chrisvoncsefalvay/vaers-outcomes huggingface dataset:
palpitations; Hypertension; injection site (entire arm from elbow to armpit) swelling; anxiety; This is a spontaneous report from a Non-contactable Other HCP (patient herself). A 40-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: FC3183, expiry date: unknown) via unspecified route of administration, in left arm on 03Sep2021 16:30, (age at vaccination: 40-years) as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Facility type vaccine was Pharmacy or Drug Store. Patient did not take any other vaccines in four weeks, or medications in two weeks. On 05Sep2021, patient experienced hypertension, palpitations, anxiety, injection site (entire arm from elbow to armpit) swelling. Treatment was given due to the adverse events with HTN. AE resulted in doctor or other healthcare professional office/clinic visit .It was unknown whether patient had been diagnosed with COVID-19 prior to vaccination and was not tested since the vaccination. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
some vaccine leaked out; some of the vaccine leaked out the arm; vaccine leaked out the arm; A spontaneous report was received from a 71-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and some of the vaccine leaked out of arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient reported he was given his first dose of the Moderna vaccine and some of the vaccine leaked out of his arm. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events were considered recovered on 10 Feb 2021.; Reporter's Comments: This report refers to a case of underdose and exposure via skin contact for mRNA-1273 (lot # unknown) with no associated AEs reported.
I got the COVID vaccine at 10 am and at 8 pm experienced numbness around injection site, hot flashes, and then pass out.
This spontaneous report was received from a registered nurse concerning a currently 2 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot# N024567, expiration date: 07-SEP-2019; lot# N022995, expiration date: 23-AUG-2019 or lot# N017701, expiration date: 09-JUN-2019) (dose and route of administration were not provided) as prophylaxis following temperature excursions of 15°F to 46°F (-9°C to 8°C) (19F). The previous temperature excursions were 6°F to 14°F (-14°C to -10°C) (12.7F) for 55 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effect was reported. No product quality complaint was involved. The nurse did not indicate which lot#/expiration date of (Oka/Merck) VARIVAX was received by the patient. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1805USA006682: US-009507513-1805USA007511: US-009507513-1805USA007507: US-009507513-1805USA007508: US-009507513-1805USA007509: US-009507513-1805USA007504: US-009507513-1805USA007510: US-009507513 1805USA007506.
This case was reported by a physician via other manufacturer and described the occurrence of injection site infection in a female patient who received FLUARIX TRIVALENT. On 9th September 2015, the patient received FLUARIX TRIVALENT. On an unknown date, less than a week after receiving FLUARIX TRIVALENT, the patient experienced injection site infection, injection site redness and injection site warmth. The patient was treated with antibiotics nos (Drug Name Unknown). On an unknown date, the outcome of the injection site infection, injection site redness and injection site warmth were unknown. It was unknown if the reporter considered the injection site, injection site redness and injection site warmth to be related to FLUARIX TRIVALENT. Additional details were received as follows: In September 2015, the patient developed injection site redness and injections site warmth. On 11th September 2015, the patient visited her physician, who stated that she had a secondary injection site infection. She was prescribed unspecified antibiotics to resolved the problem.
pt presents to hosp with hypoxemia and SOB; positive for COVID; started on remdesivir, steroids, antibiotics, n-acetylcysteine, Lovenox and Mucinex; DNI; only wants medications; refusing shocking and compressions; pt's condition worsened and she died in the hosp; AHRF secondary to COVID pneumonia
Rash on chest, stomach and entire back.; This is a spontaneous report from a contactable other hcp (patient). A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date were not reported), via an unspecified route of administration, administered in the right arm on 26Feb2021 07:00 (at the age of 48-years-old), as dose 1, single for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium (LEVOXYL) taken for an unspecified indication, start and stop date were not reported. The patient previously took cefalexin (KEFLEX) and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced rash on chest, stomach and entire back on 28Feb2021 03:00. No treatment was received as a result of the event. The event also did not result to either emergency room or physician office visit. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient complains of soreness at injection site "welt" developed next day. Measured site 3-25-04. Two areas from injection site to midline. One (top) measures at 8 cm length, 1 1/2 cm wide. Second (bottom) measures at 10 cm length 2 1/2 cm wide.
