chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; The caller previously reported an incident where two kids were given the Pediatric Pfizer Covid 19 Vaccine that was expired; The caller previously reported an incident where two kids were given the Pediatric Pfizer Covid 19 Vaccine that was expired; Mixed 0850 am 24Nov2021, given 26Nov2021 @ 1400; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 7 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Nov2021 14:00 (Lot number: FK5618, Expiration Date: 27Jan2022) at the age of 7 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cold" (unspecified if ongoing); "fever" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset Nov2021, outcome "unknown", described as "Mixed 0850 am 24Nov2021, given 26Nov2021 @ 1400"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), EXPIRED PRODUCT ADMINISTERED (non-serious) all with onset 26Nov2021, outcome "unknown" and all described as "The caller previously reported an incident where two kids were given the Pediatric Pfizer Covid 19 Vaccine that was expired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional information: The reporter stated that two kids were given the Pediatric Pfizer Covid 19 Vaccine that was expired. The caller also submitted a temperature document to Pfizer to see if the patients needed to be revaccinated. Both kids had sore arm. No fever, no other side effects recorded from the twins. NDC: 59267105501. There was no Specific relevant test for thromboembolic events with thrombocytopenia.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101676888 same reporter/product/event, diff patients
8x10cm redness warm, hot to touch 24hrs after injection-lasted 72hrs.
I experienced my soy reaction (a seizure) to the PEG in the shot; I experienced my soy reaction (a seizure) to the PEG in the shot; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional.   A 59-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date (at the age of 59-years-old) as dose 2, single for covid-19 immunization. Medical history included refractory epilepsy, asthma, Sleep apnea, back injury, joint injury, Neuropathy in left thigh all from an unknown date and unknown if ongoing. Patient had known allergy to soy, Polyeythylene glycol, Penicillin, Sulfa and Latex from an unknown date and unknown if ongoing. Concomitant medications included eslicarbazepine acetate (APTIOM), clobazam (ONFI), gabapentin, buspirone hydrochloride (BUSPAR), vitamin c [ascorbic acid], ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), zinc all taken for an unspecified indication, start and stop date were not reported. The patient received these medications within 2 weeks. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had been not tested for COVID-19 since the vaccination. On an unspecified date in 2021 the patient experienced her soy reaction (a seizure) to the PEG in the shot. Event reported as medically significant. No treatment was received for the events. Outcome of the events were resolving.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Fever MUSCLE PAIN Narrative: SX NOT RELIEVED BY THE TYLENOL AND LASTED 48 HOURS
1st reaction Time course-9:50 AM-10 :30 AM (Throat tightness and lips tingling) Doctors gave me Benadryl for symptoms @ vaccination center.  2nd reaction  Time course- Around 7:00 PM (Throat tightness, nausea, abdominal pain, numbness in lips) Went to urgent care. Benadryl from earlier may have worn off.
sciatic back pain; 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 BACK PAIN (sciatic back pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sciatica.    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced BACK PAIN (sciatic back pain). At the time of the report, BACK PAIN (sciatic back pain) outcome was unknown. Not Provided          Concomitant product use was not provided. Action taken in response to mRNA-1273 in the event was not applicable. Patient was asking Is it okay  to take prednisone.   Reporter did not allow further contact
Bivalent Pfizer  was given instead of the primary Pfizer vaccine for 2nd dose
Arm pain; A little swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and SWELLING (A little swelling) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain) and SWELLING (A little swelling). At the time of the report, PAIN IN EXTREMITY (Arm pain) and SWELLING (A little swelling) outcome was unknown.      It was reported that the patient is a cancer survivor and has received a triple bypass in the past. He claims to have had 7 surgeries in a row, and has no memory. He takes 20 pills a day as regular medication, but no treatments specific to his symptoms.   This case was linked to MOD-2021-370114 (Patient Link).
Pt had chills, fatigue, malaise, arm soreness 4/16 - 4/20.  4/21, these symptoms largely resolved.  Pt was in school when a teacher noted that her R hand was shaking.  She has continued with a fine tremor of R hand since this time.  Present at rest, does not change with movement.  No other neurologic symptoms reported by patient or noted on exam.
Patient was given the first Covid booster instead of the bivalent.  Patient has been informed and will get the bivalent in 2 months.
