chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Subsequent to one dose of varicella virus vaccine live the pt presented with irritability and wobbling. It was noted that the pt was unable to walk. The pt was diagnosed with cerebellar ataxia.
Patient with 3 COVID Moderna vaccinations admitted COVID detected test.  Provider d/c note below:  "78 YO male history of chronic obstructive pulmonary disease, hypertension, sleep apnea, Parkinson's disease, recent COVID infection presented with weakness and confusion.  Patient subsequently admitted for evaluation and management of acute toxic, metabolic encephalopathy.   During his hospitalization stay, who suspected that his encephalopathy is stemming from recent COVID infection, worsening dementia in association with his Parkinson's disease and also medication induced from recent ropinirole increased.  Psychiatry was consulted who started patient on Zyprexa and decrease his dose of ropinirole.  He was also reported to have urinary retention with bilateral moderate hydronephrosis that resolved post Foley placement.  His encephalopathy has resolved after Zyprexa, decreased ropinirole dose and resolution of his urinary retention.  He will be transferred to Rehab. "
The patient received Td-112 on 5/9/2005, and came back to the doctor's office on 5/11/2005 complaining of redness and swelling at the injection site, and two red bumps also at the injection site. He also had the following systemic reactions: chills, body aches, headache, and fatigue. These reactions began early in the morning on 5/10/2005. Follow-up information received May 17, 2005: The patient's arm was sore until 5/14/2005, but is now better; all of his systemic symptoms have resolved. He also said that the redness and swelling and the two red bumps on his arm are gone, and he feels fine.
No adverse event; the patient was inadvertently administered a dose of varivax that had been improperly stored; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions and allergies were not reported.      On 10-MAR-2020, the patient was inadvertently administered an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (product storage error) lot # S021322 and expiry date 09-JUL-2021 for prophylaxis (strength, route, anatomical location not reported). The vaccine was reconstituted with properly stored sterile diluent (lot # and expiry date not reported). The time frame for multiple temperature excursions was -8.3 degrees celsius (°C) for 24 minutes. It was unknown if any previous temperature excursion was done. Data logger was involved. No adverse effects reported. No product quality complaint was involved in this report.
MUSCLE ACHES; STORED OUTSIDE OF THE RECOMMENDED TEMPERATURE RANGE; OUT OF SPECIFICATION PRODUCT USE; MINOR REACTIONS; This spontaneous report received from a pharmacist concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received with covid-19 vaccine ad26. cov2. S (dose number in series: 1), (suspension for injection, route of admin not reported, batch number: unknown, and expiry: unknown) dose was not reported, 1 total, administered on 21-MAY-2021 for prophylactic vaccination.  On an unspecified date, following administration of covid-19 vaccine ad26.cov2.s, the patient experienced muscle ache (dose number in series: 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2), (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: unknown) dose was not reported, 1 total, administered on 10-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-DEC-2021, vial was stored outside of the recommended temperature range which is incorrect product storage (dose number in series 2), 2 doses were drawn from vial and placed back in the fridge then the next day another 2 doses were drawn from that and 1 of the dose was given to the patient which is out of specification product use (dose number in series: 2). In DEC-2021 (unspecified date), following administration of covid-19 vaccine ad26.cov2.s the patient experienced minor reactions and muscle aches (both events dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stored outside of the recommended temperature range, muscle aches, minor reactions and out of specification product use was not reported. This report was non-serious. This case, involving the same patient is linked to 20211233937. This case, from the same reporter is linked to 20211233321 and 20211233061.
Inside of arm (elbow to armpit) and left side of body with hives and itching.  Have been using medicated powder to stop itching.
dizziness.  muscle spasms and pain not relieved with rest/tylenol or ibprophen.  short of breath on exertion.
Patient started having substernal chest pain non radiating at first. After 10 minutes she stated it was moving to her left arm. She complained of shortness of breath. Vital signs were taken and with exception of slightly elevated blood pressure they were within normal limits. Patient was on a gurney, VS taken every 15, she was given water. After 30 minutes she said she was still having pain and did not want to go home. A team alert was called at that time and she was taken to the emergency room.  She was admitted to the Emergency department at 7:32pm and left at 8:39pm
This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 15-AUG-2016, the patient was vaccinated with improperly stored dose of PROQUAD (lot # L050907, expiration date 14-JUL-2017, exact dose and route of administration were not reported). The administered dose experienced a temperature excursion of 11.5 degree Fahrenheit for 3 hours and 54 minutes. Previous temperature excursion was reported. The call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
SORE ARM; UPSET STOMACH FOR 48 HOURS; HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On 2021, the subject experienced sore arm. On 2021, the subject experienced upset stomach for 48 hours. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, headache and upset stomach for 48 hours was not reported. This report was non-serious.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received SHINGRIX (batch number YE9YL ?, expiry date 6th February 2021,GSK note: the reported lot number did not match with any GSK lot number) for prophylaxis. On 27th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 28th June 2018, the patient experienced influenza-like symptoms, muscle pain, tiredness, lethargy, fever and malaise. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the influenza-like symptoms, tiredness and malaise were not recovered/not resolved and the outcome of the muscle pain, lethargy and fever were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, influenza-like symptoms, muscle pain, tiredness, lethargy, fever and malaise to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. One day after receiving SHINGRIX, the patient experienced flu like symptoms, clarified as feeling kind of run down, muscle ache, malaise, tiredness, lethargy and a low grade fever. No emergency room or doctor visit, or intervention was required. The symptoms were not considered disabling or life threatening.
