chrisvoncsefalvay/vaers-outcomes huggingface dataset:
routine blood test showed lipoderma; Tiredness; minor sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (minor sore arm), POST THROMBOTIC SYNDROME (routine blood test showed lipoderma) and FATIGUE (Tiredness) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included Clot blood (two). Concomitant products included RIVAROXABAN (XARELTO) for Clot blood.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (minor sore arm) and FATIGUE (Tiredness). On 19-Apr-2021, the patient experienced POST THROMBOTIC SYNDROME (routine blood test showed lipoderma). On 09-Apr-2021, PAIN IN EXTREMITY (minor sore arm) and FATIGUE (Tiredness) had resolved. At the time of the report, POST THROMBOTIC SYNDROME (routine blood test showed lipoderma) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Blood test: lipoderma (abnormal) lipoderma.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. The patient is due for her second dose of mRNA-1273 (Moderna COVID-19 Vaccine) on 06 May 2021.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I have received 2 booster shots, both the Moderna brand. While I had no significant reaction to either of my initial doses, I think I may be allergic to the booster. My first booster was on 12/27/21 and starting 1/7/22, exactly 2 weeks after, I began having a reaction that consisted of painful and itchy hives all over my body that didn't respond to anything and lasted consistently for about a month following. My second dose of the booster was on 4/11/23 and starting 4/25/23, also exactly 2 weeks later, I developed painful and itchy hives that have not responded to anything. With still being in the presumable month if this follows the first time, I don't know how long it will last.
Initial misuse report received from a healthcare professional on 11 November 2013. A 12-year-old had received a dose of FLUZONE ID. No adverse event was reported. List of documents held by sender: none.
Tinnitus - ringing in both ears.  No Treatment for it and symptoms  continue.  No change since the onset of the symptoms.
patient received dose of Moderna vaccine post excursion; patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion).    Concomitant medication was not reported. Treatment drug was not reported. This case contains information for the 18th of 19 patients reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941
2wk post vax pt devel measles;pt began to break out in chickenpox like lesions which cont to devel over the course of approx 6wk;pt to MD w/approx 200 chickenpox like lesions over body @ different stages of devel;some at papular stage;
his body does not feel right; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002191). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 21Jul2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset Jul2021, outcome "unknown", described as "his body does not feel right". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
GBS and then CIDP.  Unlcear if he had CIDP prior the vaccine
At 3:40 pm I felt weakness in my jaw and also in the left arm (the one that received the vaccine).  I felt a little dizzy. The weakness in my jaw last aproximately two minutes and the sensation in my arm improved but last a couple of hours more.  The dizziness improved at the moment that the weakness of the jaw wore off.  I did not receive treatment, because I didn't go to a hospital.
Headaches/gotten worse today; This is a spontaneous report from a contactable consumer. A 24-year-old female patient (reporter's daughter in law) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection), via an unspecified route of administration, administered in Arm Left on 18Jun2021 (at the age of 24-year-old) (Batch/Lot Number: EW0151) as single for covid-19 immunization. Medical history included headache from an unknown date  was ongoing, depression from an unknown date and unknown if ongoing and pregnancy from an unknown date and unknown if ongoing. The reporter stated she (patient) has been having some headaches because she was on some medication for depression after having a baby and she stopped the medication and she thinks it is possible that could have caused that. Concomitant medication included escitalopram oxalate (LEXAPRO) at 10 mg every night at bedtime taken for depression (antidepressant) from Jun2021 to Jun2021 (additional Information was provided as she quit taking it 2 days before the vaccine and was only taking for a week and a half) and some unspecified sleeping pill (additional Information was mentioned as they gave her some type of sleeping pill, she only took it once, they only gave her one pill, does not remember the name of the medication). History of all previous immunization with the Pfizer vaccine considered as suspect was none and additional vaccines administered on same date of the Pfizer suspect was none. Family Medical History Relevant to AE(s) was not provided. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was not provided. Reporter mentioned her daughter-in-law received the first dose of the Pfizer-BioNTech COVID-19 Vaccine, and reported having some headaches on 18Jun2021 and asked if they can take Tylenol or Ibuprofen because reporter wanted to verify because she has been told that some medications might "lessen the effect of the vaccine". Caller had reported that the patient had been experiencing headaches before the Covid 19 vaccine but they had gotten worse. States that she was taking an antidepressant (Lexapro) and then stopped taking it. When asked when the headaches began, caller states her daughter in law, has been having headaches but they have gotten worse today and they wanted to take something for them and did not know what to they could take. AE did not result in Emergency Room or Physician Office visit. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) :PFIZER INC-2021734937 same reporter/ product/ event, different patient
Immediate vasovagal syncope at time of injection AEB brief loss of consciousness, diaphoresis, and pallor noted.  Lowered pt to floor and elevated BLLE w/ chair.  Pt awakened to smelling alcohol pad and verbal cues.   calm and cooperative, AOx4.  Denies pain, denies SOB.  Taken to MedObs via litter where pt was assessed and encouraged to eat snack and drink water as pt reports he has not eaten or had any fluids today.  Pt drank 1 bottle of water and declined a snack.   Pt VSS though BP elevated and pt encouraged to monitor daily at home and f/u w/ provider.  Pt allowed to leave at approx 1405 after 30 minutes, VSS and reported feeling "fine"  Not edema, erythema, hives, SOB or any other s/s allergic reaction noted VITALS 1337 sitting HR 86, RR 18, BP 163/98, O2 96%RA 1342 sitting HR 84, RR 16, BP 146/96, O2 96%RA 1347 sitting HR 74, RR 18, BP 161/100, O2 96%RA 1354 sitting HR 76, RR 18, BP 156/94 (manual BP), O2 98%RA 1400 standing HR 80, RR 18, BP 168/98, O2 96%RA
On 6/3/2016, Patient noted a red rash to injection site and left deltoid (but not reported to clinic at that time).  Patient returned to clinic on 6/10/16 with redness to left deltoid, area sore to touch, arm to touch and redness expending up to left shoulder. MD prescribed clarithromycin 500mg PO 2 times daily.  Patient returned to clinic on 6/13/16 and improvement to site was noted, improved appearance of rash on left arm with decreased extention and significantly decreased erythema, no warmth and area nontender.
tender; Fatigue; dry mouth; injection site extremely painful/injection site was sore/injection site was tender; body ache; low grade fever; injection site warm to touch; headache; This spontaneous case was reported by a patient and describes the occurrence of DRY MOUTH (dry mouth), TENDERNESS (tender), VACCINATION SITE WARMTH (injection site warm to touch), HEADACHE (headache) and VACCINATION SITE PAIN (injection site extremely painful/injection site was sore/injection site was tender) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site warm to touch) and HEADACHE (headache). On 09-Mar-2021, the patient experienced DRY MOUTH (dry mouth), VACCINATION SITE PAIN (injection site extremely painful/injection site was sore/injection site was tender), MYALGIA (body ache) and PYREXIA (low grade fever). On 10-Mar-2021, the patient experienced FATIGUE (Fatigue). On 11-Mar-2021, the patient experienced TENDERNESS (tender). At the time of the report, DRY MOUTH (dry mouth), TENDERNESS (tender), VACCINATION SITE WARMTH (injection site warm to touch), HEADACHE (headache), VACCINATION SITE PAIN (injection site extremely painful/injection site was sore/injection site was tender), MYALGIA (body ache), PYREXIA (low grade fever) and FATIGUE (Fatigue) had resolved.      No concomitant medications were reported. Treatment information was not provided.    This case was linked to MOD-2021-047942 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Updated event outcome from unknown to recovered/resolved.
