chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Saturday evening 1/9/2021 I started to have a moderate reaction to my vaccine that I received on 1/3/2021, I started to itch from head to toe with rash in multiple areas of my body. I was able to control the reaction/symptom with Benadryl 50mg every 6 hours.
She states that the products were labeled but still accidentally administered after the new short dated expiration date; Caller reports that they had a temperature excursion; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-MAR-2023, measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHa) (PROQUAD) underwent temperature excursion in 6°F up to 14°F 4 hours 0 minutes; 14°F up to 46°F 4 hours 0 minutes ; 47°F to 77°F (50 F) 3 hours 57 minutes (product storage error). On 05-JUL-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHa) (PROQUAD) injection, 0.5 milliliter, lot #W035470, expiration date: 06-MAY-2024 (also reported as 30-JUN-2023), administered for prophylaxis (strength, and route of administration were not provided).Due to temperature excurion the expiration date was estimeted as "short dated" (Product expiration date issue).
Breakthrough COVID 19 infection not requiring hospitalization.  Patient had recently received 3rd dose of COVID 19 vaccine
12/21/2022 ? I got up in the night and noticed my face was red and itchy and it was spreading. I took Benadryl and it continued to get worse. I went to a walk-in clinic. I was told to take more Benadryl and Pepcid Complete which resolved the issue.  The doctor told me to report this to the pharmacy, which I did. On 12/24/2022, my blood pressure went up high. I had never had issues with my blood pressure before.  My ears began ringing and I had a headache.  I could not get the blood pressure down. I went to the Emergency Room and was kept overnight. I was started on Amlodipine which did not help and I had side effects, so I stopped taking the medication.  I then started taking 7.5mg ? 12.5mg of Hydrochlorothiazide and my blood pressure is now coming down.
Information has been received from a pharmacist, concerning a 67 year old female patient who was vaccinated with a dose of VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck) by mistake because one technician said to another one that the patient needed the shingles vaccine and when the other technician saw the packaging he said that the vaccine shown was the one for shingles not realizing that he was looking at the wrong vaccine. The pharmacist reported that hen the vaccine was sent to the patient's primary care office to be administered to the patient. At the clinic the nurse administering the vaccine did not do a final check and gave then the wrong vaccine to the patient. The pharmacist stated it was not a product confusion. There were no adverse reactions reported. The pharmacist also reported the patient's husband who received the wrong vaccine (refer WAES 0808USA04634). Additional information has been requested.
Car accident; she felt fatigued; She had a cough for a few hours; arm soreness/could feel in her left arm where she got the shot; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 16Mar2021 around 15:20 (Lot Number: EN6204) as single dose for covid-19 immunisation. Medical history included ongoing chronic fatigue immune dysfunction,  She was diagnosed in her 30s. She is on no medications for the currently, ongoing herpes. Concomitant medication included valaciclovir 1 tab, 1000mg, oral 2 times a day as needed taken for herpes. The patient experienced arm soreness, could feel in her left arm where she got the shot on 2021, she felt fatigued on 16Mar2021, she had a cough for a few hours on 2021, car accident on 27Mar2021. The patient underwent lab tests and procedures which included X-rays of her neck on 05Apr2021 with unknown result. The outcome of Pain in arm was recovered, fatigue was recovering, the other was unknown.  No follow-up attempts are needed. No further information is expected.
Pt recv vax on 9/4/98; on 9/6/98 pt exp fever,fussiness,irritability,unconsolable crying,dec eating.
This spontaneous report as received from healthcare worker refers to a 12 year old female patient. On 23-NOV-2013 the patient was vaccinated with GARDASIL (lot # and expired date not provided). No concomitant medication was reported. Second dose was administered on 23-AUG-2031 and the third dose on 23-NOV-2013. No adverse effect reported. There was no product quality complaint. Outcome of the event was unknown. Additional information is not expected.
Patient received Janssen vaccine on 10/29/21. On 11/2/21 patient woke up at 4:00 am with left arm and right leg weakness, had slurred speech and face drop, transferred to ER, diagnosed with right MCA stroke, had thrombectomy diachged home on statins and Eliquis.
pt recv vax 1JUN95 & 18NOV97 pt devel chickenpox, approx 60 lesions w/itching, h/a, slit fever;pt lethargic & vomited twice;
run down feeling; listlissness; joint pain; pain at the site of the injection 3rd dose, soreness in his  left arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (run down feeling), ASTHENIA (listlissness), VACCINATION SITE PAIN (pain at the site of the injection 3rd dose, soreness in his  left arm) and ARTHRALGIA (joint pain) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A, 016M20A and 029o20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (pain at the site of the injection 3rd dose, soreness in his  left arm). On 28-Aug-2021, the patient experienced FEELING ABNORMAL (run down feeling), ASTHENIA (listlissness) and ARTHRALGIA (joint pain). At the time of the report, FEELING ABNORMAL (run down feeling), ASTHENIA (listlissness), VACCINATION SITE PAIN (pain at the site of the injection 3rd dose, soreness in his  left arm) and ARTHRALGIA (joint pain) outcome was unknown.            No concomitant medications details were reported. No treatment information details were reported.   This case was linked to MOD-2022-465694, MOD-2022-465812, MOD-2022-465769 (Patient Link).
