chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Aches; Fever of 101; Weird headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches), HEADACHE (Weird headache) and PYREXIA (Fever of 101) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 071F21A) for COVID-19 vaccination.     Concurrent medical conditions included Selective IgM immunodeficiency (Low IgM an autoimmune thing.).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Weird headache). On 06-Mar-2021, the patient experienced MYALGIA (Aches) and PYREXIA (Fever of 101). On 06-Mar-2021, HEADACHE (Weird headache) had resolved. On 06-Mar-2021 at 5:00 PM, MYALGIA (Aches) and PYREXIA (Fever of 101) had resolved.            Patient's Past medical History stated history of low IgM an autoimmune thing. She doesn't build a lot of antibodies. No concomitant medications were mentioned. Treatment medication reported included Long acting arthritis Tylenol which was used after 3rdd dose.   This case was linked to MOD-2021-367692 (Patient Link).
All symptoms I had when I had Covid in March 2020 returned within 12 hours of receiving this vaccine.  Had body aches, severe chills, nausea, and 102.5 fever along with fatigue.  Symptoms lasted 36 hours and subsided only to return 12 hours later. with chills and fever of 101.7.  Taking Advil and Tylenol alternating every 4 hours.
aching in arm; aching in neck; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced pain in arm and neck pain. On an unknown date, the outcome of the pain in arm and neck pain were unknown.   It was unknown if the reporter considered the pain in arm and neck pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-NOV-2022 Reporter's Comments:  This case was reported by a consumer via interactive digital media. The patient reported that he or she had aching in his/her arm and neck 3 weeks after receiving 2nd shingles shot. The patient asked it was normal or not.  Additional Supportive Information:The follow-up could not be possible as no contact details were available.
After receiving the Moderna  vaccine at health facility, Itching  and swelling occurred in area of injection. Size:  5?    Appeared about 5 days after injection.
Administered Vaccine that was a punctured vial and stored at room temperature for more than 6 hours; A spontaneous report was received from a pharmacist concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered a vaccine from a punctured vial stored at room temperature for more than 6 hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026020A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 05 Jan 2021, a pharmacist administered the vaccine to the patient from a vial that had been previously punctured and stored at room temperature for a total of 18 hours. The patient reported no adverse reactions. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, administered a vaccine from a punctured vial stored at room temperature for more than 6 hours, was considered resolved on 05 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use for mRNA-1273.  There were no reported adverse events associated with this case.
August 14, 2007 - lot # 0384U - afternoon shot injection site itchy, sore. Flu like symptoms. Sore joints and muscles in the months to follow. Exhaustion. Dr.'s office said the symptoms were normal. November 14, 2007 - lot # 0927U - afternoon shot. Injection site more itchy, sore, red, swelling. Flu like symptoms for days. Sore joints and muscles, headaches, hair loss, exhaustion. Dr. office was not worried about symptoms. February 14, 2008 - lot # 12APR10 - vomiting, shaking, feverish, itchy/sore injection site, redness, swelling entire arm. Sore joints, muscles, fatigue, hair loss (more) migraine, home from school 1 1/2 wks flu like symptoms. Many, many, many Dr. visits, hospitalization ER visits until October 2009 when she became paralyzed on right side, loss of vision, hearing loss. Stay for couple weeks, home recovery. Learned to walk again. Repeat of above January 2011. Week stay. Hospitalization for seizures (4 days). Medical diagnoses: Perfectly healthy until GARDASIL now suffers daily from: Leaky Gut Syndrome, pins/needles in extremities, dizziness, dental issues, brain fog, sensitivities to chemicals, chest pains, constipation/diarrhea, enlarged liver, sound sensitivity, anxiety, extreme pain tailbone, fainting, fevers and blisters, back pain, hot/cold intolerance, sleep problems, itching, joint pain, knee pain, light sensitivity, blindness (right side), depression, personality changes, panic attacks, loss of bladder control, bladder issues, muscle aches, spasms, muscle tension tumor in left tibia, paleness, chronic fatigue syndrome paralysis, pneumonia, severe nerve pain, shortness of breath, slurred speech, smell sensitivity, sore throat stomach pain, swelling/edema, tremors, random twitching of extremities, bloating, uterine spasms, blood clotting, numerous UTI's, kidney problems, vision loss, stomach aches, nausea, rashes, appetite loss, vomiting, dyslexia, hallucinations, large weight loss, seizures, autistic behaviors. Tumor removed December 2010.
