chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SINUS INFECTION A WEEK AFTER SHOT; This spontaneous report received from a patient concerned a male 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 was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported. On 19-APR-2021, the patient experienced sinus infection a week after shot. Laboratory data included: Blood test (NR: not provided) results came out clear, and CAT scan (NR: not provided) results came out clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sinus infection a week after shot was not reported. This report was non-serious.
6 days post injection developed Left post and outer shoulder shingles.  1 week later developed severe shoulder weakness.
c/o h/a, nausea & body aches onset 30 hr p/vax;sx persisted x <24hr & resolved w/o med tx or further problems;
Patient was administered Covid Vaccine and went home and one hour later broke out in Hives/ Mom gave benedryl, the hives went away. He was fine.
This spontaneous report as received from a physician refers to his wife, a 74 year old female patient. The patient had no drug reactions or allergies. On 23-JUL-2014 the patient was vaccinated with ZOSTAVAX, (0.65 ml, subcutaneous; anatomical location, dose number and lot number unknown) for vaccination. Concomitant therapies included NEURONTIN, oxycodone and another unspecified narcotic. Approximately on 26-JUL-2014 (reported as: 3 days later) the patient experienced numbness in the right ear, numbness in both hands, a burning sensation in both ankles, decreased appetite and fatigue. The patient sought medical attention and received treatment with prednisone (manufacturer unknown). No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. Additional information has been requested.
This spontaneous report as received from a pharmacist, as a part of a marketing research program conducted by agency, refers to a 112 year old female patient. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. The patient was recommended to have the shot even at her age because she was in a really good health. However, she was very small and very frail and later, on an unknown date, she had a reaction from the shot. She was very weak for about a week afterwards. The patient was glad she had the shot and it was worth having the reaction knowing that she was protecting herself from getting shingles. The outcome of the event was not reported. The reporter considered the event to be related to ZOSTAVAX. Additional information has been requested.
Woke up in the middle of night with severe body and joint aches...headache, hot and cold   Throughout the day on the 20th, I took 2 extra strength Tylenol every 4 hours, which started at 5 am that morning.   No energy or appetite either... Today, which is Sunday March 21, I still have slight body aches but seem to be improving, but still no energy or much appetite
Acquired covid 19, exposed 18Jan2021. Symptoms began 22Jan2021. Positive PCR through DHEC; Acquired covid 19, exposed 18Jan2021. Symptoms began 22Jan2021. Positive PCR through DHEC; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), via an unspecified route of administration on 05Jan2021 at 09:15 am in the Left arm at single dose for COVID-19 immunization in hospital. Medical history was not reported. Prior to vaccination, it was unknown if patient was diagnosed with COVID-19. The patient's concomitant medications included fludrocortisone acetate, loratadine, escitalopram oxalate (LEXAPRO). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient acquired COVID 19 on 22Jan2021, exposed 18Jan2021. Symptoms began 22Jan2021. Positive PCR through DHEC. Since the vaccination, patient had been tested for COVID-19 PCR on 22Jan2021: Nasal Swab, result was Positive. No treatment was received for the events. The outcome of the events was not recovered.; Sender's Comments: The positive COVID-19 test occurred 17 days after the injection of suspect vaccine BNT162B2. The lack of efficacy of suspect BNT162B2 to the COVID-19 infection cannot be totally excluded. While the steroid fludrocortisone acetate and the target disease may predispose the patient to the virus infection.
Random chest pain after first dose; Blood clots vaginal bleeding after first dose/A lot of vaginal bleeding after first dose; Tingling on fingers after first dose; Fingers getting numb after first dose; Pain in both entire arms after first dose; Lightheaded after first dose; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Random chest pain after first dose), VAGINAL HAEMORRHAGE (Blood clots vaginal bleeding after first dose/A lot of vaginal bleeding after first dose), PARAESTHESIA (Tingling on fingers after first dose), HYPOAESTHESIA (Fingers getting numb after first dose) and PAIN IN EXTREMITY (Pain in both entire arms after first dose) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020.    On 25-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced CHEST PAIN (Random chest pain after first dose), VAGINAL HAEMORRHAGE (Blood clots vaginal bleeding after first dose/A lot of vaginal bleeding after first dose), PARAESTHESIA (Tingling on fingers after first dose), HYPOAESTHESIA (Fingers getting numb after first dose), PAIN IN EXTREMITY (Pain in both entire arms after first dose) and DIZZINESS (Lightheaded after first dose). At the time of the report, CHEST PAIN (Random chest pain after first dose), VAGINAL HAEMORRHAGE (Blood clots vaginal bleeding after first dose/A lot of vaginal bleeding after first dose), PARAESTHESIA (Tingling on fingers after first dose), HYPOAESTHESIA (Fingers getting numb after first dose), PAIN IN EXTREMITY (Pain in both entire arms after first dose) and DIZZINESS (Lightheaded after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took Motrin at home for the treatment of COVID-19. She states that she did not have chest pain and heavy vaginal bleeding prior to vaccination. No concomitant medication was provided. Patient had her period on time on 23-Oct-2021 and was bleeding normal prior to vaccination.
