chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This retrospective cohort study report has been received from the authors of a published literature. This paper described a 9.5-year cohort study evaluating the incidence of herpes zoster after concomitant administration of ZOSTAVAX (ZVL) and PNEUMOVAX 23 (PPSV23). A retrospective cohort study was conducted from 01-JAN-2007 to 30-JUN-2016. The exposed cohort (concomitant vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL and PPSV23 on the same day from 01-JAN-2007 to 31-DEC-2014. The comparator cohort (prior vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL during the same period as the exposed cohort but were previously vaccinated with a dose of PPSV23 from 365 days to 30 days prior to receiving ZVL. Both groups had been continuous members in the year prior to date of ZVL vaccination, allowing for a 31-day gap in membership. The patients from both groups were followed from the date of ZVL vaccination until the date of herpes zoster occurrence, termination of membership (allowing for a 31-day gap), death, or 30-JUN-2016, whichever was earliest. This report refers to 4509 adult (60 year old to 64 year old) patients. On unknown dates the patients were concomitantly vaccinated with ZOSTAVAX (lot#, expiration date, dose, route and frequency unknown) and PNEUMOVAX 23 (lot#, expiration date, dose, route and frequency unknown) for prophylaxis. The prescribing information stated that these vaccines should not be given concurrently. This is one of several reports from the same literature (linked report MARRS #1804USA008699, 1804USA010349, 1804USA010350, 1804USA010351, 1804USA010377).
Vaccine given on 1/15/22. Sudden hearing loss and tinnitus developed 1/31/22. In right ear.  Went to immediate care on 2/3/2022 and prescribed Dexamethasone 4 mg twice daily which I am on my second day with no improvement.  Will be seeing ENT specialist on 2/10/2022.
Moderna Bivalent dose administered to 1 patient after 12 hours post puncture Dose administered; No adverse event; Moderna Bivalent dose administered to 1 patient after 12 hours post puncture Dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent dose administered to 1 patient after 12 hours post puncture Dose administered), PRODUCT STORAGE ERROR (Moderna Bivalent dose administered to 1 patient after 12 hours post puncture Dose administered) and NO ADVERSE EVENT (No adverse event) in a 47-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023 at 10:11 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023 at 10:11 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent dose administered to 1 patient after 12 hours post puncture Dose administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Bivalent dose administered to 1 patient after 12 hours post puncture Dose administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent dose administered to 1 patient after 12 hours post puncture Dose administered), PRODUCT STORAGE ERROR (Moderna Bivalent dose administered to 1 patient after 12 hours post puncture Dose administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent dose administered to 1 patient after 12 hours post puncture Dose administered) and PRODUCT STORAGE ERROR (Moderna Bivalent dose administered to 1 patient after 12 hours post puncture Dose administered).    Concomitant medications were not reported.  It was reported that the Moderna Bivalent dose administered to 1 patient after 12 hours post puncture dose administered greater than 12/24 hours post puncture.  Individual vial with size 2.5 mL.  On 10-Jan-2023 at 9:00 AM, the vial was first punctured, and vial was stored at room temperature post puncture. The vial exposed to room temperature for more than 24 hours. On 11-Jan-2023 at 10:11 AM, vaccine was administered.  The vial did not undergo any temperature excursions.  No treatment information was provided.