On 1/28/2021, starting having severe pain in chest/lungs and especially a quarter size area above rib cage located on top of right breast next to breast bone. This area was especially painful when pressure applied. No shortness of breath.  Symptoms lasted for about 10 hours and  subsided somewhat on 1/29/2021.  Severe pain symptoms returned early morning on 1/30/2021 and resulted in my going to the ER at the local hospital around 10:00 a.m.  An EKG , CT scan, and blood tests determined no heart attack or other life threatening conditions and I was released from the hospital around 4:00 p.m., still experiencing pain without a cause being determined.  Pain and painful area were no longer present on 1/31/2021.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patient post temperature excursion,; Moderna COVID-19 vaccine administered to patient post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion,), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion,), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion,), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) 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 WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion,) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion).    No concomitant medication was provided.  It was reported that there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was administrated between 08 Sep 2022 to 09 Sep 2022.AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 1 Aug 2022 and individual vials were put in the refrigerator on the day of use.  Treatment medication was not provided by the reporter.   This case contains information for the 77th patient out of 104 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 04-AUG-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
no adverse event , received dose which was expired by 7 days, Pfizer was contacted, they okayed the dose , and declared no intervention necessary
Sweats; Fatigue; Nausea; Diarrhea; Fever; Chills; This is a spontaneous report from a contactable physician. A 33-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration on 23Apr2021 at 09:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to pork/porcine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021, the patient experienced sweats, fatigue, "HA", nausea, diarrhea, fever and chills. The events resulted in emergency room/department or urgent care. On 28Apr2021, the patient underwent polymerase chain reaction (PCR) SARS-CoV-2 test (nasal swab), and the result was unknown. Therapeutic measures were not taken for the events. Since the vaccination, had the patient been tested for COVID-19. The clinical outcome of the events sweats, fatigue, "HA", nausea, diarrhea, fever and chills was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Temp. 100.5 degrees F, achy joints/neck, HA eyes sensitive to light, numbness in feet/hands. 5/21/09. 5/27/2009 Follow up with parent. Parent stated child was taken to ER and was observed for several hours. States no lab work was done. No follow up has been done and child no longer has any symptoms as stated. 5/20/09.
Information has been received from a female consumer, reporting on herself, who in August 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot #, dose and route not reported). Consumer reported that the next day after receiving the vaccine she had a perm done on her hair and that her hair had been breaking off since then. It was unknown if patient sought medical attention. At the time of the report the patient's outcome was not recovered. Additional information has been requested.
7/01/02 PC from mother reporting client developed not, redness and itching to right upper arm at injection site area with increased warmth to touch, tired and decreased appetite. No fever. See by doctor and diagnosed with staph infection per mother and treated with augmentin 250mg for 10 days.
extended chest cold (6 wks) with 1 week  diarrhea and extended fatigue.  Began 6/6/21 after recent travel, resolved mid July
I have had NO adverse reactions or events due to the COVID vaccinations.  I am replying here since I received a phone call asking about an adverse event, but there have been NO adverse events!
mother counted a dozen or so pox, no crusting, resolved in 7 days. no fever no rx medicine given
Information has been received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. On 29-JUL-2014 the patient was vaccinated with the first dose of GARDASIL intramuscularly (dose and lot# were not reported). On 11-APR-2015, the patient was vaccinated with the second dose intramuscularly (dose and lot# were not reported)(inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
2nd and 3rd day experience upset stomach and on the 3rd day had diarrhea.
