chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STROKE WHICH PARALYZED RIGHT SIDE; TUMOR IN THE BACK OF THE BRAIN; COULD NOT GET OUT OF BED; RIGHT SHOULDER HURT; RIGHT LEG PAIN; NECK HURT; This spontaneous report received from a patient concerned a 62 year old female of other ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, 1 total, administered on 22-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 23-MAR-2021, after vaccination, the patient experienced neck hurt, right shoulder hurt and right leg pain. The patient used Tylenol initially to treat her neck pain. On 24-MAR-2021, the patient could not get out of bed. On an unspecified date in JUL-2021, the patient then had a stroke which paralyzed her right side, affecting speech. The patient had slurred speech and was difficult to understand. The patient could not recall what happened but she woke up was in the hospital. On 14-JUL-2021, she had computerized tomography (CT) scan of the head which showed a tumor in the back of her brain. The patient was hospitalized for 1 week from the 14-JUL-2021 to 21-JUL-2021, and was currently doing physical therapy, and taking unspecified medication for the stroke. The patient was currently using a walker and was unable to walk on her own, receiving assistance from her daughter. The patient was hospitalized for 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain, and could not get out of bed, was recovering from right shoulder hurt, and had not recovered from right leg pain, tumor in the back of the brain, and stroke which paralyzed right side. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V.0: 20210823410-Covid-19 vaccine ad26.cov2.s-stroke which paralyzed right side, tumor in the back of the brain. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE, NATURE OF EVENT
Second in the Shingrix series. Individual experienced about 24-48 hours later; body was stiff, achy. Achiness was persistent till 12/7/2020.  Ongoing temperature, treating with Tylenol as-needed.   Individual had flu shot approximately early 10/2020
Dosed on 8/27/20 - 8/28 fever up to 102.4. Chills, headache & rash around site of vaccine
real light headed; she could be dehydrated; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 23Mar2021 15:30 (Lot number: EN6207) at the age of 59 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "diabetic" (not ongoing), notes: she was told she is no longer diabetic; "allergies" (unspecified if ongoing); "for stomach" (unspecified if ongoing). Concomitant medications included: SINGULAIR taken for hypersensitivity; NEXIUM [ESOMEPRAZOLE SODIUM] taken for gastric disorder; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN B COMPLEX; ZINC; TURMERIC [CURCUMA LONGA]; VITAMIN D [ERGOCALCIFEROL]; SYMBICORT; SPIRIVA; B12 SHOT, start date: 19Mar2021, stop date: 19Mar2021. The following information was reported: DIZZINESS (non-serious) with onset 24Mar2021, outcome "recovering", described as "real light headed"; DEHYDRATION (non-serious) with onset 24Mar2021, outcome "unknown", described as "she could be dehydrated". The events "real light headed" and "she could be dehydrated" were evaluated at the physician office visit. Therapeutic measures were taken as a result of dizziness, dehydration.  Additional information: Additional concomitant medications included cholesterol pill, multivitamin, and probiotics. The patient stated the next day (on 24Mar2021) she was fine until she was out exercising outside her house on a walk and she felt light headed and it was scary. She stated she was still light headed and it has been bothering her for 5 days. She called her doctor and was told to drink lots of water and that she could be dehydrated and they would see her on Wednesday (not further specified) if it still persisted for blood pressure and blood work.   No follow-up attempts are possible. No further information is expected.
One vial of Pfizer vaccine was reconstituted on 8/18/21, with two doses having been given. Vial was labeled, but left in refrigerator after expiry. Vaccination administration errors occurred when the remaining for patients in this vial were administered the following day on 8/19/21, later than the 6-hour expiry period after reconstitution. It is unknown which patients received these doses at vaccine clinic this day.
10/31/08 by 5:30 L Deltoid red, swollen, tender, hot to touch from elbow to shoulder.  Pain increase to point, client unable to use L arm rest of the evening/night.  For next 2 days, deltoid warm, red, tender.  11-01-08 - Resolved.  Client used TYLENOL for pain.