Post vaccine patient reports feeling raised heart rate. Pt was transported to med obs via wheel chair. Pt remained in wheelchair.  Pt reports not feeling this way  after her first vaccine . Per patient her BP is higher then usual . Pt didn't want anything to drink . Pt reported feeling better and was released at 11:30 with her grandson .  Vitals as follow:  1114 BP 168/81 HR 67 RR 18 SpO2 96 1119 BP 157/80 HR 66 RR 20 SpO2 96 1124 BP 168/76 HR 67 RR 18 SpO2 98  1129 BP 158/75 HR 67 RR 18 SpO2 98
This spontaneous report was received from another healthcare professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored dose of GARDASIL (strength, dose, route of administration and lot # were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a healthcare professional referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On 19-OCT-2015, the patient was vaccinated with PNEUMOVAX 23, (dose, lot # and expiration date were not provided). Concomitant medication was not reported. On 20-OCT-2015, reported as "within 24 hours", the patient experienced terrible pain in the arm after being vaccinated with PNEUMOVAX 23. The outcome of pain in extremity was reported as recovered on an unspecified in October 2015, reported as "approximately one week after vaccination". The reporter did not assess the relatedness between pain in extremity and PNEUMOVAX 23. This is one of the several reports received from the same source. Additional information has been requested.
It was reported that a female received Fluzone SV '99-'00 on 10/12/99. On 10/17/99, she experienced a rash and itching of the head, back and chest. She has not been evaluated by a physician. No further information is available at this time. From additional information received on 10/19/99, the hospital states that "the rash was from Tetracycline, not Fluzone." From additional information received on 11/18/99, it was reported, "Patient stated reactions due to antibiotic not due to vaccine."
Localized swelling and itching treated with oral antistamines and topical steroid cream.
pt recvd vax & was pregnant 4 wks later; @ 40 wks gestation, there was fetal demise; cesarean performed & female infant was delivered w/nuchal cord X 5;
Started with a fever on the night of 10/20/17 up to 103.8. Patient was given MOTRIN. Woke up a 3 am and vomiting 1 time. Around 7:15 pm on the night of 10/20/17 parents noticed left side of face to be numb and his Tics increased. Mom stated it looked like he had dental work done. The numbness started improving after a few hours but last around his left eye for a day and a half. On 10/26 patient saw Dr., his pediatric neurologist. Patient was cleared by Dr. per mom.
Swelling at injection site from shoulder to elbow - no fever or chills. Lasted until 10/14/12.
Irregular menstrual cycle. Constantly missing periods and when period finally happens it is extremely heavy and painful.
Then about 10 minutes later, the patient fainted for about 7 seconds.; He sat in a chair and fainted again for about 5 seconds.; Laceration to the back of the head and the right lower eyelid; Laceration to the back of the head and the right lower eyelid; When he fainted, he hit the back of his head on the floor and the front of his head on the countertop.; This spontaneous report was received from a health care worker referring to an 18-year-old male patient.   The patient did not have any medical history, concurrent conditions, drug allergies/reactions and was not taking any concomitant medications.  On 28-MAY-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection via intramuscular route (lot # R036913, expiration date: 23-SEP-2021, strength and anatomical location were not reported) to prevent human papilloma virus (HPV).   On the same day, about 10 minutes after the administration of vaccine, the patient fainted for about 7 seconds (syncope). When he fainted, he hit the back of his head on the floor and the front of his head on the countertop (fall). As a result, the patient now had a laceration to the back of the head and the right lower eyelid (eyelid injury and skin laceration). The patient regained consciousness and he sat in a chair and fainted again for about 5 seconds (syncope). Then, the patient was taken to the hospital and it was unknown if the patient was admitted to the hospital. There was no treatment given for adverse events. No lab diagnostic test performed, and the present status of the patient was unknown by the reporter. The patient sought medical attention and seen by a physician. No product quality complaints (PQC) were involved. The outcome of event syncope (first episode) was recovering. The outcome of the events syncope (second episode), skin laceration, fall and eyelid injury was unknown. The causality assessment was not provided.  Upon internal review, the event syncope was determined to be medically significant. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R036913; expirationdate: 23-SEP-2021; 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 suggest a causal association with the device or device constituent
This spontaneous report as received from a Licensed Practical Nurse refers to a 2-month-old patient of unknown gender. No information was provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies. On 18-DEC-2017, the patient was inadvertently vaccinated with PNEUMOVAX 23 (exact dose, route of administration, lot# and expiration date were not reported) for prophylaxis. No adverse symptoms were reported.
