chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered unknown amount of doses from a vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (administered unknown amount of doses from a vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 10-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (administered unknown amount of doses from a vial). At the time of the report, INCORRECT DOSE ADMINISTERED (administered unknown amount of doses from a vial) 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.   Pharmacist called as a third party from a national medical company that has been involved with vaccinations. She received a call from a pharmacist today stating that they had administered unknown amount of doses from a vial that was punctured and left in the fridge for greater than 6 hours.
SWELLING AT INJECTION SITE, RUE, 1 WEEK POST VACCINATION. WENT TO ER AND DIAGNOSIS OF CELLULITIS
Complained of reddened area on arm, approx. a dollar piece in size, with redness extending down arm towards elbow. Site feels hot to touch; however client denies pain at site, fever, nausea, vomiting or diarrhea.
Patient received vaccination on 08/25. on 08/26 patient developed SOB with witnessed cardiac event. CPR start immediately,  found to be in v fib. single shock administered and 1 round of epi. ROSC. ekg  showed St changes with RBBB.  NSTEMI, pt transferred to ICU and placed on vent.  Ultimately patient transferred to outside hospital for placement of AICD.
Pt recvd vax on 4AUG92 & exp retro-orbital pain in both eyes;
Patient inadvertently received FluzoneHD instead of Fluzone. Spoke to patients mother and she states patient was coming down with sickness Saturday morning before he received his vaccine. States he has cold symptoms including runny nose, congestion, and fatigue.
Feverish; ache all over; had my Third Booster Mederna shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Feverish), MYALGIA (ache all over) and EXTRA DOSE ADMINISTERED (had my Third Booster Mederna shot) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Feverish), MYALGIA (ache all over) and EXTRA DOSE ADMINISTERED (had my Third Booster Mederna shot). At the time of the report, PYREXIA (Feverish) and MYALGIA (ache all over) outcome was unknown and EXTRA DOSE ADMINISTERED (had my Third Booster Mederna shot) had resolved.            Concomitant medications were not reported. Treatment medications were not reported. Patient had Third Booster Moderna shot yesterday.
My water broke and I miscarried my baby. I had to undergo a D&C and my doctor told me I bled buckets of blood. I needed a transfusion but was not given one. Since then I am extremely dizzy, have severe migraine headaches, I'm always exhausted, have had slurred speech, have dry mouth, and my eyes hurt really bad. I can not be in the light without sunglasses and long sleeves because the light hurts my eyes so bad I can't see and the sun burns my skin. I am yet to return to work and it's been two weeks since my miscarriage. I'm going to mark that patient died because I had a healthy fetus with a strong visable heartbeat and two days after receiving the vaccine I miscarried my baby. 11/17/2009 ED record for 10/29/2009, DX Spontaneous Abortion  patient with c/o's vaginal bleeding, pelvic pain and "passing tissue". Patient is 12 weeks pregnant. D&C performed. . 12/14/09 OB/GYN Records received. Service dates 9/22/09 to 11/30/09. Assessment: Spontaneous Abortion, incomplete. Patient started to have some cramping, losing fluid, bleeding heavy. Suction Dilation and Curettage
Following vaccination, pt. and his mother walked to the front desk. Child walked towards exit door to lobby and knees buckled and child fell forward. Fall was guarded but forehead may have hit floor (no thud heard). Child taken back to exam room. BP 80/50 and child initially confused but able to recount what occurred.
I think the vaccine messed with my immune system; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "I think the vaccine messed with my immune system".  Additional information: The reporter stated that she wanted to know if there are doctors that are treating the side effects or know how to treat the side effects. Wanted to know if she should see her doctor, stated that she is having an adverse event, stated that she had every adverse event and then some and still has them, stated that everything she had problems with in her body has revved up again, stated that she thinks that it messed up her immune system who knows or does she have to wait. No further details provided  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received (R) outer arm 1030 varicella-noticed some itching at 2 am and this morning swollen/warm to touch.
itches terribly; red; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itches terribly) and VACCINATION SITE ERYTHEMA (red) 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 22-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itches terribly) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE PRURITUS (itches terribly) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.            No concurrent and treatment medication was reported by patient.  Patient experienced the same reaction after two shots.   This case was linked to MOD-2021-298578, MOD-2021-298578 (Patient Link).   Reporter did not allow further contact
FEVER, NAUSEA, SHAKES, CHILLS, BODY ACHES
Patient was given covid Pfizer vaccine first dose and I consulted patient to  wait in the store  15 minutes and told her some common side effects. After 10 minutes, she felt dizziness and light headed, we offered her to drink some water . About 30 minutes, she was felt okay and walk out the store
Started with nausea at 2am. Later had fever (99,3F), chills, joint pain, pounding headache,
10 minutes after receiving the injection I was experiencing dizziness and lightheadedness. As I was moved to a new location I was still experiencing aforementioned symptoms in addition to feeling hot and nauseous and I vomitted. I was moved to the ER for further evaluation. I was given a COVID test, an EKG and my vitals were monitored. I was discharged home.
