chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She was given chickenpox vaccination and MMR.  Started with fever and she became jerky. She is now screaming about everything all day long, will not sit still for more then five minutes.  She no longer plays without screaming.  She reacts to small things all day long.  She is not the same child she has outburst of anger for no reason.  She asks for things when she already has them in her hand.  She seems to not be able to get comfortable at any time, seems frustrated and can't explain what is wrong.
5-8 hours after dose #3 and dose #4 of Rabies vaccine she started running fever 103 axillary. She C/O nausea both times. Child reported her throat felt tight and she had a headache. After reaction to dose #3, symptoms lasted close to 12 hours. She is now approx 14 hours after dose #4 symptoms have lasted about 14 hours and she still is feeling well.
Syncope; Excessive eye blinking; Fall; This case was received via on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), EXCESSIVE EYE BLINKING (Excessive eye blinking) and FALL (Fall). At the time of the report, SYNCOPE (Syncope), EXCESSIVE EYE BLINKING (Excessive eye blinking) and FALL (Fall) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Respiratory rate: increased (High) increased.     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 and treatment medications were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Body ache; Headache; Chill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 14May2022 at 14:00 as dose 1, single (Lot number: FM1553) at the age of 50 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LOSARTAN; ROSUVASTATIN. The following information was reported: PAIN (non-serious) with onset 15May2022 at 03:00, outcome "recovering", described as "Body ache"; CHILLS (non-serious) with onset 15May2022 at 03:00, outcome "recovering", described as "Chill"; HEADACHE (non-serious) with onset 15May2022 at 03:00, outcome "recovering". Therapeutic measures were not taken as a result of pain, headache, chills.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for Covid-19 since the vaccination.
Pt reports that she developed circular itchy rash over the back and the front of chest and trunk on 4/2/21 5 days after her vaccination .The rash also spread to the arms and upper leg .Pt also reports mild wrist pain with no swelling.  No headache or blurry vision or dizziness or any calf pain or any bruising noted .Vital stable Exam:  rash are multiple circular reddish and scaling visible  maculopapular lesions  and present over the back ,right neck ,front of chest and small spots on the left arm and the upper thigh .No pai n or fever  .
2nd dose not administered beyond 35 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose not administered beyond 35 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose not administered beyond 35 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose not administered beyond 35 days) 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 were reported.  No treatment medications were reported.
Itchy all over my body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy all over my body) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PRURITUS (Itchy all over my body). At the time of the report, PRURITUS (Itchy all over my body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Swelling throat / throat swelled; Itching over body; Dizziness; weak; Lip swelling; Tongue swelling; uvula swelling; Heart rate irregular; Throat discomfort; palpitations; larynx swelling; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Swelling throat / throat swelled), PRURITUS (Itching over body), DIZZINESS (Dizziness), ASTHENIA (weak) and LIP SWELLING (Lip swelling) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21AA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hives and Hay fever. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 03-Mar-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 11:45 AM, the patient experienced PHARYNGEAL SWELLING (Swelling throat / throat swelled), PRURITUS (Itching over body), DIZZINESS (Dizziness), ASTHENIA (weak), LIP SWELLING (Lip swelling), SWOLLEN TONGUE (Tongue swelling), ENLARGED UVULA (uvula swelling), HEART RATE IRREGULAR (Heart rate irregular), OROPHARYNGEAL DISCOMFORT (Throat discomfort), PALPITATIONS (palpitations) and LARYNGITIS (larynx swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 04-Mar-2021, PHARYNGEAL SWELLING (Swelling throat / throat swelled) and PRURITUS (Itching over body) had resolved. On 03-Jun-2021, DIZZINESS (Dizziness), ASTHENIA (weak), LIP SWELLING (Lip swelling), SWOLLEN TONGUE (Tongue swelling), ENLARGED UVULA (uvula swelling), HEART RATE IRREGULAR (Heart rate irregular), OROPHARYNGEAL DISCOMFORT (Throat discomfort), PALPITATIONS (palpitations) and LARYNGITIS (larynx swelling) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Heart rate: irregular Irregular.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant Follow up appended on 22-Jul-2021. Updated: Reporter, Patient (Allergies and Lab data), Product (For vaccine updated facility type and name and added concomitant drug), Event (added newevents and causality updated) and Narrative updated.
This is a spontaneous report from a contactable Other-HCP via Pfizer sales representative. A patient of unspecified age ethnicity and gender started received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization, HIB vaccine, via an unspecified route of administration on an unspecified date at an unspecified dose for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that pneumococcal 13-val conj vac (dipht crm197 protein) was given with HIB vaccine in same leg. Patient's leg swelled and got Hives. MA said this happened 5 years ago. Now gives vaccines in separate legs. The outcome of the events was unknown.
