chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information have been received from a pharmacist concerning a 73 year old female with concomitant medications, drug allergies, and pertinent medical history not specified, who on 12-MAY-2008 was vaccinated, Sub Q, with a dose of pneumococcal 23v polysaccharide vaccine (Lot #, while hospitalised for diverticulitis. On 12-MAY-2008, the patient's left upper arm began to swell. The injection site became puffy and warm to the touch with redness along the edges. The doctor was notified. Ice was wrapped around the site. The patient also developed a red and itchy scalp. The patient was given BENADRYL for the itching. On 13-MAY-2008, the patient developed a rash on the left inner arm. Ice was applied. The patient noted feeling better with the ice. Follow up phone call to the pharmacist reported that the patient was discharged from the hospital on 16-MAY-2008, and the pharmacist reported that as far as she could tell by what was noted in the chart, hospitalisation was not prolonged by the patient's experiences with pneumococcal 23v polysaccharide vaccine. Upon discharge, the patient had recovered from itching, swelling, edema, redness of the scalp, rash and redness of the left inner arm. The discharge diagnosis was diverticulitis, and the patient reportedly recovered from the diverticulitis. At the time of discharge, the patient was prescribed AUGMENTIN for diverticulitis as they were questioning an early abscess. No additional information is expected.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 11th June 2018, the patient received SHINGRIX (intramuscular). On 12th June 2018, 1 days after receiving SHINGRIX, the patient experienced fever, general body pain and chills. On an unknown date, the outcome of the fever, general body pain and chills were recovering/resolving. The reporter considered the fever, general body pain and chills to be related to SHINGRIX. Additional details were provided as follows: The patient reported of receiving the SHINGRIX vaccine on Monday. The patient started having symptoms on the day before reporting. The patient had a fever of 101 degrees, chills and body aches and was feeling better on the day of reporting. The patient had denied permission to contact their physician.
Painful reaction began within 2 hrs, 10/25. Used ice packs and took MOTRIN regularly. Called EHP nurse 10/27 - switched to heat to area, massages. Called EHP nurse 11/1 and 11/4. Fever 103 degrees, chills, arm red and firm shoulder to elbow (R) can't move it, can't lift, can't sleep, can't bathe. Called Dr - ref. to ER but didn't go. Improvement began 11/2 in gradual increments. Stopped MOTRIN on weekend of 11/5. Afebrile (without MOTRIN) 11/7. Now "brownish rash" (R) arm but full ROM. So edema - erythema. No pain unless inj. site touched.
Swollen lymph nodes on face and ears; Doesn't feel well/started feeling weird; Sore muscle around injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes on face and ears), VACCINATION COMPLICATION (Doesn't feel well/started feeling weird) and VACCINATION SITE PAIN (Sore muscle around injection site) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN and METFORMIN (GLUCOPHAGE [METFORMIN]) for Diabetes mellitus.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes on face and ears), VACCINATION COMPLICATION (Doesn't feel well/started feeling weird) and VACCINATION SITE PAIN (Sore muscle around injection site). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes on face and ears) and VACCINATION SITE PAIN (Sore muscle around injection site) outcome was unknown and VACCINATION COMPLICATION (Doesn't feel well/started feeling weird) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events,a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,a causal relationship cannot be excluded.
Patient became dizzy 7 minutes post vaccination.  Stated he didn't feel he could go back to work. Supervisor came 17 minutes post vaccination. Patient was taken via wheelchair to ambulatory care to be observed by  and arranged for ride home.
Patient states that Saturday 09/21/02, right arm was very sore. Came into clinic Monday 9/23/02 right arm red, swollen, hot to touch. Instructed to go to personal physician for follow up.
Information has been received from a physician concerning a female (age not reported) who on April 2007, was vaccinated with Gardasil.  Subsequently the patient experienced an outbreak of genital warts.  The patient's outbreak of genital warts persisted.  Additional information has been requested.  The product quality complaint unit was not involved.
Uncontrolled movement of the left arm and leg, started 10/25 on the flight. The symptom lasted about an hour. Then on 10/26 AM, uncontrolled flailing of the left arm and leg happened again. Patient went to Emergency Department for evaluation. Uncontrolled movement continued. MRI and Blood testing were normal. and patient was admitted to the hospital for additional testing, evaluation and observation. Patient discharged 10/28 with diagnosis of Choreoathetosis of unknown etiology.
Thursday 09/09 after a year of being diagnosed and without any crisis. 12 days after the vaccination, I have a crisis like the previous ones, and I have a continuous beeping and dazed that does not stop after modifying the treatment as I was in the emergency twice.
it was rpt fr RN concerning pt who was vax in 1996 & in 1999 pt exp a mild case of chickenpox. no further info avail
She experience throat swelling about 20 minutes after she left the store.  She then drive herself to the hospital where she was treated and she also experience a migraine headache. She was treated with epinephrine and benadryl
Left arm pain at injection site; When you get the shot, it is a little sore/achiness started about a week or so after; aching in bone; His arm is aching and hurting; cannot hardly move his left arm and can't hardly reach his back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 10:00 (Lot number: EW0151) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: takes a high blood pressure pill , he was taking this prior to getting the vaccines. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06Apr2021, outcome "not recovered", described as "Left arm pain at injection site"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "When you get the shot, it is a little sore/achiness started about a week or so after"; BONE PAIN (non-serious) with onset 2021, outcome "unknown", described as "aching in bone"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "His arm is aching and hurting"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "cannot hardly move his left arm and can't hardly reach his back". No follow-up attempts are possible. No further information is expected. Follow-Up (11Feb2022): Follow-up attempts are completed. No further information is expected.
