chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vomiting; dizzy headed; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non- pregnant female patient, received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 26Mar2021 at 12:30 (at the age of 48-years-old) in left arm as a single dose for COVID-19 immunisation. Medical history included egg allergy. Concomitant medications included methylprednisolone (MANUFACTURER UNKNOWN) and caffeine; paracetamol(EXCEDRIN) all from unknown dates for unknown indication. 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. Since the vaccination the patient had not been tested for COVID-19. On 27Mar2021 at 09:00, the patient experienced vomiting, dizzy headed and sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of vomiting, dizziness and pain in arm were recovering at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
2 days after taking the vaccine, he felt chest pain. He can't lie down as he will feel the pain, but sitting in the chair is ok.
Photosensitivity, pain behind eyes, stiffness in neck, chills and overall body aches lasting over 48 hours post-vaccination.
This spontaneous report was received from a patient of unknown age and gender who was also a pharmacy technician. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. In January 2016, the patient was vaccinated with the first dose of GARDASIL 9 (strength, lot #, expiration date, dose, route of administration or anatomical location were not provided), for prophylaxis. Later in May 2016, the patient received the second dose of GARDASIL 9 (strength, lot #, expiration date, dose, route of administration or anatomical location were not provided) for the same indication. No adverse effect was reported.
Patient developed a rash (welts) on buttocks the evening that the vaccine was given.  Rotavirus vaccine was given on 5/24/07.  She developed diarrhea on 5/26/07.  She had 1-3 episodes of diarrhea per day from 5/26-6/4/07.
Pt. not available to speak. Wife stated two days after last injection, pt. started rash and itching which became worse. Did go through ER for treatment, received steroids started up in one month. No long term effects. Physician instructed not to receive any more TWINRIX.
Severe muscle spasms 2 days after injection received in rt arm. Swelling redness and severe pain in rt hand and arm (unable to hold a pen to sign my name). Then 1 week later my left hand became swollen and red. Treated in Emergency Ro on 10/2/16, 10/4/16, 10/6/16 and 10/8/16 and in Dr office on 10/3/16. (No elevated temperature) had residual pain until 12/31.
Rt deltoid area. Patient noticed during shower that she had a red, swollen knot at injection site for shingles vaccine. Normally takes ADVIL. On the day of shingles shot, PCP started her on cephalexin for sinusitis.
High fever, shakes, muscle soreness, dizziness, weak - day 1. Bad headache - day 2.
body ache/pain; fever; fatigue; headache; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN (body ache/pain), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced PAIN (body ache/pain), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, PAIN (body ache/pain), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 106 (High) 106.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Regulatory Authority - Patient declined for follow-up further
Patient to PCP with the following complaints today 5/18/21: Vaccine Saturday 5/15/21, felt normal Sunday, and Monday 5/17/21 woke up with sx.  Swelling and pain above left eye. Darkening of skin. Darkening eyelid. Chest pain and upper back pain. SOB lying down. CP with breathing. Occasional dizziness. Denies fever, nausea, abdominal pain. Denies fall or head trauma.  Sent to ED.
Daughter had minimal common side effects after the first dose.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Daughter had minimal common side effects after the first dose.) in a 22-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Daughter had minimal common side effects after the first dose.). At the time of the report, VACCINATION COMPLICATION (Daughter had minimal common side effects after the first dose.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2022-546539, MOD-2022-546543 (Patient Link).   Reporter did not allow further contact
Abdominal pain on 10/04/2021 followed 4 days after with pain in tibia of left foot. Got up during sleep with my body trembling and feeling nervous. The next day tingling and burning of toes on same foot then the pain moved to the toes.Later that day left shoulder started paining then fingers of left hand started tingling and burning. Pain continued on left hand. The next day the same started on right foot and hand, with dizziness and headaches. I started taking Nuerobion. Now I'm on neoropat plus. At times I will feel nauseous with my throat feeling heavy.
Information has been received from a pharmacist, referring to a 30 year old patient. Information of concurrent condition, medical history and concomitant therapy was not provided. On 17-OCT-2017, the patient was vaccinated with PROQUAD (strength, lot# and expiry date unknown) one dose, subcutaneous for prophylaxis(drug administered to patient of inappropriate age). There was no known adverse effects.
I got my shot on the morning of Monday, 4/5. On Thursday, 4/8 I woke up very tired, weak and achy. I experienced some abdominal pain around 2pm. By Friday, I had body aches and a headache and a slight fever. On Saturday and Sunday night I had chills and fevers of over 100. One week following my shot, on 4/12 I woke up with a fever.
Approx. 8hrs after shot I was lying on my side. Went to get up and I was dizzy. Today, still mildly dizzy at times. If I turn my head fast or bend it down & look up.
3 inch welt below injection site the next morning. Second day, after 24 hours of the shot, welt is bigger, about 4 inches, itches horribly and the welt is warm to touch.
