chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse event; Received doses out of the wrong vial/ supposed to get the bivalent vaccine, but they got the original.; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received doses out of the wrong vial/ supposed to get the bivalent vaccine, but they got the original.) and NO ADVERSE EVENT (No Adverse event) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received doses out of the wrong vial/ supposed to get the bivalent vaccine, but they got the original.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received doses out of the wrong vial/ supposed to get the bivalent vaccine, but they got the original.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received doses out of the wrong vial/ supposed to get the bivalent vaccine, but they got the original.).    No concomitant medications were reported.  Reporter states that on 17-Oct-2022 six patients received doses out of the wrong vial. They were supposed to get the bivalent vaccine, but they got the original vaccine.   Temperature excursions was not involved, and the vaccine was not expired.  No treatment information was reported.
Client  received the COVID Booster vaccine Pfizer at 1:35 pm.  Client received 1st COVID vaccine Janssen on 06/09/2021.  At 2:15 pm client made EMT aware she was feeling dizzy and had pressure in head, "behind eyes and bottom of forehead" , rates pressure 3/10 on scale.  Client placed in gravity chair.  Vital signs @ 2:17pm:  blood pressure is 110/78, pulse 68, oxygen saturation 98%.   Client reports  she had the same head pressure in pregnancy when her blood pressure was low.  Client denies any trouble breathing, no throat tightening, no trouble swallowing.  Client denies similar reaction to 1st COVID vaccine.  Client denies any allergies, not taking medications.  Client offered and given a snack and juice.  Vital signs @ 2:30 pm:  blood pressure 100/70, pulse 67, oxygen saturation 99 %.  Blood pressure repeated with digital blood pressure monitor and is 113/77.  Client reports at this time that she feels her heart rate elevating, states she feels it's related to feeling anxious.  Client denies any trouble breathing.    At 2:34 pm, client reports 0/10 head pressure, states she feels her heart rate increasing, denies dizziness, denies trouble breathing.  Vital signs at 2:45 pm:  blood pressure 110/63, pulse 78, oxygen saturation 97%.  At 2:48 pm, client reports no longer feeling heart rate accelerate, no dizziness, no head pressure.  Client educated on ER precautions and to follow up with primary care provider if symptoms return.  Client leaves observation area at 2:50 pm, walks with steady gait.
PAIN IN GROIN; PAIN IN ARM/PAIN IN THIGH; PAIN IN SHOULDER; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced pain in groin, pain in arm/pain in thigh, and pain in shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in arm/pain in thigh, pain in groin, and pain in shoulder. This report was non-serious.
This literature marketed report has been received from the authors of a published literature article,  and refers to a 62-year-old male patient with history of obesity and obstructive sleep apnea. On an unknown date, the patient was vaccinated with ZOSTAVAX injection (dose, route of administration, injection site, lot number and expiration date were not provided) for prophylaxis. On an unknown date, 19 days later, the patient developed disseminated herpes zoster or varicella-like rash with slight fever and fatigue. The patient received unspecified treatment and on an unknown date, he recovered from the events. On an unknown date, a polymerase chain reaction (PCR) test was performed on an unspecified specimen from the patient and confirmed a vaccine strain varicella-zoster virus. The authors considered the events to be related to ZOSTAVAX. Upon internal review, the event of disseminated herpes zoster was considered to be medically significant. This is one of several reports derived from the same literature article (cross referenced with MARRS 1109USA00990, 1306USA004543, 1708USA001383, 1303USA012949, 1411USA011593).
pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 14-Dec-2020 and the estimated date of delivery was 20-Sep-2021. On 06-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided. No treatment information provided.
sensorineural hearing loss requiring use of hearing aids; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 11-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered sensorineural hearing loss requiring use of hearing aids. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event sensorineural hearing loss requiring use of hearing aids was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event sensorineural hearing loss requiring use of hearing aids to be disability.   Upon internal review, the event sensorineural hearing loss requiring use of hearing aids was determined to be medically significant.
Right thigh with 20x16cm area of erythema and induration, non tender, slightly warm. Pt is ambulatory and eating and sleeping well.
On 1/22/20, mother of patient reports patient has a red, painful arm where his varicella vaccine was given 13 days ago. She stated he had only just brought it to her attention. He does not complain of itching, only pain. She says he has a low grade fever, but she thinks that's from an illness his sister has had. He does not have a rash. Phone call on 1/23/2020, Mom says hard lump is less today, but still red and rashy at vaccine site. Otherwise, no fever, feels well, active. No new symptoms. Mother of patient brought patient into Health Office on 1/24/2020. Swelling has decreased significantly, although there are now 5 vesicles noted around vaccine injection site. No fever. Patient reports they are starting to itch.
