chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had both shots and shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient had both shots about two years before day of reporting and had a mild case of shingles this past spring. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation was unknown at the time of reporting. The follow up was not required.
,body aches,shortness of breath,pain and fog in brain, entire bone and joints shooting with pain couldn't sleep for,2 days, dizziness,etc etc
On 3/1/21, about 10 AM, I found a new pink oval spot on Left deltoid, about 2 1/2 in tall, 2 in wide.  Pink color,  firm and slightly warm, mildly tender, some rash spots above it.  Edges not raised.  Blanched in center with pressure.  Exactly 2 weeks after 1st dose Moderna vaccine.    No systemic symptoms at this time.     Prior to this:  On the day following 1st dose, the injection site became tender and sore, no change in skin color then, but some induration and was particularly sore when I raised my arm above my head.  That Lasted about 3 days, and has been completely resolved.   On the 3rd and 4th day post vaccination, I had mild fatigue and napped each of those days (very unusual for me).   Otherwise I have had nothing else from vaccination.      I took picture this morning, but do not know how to attach it.
Received shots approx 2:30pm-given Tylenol .8cc prior to shots. 6:45pm playing ok-suddenly started to cry, scream, stiffen legs, eyes seemed glazed, unable to focus, pasty, pale, crying continued for 1/2 hr, went to sleep and could not wake up-paramedics called-ER; monitored and released after few hrs.
smallpox vaccine 4/29/04, site examination on day 7, major rx; on day 8 returned to clinic with large erythematous area surrounding pustule approx 4" diameter warm tender. No LA, no satellite, a son rx'd with Tequin 400x 5d- resolution.
Breakthrough COVID infection; Breakthrough COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Breakthrough COVID infection".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Reporting side effects for Moderna COVID-19:first injection March 2. No effects. Second injection Tuesday, March 30: Wednesday- fatigue, muscle weakness and tender injection site; Thursday: cancelled appointments due to serious muscle weakness with pain and recurring strong headache; Friday: fatigue with weakness, hard, hot, painful, reddened area at injection site, occasional headache, episodes of nausea; Saturday: itching reddened injection site ( approx. 3"x2"), leg muscles very weak, general malaise; Sunday: itching light reddened injection site (all day), extreme muscle weakness with significant pain, swelling of lips and glands under jaw bone (11 pm), Monday, April 5: all effects subsiding; Tuesday (today): beginning to feel more like myself.
The patient complained of feeling dizzy about 2 minutes after receiving the vaccine. He sat down and immediately fainted. I caught him and placed him on the floor with his head clear of the wall and the table and chairs in the room. At this point, his arms were tensed up, his wrists were bent inward, and his body was slightly shaking. I called out for help and went to get a wet paper towel. As another pharmacist arrived on the scene, he gained consciousness (he was out for about 30 seconds). A few minutes later, he sat up and was extremely pale. The EMTs were called while he was unconscious, and they arrived and took his vitals. His blood pressure was about 110/70 mmHg and his pulse was 30 BPM.  He again laid down, as he was dizzy again. He did not want to ride in the ambulance, and asked me to call his mother to bring him to the emergency department.
patient fainted after the vaccine administration, within 5 min, patient experienced temporary black out of vision, tingling in the hands and feet, patient came to quickly, was checked out by emergency personal, blood pressure 128/68
Rash on shoulder, upper back, upper chest about 1 hour after injection. Dexamethasone 4 mg and KENALOG 40mg, BENADRYL 25mg.
Developed sore, red  bumps  under both arms (armpits).  Felt feverish and achy too.  Six days after second shot.
