chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Weak; Muscle aches; Not eating; Had no water; Lost 4 pounds; Stayed in bed all day; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ASTHENIA (Weak), MYALGIA (Muscle aches), DECREASED APPETITE (Not eating) and DEHYDRATION (Had no water) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PYREXIA (Fever), ASTHENIA (Weak), MYALGIA (Muscle aches), DECREASED APPETITE (Not eating), DEHYDRATION (Had no water), WEIGHT DECREASED (Lost 4 pounds) and FATIGUE (Stayed in bed all day). On 17-Jan-2021, MYALGIA (Muscle aches), DECREASED APPETITE (Not eating) and DEHYDRATION (Had no water) had resolved. At the time of the report, PYREXIA (Fever) had resolved, ASTHENIA (Weak) had not resolved and WEIGHT DECREASED (Lost 4 pounds) and FATIGUE (Stayed in bed all day) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever, rash covering body, trouble waking him up, swollen and painful injection site. Within a week he was unable to walk and was in therapy until age 2. He did not walk again until 21 months. He stopped eating solid and was also in therapy to help as well with feeding. He stopped talking and was diagnosed with autism a month later.
Headache, body aches, mild fever 100.1, heavy fatigue, injection site pain
sore arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the third of three reports. A patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date. The outcome of events was unknown.   Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092683 same reporter/drug/event, different patient;US-PFIZER INC-2021092693 same reporter/drug/event, different patient
Client was given Varicella #1 10-28-03, #2 10/5/06, #3 3/8/07 & #4 10/16/07.  No problems past administration.  Mom was told that if she desires to call child's private MD to do so.
Initial unsolicited report received from a consumer on 26-Oct-2016. This case involves a 61-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number expiry date, dose strength, form, frequency, route of administration were not reported) on an unknown date. Patient's medical history included cyst on her spine. Concomitant medications included teriflunomide for multiple sclerosis. Concurrent conditions included cyst on the spine and multiple sclerosis. On 17-Oct-2016 unspecified days post vaccination the patient reported that her arm was sore and she had fever and body aches. The patient also reported that she was experiencing feeling shaky on and off over the past few weeks. Laboratory investigations included MRI scan on an unspecified date which revealed cyst getting larger and a surgery was planned for the same. Corrective treatment was not reported. At the time of the report the patient had recovered from the events fever, body aches and sore arm while the outcome of the event "feeling shaky on and off" was not recovered. List of documents held by the sender: None.
muscle pain joint pain feverish 99.8F  symptoms lasted around 8h. Took Tylenol 500 and was better after a couple of hours
Pt. received HPV9 on 2-4-16 at approx 10:15AM, at 12:11 PM, foster home staff called and reported pt.  was lethargic, non responsive to staff questions, vomited x2. Advised to call 911.
I believe the injection of the Moderna vaccine was made too high in my left upper arm resulting in a brachial neuritis. Commonly known as  SIRVA. shoulder injury related to vaccine administration I had pain within 6 hours of the injection that was severe and was unable to sleep for control of pain for a good 48 hours.  I had loss of strength of my arm on abduction and continued to have pain and weakness in my left arm nearly 6 weeks from the first injection.  I have had my second Moderna vaccine subsequently at 28 days.
This is the 2nd time since my 2nd shot my throat neck glands are big and sore & thyroid is swelled up & sore difficult to swallow. Extreme long lasting exhaustion. Body is weak & sore muscles & joints. I have not been ok since my 2nd shot. I had a hard marble lymph node in my neck after the 2nd shot too.
On 2/20 woke up in middle of night crying in pain, would not move or ambulate on (L) thigh where immunizations given. Father gave APAP for pain. (L) leg/upper thigh visibly swollen, mild erythema at injection site, and muscle hardness at site today (2/20/18) at 1100 on exam. Will go ice and MOTRIN to help with swelling.
