chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unknown dates, the patients were administered with unknown number of doses of improperly stored RECOMBIVAX HB (dose strength, route, lot # unspecified). No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a health professional refers to unspecified patient of unknown age and gender. No medial history and concurrent conditions were reported. The reporter reported that on an unknown date, unknown number of patients were administered ROTATEQ (unspecified dose and route) lot @ K004468, expiry date 08-DEC-2015 and lot # K0006457, expiry date 09-MAR-2016. On an unspecified date the vaccine had been improperly stored. No adverse effects were reported. There was no product quality complaints (PQC) involved. The outcome of the event was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Some diarrhea, coughing, scratchy throat and fatigue. The fatigue and coughing was the worst. I'm still fatigued now. The doctor gave me PAXLOVID and cough medication.
On 02/03 I got red bumps on the injection site.  On 02/04 the injection site became completely red and itchy, I have also noticed a change in my vision.
Pt stated that her arm was red and slightly swollen from the flu vaccine, when pt came into office on 10/16/2018, spot was a small scab and arm was minimally red and swollen.
Congestion/stuffy nose at 9:30 pm on 1/26/21 Chills (extreme) 1:30 am on 1/27/21 Fever (100°F) 3:00 am 1/27/21 Coughing 8:00 am 1/27/21 Headache 8:00 am 1/27/21 Joint aches 8:00 am 1/27/21 Nausea 10:00 am 1/27/21 Dizziness 10:00 am 1/27/21
Dizzy, lightheaded, severe headache, shaking, freezing cold, profuse sweating, muscle aches, joint pain, tachycardia, minor chest pain, nausea, dehydration with constant thirst, metallic taste in mouth. Took 2 tylenol pm pills, drank water and 7-up. Symptoms were gone 20 hours later except for very sore right arm, neck and back muscles which were completely gone and normal by day 3.
From MD Chart note:   The patient had seen me on May 24th for her Prevnar 20, which was a Wednesday  and then the following Tuesday on May 30th, she developed erythema and swelling.  She went to urgent care for evaluation on May 30th and was advised to monitor  it.  She then called the on-call doctor last night, Dr., who felt it  was probably allergic reaction.  As a result, she took 50 mg of Benadryl and  reports significant improvement throughout this period.  Again, the initial  reaction was about a week after the injection.  She had no fevers or chills.   There is no drainage.  It is not sore.  It felt hot, not really a welt kind of  reaction, just generalized swelling in a well demarcated area, but an irregular  shape.  No respiratory symptoms and again with the Benadryl, she is improved.   She does report some fatigue. MPRESSION AND PLAN: Likely, allergic reaction, certainly possible after injection, but the timing of it happening 1 week later is what is atypical.  Fortunately, she has no  respiratory symptoms and she did improve and respond to an antihistamine.   Therefore, I recommend that she continue the Benadryl 50 mg tid, alerting her  for symptoms of drowsiness, although she does not drive if she is drowsy and she can use ice, over-the-counter topical hydrocortisone and if her symptoms worsen, she is advised to followup.  I have offered allergy consultation, but she defers for now.  It does not appear to be infectious, especially as it is improved with the antihistamine.  We may mark this is an allergy in the future and avoid  Prevnar 20 in the future.  Follow up call by RN on 6/9. Pt. reports improvement, has stopped taking anithistamine, denies pain, denies SOB, denies wheezing.
I experienced a few hives in the late afternoon after receiving the first dose. They disappeared quickly - maybe within an hour. I also however woke up the next day with a bruise like spot on the right side of my skull. It felt tender and painful to depress - very similar to a bad bruise - but I had not hit my head. I believe this spot lasted about 4 days. (I reported these symptoms to the vsafe software too - and now that is probably the better resource to check for timing. I also reported this to Moderna and called J&J because I feared the swelling on the right side of my skull was blood clot related. I had a video visit with a primary care physician who did not believe the swelling had been blood clot related, or a stroke risk. However, she did not explain what it was. I might guess it was lymph related reaction. My facial swelling, though typically attributed to allergies seems also lymph related.