None. Got flu shot at mom "request", got at 2 mo and 1 mo.
pt recvd vax 9APR92; pt seen in ER 24APR92; sx 1st present 19APR92 sx heavy rash over entire body, fever 100-102 ax, vomiting, diarrhea; tx hosp 1 day; MD stated could have contacted another virus;
22 y/o was in his usual state of excellent health prior to Feb-Mar 2010. At the time, he was attending college. Looking back, around Feb 2010, former SM recalls developing fatigue and the feeling of being run down - "activity taking more out of me". He recalls experiencing polydipsia and polyuria during the month of March 2010. He was not aware of weight loss, but he recalls a few people asking him about how much weight he had lost. He did not experience visual changes, N/V, polyphagia or numbness and tingling in his extremities. By 21 Apr 2010, his symptoms had increased significantly to the point they were interfering with his daily activities and he sought evaluation with his PCM. At that time, a glucose level of 318, trace positive urine ketones, and HgbA1c of 10.5 led to his diagnosis of T1DM. Insulin was initiated as outpatient a time of diagnosis. Patient then received D5ME and his insulin was titrated as needed. Around May, he was evaluated by his Endocrinologist and in August 2010, he was placed on an insulin pump. He was medically discharged from the National Guard in Feb 2011. He currently is working and residing in MD and has found a local PCM, but continues Endocrinologist follow up. SM received Hepatitis B and Influenza vaccines in Nov 2009 and MMR vaccine in July 2009 - See left column for vaccine History. He denies any unusual or prolonged reactions within the first 1-2 weeks following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. Patient does not recall a history of infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea in months prior to his diagnosis of T1DM. He denies a history of an elevated glucose levels, elevated blood pressure levels or history of hypertension prior to diagnosis of T1DM. He was not overweight and stayed very active. He has no family Hx of T1DM.
got shingles / after this vaccine/suspected vaccination failure; Got shingles near their eyes; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got shingles near his/her eyes after Shingles vaccine. The follow-up would not possible as no contact details were available. This case considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not reported. This case had been linked with US2021AMR174963, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR174963:same reporter
Patient seemed to have a bad reaction to the shots he received on Friday 1/23. He started screaming at 3:30 am Sunday morning and it continued ALL day. He was abnormally fussy and crying and screaming like he was in so much pain. He was shaky as he screamed. He got really hot as well. He was also waking up every 30 to 45 minutes (instead of the usual 2 hours) after the first screaming session at 3:30 am. He didn't sleep the same Sunday night either, he would usually be awake after I changed him in the middle of the night. This time he was out solid, not budging or moving much either.
Light red rash around injection site appeared approximately 9 days after receiving vaccine. Slight itching at site.  Slight swelling of upper left arm where injection was administered.
High fever with chills. Measured 101.7 F at 12:30 am on 3/25/21 with non touch thermometer.  Took 1300 mg of slow release Tylenol at 1:30 am.  Fever and chills subsided in couple of hours.
Patient with PMH of asthma and significantly  elevated IgE 2159 was admitted with the right axilla pain after the pneumovax and flu shot in the right arm yesterday earlier during the day. He was also given Td in left arm.  Patient had equisitely tender anterior aspect of right  axilla when moving adducting and abducting the right shoulder. Patientwas seen by the neurology, general surgery and orthopedic teams, and was  also discussed with allergy immunology aeam. He was empirically given abx, pain meds and IVF. MRI of the right shoulder was obatined that confirmed "cluster of enhancing masses in the right axilla most consistent with lymph nodes with surrounding mild inflammation. No abscess. Therefore, it was believed that patient has had reactive lymphadenitis to the immunization (flu, pneumovax) that he received in the right arm on 11/25/08.
Under 18 years old vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years old vaccination) in a 12-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years old vaccination). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years old vaccination) had resolved. Not Provided          Patient was schedule the HPV vaccine and she was given the Moderna COVID-19 vaccine. No concomitant information was reported. No treatment information was reported.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies. On unknown dates from 01-FEB-2017 to 18-APR-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot#: M025569, expiry date: 18-JAN-2018 (dose not provided) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 8 hours 10 minutes. Data logger was not used to capture temperature excursions. There were no previous excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA008219: US-009507513-1705USA003081: US-009507513-1705USA003082.
Started on 8/23/05 with red spots, look like bug bites. Fever off and on x 3 days, no appetite, fussy, not herself.
This spontaneous report was received from an X-ray technician concerning an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, frequency, lot #, expiration date and indication unknown). No adverse symptoms were reported. The vaccines were exposed to temperature of 47 F to 77F for an unspecified period of time, there was also a previous temperature excursion of 47 F to 77F for an unspecified period of time. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA011479:
Headache. Sore throat fever stuffy nose coughing chills. On 10/5 Patient completed course of Z - pac for yellow phlegm cough.
Pt became light headed after receiving the 3rd dose of the vaccine. Nursing staff was called and the pt was taken into the clinic by the nurse staff to be monitored.
Left upper arm swollen @ injection site.  Right arm swollen from elbow to injection site.  Both arms hard, red, and hot to the touch.  Child taken to ER.