chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red circle (size of a quarter) appeared 7 days after the vaccination. Red spot is warm to the touch, but not pain
Shivering, body aches, site ache, fever up to 101.4, tiredness, unsteady pace walking
Reporting a symptomatic positive COVID swab after the completion of Moderna Vaccine series. Became symptomatic  on 5/11/2021:  Description of symptoms-Characteristics (severity/quality/duration)  Runny nose Headache Body aches Nausea earlier-gone now   Vaccinated with Moderna vaccine 2/9/21, 3/15/21
sore arm at the site of the injection; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (sore arm at the site of the injection) in a 62-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     The patient's past medical history included Heart attack ((before the vaccine)), Lung cancer (2x (2019, 2021 not sure if after the 1st dose)) and Radiation therapy. Concurrent medical conditions included COPD, Blood pressure high ((before the vaccine)) and Osteoporosis ((just diagnosed a few months ago)).    On 17-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced INJECTION SITE PAIN (sore arm at the site of the injection). At the time of the report, INJECTION SITE PAIN (sore arm at the site of the injection) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2023-748633 (E2B Linked Report). This case was linked to MOD-2023-748624 (Patient Link).; Sender's Comments:  MOD-2023-748633:husband case
Laryngitis; This spontaneous case was reported by a consumer and describes the occurrence of LARYNGITIS (Laryngitis) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LARYNGITIS (Laryngitis). At the time of the report, LARYNGITIS (Laryngitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.    Reporter did not allow further contact
pt didn't notice anything until this morning, came in and showed me approx 5-6 small inflammatory patches (without any other symptoms ie no itching) on same arm as the shot but different location.  pt is also experiencing nasal congestion.  Advised patient to take benadryl, keep area cool, inform her md's tomorrow, keep a close watch on symptoms, and get help immediately if experience any breathing issues.  She said she will go into primary care doctors office tommorrow.
doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The vaccine was removed from freezer on 18-Oct-2021 at 8 am. No treatment information was provided by the reporter. This case concerns a female patient, unknown age, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred on the same day after first dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient, unknown age, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after first dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
This patient was given a dose that was expired. The ActHib vaccine had expired on 3/7/21 and it was administered on 3/22/21. There were no adverse symptoms observed. The patient has been notified and scheduled for a new ActHib vaccination.
Narrative: patient reported to have rash/hives behind knee and spreading one day after receiving vaccine. Also reported shortness of breath, fever (104) and hypotension (80/60). Patient admitted to local hospital (date of admission/length of stay not clear) patient was given IV antibiotic and discharged on 14 days of doxycycline for lyme flare-up. Symptoms: Symptoms: 1. Fever, 2. RespDepression, 3. Rash, 4. HYPOtension  10/17/08 Reviewed ER medical records of 7/25 & 7/26/2008. FINAL DX: injection site allergic reaction, Lyme's disease Records reveal patient experienced fever, chills, aches, back & joint pain, weakness, right popliteal swelling & rash. Left arm injection site allergic reaction, erythema, induration.  Tx w/IV antibiotics & d/c to home on continued oral antibiotics.
My son was a normal kid from birth to 4 years old when he had a seizure and brain strokes. Post vax, he slept about 3 hours and when he awoke he was staring at the TV which was turned off. His eyes rolled over, he threw himself backwards and started to shake. I placed him on the floor and he started to clench his teeth, still shaking and foam was coming out of his mouth. At this point, his tongue was purple and he started to get pale and cold. I called 911 and they took him to the hospital. He was found to have an ear infection. We went home on 11/26/01. He had a second seizure on 11/28/96. He has seizure activity occurring about 5 X a month. He started going to rehabilitation clinic, occupational therapy, physical therapy and a neurology clinic. He also started going to the psychiatric clinic. He had to go to a special school class to learn all he had lost. On 11/25/96, I called 911 and they come and took him to the hospital. At 4 1/2 years of age, the pt has frequent tantrums, kicks, pushes, bites, throws objects around. He has poor listening skills, retention and comprehension, short attention span and unable to sit for a while (high energy level). He has a severe speech problem. His right hand was effected by a mild stoke due to vaccination while suffering from an ear infection. Behavior deteriorating both at home and at school. He has developmental delay of speech and motor. Started Ritalin and hold off on anti-epileptic drugs and return to clinic in a month. Start occupational therapy, physical therapy and speech therapy. On 12/12/97, increase Ritalin on a trial. Seizures preceded by occipital pain. Pt was started on Tegretol in 3/97. He also now wets the bed.
About one half hour after vaccine given patients mom called swelling on L side of face and eye swollen shut.  Patient returned to office was also having cough and sneezing which was new after vaccine.  Given benadryl dose, evaluated by NP and Dr. who felt patient was stable to drive to er.  ER gave Epi and steroid and monitered him for 4 hours.
High Fever (103.5) for two days.  Tylenol did not bring it down.  Two days later developed terrible, painful rash all over entire body...especially bad near injection site and around diaper area.  Currently child still has rash and feels terrible. Taking him to the doctor again on Monday.
