chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered Anthrax, Hep A, and Influenza vaccines at 1130 a.m. inside the immunization room. While patient was waiting in the hallway outside of the immunizations room, bystanders recalled seeing the patient collapse to the ground. The patient's legs were elevated above heart level and assessment was completed at 1144. Patient was alert and oriented to person, place, time, situation. Patient's vital signs were recorded Blood pressure: 105/52, SPO2: 100%, Pulse: 54. At 1148 orthostatic blood pressure was taken Blood Pressure: 119/72, SPO2: 100%, Pulse: 62. Sitting blood pressure: 137/84, SPO2: 99, Pulse: 66. Standing blood pressure: 135/81, SPO2: 100, Pulse: 65. Patient reported no medical history of allergies, use of medications, or adverse reactions. Patient reported last recent drink or meal was from previous day at night. Patient was given passion-orange canned juice.
Reaction on the 17 was a lot of sneezing and then having to blow my nose constantly for about 24 hours.  Much like hayfever feels Had a second reaction - COVID arm - starting on February 20 - large red oval with some swelling and a ton of itching.  Have taken Benedryl today and used an ice pack
p/vax pt exp rash on arm; sore muscles; fatigue; inj site induration & itching;
RECEIVED DOSE 1 PFIZER AT 1053 AM, @ 1115 AM REPORTS FEELS A HEADACHE AT TEMPLE AREA. B/P 134/86, DENIES ANY OTHER SYMPTOMS.  NURSE AND MONITOR STAYED WITH PATIENT TO ASSESS FOR WORSENING OF SYMPTOMS OR NEW SYMPTOMS.   PATIENT REPORTS SAME SLIGHT PAIN TO TEMPLES, NO WORSENING.  FEELING A LITTLE BIT OF EASE PRIOR TO LEAVING AT 1150. SHE REPORTS SHE WILL SEE HER PCP IF GETS TO FEELING ANY DIFFERENT
joint pain; chills; tiredness; fatigue; Fever; headache; body aches; muscle pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205) via an unspecified route of administration, administered in Arm Right on 02Mar2021 11:15 (at the age of 54-year-old) at dose 1, single for covid-19 immunisation. Medical history included high blood pressure, covid-19 (covid prior vaccination Yes). Patient had no Known allergies. Patient has not tested covid post vaccination. Concomitant medications included atenolol (ATENOLOL); simvastatin (SIMVASTATIN); ibuprofen (IBUPROFEN) (Other medications in two weeks). Patient did not have other vaccine in four weeks. On 03Mar2021 13:15 the patient experienced fever, headache, body aches, muscle pain, joint pain, chills, tiredness, fatigue. The patient did not receive treatment for the adverse events. Outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
My son started having some type of seizure, my first reaction was a stroke.  His entire left side of his body was twitching, his eye, arm, wrist, leg, foot.... It lasted a minute before he snapped out of it.  It has since happend again 11/5/2009 records from PCP, child with c/o's lt sided body twitching, staring episodes, eyes crosssing. PE: was normal, refurred to Pediatric Neurologist and Opthalmologist
Patient complained of aches, feeling feverish, and a large red rash with bump. The symptoms lasted a couple of days, the rash lasting the longest.
This spontaneous report was received from a physician, via a company representative, referring to a patient of unknown gender and age, but older than 26 year old. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patient was vaccinated with three doses of GARDASIL for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient was diagnosed with lymphoma and it was stated that it was unknown if the patient developed this event after receiving the GARDASIL series or prior. He was treated with stem cell therapy on unspecified dates for the lymphoma. The outcome of the event was unknown at the time of this report. Causality relationship between the event and GARDASIL was not reported. Upon internal review, the event lymphoma was determined to be medically significant.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient fainted after getting his pfizer shot. he was sweating.
mom stated noted pt was scratching bottom; noted to have rash on buttocks which looked like it was spreading up back; pt stated been itching for a few days;
Focal seizure lasting about 15-30 sec with post-ictal period lasting about one minute. Occurred 6 days after Varivax given.
