chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillain Barre syndrome; diffuse weakness; This is a spontaneous report from a contactable physician (Neurologist). A 64-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 25Mar2021 (Lot number was not reported) as single dose (age at vaccination: 64-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. It was unknown about any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On an unspecified date patient experienced guillain barre syndrome and diffuse weakness. Events resulted in Emergency Room and Physician Office visit. The reporting Neurologist stated that he saw a patient this week and wanted to report the patient presented with guillain barre syndrome (GBS) approximately 2 weeks after receiving the vaccine. He clarifies that within 2 weeks after receiving the vaccine, the patient presented to the Emergency room with diffuse weakness and Guillain-Barre syndrome. Caller is wanting to know what the appropriate way to follow-up is. He clarifies he knows how to treat Guillain-Barre, he is a neurologist, he knows what to do, he just really wanted to know what channels to go through to log the adverse event. Reporter stated he had rules about HIPAA. He had yet to contact the patient to discuss the possibility of sharing their information. Reporter stated that the patient had knee surgery 2 days before the onset of weakness. The surgery date was 06Apr2021. The patient had electrodiagnostic testing done, clarified as an electromyogram (EMG). An EMG makes the diagnosis of GBS on unknown date. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided regarding, the causal association between the event Guillain Barre syndrome and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a physician, via a company representative, and follow up information has been received from a licensed practical nurse concerning a 74 year old white female, with unknown drug reaction/allergies, who on 28-FEB-2006 was vaccinated intramuscularly in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (Lot#649697/1038P).  It was reported that the patient was vaccinated in approximately 1998 with a dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included therapies (list not given).  On 28-FEB-2006, at 8:00 pm, the patient developed redness, warm skin, pain, and swelling from shoulder to elbow in injected arm, and also pain.  Ice was applied and ibuprofen (ADVIL) was taken.  Subsequently, approximately 36 hours post vaccination, the patients symptoms resolved.  There was no illness at the time of vaccination.  No product quality complaint was involved.  Additional information is not expected.
Feeling bad; I get sick; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling bad) and ILLNESS (I get sick) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling bad) and ILLNESS (I get sick). At the time of the report, FEELING ABNORMAL (Feeling bad) and ILLNESS (I get sick) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported
Sore Arm; This is a spontaneous report from a non-contactable consumer. A non-pregnant female patient of unknown age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Feb2021 as a single dose for COVID-19 immunisation. It was unknown whether the patient had any relevant medical history. It was unknown whether the patient was allergic to any medications, food or other products. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. It was unknown whether the patient received any medications within two weeks of vaccination. On an unknown date in Feb2021, the patient experienced sore arm. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of the reported event. S The clinical outcome of the event sore arm was recovered on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
received 3 doses of Shingrix; First dose:¨11/12/2019 / Second dose: 9/17/2020 (late dose); This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 5S43T, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th November 2019).   On 2nd February 2021, the patient received the 3rd dose of Shingrix. On 17th September 2020, the patient received the 2nd dose of Shingrix. On 17th September 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 2nd February 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The patient received 3rd dose of Shingrix, which led to extra dose administered. No information about lot number of 1st and 2nd at the time of reporting. The reporter consented to follow up by email.
2month old had vaccines at 0800 apt. She began non-stop crying shortly after we got home about 0930. Crying was inconsolable, whaling open mouth. We tried breastfeeding, holding, bottle feeding, bath, pacifier,  rocking, nothing calmed her.  Called nurses line, they handled poorly and gave no help besides what I'd already tried. No fever was present. Finally infant calmed skin to skin on her belly to mother and slept in a very light state for the rest of the day until a little before 4pm. If i even moved a little while she reared on me she would began screaming and crying again. Infant wouldnt eat while dealing with this adverse reaction all day.
