chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received on 04-APR-2017 from a female nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. The nurse reported that since 27-MAR-2017, an unspecified number of patients were administered doses of VARIVAX (Lot # M032493, expiration 06-JUL-2017; Lot # M041513 (as reported), expiration 11-OCT-2018) for prophylaxis and PROQUAD (Lot # M043306, expiration 24-APR-2018) for prophylaxis which were exposed to the temperature range (minus 14 degrees Celsius to minus 10 degrees Celsius) for 94 hours. Previous temperature excursion was reported as "yes".  The call was because of a "data logger." The outcome was reported as "supportive." The strengths, doses, routes of administration and anatomical locations were not provided for VARIVAX and PROQUAD. The nurse could not provide the Lot and expiration date for the properly stored Sterile diluent used to reconstitute the doses of VARIVAX and PROQUAD. No adverse effects reported. No further information provided. Additional information has been requested.
After receiving vaccination I began experiencing tingly sensation in my toes.  Sometimes it is just tingly sensation, other times it feels like a quick shooting cold pain.  I received my second dose on March 14th, 2021 and still occasionally experience the tingly sensation/cold shooting pain in may toes.
history of chronic back pain/ after getting the vaccine, the patient can now do things she couldn't do before; This is a spontaneous report from a non-contactable consumer (patient) received via a Pfizer-sponsored program. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date in Apr2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included chronic back pain for over 30 years. The patient's concomitant medications were not reported. The patient has never taken a flu vaccine. The patient reported that after getting the vaccine on an unspecified date in Apr2021, she can now do things she couldn't do before: clean house, vacuum, sit in a chair without a pillow, work for hours in her yard, sit in the chair for a longer period of time. She's like a new person. Nothing else she has tried for her pain in the past has worked. The patient also reported that she had no "side effects" from the vaccine. The outcome of event was unknown. The patient has received the first dose of the vaccine on an unspecified date in Apr2021 (reported as a holiday) and the second dose three weeks later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient stated that after he stayed around the pharmacy for about 20-30 minutes after his dose (recommended at least 30 min for patient to stay on site), he had just started his trip home and he started to notice a "tingling" in his face, "almost like a bels palsy type of a feeling."  once he got home about 30 minutes later he was instructed by ems (who he had first called while on his way home) to take some Benadryl as soon as he got home.  Stated that these symptoms lasted for a total of about an hour and then subsided.  Patient reports no other symptoms or side effects at this time.
Injection site pain days 1-3, itching at site days 4-7 Narrative:
Headache; Sore arm; This is a spontaneous report from a contactable consumer. A 12-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 15May2021 at 17:00(at the age of 12-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergy to medications, food, or other products. The patient did not receive any medications within two weeks of vaccination. 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 15May2021 at 21:00 the patient experienced headache and sore arm. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were taken as a result of headache and sore arm and included treatment with TYLENOL. The clinical outcome of the event headache and sore arm was resolved on an unknown date in May2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Ongoing headaches:  Some quite painful. Never had headaches before this. Pain behind/above eyes (one at a time, alternating)
Case number PHEH2014US015701 is an initial spontaneous report received from a medical assistant on 01 Aug 2014. This report refers to a 17 year old patient of an unspecified gender. The past medical history and concomitant medications of the patients were not reported. On 01 Aug 2014, the patient was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) at a dose of 0.5 ml intramuscularly which had multiple temperature excursions while in storage. The temperature of the vaccine reached a maximum of 47.5 for one hour and 17 minutes on 18 Jul 2014, a maximum of 47.5 F for 42 minutes on 21 Jul 2014, a maximum of 47.5 for one hour and three minutes on 24 Jul 2014 and a maximum of 47.5 for one hour and three minutes on 31 Jul 2014. No adverse events were reported following this maladministration.
Short of breath, smell of fumes, clavical left lymph node swelling, left arm soreness at injection site.
No adverse reaction to patient noted Vaccine administered over 12 hrs after vial was punctured.
Breakdown in communication between clinic and nursing home.  Patient had already received vaccine series at SNF.  No reaction reported.  MD made aware.
Patient stated that the day after flu shot given, she experienced severe coughing that led to nausea/vomiting, she lost her voice, developed an eye infection and felt a lump in her throat.
Severe abdominal pain, like contraction; Feeling like she would vomit; A spontaneous report was received from a consumer, concerning her daughter, a female patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced severe abdominal pain, like contraction and feeling like she would vomit.  The patient's medical history was not reported. No relevant concomitant medications were reported.   On 07 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for prophylaxis of COVID-19 infection.   On 07 Jan 2021, after vaccination, the patient had severe abdominal pain, like contractions. She also felt like she would vomit. No treatment information was provided.     Action taken with mRNA-1273 in response to the event were not reported.   The outcome of the events severe abdominal pain, like contraction and feeling like she would vomit were unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. Nausea is consistent with the known safety profile of the vaccine.
