chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BODY STIFFNESS; COULD NOT MOVE/UNABLE TO MOVE; COUGH; BODY PAIN; MUSCLE ACHE; POUNDING IN HEAD/HEADACHE; This spontaneous report received from a patient concerned a male 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 24-JUL-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-JUL-2021, the subject experienced body stiffness. On 24-JUL-2021, the subject experienced could not move/unable to move. On 24-JUL-2021, the subject experienced cough. On 24-JUL-2021, the subject experienced body pain. On 24-JUL-2021, the subject experienced muscle ache. On 24-JUL-2021, the subject experienced pounding in head/headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from could not move/unable to move, and body pain, and the outcome of body stiffness, muscle ache, pounding in head/headache and cough was not reported. This report was non-serious.
Brachial neuritis; Severe pain; Oral route of drug administration; This spontaneous case was reported by a consumer and describes the occurrence of RADICULITIS BRACHIAL (Brachial neuritis), PAIN (Severe pain) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Oral route of drug administration) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Oral) 1 dosage form. On an unknown date, the patient experienced RADICULITIS BRACHIAL (Brachial neuritis), PAIN (Severe pain) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Oral route of drug administration). At the time of the report, RADICULITIS BRACHIAL (Brachial neuritis), PAIN (Severe pain) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Oral route of drug administration) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Oral) was unknown.       The concomitant medications were not provided. The treatment information was not provided.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 31Mar2021 as dose 2, single (Lot number: FW0151), in left arm and on 28Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 45 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) positive; (unspecified date) Unknown result; (unspecified date) Negative. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Additional information: Adverse event-  Return of Covid-19 symptoms 7 days after finishing Paxlovid and a positive antigen test on day 8. I'd previously tested negative after finishing treatment. No follow-up attempts are possible. No further information is expected.
I had 4 joints (left middle toe, right ankle, left knee, and right index finger) that started to swell, decreased mobility, pain.  Got worse over the next 15 days and ended up on crutches.  I was started on prednisone in the beginning of November (still on crutches) and took this until June 2013.  The decreased mobility and pain were gone around April 2013, although slight swelling still exists in the right ankle today.
mild fever, chills, over heated, nausea, diarrhea, body aches
Red, itchy raised, hot area around vaccine injection site approximately 3 inches in diameter with irregular edges. Area was red for 4 days and is bruised still today, 4/2/2021.
Body pain; Weakness; Fatigue; Respiratory symptoms (runny nose); Fever of 103 F/temperature is 101 F; This spontaneous case was received on 08-Nov-2023 from a physician (consumer) via Regulatory Authority (reference number: SEQW23-04137) and concerned a 27-year-old, female patient.  The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included unspecified flu vaccination, administered on an unreported date, after which the patient experienced a low-grade fever.   On 06-Nov-2023, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; dose: 0.5ml; anatomical location: left arm; route of administration: not reported) for influenza prophylaxis. The batch number reported was AU1073A and expiry date 30-Jun-2024.    On 07-Nov-2023, one day after receiving Afluria Quadrivalent, the patient experienced a fever of 103 degrees Fahrenheit (F), body pain and weakness, fatigue, and respiratory symptoms (runny nose).   On 08-Nov-2023, the patient's temperature was 101 F. The patient was worried that she may be developing an infection such as COVID, flu, common cold, or respiratory syncytial virus (RSV).  At the time of the initial reporting, on 08-Nov-2023, the patient had not recovered from all events. As reported, issues have not resolved.  The reporter did not provide a causality assessment. As reported, the patient was unsure if these symptoms were related to receiving the vaccine itself or were due to some type of infection she had developed.  The case was assessed as non-serious.  This case is linked with the case 202306493 (the same patient and the same reporter).  Company comment: A patient was vaccinated with Afluria Quadrivalent. One day following vaccination, the patient experienced fever, body pain, weakness, fatigue, and respiratory symptoms (runny nose). The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included unspecified flu vaccination, after which the patient experienced a low-grade fever. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events pyrexia, pain, asthenia, fatigue, rhinorrhoea, with the currently available information and chronological plausibility.; Sender's Comments: A patient was vaccinated with Afluria Quadrivalent. One day following vaccination, the patient experienced fever, body pain, weakness, fatigue, and respiratory symptoms (runny nose). The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included unspecified flu vaccination, after which the patient experienced a low-grade fever. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events pyrexia, pain, asthenia, fatigue, rhinorrhoea, with the currently available information and chronological plausibility.
