chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Improperly stored vaccine adminstration; shipment was received a day late; This spontaneous report was received from a an administrator via a field representative referring to a 66 years old female patient. Information about concurrent condition, concomitant medication, medical history, drug reactions or allergies was unknown.   On 22-OCT-2020, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shipment was received a day late (expected arrival date was 21-OCT-2020, product shipment delay) to the reporter's practice, they were not viable for use, and someone in the office mistakenly placed them in the vaccine fridge (confliction information: the box of vaccines got placed into a refrigerator at recommended storage range once received).   On 27-OCT-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # T020638, expiration date 26-FEB-2022; route was not reported) for prophylaxis (improper storage of product in use).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020638; expirationdate: 26-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2011USA015360: US-009507513-2011USA015361: US-009507513-2011USA015362: US-009507513-2011USA015359: US-009507513-2010USA011251: US-009507513-2011USA015357: US-009507513-2011USA015358:
pt recv vax;devel neck pain & HA at 3pm; knee, ankle swelling at 6pm;elbow pain & swelling 9pm; wrist pain 3am;had gene weakness cont; pain intermittent; tx w/ advil, heat;
Panic attack, vomiting for 10 hours, vision disturbance, auditory and visual hallucinations, fearfulness, insomnia.
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 23-MAY-2016, the patient was vaccinated with a dose of improperly stored GARDASIL or GARDASIL 9 with lot number K010215 and expiration date of 05-APR-2017 (dose, route of administration and anatomical location were unknown), which was stored at the lowest recorded temperature of 34 (1.111111111 Celsius degrees) for 544 hours and at the lowest recorded temperature of 32 (0 Celsius degrees) for 168 hours. The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
My body hurt, I had fatigue, my tongue felt funny, I had numbness and tingling in my left arm and hands. Later on I started noticing headaches and blurry vision. I could barely hold my urine. I went to the doctor and they told me my sugar was high thats why I couldn't hold my urine and I never had these problems.
had a rash to the side of the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site rash. The patient was treated with topical steroid nos (Steroid Cream) and cetirizine (Zyrtek). On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient stated that the physician suggested that patient should pick up the injection and bring it to the physician's office for them to administer, but the pharmacy said they had to administer it. In September 2020, the patient received 1st dose of Shingrix and after the injection patient had a rash to the side of the injection site. The patient went to the physician and they prescribed a steroid creme and said to take Zyrtek. Patient's 2nd dose would be due in a couple of weeks and patient wondering if it would be okay to get the 2nd dose at the pharmacy since patient had a rash after the 1st dose.
Patient had a syncopal event with fall, no injury, the morning after she received the vaccine.
mild vaginal bleeding. started the day after vaccine #1.  appeared to be a light period though unusual since I have mirena IUD. Resolved after 3 days.  no medical care was required.   no other signs of bleeding/bruising.
An initial report was received in the USA from a health care provider on Jul 20 2005. An 18 year old male patient felt feverish but no temperature was taken after he had received his first dose of Menactra, lot # U1657AA intra muscularly in the left deltoid. He also experienced profuse sweating. The date of vaccination and onset of reaction was not reported. He took ibuprofen and the symptoms resolved. Follow up information received on Aug 10 2005. The patient had received Menactra on the left deltoid on Jul 18 2005 at 11:30 am and the onset of reaction was on Jul 19 2005 at around 8:30am. It was unknown if the patient received any other medications. No further information is awaited. The case is closed.
loss of appetite/maybe due to depression/decreased appetite persisting; numbness of the left hand; sore arm (injection arm ); joint pain at the wrist/joint pain at the fingers; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite/maybe due to depression/decreased appetite persisting), HYPOAESTHESIA (numbness of the left hand), VACCINATION SITE PAIN (sore arm (injection arm )), ARTHRALGIA (joint pain at the wrist/joint pain at the fingers) and FATIGUE (fatigue) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included Depression since an unknown date.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm (injection arm )), ARTHRALGIA (joint pain at the wrist/joint pain at the fingers) and FATIGUE (fatigue). On 14-Apr-2021, the patient experienced DECREASED APPETITE (loss of appetite/maybe due to depression/decreased appetite persisting). 14-Apr-2021, the patient experienced HYPOAESTHESIA (numbness of the left hand). At the time of the report, DECREASED APPETITE (loss of appetite/maybe due to depression/decreased appetite persisting) had not resolved and HYPOAESTHESIA (numbness of the left hand), VACCINATION SITE PAIN (sore arm (injection arm )), ARTHRALGIA (joint pain at the wrist/joint pain at the fingers) and FATIGUE (fatigue) outcome was unknown. loss of appetite may be due to depression patient was undergoing.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications are not provided by the reporter. No treatment drugs are not provided by reporter.    This case was linked to MOD-2021-147816 (Patient Link).
