chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received an extra dose of VARIVAX on 1-MAY-2022; low or undetectable antibody levels after vaccination with VARIVAX; This spontaneous report was received from a registered nurse and refers to a 15-year-old male patient. Information regarding his concomitant medications, concurrent conditions and medical history was not reported.  On an unknown date, the patient received the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 23-APR-2022, the patient received the second dose of varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter (ml), administered subcutaneously, lot # U020244, expiration date: 28-JUN-2023 (anatomical location was not reported). On an unknown date in 2022, after the second vaccination, the patient had low or undetectable antibody levels. On 01-MAY-2022 (described also as approximately one week after receiving the second dose), due to low or undetectable antibody levels, the patient received third dose of varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 ml, administered subcutaneously, lot # U020244, expiration date: 28-JUN-2023 (anatomical location was not reported) (extra dose administered). The outcome of the low or undetectable antibody levels was unknown.  The causality assessment between the event and the suspect vaccine was not provided.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for permanent prevention and protection against shingles and zoster related injuries. In February 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a male patient of unknown age. The patient relevant medical history, concomitant medications and past drug therapy were unknown. On 17-MAR-2015, the patient was vaccinated with PNEUMOVAX 23 (lot # J009689 and expiration date 29-JAN-2015) unknown dose, vial right deltoid injection for an unknown indication which was expired on 29-JAN-2015. No adverse event was reported. It was unknown if there was any relevant laboratory data. As of 17-MAR-2015, it was unknown if the patient will receive another PNEUMOVAX 23 injection. Action taken was not applicable. The outcome of receiving an expired vaccine was unknown. Causality was not assessed by the reporter. Comments: The pharmacist did not feel comfortable providing detailed information regarding the patient due to HIPAA, limited information available. Additional information has been requested.
ADMINISTRATION OF EXPIRED VACCINE DUE TO TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 34 year old male. 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: 1808986, and expiry: 02-OCT-2021) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-JUN-2021, the patient experienced out of specification product use. On an unspecified date, the patient experienced administration of expired vaccine due to temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine due to temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915719, 20210915623, 20210915661, 20210916907, 20210917163, 20210916553, 20210916768, 20210917515, 20210917226, 20210916697, 20210916910, 20210915852, 20210915646, 20210916965, 20210916658, 20210916300, 20210916584, 20210916811 and 20210918425.
Patient reported a rash around hairline just days after receiving the shingles vaccine. Reports occasional sting and occasional itch.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 07-NOV-2016, a healthcare provider at a medical branch administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries and conditions (dose, route, and lot # not provided). On or about 23-NOV-2016, the patient was treated by a healthcare professional at a medical clinic for left cerebellar stroke. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Upon internal review, left cerebellar stroke was determined significant medical event. Additional information has been requested.
The patient presents with Patient is 80-year-old female with history hypertension, hyperlipidemia, diabetes, not feeling well for the past week.  Patient states she had symptoms of fever, productive cough.  Patient called her primary care doctor, who started her on steroids, cough medication, but not improved.  Soon after, patient began having nausea, vomiting, and unable to tolerate anything p.o..  Patient also describes worsening general weakness.  Increased urination.  Patient states she has not been taking her diabetes medication.  No diarrhea, hematuria, dysuria, chest pain, shortness of breath, leg swelling.  Patient got both her Pfizer vaccines earlier this year.
chilling; A spontaneous report was received from a consumer concerning himself, a male patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills.  The patient's medical history was not included. Concomitant products was not included.  On 19 Feb 2021, prior to the onset of events the patient received dose of their two planned doses of mRNA-1273 (Batch N0: unknown) intramuscularly for prophylaxis of covid 19 infection.  On 19 Feb 2021, the patient experienced chills.   Treatment information was not included.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, chills was resolved on an unknown date.
NO adverse event; received an expired second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired second dose) and NO ADVERSE EVENT (NO adverse event) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (NO adverse event). On 14-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received an expired second dose) had resolved. At the time of the report, NO ADVERSE EVENT (NO adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant Follow up - No Adverse event experienced.
heart rate is fast after second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (heart rate is fast after second dose) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (heart rate is fast after second dose). At the time of the report, HEART RATE INCREASED (heart rate is fast after second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
RASH; This solicited report received from a patient: concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Concomitant medications included macitentan. On an unspecified date, the patient experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and rash as possible.  This report was non-serious.
