chrisvoncsefalvay/vaers-outcomes huggingface dataset:
period was affected/extremely heavy; This is a spontaneous report from a contactable consumer (patient's sister). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration in left arm on 03Mar2021 11:00 as unknown, single for covid-19 immunisation. The vaccination facility type was a pharmacy/drug store. No other vaccine in four weeks. Prior to vaccination, patient was not diagnosed with COVID 19 and since vaccination, patient have not been tested for COVID 19. The patient's medical history was not reported. The patient had no concomitant medications (no other medications in two weeks). The patient's period was affected, had extremely heavy on 10Mar2021 which was uncommon for her after bnt162b2. The consumer considered as non-serious as did not result in death, not life threatening, did not cause/prolong hospitalization, not disabling and incapacitating and no congenital anomaly and birth defect. No treatment was received for the event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt was given Pfizer vaccine that had a BUD of 10/16/2021
Patient was given Moderna Monovalent brand vaccine after date was instructed not to administer that brand of vaccine.
Pt. C/o pain onset in Left arm, about an hour after receiving shot.  Said pain was severe and requested pain medication. No redness or warmth noted, pt. unable to complete ROM with left arm and pain radiated from shoulder to elbow.  Pain persisted through night and the next few days after disrupting her sleep and ranged from mild to severe. Continued to tx with Tylenol and ice packs. Res. does not want second dose.
patient received a dose of MMR II 6 days before the patient's first birthday; No adverse effects were reported; This spontaneous report was received from a physician referring to a 11 months old patient of unknown gender. The patient's concomitant therapy, pertinent medical history and concurrent conditions were not provided.   On an unknown date (6 days before the patient's first birthday), the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose number, frequency, route of administration, anatomical location, lot number and expiration date were unknown by the reporter) for prophylaxis (product administered to patient of inappropriate age).  No adverse effects were reported. No product quality complaint (PQC) was involved.
This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 75-year-old female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a month after receiving Shingrix, the patient experienced abdominal pain, general body pain and headache. On an unknown date, the outcome of the abdominal pain, general body pain and headache were unknown. It was unknown if the reporter considered the abdominal pain, general body pain and headache to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The reporter indicated that she believes that her mother received the Shingrix vaccine approximately two weeks ago. The patient had been in the emergency room on three separate occasions since getting the vaccination. The first time she went to the emergency room she was experiencing a headache and body aches. On the date of reporting, the third visit to the emergency room and the patient was experiencing abdominal pain.
1/11/22 pt saw PCP and was positive for COVID; 1/13/22 worked up in ED, given Decadron, albuterol, ABX and dc'd to home; 1/15/22 pt back to ED for increasing SOB, cough, flu-like sx (x 8 days); CT in ED showed multifocal pneumonia; admitted; O2 supplementation; 1/31/22 pt went into respiratory arrest and was intubated; PEA arrest requiring CPR, ACLS protocol followed; poor prognosis; required a 2nd round of CPR; family transitioned pt to Comfort Care; palliatively extubated and pt expired in the hosp
Fever no more than 102.0, vomiting, convulsion that last 2 minutes. Pt was taken to ED, Sx started around 6:00 pm on 11/16/20 then   on 11/17/20 around 1:00 am she started vomiting and at 5:00 am have a seizure, taken to ED
Chills, tiredness, fever and mild discomfort in the head and the body in general
cherry color pin point papules v.s. one time x 24 hr O2 sats
Patient with lip and tongue tingling.  Patient had same symptoms with first dose, her MD instructed her to premedicate with Benadryl at home before second dose.  Patient did premedicate with 25mg of Benadryl before 2nd dose today.  Patient states she does have some lip and tongue tingling. 0910 BP 128/84 P 87 SPO2 99% RA,  0930 BP 138/90 P 78 SPO2 97, 0945 BP 148/96 P75 SPO2 99, Patient feeling improved before she left.  Patient stated she felt fine and wants to go home.
