chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 2:32 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 2:06 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) 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 31.37 and 31.27.  Concomitant products were not provided.  On 11 Jan 2021, Excursion time was 9 AM and 10 AM temperature was 32, 34 total doses given for the day was 94, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 16 Mar 2021, vial was moved to clinic on 21 Mar 2021. 10 vials were sent to clinic. Vaccine BUD date was 15 Apr 2021. Excursion time was 9 AM, 10 AM, 11 AM, 2 PM, 3 PM temperature was 32, 35 total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 13 Jan 2021. 30 vials were sent to clinic. Vaccine BUD date was 10 Mar 2021  On 31 Mar 2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  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.
This spontaneous report as received from a health professional refers to a 17 month old patient. On 17-JUN-2014 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # J009728, expiration date: 07-AUG-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2021-395985.
Sinus infection, drainage in the back of throat, headache, fluid in ears, mild cough
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number F9TG5, expiry date 18th September 2023) for prophylaxis.   On 2nd September 2022, the patient received the 1st dose of Shingrix. In September 2022, 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK receipt date: 30-NOV-2022 Reporters comment: The pharmacist reported that the patient developed a shingles approximately two weeks after the 1st dose of shingrix.  The reporter consented to follow-up. Additional supportive information: This case is linked to the case US2022179394, reported by the same reporter.; Sender's Comments:  US-GSK-US2022179394:Same reporter
He got the vaccine and had the soreness in his arm. It's still sore today 8/1/2022. He went to work. When he got home he had a temp of 101.6 and nausea. He took some acetaminophen 2 tablets, and went to sleep. The next morning he took his temp again and it was 100.6. Took some more acetaminophen. He still felt a bit nauseous throughout the day, tired and slept most of the day. The following day, the fever was gone. He still felt somewhat nauseous. This eventually went away except for the soreness in the arm. He is feeling ok today, except the arm at the injection site is tender to the touch.
swollen throat; Bad taste in mouth; sore throat; This is a spontaneous report received from a non-contactable consumer, the patient. A 42-year-old male patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 28Mar2021 at 11:30 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 29Mar2021, the patient experienced throat swelling, sore throat and bad taste in the mouth. The adverse event resulted in emergency room or department or urgent care. The patient was tested for COVID-19 post-vaccination. The patient underwent a SARS-CoV-2 nasal swab test on 04Apr2021, and the result was negative. The patient received pain medicine as the treatment for the adverse events. The clinical outcome of the events throat swelling, sore throat and bad taste in mouth were not recovered at the time of the report.  No follow-up attempts are possible; information about the lot number cannot be obtained.
no adverse event; M-M-R II that has experienced an ongoing temperature excursion; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions and allergies was not provided.  The reporter stated measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) experienced ongoing temperature excursion started on 13-MAY-2021 at 09:15 with highest temperature at 114. 8 Fahrenheit (F). On the same day after excursion started, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (dose, route of administration and anatomical location were not provided; lot # S039319 has been verified to be a valid lot number, expiration date was 04-DEC-2021) for prophylaxis (product storage error). The vaccine's temperature was not back in range, the temperature at time of administration was unknown. It was reported that there were no previous temperature excursions. The digital data logger was involved in recording excursion details. No additional adverse events (AEs) were reported.
HEADACHE; FEVER; This spontaneous report received from a consumer concerned a 19 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and fever. This report was non-serious.
Patient presented 5 days after receiving the MPSV4 vaccine with rash over her trunk and upper arms. Will monitor patient. Refer also to dermatology for further evaluation.
Headache, Myalgia, Fever, chills, sore throat, arm pain Narrative:
Symptomatic  covid 19: low grade fever , congestion, cough and SOB. Body aches and headaches.
