chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a female patient of unknown age reporting on herself. Information regarding drug reactions or allergies and medical history was not reported. In 2009 (exact dates not reported) the patient was vaccinated with ZOSTAVAX (dose, anatomical location, route of administration, lot#, expiration date were not reported). Concomitant medications were not reported. The patient reported that, on unknown date, she thought she might have had an outbreak of a mild case of shingles after being vaccinated with ZOSTAVAX. The only thing the patient mentioned was a possible rash. The outcome of the events was not reported. The relatedness between the therapy with ZOSTAVAX and the events was not reported. No other information was provided before the patient disconnected the call. Additional information is not expected because there was no patient's and physician's contact details provided.
1-Pain at site of injection. 2-Pain and redness about 3" under the injection site 3-about 2' diameter of redness 3" under the injection site. 4- Dr diagnosed it as staph infection as patient had staph infections before,. 5- Dr informed the patient that the infection was because of the injection. 6- Dr prescribed Bactrim DS (take one tablet twice daily for 10 days)
4 days after MMR was given, mom reports she markedly regressed with her autism.  She lost language, she's flapping her hands, she's miserable.  Mom reports she's gone from "high functioning" to "low functioning again."
I began experiencing sharp, stabbing chest pains the day after my vaccination.  No OTC treatment was effective, so I consulted my primary care physician the following day, 9/26/22..  He described my symptoms as a likely reaction to the vaccine.
Reports developed sharp pain at collarbone region.  States was constant yesterday but today is only when laughs or takes a deep breath.
change in menstrual cycle of about a week; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (change in menstrual cycle of about a week) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced MENSTRUATION IRREGULAR (change in menstrual cycle of about a week). At the time of the report, MENSTRUATION IRREGULAR (change in menstrual cycle of about a week) outcome was unknown. Not Provided
Visual disturbance; Blocked out partial vision; Large moving floating/glare in left visual field.; This is a spontaneous report from a contactable nurse, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 01Apr2021 at 15:15 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01Apr2021 at 20:30, the patient experienced visual disturbance, six hours post vaccination, large moving floating/glare in left visual field which lasted 15-20 minutes. The patient was also unable to focus and had blocked out partial vision in only left peripheral field. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for visual disturbance, partial visual loss and glare. The clinical outcome of the event visual disturbance and glare were resolved on 01Apr2021, while that of the event partial visual loss was resolved 1n Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever, body aches, shivers, drowsy, swollen lymph node (painful)
Shortness of Breath; Shaking; Sweating; Numbness in Arms and Legs; Cold; Became bed ridden; Low Fever; Felt very fatigued; Chills; Cough; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath), TREMOR (Shaking), HYPERHIDROSIS (Sweating), HYPOAESTHESIA (Numbness in Arms and Legs) and COUGH (Cough) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A211A and DO1AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included MELATONIN from 01-Feb-2018 to an unknown date for Sleep disorder.   On 26-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COUGH (Cough). On 27-Mar-2021, the patient experienced DYSPNOEA (Shortness of Breath), TREMOR (Shaking), HYPERHIDROSIS (Sweating), HYPOAESTHESIA (Numbness in Arms and Legs), NASOPHARYNGITIS (Cold), BEDRIDDEN (Became bed ridden), PYREXIA (Low Fever), FATIGUE (Felt very fatigued) and CHILLS (Chills). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at a dose of 1 dosage form. On 29-Mar-2021, TREMOR (Shaking), HYPERHIDROSIS (Sweating) and HYPOAESTHESIA (Numbness in Arms and Legs) had resolved. On 28-Apr-2021, DYSPNOEA (Shortness of Breath) had resolved. At the time of the report, COUGH (Cough), NASOPHARYNGITIS (Cold), BEDRIDDEN (Became bed ridden), PYREXIA (Low Fever), FATIGUE (Felt very fatigued) and CHILLS (Chills) had resolved.            The action taken with mRNA-1273 in response to the event was not applicable. Patient has taken aspirin for the treatment.  Patient has not been diagnosed with/tested positive for COVID-19.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Reporter details and events outcome was updated. On 14-May-2021: Patient details, concomitant medications, therapy details, event outcome and reporter causality was updated.
