chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling burning in all extremities, trunk and face; Tingling burning in all extremities, trunk and face; weakness in all extremities; Shortness of breath with after completing one flight of stair.; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for himself. A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included high blood pressure (BP), ocular migraine. Concomitant medication included amitriptyline, amlodipine. The patient received first dose of BNT162B2 on 02Jan2021 4:00PM for Covid-19 immunization and expedited tingling in right 15 days first dosage. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Tingling burning in all extremities, trunk and face after second dosage. Tingling and burning was followed by weakness in all extremities including Shortness of breath with after completing one flight of stair. Visited primary care physician and blood work results were not significant for any abnormalities. Visited emergency room (ER) and was seen by neurologist who did think symptoms were severe. Awaiting EMG scheduled for 24Mar2021. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect drug administration to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
The patient developed "hot" boil at site and the arm was very painful to touch for 4-5 days. The patient did not seek medical follow up.
I had a sore throat on Thursday night 05/18/2022. It developed into a cough, muscle ache and joint pain, loss of taste and smell, and body chills over the weekend. I took 3 at-home rapid antigen COVID-19 test, but they all came back negative. But I kept feeling and getting worse and worse over the weekend. So I went to a clinic and got PCR-tested at 05/22/2022, and the following Monday it came back positive. I contacted my healthcare provider about any medications I should take; I started taking NyQuil severe cold and flu and Tylenol to help reduce my symptoms the best way possible.
7 minutes after receiving my 1st dose of Pfizer, I felt slight swelling in the back of my throat behind my punching bag.  I waited a couple minutes thinking I was having a mental reaction, but then I couldn?t swallow.  I notified a nurse and was given Benadryl.  A few minutes later the swelling went away and I could swallow again.  I was breathing just fine during all of this.  Then the swelling moved to the left side of the back of my throat and my tongue on the left began to swell.   I was given Epi and sent to the emergency room for observation.  I continued to have weird swelling coming and going on my left side of the throat for 90 minutes.  I continued to breath just fine through all of this.  Was given Benadryl, solu medrol and Pepsi?s by IV injection.  Sent home with 5 days of prednisone.
Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 12:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 12:30 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 35.69  On 14-Feb-2021, Excursion time was 09 AM, 10 AM, 11 AM, 02 PM, 03 PM temperature was 32, 32, 32, 35, 35 total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.   On 21-Mar-2021, Excursion time was 09 AM, 10 AM, 11 AM temperature was 32, 34, 32 total doses given for the day was 94, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 16-Mar-2021, vial was moved to clinic on 21-Mar-2021. 10 vials were sent to clinic. Vaccine BUD date was 15-Apr-2021.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Concomitant product was not provided by the reporter Treatment medications were not reported.
Pt recvd vax 17DEC92 & 27DEC92 pt devel jaundice; No further details were provided;
ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/24/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE
This spontaneous report was received from a pharmacist refers to a female patient of unknown age (also reported as about 45 years old). On an unknown date, the patient was vaccinated with ZOSTAVAX (dose and frequency was not reported). On an unknown date, the patient experienced cold sores after administering with ZOSTAVAX. It was reported that the patient was not sought any medical attention. It was also reported that the patient had not received any treatment. The pharmacist also reported that developing of the cold sores happens frequently. The outcome of the event cold sores was unknown. This case is linked to case 1401USA014439 and 1401USA014549 (same reporter link). Additional information has been requested.
Received Pfizer vaccines on 1/29, 2/19, 8/21/21 COVID-19 positive by PCR on  1/11/22. admitted to hospital on 1/11-1/14/22 w/ pneumonia d/t COVID
He got his vaccine, it was painful but not all that bad.  By the time he got home and got settled he started getting pain in his arm, and steadily has increased.  His arm hurts so bad that he is not able to lift his arm.  It is sore and sits in the chair and lets it hang.  He is not having any other symptoms other than the arm pain.  He has a lot of pain from his elbow and under his arm and thinks it may be related to lymph nodes.  He has shoulder pain down to his hand, severe pain.  He is on pain medicines and they are not touching the pain.  He has taken an extra Norco and Methadone with no relief.  He has also been putting warm compresses on it.  He did call his doctor, they told him that if he got more symptoms to be checked for COVID.  He has not gone to the ER for his pain.   The muscles in that arm are just really bad and in the arm only.    He has gotten the flu shots every year and has not had any reaction to any of those.
