chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient complains of muscle and joint pain occurring since receiving her Pfizer Covid vaccine 4/9/21.  Pt has tried using ibuprofen but gets minimal pain relief.  Recommended for patient to contact her prescriber.
Arm pain began about 30 minutes after vaccination. About 90 minutes after vaccination, headache, chills, and fatigue began. Woke with chills and headache this AM.
Extreme pain at injection site, pain radiating down arm, around shoulder and around back also numbness in fingers on same arm.
Sudden Dermatographia and itchyness all over body, occurs mainly at night in cold weather.
Angioedema Right eye swollen shut and tearing within 24 hours, now resolved Narrative:
received a higher than recommended dose of the purple cap formulation; Redness of the area and usual pain from the injection; Redness of the area and usual pain from the injection; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 12 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 19Nov2021 15:22 (Lot number: EW0182) at the age of 12 years as dose 1, 0.5 ml single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: OVERDOSE (non-serious) with onset 19Nov2021, outcome "unknown", described as "received a higher than recommended dose of the purple cap formulation"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset Nov2021, outcome "unknown" and all described as "Redness of the area and usual pain from the injection". Therapeutic measures were not taken as a result of overdose, vaccination site pain, vaccination site erythema.  Reporter reports two patients received a higher than recommended dose of the purple cap formulation. A 12 y/o male and a 14 y/o female both received 0.5 ml dose instead of 0.3 ml dose. It was their first Comirnaty dose and it occurred on 19Nov2021.She wants to know what to do about the second dose. Transferring agent stated, "She is calling regarding Comirnaty Vaccine, she states that 2 patients, a 12-year-old male (consumer) and 14-year-old female they both were given a higher than recommended dose of the adult formulation of the Comirnaty Vaccine, so the purple cap vial. They were given 0.5 ml instead of recommended 0.3 ml dose. That happen on 19Nov2021 and she was calling into Medical Information to inquiry about, what to do about the second dose. Vaccine LOT#EW0182. When probed for vaccine Expiration date, Nurse stated, "Nov2021, that are expiration date as far as when it was taken out of the cold and put into refrigerator because of the 30 days that's not the listed expiration date, that our expiration date. When probed to confirm if patients experienced any adverse event, Nurse stated, "No, just a generalized redness of the area and usual pain from the injection were the only complain." When probed for any treatment, Nurse stated, "The provider spoke with them, there was no treatment."  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101652350 same reporter/drug/AE, different patient
Urticaria at site of RVL immunization given Prevnar seen by MD at health dept Dx allergic reaction right upper thigh at site of immunization 4th dose of Prevnar given at that site.
Narrative: COVID infection following COVID vaccine series 05/18 Janssen, dose# 1 08/13 COVID swab, result: detected 08/13 SARS-COV-2 Variant Sequencing result: pending 08/14 pt cc: unknown exposure: unknown
I received the PNEUMOVAX 23 vaccine and experienced the following untoward events - severe headache, fever, chills, nausea, malaise, loss of appetite, injection site reactions (pain, induration, pruritis, erythema). It also caused an exacerbation of herpes on my lips and intra-nasally.
pt recv vax 29OCT97 & was sitting in chair w/jerking motions of head;eyes twitching;did not answer when spoken to;color pale;twitching lasted 20sec & pt became alert & responsive;BP 110/palp;sl upper extremity tremors;
Case number PHEH2014US022297, is an initial spontaneous report from a pharmacist received on 05 NOV 2014. This report refers to a 61-year-old female patient. Concurrent conditions included latex sensitivity/allergy. She was vaccinated with FLUVIRIN 2013/2014 (batch number: not reported) intramuscularly on an unknown date. On an unknown date after vaccination, she developed a swollen arm at the injection site. The outcome of the event was unknown. Seriousness and causality was not reported. The pharmacist reported that the patient did not receive the vaccination at pharmacy and does not have any additional data.
