chrisvoncsefalvay/vaers-outcomes huggingface dataset:
53 yo vet with history of malignant fibrosing histosaroma resolved pneumovax in left arm on 5/1/06. Pt noted tenderness and swelling around site, took Benadryl. Swelling and tenderness continued to increase an pt was seen by PCP 5/2/06 and there was concern for infection/local allergic reaction. Pt did have subjective fevers today. No SOB, throat swelling or difficulty breathing at any time. Pt received Levaquin IV x1 and Benadryl as outpt. On arrival pt reports swelling is worse, though no numbness, weakness in left arm. Admitted and started on vancomycin/ciprofloxacin for cellulitis, IV methylprednisolone and po diphenhydramine for injection site reaction. Cellulitis has been rarely reported within 2 days of Pneumovax. 08/10/06-DC Summary received for DOS 5/2-5/5/06. Patient demographics removed. DC DX: L UE cellulitis             Hx of malignant fibrosing histosarcoma             COPD stable             Lower abd nodules r/o recurrent cancer             Hep C Summary: 53 year old male with HX of malignant fibrosing histosarcoma received Pneumovax in left arm day before presentation. C/O tenderness and swelling around site, took Benadryl. Swelling and tenderness continued to increase, seen by PCP concern for infection/local allergic reaction. Subjective fevers on admission. No SOB, throat swelling or difficulty breathing at any time. RX with Levaquin and Benadryl as outpatient. On arrival patient reports swelling worse though no numbness, weakness in left arm. RX with Vancomycin and Cipro, steroids. Cellulitis significantly improved over next days.
Chills, headache, nausea followed 12 hours later by vomiting, associated with possible vasovagal reaction as diagnosed by the telephone advice nurse (intense lower back pain, extreme tingling in both arms).
Patient had seizure-like activity about 10 minutes after receiving the Johnson & Johnson Covid Vaccine. Nurse saw her eyes rolling back and struggling to breath. She was placed on her side until wheelchair was brought to her side and then transferred to wheelchair and taken to the ER.  While in transit she regained consciousness and was lethargic but was responding appropriately to questions. Patient was checked by Dr.  and his review was tachycardic and mild dyspnea. Skin was pink and warm. She was taken to the ER for further evaluation.
Severe thrombocytopenia requiring hospitalization Subdural hematoma from low platelets  Pt in excellent state of health until about 2 weeks after vaccine.   Pt started exhibiting spontaneous bruising and petechia without external causes of trauma.  Days later patient started exhibiting signs of confusion and sluggishness and complaining of headache.   On post vaccination day 21 patient taken to ER where platelets found to be 18 and CT scan showed a subdural hematoma.     patient continues to be hospitalized and workup is underway to determine cause. My belief is the severe thrombocytopenia is related to the vaccine.
At 1:30 pm September 4th I suddenly felt crushing f chest pain, lightheadedness, dizziness, almost passed out, a popping sensation inside my abdomen, a feeling of something making its way behind my eye, my heart was racing, I thought I was having a heart attack. I went to the ER where they did an ekg and chest xray. My bp was high, especially my diastolic. I have had a racing heart beat, chest pain, palpitations, and my heart rate wouldn't go below 85. I am currently still having chest pain and feeling unwell. I had a echocardiogram and wore a heart monitor for two days. I haven't had caffeine or sodium since September 4th. I am waiting on a blood panel and have talked to my PCP.
sl nausea x 1 day, soreness @ inject site;  erythema & induration 48 hrs post inject 4x4 cm; rx DPH & ice packs;
Woke up 11 hours after 2nd dose with severe chills, body aches, headache fever, joint pain and enlarged supraclavicular lymph node. Unable to function the next day. Symptoms did not improve with tylenol or NSAIDS. Body aches started to improve around 1800 on 2/4/21. At 0445 on 2/5 headache continued as well as enlarged lymph node and malaise. All other symptoms were resolved. 2 days of work missed.
The following day after the receiving the vaccine,  patient complained of feeling run down with a headache.  Took some tylenol for the headache.  In the proceeding days, the patient complained of body aches and feeling unwell.  Day 3-4, patient reported having shortness of breath and feeling exhausted.  Patient woke up on day 5 after the vaccine, breathing heavily.  Patient died shortly thereafter.
the large spacing between the 1st and 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the large spacing between the 1st and 2nd dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the large spacing between the 1st and 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the large spacing between the 1st and 2nd dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No Treatment information was provided by the reporter. Patient did not have an adverse reaction to the vaccine, nor was the vaccine expired.  Patient simply did not receive the vaccine within the recommended 28 days, and was also past the manufacturer's 42 day extension for proper vaccine scheduling between doses.  Patient did not had any adverse reactions, and he was informed that due to the large spacing between the 1st and 2nd dose, there was no need to repeat the series but getting the 2nd dose could lead to decreased efficacy of the vaccine overall.
Temperature 101F less than 12 hours, post vax. Persisted at least 24 hours. Also had body aches, arm was red and swollen at injection site. Treated with Tylenol and ice on arm.
