chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hair loss; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 28Feb2021 at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 02Mar2021 the patient experienced hair loss. Reporter received first CoVax 28Feb2021, reported experiencing continuous hair loss 2 days later through now. Confirmed reporter did receive both CoVax doses. Outcome of the event was not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pain; Shingles now after shots in 2017/suspected vaccination failure; I now have SHINGLES again; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. In MAR-2023, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles now after shots in 2017/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I now have SHINGLES again). On an unknown date, the patient experienced pain (Verbatim: pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-Mar-2023 The case was received from the patient via interactive digital media. The patient had an almost natural child birth because the opening to her wound was upside down and they kept telling her that she was not labor. The patient had taken her shots since 2017 and now had shingles again. The patient stated that well she was but the pain was not as bad as this bout of the shingles. The patient mentioned 5 drugs (RXs) and nothing works. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Vertigo upon changing positions from lying down to sitting or standing, and from standing to lying down. Vertigo also when rolling over in bed.
His left arm was extremely sore in the shoulder area; A spontaneous report was received from a consumer concerning a 76 years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left arm  extremely sore in the shoulder area.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their dose of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the left arm was extremely sore in the shoulder area.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events left arm was extremely sore in the shoulder area was unknown.
After 5 minutes felt warm flush and had headache, about 8 hours after vaccine had nausea next day, after 1 hour had fatigue, body aches, swollen LN. symptoms resolved after 48 hours.
This spontaneous case was reported by a consumer and describes the occurrence of PROSTATE CANCER (Diagnosed with prostate cancer) in a 79-year-old male patient 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) (unknown route) 1 dosage form. In October 2021, the patient experienced PROSTATE CANCER (Diagnosed with prostate cancer) (seriousness criterion medically significant). The patient was treated with ABIRATERONE ACETATE (ZYTIGA) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, PROSTATE CANCER (Diagnosed with prostate cancer) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient weight was 190. No concomitant medication information was provided. Patient states he was diagnosed with prostate cancer after receiving the vaccine on Oct2021. He does not have his dosage dates or lot numbers to provide for safety. He states he is on Zytiga and wants to know if there are any drug interactions? He is also on Prednisone. He does not have any past medical history. Company comment: This spontaneous case concerns an elderly 79-year-old male patient with no medical history, who experienced the serious (medically significant) unexpected event of Prostate cancer, unknown days after receiving an unspecified dose of mRNA-1273. Patient´s advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: Company comment: This spontaneous case concerns an elderly 79-year-old male patient with no medical history, who experienced the serious (medically significant) unexpected event of Prostate cancer, unknown days after receiving an unspecified dose of mRNA-1273. Patient´s advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Chest pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chest pain aggravated in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included shingles (4 years ago). Previously administered products included Shingles vaccine with an associated reaction of chest pain (received vaccine an unknown date, since and they also caused more pain on the spot on his/her chest, refer link case, US2023AMR041272), Shingles vaccine with an associated reaction of chest pain (received vaccine on an unknown date, since and they also caused more pain on the spot on his/her chest, refer link case US2023AMR041280,) and Covid vaccine with an associated reaction of chest pain (received vaccine on an unknown date). Concurrent medical conditions included chest pain.   On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced chest pain aggravated (Verbatim: Chest pain). The outcome of the chest pain aggravated was not recovered/not resolved.   It was unknown if the reporter considered the chest pain aggravated to be related to Flu vaccine.     It was unknown if the company considered the chest pain aggravated to be related to Flu vaccine.   Linked case(s) involving the same patient:  US2023AMR041272, US2023AMR041280   Additional Information: GSK Receipt Date: 10-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she had shingles four years ago and still had some pain on chest. Most time it was just a very mild irritation, but when patient got a flu shot, or Covid shot the spot on his/her chest was more painful.  The patient had both the old and two new shingles shots since and they also caused more pain on the spot on his/her chest.  The follow-up could not be possible as no contact details were available. This case refers to additional dose of singles vaccine. This case had been linked with US2023AMR041272 and US2023AMR041280 for single patient.; Sender's Comments:  US-GSK-US2023AMR041280:Same reporter US-GSK-US2023AMR041272:Same reporter
On  5/20/2022 I received the vaccination at approximately 10:30.   I had no symptoms until 7:30 that night when I began to feel chills and body aches.  By 11:00 that night I spiked a fever up to 104.3.  At approximately  4 a.m. the fever broke,  On 5/30/2022 I started noticing small (nickel-size) bruises that go from my left hand all the way up my forearm (8).  I also noticed a large (palm-size) bruise on the back of my calf just below my left knee with 5 quarter-size ones lined up below that.  There are also 9 bruises in a line up the front side of my right shin and two nickel-size bruises on my upper right thigh.  On 6/1/2022 I began loosing my voice and I still have not go my voice back.  On 6/3/2022 and 6/4/2022 I began feeling heart palpitations.  I went to urgent care on 6/5/2022 to be seen for the above listed issues.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 42-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that, their facility had not been able to download the digital data logger, they had been put on hold at the moment. There had been no power outages that would have impacted the Moderna vaccine.  Reporter stated that they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022.  The reporter stated that no adverse reactions were reported by any patients.  No treatment medications were reported.