Injected patient with syringe and began to move the plunger. The plunger did not move or moved very little. I withdrew the needle from the patient and shielded the needle. I looked and saw that the full volume of the immunization was still in the syringe. The patient reported feeling a thud when injecting.  She did not report any other symptom or issue. The immunization was given again with a new needle and syringe.
Patients primary care provider at facility was notified patient went to ER on 5/20/22 for allergic reaction, possible allergic rhinitis, and 20 weeks pregnant. Patient had Covid vaccine #2 at Medical Center on 5/18/22. Symptoms included ""itchy" since Moderna Covid vaccine 2 days ago. Also has red, raised 4cm spot around injection site. Denies pregnancy complaints at that time".  Also had "puffy/itchy eyes/infraorbital areas and painful, red, raised area of skin over her left shoulder. Denied fever, swelling of tongue/lips, difficulty breathing, hives/disseminated rash, syncope, weakness, or concerns to her pregnancy".  Clinical Impression: Allergic reaction, initial encounter, possible allergic rhinitis.
Body aches; fatigue; headache; not feeling well; Muscle aches; elevated temperature; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received the first dose of bnt162b2 (BNT162B2 also reported as Covid-19 vaccine by Pfizer, lot EK5730), intramuscular 20Dec2020 15:15 at single dose in left arm for Covid-19 immunisation. Medical history included High blood pressure and interstitial cystitis interstitial. Concomitant medications included losartan and hyoscyamine sulfate, methenamine, methylthioninium chloride, phenyl salicylate, phosphoric acid sodium (URIBEL). The patient previously took doxycycline and experienced drug allergy.  The patient experienced body aches, fatigue, headache, was not feeling well, muscle aches, elevated temperature, all on 21Dec2020 12:00. The events were reported as non-serious. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, the patient was been tested for COVID-19 via nasal swab on 22Dec2020 with pending results. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Red blotches and rash on upper arm with very slight bruising.  Lasted from day 7 until day 11 after shot.
Kindergarten vaccinations given 7/19/05. 7/20 right arm swelling around site, itchy. Mom gave Benadryl, Tylenol cool compress. Seen in office 7/21; swollen, warm right arm to elbow. Mild exacerbation from scratching, no adenopathy or systemic sx.
p/vax pt broke out w/few spots & more spots around site given; no fever; doing well otherwise
A  male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Apr2021 12:30 or 12:35  (Batch/Lot Number: ER8731) as single dose for covid-19 immunisation. Medical history included migraine from 2000 to an unknown date, ongoing hepatitis c. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE) taken for migraine. The patient previously took atropine and experienced hypersensitivity. Caller states that he got the vaccine at 12:30 in the morning and he got a headache at 5 or 6 o'clock in the evening. He read also, in his country, that with other vaccines, not Pfizer, that after each shot they had a mild headache.  He states that he read on line that it is normal to get a headache after getting the vaccine and that it can last up to three days. He states that the headache can come on again and off again. He states that once you get a migraine it doesn't go away until you take medication. He states that he has been taking medication for years so he knows that this is a migraine headache and not related to the vaccine. He states the next day after getting the vaccine the headache was gone. From Friday until Sunday he was fine, for 3 days he had nothing. Now he states its a migraine. He woke up and felt like he has motion and wants throw up. He states that if you are hungry and you go to sleep and then you wake up that feeling will come back after sleep. So when he goes to sleep, and wakes up with a migraine, he takes medication and it goes away.  He states that he read online that within 24 hours don't take any medication because it can lessen the effect the vaccine. He states he knew that getting a headache was normal, now he know it is not Pfizer's vaccine effect, he knows it's a migraine. He was just wondering if he can take his medication. He states that he read that you can have a headache for two or three days after the vaccine. He is calling because has been sick with a migraine for a long time. He has been taking Excedrin migraine medication for migraines because it saves him all the time. He wants to know if he can take medication now or should he avoid it. He states that he read somewhere that it is normal to have a headache for up to three days after getting the vaccine so he was ready for it. He also read some where that he should not to take and medication with in 24 hours of getting the vaccine and he wants to know if he can take the medication now. The outcome of the event headache was recovered The outcome for the events migraine and he has a motion and wants to throw up was unknown. No follow-up attempts are needed. No further information is expected.