being miserable; This is a spontaneous report from a contactable nurse and consumer (patient) received from a Pfizer-sponsored program. A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in 2021 as dose number unknown, single for COVID-19 immunization; tofacitinib citrate (XELJANZ XR), via oral from Jan2020 (Batch/Lot number: unknown, Expiration Date: 30Jan2023) to an unspecified date, at 11 mg, daily for rheumatoid arthritis.  The patient's medical history and concomitant medications were not reported.  The patient experienced being miserable in Mar2021. The patient was advised by her medical doctor (MD) that tofacitinib citrate was held for one month (Mar2021), while getting COVID vaccine. It was reported that the patient was being measurable when off for that month (Mar2021). The action taken in response to the event for tofacitinib citrate was post-therapy. The outcome of being miserable was unknown.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Hives on arm.  3 about the size of a dime vicinity of injection and one about the size of a silver dollar about 3 inches away toward front of arm.
Information has been received from a pharmacist concerning a female who "about 4 months ago," was vaccinated subcutaneously instead of intramuscularly with the first dose of GARDASIL vaccine (yeast) (lot number not reported). The physician's office who gave the dose has it documented as given in the left arm however the patient and her mother state it was given in the right arm. The patient has a big discoloration of the right arm. The patient was referred to a dermatologist. The patient's discoloration of the right arm persisted. Additional information has been requested.
arm pain; stomach cramps; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 17Apr2021 15:00 (lot number ER8731) at the age of 38-years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, lot number ER8730, administration time 14:30), administration date: 27Mar2021, when the patient was 38-years old, for Covid-19 immunization, reactions: "arm pain for 48 hours", "early menstrual cycle (came 4 days early)". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "arm pain"; ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "recovering", described as "stomach cramps". Therapeutic measures were not taken as a result of pain in extremity, abdominal pain upper.  Additional Information: The vaccine was given in a pharmacy or drug store. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination. The patient was not tested for covid-19 post-vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous prospective pregnancy report as received from a registered nurse refers to a 19 years old female patient with no pertinent medical history and no Drug Reactions/Allergies. The patient was vaccinated SC with a dose of VARIVAX (Merck) (lot number 671027/1067AA; expiration date 05-JUL-2013) on 30-JUL-2012. No other co-suspects were reported. Concomitant medications included cefdinir and pseudoephedrine. On 29-OCT-2012, the patient went to the physician's office with complaints of "upset stomach and nausea". The physician noticed that the patient's abdomen was distended. ZOFRAN was given for the nausea. The patient reported that her last menstrual period was on 15-OCT-2012 and that she has been experiencing menstrual periods on a regular basis. She was sent for an ultrasound on 30-OCT-2012. The ultrasound found that the patient was pregnant and might have been pregnant since May of 2012. The patient was exposed to VARIVAX (Merck) during trimester 1 and 2. On an unspecified date, the nausea resolved. At the time of the report, the patient's outcome for menstrual periods on a regular basis was unknown. The patient continued to be pregnant. The relatedness for patient's abdomen was distended and menstrual periods on a regular basis was not reported for VARIVAX (Merck). Additional information has been requested.
Patient says she always passes out when getting an injection. I laid her down on the exam table and gave her the injection and she was fine for about 30 seconds and then passed out and appeared to have a vasovagal episode. It lasted about 30-45 seconds and then she was aware of her surroundings. I made her continue to lay down for 5 minutes and slowly let her sit up and then dangle her legs. She then moved to a chair and she sat there another 10 minutes with her mother before her mother took her home.
Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 25-SEP-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # M012990, expiration date 14-MAR-2018, 0.5 ml, once, subcutaneous). The vaccine was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. This is one of several reports received from the same reporter. Additional information has been requested.
