chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Swollen arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Swollen arm) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A, 013L20A and 011F21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism in 1995 and Cholesterol high in 1999. Concomitant products included SIMVASTATIN (ZOCOR) for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, TRAZODONE for Insomnia, CALCIUM for Osteopenia, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Swollen arm) and HEADACHE (Headache). On 29-Oct-2021, HEADACHE (Headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and PERIPHERAL SWELLING (Swollen arm) had not resolved.            No treatment medication was reported.   This case was linked to MOD-2021-372770, MOD-2021-365112 (Patient Link).
My daughter was given Moderna booster shot by mistake as she is only 15 year old. We went for Pfizer booster shot on 1/13/2022. Upon arrival, we were told that Pfizer booster had run out. We were asked if we could like to receive Moderna instead. At the time we were not aware that Moderna booster was not authorized for people under 18 years of age so we accepted the shot.  We realized the mistake after returning home. The next day I went back to the clinic to ask whether Moderna booster would cause adverse effect the wrong age group. The nurse in charge, instead of admitting the mistake, said that they gave my daughter Pfizer but wrote down Moderna vaccine info on the paper work and the vaccine card by mistake. She proceeded to alter the vaccine card by wiping out Moderna lot number and wrote down a Pfizer lot number instead.   I did not object  at the moment because I believed that they made a clerical error. However, my daughter told me that the doctor who performed the injection noticed, and asked my daughter to confirm, that she wanted Moderna booster.   I took a picture of the consent form that myself, my daughter and the injecting doctor signed. It was quite clear that the doctor circled Moderna on the consent form, which was crossed out and Pfizer was circled instead.
My symptoms started one minute after receiving the vaccine. It started out I was itchy where the shot was. Then my whole body became itchy. The pharmacist gave me 200mg of Benadryl. It helped but not completely. I went to the doctor within a couple of days to try and get treatment for the itchiness. They prescribed some kind of steroid but I did not take it because I did not want it to prevent the vaccine from working. The itchiness lasted about one month. It was very intense and I had to take Benadryl the whole month.  I did see an allergist that told me it was a case of hives, but the hives do not show.
Respiratory Acute respiratory failure (CMS/HCC) Assessment & Plan Acute respiratory failure 1/23, etiology unclear.  Note radiographic findings. In conjunction with fever and elevated procalcitonin, the possibility of pneumonia is a concern, with onset of shortness of breath and non-productive cough on 1/23 per chart review, with accompanying drop in 02 sat (which appears to have actually begun the evening prior). Initial findings on CXR appeared to primarily involve the right lung, with subsequent rapid progression throughout 1/23 to involve the bilat lung fields. His coverage has been broadened to include cefepime and azithromycin with continuation of vancomycin. The possibility of aspiration has also been raised, although he doesn't appear to have any obvious risk factors of aspiration, and none was witnessed. Could the radiographic findings be due to non-cardiogenic pulm edema? But if so, why? Could there be a relationship to the MRSA bacteremia? Endovascular infection? Possible, although initial TTE on 1/4 was negative for vegetation (recognizing limited sensitivity of this test), and repeat BC 12/30 were negative.    For now, will continue empiric antibiotic coverage and monitor his clinical course. Obtain resp culture, and repeat NAA for SARS CoV2 (specimen collected personally). Await blood cultures. Await results of repeat TTE - if non-diagnostic, TEE? Will discuss.  Discussed at bedside with his wife, and questions addressed.  She thanked us for our care.
fatigue, sore arm, headache, nausea, loss of appetite, chest tightness, weakness.
Eye began to turn in on 07/20/2003.  Constantly following an intermittent turning beginning 07/17.  Examined left cranial nerve paresis.  No associated illness, fever, injury.  No evidence of Papilledema.
Soreness in arm that felt like my arm was hit with a sledge hammer that latest 4 days,  low grade fever, lethargy and nausea all that lasted for 4 days.  Still not feeling 100% after 5 days (extremely tired and feeling run down).
Developed typical local reaction with redness, swelling and pain thereafter injection, but has subsequently had ongoing pain since and appears to have developed a biceps tendonitis as a result
The patient lives in a group home. He was noted to have fever, cough and oxygen saturation was 93%. He was sent to the hospital. COVID test was negative. He was admitted for rule out pneumonia. He also had lower sodium (123) than previous baseline of 130. His antibiotics were stopped on day 2 of admission because fever resolved, chest x-ray was clear and oxygenation was improved. He was observed, remained stable and then discharged on his usual medications on 1/26/21.
Child vomited and had diarrhea after receiveing nasal h1n1 - child had received nasal vaccine dose #1- 28 days before and vomited and had stomach discomfort after that dose also.
Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 52 years old patient (gender unknown) who received vaccine FLUZONE QUADRIVALENT. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Sep-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT5937LA, expiry date 30 Jun 2018 via intramuscular route in the left deltoid. It was an actual medication error due to  Expired vaccine used. It was reported that expired dose of FLUZONE QUADRIVALENT was given to one of their employees. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
shingles; postherpetic neuralgia; nerve damage; Information has been received from a lawyer and a consumer (reported as spouse) referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  In or about November 2014, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for the prevention of shingles (herpes zoster) and routine health maintenance.  On an unknown date, the patient experienced shingles, nerve damage, and postherpetic neuralgia. The patient did not recover from the events. As per the reporter, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The events were disabling.   The reporter considered the events were related to Zoster Vaccine Live (ZOSTAVAX).
The needle went into the arm after the vaccine.  The syringe 1ml (25Gx1") was used.  The needle could not be extracted from the left deltoid.
SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (SORE ARM) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PRAVASTATIN and METOPROLOL SUCCINATE (METOPROLOL [METOPROLOL SUCCINATE]) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced MYALGIA (SORE ARM). At the time of the report, MYALGIA (SORE ARM) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details not provided Consent for safety to follow up was received. Patient states she went shopping and had her N-95mask.   This case was linked to MOD-2021-060440 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-060440:First dose case
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 42-year-old, concerning a 42-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 13-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804103 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Patient had dyspnea and cough for one week and will be treated for COVID pneumonia.
Left shoulder pain, post vax. Arthus reaction the next day on 11/21/00. Treated with heat and elevation.
Developed cold like symptoms a few days later, then refused to lie down for five nights. He'd scream and cry, and would only sleep if we held him. In his crib, if he fell asleep standing, he'd stumble and wake up, then start screaming again. The pediatrician diagnosed him with a pre-sinus infection.
undiluted Pediatric Pfizer was administered to patient at 0.2 ml .  Advised parents of potential for local and systemic adverse events
Noted 24 hours later swollen thigh mid-thigh to knee spanning joint. Spoke to Dr on call, then came in to see provider Monday afternoon. Site swollen, inflamed, no pain to palpitation, small amount exudate serous vesicles about 3" diameter on mid-thigh. Given Benadryl 1 1/4 tg.
Hives on body, in mouth; facial swelling, swelling around eyes.  New reactivity to soaps, shampoos, makeup, - seems to be things containing PEG and palm oil and coconut.  Also reacted with mouth hives from avocado. Hives still present as of today 4/21/2021, but reducing in frequency and severity.   Some hives present after first vaccine, and did contact physician .  They remained up until 2nd dose at which time they increased in frequency and amount.   Had throat swelling, swollen eyes and hives around eyes after ingesting salmon post 2nd vaccine.  Not a previous food allergy.  Shortness of breath was exacerbated after first dose of Pfizer, with significant increase in shortness of breath and accompanying throat tightness after 2nd dose.
All day on December 11, experienced common symptoms of fatigue, body aches, chills etc.  However at approx. 2:00 am on December 12, in addition to continued body aches, had awful stomach pain - felt like my intestines were inflamed - could not get comfortable to sleep.  Throughout the rest of the day (December 12) had constant diarrhea that was reminiscent of colonoscopy prep, along with continued weakness and fatigue.  It has improved slightly but still continues to date along with intermittent abdominal cramps.
Quarter size raised red circle; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 22Feb2021 at 11:45 (at the age of 68-years-old) (Lot Number: 6201) as dose 1, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of the events. The patient has known allergies. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior to vaccination and had not been tested for COVID post-vaccination. On 22Feb2021 at 12:00, the patient experienced quarter size raised red circle where the shot was given. It was reported that it does not hurt and has not gone away after 4 days. No treatment was received for the event. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately three months after the second dose of the vaccine I noticed that my periods had become irregular. They began approximately a week early and continued with irregular spotting for approximately a week and then my normal period happened as well. This has been happening most months since, but occasionally it does not. Around the same time as the early spotting begins I have been having outbreaks of oral HSV-1 (cold sore). This has started happening almost every month or every other month. Previously I would only every have an outbreak of symptoms up to once a year (often less than that). After several months of this happening I contacted my doctor about it but never got a call back so I made a teledoc appointment and was advised to get on a suppressive dose of daily valacyclovir to prevent outbreaks. I went to planned parenthood clinic and received the same advice and a prescription for the medication. When I take it daily the cold sore symptoms do not appear but the irregular periods still happen most months. I stopped taking the valacyclovir for approximately two week earlier this month (after having taken it daily for three months with no symptoms). After two week I got a cold sore and a couple of days later my period started a week and a half early. It is still going. I?ve resumed taking the valacyclovir daily.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Feb 2021; both single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced lymphadenopathy (swollen lymph nodes), onset 2021, with outcome of not recovered. Additional information: Patient's 3rd dose, the booster shot of Pfizer COVID-19 vaccine scheduled on Wednesday, Oct 6, 2021. She wanted to check if it was or not recommended to get the booster shot with her still having ongoing swollen lymph nodes. She never had swollen lymph nodes prior to getting the Pfizer COVID-19 vaccine doses. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Several children, ages 6-16, vax w/ booster dose;  complained of stinging at inject site.  Stinging lasted 1 minute.