Developed an itchy rash on left side of neck that spread up neck onto scalp. Three days later it was excruciatingly painful. Diagnosed as shingles. As of today it is improving but still present
Dizziness, Headache, Myalgia, Diarrhea, severe dehydration, sweating, fatigue Narrative:
Rash like sores appeared on left forearm 2X5 rectangle, as well as the corner of left eye extending to the eyebrow area. Patient states area around eye the rash burns mildly (3/10), the area on left forearm area itches. Patient denies fever, nausea, vomiting or being light headed.
2/17/2017 1200 hr: Received direct call from clinic and spoke directly with patient. Pt reports received varicella #2 to left tricep region on 2/15/2017. Over last two days the area is red, painful and itching. She denies any fever, n/v/weakness to her fingers, elbow, and no limitation in ROM to her arm. Clinic confirms reaction about 6cm circular in duration. (Vaccines given as part of nursing school requirements - Var Titer 10/15/2015 was negative.) Localized edema, rash and oth nonspec skin eruption.
Hot pink itchy rash bilateral flank areas and across lower abdomen  Felt itchy for the next 48 hours Today  rash has cleared up on abdomen  Still has rash lighter pink on bilateral flank areas and still itchy
Initial report was received from a health care professional on 20 September 2010. A 72 year-old male patient with a past medical history of cardiac bypass and knee surgery, had received an intramuscular left deltoid injection of FLUZONE HIGH DOSE, lot number U3106AA (lot number invalid) on 17 September 2010 and five hours later, experienced nausea, vomiting, "cramping", chills, achy and a fever of 101.4. On 20 September 2010 the patient reported he "still did not feel well". No further information was available at the time of this report. Follow-up information was received from a health care professional on 24 November 2010. The correct lot number for FLUZONE HIGH DOSE was U3635AA. No further information was available at the time of the report. Documents held by sender: None.
Injection site on left upper arm became raised, swollen, red, and hot to the touch. It subsided 72 hours later.
Information has been received from a physician concerning a 10 year old patient who was vaccinated with a 0.5ml dose of Varivax. Subsequently, a couple of years after receiving the vaccine, the patient experienced breakthrough chickenpox. It was unknown how many lesions the patient developed. Unspecified medical attention was sought. Additional information has been requested.
Swelling and pain at injection site of BOOSTRIX. Induration 5 cm diameter.
CDC reports: 5 mo infant developed fever to 100, local rxn @ inject site - adenopathy, & screaming episode following immunization. Recovered in 7 days.
Mess with your vision; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Mess with your vision) in a female patient of an unknown age 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 VISUAL IMPAIRMENT (Mess with your vision). At the time of the report, VISUAL IMPAIRMENT (Mess with your vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
This spontaneous report as received from a physician refers to a 13 year old male patient. On 13-MAY-2013 the patient was vaccinated with the first dose of GARDASIL lot # H021346, exp. 01-OCT-2015, intramuscular. The physician administered the GARDASIL shot to the male patient, then had the male patient wait 10 minutes prior to leaving the office area to go complete blood work in another area of the facility. Upon completing the routine blood work, which was scheduled during this doctor's appointment, this male patient experienced lightheadedness and feeling of being dizzy. The laboratory staff then escorted the male patient back to the office area where the office nurse was informed of the patient's condition. The office nurse had the male patient lie down in the room and vital signs were taken, of which blood pressure reading of 128/109 was obtained. The office nurse continued to monitor the patient's condition which was not improving much. The patient was very lethargic and had to be shaken 3 times to be aroused along with having to have his father assist him to the bathroom "because of being out of it." After a period of 1 hour, the physician felt as though the patient was stable enough to be sent home. The physician followed up on 15-MAY-2013 with the patient who was still experiencing lightheadedness and being dizzy, "I just don't feel like myself." The patient was not recovered from the event at reporting time. Therapy with GARDASIL was reported as continued. Additional information has been requested.
1st Vaccine 1/27/21; 2nd Vaccine 2/17/21;  presented to ED 2/17/21 with c/o bodyaches, elevated  BP,  generalized weakness, palpitations, and headache; onset 2/17/21 several hours after 2nd dose vaccine 2/17/21. Admitted to hospital from ED 2/17/21 with elevated troponin.
