chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other=moderna, Vaccine dose number=3 / Vaccine brand=Pfizer / BioNTech, Vaccine dose number=2; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 as dose 4 (booster), single (Lot number: gh9903) at the age of 49 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: el3247), in left arm and on 03Feb2021 as dose 2, single (Lot number: en5318), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Apr2021 as dose 3 (booster), single (Lot number: 071f21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "IgA nephropathy" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: egg" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Apr2021, outcome "unknown", described as "Vaccine brand other=moderna, Vaccine dose number=3 / Vaccine brand=Pfizer / BioNTech, Vaccine dose number=2"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Fever of 102.3, initially lethargic, then with fever spike unconsolable crying for 1+hours until fever went down with Acetaminophen. Low grade fever of 100 in the am. More Acetaminophen was given and temp returned to normal.
made my arm very sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 23-FEB-2023, the patient received Shingles vaccine. In FEB-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: made my arm very sore). The outcome of the pain in arm was recovering/resolving.   It was not reported if the reporter considered the pain in arm to be related to Shingles vaccine.     It was not reported if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 28-FEB-2023 This case was reported by a patient via interactive digital media. The patient got the shot on Thursday. The shot made patients arm very sore and getting better today. The follow-up could not be possible as no contact details were available.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. The physician heard about the event reported below from the media, possibly from the Internet. On an unknown date, the patient was vaccinated with an unspecified GARDASIL or GARDASIL 9 could not be ruled out (lot #, expiration date, exact dose and route of administration were not reported). On an unknown date after receiving the unspecified HPV vaccine, the patient was hospitalized due to an unknown reason. The outcome of the event was unknown. The relatedness between the event and the suspect vaccine was not reported. Additional information has been requested.
Evening of second shot, patient experienced cold sweats, no appetite, was listless and "passed out".
Bruise on arm under injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise on arm under injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 002B21A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE BRUISING (Bruise on arm under injection site). At the time of the report, VACCINATION SITE BRUISING (Bruise on arm under injection site) outcome was unknown.            Concomitant medications included High blood pressure medicine and Water pill. No Treatment information provided
Serologic adverse reaction Adverse reaction to the shot Affected his Neuro periphery  (Brain stability) Caused an imbalance and Seizure related affects
RECEIVED COVID VACCINES ON 01/20/21 AND 02/10/21. 2/11/21 EMS CALLED BY FAMILY FOR ALTERED MENTAL STATUS AND ACCUCHECK OF 40 AND TAKEN TO ER HAD NEGATIVE COVID PCR ON 02/11/21 DIAGNOSED IN ER ADMITTED TO HOSPITAL INPATIENT WITH HYPOGLYCEMIA DUE TO DMII, AMS, UTI, AND PLEURAL EFFUSION
Patient is 63 and immune compromised, and received a FluZone High dose. Patient  was not in the eligible age range for this vaccination. Monitored patient for any signs and symptoms of anaphylaxis. Patient stated no pain at injection site. ROM within normal limits.
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9, lot N002720, expiration date 12-MAY-2019 (dose and route were not reported)  for prophylaxis. The vaccine was exposed from 32 Fahrenheit degrees (°F) to 35 Fahrenheit degrees (°F) for 1 hour. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Immune thrombocytopenia in 2 healthy young women after the Pfizer-BioNTech BNT16B2b2; This is a literature report.  A female patient received BNT162b2 (BNT162B2), 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: IMMUNE THROMBOCYTOPENIA (medically significant), outcome "unknown", described as "Immune thrombocytopenia in 2 healthy young women after the Pfizer-BioNTech BNT16B2b2".; Sender's Comments: Based on a temporal association, a causal relationship between the event immune thrombocytopenia and BNT162B2 is considered possible.  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.,Linked Report(s) : US-PFIZER INC-202200986266 Same Article/drug/event; Different patient.;
This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported that a 64-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (trade name not reported) on an unspecified date, at single dose, for immunization. Medical history and concomitant medications were not reported. The patient was allergic to pneumococcal vaccine. Event outcome was not reported. Pfizer is a Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Case number PHEH2014US014490 is an initial spontaneous report received from a nurse on 17 Jul 2014. This report refers to an 18 year old male patient. Past medical history and concomitant medications was not reported. He received only Men A lyophilized conjugate component of MENVEO (batch number: M13014), intramuscularly reconstitut4ed with a sterile water instead of MenCYW-135 liquid component on 14 Jul 2014. No adverse reaction reported following this administration error.
