chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received a FLUZONE HD QIV in error, due to patients age with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 59 years old female patient who received an influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] in error, due to patient with no reported adverse event.  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 quadrival A-B high dose HV vaccine (Lot Number:UT7743CA,Expiration Date :30-06-2023) reported via unknown route in unknown administration site for prophylactic vaccination in error, due to patient age with no reported adverse event (product administered to patient of inappropriate age) (unknown latency).  Action taken:  not applicable.  Outcome : Unknown.   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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.; Sender's Comments:  01320915:
Right side of the body started to convulsion or seizure, and lasted 30 minutes.  She was rushed to hospital still seizuring. No treatment administered.
On Monday, Dec. 12--three days after receiving the vaccine--I noticed blood in my stool (gastrointestinal bleeding).
Rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported
Rash occurred approximately 2 weeks after receiving each dose of vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 2021, outcome "recovered" (2021), described as "Rash occurred approximately 2 weeks after receiving each dose of vaccine.". The event "rash occurred approximately 2 weeks after receiving each dose of vaccine." was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of rash.  Additional information: Known allergies was unknown. Other medical history was unknown. Facility type vaccine was unknown. It was unknown whether other vaccine was administered in four weeks. Patient was co-worker of spouse. It was unknown if she had Covid prior vaccination. It was unknown if she was tested for Covid post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt recvd vax & exp dizziness which subsided; The next day, pt devel a low grade fever & h/a which has not subsided; also, 2 days p/vax pt exp back & leg pain as well as insomnia & nervousness 3 days p/vax;
hair growth increased; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program. The reporter is the patient.  A 62 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "alopecia universalis" (unspecified if ongoing), notes: I have had alopecia universalis for 30 years or so. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "hair growth increased".  Additional information: Clinical course: It was reported that patient saw that some people said they had hair loss after receiving the Pfizer vaccine for covid. Patient have had alopecia universalis for 30 years or so and she noticed minimal hair growth after receiving three doses of Pfizer covid vaccine. She was not saying the vaccine caused the hair growth. She just stating it has happened.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have the first shot at August 3rd 2018, since then, my left arm muscles are in sore status. Now after 7 months, I can not lift my arm since the muscle is so painful from the shot. I have the second shot on my right arm at 10/09/2018, which is ok, not much muscle so far.
For unknown reason (not documented in chart) patient received the first Moderna COVID-19 Vaccine dose on 4/30/21 and the second dose of Moderna COVID-19 Vaccine on 5/28/21. Patient also received a third booster dose on 11/5/21 (on day 161), which is earlier than 168 days after second dose. 7 days x 24 weeks (4 weeks/month x 6 months) is 168 days. There were no adverse events associated with administration of the vaccine. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
Patient seen in follow up for severe acute hypoxic respiratory failure/ multifocal pneumonia due to COVID + 12/15.  Moderna Vaccine 3-4 2021. Patient is requiring 100% BIPAP Critical care has discussed cautious monitoring for potential need for intubation and vent support. High dose Decadron/Remdesivir and Baricitinib in progress 12/26 AKI 1.41 Intermittent Bradycardia ? Related to covid, ? remdesivir
Extreme fatigue, headaches, nausea, muscle weakness, low blood pressure, dizziness, blurry vision, seizures, heavy menstrual periods with severe cramps, sleeping 14-16 hours and still feeling tired, muscle pain, joint pain, dysautonomia/POTS, fainting, brain fog, problems concentrating, depression, anxiety, panic attacks, sensitivity to light, swelling in eyes.  All of these symptoms have been evident since first HPV vaccine.
Immediately following immunizations pt developed high pitch inconsolable crying. She was given Tylenol one hour later. Crying continued for a total of 4 hours. She was then reexamined, crying but consolable.