runny nose, temp going up & then dec (101-103) for nearly 3wks, pain in legs & joints; severe rt jaw pain, swollen jaw; rash (like hives), bronchitis; rt side jaw still swollen 20APR92;
HOSPITALIZATION AND DEATH RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY VACCINE SERIES
Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient. A 31-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 11:15 as dose 4 (booster), single (Lot number: GJ5342) at the age of 31 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Sep2022 at 01:15, outcome "recovering", described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: If other vaccine in four weeks was reported as no. If COVID prior vaccination was reported as no. If COVID tested post vaccination was reported as no. No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning a 19 year old male patient with hydrocephalus and neurogenic bladder who in 2010 was vaccinated with a dose of MMR II (dose route not reported), (Lot#664660/1016Y). Subsequently on an unknown date, the patient experienced anaphylactic reaction from MMR II. The patient was given BENADRYL and "epinephrine shot" and sent to ER. It was unknown if the patient was hospitalized from the emergency room. The patient was recovered (recovery date was not reported). Anaphylactic reaction was considered to be immediately life-threatening. Additional information has been requested. A lot check has been initiated.
Numbness on  Face ,  arms and legs  mouth , neck.  tingling sensation in many areas of the body   (  Diagnosis)  Paresthesia  They prescrbed  Methylprednisolone tablets  USP 4MG.
It hurst a little bit at the injection site; at the injection site it is a little bit inflamed; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (It hurst a little bit at the injection site) and INJECTION SITE SWELLING (at the injection site it is a little bit inflamed) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE PAIN (It hurst a little bit at the injection site) and INJECTION SITE SWELLING (at the injection site it is a little bit inflamed). At the time of the report, INJECTION SITE PAIN (It hurst a little bit at the injection site) and INJECTION SITE SWELLING (at the injection site it is a little bit inflamed) outcome was unknown.        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 reorted.  No treatment medications were reported.
Local redness at site of the injection. Warm to touch, no other signs or symptoms. Seen in ER on 09/21/04 with follow up in clinic office 09/22/04.  Follow up on 09/28/04.
soreness; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), PYREXIA (fever) and FATIGUE (fatigue) 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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-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 PAIN (soreness), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, PAIN (soreness), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant and treatment medications were not provided.
According to mother, mom called office stated that she walked into baby room he was unresponsive, she called EMS and baby was taken to local ER where he was pronounced dead. Have not spoken to mother, she called office and spoke with nurse.
This spontaneous report as received from a nurse refers to a 12 month old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. The reporter stated that on 15-JUN-2018, the patient inadvertently received a dose of M-M-R II rHA, lot # N019615, expiration date 09-JUL-2019, subcutaneously concomitant with PROQUAD rHA, lot # R004438 and expiration date 12-AUG-2019, subcutaneously for prophylaxis. The nurse states the patient received the doses separately in each thigh. The possible diluent information for one or both vaccines that were administered was sterile diluent (MERCK) Lot number N027625, expiration date 19-MAY-2019. "There was no report about information on vial". It was also reported that the patient was not experiencing any adverse effects and was doing fine. The patient did not sought medical attention or received any treatment.
pt recv vax 4MAY98 & w/in 16hr pt devel generalized hives;
pt recvd vax 25JAN95 seen by MD on 27JAN95 w/cellulitis extending from inject site lt deltoid area to mid forearm; area swollen, red, hot to touch & painful; was adm to hosp for rx of cellulitis;
expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.  Company Comment: This case concerns a 26-year-old female patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 26-year-old female patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
This case was reported by a healthcare professional and described the occurrence of elevated alanine aminotransferase in a 17-year-old female subject who was vaccinated with Engerix B for prophylaxis. On 9 November 1998, 8 May 1998 and 9 April 1998 the subject received 3rd dose, 2nd dose and 1st dose of Engerix B (10 mcg, unknown) to complete the three dose series. Lot numbers of ENG2599A4 and ENG2725A2 were provided, but corresponding dose numbers were not specified. On an unspecified date in 2007, the subject began to experience weight loss. As a result, the healthcare provider/reporter decided to check the subject's liver enzymes. The subject's alanine aminotransferase (ALT) level came back elevated. The subject's ALT was rechecked later and a hepatitis B panel was done. The hepatitis B antibody came back negative as well as the surface antigen. ALT was still elevated. The reporter did not believe that the weight loss and elevated ALT was related to vaccination with Engerix B. The reporter was only concerned with the negative hepatitis B antibody. This case was assessed as medically serious by manufacturer. At the time of reporting the outcome of the events were was unspecified.