fatigue; localized tenderness; significant left axillary swelling and tenderness; significant left axillary swelling and tenderness; Dose 3 (booster), single; This is a spontaneous report from a contactable nurse. This 50-year-old female nurse reported for herself that:  A 50-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FF88-39) via an unspecified route of administration in arm left on 06Oct2021 12:15 (at the age of 50-year-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken 81 mg, ascorbic acid (VIT C), vit d [vitamin d nos] (VIT D [VITAMIN D NOS]), birth control pills and all taken within 2 weeks of vaccination. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EJ1685) via an unspecified route of administration in arm left on 20Dec2020 (at the age of 50-year-old) as DOSE 1, SINGLE and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EK9231) via an unspecified route of administration in arm left on 10Jan2021 (at the age of 50-year-old) as DOSE 2, SINGLE for COVID-19 immunization. On 08Oct2021 in general with all injections: fatigue, and localized tenderness With Booster (#3 in series) I have had significant left axillary swelling and tenderness. Adverse event treatment hydration fluids and stiches. Patient didn't received treatment. The clinical outcome of the events was not recovered.   Follow-Up (13Oct2021): Follow-up attempts are completed. No further information is expected.
Member received the vaccination on the 4 October 2008. Member came in on 7 oct 2008 and said that the night after receiving the flu Mist that he developed a fever and night sweats that last thought the night. Member as noted that he has swelling on the midial anterial part of the lower leg. Member is take to asprin 2 times a day PCN.
This case reported by a healthcare professional via a sales representative and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with (FLULAVAL, GlaxoSmithKline). In 2008 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, unknown arm). On an unspecified date in the fall of 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced injection site reaction, pain, small local reaction and nonspecific reaction. At the time of reporting the injection site reactions, pain and small local reaction were improved. The events improved in possibly a week or more. Outcome of nonspecific reaction was unspecified. This facility vaccinates long term care subjects. They stated to sales representative that they have had a lot of reactions this year and were wondering if it was because we had some type of preservative that other companies do not. When we asked if they felt this was a bad lot, the sales representative said no. The healthcare professional considered the injection site reaction, pain and small local reaction was probably related to vaccination with FLULAVAL. Causality was unspecified fro nonspecific reaction.
Swollen left leg, erythema, left anterior thigh and knee, hot to touch, non-tender.  Diagnosis: cellulitis.
Redness and tingling of the hands, arms and then body about 5 minutes after vaccine administration. Was also hypertensive to 142/87. Did not have progression of symptoms and BP and redness improved after about 30 minutes of resting and monitoring.   Did not require any medications.
Fever 102.6, vomiting, diarrhea, listless; Amoxicillin prescribed;
10/22 - received vaccine; mild symptoms started. 10/24 - symptoms & cough continue. Cough is occasional & mild. 10/29 - cough severe & constant. Visit to ER discharged with analgesics. 11/4 - Return to a different ER - comm. acq. pneumonia.
A consumer report has been received concerning a 27 year old, Female patient. Reporter stated that in Feb-2014, nurse administered FLUMIST quadrivalent (intranasal), 0.2 milliliters, once/single administration, at her daughters pediatricians office. She received one dose, in one nostril. Within a month after getting FLUMIST she started falling asleep while she was driving. She went to facility and they thought she had depression. In Mar-2014, the second symptom developed, when she laughed or told a joke, her hand would fall, which was called cataplexy. She went back to the doctor in May-2014 and was referred to a neurologist. On 06-Jun-2014, she was diagnosed with narcolepsy. One of the medicines prescribed for narcolepsy blocked her birth control and she became pregnant in Apr-2015. She stated this pregnancy was a little rough. The outcome of falling asleep while she was driving, depression, cataplexy, narcolepsy and received one dose, in one nostril was unknown. The company physician assessed falling asleep while she was driving, depression, cataplexy, narcolepsy and received one dose, in one nostril to be non serious.
Individual received her second moderna vaccine at 9:30 on 4/29/21- 12 hours later she went to bed and had right hip, groin and lower back pain that was described as extreme and she was unable to sleep. She did not take any medication at this time because she was afraid to due to the vaccine.   On 5/1/21 she went to healthcare facility because she was having severe pain in her abdominal right lower quadrant, and stated she was worried she had appendicitis. 5/1/21 CT, blood work and urinalysis- client indicated the CT was clear, blood work was good, urinalysis showed some bacteria and she was started on antibiotics.   5/9/21 Went to healthcare facility due to not being able to walk, pins and needles sensation with stabbing hot pain in her groin and back. Her urine screen was clear, xrays were taken but looked okay considering her age. Stated She was started on prednisone, muscle relaxers and anti inflammatory medications. Stated she had never taken the meds they prescribed but they did not help.   She went back to her PCP on 5/13 - was referred for Physical therapy.   Individual stated she has gone to two therapy appointments and pain is lessening but is elicited with standing. pain continues to be localized in groin and upper leg.
