chrisvoncsefalvay/vaers-outcomes huggingface dataset:
painful joint inflammation and swelling above right big toe area; painful joint inflammation and swelling above right big toe area; painful joint inflammation and swelling above right big toe area; Progressing to include ioint inflammation both hands and achy lower back and toes swelling and inflammation still present; Progressing to include ioint inflammation both hands and achy lower back and toes swelling and inflammation still present; Progressing to include ioint inflammation both hands and achy lower back and toes swelling and inflammation still present; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Nov2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "mild hypertension" (unspecified if ongoing). Concomitant medication(s) included: LYSINOPRIL taken for hypertension. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation; Bnt162b2 (Dose number unknown), administration date: Mar2021, for COVID-19 immunisation. The following information was reported: BACK PAIN (non-serious), PERIPHERAL SWELLING (non-serious), INFLAMMATION (non-serious) all with onset 11Nov2023 at 06:00, outcome "not recovered" and all described as "Progressing to include ioint inflammation both hands and achy lower back and toes swelling and inflammation still present"; ARTHRALGIA (non-serious), ARTHRITIS (non-serious), JOINT SWELLING (non-serious) all with onset 11Nov2023 at 06:00, outcome "not recovered" and all described as "painful joint inflammation and swelling above right big toe area". Therapeutic measures were not taken as a result of arthralgia, arthritis, joint swelling, back pain, peripheral swelling, inflammation. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
I was not the vaccinator. Pt came to office 3/9/2021 for a rash.  Only thing different is that he received Moderna Vaccine
Patient was given MMRV (Proquad) instead of MMR. This was realized on 3/21/22 during a vaccine count.  Lot # of vaccine administered was  determined to be MMRV and not MMR. Patient's mother was called as soon as mistake was realized. Patient's mother said that pt. was doing fine and had no adverse reactions or concerns.
Poison ivy; This case was reported by a pharmacist via call center representative and described the occurrence of poison ivy rash in a female patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2020) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced poison ivy rash. On an unknown date, the outcome of the poison ivy rash was unknown.   It was unknown if the reporter considered the poison ivy rash to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated the patient experienced posion ivy 1 week after receiving the 2nd dose od Shingrix. The reporter stated that the patient needs prednisone but wants to know interaction with Shingrix.  No additional information. The reporter consented to follow up.
Pain up and down back, arm at time of injection. Lasted rest of day. Next day arm still hurt and then concentrated in arm pit, was sore to the touch and had a lump for a week.
WHITE PLAQUES ON TONGUE AND THROAT; NO ENERGY OR LACK OF ENERGY; HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. 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: Unknown) dose was not reported, administered on 13-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 13-SEP-2021, the patient experienced no energy or lack of energy. On 13-SEP-2021, the patient experienced headache. On 14-SEP-2021, the patient experienced white plaques on tongue and throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from no energy or lack of energy, white plaques on tongue and throat, and headache. This report was non-serious.
Took the first shot, her throat closed up; This is a spontaneous report from a contactable consumer (husband).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took the first shot, her throat closed up on an unspecified date. Patient took 2 Benadryl, and it went away. Patient was recommended to go to the ER, she didn't want to go, went home and was recommended take 2 Benadryl, and that took care of her problem. Patient also took 2 Benadryl before with the second, and that eliminated her throat closing down. Reporter did not want to go through a report for patient, as patient was ok at the time of this report, it was no problem, but he thought to mention, as it might be a problem with the batch, she was ok and had no repercussions. Therapeutic measures were taken as a result of the event. Reason for no lot number of Pfizer COVID vaccine stated as caller unwilling to complete the report. Outcome for the event was recovered on an unspecified date.  Lot number for the vaccine (BNT162B2), was not provided and will be requested during follow up.
Information has been received from the mother of a female child who on 07/25/2000 was vaccinated with one dose of varicella virus vaccine live. Subsequently, the patient experienced a light case of chickenpox with 100 lesions or a severe case of chickenpox (one sibling developed a severe case, and one developed a light case, the reporter did not specify which sibling developed which case.) The patient had been exposed to varicella approximately 24 months after vaccination with no problem. The patient's sibling had a similar reaction following vaccination with varicella virus vaccine live.
RASH AND SWOLLEN ARM TREATMENT GIVEN BENADRYL 25 MG ORALLY AND ICE PACK APPLIED TO SITE OF INJECTION
Generalized fixed drug eruption; This is a literature report for the following literature source(s):   A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GENERALISED BULLOUS FIXED DRUG ERUPTION (medically significant), outcome "unknown", described as "Generalized fixed drug eruption".; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported event Generalized bullous fixed drug eruption and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
fever of 103.3, confusion and fatigue, treatment initiated by physician symptoms lasted 2 days, Res is back to baseline.
