chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blind; brain injury; visually impaired; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 28-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown (booster),single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Latex allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization; Pneumococcal vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN), for immunisation. The following information was reported: BLINDNESS (medically significant), outcome "unknown", described as "blind"; BRAIN INJURY (medically significant), outcome "unknown"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "visually impaired". Clinical course was reported as follows: caller mentioned that she's only gotten two vaccines in 28 years, the Pfizer pneumonia vaccine and booster. Did not clarify if she meant a pneumonia booster or a Pfizer Covid booster. Caller also mentioned that she went blind during Covid global pandemic but had regained vision in one eye but she was visually impaired and had a brain injury. Caller did not specify whether she experienced blindness before or after receiving vaccines.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded. 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.
Narrative:  67yo male patient with recent new renal failure and 4 cm infrarenal AAA and 9 cm L common iliac artery aneurysm also with hx of CAD. On 11/21/21 pt covid + with pneumonia inpatient admission. Pt had received covid vaccine (J&J) on 3/29/21. Vaccine breakthru/failure infection. Pt was discharged home on oxygen & dexamethasone 6mg tablets on 11/28/21 as pt demanding to leave AMA. On 11/29/21 pt died at home likely of covid infection
Immediately after giving second vaccine, pt began convulsing/seizuring for 12-15 seconds after which pt was disoriented for 5 minutes. No recollection of event. Vomited x3. c/o dizziness, nausea, headache. Sent to ER. Diagnosis : new onset seizure.
Patient reported muscle soreness, fatigue and fever around 100 degrees Fahrenheit about 48 hours after receiving vaccine.  She also reported diagnosis of macular dystrophy later in the week.
This spontaneous report was received from nurse prescriber, via a company representative, referring to a 21 year old female patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with the complete dosage schedule of GARDASIL 9, for prophylaxis when she was 1112 years old (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, the patient was diagnosed with human papilloma virus (HPV) with low grade lesions. It was unknown by the reporter whether the patient received treatment, sought medical attention or if any laboratory tests were carried out. The outcome of papilloma viral infection was unknown. Causality assessment was not provided.
A lump developed in the area between my shoulder and neck on the same side as the vaccine was given.   Information provided with vaccine provided a link which after review makes me think this lump is a swollen lymph node.
This spontaneous report as received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. Between March and July 2016, possible several doses of improperly stored ZOSTAVAX subcutaneously lot # L029482, expiration date 06-NOV-2016, may had been administered to unspecified patients. The data logger had showed a minimum value of -13 C on multiple days between March and July 2016. No adverse effects had been reported. No product quality complaint was involved. This is one two reports from the same source. Additional information has been requested.
08/27/22 presents to EC ED for "wound infection, dizziness". PMHx of "Bipolar disorder"
Left arm redness, stiffness, pain, warmth, left shoulder pain, spreading towards left side of neck and left upper back.
tested positive for Covid; tested positive for Covid; This is a spontaneous report via a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced tested positive for covid on 2021. The outcome of the event was unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.  .
hive like reaction. Itching/ burning / and swelling of skin. My skin from head to toe will swell up when scratched even if lightly it then becomes insanely itchy and burns. lasts a few hours.
No adverse events experienced by patient. Patient returned for dose three Pfizer vaccine but given Moderna 0.25mL dose for dose 3 booster dose as a mix and match. Pfizer vaccine unavailable at site until the next day. Patient's family notified. Family denied any adverse event.
was a little bit sore after her first dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (was a little bit sore after her first dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (was a little bit sore after her first dose). At the time of the report, MYALGIA (was a little bit sore after her first dose) outcome was unknown.            No concomitant product information were provided by the reporter.  No treatment information was provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-295504.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt states to have experienced a blister formation to injection site. (+) redness/swelling/pain, fever and nausea. Symptoms lasted approximately 4-5 days. Pt did not seek medical attention at the time.
Mild erythema, moderate tenderness, and mild swelling of vaccine injection site 7d after vaccine. Afebrile.
