chrisvoncsefalvay/vaers-outcomes huggingface dataset:
liquid only of Shingrix; received the liquid only of Shingrix and then a properly reconstituted  dose; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was reported. The reporter stated that, the patient received the liquid only of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. On 22nd September 2021, the patient received properly reconstituted dose. The reporter consented to follow up.
The patient had her Covid booster vaccine and Flu vaccine on 10/26/21. She was doing well not until 10/27/21 evening started to scratch her upper back shoulder. Around 10 pm noticed to have hives around the belly, upper and lower extremities. Her doctor was notified and ordered to start giving Benadryl 25 mg po every 6 hrs. until hives are gone and Tylenol po too.    Recently she was treated for UTI with Augmentin from 10/20/21 ? 10/27/21.   On 10/28/2021 morning, the rash did not get any better. Her vital sign was stable, no fever, O2 sat stable, not in any respiratory distress. Gave Claritin PRN orders with Tylenol at 9AM . RN was called and informed about the patient's condition and to relay message to her doctor.   12:20pm the rash become more worst and spread more to the face and eyes were slightly swollen.   Called RN that we will bring the patient to emergency department at the Hospital for further management and to avoid anaphylactic response.    Arrived at the hospital around 1:20 pm. The ED was fully packed and they were very busy during that time. Some of the patients have to wait outside. Luckily, we were able to get in on time at the waiting area. We waited for a long time to be seen by MD not until almost 5 pm.  She was treated with Decadon 6 mg IM and was also given Vistaril 25 mg PO. The patient was discharged at 7:25 pm and arrived home at 7:40Ppm. Her doctor was called and informed about the patient's condition status. She was diagnosed to have Maculopapular rash, generalized and adverse reaction to COVID 19 vaccine. With new discharge order from the hospital to give Atarax mg po every 6 hrs. PRN for itching.
She reported 3 red blotchy areas on the arm where the vaccine was administered. She also reported hives on her trunk.
The 1st dose (on 3/3/21) caused nausea, gerd, fever of 100.4 for and body aches for 2 days, with mild headache. The 2nd dose, (on 4/8/210 I took Tylenol prior to vaccine and every 5-6 hours for over 48 hours but still ran 103 fever for two days after the injection. The reaction began with nausea, vomiting and 102 fever about 12 hours after injection and quickly rose to 103 for the next 48 hours. I had severe headache, dizziness and body aches for 3-4 days after the vaccine.
1st vaccination  12/23/2020  2nd vaccination 1/19/2020 *in between vaccinations, diagnosed with Shingles 1/7/2020 *I have had consistent pain. The Shingles presented itself I had rash on right side, abdomen and back. The dr. gave antiviral, stated I have Shingles, and she also gave me narcotic pain med for pain. I had the pain and rash for 3 weeks. 1/19 I was recovered, had 2nd vaccination, a week later presented rash on both arms, itching. I take Ibuprofen daily, the pain on my back is same location. 10-15 days of constant pain, LEVEL 7-8/10. I also had another rash in between my breasts, arms, and nipples. Using over the counter hydrocortisone cream.
Two days after my first shot I started experiencing double vision which got progressively worse. Seven days after my first shot my left eyelid was drooping very badly. My left eyeball is pointed slightly downward.  I'm taking Pyridostigmine with some improvement to my eyelid, but no improvement to my double vision.
Delusions, fever, crying and scared something was going to happen to her. Went to ER on 12/23/2014, back to ER on 12/24/2014 and physican office same day.
feel worse than COVID did; feel worse than COVID did; it was reported that patient experienced: feel worse than COVID did; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Secondary progressive multiple sclerosis" (ongoing). Concomitant medication(s) included: OCREVUS. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "feel worse than COVID did"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it was reported that patient experienced: feel worse than COVID did".  Additional information: On Apr2021 patient started therapy for Pfizer Biontech covid19 vaccine for on unknown date, it was reported that patient experienced feel worse than covid did   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd vax; devel redness & swelling at inj site;ice applied to site & all sxs resolved;
Child had a seizure, lasting approx. 30-45 seconds. Took child back to doctor's office for a re-check.
Recieved vaccine @ right DELTOID (arm) after 7 hrs noted blue eccymoised area distial to site on inner aspect of upper arm 3x3 inches wide
Hard swollen tissue at injection site, hot to the touch with a mild rash present. Numbness and tingling down the right arm to the fingers and up into the right side of the neck. Grip strength in right hand reduced. Itching on right arm within an hour of injection and spread to neck and torso within 24 hours.
