chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm hurt; Cannot lift arm; Red rash around the injection site; Red rash around the injection site; Red rash around the injection site which itches; Fever of 99.6F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), MOBILITY DECREASED (Cannot lift arm), VACCINATION SITE RASH (Red rash around the injection site), VACCINATION SITE ERYTHEMA (Red rash around the injection site) and VACCINATION SITE PRURITUS (Red rash around the injection site which itches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 028A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (Hives), Drug allergy (Hives), Crohn's disease since 01-Jun-2020 and Cystitis interstitial since 01-Jul-1987. Concomitant products included VITAMIN D3 for Osteoporosis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt), MOBILITY DECREASED (Cannot lift arm), VACCINATION SITE RASH (Red rash around the injection site), VACCINATION SITE ERYTHEMA (Red rash around the injection site), VACCINATION SITE PRURITUS (Red rash around the injection site which itches) and PYREXIA (Fever of 99.6F). On 27-Oct-2021, PYREXIA (Fever of 99.6F) had resolved. On 28-Oct-2021, PAIN IN EXTREMITY (Arm hurt), MOBILITY DECREASED (Cannot lift arm), VACCINATION SITE RASH (Red rash around the injection site), VACCINATION SITE ERYTHEMA (Red rash around the injection site) and VACCINATION SITE PRURITUS (Red rash around the injection site which itches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2021, Body temperature: 99.6 (High) 99.6 Degree Fahrenheit.         No treatment medication information was provided.  The patient stated that she had "very slight fever for 24 hours". The patient also mentioned that the day of the call (27Oct2021) she  ad "hardly any pain" and that her arm "didn't hurt that much", it was "pretty much gone".   This case was linked to MOD-2021-366442, MOD-2021-366456 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: The follow up document was received and Outcome of event Pain in arm updated to recovering/resolving. On 03-Nov-2021: Significant follow up received contains patient demographic data, relevant medical history, event stop date and outcome added and updated.
Itchy Rash on upper body. Medro Dose Pack and Mometasone Furoate  topical cream, Benedryl
I have been experiencing neurological issues, i.e., facial numbness, and numbness/weakness in the extremities (arms and legs), frequent dizziness, and confusion.
Approximately 3pm 2/27/21 began to have muscle aches all over similar to having the flu and a bad headache that Tylenol did not effect. Increased as evening went on. On 2/28/21 awoke with flu like symptoms. At 8a developed nausea and diarrhea which turned into explosive diarrhea at 9a. Diarrhea continued non stop and at 10a became dizzy and disoriented and lost conscientiousness for over 20 min. Transported to ER at approximately 10:30. EMT's started fluids immediately and fluid was continued in the ER. Complete blood work was ordered. All things normal. Chest x-ray was normal. DX stated was severe dehydration.
After injection, red/purple welt with swelling at site, lasted 3-4 days. one week after injection, same instance except with itching, more like a rash.
Complaining of muscle pain on right side of neck. Pain extends from back of jaw on right side of neck down to shoulder.  Also has a warm sensation on right side of neck in painful area. Pain worsens with movement of area.
Severe pain after the first injection. Headache for two days and the lymph node under that arm swelled and hurt for two weeks. After second injection, arm pain started within two hours. 18 hours after shot, I had chills and hot flashes. It felt like my bones were cold and my skin was hot. 101.7 fever that lasted two days. Light and sound sensitivity with killer headache. Exhausted and short of breath for two days also. Today, third day after the shot, I still have a bruise and large, hot, red welt on my arm. My lymph node is more swollen than the other one was. Hurts to put my arm down all the way. I have been taking Tylenol and Motrin for fever and pain. Warm towels to the lymph node also.
20MAY04 wet cough only & cont presently in Egypt & will return 22JUL94;
Two hours after she received flu shot, her arm began to hurt. Later that night, she reports severe pain in her arm. Pain lasted 3 days.
Patient received 2nd dose of Pfizer-BioNTech COVID-19 vaccine on 8/31/2021; and called pharmacy on 9/3/2021 to report symptoms of migraine/headache and diarrhea that began shortly after vaccination. Symptoms have not completely resolved.
moderate nausea; severe headache; moderate joint pain; Muscle pain; So bad she cannot get up from the bed; pain at injection site; small redness at injection point; chills; fever 102 F; She couldn't sleep well due to fever and chills.; This is a spontaneous report from a contactable consumer and Follow-up (15Apr2021) received from same reporter processed together with initial information. A 49-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727) via an unspecified route of administration on 14Apr2021 at 10:00 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Apr2021, 3-4 hours after the patient experienced pain at injection site, small redness at injection point, At night chills, fever 102 f, patient couldn't sleep well due to fever and chills and On 15Apr2021, moderate nausea, severe headache, moderate joint pain, muscle pain, so bad she cannot get up from the bed. The patient underwent lab tests and procedures which included body temperature increased: 102 Fahrenheit on   fever 102 F. Outcome of the event's moderate nausea, severe headache, moderate joint pain and muscle pain was not recovered, and remaining events was unknown.