PATIENT IS SUFFERING FROM MIGRAINE WITH FLASHES OF LIGHTS, BODY ACHES AND PAIN, HIGH FEVER (104), AND SAID SHE WAS HAVING SENSORY ISSUES
Flu like symptoms; Muscle aches; Chills; Nausea; Eye swelling both eyes; Light headed; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eye swelling both eyes), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Light headed), MYALGIA (Muscle aches) and CHILLS (Chills) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced DIZZINESS (Light headed). On 12-Mar-2021, the patient experienced EYE SWELLING (Eye swelling both eyes). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Muscle aches), CHILLS (Chills) and NAUSEA (Nausea). On 20-Feb-2021, DIZZINESS (Light headed) had resolved. On 19-Mar-2021, EYE SWELLING (Eye swelling both eyes) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Muscle aches), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.            Concomitant medications included unspecified birth control medication.  Treatment details included steroids, not otherwise specified.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-019692 (Patient Link).
Severe right side parkinsonian hand tremor and right leg RLS. I ALREADY HAD MILD TREMOR. AFTER VAX BECAME SEVER
This spontaneous report was received from a medical assistant and refers to a 16 year old male patient. There were no concurrent conditions or medical history. Concomitant and historical drugs or vaccines were not reported. On 29-DEC-2017, the patient was inadvertently vaccinated with an expired dose of GARDASIL 9 dose 1, in the left deltoid, lot # L040054, expiration date 26-DEC-2017, for prophylaxis (strength, dose and route of administration were not reported). The medical assistant stated that the date marked on the box of GARDASIL 9 was incorrect, as it was marked as December 2017 (reported as "12/17"). No prescription drug treatment was required. No adverse effects were reported.
Fever; Chills; Sleepy; feels so so bad; pain in your arm; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot Number: ER8733), Solution for injection, via an unspecified route of administration, administered in Arm Left on 31Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were reported as none. On 31Mar2021, patient experienced pain in arm, on 07Apr2021, she had fever, chills, felt so bad and sleepy. It was reported that, patient got her vaccine last Wednesday, 31 MAR 2021, stated she felt so good and only a pain in her arm, stated last night, one week after the vaccine, around 2 or 3 in the morning she had a fever of 102 degrees and a lot of chills and felt so bad. Treatment took Tylenol and felt a little better. Wanted to also know if the second dosage safe for her. Therapeutic measures were taken as a result adverse events, Tylenol. The outcome of event sleepy was not recovered and outcome of all other events was recovering.
Information has been received from a 61 year old female patient with atrial fibrillation and allergy to DIFLUCAN, who on 03-NOV-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not provided) in the left arm. The patient also received a dose of influenza virus vaccine (unspecified) (Lot # not provided) on the right arm. Concomitant therapy included clindamycin, flecainide acetate, diltiazem HCL, generic simvastatin, vitamins (unspecified), magnesium (unspecified), vitamin B complex, calcium (unspecified), and "CIMUDEN" (therapy unspecified). The patient stated that after receiving the vaccine, by that evening she noticed itching, burning, and warmth on her left arm where the injection was given. The spot started out as quarter size and was not 6-7 inches long and 3-4 inches wide, and the redness was getting bigger. At the time of this report, the patient's outcome was unknown. The patient sought unspecified medical attention. Follow up information has been received from a physician concerning the female retired patient with dyslipidemia, chest pain, osteoarthritis and allergy to codeine who on 03-NOV-2010 at 10:40 was vaccinated SQ in the left upper with a first dose of ZOSTAVAX (Merck) (Lot # 665527/0696Z) (Expiration date: 21-APR-2011). The physician reported that the patient developed a rash patch over the site of injection which lasted for more than 1 week. The physician stated that the patient was treated conservatively. No further information is available.
the pain went over to his left upper chest.; it got really bad for the whole day; The left arm he received the vaccine was pretty sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The left arm he received the vaccine was pretty sore), FEELING ABNORMAL (it got really bad for the whole day) and CHEST PAIN (the pain went over to his left upper chest.) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011620A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced PAIN IN EXTREMITY (The left arm he received the vaccine was pretty sore). On 18-Jan-2021, the patient experienced FEELING ABNORMAL (it got really bad for the whole day). On 19-Jan-2021, the patient experienced CHEST PAIN (the pain went over to his left upper chest.). The patient was treated with IBUPROFEN at a dose of 800 mg. On 17-Jan-2021, PAIN IN EXTREMITY (The left arm he received the vaccine was pretty sore) had resolved. On 18-Jan-2021, FEELING ABNORMAL (it got really bad for the whole day) had resolved. On 19-Jan-2021, CHEST PAIN (the pain went over to his left upper chest.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Headache lasting at least 12 days (time of appointment scheduled) w/ sensation of "foggy" vision day after vaccine (that resolved after that).  Headache is improving, but not resolved at day 12, and was "excruciating" day after he received.