This spontaneous report was received from a pharmacist via a company representative refers to an approximately 75 year old female patient. No relevant medical history of the patient was reported. On an unknown date in October 2013 the patient was vaccinated with ZOSTAVAX (19400 PFU) (dose, route and lot number were not reported). No concomitant medications were reported. The pharmacist reported that the patient subsequently developed a mild case of shingles along the waist area on an unknown date in January 2014, following vaccination in October 2013. The patient then developed a severe case of shingles and post herpetic neuralgia on an unknown date in July 2014. It was unspecified whether any treatment was given for the patient. it was unknown if any lab diagnostic tests were performed. It was reported that the patient had sought medical attention. There was no product quality complaint (PQC) involved. The outcome of mild case of shingles, post herpetic neuralgia and severe case of shingles was unknown. The causality of the events were not provided. Additional information has been requested.
Immediate intense pain in left arm at administration site lasting for 1/2 hour.  At 11:00 PM (approximately 12 hours after vaccination), muscle aches in upper arms and upper legs lasting approximately 5 hours (until 4:30 am). Difficulty sleeping.  I did not have this response to the first dose of J&J that I received in April.
Mild Myocarditis, Fatigue, Arrhythmias (since first shot) and  Sharp Heart Pain following exercise (with 2nd shot).   Doctor has advised No Exercise.  Not even hiking.  Estimates recovery around March 2022.
Information has been received from a physician concerning an approximately 50 year old female who was working as evening driver for one female patient and a day time care taker for other female patient.  It was reported that on 29-MAY-2007 both the females were vaccinated with a dose of Zostavax (Oka/Merck).  On approximately 11-JUN-2007, 2 weeks after vaccination the patient developed herpes zoster.  The patient was seen by her physician on 11-JUN-2007.  A product quality complaint was not involved.  It was reported that one of the female patient was 91 years old and relatively healthy.  Concomitant medications included COUMADIN 1 mg, 6 days/wk, "LEXIPRO" 5 mg/day, "TETIKOSYN" 250 ug/BID, "LORAZIPAN" 0.5 mg/BID, "ATTINALOL" 125 mg/day, "LOTRIL" 2.5/10 mg/day.  Other female patient was 81 years old and relatively healthy.  Concomitant medications included "LOVOXATHOL" 0.75 mg/day, alendronate sodium (MSD) 70 mg/weekly, LIPITOR 10 mg/day, EFFEXOR SR 75 mg/BID, REMERON 15 mg/day and AMBIEN per night.  Additional information has been requested.
Approx 12 hours after vaccine rapid onset of severe body aches, bone pain, chills, difficulty catching breath, few minutes episodes of involuntary rigors, severe headache, nausea, dizziness, and tmax of 101.5. Now at just over 24 hours out, everything still present but difficulty with breath.
The patient presented on 10/05/18 around 10:30 AM to ask about arm soreness after a flu immunization. She received it on 10/03 and has had arm pain and some limited movement/numbness. It appears she has been aggravating it further by trying to move it and massage the arm. She has never received a flu vaccine previously and has never had a reaction previously to vaccines she has received. She had not taken any medication at time of speaking with me. I suggested resting the arm and taking tylenol to help with pain and inflammation. If symptoms do not improve, go to see the doctor. Will call patient for follow up over the weekend. I called patient around 3 pm today (10/05) and she has taken a dose of tylenol and is about to take another. She just got home and will be icing and resting her arm.
8 days after injection developed softball sized (approx. 3? long 2? wide) red, itchy, bumpy, warm to the touch, welt around the injection site.  It stayed that size for 24 hours and slowly decreased until it disappeared 72 hours later. Symptoms consistent with ?COVID arm?.  Did not use any medications to treat it.