Patient was given Kinrix  after she aged out for vaccine.  Patient has not had any type of reaction
Received a call from Lead RN, patient received J & J vaccine @ 1555, patient walked over to the observation area and sat down.  At 1600 patient told her wife she was feeling light headed, patient slumped over in chair and fell off the chair hitting the gravel pavement.  Per RN patient lost consciousness for a few seconds, small laceration noted to the side of her head.  EMS called at 1602, arrived at 1610, evaluated by EMS, per patient she does not want to be transported to the hospital.  Patient left site with wife at her side, in stable condition.
Arthralgia, SkinRash, localized rash and joint pain that resolved Narrative:
3/8/21 - woke up at 2:30am with elevated temp (normally at  97.6 and showed 98.9) sleep was restless, couldn?t go back to sleep  and had chills. Felt punky on 3/8/21 - still worked all day and all week.   3/13/21 - woke up at 4:30am and had exact same symptoms as above but with a 99.7 temp.  Feeling punky.
Freezing, dizzy, loss of feeling in left leg, was taken to ER via ambulance. Ran a series of tests ruled out stroke and came to the conclusion that it was an adverse reaction to the vaccine
Chills-hard coughing-loud wheezing-throat tight-short of breath-very difficult breathing-skin red lumpy and very itchy at shot sight for 3 weeks- still itchy for another week-sleeping sitting up.
Bruising at injection site. Red from rash/discoloration approximately 2 inches from injection site. Resembles rash or subdermal infiltration.
Red bumps; several small swollen bumps; Chills; Fatigue; Body aches; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-APR-2023, the patient received the 2nd dose of Shingrix (right arm). On 26-APR-2023, 1 days after receiving Shingrix, the patient experienced chills (Verbatim: Chills), fatigue (Verbatim: Fatigue), general body pain (Verbatim: Body aches) and headache (Verbatim: Headache). On 27-APR-2023, the patient experienced red rash (Verbatim: Red bumps) and swelling (Verbatim: several small swollen bumps). The outcome of the chills, fatigue and general body pain were resolved and the outcome of the headache was resolving and the outcome of the red rash was not resolved and the outcome of the swelling was not reported.   It was unknown if the reporter considered the chills, fatigue, general body pain, headache, red rash and swelling to be related to Shingrix.     It was unknown if the company considered the chills, fatigue, general body pain, headache, red rash and swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-APR-2023 The patient self-reported this case. On 27-APR-2023, 2 days after receiving Shingrix the patient experienced localized erythema and local swelling  The patient received Shingrix and experienced chills, fatigue, headache, and bodyaches.   The patient reported that he noticed several small, red, and swollen bumps on her left wrist, the bumps were not tender to the touch, but do appear to be getting redder as time progressed. The patient reported that she wore their fitness band on that wrist, but never having any type of issue with redness, swelling or bumps from wearing the fitness band.
9/18/12 Spoke with employee reports received flu vaccine on 9/13/12 at 12AM from peer. Arrived home at 730AM-8AM noted left side of lips looked lower than right side & was twitching off & on - didn't feel well T 99.3, headache, nausea later Lt eye started to twitch took BENADRYL & felt better by 9/14/12 evening. Questions from flu vaccine.
Information has been received from a nurse concerning a 15 year old female with no past medical history and no prior drug reactions who on 26-APR-2007 received her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), (lot#  0211U), 0.5mL intramuscularly (IM) for prophylaxis. There were no concomitant therapies. On 28-JUN-2007 the patient received her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), (lot# 0210U) and after a few minutes, fainted. Medical attention was sought in the office. The patient had no other symptoms and has fully recovered. Additional information has been requested.
On 10/8/11 employee started feeling achy all over her body on 10/9 started having mild muscle spasms starting in the arm (R) by 10/10 was having muscle spasms in back, legs, & neck increased severity. Saw several MDs was treated with muscle related, VALIUM, and pain meds, steroids.
Severe chills, joint aches, headache, fatigue.  Took some Aleve which improved symptoms, but felt like mild flu symptoms for about 12 hours.  Felt better about 12 hours later, then felt completely normal by the next morning.
Experiencing ringing in the ears; This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional) from medical information team. The reporter is the patient.  A 64-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), administration date Feb2021 (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: TINNITUS (non-serious), outcome "unknown", described as "Experiencing ringing in the ears". The event "experiencing ringing in the ears" was evaluated at the physician office visit. Additional information: for about 3 days her ears just blasted her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
TIREDNESS; HEADACHE; LEG DRAGGING; UNABLE TO MOVE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been request.  No concomitant medications were reported. On an unspecified date, the patient experienced tiredness, headache, leg dragging, and unable to move. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness, headache, leg dragging, and unable to move. This report was non-serious.