Pt received 1st dose Covid-19 Janssen vaccination.  Pt stood up and stated that he felt dizzy and immediately began to fall to the floor. Staff caught patient as he was falling and lowered him to the floor.  Pt remained conscious. Feet were raised and pt was verbal, states he didn't know what happened but he was okay. Pt alert, remained on the floor and drank juice.  Pt helped up from the floor and became pale and diaphoretic,  wheeled to the cot. VSS, cold compress applied to head and pt drank another juice. Pt lie on cot for approximately 5 minutes, stated again that he felt okay, observation team performed orthostatic VS.  VS remained stable. Pt ambulated out of clinic with parents.  VSS, A&O x4, GCS 15
Pt recvd vax 20JUL92 & 21JUL92 devel h/a & a visual disturbance which described as shaped blurred vision & squiggly lines; blurred vision persisted for aprox 45 mins & then subsided;
EXTREME MUSCLE CRAMPS; CAN'T SIT; CAN'T DRIVE; CAN'T GO TO BATHROOM; NEEDLES AND PINS IN THE FEET/LEGS; NEEDLES AND PINS IN THE SHOULDER/GROIN NECK; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis, and other pre-existing medical conditions included: Patient was on some type of pain medication. 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 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included paracetamol for arthritis, and gabapentin.  On 01-APR-2021, the patient experienced extreme muscle cramps. On 01-APR-2021, the patient experienced can't sit. On 01-APR-2021, the patient experienced can't drive. On 01-APR-2021, the patient experienced can't go to bathroom. On 01-APR-2021, the patient experienced needles and pins in the feet/legs. On 01-APR-2021, the patient experienced needles and pins in the shoulder/groin neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme muscle cramps, needles and pins in the feet/legs, can't sit, can't drive, can't go to bathroom and needles and pins in the shoulder/groin neck was not reported. This report was non-serious. This case, from the same reporter is linked to 20211009251.
Patient became febrile and vomited several times. Fever responded to Tylenol but returned. The fever lasted 24 hours, and the vomiting lasted 12 hours.
arm got sore; upset stomach; terrible taste on the mouth  - metallic taste; does not have much of an appetite and gait is a little off; does not have much of an appetite and gait is a little off; chills; sweats; headache; feeling sick; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in Arm Right on 06Apr2021 (at the age of 85-year-old) as single dose for COVID-19 immunization. Medical history included prior Covid virus survivor, that she was hospitalized in Apr2020 and intubated, states she had to have surgery a couple of weeks ago, had vocal cord surgery due to damage from being intubated, prior to vaccine. History of COVID 19 infection and was intubated 07Apr2021 (as reported)- Patient undergone surgery for removal of large cyst in the vocal cord last Mar2021. She had cellulitis in left arm around a year and a half ago so she got the vaccine in her right. Concomitant medication(s) included atorvastatin taken for cholesterol from an unspecified start date and ongoing. The patient experienced chills, sweats, headache, upset stomach, no appetite, terrible taste on the mouth - metallic taste and gait was off since 08Apr2021; arm got sore since 09Apr2021. Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 07Apr2021 (as reported) and she experienced feeling sick, chills, sweats, headache, arm got sore, upset stomach, terrible taste on the mouth - metallic taste. The patient stated she had her first dose of the Pfizer Covid vaccine on Tuesday morning 06Apr2021, states she had never been that sick, states she felt like she had every side effect she could possibly have. After the vaccine she was alright during the day and at home, states she then woke up in the early hours Thursday morning, 08Apr2021, states she had a headache, sweats, chills, that her arm did not bother her until this morning (09Apr2021), had upset stomach, the taste in her mouth was unbelievable, felt a little better, was improving, did not have much of an appetite and gait was a little off, but better. Asking if the 2nd dose will give her more side effects and if she could still get the 2nd shot because of the reactions. Caller wanted to know if she should have not gotten the vaccine since she had Covid last year. Outcome of the event sore arm, gait is off was not recovered; feeling sick was unknown; other events was resolving.  No follow-up attempts are possible. No further information is expected.