Initial and follow-up information has been received from a nurse midwife for the pregnancy registry for VARIVAX (Merck), concerning an 18 year old female with a history of 8 pregnancies and 0 live births who on 03-OCT-2008 was vaccinated with the second dose of VARIVAX (Merck), the third dose of RECOMBIVAX HB (MSD) and the first dose of VAQTA (MSD). Concomitant therapy included MENACTRA and DTaP (unspecified). The patient may have been pregnant at the time of administration (LMP 08-SEP-2008 and EDD 15-JUN-2009 also reported 19-JUN-2009). No adverse reaction reported. No product quality complaint involved. The patient did not seek medical attention. Follow up information has been received from a nurse midwife reported that on 15-JUN-2009 the patient delivered a normal, healthy male baby weighing 8 pounds 7 ounces. Medication taken during pregnancy included PHENERGAN for the treatment of nausea and vomiting on 18-NOV-2008 and FLAGYL for the treatment of Bacterial vaginosis on 10-APR-2009. Additional information is not expected.
For months all I could taste was metal; I was never so sick in my life; Initial information received on 07-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves adult patient (unknown age and gender) who experienced "for months all i could taste was metal" (dysgeusia) and "i was never so sick in my life" (illness) while receiving vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious "for months all i could taste was metal" (dysgeusia) and "i was never so sick in my life" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "last time I got one because my doctor told me I'm old and need one. I was never so sick in my life. For months all I could taste was metal. Doctor said don't get it again. Haven't been sick since".   Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported events.  There will be no information available on the batch number for this case.
On Thursday December 6th in the AM patient began experiencing urticaria. He started taking Benadryl 50 mg Q3 hours except when sleeping. He stopped taking Benadryl on Sunday because symptoms were improving and patient states symptoms were gone by Monday December 10th. For patient's remaining vaccines - 2 total - he will receive Rabavert. Today December 13th, he received his 4th shot with Rabavert - Lot # 419011A, EXP 07/10.
mom states 9APR96 pt awoke w/raised red blotches on several areas of body;pt seen 9APR96 @ clinic observed raised red blotchy areas of skin;hives cont & pt agitated & hot;dx allerg rxn;pt vomited
Moderna COVID-19 Vaccine that was left at room temperature during 27 hours; Dose administered after exposure to room temperature during 27 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature during 27 hours) and PRODUCT STORAGE ERROR (Moderna COVID-19 Vaccine that was left at room temperature during 27 hours ) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A and 004F21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa drugs), Thyroid disorder (Thyroid issues) and Arthritis. Concomitant products included LEVOTHYROXINE, MELOXICAM and TOPIRAMATE for an unknown indication.   On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature during 27 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna COVID-19 Vaccine that was left at room temperature during 27 hours ). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature during 27 hours) and PRODUCT STORAGE ERROR (Moderna COVID-19 Vaccine that was left at room temperature during 27 hours ) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was 14-Apr-2022. Maximum or minimum temperatures reached was 73°F Temperature excursion: yes. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 27 hours Caller did not know if patient experienced any Adverse events or if any treatment was given after getting the vaccine.  Treatment medication was not reported.