This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a nurse concerning a 61 year old female with penicillin, estrogen and tetanus toxoid allergy, and a history of breast lump removal who on 11-JUL-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # 638210/1079U) into her left deltoid. On 02-AUG-2008 the patient developed an unspecified rash on the buttocks. The patient sought treatment at an unspecified urgent care center and was prescribed FAMVIR 500 mg three times a day and CIPRO 500 mg two times a day. On 04-AUG-2008, the patient sought treatment with the physician who administered ZOSTAVAX (Oka/Merck). The patient was placed on acyclovir. No other symptoms or treatment reported. As of 04-AUG-2008 the patient was recovering from the rash. Additional information has been requested.
Very restless; Mild headache; woke up nauseaous; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESSNESS (Very restless), HEADACHE (Mild headache) and NAUSEA (woke up nauseaous) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RESTLESSNESS (Very restless), HEADACHE (Mild headache) and NAUSEA (woke up nauseaous). At the time of the report, RESTLESSNESS (Very restless), HEADACHE (Mild headache) and NAUSEA (woke up nauseaous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had mild COVID-19 in march. No concomitant medication was reported.  The treatment information was not given.
I was given the Flu vaccine on 10/15/07. Since that time I have this horrible pain in my shoulder, back and down my arm. I've never had this kind of pain before with the flu vaccine. The nurse at this practice gave the injection very high up on the shoulder area. My arm hurts and I can't lift it above my head. It hurts a lot at night. I can't pull up the blankets on my bed at night. I think it is tendonitis. Is it common to give it so high up?? I believe this is an administraion error. When will this go away?? It may involve the nerves as well because I feel a sharp pain down my arm to the elbow area. The pain started as soon as I got the vaccinaton and got worse over a few days. It still hurts. My shoulder, upper back, arm are still hurting from this flu shot. You can contact the doctor for specifics like the lot number, etc.
dark, red, raised hard lump 1/2 x 1 1/2" @ site of immun (DTP); lump less red on 1JUL93; mom gave APAP x 1; MD called felt it was a localized reaction;
First COVID-19 vaccine: tired; did not feel good; First COVID-19 vaccine: felt so sick, felt like she was going throw up; First COVID-19 vaccine: little diarrhea; First COVID-19 vaccine: allergies were triggered; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER7833), via an unspecified route of administration on 08Mar2021 08:40 (at the age of 56-years-old) as dose 1, single for COVID-19 immunization. Medical history included compromised immune system, seasonal allergy, allergic reactions to things like smells, bites or stings, super hypersensitive. The patient's concomitant medications were not reported. The patient felt so sick, felt like she was going throw up on 10Mar2021, allergies were triggered on 09Mar2021, little diarrhea on 10Mar2021, tired on 11Mar2021 and did not feel good on 10Mar2021. The outcome of all events was recovered on 18Mar2021 or 19Mar2021.   No follow-up attempts are possible. No further information is expected.
At about 1520 during observation period, Pt reported feeling dizzy, light headed, clammy and sweaty followed by syncope while in the passenger seat of car. RN crushed ammonia inhalant and placed under Pt's nose and he immediately regained consciousness. Pt became alert and oriented x4. Instructed to recline seat, elevate legs and do PLB. Pt reported feeling better after a few minutes. Water given and observed for total of 30 min. Pt reported symptoms resolved and ED precautions given. Pt verbalized understanding and left in stable condition in passenger seat of car.
I tested positive for Covid in early December, 2020.  5 days after I received the vaccine, I woke up to extreme dizziness with the room just spinning.  My blood pressure increased to around 212/101 for much of the day.  Normal is around 120/70.  The dizziness finally subsided later in the day and the blood pressure went down to about 168/85 by evening.  Then I minor developed a headache.  I also developed sores in my mouth and on my tongue.  I still have those today (the day after).
SIDS death;pt found by mom 2MAY99 @ 716AM face down, in playpen not breathing;paramedics called by father;pt had been fed 1MAY99 11PM by mom & put down in playpen on back @ midnight 2MAY99; no signs of trauma or foul play
Patient called and reported muscle and body aches, chills, red and sore throat, cough, and shortness of breath that started about 6 hours after receiving her vaccine.  Her symptoms lasted for about 2 weeks.  She was started on Augmentin 875 and Albuterol HFA 10 days after her vaccine.  She was tested for COVID and Strep, both were negative.
