chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diagnosed with covid-19; diagnosed with covid-19; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program COVAX US Support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 19Mar2021 as dose 1, single for covid-19 immunisation. The patients medical history and concomitant medications were not reported. On an unspecified date, the patient was diagnosed with covid-19. The patient wanted to know if he can still get the 2nd does, on 10Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on an unspecified date in 2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
A week after my first shot, I first developed a red circular rash at the injection site. Now a similar one has popped up on my arm in a different location.
Day of shots, woke up w/ fever of 100.9 & repetitive seizures. Req'd antiseizure meds & hospitalization.
Pain at site of injection upon waking the next morning and in shoulder area.   About 15 hours after vaccine. Began to feel moderate body aches all over body with a headache. Began using restroom repeatedly with significant back pain and spasms.  Muscle aches and pain continue. This reaction is after the 1st dose and I have had Covid July 2020.
Pt vaccinated with MMR/PROHIBIT experienced seizure lasting over 5 minutes, fever.
Infant seasonal flu shot, not sure specifically what kind. Hours after receiving the shot, the baby was very fussy and had a runny nose. This is now the third day where he has been easily irritable and is very congested and is developing a cough.
Left shoulder/deltoid area 2+ edema, 2+ erythema, tense skin over lateral deltoid, no tenderness, no mass, full range of motion-distal neuro vascular, status fully intact.
severe muscle pain in left arm and body; This is a spontaneous report from a non-contactable consumer. An elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on the left arm on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior and was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. The vaccine was administered at a hospital. On an unspecified date, the patient experienced severe muscle pain in left arm and body. No treatment was received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. Outcome of the event was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient experienced fever and body aches on 03/19/22 and was treated with Tylenol. Patient returned to school on Monday 03/21/22
Vaccine exposure during pregnancy; Burning sensation on tongue; appearance of tongue sores; This is a spontaneous report received from a contactable consumer (patient). A 37-year-old pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6206) via an unspecified route of administration in right arm on 06Mar2021 at 13:30 (at the age of 37-year-old) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history included hypothyroidism and PCOS (Polycystic ovary syndrome). The patient had allergy to Minute Maid Fruit Punch. The patient last menstrual period was 02Dec2020 and expected date of delivery was 05Sep2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included Levothyroxine (MANUFACTURER UNKNOWN), Prenatal vitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number; En9266) via an unspecified route of administration in right arm on 06Mar2021 at 15:00 as a single dose for COVID-19 immunisation. On 07Mar2021 at 02:00 am, the patient experienced burning sensation on tongue, followed by the appearance of tongue sores. It was reported that this happened frequently when the patient gets sick. Since, the patient was pregnant at the time of vaccination. Hence, vaccine exposure during pregnancy was captured as separate event. The patient did not receive any treatment for the events.The outcome of events burning sensation on tongue, followed by the appearance of tongue sores was recovering and other events was unknown.
Headache, Myalgia, Fever, Diarrhea &  NauseaVomiting Narrative:  Other Relevant History:
This case meets criteria for vaccine breakthrough review. SxS include confusion, difficulty swallowing, cough.
Approx 8 days after vaccine itchy red spot appeared around injection site. 2 in round shape, swollen and firm. Contacted PCP, no immediate concern. Benadryl for itching if needed and cool compress. Day 9 red spot increased in size move down the arm towards elbow. Original 2in spot redness is less. Day 10, same as day 9. Red swollen itchy spot increased but the original spot is not as red and swelling is going down.  Date of sumission is day 10 and reaction is still occurring. No worsening of itching, swelling. Only increase in size every day moving down the arm towards elbow. On day 10 size of total area is approx 6 in long and 3 in wide.
Swollen arm that was red and hot. Continued to swell and hurt for 2 days. Also itching for 24 hrs.  Small hives for 2 hours following shot.
My son was given the Pfizer Vaccine on 6-24-2021 and a few days later his back being having involuntary movements (spams) and than he told me a day or so later his left arm where he had the shot started to have involuntary movements as well. On Sunday July 11th I noticed his arm jumping and I asked him why is he jerking his arm he said it?s doing it on it?s own. I scheduled an appointment for him to be seen by his doctor. He was seen on July 13th, they saw him and gave us these forms to fill out and asked us a series of questions. He was scheduled to take the second dose of the Pfizer Vaccine on July 15th but I will not take him until I?m sure this is not a side effect of the Vaccine. Any information would be very helpful.