sore arm; 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 PAIN IN EXTREMITY (sore arm) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-097395 (Patient Link).
diagnosed positive for COVID on 10/13/21; to hosp with increasing SOB and O2 sats in the 70s on 2L O2 via NC; coughing up yellow sputum; placed on NRB mask; cardiomegaly, chronic renal failure, UTI, suspected pneumonia; started on antibiotics; required intubation with mechanical ventilation due to worsening respiratory status; multiorgan failure; DNR; family withdrew care; comfort measure; pt extubated and died in the hospital
This spontaneous report as received from a Medical Assistant referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On unknown dates, the patient was vaccinated with an improperly stored dose of vaccinated with PROQUAD (route, dose, frequency, and anatomical location were unknown) with lot# N021727 and expiration date 06-FEB-2019 for prophylaxis. The administered dose of vaccine experienced the temperature excursion of -9 C to 8 C (5C) degree Celsius for 1 hour and 4 min. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effects were reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: had positive antigen test 5 days after end of treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took antiviral for COVID 19 treatment, brand from 04Jul2022 till 08Jul2022. COVID rebound. Began experiencing rhinitis and had positive antigen test 5 days after end of treatment, after prior symptoms had resolved. In addition, patient experienced dysgeusia while taking Paxlovid. Resolved 24 hours after final dose was taken. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I got a lump on the injection site; red circle / at the injection site / kept getting bigger.; This case was reported by a consumer and described the occurrence of injection site lump in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site lump and injection site erythema. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site lump and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site lump and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and got a lump on the injection site and a red circle that was at the injection site but kept getting bigger.  The patient took some Benadryl once a day for four days it went away and was fine.  The patient asked if he/she should get the second shot.
Tension and spasm of left trapezius and dysesthesia into deltoid area and lateral forearm.
No additional AE's; Pneumovax was administered past its expiration date; This spontaneous report has been received from a clinic supervisor, concerning a patient of unknown age and gender. No information was provided regarding the patients' pertinent medical history, current conditions, concomitant medications and previous drug reactions or allergies.  On 26-AUG-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vial (lot number T007383 has been verified to be valid, expiration date reported and validated as 23-AUG-2021) (dose, vaccination scheme, route and anatomical location of administration were not reported) as prophylaxis. No additional adverse events details (no adverse event).
He did have itching and rash after the first one; He did have itching and rash after the first one; This is a spontaneous report from a contactable consumer (patient's friend).  A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Feb2021 (at the age of 70 year old) as dose 1, single for COVID-19 immunisation. The patient's medical history included, he had complication from egg and orange from an unspecified date and has unspecified health conditions. The patient takes unspecified concomitant medications. A couple of weeks ago, he was weighed down to 135. It was reported that patient has serious health issues already, where he has severe rheumatoid arthritis from an unspecified date. He has been given every rheumatoid arthritis medication (unspecified) on the market but none of them really helped him. Patient is now on an infusion of some kind of drugs (unspecified). He is on so many different unspecified medications and then he was having problems with his feet on an unspecified date, so the reporter bought the patient Gold Bond Diabetic Lotion (product name as reported), to put on his feet. The reporter does not know if this was all related because he is on so many medications. On an unspecified date, after the first shot, patient had itching and rash. It has been about a month since he had extensive lab test because he has to go for extensive lab test every time before he has that infusion of those drugs. On 26Feb2021 and on 03Mar2021, patient had extensive lab test and results were unknown. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm swelled (claimed pneumo shot) and went to Urgent Care with a severe reaction and was given steroids and pain medication.
Patient was unable to urinate for over 36 hours after he received the Hep B vaccine. We were kept in the hospital for an extra two days due to his inability to void.
Excessive Bowel Movements; This spontaneous case was reported by a consumer and describes the occurrence of FREQUENT BOWEL MOVEMENTS (Excessive Bowel Movements) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced FREQUENT BOWEL MOVEMENTS (Excessive Bowel Movements). On 25-Feb-2021, FREQUENT BOWEL MOVEMENTS (Excessive Bowel Movements) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications or treatment details reported.
