chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling symptomatic after my second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (feeling symptomatic after my second dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (feeling symptomatic after my second dose). At the time of the report, VACCINATION COMPLICATION (feeling symptomatic after my second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided by the reporter.  Treatment information was not provided.
Patient presented to the ED and was subsequently hospitalized for Atrial fibrillation with RVR within 6 weeks of receiving covid vaccination booster.
On 09/23/2022, I noticed a blistery rash, which I thought was shingles on my lower back just below the waistline around the spine. I scratched. I put oil on it. I went to the doctor for my regular check up a couple of months later. It was started to form on my arms and stomach. My doctor thought it was Alpha Gal again, so I went to my acupuncturist. She said it was not Alpha Gal, it was antibodies causing the reaction. She gave me a holistic spray and it cleared up.
Arm felt itchy, hot, looked red.  All symptoms close to elbow, not at injection site.
Chest pain, dizziness, felt faint, and hives on upper torso 15 minutes after the injection was administered
Information has been received from a woman in a doctor's office concerning a 4 year old male child with no known allergies and no past medical history who on approximately 03/19/1998 was vaccinated SC with varicella vaccine. Concomitant therapy on approximately 03/19/1998 included a dose of MMR vaccine. On the evening of 06/21/2001, the child started breaking out with a rash. It was noted by the child's mother that the rash had spread and contained blisters. It was reported that the scalp and trunk were the areas effected and that itching was also present. Follow-up info received on 09/24/2001 from a physician indicated that because the child received the vaccination over one year prior to the rash outbreak, that the reaction was not an adverse reaction to the vaccine. The reporter felt that rash on the scalp and trunk with blisters and over 20 lesions and itching were not related to therapy with varicella vaccine. No further info is available.
Pain at injection site within minutes.  A few hours later - most of arm started to ache, headache, tired, muscle pain.  Occurred at night-  shivering, intestinal discomfort  and minor nausea and fever of 100.8.  After 24 hours temperature normal but still have arm pain, headache, tired and some muscle pain.
Had her first seizure on Sunday morning while attending church. No history of seizures, and no family history of seizures.
called complaining of uncontrollable chills and a fever this morning.  He was advised to seek an appointment with his PCP or a walk in facility
Extreme fatigue, sore throat, sore chest, coughing,  nasal congestion,  nasal discharge,  ear ache, extreme body aches, dizziness, light headed, foggy brain, loss of concentration
This is a spontaneous report from a noncontactable consumer (patient). A 39-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# unknown), at the age of 39, via an unspecified route of administration, on an unknown date, in Apr 2021, at 10:00, single dose, for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included Singulair (montelukast sodium), from unknown date for unknown indication and unknown if ongoing. On an unknown date in Apr 2021, at 19:00 (about 8 hours after first injection), patient was a little nauseous and arm was sore for most of the day. No therapeutic measures taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. The clinical outcome of nausea and sore arm recovered on an unknown date in Apr 2021. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Left arm pain immediately during flu shot then few days later pain with raising the left arm away from the body. One month later still same with pain with raising arm away from body. Able to perform full range of motion, but with pain.
This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), OFF LABEL USE (Off label use), PRURITUS (Extremities itchy sensation of), ERYTHEMA (Skin red) and VACCINATION SITE URTICARIA (Vaccination site urticaria) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling unwell), OFF LABEL USE (Off label use), PRURITUS (Extremities itchy sensation of), ERYTHEMA (Skin red), VACCINATION SITE URTICARIA (Vaccination site urticaria) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form; PREDNISONE ongoing since an unknown date for Itchy, at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Allergy, at a dose of 1 dosage form. At the time of the report, MALAISE (Feeling unwell), OFF LABEL USE (Off label use), PRURITUS (Extremities itchy sensation of), ERYTHEMA (Skin red), VACCINATION SITE URTICARIA (Vaccination site urticaria) and FATIGUE (Tiredness) outcome was unknown. No concomitant was provided. Steroids were given, but did not know if the symptoms were from the booster or not. This case was linked to MOD-2021-322305 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow-up received contains treatment medication and event outcome updated.
Had altered mental status after vaccination.  Potassium was low at 2.6; Lactate elevated at 5.7.  Head CT was normal.  PMHx: Diverticulitis and GERD.  She has history of Airway constriction and Hives with lo dose aspirin
Sunday 12am I was awaken by severe nights sweats that soaked my clothes and sheets. Then it happen again after 4 am. This time I developed dull pain in chest and pain and discomfort in both legs. Late afternoon went To Er with concerns about symptoms. Symptoms worsen next day. Now chest pain and dizziness and near syncope. Went back to Er. Next day Near syncope got worse! Back to ER. Currently still having  near syncope and dizziness with occasionally pressure in head and nose and face.