02/08/22 presents to ED for "Hypoglycemia and hypotension". PMHx of "CAD with CABG x2 in 2009, ischemic cardiomyopathy with ICD, Paroxysmal Afib, OSA with BIPAP on oxygen atnight, COPD on 4L of home oxygen, sick sinus syndrome with pacemaker in place in 2017, CHF, Factor V Leiden, TIA, DM2, HTN, HLD and GERD with hiatal hernia, pancreatic cyst"
I developed a severe pain in the mid anterior area of my humerus on my left arm (the shot was given in the L deltoid), where the deltoid tuberosity is.  It initially felt like a muscular spasm and there was a knot in the muscle.  Pain was worse at night and was not relieved by ibuprofen.  Pain has continued to vary from being spasm-my to achy at rest and I can not do normal range of motion without pain.  I have never had a pain like this previously.  This was the second year I got the injectable flu vaccine.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Aug2021 (Lot number: FC3180) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lyme disease" (unspecified if ongoing), notes: That is with the joints and they haven't acted up in a long time. Concomitant medication(s) included: SYNTHROID taken for thyroid disorder (ongoing). Vaccination history included: Bnt162b2 (First dose, Lot Number / Expiry Date: EW0198 /unknown, Route, Anatomical Location: right arm), administration date: 03Aug2021, when the patient was 76 years old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "not recovered", described as "hair falling out"; SOMNOLENCE (non-serious) with onset 2021, outcome "unknown", described as "can't seem to wake up and has been sleeping a lot"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "still get tired during the day"; VERTIGO (non-serious) with onset 2021, outcome "unknown", described as "had a little bit of vertigo"; BALANCE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "She was losing balance". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of balance disorder. Additional information: Patient received her 2nd dose of the Comirnaty vaccine last 23Aug2021 and for the last 2 weeks she has been experiencing hair loss. she had experienced headache and nausea. She added that she "still get tired during the day" but her main issue is the hair loss and she doesn't want to lose any more hair. It was worse yesterday, 12Sep2021. She also mentioned that she "had a little bit of vertigo," that she was losing balance and that her daughter-in-law also has vertigo. She said that both of them got it from the Comirnaty vaccine. stated that her side effects are definitely after the 2nd dose. stated she just want to get some treatment. Concomitant Dug: Synthroid, Dosage text: 0.150, unknown if mcg or mg, states that it is a little blue pill, once a day, Has been taking for 35 years. Test results: she just had blood work and had a physical a couple of months ago and passed with flying colors. She does have low vitamin D, which is probably normal. Prior Vaccinations (within 4 weeks) is No. Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a nurse refers to multiple unspecified patients. On unspecified dates multiple unspecified patients were vaccinated with improperly stored PEDVAXHIB (lot # L030867, expiration date 09-JUN-2018; lot # K019701, expiration date 17-JUL-2017; lot # K025006, expiration date 22-JUL-2017; lot # L035878, expiration date 11-AUG-2018). PEDVAXHIB (lot # L030867, expiration date 09-JUN-2018 was stored in temperature 31°F or colder (31 F) for 77 hours 30 minutes and 47°F to 77°F (56 F) for 15 hours 30 minutes. No temperature timeframe was reported for PEDVAXHIB (lot # K019701, expiration date 17-JUL-2017; lot # K025006, expiration date 22-JUL-2017; lot # L035878, expiration date 11-AUG-2018). Digital Data Logger was involved. None of the vaccines was administered after their expiration dates. No adverse events were reported. The outcome of the events was unknown. This is one of several reports received from the same source. Sender's Comments: US-009507513-1710USA000208.
pt 4 years 362 days received pediatric pfizer vacc.  No adverse reactions
Diarrhea for 2 days after vaccine on 3/3/2021.
pt recv vax & exp worsening joint pain;pain in elbows bilat w/diff in extension;morning stiffness;MD impression seronegative polyarticular JRA poss spondyloarthropathy;dec appetite, 7lb weight loss;
Patient blacked out for about 1 hour per husband, shortly following vaccine administration.  No other adverse effects reported.
On approximately 6/1/00, the pt experienced joint pain, and stiffness in his hands and arms. The pt has seen several MD's and received genetic testing. Tested positive for some of the HLA group. The annual follow-up states pain in joints and hands.
PT noticed papules on back of neck 3/22/03, over the next 3 days PT noticed papules on lower back, upper chest, and top of head. PT states papules are itchy on occasion. Findings consistent w/folliculitis.
Fatigue, muscle pain, chills, fever, headache, injection site swelling and pain.