My left breast started hurting  3/25/2021 and red rash on the right breast.  Got vaccine on my right arm
The morning after the vaccine when I woke up feeling very run down, tired and very fatigued.  My arm felt really achy and had a lot of body aches and skin sensivity.
PATIENT HAD ABSCESS LATERAL TO SMALLPOX SITE 3 WEEKS AFTER IMMUNIZATION. ALSO MARKED ABSCESS ON LEFT INNER ARM AND RIGHT INNER THIGH
were stored below temperature and not viable but administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix, Havrix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix, Havrix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The medical assistant reported that Havrix, Engerix, and Infanrix were stored below temperature and administered to unknown number of patients, which led to  incorrect storage of drug. The vaccines were deemed not viable. The reporter consented to follow up.
Information has been received from a pharmacist concerning a 4 month old male with pertinent medical history and drug reactions/allergies reported as none who on 29-DEC-2006 was vaccinated with PEDVAX HIB (OMPC).  On 29-DEC-2006, the patient was given 2 doses of PEDVAX HIB (OMPC) on the same day.  The pharmacist reported that this was an overdose of PEDVAX HIB (OMPC).  Medical attention was sought.  The infant developed a fever later the same day that persisted for one and a half days.  The infant was given acetominophen (TYLENOL) alternating with ibuprofen for the fever later on in the day on Friday, 29-DEC-2006 through Saturday 30-DEC-2006.  No diagnostic studies were performed.  The infant had no fever on 31-DEC-2006.  The infant has been irritable and there has been a green substance (no mention of what area of the body this has been seen or what date this occurred).  The patient will be seen by the physician on 02-JAN-2007 for these other symptoms.  No further information was available at the time or reporting.  Additional information has been requested.
Suffered ischemic stroke, hospitalized, treated with aspirin and atorvastatin  Right hand paralysis persists  now taking warfarin, aspirin, and lovanox
Pt began crying around 130PM, this continued until 1230AM next morning, t105, irritable for nearly 12 hrs following immun despite doses of APAP;
This spontaneous report as received from a nurse refers to her husband, a 63 year old male patient. On an unknown date in July 2013 the patient was vaccinated with ZOSTAVAX (lot # was not reported, subcutaneous) for Prevention of shingles. On an unknown date in July 2013, the patient experienced an injection-site reaction, described as "extreme swelling that covered" the majority of the upper arm, nearly to the elbow." In addition there was redness and discomfort. The reaction lasted "about a week", after which time, it subsided. The patient did not seek medical attention. This is one of the reports from the same source. Additional information has been requested.
Whole body aches and headache - Tylenol just lessens the symptoms doesn?t stop them Fever -Tylenol  vomiting - Gatorade   It?s been since 12am 4/3/21 and still happening at 645pm 4/3/21
2" round oval rash at side of second injection and a little swollen and warm; 2" round oval rash at side of second injection and a little swollen and warm; 2" round oval rash at side of second injection and a little swollen and warm; Redness at Injection Site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 09:00 (Lot number: EW0183) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single; Lot: ER8734; Event onset date: 09Apr2021, Event stop date: 11Apr2021; Duration: 2 days; Outcome: Recovered), administration date: 08Apr2021, when the patient was 63 years old, for COVID-19 immunization, reaction(s): "Arm was sore". The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 09May2021, outcome "not recovered" and all described as "2" round oval rash at side of second injection and a little swollen and warm"; VACCINATION SITE ERYTHEMA (non-serious) with onset 08May2021 08:00, outcome "not recovered", described as "Redness at Injection Site". Therapeutic measures were not taken as a result of vaccination site rash, vaccination site swelling, vaccination site warmth, vaccination site erythema.  Additional information: No any additional vaccines administered on same date of the Pfizer suspect. Any AE(s) does not require a visit to emergency room, physician office. Prior Vaccinations (within 4 weeks): Patient has received both doses of the Pfizer Covid Vaccine.  No follow-up attempts are possible. No further information is expected.