felt very uncomfortable; tenderness; muscle pain/muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt very uncomfortable), TENDERNESS (tenderness) and MYALGIA (muscle pain/muscle ache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 032M20A) for COVID-19 vaccination.     The patient had never been tested positive or diagnosed with COVID-19 disease. No other vaccine was given to the patient within 1 month prior to Moderna COVID-19 vaccination.  Concurrent medical conditions included Penicillin allergy and Herniated disc. Concomitant products included BUPRENORPHINE HYDROCHLORIDE (BELBUCA) for Pain, MULTIVITAMINS [VITAMINS NOS], COLECALCIFEROL (VITAMIN D3), VITAMIN B2 [RIBOFLAVIN], ZINC and PARACETAMOL (ACETAMINOPHEN) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt very uncomfortable), TENDERNESS (tenderness) and MYALGIA (muscle pain/muscle ache). At the time of the report, FEELING ABNORMAL (felt very uncomfortable), TENDERNESS (tenderness) and MYALGIA (muscle pain/muscle ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, HLA-B*27 assay: positive (Positive) positive.         Concomitant medications also included Soloxide, anti inflammatory medications and birth control medications.  The patient did not experience any issues after receiving the first dose. The side effects lasted for 3 weeks. The symptoms were not as severe in nature as compared to the events experienced after the booster dose.  No treatment information was reported.   This case was linked to MOD-2022-551348 (Patient Link).
CHILD FAINTED AFTER RECEIVING HPV VACCINE AT FRONT COUNTER IN OFFICE. WHEN SHE CAME AROUND SHE EXPLAINED TO THE PHYSICIAN THAT SHE HAD PAIN AND NUMBNESS FROM HER SHOULDER TO HER ELBOW AFTER RECEIVING BOTH OF THE HPV VACCINES (THIS WAS HERE 2ND)
anaphylactic reaction; coughing; sneezing; swollen throat; couldn't breath; first dose of DTap (Infanrix) in 2013, the second dose in 2016 and the third dose in 2017; first dose of DTap (Infanrix) in 2013, the second dose in 2016 and the third dose in 2017; This case was reported by a physician via other manufacturer and described the occurrence of anaphylactic reaction in a patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   Previously administered products included Infanrix (received 1st dose in 2013).   On an unknown date, the patient received the 2nd dose of Infanrix and the 3rd dose of Infanrix. On an unknown date, not applicable after receiving Infanrix and unknown after receiving Infanrix, the patient experienced anaphylactic reaction (serious criteria hospitalization and GSK medically significant), cough (serious criteria hospitalization), sneezing (serious criteria hospitalization), throat swelling (serious criteria hospitalization), difficulty breathing (serious criteria hospitalization), drug dose administration interval too long and drug dose administration interval too long. On an unknown date, the outcome of the anaphylactic reaction, cough, sneezing, throat swelling, difficulty breathing, drug dose administration interval too long and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the anaphylactic reaction, cough, sneezing, throat swelling and difficulty breathing to be related to Infanrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose in 2016, which led to lengthening of vaccination schedule. The patient received 3rd dose in 2017, which led to lengthening of vaccination schedule.  The patient experienced anaphylactic reaction. The patient went to urgent care by ambulance to the hospital. The patient experienced coughing and sneezing and swollen throat and could not breath. No additional information was reported.