20 minutes post injection, itch and few very small urticarial lesions on left forearm. BENADRYL given and pt monitored for 15 minutes more.
This spontaneous report as received from a medical assistant refers to a 60 days old male infant patient. On 27-SEP-2013, the patient was vaccinated with the first dose of ROTATEQ 2 ml, suspension, lot # J005073, expiration date 17-SEP-2014, 2 ml, oral. There was no information about concomitant medication, pertinent medical history and drug reactions or allergies. On 01-OCT-2013, the patient's mom called the office to report diarrhea since the vaccination with ROTATEQ on 27-SEP-2013. Mom called again on 03-OCT-2013 and reported that patient's diarrhea was not improving and stool color was changing. On 09-OCT-2013, the patient was brought to the office and stool culture was ordered and culture came back positive for rotavirus. No treatment was given for adverse event. The outcome of events was reported as recovering. Additional information has been requested.
8 Sep 07 - drew 15-20 syringes of Anthrax for shot line - vaccine aerolized. 8 Oct 07 - Sx started of muscle spasm (L) shoulder - hand with numbness (L) hand. Rx Prednisone taper x2, physical therapy and chiropractic care. Symptoms did not get better but worsened. 3 Dec 07 - MRI C spine = transverse myelitis, C3-C6 (swelling in spinal column (L) eccentric). Hospitalized for high dose IV Solumedrol. Sx better but not better as of 3 May 08.  5/9/08 Reviewed hospital medical records of 12/5-12/11/2007. FINAL DX: transverse myelitis & GERD. Records reveal patient experienced left neck & shoulder pain & stiffness upon awakening 10/8/07 & fingers were numb.  Also had sensation of muscle spasm in forearm & biceps.  Tx w/steroids & muscle relaxant w/o relief.  PCP then prescribed additional steroids & PT w/worsening s/s.  Developed URI symptoms & tx w/antibiotics & developed blister on left buttock that was painful.  Neuro & ID consults done.  During admission tx w/IV high dose steroids w/improvement.  D/C to home on tapering oral steroids & to f/u w/neuro & ID.  5/23/08 Reviewed neurologist medical records of 12/13/07-4/7/08. FINAL DX: transverse myelitis Records reveal patient experienced HA s/p hospitalization for transverse myelitis.  Had HA since LP on 12/6 when ever upright.  Dx w/post LP HA.  Referred for blood patch.  Originally seen in office 12/5/08 w/left arm numbness, weakness & weakness in legs.  Sent for MRI of c-spine which was c/w transverse myelitis & was hospitalized.  Office vs of 1/4/08 revealed pt w/residual numbness of fifth digit, ulnar surface & palm of hand but w/improved dexterity & slow steady progress.  Left hand pain interfered w/sleep.  Meds adjusted.  4/7/08 still contined w/dyesthesias & pain of left hand.  Continued to make slow steady progress & referred for repeat MRI.  Hospital consults & labs included w/records. Follow-up: Still have surface numbness of L hand, palm side of hand and fingers. Increase numbness with increase activity / stress with pain in L palm and hand around finger tips of index, middle and ring fingers. Also, some light paresthesia in L arm during that time as well.
Elevated temperature for 90days +1deg F Daily headaches for 90days Chest pain similar to Myocarditis persistent 1yr post vaccination Elevated Lymphocytes% and Monocytes% confirmed via blood test 1yr post vaccination
Presents to Center for "induction of labor" "39w0d" PMHx of "ANA positive, Anemia"
No adverse event but vaccine was inadvertently administered to a 16 y.o. patient when manufacturer guidelines state 18+
UTI; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 26Jan2021 (at an unspecified age) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. In Jan2021, after the vaccination, the patient experienced a UTI (urinary tract infection). Treatment for the event UTI included sulfamethoxazole/trimethoprim (BACTRIM). The outcome of the event UTI was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Pt was sitting out in the lobby and almost immediately after vaccination states she became very nauseated, lightheaded, and had a headache. She felt a sensation of the vaccine course through her body and became very tired and lethargic. Left hand fingers feel numb.
