chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unable to play tennis / because did not feel well; Bad headache; Soreness at injection site; This case was reported by a consumer and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 23rd February 2021, the patient received the 2nd dose of Shingrix. In February 2021, less than a week after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site pain. On 24th February 2021, the patient experienced headache. On 25th February 2021, the patient experienced feeling unwell. On 25th February 2021, the outcome of the headache was recovered/resolved. On 26th February 2021, the outcome of the feeling unwell was recovered/resolved. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the headache, injection site pain and feeling unwell to be related to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. The patient received 2nd dose of Shingrix on Tuesday, 23rd February 2021. The patient had a bad headache day after vaccination until morning of following day (Thursday). Also had soreness at injection site. The patient was unable to play tennis on Thursday because did not feel well. He felt better by Friday evening. Report was originally made by another family member on 27th February 2021 but then reporter spoke directly to patient on 28th February 2021.
I would like to know what is the common side effect of this vaccine?/Consumer answered "Yes" when the ChatBot asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (I would like to know what is the common side effect of this vaccine?/Consumer answered "Yes" when the ChatBot asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I would like to know what is the common side effect of this vaccine?/Consumer answered "Yes" when the ChatBot asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect). At the time of the report, VACCINATION COMPLICATION (I would like to know what is the common side effect of this vaccine?/Consumer answered "Yes" when the ChatBot asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter. No concomitant medications were reported; Sender's Comments: Very limited information regarding this event has been provided at this time. Details regarding the event term and date of vaccination is required for further assessment.
Immediately after vaccination - profuse sweating, dizziness, and nausea. Resolved in 15 minutes with water Day after vaccination - headache  2 days after - intense body aches and pain through shoulders. Heart pain. Soreness in legs
Pt recd vaccine in right upper arm on 11/13/13. He called Saturday 11/16 stating arm sore and red. Pt said he was taking ibuprofen and using rubbing alcohol on area. Came in to see RPh on Sat. arm was red going down from the vaccine administration site and warm to touch, but not centered around vaccine spot. Told pt to use IBU and Hydrocort crm, and if still happening Monday to call MD.
Pt has received her 4 y.o. vaccination 5 min later had SOB, swollen face and eye lids, redness of the skin, slight wheezing. Received: EPIPEN, BENADRYL, ORAPRED.
extended time between both doses/First Moderna shot in March & second dose in November; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (extended time between both doses/First Moderna shot in March & second dose in November) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (extended time between both doses/First Moderna shot in March & second dose in November). In November 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (extended time between both doses/First Moderna shot in March & second dose in November) had resolved.            No concomitant drug details were reported. No treatment details were reported.   Reporter did not allow further contact
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter. The vials were placed in refrigerator on 6-Dec-2021. The vaccine was used past 30-day use by date.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX vaccine in 2011, at a medical center, as recommended for routine adult health maintenance for the prevention of shingles.  The vaccine did not prevent shingles as intended, and subsequently the patient contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Vaccine that was to be provided was Meningococcal Conjugate, available as MENACTRA at clinic. Vaccine actually provided was Hib-HepB.
The next afternoon after receiving the injection the pt. experienced swelling > a baseball on (L) arm at the site of injection & some swelling above (L) shoulder & (L) side of neck. No fever. Swelling decreased over 3 days time. Mother reported this today.
Dose administered after 30-day Use By Date; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date). On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication details were reported. on 24 feb 2022 case was treated from  invalid to valid as patient was identified. Vaccines placed in refrigerator 13 feb 2022 Expiration date placed on vials 12 feb 2022 Doses administered to patient 17 feb 2022   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2022: Follow up document received contains No New Information. On 24-Feb-2022: Significant Follow Up- Patient demographics added, suspect product dosage added and new event product storage error was added.
Administered booster shot, for more than 12hrs out of refrigerator for 5 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered booster shot, for more than 12hrs out of refrigerator for 5 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered booster shot, for more than 12hrs out of refrigerator for 5 patients). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered booster shot, for more than 12hrs out of refrigerator for 5 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Reporter stated that date the vial was initially stored in the refrigerator on 5-Nov-2021,Date and time vial was first punctured on 11Nov2021- 11:25 am date of administration of vaccine on12-Nov-2021 and the vails stored post puncture in RT over 25 hours for the first dose up to 29 hours for the last dose.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Non significant follow up  received on 15-Nov-2021
Shortness of breath, with low grade chest pain, and then the onset of symptomatic atrial fibrillation requiring cardioversion.
received an expired dose of ADACEL with no reported adverse event; Initial information received on 17-Jan-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 11 years old male patient who had received an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA).  On 17-Jan-2020, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE  (strength, frequency was unknown, lot C5631AA and expiry date was unknown) via intramuscular route in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On 17-JAN-2022 the patient developed a non-serious event "received an expired dose of adacel with no reported adverse event" (expired product administered) 2 years following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (received an expired dose of ADACEL with no reported adverse event).  At time of reporting, the outcome was Unknown for the event received an expired dose of adacel with no reported adverse event.   Reporter Causality: Related
Reaction began with light-headedness and progressed over next two hours to extremely high blood pressure, difficulty catching a breath, confusion, blurry vision, numbness and tingling of right side of head, face, and arm.  Symptoms slowly faded over five hours in the hospital emergency room.
