chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 22-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 14May2021 11:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included asthma, rocky mt spotted fever, MRSA, sepsis x2, mono (monocytes) from an unknown date. The patient's concomitant medications were none. No other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The patient received first dose of bnt162b2 on 23Apr2021 for covid-19 immunization at 22-year-old. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has been tested for COVID 19. The patient experienced Anaphylaxis, swollen closing throat,sob, wheezing, itching, dizziness on 14May2021 11:45. The adverse event result in Emergency room/department or urgent care. Therapeutic measures were taken as a result of all the events, treatment included Epi,Prednisone,Benedryl, IV. The outcome of the events was recovering.  Information about lot/batch number cannot be obtained. Additional information has been requested.; Sender's Comments: Based on the known safety profile of the drug and plausible temporal relationship, a causal association between the event of Anaphylactic reaction and suspect drug BNT162B2 cannot be excluded
Information has been received from a pharmacist concerning a 16 year old female with penicillin allergy and a history of Guillain-Barre syndrome and autism who was vaccinated with a first and second dose of VARIVAX (Merck) 0.5ml subcutaneously on 04-APR-2006 (lot number: 659529/1590U) and 08-APR-2008, respectively. Concomitant therapy included CELEXA and gabapentin. The patient developed generalized pain, agitation, urinary retention and urinary frequency about 10 days after receiving a dose of VARIVAX (Merck) on 08-APR-2008. The patient's generalized pain, agitation, urinary retention and urinary frequency persisted. No other information was available at this time. Follow-up information has been received from a consumer concerning her daughter with penicillin allergy and a history of Guillain-Barre-like syndrome in fall 2007 and autistic who on 08-APR-2008 was vaccinated with VARIVAX (Merck) (route not reported). Concomitant therapy included CELEXA, gabapentin, RISPERDAL, ZANTAC and MOTRIN. After receiving the vaccine the patient experienced behavioral changes, extreme sensitivity touch and pain. She was unable to tolerate wearing clothes, refused to get in her wheelchair, and would not get out of bed. She would not allow anything to touch her skin. She also had an increase in her heart rate and blood pressure which required medication. She was unable to move her extremities or trunk area. She experienced increases in her urination frequency but with small amounts of urine each time. She was unable to have a bowel movement and would "dig out her feces". She was eating most foods but receiving medication via gastric feeding tube prior to receiving her second dose of VARIVAX (Merck). After receiving second dose of VARIVAX (Merck) she refused to eat. She had to be transported twice by ambulance to the hospital because of problems with the gastric feeding tube but was not admitted either time. The first dose of VARIVAX (Merck) was administered when she was younger but the date was not known. Presently the patient's symptoms have improved except for her lower legs and feet. Follow-up information received from the pharmacist indicated that the patient also had a medical history of asthma, anxiety and polyneuropathy acute inflammatory demyelinating. The patient's mother noticed that the patient refuse to wear her diaper and clothes a few weeks after vaccination. The patient would only sleep without sheets. The patient's psychiatrist started treating the patient for nerve pain and the patient's mother thought the patient was in pain. The patient developed rash on body looked like chickenpox. The patient's rash was not reported to the physician. The patient still had rash on buttocks and thighs and under arm going down toward waist with red marks. Per the mother, she was unable to lift the patient or get her in her wheelchair. The patient did not recover. Additional information is not expected.
Pt came into the pharmacy on 2-12-2007 said her arm is still sore/limited movement without pain-right arm where injection was given. Arm before injection was fine after injection - maybe next day stiff & sore - never got better but we did not hear from patient until the date of report. Sorry to be so vague on onset.
