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 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 9:03 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 9:03 AM, 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. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 66.51 for dose administered on 28-Feb-2021  No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 28-FEB-2021 with temperature 27 degrees Fahrenheit from 09:00 AM to 01:00 PM. This vial was moved to fridge on 24-FEB-2021 and beyond use date for the vial was reported as 26-MAR-2021. Product moved to clinic on 27-FEB-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported. 014M20A   This case was linked to MOD-2022-566976 (Patient Link).
Complaints of rash arms, neck, ear region 5 days after completing typhoid oral capsules (vaccine). States does not itch or bothersome.
Shingles diagnosed on May 17, 2021.  Pain and rash started on Monday, May, 10, 2021.  Rash followed on May 12.
Information has been received from a physician concerning a 12-month-old patient who was vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently, one week after vaccination, the patient experienced a rash. No further information is available. There was no product complaint involved. Additional information has been requested.
Injection site arm tender; Bruised; Injection site arm is weak; A spontaneous report was received from a consumer concerning an 80-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site arm tender/vaccination site pain, bruised/contusion and injection site arm is weak/muscular weakness.  The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.   On 10 Feb 2021, prior to the onset of the events, the patient received their unknown of two planned doses of mRNA-1273 (Lot number: 016M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 10 Feb 2021, patient experienced injection site arm tender, bruised and injection site arm is weak.  Lab details were not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, injection site arm tender, bruised and injection site arm is weak were unknown.
Information has been received from a physician concerning a 64-year-old female who on 05-FEB-2008 was vaccinated subcutaneously with "1 vial" of ZOSTAVAX. In the evening of 06-Feb-2008 the patient developed a "burning feeling" in her hands and feet with some mild swelling of the hands and feet. Medical attention was sought via a phone call on the morning of 07-Feb-2008. There was no laboratory or diagnostic studies. The outcome was reported as recovering. No product quality complaint was involved. Additional information has been requested. Follow-up information has been received on 04-Apr-2008 from her physician who indicated that he "does not remember which patient it was or the specifics of the reactions". Additional information is not expected.
This spontaneous report as received from nurse practitioner refers to a 18 years old female patient. The patient's medical history included palpitations. The patient's relevant past drug history was unknown. The patient was vaccinated with the first, the second and the third dose of GARDASIL in August 2011, November 2011 and on 26-JUN-2012, respectively. No other co-suspects were reported. Concomitant medications included: multivitamin (unspecified). Nurse practitioner reported that on 25-APR-2012, a test results showed that the patient had "mild buckling of anterior mitral leaflet (AML), no Mitral valve (MV) prolapse". On an unknown date, after a dose of GARDASIL, the consumer developed supraventricular tachycardia (SVT). No treatment information was reported. On 13-JUL-2012, the nurse practitioner reports that the consumer was scheduled for a radiofrequency oblation. As of 14-JUL-2012 the patient continued to experience supraventricular tachycardia (SVT) and it was unknown if she continued to experience "mild buckling of AML, no MV prolapse". The relatedness for the patient's events was no reported for GARDASIL. Additional information has been requested.
Pt had a flare of her multiple sclerosis and will be on prednisone.
left side of the body was numb from neck, ear, and whole left head area/left arm was numb /left arm was numb; pain at vaccination site (left arm) on regular basis/left arm is still hurting; feels like it is heating up; having general discomfort; got sick with flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (got sick with flu symptoms), HYPOAESTHESIA (left side of the body was numb from neck, ear, and whole left head area/left arm was numb /left arm was numb), VACCINATION SITE PAIN (pain at vaccination site (left arm) on regular basis/left arm is still hurting), FEELING HOT (feels like it is heating up) and DISCOMFORT (having general discomfort) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced INFLUENZA (got sick with flu symptoms). On an unknown date, the patient experienced HYPOAESTHESIA (left side of the body was numb from neck, ear, and whole left head area/left arm was numb /left arm was numb), VACCINATION SITE PAIN (pain at vaccination site (left arm) on regular basis/left arm is still hurting), FEELING HOT (feels like it is heating up) and DISCOMFORT (having general discomfort). On 25-Mar-2021, INFLUENZA (got sick with flu symptoms) had resolved. At the time of the report, HYPOAESTHESIA (left side of the body was numb from neck, ear, and whole left head area/left arm was numb /left arm was numb), VACCINATION SITE PAIN (pain at vaccination site (left arm) on regular basis/left arm is still hurting), FEELING HOT (feels like it is heating up) and DISCOMFORT (having general discomfort) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) normal. On an unknown date, Magnetic resonance imaging: normal (normal) normal.         No concomitant medications were reported. No treatment medications were provided.