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.  An 80-year-old male patient received BNT162b2 (COMIRNATY), on 09Aug2021 at 12:00 as dose 1, single (Lot number: ew0198), in left arm, as dose 2, single (Lot number: FD8448), in left arm and on 01Feb2022 at 12:00 as dose 3 (booster), single (Lot number: FK9896) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GBS", start date: 2014 (unspecified if ongoing), notes: In 2014 after receiving the flu vaccine I developed GBS. Concomitant medication(s) included: TAMSULOSIN, start date: 02Jan2018, stop date: 07Jul2022. Past drug history included: Flu vaccine, start date: 2014, stop date: 2014, for Immunization, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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) Unknown results, notes: Indication: COVID 19 Treatment; (2022) Negative, notes: 5 day paxlovid treatment I tested negative for about 4-5 days; (2022) Positive, notes: then tested positive; (07Jul2022) Positive, notes: I am still positive as of 7Jul2022. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
Information has been received from a lawyer regarding a case in litigation referring to a male patient of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 26-OCT-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered neck pain, skin sensitivity, and red spots on the back of the scalp and was diagnosed with acute shingles. As a direct and proximate result of the defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccine, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the conduct, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The causality assessment was considered as related by the lawyer. The lawyer considered the event shingles to be disabling.
Woman received on 12/09/2009  in her Left arm H1N1 vaccine with no discomfort. The next day 12/10/2209 she received the Seasonal Flu  vaccine in  her right arm. About  6 hours later,  her arm was doubled in size, red and painful.  Hurt in arm, neck and leg all on right side.  She called her boss ( an RN) the next day,  the boss  looked at it.   The redened area was marked and  the woman was advised to  go to the emregency room if  the redness went outside of the mark.   The next day at work,she felt hot and the redness spread outside the circle.  The woman called the emergency room , she states the ER  advised  her there was nothing to do about it.  Then on Sunday evening the area decreased in size and the redness was gone.    All  is fine now.  the woman has Thyroid disease  and High BP.  Medications: lisinopril and synthroid.
Initial report was received on 03 October 2011 from a health care professional which involved a case of overdose. A female patient (date of birth not reported) had received on 30 September 2011 at 9 AM a one ml dose of FLUZONE (lot number, route and site of administration not reported) and three and a half hours later at 12:30 PM, experienced heaviness in her chest and felt her throat closing. The patient was sent to the ER (emergency room) for treatment. The patient's past medical history, concomitant medications and treatments were not reported. No further information was available at the time of the report. Outcome was recovered. The reporter for this case is the same as for case 2011-09484. Documents held by sender: none.
arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dsoe in October 2020, refer case US2021025199.).   On 21st January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experiencing arm soreness in both arms, but more in the arm that was vaccinated in October. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021025199:same reporter
Patient hospitalized for new onset atrial fibrillation within 6 weeks of receiving COVID vaccination.
Death SEPTIC SHOCK, HYPOTENSION, DIABETES MELLITUS TYPE 2, RHEUMATOID NODULAR FIBROSIS
On 12/14/2022  in the morning  I had a runny nose, sneezing, head cold and sore  throat .  I did a home COVID-19 test on 12/15/2022 which was positive. I did  a tele health on 12/19/2022 with my doctor since it was past 7 day cycle he didn't prescribe me any medication.
This spontaneous report was received from a physician refers to a 41 year old male patient. The patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23. On an unknown date, the patient experienced high fever of 104 degrees, aches and pain, dizziness and excruciating pain in the armpit are after receiving the vaccination. The outcome of the events were unknown at the time of this report. This is one of the several reports received by the same reporter. Additional information has been requested.
One week after vaccines he started with a temp of 101.4.  Fever lasted from that Thursday until Sunday.  Went to ER 9/27/2020. 9/28/2020 developed rash from neck down on back/trunk.  9/29/2020 seen in office, 1-2 mm blanching papules on back, trunk, arms, legs.  Slight pink cheeks.
This spontaneous report as received from a physician via a company representative, refers to a 13 year old female patient. The patient's medical history and concurrent conditions were not reported. On 01-MAR-2017, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis (as Centers for disease control (CDC) recommendation). There were no concomitant therapies reported. On an unspecified date in March 2017, the patient developed swollen lymph nodes in the axillary region (lymphadenopathy). It was reported that the patient sought medical attention. The outcome of lymphadenopathy was unknown. The causality between GARDASIL 9 and the event was not provided. Additional information has been requested.
After we gave first dose Of COVID vaccine, his Crohn's symptoms have come back; he has high fever until he was give steroids.; My kid had weight loss; missed school and other activities.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent. Other Case identifier(s): PFIZER INC-202200333254.  A 9 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 1, single for covid-19 immunisation. Relevant medical history included: "Crohn's" (ongoing). The patient's concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant), outcome "unknown", described as "After we gave first dose Of COVID vaccine, his Crohn's symptoms have come back"; PYREXIA (non-serious), outcome "unknown", described as "he has high fever until he was give steroids."; WEIGHT DECREASED (non-serious), outcome "unknown", described as "My kid had weight loss"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "missed school and other activities.". The patient underwent the following laboratory tests and procedures: body temperature: high, notes: he has high fever; weight: loss, notes: had weight loss. Therapeutic measures were taken as a result of pyrexia.It was reported that my kid was suffering from Crohn's and was under inflectra. He was 9 yrs old and was doing okay for few months. After we gave first doze Of COVID vaccine, his Crohn's symptoms have come back and past 2 months he has high fever until he was given steroids. My kid had weight loss and missed school and other activities. Wanted to check if you your sample had Crohn's patients when COVID vaccine was tested. We have suffered a lot and my kid was still dYT.   The lot number for bnt162b2 was not provided and will be requested during follow up.