received 3rd dose today despite not being immunocompromised; Got third dose; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (received 3rd dose today despite not being immunocompromised) and EXTRA DOSE ADMINISTERED (Got third dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, the patient experienced OFF LABEL USE (received 3rd dose today despite not being immunocompromised) and EXTRA DOSE ADMINISTERED (Got third dose). On 04-Oct-2021, OFF LABEL USE (received 3rd dose today despite not being immunocompromised) and EXTRA DOSE ADMINISTERED (Got third dose) had resolved.            No concomitant medications were not reported. No treatment medications were not provided.
Red, swollen, sore hard raised lump 7 mm X 3 1/2 mm - felt a pain in arm & neck with initial vaccine. No treatment did not miss work.
No other AE details available; temperature excursion; This spontaneous report was received from a registered nurse referring to a 11 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 04-DEC-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength and route of administration were not reported, lot # T017688, expiration date was 21-MAY-2022) 0.5 ml for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of minus 13.3 degree Celsius for a time frame of 4 hours and 15 minutes, as recorded by the digital data logger. There were no previous temperature excursions. No further adverse event (AE) information was provided.  This is one of the several reports reported by the same reporter.; Sender's Comments:  US-009507513-2012USA013093: US-009507513-2012USA013095: US-009507513-2012USA013501: US-009507513-2012USA013524: US-009507513-2012USA013539: US-009507513-2012USA013585: US-009507513-2012USA013592: US-009507513-2012USA013594: US-009507513-2012USA013598: US-009507513-2012USA013601: US-009507513-2101USA000121: US-009507513-2101USA000122: US-009507513-2101USA000144: US-009507513-2101USA000266:
Patient hada headache the next day, but that symptom resolved and feels completely back to norma. We gave her the booster dose for the moderna but patient was not immunocompromised. It was in error. Her second dose of the moderna was back in March. Patient is aware, doctor is aware.
This is a spontaneous report from a contactable physician. A currently 80-year-old male patient of an unspecified ethnicity received PREVNAR, via an unspecified route of administration on an unspecified date at a single dose. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced allergy to PREVNAR. The clinical outcome of the event allergy to PREVNAR, was unknown. Follow-up (04SEP2016): Follow-up attempts are completed. No further information is expected.
Patient states that starting today, he has had pain over his whole body involving many joints and wanted this reported .
Six months after I was diagnosed with DVT or blood clots on my left leg.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 18Mar2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration on 25Feb2021 for covid-19 immunisation. On an unspecified date in 2021, the patient was diagnosed with DVT or blood clots in left leg. The patient was wondering if the clots were caused by the vaccines. The patient wanted Pfizer to make a study on the case and to find out the real cause of the clots. The outcome of the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Swelling, tender to touch.  Redness around injection shot. Slightly itchy.
Sunday, Dec 12, 2021 - was rubbing my right arm. got to the location of the shot area and could feel a lot of little bumps. Had a sore arm in that location on the evening of the shot and allday Friday.  Saturday, I did not notice anything. Don't know if I rubbed my arm in that location.  So, from Sunday to today (Tuesday) the rash is here.  just thought I would report it.  I feel fine otherwise.   Thank for your time.
Sl. edema & slightly tender posterior (L) arm at/near injection site. Tx: Ibuprofen tid x 5d & recheck prn.
I broke out in hives on November 12th 2021 and had to go to the ER for steroids. Hives returned on November 14th 2021 and I had to go to a HCF to receive more steroids because benadryl didn't alleviate symptoms.
