chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received via a claims administrator, from a lawyer, concerning a male customer (age not reported) of a pharmacy who allegedly went into a coma a few days after receiving a pneumonia and flu shot. The claims administrator reported the male indicated that the PNEUMOVAX vaccine from MSD was involved in the incident. The "date of loss" was reported as 31AUG2012. At this time if has not been determined which vaccine was responsible for this occurrence. The lot number for PNEUMOVAX is 1947AA, with an expiration date of 20OCT2013. Treatment and outcome of event was not reported. Coma was considered to be a medically significant event. Additional information has been requested.
Initial report received from a healthcare professional on 03 September 2014. A female patient (age reported as 46 or 47 years), whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (batch number-U4669EA, dose number, route and site of administration not reported) on an unknown date in 2013. On an unknown date in 2013 after vaccination, the patient experienced large, swollen, red area of upper arm with hard lump at injection site and felt "sick". It was reported that patient was recently diagnosed with gluten allergy; and patient stated that when she felt "sick" after vaccination, it was the same kind of "sick" she feels if eats food with gluten ingredient. Laboratory investigations and corrective treatments were not reported. At the time of this report, patient outcome was recovered on an unspecified date. Documents held by sender: none.
12/12/2018 - Mother reported that child became fussy and seemed to be in pain immediately after receiving Hep A vaccine and kept stiffening up. Mother took child to ER where it was reported that she appeared to be foaming at the mouth.
Chills, fever, nausea, weakness, over 101 temp. after 12 hours; weak for several days after
Eight Days after 1st Moderna vaccine shot, shot arm developed large, red itchy rash in area surrounding shot area.  The next day, 01/31/2021, in the evening, 06 PM, the itching stopped and redness almost all cleared up.  The next morning, Monday, February 1, 2021, all symptoms had gone away.
Has had persistent headaches since the vaccine. feels like a pressure on the top of her head. has presisted for 8 days. Also c/o dizzienss, sensation like drunk. has not had any syncope, fever, blurred or double vision. has had recent stress this past week. sleep has been choppy.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 27-OCT-2009, a pharmacist at a pharmacy administered the ZOSTAVAX vaccine to the patient (lot number, dosage and route of administration not provided). On or about 03-JAN-2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to 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 including care for hospitalization (dates unknown), 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 (unspecified); lost wages; loss of earnings capacity, and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Slight bronchia tightness right after shot. Went away within 5 mins. My arm really hurt for 4 days. The area where the shot was given that was inflamed was about 5 inches in diameter. I was dizzy for 24 hours. I was nauseous that evening and vomited. I was tired and had joint aches for 2 days.
very tired; This is a spontaneous report received from a contactable other health care professional and a contactable consumer. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), dose 1 via an unspecified route of administration on 21May2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient reports that continues taking IBRANCE 125 mg daily (with faslodex) but md changed to 2 weeks on then 1 week off (off label dosing per md, change in frequency due to ongoing low blood count and schedule of 2nd dose of COVID-19 vaccine to coincide while she was on the week off - 11Jun2021, 1st dose given on - 21May2021) and then she will resume frequency of 21 days on then 7 days off as prescribed. states "very tired" after 1st dose of COVID-19 vaccine but has resolved. reports since start of therapy, low platelet count has improved; mild nosebleed (present prior) has resolved since last report. md aware of all. no other information provided. (previous dose: 125 mg daily for 21 days on then 7 days off- 09Dec2020 to May2021).  Information on the lot/batch number has been requested.  Follow-up (02Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Date the vial was initially stored was on 31 Jan 2022 and patient administered vaccine on 8 Mar 2022; Receiving doses after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving doses after the beyond use date) and PRODUCT STORAGE ERROR (Date the vial was initially stored was on 31 Jan 2022 and patient administered vaccine on 8 Mar 2022) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2022 at 8:31 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving doses after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored was on 31 Jan 2022 and patient administered vaccine on 8 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving doses after the beyond use date) and PRODUCT STORAGE ERROR (Date the vial was initially stored was on 31 Jan 2022 and patient administered vaccine on 8 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  It was reported that HCP provided doses of the Moderna COVID19 vaccine after the beyond use date as the HCP did not know that the vials should not be used past 30 days from thawing the vials. Vial did not undergo any temperature excursions. Date vials initially stored: 31-Jan-2022. No treatment drug details was reported.
swollen lymph node located at armpit area of the right arm + inside of elbow, moderate pain with pressure or excessive movement
Case number PHEH2015US021058, is an initial spontaneous report received from a pharmacist on 16 Oct 2015. This report refers to an 11 year old male patient. Medical history and concomitant medication were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173988) intramuscularly at a dose of 0.5 ml on 14 Oct 2015. No adverse event was reported following this medication error (inappropriate age at vaccine administration).
