chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient complained that by the evening after receiving the Tdap he was unable to move his left arm due to pain. He described the pain as throbbing that radiated to fingertips. The patient was seen in the office 5/9/18 by his provider, he was given a MEDROL dose pack and advised to ice for the next few days. On 6/4/18, pt still was complaining of pain in left shoulder. At times the pain level being an 8. At this time, pt was referred to ortho for further evaluation.
Information has been received from a physician concerning a 3-year-old male with a possible AUGMENTIN allergy, who  was vaccinated with a dose of Varivax. Subsequently, within 5 minutes of receiving the vaccine, the patient developed drooling, runny nose, watery eyes and facial itching. It was also reported that the roof of his mouth was "hurting". He may have also had slight coughing and a red face. Medical attention was sought and he was given an oral dose of BENADRYL, but no epinephrine. His symptoms resolved without further treatment. The outcome was reported as recovered. No product quality complaint was involved. He was thought to be allergic to gelatin. Serum IgG to porcine gelatin was elevated, at 2.10 kU/L. The patient has been able to eat beef-derived gelatin for the past year, but has avoided porcine gelatin. Recently, a RAST test to porcine gelatin had fallen to 0.38 kU/L. Egg, pork, and beef have not demonstrated IgE, either by RAST testing, or by skin testing. It was reported that the patient experienced an adverse experience following another vaccination at 4 years of age (WAES# 0610USA06611). Additional information has been requested.
Initial report was received 27 September 2011 from a health care professional which involved a cluster of two patients who experienced events after receiving FLUZONE HIGH-DOSE. This case captures one patient. The other patient has been captured in case number 2011-09379. A 66-year-old male patient had received an injection of FLUZONE HIGH-DOSE (lot number, route and site of administration not reported) on 19 September 2011 and he developed "soreness right after". A few days later, blistering developed consisting of two clustered spots of vesicles on an erythematous base developed on the left deltoid; no fever, no chills. The patient was diagnosed with shingles and received VALTREX as corrective treatment. Outcome was not reported. Documents held by sender: None.
101.5 fever along with sore arm Took Tylenol and cold ginger ale
Pt recvd vax on 11SEP92 & on 14SEP92 devel severe diarrhea & treated w/Lomoti; diarrhea lasted 24 hrs; following tx med pt became nauseated; No further details were provided;
Information has been received from a registered nurse (RN) concerning an 11-year-old white female student, with no pre-existing birth defects, medical conditions, or adverse events following prior vaccinations, who on 29-JUN-1998 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). At the time of vaccination the patient presented with a sore throat and mild lymphadenopathy. On 01-JUL-2007 the patient experienced a rash from the scalp to the trunk that was very itchy and had a duration of one day. It is reported that there were 20 lesions in various stages. The patient was afebrile. It was reported in WAES# 0707USA01595 that all other "sibs" had chickenpox. It was unknown if medical attention was sought. No laboratory or diagnostic tests were performed. It is reported that the patient recovered on 09-Jul-2007. The RN also reported that four of the patient's siblings developed chicken pox following varicella virus vaccine live (Oka/Merck) administration (WAES:, 0706USA04088, 0707USA01593, 0707USA01594, 0707USA01595). This is of several reports from the same reporter. Additional information is not expected.
Td ordered by MD, inadvertently gave DT, MD & immun program notified;parents informed, MD will f/u w/pt;
11DEC92 (2 days p/vax) pt states had runny nose, coughing-moist mucous, c/o h/a & sore throat; 13DEC92 pt was assessed by MD; lungs found to be tight sounding w/inspiratory/expiratory wheezing; tx for flare up of chronic bronchitis;
positive for COVID-19 after first shot; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (positive for COVID-19 after first shot) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced COVID-19 (positive for COVID-19 after first shot). At the time of the report, COVID-19 (positive for COVID-19 after first shot) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Bell's Palsy on left side of face: eyebrow, eye lid, nostril, cheek, and mouth droop; can not blink eyelid; eye and mouth do not close all the way; numbness in mouth, tongue, cheek, and forehead; pain behind left ear; dry eye, and mouth; and fatigue. It all started when I awoke on Wednesday, March 17, 2021 at 9:27 am.