her third trimester of pregnancy.; delivered a healthy baby; administration to patient less than 60 years of age; patient was given a dose of Arexvy, instead of Pfizer's RSV vaccine; This non-serious retrospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 05-SEP-2023, the patient received Arexvy. On 05-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: administration to patient less than 60 years of age) and wrong vaccine administered (Verbatim: patient was given a dose of Arexvy, instead of Pfizer's RSV vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: her third trimester of pregnancy.) and live birth (Verbatim: delivered a healthy baby). The outcome of the vaccine exposure during pregnancy, inappropriate age at vaccine administration, wrong vaccine administered and live birth were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester  Pregnancy Details (Neonate 1):  Delivery Type: vaginal Pregnancy Outcome: Live neonate with no apparent congenital anomaly   Additional Information: GSK Receipt Date: 20-OCT-2023 Physician reports her 35 year old patient was given a dose of Arexvy, instead of Pfizer's RSV vaccine, while she was in her third trimester of pregnancy which led to inappropriate age at vaccine administration, wrong vaccine administered. Physician confirms the patient has since delivered a healthy baby and did not require a C-section. Physician could not provide lot number or expiration date of product. No additional information provided. The reporter consented to follow up.
Patient was given second dose as pfizer which did not match his first dose of Moderna. Patient left immediately left the building without waiting his 15 min observation time.
Low grade fever 37.5 degrees C. Hot and red below the injection site. Chills. The vaccine administered in AM. The symptoms started in PM.
Pt arrived for induction and was found to be COVID positive due to testing of all OB patients.
Day 1 (day of vaccine):  weakness, shortness of breath, arm swelling, headache, fatigue, fever Day 2:  face and mouth swelling, sore throat, fever Day 3:  sore throat, lightheadedness, fever Day 4:  no symptoms
Patient developed right arm pain and swelling. Started about 24 hours after vaccine. Recieved medrol dose pack, antihistamine. Pain and swelling improving.
my left side is numb like its asleep especially my left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation as unk unk, single. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE ), for COVID-19 immunisation. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "my left side is numb like its asleep especially my left leg".  Additional information: The patient has received both the initial Pfizer vaccine the first booster and just recently the latest variant booster and my left side is numb like its asleep especially my left leg. I received the booster and flu shot in the left arm. The received the variant booster 12Oct2022 and have been experiencing numbness from my left shoulder where I received the shot to my left foot.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report was received from a female patient of unknown age regarding herself. The concurrent condition and medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # K023624, Expiry: 19-FEB-2016). The concomitant medications were not reported. The patient reported that she received a letter from her physician's office stating that the ZOSTAVAX was administered was stored improperly and she might need to be re-vaccinated. No adverse effect was reported. No product quality complaint was involved. Additional information is not expected.
Pt had some pain the day after the injection. 48 Hours after the injection, the patient had continuous pain in the arm, and could not raise his arm laterally without excruciating pain. Since Sunday the 24th, the patient's pain had decreased a bit, and can move his arm with a better range of motion, but still does not have normal range of motion. Patient was using ice on the site, along with heating pads. Patient also used TYLENOL, but neither the TYLENOL, ice, or heating pads helped.
Pt. states approximately 2 days after receiving flu injection, he noticed a gradual onset of hoarseness. Denies cough, fever, sore throat, or eye redness. Pt states minimal redness at site & no soreness. Pt. states hoarseness worsen during following week. Currently - hoarseness remains with condition variable related to voice usage. No treatment at this time. Advised to seek medical attention as needed.
Patient related to another Pharmacy his arm was still sore from injection received on 12/30/2016 that was not being relieved by ibuprofen so he switched to naproxen.
Started having severe stomach pain around 6:30 pm . Began vomiting around 1 am. Began having diarrhea around 2:30 am in conjunction with the severe stomach pains and vomiting. This lasted until about 1 pm on 11/11/2021. It happened every 10 to 15 minutes all night. Stomach pains were all night. Felt better around on 11/11/2021. So lasted almost 24 hours.
Pt developed bloody emesis the evening after she was given her 2nd Rotateq vaccine. Mom also reported, low grade temp (99-100f) but no real fever. Pt was not excessively fussy-Mom advised to come in next day to have stools hemoculture and stools tested positive for blood 6/1/07-PCP called:No hospital.  Looks very good clinically but still tests + for blood in stool when seen in office yesterday.  RV test & stool c/s have been sent.  Has no s/s of milk protein allergy.  Heme + emesis only 1 x. krk 06/05/07-note received from PCP for DOS 5/30/07-parent reports one episode of emesis reports blood in emesis. Patient had dose of red Triaminic for congestion. No diarrhea, mild fever 99-100. No further vomiting.