No additional AE reported.; STERILE DILUENT vial stored improperly; improperly stored STERILE DILUENT was used as vaccine dilution; This spontaneous report was received from a pharmacist and refers to an patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 16-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, exact dose, lot #, expiration date and route of administration were not provided) for prophylaxis together with improperly stored sterile diluent (STERILE DILUENT) lot# T005074, expiration date 02-SEP-2022 (strength, dose description, lot #, expiration date and route of administration were not provided) for medication dilution (Product storage error, Product preparation issue).  On an unknown date, before the vaccination, the sterile diluent (STERILE DILUENT) underwent temperature excursion at -18.0 Fahrenheit degrees (F) for 288 hours. No previous temperature excursions were reported. No adverse events were reported (No adverse event).  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2205USA008373:
Patient received vaccine below on 3/17 (KINRIX and V2V). 3/17 Developed erythema, rash severe at left deltoid, is for positive pruritus. No papus.
L arm 2 hours after vaccination with paresthesia from shoulder into the L hand medial side; Motion in shoulder slightly limited; This is a spontaneous report from a contactable physician. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via intramuscular route of administration in the left arm on 30Mar2021 at 12:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, hypertension and gastroesophageal reflux disease (GERD). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluticasone propionate/salmeterol xinafoate (ADVAIR), salbutamol (ALBUTEROL), atorvastatin calcium (LIPITOR), fluticasone propionate (FLONASE), hydrochlorothiazide/lisinopril (LISINOPRIL/HCTZ) and pantoprazole (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Mar2021 at 14:00, 2 hours after vaccination, the patient experienced left arm paresthesia from shoulder into the left-hand medial side and motion in shoulder slightly limited. The patient reported that symptoms had not improved for 4 weeks after vaccination and the patient got second vaccine without incident. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left arm paresthesia from shoulder into the left-hand medial side and motion in shoulder slightly limited were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Was waiting in the after injection parking lot for about 10 minutes, felt fine, and then it was like a fainting switch had been flipped without much warning. Was able to roll down my window and honk horn for emt in parking lot before fainting. Woke up to emt checking blood pressure, pulse and putting oxygen mask on. Then had to throw up, continue oxygen, sat and waited about 45 minutes until I felt like I could safely drive home.  Had mild flu like symptoms starting about 3 hours later, became more moderate symptoms about 8 hours after injection - headache, fatigue, fever, body aches, nausea. Slept all next day, only remained. Still feel fatigue on Wednesday
TRANSVERSE MYELITIS; RASH IN CHEST AREA AND BACK OF RIGHT ARM; HYPERSENSITIVITY; This spontaneous report received from a patient via a company representative concerned a 4 decade old white and non Hispanic or Latino female.  The patient's height, and weight were not reported. Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 19-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 23-MAR-2021, the patient experienced hypersensitivity, rash in chest area and back of right arm, strange sensation of having clothes on covering her whole body even when not wearing clothes, stiff neck and arm and could not feel feet for about one month. Patient's current doctor mentioned that it might be transverse myelitis. On an unspecified date in AUG-2021, Laboratory data included: Blood test (NR: not provided) Negative, and X-ray (NR: not provided) Negative. The patient had multiple X-rays and blood tests that had a negative result and as per the health care professional (HCP) nothing was wrong. As of 28-AUG-2021 (currently), the patient was experiencing numbness in both hands. Patient had a physician office visit for adverse events.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from transverse myelitis, and the outcome of hypersensitivity and rash in chest area and back of right arm was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210860147-COVID-19 VACCINE AD26.COV2.S-Transverse myelitis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
One day after vaccine administration, site was swollen, red and warm.  Got worse on second day.  Administered diphenhydramine 25mg IV.
Vaccine was given to a child that was under 4yrs. of age. Age of patient at time of event: 4 months
Had all the symptoms of shingles. Constant back itch to the right side of my back, constant fatigue, chest shocks in the right side of my chest..  no rash.  8/12/22 shingles vax,10/16/22 2nd shingles vax.
Headache, itching, redness size of egg with little blisters...so started taking my Valtrex...1000mg the 20th and 500 mg everyday for 5 days.
Patient was given given Moderna Booster instead of pfizer Booster . Patient doing fine and no adverse event reported so far.
