chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had awful migraines that did NOT improve with Tylenol or Ibprophen.  My migraines had an aura to them on the 1/1/2021.  I was also nauseous and had a difficult time keeping food down.  I was also very tired and slept longer than I normally do.  I had my vaccine done on 12/30/2020 and the symptoms did not occur until 1/01/2021. An hour or so after the injection, my arm started to become sore. It was very sore until 1/3/2021. They lasted until 1/3/2021. Now I feel fine.
Diagnosed Thyroid dysfunction.  Diagnosed with hypothyroidism.  With many symptoms.  (Weak, Dizzy, Short of Breath, racing heart, Feeling faint, Insomnia, General feeling of Unwellness,  Feeling  very sick and ill.   Heart Dull Ache Pressure 7-8 severity 1-10 scale). moderate to severe Aches and pains in joints.  Blurry vision.   Now taking Levothyroxine 50mcg.     Diagnosed High Blood Pressure.  Rapid pulse rate.   Now taking Irbesartan 150mg
softness when touched; light pain when arm is raised; some swelling on injectioin site (right arm); This spontaneous case was reported by a physician and describes the occurrence of ADVERSE EVENT (softness when touched), PAIN IN EXTREMITY (light pain when arm is raised) and VACCINATION SITE SWELLING (some swelling on injectioin site (right arm)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 42B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included ROSUVASTATIN, AMLODIPINE and LOSARTAN for Blood pressure high, INSULIN for Diabetes, ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.    On 08-Apr-2021 at 10:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced ADVERSE EVENT (softness when touched), PAIN IN EXTREMITY (light pain when arm is raised) and VACCINATION SITE SWELLING (some swelling on injectioin site (right arm)). The patient was treated with PARACETAMOL (TYLENOL) on 08-Apr-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT (softness when touched), PAIN IN EXTREMITY (light pain when arm is raised) and VACCINATION SITE SWELLING (some swelling on injectioin site (right arm)) had resolved.        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.   Patient used ice pack to treat the adverse event.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: TCR received on 08-07-2021 - Events outcome updated.
This spontaneous report was received from a nurse 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. On 27-JAN-2017, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Patient received his Covid19 Jannsen vaccine April 8, 2021 and came in June 28th, 2021 and insisted on getting the first of the 2 dose series Covid19 Moderna vaccine. The patient pleaded that he needed to protect himself against the Delta variant. Patient received the Moderna vaccine.  I was asked to report this to Moderna vaers.
2nd shot put me down; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unwell (Verbatim: 2nd shot put me down).  The outcome of the unwell was recovered/resolved (duration 72 hrs).   It was unknown if the reporter considered the unwell to be related to Shingles vaccine.     It was unknown if the company considered the unwell to be related to Shingles vaccine.   Additional Information: GSK receipt date: 04-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that the second shot put him/her down for 72 hours, but it was not worse than actual shingles. The follow-up could not be possible as no contact details were available.
Nausea; headache; tiredness; very strong muscle pain at injection site; This is a spontaneous report received from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8734) via an unspecified route of administration in the right arm on 30Mar2021 at 12:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included autonomic seizures, hypothyroidism and migraines. Concomitant medications included levetiracetam (KEPPRA), lamotrigine(LAMICTAL ER), rizatriptan benzoate (MAXALT), levothyroxine(MANUFACTURER UNKNOWN) and paracetamol(TYLENOL), all from unknown dates and for unknown indications. The patient had allergies to tramadol, naproxen, ibuprofen and prozac. The patient did not receive any other vaccine in four weeks prior to COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 13:00, the patient experienced nausea, very strong muscle pain at injection site, headache and tiredness. The patient did not receive any treatments for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events nausea, very strong muscle pain at injection site, headache and tiredness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
7 days after receiving 4 month vaccines, including ROTATEQ, he began with vomiting, bloody stools. (+) Intussusception/Malrotation, required surgery to correct.
Also noticed increase in sense of smell persistent after both vaccine doses; Vomiting; Diarrhea; Cold Sweats; Disoriented; This is a spontaneous report from a contactable consumer (patient). A 43-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: not reported, expiry date: not reported), via an unspecified route of administration, administered in Arm Right on 08Feb2021 14:00 (at the age of 43-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included metformin. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: not reported,expiry date: not reported) via an unspecified route of administration on 18Jan2021 14:00 as dose 1, single for covid-19 immunisation and noticed increase in sense of smell persistent. Patient had no known allergies. No COVID prior vaccination and no COVID tested post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Feb2021 at 19:30, the patient experienced vomiting, diarrhoea, cold sweats, disoriented and also noticed increase in sense of smell persistent. No treatment was given for the events. The outcome of the events was recovered in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s): PFIZER INC-2021154724 same  patient/reporter, different AE/second dose
Dizziness and loss of hearing about 1 month. Observed for 20 minutes.