After two weeks from getting the vaccine I developed 3 inch by 2 inch rash ring around shot area. It lasted two weeks.  It was raised and was itching and raised. My right lymph gland under my right ear ached about the same time.  I took a antihistamine and motrin daily.  I messaged my doctor,  I didn't run a fever or feel bad other then mentioned above.
CHILLS; HEADACHE; SWOLLEN LYMPH NODE UNDER ARMPIT; This spontaneous report received from a patient via a company representative 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 07-SEP-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On SEP-2021, the patient experienced chills. On SEP-2021, the patient experienced headache. On SEP-2021, the patient experienced swollen lymph node under armpit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, headache and swollen lymph node under armpit was not reported. This report was non-serious.
patient had warts on hands that "went away" after GARDASIL 9 vaccination series; This spontaneous report as received from a pharmacist refers to a 21 year old male patient.    On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis.  The patient had warts on hands that "went away" after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination series. Also reported that these warts had been treated with "other medications" before and "nothing worked".
No adverse event; Customer calling for TE evaluation on frozen products states that 7 vaccines stored outside of recommended range; This spontaneous report was received from an administrator and refers to a 4-year-old female patient.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 19-APR-2022, the patient was vaccinated with an improperly store dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot # U039258, expiration date: 09-JUN-2023, in addition with sterile diluent (DILUENT MERCK) (Lot # and expiry date were not reported) solution for injection/infusion, administered for prophylaxis (strength, dose description and route of administration were not provided).  The storage temperature was 6 degrees Fahrenheit (F) up to 14 degrees Fahrenheit (7.9 F) for 4 hours 8 minutes 0 seconds. There was no previous temperature excursion. The excursion was called by a digital data logger. No adverse event was reported.   This is one of seven reports received from the same source.; Sender's Comments:  US-009507513-2205USA001202: US-009507513-2205USA000973: US-009507513-2205USA001272: US-009507513-2205USA001205: US-009507513-2205USA001043: US-009507513-2205USA001271:
Patient became very pale, shaky, and said he felt as if he were going to faint immediately after receiving vaccination We had patient lie down, checked his blood pressure which was  a little low We gave patient some glucose tablets, a coke to drink and placed cool damp towel on his head Patient stated he had not eaten anything since the day before and was very nervous about getting shot/afraid of needles when he got to pharmacy Patient began to get his color back and felt well enough to sit up in a chair We then gave him some peanut butter crackers to eat Patient stayed in pharmacy area for 30 - 40 minutes until he felt better and wanted to leave We offered to call an ambulance for him if he felt like he needed to seek medical attention but he stated he did not
Low grade fever began on April 2 without any other indication of illness.  On April 4 fever spiked from 99 to 103.5 within 3 hours.  The high fever caused a seizure which resulted in hospitalization.  Tylenol and Motrin was used to bring the fever down. Nurse follow up on 06/28/04 states: "Review of hospital d/c summary confirms final diagnosis of febrile seizure (already coded). Additionally it was noted that child's body went limp (hypotonia) and he was cyanotic (CYANOSIS) for about 1 minute. In hospital he was described as irritable (agitation) when not sleeping. Please add 2nd diagnosis of viral illness (INFECT VIRAL)."