Narrative: Pt was sent to ER at 13:30 after presented to the ED c/o lips and tongue numb tingling after receiving covid shot dose #1. Pt has a allergy to shellfish. received her 1st covid shot at 1300 on 4/7/2021. Started having lips and tip of tongue tingling and numb and some itching behind ears. Since she has gotten back to her ER room, it has mostly resolved. Gave diphenhydramine 25mg oral. All symptoms relieved. Dose # 2 contraindicated. Pt's chart flagged with ADR to covid vaccine.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-MAR-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-MAR-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-MAR-2022) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2022 at 12:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Mar-2022 at 12:36 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-MAR-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-MAR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  On 04-Mar-2022 at 12:36:33, Patient administered booster dose.   It was reported that patient received lot its 30 day expiry date.   No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
The next day all of my joints started to hurt. 2 days after the injection my right leg (knee and ankle) started throbbing and hurting when I would walk or take steps. When o do steps now my right leg starts to ache at the joints. Now when I stand for a long period of time! Bend over to pick anything up or do steps my right knee hurts. If I extend my right foot my ankle hurts as well. I have done home exercise in case it was something I can prevent or treat alone that did not help.
Pt. states that after receiving the 1st dose of Moderna 08/13/2021, started experiencing symptoms 08/16/2021 of "magnetized arm" in the left arm site of injection. "Coins" stick to the site and when removed from area nausea and sharp pain penetrates throughout the arm. Reapplying the "Coin" stops the pain, held with magnetism. No noted Primary visit.
red, hard itchy, spot on the injection site; red, hard itchy, spot on the injection site; red spot on the injection site; red spot on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (red, hard itchy, spot on the injection site), VACCINATION SITE PRURITUS (red, hard itchy, spot on the injection site), VACCINATION SITE ERYTHEMA (red spot on the injection site) and VACCINATION SITE RASH (red spot on the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concomitant products included ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]), SERTRALINE, VITAMINS NOS, TOPIRAMATE, TIOTIXENE HYDROCHLORIDE (THIOTHIXENE [TIOTIXENE HYDROCHLORIDE]) and SIMVASTATIN for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE INDURATION (red, hard itchy, spot on the injection site), VACCINATION SITE PRURITUS (red, hard itchy, spot on the injection site), VACCINATION SITE ERYTHEMA (red spot on the injection site) and VACCINATION SITE RASH (red spot on the injection site). At the time of the report, VACCINATION SITE INDURATION (red, hard itchy, spot on the injection site), VACCINATION SITE PRURITUS (red, hard itchy, spot on the injection site), VACCINATION SITE ERYTHEMA (red spot on the injection site) and VACCINATION SITE RASH (red spot on the injection site) had resolved.            The patient confirmed that she had no problems with the second dose.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up received included the suspect product dosage regimen was updated. On 22-Jul-2021: Follow up received included Outcome of the events were updated.
Began with a pinching sensation along with soreness. On 11/29/2013 I noticed a 5 x 3 inch welt at the injection site along with redness, soreness and mild itching.
This spontaneous report was received from a physician regarding a patient of unknown age and gender. No medical history, drug reactions or allergies were reported. On an unknown date, the patient was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # reported as H013847, expiry 15-MAR-2014). No concomitant medications were reported. On an unknown date, one day post vaccination the patient experienced swelling of the upper arm in the mid-bicep region, warmth (the area was hot to touch), pain, tenderness and low grade fever. The patient sought medical attention (office visit). The patient had started treatment with unspecified antibiotics and mild analgesics. No laboratory diagnostic studies were performed. The outcome of swelling of the upper arm in the mid-bicep region, warmth (the area was hot to touch), pain, tenderness and low grade fever was reported as recovering. This is one of several reports received from the same reporter regarding patient #2. Additional information has been requested.
This spontaneous report as received from a female patient of unknown age refers to herself. The patient's medical history included lupus. On an unknown date the patient was vaccinated with ZOSTAVAX in the arm, route of administration reported as: injection (dose, units, lot number were not reported). On an unknown date, after receiving ZOSTAVAX the injection site was about 2 1/2 inches and it hurt for a week. The patient also reported that on an unknown date, after the injection, she noticed her shoulder was breaking out with a rash, like erythema, and also it appeared inside of arm at elbow. The patient visited her doctor and the physician told her it was not due to the ZOSTAVAX vaccine. The outcome of events was reported as not recovered. The patient's physician assessed that events were not related to the ZOSTAVAX vaccine. Additional information is not expected because there is not enough contact data to contact the patient or the physician.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 13-APR-2016 the patient was vaccinated with an improperly stored dose of M-M-R II (lot # I023386, expiration date 25-JUN-2017, dose and route unknown). The temperature and time frame were at 14.9 Celsius degree for 280 hours. There was no out of range before. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Large local rash, 7 cm diameter with central clearing, mildly tender, no fever.