Swelling of arm from elbow to shoulder, hot to touch, sore x 4 days.
redness on rt thigh close of inj site approx 8-10min p/vax;emergency care instituted per protocol, epi given;all sx subsided;vital signs nl, eval requested tx room;
severe pain/discomfort and weakness in legs for 24 hrs (6pm on day of vaccine to ~6pm on next day); constant migraines (more than normal) over last 3 weeks; did not seek care for side effects as they only lasted till next day  appendicitis/appendectomy on 4/1/2021; hospitalization through 4/3/2021
Timeline of symptoms following vaccine #2 injection at 10:20am on 4/16: - injection site soreness began 1:30pm - accelerated heart rate (anxiety?) around 4:30pm  - no appetite/slight nausea at 5:00pm - mild headache 5:30pm - extreme arm pain and overall discomfort overnight, very little quality sleep - injection site warm and hard upon wakeup at 9am - fever developed around 11:30am, took Tylenol to combat at 2:30pm. Fever reading of 100.6 as of 2:15pm - fever broke - temp reading of 98.8 at 5:15pm - nausea increased again at 7:30pm. Temp reading of 100.4 as of 7:50pm - took Tylenol for fever at 8:00pm - mild diarrhea before bed - woke up soaked in sweat 7am - all symptoms subsided by 8am on 4/18 - no fever but experienced night sweats again 4/18-4/19 - mild night sweats 4/19-4/20
patient received improperly stored vaccine; This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's concurrent condition, concomitant medication and medical history were unknown. On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), one dose of lot # S007075 with expiry date 06-SEP-2020 (frequency, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccine was exposed to 32.5 Fahrenheit temperature for 8 hours. No previous temperature excursion was reported. Data logger was involved. The outcome of the event was unknown.
lost 50% of vision in right eye, and there was 50% eye loss; noticed a bit cloudiness; This spontaneous case was reported by an other health care professional and describes the occurrence of VISUAL IMPAIRMENT (lost 50% of vision in right eye, and there was 50% eye loss) and VISION BLURRED (noticed a bit cloudiness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Delusion, Memory impairment, Behavior disorder, Headache, Hashimoto's disease, Frozen shoulder, Heart disease, unspecified, Heart valve disorders, Allergic to poison ivy, Latex allergy, Allergy to metals, Diabetic and Blood pressure high. Concomitant products included MIRTAZAPINE, AMLODIPINE BESILATE (NORVASC), LEVOTHYROXINE SODIUM (SYNTHROID), ATENOLOL (TENORMIN), OLANZAPINE (ZYPREXA), APIXABAN (ELIQUIS) and INSULIN ASPART (NOVOLOG) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced VISUAL IMPAIRMENT (lost 50% of vision in right eye, and there was 50% eye loss) and VISION BLURRED (noticed a bit cloudiness). At the time of the report, VISUAL IMPAIRMENT (lost 50% of vision in right eye, and there was 50% eye loss) and VISION BLURRED (noticed a bit cloudiness) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient medical history includes reflux and concomitant medication as Protonix Dr and "Aspart".  Patient went to her eye doctor, who did an annual exam, and he noticed all the vessels were clear prior to the second dose.  The patient noted some cloudiness the day after the second dose. She lost eye sight after the second dose.  No treatment information was provided by reporter.  Action taken with suspect drug is not applicable.   Reporter did not allow further contact
Swelling and pain to left arm from deltoid to fingertips; Swelling and pain to left arm from deltoid to fingertips; This is a spontaneous report from a contactable nurse (patient also).  A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL3248) via Intramuscular route of administration, administered in left arm on 03Feb2021 at 08:45 AM as 1st dose single for covid-19 immunisation in hospital. The patient medical history included hypertension. The patient had allergies with eggs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient not been tested for COVID-19. The patient's concomitant medications included lisinopril, HCTZ and fexofenadine (within 2 weeks). On 03Feb2021, 09:00 AM, the patient experienced swelling and pain to left arm from deltoid to fingertips. The patient did not receive treatment for the adverse event. At the time of this report events outcome was not recovered.  Follow-up attempts are completed. No further information is expected.
slight sore throat; gigantic area at injection site; very hot at injection site; dizziness; swelled up at injection site; tired , body is uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (slight sore throat), VACCINATION SITE REACTION (gigantic area at injection site), VACCINATION SITE WARMTH (very hot at injection site), DIZZINESS (dizziness) and VACCINATION SITE SWELLING (swelled up at injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (slight sore throat), VACCINATION SITE REACTION (gigantic area at injection site), VACCINATION SITE WARMTH (very hot at injection site), DIZZINESS (dizziness), VACCINATION SITE SWELLING (swelled up at injection site) and FATIGUE (tired , body is uncomfortable). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (slight sore throat), VACCINATION SITE REACTION (gigantic area at injection site), VACCINATION SITE WARMTH (very hot at injection site), DIZZINESS (dizziness), VACCINATION SITE SWELLING (swelled up at injection site) and FATIGUE (tired , body is uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt developed rash on 6/21/10.  Seen in office 6/23/10 and dx with varicella. No associated symptoms.
