chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: En6203), in left arm, on 22Mar2021 as dose 2, single (Lot number: Ep7534), in left arm and on 13Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Dec2021 as dose 3 (booster), single (Lot number: 013h21B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Stage 4 endometriosis" (unspecified if ongoing); "hEDS" (Hypermobile Ehlers-Danlos syndrome) (unspecified if ongoing); "Asthma" (unspecified if ongoing); "positive speckled ANA" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Known allergies: Tree nuts" (unspecified if ongoing), notes: Known allergies: Tree nuts. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: (unspecified date) Positive, notes: positive speckled ANA; SARS-CoV-2 test: (30Aug2022) Positive, notes: 6-9: finish Paxlovid course in the am. Testing daily, very faint positive; (31Aug2022) Positive, notes: 6-9: finish Paxlovid course in the am. Testing daily, very faint positive; (01Sep2022) Positive, notes: 6-9: finish Paxlovid course in the am. Testing daily, very faint positive; (02Sep2022) Positive, notes: 6-9: finish Paxlovid course in the am. Testing daily, very faint positive; (03Sep2022) Positive, notes: Day 10 (today) strongly positive test; (24Aug2022) Negative, notes: (Day 0) negative rapid test; (25Aug2022) Positive, notes: Day 1: positive rapid test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Covid 19 Treatment with Paxlovid from 25Aug2022 to 30Aug2022. The patient did not took any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Device Date : 04Sep2022. No follow-up attempts are possible. No further information is expected.
1st day sore arm, diarrhea 2nd day fever  3rd day shortness of breath when working out 4th day shortness of breath when working out 5th day headache  6th day large red raise circle at injection site 7th day injection site reaction still there 8th day injection site reaction still there 9th day injection site reaction still there, also that night sweating and felt faint
Patient's daughter called to report that about 30 hours after receiving the vaccine he passed away at home. She said she didn't know the cause of death but she felt like she should let us know about it.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported. Vial was pulled from the freezer on 13-Oct-2021 with a use by date of 12-Nov-2021 (30 days storage viability in the fridge).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow Up received: Updated date of birth and age.
2 x 3.5 cm left deltoid puffy, red and warm to the touch. Benadryl prescribed.
patient had the flu; Initial information regarding an unsolicited valid non-serious case from a consumer via social media on 08-Dec-2020. This case involved patient with unknown demographics who reported having the flu, while he/she received vaccine INFLUENZA VACCINE.  Relevant medical history and concomitant medications were unknown.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number: unknown and expiration date: unknown) via unknown route in unknown administration site.   On an unknown date (latency unknown), after administration of INFLUENZA VACCINE the patient developed a non-serious flu (influenza).  Final diagnosis was patient had the flu.  It was not reported if the patient received a corrective treatment.  At the time of reporting, event outcome was unknown.  There would be no information available on batch number for this case.
9th: cold (?fever?), restless, body aches (especially headache, neck pain, bilateral knee pain), nausea, vomiting 10th: profound fatigue, hives, intermittent vertigo 11-17th: vertigo, mild headache and neck pain, nausea, vomiting 18th-current: vertigo, nausea, vomiting *Hospitalized from 17-18th, diagnosed with vestibular neuritis secondary to the vaccine
and shortness of breath during any kind of exercise.; I have developed tachycardia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 10:00 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: Shrimp" (unspecified if ongoing), notes: Known allergies: Shrimp. Concomitant medication(s) included: LOSARTAN; METFORMIN; LIPITOR. The following information was reported: DYSPNOEA (non-serious) with onset 12Mar2021, outcome "not recovered", described as "and shortness of breath during any kind of exercise."; TACHYCARDIA (non-serious) with onset 12Mar2021, outcome "not recovered", described as "I have developed tachycardia". The events "and shortness of breath during any kind of exercise." and "i have developed tachycardia" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, tachycardia.  Additional information: Patient did not take any other vaccine in four weeks of vaccination. The other medications taken in two weeks of vaccination are Losartan, Metformin, & Lipitor. Patient was not tested COVID positive prior to vaccination. Patient underwent covid testing after vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
she injured her foot since she slipped through the ice.; she injured her foot since she slipped through the ice.; This is a spontaneous report from contactable female consumer (patient) and from Pfizer. A female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced injured her foot since she slipped through the ice. Patient asked for re scheduling of the second dose of Covid-19 vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Increase in sympton of tinitus -- made the sound louder in left ear. It's not quietining down at all and maintianng it's strengh. I can describe as beyond mandening and anxiety producing.