Sore arm; Began approx. 24 hours after shot; Lasted approx. 48 hours; Not severe.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 16-OCT-2014 the patient was vaccinated with PROQUAD (0.5 ml, subcutaneous, lot # K005195, expiry date: 10-OCT-2015) which underwent a temperature excursion prior to being administered. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a medical assistant concerning  a patient who on 17-APR-2009, was vaccinated IM with 0.5 ml first dose of GARDASIL (lot # 1702X). On 19-JAN-2010, the patient was vaccinated IM with the second dose of GARDASIL (lot # 1487Y). No adverse effect was reported. Additional information has been requested.
Major swelling under the arm; Major swelling under the arm and sideof breast. (Same side as vaccine wasadministered); Very painful to touch ormove.; Very painful to touch or move. Also warm to the touch; Very painful to touch or move. Also warm to the touch and slightly red.; Major swelling under the arm and sideof breast. (Same side as vaccine wasadministered); This is a spontaneous report from a contactable consumer, the patient. A 43 years old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 19Mar2021 at 08:30 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. The patients medical history included anxiety, depression, and hypothyroidism. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and citalopram (MANUFACTURER UNKNOWN) for unknown indications from an unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an unspecified route of administration in the left arm on 24Feb2021 at 09:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 20Mar2021 at 09:00, the patient experienced major swelling under the arm and side of breast (same side as the vaccination was administered), which was very painful to touch or move. Also, warm to touch and slightly red. The clinical outcome of the events swelling in underarm, the side of breast, painful to touch or move and warm to touch and slightly red were not recovered.   No follow-up attempts are possible; information about lot number cannot be obtained.
Information has been received from a consumer concerning a child in her family who on an unknown date was vaccinated with a dose of MMR II (dose, route and lot number not provided). The consumer reported that the patient went into a coma a few days after receiving MMR II. The reporter stated, "it was documented when it happened several years ago". It was not specified if the patient sought medical attention. Upon internal review, coma was determined to be an other important medical event. No further information is available.
Employee vaccinated as part of annual influenza campaign.  Felt that vaccine was administered too high and too far posterior on shoulder.  Had immediate discomfort which progressively worsened over the next several days / weeks.  He reported to Employee Health today for evaluation.  He has a soft tissue nodule in the area of the vaccine.  It appears to be in the subacromial space rather than the deltoid.
3 days after immunization presented to clinic with left arm swollen, red, warm to touch below deltoid injection site of DTAP see diagram; Initially TX as Cellulitis but maybe immunization RXN.
developed Fever, chills, Cough, and Body ache. Got tested for Covid-19 with Rapid Antigen and came back POSITIVE.
She had her second COVID vaccine in the afternooon on April 27, 2021. She went to bed and woke up on April 28, 2021, and had paralysis on the right arm which lasted all day. The vaccine was given in the right arm. She did not have swelling or redness. She had a low grade fever and some injection site pain for one day. She had sensation in the arm but just could not move the arm correctly and it felt "spazzed."  She states she went to bed and the symptoms resolved upon waking. she did not report this to anyone initially and was not evaluated when symptoms were present.
Swelling of the legs and feet; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of the legs and feet) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of the legs and feet). At the time of the report, PERIPHERAL SWELLING (Swelling of the legs and feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.
3 days after receiving my 2nd Moderna vaccine I went into anaphylaxis. My throat felt like it was closing, tongue swelled up and could barely speak. My hands swelled and very extremely itchy. I developed hives all over my upper body including my head.    This has Never happened before.
pt recvd vax & exp diarrhea followed by fatigue & also flu-like sx; treated w/flu-like sx w/over the counter cold & cough preparations;
Tired; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) and MYALGIA (Muscle ache) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to analgesics (Anaphylaxis), Hives, Asthma and COPD (Stage 4, getting worse) since 2010. Concomitant products included VITAMIN D NOS, VITAMIN B NOS and MELATONIN for an unknown indication.  On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced FATIGUE (Tired) and MYALGIA (Muscle ache). At the time of the report, FATIGUE (Tired) and MYALGIA (Muscle ache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Treatment includes oxygen with dose as 5L for ever.   This case was linked to MOD-2021-375448, MOD-2021-375483 (Patient Link).