chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; primary series vaccine/booster dose to patient who intended to received bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (primary series vaccine/booster dose to patient who intended to received bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (primary series vaccine/booster dose to patient who intended to received bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (primary series vaccine/booster dose to patient who intended to received bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (primary series vaccine/booster dose to patient who intended to received bivalent vaccine).    Concomitant medications were not reported. The patient was above 65 years of age. The dose was given by intramuscular injection at 0.5mL between 8:30-9:00 AM on the day of this report. The patient was intended to receive the bivalent dose but were given monovalent vaccine as booster dose. No treatment information was provided by the reporter.  This case contains information for the  3rd of 3 male patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-656971, US-MODERNATX, INC.-MOD-2022-656975 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-656971:Same Reporter US-MODERNATX, INC.-MOD-2022-656975:Same Reporter
We received a call from the facility today 1/24/21 stating that the patient has a large (size of a palm), discolored (red), hot whelt  at the site of the vaccine administration.
I contracted COVID-19 from a co-worker. I started to feel a sensitivity on the back of my throat for about two days. I tested positive on a home test. I had a bit of sore throat and sinus pain. I was feeling like I had a head cold. It was minor sore throat fever and congestion. I never developed a cough. I contacted my PCP and started taking Paxlovid. About 24 hours after starting the medication I started to feel better. I testing positive for about week. I was feeling much better. I had a little fatigue and brain fog but has been subsided.
Exhaustion, muscle weakness, nausea, headache, fever, chills, pain and rash at injection site
first, and only, dose / on 14Nov2017.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th November 2017, batch number N025570).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter consented to follow up by email.
Vaccines given, rash - red, no raised, around vaccine sites - all the same, then she had some red, flat spots on chest & back & then a few minutes later on her face, cheeks flushed. Not itchy when mom & I asked her & did not scratch. No respiratory difficulty, no swelling. Called Drs office. Did give BENADRYL 20 mg IM. Mother was going to take her to an urgent care. Instructed mother to observe her for further possible allergic reaction. 1/27/11 Child was taken to see grandfather 1/26/11 who is a doctor & he said patient was fine. Mom said rash cleared up within 45 min. of being here & leaving.
It was reported that a 46 year old female patient received a Fluzone SV vaccination on 11/29/2000. Reportedly sometime after the vaccination the patient developed pain, redness and ecchymosis at the injection site. From additional correspondence received on 02/21/2001, it was reported that the patient recovered from this experience. Additional patient, vaccine administrator name and address were also provided.
back surgery two days before scheduled for second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (back surgery two days before scheduled for second dose of vaccine) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included BUPROPION, OMEPRAZOLE, OXYBUTYNIN, LOSARTAN, VENLAFAXINE, PRAVASTATIN and GLIPIZIDE for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (back surgery two days before scheduled for second dose of vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (back surgery two days before scheduled for second dose of vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reports no adverse event after first dose and is scheduled to have back surgery on 14Apr2021 and that is two days before her scheduled appointment for the second dose of the vaccine on 16Apr2021. she believes will not be able to attend her appointment for the second dose. she might not be able to get second dose within the recommended timeframe.   Reporter did not allow further contact
1st dose administered June 2019, 2nd on Nov 2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L794, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on 6th June 2019 ).   On 14th November 2021, the patient received the 2nd dose of Shingrix. On 14th November 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 08-JUL-2022 Reporter's Comment: The vaccine administration facility is the same as primary reporter. The reporter did not consent to follow up. Vaccine expiration date not recorded by health care professional. Additional supportive information The second dose was administered late which led to lengthening of vaccination schedule.
This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (Lot #, expiry not reported). No concomitant medication was reported. On an unknown date the patient developed shingles and was hospitalized. Length of hospitalization was not reported. The patient eventually died. It was unknown what treatment the patient received for shingles. The outcome of shingles was reported as fatal. Additional information has been requested.
Approximately 14 hours of shot I suffered 3 partial seizures (20-30 second duration) in short succession with 5-10 minutes of each other.  I was awake and aware during all 3 events.  After 3rd, I had a severe headache lasting 24-36 hours.
