chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient c/o left arm itching and feeling "hot" noted to have erythematous rash left neck no SOB,  itching, chest pain, or stridor.
12CM X 10CM INDURATED RED AREA  TO RIGHT THIGH AT SITE OF DTAP INJECTION. HOT TO TOUCH, DARK RED.
LEFT BELL'S PALSY, DYSEQUILIBRIUM, HYPERACUSIS LEFT,  LOSS OF TASTE LEFT TONGUE
Within 2 hours, post vax, my arm was swollen and I had chills and a temperature of 101F and more, which lasted at least 2 days.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Pain started from arm and now moved to elbow-Severe
decided not to take 2nd dose; tired, fatigued; joints hurt; headaches; swollen at the injection site; sore at the injection site; injection site red knot; depressed; had foggy thinking.; slept like 20 hours; injection site red knot that was about 4 inches across; joints hurt 10 times more than normal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEPRESSION (depressed), FEELING ABNORMAL (had foggy thinking.), HYPERSOMNIA (slept like 20 hours), VACCINATION SITE NODULE (injection site red knot that was about 4 inches across) and CONDITION AGGRAVATED (joints hurt 10 times more than normal) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included HLA-B*27 positive, Antinuclear antibodies present (SSB/LA antigens. I have autoimmune antigens in my blood, but they're not real strong.), Macrocytosis, Joint pain and Ill-defined disorder (I have 10 or 15 separate diagnoses).    On 05-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 DEPRESSION (depressed), FEELING ABNORMAL (had foggy thinking.), HYPERSOMNIA (slept like 20 hours), VACCINATION SITE NODULE (injection site red knot that was about 4 inches across), CONDITION AGGRAVATED (joints hurt 10 times more than normal), FATIGUE (tired, fatigued), ARTHRALGIA (joints hurt), HEADACHE (headaches), VACCINATION SITE SWELLING (swollen at the injection site), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE ERYTHEMA (injection site red knot). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (decided not to take 2nd dose). At the time of the report, DEPRESSION (depressed), FEELING ABNORMAL (had foggy thinking.), HYPERSOMNIA (slept like 20 hours), VACCINATION SITE NODULE (injection site red knot that was about 4 inches across), CONDITION AGGRAVATED (joints hurt 10 times more than normal), FATIGUE (tired, fatigued), ARTHRALGIA (joints hurt), HEADACHE (headaches), VACCINATION SITE SWELLING (swollen at the injection site), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE ERYTHEMA (injection site red knot) was resolving and PRODUCT DOSE OMISSION ISSUE (decided not to take 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was provided
Symptomatic breakthrough case. Exposed to vaccinated coworker with symptoms 8/14. Became symptomatic 8/17. Initially had sneezing, progressed to slight runny nose that evening, headache, neck pain, 100.5 fever. Continued to be symptomatic with cough, sore throat, loss of taste and smell. Fevers lasted 4 days, up to 101. Not hospitalized, did not require oxygen.
Sever pain on surface skin fr rt side of back to umbilicus; started 2 wks p/inject got slowly worse for 2 wks then over next 4 wks slowly left; no rash;
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # reported as L031068 and expiration date 18-AUG-2017, lot # L036830 and expiration date 24-SEP-2017, exact doses and route of administration were not reported). The vaccines were exposed to temperature of -2.6C for 59 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Mild to moderate headache daily since the 2nd injection.  Usually well treated with ibuprofen but returns after medication wears off. 4/3/2021 taken to the ER with severe headache and memory loss with diagnosis of Transient Global Amnesia. CT scans both with and without contrast were performed as well as an MRI and EKG. CBC, BMP, APTT, Protime-INR were all performed. All within normal range barring WBC which was mildly low. I spent about 6 hours in the ER and was given raglan, magnesium and some pain medication. Approximately 5 hours of my memory is still gone, but I was able to answer doctor's questions appropriately after about four hours after arrival and was sent home after all tests were completed. I am to follow up with a neurologist in office.
No adverse event; an adult in her 40's received a booster dose from a vial with NDC 80777-0275-05 instead of a Bivalent booster on 28DEC2022; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (an adult in her 40's received a booster dose from a vial with NDC 80777-0275-05 instead of a Bivalent booster on 28DEC2022) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (an adult in her 40's received a booster dose from a vial with NDC 80777-0275-05 instead of a Bivalent booster on 28DEC2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (an adult in her 40's received a booster dose from a vial with NDC 80777-0275-05 instead of a Bivalent booster on 28DEC2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (an adult in her 40's received a booster dose from a vial with NDC 80777-0275-05 instead of a Bivalent booster on 28DEC2022).    The age of patient was reported as 40's.  Concomitant medications were not reported.  The patient had 2 primary doses more than 2 months ago and received a booster dose from a vial with NDC 80777-0275-05 instead of a Bivalent booster on 28-Dec-2022.  No treatment information was provided.