Bruise; Swelling; Veins popping; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise), SWELLING (Swelling), VARICOSE VEIN (Veins popping), CHILLS (Chills) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONTUSION (Bruise), SWELLING (Swelling), VARICOSE VEIN (Veins popping), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, CONTUSION (Bruise), SWELLING (Swelling), VARICOSE VEIN (Veins popping), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  No treatment information was provided.
received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th March 2022, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 29th March 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-Mar-2022 Reporter's Comments: Registered pharmacist reported that on the day of reporting, a patient received an expired dose of Twinrix . The reporter consented to follow up. Additional Supportive Information On 29th March 2022, patient received dose of Twinrix that was already got expired on 8th February 2022, which led to expired vaccine used.
That evening, post vax, the pt developed nausea, vomiting, headache, photophobia and questionable respiratory distress. Was seen at local ER, several hours after IZ. I cannot find that any treatment was given and he gradually recovered that night.
This spontaneous report was received from a pharmacist via a company representative and refers to a female patient of unknown age. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis and immediately experienced difficulty breathing. The patient was taken to the unspecified hospital (it was unknown if she was admitted). The outcome of the event was unknown. Causality assessment was not provided. The reporter considered the event to be life threatening.
Caller stated that he developed a fever as from 11:30am of 99.7, 100.7 and last one at 02:30pm 101.7. Patient instructed to reach out to his PCP for further evaluation.
Arm soreness 8 inches around site of injection Fatigue Mild headache Chills for few hours last night
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not provided. On 01-JUN-2016 and 24-OCT-2016 the patient was vaccinated with doses of VAQTA (lot#, dose and route unknown, respectively. No adverse symptoms reported. Additional information has been requested.
p/recv vax pt devel small spot/bump @ inject site; then over following day devel spreading erythematous, edematous area  16 x 11cm; other areas of itching/patchy erythema & edema; 6/27 appeared to cellulitis, treated w/augmentin
I had a healthy pregnancy. I decided to get the covid shot sept 15. Not even 2 weeks later I experienced PPROM. No underlying infection and after examining the placenta and running blood tests they found nothing but blood clots and low blood platelet counts. No reason as to why it occurred.  The infant didn?t survive.
Presented to the office on 9/24/04 with right arm cellulitis. Was in ER 9/23/04 for same Antibiotics Zyrtec.
This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     Specific product reported as yes, specific product known from provided information.       The pharmacist reported that, temperature excursion occurred several days ago in the freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the freezer, and they just found out about the excursion in an audit. No adverse event reported for the patient.   No treatment medications were reported.
Client was sitting in chair and became pale, faint and disoriented just after receiving 3 vaccines.  She responded to touch, questions and commands.  Several minutes later she became faint again, was placed supine and given Od.  She was pale with shallow respiration's but took deep breaths when asked.  She c/o her arm tingling.  Because she remained pale and disoriented, 911 was called and she was taken to the ER.
pain in calf; Deep vein thrombosis; Blood Clot; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Deep vein thrombosis) and THROMBOSIS (Blood Clot) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Deep vein thrombosis.    On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced DEEP VEIN THROMBOSIS (Deep vein thrombosis) (seriousness criterion medically significant) and THROMBOSIS (Blood Clot) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in calf). The patient was treated with APIXABAN (ELIQUIS) for Clot blood, at a dose of 1 dosage form. At the time of the report, DEEP VEIN THROMBOSIS (Deep vein thrombosis), THROMBOSIS (Blood Clot) and PAIN IN EXTREMITY (pain in calf) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Scan: blood clot (abnormal) blood clot.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included unspecified anti-coagulant and  antibiotic.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date in 2015, the patients were vaccinated with a improperly stored dose of PROQUAD (Merck) lot # K010213, 0.5 ml, subcutaneous, expiration date 17-JAN-2016 and lot # K020750, expiration date 30-APR-2016, 0.5 ml, subcutaneous. No adverse effects reported. The dates of the temperatures outside of the recommended range were 11-APR-2015 to 09-JUN-2015. This is one of two reports from the same source. Additional information has been requested.
