chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on the front of body; This case was reported by a physician via sales rep and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-May-2022 Reporter's comments: Two weeks after receiving a dose of Shingrix, the patient developed a rash on the front of his body. The reporter did not know if dose was first or second dose of Shingrix. The consent to follow up was given.
Patient woke up about 9 am with a nose bleed and stomach burning.  Called the ER for advice and was instructed to come to ER if symptoms worsened.  Patient developed rash on arms and burning sensation on her face on 12/27 and went to ER for treatment.  She was diagnosed with an acute reaction to the H1N1 vaccine and prescribed hydrocortisone cream.  She did not fill the Rx but used some hydrocortisone cream she had at home.
Patient requested booster dose of Pfizer.  Patient did not bring vaccine cards to his booster appointment nor was he in the state vaccine database due to obtaining first vaccines out of State.  The medical assistant gave the Pfizer booster based on the patient's description and verbalized dates.  Then the patient brought in his vaccine cards the next day and was found to have had Moderna vaccine for the first 2 doses.  Patient had no adverse health events.
Itchy rash; rash/hives on front and back torso / Large patches; rash/hives on front and back torso; Itchy and warm; This case was reported by a other health professional via sales rep and described the occurrence of itchy rash in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   On 24th September 2020, the patient received Fluarix Quadrivalent 2020-2021 season .5 ml. On 26th September 2020, 2 days after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced itchy rash, rash, hives and feeling of warmth. On an unknown date, the outcome of the itchy rash, rash, hives and feeling of warmth were unknown.   The reporter considered the itchy rash, rash, hives and feeling of warmth to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. Rash or hives on front and back torso. Has happened before with other vaccines. Rash appeared on 26th September 2020. Large patches still had rash. Using lotion to sooth. Itchy and warm. Thought it was related to vaccine.
After patient received vaccine, LOC (loss of consciousness). Medical assistant supported her head to prevent head injury and patient brought to floor to lay down. Feet raised , patient flaccid, skin pale, non responsive. Within 20 seconds patient opened eyes and tried to getup. BP(blood pressure) =116/70; P (pulse) - 68. Patient had not eaten. After resting x 45 minutes, patient left clinic.
Information has been received from a pharmacist referring to an unspecified number of patients. No pertinent medical history or drug reactions/allergies were reported. On unknown dates the patients were vaccinated with doses of 0.65 ml ZOSTAVAX (lot# and expiration date unspecified), subcutaneously. No concomitant medications were reported. On unknown dates the patients experienced redness, swelling, warmth and pain at the injection site. No lab diagnostics studies were performed. The patients sought medical attention via visited to pharmacy and received BENADRYL as treatment. The outcome of events was reported as resolved. Additional information has been requested.
Interchange of vaccine products; had brain surgery and its for NPH Hydrocephalus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 81-year-old male patient received BNT162b2 (BNT162B2, NDC number and Expiry Date of Covid Vaccine was not Provided. Reason for no lot number: of Covid Vaccine: Caller unwilling to complete the report), as dose number unknown, single (Batch/Lot number: unknown) and as dose number uknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Other Products, Other Conditions and Investigations was Not Provided. Results in death, Life threatening, Disabling/Incapacitating, Congenital anomaly/birth defect: No Information. Caused/prolonged hospitalization: True. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant), outcome "unknown"; NORMAL PRESSURE HYDROCEPHALUS (hospitalization, medically significant), outcome "unknown", described as "had brain surgery and its for NPH Hydrocephalus". Reporter is the Patient. Caller states that he was calling about Covid 19 Vaccine Ba.5, clarifying he was calling about the Covid 19 Bivalent vaccines. He's had brain surgery and its for NPH Hydrocephalus, in which they put a cordage or hole in the back of the skull, and put in a shunt to the stomach, that was regulated with a valve, a magnetic valve, they did this at hospital in [place name withheld]. He did his drainer first at home the first time he got 42cc's, second time he got 30cc's, and they found that he can go 20 yards, at a speed increase of 5-7 seconds, before he was 17-20 seconds. Caller was concerned and wants to know if the Bivalent Covid Vaccine would not interfere with this operation, he was off blood thinners, but he wanted to know if the vaccine would effect this. Caller confirms that he has not been administered the Bivalent Covid Vaccine, but he has had 3 previous covid vaccines, in which 2 were from Pfizer and 1 was moderna. He did not want to do a safety report, he was not calling to report, he wanted to ask his questions. Safety report declined. He was 81 years old. Therapeutic measures were taken as a result of normal pressure hydrocephalus.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Extensive muscle twitching throughout the body. None treatment has been defined. Twitching is continuous