Pt presented for his 12 mo WCC and mother reported that patient had fine hand tremors that occurred 5x weekly for a month after his 6 mo WCC and shots. These episodes lasted for a couple of seconds. He did not have a loss of consciousness. Patient has no residual symptoms.
The onset of symptoms was around December 01, 2022. I had a headache with constant nasal drip. I had sinus drainage and upper respiratory congestion. I was taking nasal spray Flonase, Azelastine and Mucinex which helped but did not cure the symptoms. I went to the Urgent Care Clinic on December 31, 2022. After a visual examination, I was prescribed a low dose of Amoxicillin and a prescription cough drop called Ninja Cough. My symptoms improved within 24 hours. I made an appointment with an ENT doctor on January 06, 2023. He upped the level of the antibiotics I was taking to address my symptoms and also placed me on a 6-day prescription of Prednisone. Within 4 to 5 days the symptoms were completely gone. He indicated the infection was upper respiratory.
1/29 vaccination 3/6th I was working at the computer, HR 180/192. Went to the ER and it didn't resolve on its own; SVT. One dose of adenosine. I was 6 weeks pregnant at the time, 3rd pregnancy, other pregnancies were uncomplicated.  One episode before with heart racing which resolved on its own; spring 2016.
Arm is still sore; Arm is still sore and red; Arm is still sore and red and swollen; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2020, the patient received Shingles vaccine. In November 2020, less than a week after receiving Shingles vaccine, the patient experienced pain in arm, erythema of extremities and swelling arm. On an unknown date, the outcome of the pain in arm, erythema of extremities and swelling arm were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities and swelling arm to be related to Shingles vaccine.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The age at vaccination was not reported. The patient had shingle shot a week ago at doctor's office. The patient experienced arm was still sore and red and swollen.
Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concomitant conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patient were vaccinated improperly stored PEDVAXHIB (lot # M020101 with expiration date 07-MAR-2019; dose and route were unknown). The vaccines were exposed to temperature excursion of minimum (Min) -0.5 degrees centigrade for 3 hours 39 minutes and maximum (Max) 15.9 degrees centigrade for 16 minutes on 28-SEP-2016; Min 0.8 degrees centigrade for 5 hours 19 minutes on 29-SEP-2016; Min 0.7 degrees centigrade for 5 hours 37 minutes on 30-SEP-2016 and Min 1 degrees centigrade for 2 hours 26 minutes on 01-OCT-2016. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product complaint (PQC) was involved. This is one of several reports received from the same reporter.
Husband fell landing on her right arm with sudden onset of right arm pain. Admitted for Acute compound midshaft radial ulnar fracture.   Underwent open reduction and internal fixation right both bone foramen fractures with irrigation debridement of grade 1 open ulna fracture 11/17/2021.  Pain was well controlled overnight without complications postoperatively.  Felt stable for discharge to home 11/18.  Will follow up with orthopedic surgery clinic in 2 weeks for wound check and suture removal as well as x-rays.  Nonweightbearing to the right upper extremity.  Cleared to start digit range of motion immediately.  Strict elevation of the right upper extremity.  Received 24 hours of postoperative antibiotics for treatment and discontinue thereafter. Adverse event not related to vaccine but reported as required per EUA for hospital admission, irrespective of attribution to vaccine.
Felt like bronchitis was coming on Coughing and chest hurt.  These made sleeping difficult.  Saw Doctor on 3/09.  Tested positive on PCR COVID-19 Test.  Doctor Proscribed Paxlovid.  Symptoms diminished everyday after that.  Situation returned to normal after day 5 of Paxlovid, 3/14.
This spontaneous report as received from medical assistant refers to unspecified patients of unknown age. In July 2013 the patients was vaccinated with GARDASIL and RECOMBIVAX HB which was from 11-JUL-2013 to 22-JUL-2013 that was exposed to multiple fluctuations to 31F each day during this time period which was not supported. No adverse effects were reported. Additional information has been requested.
