chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diagnosed with Parsonage-Turner Syndrome; This is a spontaneous report from a contactable physician (patient). A 64-year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 07Jan2021 10:00 (Batch/Lot Number: FL3246) (at the age of 63 years old) as dose 2, single for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Concomitant medication included atorvastatin calcium taken for an unspecified indication, start and stop date were not reported. The patient took the first dose of BNT162B2 via unspecified route in right arm on 17Dec2020 10:00 (lot number: EK5730) for COVID-19 immunisation. On 11May2021 15:00, the patient had been diagnosed with parsonage-turner syndrome. The treatment received for the adverse event included occupational therapy. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, disability or permanent damage. The outcome of the event was not recovered.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Neuralgic amyotrophy and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). On an unspecified date after vaccination with Lymerix, the subject experienced pain in his joints, flu-like symptoms, fatigue, possible autoimmune disease, decreased activities of daily life, headache, neurological injuries, cardiomyopathy, heart disorders, presyncopic incidents, numbness in left arm and legs, respiratory problems and diffuse muscle weakness. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.
Patient became flushed and developed tachycardia. She reported she felt like her lips were swelling but swelling was not observed by healthcare provider. Patient heart rate, blood pressure, and O2 saturation were monitored for 30 minutes. Patient felt ok after 30 minutes of observation and was released to go home.
Flared up in colon; On 14Aug2021,She received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 18 Oct 2021,She received 2nd dose COVID-19; Ill; Pain; Vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4162646-00.  A 54-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Oct2021 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single for covid-19 immunization; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Route: Intramuscular), administration date: 14Aug2021, when the patient was 54 years old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Oct2021, outcome "unknown", described as "On 14Aug2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 18 Oct 2021, she received 2nd dose COVID-19"; MALAISE (non-serious) with onset 18Oct2021, outcome "unknown", described as "Ill"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Pain"; VOMITING (non-serious) with onset 2021, outcome "not recovered", described as "Vomiting"; GASTROINTESTINAL DISORDER (non-serious) with onset 23Oct2021, outcome "recovered" (15Nov2021), described as "Flared up in colon". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for adalimumab was unknown.  Additional information: On unknown dates, the patient experienced pain, vomiting and Humira had to stop Working. On 18Oct2021, the patient experienced ill. On 23Oct2021, the Patient experienced flared up in colon. On 15Nov2021, the flared up in colon resolved. Pfizer BioNTech covid-19 vaccine (tozinameran) was also considered suspect. Causality for Humira (adalimumab): The reporter's causality for the event(s) of ill, pain, vomiting, Humira had to stop working and flared up in Colon was not provided. Causality for BNT162B2: The reporter's causality for the event(s) of ill, pain, vomiting, Colopathy-Gastrointestinal disorder was considered possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mom complained of "hives" appearing on 9/22/01 PM on butt and top of thigh. No fever, no other symptoms. Never had a reaction to shots before. Took child to doctor, by the time they got there, buttocks were red and tops of backs of thighs was gone. He dx'd "hives". The "hives" come and go and are still present today, 9/25/01.
The patient presented herself at the pharmacy on 5/6/18  wanting to report an adverse reaction to "the Shingles vaccination."  She states that she could not move and was in a state of paralysis for about 36 hours after receiving the vaccine. Pt was given FLULAVAL and SHINGRIX on 1/15/2018.  She states that she has received the flu shot each year without any  adverse reactions prior so she thinks it was the SHINGRIX.
Heavy menstrual cycle, had to leave work was bleeding so much. My period was longer and heavier than usual. I was put on Aygestin to help with the bleeding.
patient complained of pain at the site of injection and down her arm in her elbow and into her wrist. Recommended ice and anti-inflammatories if she had no contraindications and to follow up with her physician if it didn't improve
Started screaming, high pitch, as if in pain for 2 1/2 hours at a time.  Fever started by 8PM and has not subsided.  Next day baby was fussy and had crying spells lasting 2 1/2 hours every day since.  On 07/20 seen by doctor who prescribed Tylenol  around the clock and hyposamiane sulfate to control pain that caused the crying fits, medicine has helped patient, alleviated and doesn't cry.