Patient presents complains of shortness of breath pedal edema swelling dry cough he was evaluated cardiology clinic and referred here for admission by Dr.   He is slightly hypertensive tachypneic.  He is not requiring O2.  His son came in the room and states the patient has NOT received his booster and received first two shots very early on.  The son had a COVID exposure last week and two grandkids in elementary school are staying in the same home with him.  Patient not concerned about it, says he only has leg swelling and needs fluid off him. Son aware of COVID positive result and will notify family.  PT INPATIENT.
This spontaneous report was received from a pharmacist via a company representative and refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, "a long time ago", the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiry date were not reported), at unspecified location. Concomitant therapy was not reported. On an unknown date, after receiving ZOSTAVAX, the patient experienced pneumonia and was hospitalized due to this event. The outcome of pneumonia was not reported. The relatedness between pneumonia and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Information has been received from a physician and a registered nurse concerning a 17 year old black male student who on the morning of 04AUG2003 was vaccinated subcutaneously in the right arm with a 0.5ml first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 19AUG2003, the patient developed a rash described as vesicular lesions on the trunk and extremities and pustular on his chest and back. He also had a fever of 102 degrees for 3 days. The rash cleared in about 9 to 10 days. At the time of report, on 26AUG2003, the physician reported that he would not give the second vaccine and he would draw a titer. Unspecified medical attention was sought and no prescription drug was required. Subsequently, the patient recovered. It was reported that in October 2003 the patient is to have a varicella IgG antibody titer done. No product quality complaint was involved. No further information is expected.
Injection site to (L) forearm red and swollen the evening after receiving the vaccine, approximately 4 cm. No induration noted. PT. prescribed Doxycycline for 10 days.
Pt reported dizziness/lightheadedness, was pale & sweating.  Began to shake as he was moved from wheelchair to bed. Last meal was several hours prior (BP 93/48; HR 65). Similar sx w/previous vaccines, afraid of needles. Pt transferred to gurney, legs elevated. Ate crackers & juice. Able to walk w/out difficulty & waited for father to pick him up. Released in stable condition (BP 120/54; HR 87)
8/18/2022 late in the evening I had a sore throat.  The next day I couldn?t get any sleep, Fever 39 C (102.5 F), painful swallowing, sore throat, and a cough.  Ears were ringing.  Treated with Tylenol and oseltamivir.  Tinnitus and congestion continued while symptoms gradually got better.   Tested Negative and felt better on 8/26/2022.  Felt recovered 9/01/2022, though cough tapered off for about 2 weeks after that.
nerve pain; leg pain; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingrix. On 3rd May 2022, between 1 and 2 months after receiving Shingrix, the patient experienced nerve pain and leg pain. On an unknown date, the outcome of the nerve pain and leg pain were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain and leg pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine about a month and a half ago (date unknown) and experienced leg pain which she described as nerve pain. The above symptom had not yet resolved.  The patient followed up with her HCP (Health Care Professional).  Provided medical advise disclaimer. The reporter did not consent to follow-up.
This is a spontaneous report from a contactable physician (reporting for his wife) via a sales representative. A female patient of an unspecified age received pneumococcal PREVNAR 13, via an unspecified route of administration on an unspecified date, single dose for immunization. The patient medical history was not reported. The patient's concomitant medication includes an unspecified steroid. On an unspecified date, the patient was feeling very sick, fever and chills. The physician said that his wife has been "sick" for a few months and may have also been on steroids during the time she received the vaccine. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 52-year-old male patient who received BOOSTRIX (batch number KP95K, expiry date 3rd December 2017). On 11th February 2016, the patient received BOOSTRIX .5 ml. On an unknown date, less than a year after receiving BOOSTRIX, the patient experienced injection site pain, injected limb mobility decreased and weakness of arms. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased and weakness of arms were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and weakness of arms to be related to BOOSTRIX. Additional details were provided as follows: The reporter stated that, the patient had severe reactions to BOOSTRIX. The patient was vaccinated in the left arm and was having trouble using his left arm till the time of reporting. No other information was provided and not all questions were asked.
Case previously recorded as MA2009-3339. Initial case report received from a health care professional via MedCom on 28 OCT 2009. A female patient, age unknown, was vaccinated i.m. with 0.5 ml S-OIV FLUVIRIN (batch no. 100739) in the arm on 27 OCT 2009 and 28 OCT 2009. The patient was pregnant at time of vaccination. On 28 OCT 2009 she received a second Novartis H1N1 vaccine dose instead of FLUVIRIN. No adverse event was reported. Reference no.: NA09-007176.
Pediarix given on 4/27/06. L upper arm edematous, warm to touch, erythematous, redness 6 inches elongated redness. Tx: Clarinex and Augmentin.
Crying hysterically. Lips and hands turn blue.  Shaking,  fever 103.7 2 days after shots.
headaches.; Nausea; chills; joint pain; muscle pain; This is a spontaneous report from a non-contactable consumer (patient) via Regulatory Authority Reporting Solution. A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 27Aug2021 17:00 (lot number: FC3184; expiry date: unknown) at the age of 33-years-old as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in left arm for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with Covid-19 prior vaccination. On 28Aug2021, at 17:00, the patient experienced nausea, chills, joint pain, muscle pain, and headaches. The patient did not receive treatment for the events. The patient was recovering from the events. The patient has not been tested for Covid-19 post vaccination.   No follow-up attempts are possible. No further information is expected.