Swelling on heart and lungs; Swelling on heart and lungs; Other symptoms and medical issues in left arm and shoulder where vaccine was administered; Spontaneous report received on 22FEB2020.  A consumer reported swelling on heart (PT: Cardiomegaly) and swelling on lungs (PT: Pulmonary oedema) and had other symptoms and medical issues in left arm and shoulder where the vaccine was administered (PT: Injection site reaction) following immunisation with Anthrax vaccine (anthrax vaccine adsorbed). On 20JUL2011, the consumer received anthrax vaccine (lot number: FAV248) and one other vaccine (unspecified). The consumer had swelling on heart and lungs and had other symptoms and lot of medical issues, particularly in the left arm and shoulder where the consumer received the vaccine. The outcome of the reported events was unknown at the time of report.  Company Comment: A consumer received BioThrax vaccination along with other unknown vaccine and developed injection site reaction along with swelling on heart and lungs (Cardiomegaly and Pulmonary oedema). Information on medical history, concomitant medications, and further details of the events is limited. Considering the limited information regarding onset of events - as the patient received vaccine 9 years ago, diagnoses, or patient medical history where patient developed cardiomegaly and pulmonary oedema after receiving BioThrax, causality of both the events is considered not assessable. The case is also confounded by unknown concomitant vaccine administration. BioThrax can cause local injection site reaction and the causality of the event is assessed as possible. The case is considered serious due to medical significance of the events cardiomegaly and pulmonary oedema which are unlisted as per.; Sender's Comments: Company Comment: A consumer received BioThrax vaccination along with other unknown vaccine and developed injection site reaction along with swelling on heart and lungs (Cardiomegaly and Pulmonary oedema). Information on medical history, concomitant medications, and further details of the events is limited. Considering the limited information regarding onset of events - as the patient received vaccine 9 years ago, diagnoses, or patient medical history where patient developed cardiomegaly and pulmonary oedema after receiving BioThrax, causality of both the events is considered not assessable. The case is also confounded by unknown concomitant vaccine administration. BioThrax can cause local injection site reaction and the causality of the event is assessed as possible. The case is considered serious due to medical significance of the events cardiomegaly and pulmonary oedema which are unlisted as per.
Information has been received from a physician concerning a female patient with no pertinent medical history, who on an unknown date was vaccinated with the second dose of GARDASIL (dose, route and lot number not reported). The reporter stated that 1-2 months after the 2nd dose of GARDASIL the patient experienced weakness, tiredness, fatigue and muscle aches. The physician did unspecified lab work that came up as what the physician believes as a false positive for lupus. The patient went to an unspecified Rheumatologist who ran another set of unspecified lab work (results unspecified) and the Rheumatologist did not believe the symptoms the patient was experiencing was related to lupus. The physician thought the patient's symptoms were related to the patient being a teenager and not related to GARDASIL. The patient did not have a problem after receiving the 1st dose of GARDASIL. No treatment was given for an AE. At the time of the report the patient's status was not recovered. The patient sought medical attention - office visit. Upon internal review unspecified diagnostic laboratory tests performed: the physician believed as a false positive for lupus were considered to be an other important medical event. Additional information has been requested.
