chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female who was vaccinated with a third dose of Gardasil. Approximately 6 hours after the vaccination, the patient developed a fever, nausea and muscle aches. Unspecified medical attention was sought. On 17-JUL-2007, the patient recovered from the fever, nausea and muscle aches. Additional information has been requested.
Received the first shot 10 days before; A spontaneous report was received from a consumer concerning a male patient, of unknown age, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and the patient had received the first shot ten days before/inappropriate schedule of product administration.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 FEB 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly prophylaxis of COVID-19 infection.   On 22 FEB 2021, at approximately 09:00 am, the patient received the second dose of Moderna vaccine (Lot number: O3OM2OA). The patient did not feel the vaccine went in, there was no blood on the band aid. The patient had received the first shot ten days before. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the event was not applicable.  The outcome of event, received the first shot ten days before, was considered as resolved.; Reporter's Comments: This report refers to a case of  Product administration error for mRNA-1273(Lot number: O3OM2OA), with no associated AEs.
Intestinal pain, diarrhea, nausea, fever and chills for 24 hours.
Shivers(chills) for a couple hours, low grade fever, after chills hot flashes
Small and bigger blisters form; The small ones scab pretty quick; The bigger ones burn and hurt if touched; The bigger ones burn and hurt if touched; Areas where its scratched constantly turn red, then brown. it looks like a bruise then it turns black; Areas where it's scratched constantly turn red, then brown. it looks like a bruise then it turns black; feels like it's running through my blood; I have currents of shocks all over my body; Itchiness all over my body; This is a spontaneous report from a contactable consumer (patient herself). A 43-year-old female patient received bnt162b2 (formulation: solution for injection, Lot number: Batch/Lot Number: GP7533), dose 1 via an unspecified route of administration, administered in left arm (at the age of 43-years) on 16Mar2021 17:30 as dose 1, single for covid-19 immunisation. Medical history included back legs, hips, and chronic migraines from an unknown date and unknown if ongoing. The patient had no known allergies. The patient's concomitant medications were not reported. On 31Mar2021 at 13:00 patient experienced itchiness all over her body. Small and bigger blisters form. The small ones scab pretty quick. The bigger ones burn and hurt if touched. Areas where it's scratched constantly turn red, then brown it looks like a bruise then it turns black. It felt like a mosquito bite where she first feels the sting and then the itchiness. She had currents of shocks all over her body. And it also felt like it's running through her blood. Adverse events resulted in doctor or other healthcare professional office, clinic visit and Emergency room, department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Patient had received her dose 2, single bnt162b2 (Lot number: Batch/Lot Number: ER2613) on 06Apr2021 at 5:30 PM into the left arm. The patient underwent lab test which includes nasal swab (expedited RT-PCR COVID-19 test) on 21Jun2021, and it was negative. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of all the events with pills for itchiness and allergy and scabies treatment. The outcome of all the events was not recovered.
Pt was given first dose of covid vaccine, about 5 minutes later passed out.  Passed out a total of 4 times. Face turned blue and became clammy and hot with a cold sweat Was in our office roughly 30-45 minutes before EMS arrived
48 hours after the vaccine I developed most covid symptoms. This included difficulty breathing, cough, aches, soar throat, and chills. These symptoms then decreased in severity over the next 6 days.
Swollen red sore area at injection site.  Entire left arm and upper left neck and left hand sore in the joints. Previously mild tinnitus has become much louder.
fever over 100°, fatigue, aches, hot/cold flashes, diarrhea, loss of appetite
arthritis & tenosynovitis of both feet, hands, wrists, elbows, shoulders, ankles treated w/pred, NSAID, sulfasalozine & plaquenil;
Shingles after on and a half weeks of 1st shot; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 17Apr2021 at 16:00 (at the age of 64-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history known allergies to only latex gloves with powder. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications in two 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 28Apr2021 at 10:00, the patient experienced shingles after on and a half weeks of 1st shot. Patient visited to doctor or other healthcare professional office/clinic visit. Patient received treatment for event with Acyclovir 800 mg 1tablet 5x/day for 7days. The outcome of the event was recovering.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Left upper arm is red, swollen from deltoid to elbow warm & tender to touch.  Referred to PMD. & this office to follow up with mother on Monday 7-13-09.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M006141, expiration date 28-MAY-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 67 degrees Fahrenheit for 6 hours 30 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Nausia, diarreah, Fatighe; Nausia, diarreah, Fatighe; Nausia, diarreah, Fatighe; This is a spontaneous report from a contactable consumer (patient). A 84-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: EN6206) via an unspecified route of administration in arm left on 19Mar2021 11:45 as dose 1, single (age at vaccination: 84 years) for COVID-19 immunisation. Medical history included heart disease from an unknown date and unknown if ongoing. Concomitant medications were not reported. No COVID prior vaccination and did not tested COVID post vaccination. No known Allergies. No other vaccine in four weeks. Numerous medications in two weeks but not specified. On 21Mar2021, the patient experienced nausia, diarreah, fatighe. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment was received and it was unknown and not reported. The clinical outcome of the event on an unspecified date 2021 was resolved.  Follow-up attempts are completed. No further information is expected.