vasovagal response occurred beginning at 20 minutes following injection. Patient experienced high heart rate, dizziness, feeling like about to faint, numbness in throat. Symptoms subsided when lying down. Stomach pain began at 30 minutes following injection when sitting up.
large blister to front half of scalp; itching to front half of scalp; Started to have small swelling nodes in the scalp; Started to have small swelling nodes in the scalp; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL1284), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history included allergy to dust, runny nose and blood pressure. The patient's concomitant medications included fexofenadine hydrochloride (ALLEGRA) for allergy to dust and runny nose, patient also took some medicines to control blood pressure. It was reported that the patient experienced large blister and itching to front half of scalp. The clinical course was as follows. He took the vaccine on last Monday 11Jan2021, and three days later (14Jan2021) that blisters appeared in his scalp. He noticed when he woke up the morning on his front half was a large blister and itching. He wanted to know if it is a reaction and what should he do. The physician looked at him and gave prednisone to take for 5 days. Blisters were gone. Three days after the vaccine (14Jan2021), patient started to have small swelling nodes in the scalp. Patient had about two or three nodes in his scalp. Patient didn't have a fever. Due date of second shot was 01Feb2021. Patient had lab test once in a month and everything was okay. No problem. For treatment in response to event small swelling nodes in the scalp: patient stated no, he was taking fexofenadine hydrochloride. Patient just took it by himself it was an anti-allergic. Patient normally take if he has allergy to dust or a runny nose. The outcome of blisters to front half of scalp was recovered in Jan2021, and for other events was unknown. No investigation assessment.  Information on the lot/batch number has been requested.  Follow-up (17Jan2021): New information reported from a contactable consumer (patient) includes: patient details, medical history, concomitant medications, lab data, new events (add small swelling nodes in the scalp).
Two days after my first dose i noticed a metallic taste in my mouth and smell in my stools.  I also noticed that I was unable to taste certain things and what i was able to taste had this iron taste to it.  I'm unable to smell certain things that are in front of me. all of these symptoms i was told would go away after a few days and it's been MONTHS and i am still being affected.  My next menstrual cycle after my second dose came normal but then i had a second cycle the same month and it's continued that way. I've been having two cycles each month which is very abnormal for me.
Lingering cough; Felt sick; Tested positive for COVID-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (Lingering cough), ILLNESS (Felt sick) and COVID-19 (Tested positive for COVID-19) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced COUGH (Lingering cough), ILLNESS (Felt sick) and COVID-19 (Tested positive for COVID-19). On 30-Mar-2021, ILLNESS (Felt sick) and COVID-19 (Tested positive for COVID-19) had resolved. At the time of the report, COUGH (Lingering cough) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, SARS-CoV-2 antibody test: Positive.     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 provided. No treatment information mentioned and Medical history was not provided
Since approximately March 30 (1 day after the first dose) I have had loud tinnitus in both ears, insomnia, palpitations, numbness of arms, hands and face, trembling in the hands. I went to the doctor and they did not detect anything abnormal regarding the ears and hearing. I began to take melatonin to sleep with little improvement, I have been in treatment of tinnitus with acupuncture and it is not relieved, these symptoms continue to persist from the application of the first dose.
Strong stomach cramps leading to diarrhea, about 5 instances, followed by strong stomach cramping with blood clotting discharge with 9 instances,  lasting about 16 hours, with the clotting reducing each time
12 hours after vaccine ran 103 temp ,chills, severe joint pain, sever muscle, dizziness, fever lasted about 29 hours. ran low grade temp and still joint pain for about 6 hours. had some nausea for most of the 36 hours
a titer showing that the patient does not have antibodies; This spontaneous report was received from a pharmacist and refers to a 42-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On unknown dates in 2012, the patient was administered two doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, for prophylaxis (exact dose, route of administration, injection site, lot # and expiration date were not provided).  On an unknown date, a titer showed that the patient did not have antibodies (antibody test negative). Due to the event, the patient's doctor would like for him to receive another dose of varicella virus vaccine live (oka/merck) (VARIVAX). It was unknown if the patient was treated for the event. At the time of the report, the outcome of the event was unknown.  The causal relationship between the event and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided by the reporter.
mom reported pt became cranky then unresponsive about 4 hrs p/vax; passing out, vomited, limpness, & paleness; took to ER around 10PM w/labored breathing; given APAP; was better next day;
severe rash; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH (severe rash) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (severe rash). At the time of the report, RASH (severe rash) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Treatment medications were not reported.
Information has been received from a registered nurse concerning a 22 year old female with asthma who in January 2007, was vaccinated with a 0.5 mL dose of Pneumovax 23.  The patient was concomitantly vaccinated with a dose of Vaqta (manufacturer unknown) in a different injection site.  On 16-JAN-2007, the patient developed a 2 cm circle of cellulitis around the injection site, muscle wasting, and a high fever.  On 17-JAN-2007, the cellulitis grew to a 9 cm circle, and the patient could not lift her arm.  The patient was treated with oral antibiotics since the patient was not septic as of the morning of 17-JAN-2007.  At the time of this report, the patient was still being treated and had not recovered.  Additional information has been requested.