This vaccine receiver was under the age of 18 at the time. No adverse effects noted after receiving the COVID vaccine while under 30 minute observation post injection.
This spontaneous report was received from a medical assistant and refers to two patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided.  On unknown dates, the patients were vaccinated with a dose of improperly stored VARIVAX lot #L045956 with expiration date: 27-NOV-2017, lot# reported as M000996 with expiration date: 07-JAN-2018 or lot# reported as M003440 with expiration date: 20-JAN-2018 (dose and route of administration were not reported). Administered doses of VARIVAX underwent temperature excursion at 30.128 Fahrenheit degrees, for 2 hours. Previous excursion was at 14.6 Fahrenheit degrees, for 3.72 minutes. Data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
2hr post pt broke out in hives all over body w/difficult breathing;atarax (MD rx);also lip was bleeding;placed on nebulizer still not recovered;
Three cyanotic episodes. Extreme and sudden lethargy. Failure to feed. Limpness. Inability to rouse.
Fever, (rash around injection) body aches and pain/chills, headache (severe) weakness. General feeling of killer flu. Stayed in bed due to adverse side effects of flu vaccine.  Needed to go to to hospital but could not afford to.
This spontaneous report as received from a pharmacist refers to a female patient in her 60's. The patient's current conditions and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU, subcutaneously (unknown strength and dose) to prevent shingles. Concomitant therapies were not reported. On an unknown date, the patient experienced, "itchy and painful rash that looked like shingles around the injection site after receiving ZOSTAVAX". The patient sought medical attention and visited pharmacist. The patient received lidocaine as treatment in response to the events. The outcome of the events was reported as recovered (unknown date). There was no product quality complaint involved. Causality assessment was not reported. Additional information has been requested.
15 year old female received Pfizer 5-11y/o dose for her booster.  Patient / family aware.
Pfizer 3/1 and 3/22. Positive on 12/14
8 days after receiving the 2nd dose of Moderna I began to slowly lose the vision in my right eye. It started at the bottom of the eye and throughout 6 months traveled up until I lost the sight completely. I went to the eye dr first, retina dr second, the neurologist third and had an MRI, last the Ophthalmologist. I was diagnosed with Optic neuritis by 3 of the 4 drs. 2 drs agreed it was most likely due to the vaccine.
Trigeminal Neuralgia; Most intense pain to the right-side of my face; This is a spontaneous report from a contactable HCP (patient). A non-pregnant 41-year-old female patient received BNT162B2 via an unspecified route of administration on 23Mar2021 14:00 (41-year-old) (Batch/Lot Number: ER 8730) as dose 1, single in arm left for COVID-19 immunisation. Medical history included fibromyalgia, irritable bowel syndrome (IBS), intervertebral disc protrusion (3 bulging discs), migraines (since childhood), environmental allergies. Concomitant medication included ibuprofen; diphenhydramine hydrochloride (BENADRYL); and cetirizine hydrochloride (ZYRTEC). No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Within 2 days of the 1st vaccine (25Mar2021), she started feeling the most intense pain to the right-side of her face. After 2 days of no longer being able to stand the pain, & persistent symptoms she went to the ER and no medication worked. She was told by the ER Dr. that her symptoms seemed to be trigeminal neuralgia, and to follow-up w/a Neurologist. After a slow increase of carbamazepine over the subsequent 3-4 months (and baclofen and ibuprofen as needed for intense pain), she was finally able to get the pain and symptoms controlled. Treatment received (carbamazepine/ baclofen). The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the events was not resolved. Since the vaccination, the patient hasn't been tested for COVID-19. The patient received BNT162B2 on 13Apr2021 14:00 (Batch/Lot Number: EW0151) as dose 2, single; and on 08Oct2021 04:45 PM (Batch/Lot Number: FF8841) as dose 3 single; both in arm left for COVID-19 immunisation.; Sender's Comments: Based on the reported information ,a causal relationship between the events Trigeminal Neuralgia and Facial Pain and suspected drug cannot be excluded.
pt rcvd vax; pt devel fatigue; some malaise; irregular periods; dizziness; headache; felt poorly;taken to MD,revealed SGPT 94,SGOT 80;LDH 170;WBC count 2800; lymphocytosis;anti HBC+; MD felt exp due to intercurrent viral illness;
9/6/21 EMS brought pt to ED with confusion and reported low systolic BP; BP was WNL in ED but chest x-ray showed multifocal pneumonia; antibiotic given; admitted to hospital; records do not show when pt was discharged to a nursing home; record of positive COVID test on 10/9/21, unsure if this was in hosp or nursing home; per death certificate the pt died in the nursing home and the causes of death were Hypoxic Respiratory Failure and COVID 19 infection and associated pneumonia
MMR received 9/17/04. 9/25/04 lethargy, decreased appetite, fussiness. 9/26/04 fever, vomiting. 9/27/04 rash.