This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), FEELING HOT (very hot), ERYTHEMA (spread all the way down to her elbow), INJECTION SITE ERYTHEMA (red) and INJECTION SITE PAIN (tender to the touch) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Leukemia. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FEELING HOT (very hot), ERYTHEMA (spread all the way down to her elbow), INJECTION SITE ERYTHEMA (red), INJECTION SITE PAIN (tender to the touch) and INJECTION SITE SWELLING (swollen). On an unknown date, the patient experienced COUGH (coughing), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (coughing), FEELING HOT (very hot), ERYTHEMA (spread all the way down to her elbow), INJECTION SITE ERYTHEMA (red), INJECTION SITE PAIN (tender to the touch), INJECTION SITE SWELLING (swollen), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown. 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. No concomitant medication reported.
Patient was give half dose of Moderna Bivalent Booster but was to be given full dose 0.5mcg. Wrong dosage given.
This spontaneous report was received from a physician 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. In approximately 2011 (reported as approximately 5 years ago), 2014 (reported as approximately 2 years ago) and 2015 (reported as approximately 1 year ago), the patient was vaccinated with the first, second and third dose of M-M-R II respectively (lot #, expiration date, exact doses and route of administration were not reported). On an unknown date, the patient failed to seroconvert for measles after at least 3 vaccinations with M-M-R II. The outcome of the event was unknown. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
Shot received Oct. 1, 2008.  Chest pain the morning after the shot 10/2.  On 10/3 around 11 am, I started getting a sharp pain in my left shoulder blade that radiated around to my left breast.  It kept getting worse and nothing helped except laying down.  It was hard to breathe because it hurt so much.  I took Gas-X, Tums, Advil and Xanax over the next few hours.  A co-worker who also had the flu shot reported the symptoms to me around 5pm that day.  We both felt better mentally after talking to each other because we had both considered going to the emergency room thinking we were having heart attacks.   On Sat. 10/4 when I got up, the pain was even worse like a knife was in my back.  I took 2 Advil and that helped.  I took more Advil all day and a little on Sunday, 10/5. It still hurts today, but I can tell it's getting better.
Pt insists that HCPSC report a freckle size red spot n his right deltoid area as being related to the vaccine.  Pt also attributes  on/off chills since 2nd vaccine approximately weekly.  Chills
Fever 100F; Chills; Headache; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 13Apr2021 at 09:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic rhinitis from an unknown date and unknown if ongoing. Concomitant medications included calcium carbonate; colecalciferol (CALTRATE 600-D), cetirizine hydrochloride (ZYRTEC) and unspecified vitamins once a day; all taken for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 23Mar2021 at 12:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient previously received aspirin (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 22:30, the patient experienced fever 100 Fahrenheit, chills and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events fever 100 Fahrenheit, chills, headache and included treatment with 2 ibuprofen (MANUFACTUER UNKNOWN). The clinical outcome of the events fever 100 Fahrenheit, chills and headache were resolving.   No follow-up attempts are possible. No further information is expected.
Experiencing diarrhea for 9days; This is a spontaneous report from the Pfizer sponsored program from a contactable consumer (patient). A 70-years-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, on 10Feb2021 (at the age of 70 years old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient had trouble with the virus and experienced diarrhea for 9 days, since an unspecified date. The clinical outcome of the event diarrhea was unknown. The patient was scheduled to receive dose 2 of BNT162b2 on 30Mar2021.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
pt recvd vax;had back pain & weakness,low grade fever;to er & c/o n;no v;given torodol & phenergan;referred to PP,said may be related to vax,may be virus;20feb pt's chest tight,hurts to breath;now pt breathing better;
My reaction after the shot was mild, slight headache and fatigue. 2.5 weeks post vaccine I had a Grand Mal Seizure. I don't know whether or not it is related but I had a seizure 30 years ago and no problems since that time so it made me wonder whether or not it was a result of the vaccine.
