chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Joints fingers middle finger locks; Right hand aches; Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), JOINT LOCK (Joints fingers middle finger locks) and PAIN IN EXTREMITY (Right hand aches) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free, pre-filled pen. On an unknown date, the patient experienced ILLNESS (Sick), JOINT LOCK (Joints fingers middle finger locks) and PAIN IN EXTREMITY (Right hand aches). At the time of the report, ILLNESS (Sick) had resolved and JOINT LOCK (Joints fingers middle finger locks) and PAIN IN EXTREMITY (Right hand aches) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications information was reported. The information was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were provided.
This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 24-MAR-2016, the patient was vaccinated with improperly stored (Merck) VARIVAX (dose: 0.5 ml, lot # L040421, expiry date: 15-OCT-2017) via intramuscular route (incorrect product storage). Nurse reported that the vaccine underwent a temperature excursion of 37 degree Fahrenheit for 96 hours. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Pfizer on 2/20 and 3/12. Positive on 11/17
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  OBSTRUCTIVE SLEEP APNEA NEUROPATHY
Patient, described extreme tendonitis in left upper shoulder 3 hours after injection.  Four days later, it is still difficult to move or raise her arm.  Patient states that immunizer gave vaccine too high on her shoulder.
ill, fever, fatigue, vomiting, runny nose, mild sore throat Still ongoing (24hours and continuing)
depression; feeling anguish/ feeling anxiety; felt like crying; fever; body aches; slept all night; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (depression), SOMNOLENCE (slept all night), PAIN IN EXTREMITY (arm hurt), ANXIETY (feeling anguish/ feeling anxiety) and CRYING (felt like crying) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A-HRSA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression. Concomitant products included CORTISONE for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced SOMNOLENCE (slept all night), PAIN IN EXTREMITY (arm hurt), PYREXIA (fever) and MYALGIA (body aches). On 22-Mar-2021, the patient experienced ANXIETY (feeling anguish/ feeling anxiety) and CRYING (felt like crying). On an unknown date, the patient experienced DEPRESSION (depression). The patient was treated with MIRTAZAPINE ongoing since an unknown date for Depression, at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, DEPRESSION (depression) had not resolved and SOMNOLENCE (slept all night), PAIN IN EXTREMITY (arm hurt), ANXIETY (feeling anguish/ feeling anxiety), CRYING (felt like crying), PYREXIA (fever) and MYALGIA (body aches) 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.   Additional information was provided that patient had got started after when she had got cortisone IV. Patient had took mirtazapine for depression which had affected her sleep   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24-May-2021 and contains no new information
Hands keep going numb; My arms, shoulders, hips and legs have severe pain to the point I can't take it anymore; My arms, shoulders, hips and legs have severe pain to the point I can't take it anymore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arms, shoulders, hips and legs have severe pain to the point I can't take it anymore), HYPOAESTHESIA (Hands keep going numb) and ARTHRALGIA (My arms, shoulders, hips and legs have severe pain to the point I can't take it anymore) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Levaquin).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (My arms, shoulders, hips and legs have severe pain to the point I can't take it anymore) and ARTHRALGIA (My arms, shoulders, hips and legs have severe pain to the point I can't take it anymore). On an unknown date, the patient experienced HYPOAESTHESIA (Hands keep going numb). At the time of the report, PAIN IN EXTREMITY (My arms, shoulders, hips and legs have severe pain to the point I can't take it anymore) and ARTHRALGIA (My arms, shoulders, hips and legs have severe pain to the point I can't take it anymore) had not resolved and HYPOAESTHESIA (Hands keep going numb) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Significant follow up received, contains patient demographics (Race), event onset date and outcome for pain in extremity and arthralgia was not recovered and Added new event as numbness in hands
Information has been received from a registered nurse who heard from another person that during a support group meeting for parents with kids with Hodgkin's disease, a couple of mothers mentioned that their daughter received GARDASIL before being diagnosed with Hodgkin's disease. The patients sought unspecified medical attention. At the time of the report, the patients' outcome was unknown. The nurse was not sure how many patients were involved it was all hearsay. This is a hearsay report in the absence of an identifiable patient. Attempts to verify the existence of a patient have been unsuccessful. Upon internal review, "Hodgkin's disease" was determined to be an other important medical event. Additional information is not expected.
Shot given at 11:45 am and by 10pm he had a fever. At 6:00 am the next morning he was violently throwing up to the point he couldn't stop and severe diarrhea. The nurse on call told me to take him to the emergency room. Took him to the emergency room where they stated this was reaction to the vaccine. They gave him ZOFRAN to stop the vomiting and after an hour or so gave him a popsicle and sent him home. 2 days later he broke out in a measles like rash over his entire body. He had the rash for almost 10 days. By the 4th day I took him to the doctor's office on August 20th where the doctor on call tried to state it wasn't from the vaccine but I know it was. After 10 days the rash finally cleared but then showed up again September 3rd and still has it now.