Per patient she states that on December 2 she received her second dose of the Johnson & Johnson Covid vaccination, patient states on December 4 she was at home after doing some work around the house and noticed a cramp in her left leg that was severely painful.  Patient states the next 2 days she started to develop swelling to her left lower extremity and on December 6 she was diagnosed with a DVT to her left lower extremity.  Patient was placed on Eliquis and on December 10 she came into my office to follow-up from the hospital that placed her on Eliquis and was having gross red blood in her urine.  Patient was sent to the hospital again and was sent home in stable condition.  Patient has had no other episodes of spontaneous bleeding and is currently taking the Eliquis for her continued DVT.  Patient gave me verbal consent for me to submit this to Vaers.
Diarrhea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037k20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient experienced redness/rash along with arm pain following vaccination. On a regular visit to her doctor, the doctor encouraged her to return to the pharmacy to report the reaction. Patient presented to the pharmacy with slight redness around the front and side of arm, and down the back of her arm, 1 week following vaccination. Patient stated reaction had begun to subside and felt better after warm baths.
A 4th dose/2nd Moderna booster was given to a 20 year old at 3 months from her 1st booster.
found that other people experienced this / Some people had reactions 8-10 days later; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (found that other people experienced this / Some people had reactions 8-10 days later) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (found that other people experienced this / Some people had reactions 8-10 days later). At the time of the report, VACCINATION COMPLICATION (found that other people experienced this / Some people had reactions 8-10 days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.  It was stated that the patient did some research, and patient found that other people experienced this, they talked about a reaction after 10 days of receiving the Moderna Vaccine. Some people had reactions 8-10 days later.
This spontaneous report was received from a pharmacist, who referred to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, lot# N011867 and expiration date: 08-NOV-2018 or lot# N014946 and expiration date: 01-FEB-2017 or lot# N020688 and expiration date: 09-MAR-2019 (dose, frequency, route of administration were not reported) for prophylaxis. The vaccine was improperly stored at a temperature of -1 degree Celsius (C) or colder (-10 C) for 6 days. Through 6 cycles multiple temperature excursions were involved. There were no previous temperature excursions. The temperature excursion was detected by a digital data logger. No adverse event was reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA003734.
This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (felt tired), ERYTHEMA (arm was red and swollen), PERIPHERAL SWELLING (arm was red and swollen), DYSPNOEA (shortness of breath) and HYPERSENSITIVITY (allergic reaction) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy, Hypothyroidism, Emphysema and Lung cancer. Concomitant products included ROPINIROLE, PRAVASTATIN and TIOTROPIUM BROMIDE (SPIRIVA) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 06-Feb-2021, the patient experienced ERYTHEMA (arm was red and swollen), PERIPHERAL SWELLING (arm was red and swollen) and DYSPNOEA (shortness of breath). On an unknown date, the patient experienced FATIGUE (felt tired) and HYPERSENSITIVITY (allergic reaction). At the time of the report, FATIGUE (felt tired), ERYTHEMA (arm was red and swollen), PERIPHERAL SWELLING (arm was red and swollen), DYSPNOEA (shortness of breath) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Sore arm. Unable to sleep. Sweats and chills all night. Overall body pain, intense joint pain, intense head pain. Unable to work.
Within 4 hours of receiving the vaccine on 3/9/21 I felt exhaustion, body aches, chills and headache. About 30 hours later I started to experience extreme leg pain/tremors, severe nausea and an unrelenting headache, lower back pain and continued chills. 6 days after receiving the vaccine (3/15/21) I tested positive for Covid-19 and the symptoms worsened. 8 days after receiving the vaccine I developed a cough and sore throat and trouble breathing. 10 days after receiving the vaccine I went to the emergency room (3/19/21) and received a chest x-ray and diagnosed with covid pneumonia and given antibiotics to treat along with a CT scan. Symptoms started to subside about 2 weeks after receiving the vaccine, although to this day I am still troubled with a lingering headache and constant fatigue. Throughout the duration I relied on Tylenol and Motrin. At the hospital I was prescribed indomethacin and ondansetron for pain and nausea.