pt recv vax;3 days later inject site rxn characterized by redness, swelling & tenderness at inject site;addtl info revealed pt had induration at inject site;
(06/08/2021) Flu like symptoms including weakness possible fatigue, not confirmed for CovID, lasted 2 weeks and occasional cough even now. Only stay at home and flu protocol for treatment. No prescriptions or such.
pt recvd vax & was fussy p/vax; later noted to be gasping for breath w/significant nasal congestion; poss unresponsive for 5 mins;   t101.4;
HIGH FEVER WITH NORMAL CBC,PARENT REPORTED 106 DEGREE FEVER THE NIGHT VACCINE WERE GIVEN
my arm still kills; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On 8th July 2020, the patient received Bexsero. In July 2020, less than a week after receiving Bexsero, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The primary reporter was an agent from GSK. The patient received Bexsero shot 6 days ago and reported arm still kills. The reporter asked was there something wrong because nothing showed up in and arm should have stop hurting. The reporter did not consent to follow up. Read internal comments for more information.
loss of vision; Retinal Vein or Artery Occlusion; Retinal Vein or Artery Occlusion; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 at 13:00 as dose 1, single (Lot number: HH7595) at the age of 78 years, in left arm for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 18Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 78 years, in left arm for immunisation; influenza vaccine (INFLUENZA), on 18Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), on 18Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Prediabetic" (unspecified if ongoing); "CKD" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: RETINAL ARTERY OCCLUSION (hospitalization, disability, medically significant), RETINAL VEIN OCCLUSION (hospitalization, disability, medically significant) all with onset 25Sep2023, outcome "not recovered" and all described as "Retinal Vein or Artery Occlusion"; BLINDNESS (hospitalization, disability, medically significant) with onset 25Sep2023, outcome "not recovered", described as "loss of vision". The patient was hospitalized for blindness, retinal artery occlusion, retinal vein occlusion (hospitalization duration: 5 days). The events "loss of vision" and "retinal vein or artery occlusion" required emergency room visit. Clinical course: On 25Sep2023, the patient suffered sudden onset of retinal vein or artery occlusion in left eye which resulted in loss of vision in that eye. The adverse events resulted in an emergency room/department or urgent care, hospitalization, disability, or permanent damage.  The patient did not receive any other vaccines within four weeks prior to the vaccines. The patient did not receive any other medications within two weeks to the vaccines. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies.  It was unknown if therapeutic measures were taken as a result of blindness, retinal artery occlusion, retinal vein occlusion.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
MBR presented with localized rash on (R) lateral chest and shoulder R/T smallpox vaccine rec'd 11 AUG 07. Reported minor itching and mild tenderness of area with palpation. Also stated he had painful lymph nodes, (R) axillary area.
patient came in today and showed right arm there was a red rash all around the area and down the upper arm a little. patient said had been sore and itchy and burning after injection and she rubbed her arm alot didnt know if that made it worse. I told patient to have it looked at by md
This spontaneous report was received from a medical assistant concerning a 64-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-JAN-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L029484, expiration date 06-NOV-2016 (dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
This initial spontaneous report was received on 26-JAN-2018 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 14-SEP-2010, the patient was inoculated (by an unspecified person) at a clinic with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 17-MAR-2016, he was treated (by an unspecified healthcare professional) at a dermatology office for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed VALTREX and gabapentin for management of his painful symptoms. As a direct and proximate result of these malfunctions, 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 outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Patient administered Covid Johnson & Johnson vaccine at Pharmacy. Patient c/o swelling to the left arm, dizziness, throat itching, body aches, coughing at night, chills and sweats since receiving the vaccine. Patient states she took Benadryl without relief. Patient seen by provider at a Community Health Center and prescribed Clindamycin HCl 300 mg capsules and instructed to follow up with PCP in 2 weeks for cellulitis.
Patient also received 2nd Moderna on 4/20/21 no lot number available; event occurred after 2nd vaccine; breakthrough case admission
On 5/13/00, the pt developed generalized fatigue and weakness, progressing to weakness and numbness in upper and lower extremities. Continued increasing muscle weakness with difficulty walking on 5/16/00. Sought medical advise on 5/17/00. Admitted to hospital and dxed with Guillain-Barre Syndrome based on spinal tap results and nerve conduction studies. Treated with immunoglobulins.  Follow up 07/27/2000: "Patient final diagnosis Gullian-Barre Syndrome; was diagnosed by neurologist.  Patient experienced other illnesses within 4 weeks before onset of GBS syndrome;  Patient experienced or has other previous illness or medical condition before the onset of GBS symdrome such as Ulceration Colitis in 1992, no flareups within past year. Patient received influenza vaccinations previously."
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 16-FEB-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Pt co cramping ( menstrual sx like) tingling sensation on L fingers, severe pelvic pain. Felt like going to the bathroom, chills, severe menstrual cramping. 3:45 Sx resolved within one hour.
Patient had syncope episode after administering 4th injection (PREVNAR 13) in LT IM. Infant initially cried then slumped forward. Nurse took child from parent's arms, notified provider. Approximate episode lasted 8-10 sec. Infant was examined by provider afterwards and monitored.
