chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had significant pain in my left jaw joint, especially when I opened and closed my mouth. The intense pain came in waves like it was spasming. The pain was a 6.5 out of 10. Ibuprofen didn't stop the pain. It lasted for about 10 hours and affected my sleep. By the morning, it had resolved after taking one 350 mg Vicoden. I was not informed which type of Tdap booster vaccine that I was given. I have received tetanus booster shots every ten years for my entire life, and I have never had a reaction like this one. I couldn't find any information on the internet about an adverse side effect to the Tdap that includes a side effect that affects the jaw like lockjaw, so I thought I should report it.
No additional adverse effect; PNEUMOVAX 23(syringe) that underwent a temperature excursion was administered; This spontaneous report was received from an other reporter and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 27-SEP-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection in prefilled syringe, lot # T040202, expiration date: 11-SEP-2022 (exact dose, injection site and route of administration were not provided) for prophylaxis.  On an unknown date, the administered dose experienced a temperature excursion of above 47 degrees Fahrenheit (47.5 degrees Fahrenheit) for 2 hours 32 minutes and 0 seconds. No previous temperature excursion had occurred. No adverse effects were reported.
22Apr91 pt vax 3rd vax;  after 1st & 2nd doses exp h/a, after 3rd dose exp arthralgias & h/a.  H/a resolved w/ meds but arthralgias persisted.
Started with headache, muscle and joint pain and chills. On 24th and fever 99.9 and got nauseous. Took ibuprofen and about 2 hours later symptoms improved, broke fever. Continued with joint pain and nausea. 25th - had nausea and joint pain and headache and fatigue. Nausea - didn't eat much for three days; could drink fluids - never vomited. Injection site: red, warm - two-inch red ring around it. Saturday the 26 - headache broke; nausea and joint pain stayed, and arm stayed red. COVID swab -rapid test, negative 27th - still nauseous but ate a little; injection site improved - flat hive rash from injection site down to elbow. took Ibuprofen each day once or twice a day which helped with joint aches. Monday 28, ZYRTEC went to work; hive rash on arm stayed through Wednesday, 30th And saw the Dr on Wednesday - to see if should take a second dose.  Dr advised to lose up on antihistamines; TYLENOL and ibuprofen right before I get next dose. Rash went away by end of day on 30th.
No additional adverse effects reported; one patient was administered improperly stored PROQUAD; This spontaneous report has been received from a registered nurse, concerning a 5-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not provided.  On 21-JUL-2020, the patient was vaccinated with  improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (Albumin status rha) lot # S027465 with expiration date 02-MAR-2021 (dose, frequency, route and anatomical location were not provided) for prophylaxis which was reconstituted with a properly stored sterile diluent. No additional adverse effects were reported.  The vaccine was stored at a temperature between -14 to -10 Celsius degrees which showed -13.1 Celsius degrees and a time frame of 1 hour and 18 minutes with previous temperature excursion of (-9 to 8 Celsius degrees for 8 hours and 25 minutes and, -14 to -10 Celsius degrees which shoed -10.8 Celsius degrees for 6 hours and 30 minutes).Digital Data logger was involved.
Severe joint pain in right arm, similar to pain I had when I had a torn rotator cuff.   Have taken 800mg Ibuprofen for inflammation and pain every 8 hours. Does not help. Tried taking Tramadol HCL  50 mg for pain as well to no avail. Ice and heat do not help. There is also a lump about the size of a penny at the injection site.
Hives on Face, neck, elbows, hands, ears. Swollen eyes. Extremely itchy Pruritis.
This spontaneous report was received from a pharmacist via company representative refers to a male patient of unknown age. On 02-MAR-2014, the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). On an unknown date in March 2014, the patient experienced rash. On an unknown date in March 2014, the patient experienced full blown sh ingles. The patient sought medical attention and called to pharmacy. No treatment was given to the patient. The outcome of full blown shingles and rash was reported as not recovered. The reporter did not provide the causality between the events and the suspect drug. Additional information has been requested.
Pt recvd 1st hep B vax 16APR90 & exp ache & sore inject site.P/ 3rd vax,pt exp pain & aching arm.Tx w/ rubbing alcohol.
The patient reported feeling dizzy and fell from chair to floor.  Pt hit her head on the left side; has a small bruise.  Pt received 1st dose in Left arm.  A+O x 4 medically stable.  VS with normal limits.  Pt c/o dizziness and EMS called and arrived at 1410.  Pt states feeling fine and declined EMS services. Pt husband agreed to take patient to the hospital in private vehicle.
