chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; headache; body ache; slight fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache), MYALGIA (body ache), PYREXIA (slight fever), CHILLS (Chills) and FATIGUE (Fatigue) 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.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced HEADACHE (headache), MYALGIA (body ache), PYREXIA (slight fever) and CHILLS (Chills). On 25-Jan-2021, the patient experienced FATIGUE (Fatigue). On 24-Jan-2021, HEADACHE (headache), MYALGIA (body ache), PYREXIA (slight fever) and CHILLS (Chills) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.
Administration error/deviation - Mixed Series - Incorrect mRNA COVID-19 vaccine product inadvertently administered as a additional primary dose. Original primary series received was Pfizer. Third full dose of Moderna given 8 months after completion of initial series.  No known adverse reaction in patient. Attempted to notify patient same day as vaccine given to advise of CDC interim recommendation   not to repeat the dose.
March 19, two days after my first dose I had a sudden intense low back pain and I had a hard time getting out of bed unassisted, I also needed support to walk and to even shower. This lasted for about a week and slowly subsided, but pain did not completely go away.  I got my second dose on April 7 and by April 8 very early in the morning I had all the expected side effects of fever, chills, vomiting, muscle ache and joint pain. But, my low back pain intensified again and now with cramping and spasm on my thighs and legs. I also used a massager on my thighs and legs only to be left with bruising which never happened before when I used a massager. I did not connect the low back pain and vaccine until after my second dose.
pt was given vax & 36 hrs p/vax were given pt devel hives over the arms & legs-low grade fever & irritability; pt was treated w/ Atarax; rash disappeared in 48 hrs;
admitted 9/15. pt ha had symptoms since 3 weeks prior to admit.Patient presented with symptom(s) noted the chief complaint Patient is being tested today due to having covid-19 symptoms - reports 12 days of feeling ill including symptoms of fatigue, weakness, diarrhea, dry cough and SOB"
Janssen COVID-19 Vaccine EUA 8pm 3/8/21: Nausea, vomiting, chills began; slept for 10+ hours 8 am 3/9/21: Fatigue, nausea, headache; noticed petechiae on arms and abnormal bruising on legs 8 am 3/10/21: Blurry vision, headache (unlike usual throbbing headaches, consistent pain on top of head), lightheaded/dizzy 10 am 3/10/21: Asked friend to drive me to ED at Hospital; Labs were drawn showing platelet count of 42K and I was released from ED and told to follow up with Hematologist
Severe vertigo beginning two days post injection. It is worst when laying down, but also occurs with positional change
Acute Heart Failure diagnosed 3/3/22, after 2 months of gradually worsening symptoms including collapse from arrhythmia 2 weeks prior to hospitalization.  3 months of wearing mobile defibrillator vest, very expensive heart failure medications.
pt recvd vax 30AUG94 spiked t106 @ 1230AM 31AUG94; mom stated APAP brought temp down to 104-w/cont use of APAP-temp down to 100-102 during daytime; evening of 31AUG94 temp down to nl 1SEP94;
pt recvd vax;mom states rt leg swollen almost double size,red & hot to touch;states pt screamed high pitch cry & was unconsolable for 2 hrs rt p/ shot; MD ordered motrin & states no more dtp; fever 100;
Fatigue, aches & pains, headache, chills, dizziness, whole arm pain, itchiness @site, slighr swelling @ site
I got a little ache and pain in my left knee area; She was very agitated; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 27Feb2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got a little ache and pain in her left knee area and she was very agitated on an unspecified date. It was reported that, patient was due for her 2nd shot on 22Mar2021 and she did not know what to do. Reported seriousness was non-serious. She did not know which COVID vaccine she received. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
02/04/2021 vaccination. 02/18/2021 I started to experience the heart palpitations. It would happen every 2-3 days, at rest, at one point it was so frequent I had to 'bare down' to stop palpitations. 06/2021 I had a physical and spoke to PCM who referred me to cardiologist. I couldn't get appointment until 01/2021. I got echocardiogram in 08/2021, 11/2021 had to reschedule due to location to 01/2022. I had the halter monitor just sent back 2 weeks ago and I do not know the results of that just yet. I haven't had heart palpitations like I had when had vaccinations; 'not as bad', not as frequent, not as severe. Lymph nodes swelled after 2nd vaccination.