In one day after(06/3/201) the second dose of vaccine was given I developed disseminated, itching rash on my neck, anterior chest, abdomen, back, lover back upper and lover extremities including palms and plants, face, scalp. In the first part of the day  rash was like plaques, then gradually rash become like wheels with pink borders and pale center. and it is happened every bday till now. Also I had eyelids  and lips edema at the beginning of my reaction. Also I had middle chest pain and right upper abdomen pain. The same day I was seen at the local Urgent care and was given Methylprednisolone pack, Pepcid and Benadryl. Rash was less when I was takin all that medicine, but then all came back. Iaws seen in  ER on 6/24/21  and then referred to the allergist
Fever, rash in lower lips. Temp in AM 103.2 and @ 4pm 102.5 Pt mom give Tylenol to child and monitoring .
Uncomfortable screaming, high fevers that would break only to come right back, constantly vomiting, slugging and lethargic body language. This lasted almost a full two weeks from the time of vaccine.
shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Shingles: shingrix (he got the shingles vaccine 5 years ago).   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2021, the patient experienced HERPES ZOSTER (shingles). The patient was treated with ACYCLOVIR [ACICLOVIR] ongoing since an unknown date for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.            No concomitant medications was provided by the reporter.  Patient got the first Moderna dose in his left arm in Feb-2021. He had the second vaccine in his left arm in Mar-2021. On 26-JUL-2021, he got shingles.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: The patient fainted within 5 minutes of getting the vaccination. When she regained consciousness, she stated that she tends to pass out after contact with needles and it has happened several times previously.
Fainting, dizziness, tingling in fingers hands, lips, and toes, finger contractions, muscle spasms and weakness
Patient is complaining of severe headaches (common side effect to vaccine) and also complaining of metallic taste in mouth (no new introductions of medications or new foods or no change in diet).
Problem with the thyroids after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THYROID DISORDER (Problem with the thyroids after receiving the vaccine) 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.    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 THYROID DISORDER (Problem with the thyroids after receiving the vaccine). At the time of the report, THYROID DISORDER (Problem with the thyroids after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up received and contains No new Information.
Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient called later that day and said she was losing her eye sight. Told her to go to nearest hospital
Patient received booster Covid-19 vaccine on 1/11/2022.  Patient has no prior history of illness which we are aware of.  Patient presented to the Emergency Department complaining of a headache since 9/2021.  On this day states the headache is worse and not going away.  Some nausea and vomiting with shortness of breath.  Patient was admitted to the hospital on 1/14/2022 with a hypertensive crisis of 240/120.  Patient with BMI of 33. Patient was admitted to the ICU and placed on Cardene drip. He was also given labetalol 100 mg every 8 hours.  His blood pressure came down to a systolic in the 160s. He was seen the next morning by nephrology, hematology, and attending physician.  He was still somewhat confused.  His platelet count was 117,000.   He did have an MRI of his brain which did not show any bleed but showed changes consistent with severe hypertension. It was found out that the patient received the COVID-19 vaccine about 5 days previous to his admission. This may be a reaction to the vaccine. He is thought to have TTP. His blood smear was seen by the hematologist and showed evidence of schistocytes and helmet cells consistent with TTP. Patient was transferred to a tertiary care facility for possible plasmapheresis. Patient was transferred on a Cardene drip. He has been given 2 units of FFP and steroids per recommendations from hematology.
The vaccinated arm had a large, red rash which was very itchy and hot to the touch. The rash lasted for 5 days.
Caught Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caught Covid) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced COVID-19 (Caught Covid). At the time of the report, COVID-19 (Caught Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test: unknown (Positive) COVID-19 Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were given by the reporter. No treatment information were provided by the reporter. Patient stated that she has finished her quarantine on 23-Mar-2021
Milder COVID Arm 2 days post Second Shot; Red Injection Site post second Shot; Itchy Injection Site post second Shot; Blood on the needle Post Second vaccine; Bruising on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (Blood on the needle Post Second vaccine), INJECTION SITE BRUISING (Bruising on the Injection Site), TYPE IV HYPERSENSITIVITY REACTION (Milder COVID Arm 2 days post Second Shot), INJECTION SITE ERYTHEMA (Red Injection Site post second Shot) and INJECTION SITE PRURITUS (Itchy Injection Site post second Shot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (Blood on the needle Post Second vaccine) and INJECTION SITE BRUISING (Bruising on the Injection Site). On 07-Mar-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Milder COVID Arm 2 days post Second Shot), INJECTION SITE ERYTHEMA (Red Injection Site post second Shot) and INJECTION SITE PRURITUS (Itchy Injection Site post second Shot). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 05-Mar-2021, DEVICE CONNECTION ISSUE (Blood on the needle Post Second vaccine) had resolved. At the time of the report, INJECTION SITE BRUISING (Bruising on the Injection Site), TYPE IV HYPERSENSITIVITY REACTION (Milder COVID Arm 2 days post Second Shot), INJECTION SITE ERYTHEMA (Red Injection Site post second Shot) and INJECTION SITE PRURITUS (Itchy Injection Site post second Shot) outcome was unknown.            Concomitant medications was not reported. Action taken with the mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
HPI: decompression of lumbar spine, closed fracture of left clavicle, cholecystectomy, bilateral tubal ligation, total hip replacement. No history of tobacco use. Allergies: penicillins, tetracycline, ativan, ambien, sulfa, apsirin, naproxen, advil Preliminary cause of death listed as COVID-19 with sudden cardiac death
patient reports - developed fever with sweats and chills the night following the injection.                                     - lost consciousness (not fell asleep) for undetermined time                                     - developed painful blisters on roof of mouth which have mostly resolved at time of reporting.                                     - made phone report on 10/2/21 at 2:30 PM and accepted RPh offer to report the event
Vaccine Breakthrough COVID Case. Pt. had two doses of Pfizer COVID-19 vaccine 3/11/2021 &      4/1/2021. Presented to ED with 100.3 fever, mild cough, and nasal congestion, sx onset 6/27/21. Known exposure to (+) HCWon 6/24/2021 during a hospitalization at our facility.  Exposure to same HCW  as reported in VAERS E-Report Number: 581018
Pt. developed erythematous localized skin reaction at injection site. Pruritic in nature. Occurring day following vaccination. Patient ultimately treated with antibiotics as skin reaction, presumed cellulitis resolved.