Patient presented to pharmacy on 6/14/19 with vaccine site reaction on left arm where vaccine was administered. Reaction was hot to the touch and patient stated that redness had begun the evening before.
Itchy rash on upper arm at and around the injection site. Based on a Google search, this is being referred to as "COVID Arm". The rash appeared this morning, which is approximately 1 week and 12 hours after the injection.
I did not have a reaction to the vaccine. I tested positive for COVID-19 while on vacation on 01/12/2023. I isolated for seven days per instructions on the cruise ship. I do not have any lingering symptoms.
Fatigue, fever, achy joints, itchy skin, hot arm, Covid arm rash (2 weeks later)
nasal congestion; a heavy head; About a month and a half after the 2nd shot she went swimming and began having pain at the injection site in the right arm; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (nasal congestion), HEAD DISCOMFORT (a heavy head) and VACCINATION SITE PAIN (About a month and a half after the 2nd shot she went swimming and began having pain at the injection site in the right arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-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 NASAL CONGESTION (nasal congestion), HEAD DISCOMFORT (a heavy head) and VACCINATION SITE PAIN (About a month and a half after the 2nd shot she went swimming and began having pain at the injection site in the right arm). At the time of the report, NASAL CONGESTION (nasal congestion), HEAD DISCOMFORT (a heavy head) and VACCINATION SITE PAIN (About a month and a half after the 2nd shot she went swimming and began having pain at the injection site in the right arm) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-346418 (Patient Link).
Pt recv vax on 10/22/98; on 11/10/98 pt exp pain of right knee & calf, difficulty walking, vomiting & diarrhea
Patient received an expired Vaccine. Vaccine expiration was 10/26/2022. Recieved on 10/28/2022 No adverse symptoms as 10/28/22.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a burning vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Elevated liver enzymes; liver cysts; Abnormal Thyroid lab values; chest pain; abdominal pain; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6207) via an unspecified route of administration in the left arm on 17Mar2021 at 16:00 and the second dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0151) via an unspecified route of administration in the left arm on 20Apr2021 at 16:00  (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer in 2015. The patient previously took sumatriptan (IMITREX) for unknown indication and from unknown date and experienced allergy. Concomitant medications included pravastatin sodium (PRAVASTATINE),  colecalciferol (VITAMIN D) and ibuprofen (MOTRIN) ; all from an unknown date, for an unknown indication, unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021, at 04:00 the patient experienced elevated liver enzymes, liver cysts, abnormal thyroid lab values, chest and abdominal pain. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department visit or urgent care. Therapeutic measures were taken as a result of the events which included treatment with medications (not specified). The clinical outcome of the events of elevated liver enzymes, liver cysts, abnormal thyroid lab values, chest and abdominal pain were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sudden hearing loss - 100% hearing loss upon waking up in the left ear; Sudden hearing loss - 100% hearing loss upon waking up in the left ear; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE for COVID-19 immunisation. It was reported that patient received first dose of BNT162B2 on 06Apr2021 09:00 (lot number: EP7533) in right arm, and second dose also on 06Apr2021 (lot number: EW0171) in left arm; both information has pending clarification. Medical history included underlying hearing loss from childhood. The patient was not pregnant at the time of vaccination. The patient received unspecified birth control, and vitamins within 2 weeks of vaccination. No any other vaccines received within 4 weeks prior to the COVID vaccine. The patient experienced sudden hearing loss - 100% hearing loss upon waking up in the left ear on 09Apr2021 05:30. Therapeutic measures were taken as a result of sudden hearing loss - 100% hearing loss upon waking up in the left ear which included steroid and antibiotics. The event resulted in emergency room/department or urgent care. The patient was recovering from the event. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since the vaccination.
49-year-old male presents for chest pain dizziness and a syncopal episode. Patient states he had a ostomy placed in November for bowel obstruction. He has noticed significant increase in the output from his ostomy. He believes he is getting dehydrated. He's having dizziness and feels like he is going to pass out when he stands up quickly. He did actually have one episode of syncope an hour ago after standing up quickly. He also admits that he said some intermittent tightness since midnight on the left side of his chest. He said some mild shortness of breath. Denies any black or bloody stools. Denies cough cold or covid symptoms. No other aggravating or alleviating factors. No other complaints
Dizzy, headache, tired, pain, vomiting, fever.  Lasted for 20 hours.
Patient was aged 11 years and 9 months at time of vaccination.  At the time of the vaccination, the Pfizer EUA required a chronological age of 12 years.
Beginning 18 hours after shot, chills, fever, headache, sore in many areas.