MA administered expired Menactra dose; Initial information received on 22-Aug-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 12 years old male patient who was administered with 0.5 ml dose of expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot: U5917AA, expiry date: 30-Jun-2019) via intramuscular route in the left deltoid, on 20-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
This spontaneous report as received from a heath worker refers to a 41 years old female patient with no drug reactions/allergies. The patient's medical history included back pain and anxiety. The patient was subcutaneously vaccinated with a dose of 0.5 ml ZOSTAVAX (lot number reported as H011335, expiry date 08-SEP-2013) on 17-OCT-2012. No other co-suspects were reported. Concomitant medications included FLEXERIL and LEXAPRO. On 19-OCT-2012 the patient developed redness, swelling and itching on her right arm at the injection site after receiving ZOSTAVAX. The patient had sought medical attention via office visit. Ice packs and BENADRYL were given as treatment. The outcome of redness, swelling and itching on her right arm at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Initial dizziness then c/o headache. Headache continued x about 30 - 40 mins. Student layed down and slept - felt better afterwards.
my legs stared to swell a out four day's later; Skin has a yellow tint to it/yellow tint all over my body; Pains in my back; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (my legs stared to swell a out four day's later), YELLOW SKIN (Skin has a yellow tint to it/yellow tint all over my body) and BACK PAIN (Pains in my back) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (my legs stared to swell a out four day's later), YELLOW SKIN (Skin has a yellow tint to it/yellow tint all over my body) and BACK PAIN (Pains in my back). At the time of the report, PERIPHERAL SWELLING (my legs stared to swell a out four day's later), YELLOW SKIN (Skin has a yellow tint to it/yellow tint all over my body) and BACK PAIN (Pains in my back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Patient was given high dose flu shot instead of flublock which is designated for his age group at the time of visit.  To my knowledge no adverse event has occurred to my knowlege.
Administered 2nd Hep A vaccine off schedule. Initial vaccine on 4/13/16.
Pt stated that she was fine until 7/23/12 when pt noticed a red, swollen, warm to the touch. Pt came in the following day to check up.
Hallucinations: they happen sometimes, not all the time, and only when he is anxious, after first vaccine.; when his anxiety is high; This is a spontaneous report from a contactable consumer (patient himself). A 51-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0187) via an unspecified route of administration in right upper arm (as reported) on 20Jun2021 10:35 as dose 1, single (at the age of 51-years-old) for COVID-19 immunization.  Vaccination Facility Type was reported as pharmacy. Vaccine was not administered at Military Facility. Patient medical history included ongoing high blood pressure from about 20 years ago, ongoing depression from 1996, ongoing anxiety from 1996, ongoing obsessive-compulsive disorder from about 3.5 years ago. The concomitant medications included ongoing citalopram oral tablet at a dose of 40 mg from 1996 taken for antidepressant therapy, ongoing trifluoperazine oral tablet at a dose of 5 mg from 1996 taken for antipsychotic therapy, ongoing clonezapan oral tablet at a dose of 0.5 mg taken for anxiety, started about 5 years ago, ongoing lisinopril oral tablet taken for high blood pressure started about 15 years ago. On an unspecified date in Jun2021, patient stated his hallucinations began after the vaccine, stated they happened sometimes, not all the time, and only when he was anxious after 1st vaccine. Patient stated the hallucinations were somewhat better. The adverse events did not result in physician office visit or emergency room visit. The outcome of the events was recovering.
Information has been received regarding a case in litigation concerning a child who was injected with vaccinations containing the toxic mercury-based preservative thimerosal from September 1995 through at least July 1997. The alleged result of these vaccinations is that the pt suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. Immunization info reported that the pt was vaccinated with hep B vaccine recombinant (manuf and lot not reported) on 11/14/95 and 9/25/96; hep B vaccine recombinant (Engerix B lot 1277) on 9/14/95; diphtheria toxoid (+) haemophilus B conjugte vaccine (+) pertussis vaccine (+) tetanus toxoid (Tetramune) on 11/14/95 (lot 428037), 1/16/96 (lot 429972) and 4/9/96 (lot 432656); haemophilus B conjugate vaccine (manuf and lot unk) on 1/28/97; diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (manuf and lot not reported) on 7/3/97. Upon internal review, mercury poisoning and neruological disorders were considered to be other important medical events (OMIC). No further info is available.
Patient received a dose of Pfizer vaccine.  It was noted that the vaccine 5 day expiration date/time was 5/12/2021 @ 930 am.  Vaccine was administered to patient at 9:58 am on 5/12/2021.  No adverse reactions noted during observation period.  MD and management team aware.