Awoke with Hives & itching on chest, neck, upper arms & abdomen. No pain. Also itch in throat. Took Zyrtec at 0630 and loratadine at 0630 also.  Throat better but rash remained- took Benadryl 50mg po at 10:00am.  Arrived to Dr at 1:15pm. Pruiritic urticaria on chest, abdomen, & back but no respiratory distress. Lungs clear to auscultation.  TREATMENT- continue Loratadine every 24hrs, Benadryl prn, & started on Prednisone 40mg x4days. Will report to ER if worsening symptoms, ie respiratory distress.  Avoid flu vaccine.
dizziness; being unable to balance; nausea; chills; neck pain; arm pain; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (neck pain), BALANCE DISORDER (being unable to balance), DIZZINESS (dizziness), MYALGIA (arm pain) and NAUSEA (nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product zyrtec for an unknown indication.    Concomitant products included ISOSORBIDE MONONITRATE, ATENOLOL, DULOXETINE HYDROCHLORIDE (CYMBALTA), LEVOTHYROXINE, lisinopril-hctz, BUPROPION and aspirin.   On 17-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient started zyrtec (unknown route) at an unspecified dose. On 17-May-2021, the patient experienced NECK PAIN (neck pain) and MYALGIA (arm pain). On 18-May-2021, the patient experienced BALANCE DISORDER (being unable to balance), NAUSEA (nausea) and CHILLS (chills). On an unknown date, the patient experienced DIZZINESS (dizziness). On 18-May-2021, NECK PAIN (neck pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
On Nov 3, 2008 flu shot given left arm.  Nov 4, noted tensed muscle feel- expected. 8-10 days later right shoulder started hurting in rotator cuff-intensity peaked around 11/27/08.  No further problems with LUE at injection site.  No activity noted unusual with RUE.  No pain radiation RUE + no cons changes.
Reddness and swelling at injection site the size of 50 cent piece.; Reddness and swelling at injection site the size of 50 cent piece.; Sore to the touch.; Mild headache off and on.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 09Apr2021 at 12:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetic. The patient was allergic to sulfonamide (sulfa durgs). Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and fusion gummy vitam. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 11Mar2021 at 17:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 04:00, the patient experienced redness and swelling at injection site the size of 50 cent piece, sore to the touch, mild headache off and on. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events redness and swelling at injection site the size of 50 cent piece, sore to the touch and mild headache were not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Dizziness BP: 134/82 Pulse: 78  After 15 minutes: BP: 116/78  Pulse 76  offered water to drink.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age. On 2017 the patients were vaccinated with ZOSTAVAX lot # M042850 (expiration date: 18-JAN-2018), N016185 (expiration date: 31-JUL-2018) for prophylaxis. Concomitant therapies included sterile diluent. On 08-AUG-2017 was reported incorrect product storage. No adverse event reported. The outcome of incorrect product storage was unknown. The reporter considered incorrect product storage to be not related to ZOSTAVAX. Sender's Comments: US-009507513-1709USA000913.
This spontaneous report was received from a medical assistant and refers to a 17-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-FEB-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L027282, expiration date: 21-SEP-2017; dose and route of administration were not provided). The vaccine underwent a temperature excursion of either +1 or -1 degrees Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Rash on face.  Vesicular, painless, bilateral.  Started 40 days after vaccine.  Examined on 10/13/08 and not resolved.
Beginning the evening after the injections, pt's left arm began to swell and broke out in severe erythematous rash from above shoulder down to forearm. Zyrtec given, resolved in about 2 days.
This case was reported by a pharmacist via other and described the occurrence of fainting in a female patient who received Hepatitis A and Hepatitis B vaccine. On 13th September 2016, the patient received Hepatitis A and Hepatitis B vaccine. In September 2016, less than a week after receiving Hepatitis A and Hepatitis B vaccine, the patient experienced fainting and fall. On an unknown date, the outcome of the fainting and fall were unknown. It was unknown if the reporter considered the fainting and fall to be related to Hepatitis A and Hepatitis B vaccine. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient experienced fainting resulting in fall after vaccination with Hepatitis A and Hepatitis B vaccine. The patient sought medical attention.
sore arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A female patient of an unspecified age received first and second dose of bnt162b2 (Pfizer COVID Vaccine, Solution for injection), via an unspecified route of administration on an unspecified date as 1st dose, single dose, via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm after both the doses. While reporting adverse event for her daughter with Pfizer COVID Vaccine, caller stated that all four of them in the family had sore arm and everybody said that was to be expected. She had both of them and all she had was a sore arm and declined to proceed with a report for herself and other family members. The clinical outcome of the event sore arm was unknown.  Information on the lot/batch number has been requested.