The injection did not go quickly or painlessly on 11/3/2021. I had time to look over at the RN administering and asked what was wrong, felt a mild burning, and I was told that it was going in more slowly than normal. I was not given a reason. For the next four days I had arm pain so severe that I did not want to lift my arm to get out of bed.  As of today, 12/3/2021, I continue to experience a sharp pain in my shoulder during certain arm motions, when reaching for objects and putting on clothes, lifting things in certain directions. I have been evaluated by my PCP,  and a physical therapist who suspect tissue damage and inflammation leading to issues with my shoulder nerve. I should be able to get better with treatment is what I am told, but the timetable for this is unknown. I am taking ibuprofen daily (400 mg 2X a day), icing daily and doing exercises provided by my PT. This has greatly impacted me, disrupted my time, energy and daily activities.
12 weeks pregnant got flublok with no reported adverse event; Initial information received on 18-Oct-2022 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2022SA435259(CLUSTER).  This case involves a 36 years old female patient who was exposed to vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] in context of 12 weeks pregnant got flublok with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported 12 weeks pregnant got flublok with no reported adverse event occurred at 13 weeks of pregnancy and the patient was exposed to INFLUENZA QUADRIVALENT RECOMBINANT VACCINE at 13 weeks of pregnancy, during first pregnancy trimester for INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  The date of last menstrual period was reported as 27-Jul-2022. The estimated due date is 03-May-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 18-Oct-2022, the patient received 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength, formulation was unknown, lot UJ888AA and expiry date: 08-Jun-2023) via unknown route in the left deltoid for Immunization.  On 18-Oct-2022 the patient developed a non-serious event of 12 weeks pregnant got flublok with no reported adverse event (exposure during pregnancy) (Latency: same day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken : not applicable.  Outcome: Unknown Additionally, at time of reporting, the pregnancy was still ongoing.
fever, myalgia, headache, erythema at injection site, sore throat, diarrhea, congestion
covid-19 treatment; covid-19 treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (batch/lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (batch/lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient stated, "I have a question if I reacted to your booster, is it safe to take this drug (Paxlovid) for COVID?" When paraphrased the concern, the patient stated, "That is right, and I am reacted a lot. That was to the booster not to the first two shot." The consumer stated, "No, I was calling Paxlovid already, I picked up Paxlovid, I am not calling Pfizer, I am calling for the Paxlovid. I did not call for the vaccine, I called for Paxlovid nothing about the vaccine. Is there is a safety issue?".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A report has been received from a health professional concerning a male patient. No concomitant drug, past medical history or concurrent disease were reported. On an unknown date the patient received FLUMIST QUADRIVALENT (intranasal). The patient received FLUMIST and contracted the flu, 3 years ago (2014), with exact dates unknown. The outcome of the event of contracted flu was unknown. The report was considered to be non-serious by the company physician.
Throat and ear itching within 20 minutes, lasted less than an hour. Did not recur with second dose.
The patient received the second dose of Pfizer and 5 minutes later the mother notified the pharmacist that the patient was unconscious. Pharmacist examined the patient and patient seemed to be looking into the space blank and was unresponsive. Patient was sitting down and face looked slightly blue. 911 was called immediately. While the ambulance was on the route, the patient seemed to regain consciousness and be more responsive. When EMT arrived, they examined the patient and the patient walked home normally with her family.
Bilateral tinnitus, extreme pain at injection site, fatigue, mild headache beginning about 3.5 hours after injection.  Took 2 extra-strength Tylenol which helped with injection site pain and headache, but not the tinnitus and fatigue.
After receiving the vaccine patient c/o feeling "lightheaded".  Patient was diaphoretic and warm to touch.  5pm BP 96/70  P 86 SpO2 97%  Patient assisted to lying position, given water, juice, graham crackers.  At 5:25pm patient c/o feeling better, no more lightheadedness, stated ready to leave.  Repeat BP 100/70.  No medications administered.