13MAR97 p/afternoon nap pt woke up crying, holding lt leg different than rt, seemed tender to touch;no redness or swelling, very fussy;pt given warm bath to comfort & APAP as directed;15MAR97 pt taken to ER still fussy, t100.3 (teething);
Nausea, Vomittng, Stiffness, Joint Pain, Loss of Smell / Taste, Headache, Body Ache, Fever, Fatigue
No further adverse effect reported.; patient received a dose of improperly stored VAQTA.; This spontaneous report was received from a medical assistant refereing to a patient of unknown age and unknown gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.  On 21-FEB-2020, the medical assistant called to report that the patient received a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S025993, expiration date 17-OCT-2020; strength, dose detail and route was not reported) for prophylaxis (improper storage of product in use). No further adverse effect reported. NO PQC. No additional information provided. The vaccine was exposed to temperature excursion of below 36 Fahrenheit degree (also reported as 34 Fahrenheit degree) for 27 minutes. No previous temperature excursion. No further adverse effect was reported. Data logger was involved.
I received my shot Thursday and was in bed with severe headache and extreme fatigue for 3 days. On Sunday I ate some eggs for lunch and then took a hot shower at about 1:00 p.m. After the shower, I had a moderate/severe rash inside both arms by arm pits, left and right breast, stomach, lower back and above and below my knees. It lessened but by 4:00 p.m. the rash was still not gone.
I became so very dizzy that I had to drop to the knees, I shut my eyes.  I became very sick to my stomach and being I couldn't reach the bathroom, I grabbed onto a couch and threw up and then I lost control of my bowels. 11/15/06-spoke with reporter, did not see a physician until 11/3/06. She erred in marking life threatening illness. krk  Patient seen only 1 time by Dr. on 11/14/2006. 12/5/06-Impression: right sided endolymphatic hydrops. Asymmetric sensorineural hearing loss. Recommendations: MRI, viral titers and ENG.  History of fall on right side of face in May 2003, June 25, 2004 during airplant flight her right ear closed up to the point of difficulty hearing with sporadic fluctuations in her hearing, vertigo summer of 2005, in summer of 2005 diagnosed with Meniere's disease after ENG, EcoG testing. January or February 2006 second bout of brief spontaneous vertigo. June 5, 2006 second fall again without dizziness while doing aerobics. Broker her left wrist. September 2006 blisters showed up for about 10 days on her right buttocks. Reported to be herpes type virus. Changed from Lipitor to Zocor on October 18, 2006, subsequently stopped Zocor due to Flu shot on October 21, 2006 and within 2 hours she was vertiginous as spinning. Experienced nausea, vomiting and loss of bowels with diaphoresis. Denies change in aural fullness or hearing. Duration 2 1/2 hours. November 1st and 5th 2006 had 2nd and 3rd debilitating spellings. Placed on Antivert on November 2, 2006 by ENT.
The first day when I woke up I had really bad back pain and I was really sleepy. towards the afternoon I became very itchy. The itching and hives would become increasingly worse. I didn't take it for anything. On Saturday I went to work still itching I called the nurse at work on the hotline and explained what was happening. I was told to take Benadryl but could not because it would make me drowsy. I finished work and took the Benadryl after. I also started to break out into hives, the itching was turning into hives. On Sunday I got up for work and the hives were large and like welts. This was all over my body.  The itching was still present as well. I was advised to go to an urgent care or a doctor. On Monday morning I woke up and everything was swollen: my face, my lips. I went to the Dr's office where they gave me steroids and an epi pen as well as oral steroids. After the steroids, the swelling went down after a few days. The itching had also ceased. The itching lasted from Friday up until Monday when I got the steroid shot on Thursday.
I was extremely fatigued and achy and couldn't get comfortable. This has continued since I got the shot. I had mild fevers not over 100. The exhaustion is the main issue. Last week I ended up having a lot of stomach pain and lack of appetite. I felt like I almost passed out in a store. I was taken to hospital by ambulance on 9/15/2021 and was seen in the ER. They determined that my lymph nodes in my abdomen were inflamed. The next day I went back to the ER but at a different hospital and they hospitalized me because my liver enzymes went very elevated and were concerned about liver failure. I was in the hospital for 6 days.
Awoke to uncontrollable spasmatic shivering, ice cold feet, increased heart rate of 110, increased blood pressure 151/84.  Worst of it lasting over 1 and a half hours before extreme shivering subsided with continued stress.
MMR Vaccination administered on 05/23/2007.  Adverse event began on 06/06/2007.  Child had a fever of 100.3 on 06/06/2007, fever of 99.9 on 06/07/2007, fever of 99.3 on 06/08/2007.  Low-grade fever remained through 06/11/2007.  Rash developed on face, head and neck on the morning of 06/08/2007 and spread to abdomen, chest and back that afternoon.  Went to pediatrician on 06/08/2007 and was told it was a reaction to the MMR vaccination received there on 05/23/2007.  Sent home with instructions to come back in if fever increased or rash became worse.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with LIDOCAINE for Pain in arm, at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] for Pain in arm, at an unspecified dose and frequency and GOODY for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided. On an unknown date,the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) in her right arm..  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
High fever  (103.5) for 1.5 days that resolved Swollen painful axillary lymph nodes started 8 hours after, ongoing
Patient complained of tingling in her fingers. No other symptoms, denied HA, dizziness or lightheadedness. Denied  tingling in arms or anywhere else. MD aware. Patient stayed under observation for 60 minutes.   BP 158/61 then 170/89 and then 161/86, then 146/52. Pulse ox was 99-100 entire time. Hear rate ranged 49-52   Also gave patient cookies and water. She felt improved when she left.