flu like; achiness; lymph nodes feel sore all over; feels feverish/slightly elevated temperature; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like), PAIN (achiness), LYMPH NODE PAIN (lymph nodes feel sore all over), PYREXIA (feels feverish/slightly elevated temperature) and ARTHRALGIA (joint pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A71A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like), PAIN (achiness), LYMPH NODE PAIN (lymph nodes feel sore all over), PYREXIA (feels feverish/slightly elevated temperature), ARTHRALGIA (joint pain) and HEADACHE (headache). The patient was treated with ACETYLSALICYLIC ACID, PARACETAMOL (EXCEDRIN BACK AND BODY) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like), PAIN (achiness), LYMPH NODE PAIN (lymph nodes feel sore all over), PYREXIA (feels feverish/slightly elevated temperature), ARTHRALGIA (joint pain) and HEADACHE (headache) was resolving.            No Treatment informations were reported.   This case was linked to MOD-2021-365061, MOD-2021-365066 (Patient Link).
Received 2 doses of COVID-19 vaccine (2/3/21 and 2/24/21) then tested positive for COVID-19 through symptomatic testing.
Redness to Left Upper Bicep, Gastric Pain, Diarrhea, Fever Chills
I prepared the vaccine as usual and inserted the needle in the patient's right deltoid.  As I pressed down on the plunger, however, the vaccine poured out the junction between the needle and the vaccine.  I promptly removed the needle from the patient's arm and discovered a manufacturing error in the plastic portion of the needle.  Since I was very confident the patient did not receive any of the vaccine, I vaccinated him in the left deltoid with a new vaccine and a safety needle manufactured by a different company.
Pt reacted with swollen and red left arm the next day. No fever. Came into office and was looked at. No medications.
Progressive intermittent right eye blindness.  Workup demonstrated bilateral ophthalmic arteritis and optic nerve constriction.  Treatment with 40mg oral Prednisone BID.  Over the course of 8 weeks with tapering  Prednisone dosage vision returned.
This spontaneous report as received from a registered nurse concerning unspecified number of patients of unknown age who on an unknown dates were vaccinated with RECOMBIVAX HB (doses, routes and lot numbers not provided) that were exposed to 28F for an unknown period of time. No adverse symptoms were reported. Additional information has been requested.
Received the Shingles vaccination on May 26, 2009.  Onset of Shingles on July 6, 2009. It was strongly recommended that I take the shot, so I finally did.  I questioned two Doctors and one pharmacist as to whether I was a candidate for the vaccination and they all said definitely "yes"?  And all recommeded I take the shot since I have RA and my immune system is compromised.  My husband and I went to the facility---no one questioned me as to my present medications.  After the vaccine was administered, we were given informational sheets which I read when we returned home....Much to my concern, I read that anyone on prednisone now or previously should not get the immunization.....I was on prednisone.  Too late for me...Am taking Valtrex--500 mg/3 daily.
syncopal episode, clammy, diapohoretic was given water and granola bar
Large painful lump under arm lasting 9 days. Extreme fatigue and grogginess beginning 4/27 and resuming 5/8-5/10 (today) extreme stomach pain, feels like acid. Burning insides of stomach lining from 5/1-5/3. Stomach pain back but less severe 5/9-5/10 when fatigue resumed. Do not have healthcare or physician access.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, unspecified patients were vaccinated with doses of improperly stored VARIVAX (lot # L041204, expiration date 20-OCT-2017, lot # M004329, expiration date 29-JAN-2018; dose and route were unknown). No adverse reactions was reported. Additional information has been requested.
High fever 102.5, achy, fatigue, Rt arm soreness developing approx. 24 hrs after immunizations fever decreased to 101 approx. 48hrs after immunizations. Regarding ITEM 21 - pt offered Clinic visit pt declined due to distance to clinic - but had to check off at least 1 item.
