chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got really sick; had to be in bed for a whole week; allergic to the Moderna shots; got a rash; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (got really sick), MOBILITY DECREASED (had to be in bed for a whole week), ALLERGY TO VACCINE (allergic to the Moderna shots) and RASH (got a rash) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy and Lactose intolerant.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got really sick), MOBILITY DECREASED (had to be in bed for a whole week), ALLERGY TO VACCINE (allergic to the Moderna shots) and RASH (got a rash). At the time of the report, ILLNESS (got really sick), MOBILITY DECREASED (had to be in bed for a whole week), ALLERGY TO VACCINE (allergic to the Moderna shots) and RASH (got a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had no Acute and Chronic illnesses at the time of vaccination and patient had not taken other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Symptoms were improved.  No treatment medications were reported   This case was linked to MOD-2022-555541 (Patient Link).
Patient experienced 5inch circumferenced raised red circular rash on left tricep. Patient reports noticing the rash a day after Zoster immunization. Rash is located at typical site of subcutaneous injection. Patient reports no itching or discomfort. Patient was referred to PCP. Recommended to apply ice pack to rash and use of Benadryl as needed.
This spontaneous report as received from a certified medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with an unspecified amount of doses, with unspecified lot number/unspecified expiration date of VAQTA that underwent temperature excursions starting on 01-NOV-2016 for prophylaxis (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature was 47 degree Fahrenheit-77 degree Fahrenheit and time frame was 2 hours 10 mins. Call was due to digital data logger and there was no temperature excursion before. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA006335: US-009507513-1707USA006923: US-009507513-1707USA006921:
She woke @ 0400 am with severe HA.  @ 0600 developed severe nausea & dizziness, by 0700 was vomiting.  She was unable to keep anything down for 36 hours and was vomiting every hour for the first 12 hours, then about every 2-3 hours for 12 hours, then every 4-6 hours for the last 12 hours.  Headache, low grade fever (100.6), body aches and dizziness throughout this 36 hour period.   The am of 10/9/22, she woke up with severe ear pain and enlarged lymph nodes behind ear, in neck, and in arm pit.  Lymph nodes were tender swollen and hot to touch.  Lymph nodes were so swollen, she believes that the swelling compressed the ulnar nerve which resulted in numbness and tingling to R hand.  This numb and tingling lasted 3 days and gradually subsided.  On 10/10 she developed profuse blistering of the tongue, and was unable to resume a normal diet for 1 week. Muscle spasms, aches occurred for 1 week post the vomiting episode.   She followed up with PCP (MD) on 10/24/22, where she felt mostly recovered to check labs and get an ultrasound
Pfizer 3/17, 4/7, and 12/15. Positive on 12/3
Patient received the first dose of the covid vaccine, and experienced paralysis on the side of her cheek, and then it went away the next day.; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer. A female patient (reporter's daughter) of an unspecified age (reported as in her late twenties) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included patient was healthy, patient only takes birth control from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient received the first dose of the COVID vaccine, and experienced paralysis on the side of her cheek, and then it went away the next day. Outcome of the event was recovered.
Breakthrough COVID infection in a fully vaccinated patient resulting in ICU hospitalization. Patient was COVID positive on 7/22/21 and initially admitted to hospital from 7/23/21 to 8/6/21. Discharged to home at at time, however, patient presented to the ED on 8/14/21 with worsening symptoms. She was flown from this location to another hospital at that time. She remains at this other facility in the ICU at this time.
Patient experienced syncope shortly after receiving the vaccine. According to her mother who directly witnessed the event she got dizzy/queasy and passed out, slumping off the bench and onto the floor. When I got out to her she was conscious and sitting on the floor. She then vomited a little. She was pale and sweaty.  With the mothers help i got her up on the bench seat to lie down. After about 15 minutes she said she was feeling fine.
About 2-3 minutes after receiving vaccinations  mother called. (client in vehicle waiting) and stated he was having seizure like activity arms jerked and head went down (chin to chest) he was unresponsive for 10 seconds History of fainting with immunizations.
Chills in early AM (around 2AM) but gone by 8AM, severe soreness in right arm (even hurts to type) unrelenting headache (since 2AM) that is unresponsive to 400mg Advil taken every 4 hours, very thirsty even though adequately hydrated, dizziness upon rising to standing position or sitting up from laying in bed, feeling like I have a ?foggy brain?
Patient came to office for cold symptoms 2 days after injection. Told nurse had red-swollen area - (L) arm - where immi given area red size 71/2 x 6cm. Warm to touch - notices redness swelling within 1st 24 hours of vaccine. All given in 1 arm per pt request Enc to ice/use OTC pain/fever reducer. Soon checked by provider.