He was given the MMR vaccine on Monday, December 22 and about a 7 days later had swollen lymph nodes in his groin and broke out in a systemic rash-small red bumps a day or so after that.  He was treated with childrens liquid Benadryl (1/4 tsp every 6 hours for three days).
Colitis; A spontaneous report was received from a 52-year-old, female consumer, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed colitis.  The patient's medical history was not provided. Concomitant product reported included ogmentin.  On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) in the right arm for prophylaxis of COVID-19 infection.  The patient experienced weight loss and was unable to eat after receiving the first dose.  On 15 Jan 2021, the patient reported that she started to experience lower pelvic pain and was diagnosed with colitis.  On 21 Jan 2021, she had a follow up with PCP (primary care physician) and the PCP advised not to get second dose until 29 Jan 2021.   On an unspecified date, she started her new antibiotic treatments.  Treatment for the event included levosloxacin.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, colitis, was not reported.; Reporter's Comments: This case concerns a 52 year-old, female patient, who experienced event of colitis. The event of colitis occurred 16 days after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.
This spontaneous report was received from a pharmacist concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions. drug reactions/allergies and concomitant medications were not reported. On unspecified dates since 10-FEB-2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # reported as M032816, expiration date:09-MAY-2018 and lot # M036161, expiration date: 06-MAY-2018, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion of - 1.7 Celsius degrees for 4 hours. No previous temperature excursions were reported. Data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013313: US-009507513-1703USA013315: US-009507513-1703USA013202.
Allergic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a patient who received Flu Seasonal TIV Dresden (Fluarix 2012-13 season) for prophylaxis.   On an unknown date, the patient received Fluarix 2012-13 season at an unknown dose. On an unknown date, unknown after receiving Fluarix 2012-13 season, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Fluarix 2012-13 season.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient had an allergic reaction to a Flu vaccine.  No additional details was provided. The reporter declined to provide data. The vaccine was not given at the pharmacy calling.
mild headache; Redness at injection site; Mild sore throat; Tiredness; Inability to focus; swelling and soreness in armpit/underarm on the side of injection; swelling and soreness in armpit/underarm on the side of injection.; sore arm on side of injections; The patient was received third/booster dose of BNT162b2; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received third dose (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 09Nov2021(at the age of 34-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient had received any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration on 11Mar2021(at the age of 33-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration on 01Apr2021(at the age of 33-years-old), both as a single dose for COVID-19 immunisation. The concomitant medications were not reported. On 10Nov2021, the patient experienced mild headache, redness at injection site, mild sore throat, tiredness, inability to focus, swelling and soreness in armpit/underarm on the side of injection and sore arm on side of injections. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild headache, redness at injection site, mild sore throat, tiredness, inability to focus, swelling and soreness in armpit/underarm on the side of injection and sore arm on side of injections were not resolved at the time of this report.    No follow-up attempts are possible. No further information is expected.
No other adverse events reported; Caller reports that improperly stored vaccines were administered.; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported.   On 23-FEB-2023, the patient was vaccinated with Hepatitis A Vaccine, inactivated (VAQTA) intramuscular injection (1 time dose, lot# was reported as 3397T1 but was not valid for Hepatitis A Vaccine, inactivated (VAQTA) and did not match any company product, expiration date was reported as 30-NOV-2023; strength, dose, route of administration, and anatomical location were not reported) for prophylaxis. The vaccine administered was improperly stored at -40F for 70 hours 5 minutes (product storage error). No other adverse events were reported (no adverse event).
Tingling and numbness in vaccine arm, Chest tightness and elevated BP. transport via wheel chair to the ER.  states he was monitored in the ER for approximately one hour. states no medications were administered. states the ER dr cleared the patient to go home and to continue to monitor for worsening s. sx.  states his s.sx improved in 24hr post event.