After receiving the the first booster patient developed tinnitus; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (After receiving the the first booster patient developed tinnitus) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis. No history related to mentioned both Acute and Chronic similar past illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Seasonal allergy (Just seasonal allergies).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (After receiving the the first booster patient developed tinnitus). At the time of the report, TINNITUS (After receiving the the first booster patient developed tinnitus) outcome was unknown.            Patient stated that she does take medication but not reported which medication exactly. She did not provide a calendar date instead she stated she received the 2nd dose 28 after the 1st dose.   After receiving the first booster patient developed tinnitus, but it got worse not horrible but worsened after the 2nd booster. Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-572021 (Patient Link).   Reporter did not allow further contact
Vials that was put in the fridge and after that refrozen and thawed again for adult male patient; No adverse event; Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient).    This case is for 64th  patient out of 100 patient's case. Concomitant product use was not provided by the reporter. Patient received additional booster dose. 100 male patients were received bivalent booster dose. Moderna COVID19 vaccine bivalent, dosage given was in ml but it was unknown to the healthcare practitioner. Also, lot number was unknown to the healthcare practitioner. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:
Client given 3rd dose of Pediarix and a Dtap at the same time.  The Dtap was given in error.  Client vomited once the following day, and he had a fever of 102.0 which lasted about 2 hours before it was controlled with motrin.  Both injections were given in the same leg.  The mother reported redness and stiffness for 2 days following the injection.  At 15 days after the event the mother reports no other adverse reactions.
A report has been received from a Pharmacist concerning a 53 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. It was reported that the patient experienced 53 year old received FLUMIST last year which started during 2013. The patient recovered from the event of 53 year old received FLUMIST last year on an unspecified date. The report was considered to be non-serious.
After my second dose of the vaccine, I began to experience vertigo about 2 weeks later on March 5th, 2021. I woke up early that morning with severe vertigo and dizziness, and was unable to even walk in a straight line. Later that day I went to the urgent care, and was given a medication for vertigo that I do not remember the name of. The medication did not help my vertigo it just made me very nauseaus and vomiting frequently. The next Monday, I had called my Primary care doc, I had already stopped taking the medicine by then. The primary care care doc decided to prescribe me physical therapy. The physical therapy was able to help me make substantial improvements in my balance and vertigo. After about 6 weeks, the vertigo was gone, I still continue the exercises from PT, just in case. I had a booster and that did not cause any additional vertigo. Dr. does not believe there is a relationship between the vertigo and the vaccine, but I am filing this report just as a precaution.
severe thrombocytopenia and thrombocytosis, multiple PE, DKA, NSTEMI
REPORTS DEVELOPED HIVES AFTER VACCINATION - SAME DAY.  DID NOT SEEK TREATMENT.  PHYSICIAN ADVISED HER TO REPORT IT TO US.
Headache, Myalgia, Fever, Diarrhea & Nausea Vomiting Narrative: day 1-sorearm;day2-fatigue;weekness;n/d;cough;chills;ha- lost 1.5 days of work
Fever; body aches; headache; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 29Mar2021 at 18:00 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included GERD (Gastroesophageal reflux disease). The patient did not have any allergies to medications, food, or other products. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), rizatriptan (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), d and b (unspecified medication), all taken for unknown indications from unknown dates. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration on unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 30Mar2021 at 17:30, the patient experienced fever, body aches and headaches. The patient did not receive any treatment for the reported events. The adverse events did not result in visit to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 30Mar2021, the patient underwent rapid covid test (SARS-CoV-2 test, nasal swab) and the result was negative. The clinical outcome of the event fever, body aches and headache were recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Spotting between menstrual cycles; extended menstrual cycles; extreme heavy bleeding during menstrual cycles; This is a spontaneous report from a contactable consumer (patient).  A 36-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 28Apr2021 (Batch/Lot Number: EW0170) (age at vaccination 36-year-old) as dose 2, single for covid-19 immunisation at Pharmacy or Drug Store. The patient had no known allergies. Medical history was reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications included lamotrigine within 2 weeks of vaccination. The patient received historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 07Apr2021 (Batch/Lot Number: EW0151) (age at vaccination 36-year-old) as dose 1, single for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced spotting between menstrual cycles, extended menstrual cycles and extreme heavy bleeding during menstrual cycles on 09May2021. The patient did not received any treatment for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.