This spontaneous report was received from a certified medical assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9 lot # L016429/ expiration date 09-AUG-2017, lot no. L02660/ expiration date- 19-OCT-2017, lot # L026602/ expiration date- 19-OCT-2017 (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature excursion and time frame was 49F for 143 hours and 34F for 24 hours. There was no previous temperature excursion and call was not because of the data logger. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
CIDP an extremely painful and debilitating issue; CIDP an extremely painful and debilitating issue; CIDP an extremely painful and debilitating issue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (medically significant), PAIN (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "CIDP an extremely painful and debilitating issue".  Clinical course details: The patient has been struggling with what appears to be CIDP, an extremely painful and debilitating issue. The patient has been told that gammagobulin can treat this disorder but it takes months for someone to get him in for an appointment. The patient was afraid that his time was running out.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Breakthrough atypical varicella. Papular, pink, on abdomen and left side of face, some with clear papule in center and itching.
Pt recvd 1st dose Engerix-B 06JUN91 & on evening of 12JUN91 pt c/o general malaise, muscle aches, nausea, & moderate to severe h/a; exp flu-like sx on 13JUN91; no tx given; MD suggest sx not related to vax & Globulin - poss viral infect
Metallic taste hour about an hour after shot that lasted about an hour.  Severe headache that lasted about 4 days, mild headache another 3 days  Most concerning was a super sensitive, tingly lower back.  A ?rash? developed Monday (4/12). I went urgent care on 4/17 and was diagnosed with shingles.
Asthenia / fatigue; Mental status change, photophobia, roseola -  Information has been received from a physician concerning a 1 year old female who on 26 June 2000 was vaccinated with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Concomitant therapy included the first dose of Haemophilum S conjugate vaccine (Hib Titer).  On 05 Jul 2000 the patient experienced a fever and lethargy.  The patient then developed a macular papular rash which began on her face and descended to the rest of the body.  On 08- July 2000 the patient experienced photophobia and had a questionable mental change.  The patient sought medical treatment.  Lab work from 17 Jul 2000 revealed a positive IgG and Igm was negative for antibodies to the measles virus.  A white count was 6000 with a differential that included 69% lymphocytes.  The reporting physician thought it was roseola.  On 12 Jul 2000 the patient recovered from all of her symptoms.  Additional information has been requested.
onset of body aches, fatigue, tachyccardia a few hours after receiving his second vaccine dose on 1/8/21.  onset of and L3 dermatome shingles on 1/10/21 pulse was 138 on presentation for evaluation 1/13/21. Hypertensive 170/80
Chest pain c/w pericarditis.  Ibuprofen.  Seen in ED
Delayed injection spot immune reaction: red, warm, itchy spot at injection site. Started fading the next day
HAVING ISSUES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the patient experienced having issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from having issues. This report was non-serious.
exposed to covid, sx 11Jan2022 then resolved and BF whom she lives with tested Ag+ 12Jan and she was neg Ag 12Jan but I suspect she was just too early for the Ag to show; exposed to covid, sx 11Jan2022 then resolved and BF whom she lives with tested Ag+ 12Jan and she was neg Ag 12Jan but I suspect she was just too early for the Ag to show; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 17Feb2021 (Lot number: EL3247) as dose 2, single and administration date 27Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 12Jan2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 12Jan2022, outcome "recovered" and all described as "exposed to covid, sx 11Jan2022 then resolved and BF whom she lives with tested Ag+ 12Jan and she was neg Ag 12Jan but I suspect she was just too early for the Ag to show". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) negative. It was unknown if therapeutic measures were taken as a result of suspected covid-19. It is unknown that the patient received any vaccines within 4 weeks prior to the COVID vaccine. It is unknown that the patient diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
Headaches and malaise and feeling like in a stupor upon arising the next day after the vaccine.
Heavy menstrual bleeding (menorrhagia), massive clots followed by bleeding, ongoing 11 days. Abnormally high compared to any menstrual cycle in entire life.
Pt got DTaP # 5, IPV # 4, MMR #2, and Hep A #1 on 05/10/2005 in our office. Reaction started on 05/11/05 at night, including swelling, redness, warm to the touch and tissue underneath was hard like a "knot" 4x3 1/2 " area.
After vaccination on 10/3/23 felt sluggish, malaise x 5 days.
Right after receiving a shot I asked the patient to have a seat for 15 min, about a min later patient fainted, syncope, on the chair for about half a min. While I was calling 911 he became conscious and refused ambulance. While already being conscious pt started to sweat. I was told after that he didn't eat since the day before. A person who accompanied him gave him orange juice and chocolate. In about 10-15 min pt returned to normal. Another 15 min and he left.