Soreness in underside of upper arm beginning 3 days following administration of vaccine. Continues through today et worsening pain. Patient relates that pain is worst when lying down at night. Patient is active et training for triathlon.
patient was pale white, and felt light headed and dizzy, she said her vision got blurry and fall.  we made her sit down on a chair and give her some water and took her blood pressure.   the number of blood pressure read 115/50 her grandmother called 911, when 911  arrived she was feeling better.  she did not went to the hospital, she went home with her grandmother and her grandmother later called  us at the pharmacy and said her granddaughter feels much better and eating now.
This spontaneous report was received from a pharmacist (the patient's father) referring to a female patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with GARDASIL 9 (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date the patient started having rashes (described as "generalized, all over her body"). It could not be further clarified when this event occurred relative to the patient's vaccine GARDASIL 9 dosing schedule. It was unknown if treatment was given or lab diagnostics/studies were performed. The patient sought medical attention. The outcome of rash generalised was unknown. The causality assessment was not provided.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 27-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The patient took booster dose of Moderna COVID-19 Vaccine. The vaccines was stored in freezer and they took one to two vials and placed in fridge each day as needed.
Initial unsolicited report received from a consumer (patient's parent) on 26-Oct-2015. This case involves a 16 years old female patient who was vaccinated with a dose of FLUZONE QIV (manufacturer: Sanofi Pasteur, batch number: UI492AA, expiry date: 30-Jun-2016, dose details, route and site of administration was not reported) on 24-Oct-2015. The patient had no illness at time of vaccination and pre-existing physician diagnosed allergies included seasonal allergies, there were no medical conditions, birth defects were not reported. The patient had several flu vaccines for past 10-11 years. On 24-Oct-2015, few seconds after vaccination, the patient passed out, had   "seizure like" arching of her back, muscle spasms and was incontinent of urine. Ambulance was called and she was transported to the hospital on an unspecified date. The patient received unspecified corrective treatment in the emergency room and was released. Laboratory investigations were not reported. The outcome of the events was reported as unknown. Upon internal review, the case was considered to be serious due to important medical events seizure like arching of her back and muscle spasms, passed out and incontinent of urine. List of documents held by sender: none. Follow up report received from a consumer (patient's parent) on 16-Nov-2015. It was reported that the patient was taken to emergency room by EMT (Emergency Medical Technician) after the incident, completed assessment was perform in ER and no abnormality found. The patient was referred to neurology for follow up.; Sender's Comments: Seizure may occur after the administration of INFLUENZA QUADRIVAL A-B VACCINE. Time to onset is compatible with the role of the vaccine. However, a detailed laboratory work up including but not limited to EEG, blood tests etc., concomitant medication is required to assess this case. Based on the provided information the role of the vaccine cannot be assessed.
pt recvd flu vax & pt devel a knot, & redness @ inject site & a fever;
Rigors, fever, extreme fatigue and sleepy, slightly achy. Completely unable to do anything for 24 hrs and less severe symptoms for another 12 hours.
Child slept 2-3 hours after shot. He looked weak, lethargic and pale. Shortly after being woken up he had an episode of crying (high pitch) abnormally. He would not eat nor stop crying when being comforted. He was not completely ok until at least 3 hours later.
Information has been received from a physician concerning a 19 year old female who on 23-JAN-2007 was vaccinated with a 0.5 ml first dose Gardasil (lot #654702/011U). On 26-JAN-2007 the patient developed a rash on her stomach.  Medical attention was sought and the patient was told to take diphenhydramine hydrochloride (BENADRYL). There were no laboratory or diagnostic tests performed.  Subsequently, the patient recovered from rash on her stomach.  Additional information is not expected.