6"x4" rash at vaccination site w/ itching and sore like a bruise.  Today 2/26/2010-rash still there, still sore/hurt like bruise, but now 3'x2", so it's getting smaller.
pt recv vax & exp muscle weakness, pain @ inj site, fatigue, flu like sx, nausea & diarrhea;the pharmacist reported that two other pt recv the first shot of vax from the same vial & exp same sx;They were assigned WAES96090110 & 96090112;
Severe ringing in the ears started 1-2 days after injection. Has not stopped. Made appointment with PCP (appointment 04/14/2021) who sent me to a hearing specialist after she  examined my ears. My appointment with the hearing specialist was 05/03/2021. He prescribed a drug to take at night to help with sleep.
Swelling below elbow; Pockets of bubbling; This case was reported by a pharmacist via call center representative and described the occurrence of local swelling in a elderly male patient who received Herpes zoster (Shingrix) (batch number xg7rf, expiry date 21st May 2024) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced local swelling and blister. On an unknown date, the outcome of the local swelling and blister were unknown.   It was unknown if the reporter considered the local swelling and blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-FEB-2023 Reporter's Comment: The reporter reported that the patient woke up with the pockets of bubbling and swelling below elbow. The reporter did consent to follow up.
41 YO FEMALE CONSCIOUS AND ALERT WITH A GCS OF 15 COMPLAINING OF HER THROAT FEELING LIKE IT WAS CLOSING UP. PT JUST RECIEVED HER COVID 19 VACINATION. PT DENIED CHEST PAIN, SOB, N/V/D, HEAD NECK AND BACK PAIN, BLURRED VISION, DIZZINESS. PT HAD A PATENT AIRWAY WITH EQUAL CHEST RISE AND FALL. PT HAD NO NOTED HIVES OR RASH, PT WAS EXCHANGING AIR AT 98% SATURATION. PT HAD NO OTHER NOTED DCAPBTLS, HEENT WAS UNREMARKABLE. PT VITALS WERE TAKEN AND RECORDED. PT WAS GIVEN 50 MG OF BENEDRYL PO BY PARAMEDIC. PT WAS OFFERED TRANSPORT TO THE LOCAL HOPSPITAL FOR FURTHER EVALUATION. PT REFUSED
covid test result Positive/ I have covid; covid test result Positive/ I have covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EL3247), in left arm, on 25Mar2021 as dose 2, single (Lot number: EP6955), in left arm and on 22Nov2021 as dose 3 (booster), single (Lot number: EW0186) at the age of 41 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant) with onset 23Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 23Apr2022, outcome "recovering" and all described as "covid test result Positive/ I have covid". The patient underwent the following laboratory tests and procedures: Body temperature: (23Apr2022) 100; SARS-CoV-2 test: (23Apr2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Reported Event- Patient have COVID with: fever of 100 for 2 days, headache for 2 days, back pain, fatigue.  No follow-up attempts are possible. No further information is expected.
Red swollen, painful area to upper right arm. Notice on 11/13/14. 6x4cm area overlying HPV injection site.
Swelling on her feet and hand; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 13:45 (Lot number: ER8727) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Has had asthma since birth.; "Allergy" (unspecified if ongoing), notes: Caller states she has a lot of allergies to a lot of medications and food, no further details provided; "Type II diabetes mellitus" (unspecified if ongoing), notes: She was not diagnosed with this condition until maybe her late 20's; "Hypothyroidism" (unspecified if ongoing), notes: She states she was diagnosed with Grave's disease in her early 20's, she clarifies she had Grave's disease first.; "Grave's disease" (unspecified if ongoing), notes: She states she was diagnosed with Grave's disease in her early 20's, she clarifies she had Grave's disease first.; "Ruptured eardrum" (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: Caller states she has a lot of allergies to a lot of medications and food, no further details provided. Concomitant medication(s) included: DEXAMETH taken for tympanic membrane perforation, stop date: 29Mar2021. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 29Mar2021, outcome "unknown", described as "Swelling on her feet and hand".  Additional Context:  The callers states she is calling in regards to the Covid vaccine she received back in Mar2021 and Apr2021. She had a severe allergic reaction on the second shot and she knows they are know recommending a booster shot, but caller wants to know what is Pfizer's advice on getting the booster shot if she does decide to get it?The caller states she had a slight allergic reaction to the first dose of the COVID vaccine, but at the time she thought it was from eating something very salty for lunch. She clarifies she had swelling on her feet and hand. The swelling was not so bad on the first dose. She confirms she had the first dose on 29Mar2021 at 13:45. Probably within an hour of that, she started to experience the swelling. Caller states she saw a doctor a week before she was going to get her COVID shot and she asked if it was okay to get her COVID shot and she was told it was fine. She was prescribed an ear drop for a ruptured eardrum. She provides the following off of her bottle of Eardrops. No Additional Vaccines  was Administered on Same Date of the Pfizer Suspect. o ER visit require. No Prior Vaccinations (within 4 weeks). No family history reported. There was a product complaint (Caller was prescribed an ear drop for a ruptured eardrum. She provides the following off of her bottle of eardrops)  No follow-up attempts are possible. No further information is expected.
