chrisvoncsefalvay/vaers-outcomes huggingface dataset:
now he experienced mild headache and soreness in the arm; now he experienced mild headache and soreness in the arm; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONETCH COVID-19 VACCINE; lot number and expiration ate were not reported), via an unspecified route of administration on 16Apr2021 (yesterday) at single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient experienced mild headache and soreness in the arm now on 17Apr2021. The patient wanted to know that if he could take aspirin for the headache and asked if it's true that if you had the vaccine you should not take ibuprofen, tylenol or aspirin. The patient was provided with the Pfizer medical information team's (PMI's) contact number. The outcome of both the events was unknown at the reporting time.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Vaccine was removed from refrigerator and initially punctured at 12:00pm on 10/5/21. Dose was administered to the patient at 8:30am on 10/6/21, which was 20.5 hours after initial puncture at room temperature.
c/o sore rt arm, edema @ site, followed by petechiae to rt arm & rash to all of body, itching; eyes were very bloodshot, very red, drainage from eyes et edema to eyes; sore to face
Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech, Dose Number: 5; Moderna, Dose Number: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. 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 20Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 71 years, in right arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Jan2021 as dose 1, single (Lot number: 042L20A), in right arm, on 18Feb2021 as dose 2, single (Lot number: 015M20A), in right arm, on 17Nov2021 as dose 3 (booster), single (Lot number: 013F21A), in right arm and on 11Apr2022 as dose 4 (booster), single (Lot number: 046L21A), in right arm for COVID-19 immunisation. The patient's relevant medical history included: "High blood pressure, controlled" (unspecified if ongoing), notes: High blood pressure, controlled; "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. Concomitant medication(s) included: LISINOPRIL/HYDROCHLOORTHIAZIDE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2022, outcome "unknown", described as "Pfizer / BioNTech, Dose Number: 5; Moderna, Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested Positive 3 days after 2nd negative test; Negative, notes: Tested Positive 3 days after 2nd negative test. Therapeutic measures were taken as a result of drug ineffective, COVID-19.
Having diarrhea and sinus congestion, headache, watery eyes and got a fever of 100.5. Home test was positive. Then went to the hospital and they confirmed that I tested positive for COVID. Monoclonal antibodies, chest X-ray and CT, blood work, all was clear. Still having fatigue.
Information has been received from an office manager in a physician's office concerning an 8 month old female who on 10-DEC-2007 was vaccinated with her third dose of Rotateq when she was older than 32 weeks.  No symptoms or problems were noted.  The patient did not seek medical attention.  There was no product quality complaint.  Additional information has been requested.
PT REC'D SHOTS ON 6/8/06 AND WE REC'D CALL ON 6/9/06 FROM MOM THAT SHE WAS AT CLINIC BECAUSE INJECTION SITE TO LEFT THIGH WAS SWOLLEN AND PAINFUL.  MOM STATED THAT THIGH HAD FIST SIZE KNOT IN IT.  PT WAS PLACE ON ANTIBIOTIC BY THE MD AT THAT CLINIC.  MOM CALLED ON MONDAY TO LET US KNOW THAT LEG WAS MUCH BETTER.
Reaction started within 4 hours of injection and increased all night to a severe level. It was worse than when I got Covid last year. Pain in all muscles, severe headache, chills and fever, swelling in mouth, tongue, difficulty breathing, dizziness, unable to walk until noon next day, and then only with a walker. Severe nausea and vomiting, heaving. Unable to sleep all night.
This spontaneous report was received from a nurse practitioner concerning a 14 years old female patient. The patient was vaccinated intramuscularly with the first dose of 0.5 ml GARDASIL (lot not reported) on 15-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The patient experienced fever of 100 Fahrenheit, flu-like symptoms and missed 3 days of work after receiving the first dose of GARDASIL. No treatment information was reported. The patient stated that it was the worst she had ever felt. These symptoms occurred a day later after GARDASIL vaccination and recovered within 3 days. The relatedness for the events was unknown for GARDASIL. Additional information is not expected.
Patient with tender injection site (left deltoid), fever, myalgias, headache, diffuse back pain, malaise.