My arm became swollen when I got the shot and was extremely painful and lasted for weeks, it was even painful to move the fingers. It would even wake me up in the night because it was so painful. The doctors ran test and haven't found anything wrong. It is still painful to the touch. All of the pain is isolated in the arm where I got the vaccine.
hives on my knees; light sensitivity; concentration difficult throughout experience; felt very dizzy; Knees swollen; neck discomfort; headache; area swollen from nose to chin; sore injection site,; fatigue; foggy during day; felt my heart beating hard within 5 minutes of vaccine; my lips were numb; I felt a little trouble swallowing.; Had chills; had swelling around lips/mouth; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no : ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 11:300 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. The patient had no Medical history. Concomitant medications included with supplements. The patient previously received Sulpha Drugs on an unknown date for unspecified indication and experienced a  sulfonamide allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 11:00, the experienced heart beating hard within 5 minutes of vaccine and her lips were numb and she felt a little trouble swallowing, and had chills, and had swelling around lips/mouth. On 25Mar2021, the Patient experienced area swollen from nose to chin and Had headache, sore injection site, fatigue, foggy during day. On 26Mar2021, the patient experienced Fatigue and neck discomfort. On 27Mar2021, the patient experienced very dizzy, Knees swollen and Could not sleep on injection site. On 28Mar2021, the experienced hives on her knees, Light sensitivity and concentration difficult throughout experience.  The patient underwent lab tests and procedures, which included Blood pressure on unknown date and resulted normal. The patient called clinic for instructions and receive Benadryl for lips numbness, heart beating hard, trouble swallowing and chills. Patient had called doctor and awaited to call back. The clinical outcome of felt heart beating hard, numb lips, trouble swallowing, chills, area swollen from nose to chin, headache, fatigue, foggy during day, neck discomfort,  dizzy, swollen knees, hives on knees, light sensitivity and concentration difficult was not recovered and of the vaccination site pain was recovered on 26mar2021.   No follow-up attempts are possible. No further information is expected.
Diarrhea started 1 day after getting Gardasil vaccine, associated with abdominal pain and possible bloody stool. Seen at urgent care on 2/29/08 (same address as above)
Vaccine was expired on 13-Aug-2022 and was stored in refrigerator after expiration; No adverse event; Vaccine was expired on 13-Aug-2022 and was administered on 06-Sep-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was expired on 13-Aug-2022 and was stored in refrigerator after expiration), EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-Aug-2022 and was administered on 06-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (unspecified COVID-19 vaccine Dose 1), COVID-19 Vaccine (unspecified COVID-19 vaccine Dose 3, 1st Booster) and COVID-19 Vaccine (unspecified COVID-19 vaccine Dose 2). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 Vaccine and COVID-19 Vaccine.    On 06-Sep-2022 at 2:34 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Sep-2022 at 2:34 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-Aug-2022 and was administered on 06-Sep-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 13-Aug-2022 and was stored in refrigerator after expiration) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was expired on 13-Aug-2022 and was stored in refrigerator after expiration), EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-Aug-2022 and was administered on 06-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Vaccine was expired on 13-Aug-2022 and was stored in refrigerator after expiration) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-Aug-2022 and was administered on 06-Sep-2022).    No concomitant medications were reported.   The vaccine was delivered and placed into the freezer on 18-Apr-2022. The vial size was reported as 5.5 ml. Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). Therefore, for administration on 30-Aug-2022 vial was placed into refrigerator on 29-Aug-2022. The vial did not undergo any temperature excursion.   No treatment details were reported.
could not walk; very weak; no appetite; On 01Mar2021, patient received 1st dose/On 18Apr2021, patient received 2nd dose COVID-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4195685-00 (RA).  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 05Apr2021 (Batch/Lot number: unknown) at the age of 55 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at cf[citrate free] for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Route of Administration: Intramuscular), administration date: 12Mar2021, when the patient was 54 years old, for COVID-19 immunization, reaction(s): "Felt like Humira was not working", "Feel hot", "Feeling sick", "Inflammation was getting bad", "Injection site hurt", "drug ineffective". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Apr2021, outcome "unknown", described as "On 01Mar2021, patient received 1st dose/On 18Apr2021, patient received 2nd dose COVID-19 Vaccine"; GAIT DISTURBANCE (non-serious) with onset Nov2021, outcome "not recovered", described as "could not walk"; ASTHENIA (non-serious) with onset Nov2021, outcome "not recovered", described as "very weak"; DECREASED APPETITE (non-serious) with onset Nov2021, outcome "not recovered", described as "no appetite". The action taken for adalimumab was unknown.  Additional information: The patient received booster dose on 12Dec2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
screaming & 4 1/2 hrs; vomited x 1; by time of phone call looked fine but tired. Has had  problems with pyloric stenosis improved also with dyspnea. She then required surgery but can't ? problems.
