chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (sick as a dog), MALAISE (down for the count  for the day), TERMINAL INSOMNIA (woke up early), MYALGIA (body aches) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 18-Apr-2022, the patient experienced ACCIDENTAL OVERDOSE (she was given a full dose (0.5 ml) in error instead of a half dose (for her second booster dose)). On 19-Apr-2022, the patient experienced ILLNESS (sick as a dog), MALAISE (down for the count  for the day), TERMINAL INSOMNIA (woke up early), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (low-grade fever (99.4 F)). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) on 20-Apr-2022 for Adverse event, at an unspecified dose and frequency. On 20-Apr-2022, ILLNESS (sick as a dog), MALAISE (down for the count  for the day), TERMINAL INSOMNIA (woke up early), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (low-grade fever (99.4 F)) had resolved. At the time of the report, ACCIDENTAL OVERDOSE (she was given a full dose (0.5 ml) in error instead of a half dose (for her second booster dose)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2022, Body temperature: 99.4 (High) low-grade fever (99.4 F). For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. It was reported that, patient did not have any allergies, never had COVID positive test or diagnosis and AE did not cause patient to seek medical care. This case was linked to MOD-2022-545276, MOD-2022-545277, MOD-2022-545278 (Patient Link).
hallucinating thinking that people are in the next room; agitated; she is lethargic; 1st dose in February of 2021 & 2nd dose on 23Aug2021; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of HALLUCINATION (hallucinating thinking that people are in the next room) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020 and Encephalitis in December 2020.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced HALLUCINATION (hallucinating thinking that people are in the next room) (seriousness criterion medically significant), AGITATION (agitated), LETHARGY (she is lethargic) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in February of 2021 & 2nd dose on 23Aug2021). In August 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in February of 2021 & 2nd dose on 23Aug2021) had resolved. At the time of the report, HALLUCINATION (hallucinating thinking that people are in the next room), AGITATION (agitated) and LETHARGY (she is lethargic) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided She doesn't have dementia.  Company comment- Very limited information regarding these events has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-303411 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
March 30th, 2018: Experienced fatigue/sleepiness at 1:30 p.m. Experienced a lack of appetite at 5:30 p.m. Experienced nausea and abdominal pain at 6:30 p.m., experienced diarrhea beginning at 7:30 p.m. continuing through the evening into the next day. Experienced 3 bouts of vomiting: one at 8:30 p.m, one around 11:30 p.m., another at around 7:30 a.m. on March 31st, 2018. Fever of 100.1 at 9:00 p.m. on March 30th, fever of 102 on March 31st around 10:00 a.m., and fever of 101 at 10:00 p.m. on March 31st.
Information has been received from a physician concerning a 20 week old male with no pertinent medical history or drug allergies, who on 13-MAR-2007, 15-MAY-2007, and 20-JUN-2007 was vaccinated PO with the first (lot# 656381/0875U) 2.0 ml doses of Rotateq. There was no concomitant medication. After the second dose of vaccination on 05-JUN-2007, the patient first experienced the symptoms of Kawasaki's disease and was hospitalized. Lab diagnostic studies performed included a "CBC," blood culture, urine culture, blood chemistry, and urinalysis. The patient was treated with "IVIG." It was noted by the physician that the vaccination series was completed after recovery in July 2007. There was no product quality complaint. Follow-up information has been received by the physician indicating that on 05-JUN-2007 the patient was seen for persistent fever, papular rash, bright red chapped lips, and right eye conjunctivitis. There was no evidence of strawberry tongue. On that same day blood chemistry results showed an abnormal sedimentation rate of 14 mm/h and urine culture results showed significant levels of staph aureus in urine. (10,000-30,000 range). The patient was treated with ZITHROMAX (dose not provided). On 07-JUN-2007 the patient was hospitalized for approximately 2 days and diagnosed with Kawasaki's disease by infectious disease specialists. Lab diagnostic tests performed in the ER included a normal blood culture and urinalysis, but the CBC revealed a platelet count of 525 x 10 3ml and an increased sedimentation rate to 22.9 mm/h. The patient was treated with IV ROCEPHIN and AUGMENTIN (dose not provided) but did not respond to antibiotic treatment. On 08-JUN-20007, an echocardiography was performed which revealed prominent left main coronary artery. The patient was then treated with IV immune globulin. On 20-JUN-2007 the patient was seen by the physician and was noted to be recovered. On 21-JUN-2007 a repeat echocardiography was performed and the results were normal. Additional information is not expected.  12/4/07 Received hospital medical records which reveal patient experienced fever x 6 days, rash x 4 days & conjunctivitis x 4 days. Seen by pcp & started on antibiotics.  Admitted 6/8-6/11/2007. On admit, hepatomegaly, cracked lips & red tongue, palmar erythema & rash noted.  ID & cardio consults done.  Tx w/IVIG & high dose ASA.  Improved & d/c to home on continued low dose ASA & f/u by ID & cardio. FINAL DX: Kawasaki disease.   1/11/08 Received vax record from provider which confirms RO dose & lot & adds additional vax: Daptacel #2, 02570BA; ActHib #2 UF091AA; Prevnar #2 B47442C; IPV #1, Sanofi, Y103Z.