1. Difficulty thinking clearly and remembering things. 2. Right eye vision unusually blurry until 6/28.
Extreme memory problems; Numbness in the hands and feet; problem with the grip in his hands; they hurt very badly; Speech problems; Spontaneous report received on 09FEB2022 from a patient.  A male patient (unknown age) had extreme memory problems (PT: Memory impairment), "numbness in the hands and feet; problem with the grip in his hands; they hurt very badly" (PT: Raynaud's phenomenon), and speech problems (PT: Speech disorder) following immunisation with 2 extra shots of BioThrax (anthrax vaccine adsorbed). It was reported that the patient received 2 extra shots of BioThrax in 2007. It was reported that he was experiencing extreme memory problems, numbness in the hands and feet, problems with the grip in his hands which was hurting very badly. He was diagnosed with Raynaud's disease and prescribed with gabapentin medication for Raynaud's disease. Also, he had speech problems which resolved over the time. It was reported that he had been experiencing autoimmune symptoms. Thus, he underwent tests for autoimmune diseases for lupus and rheumatoid arthritis which were negative.   Additionally, the patient reported that his vision was pixelated and described it as "little squares" and "dots" however his vision test was negative.   He did not have any surgical history.  Concomitant medication included Adderall (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine and amphetamine sulfate) for lack of energy/lethargy.   Action taken with BioThrax with respect to the reported events was not applicable.  Outcome of the reported events "extreme memory problems" and "numbness in the hands and feet; problem with the grip in his hands; they hurt very badly" was unknown while the patient had recovered from the event "speech problems" at the time of report.   No additional information was reported.  Company comment: A consumer was administered BioThrax and developed extreme memory problems (memory impairment), numbness in the hands and feet; problem with the grip in his hands; they hurt very badly (Raynaud's phenomenon), and speech problems (speech disorder). It was reported that the patient received 2 extra shots of BioThrax in 2007. Further information regarding the onset of these events and medical history is limited. Considering the limited information, the causality of memory impairment, Raynaud's phenomenon, and speech disorder is assessed as unclassifiable with BioThrax.; Sender's Comments: A consumer was administered BioThrax and developed extreme memory problems (memory impairment), numbness in the hands and feet; problem with the grip in his hands; they hurt very badly (Raynaud's phenomenon), and speech problems (speech disorder). It was reported that the patient received 2 extra shots of BioThrax in 2007. Further information regarding the onset of these events and medical history is limited. Considering the limited information, the causality of memory impairment, Raynaud's phenomenon, and speech disorder is assessed as unclassifiable with BioThrax.
Pt recv vax on 9/3/98; 1 hr later pt exp erythema &urticaria of 1/3 of body w/ urticaria 3x3 cm at injection site.  Pt tx=Benadryl orally.  Rash faded in 20-30 mins.
No adverse effect; patient received improperly stored VARlVAX; This spontaneous report was received from a medical assistance and refers to a currently 4-year-old patient of an unknown gender. There was no information about the patient's concurrent condition, concomitant medication and medically history provided.  On 10-SEP-2019, the patient received a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) injection, lot number: S003864, expiration date: 08-AUG-2020 (dose, indication and route of administration were not provided). The improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live, (recombinant human albumin) (PROQUAD) was reconstituted with properly stored sterile diluent. No adverse effect reported.  The administrated doses of the vaccines were exposed to a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (7.7 F) for 30 minutes. There was no previous temperature excursion. Data logger was involved.
