chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; Tested positive after negative tests; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Tested positive after negative tests". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested positive after negative tests; Positive, notes: Tested positive after negative tests.  Clinical course: Other medication in 2weeks product: Prednisone. Other medication in 2weeks start date: 29Nov2022. Other medication in 2weeks stop date: 07Dec2022  No follow-up attempts are possible. No further information is expected.
Patient called clinic at 12:20 pm 08/31/12 to let us know she developed a hive-like rash last night. She first noticed this before bed. Reports in the middle of the night it was worse and itchy, had spread some over chest. No trouble breathing. Much better today. No allergy medication needed today.
Seasonal flu vaccine administered 10/20/11 in left upper arm. Reports 10/22/11 3" red circle around incision site looks bruised and slightly itchy. Pt denied need for appt or tx.
Patient came in on 8/19/2014 and said that she was having a local reaction at injection site. She received the ZOSTAVAX shot on 8/14 and on 8/16 she developed pain and itching at injection site. She said it was also red, swollen and warm. She said it had gotten better since then. Still has a bit of rash.
On 02/04/2021 client calls to report "red, slightly raised, warm to touch. round, size of a grapefruit" area to injection site (left deltoid). Client denies and symptoms of anaphylaxis and or pain or drainage to area. Writer advised client to apply cold compresses to area, monitor her temperature for fever, and to monitor the area for increased redness or swelling and seek medical treatment if symptoms worsen. Follow-up call made to client on 02/05/2021. Client states that the condition of the injection site remains unchanged despite the use of intermittent cold compresses. Client continues to deny pain or drainage in area. Writer advised client to mark edges of redness and monitor for spreading of redness beyond markings, continue to monitor temperature for fever, continue to apply intermittent cold compresses to the area and wash the area two times daily with a liquid antibacterial soap. Client advised to seek medical treatment if redness spreads or fever develops. Client verbalized understanding of recommendations. Follow up call made to client on 02/08/2021. Client states that area of redness has "faded" and is "half the size" that it was previously. Client states that the area began to resolve after approximately two days of intermittent application of cold compresses. Client also stated that there was some mild itching to the area on 02/06/2021, but that this symptom has completely resolved.
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.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 5 (booster), single (Lot number: GH9697) at the age of 50 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 16Apr2021 as dose 2, single (Lot number: ER8734), in left arm, on 06Nov2021 as dose 3 (booster), single (Lot number: FH8027), in left arm and on 30Jul2022 as dose 4 (booster), single (Lot number: FP7150), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin, sulfur products, trazodone" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid treatment from 05Jul2023 to 09Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300249242 Same reporter/patient, different product/AE;
Pt developed vertigo and high BP of 202/120. 1 hour after vaccine administration   Went to Ed and full neurological and lab work up completed.  NO significant findings noted.  NO medications or treatments administered.  Follow up with PCP the next day was unremarkable.  All symptoms resoled in 3 hours.
shungles twice; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingles twice after receiving one shingles shot. The patient stated that nothing was never.
After administering vaccine, patient stated he was very anxious - has a history of needle phobia.  He then stated he was going to faint and I assisted him to the floor.  He temporarily lost consciousness ( less than 20 seconds). He appeared diaphoretic.  He regained consciousness and appropriately responded to my inquiries.  I assisted him to a chair where he sat for 3 - 4 minutes then said he was feeling better and wanted to leave.  His mother was in the waiting room and took custody.  She confirmed she was present due to this happening before.
Dizziness later that day after the shot, 4 months later diagnosed with peripheral vertigo that lasts all day / sometimes for days. Was referred to Neurologist and PT
Chronic migraines since she received second dose/Has several episodes every week; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Chronic migraines since she received second dose/Has several episodes every week) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (Chronic migraines since she received second dose/Has several episodes every week). The patient was treated with VITAMIN B2 [RIBOFLAVIN] for Adverse event, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Chronic migraines since she received last dose/Has several episodes every week) had not resolved.            Concomitant product use was not provided by the reporter.  Treatment medications also included  medication for pain relief.
Sore Arm; Moderna covid-19 vaccine were administered on 15NOV2021 after bein initially punctured on 12NOV2021 at 8:53 AM; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and EXPIRED PRODUCT ADMINISTERED (Moderna covid-19 vaccine were administered on 15NOV2021 after bein initially punctured on 12NOV2021 at 8:53 AM) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 011M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna covid-19 vaccine were administered on 15NOV2021 after bein initially punctured on 12NOV2021 at 8:53 AM). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Moderna covid-19 vaccine were administered on 15NOV2021 after bein initially punctured on 12NOV2021 at 8:53 AM) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.  This case concerns a 80 year old male with no reported medical history , who experienced non-serious event of  Expired product Administered after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The patient also reported  Non-serious , unexpected  event of pain in extremity which occurred on an unknown date with an unknown dose number of the vaccine. The re-challenge for this case is not applicable. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 80 year old male with no reported medical history , who experienced non-serious event of  Expired product Administered after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The patient also reported  Non-serious , unexpected  event of pain in extremity which occurred on an unknown date with an unknown dose number of the vaccine. The re-challenge for this case is not applicable. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
9 year old patient received a second dose of VARlVAX 16 days after the first dose; no additional AE reported; This spontaneous report has been received from a pharmacist referring to a 9-year-old female patient. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis 16 days after the first dose (strength, dose, route, lot#, and expiration date were not reported) (inappropriate schedule of product administration). The reporter did not know the exact dates of administration. No additional adverse event (AE) or further information was reported.