after receiving vaccines( shingrix, flushot, and pfizer bivalent booster), patient exhibited the following symptoms in the waiting room;sweating and getting pale. manual blood pressure was around 70/40 and I gave patient water. 911 was called. After about 10 minutes of drinking fluid patient's pressure started to go back up. blood pressure went to 130/80 and blood sugar was 130 was checked by paramedic. patient was stable and was offered to go the ER but refused. patient was picked up by family member
Pfizer COVID vaccine at 3PM in left shoulder on 19Mar22. No history of any detectable immune reactions to any of my first three Pfizer vaccinations (21Jan21, 11Feb21 and 01Oct21). Noted sore right neck within two hours after a nap, and noted increased temperature and pulse and local occipital pain within 12 hours. Sought Urgent Care on 23Mar22 for left neck discomfort. Presumed pinched nerve without finding persuasive X-Ray evidence by noting my suspected cervical impingement history. Prescribed 6-day methylprednisolone block (24-4mg). Symptoms eased but a new fever cycle developed with right testicular and lower right back pain over the six day oral steroid treatment as my beck pain subsided. A new fever cycle (99.7F Oral with night sweat) lest to the second Urgent Care visit on 28Mar22, testicle ultrasound confirmed a swollen and inflamed right testicle (with only minor pain) but clean urine test. WBC very high at 23+. Orchitis suspected (although later ruled out) so physician ordered 30-days of Cipro 1,000-mg/d. (I have a tolerant history with Cipro) for suspected bacterial UTI. WBC declined to 14 in seven days. Symptoms abated. But a new fever cycle (99.6F Oral with night sweat) led to third Urgent Care visit on 12Apr22 WBC back to 19 after 15 days of Cipro  1,000-mg/d. Full body CatScan found no apparent infections. A couple of small lung patches suggested bacterial pneumonia so physician discontinued Cipro and started ten days of Cefuroxime 1,000-mg/d. Physician announced that he had no idea of the infection (if any) but knew it was never orchitis. He referred to Infectious Disease Specialist. Fever subsided in 2-3 days and a light productive cough developed with occasional chest tightness. Immediately scheduled Infectious Disease Specialist for 20Apr22. New fever cycle (101.1F Ear with night sweats) started on 18Apr22 after five days of Cefuroxime 1,000-mg/d and abated by 20Apr22. Same date, my Infectious Disease Specialist dismissed the pneumonia diagnosis and the earlier diagnosis as unsupported by any evidence and halted all antibiotics to prepare for blood samples free antibiotics. He ordered testing to eliminate endocarditis (no evidence beyond cycling fever and fatigue) and referred to a Rheumatologist ASAP to eliminate polymyalgia rheumatica (no personal or family history of any autoimmune disorders beyond mild eczema). I had this vaccine in my left shoulder at 3PM and noted unusual right neck pain less than two hours later. I have had NO vaccine reactions in my life after 35 years of annual flu shots and three COVID shots and many many others (shingles, pneumonia, etc). so I am not convinced that these experience are causally related to my last COVID shot. But I am trained as a scientist (among other careers) and understand how important evidence is to understanding the unknown.
This spontaneous report as received from a other health professional refers to a 12 month old patient. On 22-JUL-2014 the patient was vaccinated with M-M-R II (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
doses were given after expiration date; product storage error; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (product storage error) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (product storage error) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information were given. No temperature information were given. No adverse event reported. Date place in refrigerator was 21st September 2021.
Vaccinated with Tdap, flu and received Tb test on 10/31/06. She notes that she felt bad a few hours after being vaccinated with flu like symptoms. The s/s gradually worsened over the next 24 hours and she also developed pain, swelling and redness at injection site of both vaccines, the flu shot site worse than the other. She did have some mild tingling and numbness in L arm. Recommended OTC Ibuprofen and cold compresses to injection site for pain relief. Described s/s of severe adverse reaction and to seek emergent care if she develops such.
ten days after the second moderna shot I had a TIA event and was hospitalized.  I am in general very healthy and since both JJ and astro- vaccines have had reports of clotting, I thought it appropriate to enter my event into the statistical analysis
DEATH; This spontaneous report received from a consumer via a company representative via social media (J and J corporate concerned two patients of unspecified age, sex, race and ethnic origin. 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 was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total was administered on an unspecified date for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients died from unknown cause of death. As per report, " I lost two good friends who were fully vaccinated." It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This report was associated with a product quality complaint: 90000221662. This case, from the same reporter is linked to 20220327300 and 20220327336.; Sender's Comments: V0: 20220327382-covid-19 vaccine ad26.cov2.s -Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Caller reports no additional AE at time of call; expired dose of ROT ATEQ was inadvertently administered to a patient on 4/2/2021.; This spontaneous report was received from a registered nurse and refers to a 4 month old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 02-APR-2021, the patient was inadvertently vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter administered orally (strength was not reported; lot number 1660666 and expiration date 22-MAR-2021) for prophylaxis.  No additional  adverse event was reported.
