chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Half her face was numb; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "Half her face was numb".  Additional Information: Reporter Subtype: General Public. Reporter (A 60 year old healthy male) that takes no medication, has concerns about receiving the Pfizer COvid-19 Vaccine asks question: If I get the vaccine, who will be responsible if I have an injury? Is the drug safe? I have heard of a lot of people getting bad effects from it. There was a lady who came to work and half her face was numb. No further details provided. What are the 6 months topline analysis results of the Pfizer-BioNTech COVID-19 Vaccine? Response received as On 01Apr2021, Pfizer and BioNTech announced an updated topline analysis up to 6 months following second dose of COVID-19 Vaccine Study. Analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) is effective with 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to 6 months after the second dose. Vaccine was 100% effective in preventing severe disease as defined by the Centers for Disease Control and Prevention (CDC) and 95.3% effective in preventing severe disease as defined by the Food and Drug Administration (FDA). Vaccine was 100% effective in preventing COVID-19 cases internationally, where the B.1.351 lineage is prevalent. Vaccine safety now evaluated in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after their second dose. Pfizer and BioNTech plan to share these results with worldwide regulatory agencies soon. The press release is available at: withheld: Please note that the "Pfizer-BioNTech COVID-19 Vaccine - Antibody Persistence and Duration of Immunity" SRD has been updated to include the Press Release information. Information received was helpful states reporter.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fell on the floor while leaving the building, denies hitting her head, and states she has no pain, and refused hospital treatment.
She reports the patient did not experience any adverse events; MMR II was expired then administered on 8/17/2020; This spontaneous report was received from a registered nurse concerning a patient of aproximately 16 years of unknown gender.   The patient's concurrent conditions, medical history, historical drug, drug reactions/allergies and concomitant therapies were not provided.  On 04-MAY-2005, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II); on 20-JUL-2009, the second dose was administered (dosage regimens, lot numbers and expiration dates were not provided) both for prophylaxis. The reporter informed that the patient second dose was given about 2 weeks to 1 month earlier (the patient was approximately 4 years which was still whithin the appropriate age range).    On 17-AUG-2020, the patient received the third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)(recombinant human albumin, rHA), 0.5 milliliter, lot # R019684 has been verified to be valid and expiration date 09-JUL-2020 (expired vaccine used), for prophylaxis. (route of administration was not provided).   No temperature excursions were reported. The patient did not experience any adverse events.
Vomiting, diarrhea, migraine, fatigue, deep pain that continues to get worse every day and arm is not functional. Have been using Tylenol, heat & ice as directed. No relief.
Patient got PREVNAR last year all ok came back today for PNEUMOVAX 23 and decided to add the SHINGRIX on my recommendation all was fine we talked for a while and she called me at 7:00 and said she got a sore red swollen spot on arm I told her this is an expected injection site reaction and that I would report it for her and to talk to her doctor if she feels the need to.
I started having cold symptoms on 01/07/2023. I tested negative for COVID-19 at that time, but I didn't realize the test had expired. I began having extreme gastrointestinal issues on 01/11/2023 and went to an urgent care clinic where I was diagnosed with COVID-19 on 01/12/2023. On 01/11/2023, I woke up with extreme gastrointestinal pain at around 03:00AM. I was feeling it through my entire torso. I was able to use the bathroom a few times, but the stool was loose and did not provide any relief. Around 06:00AM, I vomited. From 01/11/2023-01/14/2023, the extreme gastrointestinal pain continued, and I had extreme fatigue. I have maintained my taste and smell but have no appetite. My bathroom activity has diminished. Every time I use the bathroom it doesn't feel like as much as it should be based on what I'm taking in. I'm still having gastrointestinal pain, but it is diminished. I also continue to have fatigue. I have been experiencing a brain fog since receiving my vaccine on 01/02/2023. It seems to be getting better. For the most part, my sleep issues have improved but are not resolved. Some nights I sleep soundly and then the next night I'll have insomnia. I have been treating my stomach issues with PEPCID which provides modest improvement. Beginning on 01/11/2023 I also experienced dizziness that has been improving over time and feels mostly resolved at this point.
Breaking out with face rash, face is swollen, eyes are hurting and closing. Skin scaling, nostrils are crusted.
Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022; vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia, Hypothyroidism and Diabetes. Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE), DOCUSATE SODIUM (COLACE), METFORMIN, VALPROATE SEMISODIUM (DIVALPROEX), LISINOPRIL, GLIMEPIRIDE, ATORVASTATIN CALCIUM, HYDROCHLOROTHIAZIDE and LEVOTHYROXINE SODIUM for an unknown indication.    On 13-Apr-2022 at 3:17 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022 at 3:17 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No known allergy was reported to medications, food, and other products. Other additional concomitant medication included True Metrix for an unknown indication. The vial was initially stored in refrigerator on 25-Feb-2022. The vial did not undergo any temperature excursion. The patient was vaccinated past the 30 day storage period. Patient did not experienced covid infection within last month from this report. The patient did not experience any side effects. No treatment details were reported.
I had my vaccination on 11/12/2021. On 08/04/2022 I felt like I had strep throat was coughing a lot and barely slept. I tested COVID-19 positive.
This initial spontaneous report was received from a 70 year old female consumer reporting on herself. The patient's concurrent conditions included hypertension, arthritis, tinnitus and penicillin allergy. On 28-FEB-2016, the patient was vaccinated with ZOSTAVAX 1 injection in the left arm (route and lot# were not provided). Concomitant therapies included XANAX and unspecified blood pressure medicine. On 29-FEB-2016, the patient experienced swelling and warmth around the injection site. She did not seek medical attention. Product quality complaint (PQC) was not involved. At the time of the report, the outcome of the events was unknown. The causality assessment was not reported. Additional information has been requested.
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. The Public Health District, per guidance from the Department of Health, Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the dose of vaccine that you received is valid.
This spontaneous report was received from a pharmacist, concerning a 23 year old female patient. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported. On an unspecified date in May 2017, the patient was vaccinated with the first dose of VARIVAX injection, and then, on an unspecified date in June 2017, the patient received the second dose of the vaccine, both doses for prophylaxis (dose, route of administration, anatomical location, lot/batch # and expiration date were not reported). On an unknown date (reported as recently), the patient had unspecified titers drawn for nursing school, and the titers came back negative (antibody test negative). At the reporting time, the event was ongoing. The reporter did not provide a causal relationship between VARIVAX and the event.
Received call this morning  10/1/2021 from medical examiner that wife found patient deacesed - medical examiner states that he determinded natural causes.
PATIENT WAS GIVEN A BOOSTER DOSE OF 0.5MLS INSTEAD OF 0.25MLS FOLLOWING THE JANSSEN VACCINE. PATIENT REPORTED FATIGUE AFTER THE VACCINE FOR DAY.
This spontaneous consumer report (initial receipt 18-Nov-2011) concerns a 41-year old male patient, who had a medical history of back surgery. Concomitant medications included sertraline, dicycloverine hydrochloride, ramipril, metoprolol, cPAX Aneurysm Treatment System as a Humanitarian Use Device ('Neurovask'), multivitamins and hydrocodone; paracetamol combination. On 23-Oct-2011 the patient received a single 0.5 mL of AFLURIA (batch number: N57107) injection as routine flu shot. After receiving the vaccine the patient's eyes were glazed. He said getting the vaccine burned like alcohol. The injection site area looked as if it was sun burnt. The patient developed flu like symptoms within 3 days following vaccination. He did not usually get sick. The patient was down with flu like symptoms for about a week. When it seemed that he was 'coming back' from these symptoms, he has now suffered from memory loss, suicidal ideations and increasing depression. He was not himself. The patient sought medical attention and unspecified blood work was performed. The event outcome was not recovered.
Vaccine was not administered Intramuscular by RN administering it.   It was administered into the shoulder joint of the left arm.  Approximately 6 hours later, severe pain, unable to lift arm and shoulder, tingling in left arm and hands.  Progressed to very limited movement of left arm and unrelieved pain.    Treatment sought at ER where diagnosis was traumatic hemmorhagic bursitis from vaccine needle.
Presented to ED with progressively worse COVID like symptom.  She was diagnosed with COVID 3 days ago; admitted for COVID-19 pna w/hypoxia; tx w/abx, remdesivir, steroids, O2. Dc'd home w/home O2.
severe insomnia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 04Jan2022 as dose number unknown (booster), single (Lot number: FL3198) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization.  Additional information: Description of Event: Severe insomnia   The following information was reported: INSOMNIA (non-serious), outcome "unknown", described as "severe insomnia".