no further ae reported; Temp excursion occurred; This spontaneous report was received from a nurse referring to a 36 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 03-JAN-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously, (lot U010398, expiration date 01-APR-2023) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously, (lot T034389, expiration date 08-OCT-2022)  (strength, dose and anatomical location were not provided for any vaccine).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
I developed some itching at the vaccine site on 1/13/2021 and developed redness, warmth, swelling and increased itch at the site of injection on 1/14/2021. This continues to persist today on 1/15/2021. This required OTC hydrocortisone cream; this relieved the itch but has not lessened inflammation.
Notified by patient's daughter that she experienced nausea, vomiting, disorientation the afternoon following the shot.
3 hours following vaccine - Employee reported to RN in ER she developed a cough & a dime size something in her throat. VS were normal - not in distress. Gave .25 ml BENADRYL EE left work at 1600 - Emp stated she ended up in Hospital that night with itchy, pussy eyes & a fifty cent piece in her throat. IV BENADRYL therapy given & sent home. Emp has other exposures that may have been irritant vs. vaccine. Hard to clarify. See attached ER notes.
A few days after each injection I had extreme pain and swelling in my elbow.  It was painful to extend my elbow and to lift or exert any strength in my left  arm.  After the first shot the pain didn?t subside until two days after I received the second shot.  Now it is back again after my second dose.  The skin at my elbow is also extremely sensitive to the touch. Hi
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FMO698) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Jan2021 as dose 1, single (Lot number: 013L20A), in left arm, on 08Feb2021 as dose 2, single (Lot number: 013M20A), in left arm and on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, stop date: 16Jun2022; LISINOPRIL; METOPROLOL; LANSOPRAZOLE; CLOPIDOGREL; FAMOTIDINE. Past drug history included: Benadryl, reaction(s): "Allergy: Benadryl", notes: known allergies: Benadryl; Omnicef, reaction(s): "Allergy: Omnicef", notes: known allergies: Omnicef; Z-pak, reaction(s): "Allergy: Z-Pak", notes: known allergies: Z-Pak; Amoxicillin, reaction(s): "Allergy: amoxicillin", notes: known allergies: amoxicillin; Cefdinir, reaction(s): "Allergy: cefdinir", notes: known allergies: cefdinir; Sulfadiazine, reaction(s): "Allergy: sulfadiazine", notes: known allergies: sulfadiazine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive; (24Jun2022) Negative; (26Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took other medication in 2 weeks. The patient was treated with Paxlovid for COVID-19 from 16Jun2022 to 20Jun2022. Rebound COVID-originally tested positive for COVID and started Paxlovid 17Jun2022 then tested negative on 24Jun2022. Symptoms hit again 26Jun2022 and tested positive on 26Jun2022.
Information has been received from a consumer concerning her son with a history of chickenpox at 9 months old who on an unspecified date in his childhood was vaccinated with a dose of MUMPSVAX II (lot #, route and site of administration not reported). Subsequently, the patient broke out with mumps. No medical attention was sought. At the time of this report, the patient's outcome was not reported. The consumer stated that the patient broke out chickenpox after being administered a chickenpox vaccine at 9 months old in 1956. No further information is available.
Upon waking the morning after my vaccination,  I noticed discomfort in both arm and across chest and upper back described as stiff or sore muscles, also  Sharp pain (5/10) in right shoulder when lifting or reaching with that arm.   @ 9:30 am I too 400mg of Ibuprofen PO.     Pain severity was reduced to 2/10, but pain and discomfort  gradually fade over the day of sedentary work at a computer.  @ 17:30 discomfort was gone and pain in right shoulder was reduced to (1/10).  by 20:00 pain was completely gone.       (Note: I regularly get Influenza vaccines every year, and do not recall ever rgetting a reaction this severe before.  I am now nervous about the second dose, as I have heard it is worse for most people. )
PT HAS HX BILAT FROZEN SHOULDERS, ENDOCRINOLOGIST SUGGESTED INJECTION TO THIGH. RN GAVE PT INJECTION TO RIGHT THIGH. PT IS DOING WELL.