Developed chills, mild headache, mild upset stomach within twelve hours of vaccination.  Persisted until the morning of the 24th.
approx 730PM 11NOV98 recv vax & c/o pain, dec ROM, erythema, firm & tender to touch, pain & tenderness;became so severe by 630AM 11NOV saw MD;MD called local reaction to pneumovax;
9-19-18 sore deltoid muscle. 9-20-18 sore deltoid muscle, malaise, nausea, joint pain even at rest. 9-20-18 - 10-3-18 continue joint pain primarily in hands. 10-3-18 macular rash.
Booster\received dose 3 of BNT162B2; Swollen lymph nodes under the arm on the side of injection; Temp 102; This is a spontaneous report from a contactable nurse. A 32-year-old non-pregnant female patient received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had received any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 11Oct2021, the patient experienced swollen lymph nodes under the arm on the side of the injection and a body temperature of 102 (units unspecified). On 11Oct2021, the patient underwent body temperature test and the result was 102 (units unspecified). The reported events resulted in emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes under the arm on the side of injection and temp 102 (units unspecified) was recovering at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Post vaccine, at 6PM, I started getting pain in my left eye, twitching in my eye, blurry vision, spasm and numbness that radiated to my left ear and lower lip. And my blood pressure went much higher than normal. That day the symptoms lasted about 2 1/2 hours. Then my left eye was twitching from 10/19-10/24 and kept getting blurred. Then on 10/24 I went to the emergency room because it was getting worse. I had an ocular migraine earlier in the year. So, they treated it like an ocular migraine. They gave me a migraine cocktail and fluids. I went back to the emergency room on 10/26/2022. I had blurred vision, numbness in ear, cheeks, lips and eye, ocular pain. I had nerve pain on the right side of my head that radiated to my neck and shoulders, and my blood pressure was very high. They treated me with fluids, and a migraine cocktail. I think it is a magnesium supplement. I am still having some problems. The symptoms are less, but I am still having some. On 11/10/2022 I have a doctor's appointment.
Pt received 0.25ml of Moderna  that was opened longer than the recommended time.  No adverse effects noted. Dr and pt. notified. Per Moderna no additional booster recommended.
Well as far as I know, nothing happened the day of or anything like that. Then like 30 days after the vaccine I was short of breath and then one time I passed out, the paramedics took me in and they said that my heart wasn't beating right. I also got to episodes in the ambulance and two more in the hospital. So they put a temporary pacemaker put in on May the 1st for three days, then they put the defib in and after that I haven't had any problems and checked out.
Patient presented to the clinic 10/14/2015 with complaint of left arm/shouler pain since receiving the flu shot 09/15/15.
A serious spontaneous report of FLUMIST administered to asthma patient and wheezing after FLUMIST has been received from a health professional concerning a six-year-old male, subsequent to FLUMIST. The patient's medical history included asthma. The patient was diagnosed with reactive airway disease manifested with upper respiratory tract infection at the time of FLUMIST administration last year. The patient received FLUMIST on 31-Aug-2011. After receiving FLUMIST, the patient experienced wheezing that necessitated hospitalization. The outcome of the event FLUMIST administered to asthma patient and wheezing after FLUMIST was unknown.
Information has been received from a physician and a woman from the physician's office concerning an approx 21 month old female who, at a different office, on 10Jul95 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included montelukast sodium and budesonide (Pulmicort). It was reported  that the pt recently developed a mild case of chicken pox. The pt's physician contacted an allergist who decided to treat the pt with acyclovir. There were no further adverse events. On 30Mar04 the pt recovered. No product quality complaint was involved. No further information is expected.
