chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever / Highest temperature was 103 degrees / Staying 100 degrees to 103 degrees), CHILLS (Chills), HEADACHE (Headaches), PAIN (Body aches) and INSOMNIA (Unable to sleep for 2 days) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and Lot # 002C21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021 at 9:00 PM, the patient experienced PYREXIA (Fever / Highest temperature was 103 degrees / Staying 100 degrees to 103 degrees), CHILLS (Chills), HEADACHE (Headaches), PAIN (Body aches) and INSOMNIA (Unable to sleep for 2 days). At the time of the report, PYREXIA (Fever / Highest temperature was 103 degrees / Staying 100 degrees to 103 degrees), CHILLS (Chills), HEADACHE (Headaches), PAIN (Body aches) and INSOMNIA (Unable to sleep for 2 days) had not resolved. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) Staying 100 degrees to 103 degrees. The patient stated she would not like to receive Moderna vaccine again. She spoke to her doctor about her symptoms, they are still persisting. Concomitant medications have no been reported. No treatment for the events.
Still feel like I am recovering (from surgery); Received first dose 6 weeks ago/ due to have her second shot two weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Still feel like I am recovering (from surgery)) and PRODUCT DOSE OMISSION ISSUE (Received first dose 6 weeks ago/ due to have her second shot two weeks ago) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery in July 2021.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received first dose 6 weeks ago/ due to have her second shot two weeks ago). On an unknown date, the patient experienced MALAISE (Still feel like I am recovering (from surgery)). In July 2021, PRODUCT DOSE OMISSION ISSUE (Received first dose 6 weeks ago/ due to have her second shot two weeks ago) had resolved. At the time of the report, MALAISE (Still feel like I am recovering (from surgery)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter. Treatment information was not provided by the reporter.  It was reported that the patient's surgery was scheduled before she received the injection. However, she reported that she had it after the vaccination. Moreover, her physician advised her that it would be good to wait to get the second dose since her body is already going through the stress of recovery.
Pt presented to pharmacy complaining of a painful red rash on her right arm she states developed after she recieved her PNEUMOVAX and FLUZONE vaccines on 10/23. Pt will visit her PCP office to be examined and treated.
Patient began breaking out in a rash on his neck and left arm about two hours after receiving the shot. The rash had dissipated some by morning, but became widespread within 24 hours of receiving the shot. This widespread reaction included a diffuse rash of his neck, trunk and arms, as well as facial swelling; particularly around his mouth and eyes. He also developed a small cough.  Patient received a three-day course of oral steroids and a 30-day course of antihistamines to treat the reaction.
Alcoholic hallucinations; This is a spontaneous report from a Pfizer sponsored program. This consumer reported for a male patient (reporter's husband).  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and Expiry Date were unknown), via an unspecified route of administration, on an unknown date in 2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date on 2021, the patient experienced Alcoholic hallucinations and hospitalised. The reporter stated that her husband got hospitalized in up until now, no idea yet when he will be released from the hospital. Now, the main concern here is that 07Jul2021 would be the second dose (later clarified as Covid19 vaccine) of her husband. Her husband might not get the second dose on time." The seriousness of event alcoholic hallucination was reported as hospitalization. The outcome of the event was not resolved.  Further probing was not done. Hence, limited information available.  Information related to batch/Lot no. was requested.
Pain in arm at injection site x 2 days Fatigue on day 2 Headache on day 2 Fever of 100 on day 2 Muscle soreness on day 2
pt recvd vax;on 1nov95 devel a vaccine associated rash;3nov95 devel Bell's Palsy;at time of rpt cont to have weakness on rt side of face;
Nurse and patient unsure if there was actually vaccine in syringe used to give shot. Nurse noticed after injecting into left deltoid that syringe plunger was already pushed in and didn't notice any vaccine in syringe. No side effects or reactions following "injection". Nurse called manufacturer for guidance--- following up with pt as well.