Patient said the night of her first dose she had a sore throat, cough, and diarrhea. This lasted until Tuesday night.
No additional AE; Medical assistant reporting PROQUAD was administered after experiencing supported temperature excursion.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, current conditions, drug reactions or allergies, and concomitant therapies were not reported.  On 28-APR-2022, the patient was vaccinated after a temperature excursion (product storage error) with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) subcutaneous injection, 0.5ml/once, lot #U031562 has been verified to be valid, expiration date: 06-APR-2023 as prophylaxis (strength, and route of administration were not provided). Timeframe and temperature were not reported.  No additional adverse event was reported.
approx 24day p/vax pt devel left sided bells palsy. left sided facial numbness, weakness. rx prednisone. 7/16 facial weakness improving
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Valacyclovir, Omega 3, Vitamin D3 and Progesterone Cream. On 14th November 2018, the patient received SHINGRIX (intramuscular). On 14th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The batch number for SHINGRIX was not reported. The patient took Estrogen cream and Bioidentical hormones as a concomitant medications. The patient had planned to follow-up with her physician on an unknown date. The reporter consented to follow-up.
This spontaneous report as received from a Medical Assistant via physician refers to identifiable patient. The patient received improperly stored VARIVAX on unspecified date in time period between 31-MAR-2018 to 02-APR-2018 from lot N017395 expiry date 07-JUN-2019 for prophylaxis. The sterile diluent (lot number and expiration date was unknown by reporter) was stored properly. No adverse effects were reported. Temperature and time frame was reported as -14 degree Celsius to -10 degree Celsius (-11.7 degree Celsius) for 1 hour and 8 minutes. No previous temperature excursion involved. The call was because of a data logger. No product quality complaint was involved.
Approximately 15 minutes after receiving H1N1 injection, child was brought to nurse by teacher.  Child was pale, lips cyanotic, diaphoretic, but alert and responssive to verbal stimuli.  Child was laid flat on the floor with legs elevated, removed jacket and shoes, sponged face and neck with wet paper towels and waved ammonia inhalant under his nose.  BP was 72/50.  Within a few minutes child responded and became more verbal, skin warm and dry, color returned to normal with pink cheeks and no cyanosis noted.  Child was given some Coke to drink and returned to his classroom after being observed for about 20 more minutes.
within 2 hours of immunization experienced tenderness, swelling and pain, firm lump at injection site, within  4 hours noticed "heaviness" around eyes and face and slight vertigo and extreme lethargy, flushed face and body and thirsty.  Within 5 hours felt so exhausted and uneasy that I left work early to go home to bed and rest. I was awakened around 11:00  pm with painful body/muscle aches and extreme chills and fever of 102.9.  This lasted for about 24 more hours. I'm currently experiencing joint and muscle aches. Left arm shoulder joint  hurts to raise it.
She got her vaccine, she got very hot and sweaty, very  cold, felt faint and when she went to get dressed her arm to her shoulder past her elbow was red and itchy, hot to the touch.  She thought for a while it was going to be OK.  She went on 10/16/22 to the UC and said that she was having a reaction to the booster shot and gave her an injection of Benadryl.  She was told to put Benadryl cream on it and it took about 5 days before it all went down.  She then saw her doctor and told him about the whole incident, and made aware of it.  She was OK by the point that she saw her doctor.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 12:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 at 14:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 23Feb2021 at 14:30 as dose 2, single (Batch/Lot number: unknown), in left arm, on 13Oct2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 29Apr2022 at 14:45 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "splenectomy" (unspecified if ongoing); "pancreatic removal" (unspecified if ongoing); "Brest cancer" (unspecified if ongoing). Concomitant medication(s) included: INSULIN GLARGINE, start date: 30Jan2020. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". 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; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.