This case was reported by a pharmacist via sales rep and described the occurrence of shingles in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 2nd June 2018, the patient received SHINGRIX (intramuscular) .5 ml. In June 2018, less than a day after receiving SHINGRIX, the patient experienced shingles and feels awful. On an unknown date, the outcome of the shingles and feels awful were recovering/resolving. It was unknown if the reporter considered the shingles and feels awful to be related to SHINGRIX. Additional details were provided as follows: After receiving the SHINGRIX, the patient was very unpleasant in the first 36 hours and had some rashes as if they were shingles. Already at 48 hours, the rashes had been reduced enough but the reporter would follow up with the patient to see if she had improved. The reporter agreed for follow up.
ADULT OBSTRUCTIVE SLEEP APNEA ACUTE NON ST ELEVATION MI CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Patient called 8/26/19 reporting of redness, swelling, and severe pain in left arm. She reports vomiting and feeling sick to her stomach. This has been ongoing for over a week and she still feels the symptoms as of 8/26/19. She said she felt some soreness in her right arm but that went away within a day or two. She visited 2 separate doctors which she mention did not help her. She was advised to help alleviate her symptoms Tylenol and icing to bring down the swelling and pain. She asked that someone call her to explain to her more about the vaccine and its side effects. A clinical pharmacist will be giving her a call to explain the possible side effects of the vaccines.
Pt received her PPSV23 on 9/14/19.  She states her arm was red on the morning of 9/15/19.  She showed me her arm today which was a little red and she said the redness was almost all gone.
Runny nose, coughing, heavy phlegm , shortness of breath, wheezing, unable to sleep at night
Chest pain and pain radiating from L arm to neck. Pt. transported to the ER on 03/15/2021 and ER stated that reaction was inflammatory process from the vaccine per school nurse.
Vaccine given on 4/7. 4/8 in the evening patient developed a rash. She did not tell mom until 4/9. Seen 4/10 no new exposures. BENADRYL helped some (+) pruritis. No angioedema. No SOB. No dysphagia.Lesions do not look like hives when I saw them.
Information has been received from a registered nurse concerning a 8 week old female patient with no medical history, who on 14-DEC-2010 was vaccinated with a dose of RECOMBIVAX HB (Lot # not reported). The patient also received a dose of a dose of PEDIARIX, and a dose of ROTATEQ (Lot # not reported) and concomitantly the patient was vaccinated with a dose of Hib (unspecified carrier) on the same date. On 15-DEC-2010, the patient was vaccinated with another dose of ROTATEQ (Lot # not reported), another dose of RECOMBIVAX HB (Lot # not reported). (Lot # not reported) and a dose of a dose of PENTACEL. The nurse stated that on 16-DEC-2010 the patient's mother contacted the office reporting that on 15-DEC-2010 the child had a rash (no details) and cough. The patient would be following up with an unspecified pediatrician. At the time of the report the patient had not recovered. The patient did not seek medical attention. Additional information has been requested.
Patient had injection site redness and irritation and began running a fever. He followed up with his transplant physician and they diagnosed the immunized arm as having cellulitus  and prescribed an antibiotic.
Patient contacted us complaining of swelling and pain which began immediately after injection. I explained that if this is continuing, contact her physician to prevent a possible allergic reaction. She wanted me to fill this adverse event form out.
Initial and follow up information has been received from Pregnancy Registry for Gardasil from a Nurse Practitioner (N.P.) and with a follow up telephone call concerning a 18 year old (previously reported as 20 year old) female patient with abnormal PAP test. She was obese and was a smoker who had cervical condyloma and "SAA". It was reported that patient was vaccinated around December, 2006 with a first dose of Gardasil. On 05-FEB-2007 she was vaccinated with the second dose of Gardasil (lot # 654510/0962F). Concomitant therapy included "birth control patch", Tylenol as needed for headache and she was treated with prenatal vitamins for pregnancy. The reporter reported that patient received her first injection and was pregnant. She had routine obstetrics labs done. No further information was available. In follow up it was reported that her last menstrual period (LMP) was on 03-JUN-2007 and expected delivery date was 09-MAR-2008. There was no information about delivery or outcome of the delivery. In follow up information from the doctor's office it was reported that on 27-SEP-2007 routine serum maternal alpha-fetoprotein test was done. Patient had ultrasound on 25-JUL-2007, 22-AUG-2007, 10-OCT-2007 and in 09-JAN-2008 for confirmation dates and screening of pregnancy. On 22-AUG-2007 pregnancy associated plasma protein test and on 27-SEP-2007 maternal serum alphafeto protein (MSAFP) was done. No information for the results are available. It was reported that on 13-MAR-2008 at 40.4/7 weeks from LMP patient delivered a female normal baby by cesarean section delivery. The indication for C/S delivery was not reported at this time. The baby weighed 8 lb 12 oz and her apgar score was 8.9. No complication was reported with the baby. Upon internal review patient's failure to progress (delayed delivery and) required a cesesaren section delivery. The event was determined to be an other important medical event. Additional information has been requested.