Have not had period since first injection. Expected normal cycle on 2/15, but no occurrence since. No other abnormal symptoms. Visited Ob/Gyn for advice and tests. (Not positive for pregnancy)
On 07/09/2001 the patient developed a rash with scattered erythematous papules on the abdomen with 1 early vesicle.
Insomnia, chills, body aches, headache (next day, following sleepless night)
Rash akin to Pityriasis Rosea on torso. This would be a recurrence of Pityriasis Rosea first diagnosed in 1996.
Hives on bend of arms, left wrist, right forearm, under chin on right side of neck and right ear.
Aches and pains in body; Low grade fever (max 101.3); This is a spontaneous report from a contactable consumer. This 68-year-old male consumer reported that:  Country: Language: Report about covid vaccine: Yes Reporting type: AE Reporter type: Patient Age group Elderly: (65+ Years)  Second Dose: product=COVID 19, brand=Pfizer BioNTech,  Administration date=12Feb2021, Administration time=04:30 PM, Vaccine location=Left arm, Dose number=2  First dose: product=COVID 19, brand=Pfizer BioNTech, Administration date=21Jan2021, Administration time=02:30 AM, Vaccine location=Left arm, Dose number=1  Adverse event: Low grade fever (max 101.3) Aches and pains in body Adverse event start date: 13Feb2021 Adverse event start time: 10:00 AM Adverse event country:  Ae resulted in: [None of the above] If patient recovered: Recovered  if treatment ae No if Covid prior vaccination No if Covid tested post vaccination No Known allergies: No This is a spontaneous report from a contactable consumer. A 68-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 16:30 (Batch/Lot number was not reported) as single dose for for covid-19 immunisation.The patient historical medical history included dose 1 via an unspecified route of administration, administered in Arm Left on 21Jan2021 02:30 AM. The patient's concomitant medications were not reported.The patient experienced low grade fever (max 101.3) and aches and pains in body  on 13Feb2021 10:00.  The patient underwent lab tests and procedures which included body temperature: max 101.3 on 13Feb2021.No treatment was given for the events. The outcome of the events was recovered on unspecified date.
My second Moderna Covid-19 vaccination made me very sleepy.; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (My second Moderna Covid-19 vaccination made me very sleepy.) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-1021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (My second Moderna Covid-19 vaccination made me very sleepy.). At the time of the report, SOMNOLENCE (My second Moderna Covid-19 vaccination made me very sleepy.) outcome was unknown.            No concomitant medication were provided by the reporter No treatment medication were provided by the reporter
mom states pt had a restless, sleepless noc p/had vax;pt was cranky this AM no appetite, no diarrhea, states lt thigh is swollen;mom phoned MD ofc-was told to apply warmth & give pt APAP;sx lasted only 1 day/24hr
Woke up at about 10PM on 4/22/21 with fever and chills, unable to sleep most of the night. Fever and chills resolved by morning. Had a headache for most of the following day (4/23/21) which improved with Tylenol.
HA, sore throat, occasional non-productive cough, myalgias, chills, temps to 100.1 max. starting 1/7/22
Hib Sanofi Lot # UJ456AAA was giving during Well Child Check-up on 5/25/2021.  Starting showing signs of illness on Friday 5/28 and 5/29.  High temperatures, moaning while sleeping curled up in ball when usually child lays with arms stretched out, rapid, shallow breathing, very lethargic, chills (mild shaking), runny nose, mild cough.  Administered children's liquid ibuprofen at 6:00pm, but by 10:00p the temperature rose to 103.5.  Took to Emergency Room.  Diagnosed as Rt Ear infections.  Given antibiotics and instruction to alternate Tylenol and ibuprofen to keep fever down.   F/U after completion of antibiotics to recheck ear infection.   The CDC website states: Haemophilus influenzae type b can cause many different kinds of infections. These infections usually affect children under 5 years of age, but can also affect adults with certain medical conditions.  Hib bacteria can cause mild illness, such as ear infections or bronchitis, or they can cause severe illness, such as infections of the bloodstream. Severe Hib infection, also called invasive Hib disease, requires treatment in a hospital and can sometimes result in death.