Started with inflammation in my lower left rib cage for a few weeks. I am concerned about my spleen or broken rib. I went to urgent care they did an x-ray and out ruled that. I have also had much worse heart palpations, which I have had in the past, but these are different. I also have had harder time exercising regard to walking up hill and my normal exercising. I have an appointment next week with the cardiologist to see what is going on.
Has been smelling a strong chemical smell from his body which he has never smelled before and which he cannot get rid of and which is driving him crazy; Sometimes he gets sweaty when doing something; This spontaneous case was reported by a consumer and describes the occurrence of SKIN ODOUR ABNORMAL (Has been smelling a strong chemical smell from his body which he has never smelled before and which he cannot get rid of and which is driving him crazy) and HYPERHIDROSIS (Sometimes he gets sweaty when doing something) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 0114214 or 011A21A or 011A214) for COVID-19 vaccination.     The patient's past medical history included Urinary tract infection, Pain (Severe) and Constipation. Concomitant products included MILK OF MAGNESIA for Constipation, HYDROCODONE for Pain, LEVOFLOXACIN (LEVAQUIN) for UTI, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced SKIN ODOUR ABNORMAL (Has been smelling a strong chemical smell from his body which he has never smelled before and which he cannot get rid of and which is driving him crazy) and HYPERHIDROSIS (Sometimes he gets sweaty when doing something). At the time of the report, SKIN ODOUR ABNORMAL (Has been smelling a strong chemical smell from his body which he has never smelled before and which he cannot get rid of and which is driving him crazy) had not resolved and HYPERHIDROSIS (Sometimes he gets sweaty when doing something) outcome was unknown.            Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Outcome of the event Skin odour abnormal updated.
in contact with COVID 19 positive in his school; Very congested; Coughing; Sneezing; Runny nose; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (patient's mother) reported for a 13-year-old patient (reporter's son). A 13-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date Aug2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date Aug2021, after receiving second dose patient experienced that he was very congested, coughing, sneezing and has a runny nose. His mother was not sure if withheld is in contact with COVID 19 positive in his school because there is a lot of COVID 19 positive in his school (further clarification unknown) and stated that I am trying to figure out if this is potential side effects from the vaccine or do I need to go get him tested to see if he was along the way to get actual COVID. Further probing could not be done as the reporter was unwilling to share any further information. Hence limited information available over the call. The clinical outcome of the events was unknown.  Information on the lot/batch has been requested.
Pt recvd 2nd dose of vax & exp induration, h/a, nausea, vomiting, itching which remain unchanged; treatment APAP;
injection site very sore for a couple of days,  was very tired and out of sorts for a day
I had pain in my left arm, and within an hour or two I was pretty exhausted and out of it. I figured it would go away, it got worse the next day, and finally on Saturday when I woke up it was hard for me to breathe and I had pain/tightness in my chest. I went into the ER on Sunday morning and after a day of testing was diagnosed with: - Deep vein thrombosis of bilateral lower extremities - Pulmonary embolism, bilateral - DVT, bilateral lower limbs  I had at least 5 clots in my legs and several more in my lungs but they said there was no way to know the full amount. I had been on HRT for over two and a half years and had no problems, then 4 days after I received my first shot I was informed that I had almost died several times due to the clots. When I explained to my doctor that I thought the clots were related to my shot he shrugged it off, said it was impossible, told it was just my hormones, and said that "Covid is no big deal and we're overexaggerating how bad it is compared to other things...". So I don't think any of this was reported.   Later I saw a blood specialist who told me it was impossible for hormones to do this much damage in the span of a few days without something else effecting it, and told me to cancel my next shot even after we learned I had APS. All and all I would really appreciate someone looking into this to at least make sure there isn't something else going on, as the timing of this is was too close and I know Covid shots have had the rare chance of causing the exact kind of thing I went through.
