chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative 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: Unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be this report indicates a medical adverse event for the patient. while a positive covid test result was received after vaccination, insufficient time had elapsed for immunity to develop (10 days elapsed between vaccine and test). there was not sufficient time elapsed for the patient to achieve immunity therefore this report is not considered a lack of effect. case is approved for void. based on the PQC evaluation/investigation performed.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Administered vaccine from vial that had BUD of 6-26-2021 at 10:15 am. Vial was kept in refrigerator entire time prior to administration.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Pediatric patient: patient moved/jerked while administering dose leading to a cut on patients arm near the injection site with the needle
A report was received from a health care professional on 30 October 2003 concerning a 29 year old female vaccine who experienced tenderness at the site of injection the day of receiving Fluvirin, and a painful and tender arm 1 day after inadvertently receiving Fluvirin subcutaneously on 29 October 2003.  On 29 October 2003, the vaccine experienced a little hit of tenderness at the site of injection after receiving Fluvirin on the same day.  The Fluvirin was inadvertently administered subcutaneously.  On the morning of 30 October 2003, the vaccine experienced more discomfort and there was a long patch about 3 x 1 inches on the back of her left arm which was painful and tender.  The reporter indicated that the vaccine may have inadvertantly received Fluvirin subcutaneously instead of intranuscularly.  The vaccine is applying ice packs to the arm.  The patient had not recovered at the time of the event.    There was insufficient information to determine the reporter's causality assessment.  Update 1, 16 April 2004 Follow-up information received from a health care professional indicted that the vaccine experienced pain and redness of the left upper arm on 29 October 2003.  The vaccine was also treated with ibprofen and heat for 2-3 days.  These events resolved on 31 October 2003.  No follow-up pending, all information received.
Fever -102; Chills; Headache; Left arm pain and swelling; Left arm pain and swelling; General body aches; Nausea; Tired; Unwell; Dizzy; This is a spontaneous report from a contactable other HCP (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number E49899) (Brand: Pfizer), via an unspecified route of administration at 28Dec2020 15:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The patient medical history and concomitant medications were not reported. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever -102, chills, headache, left arm pain and swelling, general body aches, nausea, tired, unwell, dizzy at 29Dec2020 11:00 AM. It's unknown if patient received treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered. The events were reported as non-serious.
Profoundly autistic. Has no functional, expressive communication. Can't do anything by himself.   60 day follow up states that pt has not recovered. He is /or has autism. This is a life long neurologic disorder. Annual follow-up on 02/03/04: "Pt has not recovered from adverse events.  I think the residual symptoms are permanent neurological defects related to autism.  Pt will never recover from autism.  He has gastro-intestinal problems associated with this disability as well.
Redness, hardness at site 2 3/4" diameter swollen, swelling started next day after vaccination on left thigh. Patient monitored, recovered spontaneously.
left upper arm was swollen (double its size); This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left upper arm was swollen (double its size)) 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.   In October 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced PERIPHERAL SWELLING (left upper arm was swollen (double its size)). At the time of the report, PERIPHERAL SWELLING (left upper arm was swollen (double its size)) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Extensive redness and swelling of left upper arm with pain, one day after receiving flu vaccine. Patient also complained of difficulty in moving left arm this adverse event was reported to clinic 2 days post-vaccination. Patient reported reaction to flu clinic and was reported to clinic and examined by MD.
Vaccine given on 6/24 - tested positive for Covid on 6/30. Woke up to stuffy nose, scratchy throat, and overall achey-ness. Took at-home covid test in AM of the 30th, it was negative. As day progressed, pelvis started to really hurt and started to run a fever of 100.5 being the highest noted. Took second at-home covid test in late afternoon, it was positive. (the test line popped positive before the serum even made it to the control line). On 7/1, visited Drug store for a Rapid test, that was also positive.
DIAGNOSED WITH DOUBLE PNEUMONIA AS A RESULT OF COVID-19; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a (media report) patient via a company representative concerned a 56 year old female of unknown race and ethnicity. 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 administration was not reported, batch number: Unknown, expiry- unknown) dose, frequency 1 total, 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.  After just a week receiving of vaccine patient tested positive for COVID-19 and experienced suspected covid-19 infection, she could not breath hence she was gurgling at night trying to breathe. On next day after woke up patient and her husband went to hospital and her oxygen levels were so low hence that she was immediately admitted and taken to the intensive care unit. At hospital she was diagnosed with double pneumonia as a result of COVID-19. Her lungs was tore. Laboratory data (dates unspecified) included COVID-19 virus test was positive and oxygen saturation was low. Patient was admitted in hospital for 10 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diagnosed with double pneumonia as a result of COVID-19 and suspected covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is associated with product quality complaint.; Sender's Comments: V0: 20210935146- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Diagnosed with double pneumonia as a result of COVID-19, Suspected COVID-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
I have had increasing vertigo since the vaccine almost a month ago. The dizziness also includes migraine and nausea. It began only when I would roll over at night after falling asleep.  A week later it began as soon as I lay my head down or rolled over.  Now it can hit when I'm awake and upright such as at work.