I haven't gotten the second dose yet; I was waking up in the middle of the night, having that pinching; sharp pains, like somebody was actually pinching me; It was only in my right leg from ankle area to calf/I would be walking and then I would feel like somebody was stabbing; It was almost like a stab around my ankle area, I would be walking and then I would feel like somebody was stabbing; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (I was waking up in the middle of the night, having that pinching), PAIN (sharp pains, like somebody was actually pinching me), PAIN IN EXTREMITY (It was only in my right leg from ankle area to calf/I would be walking and then I would feel like somebody was stabbing), ARTHRALGIA (It was almost like a stab around my ankle area, I would be walking and then I would feel like somebody was stabbing) and PRODUCT DOSE OMISSION ISSUE (I haven't gotten the second dose yet) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was provided by the reporter.  Concomitant products included GABAPENTIN for an unknown indication.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced INSOMNIA (I was waking up in the middle of the night, having that pinching), PAIN (sharp pains, like somebody was actually pinching me), PAIN IN EXTREMITY (It was only in my right leg from ankle area to calf/I would be walking and then I would feel like somebody was stabbing) and ARTHRALGIA (It was almost like a stab around my ankle area, I would be walking and then I would feel like somebody was stabbing). On 20-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I haven't gotten the second dose yet). On 20-Aug-2021, PRODUCT DOSE OMISSION ISSUE (I haven't gotten the second dose yet) had resolved. At the time of the report, INSOMNIA (I was waking up in the middle of the night, having that pinching), PAIN (sharp pains, like somebody was actually pinching me), PAIN IN EXTREMITY (It was only in my right leg from ankle area to calf/I would be walking and then I would feel like somebody was stabbing) and ARTHRALGIA (It was almost like a stab around my ankle area, I would be walking and then I would feel like somebody was stabbing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Patient fell backwards out of chair 3min after administration (later noted was lightheaded right before collapse). Unresponsive, seizure-like behavior initially. EMS administered epinephrine 0.3mg autoinjector into left thigh. By 3:15pm (5min after collapse, 8min after vaccine administration), patient was responsive. Patient eating snack bar by 3:34pm. Patient notes he has exhibited this behavior before with other vaccines and worksite wellness blood draws. Clinic nurse noted patient did not collapse until watching neighbor coworker receive vaccine. Co-workers noted this is a behavior they have witnessed him exhibiting before. Patient called and requested boost dose scheduling the following week; recommended he receive it in a healthcare setting and coordinated local hospital distribution for an appointment.
Myalgia, Fever, chills, temp 38.4, pain at injection site, worse w/ movement Narrative:  Other Relevant History:
No bowel movement; Was awake every hour/Couldn't go back to sleep/ Was awake every 30 minutes; Headache; Fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Was awake every hour/Couldn't go back to sleep/ Was awake every 30 minutes), BOWEL MOVEMENT IRREGULARITY (No bowel movement), HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Body aches) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069H21A and 033F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Body aches). On 28-Dec-2021, the patient experienced SLEEP DISORDER (Was awake every hour/Couldn't go back to sleep/ Was awake every 30 minutes). On 29-Dec-2021, the patient experienced BOWEL MOVEMENT IRREGULARITY (No bowel movement). At the time of the report, SLEEP DISORDER (Was awake every hour/Couldn't go back to sleep/ Was awake every 30 minutes), BOWEL MOVEMENT IRREGULARITY (No bowel movement), HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Patient hasn't tried any medication to alleviate the symptoms.
About 13 hours after receiving the vaccine I experienced excruciating body aches both muscular and skeletal throughout my body.  I have never been in such pain before.  I took 2 ibuprofen immediately upon being awakened by the pain.   The episode last 2 hours.  I also became quite nauseous during the latter part of the 2 hours.  I experienced a brief but intense headache during the episode.  After that I had intermittent intense pain at sites on my body where I have had injuries in the past year (right shoulder, right foot/ankle, and left elbow tendon.  Also, throughout the night I had multiple occurrences of what I deemed extra heart beats.   I had extreme dry mouth and periods of feeling hot and cold.  FYI, after first shot I had what has been described as "covid arm."
Indurated skin, red, swollen area 4 cm x 5 cm, in left upper arm, area (initially it was "bumpy" as well).