Stated on 4-3-08 approx 1 1/2 mo after leaving medical center-states felt "nausea, hot, sweaty" for "20 min- 30 min". It disapated and went about my business". Reported to center on 4-8-08.
pt recv vax;mom reports pt shaking & responsive;she said pt's hands were beginning to turn blue but denied diff breathing;felt hot per mom but did not gave fever med;pt looked like "wanted to fall asleep" per mom;
expired vaccine was stored in refrigerator on 30Mar2023; no adverse event; PATIENT 1Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (PATIENT 1Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (expired vaccine was stored in refrigerator on 30Mar2023) and NO ADVERSE EVENT (no adverse event) in a 7-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (PATIENT 1Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vaccine was stored in refrigerator on 30Mar2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (PATIENT 1Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (expired vaccine was stored in refrigerator on 30Mar2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (PATIENT 1Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (expired vaccine was stored in refrigerator on 30Mar2023).    No concomitant medications were reported.  It was reported that 4 expired doses of vaccines were administered on 31-Mar-2023. Patient received Monovalent 6 months to 5 years vaccine, there was individual vial of size 2.5 ml. The vial was initially stored in the refrigerator on 30-Mar-2023. The vial did not undergo any temperature excursions.  No treatment details were reported. This case was reported for Patient 1 of 4 Patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718108, US-MODERNATX, INC.-MOD-2023-718179, US-MODERNATX, INC.-MOD-2023-718157 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718108:same reporter, patient 4 US-MODERNATX, INC.-MOD-2023-718179:same reporter, patient 2 US-MODERNATX, INC.-MOD-2023-718157:same reporter, patient 3
Anaphylaxis  - started ten minutes after the vaccine. Ended up in an ambulance and to the emergency room. Was given benadryl and steroids through IV and was home about five hours later.
Individual was given standard dose of Moderna instead of booster dose.  After it was identified of the incident occurring, the individual was directly notified of the situation and received guidance on what to expect/look out for the next 48-72 hours.  Current questions/concerns answered.  Individual instructed to continue to monitor side effects and if something additional or more serious occurs, they should seek medical attention. Patient was given a contact at the clinic to reach out to if there were any additional questions/concerns or felt the need to be evaluated.
Large local reaction at vaccine site involving pain/erythema/warmth/pruritus, approx 4i inches in diameter, without associated systemic symptoms.
Pt. c/o pain in Rt. deltoid about 2-3 hours after receiving pneumonia vaccination. Pt could not move her arm or fingers and went to the ER. Pt given a sling and PERCOCET and told to apply ice. These tx's did not help. Pt. saw PA on Mar-29 and was given SOLUMEDROL 60mg IM. Pt. given NSAIDS as well. Pt. also referred to physical therapy.
Chills and fever lasting up to 3 days. Spent 3 days in bed. Severely sore arm. Patient unable to sleep on side of injection.
patient states she wok up with n/v diarrhea, back pain. temp 98.8.phoned PCP who rx ondansetron 4 mg. Dr stated to take medication, did not want to see her. she started to feel some better, then was able to sleep. 1-8-21 pt phoned and stated n/v diarrhea has subsided she just has headache now.
Information has been received from a medical assistant concerning a 67 year old male patient who on 07-JUN-2010 was vaccinated with a first dose of PNEUMOVAX 23 (Lot No. not reported). On an unspecified date, the patient experienced fever, headache, muscle aches and soreness at the site. It was unknown if the patient sought medical attention. At the time of the report, outcome for the events was unknown. This is one of several reports from the same source. Additional information has been requested.
Patient received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a male patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 17th June 2022, the patient received Havrix. On 17th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-Jun-2022 Reporter's comments: A medical assistant reported that the patient received an expired dose of Havrix. No symptoms were reported. The consent to follow up was given. The healthcare professional did not have the patient's date of birth at time of report. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.