The medication was mixed with the wrong diluent and administered intramuscularly into the patients left arm.
Passed out the day of, numb and tingling face and body for over a week, shortness of breath, dizziness, fast heart beat
Moderna COVID-19 Vaccine EUA I lost my sense of taste for one day, immediately after taking the first shot on Jan. 27th.  There were no other side effects.   I had the second shot on Feb 24th, with no side effects at all, to this point.
I received my first dose of Pfizer vaccine (lot # EN6200) around 10 AM. I was perfectly fine after the shot. However, 6 hours later around 4PM my Left outer ear turned bright red and get itchy (no raised or macular rash, no hives, no signs of insect bites or anything) No other redness or rashes in any other parts of my body. I did not develop any other symptoms (no SOB/difficulty breathing, etc) My R ear is fine too. I observed myself to see if the redness/itchiness will spread but after about an hour or so, the redness and itchiness went away. I did not take any antihistamine and did not I apply any hydrocortisone. Just went away on its own.  Four days later, it happened again, my L outer ear turned red again, this time it is not itchy but more like throbbing pain. It went away after 1-2 hours without any treatment.
Patient had COVID in December 2020. He  received his Pfizer vaccine in April and May of 2021. He contracted Covid on August 30,2021 and died on October 11, 2021.  He was evaluated at local clinic on 9/2/2021 with joint pains and painful rash in mouth, hands and feet. He was hospitalized on 9/4/2021 and treated with REMDESIVIR, STEROIDS,ZPAK and LOVENOX and D/C to home on 9/7/2021.  He went back to the ER and sent home with Doxycycline. He was again hospitalized on 9/15/202 and given REMDESIVIR, Vancomycin, Toradol, INVANZ, LOVENOX and DEXAMETHASONE. He was discharged on 9/23/2021. He was evaluated again at physicians office with purpuric rash over his body, angioedema of his lips, hypotension and anemic. He was sent back the hospital due to his septic appearance. He was hospitalized at another hospital and given multiple transfusions, antibiotics and steroids. He died after coding three times on October 11,2021.
Patient was in preventive visit and received vaccination for COVID on 8/15/23. On 8/21/23 it was discovered that that lot number had expired on 8/1/23. The error likely occurred due to confusion with multiple expiration dates, one being a revised manufacturer date and one being the 10 week "out of freezing" date.  No documentation of any patient adverse event.
lower body paralysis; Brand=Pfizer/ Dose number=3; prev dose brand, Moderna; prev dose brand, Moderna; This is a spontaneous report from a contactable Consumer. A 65- years- old male patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: FH8020) via an unspecified route of administration on 30Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization (at an age of 65 years).The patient medical history had included diabetes, neuropathy, heart condition and allergic to Fentanyl and Niacin.The patient concomitant medication had included Influenza vaccine (FLU) for unknown indication on 29-SEP-2021 and Flupentixol dihydrochloride, Melitracen hydrochloride(U) for unknown indication from unspecified date and ongoing: unknown. The patient previously took MODERNA COVID-19 VACCINE Batch/lot number: 026A21A) via an unspecified route of administration on 06Mar2021 as DOSE 1, SINGLE for covid-19 immunization (at an age of 64 years)and also took MODERNA COVID-19 VACCINE Batch/lot number: 0188218) via an unspecified route of administration on 06Apr2021 as DOSE 2, SINGLE for covid-19 immunization(at an age of 64 years). It was reported that patient did not have Covid-19 prior to covid-19 vaccination. The patient underwent for covid test after receiving the vaccination. On 30Oct2021at 20:00 the patient had experienced lower body paralysis .On 01Nov the patient underwent lab test and procedures which included SARS-CoV-2 nasal swab test and diagnosed with negative value. Therapeutic measures were taken for the AE and treatment was given with IV. The patient visited emergency room for the AE and was hospitalized for two days. The clinical outcome of the event was not recovered.   Follow-up attempts are completed. No further information is expected.
Information has been received from Sanofi Aventis (manufacturer control number 200918853US) via consumer concerning a 78 year old male husband who in approximately in October 2009, was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported) in the abdomen. Suspect therapy included LOVENOX (lot # 21078 and expiration date: February 2012) 100 mg twice daily starting on 01-OCT-2009 for surgery for pacemaker insertion and in approximately October 2009 a dose of influenza virus vaccine (unspecified) (dose, route and lot number not reported). The consumer reported that her husband's abdomen was all bruised from these injections (injection site haematoma). The consumer also reported that the nurse had given him his pneumonia shot and flu shot in the abdomen while he was in the hospital. Additionally the consumer reported that her husband was on LOVENOX until his COUMADIN levels returned to where the doctor wanted them. This was originally reported by the consumer. Additional information has been requested.