Back is Itching/ Head, eyes, ears itching/still experiencing the itching on back and scalp; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Back is Itching/ Head, eyes, ears itching/still experiencing the itching on back and scalp) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A. and 011A21A) for COVID-19 vaccination.     The patient's past medical history included Cancer (Surgery Removal) in April 2002, Liposarcoma (Surgery Removal) in February 2016 and Thighplasty (Surgery Removal) in 2021. Concomitant products included BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (ZIAC [BISOPROLOL FUMARATE;HYDROCHLOROTHIAZIDE]) for Blood pressure, SIMVASTATIN for Cholesterol, APOAEQUORIN (PREVAGEN [APOAEQUORIN]) for Memory deficit, ZINC for Vitamin supplementation, CHOLESTEROL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PRURITUS (Back is Itching/ Head, eyes, ears itching/still experiencing the itching on back and scalp). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse reaction, at a dose of 1 UNK. At the time of the report, PRURITUS (Back is Itching/ Head, eyes, ears itching/still experiencing the itching on back and scalp) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included  unspecified blood pressure medication. Patient had experienced itching in back and near eyes.  Treatment included Benadryl but was not useful.  For the last discontinued use of gel supplementation except BP pills , cholesterol, and aspirin as well as new pain products .   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Additional information received on 2-AUG-2021 that contains Significant Follow-up Append Information that includes concomitant medications ( ziac , simvastatin, zinc, prevagen and aspirin ) , Ethnicity and patient demographics ( Height and Weight updated ), race information updated , facility details added. medical history updated ( cancer, liposarcoma. thigh surgery). On 15-Aug-2021: Follow up information received : Event description and outcome updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, concomitant medication is a confounder.
I was very fatigued; Had Chills; Migraine; Arm Pain; The worst reaction was the lymph node in my left armpit was incredibly swollen, about the size of an orange.; The worst reaction was the lymph node in my left armpit was incredibly swollen, about the size of an orange. It was very painful.; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 12Mar2021 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient was very fatigued, had chills, a migraine and arm pain. The worst reaction was the lymph node in the left armpit was incredibly swollen, about the size of an orange. It was very painful. The other symptoms lasted about 2-3 days, but the swollen lymph node lasted about a week. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigued, had chills, a migraine, arm pain, lymph node in the left armpit was incredibly swollen, about the size of an orange and it was very painful were resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
suspected vaccination failure; shingles; PHN; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient received shingles vaccine and still experienced  a severe case of shingles and still suffer from PHN (Post herpetic neuralgia) years later. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Dizziness, tightness in back of neck, tightness both sides of throat, tightness in TMJ both sides immediately and over the next 30-40 minutes.  Pink donut shaped 3 inch diameter patch at injection site the next day.  Immediate reactions resolved within the 40 minute period.
This is a spontaneous report from a contactable consumer (patient's mother). A male baby of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0187) via trans mammary route on 04Jun2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0217) on 25Jun2021 as single dose for COVID-19 immunization. Patient had no medical history or known allergies. Patient concomitantly received prenatal multivitamins via trans mammary route within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19. On 04Jun2021, patient received first dose of vaccine via trans mammary route (Vaccine exposure via breast milk) and later received second dose on 25Jun2021. On 02Aug2021, patient underwent lab test of Abbott BinaxNOW (Nasal Swab) and was tested positive, diagnosed with COVID-19. As per reporter (patient's mother), since her child got COVID-19, so the antibodies transferred through her breastmilk wasn't enough to protect him. Outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100998441 Mother case
approx 9 hrs p/inject began having prolonged crying-mom states cry was high pitched & cont but would stop briefly; crying lasted about 1hr;
This spontaneous report was received from a nurse regarding a female patient (who is also a nurse). The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-JAN-2019, patient was vaccinated with GARDASIL 9 lot # R002345 for prophylaxis with no incident. On 02-JAN-2019 when the nurse was placing the safety lock on needle post administration, the syring hub broke (Syringe issue) and needle went into nurse's hand (exposure via skin contact, occupational exposure to product and Accidental exposure to product). No adverse events were reported.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9265) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "hyper- cholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, stop date: 05Aug2022; DILTIAZEM, start date: 03Aug2022. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain add the injection site". Therapeutic measures were not taken as a result of vaccination site pain.
Burning in eyes; itching eyes; swelling arm; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Burning in eyes), EYE PRURITUS (itching eyes), PERIPHERAL SWELLING (swelling arm), CHILLS (chills) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced EYE IRRITATION (Burning in eyes), EYE PRURITUS (itching eyes), PERIPHERAL SWELLING (swelling arm), CHILLS (chills) and HEADACHE (headache). At the time of the report, EYE IRRITATION (Burning in eyes), EYE PRURITUS (itching eyes), PERIPHERAL SWELLING (swelling arm), CHILLS (chills) and HEADACHE (headache) outcome was unknown. Not Provided          No concomitant medication was reported.  Treatment information not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Trouble speaking, dizziness, trouble walking, weakness-almost fell (I caught her). Got her inside, sat her down, got her a drink of tea. She seemed ok at that point, but did call after hours doctor. Told to check blood pressure (a little high, but not out of norm). Doctor said the shot did not cause.
2x4 inch bruise surrounding inj site. Pt said bruise started day after inj. She came to me today. Described as sore.
12-4-12 started with petechiae that spread to trunk & extremities. No fever or other illness. Seen in office 12-6-12 dx'd with ITP S1 (platelet count of 8000) referred to hematology.
broke out in hives, itchness all over body, redness, swelling and warmth at site of shot.