Patient had sore arm & tiredness, which she said it's typical for when she gets vaccine.  10 days after vaccination, she experience tingling on both arms (left first) and feet.  Later she developed burning sensation as well as overall neuropathic pain and general weakness.  She also complained of dizziness that worsen at night.   Patient spoke to her primary physician who prescribed Prednisone and refer her to neurologist who she sees for headache treatments
My daughter was scheduled at her doctors appointment for her 15 month well child visit to receive the DTAP booster and MMR. The medical assistant gave me medication sheets for both vaccines and even instructed me on how she was to administer the vaccine slightly different for the MMR noting which of my daughter's legs would receive each vaccine. I received a phone call later that afternoon from our family practice physician apologizing that instead of the MMR my daughter received MENACTRA a meningococcal vaccine instead. After researching the dose, she received 0.5 ml of this vaccine via injection. When asked how this happened, I was informed that their "triple check" failed them. Additional comments: After researching MENACTRA my daughter could have experienced fainting or seizure like activity within the first 15 minutes after administration. I have had to do all my own research online in order to find out what to look for regarding side effect and long term effects. I also had to call my physician's office to find out which dose she indeed received as the medication for her age should have been divided and doses given 3 months apart. It was my research that brought to my attention that she received the dose normally given to 11-18 year olds. Mediation administered to or used by the patient: No. Outcome: Final outcome: Nothing/no harm Final outcome comment: At this time no adverse reactions have been noted. These happened as a result of the error: More medicine to reduce or relieve the possible bad effect of the error. Other explanation: I had to give additional infant TYLENOL for fever and discomfort. When and how was error discovered: I was informed by my physician via phone. Patient counseling provided: Unknown. Reporter's recommendations: The medical assistant should not have violated their policy and medication verification. I think in the future the vial of the vaccine should be brought into the room for parents viewing and verified. Relevant material provided: None.
little redness/experienced red skin and irritation after vaccines; tenderness; experienced red skin and irritation after vaccines; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (little redness/experienced red skin and irritation after vaccines), TENDERNESS (tenderness) and SKIN IRRITATION (experienced red skin and irritation after vaccines) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (little redness/experienced red skin and irritation after vaccines), TENDERNESS (tenderness) and SKIN IRRITATION (experienced red skin and irritation after vaccines). At the time of the report, ERYTHEMA (little redness/experienced red skin and irritation after vaccines), TENDERNESS (tenderness) and SKIN IRRITATION (experienced red skin and irritation after vaccines) outcome was unknown. No relevant concomitant medications were reported. Patient started treatment on 27-OCT-2021 (booster number one) and JUN-2022 (second booster) with Moderna COVID-19 Vaccine at Dose 3 and Dose 4 for COVID-19 immunisation. It was reported the patient got a little redness and tenderness, nothing out of the ordinary after a vaccine and he experienced red skin and irritation after his vaccines. No treatment information was provided
NUMBNESS IN LEG; This spontaneous report received from a patient concerned a male of unspecified age. 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: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced numbness in leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in leg. This report was non-serious.
This spontaneous report was received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 11-MAR-2013, patient received improperly stored VARIVAX dose 2, from batch/lot # 0610AE (expiry date, dose units, route and anatomical location were not specified). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Patient called, concerned that a rash with white spots on her lower arm before elbow was caused by flu shot. Recommended to see doctor, but they stated they did not have one. Recommended to try hydrocortisone cream. We followed up with patient next day and patient states rash was gone.
I went on Sunday March, 14, 2021  to get the Johnson and Johnson shot offered through the school system.  I noticed that my blurred vision intensified.  I went to the eye doctor 3/16 and that is where they found blood clots behind my right eye close to my center.  I was referred to a Retinol specialist 3/26/21 and sent me to get  a physical to check for diabetes.  It had started to heal a little. There was not clear diagnosis on what could have been causing the the blood behind my eye.  4/2/2021 Went for physical at PCP and results of physical was good with no Diabetes.
Nausea; This is a spontaneous report from a contactable consumer or other non-healthcare professional reported for reporter's sister-in-law. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administered at unspecified anatomical location on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, The patient experienced nausea. The reporter while talking her nephew on the phone and she told him that she just does not feel right, and it was when she was reading that she would get the nausea. She said that in the background, she heard her sister-in-law say that she also had nausea after the vaccine, but hers went away. The reporter declined to complete a report for her sister-in-law. She said that it seems like every time she puts something into her body, she does not react well to it. She said that if the nausea is something that will go away, she will not go to the doctor for it, but if it does not go away, she will need to see her doctor. The outcome of the event was resolved.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021182870 same reporter/drug/event, different patient
10/26/2001 On day Following vaccine admin., client came to office stating that about 2 hour after injection was given, her left arm got swollen, red and very painful. She still had minimal swelling and slight redness at time. 10/30/2001 Phone call to pt who states that she's been pain free since Friday 10/26/2001 PM after she applied warm packs to arm, has very little swelling yet though no redness.
arm is very stiff; low grade fever; At the injection site, it hurts; getting body aches,arm is very sore; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (arm is very stiff), PYREXIA (low grade fever), VACCINATION SITE PAIN (At the injection site, it hurts) and MYALGIA (getting body aches,arm is very sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (arm is very stiff), PYREXIA (low grade fever), VACCINATION SITE PAIN (At the injection site, it hurts) and MYALGIA (getting body aches,arm is very sore). At the time of the report, MUSCULOSKELETAL STIFFNESS (arm is very stiff), PYREXIA (low grade fever), VACCINATION SITE PAIN (At the injection site, it hurts) and MYALGIA (getting body aches,arm is very sore) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant included vitamins was noted. No treatment medications are provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received included no new significant information. On 03-Aug-2021: Follow up received included outcome of events updated from not recovered to recovered.