Body aches; Persisting neck pain; Blurred vision in left eye; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 01Jun2021 at 17:30 (at the age of 29-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none and the patient did not have a history of allergies to any food or medications or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Jun2021, next day after vaccination, the patient experienced blurred vision in left eye, persisting neck pain for multiple days. On 03Jun2021 day after vaccination, the patient experienced body aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcome of the events blurred vision in left eye, body aches and persisting neck pain were not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
may be shingles; Rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 49Y35, expiry date 22nd October 2021) for prophylaxis.   On 30th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on the left arm. The patient experinced a little rash and felt that it might be shingles. The reporter consented to follow up.
body sweats; muscle pain; vomiting; fever; This is a spontaneous report from a Regulatory Authority. A contactable consumer (patient) reported that a 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at the age of 70 years, as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that she was currently out of Genotropin medication. She also stated that on an unspecified date, she was not feeling well post COVID vaccination as she has had body sweats, muscle pain, vomiting and a fever and she was not able to get out of the bed. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Narrative: 38 yo male presented to ED on 2/23/22 for persisting cellulitis of his lower abdomen. He noted it started 2 weeks prior and spread to much of his abdomen. Recently treated with cephalexin and reports did not help. Pt COVID positive 2/23/22. Treated with remdesivir 2/23-2/27 and dexamethasone 2/24-2/27. Hospital stay complicated with rhabdomyolysis, AKI on chronic stage 2 and refusal of CPAP. Acute hypoxic respiratory failure and cellulitis resolved. Pt discharged to home on 2/28/22. PMH significant for HTN, morbid obesity, OSA, former smoker (sopped 08/21), and DM2.
States left arm swelling, redness running from shoulder to forearm approx. 4 days post vax with black lesions 3mm. Resolved after a few days with ln complications.
The primary reporter is medical assistant. Medical assistant reporting that a patient who received 3 doses of VARIVAX is currently showing negative antibody titers to VARIVAX was administered on 05/29/1998, Dose 2 was administered in January 2012 (exact date unspecified) and Dose 3 was administered 6 weeks after Dose 2 (unspecified date). The patient also reported to the physician that she did not respond to 3 doses of hepatitis B vaccine in the past (unspecified brand, unspecified manufacturer). Dates of administration for the hepatitis B vaccine are 05/18/1995, 08/25/1995 and 08/26/1996. The patient then received an additional unspecified number of doses of the hepatitis B vaccine on unspecified date (s), and she later tested positive for hepatitis B antibody titers. All vaccine doses of VARIVAX and hepatitis B vaccine were administered by a different provider (unspecified provider's name). No other details.
This report describes the occurrence of autism in a male child of unspecified age who was vaccinated with hep B vaccine (Engerix B) for prophylaxis. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject reportedly received an injection of Engerix B "in or about 1998." "In or about 1998 and 1999, the subject also reportedly received injections of hep B vaccine (Recombivax HB, Acel-Imune, and HibTiter. The subject's attorney alleged that "As a result of the mercury in the thimerosal-containing vaccinations received during these developmental years, the subject now suffers and in the future will continue to suffer, from the toxic neurological effects of his mercury poisoning, including but not limited to autism." The autism and mercury poisoning in this report are considered to be medically serious (OMIC).
Patient had severe erythema and edema surrounding the injection site of the Kinrix vaccine starting 05/12/22 with some improvement as of the morning of 05/13/22. Patient was treated with cetirizine 5mg once daily and diphenhydramine 12.5mg every 6 hours. Recommended application of cool compresses to affected area throughout the day. Recommended ibuprofen every 6-8 hours as needed for pain. Patient also experienced multiple episodes of vomiting and low-grade fever. He had pain of the left shoulder and limited range of motion of the left arm. Parents advised to closely monitor patient and will return patient to office as needed for new or worsening symptoms. Outcome unknown as treatment began this morning.