5/18/2004: Received telephone call from patient reporting onset of general malaise, body aches and fever on Saturday, 5/15/04, one day after receiving MMR vaccine.
Optic neuritis; This spontaneous case was reported by a consumer and describes the occurrence of OPTIC NEURITIS (Optic neuritis) in a 20-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OPTIC NEURITIS (Optic neuritis) (seriousness criterion medically significant). At the time of the report, OPTIC NEURITIS (Optic neuritis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment information was mentioned.  Company Comment : This case concerns a 20-year-old, female patient with no relevant medical history, who experienced the unexpected event of optic neuritis. The event optic neuritis occurred 3 weeks after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 20-year-old, female patient with no relevant medical history, who experienced the unexpected event of optic neuritis. The event optic neuritis occurred 3 weeks after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
pain in my pinky finger; extremely ill; nauseous; headache; dizzy; diarrhea; sore arm; muscles started twisting in her legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MUSCLE SPASMS (muscles started twisting in her legs), PAIN IN EXTREMITY (pain in my pinky finger), NAUSEA (nauseous) and DIZZINESS (dizzy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE, LORATADINE and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MUSCLE SPASMS (muscles started twisting in her legs), NAUSEA (nauseous), DIZZINESS (dizzy), DIARRHOEA (diarrhea) and HEADACHE (headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in my pinky finger) and ILLNESS (extremely ill). At the time of the report, PAIN IN EXTREMITY (sore arm), MUSCLE SPASMS (muscles started twisting in her legs), PAIN IN EXTREMITY (pain in my pinky finger), NAUSEA (nauseous), DIZZINESS (dizzy), DIARRHOEA (diarrhea), HEADACHE (headache) and ILLNESS (extremely ill) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment medication was not reported.
A nurse reported that a 28 year old female passed out after being vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject had no adverse experiences following previous immunizations. On an unspecified date, the subject received her second injection of Engerix B (5362A2). The nurse reported that the injection caused the subject to "scream out in pain" and she "passed out." The events resolved after an unspecified period of time. The reporting nurse considered the vents to be possibly related to Engerix B administration.
Redness, non tender- size of tennis ball at injection site. Advised cool compresses.
Information has been received from a physician's assistant concerning a 23 year old female patient with no pertinent medical history and not known allergies, who on 28-JUL-2009 was vaccinated with the first dose of GARDASIL (lot not reported). On 29-SEP-2009, the patient has been vaccinated with the second dose of GARDASIL (lot not reported). Concomitant therapy included YAZ. The physician's assistant reported that the patient started to experienced generalized thinning of her scalp hair "almost immediately" after the second dose of GARDASIL. On an unknown date, the hair loss resolved. Patient's outcome at the time of the report was recovered. The patient sought medical attention through an office visit. Follow up information has been received from the physician's assistant via medical records concerning the female patient who on 29-SEP-2009 at 17:52 was vaccinated with the second dose of GARDASIL (lot number 661453/0249Y) into left deltoid. On 29-SEP-2009, almost immediately after injection, the patient experienced hair loss which began to resolve as of appointment date on 10-FEB-2010, the patient was recovering from hair loss. On 26-JAN-2010, which blood cell count, red blood cell count, hemoglobin, hematocrit, MCV, MCH, MCHC, RDW, platelet count, MPV, segs (polys), lymphocytes, monocytes, eosinophils, basophils and TSH were performed which were in normal range. Additional information has been requested.
Case reference number B0986685A was reported in a literature article and refers to 84-year-old female subject that developed pancreatitis 10 hours after receiving an unspecified low dose influenza vaccine (manufacturer, batch number, dose and injection site unknown). The subject is reported to have been healthy prior to the event. She had no history of prior gastrointestinal symptoms, gall stones, fatty food intolerance or alcoholic intake. She had been diagnosed with acute pancreatitis seven years before and 12 hours after having an influenza vaccine. She had been on hydrochlorothiazide which was thought to have been the precipitant at the time. No other information on the subject's medical, family history or concurrent medication has been provided. An 84-year-old female subject presented to an emergency department on an unspecified date with complaints of severe abdominal pain, nausea, vomiting and one episode of diarrhea, but she denied fever or chills. She had received an unspecified low dose influenza vaccine 10 hours before during a routine follow up visit at her primary care physician's office (manufacturer, batch number, dose and injection site unknown). On clinical examination she was afebrile with a pulse rate of 95 bpm and a blood pressure of 100/68. She had significant epigastric tenderness but without guarding or rebound. Her liver and renal function tests were normal, her lipase level was 1081 and the triglyceride level was normal at 54 mg/dl. Diagnosis was pancreatitis following influenza vaccination. Treatment was conservative and consisted of bowel rest, intravenous fluids and analgesia. Outcome was recovery with discharge after three days. Author's conclusion: "The two episodes of pancreatitis in our patient followed the vaccinations too closely to be explained by chance alone. In view of the absence of predisposing factors, pancreatitis was almost certainly precipitated by the influenza vaccination, although underlying pathophysiological mechanism is unexplained."