Initial unsolicited report received from a non-healthcare professional on 9 June 2015. This case linked to 2015SA082766. (Same suspect same events). A female patient, whose age, medical history and concomitant medications were not reported, had received an intramuscular dose of ADACEL (batch number- C4714AA, expiration date- 8 April 2017) in left deltoid on an unspecified date. On an unspecified date, after vaccination, the patient experienced pain, erythema, swelling, warm to touch, area at injection site. The patient was diagnosed with cellulitis. The patient required emergency room/doctor visit. Laboratory investigations were not reported. The patient was treated with BACTRIM. At the time of this report outcome of event was unknown. Upon medical review, the case was considered as serious due to important medical event: cellulitis. Documents held by sender: none.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent (DILUENT MRK). The patient's concurrent conditions and medical history were not reported. On 01-JUL-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # M041086 with expiration date of 03-JAN-2018, for prophylaxis (route, anatomical location and frequency were not reported). No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 15 to 46 degrees Fahrenheit for 40 hours 16 minutes. Previous temperature excursion was reported as 15 to 46 degrees Fahrenheit for 60 hours (worst case). The call was not because of a "data logger". No further information was provided. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA007536:
GOT COVID-19; FELT DRUNK; HARD TO CONCENTRATE; DIZZY/LIGHT HEADED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190 expiry: UNKNOWN) dose was not reported, administered on 31-MAY-2022 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2022, the patient experienced got covid-19, felt drunk, hard to concentrate, and dizzy/light headed. Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got covid-19, felt drunk, hard to concentrate and dizzy/light headed was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000235409. The suspected product quality complaint has been confirmed to be voided (did not meet criteria) based on the evaluation/investigation performed.; Sender's Comments: Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Patient received an influenza vaccine at an off-site flu clinic on October 6, 2019.  Patient indicated she experienced pain (extreme soreness in the shoulder and arm) at the time of her influenza  injection with has not resolved.  She told her primary care provider of the issue on 10/21/19.  She went to the walk-in clinic on November 22, 2019  where an X-ray and lab work was done.  She was told at that time it was a frozen shoulder and referred her to an orthopedic.   The orthopedic determined the problem was SIRVA and put her on an oral steroid for 6 days.  She returned to the orthopedic for a follow up on December 16, the oral steroid had not helped the issue, so she was given a steroid injection and was then referred for physical therapy.  She will start the physical therapy on December 23, 2019 and has a follow-up appointment with her orthopedic in January.
Rec'd influenza vaccine 10/18/04 developed redness, swelling (5cm) on right upper deltoid.
fatty liver; Titers for Hepatitis B nonreactive; (Liver Function Tests) were elevated; 1st dose SEP2011, 2nd in JUN2012, 3rd in MAY2013; This case was reported by a nurse via call center representative and described the occurrence of fatty liver in a 19-month-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and HEPATITIS B VACCINE (batch number 0491AA, expiry date unknown) for prophylaxis.   On 27th September 2011, the patient received the 1st dose of Hepatitis B vaccine. On 9th May 2013, the patient received the 3rd dose of Hepatitis B vaccine. On 27th June 2012, the patient received the 2nd dose of HEPATITIS B VACCINE. On 9th May 2013, not applicable after receiving Hepatitis B vaccine and unknown after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long. On 27th October 2021, the patient experienced raised liver function tests. On 30th December 2021, the patient experienced therapy non-responder. On an unknown date, the patient experienced fatty liver. On an unknown date, the outcome of the fatty liver, raised liver function tests, therapy non-responder and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the fatty liver and raised liver function tests to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was unknown. Licensed Vocational Nurse (LVN) reported that, the patient completed a Hepatitis B series when she was younger. The brand for 1st dose and 3rd dose was unknown, the 2nd dose from Pfizer (Lot 0491AA). The patient received 2nd and 3rd dose later than the recommended interval, which led to lengthening of vaccination schedule. On 27th October 2021, the patient had lab tests on and her LFTs (Liver Function Tests) were elevated. Specialist retested her on 30th December 2021, however, the reporter did not have results of retest. Titers for Hepatitis B were done on 30-Dec-2021 as well and came back nonreactive, which led to therapy non-responder. When clarifying about patient's overall health, the reporter stated that, the reason why they came down was she had a fatty liver. The reporter consented to follow up. No additional information shared. No details regarding manufacturer of 1st and 3rd dose of Hep B.
Patient had a reaction immediately after receiving the vaccination.  The injection site location swelled and there was discoloration.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (DILUENT MRK INJ) which was used for the reconstitution of PROQUAD (unknown lot# and expiration date). On an unknown date the patient was vaccinated with improperly stored PROQUAD (dose, units and frequency not reported) (lot # N020620 and expiration date: 22-JAN-2019) subcutaneously at a temperature from -14 degree Celsius ( °C) to -10 °C for 13 hours (product storage error). It was unknown whether previous temperature excursion was occurred for the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) or not. No data logger was involved. No adverse effects and no additional information was provided. No product quality complaint was involved. This is one of the 6 reports received from the same reporter.; Sender's Comments: US-009507513-1803USA004757: US-009507513-1803USA004613: US-009507513-1803USA004759: US-009507513-1803USA004761: US-009507513-1803USA004760:
screaming from 1 hrs p/vax for 2 hrs duration was inconsolable; t101 for several hrs; mom called MD who said to cont w/APAP & get DT next time; pt apparently has no residual effect noted;
5 hours after getting flu shot patient's airway began to close. Rushed to ER meds administered and kept patient overnight.  11/18/2008 MR received for DOS 10/28-29/2008 with D/C DX: Possible allergic reaction to Flu shot, now doing well. The pm of Flu shot pt developed a sore throat, recurrant coughing, SOB and respiratory distress.  Tx with epi and solumedrol with no recurrance of sx.