Per PCP: "#Vaccine reaction received 1st Covid 19 Pfizer vaccination (ER8737) on for 4/2/21 (1:48pm)  4/3 developed injection site redness, swelling with warmth  Swelling redness resolved over the course of week  4/11/2021 recurrence of injection site redness, warmth and swelling  Redness and warmth have gradually improved over the last 2 days  Has an approximately 2 inch wide red area on left upper outer arm  Due for second vaccination 4/23, concerned whether she should receive vaccination  Denies itching, fever/chills, cough/shortness of breath, decreased range of motion to the upper arm, peripheral numbness or tingling, arm weakness. Denies additional adverse effects of vaccines such as nausea vomiting, body aches, fatigue."
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age, unknown gender. The patient was vaccinated intramuscularly with first and second doses of GARDASIL (lot number not reported) on 17-JAN-2007 and 07-DEC-2007 respectively. No other co-suspects were reported. No concomitant medications were reported. The patient would be administered the third dose in the vaccination schedule on 15-OCT-2012. No adverse effect reported. Additional information has been requested.
Severe sepsis secondary to Covid 19 pneumonia. He was on IV antibiotics for 4 days and we transition to levofloxacin for an additional 4 days. He was given IV fluids and treated for severe sepsis the patient overall did improve his lactic acid normalized. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Information has been received from a registered nurse, a physician, and medical records concerning a 18 year old female with no reported allergies who on 08-APR-2011 at 0900 was vaccinated intramuscularly in the right arm with a first dose of GARDASIL, 0.5 ml (Lot # 667930/15612). On 08-APR-2011 at 0854, prior to the patient's vaccination, the nurse reported the patient's blood pressure was 110/70 mmHg. The patient had denied any illnesses at the time of the vaccination. The nurse stated the patient had reported to her mother that within an hour after the first GARDASIL dose, on 08-APR-2011 at 1300-1700, the patient had a "hard time seeing" and had numbness in her teeth, mouth and arm. The patient reported her last menstrual period was 07-MAR-2011. The nurse reported the patient went to the emergency room and was treated with a CT scan of the brain, electrocardiogram and blood work. Her vital signs revealed an increase temperature of 99.2, blood pressure of 134/72 and a pulse rate of 80. According to medical records, on 08-APR-2011, at approximately 15:00 PM, the patient was seen in the emergency room and had the following diagnostic tests performed: CT of the brain without contrast indicated for a headache showed a normal CT brain, complete blood cell count and chemistry blood test both showed normal results and a completed electrocardiogram (results not provided). The patient was also given a screening urine drug test that was negative for amphetamine, tricyclics, tetrahydrocannabinol (THC), cocaine, benzonatate, barbiturate, phencyclidine (PCP) and opiates. On 08-APR-2011, the patient's outpatient medication listed LOESTRIN FE 1 mg-10 MCG/10 MCG, 1 tablet daily. The patient's follow-up instructions were to return to her doctor's office in about two months (around 08-JUN-2011) for her second dose of GARDASIL. On 27-APR-2011 at 1740, the nurse was informed by the patient's physician, that the patient had an allergic reaction to GARDASIL injection, noted as swelling of the mouth and lips. The patient's outcome was not provided at the time of this report. All available medical records will be provided upon request. Additional information has been requested.
Pt. described injection site/arm as in excruciating pain. Injection site presented red and swollen. 48 hours after all symptoms resolved.
Immediate soreness - worsened over last 3 days - Erythema extending through upper outer arm - low-grade fever - Questionable cellulitis. Given antibiotics x10 days.
Child received vaccines during the day of the 15th of October. That night the child c/o pain and cried thru the night. C/o  severe pain left arm, swelling down to elbow and radiating to left shoulder blade region.  Scaling hot in temperature. Mother applied cool compressesand cold packs, gave Tylenol. Saw the doctor on wednesday. who gave the child Benedryl and some steriods. Next day, child was fine, swelling gone and feeling better.  Mother stated child's brother died fews back and was allergic to pertussis. The child received all DTaP vaccines since age 2 months. Child did not receive any varicella before age 5 years.