Fever (102.2), chills, extreme sweating at night, headache, body aches, nausea, fatigue. Symptoms lasted for approximately 48 hours.
Discomfort in left arm from shoulder to wrist. Began 5 days after immunization. Described by mother as sore, aching (not sharp or tingling). No redness, swelling or limitation in movement. Discomfort intermittent, not continual. Physician notified 7/15/02.
PATIENT DEVELOPED SHINGLES AROUND 4-25 AND THOUGHT IT MAY BE RELATED TO THE VACCINE
Information has been received from a 26 year old female consumer, for VARIVAX (Merck), a Pregnancy Registry product, concerning herself with no pertinent medical history and no drug reactions/allergies who received the vaccine (VARIVAX (Merck)) even though she had already had the chickenpox. On 15-APR-2013 the patient was vaccinated with VARIVAX (Merck) (dose, route and lot # not reported) at her right arm while she was 20 weeks pregnant. Concomitant therapies included doxycycline succinate. The patient became pregnant with LMP of 26-NOV-2012 and EDD of 02-SEP-2013. Initial exposure to VARIVAX (Merck) was at 20 week(s). On 15-APR-2013, a few hours after receiving the vaccine she began to experience contractions. The patient had not sought medical attention. There was no treatment was given for the adverse event. There were not laboratory diagnostics studies performed. The outcome of contractions was reported as recovered/resolved on 16-APR-2013. Additional information has been requested.
Dermatitis on torso, hands and feet, skin peeling on left foot A few nosebleeds with small clots
Multiple hives noted to the upper limbs with itching. Hives subsided and through the weekend and redness faded
This spontaneous report as received from a consumer regarding her stepson who was 49 year old patient. On 11-APR-2013, the reporter was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported) the day her stepson (patient) came over. The reporter stated that the patient was not in close contact with her. But approximately on 25-APR-2013 (reported as 2 weeks later), the patient experienced shingles via secondary transmission which had occurred on 11-APR-2013, the day the reporter was vaccinated. The patient was treated with LYRICA for the nerve pain from shingles. The outcome of shingles and secondary transmission was unknown. The reporter felt that the event shingles was due to stress related and not due to ZOSTAVAX. Additional information is not expected.
Patient had a sore arm next day after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient had a sore arm next day after receiving 1st dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Patient had a sore arm next day after receiving 1st dose). On 20-Mar-2021, PAIN IN EXTREMITY (Patient had a sore arm next day after receiving 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided.   Patient reported in TCR that sore arm cleared up the next day. No medical care was needed. No further follow up required.   This case was linked to US-MODERNATX, INC.-MOD-2021-059984 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-May-2021. Outcome of event was updated to recovered/resolved. It contains significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-059984:Case for wife
8/27/10 call. Patient had immunizations on Wednesday, leg where she had 2 shots is swollen, red & hard. Mom was advised to apply ice & then heat to affected area.
30 YO Male patient received injection of Janssen (lot#202A21A) at 4:31 PM  PST, at 4:35 he complained of being  dizzy and within a few seconds became incoherent and had a seizure that lasted about 10 seconds.  He awoke lucent yet  confused about what occurred.  I told him he had a seizure and took his blood pressure at 90/45.  He started to complain about having difficulty breathing.  Staff called 911.  EMR  arrived within minutes  and took his blood pressure again.  I observed his BP on the EMR monitor to be at 98/68.  The patient reported he was feeling somewhat better and able to breath better.  He was transported to Providence ER at 5:02 PM lucid and alert.