pain medicine made her nauseous and dizzy; pain medicine made her nauseous and dizzy; back pain under ribs on left side; hard to breath; This is a spontaneous report from a contactable consumer.  A 60-year-old female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6200, Expiration date: unknown), via unspecified route, administered in left arm on 19Feb2021 (at the age of 60-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Foot surgery on 17Feb2021, and concomitant medications were not reported. On 20 feb2021, after the vaccination, the patient States her back has been hurting prior to vaccine because of her foot, but states that was usually her lower back, mid back. States she was not paying much attention to symptoms for aftereffects of the vaccine, states she experienced back pain under her ribs on the left side, same side she received the vaccine. Patient also stated that the pain made it hard to breathe, pain in the ribs is what takes her breath away. Caller states she did not take any pain medicine after her foot surgery on Wednesday, except for the first day. States the pain medicine made her sick, so she just took Ibuprofen.  She States she cannot handle pain medication. This medication was taken prior to the vaccine. States she took it Wednesday night, Thursday morning and Thursday night and then stopped taking it. States she was told not to take Ibuprofen the morning of the shot, she did not take any Friday morning prior to the vaccine. Patient also mentioned pain medicine made her nauseous and dizzy on an unspecified date. The events assessed as non-serious. The outcome of the events backpain and dyspnoea was not recovered and the outcome of nausea and dizziness was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (17May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Medical history included ongoing asthma, ongoing hypertension, ongoing mitral valve prolapse, ongoing Tarlov cysts. The concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) for Pain.  The first vaccine she had no problems and just soreness in her arm on an unspecified date. The event outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Fever, severe pains in all joints, vomiting, diarrhea, severe headache, puffy eyes.
Diarrhea After 1st dose c/o pain in back, neck, back of leg, runny nose, diarrhea and arm pain at injection site. Narrative:  After 1st dose c/o pain in back, neck, back of leg, runny nose, diarrhea and arm pain at injection site. c/o flu-like symptoms. neg COVID test. off work 12/31. resolved. 2nd dose on 1/21/2021.
Pt reports gradual swelling of arm, starting 1st day, 4 to 6 days post shot, arm black and blue. Saw physician received steroid shot, No temp elevation. Four days later face swollen received injection for that then had trouble swallowing. When she bends over face gets hot and bright red. Pt is still on antibiotic with continued symptoms.
Patient presented to office with seizure like activity. Patient treated by DNP was treated for symptoms for 20 minutes while waiting for ambulance. Administered O2 in office and transported to ED. Subsequently sent to another hospital.
I got a metal taste right away after getting the shot. My joints and muscles got sore starting that night. I also experienced headaches, trouble sleeping, fatigue, and increased heart rate. It was beating fast like it was trying to beat out of my chest, so I guess my blood pressure was high. Those symptoms lasted for about a week. Probably until 9/16/2021. The night of 09/16/221 I woke up in the middle of the night and my right knee was incredibly sore. I could not walk. It woke me up at about 4 am. It was incredibly painful. On Friday morning I went to the doctor to get that knee checked up. They did not do any medical tests. They just checked the structure of my knee. There was nothing physically wrong with it so they could not do any determinations.  It was also swollen behind my knee. There was no visible clotting issue or anything. They just told me to take some Aleve for the joint pain. My knee is a little sore but its gotten better, it does not hurt. Not even close to that night.
This spontaneous report was received from a licensed practical nurse (L.P.N.) referring to unspecified number of patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with doses of M-M-R II (dose and route of administration were not reported) (Lot# K007107, expiration date: 16-MAY-2016; Lot# J015505, expiration date: 05-DEC-2015; Lot# J008729, expiration date: 31-JUL-2015: Lot# K021152, expiration date: 02-NOV-2016), which were exposed to temperatures outside of the recommended range. No adverse experiences have been reported. There was no product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Pt developed urticaria next day following vaccination. urticaria was localized from cheeks to neck. Pt experienced itchiness and burning on the face. Pt developed localized redness, swelling at the injection site. Pt presented on 2/16, 6 days from vaccination with mild, lingering rash on neck. Pt states they took one dose of Benadryl on 2/12 and one dose on 2/13 with mild relief. Pt states took Tylenol OTC for pain in shoulder.
brain injuries; COPD; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 24Mar2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious) with onset 2022, outcome "unknown", described as "COPD"; BRAIN INJURY (medically significant) with onset 2022, outcome "unknown", described as "brain injuries".  Clinical course: The reporter who had brain injuries and COPD would like to know if he can take the Bivalent vaccine. His last shot was 24Mar2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe hoarseness; sore throat, treated with Sudafed, Aleve, and Vitamin C 500mg, plenty of fluids. I still have symptoms present after one week, expectorating yellow secretions.