Horrible cough; Flu like symptoms; Body aches so bad she can't touch her skin; Vomited; Fever of 102F; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Horrible cough), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches so bad she can't touch her skin), VOMITING (Vomited) and PYREXIA (Fever of 102F) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced COUGH (Horrible cough), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches so bad she can't touch her skin), VOMITING (Vomited) and PYREXIA (Fever of 102F). At the time of the report, COUGH (Horrible cough), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches so bad she can't touch her skin), VOMITING (Vomited) and PYREXIA (Fever of 102F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: fever of 102 f (High) Fever of 102 F. In March 2021, SARS-CoV-2 test: negative (Negative) patient reported that prior to taking the 2nd dose she tested Negative for COVID-19.         No concomitant medications were reported. No treatment medications were provided.
Pt experienced a large, circular area of swelling, approximately 9cm in diameter.  This area was very tender to touch and very warm to touch.
Seizure. Loss of consciousness. 911. Ambulance to ER. Stabilization and release.
fever 1hr p/vax severe rt hip, leg pain & bilat rib pain 24OCT;fever lasted only 21OCT;hip & leg pain cont;saw chiropractor 24OCT;also had gen achiness;
Heartburn radiating from left to right of body; Rash; Lymph nodes on the side of Neck are swollen; This spontaneous case was reported by a patient and describes the occurrence of DYSPEPSIA (Heartburn radiating from left to right of body), RASH (Rash) and LYMPHADENOPATHY (Lymph nodes on the side of Neck are swollen) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 immunisation.     The patient's past medical history included COVID-19 in 2020.    On 21-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Sep-2022, the patient experienced DYSPEPSIA (Heartburn radiating from left to right of body), RASH (Rash) and LYMPHADENOPATHY (Lymph nodes on the side of Neck are swollen). At the time of the report, DYSPEPSIA (Heartburn radiating from left to right of body), RASH (Rash) and LYMPHADENOPATHY (Lymph nodes on the side of Neck are swollen) outcome was unknown.            No concomitant medications were provided. No treatment medication was provided. The patient was screaming and asking, what vaccine did they give and did not want to speak health department.   This case was linked to MOD-2022-658039 (Patient Link).   Reporter did not allow further contact
Patient received the second dose 21 days after the first dose at 9:40 am. A 4-day grace period allowed, however 21 days is fewer than 23 days; therefore required to report as an administration error. Patient informed at 11:40 am (immediately after it was discovered), the dose should be repeated at least 28 days after today's dose. Patient understood.
Lightheaded about 5 minutes after injection. Medical team took HR and BP and was normal Took about 20 minutes and light headedness went away  Later that night at around 12:30 am, felt very cold and shivering with severe headache Did not take temperature Had a hard time going back to sleep Got up around 1:00 am to take 800 mg of OTC Advil When walking back up stairs had severe muscle pain in arms and legs Was fine after that Seemed to get better by 2 am No issues next day  About 7-10 days later developed severe frontal headaches/sinus pressure No other symptoms Used Neti Pot with saline solution and did nothing Took OTC allergy meds and Advil and did nothing  Say my primary care Dr and he prescribed Flonase, Singular and Allegra + continue Neti Pot and Advil as needed Not much improvement on this regime after 3-5 days of use  About a week later developed severe pain in bottom right jaw Took OTC Advil and again no improvement Went to Dentist and said not tooth related but probably TMJD Recommend dental appliance to help with grinding  About a few days later after this jaw pain developed, developed sharp stabbing pain in bottom of left knee cap. No recollection of any insult that would cause this  All three of these pain sites were perfectly fine prior to getting J&J vaccine.  No history of pain or injury to these areas prior  All of these incidents to me seem to be inflammatory/immune in nature and could be related to J&J vaccine based upon how I reacted to injection.  Curious if others are seeing the same thing and if so what should be done or how long should this last?