Patient was given varicella and meningococcal vaccines.  After vaccination patient stated "I feel lightheaded."  While still seated, pt began to rest head on arm and began to faint.  She became stiff and voided.  An ammonia capsule was broken and placed under pts nose.  She was then alert and had no knowledge of what had happened.  Pt was assisted onto a cot with legs raised.  BP taken.  O2 sat taken.  EMS called.
the back (mostly left side) of her head gets so tight and sore; felt like the back of her skull was fractured/the back (mostly left side) of her head gets so tight and sore; all color drained from her face; tunnel hearing; tunnel vision; felt the worst feeling about to faint; felt a "static" feeling all over her body; throwing up; fever; migraine; aches; Chills; hot sweats; This is a spontaneous report from a contactable consumer (the patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6207), via an unspecified route of administration in the left arm on 13Mar2021 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: asthma and lactose Intolerance- not allergy though (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: fluticasone propionate/ salmeterol xinafoate (ADVAIR), loratadine, bupropion hydrochloride (WELLBUTRIN), and vitamins (as reported), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6200), via an unspecified route of administration in the left arm on 20Feb2021 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunization. The patient stated that 24 hours after her second dose (14Mar2021 12:00), she felt the worst feeling about to faint, all color drained from her face. She got tunnel vision/hearing and felt a "static" feeling all over her body. Then started throwing up. She took a nap and woke up an hour later with 101.2 (degree) fever (14Mar2021) and fought that, along with migraine, aches, chills, hot sweats (14Mar2021). About 8 hours after initial fever (14Mar2021), it spiked to 102.4 (degree) for two hours. It came down quick. The next day, 15Mar2021, it felt like the back of her skull was fractured. And since then (unspecified date), the back (mostly left side) of her head gets so tight and sore especially when laying down. She has been sleeping on heating pad for 10 days now, and it got a little better but still super sore (head). The events involved a doctor or other healthcare professional office/clinic visit. Treatment was received for the back (mostly left side) of her head gets so tight and sore. There was no treatment for the other events. The outcome of the events was recovered with sequelae. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
This adverse event report pertains to an administration error which is leading to recipient needing to be re-vaccinated. On 3.11.21 vaccinator believes this individual may have received either an 'empty syringe' injection or possibly a sub-therapeutic dose. This has been reported to the recipient. Per published guidance from the CDC (reiterated by Moderna) and per guidance of  Immunization Program and the medical advisor Dr.  the attempted dose should be repeated. Moderna report # MOD21-053497. Dose # 1 will be administered/readministered on 3.23.21 .
Headaches, swelling in area where shot was administered, severe itching in area where shot was admin.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent medical conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with an improperly stored dose of PROQUAD recombinant human albumin status (lot# L050909 with expiration date 14-JUN-2017; lot # L033697 with expiration date 28-FEB-207; lot# L051099 with expiration date 17-JUN-2017; lot# L030585 with expiration date 10-FEB-2017; dose, anatomical location and route of administration were not reported). The vaccines were exposed to 4 hours 30  minutes at 47.5 Fahrenheit (F)  on the fifth of April (year unspecified), 1 hour and 30 minutes at 48.9 F on the fifth of May (year unspecified) and 1 hours at 51.6 F on the sixth of May (year unspecified). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
We had an incident at our flu shot clinic where the patient had a reaction to the flu shot. The patient was a 30 year old male, DOB 5/13/75 he had no previous flu shot. I verified with the patient if he was allergic to eggs and he stated that he was not. The patient was Hispanic but spoke perfect English. I gave him the shot an the he told him to stay in the store for 15-20 minutes and if he "felt funny" then he would come back to me. He came back about 7-10 minutes later and said that he couldn't feel his arm and that his hands were swelling. I told him to sit down and asked if he was having trouble breathing. He said no. I told my technician , who was helping me to call 911. She did and gave them the info that was available. As the patient was sitting and I was talking to him. he said he was feeling a little dizzy and his head went down.. I said stay with me.. talk to me.. he was. And I gave him the first Epi-Pen dose about 2 minutes after we got off the phone with 911. After I did that I was talking to him ad he started seizing. I held his head and was talking to him. When the seizure was over he was talking to me again and saying that his head hurt. After about another 2-3 minutes, I gave another Epi-Pen and then the paramedics came and took him away after doing the vitals. He was talking when he left. If you have any questions, please don't hesitate to call.