Tested positive for COVID-19 08/12/2021- asymptomatic (pre-procedural testing).
Headache Runny nose, cough, congestion chills, fever, hoarseness, very tired no energy , went to urgent care was given 5 days of molnupiravar 200 mg 4 capsules every 12 hours
He was severely hypoxic requiring intubation.  Now has developed ARDS and DIC.
Patient began having symptoms of shingles on 1/28/08.  He had a rash under shoulder blades and pain associated with rash.  Patient under treatment.
"Moderna Vaccine EUA" Stiffness in right arm, swollen and painful with pain and discoloration in fingers
has right hand pain; difficulty gripping her coffee cup; fatigued; This is a spontaneous report from a contactable consumer (Caregiver). A 86-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number, Expiration date were not reported) via an unspecified route of administration on 09Feb2021 as dose 1, single for COVID-19 immunization. Medical history included arthritis, this is localized to one hand from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On an unspecified date Feb2021, the caller stated, calling on behalf of mother, received vaccine on Tuesday. approximately 36 hours later she had right hand pain, and having difficulty gripping her coffee cup or cane. The hand that is in pain is on the same side as the vaccination site. She is also fatigued. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
The shot itself was very painful. More so than the first one, which only caused fatigue. By morning the next day I was dizzy and sick to my stomach. By 9AM I was full blown chills and could not get warm and had a headache. Took Ibuprofen, left work and went home and laid under blankets and high room temperature for 2 hours and slept. Continued with chills and fever until bedtime. Fatigued and went to be very early. Woke up the next morning (2nd morning after shot) with an extreme headache. Took more Ibuprofen had to stay in bed for a couple more hours, feeling sick to my stomach and chilled. The point of entry of the shot made my whole top of my arm lame and sore. Could not hardly lift it past shoulder height. Finally on Sunday, I was still fatigued but not sick. Slight headache still but not nearly as bad. Monday back to full function, no arm soreness just a bit of a headache still. All in all, if I do not get shingles it will have been worth it but 2 days of reactions to it seems like a bit much.
an Expired MMRII administered to patient; This spontaneous report has  been received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.    On an unknown date, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) formulation not reported but defaulted to subcutaneous injection for prophylaxis (dosage regimen, Lot # and expiration date were not reported).  Follow up information was received on 27-OCT-2020. On 26-OCT-2020, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot number was R030813, expiration date reported and validated as 24-OCT-2020). There was no experience  temperature excursion.
Information has been received from a nurse practitioner via a company representative concerning a female patient of unknown age. The patient's medical history or concurrent condition was not provided. On unknown dates, the patient was vaccinated with the first and second dose of GARDASIL (intramuscular; dose, lot number and expiration date were unspecified). The nurse practitioner reported to the company representative that on an unknown date the patient had prolong pain in the deltoid muscle that lasted for at least 2 weeks after receiving the second dose of GARDASIL. It was confirmed that the vaccine was GARDASIL and not GARDASIL 9. The patient sought unspecified medical attention. At the time of reporting, the outcome of the events and causality were unknown. Additional information has been requested.
Started having chest pain. Went to the ED on 11/14/15 and diagnosed with pleurisy.  On Monday, 11/16/2015, broke out with shingles.
Pt experienced left brachial pleuritis (2 episodes with doses 4 and 5. 1st episode resolved over a 4 month period, 2nd episode currently improving.)
Constant crying, her leg where vaccine was given tripled in size, whole body is covered in a rash, other limbs are swollen, and she is lethargic.
This spontaneous report was received from a registered nurse, referring to a 48 patients of unknown ages and genders. The medical history of the patients or concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (35 patients with doses of the lot number: L020189, expiration date 30-JUN-2017, 3 patients with doses of lot number: L015282, expiration date: 30-APR-2017, 10 patients with doses of lot number: L030872, expiration date: 11-JUN-2018) (doses, anatomical sites and routes were not reported). Concomitant medication of the patients were not provided. Additionally, no adverse effects were reported and there was not product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
I started getting symptoms of a scratchy sore throat, aches, pains, fever, fatigue, and headaches. I then had diarrhea and chills. I had 2 COVID-19 home test that was negative. Then I went to a pharmacy and got a positive COVID-19 test. I seen my doctor and received an antibody infusion. I was also prescribed Flonase. I still have some symptoms of tiredness, fatigue, and congestion.
12 hours after having the shot , I started a fever .  When I tried to take Tylenol , I began vomiting which I did for 8 hours , and ran a fever for 12 hours with intermittent vomiting. 3 weeks later , I still am sick . , no energy , aching .