This vaccine was given before the nurse realized that the refrigerator thermometer was broken.  The vaccine's temperature had been out of range.  Pfizer was contacted and the remaining vaccine needed to be wasted.  The patient had to be notified that the dose he received was not valid and has to be repeated.  No side effects noted.
COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Patient is fully vaccinated.  Hospitalized on 12/22/2021.  COVID + on 12/22/2021. 62-year-old female patient with history of severe COPD on 3 L nasal cannula at home, presents to the ED with increased shortness of breath and cough.The patient states that she is having coughing fits with pleuritic chest pain without sputum production. She states that she has a history of DVT, though not on any anticoagulation.  Denies any abdominal pain, nausea, vomiting, or diarrhea.  She does have a historyof colostomy bag with n ormal output. Admitting dx:  SOB, COVID 19, acute kidney injury. CT PE: No evidence of acute pulmonary embolism. CXR No acute cardiopulmonary abnormality, stable chest.Venous Duplex BL LE--negative for DVT. D-dimer 547-397; CRP 9.1-5.4Positive for Thrombocytopenia, 118-108.
- (L) arm site is red with induration (3 in width x 4 in ht). - Painful to touch. - Warm to touch. - Tx with ibuprofen for pain, BENADRYL et ice (cool) compress.
Felt dizzy after 2 minutes of receiving the vaccine. I was sitting on a chair and I thought I'm gonna pass out. Felt better after 5 mins and completely normal after 10 mins.
Vaccine stored in refrigerator beyond 30 days. Pharmacist recommended revaccination. Patient received repeat dose 10/3/2021 and reported no adverse effects.
injection site pain-lasted 7-10 days (lost sleep due to pain, tingling, significant pain for several days) headache-24 hours body aches-24 hours
Stroke like symptoms with acute onset headache, dizziness, slurred speech, generalized weakness beginning around 11:00 am on 5/24. She initially had lightheadedness after standing and moving from porch to living room, as well as sharp R sided headache and generalized weakness in all extremities.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: pt developed a cellulitis type reaction from the Shingrix
patient received a dose / that had expired on 07-06/2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 10-year-old female patient who received HAV (Havrix) (batch number PA99T, expiry date 7th June 2021) for prophylaxis.   On 11th August 2021, the patient received Havrix. On 11th August 2021, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provide are as follows: The case was reported by Medical assistant. The patient received a dose of Havrix after expiration date, which led to expired vaccine used. The reporter consented to follow-up via fax.
Early Menstrual Cycle with Heavy bleeding: Period started on the 20th of March, 10 days early. Bleeding was very heavy. Period lasted ten days as compared to the normal 5 days. Bleeding was heavy the first 3 days then reduced and then increased again on day 5 and seemed like it was two periods.   Noticed spotting again on the 5th of April. Spotting continued until the 7th and extremly heavy bleeding started  on the 8th of April.   Other symptoms: Tiredness and paleness
Patient received vaccine and within a couple of minutes, became completely pale, started sweating, and felt nauseous. Continued for 20-30 minutes and then started to resolve. Did not need additional assistance and came into store later on and was feeling better.
2/21/07-Mother called and stated that her daughter-(14 mths) received 3 vaccines on 2/6/07. She states her daughter had a reaction to vaccine and was told by her pediatrician to report reaction to health dept. First noticed 3 red dots on shoulder above vaccine site. Pt has been breaking out sporadically on face, neck and legs with chickenpox. Pt ran fever of 103F on 7th day after injection mother took child to doctor on 2/20/07 to examine rash.
CDC reports: 2 yo child rec'd DTP/MMR on 13FEB90 & on 21FEB90 had fever to 104.4 & rash, duration of illness - 3 days.
Nasal redness, swelling, bleeding and pus on inside of both nostrils. Phone call with ENT specialist diagnosed as nasal vestibulitis.
Muffle hearing and Tinnitus  in right ear. Echoing sounds in right ear.