Initial report was received on 28 July 2008 from another manufacturer who received the report from a health care professional.  A female patient (age and date of birth not reported) had received an Influenza vaccination in 1986 and developed the flu.  She also received a Tetanus vaccination in 1986 and developed lock jaw and drooling.  The event onset dates were reported as "1986".  The vaccine names, manufacturers, lot numbers, routes and sites of administration were not reported.  The patient's recovery status was not reported.
He has a problem with his sense of smell and taste; he has a problem with his sense of smell and taste/has a weird sense of taste in his mouth; Fever; Heachache; Chills; Flu like symptoms; Stuffy nose; Sore throat; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), NASAL CONGESTION (Stuffy nose), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and ANOSMIA (He has a problem with his sense of smell and taste) 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 01-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 03-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), NASAL CONGESTION (Stuffy nose), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), PYREXIA (Fever), HEADACHE (Heachache) and CHILLS (Chills). On an unknown date, the patient experienced ANOSMIA (He has a problem with his sense of smell and taste) and AGEUSIA (he has a problem with his sense of smell and taste/has a weird sense of taste in his mouth). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), NASAL CONGESTION (Stuffy nose), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), ANOSMIA (He has a problem with his sense of smell and taste), AGEUSIA (he has a problem with his sense of smell and taste/has a weird sense of taste in his mouth), PYREXIA (Fever), HEADACHE (Heachache) and CHILLS (Chills) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was reported.
3:30AM  began to have chills, headaches, sweats, at 12:40PM Blood pressure- 112/54, Pulse-175, 3:45PM Pulse- 94. On 08/10/2021 Pulse-74. Contracted Shingles 4 years ago.
Woke up at 2:00 AM with excruciating pain in both knees (total knee replacement in 2002).  By 6:00 AM, fever topped out at 102 degrees.  Fever persisted for 24 hours.  Knee joint pain persisted for 5 days.
Adult dose (0.3 mL) administered in error to child (8 y.o.)..  No adverse events have been reported as of the time this form was completed.  A date/time was required to be entered on page 1 for "Time of adverse event onset."
Patient received vaccination 8/20/16. On 8/22/16 productive cough. Went to walk in clinic 8/30/16. (Azithromycin Z-PAK, TESSALON prescribed). Fully recovered.
PT BEGAN TO DEVELOP SIGNIFICANT SWELLING IN ANKLES/LOWER EXTREMITIES, AND THEN ALSO IN HANDS.   SHE MONITORED THIS HERSELF FOR 3 WEEKS, BEFORE GOING TO HER PRIMARY CARE PHYSICIAN. SHE WAS ADMITTED SHORTLY AFTER TO ER AS HER BP HAD ALSO RISEN SIGNIFICANTLY FROM A NORMAL BP OF 106/80 TO 199/99.   SHE REMAINED IN THE HOSPITAL FOR SEVERAL DAYS AS THEY WORKED TO GET THE FLUID AND SWELLING DOWN (WHICH PT REPORTS WAS 15 LBS WORTH OF WEIGHT) AND IT WAS DISCOVERED SHE WAS SPILLING PROTEINS IN HER URINE.   SHE WAS ALSO REFERRED TO A NEPHROLOGIST WHO SENT KIDNEY BIOPSY TO ANOTHER CLINIC (THE REPORTS CAME BACK NEGATIVE FOR ANY TYPE OF CANCER).    SHE ALSO REPORTS THAT SHE HAS COVID EYES (RED AND PUFFY EYES) AND IS USING MOISTURIZING DROPS REGULARLY FOR COMFORT.    PT ALSO REPORTS THAT SHE HAD COVID IN OCT. OF 2020  SHE RECIEVED HER 2ND MODERNA VACCINE ON 4/23/21
13 yo female received 1st dose Moderna COVID 19 vaccine. 2nd dose scheduled for 4/21/21 but error was caught and was not given
I had overwhelming body aches some respiratory issues but mostly body aches it felt like I had the flu no nausea.