On 12/5/00, noticed arm was red with a knot and warm to touch in the area where the shot had been given. On 12/6/00, the redness was greatly increased (inner part of upper arm and down to elbow region). Describes as splotchy and angry and red looking with fever in arm. No shortness of breath or other breathing problem. No actual increased temperature. On 12/11/00, redness present over most of upper arm. Pt denies itching or discomfort or temperature today. MD told her she had an allergic reaction.
approximately 12 hours after receiving, I felt like I was coming down with COVID again.  Having just recovered last month, it felt like a recurrent nightmare.  Shaking chills, slight temp, body aches, exhaustion.  It lasted overnight and into the following day until approximately 3pm when I was able to get out of bed and drink water.
Large, red area on upper (Rt) arm, size of 1 1/2 softball. Area edematous and raised. Red rash on torso. (Rt) arm warm to touch. Took Ibuprofen and BENADRYL. Redness almost gone by 5/26/13 in morning.
pain in his foot; it's hard to walk and bend himself; he's lame; he started having chills for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in his foot), GAIT INABILITY (it's hard to walk and bend himself), GAIT INABILITY (he's lame) and CHILLS (he started having chills for 3 days) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in his foot), GAIT INABILITY (it's hard to walk and bend himself), GAIT INABILITY (he's lame) and CHILLS (he started having chills for 3 days). The patient was treated with IBUPROFEN (ADVEL) for Prophylaxis, at an unspecified dose and frequency. On 20-Mar-2021, CHILLS (he started having chills for 3 days) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in his foot), GAIT INABILITY (it's hard to walk and bend himself) and GAIT INABILITY (he's lame) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information included advel.
Patient received the TD vaccine on 06/01/2023 and noticed the next day, 06/02/2023 that her left deltoid area around the injection side was raised and red "like a mosquito" bite. The area proceeded to grow in redness and size, along with becoming itchy and the patient decided to be seen for these symptoms on 06/08/2023.
New employee with (-) VZ and Hep B titers given one dose each vaccine 4/16/15. Approx 24 hours later, gums felt swollen and irritated. No Tmt. Lasted until 4/19/15. Symptom free 4/20/15.
Pt was given the 0.5ml dose of the 6m-11yr COVID vaccine instead of the 0.5ml of the 12+dose formulation.
Redness inflammation extreme itchiness and hives from axilla to elbow lasting 7-10 days treated w/ antihistamine.
Approximately 4 months after receiving my second dose of Pfizer Covid 19 vaccine, I suffered a 2nd trimester miscarriage in a otherwise completely healthy pregnancy and baby. NIPS test results showed no chromosomal abnormalities. Ultrasound confirmed no heartbeat. Baby girl was measuring 13 weeks.
Triggered a massive immune response and changed me from Hypothyroidism to Hyperthyroidism.
SORE ARM; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210801525.