No additional AE; expired PROQUAD on 09/17/2021 which had underwent a previous temperature excursion.; expired PROQUAD on 09/17/2021 which had underwent a previous temperature excursion.; Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent condition, concomitant medication and medical history were not reported.   On 17-SEP-2021, the patient was vaccinated with an expired Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot# S022109, expiration date: 12-JAN-2021; dose, frequency, route unknown) for prophylaxis (Expired product administered). The vaccine had underwent a previous temperature excursion of -10 to 8 Celsius degrees for 5 hours 15 minutes on 07-SEP-2021 (Product storage error). No additional adverse event (AE).
I was diagnosed with COVID-19 on 12/21/2021. My very first symptom was the pink eye and I didn't think I had COVID and I was putting in eye drops because they were pink, running and itching. Then I started having a low grade fever, body aches and chills on day two. On day three I went in and got tested for COVID and they said that I was asymptotic. So they sent me back home. The next morning I went back and then they tested me for COVID and then I went back home I still had the low grade fever. I was congestion and stomach problems, sneezing and coughing. About a week later I started losing my taste and smell. I stated tested my oxygen level and it was fine. After it ran its course I was getting back to normal. The congestion and the headache was still there after a couple of work. I was off work for a week. But I am better now.
Dementia like symptoms (i.e-unable to perform normal cognitive and behavioral functions) for approximately 48 hours after second dose of Moderna vaccine. Patient also reported dementia-like symptoms and tremors after first dose of Moderna, but were not sure if it was vaccine related, so both patient and their physician determined patient should receive the second dose.
Pt. was given pediatric influenza vaccine -sanofi- lot UT3574CA at approx. noon on 11-24-10. Pt. was admitted with diagnosis of febrile seizure on evening of 11-24-10. Pt. was given antipyretics and observed overnight and discharged the following day with not apparent continuing sequella. I am submitting this report as a result of a media report that I read regarding Ped. Influenza vaccine and what may be an apparent increased incidence of seizure. I followed up with mother today 1-25-2011 and child has had no further problems or seizure activity and is not currently receiving any medication.
Woke up with vertigo.  Felt dizzy, nauseated and cold.  Around noontime this feeling had passed, although still feeling a bit sluggish.
Pt recvd 3 doses of Engerix-B on 22MAR90, 4MAY90, & 19SEP90 & was found to be a non-responder;
Pt presented with signs shortness of breath. RN checked patients throat and saw that it was closing. Pt given epi 0.3mg on left thigh at 1617. Vitals taken, 96-98% O2 levels. Pt transferred to  ED on first floor.
12/27 vaccination 12/30  felt good all day. Ate supper. Sat down to watch news, read. At about 8 o'clock, i had almost collapsed out of the chair. I was extremely flushed, never felt so hot in my life, thought i was going to pass out. I got to the floor, I was extremely weak. I had a hard time getting up. I made the call to my dr answering service. I did get up and get some water. I took my BP evening meds, it was in the 200's/90-100. When dr called me, i relayed info. Words not slurred, no paralysis. Extreme sensation of being flushed. O2 stats were good; 96-100%. I went to local emergency in  my neighborhood.  'uncontrolled pain' BP 192-100
J&J COVID-19 vaccine and Moderna COVID-19 vaccine 4-6 weeks later developed symptoms of Guillain-Barré (GBS); This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (J&J COVID-19 vaccine and Moderna COVID-19 vaccine 4-6 weeks later developed symptoms of Guillain-Barré (GBS)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication.    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 and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (J&J COVID-19 vaccine and Moderna COVID-19 vaccine 4-6 weeks later developed symptoms of Guillain-Barré (GBS)) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (J&J COVID-19 vaccine and Moderna COVID-19 vaccine 4-6 weeks later developed symptoms of Guillain-Barré (GBS)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter. Consumer stated they went on VAERS Report and noticed that patient who have received J and J COVID-19 vaccine and Moderna COVID-19 vaccine 4-6 weeks later developed symptoms of Guillain-Barre.  Company comment: This case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, serious (medically significant) event of Guillain-Barre syndrome. The event occurred an unknown time after a dose of mRNA-1273. Concomitant administration of JANSSEN COVID-19 vaccine is a confounder. Information regarding medical history, clinical presentation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, serious (medically significant) event of Guillain-Barre syndrome. The event occurred an unknown time after a dose of mRNA-1273. Concomitant administration of JANSSEN COVID-19 vaccine is a confounder. Information regarding medical history, clinical presentation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Client passed out around 10 minutes after vaccine was given. Came to without any injuries, with normal vital signs. Left building unassisted after around 20 minutes and refused transport.
Information has been received from a physician concerning a female patient who was vaccinated with a first dose of GARDASIL and experienced high fever for about 2-3 days that spiked up to 103 degrees and nose bleeds. The patient was in the physician's office for her second dose of GARDASIL. The physician stated that a fever over 102 degrees is a contraindication for continued doses. The patient's outcome is unknown. Additional information has been requested.