Developed chest pain around 7/12/1998. Seen on sick call on 7/14/1998 for chest pain. Seen again on 7/28/1998 for chest wall pain and shortness of breath with exercise. Had CXR, EKG done, but results not visible; treated with NAPROSYN. Documentation of ER visit and admission to hospital between 15 Sep and 16 Sep 1998 for pericarditis.  10/1/08 Reviewed hospital medical records of 9/15-9/17/1998. FINAL DX: pericarditis, likely secondary to viral infection Records reveal patient experienced chest pain x 2 days after vaccinations.  Had body heaviness & weakness. Tx w/NSAIDS
Initial unsolicited case received from a consumer (patient herself)  on 09 Jan 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE HD (Batch number, expiry date, dose and site of administration was not reported) administered intramuscularly on an unspecified date in Oct 2016. The patient illness at the time of vaccination , Pre-existing physician diagnosed allergies, birth defects, medical conditions was not provided and Any other vaccinations within 4 weeks of vaccinations was not reported. The patient concomitant medications were unknown. On an unknown date in Oct 2016, after the vaccination the patient had 3 or 4 colds, runny nose, sneezing and feeling tired. The patient lab tests and corrective treatment was unknown. The outcome of the events were unknown. List of documents held by sender: none.
Pfizer-BioNTech Covid 19 Vaccine  Symptoms similar to heartburn: burning acidic pain below my ribs, excessive burping, burning throat, mouth tasted like metal. It lasted several hours in the evening.  I had very little to eat that day.  (I have never had heartburn or anything like this before.) Woke up  the next morning with body aches and intense back pain and headache.
Extreme flu-like symptoms. Shivering uncontrollably, fever, pain in muscles, nausea.
Immediately on the day of the vaccine and on the day after the vaccine,  I had periods when I felt a little lightheaded but otherwise felt fine except for a little injection site discomfort.  Two days after the vaccine I began to feel back and right leg discomfort. By Day 3, the pain in my leg was severe and I started to notice the tell tale signs of Shingles.  I immediately contacted my PCP and the shingles diagnosis was given on 2/8/21 due to my symptoms and appearance of my leg.  I was immediately put on a 7 day course of Valtrex. On 2/9/21, because the pain was intolerable, I contacted my primary care physician ad was given a 50 mg dose of Lyrica to be taken twice a day.On 2/10/21 the lyrica was increased to 75 Mg dose twice a day since the 50 mg wasn't totally helping.  On 2/12/21 the lyrica was ordered for 3 more days and just to be sure there wasn't a herniated disk causing any of the pain, am xray of the thorasic spine was ordered.  On 2/17/21, I had an appointment with a pain management physician.  He examined me and performed a neurological check and checked the function of my back and confirmed the shingles diagnosis. He continued the Lyrica for 3 months and ordered a Medrol 5 day dose pack. His follow up is in  3 months. He told me not to take Dose 2 of the Covid Vaccine.
Twinrix was administered in 2 doses administered in 2017, 3rd dose was today on 10/24/22; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in 2017) and Twinrix (received 2nd dose in 2017).   On 24th October 2022, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 24th October 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-Oct-2022 Reporter's comment: The pharmacist reported that the 3rd dose was today (on the day of reporting). The health-care professional was unable to provide any adverse event details today.  The health-care professional consented to follow up by safety team. The consent to follow-up was granted. Additional Supportive Information: The patient received 3rd dose of Twinrix later than recommended time interval, which led to lengthening of vaccination schedule.
patient received covid vaccine on march 15th. she called today stating she is experiencing tingling and numbness in the arm she received her vaccine in.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 24 year old, male. Initial information was processed along with additional information received on 01-JUL-2022. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: None. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204821A, expiry: unknown) dose was not reported, 1 in total was administered to right arm on 15-JUL-2021 for prophylactic vaccination. Age at time of vaccination 23 years old. No concomitant medications were reported.  On 21-JUN-2022, the patient had bad cough and headache. On mid last week, week before 26-JUN-2022, patient started feeling sick and also had strep throat (confirmed covid-19 infection). On 26-JUN-2022, Laboratory data included: COVID-19 virus test Positive (confirmed clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000240652. This case, from the same reporter is linked to 20220702424.; Sender's Comments: V0: 20220702322-Covid-19 vaccine ad26.cov2.s -Confirmed Clinical Vaccination Failure . 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. Therefore, this event(s) is considered not related.
