chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme weakness in her arms and legs; Really bad cough; painful in arms and legs; not been feeling well; This is a spontaneous report received from a contactable consumer (Parent). A 14-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration in right shoulder on 23May2021 14:00 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. Family history was reported as none, they were basically a healthy family. Patient was not vaccinated within 4 weeks and no additional Vaccines administered on same Date of the Pfizer Suspect. On 23May2021, the patient experienced extreme weakness in her arms and legs, really bad cough, on an unspecified date in May2021, she had severe pain in her legs and on an unspecified date in 2021, she was not been feeling well. Patient's father called on behalf of his 14-year-old daughter who received the first dose of the Pfizer COVID-19 vaccine about two weeks ago and had extreme weakness in arms and legs, 2 weeks ago, on Sunday 23May2021. She had not been to school since then, she went for a couple hours and then they send her back. His daughter also said that it had been painful but caller states that he does not know exactly what his daughter means by that, she said that her legs hurt her, that started probably 24May2021 or 25May2021 with the bad cough also and not been feeling well. Had all leveled out the past 10 days. Had blood work and the results came back Friday. Thought there was an outside chance based on the blood work that it was strep related. Her doctor had suggested that the parents call Pfizer to see if this type of reaction had been reported in her age group after receiving the Pfizer COVID-19 vaccine. She never really had a fever. This started the day after the vaccine, and they are not sure if it was related to the vaccine or not. A couple of results were off. The Streptolysins were 468. The antinuclear antibodies were 1 to 160, which was off. Everything else was negative. The patient underwent lab tests and procedures which included antinuclear antibody: 1 to 160, streptococcus test: 468. Patient received therapeutic measure to treat adverse events, they tried Amoxicillin, which had no impact, they thought maybe it was just a virus. They also tried Tylenol and Advil, which also had no impact. Stated that the Amoxicillin was 875mg twice a day and that the Tylenol and Advil were from different packages lying around the house. Patient was scheduled for the second dose this coming Sunday but they were holding off until she was better. The outcome of events was unknown.    Information on the lot/batch number has been requested.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in March 2016 (reported as excursion occurred "at the beginning of the month (March 2016)"), the patients received improperly stored (refrigerated in temperature of 31.3 degrees Fahrenheit for 1 hour; previously temperature excursion was reported as 2 times: less than 34 degrees Fahrenheit for 20 minutes each time) doses of PNEUMOVAX 23 single dose syringes Lot # L007720, expiration date: 08-JUL-2016 and Lot # L001311, expiration date: 06-JUL-2016 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Red raised rash - softball in diameter, 1/2" in height - surrounding immediate vaccination site.
Patient called ADR line complaining of warm, tender spot above ankle 2 days after receiving Moderna COVID vaccine (2nd dose). Patient instructed to seek immediate medical attention.
Swelling in lips; Swelling in cheek; This case was reported by a consumer via interactive digital media and described the occurrence of lip swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14th October 2022, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced lip swelling and cheek swelling. On an unknown date, the outcome of the lip swelling and cheek swelling were not recovered/not resolved.   It was unknown if the reporter considered the lip swelling and cheek swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comments:  This case was received from patient via interactive digital media. The reporter stated that the patient got 2nd shot on Friday and experiencing swelling in lips and cheek.  The reporter wants to know what should need to do. Additional supportive information: The follow-up could not be possible as no contact details were available.