Presented to the ER on 9/18/21 with Cough sputum production shortness of breath.  Today she presented to the ER tested positive for COVID requiring oxygen to maintain oxygen saturation in the ER.  She denies chest pain abdominal discomfort urinary discomfort.  She states she is fairly active drives by herself and is independent to activities of daily living.  She has been able to eat and drink.  Denies fever chills nausea vomiting.  She does not have any other symptoms per patient.  She reports she does not want to be resuscitated or intubated she states she has paperwork.   Blood pressure 148/77, pulse 66, temperature 97.8 °F (36.6 °C), temperature source Oral, resp. rate 20, height 5' 1" (1.549 m), weight 126 lb (57.2 kg), SpO2 96 %.  Patient on nasal cannula Appears comfortable at present Appears to be hard of hearing Lungs are moving air there are occasional crackles no use of accessory muscles S1-S2 systolic murmur rate and rhythm appears to normal Abdomen is soft nondistended it did not appreciate any tenderness Legs are nonedematous Patient appears to be alert oriented and giving a good story no focal neurological deficits appreciated . Started on antibiotic, dexamethasone, remdesivir             CXR-Left lower lobe and right middle lobe pneumonia with a left parapneumonic effusion.  This is new when compared to a February 1, 2021 study.  Lasix dose increased IV .  Other cardiac med dose decreased. Pulmonology and ID recommendation appreciated.             Continue improving.  Plan to continue remdesivir 5 days.  If clinically stable home with oral antibiotic and steroid.  6 minute walk test prior to discharge. Was on room air on 9/25. Discharged 9/25/21
3 days after injections left upper arm erythema and swelling without clear demarcation and no systemic signs of infections diagnosed as delayed hypersensitivity reaction. Prescribed oral antihistamine, acetaminophen, topical steroid, icing to area.
Vaccine was drawn up on 6/9, kept refridgerated in vaccine refridgerator and administered on 6/12. We know now that we should have administered the vaccine once drawn up within 12 hours. The staff member who received the vaccine did not experience any adverse effects . This is reporting a vaccination administration error.
Received H1N1 injection approximately about 10:25 am on 11/03/2009 in left deltoid. Felt light headed and had tingling in left hand and arm was placed in reclining position with behind neck for 15 minutes. then was able to sit up. Was discharged alert with friend to take her back to dorm at 11:20. Not light headed but still complaining of tingling in left arm and hand. Advised to visit student center if this continues.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
INJECTION SITE PAIN; HURTS; This spontaneous report received from a patient. 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: 1805031, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced hurts. On 17-MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, and the outcome of hurts was not reported. This report was non-serious.
Headache, Fever, NauseaVomiting, chills, malaise Narrative:
passes out and dies after practice; passes out and dies after practice; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 17 years old male patient who passes out and dies after practice while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer, lot number not reported via unknown route in unknown administration site.  On an unknown date the patient passes out and dies after practice (death) (Loss of consciousness) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  Final diagnosis was (fatal) passes out and dies after practice.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (passes out and dies after practice).  At time of reporting, the outcome was Fatal for the event death, unknown for Loss of consciousness.  It is unknown if an autopsy was done. The cause of death was reported as Unknown cause of death.; Sender's Comments: Sanofi Company Comment date 03-Feb-2022: This case involves a 17 years old male patient who passes out and dies after practice while receiving vaccine INFLUENZA VACCINE. The causal role of the suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event, latency to onset, concomitant medications, medical history, family history for unexplained death, autopsy details if available, interventional therapy (if received), cause of death, pre-existing risk factors would aid in a complete case assessment.; Reported Cause(s) of Death: passes out and dies after practice
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 22-JUL-2014 the patient was vaccinated with ZOSTAVAX (also reported as ZOSTAVAX Vial 19400 PFU) (lot # K000328, Exp. date: 06-MAR-2015, strength, dose, frequency and route unspecified. In July 2014 the patient experienced injection site reaction. The patient sought medical attention via contacting pharmacist. The outcome of injection site reaction was unknown. This is one of several reports received from the same source. Additional information has been requested.
ABDOMINAL PAIN; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 51 year old female. 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: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced abdominal pain. On 10-APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal pain, and the outcome of severe headache was not reported. This report was non-serious.
Report 20020003781 describes arthritis in a 44 year old male who received Lyme disease vaccine recombinant OspA (LYMErix). The medical history included asthma. The vaccinee had no known drug allergies. The vaccinee's occupation reportedly put him "at risk for tick bites." Concurrent medical conditions and medications were not known by the reporter. The vaccinee received his first injection of LYMErix (lot Ly104A2) on 04/12/1999. He had no adverse experience following receipt of this injection. He received his second injection of LYMErix (lot LY136B9) on 05/03/2000. An unknown time post-immunization, he experienced "extreme' joint pain (NOS). The vaccinee reported that he was seen by an "arthritis specialist," who mad a diagnosisi of arthritis (NOS). The vaccinee stated that he remains in a lot of pain and is having difficulty just trying to move about. The vaccinee refused the third injection of LYMErix. The adverse event 'arthritis' does not meet ICM serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter. The follow up received on 2/4/02, states the vaccinee stated that this specialist recommended that he not receive the third injection of LYMErix and did not specify the treatment or outcome of the event.