This spontaneous report was received from a physician, via a company representative, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-JUN-2016, the patient was vaccinated with a dose of RECOMBIVAX HB, "10Pk 5 mcg/0.5 mL SDLLokCap Ped", lot # L016959, expiration date:12-MAR-2018, (dose number and route of administration were unknown), which was improperly stored. On unspecified dates, the RECOMBIVAX HB vaccine had three temperature excursions of 0.55 Celsius Degrees (33 Fahrenheit) for 96 hours, 1.11 Celsius Degrees (34 Fahrenheit) for 528 hours and -0.55 Celsius Degrees (31 Fahrenheit for 72 hours, respectively. The vaccine status was reported as in excursion and the type of excursion and storage criteria were reported as refrigerator (R). No adverse effects were reported and no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Wednesday, March 24, 10:30am, facility  First vaccination o Upper Arm shot was stronger than sore with full mobility. Wednesday, April 21, at 1pm, facility  Second vaccination o 2pm arrived back at work. o 2:30pm left arm started to feel tight. o 3:30pm headed home arm hung on my side had to use my right hand to place on my lap. Drove home with one hand. o 7:30pm lightheaded and shooting pains in arm. o Excruciating painful sleep all night maybe only one hour sleep at 4am awake all night from shooting pains in arm, aches, feverish hot up and down, vomited once, unable to lay sleeping must stay in seated position. Thursday, April 22 , 4:34am o Unable to move full left arm and hand, aches, temperature
The patient received the pediatric pfizer vaccine without it being diluted first. No side effects currently reported.
Stomach cramps; Headache; Arm hurt; Diarrhea; Fatigue; This is a spontaneous report from a contactable consumer, the patient.  A 71-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: OEN6208) via unspecified route of administration in left arm on 13Mar2021 at 16:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation.  Medical history included asthma, rectal cancer, cervical cancer, allergies. The patient was allergic to sulfa, penicillin, ceclor, wheat, yeast, malt. Past drug history included ceclor had taken from an unspecified date. Concomitant medications included renew life probiotics (MANUFACTURER UNKNOWN), Buspirone (MANUFACTURER UNKNOWN), Montelucast (MANUFACTURER UNKNOWN), ZIO had taken within two weeks of vaccination for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 14Mar2021 at 12:00, the patient experienced headache, arm hurt, stomach cramps, diarrhea, fatigue. No treatment was received for the events. The clinical outcome of headache, arm hurt, stomach cramps, diarrhea, fatigue was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected.
Three days post vax, this pt reported having a wheal of 2 inches at the site and erythema of 6-8 inches at the injection site.
DIZZINESS; COUGH; SNEEZING; SORE THROAT; SOME HOARSEN; This spontaneous report received from a patient concerned an 83 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced sore throat. On 15-MAY-2021, the subject experienced some hoarsen. On an unspecified date, the subject experienced dizziness, cough, and sneezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore throat, and the outcome of dizziness, cough, sneezing and some hoarsen was not reported. This report was non-serious.
Pt recv vax on 9/16/98; approx 6 hr post vax pt exp swollen/pain/ warm/tender at vax site, fever, malaise; tx=ice, Advil, Prednisone
Pt developed 18 by 12.5 cm area of erythema that was present along with significant swelling of the upper thigh and warmth.  Pt diagnosed with cellulitis and treated with oral antibiotics.