55 year male presented to vaccine clinic, scheduled for a Moderna booster. Reconciled past immunization records on system, pt had received 1st  dose (1/16/21) and 2nd dose (2/15/21) of Moderna and indicated to proceed with administration of 3rd dose. Pt received 0.5cc of Moderna on 10/21/21 @ 15:24, double the recommended volume 0.25cc for booster. Pt did not have any allergic reaction or adverse event during 15 min monitoring period nor upon leaving.    Moderna Lot #11F21A, exp 1/19/2021
Headache, chills, body aches.  Ibuprofen 800 mg  every 8 hours for 3 doses.   Currently still has headache.  Unclear if related
feel like she has a horrible cold; Runny nose; like a bad cold; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feel like she has a horrible cold), RHINORRHOEA (Runny nose), NASOPHARYNGITIS (like a bad cold) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for No adverse event: Pfizer BioNTech COVID-19 Vaccine (First dose) in May 2021 and Pfizer BioNTech COVID-19 Vaccine (Second dose) in 2021. Past adverse reactions to the above products included Product used for unknown indication with Pfizer BioNTech COVID-19 Vaccine and Pfizer BioNTech COVID-19 Vaccine.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, the patient experienced FEELING COLD (feel like she has a horrible cold), RHINORRHOEA (Runny nose), NASOPHARYNGITIS (like a bad cold) and INFLUENZA LIKE ILLNESS (flu like symptoms). The patient was treated with VITAMIN C [ASCORBIC ACID] in 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING COLD (feel like she has a horrible cold), RHINORRHOEA (Runny nose), NASOPHARYNGITIS (like a bad cold) and INFLUENZA LIKE ILLNESS (flu like symptoms) had not resolved.            she got the booster dose of the Moderna COVID-19 vaccine (Lot number not provided in the card). About 2 days after the Moderna booster she started to feel like she has a horrible cold, runny nose, like a bad cold (agent asked her to repeat other side effects she mentioned that made her feel like she had a cold but she did not repeat them).  She was taking Vitamin C and cold meds and tried to get rest. This flu like symptoms have been non stop. It's not so severe to go to a doctor  No concomitant medication were reported.
12/19/09 According to mom, pt developed hives, itching and burning, subsided by 12/20, however, rash came back and persisting. Pt already had cough and runny nose prior to vaccination; however, cough, runny nose, fever 100-103 worsened.
Swelling and itching after  vaccine, a slight headache and then 9 days later the vaccine injection site started itchin again and there is redness with swelling.
Migraine going on for 4 days. Loss of appetite. Light head and dizzy.
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever 99ºF after first shot) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 006B21A) for COVID-19 immunization. No medical history reported. On Mar 21, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 21, 2021, patient experienced pyrexia (fever 99ºF after first shot). On Mar 23, 2021, pyrexia (fever 99ºF after first shot) resolved. Diagnostic results: On Mar 23, 2021, body temperature: Fever 99ºF (high) after first shot. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-375574, MOD-2021-374581 (patient link).
cramps for ten days; severe spasms in my right eye lid, closing my eye, for five weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 12:30 (Lot number: FC3180) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid disease" (unspecified if ongoing); "IBS" (unspecified if ongoing); "I haven't had a period for ten years" (unspecified if ongoing); "Prior to vaccination, was the patient diagnosed with COVID-19?:Yes" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; LIOTHYRONINE; LOSARTAN; SPIRONOLACTONE. The following information was reported: DYSMENORRHOEA (non-serious) with onset 02Sep2021 05:00, outcome "unknown", described as "cramps for ten days"; BLEPHAROSPASM (non-serious) with onset 02Sep2021 05:00, outcome "unknown", described as "severe spasms in my right eye lid, closing my eye, for five weeks". The events "cramps for ten days" and "severe spasms in my right eye lid, closing my eye, for five weeks" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of dysmenorrhoea, blepharospasm.  Additional information: The patient had not had a period for ten years, had cramps for ten days and had her period for a week, had severe spasms in right eye lid, closing her eye, for five weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient did not have any known allergies. The patient later received second dose of BNT162B2 on 22Sep2021 13:30, at arm left, lot # 301358A as dose 2, single for COVID-19 immunization.  Follow-up attempts are completed. No further information is expected.
To ER 630PM same day immun given t105 checked & sent home; took pt back 230AM fever 105 vomited; Seen by MD next day t102-104, fever lasted until Tuesday;
Patient is a 27 year old female referred to observation area after previously staying in observation area for 15 minutes.  Patient complained of having weakening, trembling of upper and lower extremities.  Encouraged pt. to relax, remain calm.   Fire Rescue called and arrived to scene for further evaluation.  Patient recovered from adverse event at 12:04pm.  Denies any pain, discomfort, trembling of all extremities, or weakness at this time.  Patient left observation area at 12:07pm via personal vehicle.