SLOW PROGRESSING PRURITUS OF LEFT NECK, LEFT THIGH/LEG, RIGHT THIGH AND BACK. NO OTHER SYMPTOMS OR FINDING ON CLINICAL EXAM. EVALUATED FOR RASH THE NECK DAY. GIVEN 25 MG OF ORAL BENADRYL AND MONITORED FOR 30 MINUTES WITH RESOLUTION OF PRURITUS.
Have significantly reduced sense of taste and smell one week after second vaccine shot. Then tested for and received negative COVID-19 test. Symptoms continue.
Case number PHEH2014US003605 is a spontaneous report initially received from a pharmacist on 20 FEB 2014 with a follow-up received on 07 APR 2014. Pharmacist confirmed patient demographics on 07 APR 2014; therefore the case was processed as a valid case. This report refers to a 13-year-old female patient. Her medical history and concomitant medication were not reported. Her vaccination history included administration of flu vaccines in the last which were well tolerated. She was vaccinated with FLUCELVAX 2014/2014 (batch number: 010031A) intramuscularly into the right deltoid at 0.5 ml on 08 DEC 2013. This was the initial application of FLUCELVAX. No adverse event was reported following this administration error (inappropriate age at vaccine administration). She was vaccinated with a dose of FLUVIRIN 2014/2014 (batch number: unknown) on 13 JAN 2014., which was approved for her age.  Follow-up received from the pharmacist on 27 APR 2014: After receiving confirmation on patient identifiers, this case was data based as a valid case with four minimum criteria met. Therefore, the report type was changed from "other" to "spontaneous". Updated patient demographics, vaccination history, details about FLUCELVAX (batch number, dosage and route and site of administration), date of vaccination and information about re-vaccination with the age appropriate flu vaccine (FLUVIRIN).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 07 APR 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
HEAVY ARM; PAIN OF LEFT ARM; NUMBNESS OF LEFT ARM; This spontaneous report received from a patient 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 not reported, batch number: Unknown) dose was not reported, administered on 09-SEP-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. On SEP-2021, the patient experienced heavy arm. On SEP-2021, the patient experienced pain of left arm. On SEP-2021, the patient experienced numbness of left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heavy, pain of left arm, and numbness of left arm on 12-SEP-2021. This report was non-serious.
Information has been received from a pharmacist concerning a 66 year old female patient who on 12-OCT-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# unknown). The pharmacist reported that on approximately 12-OCT-2010, the patient experienced redness and irritation on her arm. The pharmacist stated that the patient's symptoms from her ZOSTAVAX (Merck) lasted a month (conflicted information). At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information is not expected.
I cannot remember initial reactions but we were always told "that is normal". Fevers, lethargy etc. Tremors started years later as minimal and progressed. Upon researching I became concerned that the hand tremors and ear problems were due to vaccinations. After many tests we were told by a nurse, confirming my suspicions that this is probably a vaccine injury.
1day after flu shot > (flu IM U3196AA Pasteur 6/10) given in right deltoid. Pain, flushing - 7cm x 10 cm  area of redness and warmth right deltoid.
Pain in (L) armpit with mild pain at inj. site. Non indurated red patches of 2cm x 2" in anterior shoulder with 1 1/2 cm x 1 and 8x4cm x 1 in anterior axillary leve.
Erythematous rash face, legs, chest, trunk.  No itching or other symptoms.  Rash has continued to occur with lesions becoming purple and flat, initially erythematous and raised, blanching.
Believes he had an allergic reaction to the flu shot he has pain in his back muscle twitches and a stiff arm.
Evening after vax given fever 103.2, increased RR - seen in urgent care clinic where O2 sat initially 98%, fairly quickly decreased to 40's with cyanosis and child described as being "out of it". No area sz activity. Coughed and then O2 sat increased. TX = O2. Has incurred viral URI. 05/15/07-records recevied for DOS 4/16-4/17/07-DC DX: fever. Syncope and collapse. Severe desaturation event in clinic O2sat 40% on room air. Perioral cyanosis. Non responsive but not apneic. Febrile to 103.
Redness, pain, swelling of upper left arm 24 hrs after injection, evening after injection felt tired, body aches, chills, fever 100.6., headaches.  These symptoms lasted through 1/10, except fever was only the evening after injection.
Dizziness, tenderness, redness where injection was given x 2 days. (L shoulder w/4 x 5 cm patch of tender/redness). ZITHROMAX for possible cellulitis given, increase fluids, MOTRIN for tenderness, follow up Tuesday 6/15/2010.
Mother states developed hives 4 hours after getting gardasil then next day covered in hives. Mother didnt call office gave Benadryl then Zyrtec. She also has nausea.
she felt crappy; Sore arm; Headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she felt crappy), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and NAUSEA (nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included COPD.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced MALAISE (she felt crappy), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and NAUSEA (nausea). At the time of the report, MALAISE (she felt crappy), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and NAUSEA (nausea) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.