Patient came into pharmacy 8/24/16 the day after the Fluzone Quad and Pneumovax 23 injections complaining of soreness in deltoid muscle of left arm where the two injections were located.  I explained that it was normal to feel sore.  On 8/25/16 patient returned to the pharmacy with a swelling in the left arm where the injections where given.  The skin was sensitive to touch and felt warm.  She described how she was unable to lift her arm without pain and her arm felt like a rock.  An ice pack was provided to her and recommendation to take Tylenol or Ibuprofen once she got home.
muscle aches; temperature; 10 cm area around her injection site of raised, red, warm and tender to touch; 10 cm area around her injection site of raised, red, warm and tender to touch; Initial information received on 22-Jan-2020 regarding an unsolicited valid non-serious case received from a other non-health professional.  This case involves a 74 years old female patient who experienced patient had temperature (Body temperature increased) and muscle aches (myalgia) and 10 cm area around her injection site was raised, red, warm and tender to touch (Inflammation and vaccination site reaction) while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included Influenza Vaccine and she did not had any reactions.  The patient's past medical history, medical treatment(s) and family history were not provided.   On 16-Jan-2020, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ27488 and expiry date: not reported) via unknown route in the left arm.  On unknown date, the patient developed a non-serious 10 cm area around her injection site was raised, red, warm and tender to touch (Inflammation) two days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On unknown date, the patient developed a non-serious muscle aches (myalgia) and temperature (Body temperature increased) (Unknown latency), following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No lab data was reported.  Final diagnosis was myalgia, Body temperature increased, vaccination site reaction and Inflammation.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for muscle aches and temperature,   On 22 jan 2020, the patient was Recovering from inflammation and it was still somewhat tender to touch.
-vomiting immediately, -hives with facial edema given Benadryl PO, -Cough croup like Decadion IM
I woke up feeling achy and coughing with a runny nose. I woke up and tested myself using a COVID 19 home test. It was positive. I had a virtual appointment. The provider ordered the PAXLOVID and advised me to isolate. I started the PAXLOVID on the same day. My symptoms improved within 2 days. I do still have a little cough but I am not aching any longer. I feel like I have completely recovered.
Chest pain with elevated troponin; Chest pain with elevated troponin; Suspect myocarditis; This is a spontaneous report from a contactable physician. A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0178) via an unspecified route of administration, on 06Jun2021 (at the age of 15 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. The facility where the most recent COVID-19 vaccine was administered was at the Pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications that the patient received within 2 weeks of vaccination was not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0176) on 16May2021. On 08Jun2021, it was reported that the patient experienced chest pain with elevated troponin which was treated with IVIG and ketorolac. Suspect myocarditis was also reported. The outcome of the event was unknown.  Follow-up attempts are possible. Further information is expected.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the events chest pain with elevated troponin, Suspect myocarditis  onset.  More information such as complete medical history and concomitant medications are needed for fully medical assessment. 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.
Information has been received from a physician, referring to 9 month old patient of unknown gender. Information about medical history, concurrent condition and concomitant therapy was unknown. On 05-OCT-2018, the patient was vaccinated with a dose of VAQTA (1DF; strength, route, frequency, lot # and expiration date unknown) for prophylaxis. No adverse effects were reported.
Tested COVID positive and eventually died. Symptoms included chills, chest pain, and fatigue.
Chills, headache, shortness of breath the day after vaccine; shortness of breath has persisted.
Approximately one month post vax (09/20/1999) the pt experienced joint pain and underarm pain without fever or chills. The joint pain involved multiple joints including hands, wrists, knees, shoulders, etc. She also experienced a feeling of weakness. She was seen by a physician (10/11/1999) and all blood tests were negative, including Mono, blood count, Sed rate, and ANA. On her 11/09/1999 visit to the physician some improvement in her joint pain was noted. The most recent information received, reports the condition of the pt is improving.
Information has been received from a physician concerning a patient who was vaccinated with a dose of Zostavax. Subsequently the patient experienced lesions at the injection site. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
March 9 shot given. Thereafter, full body aches, constant runny nose, severe sore throat making it painful to swallow, light cough.
approx 2-2 1/2 hrs p/vax temp of 104 ax, vomited x 2;
No adverse event reported as of 3/31/21. Moderna vaccine not authorized in this age group. Patient is 16 years old.