chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Low grade fever; her arm got real red, and the redness spread down her arm and is hot to touch; hot to touch; her arm got real red; This is a spontaneous report from a non-contactable consumer (patient) via a sales representative. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), at SINGLE DOSE and a high dose flu (INFLUENZA VACCINE ) at an unknown dose, both via an unspecified route of administration on 06Oct2020 for immunisation. The patient got both shots in the same arm. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported the patient went to the doctor on 06Oct2020 (Tuesday) and she got two shots, a high dose flu and pneumococcal 13-val conj vac (dipht crm197 protein). Ever since 06Oct2020, the patient had a low-grade fever, her arm got real red, and the redness spread down her arm and was hot to touch. And the patient stated it's gotten better since Tuesday however. The patient talked to a nurse at the doctor's office on 07Oct2020, they had drawn a line on the patient's arm to see if it spreads, it didn't spread, the nurse told the patient that if her arm doesn't get better they would have to give her an antibiotic because she might have cellulitis. The event outcome was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patients husband called pharmacy 11-15-12 said wife got her flu & pneumonia shot here 11-12-12, Next day the injection site was red and painful. On 11-14-12 went to hospital and was admitted with elevated, white blood cell count. Dr said infection could of been from injection site. Is on I.V. antibiotics in hospital.
Not feeling well; This non-serious case was reported by a physician and described the occurrence of feeling unwell in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (1st dose received on an unknown date, refer linked case US2023AMR132345).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: Not feeling well).  Rechallenge with Shingrix was positive. The outcome of the feeling unwell was resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     It was unknown if the company considered the feeling unwell to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR132345   Additional Information: GSK Receipt Date: 22-SEP-2023 The reporter reported that the patient received Shingrix vaccine and experienced not feeling well. The reporter did not specify the nature of his not feeling well but stated that it was lasted for a couple of days. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR132345:Same patient/ Shingrix dose first
Pfizer-BioNTech COVID-19 Vaccine:  About 15 minutes after vaccination, patient started to feel tingling in throat and also weakness. Paramedic was on site and put patient on EKG monitor. Paramedic administered diphenhydramine 50 mg  IV. Patient recovered and left site independently. Patient state no throat tickle or further issues.
IMMEDIATELY UPON RECEIVING THE MMR VACCINE IN HER LEFT DELTOID (LOT# 0466R EXP.4-4-07) THIS PATIENT DEVELOPED WELTS & HIVES.  NO RESPIRATORY DISTRESS WAS EVIDENCED. DR. ADMINISTERED ORAL BENADRYL AND AFTER AN HOUR OF OBSERVATION, PATIENT WAS ALLOWED TO GO HOME.
This spontaneous report as received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2017, (also reported as"27-JUL-2017-12-SEP-2017"), the patients were vaccinated with improperly stored doses of PROQUA) recombinant human albumin (rHA) lot # M033209 with expiration date 09-JAN-2018, lot# N009773 with expiration date 20-AUG-2017, lot# N010247 with expiration date 25-AUG-2018, N013268 with expiration date 25-OCT-2018, (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of PROQUAD experienced the temperature excursion from 15 to 46 degrees Fahrenheit for 21.5 hours. Digital data logger was involved. there was no previous temperature excursion. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007003: US-009507513-1709USA007002:
information has been received from a physician concerning a 70 year old male consumer with a cardiac history who on 19-MAR-2008 was vaccinated with ZOSTAVAX. Concomitant therapy included "routine medicines." Subsequently, on 26-MAR-2008 the patient developed chest pain in the left nipple area. The patient was taken to the emergency room since he had a cardiac history. It was unspecified if lab studies were performed. The patient also had a rash on his left chest and back area and was diagnosed with shingles. The patient was hospitalized overnight. At the time of the report the patient still had shingles. The status of his chest pain was unknown. There was no product quality complaint involved. Additional information has been requested.
Received injection on 12/29/2020 with no adverse event until 10 days post injection on 1/7/2021.  Woke up with strong dull headache; raised, red injection site with heat to the touch and severe itching of site.  Experienced severe fatigue for 24-48 hours.  Following day, 1/8/2021, site is less red, warm still, less itchy, and fatigue is better.
On 11/5/2021, in the afternoon, I suddenly experienced blockage/fullness in my left ear, with tinnitus of dull/buzzing sound, and my whole left head had a weird sensation.  The next day 11/6/2021, in the morning, I started noticing hearing loss in the left year.  I went to the ER on 11/7/2021 and have been taking prednisone for the past 12 days.  Now my hearing is back to normal, but the tinnitus till persists (which has changed from dull sound to high pitch ringing sound).