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 03-FEB-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot #: T013204, expiration date: 03-DEC-2021 or lot #: T013546, expiration date: 28-OCT-2021 (two lot# of vaccines have been reported, no information of which one was administrated to the patient); dose, strength and route were not reported) for prophylaxis.          The vaccines underwent temperature excursions and were stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported.   This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002944: US-009507513-2104USA002970: US-009507513-2104USA002971: US-009507513-2104USA002972: US-009507513-2104USA002973: US-009507513-2104USA002974: US-009507513-2104USA002975: US-009507513-2104USA002976: US-009507513-2104USA002978: US-009507513-2104USA002980: US-009507513-2104USA002981: US-009507513-2104USA002982: US-009507513-2104USA002983: US-009507513-2104USA002984: US-009507513-2104USA002985: US-009507513-2104USA002986: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
shortness of breath; high blood pressure; This is a spontaneous report from a contactable consumer (patient's friend). A 51-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown) via an unspecified route of administration on 17Mar2021 (at the age of 51-years old) as SINGLE DOSE for COVID-19 immunisation. Medical history included cardiac event and stent placement in Jan2021. The patient's concomitant medications were not reported. On 18Mar2021 at 10:30am, patient was admitted to the ER (Emergency Room) due to shortness of breath and high blood pressure. He had cardiac event and a stent placed in Jan2021. Patient was admitted due to not knowing if the issues were due to the COVID shot or the recent heart issues. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room or urgent care and hospitalization on 18Mar2021. The patient was not tested for COVID prior to vaccination. Patient was tested for COVID (Nasal swab) post-vaccination on 18Mar2021, results pending. The outcome for both events was unknown.    Information about Batch/Lot number has been requested.
Within 3 days post vax, the pt developed a fever of 101-102, dehydration, bronchitis, thrombocytopenia, hemolytic anemia, lethargy, somnolence, greenish mucous, could not move her arm from the pain.
fatigue and aching a few hours after for about 24 hours itchiness on face, minor swelling/burning/redness of lips - onset about 36 hours after, treated at home with topical and oral benadryl
injection site pain the day after vaccination; This is a spontaneous report from a contactable Other HCP (patient). A 33-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: El2348) via an unspecified route of administration on 18Jan2021 at 15:00 (at the age of 33-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included ADHD and pneumonia 4 years prior, unspecified if ongoing. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (other medications in two weeks) included lisdexamfetamine mesilate (VYVANSE), trazodone, and daily multivitamin, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2021 the patient experienced injection site pain the day after vaccination. The clinical outcome of the event injection site pain the day after vaccination was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Delayed localized reaction - onset 7.5 days after administration 6? diameter hot reddened area around administration site
LPN giving 6 month immunization noted that pneumococcal entry of 9-25-06 was a  manufacturer mentioned vaccine rather than other manufacturer mentioned.  Patient received Pneumovax rather than Prevnar.
Client reported feeling shortness of breath during observation period and for a period totaling approximately 45 minutes. She denied any other symptoms including HA, chest pain, tingling of mouth, lips or throat. She did not notify paramedic and EMT during observation period.
nurse checked inj site approx 10min p/vax (approx 910AM) nurse noted oval shaped hive @ inj site;ice given pt advised to APAP & force fluids;
I and my whole family came down with COVID. I was fully vaccinated; I and my whole family came down with COVID. I was fully vaccinated; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at dose 2, single and first dose at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient and whole family came down with COVID. Patient was fully vaccinated, and was able to take care of family while they were sick. Patient wrote to thank the company and also to protest the use of aborted fetal stem cells in the production of the vaccine. The outcome of the event was unknown.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Headache, Myalgia, NauseaVomiting, CHILLS, SWOLLEN R EYE, FATIGUE, L ARM INJECTION SITE LARGE WITH WARMTH TO TOUCH Narrative:
55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2021-418964 (Patient Link).
dizziness for one week after vaccination. Initially first 24 hours had fever, chest pain.
Pharmacist called to tell me that my son received the full adult dose of the Covid vaccine for his second dose. She did not disclose which manufacturer my son received. She stated an intern drew up the vaccine and administered- she could not tell me where the mistake occurred, as barcode scanning was not used. I am also a practicing pharmacist, and the lack of attention to detail that an INTERN displayed should result in this intern not being licensed. I was not told to contact my son's pediatrician, and that when pediatrics have received the adult dose in the past, it has not been a big deal
Arm red, purple & swollen to grapefruit size. 9/16/11 called swelling spreading. Already icing, elevating & using BENADRYL PRN. Abx given KEFLEX 250 mg 1 BID x 7 days.