Headaches. Dizzy. Chills. Leg cramps. Heavy chest. Breath shortness
Discharge Provider: DO Primary Care Provider at Discharge: MD  Admission Date: 9/26/2022 Discharge Date: 10/4/2022   PRESENTING PROBLEM: Hypoxia [R09.02] Hypervolemia, unspecified hypervolemia type [E87.70] COVID-19 [U07.1]   HOSPITAL COURSE: 82-year-old gentleman presents with a 10 day history of nausea vomiting and diarrhea.  Patient with very poor oral intake.  He also has a non productive, dry, hacky cough.  Denies any shortness of breath.  Patient noted some dizziness and had a fall while at home.  Because of persistence of his symptoms and developing dizziness patient was concerned about dehydration so came to the emergency department.  Workup in the emergency department was positive for COVID 19. Patient did have some hypoxemia which was transient in the emergency department which has since resolved.  Currently patient is on room air.  Patient was outside the window for remdesivir.  Chest x-ray does not have significant abnormalities.  Today patient is doing better.  No diarrhea since presentation.     Patient's oxygenation remained stable throughout hospitalization.  He was maintained on 2 L per nasal cannula it was eventually weaned she to off.  Patient's diarrhea was slow to resolve.  He did have a short course of vancomycin pending culture results.  Patient did not produce sample that could be tested for C difficile, because of improvement stools patient's oral vancomycin was discontinued.  There is no evidence of C difficile at this time.  Patient also still required intermittent oxygen.  With volume resuscitation patient started exhibiting signs possible congestive heart failure.  He was placed on IV diuretics with good results.     Patient also complained of knee pain during hospitalization.  Orthopedics was consulted and He underwent a left arthrocentesis.  It was consistent with a gouty arthritis.  Patient was given a short course of steroid with good results.       Patient was evaluated by Physical therapy and Occupational therapy who recommended home health care.  Patient underwent oxygen study on the day of discharge.  He qualified for oxygen with activity.
This spontaneous prospective pregnancy report was received from a registered nurse, via a company representative, referring to a 16 year old female patient. No pertinent medical history, concurrent conditions or drug reaction/allergies were reported. On an unknown date, the patient was vaccinated with VARIVAX, subcutaneous, (dose, frequency, lot # and expiration date were not provided), and the patient was pregnant (exposure during pregnancy) which is other-than-indicated in the Prescribing Information (contraindicated drug administered).
Patient received 3 shots on 09/25/2003.  1 on left deltoid was DPT and IPV, the other arm was MMR. Next day 9 AM 09/20/2003, patient had appointment with provider for local reaction of vaccine on left arm.  Was hard and warm to touch.  Patient was treated with Compresses and Zithromax 100mg/5mL for 10 days, returned check on 10/07/2003 left arm swollenness , but much better.
Pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Jun-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) 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 reported by investigator No treatment medications provided by the reporter.  This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Information has been received from a nurse concerning unspecified patients of unknown age and gender. On unspecified dates, the patients were administered with GARDASIL (dose and route not provided, lot# K011325 with expire date of 08-APR-2017, K010215 with expire date of 05-MAY-2017, L040459 with expire date of 06-APR-2017), which was exposed to temperatures outside of the recommended range (incorrect product storage). The conditions storage was 11 Celsius degree for 1333 hours, 41 minutes. There was no previous temperature excursion. No adverse effects have been reported. Additional information has been requested.
