chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced fever, diarrhea and adverse reaction. The patient was treated with Ice Pack. On an unknown date, the outcome of the fever and adverse reaction were recovered/resolved and the outcome of the diarrhea was recovering/resolving. It was unknown if the reporter considered the fever, diarrhea and adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a temperature of 102 the first night and another spike in fever the next day. The arm reaction was acute. The treatment required icing for three days and a total of six days to fully resolve. The patient experienced acute, violent diarrhea which did not fully resolve for a week. The patient had some abnormal blood chemistries 10 days after the vaccine was administered.
Pt recvd vax in 1988 & became jaundiced & was seen by MD & dx w/acute hepatitis B; hepatitis profile was positive;
12.45 hours after 2nd dose: fever, chills, shaking, joint pain, HA, lethargy, tired; Symptoms lasted 2-3 days, but the following symptoms are still present (10 Days post 2nd dose):  HA, lethargy, fogginess and tiredness
left sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left sore arm) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 05ZE21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced VACCINATION SITE PAIN (left sore arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of 2 dosage form. At the time of the report, VACCINATION SITE PAIN (left sore arm) outcome was unknown.            The concomitant medications information was not reported. The patient had no known allergies.
Information has been received from a 68-year-old female with a sulfonamide allergy and no pertinent medical history, who in October 2007 ("towards the end of October"), was vaccinated subcutaneous once with a 0.65 ml dose of ZOSTAVAX. Concomitant therapy included HCTZ and DILTIAZEM XR. In October 2007 ("towards the end of October"), the patient stated "she is still sore at the injection site". The patient also stated that she developed bronchitis "shortly after receiving the shot". She has also developed muscle pain, "can't event walk", and "can't even bend my fingers". She also has pain in her feet and "even my fingernails hurt". The patient did not seek medical attention. No diagnostic labs were performed. The patient started taking LYRICA 6 days ago and it "seems to help the pain". At the time of the report the patient's status was recovering. A product quality complaint was not involved. Follow-up information received 04-FEB-2008 via a phone call with a physician. The physician reported that the patient did not call the office to report these adverse events. He stated he would follow-up with the patient on the reported adverse events. Follow-up received 25-FEB-2008 from the consumer: The patient stated "I have been feeling like I have pins and needles in my hands and feet". "I Have a hard time getting up and walking after sitting, and I Have had two major falls where I had to go to get x-rays. I have gained 13 pounds". She also stated that her physician did "bloodwork" but she "didn't know what he was looking for". Her physician referred her to a neurologist because of "severe pain" who performed an MRI and checked her for lupus, lyme disease, and B-12 deficiencies. All the tests came back negative. The patient is currently taking CELEBREX and NAPROXEN and switched from LYRICA to GABARONE. The patient also stated  about two weeks post vaccination, her finger nails got paper thin and started "feeling". Her hands and feet got numb and her tongue is numb too. She said it "feels like the end of my tongue is burned". The patient was also vaccinated with influenza virus vaccine (unspecified) the same day she received ZOSTAVAX. Additional information has been requested.
I'm Guessing  the dose # was how many vaccinations i've had? It all started after the booster! Cough and sinus drainage that is still on going! My wife has same problem after her booster!
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 and expiry: Unknown) dose was not reported, 1 total, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, Laboratory data included: Body temperature (NR: not provided) 97.6 range, and Oxygen saturation (NR: not provided) 97/98. On 11-AUG-2021, the patient began to show symptoms of Covid19 which includes scratchy throat, runny nose, cough, loss of taste/smell (suspected covid-19 infection) and tested positive on 16-AUG-2021 (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191110. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified. Based on the evaluation/investigation performed.  Additional information received on 27-AUG-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: Version created to update additional information received. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result. This update does not alter the prior causality assessment of previously reported events.  20210855251-COVID-19 VACCINE AD26.COV2.S-Suspected 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
Mom reports worsening of IBS symptoms, onset of worse migraine, and onset of worsening Menstrual symptoms since vaccination of second Moderna covid immunization
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. It was also reported that patient was not pregnant at the time of the report. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot# were not reported). No concomitant medications were reported. The pharmacist reported that subsequently after the administration of the vaccine, couple of weeks later (dates unspecified) she went to the hospital (unspecified name and location). It was reported that she was diagnosed with a case of shingles. The outcome of shingles was unknown. The reported event shingles was considered to be serious due to hospitalization. Additional information has been requested.
C/o (L) arm felt red and warm to touch. Bright red macular blotches on chest and face. Denies itching of throat, no swelling. Given Benadryl 50mg IM (R) arm. BP 120/72 P100. Monitored Q 15 min.