TWO BLOOD CLOTS; LEFT CALF PAIN FOR A COUPLE OF DAYS/FELT LIKE MUSCLE STRAIN; This spontaneous report received from a patient concerned a  male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: unknown) dose was not reported, 1 total, administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 25-MAY-2021, the patient experienced left calf pain for a couple of days which the patient believed that it was a muscle strain and was increasingly painful. On 28-MAY-2021, the patient was sent to the hospital to do an ultrasound and the HCP (health care professional) suggested for the patient to go to the emergency room visit because the patient had two blood clots. On 28-MAY-2021, the patient was hospitalized and was discharged on 28-MAY-2021. The patient was hospitalized for 1 day.  Laboratory data included: Diagnostic ultrasound (NR: not provided) 2 blood clots. On the day of reporting, it was informed that the patient was taking treatment medications (dates unspecified) which included: Eliquis (apixaban) for blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from two blood clot, and the outcome of left calf pain for a couple of days/felt like muscle strain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210601553-covid-19 vaccine ad26.cov2.s - two blood clots in patient. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
After vaccinated period radically changed in length, duration and severity. Was very regular prior, but after both vaccines my first period arrived suddenly, much heavier and a lot more tissue for 3 days (instead of 5), my next period arrived 11 days later and also very heavy with a lot more tissue/clots, and my period now started 20 days after and much stronger cramping.
dose_number=3; Fever; chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 29Nov2021 (Lot number: FF8839) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "dose_number=3"; PYREXIA (non-serious) with onset 29Nov2021, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 29Nov2021, outcome "unknown", described as "chills". Therapeutic measures were not taken as a result of immunisation, pyrexia, chills.  Additional information: The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 Prior to vaccination. Since the vaccination the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
First dose of Pfizer vaccine was given 8/30/21.  Second dose of Pfizer vaccine was given on day 15 instead of 21.
Information has been received from a health professional concerning a 5 year old male student with a delayed delivery who on 27-AUG-2009 at 10:00 am, was vaccinated with the second dose of MMR II (Lot number: 664364/0707Y) subcutaneously in the right thigh. On 27-AUG-2009 at 11:00 am, the patient experienced a systemic reaction; hives and facial swelling. The patient required a visit to his physician and the symptoms were treated with oral BENADRYL. At the time of the report, the patient status was unknown. Upon internal review systemic reaction was considered an other important medical event. Additional information has been requested.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 25-FEB-2015 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, lot # J013452, subcutaneously which was expired (expiration date 24-JAN-2015). The dose was supported. No adverse experience was reported. Additional information has been requested.
Right Upper arm 5in x 4 in red ring around injection site.  None tender, mild bruising at injection site.
This spontaneous report was received from a medical assistant, referring to a 19 month old patient of an unknown gender. The patient's medical history, concurrent conditions or concomitant medication were not reported. On 08-JUN-2018, the patient was vaccinated with improperly stored doses of Oka/Merck VARIVAX lot # N024568, expiration date 07-SEP-2019 or lot # N029631, expiration date 23-OCT-2019, for prophylaxis (dosage information and route of administration were not informed). Other suspect therapies included MERCK STERILE DILUENT lot # M029682, expiration date 12-JAN-2019. No adverse effects were reported. It was also reported that the temperature and time frame were -14°C to -10°C (-12.7°C) for 20 minutes. There was no previous temperature excursion. A "data logger" was involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1806USA012318: US-009507513-1806USA012317: US-009507513-1806USA005053: US-009507513-1806USA012316.
Dizziness and drunk feeling after 3 hours, shortness of breath after 13 hours
Pfizer-BioNTech COVID-19 Vaccine EUA: Injection site/right bicep pain 36 hours; tiredness 12 hours; feeling unwell 12 hours. No treatment sought.
glands under his neck are hard and swollen; tired; Irritable; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administration date Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 17Mar2021, outcome "unknown", described as "tired"; IRRITABILITY (non-serious) with onset 17Mar2021, outcome "unknown", described as "Irritable"; LYMPHADENOPATHY (non-serious) with onset 18Mar2021, outcome "unknown", described as "glands under his neck are hard and swollen".  No follow-up attempts are possible. No further information is expected.
Patient was crying; This spontaneous case was reported by a consumer and describes the occurrence of CRYING (Patient was crying) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CRYING (Patient was crying). At the time of the report, CRYING (Patient was crying) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medication was not reported.  Treatment information was not provided.  The reporter stated that mother had side effects a month later but was not aware for whom she was crying for.   This case was linked to MOD-2021-317744 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Upon internal review on 12-May-2022, significant correction was performed. The country of incidence was updated from unknown to the, suspect product was recoded, added reporter details and narrative was updated accordingly.