Warmth, redness, and moderate induration measuring 6.5 cm in width by 7 cm in longitude from injection site at top of left deltoid down the left upper arm with smaller round area of slightly darker redness measuring 2.25 cm in diameter posterior to this (at varivax injection site). Advised ibuprofen, cool compresses PRN.
Information has been received from a licensed practical nurse concerning a 12 year old female pt without food or drug allergies, and a history of allergic rhinitis, eczema and environmental allergies, who on 02Jun97 was vaccinated with one dose of the series of hep B virus vaccine rHBsAg (yeast) (manf unk) (lot not available). Concomitant therapy administered on the same day included a dose of tuberculin purified protein derivative. There was no other concomitant medications. On 02Jun97 the pt developed a whole body rash. The licensed practical nurse reported that a dermatologist report followed the pt had an allergic response to hep vaccine. The pt was treated with (APARAX) 20mg QID and the symptoms resolved. There was no product quality complaint reported. The licensed practical nurse questioned whether the pt would have an adverse reaction to hep A virus vaccine inactivated since the pt had an adverse reaction (rash) after vaccination with hep B virus vaccine rHBsAg (yeast). No further information is available.
Off label use; Drug use in unapproved population; dry cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 24Jun2021 (Lot number: EW0187) at the age of 20 years as dose 1, single and administered in deltoid left, administration date 15Jul2021 (Lot number: FA6780) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: COUGH (non-serious) with onset 2021, outcome "not recovered", described as "dry cough"; OFF LABEL USE (non-serious) with onset 24Jun2021, outcome "unknown", described as "Off label use"; PRODUCT USE ISSUE (non-serious) with onset 24Jun2021, outcome "unknown", described as "Drug use in unapproved population". Therapeutic measures were taken as a result of cough. Additional information: The patient received dose 2 at the age of 21 years. Patient took vitamins daily, so Selenium, Zinc, Vitamin C, Vitamin D, Iron, Calcium (further not clarified). Patient had no prior vaccinations (within 4 weeks). Patient stated that she was breastfeeding at the time of her vaccine (further not clarified). Patient used a cough drop as treatment on the days it got worse and other days, she just cough it out.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200513465 same reporter/drug, different patient/event, baby case
Client given adult dose of Hep B vaccine 1.0 mL instead of appropriate pediatric dose of 0.5 mL.
Felt very cold for most of the day, from when I woke up to when I went to bed.  Had a headache and felt a little dizzy when standing up right.
Swelling, redness, warm-to-the touch on vaccinated arm beginning 7 days after vaccination.  Reaction occurred on entire upper arm and did not begin at injection site.  Pt did not experience any initial swelling or soreness at injection site.
Patient was dizzy 10 minutes after. Needed to lay her down. Called parademics because she was not feeling well.
FAST HEART BEAT, DIZZINESS, WEAKNESS, PALENESS, MUSCLE ACHES, SERIOUS SORENESS IN ARM WHERE SHOT WAS ADMINISTERED FROM ARM PIT THRU HAND.
severely ill; Initial information received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves an unknown demographic patient who experienced severely ill (illness) after receiving INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious severely ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I was really poorly from flu once so got the jab next Yr and think I will stick with flu. Made me severely ill."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.
Injection site reaction-red and swollen at the injection site since injection. Armpit pain began 5/6.
Received flu vaccine on 10/12/04 at 0830.  On 10/13/04 at 1530 noted maculopapular rash at injection site.  Rash covers area about 60mm by 100mm at injection site on L arm.  It is irregular and does not cover entire site.  States it is not itchy.  Does not have any respiratory symptoms.  Denies egg allergy and eats eggs regularly.  Has had flu shot for the last 6 years.  Had varicella as a child.  Has not changed laundry soap, soaps, lotions, or new medications.  Has not had any new foods.
nausea, soft stools, fatigue, brain, lump in left arm, brain fog x3 weeks
Fever began approx 12 hrs post-injection and varied between 101 to 103.5 for 48 hours accompanied by severe headache, chills and exceptional low energy state. A 'brain fog' remained and is still evident at time of submission (simple math and some memory details difficult to execute/recall).
Information has been received from a registered nurse concerning an approximately 65 year old female with no medical history who in approximately September 2009 (fall of 2009), was vaccinated with ZOSTAVAX (Merck) (lot# not reported). There was no concomitant medication. In July 2010, the patient experienced developed shingles in the groin area. The nurse would check with the physician to see if testing was desired. Unspecified medical attention was sought. The outcome of the event was unknown. Additional information has been requested.
06/01/2021 06:30PM Pfizer covid 19 vaccination fatigue, pain, red and swelling at the injection site, fever forehead temperature of 98.6°F, Sore calves, Sore feet, thirst 06/02/2021 fatigue, headache, pain and swelling at the injection site, muscle fatigue in the legs and feet, fever forehead temperature of 98.6°F, sweating, Sore calves, Sore feet, thirst 06/03/2021 Fever forehead temperature of 99.0°F, pain and swelling at the injection site, Left chest pain started at 09:00 pm. Never had pain in the past, Phlegm in my throat, Sore calves, Sore feet, thirst 06/04/2021 Left breast pain all day, thirst 06/05/2021 Injection site itchy, feeling cold, thirst, spider varicose veins on appear on the legs and breast
Patient with a rash under the site of injection that is fine and papular and also noted on the opposite thigh and calf as well, some on the abdomen.  The one on the calf is slightly urticarial.  Advised them to give patient a bath as she was outdoors and to also give 6.25mg of Benadryl every 6 hours and if the rash fades would most likely be due to exposure to seasonal allergens by contact versus the vaccine.  Mother to update me tomorrow.
Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2012, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On an unknown date, the patient experienced shingles (herpes zoster) and other zoster-related injuries despite being inoculated with the ZOSTAVAX vaccine (vaccination failure). On an unknown date in 2016, the patient was treated by a health care provider for shingles. It was also reported that, on unknown dates, the patient suffered serious physical, emotional and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering (Emotional distress and pain), extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of laten conditions, lost wages, loss of earning capacity and other losses and damages. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased, and the pre-existing unspecified conditions aggravated was unknown. The reporter considered the adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-treathening and medically significant.
Large erythematous blotchy/patch localized. Reaction warm to touch but no signs of infection.
Patient reported pain in chest and back when lying down each night. Pain in arm at injection site. Itching and golf ball sized swelling at injection site. Reported to pharmacy on 10/19/2015, and patient stated that still some tenderness and puffiness at injection site.
lot of hair was falling off; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (lot of hair was falling off) 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 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 ALOPECIA (lot of hair was falling off). At the time of the report, ALOPECIA (lot of hair was falling off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
No issue on day of immunization. Patient returned to pharmacy 3 days post and complained of (L) arm nerve pain, numbness and tingling down arm will follow up 9/29/15.
2nd dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 18 January 2022 the patient received 1st dose, Lot number 3AA9T, expiration date 20Apr2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-APR-2023 The pharmacist reported that a patient received the first dose of Shingrix and had not yet received 2nd dose.  The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Chills; joint pain; slight fever; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via unspecified route of administration on 17Mar2021 (52-year-old at the time of vaccination) as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 18Mar2021, the patient developed chills, joint pain and slight fever. The patient did not receive any treatment for events. The clinical outcome of the events was resolved on unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's age and age at vaccination (52-year-old), and lead sentence in analysis tab was updated.
As of this date and time, I am still suffering from the following: Numbness in entire left arm and fingers tingle  Hands now shake when I hold them up Dizziness Headache Soreness  Fatigue Shoulder and neck muscles are sore Legs are weak/tired and hurt behind my knees and muscles
Moderate pain in arm, enough to disturb sleep. Fatigue and general achiness. Fever above 100 degrees.
Arm was bruised at vaccine site initially.  A week later a red rash started.  Eight days later a red area appeared, approximately 1 1/2 by 3 inches, which was slightly swollen and as red as a bad sunburn.  It was somewhat mottled.
Immediate severe sore arm. Headache within one hour. 17 hours later woke up vomiting with a fever of 101, chills, body aches, joint pain, severe headache, and extreme exhaustion.
hurts in the area of the breastbone in the beginning evening, next day could hardly breath, standing, sitting, walking was hardly possible, just to lay in bed the whole day. on the 3rd day it became better.
the next day he got sick; Initial information received on 03-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-HCP.  This case involves an unknown age male patient who stated that the next day he got sick after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect influenza vaccine (with an unknown strength, formulation, dose, frequency, route, lot number, expiry date) for Immunization.  On an unknown date the patient stated the next day he got sick (illness) (unknown latency) following the administration of vaccine.  No lab data was reported  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Information has been received from a consumer, concerning her 17 year old son with a penicillin and CECLOR allergy, sulfonamide allergy, drug hypersensitivity to FLUVIRIN (involving an anaphylactic reaction, 02-OCT-2007), latex allergy, and multiple food allergies, who on 15-NOV-2007 had a skin allergen test performed prior to vaccination with a dose of pneumococcal 23v polysaccharide vaccine (lot #658555/0964U). Concomitant therapy included ZYRTEC. Her son's skin "flared up and became red" at the injection site, and he consequently was not administered a full dose of the vaccine. At the time of this report, her son had recovered from the event (duration not specified). The patient had a history of a positive allergy skin test when exposed to varicella virus vaccine live (MSD) (WAES #0801USA05565). Additional information has been requested.
Rheumatoid Arthritis, with no family history of RA. With no previous symptoms, all of a sudden started after the booster dose in December 2021.
Nausea and Headaches occurred about 5 hours after the injection, since then they have come and gone periodically, usually lasting about 30 minutes, then going away for a few hours. I have been experiencing tightness in my chest and dyspnea upon exertion since about noon, Tuesday, March 23.  NSAIDs have helped relieve some discomfort. Last night, I woke up with racing heart palpitations and tingling in my extremities. Today, I have experienced a sore neck and cramps in my legs, tingling in my extremities, and chest tightness with tachycardia. I have spent the week studying for an exam on Friday, so I plan on going to urgent care afterward.
nausea, vomiting, weak, rapid heart beat, insomnia.  Went to hospital (Medical Center) where they performed test on my heart, echocardiogram, ekgs.