she felt like she has "cotton in the ear"; "partially-blocked ear similar to an infection".; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 13Apr2021 (Lot Number: ER8733) as single dose for covid-19 immunisation. Patient's medical history and concomitant medications was reported as none. The patient previously took the first dose of BNT162B2 in Arm Left on 21Mar2021 (lot: EN6208) for COVID-19 immunisation. The patient received the second dose of the Pfizer-BioNTech COVID-19 Vaccine last Tuesday, 13APR2021. The patient reported that by Friday or Saturday (Apr2021), she felt like she has "cotton in the ear"; "partially-blocked ear similar to an infection". The patient didn't have any side effects, she more or less has a quick question. She felt like there was  cotton in her ear, after getting it. She asked if that is a side effect to the Covid shot. She was  not sure if it is associated. She wondered if this feeling of cotton in her ear will clear up or what's going on. It felt like it was blocked.  She didn't feel so bad right now. It gets worse later in the day. She had a physical in January and there was nothing wrong with her ears at the time.  The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Approximately 77 patients received Moderna bivalent; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Approximately 77 patients received Moderna bivalent), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Approximately 77 patients received Moderna bivalent), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Approximately 77 patients received Moderna bivalent), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Approximately 77 patients received Moderna bivalent) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant medication was provided. Reportedly, the doses were administered before it was known if the vaccine was ok to use after the excursion.  No treatment information was provided. This case was related to patient number 44 out of 77 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Baby lost eye contact, lost focus, did not respond to parent when I spoke to patient, within 3 hours after both the DTaP and IPV shots at Dr. office on October 28, 2013. Eyes roll like seizures. I called and spoke to both the nurse and also Dr. on the phone about patient's lost of eye contact and lost of focus. Baby had several vaccinations before his two shots of DTap and IPV vaccinations on October 28, 2013, when he was 8 months old. Baby lost eye contact, lost focus, and he did not respond when I spoke to him, within 3 hours after the shots on October 28, 2013 from Dr. office. The next day I called, and spoke on the phone with the nurse and Dr. about patient's lost of eye contact and lost of focus, and Dr. told me that it is unusal. After his shots, his eyes rolled like seizures. Little patient also started flapping his hand, was speech delayed, and showed poor social communication skills. I have a video of his hands flapping. Actually, several videos of hands flapping. Dr. from Hospital Autism Center diagnosed little patient with Autism, level 2 moderate level AUTISM on June 19, 2015. Baby seemed very lethargic, non-alert, and tired after his August 6, 2013 Hepatitis B vaccine at the Hospital. Treatment: Pump breast milk until he was 5 years old, and fed him partial of my breast milk. Treatment: Speech Therapy, Occupational Therapy, Physical Therapy, ABA Applied Behavioral Analysis Therapy. Status: People in public sometimes tell me that he is abnormal when he talks, and they are wondering why he is not acting the same way as the typical kids, and I did not tell them patient has AUTISM. He is currently in an AUTISM program at a public school. Patient is a special needs child with an IEP Individual Educational Plan at school. Please keep his AUTISM diagnosis CONFIDENTIAL from public records, because he has suffered through discrimination and rejection from his AUTISM. Attached is his AUTISM Diagnosis paperwork. Attached is his vaccination record that occurred on October 28, 2013.
Sore throat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache) had resolved.            Concomitant medications details were not reported by the reporter.  Treatment Included took muscle relaxant and prescribed pain medication but still sore and painful.  Events recovered after resting.   This case was linked to MOD-2021-398431 (Patient Link).
swelling of the lower edge of his lip that is quarter inch and a half long; swelling of the face; This is a spontaneous report from a contactable consumer (patient himself). A 79-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EP7534; Expiration date: unknown) via an unspecified route of administration on 16Mar2021 (at age of 79-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6198; Expiration date: unknown) via an unspecified route of administration on 23Feb2021 (at age of 78-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced swelling of the lower edge of his lip that is quarter inch and a half long and swelling of the face on Aug2021. It was reported that, the patient had received the both doses of the vaccine in one in February and second in March - 6 weeks ago he experienced swelling of the lower edge of his lip that was quarter inch and a half long - He went to his dermatologist, main hospital in withheld, and his doctor but no one can provide any idea on why he had it - His dermatologist gave something to put on and it was not able to treat it - He will go to withheld in about 2 weeks for consultation - Asking if this has been reported before and what was the percentage of reported cases for swelling of specific body part. Therapeutic measures were taken as a result of adverse event (treatment not specified). This report was not serious. The outcome of both the events was unknown.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 31-JAN-2017 at 15:34, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457
ADVERSE REACTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 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. On an unspecified date, the patient experienced adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reaction was not reported. This report was non-serious.
immunisation. Prior to the vaccination, the patient was 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. On 28Mar2021, after 12 hours of vaccination at 23:00, the patient experienced shortness of breath, brief fever, chills, muscle soreness, head fog and exhaustion. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were provided for the reported events. The clinical outcome of the events shortness of breath, brief fever, chills, muscle soreness, head fog and exhaustion were resolved with lasting effects at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Fever of 104. Target erythematous maculopapular rash day 2 post immunization (face, trunk, back, extremities) for one week. Responded to steroids while hospitalized. Very detailed record for this admission is received and confirms a diagnosis of Steven-Johnson Syndrome for this event. Secondary diagnoses include conjunctivitis and mucositis. Of note, this record indicates that child was treated w/ penicillin one month prior to this event for URI and OM. She was discharged to home on po steroids to be followed by PMD and allergy clinic
Fully vaccinated with two doses of Pfizer. Tested positive for COVID 19 on 01/06/2022. Admitted to Medical Center on 01/20/2022. Expired on 02/10/2022 while still hospitalized.
