chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8/22/07-Emesis, diarrhea, cranky, no dehydration AE persisted x 5 days.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the second dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
In addition to the ?normal? side effects of pain on the injection place, shivers and fever after ca 24h of the vaccination I started, in the first week after the vaccination, having pins and needles in my hands and feet (those came and went) and severe nerve pain in my right arm where my neuroma is. The neuroma then got much bigger, harder and painful. The pins and needles eased off after couple of weeks apart of that right hand. They still persist though are easing off now and my right arm hurts and feels heavy. Also my heart started beating now funny in the first week after the vaccination- it, from time to time, just stops beating regularly and just ?goes overdrive? (for about 10-15 seconds) and the feeling is like it wants to jump from my chest. It doesn?t seem to be beating faster, it?s kind of like it is seizing. I have managed to catch end of such an episode with KardiaMobile. It was happening several times per day initially, now after almost 3 months it happens every few days.
child patient received MMR II intramuscularly; No adverse effects; This spontaneous report was received from a pharmacist and refers to a child patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), intramuscularly (instead of subcutaneously) for prophylaxis. Concomitant medication included sterile diluent. No adverse effects were reported
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant  medications were reported.  Treatment medicines include Tylenol  Action taken with mRNA-1273 in response to the event was unknown   This case was linked to US-MODERNATX, INC.-MOD-2021-074739 (Patient Link).
Left deltoid swollen, warm to touch. C/o pain when raises arm to shoulder level. Rates pain as 5 on 0-10 scale with movement.
About 9 1/2 hours after administration of the vaccine I felt a large, hard lump on my left cheek. This was one of the sites of Juvaderm facial filler that was administered on July 22, 2021.
On January 19, 2021 her triglycerides were 1513 which is extremely high.
Given vaccine from punctured vial that was on the counter since 16-Jul-21 in unknown arm; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given vaccine from punctured vial that was on the counter since 16-Jul-21 in unknown arm) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given vaccine from punctured vial that was on the counter since 16-Jul-21 in unknown arm). On 30-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Given vaccine from punctured vial that was on the counter since 16-Jul-21 in unknown arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up received contains no new information.
Patient was given 2ml of Pfizer 5-11yr orange cap that had been prepared with 1.0ml of diluent instead of 1.3ml of diluent.  There was no adverse reaction noted at observation and none reported by parents 5 hours after vaccination.
Received call from pt. Caller reported redness, swelling, pain and inability to move R arm post pneumonia vaccine injection. Plans to notify physician. Caller reported she received flu injection in L arm and pneumonia injection R arm on 10-23-09.
Self Reporting:  4/8/21 - Metallic taste in mouth within 20 minutes of vaccination, within 1 hour fatigue and nausea. Later feeling worse with muscle aches, afebrile. 4/9/21 - Awakened with fatigue, Temp 99.8 at 1630 with chills. Tylenol 1000mg PO taken. 4/10/21 - Evening temp 99.4 with chills:Tylenol 1000mg PO taken. 4/11/21 - Fatigue continued. No chills or temp.  4/12/21 - Evening temp 99.0 with chills.
Rash developing on neck, arms, and thighs.  On my neck 19Dec07 (after 1st shot) 12/17/07, arms & thighs 4Jan08 (after 2nd shot) 01/03/08.
pt recv vax in 1993 & 2 wk later devel Bell's Palsy;No further details were provided;
A non-serious spontaneous report of rash and whelps was received from an office manager of a doctor's clinic concerning a 31-year-old female health care worker after receiving FLUMIST.  The patient has no known allergies to food including eggs or other medication.  She is not taking any concomitant medications.  The patient received FLUMIST intranasally on 17-Sep-2008.  Upon awakening on 19-Sep-2008, the patient noted rash and whelps over her entire body and inside her mouth.  On the same day, she consulted with her health care provider.  She was given an unknown steroid injection in the clinic and prescribed unknown steroid to be taken orally.  The patient's rash and whelps resolved on 21-Sep-2008.
Chronic fatigue Fibromyalgia like symptoms  Brain fog Muscle Aches  I've been experiencing these symptoms for about a year. I've been taking different supplements and antihistamines to try to alleviate the symptoms.
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: intense pain in shoulder, neck, and left lower portion of left breast
vaccinated and still got shingles/ suspected vaccination failure; still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: vaccinated and still got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-Mar-2023 This case was reported by a patient's wife via interactive digital media. The patient was vaccinated and still got shingles, some people would still get shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up was not possible, as no contact details were available.
Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   On 17th January 2023, the patient received Havrix. On 17th January 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 18-JAN-2023 Reporter's Comment: The pharmacist reported that the patient received expired Havrix vaccine.  The patient was planning to travel.  The reporter did not consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix vaccine, which led to expired vaccine used.
This spontaneous report as received from a healthcare worker refers to patients of unknown age and gender. On an unknown date approximately in 2015 (reported as "on unspecified dates since 08-JUN-2015"), an unspecified number of unspecified patients were vaccinated with ROTATEQ (lot # K013868, expiration date 27-MAY-2016). No adverse effect reported. This is one of several report received from the same source. Additional information has been requested.
Rapid heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration in the left arm on 19Mar2021 at 11:00 (at the age of 62-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. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within for weeks prior to the COVID-19 vaccine. The patient experienced rapid heartbeat on 20Mar2021 at 23:00. The patient did not receive any treatment for heartbeat increased. The clinical outcome of the event heartbeat increased was unknown at the time of this report.  Information about lot number cannot be obtained. No further information is expected.