Delayed injection site reaction: 7 days later redness, warmth, soreness and induration at and  just below site, approximately 6x4cm by 9th day after injection.
Continuous arm/muscle pain beggining from injection site to upper left shoulder.  Can no longer fully lift or hold heavy items with left arm painlessly.  Pain is throbbing and worse at night making it difficult to sleep. Anti-inflammatory over the counter medicine, salon pass and lidocaine rubs do not help with pain.
0950 Pt c/o redness and itching to left posterior ear. Stated she self administered 50mg of Bendaryl at 0900 prior to vaccine and an additional 25mg while being monitored in the waiting room.   0958 Pt c/o continual itching. Pharmacy Supervisor notified. Pharmacy Supervisor escorted Pt to ED for further evaluation.
pt recv vax & exp nausea & shakiness approx 15min later;epi given;taken to amb per stretcher by paramedics;
hives to scalp, neck & eyes;muscle aches in extremities & torso;swelling of eyes & lips;initial series in 1991, booster 93;had hives p/1st booster but did not tell anyone;tx w/pred & DPH;
The patient notice his left hand start itching which was follow by appearance of an elevated red skin lesion, this eruption continued until both arms and neck were affected. No treatment was giving at that time.
After about 3 days of flu like symptoms the flue like symptoms began to decline however late in the night, roughly 2am  wednesday night/thursday morning, I woke up with a high pitched squealing in my left ear.  The pitch started at 9,000Hz.  After about 2 weeks I saw my family physician where I was prescribed corticosteroids orally.  That slightly diminished the high pitch and changed it to more of a oscillating frequency however once one the steroids were complete the pitch continued to get worse and back to original levels.  I went back again about 4 weeks later and was prescribed a second dose.  Same outcome occurred.  I then went to a ENT and was prescribed a different corticosteroid and again same outcome occurred.  The frequency is so bad I can't sleep, read, and can barely do my job.  Besides the tinnitus their is consistent pressure on my left ear and ear popping every time I swallow.  I have taken Zyrtec-D however this only mildly works for the pressure.  Although the pressure is consistently there it varies in intensity.  This has been one of the worse experiences of my life and I hope the matter is taken seriously as both physicians correlate the occurrence with the vaccine but are unsure why it's happening.
Very vivid and lucid dreams that I can remember even a day or 2 after. They have been happening most nights ever since I received the vaccine
Every time I take a sip of a drink my lips get a sense of pins and needles. Also, every time I move from a different position, for example, from seated to standing, or or seated to laying down, I get pins and needles in my left arm and in my legs for about a minute. It seems as though my body needs a minute to realize it moved. Once my body is used to that position (normally about a minute or less) that sensation goes away.
Injection Site Pain, Swelling (3x the normal size) rash and itching, warmth and redness of the entire arm
Eight (8) inflamed, itchy, painful blisters at / near vaccine injection site with single lesions /blisters breaking out between 8/14/2014 & 8/18/2014 on back, buttocks, lower leg, breast, & labia majora. As of 8/18/2014, these lesions have not resolved, but they are less itchy with each passing day. No treatment was used.
VERY DEPRESSED; SLEEPING A LOT; MIGRAINE; SORED ARM, PAIN IN ARM; NAUSEA; WEIRD HEART BEAT; EXTREMELY TIRED; GI ISSUES; VOMIT; DIARRHEA; EXTREMELY DIZZY; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at time of reporting. the patient also stated that she had underlying condition.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered in left arm on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced weird heart beat. On 13-MAR-2021, the subject experienced extremely tired. On 13-MAR-2021, the subject experienced gi issues. On 13-MAR-2021, the subject experienced vomit. On 13-MAR-2021, the subject experienced diarrhea. On 13-MAR-2021, the subject experienced extremely dizzy. On 13-MAR-2021, the subject experienced migraine. On 13-MAR-2021, the subject experienced sored arm, pain in arm. On 13-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced very depressed. On 14-MAR-2021, the subject experienced sleeping a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird heart beat on 13-MAR-2021, and gi issues, vomit, extremely dizzy, and nausea, had not recovered from extremely tired, very depressed, sleeping a lot, migraine, and sored arm, pain in arm, and the outcome of diarrhea was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
like vomiting and diarrhea after the second dose of vaccination; like vomiting and diarrhea after the second dose of vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 38 year-old male patient received bnt162b2 (BNT162B2), administration date 12May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 15Apr2021, for Covid-19 Immunization, reaction(s): "Throwing up"; Bnt162b2 (Dose 1), administration date: 15Apr2021, for Covid-19 immunization, reaction(s): "Diarrhea", "he got really sick". The following information was reported: DIARRHOEA (non-serious) with onset 2021, outcome "unknown", VOMITING (non-serious), outcome "unknown" and all described as "like vomiting and diarrhea after the second dose of vaccination". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My son had what I believe to be a seizure on the day after he received a flu shot. He fell out of his chair (as if something had scared him) and he started to convulse on the floor for about ten seconds and then stood up, sat down and continued to play while his body was stiff and still jerking a bit.