While on active duty status, patient was given the smallpox shot and had an allergic reaction. Member's right hand became swollen, itchy, and covered in blisters over his complete hand.  Member was medically treated and diagnosed with hand dermatitis, a skin condition.  He was prescribed a topical hand cream and advised to follow up with his primary care doctor.
I felt "fuzzy" and sort of "tipsy" as though I'd drunk a couple of pints of very strong beer for about 30 minutes. No other effects, no treatment sought or given.
Information has been received from a physician and a nurse concerning a 14 year old patient who was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (lot# 0838U). Subsequently the day after administration, the patient developed abnormal swelling and redness at the injection site. It was unknown whether medical attention was sought. The patient's recovery status was unknown. There was no product quality complaint. This is one of several reports from the same source. Attempts are being made to obtain the identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available.
Information has been received from a nurse referring to multiple unspecified patients of unknown gender and age. The patients' concurrent condition, medical history and concomitant therapy were not reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PEDVAXHIB (dose and route unknown, lot # M047666, expiration date 24-OCT-2019) for prophylaxis. The vaccine was improperly stored at 32 to 35 degrees Fahrenheit (35.4 degrees Fahrenheit) for 1 hour. There had not been a previous temperature excursion and the phone call was a result of the data logger. No adverse effects were reported. No Product quality complaint (PQC) was presented. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA000777.
Patient had outbreak of Shingles (Rash according to patient which resembles shingles. Patient went physician and has been put on Valtrex 1g (1 tid x10).
Information has been received from a physician concerning a female pt who in 1998 was vaccinated with MMR II(lot 621155/0289E). The physician reported that the pt "now" (on approximately 1/17/02) had an increased CA125. The physician indicated that the pt did not have cancer, not did she think vaccination with MMR II was the cause. Unspecified medical attention was sought. Additional info has been reqeusted.
This spontaneous report was received from a medical assistant refers to a patient of unknown age. On an unknown date in 2011 (reported as 2 years ago), the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date and route was not reported). On 13-AUG-2013, the patient was vaccinated with second dose of GARDASIL, (lot number, expiry date and route was not reported). No adverse effects was reported. Additional information is not expected.
Hives on arm (not just around injection site), swelling and redness of warm and fingers. Hives on torso.
9/2/04- spv (left upper arm), Hep A #2, Hep B #2, and typhoid (right upper arm). 9/3/04- started to notice erythema/edema/tenderness around the smallpox vaccine inoculation site. 9/7/04- pain now radiated up to left-sided neck/jaw/ear- c/o neck stiffness and limited ROM due to pain. 9/13/04- anthrax #2 (right upper arm)- above mentioned symptoms worsened- c/o fever (temp not taken) and chills. 9/15/04- pt. seen by his Case Manager- states inoculation site appears much improved- pain in his left-sided neck/jaw/ear has not spread to the right side- limited ROM of neck and left shoulder now worse.
chills, body ache, chest pain, abdominal pain, after two days post vaccine patient decided to go to the ed due to concern for the chest pain.  Worked up in ED but nothing of significance found.  Will follow with PMD
I brought my 5 year old to get his second dose of the COVID vaccine.  As we were waiting in the wait area after his vaccination, the person (I assume it was a nurse) that administered the vaccine in his arm told me that she had accidentally forgotten to dilute his vaccine.  She told me to watch for side effects and that there maybe be more than usual.   I didn't quite understand what that meant, so I asked her if she still had a pediatric dose and she assured me he had.  She mentioned that they would be sure to call to check on him, since there had been a mistake with his vaccination.  She also mentioned that the incident would be reported.   I had no idea what that meant.   A few minutes later she came back into the waiting area and told me that she had done the math and my son had actually gotten 1.5 doses because of her mistake.  She again assured me that it was a pediatric vaccine but at a higher dosage.  She said there could be worse than usual side effects because of the higher dose and the fact that it was not diluted as it should have been.  She also told me again that they would be calling to check in on how my son was doing.