Ist vaccine: just pain at injection site for 2 days 2nd vaccine: fever of 100 degrees lasting  48 hrs and redness at site that spread over top outside of arm over and was visible and painful  for 4-5
pt received both vaccines in the same arm and thought 1 was given too high had severe arm pain and a painful red lump at injection site went to urgent care and was told that it was given too high and to report incident
Chest pain, nausea, lightheaded, shortness of breath led to emergency room visit an hour later.  EKG, Blood tests, chest X-ray, were performed.  Continually elevating troponin.  Cardiac catheterization performed.  Outcome reported as ?Suspected SCAD (spontaneous coronary artery dissection) in OM1 vessel with 60-70% stenosis long diffuse tapering lesion, TIMI III flow, no improvement with nitroglycerin. Otherwise no evidence of epicardial coronary artery disease. ?
Fever to 102 for 24 hours following immunization. Induration 6 cm X 5 cm at site of DTAP with 10 X 5 cm erythema and pruritis at injection site.
I have tested positive for COVID. I am in the hospital, they admitted me; I have tested positive for COVID. I am in the hospital, they admitted me; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002591). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 71 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset Jan2022, outcome "unknown" and all described as "I have tested positive for COVID. I am in the hospital, they admitted me". The patient was hospitalized for drug ineffective, covid-19 (start date: 28Jan2022). The patient underwent the following laboratory tests and procedures: oxygen saturation: (Jan2022) unknown; sars-cov-2 test: (unspecified date) negative; (Jan2022) positive. Therapeutic measures were taken as a result of covid-19. It was reported that the patient had the two vaccination, (Clarified as COVID 19 Vaccine) then had the booster shot and even had a flu shot (Further not clarified, hence captured as Unspecified Flu shot). So and then patient tested since there were so many breakthrough cases we tested again and patient was found tested negative for it and then just like couple of weeks later patient when patient got shortness of breath and everything and they decided that patient should go to the hospital and then they did a test again and patient was positive. So, the patient was admitted right away. Patient was not sure about the outcome of the event it was mentioned that they were still trying to adjust an oxygen level. They just tap on oxygen and they keep fluctuating it. Reason of hospitalization was reported as shortness of breath, patient wasn't able to walk by herself, they ended up bringing her an ambulance. As far as patient thought she was dehydrated, patient had no idea with admitting diagnose issue.  The lot number for bnt162b2 was not provided and will be requested during follow up.
She felt weak; Didn't felt great; Sore arm; Felt really tired for three days; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (She felt weak), FEELING ABNORMAL (Didn't felt great), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt really tired for three days) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS (Thyroid). Concomitant products included THYROID (ARMOUR THYROID) for Thyroid disorder NOS.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced ASTHENIA (She felt weak), FEELING ABNORMAL (Didn't felt great), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt really tired for three days). On 06-Aug-2021, ASTHENIA (She felt weak), FEELING ABNORMAL (Didn't felt great), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt really tired for three days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.    This case was linked to MOD-2021-367647 (Patient Link).   Reporter did not allow further contact
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 09-OCT-2012 21:29, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not provided. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
sore arm, mild flu like symptoms  To date, arm is still sore, developed headaches, tinnitus, dizziness, inbalance.  Went for physical therapy, Nate and acupuncture.  Not much help.  Still suffering.
Febrile Response within 36 hrs, T 105.6 F & then next 2 days up to 104 F.
I was pregnant at the time of the flu shot, Influenza Four-QIV Preservative Free 3+ Years IM 2015/16. After receiving the flu shot I began bleeding 2 days later. On 4/16/16 I miscarried and was 7-8 weeks pregnant at the time of miscarriage.
swollen lymph nodes in arm of vaccine ancillary and basilic.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jan2021 09:00 (Lot number: El3248) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 09Mar2021 12:00, outcome "not recovered", described as "swollen lymph nodes in arm of vaccine ancillary and basilic.". The event "swollen lymph nodes in arm of vaccine ancillary and basilic." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy.  Additional information: Yes treatment received and Tested again and given Tamiflu. No other vaccine in four weeks and Birth control other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
Patient was administered an expired dose of the Pneumovax 23 vaccine.  The vaccine was administered on 08/24/2023 but it expired on 08/18/2023. Pt was monitored post injection with no adverse reaction noted or reported. Patient was ambulating independently when he left the clinic and was alert and orientated to person, place, and time. Upon follow-up, twenty-four and ninety-six hours post vaccination, patient denied symptoms/adverse effects related to the vaccine warranting medical follow-up. Clinic will continue to monitor the client at interval.
Information has been received from a pharmacist concerning a nurse who in approximately 2001 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the patient developed a local erythema and warmth. Unspecified medical attention was sought. Additional information has been requested.
No additional AE reported; received the VARlVAX too early, on 25-MAR-2021; This spontaneous report was received from an office manager and refers to a 9-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 10-MAR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (dose number, dose, route of administration, anatomical location, lot number and expiration date were not reported). On 25-MAR-2021, the patient was vaccinated too early with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S022755, expiration date: 22-JUL-2021 (dose number, dose, route of administration and anatomical location were not reported) for prophylaxis ( inappropriate schedule of product administration).  No additional adverse event was reported.
Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F; Doses 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 (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 4:39 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 4:39 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 29.35. No concomitant medication was reported by reporter. Batch number 007C21A underwent temperature excursion on 27-Apr-2021 with temperature 35 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 19-Apr-2021 and beyond use date for the vial was reported as 19-May-2021. Product moved to clinic on 27-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time 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 by using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
Uncontrollable shaking of right hand/ arm- tremors that progressed to leg and shoulder twitching.
No adverse effects, patient was given wrong dosage. Patient received 0.5mL instead of 1mL.