chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021 at 3:31 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Mar-2021 at 3:31 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 38.29.  Concomitant products were not provided.  On 02-Mar-2021,Excursion time was from 09 Am to 3 Pm and the temperature range was from 27 to 36 degrees, total doses given for the day was 177. Condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 02-Mar-2021. 16 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 02-Mar-2021, vials were stored in cooler 1, at following time and the temperature range was from 27 to 37 degrees between from 9 AM to 5 PM. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Shortly after vaccination, patient began to experience a vague sense of tightness in the chest which she had no history for.  Vital signs found mild hypertension consistent with her baseline.  Symptoms resolved in clinic
2 days after immunization, this patient went to the center for redness and swelling to varicella site on the right arm. The patient was seen by a doctor and told to keep the area clean and dry, and use over the counter Tylenol return if necessary.
Extreme fatigue, Chills, injection site discomfort, dizziness, nausea
Headache & Fever Narrative: "really bad headache on 1/2/021 and on 01/21/21 and low grade fever and very tired - scheduled off on 1/20/21 but did take sick leave 1/21/21.
soreness at injection site; lightheadedness; sleepiness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, light headedness and sleepiness. On an unknown date, the outcome of the injection site pain, light headedness and sleepiness were unknown.   It was unknown if the reporter considered the injection site pain, light headedness and sleepiness to be related to Shingrix.  Additional details were provided as follows: The patient reported that he was experiencing soreness at injection site, lightheadedness and sleepiness. The reporter did not give consent to follow up.
I have low grade temp; body ache; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (I have low grade temp) and MYALGIA (body ache) 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 22-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (I have low grade temp) and MYALGIA (body ache). At the time of the report, PYREXIA (I have low grade temp) and MYALGIA (body ache) outcome was unknown.
Vomiting for over 48 hours after taking covid vaccine. Had two doses Pfizer and one dose moderna which immediately cause intense nausea and vomiting. Since the vaccine recurrent vomiting has been occurring every 3 weeks for 48 hours.
The patient was given the primary series instead of the Bivalent booster. The patient has had no adverse effects from this.
The day of the vaccination, I felt a little woozy and tired; went to bed early, woke up the next morning feeling much better. But about two days later, I began feeling a slight vestibular disturbance. I wouldn't say I was nauseated, but I felt a little dizzy every time I turned my head, changed position, or breathed in. This was not debilitating, but also definitely wasn't normal. It lasted for about 10-12 days before beginning to get better, and now I feel completely fine. I didn't do anything to treat it except to exercise less (for fear of falling while running) and sleep a little more. I wasn't ill at any time during this period, had changed nothing else in my routine, and had no other symptoms. I'm assuming this event must have been related to the vaccine.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 28th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: The patient received the SHINGRIX in the left arm at a local pharmacy. The patient stated that, in the evening after receiving the SHINGRIX vaccine, the injection site was red, sore, painful and warm to touch. Due to the soreness he could not lay down on that arm. It resolved within 3 days. The patient stated, he was not been able to find any pharmacy which had SHINGRIX available for the 2nd shot. The patient was told, it should be administered in the next 2 months. No further details were provided. The patient gave permission to contact their healthcare provider.
Patient received on 10/11/14 and noticed the usual side effects but on 10/15/14 she noticed leg pain. She had back/leg issues in the past but she said this was buttocks pain also descending into both legs. Never experienced this before. She said the pain has now reverted back to one leg and she hopes it is disipating.
Adverse events included pain at injection site, low grade temp, extreme fatigue, joint discomfort and the most significant event being angina which started on the evening of day four post injection. Pain continued throughout day six and then started to subside. Symptoms were treated with tylenol, motrin and  much rest.
chest tightness and shortness of breath with abnormal EKG, symptoms lasted 24 hours and in the process of further evaluation by cardiologist. Pt reports similar symptoms after the first dose, but did not seek medical attention at the time.
Pregnant/4-weeks in/Wife is pregnant/Found out that wife is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY 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 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 09-Oct-2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY. On 09-Oct-2021, MATERNAL EXPOSURE BEFORE PREGNANCY had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. No concomitant medication was reported. Patient was not pregnant before the 1st dose was administered.  This case concerns a female with unknown age, who experienced non-serious event of maternal exposure before pregnancy which occurred with the 1st dose of mRNA -1273 vaccine (Moderna Covid 19 Vaccine. The re-challenge for this case is not applicable. The benefit -risk relationship of mRNA-1273 vaccine (Moderna Covid 19 Vaccine) is not affected by this report.