29AUG92 AM vomiting started 3-4 days of & on for 2 wks; Reddened area around shot site; t101.4;
Swelling, redness, tenderness at site. Fever, chills, myalgia, rigors, headache.
Was tired starting a few hours after the shot and pretty immediately was sore in my arm, in the middle of the night woke up with severe full body aches and a presumably a fever (however didn?t take temperature until the morning. During the day was exhausted, has a fever of 101.3°F at around 11 am and body aches continued. I had been taking Motrin every 4 hours up to this point for the aches and added in Tylenol as well. Around 5pm noticed lymph nodes in arm pit were severely swollen. Continued to be sore and noticed fever start to come down and was 99° by the time I went to bed. Aches became more localized to the arm and arm pit. Woke up in the morning with still bad pain in the arm. Around 12 pm took a bath and noticed the injection site had a distinctive red circle reaction and was warm to the touch and extra swollen like a welt. Fever at this point was gone temperature was 98.5°.
This spontaneous report was received from a medical assistant and refers to an unspecified multiple number of patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M036293, expiry date 17-AUG-2018; lot # M040138, expiry date 28-SEP-2018; lot # M045204, expiry date 11-NOV-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 15 to 46 degrees Fahrenheit for 5hours. Data logger was involved. There were no previous excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA007391:
Immediate heart racing, dizziness, stomach upset and mild wheezing after first dose. Diarrhea and dizziness for hours. Had Epi pen just in case I needed it, but didn?t use it.  Did not get second dose.
Extreme nausea and vomiting Fever Dizziness Fatigue Diarrhea Fainting No appetite Symptoms listed above lasted 56 hours. Treated at home, no visit to doctor. Injection site was sore 24 hours.
AFTER PT RECIEVE IM SHOT in the left arm, a nodule form there. it look like reaction to the vaccine. the pt was intructed to put ice on it and it should go oway. pt was reach out 7 days latter to confirm it went oway.
51 yo female with c/o foreign body sensation in left eye x one week beginning ~6 days post smallpox vaccination.  Sensation worsened throughout the week and patient reported ocular discharge on 4/9.  No c/o eye pian, itching, redness of eye, or visual changes.  Contacted clinic on 4/9 and was referred to Eye and Ear Infirmary for ophthalmologic evaluation.  Examination of the eye was completely normal except for some mild blepharitis on left.  No foreign body seen, no corneal abrasions.  Exam of the retina, ocular nerve, conjunctiva and periocular area all normal.  No discharge noted on exam.  Specimens not sent for testing.  Patient treated with artificial tears and discharged.
