chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling sick; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, the patient experienced MALAISE (Feeling sick). At the time of the report, MALAISE (Feeling sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
pt recv vax 6JUN95 & 11APR96 pt devel full-blown case of chicken pox w/over 200 lesions;pt was seen in MD office & recovered;
2 days of flu-like symptoms post 2nd dose; This is a spontaneous report from a contactable Consumer (husband) reported for himself.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for Injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (1st Dose) for COVID-19 immunisation. It was reported that the patient's spouse queried that had have there been Covid-19 Vaccine studies looking specifically on Epstein-Barr Virus and Herpes II virus, and any related reactions, positive, perhaps lessened viral load, or no reaction. Reporter stated his wife, 66, has had post vaccination flare-ups, and wondering if there are studies to find and share info. On an unspecified date, the reporter also stated they both had 2 days of flu-like symptoms post 2nd dose of COVID-19 vaccination that cleared, and we are grateful and thankful for your work. The clinical outcome of the event was resolved.  Information on the lot/batch number has been requested.
This is a spontaneous, non-serious report received from a consumer. A female, of unspecified age (height, weight and concomitant medications not reported), received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch/lot# unknown), dose not reported, administered on Mar 7, 2021, for immunization. The patient's concurrent conditions included: type 1 diabetic. The batch/lot number requested. On Mar 8, 2021, patient felt nauseous (like flu coming on) and tired. Laboratory data included: Body temperature (NR: not provided/not over 100). The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient recovered from felt nauseous (like flu coming on) and tired on Mar 10, 2021. This case, from the same reporter linked to 20211031878.
My arm started itching the day I received the vaccine, has increased in redness and warmth to include  an area that is 3.5 inches wide and 1.5 inches tall on day 4. It is warm to touch and firm. I have had a headache for 4 days. very bad body aches for 1 day that did not even respond to 1 extra strength tylenol and 2 motrin over the counter. Also have had nausea for 3 days.
May be late for 2nd dose; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-FEB-2023 Reporter's Comment: The doctor called to request information about a patient that might get a third dose of Shingrix vaccine, intention was to administer another dose if the doctor considered it safe enough and patient agreed. The patient had no recollection of receiving a second dose and pharmacy had no records of vaccination. The reporter reported that if no second dose was given the patient might be late for it, if a second dose was given the patient could be getting a third dose. At the time of reporting, the doctor had no patient or vaccine information. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
I start having a lot of pain on my left side of the neck, some days I have problems even moving my neck, wake up with headache; I start having a lot of pain on my left side of the neck, some days I have problems even moving my neck, wake up with headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR; LOSARTAN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Don't know), for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Don't know), for Covid-19 Immunization. The following information was reported: NECK PAIN (non-serious), HEADACHE (non-serious) all with onset 24Dec2021 at 12:00, outcome "not recovered" and all described as "I start having a lot of pain on my left side of the neck, some days I have problems even moving my neck, wake up with headache". The event "i start having a lot of pain on my left side of the neck, some days i have problems even moving my neck, wake up with headache" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of neck pain, headache.  Additional information:Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Generic Crestor  Losartan other medications the patient received within 2 weeks of vaccination. Prior to vaccination, was not diagnosed with COVID-19. Since the vaccination, has the patient was tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
101.5 fever,  six hours after Extreme lower back pain, five-six hours later Nausea, about six hours later  I feel like I?ve been hit by a truck. Feels like the flu. Can only lay down with blankets.
0915 Immunization given. 0920-0923 Mom came out of exam room with baby, baby had slightly raised red rash on face, trunk, arms. 0925 Benadryl 10mg given.
Patient developed an itchy rash on the opposite (right) forearm within the 15-minute observation period. Patient was given an IM shot of 25 mg of Benadryl in the hip. Problem was resolved and no other adverse effects occurred.
Pt experienced shooting pain through neck, trouble breathing. Went to ER. She still feels tired but symptoms have slightly improved.