On 1-6-10 Employee reported hot, itchy, reddened area on chest, abdomen and upper back.
pt recv vax; devel chronic hives & was thinking perhaps due to vax; devel stiff neck, fine red rash on hands; was pruritic; T 99 and dec of appetite with sore throat; to MD; tx w/ meds;
MEDICATION ERROR; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION (BREAKTHROUGH); SEVERE REACTION TO JNJ VACCINE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was needed to take steroids. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry date: unknown) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. Concomitant medications included mrna 1273 for covid-19 vaccine.  On 05-OCT-2021, the patient experienced suspected clinical vaccination failure, suspected covid-19 infection (breakthrough) and severe reaction to JNJ vaccine. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On an unspecified date, the patient experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection (breakthrough), and the outcome of severe reaction to JNJ vaccine, suspected clinical vaccination failure and medication error was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000196555.; Sender's Comments: V0: 20211010258-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient turned 12 but when received the vaccine on 11/30/21 only received the pediatric dose, family was made aware
He had an infection and headache after the first dose; He had an infection and headache after the first dose; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored Program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient received first dose of Covid-19 vaccine on 26Feb2021 and has a schedule for a second dose on 19Mar2021. On an unspecified date he had an infection and headache after the first dose and took antibiotics because of the infection. Patient wanted to know if he can take second dose tomorrow. Therapeutic measures were taken as a result of infection with antibiotics. The outcome for the events was reported as unknown.   No follow up attempts are possible. Information about lot/batch number cannot be requested.
Patient reported that the morning of 12/15/18 he felt extremely weak and couldn't walk (was unable to make it to the bathroom in time as well). Patient felt so bad that he went to the hospital on 12/16/18 and the hospital did not find anything "wrong" with the patient (no urinary tract infection, nothing wrong with legs, no fever, no changes to EKG, etc). Patient stated on 12/17/18 that he was feeling better but still feels weak. He is due for surgery on 12/21/18 and feels he may have to reschedule due to his current state.
Fully vaccinated with Janseen x 1. Tested positive for Covid on 01/23/2022. Admitted to Hospital on 01/23/2022. Expired on 01/27/2022 while still hospitalized.
pfizer vaccine was accidently given one week too early. Patient got first vaccine on 8/15/21 and should have received second vaccine on 9/5/21 but received the second dose on 8/15/21. Spoke to patient on 8/29/21 and 8/30/21. Patient did not report and adverse symptoms.
A spontaneous report has been received from a health professional via medical representative concerning a patient of unknown gender.  Patient relevant history, concurrent diseases and concomitant drugs were not provided. During the 2013-2014 season the consumer received the FLUMIST QUADRIVALENT (intranasal) vaccine and developed the flu. The outcome of the event of flu was unknown. The company physician considered the event of flu to be non-serious.
17 hours after shot, diarrea, vomiting, arm swelled like a baseball and rash, (2 days), then vertigo and SEVERE joint pain and weakness for about 5 to 7 days.
This case was reported by a nurse via sales rep and described the occurrence of feeling unwell in a 64-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (4 years ago). On 23rd December 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced feeling unwell, chills, tremor, fever, energy decreased, fatigue, influenza-like symptoms and injection site tenderness. The patient was treated with naproxen. On an unknown date, the outcome of the feeling unwell, chills, tremor, fever, energy decreased, fatigue, influenza-like symptoms and injection site tenderness were recovered/resolved. It was unknown if the reporter considered the feeling unwell, chills, tremor, fever, energy decreased, fatigue, influenza-like symptoms and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a Nurse Practitioner (NP) who herself was a patient. The patient had received ZOSTAVAX 4 years ago when she was 60. The patient stated they were she was not feeling well after administration of SHINGRIX in the left deltoid. The patient experienced chills, shaking, low grade fever (100.5 degree F), low energy, malaise, fatigue, flu like symptoms. The patient also had local site tenderness. The patient took Naproxen did not seek additional care outside of self-treatment, as she was a Nurse Practitioner. All symptoms lasted about 4 days and did not anticipate them to be this severe. Low energy level lasted longer. At the time of this report, the patient was feeling like she was getting back to normal. The reporter agreed to follow up.
within 24 hours of injection: fatigue, muscle & joint pain. 36 hours after injection: extreme pain and inflammation in right elbow, burning sensation along entire right arm. within 48 hours: elbow swollen to size of tennis ball, unable to flex right arm without extreme pain. elbow pain and inflammation responded well to treatment with alternating cold and warm compresses. swelling went down after 3 days. After 1 week, fatigue, muscle and joint pain, severe joint pain in feet (esp right), unable to walk, some tingling & pain remain in elbow, full range of motion not yet restored. Missed over 6 days of work - not yet able to see PCP - no appointments available.