Information has been received from a pt's husband and a RN that post vaccination the pt developed a fever on 2 occasions of up to 102 F. the pt was seen the the Dr's office a few days later with a skin reaction of left deltoid, are 6X8 cm indurated with erythema, aching,. At this time the pt was afebrile. The local reaction resolved by 11/20/2000. The pt's Dr reported that the pt developed a moderately severe local reaction. The pt complained of chills and general malaise. The husband reported that she had a nodule in the back of her throat which has gone away. The pt has been developing a fever off and on with weakness and fatigue.
Concern for Covid vaccine given on 9/8/22.  Nurse took thawed vial out of refrigerator and diluted with .7ml of sterile diluent that is normally used to dilute the Proquad/MMR/Varicella. Nurse withdrew .2 ml from vial and administered. Wrong diluent used with incorrect amount of diluent. Patient parent notified on 9/8/22 and informed to notify MD of any type of reaction.  None has been reported as of 9/10/22.
90 y/o with h/o dementia presented after a fall with head CT at that time (11/26) demonstrating trace IVH b/l with chronic SDH, which improved on repeat scans. Since then patient continued to be hospitalized as waiting SNF placement. On 12/2, around 11:25 AM, after receiving COVID vaccine, patient was found slumped in his chair and unresponsive, lost pulse with ROSC achieved after 20-30 seconds w/ chest compressions. After ROSC, patient profoundly altered, for which code Stroke was called at 11:43 AM. NCHCT without acute hemorrhage, CTA without LVO. So acute change in mental status, likely in the setting of brief asystole/hypoxia during code blue event. Neurology/stroke consult team, recommending work-up for other causes including toxic-metabolic, however most likely etiology of alteration of mental status due to asystole/hypoxia event which triggered the Code Blue. Given acute change in clinical condition, needing closer monitoring, further evaluation and potential for clinical decline, appropriate to update bedded outpatient to inpatient level of care ED to Hosp-Admission (Current) on 11/26/2022
Local site swelling and itchiness. Local site is also fevered. Local site of injection is also firm to the touch. Has persisted for 9 days post injection.  Minor inconvenience, not a major adverse event
Since 7 years, no bowl movements, my chronic colon disease was "sleeping". Since day after vaccination, I have about 30 bowl movements a day.
4/10/21 - I took 4 low dose Bayer aspirin about 11:45 AM on 4/10/21.  I received the Janseen COVID19 vaccine about 12:45 PM on 4/10/21.  I cleared the 15 minute monitor period at 1:05 PM.  About 8:00 PM on 4/10/21 I felt slight chills and left wrist was achy.  About 9:00 PM on 4/10/21 chills persisted and I felt fatigued.  About 9:45 PM on 4/10/21 I felt more body aches and took 4 low dose Bayer aspirin at 81 mg.  About 10:15 PM I had a temp of 100.4 F and body chills.  4/11/21 - About 2:35 AM I had a body temp of 101.6 F with body chills and night sweats.  About 11:25 AM body temp decreased to 99.9 F and had a headache.  I took another dose of 4 low dose Bayer aspirin.  I slept a total of about 3 hours from 10 PM on 4/10 to 10 AM on 4/11.  About 9:00 PM body temp was 99.6 F.  4/12/21 - About 8:30 AM body temp was 97.9 and slept more than 5 hours with light to moderate night sweats.  Experienced injection site pain from 4/10/21 to 4/13/21.
