chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BACK PAIN; HAND PAIN; KNEE PAIN/WRIST PAIN; COVID VACCINES CAUSED HEADACHE; TIREDNESS; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (BACK PAIN), PAIN IN EXTREMITY (HAND PAIN), ARTHRALGIA (KNEE PAIN/WRIST PAIN), HEADACHE (COVID VACCINES CAUSED HEADACHE) and FATIGUE (TIREDNESS) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   In August 2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced BACK PAIN (BACK PAIN), PAIN IN EXTREMITY (HAND PAIN), ARTHRALGIA (KNEE PAIN/WRIST PAIN), HEADACHE (COVID VACCINES CAUSED HEADACHE) and FATIGUE (TIREDNESS). At the time of the report, BACK PAIN (BACK PAIN), HEADACHE (COVID VACCINES CAUSED HEADACHE) and FATIGUE (TIREDNESS) outcome was unknown and PAIN IN EXTREMITY (HAND PAIN) and ARTHRALGIA (KNEE PAIN/WRIST PAIN) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Normal.  Concomitant product use was not provided by the reporter.  In Aug 2021, patient switched from Humira to Rinvoq and was still experiencing pain in one knee as well as new pain in the wrist and hand since beginning Rinvoq. Covid vaccines caused headache and tiredness. She mentioned she had back pain and knee pain in joints.  Blood work had been normal since being on Rinvoq.  It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of knee pain/wrist pain and hand pain with Rinvoq (Upadacitinib) was a reasonable possibility.  The reporter's causality for the events of covid vaccines caused headache and tiredness unknown onset, covid vaccines caused headache and tiredness unknown onset and back pain with Rinvoq (Upadacitinib) was no reasonable possibility.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Live follow-up information received included added event of Back Pain and suspect product dosage information updated.
lump on her right groin 2 to 2.5 inches in size; hard lump underneath her arms, size of a quarter; lymph nodes from said areas are swollen, hard and warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (lump on her right groin 2 to 2.5 inches in size), PERIPHERAL SWELLING (hard lump underneath her arms, size of a quarter) and LYMPHADENOPATHY (lymph nodes from said areas are swollen, hard and warm to touch) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039321A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (lump on her right groin 2 to 2.5 inches in size), PERIPHERAL SWELLING (hard lump underneath her arms, size of a quarter) and LYMPHADENOPATHY (lymph nodes from said areas are swollen, hard and warm to touch). At the time of the report, SWELLING (lump on her right groin 2 to 2.5 inches in size), PERIPHERAL SWELLING (hard lump underneath her arms, size of a quarter) and LYMPHADENOPATHY (lymph nodes from said areas are swollen, hard and warm to touch) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 96.6 (Inconclusive) 96.6 in Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
She's having a little pain in her arm where the injection is; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program.  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. on an unspecified date, the patient had little pain in her arm where the injection is and was enquiring whether to take Tylenol. The outcome of events was reported as unknown.  No follow up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
Information has been received from a pharmacist referring to a currently 14 year old male patient with Precursor B cell acute lymphocytic leukemia, meningitis, Graft Versus Host Disease and allergy to chlorhexidine and metoclopramide. On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot# were unknown) as a child (medication error). Concomitant therapies included sirolimus, calcium (unspecified), omega-3 marine triglycerides (reported as "fish oil"), budesonide, BACTRIM, lisinopril (manufacturer unknown), vitamin D (unspecified), multivitamins, MARINOL, tacrolimus and triamcinolone. On an unknown date, the patient had a bone marrow transplant and hospitalized. In February 2015, the patient had a cord blood stem cell transplant. On 18-DEC-2015 the patient developed a rash. He was hospitalized and treated with acyclovir intravenously since 24-DEC-2015. The reporter didn't know if the vaccine strain reactivated after the transplant. Lab tests including varicella zoster virus (VZV) polymerase chain reaction, VZV in cerebral spinal fluid and VZV in plasma were performed and the results were unavailable. At the time of reporting, the outcome of rash and bone marrow transplant was reported as recovering. The outcome of cord blood stem cell transplant was unknown. Causality was not provided. The reporter considered the events "rash" and "bone marrow transplant" as life threatening and also considered the event "rash" to be medically significant as acyclovir was given to prevent serious criteria. Additional information has been requested.
After receiving the pfizer booster on November 5, 2021 I started having pain in both breast and under my arms.  The pain lasted about 4 weeks in the left breast and still have tenderous in the right side near breast area as of 1/4/2022. I received the booster in my right arm.   I had a mammogram last week and another today and was told by the doctor I have a cyst in my right breast. I had no pain or symptoms until a couple of days after receiving the booster.
pt had vaccine at local pharmacy - next day had profound weakness & hypertension; went to ER. Follow up c PCP 6-23-2021. Significant weakness Left side ARM & leg. Elevated B.P. Medication ordered. Pt Refused physical therapy. Profound left leg-drag & had to lift leg to walk. Return appt at PCP office on 7/1/21. Very improved muscular Status Left leg & ARM. Persistent HTN.