Pregnancy; Initial Report Received on 10-Nov-2020  A nurse in the US (MA) reported to the HEPLISAV-B pregnancy registry that the "office has vaccinated a few of their pregnant patients with HEPLISAV-B but they have already delivered."  The exact number of patient or any details were not available. The reporter declined to enroll their patients in the pregnancy registry.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
on going shingles and took the shots/suspected vaccination failure; chronic shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: on going shingles and took the shots/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: chronic shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient took the shingles shots. The patient had chronic on going shingles and had to take Rx (medical prescription) everyday. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.  The follow up would not possible as no contact details were available.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Pt was 90 years of age, with a PMH significant for HF, AF, DM, vitamin d deficiency, neoplasm of skin, obesity, hyperlipidemia. Pt was previous admitted for worsening leg swelling. EF less than 20%. Hypotensive, and transferred to SDU on 3/29. Transferred to micu on 4/2. Transferred to hospice care on 4/3.
I21.4 ACUTE NON ST ELEVATION MI 4/26/2023 CHEST PAIN I95.9 HYPOTENSION 4/25/2023 CHEST PAIN
Chest pain; Arm pain; 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 CHEST PAIN (Chest pain) and MYALGIA (Arm pain) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain) and MYALGIA (Arm pain). At the time of the report, CHEST PAIN (Chest pain) and MYALGIA (Arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information reported.
Vaccine booster on 12/08, and on 12/15 had left calf pain that felt like a muscle cramp, lasting 4 days.  Then had distension of veins in left leg with pressure and discomfort.  On 12/22 had bloodwork and office visit.  D-Dimer was high at 0.79.  PT normal 13.5 and INR 1.0.  Same-day U/S of LLE performed and was given single dose of lovenox.  Final report was negative for DVT.  Symptoms persisted and follow-up D-DImer was performed on 12/27 remained elevated at 0.5.  I went back to clinic on 12/30 and had repeat U/S that showed approx 6 inch DVT LLE.  Was seen by provider and had EKG, troponin, and CT chest which ruled out any PE.  Was started on lovenox bridge to oral anticoagulation.
1 week after vaccine developed symptoms of headache, photophobia, phonophobia, meningisumus. Later was confused and irritable, worsened about 4 weeks after vaccine to witnessed, myoclonus, opsoclonus, dysarthria, decreased level of consciousness. LP with lymphocyte predominant pleocytosis. MRI with leptominengeal enhancement, later T2 hyperintensity upper cervical cord to thoracic cord.  Diagnosis: meningoencephalomyelitis, no alternative cause identified and suspected related to COVID-19 vaccine.
Day 8 itching, redness and swelling about an inch below injection site - a quarter-sized spot and a nickel-sized spot. Lasted 2 days. Fatigue days 2 (mild), 8 & 9. Fatigue on days 8 & 9 was mild - moderate.  Day 9, arm started to ache as if I had just gotten my shot. Lasted 1 day.
Chills, severe body aches, nausea started 10 hours after vaccine.  They ended about 24 hours after vaccine.  HOWEVER, the nausea continues on and off, at 58 hours after vaccine, which is the current time.  Also lower abdominal pains from 48 to 58 hours after vaccine.  I ammat the 58 hour mark now, so am not sure how much longer this will last.
Patient described joint and muscle pain in the left hip/leg area once she arrived home after her injection.
Dizziness, Headache, NauseaVomiting, CHILLS, NO FEVER, PALOR Narrative:
Dose received 3; Chills/shaking; Chills/shaking; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is company representative.  A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 23Dec2021 (Lot number: unknown) at the age of 56 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were reported as unknown. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN), and Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 23Dec2021, outcome "unknown", described as "Dose received 3"; CHILLS (non-serious), TREMOR (non-serious) all with onset 23Dec2021, outcome "recovered" (23Dec2021), and all described as "Chills/shaking". Therapeutic measures were not taken as a result of chills and tremor. Additional Information: It was unknown whether the patient had any known allergies. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient said she had a tingling sensation all over body, felt hot, thirsty and anxious. After a couple sips of water patient stated she felt cold and dizzy. Gave cold compress and put on her neck, escorted her to chair in front of pharmacy and monitored her. After 30 minutes patient felt better.
BLOOD CLOTS IN BRAIN; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnic origin. 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 not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  Two weeks later on an unknown date in MAR-2021, the patient experienced blood clots in brain and died from blood clot in her brain. It was reported that, the plug was pulled after one week. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  This report was serious (Death).; Sender's Comments: V0: This spontaneous report received from a patient via a company representative concerned a female of unspecified age and ethnicity, who experienced blood clots in brain two weeks after receiving Janssen Covid-19 vaccine Ad26.COV2.S. It was reported that, the plug was pulled after one week. The patient died from blood clots in brain. It was unspecified if an autopsy was performed. The patient's height, and weight were not reported. No past medical history, concurrent conditions, and concomitant medications were reported. Information is limited in this case, and the occurrence of blood clots in brain could represent background incidence of such events in the general population. Hence, the relationship to the vaccination is considered unclassifiable. Additional information has been requested.; Reported Cause(s) of Death: BLOOD CLOT IN BRAIN
This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 16-year-old female patient received a single dose of TRUMENBA, via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The day following after her first injection of TRUMENBA, the patient had a red rash on her arm and it was bumpy and there was some minimal swelling on an unspecified date. The outcome was unknown. Causality was not available. Follow-up (17SEP2015): Follow-up attempts completed. No further information expected.