On 10/10 a rash was noted on the patient. On 10/11/2001 the rash increased with itchy eyes. The patient was treated with Benadryl. The patient was seen in the office which revealed red macular papular lesions on the face and trunk. On 10/12/2001 the rash was improved.
This spontaneous report as received from a medical assistant who administered vaccines refers to a patient of unknown age. The medical assistant noted that the patient was intramuscularly administered the first and second doses in the GARDASIL (dose and lot # not reported) vaccination series on 08-MAR-2012 and 20-MAR-2013, respectively. No adverse effect reported. It was unspecified if the patient had sought medical attention. Action taken and causality of GARDASIL were not reported. Additional information has been requested.
2nd dose on day 38; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose on day 38) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     The patient's past medical history included No Adverse Events since an unknown date.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 mg. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose on day 38). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose on day 38) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       there is no concomitant medications given in the treatement   Reporter did not allow further contact
SUBJECTIVE: 64-year-old woman, patient of Dr., in for acute visit. At time of patient's CPE visit 3 days ago, she received injection of shingles vaccine in right upper arm. Over the subsequent 3 days, patient has developed an area of fairly severe soreness and tenderness at site of injection, with an expanding oval area of pink erythema. She has not developed any vesicular or chickenpox-like lesions, but she has developed some nausea and headache. No fever. Patient did have one episode of actual zoster, in the lower back, about 6 years ago. For the current soreness, patient has been using some ice, but has not tried any other medication so far. Prefers not to take BENADRYL, since it has made her very tired in past. However, she has taken CLARITIN in past, and agrees to try that now. Please see below. Patient does have diabetes and is on metformin, says her blood sugars have been quite well controlled lately, and the physical exam note documents excellent weight loss. AT BEGINNING OF TODAY'S VISIT: Current Meds: CALCIUM 500 MG TABS (CALCIUM) 1 by mouth twice a day; FREESTYLE LITE TEST STRP (GLUCOSE BLOOD) BID testing; FREESTYLE LANCETS MISC (LANCETS) Use for blood glucose monitoring two times per day; DX : E11.9; LISINOPRIL 10 MG TABS (LISINOPRIL) Take 1 tablet by mouth once daily; METFORMIN HCL 500 MG TABS (METFORMIN HCL) Take 1 tablet by mouth twice daily with breakfast and dinner; ASPIR-LOW 81 MG TBEC (ASPIRIN) Take 1 tablet by mouth once daily. OBJECTIVE: Very pleasant woman, vital signs as above. Exam of right upper arm shows a large oval-shaped area of erythema, 3" x 5" to my measurement, with central induration and tenderness at presumptive ZOSTAVAX injection site. I see no papular vesicular lesions. ASSESSMENT: Localized reaction to shingles vaccine, moderately severe, and patient does report at least subtle systemic symptoms of nausea and headache, but no fever. PLAN: Discussed the nature of localized reactions to vaccinations, and this should be self-limited. I did recommend patient use an over-the-counter antihistamine, nonsedating, such as CLARITIN or ZYRTEC or ALLEGRA; also supported her continuing use of ice as helpful, and the use of either ibuprofen or naproxen as helpful. The latter to be taken with food. While patient was in the office, I actually did call infectious disease consultant Dr. on the telephone, to ask if there would be any point in considering acyclovir or other measures, and he felt that it should not be necessary to use that nor prednisone. Patient expresses understanding and agreement, I did use a purple skin marking pen to outline the current size of the localized reaction, and I asked patient to notify us if it is expanding significantly further, or if she is having other worsening. Please see end of visit instructions below.