This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (dose, lot # and expiration date were not reported). No adverse symptoms were reported. The administered doses were exposed to the temperature of 49.6 degrees Celsius for 1 hour and 20 minutes. There were no previous excursions. Data logger was involved. This is one of several reports received from the same source. Additional information has been requested.
After receiving my second shot on October 12th I went on to have a regular menstrual cycle the following week on October 25th. On November 22nd  my period came as scheduled however it continued to be on and off with light spotting for 2 weeks only to come again full force on Dec 6th. So I basically had my period for 3 weeks. As of this entry I have not had my period since Dec 6th when it came back, leaving me now 2 weeks late.  My menstrual cycle is like clock work, in fact I have records going back at least 7-8 years of my period cycle on my online calendar. I have never had an experience like this no less a period that was on and off for 3 weeks straight. In addition to the disruption to my menstrual cycle since my shot I have a random dull pain that comes and goes at the vaccination injection site. It is very noticeable when it comes and can be very uncomfortable.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 08-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
chills, muscle aches, headache, hot skin for two days. Red, hot, soreness and tightness in injection location size of a grapefruit for three days.  spread down to elbow.
I got the shingles!!!; Painful; This case was reported by a consumer via media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient. The patient got the Shingle shot and in a couple of days got the shingles and it was painful.
Headache for nearly 2 weeks: Occasionally feels like wrapping around head, mostly frontal. Dull ache. Was constant, unsure frequency now. Slight improvement with OTC meds. Chest discomfort for nearly 2 weeks: "Feels like there is a brick" on chest, sometimes lasts a couple minutes to up to entire day. Worse with exertion. Denies SOB. Painful varicose veins
Given a first dose of the Moderna vaccine of 1ml instead of .5 ml; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was given a first dose of the Moderna vaccine of 1 mL instead of 0.5 mL.   The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 29 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection. During the administration, the pharmacist stated that the patient was given a first dose of the vaccine of 1.0 ml instead of 0.5 ml. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event was not reported.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot 011L20A), reporting Incorrect dosage administered without any associated adverse events.
rash developed on the inner bicep of the  OPPOSITE arm of the injection.  Treated with cream.  Rash was gone 3 days later.
The patient arrived at the pharmacy nauseous because she is very nervous about getting vaccinated. It is explained to her and mom that she must sit down 15 minutes after the administration of the vaccine, but they decided to go to the bathroom with her mother and fainted on the way. We called 911 they arrived and took her blood pressure and was low, after 10 minutes the blood pressure was ok. Her mother did not want to go to the hospital because this happen to her before.
Symptom onset in evening of 7/8/21.  Symptoms included:  fever (temp 101), feeling weak/wobbly, tachycardia and chest feeling heavy.   Also reports fast heart beat.   Advised to seek medical care through her pcp or urgent care
Sever body aches including to touch skin throughout body.  Sever pain shooting through body and muscle.  Severe headache and lethargy.  Swollen painful lymph node under left arm pit that continues...
No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 21-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
1855 BP 125/86 HR-86 O2 Sat 99% on room air. Patient reported numbness in left arm to wrist and on left side of mouth. Numbness remained localized throughout 30 minute extended monitoring. Lungs CTA, Cap refill <3 sec, AOx4, 0/10 pain, no tingling sensation. No loss of taste/smell.  Pt reports similar numbness as a first sign of migraines. Patient has fainted during blood draw 1 year ago.  1920 No improvement in numbness, provided snacks and water during monitoring. No swelling, denies dizziness, no weakness in arm or generalized weakness reported. No redness, no inflammation at injection site on inspection. Airway clear, no difficulty breathing. Skin pink, arm to touch WNL. Patient responsive to pin prick sensation and deep pressure in left arm. Motor functions WNL on assessment. No edema.   1934 Patient stable, will end extended monitoring. Patient will visit urgent care if symptoms do not improve or worsen. All s/s will be reported in v-safe app.