hands and legs swollen; arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 93-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EL3246 and expiry date was not provided), via Intramuscularly, in right shoulder (right arm)on 04Feb2021 at 10:30 (at the age of 93-years-old) as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. No previous immunization history with the Pfizer vaccine considered as suspect. No additional vaccine was administered on same date of the suspect. No prior vaccinations within 4 weeks. No adverse events following prior vaccinations. On 04Feb2021, patient experienced hands and legs swollen and arm was a little sore. Patient's arm was a little sore last night but that did not bother him. About 10 hours later between 19:00 and 21:00 he got up to go home from watching a movie and both of his legs and both of his hands were swollen up. Reports he had a heck of time getting up for a bowel movement. Patient's wants to know if this will reoccur itself tonight or was it a onetime thing. Reports it was not life threatening. His hands were swollen and he could not make a fist. The swelling was in both his hands and legs. Sometime during the night it got down to normal, and his hands and legs appear to be normal now. Since waking up about 30 minutes ago his hands and legs appear to be normal. He was just surprised and shocked that he experienced that about 8 to 10 hours after the injection. Patient did not feel the darn thing when he received the injection. As reported he takes a whole bunch of things for his other problems but they do not have anything to do with this. No treatment was received. Events does not require a visit to emergency room or physician office. Lab test included body height and result was shrinking. Second dose of vaccine was due on 25Feb2021. The outcome for event hands and legs swollen was recovered and for arm was a little sore was unknown.  Follow-up attempts are completed. No further information is expected.
COVID 19; COVID 19; Pfizer / BioNTech; Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 20Sep2023 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15May2023 at 12:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypo parathyroid" (unspecified if ongoing); "THoracid aortic aneurysm" (unspecified if ongoing). Concomitant medication(s) included: SENSIPAR, start date: 01Oct2021, stop date: 20Sep2023; POTASSIUM, start date: 01Apr2020; MAGNESIUM, start date: 01Oct2020; VIT D3, start date: 01Oct2020; VIT B12, start date: 01Oct2020; VIT C, start date: 01Oct2020; LORATADINE, start date: 01Oct2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer / BioNTech; Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 22Sep2023 to 26Sep2023.  Clinical course: Paxlovid rebound. Free of symptoms on 5th day after Paxlovid treatment. Tested negative for Covid on at-home test on day 7. On day 8, at 5pm fever 100.7, achey, chills/sweat, congestion, sore throat and sneezing.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
This case was reported by a physician via call center representative and described the occurrence of numbness in a leg in a 19-year-old female patient who received BEXSERO (batch number 159001A, expiry date unknown). On 25th May 2017, the patient received the 1st dose of BEXSERO. In May 2017, several hours receiving BEXSERO, the patient experienced numbness in leg. On an unknown date, the outcome of the numbness in leg was recovered/resolved. The reporter considered the numbness in leg to be almost certainly related to BESERO. Additional information was provided as follows: The patient experienced numbness in the legs for five days after being administered BEXSERO. The healthcare professional did not have expiry date.
Employee came in for covid booster. Currently giving only Pfizer boosters. After completing questions, Pfizer vaccine given. When given vaccination card, noted that previous doses were Moderna. Patient monitored for 15 minutes. No adverse effects noted.
Menstrual Cycle extended.; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Jun2021 at 17:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included pernicious anemia, bi-lateral carpal tunnel, costochondritis and degenerative disc disease. The patient had known allergy to penicillin. The patient previously received ibuprofen (MOTRIN) and amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included cyanocobalamin injections (B-12) for unknown indication and allergy medicine unspecified (MANUFACTURER UNKNOWN) both from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 08:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. On an unknown date in Jun2021 the patient's menstrual cycle extended. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event menstrual cycle extended was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient experienced dizziness, felt faint, nausea, and vomiting.  Symptoms started approximately 3 minutes after vaccination.  Symptoms lasted 10 to 12 minutes.  Patient stated he felt better after 15 minutes. He remained another 20 minutes. He then left the Pharmacy area stating he felt normal and fully recovered,
Redness and possible cellulitis in (L) arm. Patient was given doxycycline 100 mg.
Received the vaccine, and at 3:00 to 4:00 her left arm felt like it was in a vice, being squeezed tighter and tighter, and could not lift or move her arm.  Took Tylenol which did not improve any symptoms.  Got headache and had that with the arm in the pain all night long.  Woke up totally drenched by sweating, and went to the bathroom and felt dizzy yelled for her husband and passed out, and her husband caught her while passing out and woke up on the floor.  On the Thursday she was in her recliner the entire day, had nausea, fever, chills, headache, continued with the pain of the arm in a vice, which lasted all day long.  Her husband forced crackers and water down her as she had no appetite either for 3 days.   She felt so fatigued and her head was not clear.  She slowly gradually improved, and yesterday 3/18/21 she feels her head fogginess has improved, and her arm is gone as she has been exercising with a band.  It is a little sore but otherwise fine.  The excruciating pain lasted for 2 full days.   She put some Lidocaine and it possibly helped.  She called her doctor and they told her to exercise the arm, and to take more Tylenol, which she had tried which did not improve anything.