This spontaneous report was received from a medical assistant and refers to a 20 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 13-DEC-2018, the patient was vaccinated with a pediatric formulation dose of VAQTA lot # R021233, expiration date 05-SEP-2019, intramuscularly for prophylaxis (underdose). No adverse reactions were reported.
Low grade fever 24 hours after A little less than 48 hours later red rash at injection site- warm and sore.  Rash is getting larger as night goes on.
h/a, fever & urticaria p/2nd shot; 23NOV92 f/u vax was given by clinic;
SLIGHTLY DIZZY; A SPLITTING HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021, the subject experienced slightly dizzy. On 15-MAR-2021, the subject experienced a splitting headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from slightly dizzy, and a splitting headache. This report was non-serious.
Breastfeeding mother; This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding mother) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding mother). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding mother) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.
Patient had her first dose of Moderna COVID vaccine 1/14. On 1/22 developed redness and itching of her arm, thought may be due to cellulitis, started keflex. However, since then has had no improvement and has developed worsening redness. The redness now affects her upper L arm, with swelling, itching and less so, but occasional pain as well. Has some firmness in the area where the vaccine was given but the rest of the red area is soft and not painful to touch.  Discussed with our ID specialist, suspect delayed allergic reaction.
~Tingling/numbness in her tongue, itchy throat  that began 10 minutes after she was given her 1st dose of Moderna Covid vaccine ~Pt was given Epinephrine 0.3mg to the right thigh and monitored  Lot # OFM501 exp : 05/2022 ~ Pt initially rated the severity of her symptoms an 8 prior to the shot , epinephrine was given and after 5 mins , she rated her symptoms a 0 .  ~pt was given an epinehrine shot to take home and strongly advised if her symptoms reoccur to give her self another shot and call EMS  ~Vitals : 129/80, P=70, 02=97% on RA
I had a headache, congestive, cough, body ache, fever, and fatigue. I lost my sense of smell. These symptoms lasted for about 6 weeks. The fatigue lasted forever. My sense of smell was about 3 months. I went to get a COVID-19 test, positive result.
Cough, tight upper chest, stiffened upper body, headache, major chills/cold feet, drippy nose, thick mucus, swollen glands, red burning matted runny eyes, stuffed sinus much better AM 1/4, PM 1/4 feeling drained, fine by AM 1/5/18. Called Nurse advisory # AM 1/4; will relay info to Dr. who had her nurse call me that PM saying I contacted a virus which I said I could not be convinced of that.
Arm was quite sore two hours after shot. At approximately 9 pm had severe neck pain such that I couldn't move my head to right or left. Discomfort extended to sides and front of forehead. At 6 am the next morning pain was so severe I could not get out of bed for two hours. I eventually forced myself awake and applied warm compresses to the neck. At around 10 I was able to move my head right and left. It is still somewhat uncomfortable, but I am not in pain.
There was an attempt to give me the 2nd dose of vaccine by a student nurse. When she attempted to give it to me the liquid of the vaccine dripped down the entire length of my arm and onto the floor. I pointed it out to her. She called her teacher over and then the Dr. at the site talked to me. He said that they are not authorized to give a 3rd vaccine. I said I did not get the 2nd vaccine as it dripped down my arm and he witnessed this. The Dr. continued to state that they could not give me a 3rd vaccine and I continued to state I did not receive the 2nd vaccine as it ran down my arm.
Sx of weakness, difficulty with ambulation, muscle atrophy, pain with minimal muscle movement, starting in lower extremities and spreading to arms, shoulders, chest and back. Difficulty with sphincter control; sx consistent with Guillain-Barre Syndrome. Pt. continues with sx.
Injection site pain; tiredness; muscle pain; chills; joint pain; feeling unwell; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A patient (Age: 73; Unit: unknown) of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 20Feb2021 at 14:30 (02:30 PM) as dose 1, single for COVID-19 immunization. The patient medical history included COVID-19 (If COVID prior vaccination: Yes) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within four weeks. Patient was diagnosed with COVID prior vaccination. Patient had not COVID tested post vaccination. On 20Feb2021 at 12:00 AM, the patient experienced injection site pain, tiredness, muscle pain, chills, joint pain, feeling unwell. The patient did not receive treatment for the events. Outcome of the events was recovering.  No follow-up attempts are possible. Information about lot/batch number could not be obtained. No further information is expected.
Pt mother brought child in for a DTAP vaccine to catch up pt with immunization schedule. Pt mother stated she noticed swelling a days later.