Systemic: ear pain and pain in neck-Severe, Systemic: Headache-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: patient reports having severe headache with auroa along with severe ear pain and pain in side of face when turning her neck
Total forgetfulness. Extreme difficulty multitasking or thinking about more than one thing at a time. Overwhelmed. Never had any of these issues before. Have always been mentally strong and aware.
consumer received an extra dose prior to when the dose should have been given with no reported adverse event; consumer received an extra dose prior to when the dose should have been given with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2023SA350940.  This case involves a 16 years old male patient who received an extra dose of IPV (VERO) [IPOL] prior to when the dose should have been given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TENIVAC); HEPATITIS B VACCINE (HEPATITIS B VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); HPV VACCINE (HPV VACCINE) and VERESELA for prophylactic vaccination (Immunisation).  On 19-Mar-2023, the patient received 0.5 mL dose 1 of suspect IPV (VERO) (Suspension for injection) (Frequency = TWICE), (Strength = standard) (lot W1C751M and expiry date: 18-Nov-2025) via subcutaneous route in the right arm for Immunization. In September 2023, the patient also received 0.5 mL dose 2 of same vaccine.  On 01-Nov-2023 he also received an extra dose prior to when the dose should have been given with no reported adverse event (extra dose administered) and (inappropriate schedule of product administration) 7 months 13 days following the administration of IPV (VERO).  It was reported that "once the extra doses were already given and consumer did not need that second round of immunization, and the dose was given due to timing error."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Experienced unusual heavy bleeding and heavy clotting that patient had never experienced before with menstrual flow
Pt recvd vax 23OCT93 & devel rash on back, shoulder, swollen lymph glands in neck;
Hives and bit of trouble breathing within 3 minutes of immunization; given BENADRYL. Medicine got rid of hives but 3-4 hours later had to take another dose. Next day, arm so swollen couldn't get arm through sleeve. Went to doctor who recommended over the counter MOTRIN. Has an appointment on 9/11 with pulmonologist because doctor thinks she has pneumonia now.
T103-104, emesis, hallucinations; no sz acitivty; 19MAY92 t102, nl neuro exam, still emesis until PM;
While administering the vaccine, the needle came off the plunger and stayed in the patient's arm. An unknown amount of the vaccine was also visibly dripping down the patients arm, the patient noticed this and asked if she will need another dose. I called Moderna for recommendations. They advised me to give a second dose immediately in the patients opposite arm.
11/22/22 presents to ED for "altered mental status". PMHx of "CVA, CKD, left bundle branch block, hypertension"
Received Pedirix, Pneumococcal and possible IPV Polio doctor said Hib approximate time 5:00 pm. cried off and on since injection whole leg turned red and one side of face at 5:01 pm at 7:00 pm at home confused, unresponsive state for approx. 5 min then screamed crying continuous until 9:00 pm went to sleep till 9:20. Cried 9:20 to 12:30 excessively without stopping. Sleeping habits have changed and personality. Follow Up: Mother left message that child had a CT scan that identified brain damage. She will file a claim with Vaccine Injury Compensation.
7 year old patient was administered QUADRACEL which is not the indicated age group with no reported adversee event; Initial information received on 07-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 years old female patient who was administered quadracel (DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE) which is not the indicated age group with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A).  On 06-Sep-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (formulation, strength: unknown) lot C5851AA, expiration date: 25-Mar-2023, via intramuscular route in the right thigh as Immunization.  On 06-SEP-2022 the 7 year old patient was administered quadracel which is not the indicated age group with no reported adverse event (product administered to patient of inappropriate age) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (7 year old patient was administered QUADRACEL which is not the indicated age group with no reported adverse event).  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Approximately 20 minutes after vaccination developed burning sensation in sternum. States non radiating. Felt similar to heartburn. Persistent. No SOB. No changes to pain with deep breathing. Approximately 445 mins post vaccination developed dizziness as well. Patient was seen in clinic and EKG performed. Noted to be SR. Vital signs stable. Patient sent via EMS to local hospital for full workup.
Systemic: Fainting / Unresponsive-Severe, Additional Details: On 09/23/2022 at around 1805, the emergency medical button on the wall was pushed and 911 was contacted for an emergency in the clinic.  The patient received her first dose of the Covid-19 vaccination. Immediately after the vaccination, the patient started violently jerking and was unconscious. The patient was diaphoretic also. This is the second episode of the FNP being alone and activating the emergency button and no one coming.
Patient presented with redness, swelling, discomfort, hot to touch, at the vaccine site. No fever. Diagnosed with cellulitis.
Severe shoulder pain for several weeks. Chronic shoulder joint pain for 1 year, ongoing.