11 days post injection, upper Left arm large blotchy red area,hot.  Red area below site of injection  Site of injection hard but not red.  Blotchy area faded but small presence  on upper arm still seen.Never any fever. I took 2 Benadryl and used cold packs for 24 hours.   Arm seen by doctor on 1-14-21 at time of scheduled visit. Doctor advised Benadryl before 2nd shot and 2 weeks of antihistamine after 2nd shot.
Child is over age 12 and should have gotten adult dose of Pfizer vaccine.  Parent signed up for pediatric dose.  Child is very small for his age and error not noticed until after vaccine given
Injection site hurts; arm feels like black and blue but its not; This is a spontaneous report received from contactable consumer (patient) from a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, on 04May2021, 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, after she received her first dose, her arm felt like black and blue but it is not (as reported) and injection site hurts a little. The provider asked the patient when she wanted to receive the second dose and the patient picked 19May2021 (2 weeks). The patient read the fact sheet that the facility gave her after receiving the 1st dose and she had read that the 2nd dose should be given 3 weeks after the 1st dose hence the patient rescheduled her second dose. The outcome of the events was not recovered.  No follow up attempts are possible. Information on lot/batch number cannot be obtained.
It burned more than past flu vaccines when being injected. Approx 30-45 minutes later, arm started to itch and burn at the injection site. Also started to feel a tingling sensation down the arm and on the palm of left hand. Voice became horse and became very dizzy and didn't  feel "right". Felt like heart was racing and it was difficult to take a deep breath. Also had a headache.
Sore arm; Tingling around her lips/Tingling on the roof of the mouth; This case was reported by a consumer via call center representative and described the occurrence of tingling lips in a female patient who received Herpes zoster (Shingrix) (batch number 2ZN2D, expiry date 16th September 2022) for prophylaxis.   Concurrent medical conditions included cancer. Concomitant products included linum usitatissimum (Flax Seed), cinnamomum verum (Cinnamon), colecalciferol (Vitamin D 3), calcium citrate (Citracal), ubidecarenone (Coq 10), vitamin B nos (Vitamin B), pravastatin, levothyroxine sodium (Synthroid) and amlodipine.   On 9th September 2020, the patient received Shingrix. On 9th September 2020, several hours after receiving Shingrix, the patient experienced tingling lips. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the tingling lips was recovered/resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the tingling lips and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of shingrix and experienced tingling in lips and over the mouth, sore arm. She was cancer survival patient. The reported batch number 2ZN2 was not found in sales data sheet hence was updated to 2ZN2D. Concomitant medications reported were Synthroid, Amlodipine, Pravastatin, Vitamin B Complex , CoQ-10 Enzyme, Vitamin D-3 1000 units, Citracal (Calcium Citrate) , Cinnamon Pills, and Flax Seed. She did not know if she can get 2nd dose of shingrix. The reporter did not consent to follow up.
fever; diarrhea; nausea; bad pain in the arm; This non-serious case was reported by a nurse via sales rep and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever (Verbatim: fever), diarrhea (Verbatim: diarrhea), nausea (Verbatim: nausea) and pain in arm (Verbatim: bad pain in the arm). The outcome of the fever, diarrhea, nausea and pain in arm were not reported.   It was unknown if the reporter considered the fever, diarrhea, nausea and pain in arm to be related to Shingrix.     It was unknown if the company considered the fever, diarrhea, nausea and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-JUL-2023 On first couple of days after administration of first dose of Shingrix patient experienced fever. On day 4 and day 5 later, she had nausea and diarrhea. She also experienced bad pain in the arm. She said she will not administer the second dose of Shingrix due to side effect she experienced on the first dose of Shingrix. The reporter did not consented to follow up.