fever 102.0, headache, myalgias, severe for 6 hours, moderately severe for the next 12 hours, fatigue only by 48 hours after injection, 100% resolution by 72 hours post injection
This spontaneous report as received from a healthcare pharmacy student refers to a 43 year old female patient. The patient may have been administered the first dose of Hepatitis B Vaccine (manufacturer unknown). On 12-MAY-2015, the result of hepatitis B surface antibody test was non reactive. It was also reported that on 27-MAY-2015. The second dose, was administered on 23-JUN-2015 (Lot, route and dose were not reported) which was 27 days after the first dose. (Inappropriate dose of vaccine administered). Concomitant therapies included JANUVIA, CRESTOR, lisinopril (manufacturer unknown), metformin (manufacturer unknown) and NOVOLOG. On 12-MAY-2015, the hepatitis B surface antibody was performed which result was negative. It was reported that the patient was diagnosed with type 2 diabetes on an unspecified date and the pharmacist could not confirm if the patient was diagnosed with Type 2 Diabetes before or after the administration of the first documented dose of the vaccine. The outcome of the events was reported as unknown. The causality between the events and RECOMBIVAX HB were unknown. Additional information has been requested.
premature ovarian failure/insufficiency; infertility; Information has been received from a lawyer to a case in litigation and the patient's mother and refers and referring to a currently 12-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On 25-JUL-2017, when the patient was 9-years-old, the patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (lot #, expiration date, anatomical location, route and frequency were not reported) for prophylaxis.    On 25-JAN-2018 and 01-JUL-2018 the patient was vaccinated with a second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) respectively (lot #, expiration date, anatomical location, route and frequency were not reported) for prophylaxis.  On an unspecified date in April 2018, the patient reached puberty and began menstruating.  On an unspecified date in July 2018 (reported as "within three days of her third dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)"), the patient began to experience tenderness in her breast. Then, within four months, she experienced sweating, mood swings, and thinning and loss of hair.  In or around October 2020, the patient suddenly stopped menstruating (when she was 12-years-old); and her physician prescribed hormones for four months after her periods stopped to attempt to jumpstart her menstruation, but it failed to work. Later, when she was 13-years-old The physician determined that the patient was menopausal and diagnosed with premature ovarian failure/insufficiency and, as consequence, the patient must take estrogen and progesterone for the rest of her life.   The outcome of the events was not recovered. The reporter considered all the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  All events were considered disabling since it was mentioned that the patient always dreamed of becoming a mother, and she will never be able to have children of her own.
dizziness, headaches, coughing, felt under the weather, congestion, couldnt breath, fever, fells like shes pulled a muscle in the right side wants us to know she tested positive for anti bodies in may of 2020
Child received 12 month old vaccines (DTaP, HIB, PCV, MMR, Varicella) at approximately 2:00 pm.  Mom went to grocery store next to clinic and came back approximately 10 minutes later complaining her child was breaking out in a rash.  Child was itching his head and seemed irritable.  At this time the nurses in the clinic evaluated child and agreed child be seen by a physician assistant.  PA assessed child and instructed to give Benadryl 2.5 mg/ml to equal a total of 10 mg per mom's verbal weight given of 24.2 lbs (11 kg).  Child was monitored for 20 minutes after dosage of oral Benadryl and showed no further reaction.  Mom instructed to monitor child, if he started having difficulty with breathing or the rash presented more rapidly to take child to nearest emergency room.  Verbal Understanding by mom noted.
Newborn baby given Hepatitis vaccine and HBIG both in right anterior thigh.
adverse reaction was local inflammation, localized rash,  tingling in left arm, soreness of left arm and hand.  Tx was antihistamines consistently and cold therapy. Outcome: Improving on 4/15/2021 with multiple doses of antihistamine  loradamed and antihistamine  (allegra 2X) and 1/2 benadryl. on 4/14 and hydrocortisone cream.  Pt was evaluated by PAC at clinic for first aid on 4/13 and 4/15 and PCP on 4/14/21 . Attempted call on 4/14 and left message for return of call to patient and no call back by the Moderna Adverse line and Health Department Nurses line.
Patient received vaccine of Menquadfi on 4/4/23 on the Lt deltoid. Patient reports; following that appointment her arm became sore and swollen. This was expected from the patient. Patient reports that the pain never went away. She also had fever for the first two days. She reports pain in his left shoulder radiating down her arm
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. In 2016 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. At the time of patient's vaccination, patient relied on the warning label affixed to zoster vaccine live(ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live(ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced patient to be vaccinated. On an unspecified date (reported as subsequent to zoster vaccine live(ZOSTAVAX) inoculation), patient was treated for shingles. As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not provided. The lawyer considered shingles to be related to zoster vaccine live(ZOSTAVAX).
Hours after injection: 100.2 fever,  chills, lethargy, muscle aches, couldn't lift left arm, muscle pain at injection site  Next day: pain in arm, struggle to lift arm above shoulder, rash on chest, neck, and forehead. All other symptoms abated.