broke out with reaction under her eye / each day it was getting redder and redder / because of the rash the doctor prescribed a cream; and got cream under her eye; the whole white of that eye was bloody red; pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "on BP medication" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: RASH ERYTHEMATOUS (non-serious), outcome "recovered", described as "broke out with reaction under her eye / each day it was getting redder and redder / because of the rash the doctor prescribed a cream; and got cream under her eye"; OCULAR HYPERAEMIA (non-serious), outcome "recovered", described as "the whole white of that eye was bloody red"; PAIN (non-serious), outcome "unknown". The events "broke out with reaction under her eye / each day it was getting redder and redder / because of the rash the doctor prescribed a cream; and got cream under her eye" and "the whole white of that eye was bloody red" required physician office visit. Therapeutic measures were taken as a result of rash erythematous, ocular hyperaemia, pain. Additional information: Reporter stated her sister (patient) got Pfizer Covid booster and shots and broke out with reaction under her eye and the whole white of that eye was bloody red. Her sister did not go to the doctor and got 2-3 more boosters. Caller stated she found that out 2 days prior to her getting her vaccines which was why she chose not to get Pfizer product (for the reporter herself). Caller stated patient told her she got maybe 3-4 since this all came out; she thought more like 3. Reporter just found this out because reporter was going for a shot from another company. Reporter had a reaction and wanted to make note but she won't give her name. The very first Pfizer Covid vaccine the patient ever got, that was when it all started (as reported). Within a couple days, patient broke out under her eye and each day it was getting redder and redder. Her husband was really concerned. It's gone now. Reporter doesn't know how long it took to go away. Patient doesn't take as many concomitant medications, she's on BP medication and vitamin supplements she has always taken; has been on before vaccines. No testing. Because of the rash, the doctor prescribed a cream and patient went to the ophthalmologist and got cream under her eye for the same eye, guessed it was just one eye, not both and got steroid eye drops. Reporter thought it was the left eye but was not sure. It was also reported that the previous nurse was going to connect the patient with pain patches that Pfizer doesn't make anymore, Flector pain patches.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case previously recorded as MA2009-4490. Consumer reported the following information via MedCom on 17 NOV 2009: A female patient was vaccinated into the arm with influenza virus vaccine (manufacturer and batch no. unknown) on an unspecified date. While administering a nerve on the her arm was hit. She experienced pain in arm on an unknown date. The outcome of the symptom was unknown at reporting date. MedCom Ref. no.: NA09-008416.
Extreme shoulder Pain / extends from her shoulder down to her elbow; Tired; This case was reported by a consumer via call center representative and described the occurrence of arthralgia in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th May 2021, the patient received the 1st dose of Shingrix (intramuscular). On 25th May 2021, less than a day after receiving Shingrix, the patient experienced arthralgia and tiredness. On an unknown date, the outcome of the arthralgia was not recovered/not resolved and the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the arthralgia and tiredness to be related to Shingrix.  Additional details were reported as follows; This case was reported by a consumer. The patient received her first dose of shingrix. Post that, the patient experienced feeling tired and extreme shoulder pain. The patient stated that, the shoulder pain never stopped and now seems to be getting worse. The pain extended from her shoulder down to her elbow. The patient consented to follow up.
Pt states that L upper arm has ached like the toothache since she received the flu vaccine on 11/8/02.
This spontaneous prospective pregnancy report as received from a pharmacist refers to a 21 years old female patient. The patient's history of previous pregnancies and lives births was not known. The patient was vaccinated with  dose of M-M-R II (lot number 0497AE, expiration date 07-MAR-2014) subcutaneously on 12-OCT-2012 when she was seven months pregnant. It was not known which dose this was in the M-M-R II. There were no co-suspects and no concomitant medications. The patient became pregnant with an LMP of approximately 12-MAR-2013 and an EDD of approximately 17-DEC-2012. Initial exposure to M-M-R II was at 30 week(s). The patient was exposed to M-M-R II during trimester 3. No treatment was given for adverse event. No laboratory diagnostics studies were performed. The pharmacist noted the patient "went to her physician" for see medical attention. Additional information has been requested.
Given varicella vaccine 6/16/08. Developed widespread urticaria on 7/6/08. Recovered uneventfully.
Flu vaccine admin. 9/21/13. On 9/23/13 pt. returned to store to report pain, inflammation and warm at injection site. Pharmacist referred to physician. Pt. dx: cellulitis.  Rx cephalexin 500 mg TID x 10.