After receiving all three vaccine pt felt lightheaded and passed out while sitting in the upright position on the exam table for under ten seconds. After incident vitals were wnl. BP was 94/58
Sensation of fever, chills, sore arm, redness, fatigue, flu-like symptoms, local tenderness and erythema.
Approximately 5 minutes following vax, the pt felt an intense, steady pain from the lower back bilaterally down to the lower legs. Upon walking the pain became sharp and intense in all extremities. The pt couldn't walk and sat on an adjacent sofa at which time the pt complained of chest tightness upon inspiration and pressure in head accompanied by slight dizziness, toes were pale and slightly cyanotic, felt drained of energy. Legs were elevated. No complaints of nausea or vomiting. Symptoms subsided gradually over 20 minutes except for feeling "drained of energy". The following day, the pt developed hot, swollen and hard left arm at the injection site which persisted for days. Slept allot the next several days after working at school No complaints of further symptoms.
Diarrhea; Headache; Fatigue; Nausea; This is a spontaneous report received from a non-contactable consumer (patient) via a Regulatory Authority. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on 25Jun2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 26Jun2021, patient experienced headache, fatigue, nausea, diarrhea on 29Jun2021. Patient did not provide any other personal information other than name. Patient reported the side effects and she was also calling because her doctors won't see her so she did not know what to do. Patient further stated that all of that started on Saturday such as the nausea, headache and all that had been every day. The running to the bathroom started last night and it had been all day today. It's like every day since after the shot. She just wanted to know if this was normal. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
TINNITUS/RINGING IN THE EARS; VERY SICK; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unk) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the patient experienced very sick. On an unspecified date, the patient experienced tinnitus/ringing in the ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sick, and had not recovered from tinnitus/ringing in the ears. This report was non-serious.
ONE WEEK AFTER RECEIVING THE VACCINE, THE PATIENT HAD SWELLING, PAIN, AND A RASH THAT DEVELOPED AROUND THE INJECTION SITE. IT RESOLVED AFTER A FEW DAYS.
This case was reported by a consumer via call center representative and described the occurrence of immobile in a adult male patient who received BOOSTRIX for prophylaxis. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced immobile (serious criteria GSK medically significant), nausea, mobility decreased and unable to walk. On an unknown date, the outcome of the immobile, nausea, mobility decreased and unable to walk were unknown. It was unknown if the reporter considered the immobile, nausea, mobility decreased and unable to walk to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was healthy and was an avid runner. At some point he received a BOOSTRIX vaccination and experienced nausea and was unable to get up and move or walk. The patient declined to provide any details regarding his event and stated that he would have his attorney contact GlaxoSmithKline.
Patient received a Fluad vaccine indicated for patients 65+ when the patient was only 63 years old. Pt was contacted, and no adverse effects were evident
Started feeling discomfort and sweating profusely, then freezing and shivering. Went to ER and was given an X-ray, EKG and bloodwork. Findings were inconclusive. Two months later on 01/25/2023, started experiencing these same symptoms again and went to the ER. Was admitted over night for observation. Nothing was ever found and was released the next day.
Tested positive last week for COVID; Tested positive last week for COVID; This is a spontaneous report from a Pfizer-sponsored programt. A contactable consumer (patient) reported that a 53-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 02Apr2021 (Batch/Lot number was not reported) (at the age of 53 years old) as single dose for COVID-19 immunisation.  There were no medical history and concomitant medications. The patient got his first shot of the vaccine and he was scheduled to get his second dose but he tested positive last week for COVID (Apr2021) and he wanted to know if he can get his second dose. He wanted to make sure about what he had to do because his second shot is supposed to be tomorrow but he was positive now, he was tested positive. The patient did his COVID test on Friday and Saturday night he was positive. Tomorrow is going to be his second shot on 23Apr2021 at 4:15 PM. No treatment for the event. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Pain, redness, hardness, itching, swelling, welting, tingling and aching on left arm that has continued to spread after Benedryl. Still continuing after 36 hours.
Information has been received from a pharmacist concerning a 66 year old female patient with no drug reactions or allergies and with high blood pressure who on an unknown date, was intramuscularly vaccinated with a dose of ZOSTAVAX (Merck) (dose and lot number not reported). Concomitant therapy included BYSTOLIC and over the counter supplements. On an unknown date, the patient experienced a welt at the injection site and it was painful. The welt looked like a "bug bite" that was red, raised and painful. The ZOSTAVAX (Merck) was given by another pharmacist. The patient sought medical attention-pharmacy visit. No lab diagnostic studies were performed. There was no treatment given for AE. At the time of the report the patient's outcome was not recovered. Additional information has been requested.