PNEUMONIA; CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a 78 year old female. Initial information was processed along with additional information received on 26-JUL-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, chronic obstructive pulmonary disease (COPD), obesity, pneumonia, and atelectasis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total, administered on 10-APR-2021 at left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-JUL-2021, patient was diagnosed with COVID by a confirmed PCR (polymerase chain reaction) test (confirmed covid-19 infection and confirmed clinical vaccination failure) and was hospitalized and was then discharged. Number of days hospitalized was not reported. On 17-JUL-2021 patient went back to the hospital and was still hospitalized. The patient experienced cough, shortness of breath and had low oxygen saturation. On an unspecified date, patient experienced pneumonia. Since the patient had an underlying condition of pneumonia, according to reporter it was not clear if the pneumonia was caused by COPD or due to COVID. On unspecified date in JUL-2021, laboratory data included: Oxygen saturation (NR: not provided) low. The patient was hospitalized for the events of pneumonia and confirmed covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and pneumonia was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000187079.; Sender's Comments: V0-20210752946- covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. 20210752946- covid-19 vaccine ad26.cov2.s -Confirmed covid-19 infection, Pneumonia . These events are considered not related. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Very bad nausea; Very bad vomiting; Bad dry cough; Body aches,Sore arm; Fever; Flu-like symptoms; Couldn't get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), BEDRIDDEN (Couldn't get out of bed), COUGH (Bad dry cough), NAUSEA (Very bad nausea) and MYALGIA (Body aches,Sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included vitamins and GABAPENTIN for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), BEDRIDDEN (Couldn't get out of bed), MYALGIA (Body aches,Sore arm) and PYREXIA (Fever). In June 2021, the patient experienced COUGH (Bad dry cough). On an unknown date, the patient experienced NAUSEA (Very bad nausea) and VOMITING (Very bad vomiting). On 10-Feb-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), BEDRIDDEN (Couldn't get out of bed), MYALGIA (Body aches,Sore arm) and PYREXIA (Fever) had resolved. At the time of the report, COUGH (Bad dry cough) outcome was unknown and NAUSEA (Very bad nausea) and VOMITING (Very bad vomiting) had resolved.            The patient treatment information include The first time the patient was given a Z-pack and a steroid shot. The second time the provider prescribed steroid pills, codeine cough syrup, pills to suppress a cough, and omeprazole for possible heart burn. During the last visit the provider gave a steroid shot to the patient and a very strong antibiotic, which the patient thinks was azithromycin.   This case was linked to MOD-2021-297574 (Patient Link).
redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a elderly 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 injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter had a patient that called with redness at site of injection.  They indicated it was 1 to 1 and half 2 inch around of the injection site.
The patient is a 82 Y male who presents to the Emergency Department with reports of syncope.  Wife reports over the past few months he has had lightheadedness most mornings.  He had 1 episode a few weeks ago where she thought he had a near syncopal episode.  The patient got into his stair chair this morning while the wife was downstairs.  She heard a thud.  She found him unconscious leaning against a counter.  He quickly regained consciousness, he was oriented, denies headache, tongue biting, or micturition.  Wife did not note convulsions
Heat, redness, tenderness, firm at injection site. Flushed red face, complaints of shortness of breath, headache.
This spontaneous report was received from a doctor of pharmacy refers to a 66 years old female patient with no pertinent medical history, no drug reactions or allergies and a skin disorder who on 24-AUG-2012, was vaccinated subcutaneously with a 0.65 ml dose ZOSTAVAX (lot number not reported). No other co-suspects were reported. The patient using unspecified ointments and creams for her skin condition prior to vaccination with ZOSTAVAX. The pharmacist reported that the patient came into the pharmacy on 14-SEP-2012, with a prescription for prednisone 60 mg for 5 days and Z-PAK. The pharmacist did not feel that the prednisone and the Z-PAK were related to the patient receiving ZOSTAVAX. No labs diagnostics studies were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Since my vaccination, I've been experiencing itchiness all over my body. The most troubling adverse reactions have appeared in the last two days, five days after receiving the vaccination. Those reactions include the following: vertigo, general feeling of unsteadiness, nausea, visual focusing issues, mental focusing issues, and weakness that is mainly in my arms and legs.
Severe arm swelling, redness, warmth Deltoid area to almost elbow. 1st time patient ever received the pneumovax. Spoke with patient 10/27 - arm muscle improved, feeling overall better.
(L) arm x2 vaccines given - deltoid. Erythema, swelling, and itching, warmth to touch measures 12cm x 10cm.