This spontaneous report as received from a female patient in her sixties. The patient's concurrent conditions included diabetes. The patient had no drug reactions and no allergies. On 03-MAY-2016, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). The patient's concomitant medications included LYRICA and SYNTHROID. On 06-MAY-2016, the patient experienced itching at the injection site. The patient did not seek medical attention and did not receive any treatment for the event. The patient recovered from the event on 08-MAY-2016. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
LOSS OF TASTE; LOSS OF SMELL; EYES ARE BURNING; ARMS ARE VERY SORE; EXTREME TIREDNESS; FEVER; MASSIVE HEADACHES; ARMS ARE VERY COLD; SHORTNESS OF BREATH; CHEST PAIN; BODY IS VERY HOT; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's past medical history included had a surgery on the finger, and other pre-existing medical conditions included the patient had no known allergies. The patient was previously treated with paracetamol for surgery on the finger. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-JUL-2021, the subject experienced shortness of breath. On 21-JUL-2021, the subject experienced chest pain. On 21-JUL-2021, the subject experienced body is very hot. On 21-JUL-2021, the subject experienced arms are very cold. On 21-JUL-2021, the subject experienced eyes are burning. On 21-JUL-2021, the subject experienced arms are very sore. On 21-JUL-2021, the subject experienced extreme tiredness. On 21-JUL-2021, the subject experienced fever. On 21-JUL-2021, the subject experienced massive headaches. On 22-JUL-2021, the subject experienced loss of taste. On 22-JUL-2021, the subject experienced loss of smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, chest pain, body is very hot, arms are very cold, eyes are burning, extreme tiredness, fever, and massive headaches on 21-JUL-2021, was recovering from arms are very sore, and had not recovered from loss of taste, and loss of smell. This report was non-serious.
High pitched cry that was un-consoling for hours at a time, constant spitting up.  Non-stop kicking of both legs.  Ultra sensitive to sunlight.  Seizure like activity.  Delayed milestones and hypotonia. 1/14/09-records received-DOS 4/9/08, DX: Developmental dealy gross motor and expressive language of unknown etiology. Hypotonia, probable central, no evidence of neuromuscular problem.  Follow-up: My daughter still has to attend weekly therapy sessions for P.T. OT and Speech.
Redness and swelling of upper arm around injection site and nausea and felt light headed.
Day two after injection, large red bump developed.  Approximate size of a half dollar.  Hot, swollen, hard, and tender to touch.  No fever; vitals good.  Began course of Motrin and ice packs (20 minutes on/20 minutes off).  Ama took 2 weeks to clear up.
ErythemaMultiform, UrticariaPruritus, swelling at injection site, swollen lymph nodes causing pain in armpit (axillary lymphadenopathy) Narrative: 1/10 itch, erythema multiform, swelling at injection site, swollen lymph nodes causing pain in armpit (axillary lymphadenopathy) Instructed to take antihistamine, tylenol, and apply cold compress. Will continue to monitor.
lethargic; achy; chills; arm soreness; felt bad/not feeling right; did not feel well; This case was reported by a consumer via call center representative and described the occurrence of lethargy in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 4 hrs after receiving Shingrix, the patient experienced lethargy, pain, chills, pain in arm, feeling bad and feeling unwell. On an unknown date, the outcome of the lethargy, pain, chills, pain in arm and feeling bad were recovered/resolved and the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the lethargy, pain, chills, pain in arm, feeling bad and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix over two months ago in her left arm and experienced lethargy, achiness, chills, not feeling right, arm soreness and she felt bad and did not feel well.   She claims that the side effects all lasted for two whole days and then resolved. The reporter consented to follow up. The reporter can follow up with the patient directly and the pharmacy.  For tolerances of 2nd dose, refer case US2019AMR217074, reported by same reporter for the same patient.
Ten minutes after receiving shot, she became hot with tunnel vision. Patient passed out for a few seconds. Was very nauseous and dizzy and vomitted several times.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with an unspecified number of doses of ROTATEQ, orally (dose, frequency and lot# were not reported), which were improperly stored. Information regarding concomitant medications was not reported. No adverse experiences were reported. This is one of several cases from the same reporter. Additional information has been requested.
On 12/15/2017 patient was given a third vaccination of MMR. He had already completed the 2 of 2 series. Prior MMR was given on 01/24/2011. No adverse reaction had.
Large baseball size welt on right arm at injection site.  Arm was very sore for 3+ days.