chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received DTaP 6/12/17. Noted red swollen (L) upper arm 6/13/17. Itching arm. No constitutional SXs. Negative F/CH/SW/N/V/D. Rash not spreading. Given antihistamines and NSAIDS, cool compresses.
This spontaneous report was received from a registered nurse concerning an approximately 50 year old female patient. The medical history of the patient included internal shingles on her right side approximately in 2011 (last 2 years) for 6 weeks, neuralgia pain (for 9 months after). The patient had an allergic reaction to an unnamed flu shot when she was a baby and nearly died and she could not take any flu shots. On 29-JAN-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date unspecified), subcutaneously. Concomitant medications included PREMARIN (reported as PRIMERIN), cholestyramine resin (reported as cholestremine), SYNTHROID and an unspecified medication of sleep drug. On an unknown date, approximately in 2013, the patient experienced rash on arm like 2 silver dollars, a fever in her arm and a low grade fever. On an unknown date, approximately in 2013, the patient broke out into a rash on her side, her legs and arms, backside and under her breasts. She called the healthcare professional (HCP) the next Monday and the HCP did not diagnose her with Shingles. It was reported that, it was going on for approximately forty-five days. It was reported that taking an unnamed prescription of sleep drug and scratching herself until she was bleeding. The patient sought an unspecified medical attention. She was treated with VALTREX (2 rounds). Silver sulfadiazine, Nyspapin, triamcinolone acetonide cream. No lab tests were performed. The outcome of itchy rash was reported as not resolved as the patient still had itchy rash all over the body below her neck at the time of reporting. The outcome of fever in her arm and low grade fever was unknown. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
This patient was administered an invalid dose of VARIVAX (due to non-supported TE); This spontaneous report was received from a physician via an agent regarding a female patient. The patient's concurrent condition, pertinent medical history, concomitant therapies, drug reactions and allergies were not provided.   On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (route of administration,  anatomical site, dose, lot number,  and expiration date were not provided) for prophylaxis. It was unknown the temperature excursion of the dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) administered.   On an unknown date, the physician was requesting information of dosing schedules for second doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD). Subsequently, he reported that this patient was administered an invalid dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (due to a non-supported temperature excursion (TE)) (Incorrect product storage) when she was one year old.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions/allergies and medical history were not reported. On 29-JUN-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally, lot number was L037921 and expiration date of 31-MAY-2017 (strength and dose were not reported). No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Aug2021 as dose 2 (booster), single (Lot number: Ew0185) at the age of 45 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 04Apr2021 as dose 1, single (Lot number: 1805020), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Jun2022 at 16:00 as dose 3 (booster), single (Lot number: 056 M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19,  which included Paxlovid from 19Jun2022. Patient did not received other medication in 2 weeks.  Follow-up attempts are completed. No further information is expected.
Pt was in for routine physical. She had fasted overnight. Immediately after HPV injection pt passed out. Mild perioral cyanosis. Episode 1 minute. Pt did not remember syncope.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Additional Details: Patient had swelling and redness of arm, chest and neck. The symptoms are getting better over time. Patient called MD and nurse told her to alternate naproxen and tylenol and monitor.
Pt with hot, tender, swollen area right shoulder and fever. Seen 4/9 (2 days after) not on pain/fever meds. Pt returned for PPD reading so its not clear if return visit was required. Patient improved on meds and now resolved.
Patient missed the second dose /late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient did not received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Patient missed the second dose /late second dose). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-MAY-2023 The pharmacist asked information about a patient who receive the 1st dose Twinrix. The patient missed the second dose (1 month after first dose). The reporter asked how to proceed with patient vaccination. The reporter did not provided information about the first dose given (lot number, exp date). The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
This is a spontaneous report based on the information received by Pfizer from Merck & Co. Inc. (Case Number: 00644505). A non-contactable consumer reported for him/herself. A patient of unspecified age ethnicity and gender started to receive PREVNAR 13 (Lot # and Exp Date unknown by Reporter) at single dose on an unknown date in Nov2015 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe pain in the patient's shoulder after receiving the injection on an unspecified date in Nov2015 with outcome of unknown. The patient was treated for the pain with physical therapy for approximately six months. No follow-up attempts are possible. No further information is expected.