99-year-old female who presents with acute hypoxemic respiratory failure due to Covid-19, she will      be admitted for oxygen supplemental and then further evaluation treatment the      hospitalist.  She was requiring high flow nasal cannula oxygen, given an IV dose of steroids of      Decadron.  She does have also paroxysmal atrial fibrillation, formerly on warfarin but her daughter      states the son who she lives with has been holding it.  She is in atrial fibrillation with rapid      ventricular response and started on IV Cardizem at 10 mg/h.   She ultimately died on 09/23/2021 from complications of COVID-19 despite being fully vaccinated. This is a breakthrough case of COVID-19 that resulted in death.   Death Certificate Details: Part I Cause of Death A: Acute Hypoxemic Respiratory Failure B: COVID 19 Pneumonia Part II Other Significant Conditions: Dementia, Atrial Fibrillation
5 days after I had the vaccine, I developed an earache and fever.  I went to my doctor, he said I had otitis media in my left ear.  He treated me with an antibiotic.  I returned two more times to him due to the pain.  I have no other hx of ear infection.  He referred me to an ENT as I was losing my hearing, felt dizzy.  The other doctor said I no longer had an infection and tested my hearing and I had some deafness in my left ear (I had no trouble hearing prior to vaccination).  In a couple of weeks, I return to the specialist and I told him that the pain and deafness was gone.  He wanted a MRI to r/o a brain tumor.  I had the MRI and it suggests demyeinating disease.  I will see a neurologist in about 1 week.  I wonder if the ear infection, deafness, and lesions of white matter on MRI could be related to the vaccine.  Did this happen to anyone else?  Thank you.
positive for COVID; post nasal drops; Myalgia; cough; sore arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore arm), FATIGUE (tiredness), SARS-COV-2 TEST POSITIVE (positive for COVID), RHINORRHOEA (post nasal drops) and MYALGIA (Myalgia) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (sore arm) and FATIGUE (tiredness). On 30-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive for COVID), RHINORRHOEA (post nasal drops), MYALGIA (Myalgia) and COUGH (cough). On 19-Mar-2021, FATIGUE (tiredness) had resolved. On 23-Mar-2021, PAIN (sore arm) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (positive for COVID) had resolved and RHINORRHOEA (post nasal drops), MYALGIA (Myalgia) and COUGH (cough) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medicine has been reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: No specific follow-up information recorded.
Swollen lymph nodes R arm, pain in R arm and swelling in R arm, tingling in fingers R hand.
Right deltoid erythema and induration 10cm x 6 cm. Tender to the touch. Mild numbness to injection site. Right flank pain. May take Tylenol or Ibuprofen
Bruise almost near the elbow, significantly lower than where injection occurred. Hot to touch but not red. No movement issue or pain in shoulder.
having menstrual periods; precramping a little bit.; 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 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 (Lot number: EWD162) at the age of 66 years as dose 2, single and administered in arm left, administration date 16Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "recovered" (2021), described as "having menstrual periods"; DYSMENORRHOEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "precramping a little bit.".  Additional information: Patient was administered covid vaccine. After the first vaccine she had no changes. After the second dose of the covid vaccine, three weeks after, started getting a period and the normal kinds of things that go along like precramping a little bit. She had about 5 days of it and then it went away. About 30 days later she got another period, then after that it went the same way as the previous period. After that second period, she had a about 5 months before she just got the booster on 17Dec2021. She started a period three days ago.   No follow-up attempts are possible. No further information is expected.
Recieved pneumococcal vacination to R deltoid.  Subsequently developed pain, swelling, fever, hypotension, thrombocytopenia, and worsening renal failure.  Patient's R shoulder was operative explored with frozen path showing evidence of myositis.  Patient transferred to ICU for 36 hours for treatment of hypotension.  Improved with debridement and antibiotics.  Suspect staph toxic shock syndrome.
Late second dose/had not been given a second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received around 7 months ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had not been given a 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. There was no specific date collected by reporter from the patient.  No other patient or vaccine information was available to reporter. The reporter declined follow-up since they were not aware if they would be available for follow-up due to them not working there all the time. The reporter did not consent to follow-up.