SEVERE EAR INFECTION; URINARY TRACT INFECTION; STOMACH CRAMPS; SEVERE/WORSENING HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced severe ear infection, urinary tract infection, stomach cramps, and severe/worsening headache. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) No blood clots. Treatment medications (dates unspecified) included: cefalexin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe/worsening headache, stomach cramps, severe ear infection and urinary tract infection was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
swelling arm; Arm sore; Itching at vaccination site; soreness of the injection site; that it was like lyme disease and looked like a bull's-eye; fever; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling arm), PAIN IN EXTREMITY (Arm sore), VACCINATION SITE PRURITUS (Itching at vaccination site), VACCINATION SITE PAIN (soreness of the injection site) and VACCINATION SITE RASH (that it was like lyme disease and looked like a bull's-eye) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis and Lyme disease.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling arm), PAIN IN EXTREMITY (Arm sore), VACCINATION SITE PRURITUS (Itching at vaccination site), VACCINATION SITE PAIN (soreness of the injection site), VACCINATION SITE RASH (that it was like lyme disease and looked like a bull's-eye), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills). At the time of the report, PERIPHERAL SWELLING (swelling arm), PAIN IN EXTREMITY (Arm sore), VACCINATION SITE PRURITUS (Itching at vaccination site), VACCINATION SITE PAIN (soreness of the injection site), VACCINATION SITE RASH (that it was like lyme disease and looked like a bull's-eye), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient stated that her symptoms were like Lyme disease and looked like a bull's eye. She did not take anything to treat her symptoms and she wasn't taking any other concomitant medications. patient said vaccine helped with her arthritis symptoms.   This case was linked to MOD-2021-090348 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up received- Contact info and medical history updated.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced tiredness, pain, cold, pain in arm and drug dose administration interval too long. On an unknown date, the outcome of the tiredness, pain, cold and pain in arm were recovered/resolved and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the tiredness, pain, cold and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient was late to receive the second dose in the series, which led to which led to lengthening of the vaccination schedule. The patient reported that she experienced feeling super tired, achy, and cold starting the next day after receiving the vaccination. These symptoms resolved within one day of starting. The patient also reported that her arm was sore for a couple of days after receiving the vaccination. The reporter gave consent to follow up. The reporter gave permission for her physician to be contacted.
Shingles; Rash; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 69-years-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 07May2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient started getting rash on "tuesday" so the patient went to doctor and got shingles from it now. Patient was not aware that you could get shingles by talking the Pfizer vaccine. Now patient has an appointment to take the 2nd dose 28th of this month, now the doctor said to call back evidently some time in last 7-10 days, so said to call back on 10th but if the rash does not completely go away so should the patient take the second dose or should wait a little longer to let the body recover. The clinical outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient. On 28-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M035693, subcutaneous for prophylaxis.  Concomitant therapies included sterile diluent (STERILE DILUENT). On 30-AUG-2017, 3 days after onset of therapy the patient experienced injection site pruritus, skin warm, erythema, pruritus and injection site erythema. The outcome of pruritus, injection site erythema, injection site pruritus and erythema was reported as recovering/resolving. The outcome of skin warm was reported as not recovered/not resolved.
Vaccines given on October 8th at 12:00pm. Patient was fine that night following morning at 5:30am the patient's lips turned blue, she clenched up lasted for one minute second seizure was at 8:00am lasted one minute as well.
Infant developed poor feeding and lethargy 8/12 PM - 8/13. Admitted 8/13/11 to general pediatric floor to "rule out sepsis" and suffered recurrent seizures and subsequently, respiratory failure, resulting in intubation. Intubated 8/14 - 8/20.
On 2 August, the 28  yo patient developed atrial fibrillation with rapid ventricular rate necessitating hospitalization for rate control.
5:15 pt complained of itchy and hot in the left arm. pt denied SOB and Difficulty breath  Pt monitored and removed his sweatshirt and provided water. Pt. stated, "Left elbow was swelling and itching continued." Ice was applied. Patient denied allergies and does not received the flu shot.  5:20 Benadryl 25 mg P.O.. given . 5:35 pt stated, "Having discomfort in left shoulder." Vital sign B/P 210/115, HR-93,  Pt was assisted to laying position. 5:38 B/P 190.105 HR 100 O2sat 96% EMS contacted Per EMS B/P 200/116, HR 100, transported to hospital via EMS
I started feeling moderate chest pain right in the center of my chest and it turned into heavy heart palpitations and a lot of anxiety. I was given an Echo and stress test that were normal, but I am still having the issue. I have an upcoming appointment with a cardiologist.