Fever, body aches, headache, fatigue and sore injection site. Took aspirin and rested for 2.5 days and starting to feel better.
fast heartbeat; fever; chills; tired; sleepy; dizzy; I felt like I was getting poison that bit me everywhere/I feel like ants inside my body, as if my blood pressure had lowered,I felt like I was going to faint; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date at 8:30 AM as unknown, single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fever, chills, I felt like I was getting poison that bit me everywhere. I also felt tired and very sleepy, fast heartbeat. I continue with those symptoms, I get up and feel dizzy, I feel like ants inside my body, as if my blood pressure had lowered, I felt like I was going to faint, I get up and try to do my normal activities but I get dizzy on an unspecified date. The outcome of events was unknown.  Information on batch/lot no. are not available. Further information has been requested
(1) Headache. (2) Numbness on arms and legs, (3) Joint swelling and pain (Elbows, wrist, (4) Hives and Macucopapular rash on arms and legs. Menactra verified.
Child c/o mild HA at 4 pm 11/29 when home from school, refused meds at that time. At 9:30 pm same night, woke up in tears c/o severe headache, body aches, nasal congestion & low grade temp (mom did not measure with thermometer). Gave ibuprofen & went back to bed.  Mom called in to report event at 11:30 am 11/30/2011 on her way to child's school to pick her up d/t child in tears with HA again.
Arm/hand pain and swelling. Hand throbbing. She said she went to Dr and they gave her pain meds for the pain/throbbing. Still experiencing pain/throbbing/tingling 1 week after immunization, but swelling is gone.
Injection site was swollen, itchy, and began to produce large bumps. Days later the itchiness was all over my body, with red rashes and swelling all over.
Rigth thigh area with 3cm x 3cm area of erythema, tender to touch. No treatment given. Patient was readmitted with pneumonia and erythema to injection site noted.  Patient then transferred to tertiary care center for further treatment and diagnosis of pneumonia.  Unable to determine if patient would have been hospitalized just for reaction to vaccine.
Facial swelling with dry skin, fever, chills and body aches. Took OTC Tylenol and Claritin and symptoms resided.
Started menstruation that afternoon. Off cycle... 1 week - 2 weeks early. Not typical for me... I'm very regular. Not on birth control but husband has vasectomy.  Chance of pregnancy is extremely unlikely.   Started with bad cramping in pelvis and aching legs. Cramps have lessened. Dark blood. Brownish in color.
This spontaneous report has been received from a Licensed Vocational Nurse referring to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose and route of administration were not reported) for prophylaxis. The doses were stored at temperatures 47-77 degrees Fahrenheit for a total time of 1 hour as identified by a digital data logger. It was reported that there were no previous temperature excursions. No adverse effects were reported. Additional information has been requested.
Took a COVID PCR test and was positive; Took a COVID PCR test and was positive; Chills; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 58-year-old female patient received BNT162b2 (COMIRNATY), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHILLS (non-serious) with onset Dec2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Took a COVID PCR test and was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2021) Positive. Clinical information: I will see if I can obtain lot number and expiration date within the next few days. In Dec2021 the patient experienced chills and then took a COVID PCR test and was positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug BNT162b2 to all the reported events cannot be completely excluded based on temporal association and known drug safety profile
Flu like symptoms 2 days after vaccine muscle, joint pain, nausea/vomiting. Aug. 4 - Dx with cellulitis. Adverse reaction to TDaP (antibiotics, swollen, tender, red arm/numbness). Sept. - Dx with post vaccination syndrome - allodynia, sore muscles, numbness/tingling extremities, headache, nausea, sore throat, vomiting, sore joints/bones/nerve pain/anxiety, muscle spasms/twitches. Jan. diagnosed with fibromyalgia. Off work x 3 months short term disability. Symptoms still persist. Also diagnosed with (L) bundle branch block.
Pericarditis, moderate to severe chest pain, treated with 200mg Ibuprofen TID, currently out of work due to continued nausea, headaches and feeling light headed.