Severe muscle pain, Headache, Gastric discomfort, Light fever, Severe Chills, Dizziness.
This spontaneous report has been received from a nurse, also the patient's mother, via a company representative; referring to her currently 15 years old male son. The nurse stated that her son did not have any pertinent medical history, nor was taking any medication concomitantly. As part of the patient's drug reactions and allergies information, the nurse reported sesame seeds (food allergy) as current condition. In an unspecified day in June 2017, at the age of 14 years old, the patient was vaccinated with the first dose of GARDASIL 9 vaccines series, by receiving 0.5 ml, intramuscularly, as Human Papillomavirus (HPV) prevention (prophylaxis) (anatomical location of vaccination was not provided; lot number and expiration date were unknown by the nurse). The nurse stated that "the day after" receiving GARDASIL 9, on an unspecified day in June 2017, the patient developed a blister on his upper lip (lip blister). Medical attention was not seek, no laboratory or any other diagnostic studies were performed, nor treatment was given to the patient for lip blister. No product quality complaints were involved either. It was reported that the patient did not receive the following doses in the GARDASIL 9 vaccinations series. The patient was reported to be recovered from lip blister at reporting time. The nurse did not assess the causality relationship between the occurrence of lip blister and GARDASIL 9 vaccination.
This spontaneous report was received from a 67 year old male patient reporting on himself. The patient did not have any pertinent medical history and drug reactions or allergies. The patient's concomitant therapies included several unspecified medications. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, lot # and expiration date were not reported, frequency: one shot (also reported as therapy was not discontinued), route reported as injection). On 18-JUN-2015, the patient experienced shingles. The patient was treated with valacyclovir hydrochloride generic medication. No laboratory tests were performed. The patient sought medical attention by visiting the doctor. The outcome of shingles was reported as not recovered/not resolved. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Redness swelling hard bump. We are seeing many more reactions recently to ADACEL.
Pt took tablet #1 of oral Typhoid Rx on 4-4-2017 at 9:30 PM. By 9:35 pm pt C/O abd cramping diarrhea and fever x 2 hours. She then went to bed and slept the night.
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
DIED; COVID-19; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a traditional media report concerned an 82 year old female of unspecified ethnicity. 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: Unknown and expiry: UNKNOWN) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was reported that on 04-NOV-2021(Thursday), at about 2:00, the patient was died after contracting covid-19. The patient's son also reported that after receiving the JANSSEN COVID VACCINE, the patient was still felt ill (suspected clinical vaccination failure). Reporter also stated that the patient had been hospitalized for days before dying at about 2:00, on 04-NOV-2021 (Thursday). The patient died from unknown cause of death. On an unspecified date the patient was hospitalized. Number of days of hospitalization was not reported. It was unknown if patient was discharged. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of died on 04-NOV-2021, had not recovered from covid-19, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with a product quality complaint 90000200900.; Sender's Comments: V0: 20211115285- Covid-19 vaccine ad26.cov2.s- Died, Covid-19. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20211115285- Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
developed tender lymph nodes in neck and above (L) clavicle 1/9/2021 - palpable on exam as shotty Lymphadenopathy anterior cervical with slight rash at injection site
Temperature excursion occurred over the weekend; Poor quality vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred over the weekend) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 27-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred over the weekend). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred over the weekend) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.   A refrigerator temperature excursion occurred over the weekend. The HCP would like to know if the two Moderna vials were still okay to be use. The vials went out of range for a little over one hour and then went back into range.The vial  was punctured and administered to a patient on  27Jun2022 and gave one dose to a patient that morning.   It was reported that, after use of online temperature excursion tool, the HCP stated the vials were okay to use as per tool.  No treatment information was reported.
Vaccination site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tenderness at injection site for 72 hours) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE PAIN (tenderness at injection site for 72 hours). On 02-May-2021, VACCINATION SITE PAIN (tenderness at injection site for 72 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
This spontaneous report as received from a physician via a company representative refers to a male patient in his 70's, who was immunocompromised. The patient had a history of lung cancer. It was unspecified if this was known at the time of vaccination. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number not provided), 0.65 ml, subcutaneous. On an unknown date the patient experienced herpes zoster. The outcome and relatedness of herpes zoster were not reported. Additional information is not expected.