Pt recvd 1st dose of Engerix-B 22APR91; 23APR91 pt exp fever 100, nausea, vomiting & swelling in opposite armpit; No treatment given; events resolved;
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. Information about pertinent medical history, concurrent conditions, concomitant medication, and drug reactions/allergies was not provided. From 12-DEC-2018 to 08-JAN-2019, the patients were administered improperly stored doses of ROTATEQ (lot #: R021055, expiration date: 01-APR-2020, temperature: 32 fahrenheit up to 35 fahrenheit (33.9 fahrenheit), time frame: 7 hours; strength, dose, and frequency were not reported) orally, for prophylaxis. No adverse effects reported. There was no previous temperature excursion. The data logger was included.
Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her a 10 year old daughter who experienced fever (101 deg F), felt achy and runny nose.  At 10 years of age, the pt received a dose on 12/08/03.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/08/03.  Dose regimen was 1 dose 1 time per day (IN).  Pt was not taking concomitant therapy.  On 12/10/03, the pt woke up with a fever (101 deg F).  She also felt achy and had a runny nose all day.  She was treated with Tamiflu, which she took one dose of, and Vantin.  The mother reported that as of 12/11/03, her daughter felt better, and her temperature was 99 deg F.  No additional information was available at the date of this report.
Booster on 10/22/21. On 10/24/21 my blood pressure elevated to 191/100- and lower legs has 2+ pitting edema. I have B/P meds to take as needed. This was a Sunday and then Monday called my cardiologist. Placed on Lasix (water pill) and bed rest. apt made for angiogram and cat scan. Extreme fatigue Brain Fog
Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of Shingrix. On 24th September 2020, 2 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with 1st dose of Shingrix and experinced side effcts. The patient had fever after vaccination. The patient was inquired about 2nd dose.
Can not lift his arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can not lift his arm) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can not lift his arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can not lift his arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Mom describes patient having eye blinking the day after receiving the Hep A vaccination. Symptoms are still present per mom, but are improving.
Pt. states on the way home his ears turned bright red and itching,  hands, legs and face started itching.  He did state that he had chest pain and contributed the chest pain to anxiety.  Pt. called  and advised Pt. to take Benadryl and if he get worst to contact the EMS and seek medical attention.  Pt. did go home and took Benadryl for the itching.   07/29/2021 @ 0835: Telephone call to follow up with Pt. this morning he states that he is better, no shortness of breath.   Pt. voice over the telephone was calm and speech is clear.  Pt. states he is not planning to get his 2nd vaccine.  Pt. advised to contact his medical provider for guidance for 2nd vaccine,  Pt. agrees.
experiencing severe symptoms after her second Gardasil vaccine; from feeling miserable to feeling great; a case when homeopathic # Gardasil (highly diluted homeopathic remedy made of the vaccine); This spontaneous report as received from a reporter refers to a female patient of unknown age. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with dose 1 of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and also on an unknown date, the patient was vaccinated with dose 2 of the vaccine (dose, route of administration, lot number and expiration date were not reported for both doses).  On an unknown date, after her second quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) dose, the patient experienced severe symptoms. On an unknown date, she received quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) reported as homeopathic remedy made of the vaccine (dose, route of administration, lot number and expiration date were not reported). The patient was also treated with other remedies (unspecified) for the side effects of the vaccine. It was reported that on an unknown day, she went from feeling miserable to feeling great (feeling abnormal). The outcome of events was unknown.  The reporter considered severe symptoms to be related to the vaccine. The relatedness of feeling abnormal was unknown.
Patient has received an extra dose of Twinrix. No adverse reaction had been reported just yet. Awaiting response from patient.