Dural sinus thrombosis postpartum diagnosed postpartum day 6 after uncomplicated vaginal delivery
rash began to develop on lower back & abd;w/in 2 days it spread over entire back, & chest, thighs;fever over 100;rash began 1wk p/vax & lasted about 5 days;
Diffuse urticarial which lasted for 2 weeks. Treated with Benadryl, Claritin and orapred.
About 3 days after my first dose, I instantaneously started having extreme muscle twitching all over my entire body. My legs, feet, arms, fingers, stomach, neck, even my tongue were affected. This lasted about a month, but was still having some residual twitching at my 2nd dose. At my 2nd dose, I experienced twitching in my forearm where the shot was given immediately after, and several days later some more twitching across my body but not as bad as the 1st dose. It took several months for the twitching to slowly reside. I also developed tinnitus in both ears, which has now gone away also.
Chills. Fever.  Body ache.  Extreme tiredness and sleepyness. Sore arm.  Fatigue.
I developed a rash on my butt and it seem to be getting worst. I went to my dermatologists and I was diagnosed with shingles.
WEAKENING OF LEG MUSCLES, CHRONIC PAIN, INABILITY TO GET UP UNAIDED, FLUCTUATING BLOOD PRESSURE, SYNCOPE, NAUSEA, DYSPHASIA, DYSPHAGIA
I have a lump at the injection site that hurts, and feels warm to touch. also I have what feels like nerve pain in my arm when I move it a certain way
Fever, chills, vomiting, decreased o2 sat, tachycardia
Approximately 3 months post vax pt developed varicella that consisted of less than 10 lesions and a low grade fever. Pt recovered within 2 days.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. Treatment information were not provided.    Reporter did not allow further contact
Information has been received from a consumer concerning her 13 year old daughter who on unspecified dates was vaccinated with 3 doses of GARDASIL (lot number not reported). Concomitant therapy included TOPAMAX (ineffective). After completed the dosing schedule for GARDASIL, in August 2009 the patient experienced severe stomach pain, aches, exhaustion, headaches, blurred vision, back pain, swollen glands, sore throat, fatigue, seizures, high blood pressure and very frequent diarrhea. Around " the end of February 2010", on approximately 28-FEB-2010 the patient was hospitalized because" her right arm and leg went numb and she temporary lost vision". Both events were reported as not being related to seizures. On 05-APR-2010 the patient was air lifted from the hospital to another hospital for seizures. On 10-APR-2010 the patient was sent back to the hospital via an ambulance for seizures again. At the time of the report, the patient had not recovered. Additional information has been requested.
Death  4/26/2021 Causes of death listed on death certificate: 1) Pneumonia  2) Coronary Artery Disease  Other: Covid 19
C/o left leg pain & rash on evening after vaccine. Received 2 vaccines in same leg. Rash increasing in size and became blister like - 2 x 2 cm erythematous & blistering with mild weeping. BENADRYL 10 mg given in office. KEFLEX 250 mg/5ml  x 10 days. May apply cool compress.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ZOLEDRONIC ACID (RECLAST) and Advil                                                          for back painÍ¾ Daily for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was unknown   This case was linked to MOD-2021-108971.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Attached vaccine adverse event reporting form
due to illness then underwent surgery; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer reported that a male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient had his 1st dose 6 weeks prior to the report, missed his 2nd dose due to illness then underwent surgery, and he's at the time of the report in rehabilitation and concerned about getting the vaccine. He wanted to know if he could still take the 2nd shot or he would start over again. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Flu shot was high on the left arm. Experiencing pain in upper arm area. Can't lift my arm up without pain, and it won't go away even 3 months later. Especially hurts lifting my arms out to the side and up and over. Never thought my problem was related to the flu shot until I mentioned it to someone at the gym, and they were having the same issues. Hence filing this report.
Did excellent with administration, used ice on the site prior, watched vaccine being given, no crying, not upset. Several minutes following as mom was getting up to leave with her, the patient started coughing/gagging, went limp, eyes rolled back and collapsed on mom for 5-10 seconds, remained breathing throughout but unresponsive.  After about 5-10 seconds began coughing again a little, crying and but became responsive to her name with visual contact.  Was able to answer questions and alert within a minute or so.  Following was a little clammy, and cuddly with mom but smiling and fully oriented.