Td administered 18JUL95 approx 130PM; pt mentioned diabetes; 140Pm c/o lightheadedness & woozy, refused glucose finger stick @ this time- popped a piece of hard candy in mouth; p/leaving bldg returned @ 148 c/o lightheadedness, BP 70/50;
08/23/22 presents to EC ED for "rapid heart rate and low blood sugar". PMHx of "diabetes mellitus type 2, hypertension"
I started to notice symptoms on Friday. I was having a scratchy throat and was sneezing. I typically do not sneeze. Saturday it was getting worse and I had a low-grade fever. I tested myself and it was positive. My fever went up a little the next day. I called my doctor on Sunday and due to my risk factors, I was prescribed PAXLOVID. At that point I was congested had a low grade, sneezing and a scratchy throat. The medication helped with the symptoms almost immediately. By Monday I was feeling better and by Tuesday they were gone, I still have a metallic bitter taste in my mouth and nothing I could do would make it go away.
Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 77 and suffering from end stage renal disease on dialysis. Uncontrolled pain was a complaint on note from 1/27/21, and it was noted that patient missed at least one dialysis appointment due to not feeling well. Unconfirmed cause of death but likely due to age/end of life complicated by end stage kidney disease
pt recv vax 21JUN96 & during morning of 22JUN96 pt exp urticaria on inj arm which spread all over body & became generalized;tx Atarax & a topical lotion; sx resolved on 3JUL96;
I got a broken blood vessel right eye  contacted my doctor stated it was (subconjunctival hemorrhage). I'm not certain if this is related to the vaccine however this happens during the timeframe. I still exp redness in my eye.
Patient received 2nd dose of Pfizer CoVID vaccine at 15 days after 1st dose
sever itching all over including eyes. Hoarse Cough (therefore sore throat), slight trouble breathing, headache
No reaction originally; but 10 days after receiving the PFIZER-BioNTech COVID 19 Vaccine EUA I had severe pain in my left (vaccine site) upper arm  muscle and shoulder joint; and was unable to lift my arm up away from my left hip.  I have been experiencing these severe symptoms  since the 10th day after receiving the COVID Vaccine (now the 12th dasys after the vaccine)
Information has been received from a physician concerning an approximately 77 year old female ("late 70's") who was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck).  Subsequently the patient developed Guillain-Barre C3 A9 syndrome and was hospitalized.  The patient was released from the hospital and was noted to be "now doing better".  There was no product quality complaint.  Additional information has been requested.
Pt vaccinated with Heptavax-B developed urticaria, swelling all over her body, wheezing, bronchiolitis.
face was red andflushed; had a warm and fuzzy numbfeeling; kind of felt weird; metallic taste; headache; face was red andflushed; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN620S) via an unspecified route of administration in the left arm on 23Mar2021 at 11:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included fibroids, asthma and pre-diabetic. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), salbutamol (ALBUTEROL), montelukast (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN), ethinylestradiol; norgestimate (TRI-LO-SPRINTEC) and vitamin b12 (MANUFACTURER UNKNOWN). The patient had a history of allergy to penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 23Mar2021 at 11:45, the patient felt her face was red and flushed and had a warm and fuzzy numb feeling, kind of felt weird, and had a metallic taste. The patient also experienced headache all day and the next day. Since the vaccination, the patient had been tested for COVID-19 which included a COVID-19 virus test on 26Mar2021 and the result was pending. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events face was red and flushed, numbness, weird feeling, metallic taste was resolved on 23Mar2021 at 12:45 while the clinical outcome of the event headache was resolved on 24Mar2021.  No follow-up attempts are needed. No further information expected.
Covid Arm rash below injection site going down to elbow. Ice, Benadryl, Hydrocortisone Cream.  Still have rash.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown), by a physician, as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated (by an unspecified healthcare professional) at a healthcare facility, for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Symptoms: Red rash like blotchy bumps covered my upper torso and neck pretty badly. Itchy from the inside out to my skin.
Information has been received from a registered nurse concerning an eight year old male with attention deficit disorder and no known allergies, who on 05/03/2001 was vaccinated with the first dose of varicella vaccine in the left arm SC, following exposure to varicella at school and through neighbors. Concomitant therapy included Adderall tablets. Subsequently on 05/18/2001, the pt experienced lesions on his neck and body. The pt's physician ordered calamine lotion, Benadryl and Aveeno baths as needed. Upon follow-up, it was reported that on 05/18/2001, the child developed chicken pox "all over," was afebrile, and was not seen in the office. The pt recovered. No further info is available.
Patient became violently ill. Symptoms included nausea, vomiting, diarrhea, and malaise. Patient went to urgent care and was treated and released. Patient was ill for 3 days