chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Localized reaction observed on 6/4/05 where varicella vaccine was given. Measurement of  induration of 27mm x 52mm and reddness of 80mm x 65mm. Temp=100 F (oral). 6/5/08 measurements were 36mm x 54mm induration and 44mm x 54mm reddness. temp= 100 F (oral).
LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient 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: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced low grade fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever and headache was not reported. This report was non-serious.
Rapid Heart Rate - still on going Fever Chills Headache Muscle Pain Leg Pain
This spontaneous report was received from a pharmacist and refers to one unspecified patient of unknown age and gender. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX, dose and frequency unknown (lot # L029482, expiry date 06-NOV-2016). No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a back office lead and refers to a 29 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L038499, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Hive-type rash around the injection area.   Not necessarily at the injection point but around a circle, centered at the injection point,  about 2" - 3"  away..
Information has been received from a pediatrician concerning an 11 year old male with Shwachman-Diamond syndrome including variable hypogammaglobinemia and inconsistent white blood cell status and no history of varicella who in mid August, 2006 was vaccinated with a dose of Varivax. The patient has had at least three outbreaks of varicella described as papules, no vesicles. He has been admitted to the hospital three times since September 2006 and responded to intravenous acyclovir twice. He also received intravenous immune globulin but it made no difference. There have not been any T-cell studies. The patient went home on oral acyclovir but it was not effective. He continued to have an atypical varicella and is currently hospitalized although discharge is pending. It was noted that the patient's younger sister was vaccinated with Varivax at the same time and also has Shwachman-Diamond syndrome and has not had any adverse reaction to date. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological sample to be analyzed by PCR to identify if VZV is present and if it is present to identify whether it is associated with the wild-type VZV strain or with the  Merck vaccine VZV strain. The pediatrician noted that she can also do PCR analysis at her hospital and was not sure if she would be sending specimens. Additional information has been requested.
Patient was administered 0.25 ml of the Moderna bivalent covid vaccine on 5-1-2023.  She was contacted and advised to come back to receive the other 0.25 ml.  She returned and received the second 0.25 ml 5-2-2023.
Patient was to receive the bivalent Pfizer vaccine but was administered the monovalent vaccine. The monovalent vaccine vial was inside the same box of the bivalent vaccine vials. Patient was notified to come back in 2 months to receive the bivalent vaccine
Patient received the Men B and HPV Vaccine, few minutes after HPV  patient was receiving TB test when the MA notice her head tilting to the left side and eyes rolling with mild shaking lasting for 30seconds. Provider came in  Patient was on the bed and she was laid down with feet elevated and MA recheck Vitals and kept in the room for 20min. patient was sit up position and gave some cold water as provider indicated. Patient Blood pressure was low and patient had Dizziness 95/60 Provider indicated to send patient to ER. Called patient mother at 4:45pm and followed up patient was discharge she was doing beter.
Pt recd 3 vax doses 26Jul89, 31Aug89, 25Jan90. Titer was neg. 4th dose given 8Aug90. Titer not repeated.
Nausea lasting 2 to 3 days 3X since vaccination.  Antacids did not work.  Takamine did not work.
I have a red area the size of your fist on bicep that is very sore to the touch like a bruise and it itches.  This is not the injection site.  This is where the solution seeped down into the muscle.  This is the 7th day after injection.
I had Covid-19 on January First. On the same evening as I got the shot I noticed when I ate something that it tasted metallic. All food tasted and smelled metallic for two weeks.  Three weeks after the shot the problem resolved for cold food. It is five weeks I still have a problem with eating hot food that it tastes and smells metallic. I consulted a doctor and he told me that he doesn?t know what to do.
This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. The patient's medical history, rug reactions or allergies and concurrent conditions were not reported. On 15-JUL-2015, the patient was vaccinated with a dose of an improperly stored PROQUAD (Merck), lot number K003818, expiration date 14-SEP-2015 (confirmed as 15-SEP-2015), (dose and route were not reported). No adverse effects were reported. There was no concomitant medication reported. This is one of several reprots from the same source. Lot number K003818 has been verified to be a valid lot number for PROQUAD (Merck). Additional information has been requested.