Pt reported  chest pressure and pain 1 hour after receiving her 2nd Pfizer vaccine. Negative cardiac work up in emergency department but she has a history of pulmonary embolism so she was admitted to the hospital for observation and further work up with no definitive diagnosis
pt  recvd vax;exp inject site rxn consisting of swelling, erythema, tenderness & warm to touch; event occurred w/in 24 hrs of vax;seen by MD; tx w/ warm compresses;
Initial information received on 03-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six-months-old male patient who received an 0.5 ml second dose of expired PENTACEL (lot number: C5456AA, expiry date: 18-Dec-2018) via intramuscular route in an unknown site of administration on 03-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE for Immunisation; ROTAVIRUS VACCINE for Immunisation; and PREVNAR for Immunisation on 03-Jan-2019. It was a case of actual medication error due to expired vaccine used. Did not observe any side effects after the injection. 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. Documents held by sender: none.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Dec2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. Concomitant medication(s) included: MULTIPLE VITAMINS; BISOPROLOL; BUPROPION. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: other medication in 2weeks product were Multiple vitamins daily, Bisoprolol, Buproprion. Reoccurence of covid symptoms 5 days after paxlovid along with positive covid test.  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 reported information, causal association of event drug ineffective, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
Tested positive for Covid 19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid 19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for Covid 19). At the time of the report, COVID-19 (Tested positive for Covid 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for COVID 19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
interchange of vaccine products; Diabetes Mellitus; Asthma; This is a spontaneous report received from contactable reporter(s) (Nurse). Other Case identifier(s): MOD-2023-727302.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jul2022 as dose 3 (booster), single (Lot number: FM7553) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Allergies to medications, food, and other products: penicillins" (unspecified if ongoing), notes: Allergies to medications, food, and other products: penicillins, sulfa; "Allergies to medications, food, and other products: sulfa" (unspecified if ongoing), notes: Allergies to medications, food, and other products: penicillins, sulfa; "Essential Hypertension", start date: 07Mar2018 (unspecified if ongoing), notes: recent changes in condition status? If yes describe: No; "Obstructive Sleep Apnea", start date: 09Oct2018 (unspecified if ongoing), notes: recent changes in condition status? If yes describe: No; "Dyslipidemia", start date: 12Mar2018 (unspecified if ongoing), notes: recent changes in condition status? If yes describe: No. Concomitant medication(s) included: LISINOPRIL AND HYDROCHLOROTHIAZIDE oral taken for essential hypertension (ongoing); SIMVASTATIN oral taken for dyslipidaemia. Vaccination history included: janssen (DOSE 1, SINGLE, Lot/Batch #: 042A21A), administration date: 02Apr2021, for COVID-19 immunization; BNT162b2 (DOSE 2 (BOOSTER), SINGLE, Lot/Batch #: FJ1611, Route & Body site: IM LEFT DELTOID), administration date: 23Dec2021, for COVID-19 immunization. The following information was reported: ASTHMA (non-serious) with onset 02Aug2022, outcome "unknown"; DIABETES MELLITUS (medically significant) with onset 06Jan2023 at 07:23, outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". Therapeutic measures were not taken as a result of diabetes mellitus. Therapeutic measures were taken as a result of asthma.   Additional information: No acute illness at the time of vaccination and up to one month before. Patient was seen in clinic on 01Jun2023 for a lab draw/ nurse visit. After checking in for her visit, she mentioned that she wanted to update her COVID Vaccine status and receive the bivalent vaccine. Prescription, over-the counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event:; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (DIABETES MELLITUS,INTERCHANGE OF VACCINE PRODUCTS) and BNT162B2.  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.
Information has been received from a physician concerning an approximately 83 year old female who on 01-AUG-2007 or 02-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On 02-AUG-2007 or 03-AUG-2007 (the day after receiving vaccine) the patient developed shingles.  The diagnosis was made by an unspecified dermatologist.  No other information was provided.  There was no product quality complaint involved.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Initial and follow up information has been received from a physician concerning an 83 year old female with hypertension, hyperlipidemia, anemia, and osteoporosis, who on 01-AUG-2007 at 14:45 was vaccinated SC in the right arm with a first dose of ZOSTAVAX (Oka/Merck) (Lot#658081/0743U). On 01-AUG-2007 in the evening the patient developed shingles. There was a non painful eruption of the left thigh, left lower leg and left medial ankle. The diagnosis was made by a dermatologist who saw the patient on 06-AUG-2007. It was noted that she had characteristic herpes zoster probably of the sacral dermatome on the left. The physician prescribed valacyclovir 1 gm orally three times a day for 1 week. No other information was provided. There was no product quality complaint involved. On an unknown date the patient recovered. Additional information is not expected.
Technician attempted to give the shot and was not able to puncture skin.  She asked the pharmacist to administer the vaccine.  When pharmacist administered vaccine, patient's eyes rolled back and they passed out.  They were unable to wake the patient and called 911.