Noticed Raised, warm, itchy spot about size of sand dollar on 9/11/2013. Also had some chills and slight headache. Headache went away and came in to see doctor on 9/12.  No treatment.
aching rt upper arm couldn't straighten arm then today red, swollen to elbow, warm to touch; 4NOV93 sx gone;
I took off the band-aid and the injection point was in my small pox scar and fluid ran down my arm. I didn't receive the full injection of the vaccine. Eight days later, I had the superficial reaction to the area. I called the Health Department and was told there was no protocol from the CDC for the situation when the full injection is not given.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 09-JUL-2018 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # N030965, exp date 25-AUG-2019) (dose not reported) orally. There was a data logger issue reported. The temperature of excursion was 32 degrees F up to 35 degrees F (multiple excursions) for a time frame of 13 hours. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1807USA004813; US-009507513-1807USA010173; US-009507513-1807USA010174; US-009507513-1807USA010175; US-009507513-1807USA010176; US-009507513-1807USA010178; US-009507513-1807USA010214.
Patient received both a pneumovax and influenza injection on 10/21/08, The influenza vaccination was given in patient's right arm, and the pneumovax in the left. Patient is now reporting that since the pneumovax injection in her left arm, some 5 months ago,she has been experiencing persistant neural pain.
vaccine given subcutaneous in Buttocks; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) subcutaneous in buttocks site(Product administered at inappropriate site ).      The patient's medical history not provided.  On 19th JAN 2021 onset of the events, the patient received their one of two planned doses of mRNA-1273 subcutaneous in buttocks site and HCP wants to know what to do.      On 20th JAN 2021, Agent called back HCP at 12:55pm on 20Jan2021 and was unable to reach. Submitting AE with limited info.    Treatment has not provided.   Action taken with mRNA-1273 in response to the events was not reported.     On 20th JAN 2021, the outcome of the event Product administered at inappropriate site is Resolved.; Reporter's Comments: This report refers to a case of Product administered at inappropriate site for mRNA-1273, lot # unknown with no associated AEs.
Nodule; Inflammation localised; Armpit pain; lymph nodes still swollen/ lymph nodes on left side remained swollen; lymph nodes still swollen and sore; This spontaneous case was reported by a patient and describes the occurrence of NODULE (Nodule), INFLAMMATION (Inflammation localised), AXILLARY PAIN (Armpit pain), LYMPHADENOPATHY (lymph nodes still swollen/ lymph nodes on left side remained swollen) and LYMPH NODE PAIN (lymph nodes still swollen and sore) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 025B21A) for COVID-19 vaccination.     The patient's past medical history included Oophorectomy bilateral (removal of one ovary at the age of 40). Concurrent medical conditions included Tumor and Hot flashes (every 7 minutes began after removal of one ovary). Concomitant products included ESTROGEN NOS;PROGESTERONE;TESTOSTERONE from 01-Sep-2004 to an unknown date for Hot flush, Hormone replacement therapy and Oophorectomy.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NODULE (Nodule), INFLAMMATION (Inflammation localised), AXILLARY PAIN (Armpit pain), LYMPHADENOPATHY (lymph nodes still swollen/ lymph nodes on left side remained swollen) and LYMPH NODE PAIN (lymph nodes still swollen and sore). At the time of the report, NODULE (Nodule) had resolved, INFLAMMATION (Inflammation localised) and AXILLARY PAIN (Armpit pain) outcome was unknown and LYMPHADENOPATHY (lymph nodes still swollen/ lymph nodes on left side remained swollen) and LYMPH NODE PAIN (lymph nodes still swollen and sore) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   laboratory data included - ultrasound scan was done, Patient denied mammography suggested by physician as it was not covered in the medical insurance.  Patients lymph nodes on left side remained swollen and sore even still.  No treatment medication was provided.   This case was linked to MOD-2021-074756.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant followup: Reporter details added, Events added as lymph nodes were still swollen/ lymph nodes on left side remain swollen, lymph nodes were still swollen and sore.
High fever, muscle aches, headache, chills, hot flashes dizziness, extreme fatigue. This was my 3rd Moderna dose. The first two doses (February 18, 2021 and again on March 18, 2021) did not affect me at all.
Patient received H1N1 nasal mist on 12/7/09.  He felt fine that day was when he went to work on 12/08/09 he had a syncopal episode, falling and hitting his head on the wall.