The itching I had developed shortly after the first vaccination exacerbated to an intense level. I was up in the middle of the night taking hot showers to calm the itching. My scalp broke out into pustules. The front my of my arms started to break out.. It only went to from my elbows up to my wrist. I went to the clinic to see a doctor. He thought I ate something that I was allergic to, however I don't have any food allergies. He gave me an antihistamine, Hydroxyzine. I took it that night but the itching kept going. It spread to my stomach, chest, chin, and back of neck. I continued the medication but the sores were breaking open. I went to another town and had my dermatologist check up and she was concerned about the itching. She gave me a refill of a prescription of Mupirocin, as well as hydrocortisone. I had my yearly check up at the clinic. They completed a blood panel and my liver panel showed that I was very sick. I was sent to a hepatologist and I had a CAT scan with contrast, ultrasound, and scan for liver elasticity. I was diagnosed with an autoimmune disease, Primary Biliary Cirrhosis. I was told to take Ursodiol, but I refused because I was on a medication called Evenity. I then had to do a liver panel every 3 months. The doctor told me that its possible the vaccination is the cause of my liver issue but there is no research to prove it. I was told that I could not get by without a local doctor. The internist that I was given told me I had a staph infection and he put me on very strong antibiotic and I had a blood test later after I finished the antibiotic to see if the infection clear. I was also put on Clobetasol. I was told that I had to stay on the Ursadiol after my zoom call with the doctor at the clinic. The clinic called back and told me that I had to stop the Ursadiol immediately because I was probably having an allergic reaction to it. I have bee off the Urasdiol for 2 1/2 months now and each day the itching subsided. But my liver numbers kept going up. I had another liver panel and it came back normal. However my cells were showing inflammation and that I no longer had PBC.
fatigue; 99 degree temperature; rash on all parts of my torso; lost my sense of smell; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Dec2021 10:00 (Lot number: FG3527) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "back problems" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 22Apr2021, when the patient was 57 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 01Apr2021, when the patient was 57 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 04Dec2021, outcome "recovered" (10Dec2021), described as "Booster"; FATIGUE (non-serious) with onset 05Dec2021, outcome "recovered" (10Dec2021), described as "fatigue"; BODY TEMPERATURE INCREASED (non-serious) with onset 05Dec2021, outcome "recovered" (10Dec2021), described as "99 degree temperature"; RASH (non-serious) with onset 05Dec2021, outcome "recovered" (10Dec2021), described as "rash on all parts of my torso"; ANOSMIA (non-serious) with onset 05Dec2021, outcome "recovered" (10Dec2021), described as "lost my sense of smell". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of immunisation, fatigue, body temperature increased, rash, anosmia.  Additional Information: The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient was not tested Covid post vaccination. Other medications in two weeks: Gabepentin-daily.   No follow-up attempts are possible. No further information is expected.
Crying 1-2 hrs periods; Pale, confused, stiff, unwilling to walk, no temp elevation; Parents called the state Hlth ctr & were referred to LMD; Saw child - referred child to Peds; Parents to monitor child next 48hrs; MD felt vax related;
This spontaneous report was received from a registered nurse and refers to a 4 month old female patient. The patient had no pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 16-JAN-2019, the patient was vaccinated with improperly stored doses of LIQUID PEDVAXHIB second dose, intramuscularly in the right upper thigh lot number R013572. Other suspect therapies included PEDIARIX second dose, intramuscularly, in the left mid thigh, lot number XT73A, PREVNAR 13 second dose, intramuscularly, in the left lower thigh, lot number W33490 and ROTARIX second dose, orally, lot number 7Y2YE all of them for prophylaxis (expiration date was not provided). No adverse events reactions thus no treatment was prescribed. Data logger was involved.  The vaccine was exposed to a temperature excursion in the refrigerator below 2°C. The reporter stated that the refrigerator had been checked and the temperature was stable. The reporter spoke with a company representative and the vaccine was considered viable as it was not exposed for a too long period that affect the vaccine adversely. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA002414: US-009507513-1902USA002412: US-009507513-1901USA011370.
had covid about two weeks ago; had covid about two weeks ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "had covid about two weeks ago". Clinical course: A caller said that her husband had covid about two weeks ago and wanted to know if her husband could get the second bivalent vaccine shot now or if he had to wait. Transferred.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received Pediarix, MMR, Varivax on 2/07/08.  Was seen in my office on 2/8/08 with report of fever to 104.  Was 102.6 in the office, otherwise was a normal exam.  This was the second such history of fever after immunization given 3-28-07 by health dept.