L upper arm above elbow erythema with swelling. Tx-Keflex 500mg q 6 hr x 7 days, Benadryl 25mg q 6 hr x 3-5 days.
booster; got infected with covid19 two weeks after receiving the booster dose; got infected with covid19 two weeks after receiving the booster dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got infected with covid19 two weeks after receiving the booster dose". The reporter stated that the patient chose to get the 3 doses of the vaccines but got infected with covid19 two weeks after receiving the booster dose and was feeling severely unwell. She stated that the vaccines may as well not be effective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 30 minutes after receiving vaccine, pt noted facial itching and feeling of disorientation, "like things are moving in slow motion".  On exam, no rash no angioedema, no neurologic abnormalities.  Pt given Benadryl 50mg IM with subsequent resolution of symptoms.
When the shot was being administered the plunger was jammed and had problems being pushed down to inject. About 36 hours after the shot, the patient started having shooting pain in his arm, and he has had trouble lifting his arm. He has been in pain when trying to sleep. He is still having pain, but it is getting better. He is taking ibuprofen for it and said it feels best when in a warm shower.
Pain, redness, swelling (R) arm. Patient taking ALLEGRA, IBU, and using ice packs.
Patient was fully vaccinated with a booster but tested positive for Covid on 6/6/21; Patient was fully vaccinated with a booster but tested positive for Covid on 6/6/21; Patient was fully vaccinated with a booster but tested positive for Covid on 6/6/21; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: IMMUNISATION (medically significant), outcome "unknown", DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jun2021, outcome "unknown" and all described as "Patient was fully vaccinated with a booster but tested positive for Covid on 6/6/21". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jun2021) positive.  Clinical information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report received from a patient via a company representative via social media (J&J Corporate) concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient's were previously treated with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose not reported, 1 total,  administered on an unspecified date for covid-19 prophylaxis. It was unknown if patients experienced any adverse event after covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient's received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the people were dropping off like flies until they got all these vaccinations and booster shots (dose number in series 2). It was reported that: "People that I know are dropping off like flies that were in good health until they got all these vaccinations and booster shots." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of people that know are dropping off like flies until they got all these vaccinations and booster shots was not reported. This report was non-serious. This case is a duplicate of 20220809692. Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Approximately 4 hours after vaccine administered patient reported:Visual changes including letters appearing in different sizes, unsteady gait, muscle weakness and unusual sensation in hands while typing. Patient went to emergency room for evaluation. Patient was contacted on 9/10/09 and symptoms resolved.
Has just tested positive for covid virus; high fever; wasn't feeling well; headache; This is a spontaneous via medical information team. A contactable consumer (patient) reported that a 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 26Jan20021 at single dose for COVID-19 immunization. The patient medical and concomitant medications were not reported. The patient got first dose of the Pfizer covid vaccine on 26Jan2021 and came down with a headache on 26Jan2021, was running a high fever, wasn't feeling well on 29Jan2021 on the weekend. tested positive for covid virus on the 01Feb2021. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Information has been received from a physician concerning a 15-month-old male who on 02-NOV-2007 was vaccinated subcutaneously in the right leg with a first dose of varicella virus vaccine live (Oka/Merck) (lot# 658300/1022U). On 06-NOV-2007, the patient experienced papules, vesicles on the legs and back and was diagnosed with possible varicella from the vaccine. The outcome was unknown. Additional information has been requested.
Approximately 5 days post-initial injection, severe histamine, allergic reaction with skin redness and swelling covering entire body. From head to feet, circumferential redness, tachycardia (HR >130), and Shortness of breath. Treated with 50mg benadryl, 300mg glucocorticoid, and 10mg of Famotidine. Medicine administered within 30 min of symptom onset  Facial swelling lasted approximately 2-2.5hrs post medication administration. Whole body redness lasted 5 hours from initial reaction.
Employee reported to the employee health clinic 3 days after receiving the Pfizer COVID vaccine and had complaints of a 30mm indurated area on her right arm. She states she vomited once that night and had a headache. Took Tylenol and seemed to help. Encouraged employee to apply cold compress to arm and notify if symptoms of arm swelling get worse or any new symptoms of a reaction arise.