Could not close her hand and not able to use her arm; Blood sugar went to 500; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOKINESIA (Could not close her hand and not able to use her arm) and BLOOD GLUCOSE INCREASED (Blood sugar went to 500) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GLIPIZIDE, ATORVASTATIN, FUROSEMIDE, AMLODIPINE, PAROXETIN [PAROXETINE], HYDROXYZINE, CLONIDINE, CLOPIDOGREL, CALCITRIOL, ASPIRIN [ACETYLSALICYLIC ACID] and ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, IRON, PYRIDOXINE HYDROCHLORIDE, ZINC CITRATE (CORVITE [ASCORBIC ACID;CYANOCOBALAMIN;FOLIC ACID;IRON;PYRIDOXINE HYDROCHLORIDE;ZINC CITRATE]) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HYPOKINESIA (Could not close her hand and not able to use her arm) and BLOOD GLUCOSE INCREASED (Blood sugar went to 500). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, HYPOKINESIA (Could not close her hand and not able to use her arm) and BLOOD GLUCOSE INCREASED (Blood sugar went to 500) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Blood glucose: high (High) Blood sugar went to 500.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up received on 08-JUL-2021. Updated regarding event outcome and patient declined for follow-up.
Inappropriate Schedule of Vaccine; Shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number H547E, expiry date 22nd February 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On 1st December 2018, 91 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for 2nd dose of Shingrix. The pharmacy technician reported a patient received Shingrix and broke out with Shingles in December. The reporter asked if patient could receive 2nd dose or restart series and till the time of reporting did not receive the 2nd dose, which led to incomplete course of vaccination.  It was unknown when Shingles resolved.  Technician said physician said to wait 6 months after Shingles clear prior to receiving 2nd dose. Provided phone number to MI and transferred, however, caller abandoned.
Received COVID-19 vaccine on 3/10/21; inadvertently administered other manufacturer today as dose #2
pt was extremely fussy, lethargic, & dazed for approx 5 days; fever;
I experienced onset of a severe headache and vomiting (x2, small amounts) the day after (2/2/2021)receiving the vaccine at noon-3pm. That evening as the headache resolved,  i noticed that the corners of my mouth and the area below my lips were sore and hard to the touch. These are all areas where i had fillers injected in the past (August 11, 2020). Restylane was the filler, i think. The symptoms i experienced felt exactly like when i received the injections in August 2020. The symptoms were gone by the next evening. I called my dermatologist  when i saw on the CDC Moderna training site (i'm a Public Health Nurse volunteer vaccinator) that this "rare" side effect should be reported. She refused to file a VAERS report and told me that my symptoms were because i had vomiting and the muscles around my mouth were irritated, and that it was not from inflammation or a side effect of the vaccine.
Hip pain; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (Hip pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Hip pain). At the time of the report, ARTHRALGIA (Hip pain) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2016, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date in 2016, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a healthcare provider for shingles in 2016. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death- aggravation of preexisting conditions and activation- of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
12-03-14 Vaccines administered. 12-04-14 Wife called stating pt has fever 103. I encouraged call to PMD immediately. 12-5-14 Spoke to wife, pt was dx with UTI and put on LEVAQUIN by his PMD.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jan2023) Negative; (Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid treatment from 30Dec2022 to 04Jan2023. Patient felt better during treatment and tested negative two days after completing 5 day regimen. Patient then tested positive for COVID 4 days after last dose and has symptoms of infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness and heat around injection site. Fever, aches, pains, nausea.
After receiving my shot on Friday 2/4 later that evening I had pain and swelling in my underarm
she said she was not able to receive the 2nd dose because she has Covid; she said she was not able to receive the 2nd dose because she has Covid; This is a spontaneous report received from a contactable consumer (patient) 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6206 and expiry date was not provided), via an unspecified route of administration, in Arm Left on 03Mar2021 15:00 (Age at time of Vaccination; 60-year-old) as single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Patient's mother-in-law had COVID 19. Patient reported that she received the first dose of the COVID-19 vaccine on 03MAR2021 at 15: 00PM in the left arm. She had no side effects from the vaccination. Patient was exposed to her mother-in-law who had COVID-19 and had to get tested. Patient had Covid-19 PCR test and positive for COVID 19 on 17MAR2021 although she might have it before then. Patient didn't have any symptoms with the COVID 19 infection either. She supposed to get her second shot today (24Mar2021) but she couldn't get it because she is still in quarantine. She was asking when can she get the second dose of the vaccine after having COVID 19 infection?. Patient was not admitted to Emergency Room and not visited physician office for the event. However, she said that she was not able to receive the 2nd dose because she had COVID, and tomorrow (25Mar2021) is her last day of isolation. She wanted to know when she can get her 2nd dose. The outcome of the events was unknown.    Additional information has been requested.