Information has been received for the  pregnancy registry for GARDASIL from a nurse practitioner concerning a 21 year old female with no pertinent medical history, no previous history of pregnancy and no drug reactions/allergies who on 11-JAN-2008 was vaccinated with the first dose of GARDASIL, on 11-MAR-2008 was vaccinated with the second dose of GARDASIL and on 19-JUL-2008 was vaccinated with the third dose of GARDASIL. Concomitant therapy included PHENERGAN 25mg, Q6H for the treatment of nausea, given on 25-JUL-2008. The patient received the complete series of GARDASIL and was pregnant. The patient sought medical attention, in office. The last menstrual period was on 02-JUN-2008. Estimated date of delivery on 09-MAR-2009. Pregnancy was normal to date. Follow-up information has been received which reported that the patient was taking prenatal vitamins as concomitant therapy. The patient experienced gestational diabetes on an unspecified date, as complication during pregnancy. There were no any complications during labor/pregnancy. On 05-MAR-2009, the patient gave birth a healthy baby female at 38 weeks from the last menstrual period, without congenital anomalies or complications. The baby weighted 7 pounds, the length was 19.5 inches and the apgar score was 8/9. No additional information is expected.
"Red itchy rash on both arms and between her thighs."; "Red raised bumps from scratching it."; "Red itchy rash on both arms and between her thighs."; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC ("Red itchy rash on both arms and between her thighs."), SKIN MASS ("Red raised bumps from scratching it.") and RASH ERYTHEMATOUS ("Red itchy rash on both arms and between her thighs.") in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced RASH PRURITIC ("Red itchy rash on both arms and between her thighs."), SKIN MASS ("Red raised bumps from scratching it.") and RASH ERYTHEMATOUS ("Red itchy rash on both arms and between her thighs."). The patient was treated with CETIRIZINE HYDROCHLORIDE (CETRIZINE) at a dose of 10 mg. At the time of the report, RASH PRURITIC ("Red itchy rash on both arms and between her thighs."), SKIN MASS ("Red raised bumps from scratching it.") and RASH ERYTHEMATOUS ("Red itchy rash on both arms and between her thighs.") had not resolved.
Pain at injection site; Mild headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site) and HEADACHE (Mild headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included QUETIAPINE, LEVOTHYROXINE, LORAZEPAM, IMIPRAMINE, VENLAFAXINE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site) and HEADACHE (Mild headaches). At the time of the report, VACCINATION SITE PAIN (Pain at injection site) and HEADACHE (Mild headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
back ache; metallic taste in mouth; tip of tounge felt tingly; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in mouth), PARAESTHESIA ORAL (tip of tounge felt tingly) and BACK PAIN (back ache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included eloquis and LORAZEPAM (ATIVAN) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DYSGEUSIA (metallic taste in mouth) and PARAESTHESIA ORAL (tip of tounge felt tingly). On 14-Feb-2021, the patient experienced BACK PAIN (back ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Feb-2021, DYSGEUSIA (metallic taste in mouth) had resolved. On 06-Feb-2021, PARAESTHESIA ORAL (tip of tounge felt tingly) had resolved. At the time of the report, BACK PAIN (back ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Non-Significant follow up appended
HYPERSENSITIVITY RASH THAT REPORTEDLY STARTED ON FACE AND NOW SPREADING ALL OVER UPPER EXTREMETIES. I RECOMMENDED TO GET CHECKED OUT BY THE ER SINCE IT HAD SPREAD FROM FACE TO NOW ALL OVER UPPER PARTS OF BODY. HE SAID IT'S JUST ITCHY LIKE POISON IVY. IT SOUNDED LIKE HE WAS GOING TO GO TO THE ER AFTER I COUNSELED HIM TO DO SO.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.   A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EH9899), on 08Jan2021 as dose 2, single (Lot number: EK9231), on 27Sep2021 as dose 3 (booster), single (Lot number: FF8839) and on 08Apr2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Afib" (unspecified if ongoing); "Medullary Thyroid Cancer" (unspecified if ongoing); "history of Mitral Valve Repair" (unspecified if ongoing); "exercise induced asthma" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS; METOPROLOL; LEVOTHYROXINE. The following information was reported: VACCINATION FAILURE (medically significant) with onset 08Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 08Apr2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (03Jun2022) negative, notes: tested negative 03Jun; (05Jun2022) Positive, notes: Tested positive Sunday the 05Jun; (08Jun2022) Positive, notes: still positive Wednesday the 08Jun. Therapeutic measures were taken as a result of covid-19.  Follow-up attempts are completed. 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 with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available.