dose administered past the 30-day use by date was the first or second shot; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date was the first or second shot) in an elderly patient of an unknown 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date was the first or second shot). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date was the first or second shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Hives within minutes of the injections; Chills; massive headache; back pain; This is a spontaneous report from a contactable consumer. This 40-year-old non-pregnant female consumer (patient) received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 04Feb2021 at 03:00 PM (Batch/Lot Number: Ec3247) in hospital as SINGLE DOSE for COVID-19 immunization. Medical history included known allergies: mushrooms, break out in hives on morphine and oxycontin. The patient's concomitant medications were not reported. The patient previously took morphine and oxycontin, experienced urticaria with both. No other vaccine reported in four weeks and two weeks. The patient experienced hives within minutes of the injections, chills, massive and back pain on 04Feb2021 03:15 PM. The patient underwent lab tests and procedures which included COVID tested: negative in 2021. The patient was treated with Benadryl and Tylenol. Outcome of the event was recovered on 10Feb2021, side effects last about 5 days.  No follow-up attempts are possible. No further information is expected.
Mother passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Mother passed away) in a female patient of an unknown age 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) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested to confirm if this is a valid case.; Reported Cause(s) of Death: Unknown cause of death
pt had been fine since vaccine 8 days ago until yesterday evening she noticed a small red bruise on her lt lower eyelid. she woke up today and noticed got larger to half inch sized.  pt denies blurred vision, vision loss, or difficulty with extra ocular eye movements or trauma.
he doesn't feel okay; tired; chills; fever; body pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (he doesn't feel okay), FATIGUE (tired), CHILLS (chills), PYREXIA (fever) and MYALGIA (body pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced MALAISE (he doesn't feel okay), FATIGUE (tired), CHILLS (chills), PYREXIA (fever) and MYALGIA (body pain). At the time of the report, MALAISE (he doesn't feel okay), FATIGUE (tired), CHILLS (chills), PYREXIA (fever) and MYALGIA (body pain) had resolved.            No concomitant medication provided by reporter. No treatment medication provided by reporter. Action taken with mRNA 1273 in response to event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: TCR received and Updated the Event outcome to Recovered/Resolved
I was approximately six weeks pregnant at time of my first vaccine. At subsequent OB visit three weeks later I had miscarried. It may not be related to the vaccine at all, but given this is a new vaccine and not studied in pregnant women I thought it was best to report it.
Extreme fatigue / tiredness. Could not get up and stay up for 24 hours. Bad headache in lower back of head and neck.
Patient stated she developed arm swelling redness and pain in left arm as well as fever and chills. Said she has been taking ibuprofen since to help with symptoms. Patient showed her left arm and it was still noticeably red and swollen. Pt education that Benadryl/diphenhydramine may help with allergic reaction symptoms. Instructed pt to go in if symptoms do not resolve or get worse. Pt also stated she had pneumonia immunization previously about a year ago with no reaction that time.
pt recvd vax 16APR92 devel visual sx 2 wks later & dx w/retrobulbar optic neuritis on 13MAY92; has had gradual improvement to now almost total resolution w/no therapy; MD believes was post vax optic neuritis;
Severe indentation on the arm that shot was delivered.; Severe indentation on the arm that shot was delivered.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Apr2021 (Batch/Lot number: unknown) at the age of 30 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: SKIN INDENTATION (non-serious), LIMB DISCOMFORT (non-serious), outcome "not recovered" and all described as "Severe indentation on the arm that shot was delivered.". Therapeutic measures were not taken as a result of skin indentation, limb discomfort.  Additional Information: Patient had no other vaccine in four- weeks and no Other medications in two weeks. Patient had no covid prior to vaccination and was not tested to covid post vaccination   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.
2 days after injection, patient reported RA flare in injection arm. She happened to see her RA doctor that day who increased her dose of prednisone from 1 mg to 5 mg. Now, 7 days post-injection, the patient is reporting worsening RA flare in both arms.