No ADR, timer ERROR. 2md dose given 47 days after first dose Narrative: No ADR, timing ERROR, 2nd dose given 47 days after first dose
chest tightness between breast and upper back; Left arm soreness; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest tightness between breast and upper back), PAIN IN EXTREMITY (Left arm soreness) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Hypertension.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (headache). On 14-Feb-2021, the patient experienced CHEST DISCOMFORT (chest tightness between breast and upper back) and PAIN IN EXTREMITY (Left arm soreness). At the time of the report, CHEST DISCOMFORT (chest tightness between breast and upper back), PAIN IN EXTREMITY (Left arm soreness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Non immunocompromise, 73 year old male patient arrived to vaccination site after a doctors appointment and reported he was here for his second booster dose per his doctors instructions.  Patients chart and vaccine card were reviewed and it was determined he would be getting a second booster of Pfizer 0.3mL. Patient had Pfizer for all of his doses- first dose in primary series (per vaccine card and patients chart) was administered on 2/18/21, second dose of primary series administered on 3/11/21, and first booster administered on 10/4/21. Patient was given a 0.3mL Pfizer booster by LVN vaccinator. Upon going to place vaccine sticker with information about second booster on patients  vaccine card, the vaccinator turned over the card (as there was no more room on the front) and noticed that patient had actually another documented vaccine on the back of the card. Patient reported he forgot aht he actually already had another booster in another state. This was a Pfizer 0.3mL IM dose given on 5/13/22. patients chart did not state this and patient reported he has been hospitalized 3 times recently and his mind has been "all over the place." Patient was given an extra dose (for a total of 5 doses of Pfizer now). No complaints of pain at this time. MD on call was contacted and patient was instructed to monitor self for any symptoms deviating from his normal baseline and to go to the nearest urgent care or ER if symptoms develop.
severe pain; She reports severe pain and immobility, to include not being able to pull her clothes off on her own or do certain daily activities; This spontaneous report has been received from a 67 years old female patient, referring to herself. The patient had no concomitant medication and no pertinent medical history. The patient's drug reactions or allergies included seasonal hay fevere allergies.  On 19-SEP-2020 the patient was vaccinated with pneumococcal vaccine (+) polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml injection; strength, route, lot number and expiration date were unknown) for prophylaxis (reported as pneumonia).  The symptoms arrived 4 hours later on the same day (conflicting information: also reported as 18-SEP-2020), the patient reported severe pain and immobility,included not being able to pull her clothes off on her own or do certain daily activities. Over the last few days, the patient had seen improvement in mobility and pain. Treatment was not given for the events. The lab diagnostics or studies were not performed. The outcome of pain and mobility decreased was reported as recovering. The causality assessment between pneumococcal vaccine (+) polyvalent (23-valent) (PNEUMOVAX23) and the events was not provided.
On 7/2/13 developed fever to 101-102, lethargy then became fussy and difficult to console refusing solids but taking liquids, did not sleep well. Saw doctor 7/5/13 symptoms had resolved, normal exam.
Severe headache, muscle pain (whole body)  and fatigue lasting approximately 56 hours.
Moderna vaccine used past the 12 hour window of use once vial was punctured. Stored in fridge entire time of use and cleaned between  each use with alcohol .Contacted pt and no adverse reaction reported. Spanish interpreter used.
patient received the Janssen injection and at one minute became vagal and began vomiting at 2 minutes had a temporary loss of consciousness, EMS arrived at 4 minutes and patients heart rate was alternating between 20bpm-40 bpm.  EMS transported to ED.  Patient was discharged home at a later time.
Patient called to report that evening of injection (09/07/07) she had developed chills/sweats, nausea, difficulty standing x 2 days. Weak feeling x 2 days. Patient notified this office of above on 10/02/07.
Fatigue; chills; fever of 100.5; cough; headache and nausea. Approximately 24 hours with exception of that has been 48 hours and still coughing.
aches in her legs and arms; she has been experiencing fever; headache/severe headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (aches in her legs and arms), PYREXIA (she has been experiencing fever) and HEADACHE (headache/severe headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Fibromyalgia.    On 23-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (aches in her legs and arms), PYREXIA (she has been experiencing fever) and HEADACHE (headache/severe headache). At the time of the report, PAIN IN EXTREMITY (aches in her legs and arms), PYREXIA (she has been experiencing fever) and HEADACHE (headache/severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The  concomitant medications on use were not provided. No laboratory data was provided. Treatment included paracetamol.
I had the normal side effects for the vaccine, chills, low fever, nausea. All that went away on the 3rd day and I was fine. Today on my 4th day I  am feeling nausea and vertigo. I had laberintitis before, and this feels the same.
Approximately 2 days after injection #2 in the right arm, swelling of the right IB or IIA lymph node was noticeable.   Swelling lasted about 1 hour and shank rapidly.  Approximately 5 days after injection #3 in the right arm, swelling of the right IB or IIA lymph node was noticeable and painful.  The swelling persisted for two (2) days and I went to my  Dr's office  on the second day.  The office PA examined me and my neck and asked me to apply compresses and monitor the swelling for another day .  If it did not reduce  within a day or two I should return and they would run further testing.    Within that day the pain subsided and the swelling started to reduce after applying a compress. The swelling subsided.
PATIENT WAS GIVEN FLU AND PNEUMONIA SHOT THEN ONE WEEK LATER SHE PRESENTED SHINGLES.