Next morning felt super weak, had some spots on left arm break out in hives, and head a major migraine most of the day
repeated respiratory viral infections; generally not feeling well; fever; congested; feeling chills and cold; feeling chills and cold; This is a spontaneous report received from a contactable Other HCP. The reporter is the parent.  A 16-year-old male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) at the age of 16 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Mar2021, for COVID-19 immunization. The following information was reported: RESPIRATORY TRACT INFECTION VIRAL (non-serious) with onset 15Oct2021, outcome "unknown", described as "repeated respiratory viral infections"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "generally not feeling well"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; NASAL CONGESTION (non-serious) with onset 2021, outcome "unknown", described as "congested"; CHILLS (non-serious), FEELING COLD (non-serious) all with onset 2021, outcome "unknown" and all described as "feeling chills and cold". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of respiratory tract infection viral, malaise, pyrexia, nasal congestion, chills, feeling cold.  Additional information: The patient Other Products and Patient History has been Not Provided. The patient was taking Motrin and Tylenol.  The lot number for bnt162b2 was not provided and will be requested during follow up.
104 fever, hands shaking, extreme chills, headache, dizziness, exhaustion, sensitive to light. This came on quickly, less than three hours after receiving the vaccine. Drinking lots of water. I dod not get sick when I got covid. Was not comfortable getting vaccine but had to get it to participate in collegiate sports.
Intense pain under left arm (in armpit).  Lymph node swollen and continuously painful from day 3 through present.  (Pain is a 5-6 on a 1-10 scale where 10 is immobilizing and 1 is hardly noticeable.)  Motrin (800 mg) eliminates pain for a few hours.   Patient feeling continually exhausted since a couple of days after administration of vaccine.   Patient experiencing short, sporadic bouts of nausea (NO vomitting--nausea typically in evening/night) beginning 5 days after vaccination and lasting up to 10 minutes each time.  Also experienced diarrhea one time in conjuntion with nausea.
Pt states that she felt a burning sensation around her left eye and up on the left side (which was the same feeling she had when she had shingles in the past). Also, swelling and rednss and itchy around injection site (which was a rxn I told her may occur).
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Swelling beginning 9 hrs after injection, redness, pain at site and down left arm, pain in left leg as well, no fever. Redness and heat has increased from elbow to shoulder. Went to clinic Friday night 7pm with swelling and redness at site only. Now there is a red raised lesion above and below site (Sun 11 AM). Minor head pain beginning Sat PM lesion is flat, customer feels better 5/14/13 9:45 AM.
Emergency room visit for chest pain and high blood pressure. No heart attack signs were found however, they recomended a follow up appointment with cardiologist. Symptoms are on and off for about two weeks at this point.
This spontaneous report was received from a medical assistant and refers to 60 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-JAN-2016, the patient received dose of improperly stored ZOSTAVAX lot number L029484, expiry date: 06-NOV-2016; (dose, dosage number, and anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 13 year old (currently 16 year old) female patient with Crohn's disease and no drug allergy. The patient was not pregnant. The pharmacist reported that the patient received the 1st dose of VARIVAX (Merck) (lot#, dose and route unknown) "when she was little" and the 2nd dose of VARIVAX (Merck) (lot#, dose and route unknown) "when she was 13 years old (in approximately 2011)". Concomitant therapies included prednisone(manufacturer unknown, route default as oral). The patient had blood drawn on an unspecified "recent" date (in approximately 2014) which showed she had negative anti-varicella antibody titers (date unknown). No treatment given to the event. The outcome of negative anti-varicella antibody titers was unknown. No PQC (Production Quality Control) involved. Additional information is not expected since the pharmacist asked not to contact the physician.
On May17, 2022 I developed a sore throat which developed into symptoms of a head cold by the next morning.  I tested negative on 2 home tests but I had been exposed to Covid at a family wedding on Saturday May 14th so I went for a PCR test on May 18th and received a positive result on May 20th.
Client tested positive for COVID-19 on 11/07/2020. She received Pfizer COVID-19 vaccine on 03/18/2021 and 04/08/2021. She then tested positive for COVID-19 again on 05/17/2021.  She was hospitalized from 05/17/2021-05/21/2021. She has a history of gastric bypass surgery. She was short of breath at the time of her positive COVID test on 05/17/2021. She was found to have an obstructed gastric outlet at the time of her hospitalization.  When I spoke with her on the phone on 05/25/ 2021, she reported that her medical provider felt that her shortness of breath was related to her gastric issues. She is no longer short of breath  and will be having further surgery in June 2021.