Prior to the flu shot I was in excellent health with no medical concerns. Following the flu shot I had excessive decrease in energy levels and immunity. Due to the decline in immunity I was constantly sick with mild bacterial and viral infections such as a mild cold, persistent mild UTI's, and also contracted strep. These illnesses persisted for many months. In late September I had a mild UTI that developed into an aggressive double kidney infection which hospitalized me for 1 day requiring IV antibiotics and fluids. Immediately following this incident the next week I contracted the flu (for the first time in 15 years). Immediately following the flu I contracted a severe herpes type 1 infection extending from half of my upper left lip all the way up to my nose. These series of serious infections started late September and extended over a 5 week period to the end of October. These events have never occurred in my life, prior to the flu vaccine I was very rarely sick and always had great energy and immunity. It took up until July 2016 to finally start gaining back my energy levels (which are still diminished today). These series of events have cost me my health and wellness, a decreased quality of life, and financial strains due to the hospitalization, ER visit, and Urgent care visit.
Patient stated that on 09/17 she went to restroom during middle of night and started feeling funny, so she went to kitchen to get a glass of water.  She was unable to walk so she called 911 and Paramedics informed her it is a stroke and Dr. diagnosed it as a stroke also.
Narrative:  OBSERVATION ADMISSION DATE 03/12/2021 CONVERT TO FULL ADMISSION DATE: 03/14/2021 DISCHARGE DATE: 3/16/2021 Patient did receive his 2nd Moderna COVID-19 Vaccine on 4/7/2021 with no adverse reactions.
Examination of the left posterior upper arm does reveal some mild erythema.  He does have some swelling along the area of the triceps extending towards the elbow.  This is somewhat firm and tender to touch and mildly warm.  No gross abscess formation and no evidence of your tick area or rash.  There is not well demarcated erythema or any evidence of cellulitis.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 16:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. No known allergies and no other medical history. Concomitant medication(s) included: METFORMIN, start date: 01Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID 19 Treatment included Paxlovid (Treatment start date=08Feb2023, Treatment stop date=12Feb2023).  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.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.
Moderna COVID-19 Vaccine: patient reports rash on neck, chest, and back one day after receiving second dose of vaccination. Patient states rash is similar to rash after influenza vaccination last year. Also reports headache, fever, body aches, and sore arm all of which are resolving.  The rash is not itchy or painful. Prescribed prednisone and advised to use cetirizine or diphenhydramine as needed.
Alot of left arm pain; Body aches; Fever; Chills; Entire muscle in the left arm hurts; Facial flushing; Blurred vision; Dizziness; Confusion; Choking in the throat; No emotions; A spontaneous report was received from a pharmacist who was an 48-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of facial flush, blurred vision, dizziness, confusion, chocking in the throat, had no emotions, body aches, fever 99.8 degree fahrenheit, chills and a lot of left arm pain and entire muscle in left arm hurts.  The patient's medical history included migraine and hysterectomy. The concomitant medications reported included galcanezumab gnlm, sumatriptan and sertraline hydrochloride.  On 02 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A, Exp. date: 25 Jun 2021) intramuscularly for prophylaxis of COVID-19 infection.   Immediately after receiving the vaccine, the patient experienced facial flush, blurred vision, dizziness, confusion, chocking in the throat. It was noted that these effects lasted for 20 minutes after the vaccine. No treatment was administered, and the patient did not have any rash. On the same night, the patient experienced had no emotions and the confusion and dizziness got worse. The patient reported that she drank plenty of fluids to combat the symptoms.  On the morning of 03 Jan 2021, the patient experienced body aches, fever 99.8 degree fahrenheit, chills and a lot of left arm pain and entire muscle in left arm hurts. The treatment information included paracetamol for the fever and antihistamine for allergic reaction to the vaccine.   Action taken with mRNA-1273 in response to the events was withdrawn.  The events, facial flush, blurred vision and chocking in the throat, was considered resolved on 02 Jan 2021.  The events, dizziness, confusion and had no emotions was considered resolved on 03 Jan 2021.  The outcome for the events, body aches, fever 99.8 degree fahrenheit, chills and a lot of left arm pain and entire muscle in left arm hurts was not recovered/ not resolved.; Reporter's Comments: This case concerns a 48-year-old female who had unexpected pain, pain in extremity, choking sensation, dizziness, confusion, emotional withdraw, facial flushing, blurred vision and expected fever, chills, myalgia. Event onset the same day as the first dose of mRNA-1273. Treated with paracetamol and antihistamine. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a 67 year old female consumer with no pertinent medical history and no known allergies, who on 19-AUG-2010 was vaccinated with an unspecified dose of ZOSTAVAX (Merck) (lot # unknown). There was no concomitant medication. The consumer stated that on 08-SEP-2010, following the vaccination, she experienced "sudden sensorial neural hearing loss" in her left ear along with a lost of equilibrium. The consumer stated that on 09-SEP-2010, "the morning after the hearing loss", she saw an unspecified ear, nose and throat physician. Unspecified hearing tests were performed with no results provided. She was treated for 2 weeks with oral high dose prednisone (dose unspecified). On 27-SEP-2010 and 04-OCT-2010, the consumer received unspecified steroid injections to the left ear. The consumer reported that the hearing loss and balance problems continued to time of the call. Upon internal review, sensorial neural hearing loss was considered to be an other important medical event. Additional information has been requested.