After getting the SECOND dose of the shingrix on 2/1, she developed fever blisters on 2/3 that the Dr identieifed on 2/18 to be "Vaccine-associated zoster", to which they prescribed Valtrex and Gabapentin
Left axillary swelling and pain a few days after my left arm Pfizer injection. The aching pain lasted for about 3 weeks.  The swelling gradually declined, but still has not completely resolved. My left axilla is still a bit more swollen than the right. However, there is no pain/aching anymore.
Dice my second dose I have had breast pain that started on 10/02/2021.  It started out like a feeling of soreness like before a period. I also had this funny feeling sometimes in my arm pit. After the first week they started feeling sore like when your breast are full when it?s time to breastfeed.  The second week the pain is like the level of when you breastfeed but you can?t pump. It going on the 3 rd week and now I am unable to even sleep on my stomach the are so sore, to the point where they hurt to touch. Today I noticed I have shooting pains and I am unable to wear a bra, so they hurt when they move.  Although I did talk to my provider about previous allergic reactions, I was assured that this wouldn?t be an issue. I was trying to wait to see if it would go away on its on but I will be making a doctors appointment next week because I am unable to sleep comfortably and the pain is becoming unbearable.
My mother in law had a stroke 20 days after her second dose of her moderna vaccination, she was laid up so sick with a fever for the following 24 hours post vaccine and then suffered a major stroke 20 days later, her left side is completely immobile.
Patient initially experienced chills/fever the evening of day of vaccination.  Symptoms progressed to breathing problems and weakness.  Patient was seen by PCP.  Blood tests were performed and lungs were examined.  Patient stated PCP said everything looked good but they were going to possibly perform more blood test.  Patient contacted pharmacy on 05/14/19 to inform us of issues.  Symptoms are still ongoing.
chills; tired; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 17th June 2022, the patient received the 1st dose of Shingles vaccine. In June 2022, less than a week after receiving Shingles vaccine, the patient experienced chills and tiredness. On an unknown date, the outcome of the chills and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the chills and tiredness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-JUN-2022 Reporter's Comments: This case reported by consumer via interactive digital media. The case was reported by patient himself/herself. The patient received vaccine the day before reporting and was feeling chills and tired. Follow-up would not be possible as no contact details available.
Adverse rash on his foot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Adverse rash on his foot) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Adverse rash on his foot). At the time of the report, RASH (Adverse rash on his foot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Feb-2021 and was forwarded to Moderna on 09-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (Adverse rash on his foot) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Adverse rash on his foot). At the time of the report, RASH (Adverse rash on his foot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
GUILLAIN BARRE SYNDROME; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  Reporter reported that, "I got the Johnson an Johnson an 3 weeks later I had to use a walker an got GBS spent 5 days in the hospital had to go to therapy to get so I could walk still have muscle issues " On an unspecified date (3 weeks after vaccination), the patient was unable to walk hence used walker and experienced guillain barre syndrome (GBS). The patient was hospitalized on an unknown date for 5 days where patient received therapy so patient could walk but still patient had muscle issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from guillain barre syndrome. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20221142500- Guillain Barre syndrome. The event has a compatible/suggestive temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Intense pain as of 9 pm, 9/15/11 approximately 8 hours after the inoculation, which was administered high on the left shoulder. The pain for several weeks did cause tears even when the shoulder remained immobile. Five various doctors have been seen and a MRI was required which definitely showed a split rotor cup. The treatment involved was treatments of ultrasound and laser. The medicine prescribed is Acetaminophen w/ codeine #3. These are necessary to allow her to sleep. The inoculation was administered by a pharmacist. According to the internet this situation occurs often, apparently due to the inappropriate choice of site.
"feeling of heat" at 15 minute mark- per RN light redness to left arm and warmth. Slight swelling noted. Benadryl administered PO, patient monitored for an additional 15 min. No further symptoms noted.