Patient presented ill for 1 week despite antibiotic treatment by PCP. Cough, weak, unable to stop coughing.
Case number PHEH2014US019129, is an initial spontaneous report from a health care professional received on 22 Sep 2014. This report refers to a 71-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 12 Sep 2014. On 16 Sep 2014, she started sulfa medication (no details provided). On 19 Sep 2014, she experienced headache and vomiting. The outcome of the events was unknown. Seriousness and causality was not reported.
The ZOSTAVAX was administered in the tricep subcutaneous area of the left arm. The next day I experienced a swollen area 8cm x 7cm.  It was sore and red and the area was warm to the touch.
Abdominal discomfort; Soreness in left arm (injection site); General fatigue; Tongue tender; Tongue feels like sandpaper; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150), via an unspecified route of administration in the left arm on 11Apr2021 at 14:00 (at the age of 33-year-old), as a single dose for COVID-19 immunisation. Medical history included gallbladder removal on an unknown date which was not ongoing. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included multivitamins (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN) for an unknown indication and from unknown dates. On 11Apr2021 at 15:00, the patient's tongue felt like sandpaper and tender. On 12Apr2021, the patient experienced soreness in the left arm at the injection site, general fatigue, and abdominal discomfort. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events tongue feels like sandpaper, tongue tender, soreness in left arm (injection site), general fatigue and abdominal discomfort were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient complained of pain at injection site, also stated pain radiating in right arm into neck. Back pain & chills. I advised to treat with cold compress & OTC TYLENOL.
Hives all over face, when benadryl is taken, it goes away for a little & comes back around time benadryl time is up
I experience tachycardia within 24 hours of the vaccine. The tachycardia turned into AFIB. I had a heart abrasion on 09/29/2021.
DX COVID-19 virus with pneumonia.  Non-ST elevated mycardial infarction. Acute respiratory failure with hypoxia.   Treatment:  Hospice care and comfort. IV morphine
Bilateral pulmonary embolism; hypertension; shortness of breath; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via an unspecified route of administration on 25Feb2021 at age of 75-year-old at single dose for COVID-19 immunisation. Medical history included chronic lympocytic leukemia, stem cell transplant recipient, and prostate cancer. Known allergies: possibly penicillin. No COVID prior vaccination. The patient's concomitant medications were not reported. The patient experienced bilateral pulmonary embolism, hypertension, and shortness of breath on 02Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. It was unknown if treatment received for the events. It was unknown if COVID tested post vaccination. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
she was miserable for 24 hours; body ache; she felt tired; had a headache; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (she was miserable for 24 hours), PAIN (body ache), FATIGUE (she felt tired) and HEADACHE (had a headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (she was miserable for 24 hours), PAIN (body ache), FATIGUE (she felt tired) and HEADACHE (had a headache). At the time of the report, FEELING ABNORMAL (she was miserable for 24 hours), PAIN (body ache), FATIGUE (she felt tired) and HEADACHE (had a headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  After dose 2, patient felt tired and had a headache and after dose 3 patient was miserable for 24 hours with a headache and body ache.  Treatment medications were not reported.   Reporter did not allow further contact
tested positive for covid on binax rapid antigen test 11/29/22, asymptomatic, tested as f/u to known exposure
Extreme vertigo, onset approximately one week after each dose.  Vertigo accompanied by pain in neck and back of head.  First instance continued for 10 days; current symptoms ongoing for three days thus far.
Rash around wrists bilaterally for 24 hours. No fever or myalgia. Erythematous raised papular rash, no vesicles. Treatment steroid cream, Zyrtec and Benadryl.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 1:09 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 1:09 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 66.40 years.  Concomitant products were not provided.  Batch number 031L20A underwent temperature excursion on 14-Feb-2021 with temperature 32 degrees Fahrenheit and 35 degrees Fahrenheit from 09 AM to 3 PM. This vial was moved to fridge on 09-Feb-2021, beyond use date for the vial was reported as 10-Mar-202. Product moved to clinic on 13-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Migraine HA. Medications could not break it. it lasted 5days. Had to go to my neurologist for a shot to try and relieve the pain