Adverse events:  Weakness in legs (had a fall), feeling of pins and needles in legs, feet and hands, loss of normal leg activity and  strength, numbness in fingers, loss control of walking abilities Diagnosis: Guillain Barre Syndrome Treatment: 5 days of intravenous immunoglobulin Outcome: Don continues to slowly progress at home with therapy
Information has been received from a health professional concerning a patient who was vaccinated with a first oral dose of rotavirus reassortant vaccine live (human-bovine) a month later than indicated. It was reported that no adverse effect was involved. It was noted that a second dose would be administered as indicated. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Abdominal muscles and tissues pain on my digestive system; Muscles and tendons tied up cause cramping and pain; Muscles and tendons tied up cause cramping and pain; Problem flared up; Extreme pain for five days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Jun2021 17:00 (Lot number: G000196) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: ABDOMINAL PAIN (non-serious), outcome "unknown", described as "Abdominal muscles and tissues pain on my digestive system"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Extreme pain for five days"; MYALGIA (non-serious), MUSCLE SPASMS (non-serious), outcome "unknown" and all described as "Muscles and tendons tied up cause cramping and pain"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Problem flared up".  Additional information: The first dose, dose one. You want me to explain? So, I have had an ongoing problem with my abdominal muscles and tissues pain it's on my digestive system, I have had extensive testing on the digestive system and it's okay so it's just the muscles and tendons that tied up and cause cramping and pain and this is been going on for about a year and a half and so after the first dose and so this problem had really lessened and almost seem to be gone and then when I had the COVID vaccine within in a day this problem flared up again so, it was like a relapse of the problem and I was in extreme pain for five days. I take vitamins, lots of vitamins like Vitamin C and D. I take something called GI restore so it's mainly supplement, vitamin supplements.  Follow-up attempts are completed. No further information is expected.
13 days, after varivax in left arm, pt developed vesicular rash 4cm round below vaccine site.
One week to the day after injection, developed injection site redness, itching and some "thickness" to the feel noted about 8 pm.   Took 650 mg of Tylenol and applied a cold pack.   On morning of Jan 22, applied cold pack again.  Area affected after those twelve hours is approximately 7 cm by 4cm.     Discomfort is minimal but no such reaction has ever occurred before with a vaccination.
Large hard, hot, red knot on arm at injection site. Very hot and itchy.  Knot is about 3 1/2 inches wide
herpes outbreak; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 06Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "herpes", start date: 2018, stop date: 2018, notes: his wife contracted "herpes" in 2018. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "herpes outbreak".  Additional information: The caller states that he is embarrassed about this but since getting the 2nd dose of the Pfizer COVID 19 Vaccine him nor his wife have had a herpes outbreak. They received their 2nd dose of the vaccine 06Jun2021. The caller states that he generally has 3 outbreaks a year and she gets outbreaks about 2 times a month. The both of them have since had zero outbreaks. Caller wanted to know if we have seen this correlation before or if they have gotten "lucky." He would like to report this possible positive event to Pfizer, however declines warm transfer at this time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101547176 Same Reporter/Drug/AE, Different Patient
Soon after vaccine administered within 5 minutes, child turned pale, spit up the ? and ? back to normal a few seconds later.  Still having few pale spells.
No AE/ PQC reported at this time.; VAQTA were administered with an imporperly temperature excursion; This spontaneous report was received from a health care professional referring to a 23 month old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 25-MAY-2021, the patient was vaccinated with an improperly stored temperature excursion dose of  hepatitis a vaccine, inactivated(VAQTA) prefilled syringe, lot #: T033304 , expiration date:02-APR-2022 (dose, and route of administration, were not reported)., for prophylaxis . The administered dose of the vaccine experienced a temperature excursion 36 to 47 degrees Fahrenheit  for 15 minutes, as recorded by a data logger. There was no adverse effect reported.No product quality complaint was involved.   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); devicelotnumber: T033304; expirationdate: 02-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
About 5 hours after the first vaccine I was laying in bed and passed out onto the floor. I have never passed out before and not sure how long I was out, at least an hour. I woke up and lost time I was pretty banged up.
pt recvd vax 8OCT93 & 1 wk later devel a polyneuropathy characterized by vague progressive numbness on the lt side more than on the rt side, tingling electrical dysesthenia in all 4 extremities, h/a, fatigue, difficulty thinking/concentrat
Narrative: Patient reported " cold like symptoms" after the first dose. Then felt better. Requested Mucinex in preparation for second dose.