I had flu like symptoms around 8:00PM and I had a blood pressure spike where it went up to 205. I went to the emergency room and it took a few hours but they were able to get it down with medication. I was observed for about 2 hours and released. I still had symptoms of feeling weak and tired. I still felt flu like symptoms the next day. I was nauseous for at least another 24 hours. It took about 3 days to fully recover.
likened to having seizures; muscle spasms, could not get out of bed; no control of body; could not get out of bed; This case was reported by a consumer via other manufacturer and described the occurrence of seizure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced seizure (serious criteria GSK medically significant), muscle spasm, balance disorder and mobility decreased. On an unknown date, the outcome of the seizure, muscle spasm, balance disorder and mobility decreased were unknown.   It was unknown if the reporter considered the seizure, muscle spasm, balance disorder and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient had very severe muscles spasms, that she likened to having seizures, all night long. The patient had no control of her body and could not get out of bed.  The reporter did not have further adverse event information. No additional adverse event reported. No product quality complaint was reported.
PT RECEIVED FLUMIST.  THE FOLLOWING DAY, PT AWOKE IN AM WITH BLISTERS ON TOP OF NOSE AND AROUND LEFT EYE.  PT FELT WELL WHEN WENT TO BED.  PT FEELS BLISTER HAS GOTTEN BIGGER AND ONE POPPED AND OOZED CLEAR LIQUID.  PT DENIES ANY PAIN OR BURNING INSIDE NOSE; NO FEVER, ST, COUGH, RUNNY NOSE OR ACHINESS.  TOP OF NOSE WITH 2 LG 4-6 MM BLISTERED LESIONS, 3 DISCRETE VESICULAR LESIONS AROUND LEFT EYE, 2 BELOW EYELID AND 1 LATERAL, ABOVE CORNER OF EYE EACH ABOUT 2-3 MM.  INSIDE NOSE WITH GENERALIZE REDNESS OF MEDIAL SEPTUM, BUT NO BLISTERS, SCANT MUCOUS. PLAN - KEEP CLEAN WITH GENTLE WASH, CAN APPLY NEOSPORIN.  MOC TO CALL IF ANY PAIN OR BLISTERING IN EYES, SIGNIFICANT SPREADING OR FEVER.  ADDENDUM - MOC STATES ALL BLISTERS HAVE POPPED.  LOOKS LIKE RED BLOTCHES WITH NO DRAINAGE.  MOM STATES SHE THINKS PT TOOK KLEENEX FROM YESTERDAY, THAT VACCINE HAD DRIPPED ON KLEENEX, AND THEN PT WIPED FACE WITH KLEENEX AROUND EYE AREA AND ON NOSE.
Patient came to ED with increasing shortness of breath.  Patient admitted to hospital with Covid pneumonia.
Patient was given vaccine and upon walking over to observation area, begin to feel weak. Mom grabbed patient and with assistance from EMT, was helped to chair. While sitting in chair, patient began to seize, total length of 15 seconds. After sitting for a minute or two, patient began to seize again for another total length 15 seconds. After second seizure, patient remained weak but could respond to mom when mom talked to her. Blood Pressure was not taken duh to possibility constriction causing another seizure but patient PR remained between 92-97 and respirations remained between 16-18. Mom denied calling Emergency Medical Services and patient was assisted by wheelchair out to vehicle, and transferred to vehicle by mom.
Tongue swelled after getting the booster.; Feels like no control over throat muscle.; Feels like the throat is swelling after the booster dose.; Cannot swallow after the booster dose.; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Tongue swelled after getting the booster.), OROPHARYNGEAL DISCOMFORT (Feels like no control over throat muscle.), PHARYNGEAL SWELLING (Feels like the throat is swelling after the booster dose.) and DYSPHAGIA (Cannot swallow after the booster dose.) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 041B21A and 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy (Patient has egg intolerance since patient was a child).   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022, the patient experienced SWOLLEN TONGUE (Tongue swelled after getting the booster.), OROPHARYNGEAL DISCOMFORT (Feels like no control over throat muscle.), PHARYNGEAL SWELLING (Feels like the throat is swelling after the booster dose.) and DYSPHAGIA (Cannot swallow after the booster dose.). On 21-Apr-2022, SWOLLEN TONGUE (Tongue swelled after getting the booster.), OROPHARYNGEAL DISCOMFORT (Feels like no control over throat muscle.), PHARYNGEAL SWELLING (Feels like the throat is swelling after the booster dose.) and DYSPHAGIA (Cannot swallow after the booster dose.) had resolved.            No concomitant medications were reported.   Patient did not had any other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient was never tested positive for COVID-19. All the symptoms patient experienced was recovered after a few minutes. Treatment information was not provided.   This case was linked to MOD-2022-547111 (Patient Link).
JAN96 approx 10-12 days p/vax mom noticed pt became suddenly cranky, wheezing, crying all day;pt shaking badly-then lt side drew up & flipped pt over;eyes rolled back; full body convuls;then pt stared (did not sleep) for 45"-1hr p/sz;to ER;