Severe rash on trunk of body. Started small around the belt line area and has spread to the entire abdominal and chest area, back, arms out to the elbow and mid thigh.
feeling nauseous; A spontaneous report (United states) was received from a consumer concerning, a female patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and felt nauseous/nausea.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, post receiving the vaccine the patient felt nauseous for 3 days.  Treatment information was unknown.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) was not applicable.  The outcome of the event, felt nauseous was considered resolved at the time of this report.
Fever; Fatigue; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body aches) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    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 PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body aches). At the time of the report, PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Approximately 20 minutes after my shot my throat became extremely painful and hoarseness,I had to take my rescue inhaler, I became very dizzy and weak and I ached all over. I was also running 99.4 temp. I was feeling fine before my flu shot and after I had to go home and go to bed. This lasted 2 days.Also my site swelled and became extremely red and sore.
Expired Bexsero Administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Meningococcal B Vaccine Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd August 2022, the patient received Bexsero and Meningococcal B Vaccine Pre-Filled Syringe Device. On 2nd August 2022, unknown after receiving Bexsero and Meningococcal B Vaccine Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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:02-Aug- 2022 Reporters comment: The reporter consent for follow-up. Additional Supportive information: The patient received an expired (31-July-2022) dose of the bexsero vaccine on 2-August-2022 which led Expired vaccine used. .
Rash on left arm, left wrist and left elbow. MD gave cortisone cream and it got better.
headache, nausea, fever, chills, body ache, joint aches, unable to eat, coughing, hard breathing.
The error was an administration error where the vaccine was used 6 days after the bud date.  The vial was moved from  the freezer on 1/30/23 to the frig, the vial stayed in the frig  until 3/7/23 about 1:50 pm, and the vaccine from that vial was administered on 3/7/23 about 2:05 pm.  I have contacted Moderna about the stability after the BUD and they replied that the vaccine maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.    I contacted the patient about side effects and the patient reported no side effects.
Information has been received from a father concerning his 6-month-old son who had no medical history or allergies who on 08-NOV-2007, at around 10:00, was vaccinated PO with a dose of Rotateq (Lot #657515/0668U).  The father reported that 08-NOV-2007, between 4-6 pm, his son's temperature spiked to 103 degrees and he started having watery green stools about every hour and a half.  On 10-NOV-2007, the patient was taken to the Emergency Room (ER).  No additional laboratory/diagnostic tests were performed.  Since then, his temperature was going up and down and as of 12-NOV-2007, his temperature was about 100 degrees.  He still had the watery green stools and had extreme diaper rash.  Additional information has been requested.
Hives present 3 days after (7/14). Still present 7/22. Prednisone and BENADRYL given.
Patient was sitting in the waiting area and started to feel faint, started sweating and saying he was going to pass out. He sat down on the floor and the pharmacist attending him became very worried about the diaphoresis and we called 911. Patient was given water and an ice pack, by the time EMS arrived he was sitting upright again and felt fine, denied care from EMS.
Pt received H1N1 shot at 08:30, Nov 17, 2009. At 10:00, developed fine maculopapular rash on both arms; slightly pruritic. No throat fullness, wheezing, SOB.
Throat felt like it was closing; This spontaneous case was reported by an other health care professional and describes the occurrence of THROAT TIGHTNESS (Throat felt like it was closing) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROAT TIGHTNESS (Throat felt like it was closing). At the time of the report, THROAT TIGHTNESS (Throat felt like it was closing) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  The patient felt like that it was not a good idea to receive the booster dose of the vaccine.
COVID break through case. I received my 1st booster shot on 12/04/2021 and MY COVID symptoms started on 05/18/2022  sore throat, nasal congestions, headache, low grade fever,  lost appetite, being tired, I tested on 05/19/2022 positive. I did a tele health with my doctor on 05/20/2022 he gave  zinc, D3 and antibiotics. I took all the med for 7 days.
Daughter received Rotateq vaccine. Severe vomiting and diarrhea occurred within 24 hours. Spread to household members. Required ER visit.
At 5:00AM on December 23, 2022, I woke up with a burning sore throat. I tested positive for COVID-19 on the same day.  I had a tele visit with the doctor and was prescribed PAXLOVID. Symptoms were sore throat, headache, mild fever, some chills, dry cough, and diarrhea. I continue to have digestive issues and mild cough.