Mom left clinic around 12 noon & put child down for nap; awoke @ 130PM cried until 830PM, inconsolable; Did not eat or drink all the rest of day;
Dizziness, Rash on chest, neck and upper arms, swelling of the injection site which looked like a sunburn, and blisters inside mouth which opened and bled within 48 hours of the vaccine.  Treated with 50 mg of benedryl at the outpatient center at then took 50 mg of Benadryl 2 hours later.
Having cold symptoms starting on 7/8/22, positive COVID rapid test on 7/8/22.
Headache, Myalgia, NauseaVomiting, lethargy; injection site soreness, loss of appetite Narrative:  Vaccine 12/17 @6:00 pm. On 12/18/2020 - woke up with a headache and "tight" muscles. Progressively that day she felt lethargic. She also had soreness in her arm at the site of the vaccine. Within 24 hours she developed nausea and lost her appetite. She took alleve and went back to sleep. 12/20 - slept all day. 12/21 - woke up feeling much better with a mild headache. 12/22 felt back to normal.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 03-MAR-2017 the patient was vaccinated with ZOSTAVAX lot # M034765, subcutaneous for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect route of drug administration, injection site joint erythema, injection site joint swelling and injection site joint pain. The outcome of injection site joint pain, injection site joint erythema and injection site joint swelling was reported as not recovered/not resolved. The outcome of incorrect route of drug administration is unknown. The reporter considered incorrect route of drug administration to be not related to ZOSTAVAX. Additional information has been requested.
Client developed symptoms of Covid 19 on 02/25/21. Tested positive on 03/02/21.
On May 04 after having dinner, I started to have symptoms like nasal congestion, sinus congestion and a cough. After a few hours I was achy all over. I took TYLENOL and the first thing the next morning, our doctor called to tell my husband that he had tested positive. The doctor had me come in to get tested. I returned home and drank warm tea. After 24 hours, I found out I tested positive. Thursday the congestion and cough got worse. The symptoms were like a very bad cold. The doctor recommended that I take PAXLOVID which he prescribed. I am still recovering. I still have some congestion and cough but the body aches are gone. I still have low energy.
Coughing, injection site pain, fever, headache, numbness in L/hand after getting up in morning (abated by 9:00AM) on 12/15/99.
reaction at the injection point/3 in red spot thats very warm, very sore and swollen; reaction at the injection point/3 in red spot thats very warm, very sore and swollen; reaction at the injection point/3 in red spot thats very warm, very sore and swollen; reaction at the injection point/3 in red spot thats very warm, very sore and swollen; injection site itchy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced injection site rash (Verbatim: reaction at the injection point/3 in red spot thats very warm, very sore and swollen), injection site warmth (Verbatim: reaction at the injection point/3 in red spot thats very warm, very sore and swollen), injection site pain (Verbatim: reaction at the injection point/3 in red spot thats very warm, very sore and swollen), injection site swelling (Verbatim: reaction at the injection point/3 in red spot thats very warm, very sore and swollen) and injection site itching (Verbatim: injection site itchy).  The outcome of the injection site rash, injection site warmth and injection site itching were not resolved and the outcome of the injection site pain was resolving and the outcome of the injection site swelling was not reported.   It was unknown if the reporter considered the injection site rash, injection site warmth, injection site pain, injection site swelling and injection site itching to be related to RSV vaccine.     It was unknown if the company considered the injection site rash, injection site warmth, injection site pain, injection site swelling and injection site itching to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 29-SEP-2023 The case was received from the patient via interactive digital media. The patient got the vaccine and had reactions at the injection point. The patient had 3 red spots which were warm but very sore. The patient felt warm at the injection point. Second day of vaccination soreness was little less, but he/she still had the redness and warm. It was nowitchy. The patient stated it was very strange. The follow-up would not required per process.
Severe nose bleeds,  visits to urgent care on March 6, 2021, ER on March 7, 2021, and again to ER on March 7, 2021.