Information has been received from a reporter at a physician's office concerning a 24 week old male patient who was a premature baby, was on oxygen prior, had a respiratory disease and was an intensive care unit (ICU) patient. Two months ago (on approximately 06-OCT-2011), the patient was vaccinated orally with the first dose of ROTATEQ (lot number and dose not reported). There was no concomitant therapy. The reporter stated that the patient came in for his first dose of ROTATEQ and he experienced projectile vomiting, no blood or anything (the AE onset date also reported as "about 2 month ago", approximately in October 2011). It was unknown of the patient sought medical attention. No treatment was given for the event and no lab diagnostic tests were performed. at the time of the report the patient was recovered. This is one of several reports received from the same source. No further information is available.
Erratic menstrual cycle,  having cycle every week to two weeks for at least seven months.   Increased anxiety.  Possible side effect eyes watering.
I started having random shooting pains the day after my shot. I felt really fatigued and had random chills through my body. It was not until a week after my vaccine that I really started feeling weird. My anxiety really set it and I had several panic attacks. My ears have felt clogged and are continuously having to be popped, jaw pain, hurting lymph nodes in the necks, tight neck and shoulders, random muscle spasms throughout my body, blood rushing to head when standing, dizziness,  random strong heartbeats, and heart palpitations, stomach problems, muscle weakness, for a day I had what felt like sciatica in my face, and though I can smell and taste, somethings smell different and taste different. I went to the doctor yesterday and they gave me a z pack and steroids for and ear infections. The doctor said it sounds like I have a lot of inflammation in my body right now. I have a neurology appointment next month. I also started on Prilosec.
This spontaneous report as received from a nurse refers to an 11 months 2 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Within minutes of the injections both arms got very red , his face and neck became very red and started to swell. I went and got the doctor he noticed my son appeared to have some sort of reaction and assured me he would be fine. We waited for about 30 min and left. My son developed ulcer like burns on his face and nose. We used  triple antibiotic ointment on them didn?t rub and only patted them dry kept them clean and as those started to heal after about 8 days his entire face and neck peeled leaving his skin very sensitive. During this time he required daily naps which is not something he ever does he felt very run down.
Approximately 4 hours after receiving flu vaccine injection, hives/erythema/burning skin developed over neck, chest and ears bilaterally. 24 hrs after vaccine developed severe headache, joint and muscle pain.
Hives and diarrhea. Took benadryl and Immodium ad.
Approx. 10 minutes, post vax, pt developed large, reddened area which covered 1/2 the surface of her thigh.
pt c/o below site where pneumonia vax given rt deltoid;pt c/o pain @ site in rt arm;warm to touch, no other complaints noticed, redness & swelling began 30min p/vax;
Chills; high fever; dripping wet; clammy white skin; nausea; extremely fatigued. Symptoms have improved.
Fatigue (ongoing), chills (ongoing), muscle aches (1 day), redness at injection site (3 days), shortness of breath (ongoing)
FEVER; 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 fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever. This report was non-serious.
Joint pain, muscle aches, high fever, swollen lymph node in armpit. All went away within 48 hours except for joint pain in fingers and toes that I still have 2 weeks later
Reporter states she had no energy and was actually lying in the bathroom floor due to no energy; This non-serious case was reported by a consumer via call center representative and described the occurrence of loss of energy in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced loss of energy (Verbatim: Reporter states she had no energy and was actually lying in the bathroom floor due to no energy). The outcome of the loss of energy was resolved (duration 24 hrs).   It was unknown if the reporter considered the loss of energy to be related to Shingrix.    It was unknown if the company considered the loss of energy to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-OCT-2023 The reporter was the patient who stated the night she received her Shingrix vaccine was 5.5 months ago.  The reporter stated that she had no energy and was actually lying in the bathroom floor due to no energy, this had since resolved and only lasted 24 hours.
Symptoms Sunday 4/18: Red splotch on arm and small bump near injection site (warm to touch), full body muscle aches, fever, chills, headache, tiredness, lack of appetite Treatment Sunday 4/18: 1 ibeprophen + 1 Tylenol every 3-6 hours Symptoms Monday 4/19: Red splotch on arm and small bump near injection site (warm to touch), fever, slight tiredness Treatment Monday 4/19:1 ibeprophen + 1 Tylenol every 6 hours, icy-hot on arm every 3 hours, ice pack for 30 mins on/off, cortisone cream Symptoms Tuesday 4/20: Red splotch on arm and small bump near injection site (warm to touch) Treatment Tuesday 4/20: icy-hot on arm every 3 hours, ice pack for 30 mins on/off,  Benadryl pill at 4pm, Benadryl cream
Local swelling and erythema to (L) arm at site of PREVNAR vaccine streaking down (L) arm to erythema migrans site on (L) elbow. Arm hot Dx cellulitis no joint tenderness or swelling. Pt. seen at off site Urgent Care center. Put on BACTRIM 40mg given Vancomycin 200mg.
I had pericarditis went to ER  admitted for overnight treated with Ibuprofen. I have a upcoming appt for another scan for issues with my heart. I'm no sure if this is related wanted to make a note for research.