Symptoms started within 30 seconds of administration of vaccine, patient became diaphoretic, reported loss of vision and light headedness. Patient given juice, and monitored. Patient's symptoms resolved within 10 minutes of vaccine administration and left the office under their own power without assistance shortly afterwards.
After about a week following the first shot the patient experienced eczema all over her body; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (After about a week following the first shot the patient experienced eczema all over her body) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (After about a week following the first shot the patient experienced eczema all over her body). At the time of the report, ECZEMA (After about a week following the first shot the patient experienced eczema all over her body) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant was reported by reporter.  The patient stated that about  3 months ago , her dermatologist prescribed a steroid cream.   This case was linked to MOD-2021-319068 (Patient Link).
Numbness in right foot; Tingling sensation in his right foot; This case was reported by a consumer via call center representative and described the occurrence of numbness in feet in a 56-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included anxiety (Patient takes Klonopin for anxiety) and pre-diabetes. Concomitant products included clonazepam (Klonopin).   On 15th March 2022, the patient received the 1st dose of Boostrix .5 ml and Boostrix Pre-Filled Syringe Device. In March 2022, less than a week after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced numbness in feet and tingling sensation. On an unknown date, the outcome of the numbness in feet and tingling sensation were not recovered/not resolved.   It was unknown if the reporter considered the numbness in feet and tingling sensation to be related to Boostrix and Boostrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The caller was a patient self. The patient takes Klonopin for anxiety, and he was pre diabetic. The patient received the Boostrix vaccine on 15th March, 2022 from the pharmacy at his deltoid area of his left arm. The patient stated that, since receiving the vaccine he had experienced numbness and a tingling sensation in his right foot. The patient inquired if that was normal and was provided with the medical advice disclaimer and spoke from Package Insert. The patient was  referred to Health care Professional and was offered number to Medical Information for caller to provide to Health care Professional. Health care Professional details were provided. No additional details were provided by the reporter. The patient consented to follow up and provided permission to contact his Health care Professional.
Patient had asthma flare approximately 48 hours after 1st dose Pfizer. Was put on 2 courses of high dose prednisone. Patient was still on prednisone and coughing when she came back to vaccination site for 2nd dose.  Patient was told to withhold on second vaccine for another week until patient has been off prednisone and not coughing.
pt recvd vax;started to cry as vax was administered;2 jerking motions of head;face turned gray,lips were bluish gray;appeared not to be breathing;pt started breathing & color returned to nl in ofc;mom contacted MD & pt fine now;
This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 22-MAY-2017, the patient received an expired dose of GARDASIL injection (lot # L035105 with expiration date at 14-MAY-2017; dose, route of administration and anatomical location were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was CVA.
Aggression, seizures, rapid heart rate, brain damage, weakness, no sleep, changing skin color & textures, pain, numbness.  9/14/09 Hospital records received DOS 3/13/08 to 4/7/08. Assessment: Seizure activity with behavioral disorder. Insulin dependent diabetes mellitus. Patient transferred from another facility. Behavioral changes including defiance and disinhibited behaviors. Palpitations and transient sinus tachycardia. Agitation, aggression. Panic attacks. IVIG administration.   9/14/09 Hospital records received DOS 3/13/08 to 7/15/08. Additional information abstracted. Assessment: Meningoencephalitis with neurocognitive disturbance and disinhibition. Vaginal yeast infection. Patient c/o of palpitations. Emesis. Impulsive, compulsive eating behaviors. Increased lacrimation and salivation. Oral contraception.    ICD-9 Codes: 345.90, 323.9, 341.9, 343.0, 293.0 307.51, 345.40, 343.9, 302.70, 312.9, 294.9, 310.1 293.84, 309.81, 296.90, 780.52, 250.92, 706.1, 274.9, 626.0 112.1 V15.81, V58.67, 313.81, 345.40, 293.89, 250.01, 298.9
pt recv vax & devel a 4cm x 4cm area of erythema 1/4 cm high @ the inj site; tx DPH & ice packs;
Menstrual cycle came on 2 days after receiving vaccine, which was a week earlier than expected, and only lasted for about 5 hours and has not been on since. Patient also stated that she has a low sex drive now.