All symptoms of COVID, in bed 5 days, 2 COVID tests both negative, fifteen days later still not 100%
A1C went from 6.7 to 7.9 within 6 months; A spontaneous report was received from a consumer (patient) concerning a 62-years -old female patient was who received Moderna's COVID-19 Vaccine (mRNA-1273) and A1C went from 6.7 to 7.9 within 6 months.  No medical history was reported. The concomitant medications included metformin, hydrochlorothiazide, lisinopril, levothyroxine, vitamin d [vitamin d nos], acetylsalicylic acid, calcium, alendronate, fluticasone, simvastatin, and fluticasone furoate.  On 06 Jan 2021, the patient received their first of the two planned doses of mRNA-1273 (Batch NUMBER: 025L20A) intramuscularly in left arm, and on 03 Feb 2021, the patient received their second of the two planned doses of mRNA-1273 (Batch NUMBER: 013M20A) intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 08 Mar 2021, the patient had a blood work done and her glycosylated haemoglobin (A1C) came high. Within six months, it went from 6.7 to 7.9 which she thought was really high. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   The outcome of the event of A1C went from 6.7 to 7.9 within 6 months was unknown.
8 days after receiving the first dose of Moderna COVID-19 vaccine, I noticed a swollen red rash on my upper left arm, near where I received the vaccination injection. The rash does not itch. It is about 2.5 inches tall by 1.5 inches wide. I noticed it at about 8am and it is still present 8 hours later.
Tinnitus starting approximately 10 days, two weeks after vaccine.This is very intrusive, and the lingering adverse affect I am reporting  in this form. Initial adverse reaction starting +/- two days after vaccine;  sore arm at injection site, lasting 10 days, still somewhat sore..  took Tylenol  extreme tiredness. Low appetite. Feeling  ?buzzed? ?high? ,  ( not   lightheaded.) these reactions lasted for 10 days.
Pt developed itching and then later that day noticed a rash on hip flexors, under arms, and then above ankles. Later spread to chest and thighs.
Severe swelling, redness, hot to touch, redness has spread 6in long 3 1/2 in wide
generalized hives on & off; no response to DPH but responded to Atarax;
This case was reported by a consumer via call center representative and described the occurrence of psychiatric symptom in a 25-year-old male patient who received Flu Seasonal QIV Dresden for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden for prophylaxis. Concurrent medical conditions included autistic disorder and mutism. On 2nd November 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On 29th November 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On 19th November 2018, 17 days after receiving Influenza vaccine Quadrivalent 2018-2019 season and not applicable after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced psychiatric symptom (serious criteria hospitalization). On 29th November 2018, the patient experienced extra dose administered. On an unknown date, the outcome of the psychiatric symptom and extra dose administered were unknown. It was unknown if the reporter considered the psychiatric symptom to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: This case was reported by the patient's mother. On 2nd November 2018, the patient went to a physician visit with primary care on received first flu vaccine. The reporter reported that the patient had annual flu vaccinations, and it so happened that the patient was hospitalized for psychiatric reasons on 19th November 2018 and was discharged on 29th November 2018.  The patient's mother was upset because on his discharge papers, it indicated that they had given him a second flu vaccine without her knowledge or consent, which led to extra dose administered.  The patient received second flu vaccinations prior to discharge from a psychiatric hospital on 29th November 2018. The patient's mother was concerned about possible side effects. The patient's mother also mentioned the patient was given a pneumococcal vaccine unauthorized by her. The reporter gave consent to follow up.
Information has been received from a medical assistant referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On 26-OCT-2016, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L040053 with expiration date 10-MAY-2017, lot # M024673 with expiration date 17-NOV-2017; dose and route were not provided), which was exposed to 49.1 Fahrenheit (F) for 55 minutes. No adverse effects were reported. The data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
a rash on upper back.; This is a spontaneous report from a contactable consumer (patient) and physician. A 63-years-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot# EN6208), via an unspecified route of administration in the left arm on 27Mar2021 13:00 at a single dose for COVID-19 immunization.The patient medical history included allergic rash after a Flu Shot in 1996.The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 after the vaccination. On 28Mar2021 (Sunday) at 08:00 AM, patient experienced a rash on upper back which resulted in Doctor or other healthcare professional office/clinic visit. Most of the rash is on the left side. Throughout the day, the rash had begun to spread on left shoulder and towards middle of upper back. It was reported that the location of injection information is available for all vaccines received on the same date. The outcome of the event rash is not recovered.  No follow-up attempts are needed. No further information is expected.
Sever chest pain and fatigue. Terrible headache and arrhythmia when doing even moderate level of effort activities. Tingling in left arm and hand. EKG showed ?Left Atrial Abnormality?
Medication administration error: Pt received 0.3mL instead of 0.5mL. No known adverse reaction.