This medically confirmed spontaneous report (initial receipt 28-Nov-2011) concerns a 63 year old female patient, who had a medical history of cancer and occasionally had a drug reaction to Aspirin (acetylsalicylic acid). On 14-Oct-2011 the patient received AFLURIA (batch number: N55105) injection in her left arm. In the first week of November the patient's left arm was in severe pain. Her family practitioner prescribed 'two rounds of steroids' along with various pain medication. The medication had not alleviated her symptoms and she continued to experience severe pain in her arm. She wrapped the arm now and she reported that it hurt less when she was laying down. She had been unable to work for 3 weeks. The patient received physical therapy and had blood studies. Her left arm was also 'black and blue' at the injection site. The physician has ordered an x-ray of her affected extremity. The event outcome was not recovered. The reporter considered event to be serious due to significant disability or incapacity as the patient was not able to work.
hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: hurt). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient got his/her shingles shots. The patient stated that it hurt but what he/she heard nothing in comparison to getting shingles.  The reporter further stated that most insurance covered it or went to health unit but got it . The follow up would not possible as no contact details were available.
Patient admitted for Acute hypoxemic respiratory failure. On 3/20 day of dc her O2 at rest was 92% so she will likely do all right w/o O2 at home. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Within the past months (from 13-MAY-2015 to 13-JUL-2015), the patients were vaccinated with improperly stored doses of VAQTA (lot # K019560, expiration date 02-JUN-2017; lot # K010579, expiration date 12-FEB-2017, dose and route were unknown). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored GARDASIL (dose, strength, frequency, route and lot# were not reported). No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Actor died from receiving a COVID-19 Vaccine from a specific lot number; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), as dose number unknown, single (Lot number: EN66208, Expiration Date: 30Jun2021) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "Actor died from receiving a COVID-19 Vaccine from a specific lot number". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: A call from the reporter was received complaining about why Pfizer has not called patients back from receiving a COVID-19 vaccine from a specific lot number. Reporter was not the patient, she was just calling to complain. All she stated that why haven't Pfizer called, did a recall for the patients who received the COVID-19 Vaccine Lot# EN66208. Patients were dying and was stating that an actor died from receiving the shot (Clarified as Pfizer COVID-19 Vaccine) from this particular batch number. Reported COVID-19 Vaccine expiration date was 30Jun2021.; Reported Cause(s) of Death: Actor died from receiving a COVID-19 Vaccine from a specific LOT number
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16 year-old female patient of an unspecified race and ethnicity received for immunisation on an unspecified date a single dose of TRUMENBA and a dose of MENVEO in the left arm and a dose of influenza vaccine. The patient medical history and concomitant medications were not reported. On an unspecified date, 3-4 hours post the vaccinations, the patient experienced pain in arm and she felt dizzy almost like she was going to faint. By the next day she had intense pain in entire arm, neck, chest down her abdomen and down her leg. This was only on left side where meningococcal vaccines were given together. Outcome was unknown.
Day after vaccine I felt irritable and not wanting to interact with people. But it quickly, that evening, subsided.  Heart pain during Covid positive isolation. EKG scheduled on 2/2/2022 at doctor's office.
12/08/21 presents to ED as transfer from alternate hospital for "sustaining a fall and subsequent cervical spinal injury". PMHX of "pontine cavernous malformation".
pt recvd vax; acute pain in upper rt arm characterized as "probable radiculopathy"; dx as arthritis; tx included cervical collar, motrin & soma;
Shivering, total body aches, headache. Flu like symptoms. Also arm very sore and difficult to lift arm because of pain.
First day had major chills, then fever and headache. After two days those symptoms subsided and  72 hours later feeling fatigued and tired.
Initial solicited report received on 17 May 2017 from an investigator (Defense Health Agency) in the trial. A 22-year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number and route, site of administration not reported) on 19 October 2016. On 03 November 2016, 15 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified, and on 07 November 2016, 19 days post vaccination the subject was diagnosed with I31.9 disease of pericardium, unspecified. The lab data included within 30 days post vaccination on 30 October 2016, the Troponin I was abnormal (the highest value was recorded as 51.00), ECG was abnormal, Echocardiogram was normal, MRI (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The events outcome was not reported. Relationship to investigational product according to company: associated Relationship to investigational product according to investigator: not reported. List of documents held by sender: none. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.; Sender's Comments: This case involves a healthy 22-year-old male who developed acute pericarditis unspecified with favorable temporal association post vaccination with ACAM2000. Acute pericarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis, pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
Arm was sore for about 3 days and I had a lump it might have been a little red, then on the 9th day I had a red area about 2 in in diameter and a bit of rash around the red area and the area was now hard.
Redness, swelling to injection site, worse on second day, swelling and redness went down some by third day.
Low grade fever,  pain throughout body,  localized swelling and infection on right foot of unknown origin, reocurrence of shingles outbreak previously under control by two shingles vaccines, rash on left leg from knee to hip and above right elbow, stomach issues (uncontrolled diarrhea), burning pain on right leg.