Muscle and joint ache, fatigue when I woke up day after receiving second dose. Muscle & joint aches reduced after morning run / workout, though symptoms persisted at a lower level throughout that day. Felt fine by second day after vaccination.
Severe whole body muscle aches limiting normal daily activities. Chills. Arm soreness in injection arm, swollen axillary lymph node in injection arm, swollen bump at injection site.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the pt experienced shingles as a result from pt's zoster vaccine live (ZOSTAVAX) use and was treated by a healthcare provider for shingles. The outcome of the event was not reported. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies.
*SWELLING UNDER LEFT ARM BETWEEN SHOULDER AND ELBOW - MIGRATED TO ELBOW IN FOLLOWING DAYS - WENT AWAY AFTER A COUPLE OF WEEKS
Dose given 3 days past BUD.  Consulted with CDC and Pfizer.  There was no adverse event as experienced by patient - only the administration timing.
pt recvd vax 1430 & devel fever to 103 @ 1800, fever of 104.9 @ 1930;2000, had gen tonic sz lasting 3-4mins;brought to ER treated w/APAP/Ibuprofen completely recovered;
After getting the shot, felt lightheaded, pulse raced, sweating, flushing of face. Since getting the shot I have developed allergies to everything including smells, sunlight, foods previously tolerated, heat, etc. I have now been diagnosed by a specialist with MCAS.
Raised, reddened welt that is increasing in diameter on right arm.  Warm to touch. Afebrile. Keflex started on January 15, 2015.
After 72 hours, terrible Migraine and cluster headaches started 24 hours a day non- stop since 2nd vaccine. With Dizziness, nausea & pain in stomach, left upper chest pains off & on, and high blood pressure(never had before)
c/o itching, hives, left arm swelling, warmth (L) hand swelling lip edema, sore throat.  Methylpred 125 IM / Benadryl 50IM Ibuprofen 600mg PO.
Ten days post vax, this child experienced a purpuric rash on her stomach and front portion of her thighs. She was given a 100 mg dose of ibuprofen. The pt remained afebrile and the rash was not itchy. On 06/15, the rash began to turn brown "resembling a purpuric rash." She saw physician for work up all of which were nml. The pt recovered. No further information is available.
The cases were received on 21 March 2014 at agency. Initial misuse report received from a healthcare professional on 20 September 2013. A medical assistant only administered the DTaP-IPV portion of PENTACEL. It was a vaccine underdose. No adverse event was reported. List of documents held by sender: none.
Could be tendon pain; Short of breath when wasn't before; Sneezing; Teary eyes; Could be allergies; Chest anxiety feeling of; Pain goes into the shoulder too (left arm); Left arm is painful and everything hurts in that arm (left arm); Headaches for 2-3 days, never had before; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TENDON PAIN (Could be tendon pain), DYSPNOEA (Short of breath when wasn't before), SNEEZING (Sneezing), LACRIMATION INCREASED (Teary eyes) and HYPERSENSITIVITY (Could be allergies) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Glaucoma since 2000. Concomitant products included NETARSUDIL MESILATE (RHOPRESSA), BIMATOPROST (LUMIGAN), DORZOLAMIDE and TIMOLOL for Glaucoma.   On 27-Mar-2021 at 5:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021 at 5:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced TENDON PAIN (Could be tendon pain), DYSPNOEA (Short of breath when wasn't before), SNEEZING (Sneezing), LACRIMATION INCREASED (Teary eyes), HYPERSENSITIVITY (Could be allergies), CHEST DISCOMFORT (Chest anxiety feeling of), ARTHRALGIA (Pain goes into the shoulder too (left arm)), MYALGIA (Left arm is painful and everything hurts in that arm (left arm)) and HEADACHE (Headaches for 2-3 days, never had before). The patient was treated with IBUPROFEN (IBUPROFEN MAX) in May 2021 for Adverse event, at a dose of UNK UNK, bid. At the time of the report, TENDON PAIN (Could be tendon pain) and ARTHRALGIA (Pain goes into the shoulder too (left arm)) had not resolved, DYSPNOEA (Short of breath when wasn't before), SNEEZING (Sneezing), LACRIMATION INCREASED (Teary eyes), HYPERSENSITIVITY (Could be allergies), CHEST DISCOMFORT (Chest anxiety feeling of), MYALGIA (Left arm is painful and everything hurts in that arm (left arm)) and HEADACHE (Headaches for 2-3 days, never had before) outcome was unknown and CHILLS (Chills) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up information received on 22-JUN-2021 contains significant information-Patient demographics, therapy details of suspect product updated and outcome of the event Pain goes into the shoulder too (left arm) updated to not resolved.,
Fatigue, Headache, Chills, Nausea, joint pain began on Friday Jan. 1, 2021 symptoms started about 0800. All symptoms have continued through today Jan. 4, 2021. Taking tylenol 500mg for headache Symptoms lasted for 4 days