The next day after taking the vaccine i got a bad reactive swelling all over my body and face, Went to the urgent care, was given meds, but end in the hospital for 4 day.
1045am - pain in injection site 12pm - pain spread to neck. 645pm - intense pain in lower left arm requiring ice packs. 11:30 - start of intense chills/rigor lasting about 45 mins. next 12 hours - Intermittent body and muscle aches plus fever. Fever up to 99.5 lasting until 630pm next day (day 2).  Fever broke and just a mottled red marks remain on left arm (day 3)
Booster given sooner than recommendation by the CDC. Second dose was dated 04/12/2021 making the booster 7 days early.  No other issues noted while patient was at clinic.
Information was received from a company representative regarding a female patient who received a second dose of GARDASIL ".5 ml" (route not reported). The company representative was informed by the physician office manager that the patient who had received her second dose of GARDASIL "about a year and a half ago" stood up and fainted "after being administered the vaccine. The patient was sent to the emergency room (duration of visit unknown). No further information was provided. Additional information has been requested.
incorrect product storage; No additional adverse events reported; This spontaneous report was received from an administrator via a Nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and  concomitant medications were not provided.   On 29-JAN-2021, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) which had a lot # T013204 with expiration date on 03-DEC-2021 (dose, frequency and route of administration were not reported) for prophylaxis. Other dose of hepatitis a vaccine, inactivated (VAQTA) with lot # T013204 and expiration date on 03-DEC-2021 was also improperly stored. However no adverse events were mentioned.   It was reported that the vaccines were exposed to temperature of -7.9 Centigrade range for a time frame of 52 minutes and -10.5 for 52 minutes The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Case completed primary Pfizer series in January 2021, then died of Covid September 2021. At Hospital, discharging physician MD. From some combination of pulmonary edema from non-ST elevation MI, Covid infection, moderate patchy bilateral airspace opacities -Required BiPAP on arrival to the ICU on the 25th -Decompensation with respiratory arrest, potentially associated with olanzapine IV, severe delirium on the 27th Continue BiPAP  Hospital Course: Patient was admitted about 48 hours ago with STEMI requiring coronary PCI. Unfortunately she had a respiratory arrest and went into renal failure. The family was consulted with the poor prognosis and the need for dialysis and potentially long-term ventilation care. They opted instead for comfort measures later this afternoon. She was placed on comfort care measures and passed away at 2055
Hives all over upper thighs starting the morning I woke up two days after receiving the vaccine.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 21-JUL-2015, the patient was vaccinated with an improperly stored dose of M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient felt like her face is swollen, she felt faint like about to faint. chest pressure.
Patient presented with swollen, inflamed (L) arm down to elbow - and low grad fever T99.5. (R) arm 3cc inflammation 9-3-09. CBC and IM Decadron 8mgs UOQ (R). 9-4-09 Much improved.
Night after vaccine started to have chills, headache, coughing, muscle aches, some difficulty breathing and swallowing, lack of appetite. Still having symptoms. Calling clinic today
1/31/2023  I woke up and I had a headache in the back of my head, it felt like a sharp pain. I took Tylenol and it went away. It came back for a few days. I called my doctor, and he prescribed Neurontin. My headaches went away after a week.
Information has been received from a physician concerning a 22-month-old male who on 16-SEP-2005was vaccinated in the left arm with a dose of Varivax (Oka/Merck) (lot# 649738/0120R). On 30-JUN-2006 at 08:00 am the patient broke out with chickenpox. It was not reported if medical attention was sought. Subsequently, the patient recovered. Additional information is not expected.
first noticed rash to lt forearm 12/97, stable to 1/99 @ which time saw dermatologist;given kenalog 1/99 resulted in improvement by 3/1/99 but had exacerbation by end of 3/99 w/extension to neck & later to abd;tx pred taper;
Received full dose of Moderna booster- I/O half dose, no adverse RX of patient.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 01-JUL-2013, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # H018796 and expiry date: 24-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Pain, achiness in upper left arm. Also, moved into shoulder causing pain w/certain movements similar to rotator cuff as well as movements behind back. Visited Dr. on November 30. Ordered x-ray and referred to therapy. Currently have first appt. to see therapist.
Pain in left shoulder not able to lift arm up over head. Unable to take off shirt or sweater due to the pain. Can't sleep or apply and weight on that arm . Hurts when I drive.
Patient claims since the 1st "GARDASIL" injection on 1/10/07 has been having heavy menstruation (no other cause found).