Initial report was received 27 March 2012 from the investigator for a study. A male subject (age and date of birth not reported) had received ACAM2000, Anthrax and FLUMIST vaccines on 27 September 2012, and nine days later on 06 October 2012, the subject developed a headache and non-radiating chest tightness in the middle of his chest of moderate intensity. Nothing improved or worsened the chest tightness. The subject self medicated with Ibuprofen on 06 October 2012 for headache which resolved that same day. No medications were taken for chest tightness. The subject had no relevant medical history and denied any allergies to medications. Central lab troponin and ECG results were normal. The subject was referred out for follow-up of chest tightness and a cardiology consult. According to the cardiologist, the subject did not need a cardiology work-up. EKG was normal and the study EKG machine had problem with the leads. Per the cardiologist, no suspicion for cardiac etiology. No additional information was provided. According to the investigator, this event was low suspicion for myopericarditis. The subject was referred for care, but lost to follow-up. This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: None.
Pt. presented to the after hours care clinic on 10/03/11 with raised red rash (hives) to back, neck, arms & buttocks. States she received flu shot same day at 0930 a.m.
After my second dose and about 2 weeks later, I felt very sick. I experienced diarrhea, was throwing up and felt very weak.
Patient received Kinrix, but is 3 years old. This was first dose in series so patient does not need to repeat series per CDC. No reported adverse effect by parents.
PATIENT THE EVENING OF THE VACCINE HAD FEVER , CHILL , CHEST PAIN TROUBLE BREATHING PULS OVER 120
The vaccine that was administer was Covid-19 moderna vaccine booster doses (NDC 80777-275-05)and it suppose to be toddler.
2nd shot: 4/28/2021 Pfizer Lot#EW0161  15 days after the second shot I started having eye problems.  Went to regular eye doctor and they referred me to Dr.   He said I have Vogt- Koyanagi Harada Syndrome.
A non-serious spontaneous report of lost sense of smell, feeling rundown, fever, sneezing, nasal congestion and productive cough was received from a consumer concerning a 39 year-old female that occurred two days after receiving FLUMIST. No medical history or concomitant medications were reported. The patient received FLUMIST on 14-Nov-2008. On the 16-Nov-2008, the reporter indicated that she lost her sense of smell and had a mild fever, nasal congestion, productive cough, feeling rundown and sneezing since receiving FLUMIST. Some of the symptoms resolved in 1 to 3 days others are almost resolved. The events of fever, loss of smell and productive cough resolved; sneezing, feels rundown and nasal congestion were almost resolved as of 26-Nov-2008. The reporter states that she has acquaintances who experienced similar symptoms around the same time period of her symptoms; she thinks she had a cold.
She is having dizziness and nausea consistent. The symptoms started within 6 hours of the vaccine and has lasted 8 days.
Early AM - noticed what we called rash on left hand. different sized circles - like lesions. Not raised - flat, no head or edge, not itchy or painful. Next day had a few more spots. This continued for 2 weeks as it went up her left arm. All different sizes. Dermatologist gave steroid and anti-fungal cream. Continued for another week. Second visit to Dermatologist, had biopsy. No definitive answer, but shows not fungal. Lesions have stopped, as of 10/07/15. Today 10/26/2015 woke with 4 lesions on left side of torso.
Within one minute of giving vaccine patient started to feel like she was passing out. She briefly lost consciousness and eyes closed followed by unresponsiveness. This lasted about 1 minute. When she came to she was laid on floor and reported her vision and hearing were gone but then returned. She felt better after lying on floor.
Dizzy, fever of 101, chills, aching in joints. Persisted for 24 hrs. Joints continue to ache.
Within about 4 hrs of vaccine, pt experienced twitching that escalated to shaking all over with chills and intense shivering, no loss of consciousness or fever. Pt could not take a deep breath which resulted in anxiety to almost vomiting. This lasted about 3 hrs and de-escalated when she got warmed up. Throat and chest hurt about 12 hrs after vaccine and pt exhausted.
Patient reported eruption of one hive like lesion (wheal) morning after vaccination, followed by other "pimple like" area over her body. No pruritis except for the first lesion. Disappeared over several hours. No shortness of breath, swelling or other symptoms. Patient reported to Public Health on 1/16/07.