On the 4th day after the initial vaccination shot, I began having chills about 6:00 pm and a temperature of 101.4 about 8:00 pm along with some achiness.  My temperature dropped to about 100 and chilling stopped by the time I went to bed about midnight.  The nextg morning by 11:00 am my temperature was back to normal.  I did experience some tiredness on the 10th but it was resolved by the next day.
30 day long periods, have happened 4 times since the COVID Pfizer vaccine, have never happened before.y periods in general contained a heavier flow, crippling cramps that made me incapacitated to do anything but sleep, and stronger mood swings.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients received improperly stored doses of RECOMBIVAX HB lot # M001578 with expiration date 21-NOV-2018 (dose and route of administration were not reported). No adverse effects reported. This is one several reports received from the same source. Additional information has been requested.
dizzy; injection site had been significantly swollen since the vaccine administration; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 10 years old of an unknown gender patient who experienced dizzy and injection site had been significantly swollen since the vaccine administration , after receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Patient has no known drug allergies.   On 22-Feb-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported and a dose of suspect GARDASIL 9 not produced by Sanofi Pasteur (lot 1691180 and expiration date:15-Nov-2022) at an unknown dose once via unknown route in unknown administration site for immunization.  On 24-Feb-2021 (latency: 2 days )the patient developed a non-serious event of dizzy (dizziness) and injection site had been significantly swollen since the vaccine administration (vaccination site swelling) following the administration. On 09Mar2021 the dizziness and the swelling were improving.  It was reported that "The patient had received a TdaP vaccine (Adacel by Sanofi) during the same visit, and is on several anxiolytic medications (see AE Details). Patient has no known drug allergies"  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events  Outcome: Recovering / Resolving for both events
Headache, Myalgia, pain at site of injection, chills headache, fatigue no fever Narrative:
Developed injection site redness and hives within 1 hour of administration. Ice pack was applied to area.
PROQUAD was administered to a 16 year old patient; No additional AE; This spontaneous report was received from a registered nurse and refers to a 16-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with one dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (inappropriate age at vaccine administration). There was no additional adverse event reported.
5 months later, I ended having my left side numb, I went to the hospital, and they found I had a stroke on the right side of my brain.  I am still taking medicine for my heart.
Fever, chills, aches, dizziness, lower digestive problems, headache and severe pain and inside bruising from site of shot around to back of upper shoulder blade to the left neck then down under my left arm.
contracted Covid; contracted Covid; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration on 31Mar2021 as dose 2, single, and received first dose of BNT162B2 (Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration on 03Mar2021 as dose 1, single; both for COVID-19 immunization. Medical history and concomitant medications were not reported. for COVID-19 immunization. On 02Aug2021, Patient contracted COVID. Patient stated, that patient unblinded in order to know vaccine status (placebo) and subsequently received the Pfizer vaccine. Lab test included sars-cov-2 test reported as contracted COVID (COVID positive status). The outcome of events was unknown.  Information on the lot/batch number has been requested.
Occasional allergies; Left middle finger swelled and painful; Left middle finger swelled and painful; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Occasional allergies), PAIN IN EXTREMITY (Left middle finger swelled and painful) and PERIPHERAL SWELLING (Left middle finger swelled and painful) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced HYPERSENSITIVITY (Occasional allergies), PAIN IN EXTREMITY (Left middle finger swelled and painful) and PERIPHERAL SWELLING (Left middle finger swelled and painful). At the time of the report, HYPERSENSITIVITY (Occasional allergies), PAIN IN EXTREMITY (Left middle finger swelled and painful) and PERIPHERAL SWELLING (Left middle finger swelled and painful) had not resolved.            No concomitant medication provided. No treatment information mentioned.  The patients left middle finger swelled and was painful after second dose of Moderna vaccine. She had occasional allergies.  Reporters causality of events with Rinvoq was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
This case was reported by a consumer via facebook interactive digital media and described the occurrence of irritable bowel syndrome in a 18-year-old male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. Previously administered products included Meningococcal B vaccine with an associated reaction of general physical health deterioration (1st dose, refer case US2018GSK122233). On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced irritable bowel syndrome, gastrointestinal disorder, chronic diarrhea, stomach pain and liver disorder. On an unknown date, the outcome of the irritable bowel syndrome, gastrointestinal disorder, chronic diarrhea, stomach pain and liver disorder were unknown. It was unknown if the reporter considered the irritable bowel syndrome, gastrointestinal disorder, chronic diarrhea, stomach pain and liver disorder to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient had suffered many health problems since first dose. Then the booster dose just made it worse.  No one would give the reporter a straight answer if it was a possibility. The patient had gastrointestinal issues that came out of no where. The patient had his gallbladder out. The patient had chronic diarrhea and stomach pain, liver issues. The physician said it as irritable bowel syndrome. The case was linked with the case US2018GSK122233, reported by the same reporter for the same patient.
Started with itchy burning palms. Moved to a rash on arms, legs and torso. I also developed some lumps on my wrists, fingers and feet.  Ended with very red, swollen palms and soles of my feet. Last about 4 days in total.