Nausea, weakness, later over next two days blood pressure spiraling up to dangerous levels when usually well controlled.
Neuropathy on both of my upper and lower extremities; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy on both of my upper and lower extremities) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Triglycerides high and High cholesterol. Concomitant products included METFORMIN for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy on both of my upper and lower extremities) (seriousness criterion medically significant) and HERPES ZOSTER (Shingles). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy on both of my upper and lower extremities) outcome was unknown and HERPES ZOSTER (Shingles) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment provided included acyclovir for the shingles.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up report received on 03MAY2021 included no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt vaccinated with DTP developed swollen arm, listless, low grade fever. Went to ER dx local allergic rx to DTP. Rx Benadryl. Return to Dr ofc on 1OCT90 No local swelling or redness.
Pt received the incorrect vaccine. This was a second dose of Prevnar 13 instead of Pneumovax 23. Pt says her arm was extra sore, but reported no other adverse events
Case Details:  Elderly Admit from clinic Bivalent boost in 9/2022
Arm is swollen at site of injection one week after vaccine. Swelling has lasted for over a day so far and has been sore and tingly.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a physician concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in APR-2021, the patient underwent antibody test which was found to be negative even after seven weeks of post Covid vaccination. The patient did not specify the type of antibody test was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210459344-covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Within a few minutes after receiving injections pt's legs started to get red and warm to touch at injection site. Pt didn't experience any difficulty breathing or any other problems. Pt did receive 1st MMR and Varicella and PREVNAR 13. Pt has had previous doses of PREVNAR 7. Mom stated No Known Allergies. Pt stayed in office and was treated in office same day. Diphenhydramine 9 ml given R IM thigh Lot 019077 exp 1/12 given ORALPRED ODT 15mg mom was instructed by Dr. to f/u in 24 hours with Dr. which she did pt was doing well and legs looked normal.
rash running down from her arm to her abdomen; This case was reported by a nurse via sales rep and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The GlaxoSmithKline sales representative stating at the time of reporting had adverse event about a patient.  The additional information not provided.  The patient had rash running down from her arm to her abdomen. The reporter consented to follow up.
PATIENT DESCRIBED EXPERIENCING A "VERY SWOLLEN" ARM EXTENDING FROM SHOULDER TO WRIST WITH REDNESS AND PAIN. SHE EXPERIENCED NAUSEA, FEVER AND CHILLS FOR APPROXIMATELY 24 HOURS FOLLOWING ONSET OF SYMPTOMS (ONSET APPROXIMATELY 24 HOURS AFTER VACCINE ADMINISTRATION). THE ARM PAIN AND SWELLING LASTED FOR APPROXIMATELY 7 DAYS, PATIENT TREATED SYMPTOMS WITH OTC IBUPROFEN FOR DURATION OF SYMPTOMS AND DID NOT SEEK MEDICAL ATTENTION.
On 8/17/21 I had lymph node swelling above left clavicle that lasted about 1 1/2 days. I was a little sore in left arm, very slightly fatigued but no other symptoms. I receive 2 allergy shots each week and had no reactions for first 2 weeks after shot. After receiving allergy shots on September 2nd the lymph node above clavicle got inflamed again on September 3rd. I decided to go see doctor late that evening. Doctor thought it was a lipoma and schedule an ultrasound on 09/08/21. The ultrasound showed 5 discrete slightly prominent lymph nodes with the largest being approx 17x8x16 m. I talked to my allergist who decided to keep future allergy shots to right arm. I still have slightly swollen node but it has gone down in size. We are thinking it will go away soon.
Client called for appointment for 2nd covid 19 vaccine.  Came to appointment 7/1/2021 and was given vaccine.  When filling out vaccine card, I noted two vaccines already on card. System also shows two vaccines given.  Patient stated he didn't remember getting the second one.  Possibly received 3rd covid vaccine dose.  First dose was given 4/1/21, second dose shown given on 4/29/21, and third dose today.  Patient denied any adverse reactions with previous vaccine.
Nerve Pain in sinuses; Toothache; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 9th November 2019, 1 hr after receiving Shingrix, the patient experienced nerve pain and toothache. On an unknown date, the outcome of the nerve pain and toothache were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain and toothache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm, intramuscularly and experienced severe nerve pain in sinuses developed along with referred toothache pain. At the time of reporting the patient still had severe pain. The reporter did not consent to Health care professional follow-up during call.