovered. Follow-up (12AUG2016): Follow-up attempts are completed. No further information is expected.
On Friday (2/5) a rash started forming on my hands and feet. The rash spread to my knees, elbow, hips and thighs. On Monday (2/8) I began to experience fever,  chills, and muscle aches. The rash is almost gone today (2/9).
1005 AM MMR recvd, red wheal started almost immed; pt given DPH; cried for 4 mins then quieted down & slept;
After receiving her flu shot around 12:30pm, patient said she experienced adverse effects around 6pm the same day. Patient said she had trouble breathing and had aches and pains. She said she felt like she was getting the flu. She said she never had a reaction before, but was fine the next day. Patient did not discuss this with her doctor. She reported this on 10/10/2015.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter. Treatment medication was reported.  Date of refrigeration 7 May 2021.
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 14-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 05-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
patient felt a thickening in her throat.  Throat also felt sore.  IM Benadryl administered.  Patient reported feeling better quickly.  Monitored for an hour post benadryl.
Seen in office on 1/21/12 bil legs abd with numerous vesicles on erythematous base in different stages. Dx chicken pox. No previous/known chicken pox exposures.
When pulling out injection, needle detached and fell. Approximately 1/4 of the vaccine spilled out. Approximately 3/4 of the vaccine as administered to the patient. After discussion with the MD at clinic patient decided to not receive an additional dose of vaccine. No adverse reactions observes after 30 minute observation. Patient was sent home and advised to follow up with primary MD.
Fever of 103.2 Shivering Nausea Intense Headache Pain & Swelling at injection site
pregnant female patient received vaccine/no AE; Initial information was received on 01-Sep-2021 regarding an unsolicited valid non-serious case from physician.  This case involves a 25-year-old pregnant female patient who was exposed to INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (exposure during pregnancy) during third pregnancy trimester.  Data regarding this pregnancy were received prospectively.  The gestation period at onset was 26 weeks.  The date of last menstrual period was reported as 26-Feb-2021.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  The patient had unknown previous pregnancies.  On 01-Sep-2021, the patient received first dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (suspension for injection, lot GT73255A and expiry date 30-Jun-2022) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy (latency-same day).  At the time of report, no adverse event was reported.  The estimated due date is 03-Dec-2021.  Details of laboratory data was not reported.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.
SAME DAY ONSET OF ITCHING, HIVES AND SHORTNESS OF BREATH. RECOVERED /W/ ATARAX AND STEROIDS.4-17-90 BROKE OUT IN RASH WITH ITCHINGS PERSISTING.FELT WEAK.ER BEGAN SALINE SOL.INTRAVENOUSLY.5-1-90 EVAL FOR HOARSENESS:BILATERAL VOCAL CORD EDEMA
pt recv vax 4OCT96 & on 11OCT96 pt noted redness, swollen, & warm to touch on lt deltoid area;pt w/ATB ?name
Day 2 after the vaccine a large red rash at injection site, swollen, burning and itchy.  Took Allertec and Aleve.  Cleared up in 4 days.  Then reemerged on 3/17 and took Benadryl which took a day to relieve some redness and swelling.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 12-JAN-2016, the patient was vaccinated with a dose of GARDASIL (lot # L020015 and expiration date August 2017, unknown route for prophylaxis), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
None were made aware to us.  Client was administered (2) PEDIARIX pn the same day at the same visit.