Small oral lesions developed on the underside and tip of the tongue as well as the soft palate under the tongue; A burning sensation is occurring throughout my mouth, tongue, and throat making it painful to eat or drink; A burning sensation is occurring throughout my mouth, tongue, and throat making it painful to eat or drink; A burning sensation is occurring throughout my mouth, tongue, and throat making it painful to eat or drink; throat making it painful to eat or drink; painful to eat or drink; the patient received third dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A 24-years-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: FE3590, Expiration date: not reported) via an unspecified route of administration, administered in arm right on 01Nov2021 (at the age of 24-years-old) as dose 3 (booster), single for covid-19 immunization. Medical history included fibromyalgia from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccination within 2 weeks vaccination. Patient had no known allergies. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE; Lot Number: ER8734, Expiration date: not reported), via an unspecified route of administration in the right arm on 27Mar2021 (at the age of 24-years-old) as a dose 1, single for covid-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE; Lot Number: EW0162, Expiration date: not reported), via an unspecified route of administration in the right arm on 17Apr2021 (at the age of 24-years-old) as a dose 2, single for covid-19 immunization. On 01Nov2021, the patient received third dose of vaccine (coded to booster). On 02Nov2021, the day after the vaccine, patient experienced small oral lesions developed on the underside and tip of the tongue as well as the soft palate under the tongue, burning sensation occurred throughout her mouth, tongue, and throat making it painful to eat or drink. The events were reported as non-serious. No Prolonged hospitalization and the patient did not received treatment. The patient will seek medical evaluation if events do not resolve. Device date was reported as 03Nov2021. The outcome of all the events was reported as not resolved or gotten better.  Follow-up attempts are completed. No further information is expected.
Severe Pain in left arm (that actually set in earlier making it difficult to sleep), Upper back tightness and pain, headache (not sure what time those started, but woke with them around 8:00 am), Chills, severe aches on sides, lethargic, fever, burning eyes. Around 8 pm fever broke and started feeling better.
PATIENT WAS ADMINISTERED ADACEL AND SHINGRIX IMMUNIZATIONS INTRAMUSCULARLY ON LEFT AND RIGHT ARMS RESPECTIVELY. SHE SAID SHE FELT LIGHT HEADED AND WANTED TO DRINK SOME WATER. AS SOON AS I WENT TO GET THE WATER, SHE LOST CONSCIOUSNESS AND FELL WITH HER FACE DOWN. WHEN I GOT BACK TO HER IN A FEW MINUTES SHE REGAINED CONSCIOUSNESS AFTER INHALING AMMONIA. SHE SAT AT OUR FACILITY FOR 15 MINUTES AND ATE CRACKERS AND HAD SPRITE AND LEFT AFTER THAT. SHE CALLED US BACK IN AN HOUR TO TELL US THAT SHE HAD NOT EATEN ANYTHING SINCE MORNING AND HER SUGAR PROBABLY WENT LOW. SHE SAID SHE WAS PERFECTLY FINE AND THANKED US FOR TAKING CARE OF HER.
Trembling, shaking, weakness, headache, extreme dry mouth, Cold to the touch - Dr advised Benadril, gave her 1, she slept and woke up 2 hours later extremly weak and fell.  2 hours later we still couldn't get her off the floor, called police to help.  They helped get her into bed.  She slept trembling all night. Woke around 9am, got out of bed, fell and hit her head.  Spent entire day in the emergency room.
My mother had a shingles outbreak near left eye.  It was red and swollen.  in the evening, looking much worse the next morning.  My sister took my mother to a walk in clinic and they diagnosed Singles and wanted her to go to eye doctor.  She was given aclovir for 10 days, which cleared up the shingles outbreak.
1/2 of right breast  blood rash under skin did not go away noticed next day after shot
I had sickness; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got over again in 2011 so could go back to college.  The patient received Meningococcal B vaccine and had sickness.  But at least got records of it at the time of reporting.
Patient had bivalent booster. Lot number in item #17 reflects bivalent booster information. Admitted to hospital on 10/28/22 and transferred to different hospital on 11/12/22.
patient feels like she was dying; can hardly walk across the house without having to sit down; barely able to keep anything down; very, very tired; vomiting all morning; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING ABNORMAL (patient feels like she was dying), GAIT DISTURBANCE (can hardly walk across the house without having to sit down), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (barely able to keep anything down), FATIGUE (very, very tired) and VOMITING (vomiting all morning) in an elderly female patient who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced FEELING ABNORMAL (patient feels like she was dying), GAIT DISTURBANCE (can hardly walk across the house without having to sit down), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (barely able to keep anything down), FATIGUE (very, very tired) and VOMITING (vomiting all morning). At the time of the report, FEELING ABNORMAL (patient feels like she was dying), GAIT DISTURBANCE (can hardly walk across the house without having to sit down), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (barely able to keep anything down), FATIGUE (very, very tired) and VOMITING (vomiting all morning) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  No treatment was given to the patient.