In February 2021, I started experiencing dysfunctional menstrual bleeding - I started spotting 1-2 weeks prior to the scheduled start of my period. This progressed from spotting to what felt like a regular period flow, which lasted about 3 weeks each month.  I assumed it was due to a change in my birth control (which happened in September 2020) and the stress of remote and hybrid teaching, so I never reported it on the v-safe check ins.  But, the symptoms did not subside when school let out in June.  At my annual visit in October 2021 with my gynecologist, she prescribed a new birth control pill (norethindrone) and observed an enlarged uterus during my exam.  This visit was after I received my booster shot.  In November I went for an ultrasound (internal and external), which confirmed 3 uterine fibroids.  Dr. was the doctor available to read and review the ultrasound report with me.  There was an area on the ultrasound that could also have been a polyp, so in December 2021 I went for a second ultrasound, this time with saline.  On that exam Dr. observed a cervical polyp.  The ultrasound with saline revealed a uterine polyp, and that the fibroids may have grown larger.  In January 2022 I went for an MRI to gather more information about the fibroids.  In January 2022 I also had a polypectomy to remove the cervical and uterine polyps.  At the time of this submission I have not yet received the results of that procedure.
This spontaneous report as received from a other health professional (registered nurse) refers to an approximately 12 year old female patient. Patient was not pregnant. Current conditions and medical history was reported as none. On 05-NOV-2014, the patient was vaccinated with GARDASIL injection 120 Y (dose, route and frequency was not reported). Lot number was reported as 6512156 and expiry date was February 2016. Concomitant therapies included ALLEGRA. On 06-NOV-2014, the patient experienced a reaction to GARDASIL and had redness and a rash around the injection site which was swollen and patient's arm hurt. No treatment was given for the events. No lab diagnostics studies performed. The outcome of the events was reported as recovering. Causality assessment was not reported. Product quality complaint was not reported.  Additional information has been requested.
rash, red patches, sl elevated on belly part of abd, legs, rt & lt near thighs, behind knees, spotty on one leg to ankles;chronic dermatitis around neck & shoulders exacerbated;rash itch;rash still running its course;
pt did not have a reaction to vaccine. vaccine was given after beyond use of refrigeration but lot number was not expired.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, insomnia Narrative:  onset of above s/s within 12 hours of 2nd  vaccine. leaving work.
Full blown flu with muscle aches, weakness, fever of 101.5 deg F even with anti-inflammatory drugs.  Discharge of phlegm from respiratory tract still occurred 8 days after onset of symptoms.
Early afternoon on 09 December, experienced sharp pain in right shoulder when reaching to lift something out of the car.  Got progresively worse over the next week.  Could not bend shoulder inward.  The area of the right shoulder and chest below the collar bone  was very swollen and painful to the touch.  Tried alternating ice and heat, which helped.  No falls or exercising can explain this.  Breathing was fine, never painful. The week of December 19 the swelling started to go down and it was less painful.  On Dec 26, I discovered that there was a residual lump about the size of a golf ball above the right breast, very painful to the touch.  Went to urgent care the morning of Dec 27, and they referred for an ultrasound, as regular doctors were away for the holiday week. Had ultrasound on January 3.  Radiologist said he thought it was costochondritis, as the lump was at the end of the rib.  At this point the lump was smaller and not painful.   Consulted with Dr. on his return, and he said to come see him in a few weeks if the lump was still present. Saw him on January 21.  He believed it was a lymph node and would gradually go away.  At the time of this report it is still present, smaller, and not painful.
This case was reported by a pharmacist via sales rep and described the occurrence of urinary frequency in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced urinary frequency. On an unknown date, the outcome of the urinary frequency was unknown. It was unknown if the reporter considered the urinary frequency to be related to SHINGRIX. Additional information was received as follows: The reporter was unable to provide the patient's demographic details. The reporter asked on behalf of his wife if frequent urination was a side effect of receiving the SHINGRIX vaccine. The reporter's wife had a patient who received the SHINGRIX vaccine and experienced frequent urination after receiving the vaccine. The patient went to an urgent care to seek treatment. The reporter was unable to verify if it was dose 1st or 2nd, lot number and start or stop date of the vaccine. The reporter declined to provide additional information stating that it was his wife's patient who had reported the event to her. The reporter was not open to follow-up, but requested my sales representative's business card, in case his wife was willing to provide follow up.