This spontaneous report was received from a registered nurse and refers to a 13-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # 1586752, expiration date 16-FEB-2021 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies were not reported. On 19-NOV-2018, the patient was vaccinated with PROQUAD subcutaneous injection (lot # R014353, expiration date: 18-NOV-2019, recombinant Human albumin (rHA)) (dose, anatomical location were not provided) reconstituted with properly stored sterile diluent. The vaccine was stored at a temperature of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 4 hour. There was no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1812USA009243: US-009507513-1812USA009242: US-009507513-1812USA009244: US-009507513-1811USA009124:
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM8910), in right arm, on 25Feb2021 as dose 2, single (Lot number: EN6203), in right arm, on 13Oct2021 as dose 3 (booster), single (Lot number: FF2589), in right arm and on 26May2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 74 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received treatment of Paxlovid for covid -19 from 22Jul2022 to 26Jul2022. Patient not received Other medication in 2 weeks. COVID rebound after Paxlovid. Patient had no Known allergies.  No follow-up attempts are possible. No further information is expected.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-098019 (Patient Link).
This spontaneous report was received from the patient's neighbor referred to a male patient of unknown age. The reporter advised the patient received by mistake, two doses of ZOSTAVAX (Lot# unspecified) about a year apart (dose, frequency, route and indication unspecified). Patient had a "full blown case of shingles." The reporter advised it was "not mild by any means." Outcome of the events were unknown. Additional information is not expected.
Excessive Fatigue, Shortness of breath, little interest in anything, runny nose, cough & congestion.  At about day 4-5 after second vaccine, she became more fatigued than usual, developed a mucousy cough, and had little interest in doing anything.  After day 10, a nurse came in and took vitals and suggested she see a physician for possible fluid in lungs and an irregular heart beat.  Monday, April 12 we took her to Urgent care as her Dr. couldn't see her until we went there first.  We will do a follow up with her regular physician next week.
swollen arm; itchy arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021 and was forwarded to Moderna on 14-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm) and PRURITUS (itchy arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen arm) and PRURITUS (itchy arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-Feb-2021, PERIPHERAL SWELLING (swollen arm) and PRURITUS (itchy arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-076361 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: No new information added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076361:Crossed linked, 2nd dose case
believes that she may have cancer; "thick white creamy" vaginal discharge/ started having a fishy smell; serious problems" in her vaginal area; she was advised that she has "HPV on (her) cervix; "thick white creamy" vaginal discharge; bacterial vaginosis; This spontaneous report as received from an approximately 17-year-old female patient. The patient had no pertinent medical history and drug reactions or allergies. Her concomitant therapies included folic acid.  On an unknown date in 2009, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), intramuscularly (dose, lot # and expiration date were not reported) for prophylaxis.   On an unknown date in approximately 2009, (also reported as a week after she got the vaccination), the patient started getting lots of vaginal infections. According to the patient, on unknown dates, multiple doctors did visual examinations and the patient was told that she had bacterial vaginosis. The patient received unspecified medications for the event.  In approximately 2011 (reported as 2 or 3 years after getting quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (douse, route of administration, lot # and expiration date were not reported) to "help protect from anything else happening".  On an unknown date in 2012, the patient started having a "thick white creamy" vaginal discharge and on an unknown date (reported as "over time") it started having a fishy smell. Approximately in 2013 (reported as in 2013 or 2014), the patient was advised that she had human papillomavirus (HPV) on her cervix. The patient had been to four different hospitals to try to get this events treated, however she was released from each hospital without being admitted. On an unknown date, the patient experienced "serious problems" in her vaginal area and she believed she might have a cancer. Patient stated that she was considering legal action because of the events.  The outcome of the events was reported as not recovered.  The relatedness between the events and the suspect vaccines was not reported.  Upon internal review, the event of cancer was considered to be medically significant.
COVID test on 12Jan2021, which came back positive; Developed a cold; Productive cough; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of NASOPHARYNGITIS (Developed a cold), PRODUCTIVE COUGH (Productive cough) and COVID-19 (COVID test on 12Jan2021, which came back positive) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 immunization.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced NASOPHARYNGITIS (Developed a cold) and PRODUCTIVE COUGH (Productive cough). On 12-Jan-2021, the patient experienced COVID-19 (COVID test on 12Jan2021, which came back positive). At the time of the report, NASOPHARYNGITIS (Developed a cold), PRODUCTIVE COUGH (Productive cough) and COVID-19 (COVID test on 12Jan2021, which came back positive) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test positive: Positive.     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 medication was provided No treatment details were provided.