Headache, Myalgia, SORE ARM HEADACHE LASTED 30 MIN Narrative:
She got dizzy leaving church on holiday night, including nausea and vomiting.  Woke up slightly better holiday morning until about mid morning, then dizziness came back along with nausea and vomiting continuing all day.  On 12/26 at 11:45 am, went to Urgent Care, the attending physician,  FNP, immediately referred her to Hospital ER, (Reason: Emergency medicine, Neuro, evaluation due to Nystagmus, ABNL Exam,).  The ER physician, Dr., ran CT Scan checking for stroke or seizure and then transferred by ambulance to larger ER for MRI and further neurological evaluation. MRI Brain without contrast was performed along with additional CT Scan without IV contrast and chest X-Rays, was treated with physical therapy for Vertigo, kept overnight and was prescribed Meclizine 25 mg and released the following day diagnosed with Benign Positional Vertigo.  After no change in dizziness and continued nausea approx. 2 weeks later, scheduled appointment for January 16, with ENT Specialist.  Dr. he performed further testing on January 22, and diagnosed with Vestibular Neuritis with 70% permanent damage.  Currently still having same problems with dizziness and nausea, unable to perform simple daily activities, drive vehicles, etc.
Information has been received from a physician who is over 26 years old concerning herself who was vaccinated with GARDASIL. She was greater that the label suggests and she vaccinated herself with first and second dose. She normally had a lupus like rash.  Four days after receiving dosages one and two she experienced a butterfly rash (malar rash) and (lupus like rash) it was more intensified after the first and second dose of which she took solumederol upon getting the rash. Again, she normally had this rash of the face but it was intensified through the vaccination of first and second dose. At an unspecified date the patient recovered. No product quality complaint was involved. Additional information has been requested.
Dizziness, lightheaded, nausea, fatigue, headache for four days. Treated with meclizine and zofran. Symptoms have continued.
Acute onset of Depression, Fever (100.8 F), Chills, Headache, Body aches. Duration was 48 hours.
affecting my brain; Couldn't articulate words clearly/thinking a particular word but would say a different one; stuttering; brain fog; feeling lightheaded and off balance; feeling lightheaded and off balance; pressure on my chest which made breathing slightly more labored; pressure on my chest which made breathing slightly more labored; pressure in my ears and throat; pressure in my ears and throat; my palms turned red; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 72-year-old, via an unspecified route of administration, administered in left arm on 01Mar2021 13:45 (Lot Number: EN6205) as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included left bundle branch block, high cholesterol, and known allergies: intolerance to wheat, corn, peanuts, walnuts, sesame seeds. Concomitant medication included acetylsalicylic acid (ASPIRIN) taken for an unspecified indication, start and stop date were not reported. It was reported that the patient couldn't articulate words clearly due to stuttering. She would be thinking a particular word but would say a different one. This has subsided, but she was concerned as to whether she should take the second one as it's apparently affecting her brain. Also, mild symptoms of brain fog, feeling lightheaded and off balance, pressure on my chest which made breathing slightly more labored, pressure in my ears and throat, my palms turned red. All the events occurred on 01Mar2021 at 13:45. No treatment was received for the events. The outcome of the events couldn't articulate words clearly/thinking a particular word but would say a different one and stuttering was recovered on Mar2021 and recovering for the rest of the events.
PATIENT STATING SWELLING ON ARM AND WILL CALL HER MD AS WELL. NO PAIN OR ANY OTHER ADVERSE EVENTS
Moderna Covid-19 vaccine  Fever, headache, nausea, chills and body aches
A pharmacist reported that a female, now 66 years of age, received an injection site reaction of Tetanus Toxoid in 1983. Immediately post-immunization, she developed a fever and an injection site reaction characterized by swelling and pain that extended from her fingertips up through her arm. She recovered after 5 to 6 days.
patient complained of a sore left arm.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm). At the time of the report, PAIN IN EXTREMITY (left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-404540, MOD-2021-404541 (Patient Link).
Patient states she woke up at 3 am in 1-8-10 itching and noticed hives on buttocks and some on the hands in the web spaces. No airway or respiratory symptoms. Given BENADRYL 25 mg PO and advised to take Q 6 hrs PRN.
No adverse event; Patients had been administered with the Moderna vaccine which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine which were beyond the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine which were beyond the 30 day beyond use date).    No concomitant medication was reported.  No treatment medication was reported.  Patient was administered with Moderna vaccine which were beyond the 30 day beyond use date.  Patient received vaccine from lot 042J21A with a BUD of 17-Feb-2022.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live follow-up received: Narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
60 hours post-vaccine, severe vertigo, chills and sweats.  Lasted 48 hours, but gradually diminished in severity after the first 24 hours.