Doses administered out a vial that experienced excursion for 4 hours; Doses administered out a vial that experienced excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered out a vial that experienced excursion for 4 hours) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered out a vial that experienced excursion) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 001J21-2A and 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered out a vial that experienced excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered out a vial that experienced excursion for 4 hours). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered out a vial that experienced excursion for 4 hours) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered out a vial that experienced excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  It was reported that 3 doses were administered out a vial which experienced excursion for 4 hours. The vials were returned to stable refrigerator temperature after 4 hours.   No treatment information provided   This case was linked to MOD-2022-525790, MOD-2022-525791 (Patient Link).
Severe chills, fever, nausea, sore joints, headache for days, continues to be lingering symptoms that are continuing
Information has been received from a registered nurse, concerning "many patients" who were vaccinated (dates not reported) with a dose of Gardasil vaccine (lot # not reported). The nurse reported that many patients subsequently, "pass out from Gardasil vaccine." No further details were available. Follow up information received from the nurse indicated that "1 out of every 5 or 6 patients pass out or nearly pass out" after vaccination with Gardasil vaccine. She added that the office began to warn patients prior to administering the vaccination, but then the incidence increased; since they stopped warning patients, the incidence "had gone down." She added that the event occurs more in patients receiving their first vaccination and in patients who have not eaten on the morning of vaccination. No further details are available. Additional information is not expected.
Pt broke out in several raised bumps, approx size and shape of an insect bite on arm, torso, forehead and leg. She states itching and fever, no blister or discharge from bumps.
Day 3 post tetanus/pertussis vaccination-onset of reddness, edema, pruritits to injection site area 2-3 inch diametric day 4-apply 1 degree cortisone cream, BENEDRYL cream with 0 diuitch.  Day 5,6,7 no change in condition of injection site area
injection site red and hot to touch, arm pit and lymph nodes swelled  redness lasted approximately 1 week, swelling subsided in 3 weeks
Per orders of the patient's hematologist/oncologist -Dr a 4th full dose (0.5mL) of Moderna was administered to the patient on 1/12/22,
Patient reports feeling very cold 6 hours post vaccination requiring her to increase covers and clothing. Her temp was normal. Her heart rate was elevated to 108. Incident resolved within 24 hours with no residual effects.
PT RECEIVED TDAP AND MENVEO IN THE RIGHT THIGH, COMPLAINED OF PAIN, HPV ADMINISTERED IN LEFT THIGH, COMPLAINED OF PAIN, SPREADING PAIN, PATIENT WAS NOTICED TO GET VERY PALE, SHE STARTED TO MIX UP HER WORDS, TOTAL BODY SHAKING STARTED, AS THE PATIENT WAS STARTING TO LEAN FORWARD I IMMEDIATELY EASED HER TO A LAYING POSITION ON THE EXAM TABLE. PATIENT RECOVERED FAIRLY QUICKLY AFTERWARDS, WONDERED WHY SHE WAS LAYING DOWN. SHE WAS STILL VERY PALE AND CONTINUED TO HAVE HER LAY ON THE TABLE. A COOL RAG WAS APPLIED TO HER FOREHEAD, GUARDIAN WAS INSTRUCTED TO REMAIN IN THE ROOM AS I WENT TO GET HER SOME WATER. PT DRANK THE WATER, STILL SHAKEY AND PALE AND FEELING CONFUSED, ORANGE JUICE WAS GIVEN WHICH SEEMED TO HELP MORE, PT CONTINUED TO IMPROVE. AFTER HAVING THE PATIENT SIT FOR MORE THAN 5 MIN, SHE WAS ABLE TO LEAVE THE OFFICE WITH HER GUARDIAN, AMBULATING ON HER OWN. NO FURTHER CONCERNS NOTICED.
Constant heart racing, on the verge of panic, inability to sleep becoming apparent about a week after the vaccination and still ongoing.
Pt received vaccine and 10 minutes in reported red blotches on arm and that her "teeth hurt". She was moved to an observation area via wheelchair and monitored for 30 minutes.  Vitals: 1107 142/112, 98%, HR 69; 1129 159/114, HR 71. Pt reported she did not feel dizzy or have SOB and that her "blood pressure is normally high". Pt left ambulatory from vaccine center to home.
During vaccine reconciliation, it was noted that the lot number for patients ordered MMR vaccine was the lot number to the MMRV vaccine. Upon further investigation on 10/10/23, patient was ordered to received MMR and Varivax vaccines. It was confirmed that patient was inadvertently given the MMRV vaccine instead of MMR vaccine as ordered. Patient received both MMRV and Varivax vaccines.