Interchange of vaccine products; Patient given expired vaccine; Patient 13 years old (under 18 years old); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired vaccine), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient 13 years old (under 18 years old)) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient 13 years old (under 18 years old)). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 05-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient given expired vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient 13 years old (under 18 years old)) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Pfizer report received contains information regarding new events, interchange of vaccine products.
Developed difficulty swallowing and pain in esophagus in May 2021.  Saw my primary care doctor about this (on 5/28/21).  She referred me to Dr. and underwent an Endoscopy 7/27/21.  Results showed esophagus lesions from EOE.   Went on course of Omeprazole and symptoms worsened.  Referred to Allergist - Dr.  and began food tests to determine what was causing the eosinophils.  Between September and January 2022, I received positive tests and had to eliminate 22 foods from my diet.  Am still on this extremely restricted diet until the next Endoscopy scheduled for June 2022.  Still experiencing pain with eating.   In addition, beginning 2/22, I am now experiencing what appear to be Hypnopompic hallucinations and internal vibrations.  I have never experienced anything like this before.  The episodes are increasing in frequency and severity and I am currently undergoing dr. visits and awaiting a sleep specialist appointment on 5/3/22.  My last Pfizer vaccine (booster) was 11/11/21.
Left arm is swollen and yellowish in color at site of injection. Also had spotted rash on arm. Patient went to the walk-in to have her arm checked after presenting to pharmacy and the doctor stated she was in fact having an allergic reaction  to the vaccine but felt no treatment was needed.
This case was reported by a consumer via call center representative and described the occurrence of skin nodule in a 72-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had a severe case of shingles previously in her left eye). In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 1 day after receiving SHINGRIX, the patient experienced skin nodule. On an unknown date, the outcome of the skin nodule was recovered/resolved. It was unknown if the reporter considered the skin nodule to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient developed a lump between her neck and shoulder that lasted about a week and resolved. The physician recommended that she get her 2nd dose in her right buttock or her right hand. The patient had denied permission to contact their physician.
Patient and Patient Mother denied that patient had any history of fainting or dizziness with needle puncture. Patient was administered First dose of Pfizer vaccine 11:23am. Patient was seated in observation area with mother and sibling at 11:24am. At 11:25 am patient began to verbalize that vision was disturbed and mother notified staff who informed me. When I approached patient the patients eyes were closed and patient was unconscious and unresponsive. I administered a sternal rub and patient opened eyes and tried to speak but sounded slurred. Patient was unconscious for less than ten seconds. At 11:27am patient was able to answer all LOC questions appropriately and community health worker was instructed to get Wheel chair. Patient was able to help with transfer and patient was placed in wheel chair with minimal effort. At 11:28 Patient was taken to room 8 with recliner chair. Patient was placed in recliner with minimal assistance with legs raised and patient was given water which patient sipped. Pt was encouraged to rest and patient closed eyes and laid head back. At 11:32 am Vital signs machine was unable to be used  due to power outage so E-cart had to be opened to remove stethoscope and BP cuff. At 11:34 am Vitals signs were taken: BP-92/57 HR: 65 RR: 16 and patient denied any lightheadedness, dizziness, or fainting feeling. Pt requested to have mask off during observation. Patient and patient mother were instructed that a thirty minute wait time would be recommended and both verbalized understanding. MD was not notified since patient was talking appropriately and vision disturbance was resolving. Mother agreed that because patient condition was improving, that there was no need to involve MD. Patient continued to sip water and rest. Patient continued to close eyes periodically but began to keep eyes opened longer. At 11:46 am patient stated ?I feel a little tired, but I feel better.? Vital signs were taken: BP- 96/59 HR:65 RR:16 and patient denied any symptoms. At 11:53 a Patient stated felt well enough to leave. Patient was instructed to stand up and stay standing for a few seconds to ensure patient did not become dizzy. Patient was able to walk around the room with no gait or stability issues. Patient and patient mother were instructed to relay this occurrence to RN for second Dose of Pfizer COVID-19 Vaccine to ensure that staff can take the proper safety precautions. Patient and patient mother verbalized understanding. Patient left with mother and sibling awake and oriented x4 with no issues.
Information has been received from a healthcare worker referring to a 4 year old patient of unknown gender. No relevant medical history or concomitant conditions were reported. On 15-JUN-2015 the patient was vaccinated with 0.5ml dose of VARIVAX (Merck) (unspecified lot# but could included lot # K026386, expiration date 15-DEC-2016 or lot# K020757, expiration date 31-OCT-2016) which had been exposed to temperatures outside of the recommended range, subcutaneously. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
approx 4 days p/receiving inject pt called w/ c/o redness & swelling used warm compresses area 3x3cm w/small pustules; tx Keflex;
Myocarditis verified by MRI-Cardiac.  Caused palpitations.  BBlocker treatment.  Hospitalized 3 days.
After administration, the client complained of feeling flushed.  Pt was assessed after one minute BP 138/62 O2 99% Pulse 59 at 1107.  1115 BP 138/70 O2 98% Pulse 68.