This spontaneous report was received from a pharmacist refers to an 48 year old female patient. Patient's pertinent medical history and drug reactions/allergies were not reported. The patient was not pregnant. On 06-JUN-2015 the patient was vaccinated with PNEUMOVAX23 (.5 ml, unspecified frequency, lot # K009105, expiry date: 21-JAN-2016). Concomitant medications were not reported. Reporting pharmacist stated that the patient experienced redness, swelling, irritation and tenderness at the injection site after being vaccinated with the PNEUMOVAX23. No treatment was provided for the adverse events. Outcome of all the events was reported as recovering. Causality assessment was not provided. This is one of the three reports received from the same source (MARRS # 1506USA005260 and MARRS # 1506USA005494). Additional information has been requested.
Patient administered booster dose of the Moderna vaccine 1/11/22. Patient reported history of fainting prior to administration be said it has not had an episode in a while and he did just fine with his Moderna primary series (doses 1 and 2). Immediately upon administration patient began to faint. Patient was move to the floor laid supine and feet where elevated above his head. Patient immediately started to feel better once placed in supine position with feet elevated. patient remained in that position for about 7 minutes and requested to sit up in the chair. Patient was observed for 30 minutes before being allowed to leave the pharmacy. Patient was well when he left pharmacy.
Patient woke up at 4:30a on 5/4/2018 very irritated and with a fever. She was given ibuprofen and comfort and went back to bed. She remained irritable and with a low desire for food but the fever did not return until around noon that day. Rectal temperature at 12:30 was 103.6. She was given more ibuprofen. By dinnertime (5:30) her father and I began to notice some spots on her neck/left cheek/ear/and only a couple on her legs. I spoke with the on-call nurse at her doctors' office and we briefly spoke about the spots but at that point there were maybe 15 total across her body...red, flat, small like a pin prick. By bath time at 7pm we recognized more spots, on her belly, back, bottom, arms and legs. We kept her medicated on TYLENOL or Ibuprofen as needed. She has been eating just enough to not be incredibly concerned. In the middle of the night on Friday and Saturday nights her thirst peaks and she desires a drink quite often. Saturday at 11:30 we saw the Urgent Care Physician at her Pediatrician's office. She confirmed that it was likely an MMR reaction but that she thought patient may have Hand, Foot and Mouth as well because she saw a sore at the back of her throat. I believe the sore is actually a Koplik Spot and irritation from it is the reason for her increased thirst overnight. She has not gotten any other sores in/around her mouth or on her hands and feet. It is now Sunday 05/06/2018 and her fever remains, her throat irritation remains, and the spots are now all over her body, slightly raised around the trunk and on her face.
Narrative: yo male died on 2/9/22 at hospital, cause of death unknown. Pt had received a covid vaccine on 3/18/21 (J&J). Likely death is not related to this covid vaccine given pt's advanced age, comorbidies, and long length of time between death & date of vaccine administrations. Pt's problem list from records: Retinopathy due to diabetes mellitus (12/21/2021) (ICD-IO-CM El 1.319) Vitamin D deficiency (ICD- 10-CM 12/21/2021 E55.9) Hyperlipidemia (ICD-IO-CM  E78.5) 11/09/2021 Obesity (ICD-IO-CM E66.01) 11/07/2016 Chronic post-traumatic disorder following 10/15/2015 (ICD-IO-CM F43.12) (ICD-IO-CM 110.)o essential hypertension 02/29/2016 (ICD-IO-CM El 1.65); DM-Diabetes mellitus 02/29/2016
Tingling/Fizzing/ numbing in face, gums, lips, nose, hands, feet and leg.; Tingling/Fizzing/ numbing in face, gums, lips, nose, hands, feet and leg.; Numbing in face, nose, hands, feet and leg.; Numbing in gums, lips; Lose of taste; Arms are having burning/hot sensation.. icy/hot feeling; Arms are having burning/hot sensation.. icy/hot feeling; This is a spontaneous report from a contactable consumer or other non hcp. A 34-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Pfizer NTEC), via an unspecified route of administered in Arm Left on 30Apr2021 11:15 PM as 1st dose, single for covid-19 immunisation. Patient medical history included hypothyroidism from an unknown date and unknown if ongoing. Patient Concomitant medications included Levothyroxine taken for an unspecified indication, start and stop date were not reported. Patient had no allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, did not patient been tested for COVID-19. In hospital the most recent COVID-19 vaccine was administered. The patient experienced Tingling/Fizzing/ numbing in face, gums, lips, nose, hands, feet and leg. This has continued one week after vaccine. Lose of taste the day after vaccine, taste came back & then went away once again, then finally came back. Today the numbing and tingling has slowed down but now both my arms are having burning/hot sensation. icy/hot feeling on 30-APR-2021 10:30 PM. The events assessed as non-serious. No treatment was received for the events. The patient visited doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the events was reported for Lose of taste as recovered on unknown date and while for others was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Client reports soreness in left arm approximately 1 to 2 hours after vaccination. The next day his left arm was hurting from injection site to halfway to elbow,  some tenderness also noted on back of left arm. Area was itchy and fine red raised bumps noted on arm. Client took Tylenol and Benadryl for itching. He reported adverse reaction on 10/20/20, vaccination was given on 10/14/20. Client states it is getting better not as sore or itchy. denies the need to go to his doctor for evaluation. reports no pain and full mobility in shoulder on left side
2 days after receiving vaccine, patient developed red area around injection site left upper arm.  Area has slowly spread over past 2 days.  Red, warm, firm.  No drainage.