Jaw pain, pain in throat, pain with swallowing, felt like "a punch to the throat", lost voice at one point. Resolved completely by morning.
Received 2 months immunizations on 06/08/2005 at 9:30am, at 3PM on 06/08/2005 developed urticarial rash, no other symptoms.  Resolved with Benadryl.  Reoccurence on 06/08/2005 at 3PM.  Seen in doctor's office at 4:00 on 06/08/2005.  Except urticarial rash appeared well, no other known exposures, changes in skin products.  Mother recalled rash stared 06/09/2005 several hours after formula , given 1 times a day for past week, to change formula.
2 children needing vaccines at the same time, a baby and older child. The parent took the ROTARIX and gave it to the older child.
Pt came in the store to complain about pain in her shoulder. She said the RPh who gave her the shot injected high in the arm. She wants a supervisor to contact her.
Local reaction with soreness, pain or tenderness, itching, swelling and warmth. Doctor prescribed Benadryl and it went away after 3-4 weeks of taking the Benadryl.
Migraine started 12/3/2021, continued through 12/15/2021.
patient Looked pale approximately 10min after flu shot - Pharmacist gave him 25mg Diphenhydramine - Paramedics came - After taking has BP and pulse after interviewing him they decided it was a delayed anxiety.
I received the Moderna Bivalent booster on 11/4/2022. On about 12/13/2022, I began to get sniffles, a little bit of a runny nose, but no fever. They were like mild cold symptoms. The symptoms gradually progressed over the next few days. On the afternoon of 12/14/2022 and all of 12/15/2022, the symptoms were more pronounced, though I never developed a fever. At about 7:30PM on 12/15/2022, I took a home antigen test and got a positive result. I went to the clinic that same night and took another test at 7:58PM, and the results of this test confirmed those of the home test. I was prescribed PAXLOVID, which I was to take twice a day for 5 days. I began taking the PAXLOVID at about 10:00 PM the same night. I already felt better on the night of 12/15/2022 than I had during the previous days, and I steadily made progress in recovering. I took another home antigen test at about 9 PM on 12/20/2022 and got a negative result. I have been taking the advice of the NP by isolating for 5 days (12/15/2022-12/20/2022) and then wearing a mask in public for 5 days afterwards (12/21/2022-12/26/2022).
Rapid heartbeat (like caffeine overdose) (considered a severe side effect on vaccine information sheet.)
Hives (scalp, elbows, knees) x3 Thursday, Friday, Sat hot flashes redness around injection site body ache ill feeling nausea bump in injection site.
skin rash on back of neck, abdomen and groin area.; Smooth red rash with itching; Smooth red rash with itching; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 84-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 29Jan2021 at 16:30 pm (Batch/Lot Number: EL9265) as dose 1, single for covid-19 immunization (at the age of 84-years-old). Medical history included Type 2 diabetes from an unknown date and unknown if ongoing and ongoing high blood pressure. Patient had no known allergies. Concomitant medication(s) included metformin taken for an unspecified indication, start and stop date were not reported and blood pressure pill for high blood pressure and daily vitamin taken for an unspecified indication and start and stop date were not reported for both. No other vaccine received in four weeks. It was reported that after receiving the first dose of vaccine on 01Feb2021, the patient experienced skin rash on back of neck, abdomen and groin area and smooth red rash with itching. The adverse events resulted in doctor or other healthcare professional office/clinic visit. As a therapeutic measure the patient was told to take Zyrtec. It was unknown if patient had covid prior vaccination. Patient was not tested for covid post vaccination. The outcome of the events was recovering at the time of report.   Follow-up attempts completed. No further information expected.
I had soreness in my arm that has never gone away at the injection site.  Significant discomfort since the second dose, soreness at injection site, however over the next 6 months traveled into elbow and shoulder and neck area, left side. Could not button shirt or but a belt on.  After 3rd injection that discomfort on neck and shoulder and arm has become twice as bad. That is when I saw the doctor. I had an X-ray of the shoulder that was inconclusive and referred for 6 sessions of physical therapy. PT was ineffective. No resolvement still experiencing the pain.
Extreme ulcerative colitis flare up. Was in the midst of finally escaping a recent flare, and then got the vaccine and one week later all symptoms came back tenfold and my meds don?t work anymore. Extreme diarrhea, extreme amounts of blood in diarrhea, more than 20 bowel movements a day.   You pushed a vaccine on autoimmune-impaired people without fully studying and informing us of the consequences. Now my life is ruined because I thought I was doing the right thing. I hope you?re happy.