Constantly nausea, fatigue, chronic cough, started with bronchial symptoms, was dx with chronic bronchitis, then dx with pneumonia, but chronic bronchial cough has never subsided since Feb 2021, shortness of breath at least exertion. I previously did not have any type of breathing issues. I haven't smoked in 45 years. I am unable to focus on anything and feel shaky and dizzy at various times
Maculo-papular rash over neck, face, trunk, back, upper arms and thighs. Light pink, distinct, macules 2-3mm in size. Resolved in 48 hour.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 51-year-old female patient who received the 1st dose of SHINGRIX. In April 2018, 18 hrs after receiving SHINGRIX, the patient experienced general body pain, fatigue and fever. On an unknown date, the outcome of the general body pain, fatigue and fever were recovered/resolved. The reporter considered the general body pain, fatigue and fever to be related to SHINGRIX. Additional details were provided as follows: On 4th April 2018 at 01.00, the patient received the 1st dose of SHINGRIX on left arm. On 5th April 2018, the patient experienced body aches, fatigue and fever. The employee stated that she knew of the possible side effects, which she experienced, were listed in the prescribing information. She was advised to report the side effects anyway.
Impingement syndrome of left shoulder. I had previous Td 5 years ago. 3 hours after vaccine, I couldn't lift my arm. Over about 7 day, it became obvious that problem was more than just muscle soreness. Dr. (internist) dianosed the problem. Orthopedist suggested rest. I am 50% better already.  I am slowly improving. I expect to recover fully.
Pt recvd vax on 23SEp92 & the following day pt devel h/a, fever & exp lethargy & malaise; it was subsequently reported that the pt was dx w/pityriasis; pt's exp was not considered to be related to the vax; No further details were provided;
Presented with cough and SOB.  Hx of COPD, diagnosed with Covid PNA.  Treated with O2 and abx He will be dischargedto home health.
I have been having ringing in my ears that started on 1/31/21.  I have had a slight issue with tinnitus but what I am experiencing right now is considerably worse.
had the shots, got them now/ Suspected vaccination failure; had the shots, got them now; pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient reported that he/she had the shots and man glad he/she did, got shingles now and not much pain Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not possible as no contact details were available.
This spontaneous report as received from a licensed practical nurse refers to a multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown date, unspecified patients were vaccinated with doses of improperly stored PEDVAXHIB lot # K008679, expiry date 05-MAR-2017 (routes and sites of administration, doses were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt says he developed the shingles the next day after taking the vax and lost about 70% of his strength.  He says he started having pain in his left knee.  Has loss of appetite.  He went to his PCP on 4/12/2021.  His DX was Shingles.  He was given antibiotics and pain pills. He back on 4/16/2021 and saw a NP that prescribed Tylenol 3 and gabapentin 100mg, diclofenac and prednisone.  He was also given 2 shots and had an XRAY on knee.  He has a FU appt on 5/3/21 and has not been the same since taking the vaccine.
No further AE; reported administration of pediatric dose of RECOMBIVAX HB; reported administration of pediatric dose of RECOMBIVAX HB; This spontaneous report was received from a medical assistant referring to an adult patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 10-DEC-2021, the patient was vaccinated with pediatric dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) 5MCG/0.5ML PED PF SYR CARTON OF 10 lot # U001837, expiration date reported as "21-NOV-2022", but upon internal validation established as 28-APR-2023, for prophylaxis (strength, dose, route of administration and anatomical location were not reported). No further adverse event (AE) was reported.  This is one of three reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA004333: US-009507513-2203USA004547:
On Friday September 18th at around 7:00 am the location the patient started to experience both shooting and sore throbbing pain from the arm on which she was given the vaccine. She applied a heating pad and has been applying a heating pad the area. She only took ibuprofen two 200 mg tablets every 8 hours. As of right now the pain has subsided to an extent. Not completely. She is experiencing a rash diagnosed by her doctor as shingles.
fever; This is a spontaneous report from a sponsored program. A contactable female consumer reported for herself.  A female patient of unspecified age received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as dose 2, single for COVID-19 immunization. Patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as dose 1, single for COVID-19 immunization. patient experienced arm pain after first dose. The patient medical history and concomitant medications were not reported.  On 24Feb2021, after the vaccination, the patient experienced fever. The event assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (14May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up at-tempts have been completed and no further information is expected
On 12/31/02, had watery eyes, non-responsive to stimuli and staring off in space. At 09:36, had a fever which shot up to 103.7F by 10:15, with a high-pitched cry. Also, had diarrhea for 11 days straight.
Started with sore arm, just feeling bad; about 7PM shoulders and neck began to ache. Started with extreme chills and then a severe headache. Took a Tylenol and went to bed at 9. Awoke a little later and symptoms were gone. Very tired the next day and still tired the following day.