sores on mouth; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH ULCERATION (sores on mouth) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025j20a and 029K20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CARVEDILOL (COREG), ACETYLSALICYLIC ACID, ATORVASTATIN, CLOPIDOGREL (CLAVIX GOLD), ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and multivitmamins for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced MOUTH ULCERATION (sores on mouth). At the time of the report, MOUTH ULCERATION (sores on mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
This spontaneous report has been received from a female physician office manager who was also the patient, via a field representative, concerning herself. The patient's medical history, concurrent conditions, drug allergies and concomitant therapies were not reported. On an unknown date (reported as "years ago"), the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, route of administration, anatomical location, lot number and expiration date were not provided), for prophylaxis. On an unknown date, the patient experienced injection site swelling. She did not recall any additional details about this event. At the time of reporting, the patient's outcome for injection site swelling and the causal relationship between ZOSTAVAX and the event were unknown. This is one of two reports regarding the same patient.; Sender's Comments: US-009507513-1808USA007656:
This spontaneous report was received from a Nurse Practitioner referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.   On 06-DEC-2016, the patient received a dose of ZOSTAVAX Lot # M009773 and expiration date: 17-MAY-2017, Vial 19,400 Plaque Forming Units (PFU) (dose and route of administration were not reported) for prophylaxis that was improperly stored. It was reported a temperature of 8° Fahrenheit during a time frame of 1 hour. There was a previous temperature excursions of 8.6° Fahrenheit and 41° Fahrenheit for 1 hour 30 minutes and 17 hours and 50 minutes, respectively. The call was not because of a data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received by the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1702USA001764:  US-009507513-1702USA009079:
This spontaneous report was received from a Registered Nurse referring to an unspecified number of patients of unknown ages and genders. The patient's concurrent conditions and medical history were not provided. On an unknown date the patients were vaccinated with doses of improperly stored (Merck) VARIVAX (doses, routes and anatomical locations were not provided). The lot numbers used were: L005299, expiration date: 17-FEB-2017 and L037562, expiration date: 29-SEP-2017. It was reported that the vaccines had an excursion of -10.6 Celsius degrees for 30 minutes. There were no previous temperature excursions. No adverse symptoms were reported. This is one of two reports received from the same source. Additional information has been requested.
2 weeks after 1st dose on 4/13, pt had itchy red rash all over body (scalp, arms, legs, inner thighs, back, a little bit on chest, a little bit on stomach). Described as very itchy little red bumps in small groups/clusters. Maybe only one or two dots on chest/stomach, but was severe everywhere else. Rash started about mid day, kept the patient from sleeping that night from the itchiness, and lasted until evening the next day. No change in diet or soap/detergent/lotions, no new outside exposures. She used coconut oil 2 - 3 times throughout, helped soothe a little bit, but rash eventually disappeared evening of the next day (4/14)
This case was considered medically important (OMIC). Information regarding Hib titer vaccine (haemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate) injection) was received from a consumer regarding a male patient who experienced autism. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Hib titer vaccine was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose. Additional suspect medication included Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection). concomitant medication were not reported. A mother reported that her son is autistic and the he may undergo a procedure to remove mercury from his body, Dates were not provided. No additional information was available at the time of this report.
HPI narrative: Patient was fine until 2 days ago.  Patient does have chronic dementia but got Covid vaccine 11:00 2 days ago and that night seem to be confused and not able to walk since then. Patient poor appetite since yesterday.  Patient had diarrhea 3 x 2 days ago.  No vomiting no fever no cough does not appear to be short of breath.  Patient also with left hip pain for few days with no injury.All history obtained from caretaker at bedside.
Patient received vaccine on 2/19 noticed rash on arm yesterday 2/25 did not report to pharmacy, reported today 2/26 because it was spreading to chest/trunk.  Was advised to take benadryl, told to report if still spreading and watch out for any other side effects and report to us.  Of course any difficulty in breathing or any more serious reactions to seek medical attention
large purple bruise which traveled down the arm and covered half of the upper arm with a little swelling
11/8/17-Employee received MMR subcutaneously left arm. 11/18/17-Itchy, hive-like rash presented on both arms. Took Claritin & Benadryl for relieve. 11/20/17-Employee made Employee Health aware; evaluated by doctor. Diagnosed with morbilliform eruption and advised to continue symptomatic care. No further MMR injections.
Severe hearing problem; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 89-years-old female patient received bnt162b2 (PFIZER COVID-19 vaccine, Formulation: Solution for Injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 20Mar2021 as DOSE 1, SINGLE for covid-19 immunization (Age at vaccination:88-Year-old). Medical history included none from an unknown date and unknown if ongoing. There were no concomitant medications. Caller stated, "I have a severe hearing problem. My husband and I got our first COVID-19 vaccine on 20Mar2021 and we are scheduled to get our second one on 20Apr2021 which is way over the 3 weeks that I have just read in our literature. So can you help me change. She wanted to reschedule it because it is past 21 days. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter. The vaccine was stored in freezer and the HCP had taken out 1 or 2 vials and place in the fridge each day as needed.
Symptoms and adverse events post vaccination include: Sudden onset of depression, mood changes, Anxiety, Anisocoria (unequal pupils), Pressure behind right eye, abdominal pain, lymph node swelling in armpits, groin, and neck, severe constipation, change in spine angle (rounded shoulders), sexual dysfunction, erectile dysfunction. Activation of previously dormant pathogens including Ehrlichia and Babesia.