Patient's mother called at 4:10 on 6/29 and stated patient's left arm is swollen and red. Patient received Tdap in left arm at approximately 2:00pm. Contacted patient's mother on 7/3 and she stated the swelling got worse Saturday (7/30) and into Sunday. Monday it started to get better. She stated you cannot see it but it is still hard when touching it. No fever or chills. Did not take any medication or seek medical treatment. The arm was very painful when touched.
The vaccine was given with the incorrect amount of diluent. It was diluted with 0.8ml of Nacl instead of 1.8ml.
Narrative:  Patient received COVID-19 boost dose 12/6/2021. Patient  with positive COVID test 12/12/2021. Patient remain inpatient from 12/12/2021 until his death on 12/22/2021.
A report has been received from a Health Professional concerning a child, subject of unknown gender, who had been receiving FLUMIST. The patient's concurrent disease(s) included Asthma and Bronchospasm. FLUMIST started on an unknown date. The patient experienced Pneumonia. The outcome of the event of Pneumonia is unknown. The report was considered to be non-serious.
24 weeks pregnant at time of 2nd shot. Shot given at 1430 on 1/27 in left deltoid. Felt great rest of day. @0500 on 1/28 woke up shivering uncontrollably. Mild fever of 100.5(highest recorded during this whole episode). Body aches, chills, sweats, headache rest of day. 1000 mg Tylenol helped with fever/chills but headache progressed to migraine w/nausea. Took 50 mg sumatriptan and 25 mg doxylamine in evening and this seemed to help with headache and allow me to get to sleep 1/28.  Woke up at 0300 1/29 with chills/cold sweats. Took 1000 mg Tylenol again (didn't check temp) and went back to sleep. Woke up at 0530 for work - checked temp since I'm a healthcare worker and it was 100.4 (with tylenol). Waited until clinic opened up and called them at 0700 for recommendations on going to work or not (temp by then was 99.8, with tylenol). Was advised to stay home and if febrile tomorrow to get COVID tested on 1/30. As of right now (1300 on 1/29) headache has returned but mild. Body aches still. Temp 99.4 w/tylenol redosed at 1000.
Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; first dose on 26jan2021 second dose on 12feb2021; This is a spontaneous report from a contactable consumer. This is a report 3 of 37, reports on a 57-years-old female. The report is cross referenced to report ID: E4LNU061. A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN5318), via an unspecified route of administration on 26Jan2021 as dose 1, single, and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9266) via an unspecified route of administration on 12Feb2021 as dose 2, single for covid-19 immunization. Medical history included ongoing fibromyalgia. The patient's concomitant medications were not reported. Unknown other Products. Unknown height and weight. Assistant Director of Health (non-HC) calling today from a withheld Health Department. She stated they are monitoring and tracking the vaccine breakthrough cases in their area and she had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. The caller at the time, did not have the NDC or expiration date, however, was going to work on pulling patient information so that she would be able to have this information available to provide to DSU upon transfer. Caller stated, reclarified later in report, she had 37 patients with partial identifiers. Caller stated she could not provide some identifying details and that she would need to check with her legal department first. On 10Mar2021, caller stated that covid positive was defined as having both vaccines first dose on 26jan2021, second dose on 12feb2021 (inappropriate schedule of vaccine administration) and testing positive for Covid longer than two weeks after both doses (drug ineffective). Caller stated unknown or could not provide to other questions. Caller reported 37 breakthrough cases, for fully vaccinated patients testing positive for Covid. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 10Mar2021. The consumer reported seriousness as no. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/ drug/ event for different patients
Patient received Booster and flu shot by Pharmacist. After the shot, patient was then told to stay for monitoring. within minutes, patient started to have reaction to where she stated that her throat is closing and then her speak were very faint. resident was then given epi pen, 911 was called. oxygen stayed above 90%. 911 arrived and assessed her. Patient was then taken to local facility for further evaluation.