WE WERE INFORMED THAT THE VACCINE HAD BEEN IN THE FRIDGE BEYOND THE BEYOND USE DATE AND WAS NO LONGER EFFECTIVE.
severe nausia.  to the point have requiring s IV at my home. 48 hours of vomiting and no sleep. broken rib outcome.  fun times.  Moderna. no way I am taking a 2nd dose
3 days, post vax, pt developed hives and whelps all over body. Neck and chest splotchy, macular erythema. No other complications.
Patient called and asked if redness, swelling, soreness was a normal adverse reaction. Patient was told that it was and was advised to use a cold compress or ibuprofen, and to seek attention if it was severe or did not improve. Patient presented to the pharmacy when it did not improve with redness that has spread further from the injection site and extreme swelling of upper arm. Patient was advised to seek medical attention. Patient went to local urgent care and was told it was cellulitis and prescribed cephalexin.
initial fatigue, chills. After 24 hours, extreme fatigue, lips tingled, went to bed. In am, about40 hours after vaccination developed swollen upper lip and swollen armpit on side where she was vaccinated.
On 2/4 at 9:00 a.m patient started to feel very heavy. Felt very foggy and arm was very swollen  and hot to the touch. B/P was taken and it was elevated and kept going up. Was sent to  med  clinic and blood pressure was 186/120 and no medication given there and sent to ED. IV started and 4 chewable aspirin and 5 nitro given. EKG was normal. Blood work normal. 50 mg IV Benadryl and IV Toradol given for pain.
Received shot about 1 pm, arm began to swell over next few hours, then fever, muscle aches, headache, wheezing, swelling of eyes and face. Used my Albuterol inhaler (max air) 2 puffs wheezing stopped.
Patient experienced shortness of breath, lightheadedness, and abdominal pain immediately after vaccine administered.  Patient's vital signs remained stable, 100% oxygen saturation, and lung sounds were clear.
Patient came to employee health to obtain second hepatitis B vaccine.  First vaccine was given 2/15/2019.  IM injection given  4/29/19 around 11:30 am and she left employee health office to go to lab to obtain some other lab work.  She returned 30 minutes later and stated she was having tingling in her lips, left side facial numbness, headache, and then about 5 minutes later stated her left arm was numb and tingling.  I took her straight to our Emergency Dept.  There she was treated by the ED doctor and staff.
A physician reported that a patient received an injection of Pnu-Imune 23 vaccine  and developed a delayed post-immunization. The reporter described the reaction as "red, almost cellulitic" which lasted for several days. The reporter stated that 7 patients experienced this event following receipt of Pnu-Imune lot 473-556. MANUFACTRER'S COMMENT:  The 7 patients were not presently identifiable. Additional reports will be generated when identifying information is provided. Additional information  received from the reporter on 08/30/02 provided patient identifiers for 1 patient and the lot number changed from 473-556 to 470-594. The patient remained recovered.
Patient received second dose of Pfizer COVID vaccine and told nurse she did not feel well. Patient was the passenger in the car. Nurse stood near patient and stated patient had a mild seizure. Nurse reported patient began shaking. EMS, lead nurse, and clinical site manager notified and arrived to patient. Patient alert and oriented x3. States that she has a history of epilepsy and takes medication for it. Patient states she has a phobia of needles and had a seizure when she had her tetanus shot. Patient also stated she was fasting today and did not eat or drink much and her last seizure was two weeks ago. After approximately 10-15 minutes, patient stated she felt better and did not want EMS to transport her to the hospital. She stated she felt the same way she usually feels after she has a seizure. Vital signs and pallor WNL. Patient given crackers and Gatorade. She drank half of the Gatorade. Patient sent to observation to be observed for 30 minutes. Observation reported no further symptoms. Patient's friend drove her home.
Abdominal Pain, Bloody Diarrhea, changes in menstrual periods. Ulcerative Colitis.  Lialda, Prednisone
Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated with Gardasil, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sough unspecified medical attention. Additional information has been requested.
1hr p/vax pt vomited, fever noted by parent;1 day later 21JUN96 pt ran sl fever-no vomiting pt was alright 22 & 23JUN on 24JUN96 6PM pt became shaky & vomited & had poss sz, t103.4;pt to ER had inflamed ears;
pt states red, painful rash on arm and into armpit of right arm where tdap was given