Cluster headache 15 min after injection, lasting 3 min. Burning, flesh-colored rash along forearms. Fatigue, headache and joint pain.
devel a 12x17 cm area of induation/redness @ inject site on 29AUG92, t36.8; area sl warm & tender to the touch w/no streaking noted; seen in follow up p/using cold compresses w/resolution of sx on 31AUG92;
I am experiencing vertigo which I?ve never experienced prior to this shot.  It seems like others are experiencing the same issue around 8 days after the shot.   I?m not sure if these individuals have reported this but I have provided a forum where people are reporting this same issue.    The vertigo was so intense on Monday 3/8/2021 at around 4:30am that I ended up getting sick and throwing up.  Symptoms are still around today 3/10/2021 but not as severe.
3 mon infant for first dose of DTAP and ROTA. That night developed lethargy, poor feeding, green runny stools, for one week. Resolved without treatment. One week after that, developed sudden fussiness, pulling up legs, pain, runny green explosive foul stools for 1 day. Resolved without treatment.
Hives, SOB, pressure in chest, spoke with her pharmacist told to go to the ER, went was treated and sent home after a few hours. Given a shot in ER and oral med for hives.
The patient was given a Prevnar 13 at the age of 12.  The doctor was trying to complete the series because she has asthma.  She was not aware that there was an age restriction.
Client reports that post he had Td shot on 8/8/02-he developed severe swelling from deltoid to axilla lasting 2 days and soreness unrelieved by Tylenol.
Soar arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soar arm) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE, VITAMIN D [VITAMIN D NOS], FISH OIL, VITAMIN C [ASCORBIC ACID], WITHANIA SOMNIFERA (ASHWAGANDHA [WITHANIA SOMNIFERA]), QUERCETIN, VITAMIN B NOS and ONDANSETRON HYDROCHLORIDE (ONDANSETRAN) for an unknown indication.    On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced VACCINATION SITE PAIN (Soar arm). At the time of the report, VACCINATION SITE PAIN (Soar arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  The patient reported that post receiving their first dose of the Moderna COVID-19 vaccine immediately they got a sore arm and it was still on going.
Vaccine was inadvertently administered 1 day after the BUD of refrigerated vaccine. Pfizer was contacted and their recommendation was for the dose to be repeated, CDC appendix D.  Vaccine administration errors and deviations guidance was also followed Patient was contacted and advised to return for another dose.
6 year old female with varicella exposure and amoxicillin allergy who on May 22, 1996 was vaccinated in the right thigh with one dose of varicella. On June 10, 1999 the pt developed generalized chickenpox with approximately 75 lesions.
Chills, abdominal pain, diarrhea, vomiting, diaphoresis, malaise
This spontaneous report was received from a health care worker referring to multiple unspecified patients. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with an improperly stored doses of PEDVAXHIB which had lot # L042257, expiry date 17-AUG-2018 and lot # L051123, expiry date: 13-OCT-2018 (strength, dose and route not reported). No adverse effect reported. No product quality complaint (PQC) involved. No further information reported. This is one of several reports received from the same reporter. Additional information has been requested.