Pt states she has tingling on her tongue 1 hour after for 5 minutes then it went away on its own. Pt states she didn't take any Benadryl or medications to help.
Cough, chills, elevated temperature, sore/scratchy throat, Headache, runny nose/congestion, loss of taste and/or smell, myalgia, and malaise
Sore arm for 3-4 days flu like symptoms for 2 weeks period came 4 days early (never happens) within 2 weeks brain fog continuous extreme fatigue continued depression increase continued acne began 1 week after and continues
Sore the first 24 hours; This is a spontaneous report from a Pfizer ibrance cep from a contactable consumer (patient). This 63-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 31Mar2021 at single dose for COVID-19 immunization; palbociclib (IBRANCE) oral form 13Oct2020 and ongoing at 125 mg once a day (21 days) for breast cancer. Medical history included hair falling out. Concomitant medications included FULVESTRANT (FASLODEX) for hair falling out. The patient received first covid vaccine on 31Mar2021. she was sore the first 24 hours. Second vaccine was schedule next week at the time of reporting. Md aware: yes. Action taken with palbociclib  was unknown. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sudden loss of hearing (history of Bell's palsy) followed by shingles rash outbreak after prednisone was stopped.  Occurred on 3/10/2013.
Patient fainted approximately 3 mins after receiving the booster dose of Pfizer, 0.3 ml.  Patient fell from the chair and hit his head on the ground. Patient was unconscious for approximately 10-15 seconds, and was noted with a chipped tooth and contusion on the head, with slight bleeding.  Patient was A&O x 3 upon regaining consciousness and vital signs remained WNL.  EMS was called.
My arm became swollen, red, hot and painful one week after injection. Been taking an antihistamine and applied ice pack in the beginning. Still experiencing some pain, red and heat in arm.
INCORRECT VACCINE ADMINISTERED, PATIENTE WAS SUPPOSSED TO RECEIVE PFIZER COVID 19 BIVALENT, BUT RECEIVED PFIZER COVID 19 VACCINE. NO SYMPTOMS OR SIGNS.
Leg swelling and redness within 2 hours of injections, area of redness and swelling doubled within 2 hours of initial symptoms.  Child was taken to the ER, diagnosed with cellulitis and given IM penicillin.
The next day - know appeared, bright red bulls eye, very tender. BENADRYL given. Taken to pediatrician. slowly improving.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022 at 1:44 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Mar-2022 at 1:44 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Vaccine administration time was given as 13:44:09. . No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
It was reported that an 18 year old female pt received a Menomune A/C/Y/W-135 vaccination on 02/10/00 at 14:30 and felt fine and left the office. The pt returned at 18:00, complaining of general weakness, nausea, chest tightness, hives and itching. The pt did not experience shortness of breath, BP-left 140/84-100-20; right 150/84-100-20. Treatment of Benadryl 50mg per oral was given. At 18:30, the pt's BP was left 140/84-100-20, right 150/84-100-20. The pt reportedly recovered from this experience. From correspondence received, it was reported that the pt did not experience chest tightness, hives and itching as previously reported, however, did experience diaphoresis.
Pt admitted to hospital with COVID on 9/6/21 s/p 2 doses of Pfizer (1/14/21 & 3/7/21)
Arm very stiff.  Increasing stiffness and sharp pain.  Stabbing pain became unbearable until I could no longer sleep nor lift/move my arm.  Went to orthopaedic doctor on 12/30/15.
Information has been received from a licensed practical nurse concerning a 53 year-old patient with asthma who on 17-Oct-2006 was vaccinated intramuscularly in the right deltoid with a 0.5 mL third dose of Pneumovax 23 (651320/1008P). Subsequently, the patient complained of injection site reactions. On 18-OCT-2006, the patient experienced weakness, pain and limited range of motion for a week. The patient sought unspecified medical attention. No product quality complaint involved. Additional information is not expected.