vertigo; dizzy; skin becomes hot to the touch; super light-headed; super light-headed; Body aches; chills/shivering; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), DIZZINESS (dizzy), SKIN WARM (skin becomes hot to the touch), the first episode of DIZZINESS (super light-headed) and the second episode of DIZZINESS (super light-headed) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (chills/shivering). On 05-Mar-2021, the patient experienced MYALGIA (Body aches). On 06-Mar-2021, the patient experienced VERTIGO (vertigo), DIZZINESS (dizzy), SKIN WARM (skin becomes hot to the touch), the first episode of DIZZINESS (super light-headed) and the second episode of DIZZINESS (super light-headed). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VERTIGO (vertigo), DIZZINESS (dizzy), SKIN WARM (skin becomes hot to the touch), the last episode of DIZZINESS (super light-headed), MYALGIA (Body aches) and CHILLS (chills/shivering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Within the first hour, elevated blood pressure. Elevated glucose, headache, nausea, dizziness, difficulty catching breath, overheating from shoulders up, extreme thirst and blurry vision. Throughout the same day, continued headache, swollen face, nausea, dizziness, elevated glucose, warmth on spine, weak, kidney pain, back pain, tired and blurred vision. Next couple of days, same as above including brain fog and swelling of all 4 limbs (feet and hands). Continued highly elevated glucose above 400 for fasting reading. After 3rd day, I felt a little better but continued swelling. Still elevated glucose, pain all over body, swelling of joints, pain in joints, could think a bit better, but overall ill feeling. 1-2 weeks after, continued swelling, pain in joints, headache and continued elevated glucose.
Lethargic; Weak; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), ASTHENIA (Weak) and FATIGUE (Tiredness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included Flu vaccination (she has reacting to flu vaccine). Concurrent medical conditions included Chronic kidney disease (she was born with only one functioning kidney). Concomitant products included ATORVASTATIN for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced LETHARGY (Lethargic), ASTHENIA (Weak) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Mar-2021, LETHARGY (Lethargic), ASTHENIA (Weak) and FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treat   This case was linked to MOD-2021-090383 (Patient Link).
red around injection site tenderness, itches; Red around injection site tenderness, itches; Red around injection site tenderness, itches; This is a spontaneous report from a contactable consumer (the patient). A 82-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number was not reported) via an unspecified route of administration in left arm on 03Mar2021 12:45 as second dose, single for COVID-19 immunization in hospital. Medical history included high blood pressure, atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medications were not reported. Patient previously took sulfa, keflexIlosone, penicillin and tetanus experienced events drug allergy. Patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number was not reported) via an unspecified route of administration on an unknown date as first dose, single dose for COVID-19 immunization. The patient receive other regular medications in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Mar2021 at 00:45, the patient experienced red around injection site tenderness, itches. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at a clinic for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Pt fussy & cranky 10-12 days /p vax.No fever.Then several episodes of vomiting.18 days /p vax suffered 1st seizure(petit mal)to hosp.Admitted 1Mar-4Mar91,MRI-abnormality of brain-pt suffered stroke in utero "something" precipated seizures.
After the vaccine adminstration patient felt general tiredness and soreness. They noticed redness around the injection site as well which spread further down the arm in the following days. Patient stated that the redness felt warm to the touch. Patient was advised to seek immediate medical attention.
Rash that started as two spots /  the rash had become larger; Pain; Swelling; has had to remain on her couch since the injection; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st September 2020, immediately after receiving Shingrix, the patient experienced pain, swelling and mobility decreased. On 4th September 2020, the patient experienced rash. On an unknown date, the outcome of the pain and swelling were recovered/resolved and the outcome of the mobility decreased was unknown and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the pain, swelling, mobility decreased and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine in the left arm and experienced pain and swelling that was so severe that she had to remain on her couch since the injection. The patient noticed a rash that started as two spots that were the size of a nickle and rash had became larger and she continued to have pain and swelling. The pain and swelling had improved. All information was not available. The reporter did not consent to follow-up.
When I woke up in the morning I had a sore throat. I then developed a lot of post-nasal drip which in turn caused a cough, chills and fever 99.9 degrees after I had already taken TYLENOL. I slept all day the 20th and 21st and after taking, PAXLOVID I started to feel better. By Christmas Eve I was feeling a lot better. I then rebound on the 29th and 30th, I only had pounding throbbing headache and a little congestion and cough. I am still continuing to recover.