Nipples starting itching after vaccine-3 inch circumference, dry blisters on leg, liquid blisters all over, blister burst after shaving-producing excessiuve blood, seen by 3 different allergists, anaphalactic shock, blisters on right hand and swollen hand, cellulitis on right hand-right hand unuseable, back covered in blisters, left hand, legs, right breast,
Pt began feeling malaise and fatigue about 3 days ago. Yesterday he developed a shingles-like rash that is isolated on one side of his body. It does not hurt or itch.
suffered a fatal heart attack before the game; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp via social media.  This case involves patient of unknown demographics who suffered a fatal heart attack before the game, after receiving INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, frequency, formulation, route, lot number and expiry date were unknown) via unknown route in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On an unknown date the patient suffered a fatal heart attack before the game (myocardial infarction) (latency: unknown). This event was assessed as medically significant and lead to death. The autopsy details were unknown at the time of report.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (suffered a fatal heart attack before the game).  At time of reporting, the outcome was Fatal for the event suffered a fatal heart attack before the game.  Based on information previously received, the following information (classification from non-case to non-valid case) has been amended  Based on information previously received, the following information case classification of non-valid case and justification  has been deleted; Sender's Comments: Sanofi company comment dated 27-Jan-2022: This case involves patient of unknown demographics who was suffered a fatal heart attack before the game (myocardial infarction) leading to death with influenza Vaccine (Manufacturer unknown). The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: suffered a fatal heart attack before the game
lost baby; This is a spontaneous report from a Pfizer-Sponsored Program via Regulatory Authority Support from a non-contactable consumer. The reporter reported three same cases. This is one the three cases. A pregnant female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, lot/batch number unknown) via an unspecified route of administration as a single dose, on an unspecified date, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had lost her baby after receiving the covid-19 vaccine. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101200160 Same reporter/drug/event, different patients.;US-PFIZER INC-202101200159 Same reporter/drug/event, different patients.
This spontaneous report as received from a healthcare worker (medical assistant) refers to a 12 month old patient of unknown gender. The healthcare worker confirmed that ZOSTAVAX was mistakenly shipped to this office instead of (Merck) VARIVAX. The patient was then inadvertently vaccinated with the first dose of ZOSTAVAX (dose, route not reported, lot # K007986, expiration date 03-SEP-2015) instead of (Merck) VARIVAX, "within this past week", in approximately in September 2014. Concomitant medications were not provided. No adverse effects were reported. This is one of eight reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a consumer refers to a 72 year old female patient with osteoporosis. The patient's medical history included an episode of shingles. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous for prophylaxis. It was reconstituted with sterile diluent. On an unknown date, the patient experienced pain in her neck, shoulders, back and arm. The outcome of events was reported as not recovered/not resolved. Causality assessment was not provided.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild
Pt states on the day following vaccination, she began feeling a "tightening in left shoulder" feeling eventually crossed her back. This progressed to joint pain in distal joints, lower & mid-back. Patient resorted to muscles relaxers.