17 years old patient got the first dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old patient got the first dose) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) 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 17-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old patient got the first dose). On 17-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old patient got the first dose) had resolved. Not Provided      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 concomitant product used was provided by the reporter. Treatment information was not provided
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-067714, MOD-2021-395932 (Patient Link).
cried for 5-6 hrs could not get quiet took pt to MD next day; MD recommend not to have pertussis anymore;
Vaccine was in the fridge longer than 30 days. Pt got expired vaccine but with no problems or symptoms reported.
devel initial swollen glands to neck 5MAR94 AM; temp inc to max 102.6 on 5MAR94; on 6MAR rash broke out to legs, arms, torso, neck, face;  also noted white spots to throat;
Severe itching, hives, large, all over body; 2 shots of Adrenalin; 1 shot Benadryl; Benadryl Q4hrs;
vaccination after a temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a child female patient who received Flu Seasonal QIV  (FluLaval Tetra 2021-2022 season) (batch number XF9HG, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th February 2022, the patient received FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 details were provided as follows: The nurse reported a patient received the flulaval vaccine in left deltoid after a temperature excursion.  The reporter consented to follow up.  This is 1 of 6 cases reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039273:same reporter US-GLAXOSMITHKLINE-US2022039274:same reporter US-GLAXOSMITHKLINE-US2022039275:same reporter US-GLAXOSMITHKLINE-US2022039277:same reporter US-GLAXOSMITHKLINE-US2022039278:same reporter
24 hours after booster, experienced quite uncomfortable muscle pain and fatigue, headache, chills, and a fever between 102-103.  It quickly subsided after about 18 hours.  While it was uncomfortable during the 18 hours, it all went away in just about an hour (even the muscle cramps).  More severe than I expected, but I'd do it all over again if needed.
Pediarix and Inact polio given at the same time - no ill effects noted.
No additional AE; TE case where product was administered.  10.3C for 0 hours 26 minutes 0 seconds  prior: 19.6C for 5 hours 52 minut; This spontaneous report was received from a registered nurse referring to a 3-year-old female patient. The patient's medical history historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 18-OCT-2023, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) intramuscular injection (strength: 5/0.5 mcrg/ml, lot#: W030076, expiration date: 11-APR-2024; dose and route of administration were not reported) administered by a health professional for prophylaxis. The vaccine administered experienced temperature excursion (TE) at 10.3C for 26 minutes (product storage error). Besides, this vaccine also had prior TE experience at 19.6C for 5 hours 52 minutes. No additional adverse events (AE) were reported (no adverse event).
Patient experienced a rash on left arm, a fever and soreness for a day and a half.
Left deltoid with pink swollen, warm to touch area measuring 12 cm x 9 cm. Area blanchable and slightly tender to palpation
Left arm below inj site there is an area of swelling from middle bicep to middle of forearm. Swelling has gotten better since inj. Significant heat, redness, pain at a 9 out of 10 and 3+ pitting edema.
This spontaneous report as received from a licensed practical nurse refers to multiple patients of an unknown age and gender. No information regarding the patients' concurrent conditions and medical history was provided. On an unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored VARIVAX lot# L025207 and expiration date: 07-JUL-2017 (dose and route of administration were not reported). The patients' concomitant therapies were not reported. There were no adverse effects reported. Product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Symptoms of redness, swelling in the right deltoid and reports fever Thursday night 09/24/2020 after receiving vaccination at 1433. Pt went to ER on 09/26/2020 at 2228.
pain at injection site, fatigue, SEVERE HALLUCINATIONS from late evening day of shot to late morning day after shot.  No prior hallucination ever.
HZ RASH WITH SEGMENTAL MOTOR PARALYSIS. C3 DERMATOME.
that ADACEL was given to a 6 year old patient with no adverse event; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious case received (reference number: US-SANOFI-00335397) via other health professional.  This case involves a 6-year-old patient for whom vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] was given.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the 6-year-old patient received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Product administered to patient of inappropriate age) (lot number: not known) via an unknown route for prophylactic vaccination.  Final diagnosis was Not Applicable that adacel was given to a 6 year old patient with no adverse event.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome was not applicable for the event at the time of reporting.  There will be no information available on the batch number for this case.
The patient had gotten two J&J vaccines already.  One of these should count as a booster, so he would not  be eligible for a Moderna booster.  He was given a 0.25mL (half dose) booster greater than 2 months after his last J&J dose.  No adverse reactions have been reported.
can't stay awake; slept for 30 hours straight from Saturday to Sunday; size of a baseball popped up at the injection site; it's red and hurts a little bit; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (can't stay awake; slept for 30 hours straight from Saturday to Sunday) and VACCINATION SITE SWELLING (size of a baseball popped up at the injection site; it's red and hurts a little bit) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 032MZ0A) for COVID-19 vaccination.     No medical history provided by Reporter.  Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced SOMNOLENCE (can't stay awake; slept for 30 hours straight from Saturday to Sunday) and VACCINATION SITE SWELLING (size of a baseball popped up at the injection site; it's red and hurts a little bit). At the time of the report, SOMNOLENCE (can't stay awake; slept for 30 hours straight from Saturday to Sunday) and VACCINATION SITE SWELLING (size of a baseball popped up at the injection site; it's red and hurts a little bit) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-081229 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081229:CROSSLINKED WITH DOSE 1