Breakthrough case admission after 3 vaccines Pfizer 3/23/21 Lot# ER8733;  Pfizer 4/13/21 Lot# EW0158;  Pfizer 12/28/21 Lot# FE3594
9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date; No adverse event; 9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date), PRODUCT STORAGE ERROR (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date), PRODUCT STORAGE ERROR (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date) and PRODUCT STORAGE ERROR (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date).    No concomitant medication was reported.  It was unknown if any other vaccines in the 4 weeks prior to COVID-19 vaccine was received.  9 patients received doses of the Moderna COVID-19 vaccine bivalent after its beyond use date lot AS7168B.  On 14-Dec-2022, the vial was initially stored in the fridge.  Pharmacist would like to be advised about the stability information, validity of the doses and if the patients should be revaccinated.  Vials was of size 2.5ml which did not undergo any temperature excursions.  This case contains information for the 7th of 9 patients described by the reporter.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704964 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704964:Master case - 1st adult patient (vaccine start date: 13-Jan-2023)
Patient received Janssen COVID 19 vaccine on 04/07/21 at another location.  She presented to  ED on 04/19/21 and was seen by Dr where she was diagnosed with a DVT in her left leg. She was started on Eliquis.  She saw Dr on 04/26/21 and doctor on 05/03/21 for follow ups. Still showing signs of cramping and "charlie horse" like symptoms in the leg at follow up.
no previous history of covid and was fully vaccinated being very sick due to the delta variant; no previous history of covid and was fully vaccinated being very sick due to the delta variant; This is a spontaneous report from a contactable consumer from a Pfizer- Sponsored Program Regulatory Authority, reporting same event under the same suspect product for eight patients. This is one of eight reports. A patient of unspecified age and gender received BNT162B2 (Batch/Lot number was not reported), dose 1 and dose 2, both via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient with no previous history of covid and was fully vaccinated being very sick due to the delta variant. The outcome of event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101042702 same reporter/SD/AE, different patient
Headache, Myalgia, NauseaVomiting, C/O light headness,felt hot,fatigue,chills,neck achy,injection site pain,swelling and warmth. Told to follow up with primary care doctor Narrative:
Initial misuse case was received from a healthcare professional on 17 DEC 2013. Cases were received on 21 March 2014 at the agency. A patient whose demographic details, medical history and concomitant medication were not reported received a dose of FLUZONE QIV on unspecified date. (Route, site, dose and batch number not reported). It was reported that on an unspecified date patient had administered vaccine the gluteal as an incorrect site of administration. No adverse event was reported. List of documents held by sender: none.
Teen boy received Pfizer Dose #2 on 4/25/21.    In early June, 2021 he began to have symptoms of polyuria, polydipsia, weight loss, fatigue.  He presented to my office on Friday, July 2, 2021.
9/22/21- I SPOKE TO PATIENT BY PHONE. PATIENT RECEIVED JANSSEN COVID-19 VACCINE 7/20/21AND HAD NO PAIN IN ARM FOR 2 DAYS. THEN 2 DAYS AFTER THE SHOT SHE BEGAN TO FEEL PAIN IN SHOULDER "ABOVE THE AREA WHERE SHE GOT THE SHOT". SHE CALLED IT A VACCINE RELATED BURSITIS PER HER DOCTOR. SHE SAID SHE SPOKE WITH HER DR AND THE DR ORDERED AN MRI OF HER SHOULD WHICH WILL BE ABOUT 2 WEEKS FROM TODAY, AND WAS REFERRED TO AN ORTHOPEDIC DOCTOR  (WHOM SHE SAID SHE HASNT SEEN YET.
patient reports feeling lightheaded and sleepy after vaccination.  Patient reports on 3L of continues oxygen but left oxygen at home.  Patient started on 3L of O2, patient felt immediate relief.
Swollen arm, hot to the touch, head aches, body aches, and pain. Took ibuprofen and iced the area. She is better.
Felt fine after getting the vaccine, and the day after but on 5/21/2012 patient reports vomiting, fever, chills, shaking sores on tongue, tight throat, headaches, swollen feet. Reports feeling better on 5/23/12 then vomiting again on 5/24/12 which prompted a doctors visit.