Hives, swelling and throbbing pain extending from the wrist to the collar bone and back of the neck on right side.  Arm was extremely sensitive to the touch and experienced deep muscle pain making use of arm or raising arm painful and difficult for 5 days.
27 days post 2nd and two months post 1st dose of vaccine, the pt experienced itching and rash of the hands (a glove-like effect to wrist) and swelling of lips. He was treated with Allegra and Hydrocortisone.  The most recent information received on 8/20/99 reports the condition of the pt is ongoing.
Patient received MMR 12-5-11. Returned to clinic 12-15-11 reporting fever day # 8 post vaccine then rash appeared 12-15-11 (2 days post rash).
This spontaneous report was received from a pharmacist referring to a 60 year old female patient. The patient's concurrent and historical conditions included an unspecified reaction to morphine. On 04-NOV-2015 the patient was vaccinated with ZOSTAVAX (Lot # L029480, expiration date 16-MAR-2016) dose was unknown, subcutaneous on an unknown anatomical location for prevention of shingles. The patient's concomitant medication was not reported. On an unknown date (also reported as "right after" receiving the vaccine), the patient experienced itching and a knot at the injection site which lasted for weeks. It was reported that the patient stated that 6 age spots (senilo lentigo) on an unspecified area of her body were "itchy" on an unspecified date and 1 or 2 of these spots were located at the injection site, these spots looked like "tiny cluster of warts", a different one of these spots were under the patient's bra strap and bled. The patient sought additional medical attention at an unspecified physician's office where the patient had this particular spot under her bra strap removed on an unspecified date. At the time of the report, the outcome of injection site pruritus, injection site nodule, injection site discolouration, solar lentigo, skin papilloma and pruritus was reported as not recovered/not resolved. The outcome of skin haemorrhage was recovered/resolved. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of back pain (with radiation) in a 58-year-old female patient who received TWINRIX adult (batch number B457F, expiry date 25th September 2015). On 7th September 2015, the patient received the 1st dose of TWINRIX adult .5 ml. On 23rd September 2015, 16 days after receiving TWINRIX adult, the patient experienced back pain (with radiation). On an unknown date, the outcome of the back pain (with radiation) was not recovered/not resolved. It was unknown if the reporter considered the back pain (with radiation) to be related to TWINRIX adult. Additional details were provided as follows: This case was reported to a doctor. The reported injection site was right deltoid. The patient experienced pain in her side that moved to her back after receiving 1st dose of TWINRIX adult. For tolerance to 2nd vaccination, refer case US2015GSK152583.
Skin rash; This spontaneous report was received from a physician via medical records and refers to a currently 74-year-old female patient. Information about the patient's concurrent conditions, medical history, concomitant medications were not provided.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (manufacturer unknown) for prophylaxis (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not reported).  On an unknown date, the patient experienced an allergy reaction reported as skin rash (rash). The patient subsequently experienced herpes zoster, postherpetic neuralgia and other events while on therapy with zoster vaccine live (ZOSTAVAX) (case # 1904USA006786, case was part of a litigation process).  The outcome of rash was unknown.     The reporter considered rash to be related to varicella virus vaccine live (manufacturer unknown).     All available medical records will be provided upon request.; Sender's Comments:  US-009507513-1904USA006786:
patient has failed to come in within the 42 day window for the second dose.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has failed to come in within the 42 day window for the second dose.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has failed to come in within the 42 day window for the second dose.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has failed to come in within the 42 day window for the second dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were reported.
Hives on face, back, legs, and arms. Intense itching, fever of 102 F, swelling of face. Medicated with OTC benadryl, tylenol, and prescribed oral steroids. Reaction worsened causing fluid filled blisters, mottling, and bruising/swelling on legs and arms. Reaction lasted approximately eight days.
left shoulder welt initially, severe pain x 2 wks leading to urgent care visit; left shoulder range of motion decreased x 4+ months
Pt. developed a spotty red rash on the  upper arm and neck on the left arm.It was not itchy or sore, just the red circular spots. He said it developed on 5/21/21, after receiving the vaccine on 5/19.  Pt. bought diphenhydramine capsules to see if they would help with the rash. I asked him to check back with us to let us know if the rash clears up or not.
Rash on torso, appeared 2 days after flu vaccine (High-Dose). Took a BENADRYL, and rash resolved 2 days later. No itch.