Arm swelling, redness, rash, paid up arm to should up to neck and head. Elevated heart rate. Increased WBC. Went to emergency room and was given an IV with Antibiotics and Paid meds.  Pain and swelling persisted for 3 days until a Steroid was given. Once steroid was give swelling and redness went down but shoulder, neck and head pain persisted.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: HCTZ; METOPROLOL [METOPROLOL TARTRATE]; LOSARTAN; ASPIRIN LOW; MELATONIN; CRANBERRY; VITAMIN B2 [RIBOFLAVIN]; MAGNESIUM GLYCINATE. Past drug history included: Compazine, reaction(s): "Known allergies: Compazine"; Lisinopril, reaction(s): "Known allergies: Lisinopril". The following information was reported: COVID-19 (medically significant), outcome "recovering", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Headache, Fever, BODY ACHES INJECTION SITE SORE, OVERALL FEELING OF BEING SICK, INCREASED FATIGUE Narrative:
Dizziness , light headed never fainted but needed to rush to sit down until I felt well enough to stand again. Hours later I was still light headed but the room was no longer spinning.
When reporting second Pfizer dose to the state health dept. Pt was found to have had 4 doses of Moderna and 2 doses of J&J in the State system from multiple vendors. But the patient told us he had never had vaccines before.  Attempted to call pt to verify this information and educate, but he did not answer x3.
body aches; headache; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 26Jan2021 (Batch/Lot number: unknown) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number: EJ1686, Time vaccination was 09:00 am and anatomical location of the administration of the vaccine was arm left), administration date: 05Jan2021, when the patient was 55 years old, for Covid-19 immunisation. The following information was reported: PAIN (non-serious) with onset 27Jan2021, outcome "recovered" (2021), described as "body aches"; HEADACHE (non-serious) with onset 27Jan2021, outcome "recovered" (2021), described as "headache"; DIZZINESS (non-serious) with onset 27Jan2021, outcome "recovered" (2021), described as "dizziness". Therapeutic measures were taken as a result of pain, headache, dizziness.  Additional information: Never had a reaction from any other vaccine prior. There was no predisposing factors. The patient was not admitted to hospital. AEs did not require a visit to emergency room or physician office. No culture was performed. Treatment received was only NSAIDS Tylenol and ibuprofen. Causal relationship: there was reasonable possibility that the event was related to suspect product Pfizer.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a physician referring to unspecified patients of 2 to 6 months of age of unknown gender. The patients medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. The physician reported that rarely (unspecified) patients received ROTATEQ (dose, frequency, anatomical location, lot # and expiration date were unknown) orally and spit up on unspecified dates. There was no treatment given for the adverse event. As on 01-JUN-2018, an inbound call was received from the physician in regard to a HCP vaccine letter received regarding to infantile spitting up experienced by multiple patients who received ROTATEQ. On an unknown date, the patients were vaccinated with ROTATEQ (dose, frequency, anatomical location, lot # and expiration date not reported). She stated she was unable to fill out as she did not have patient specifics and the reason for her call was to report a chief compliant. Physician stated that infantile spitting up was not the chief complaint, but choking and gagging (retching) after receiving ROTATEQ was. No patient identifiers could be provided as it happened to every baby from 2 to 6 months of age receiving ROTATEQ. It happened at least 95% of the time. The physician could not provide any additional information but she stated that she would report if she had any further information concerning it. Outcome of infantile spitting up was reported as recovered. The outcome of choking and retching was not reported. The physician did not mention the causality assessment between the events and ROTATEQ. Upon internal review, the event choking was determined to be medically significant.
This spontaneous report as received from a pharmacist via company representative refers to a 69 year old female patient. No pertinent medical history, drug reaction or allergies were reported. On 16-OCT-2014 the patient was vaccinated with ZOSTAVAX lot # K007984, expiration date 20-MAR-2015, 1 shot (dose, dose number and anatomical location were unspecified). No concomitant therapies were reported. On 21-OCT-2014, the patient experienced rash on the abdominal area, hands and injection site. The patient sought medical attention (unspecified) and acyclovir was given for 5 days as treatment for the events. The outcome of the events was reported as recovered on an unknown date in 2014. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Information was received on 20-APR-2017 from an attorney in the from of an initial legal complaint regarding a male patient (age not reported).  Medical history, concurrent condition and concomitant therapy were not reported. On 10-JAN-2013 the patient was vaccinated with ZOSTAVAX (dose not reported) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-DEC-2015 the patient was treated for a painful rash that was diagnosed as shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; PAIN IN LEFT ARM WHERE PATIENT GOT VACCINE; This spontaneous report received from a patient concerned a 39 year old, white and Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, non alcoholic, and cigarette smoker, and she had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 10-MAR-2021 at left arm for prophylactic vaccination. She takes sleep aid at night. On 11-MAR-2021, the patient experienced little pain in the arm where she got the vaccine. On 03-JUN-2021, she got an antibody test done (AC Anti- SARS-COV2 IgG S1-S2 Test). The test result came back negative (her result was 8.36) and the test indicates that anything less than 12 was considered negative (confirmed immunological vaccine failure). The patient consulted 3 different doctors who told her not to worry.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in left arm on 12-MAR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000181890.  The suspected product quality complaint has been confirmed to be not voided. The reported allegation could not be confirmed. A manufacturing related root cause could not be identified.; Sender's Comments: V0:20210612013 -COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccination failure. 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