Nonstop crying for 3.5 hours, approx 48 hours after receiving all scheduled 2 month vaccinations.  Tried infant Motrin, which had no visible effect.  Baby was unable to be comforted and did not stop crying for 3.5 hours, then finally calmed to sleep.
Patient is too young to have recieved Moderna COVID-19 vaccine which has only been approved for those 18 and older. At this time patient has had no significant reaction.
Psoriatic arthritis; Psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis) (seriousness criterion medically significant) and PSORIASIS (Psoriasis). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis) and PSORIASIS (Psoriasis) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event Psoriatic arthritis and Psoriasis with  HUMIRA(ADALIMUMAB) was no reasonable possibility. The formulation of Humira was reported as Solution for injection in pre-filled pen  No concomitant medication information was reported.  No treatment medication information was reported.  Company comment: This spontaneous case concerns an adult male patient of an unspecified age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Psoriatic arthropathy on an unknown date in the context of receiving 1st dose of mRNA-1273 vaccine, along with the non-serious event of psoriasis. Onset latency could not be determined as date of vaccination and onset date of event were not provided. Clinical course and treatment details were not reported. On an unknown date, the patient had received Adalimumab (indication unknown) which could be considered as a confounder. The outcome of event was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient of an unspecified age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Psoriatic arthropathy on an unknown date in the context of receiving 1st dose of mRNA-1273 vaccine, along with the non-serious event of psoriasis. Onset latency could not be determined as date of vaccination and onset date of event were not provided. Clinical course and treatment details were not reported. On an unknown date, the patient had received Adalimumab (indication unknown) which could be considered as a confounder. The outcome of event was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
stroke; This is a spontaneous report received from contactable reporter (Nurse) from a sales representative.  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization), outcome "unknown", described as "stroke". Patient had a stroke within 24 hrs after receiving the Covid-19 vaccine. Hospitalized then went to a hospital and was lost to follow-up.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-CEREBROVASCULAR ACCIDENT  Case will be reassessed when new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
EXTREMELY ITCHY full body rash including entire left arm, entire right arm, both underarms, right trunk, both legs, right groin. Raised red itchy bumps, some becoming pustules and bursting to scab over.   Moderna COVID-19 Vaccine EUA
headache; Body chills came on 10-12 hrs after vaccine.; nausea; fever; This is a spontaneous report from a non-contactable nurse. A 29-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were note reported), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. Medical history included RA -rheumatoid arthritis. Concomitant medication included prednisone (PREDNISONE), fish oil (FISH OIL), flaxseed oil [linum usitatissimum seed oil] (FLAXSEED OIL [LINUM USITATISSIMUM SEED OIL]), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]). The patient previously received the first dose of bnt162b2 on 17Dec2020. On 07Jan2021, the patient experienced Body chills came on 10-12 hrs after vaccine, followed by nausea, fever, headache.The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The events was assessed as non serious. No treatment involved for the events.  No follow-up attempts are possible, information about lot/batch cannot be obtained. No further information is expected.
report of testicular pain lasting 15 minutes 30 minutes after vaccine administration. Pain self resolved.
PATIENT RECEIVED THE MODERNA VACCINE BUT WAS UNDER THE AGE OF 18.  PATIENT IS CURRENTLY 16 YEARS OLD
Information has been received from a physician concerning a 11 year old male on 02-JUN-1999 and on 08-FEB-2002 was vaccinated with the first and second dose of MMR II respectively (route, site, and lot number not reported). On 27-NOV-2009 the patient experienced mumps (the date diagnosed was reported as 29-NOV-2009). The patient was afebrile. The outcome for mumps was not reported. Follow-up information was received which reported that the 11 year old (also reported as 10 year old) patient experienced mumps on 19-JAN-2010 (previously reported as 27-NOV-2009). The patient was diagnosed on 21-JAN-2010. The patient had pain under left ear and left side parotitis. On 21-JAN-2010, the first blood work was done which revealed serum IgM 0.41, serum IgG 4.45 and serum amylase 94. The outcome for mumps was not reported. This is one of several reports from the same source. No further information is available.