This spontaneous report as received from a nurse refers to 18 patients of unknown age. On an unknown date the patients were vaccinated with VARIVAX (Merck) lot # H015940. The VARIVAX (Merck) had multiple excursions reaching the highest temperature of 15.5f. The nurse was unsure how many total hours of the excursions but reported that it was over 72 hours. No adverse effect was reported. Additional information has been requested.
Temp 99 deg, R arm red, swollen hot "splotchy" 3-4 inches in diameter.
During a review of at a local Department of Health?s internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
Cried constantly for 2-2  1/2 hrs, inconsolable-mom called MD & was instructed to given APAP as directed;
By error the nurse took the box that had a beyound use date of October 18, 2022 and administrated 6 doses to patients; Case reference number US-BN-2022-004307 is a spontaneous case received from other health care professional on 24-Oct-2022 (reference: USBAV22-1762) and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medications details were not provided.  On 21-Oct-2022, the patient was vaccinated with Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00013, Expiration date: Sept-2024) at an unknown dose, through unknown route of administration, at unknown anatomical location, for monkeypox prophylaxis.  It was stated that, by error the nurse took the box that had a beyond use date of 18-Oct-2022 and administrated six doses to patients (explicitly coded as 'Expired vaccine used'). Vials were not punctured prior to administration.  At time of this report, the patients did not experience any adverse events as a result of Jynneos vaccination.  The reporter assessed causality between 'Expired vaccine used' and Jynneos as possibly related.  This case is linked with the cases US-BN-2022-004306, US-BN-2022-004308, US-BN-2022-004309, US-BN-2022-004310 and US-BN-2022-004311 (same reporter).  Additional information received on 24-Oct-2022 from Bavarian Nordic included local case ID.; Reporter's Comments: Six patients of unknown demographics were vaccinated with vials of Jynneos which were 3 days past the beyond-use date, which is considered expired product administered. No adverse events were reported. Expired product administered is considered listed per company convention. No medical history or concomitant medications information was reported. The event is considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: Six patients of unknown demographics were vaccinated with vials of Jynneos which were 3 days past the beyond-use date, which is considered expired product administered. No adverse events were reported. Expired product administered is considered listed per company convention. No medical history or concomitant medications information was reported. The event is considered not related to Jynneos, but to human error. The case is non-serious.
Patient is also feeling extremely tired; Muscle aches; Pains; Low red blood cell count; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced tiredness, muscle pain, pain and red blood cell count decreased. On an unknown date, the outcome of the tiredness, muscle pain, pain and red blood cell count decreased were recovering/resolving.   It was unknown if the reporter considered the tiredness, muscle pain, pain and red blood cell count decreased to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The reporter stated that the patient red blood cell count was lower than it should be, and also felt extremely tired, with muscle aches and pain. The patient had lab work done on 1st October 2019 and he had the appointment with the endocrinologist on 9th October 2019. The endocrinologist recommended the patient to the hematologist because the blood cell count was low enough that it merits an hematologist. The reporter stated that the patient thinks the red blood cell count was around 110,000. This case has been linked with case US2019202829, reported by the same reporter.      Lab Comments: The red blood cell count was around 110,000
Lymph node swelling in right armpit; Also experienced flu like symptoms; This is a spontaneous report from a contactable consumer reported for himself. A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 28Jan2021 08:45 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included multiple sclerosis (MS) and allergy to eggs, fish and tree nuts. Concomitant medication was received (patient received other medications within 2 weeks). The patient experienced lymph node swelling in right armpit. It was about the size of a half-dollar four days after vaccination. Also experienced flu like symptoms. The events onset on 30Jan2021 at 7:00. No treatment was received. Outcome of the events was not resolved. This case was reported as non-serious.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.