A lump inside is arm (the arm that received the vaccine) with a size of a tenis ball; This spontaneous case was received on 21-Oct-2022 from pharmacist via Regulatory Group (reference number: SEQW22-04846) and concerned a 58-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 19-Oct-2022, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; route of administration: intramuscular, dose: 0.5 ml, anatomical location: not reported) as prevention of influenza disease. The batch number reported was AS3704B.  On 20-Oct-2022, one day after receiving Afluria Quadrivalent, the patient woke up with a lump inside his arm (the arm that he received the vaccine) with a size of a tennis ball.   At the time of initial reporting, on 21-Oct-2022, the patient had not recovered from the event.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 58-year-old patient developed axillary mass one day after receiving the suspect product Afluria Quadrivalent. The patient's medical history and concomitant drugs were not provided. Based on plausible temporal relationship, causality for the reported event is assessed as possibly related.; Sender's Comments: A 58-year-old patient developed axillary mass one day after receiving the suspect product Afluria Quadrivalent. The patient's medical history and concomitant drugs were not provided. Based on plausible temporal relationship, causality for the reported event is assessed as possibly related.
This spontaneous retrospective pregnancy report has been received from a physician referring to a female patient of unknown age. No information was knew by the reporter regarding the patient's medical history, concurrent conditions, drug and allergy history or concomitant medications. On an unknown date, during early pregnancy, the patient was vaccinated with one dose GARDASIL 9 (strength,anatomical location, route of administration, lot# and expiration date were not provided) for prophylaxis. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known. The patient miscarried on an unspecified date (abortion spontaneous). Furthermore, it was reported that the pathology for the fetus showed: "placenta with unusual changes that looked like they were more viral, biopsy nuclear changes" (placental disorder). The outcome of abortion spontaneous and placental disorder, and the causality between the aforementioned events and GARDASIL 9 were not reported. The event abortion spontaneous was determined to be medically significant.
This case was reported by a consumer via call center representative and described the occurrence of runny nose in a 80-year-old female patient who received SHINGRIX for prophylaxis. On 22nd August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 23rd August 2018, 1 days after receiving SHINGRIX, the patient experienced runny nose, appetite absent, burning in eyes, eye discharge and nasal burning. On an unknown date, the outcome of the runny nose, appetite absent, burning in eyes, eye discharge and nasal burning were not recovered/not resolved. It was unknown if the reporter considered the runny nose, appetite absent, burning in eyes, eye discharge and nasal burning to be related to SHINGRIX. Additional detail were provided as follows: The patient received SHINGRIX in the left arm. The patient planned to follow-up with her physician on an unknown date.
Diarrhea; This spontaneous case was received from consumer concerning of an unknown age patient, who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination and experienced diarrhea.   The patient's past medical history was not provided. Concomitant product use was not provided.  On an unknown date, prior to the onset of the symptoms, the patient received their doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced hospitalized will be released to assisted living and diarrhea. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not reported.  The outcome of the event diarrhea was not reported.; Reporter's Comments: This case concerns a male of unknown age hospitalized with a serious unexpected event of diarrhea.  Event onset with unknown latency after first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Got her 2nd dose 5 days early and is only supposed to get up to 4 days early
Left arm soreness Narrative: 12-26-2020:  Noticed numbness at the sole of the right foot, upon waking up in the mornings & walking around, but eventually would go away as the day progressed- This continued like this for some more mornings, but not bothersome anymore.
Information has been received from a consumer concerning her relative 3 year old daughter with symptoms of autism who was vaccinated at 1 year of age with a dose of MMR II and then was diagnosed with autism. Additional information is not expected.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 10-NOV-2012 01:20, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
DEMAND ISCHEMIA 3/27/2023 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION ACUTE RESPIRATORY FAILURE 3/27/2023 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION
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, start therapy date were not reported 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 an unspecified date, the patient experienced possible adverse reaction. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible adverse reaction was not reported. This report was non-serious.
This spontaneous report was received from a nurse and refers to a 6 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 30-SEP-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N006321, expiry date: 08-NOV-2019) and ROTATEQ (dosing details not reported) (lot # N009948, expiry date: 12-OCT-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011.
Pt developed a firm knot at injection site on right thigh within 24 hours of vaccination. Approx. 6 weeks later, mom noticed area was still firm and surface skin had become purplish in color. This became raised and the center was soft. Mom applied pressure with a finger and the lesion opened and drained. Evaluation of skin per MD (not until 3/24/03) showed 1cm diameter lesion with 2 scabbed areas within purplish macular lesion. No redness or inflammation. A firm 6-8mm lesion remains beneath the skin surface. Pt was not fussy or bothered by exam and does not guard the extremity. There is no drainage. DX: Reaction to immunization (? DTAP) with questionable sterile abscess.
CHILLS, FEVER,  BODY ACHES, RINGING IN EARS INCREASED
Developed varicella after vaccination. Follow up 01/19/05: Vaccination given at another facility, manufacturer unknown.