This spontaneous report as received from a pharmacist refers to a 72 year old patient. On 19-JUL-2013 the patient was vaccinated with ZOSTAVAX (lot number reported as J001729. expiry date 20-OCT-2013). The finished volume of a dose of ZOSTAVAX that the reporter administered to the patient was 0.1 ml. The pharmacist attempted to reconstitute the dose of ZOSTAVAX, she first penetrated the stopper the a syringe with 0.7ml of air. She realized her error, and then she used a second vial of diluent from which she aspirated 0.4 ml of diluent. She used that volume of diluent, 0.4ml, to reconstitute the dose of ZOSTAVAX for the patient. She described "shaking the vial' to assist the missing of the lyophilized ZOSTAVAX with the 0.4 ml of diluent, and when she attempted to aspirate the finished volume of ZOSTAVAX, the solution was "foamy and gel-like". The volume of the finished solution was 0.1 ml, which she administered to the patient. The pharmacist was certain that the patient received the live-virus vaccine because the injection site immediately became reddened. The pharmacist placed an adhesive bandage over the injection site and the patient had not reported any other adverse effects. PQC filed for the under filled diluent vial. No treatment was given for adverse events. The adverse events was unknown. This is one of several reports from same source. Additional information has been requested.
Painful muscle spasm; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (Painful muscle spasm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced MUSCLE SPASMS (Painful muscle spasm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Painful muscle spasm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Patient visited ER but doctor did not seem to understands her. Muscle spasms are still ongoing.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Left side of face swollen, eyelid and nose; Left side of face swollen, eyelid and nose; Left side of face swollen, eyelid and nose; Under arm swollen knot; bad rash under arm; headaches; tiredness; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female non-pregnant patient received bnt162b2 (BNT162B2) formulation solution for injection, unknown (Lot Number: EN6202 expiry date was unknown) via an unspecified route of administration at arm left on 01Mar2021 15:00 as a single for covid-19 immunisation. The patient medical history and concomitant medication(s) included losartan, simvastatin, amlodipine. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient experienced 05Mar2021 06:00 left side of face swollen, eyelid and nose. Under arm swollen knot, bad rash under arm, headaches, and tiredness. Outcome of the events was unknown.    No follow-up attempts are needed. No further information is expected
Bleeding starts 1 day after dose given; large blood in urine output at night; increased lethargy; WBC and Hgb drop; WBC and Hgb drop; This is a spontaneous report from a contactable consumer (the patient). The consumer reported similar events for herself with two doses. This is the second of two reports. A 53-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0161) via an unspecified route of administration, administered in Arm Left on 21Apr2021 10:15 at age of 53-year-old at single dose for COVID-19 immunisation. Medical history included PNH anemia since 2006 and known allergies: Latex, sulfamethoxazole trimethoprim (BACTRIM). The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Concomitant medications (received within 2 weeks of vaccination) included iron, cyanocobalamin (VITAMIN B12) and one a day women vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Er8732) via an unspecified route of administration in left arm on 26Mar2021 10:15 AM at age of 53-year-old for COVID-19 immunisation. Minor side effects after first dose but did have some spotting blood in urine at night. Told MD and was told to proceed with dose 2. After second dose on 22Apr2021 23:00, large blood in urine output at night and increased lethargy. Bleeding starts 1 day after dose given. Lasted less than 1 week but white blood cell (WBC) and haemoglobin (Hgb) decreased/drop (22Apr2021). The events resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The outcome of the events was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021529122 same patient/drug, similar AE, different dose of vaccine
This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. Nurse reported that on 21-SEP-2016, the patient was vaccinated with an unspecified flu vaccine and intramuscular GARDASIL 9 (lot # L043214, expiry date: 30-AUG-2017). She reported that after the administration of vaccines, the injection site was wet and looked like it oozed out. No adverse effect was reported. Additional information has been requested.
redness at injection site; soreness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age group of the patient was not reported, but taken as an adult as per vaccine indication. The reporter reported that, a lot of patients experienced soarness and redness at the injection site after vaccination. No specific patient demographics provided.
After receiving the shot, experienced a sore arm that same night.  This soreness increased the next day, and then subsided on the evening of the 2nd day. On the afternoon of the 2nd day (5/13) I began experiencing fatigue, stuffy nose, foggy brain, difficulty concentrating, unusual irrational fears. On Friday (5/14) I felt less tired but still foggy,  with difficulty concentrating/thinking clearly, continuing irrational fears.  I also began experiencing urinary incontinence (as though I had no bladder muscles). At approximately the same time my fingernails began to crack and peel; during subsequent week every one of them cracked and peeled. It took several weeks to gradually return to feeling normal again and for my nails to begin growing back.