Chills; Headache; Fever; felt so bad; This case was reported by a consumer via call center representative and described the occurrence of chills in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 17th July 2020, the patient received the 2nd dose of Shingrix. On 18th July 2020, 1 days after receiving Shingrix, the patient experienced chills, headache, fever and feeling bad. On an unknown date, the outcome of the chills, headache and fever were recovering/resolving and the outcome of the feeling bad was unknown.   The reporter considered the chills, headache and fever to be related to Shingrix. It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient began experiencing chills, fever and headache the next day.  At the time of reporting, the patient was still experiencing these side effects.  The patient stated that, he went to the emergency room because he felt so bad but there was nothing they could do for him.  The reporter was consented to follow up. The patient was advised to follow up with his healthcare professional if they continued and were bothersome. This case was linked with case US2020138156, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020138156:same reporter
Patient initially presented to hospital on 6/15/21 with whole body rash, and end organ involvement including AKI requiring dialysis, lft abnromalities, and a cold lower extremity later requiring amputation.. Also in DKA with no history of diabetes and normal A1C. Of note patient initially developed rash after first covid vaccine in march. Rash subsequently worsened upon receipt of second dose. End of may, outpatient provider prescribed doxycycline and prednisone for diffuse rash. On June 15, upon admission to hospital workup resulted in a diagnosis of DRESS syndrome with 30% eosinophilia and end organ involvement as described above. Patient required long hospitalization and was later discharged to ECF. extensive rheum workup was all negative
11/2/19 & 11/3/19 swollen eyes, could not wear any makeup, very sensitive 11/2/19-11/6/19 very achy muscles in buttocks, muscle cramps in feet, very sore knees 11/2/19-11/5/19 extremely tired and weak 11/2/19-11/5-19 could not breath, needed to use Albuterol inhaler multiple times a day, could not breath at night, very sore diaphragm trying to breath I finally connected the dots on 11/5/19 to realize that  all these were side effects, I did not get any paperwork at them time of the shot telling me any side effects, I needed to google it.  Since I have had at least 20 years of flu shots with no side effects it never occured to me that the shot and my symptoms were related.  I called the advice nurse and then had a phone appt with a Dr. They confirmed the reaction, could not tell me how long it would last. Said I was doing the right thing using the Albuterol. No need for an appt unless the symptoms continued a few more days. I am finally feeling better today,11/6/19.
Admitted 12/16/10 for cough x 3 days, and SOB. Found to be in CHF. Hospitalized for approximately 8 days and released to hospice. Patient expired 12/26/10. Patient had ZOSTAVAX 10 days prior to admission.
A report has been received from a Health Professional concerning a 70 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 19-Sep-2013. The patient experienced gave FLUMIST quadrivalent to a patient who was 70 years of age which started on 19-Sep-2013. The outcome of the event of gave FLUMIST quadrivalent to a patient who was 70 years of age is unknown. The report was considered to be non-serious by the reporter. Summary of follow-up information received by AstraZeneca/MedImmune 08-Oct-2013: the patient age changed from 66 years to 70 years, so adverse event term was updated from gave FLUMIST quadrivalent to a patient who was 66 years of age to gave FLUMIST quadrivalent to a patient who was 70 years of age.
Pediatric dose given to adult; Adult use of a child product; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 40-year-old female patient who received HBV (Engerix B pediatric) (batch number f22ez, expiry date 03-JUN-2023) for prophylaxis.   On 10-MAR-2023, the patient received Engerix B pediatric 10 mcg/mg. On 10-MAR-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Pediatric dose given to adult) and adult use of a child product (Verbatim: Adult use of a child product). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-MAR-2023 The registered reported an adult patient received a pediatric dose of Engerix on the day reporting. The reporter consented to follow up. The adult patient received pediatric dose of Engerix B, which led to underdose and adult use of a child product.
A report was received from a health care professional on 16Oct02, concerning a 6 month old male vaccinee who was inadvertently administered 0.25ml IM into the vastus lateralis on the 16Oct02. On 16Oct02, the infant suffered a medication error by receiving 0.25ml Fluvirin into the vastus lateralis. The infant had not experienced any adverse events at the time of the report but was being closely monitored. There was insufficient information to determine the reporter's causality assessment. PJP200200609, PJP200200671, PJP200200670, PJP200200669, PJP200200668, PJP200200667, PJP200200665, PJP200200664, PJP200200662, PJP200200663.
administered acthib that was reconstituted with sterile water instead of the supplied acthib diluent with no reported adverse event; administered acthib that was reconstituted with sterile water instead of the supplied acthib diluent with no reported adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 17 months old female patient who was administered acthib that was reconstituted with sterile water instead of the supplied acthib diluent with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) and hepatitis A vaccine (HEPATITIS A) both for Prophylactic vaccination.  On 20-Sep-2022, the patient received suspect HIB (PRP/T) VACCINE at a dose of 0.5 ml (lot UJ665AAA, expiry date: 11-Mar-2023) via intramuscular route in the left thigh for immunisation.  On 20-Sep-2022 the patient was administered acthib that was reconstituted with sterile water instead of the supplied acthib diluent with no reported adverse event (product preparation error, poor quality product administered, latency same day).  Action taken: Not applicable.  Outcome: Unknown for both the events.   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 the guidelines. 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.