Fatigue, body aches, headache, nausea, woozy/dizzy, bruise at site of injection, sore arm
Rash under and above both eyes. They are pink, swollen and peeling.  The day after the vaccine, there was a pink ring under my eyes which faded the following day. However, it came back again but also had patches above my eyes as well. I thought it was starting to go away but I woke up today, 2 weeks since my vaccine and my eyes are the worse they?ve ever been.   They are darker and more swollen than ever before and they itch so bad.
Approximately 36 hours after vaccinations child had unrelieved temp of 102F, took child to ER, when temp reached 106F, was diagnosed with otitis media and treated with Motrin, Tylenol and amoxicillin.
Had grapefruit sized swelling on left leg.  Noticed 1/4/11 that legs were red & hard around vaccine sites.  Legs are itchy.  Afebrile.  Left leg is worse than right.  Legs are no warmer than rest of body to touch.  Diagnosed as Immunization Reaction & adv to continue cool compresses and ibuprofen.
Patient received the Pfizer COVID-19 vaccine on 3/2/21 and 3/23/21 so was fully vaccinated when they tested positive for COVID-19 on 9/7/21.
This is a spontaneous report from a contactable nurse through a Pfizer sales representative. This nurse reported similar events for 2 patients. This is the second of two reports. A 16-year-old female patient received TRUMENBA at single dose on an unknown date in 2017 for immunization. Medical history and concomitant medication were not reported. On an unknown date in 2017 the patient experienced dizziness directly after receiving the vaccine. The patient waited in the office for 15 minutes and the dizziness dissipated. No additional treatment was needed. The event resolved on an unknown date in 2017.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017089887 Same reporter/AE/product, different patient.
Hives developed 6 hours post vaccine.  Employee seen at urgent care.  Prescribed antihistamines.
on 12/17/19 I Obtained 2nd dose (shot) of Recombinant Zoster SHINGRIX at 0830am at Dr. First dose there was only achy feel and sort arm where shot was administered. Began feeling "flu-like" at 5pm. At 8pm I felt flu like, feverish, achy, stomach ache and minor swollen lips ( not visible but felt it ) . I took 2 Benedryl and went to sleep . At 0030am on 12/18/19 I felt worse and had a solid (not dots) rash on Neck, Inside Elbows, inside forearm, Torso, armpits, thighs. At 0700am I felt worse and rash continued and slightly itchy but not enough to scratch. Took 2 tablets of Benedryl To date 12/19 the rash continues but flu like symptoms have subsided. On 12/19 I did notify my physician Dr I do get similar reactions to NSIADS, Zinc, Penecillin
pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "pain at the injection site".  Additional information: The patient received his second dose of Pfizer-Biontech Covid19 vaccine on 26Feb2021. He is now reporting pain at the injection site, and wants to know if this is common.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
FEVER OF 101; HEADACHE AROUND EYES; SEVERE BODY ACHES; COUGHING; HORRIBLE CHILLS; HURTING OF SHOULDER BLADES BEHIND LUNGS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included shoulder blade pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On JUN-2021, the subject experienced severe body aches. On JUN-2021, the subject experienced coughing. On JUN-2021, the subject experienced horrible chills. On JUN-2021, the subject experienced hurting of shoulder blades behind lungs. On JUN-2021, the subject experienced headache around eyes. On 16-JUN-2021, the subject experienced fever of 101. Laboratory data included: Body temperature (NR: not provided) 101 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 101, horrible chills, severe body aches, hurting of shoulder blades behind lungs, headache around eyes and coughing was not reported. This report was non-serious.
Just over 24 hours after receiving the second Moderna vaccine I started to break out in hives all over my face and neck. 24 hours later my whole body was covered in hives. I was able to finally get the hives to dissipate after taking about 150 mg of Benadryl over a 8 hour period. I went to an Urgent Care the next week when the hives started to come back and the doctor said it was an adverse reaction to the second vaccine. The doctor informed me to keep taking the Benadryl as needed. The hives came back a few days later and one of the doctors I work with told me to start taking an H2 blocker on top of the H1 blocker I was already taking. It worked well. Now a month later I am still getting bad hives all over my body and the H1 and H2 blockers are not working. Heading back to the Urgent care to received better treatment.