Heat at the injection site; Swollen arm; Bruising; Mild headache; felt itchiness and burning on and off on eyes; felt itchiness and burning on and off on eyes; Lightheadedness; Blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat at the injection site), HEADACHE (Mild headache), EYE PRURITUS (felt itchiness and burning on and off on eyes), EYE IRRITATION (felt itchiness and burning on and off on eyes) and DIZZINESS (Lightheadedness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Glaucoma. Concomitant products included TIMOLOL for Glaucoma, LEVOTHYROXINE for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (Mild headache), EYE PRURITUS (felt itchiness and burning on and off on eyes), EYE IRRITATION (felt itchiness and burning on and off on eyes), DIZZINESS (Lightheadedness) and VISION BLURRED (Blurry vision). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Heat at the injection site), PERIPHERAL SWELLING (Swollen arm) and CONTUSION (Bruising). At the time of the report, VACCINATION SITE WARMTH (Heat at the injection site), EYE PRURITUS (felt itchiness and burning on and off on eyes), EYE IRRITATION (felt itchiness and burning on and off on eyes), DIZZINESS (Lightheadedness), PERIPHERAL SWELLING (Swollen arm) and CONTUSION (Bruising) outcome was unknown and HEADACHE (Mild headache) and VISION BLURRED (Blurry vision) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. 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: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
The patient received the BEXSERO vaccine in the morning. Later that same day he was at rest standing and had an abrupt onset of severe chest and upper mid back pain. He went to his school's medical center and was told he had a muscle spasm. His symptoms were not improving so he went to the PCP's office two days later (7/16). At the office visit the physician had a concern for differential breath sounds and sent the patient to the local ED. At the ED a chest x-ray showed a large pneumothorax. A chest tube was placed in the ED and the patient was admitted to the hospital for management.
Fever (101 degrees) for about 12 hours Arm soreness for 2 days (with both 1st and 2nd shot)
This is a spontaneous report received from a contactable reporter A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: RASH ERYTHEMATOUS (non-serious), outcome "recovered", described as "a young lady who said that she had a red rash and it went away after 4 days."; SWELLING (non-serious), outcome "unknown", described as "swollen up/she had same type of swelling".  Additional information: When the caller went to the pharmacy, the caller heard a young lady who said that she had a red rash, and it went away after 4 days. Said she had the same thing happen with her 3rd booster, it swollen up on her and took 4 days go down, she told her it would go away. Caller does not have the lot number of the vaccine the lady in the pharmacy that said she had the same thing, she was withheld, she was waiting for her medication, she was at the other cash register while she was explaining it to the pharmacist, she had same type of swelling. She looked quite young.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Extreme universal joint pain, mostly resolved at 3 month, difficulty resolving pelvic/S.I. Joint arthritis flare up.  5 days Prednisone did not seem helpful
RD - low grade fever, 8 cm round red, tenderness started 9-14 day after administered (MCV4, HPV). LD - 4cm round, low grade tenderness started 9-14-2010 (Tdap).
Nose bleed everyday sometimes difficult to stop and happens one to two times a day since he rcvd the shot.
Patient had large red swollen area on left arm from shoulder to elbow, rash, blisters, itching, nodular under surface of skin.  Was seen in clinic by her primary care provider.  No treatment but was advised by her provider to not get 2nd dose.
pt recv vax 25OCT95 & devel varivax 30MAY97;rt arm 4;lt arm 8;rt leg 7;lt leg 5;head 4;chest 6;back 5;total 29 lesions;
Erythemic area of induration approx. 4 inches across about 6 inches tangential from injection site with initial redness, pain, swelling. Eythema has persisted over 4 days with no decrease in size but has lightened in color. Initial somnolence, lethargy, overall feeling of weakness which has dissipated. Pt will take oral diphenhydramine and outline the area. Will seek medical treatment if area doesn't improve over 24 hours. Will discuss with PCP before receiving next dose of PPSV23.
injection site pain; tiredness; headache; muscle pain; chills; fever; joint pain; This is a spontaneous report received from a Pfizer-sponsored program via Regulatory Authority support. This is a contactable consumer or other non HCP (patient) reported for himself. A 78-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 16Feb2021 as single dose for covid-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date the patient experienced injection site pain, tiredness, headache, muscle pain, chills, fever, joint pain. Clinical course was reported as male consumer received the first dose of the COVID vaccine on 16Feb2021. His symptoms began 12 hours after the first dose, all similar to when he had COVID in November. He did not have an anaphylactic reaction, however, he had side effects of injection site pain, tiredness, headache, muscle pain, chills, fever, and joint pain. He did not have injection site swelling or redness. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.