chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from a health care professional on 10/28/03 concerning a 23 year old female vaccinee who experienced fluid filled spots that were red, itchy and raised on the day after receiving Fluvirin on 10/20/03. On 10/21/03 the vaccinee experienced fluid filed spots that were red, itchy and raised. The vaccinee had not recovered at the time of the report. There was insufficient information to determine that reporter's causality assessment. Follow up pending. Update 1, 12/11/03: A follow up report was received from a health care professional regarding the rash which was described as covering the torso, arms, legs and head and which was pimple like. The follow up report indicated that the spots eventually dried and disappeared. It has taken several weeks for them to disappear. No further follow up necessary.
pt to ED with SOB; placed on NRB with O2 sats in 90s; positive COVID test; treated with ABX, dexamethasone; transferred to ICU; later O2 sats between 40-60%, pt still comfortable just became progressively sleepy; became unresponsive and expired in the hospital
This is a 94y.o. female with history of hypothyroidism, hypertension, atrial fibrillation not on anticoagulation, and history of left mastectomy with breast augmentation who presents with chest pain, palpitations, and lightheadedness. She also describes she started experiencing flu-like symptoms on 11/1/21 with congested cough and rhinorrhea. She denies any fever or known exposures. She is fully vaccinated against COVID-19. She says the chest pain she's been experiencing occurs occasionally with exertion, but occurs other times at rest. She denies shortness of breath, orthopnea, lower extremity edema, or weight gain. No nausea, vomiting, abdominal pain, or diarrhea. Her last stress test was in 2019. She reports she lives at home and is independent with activities of daily living and even exercises often.   Upon arrival to the ED, BP 130/70, temperature 97, SpO2 97% on room air. The patient did test positive for COVID-19. CBC and BMP largely unrevealing. Initial troponin 0.10 with serial troponin 0.15 and 0.24. BNP 497, D-dimer 881. No acute process seen on chest x-ray. EKG with sinus tachycardia and non-specific T-waves, but no acute ischemia.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt was seated after the vaccine in observation area. He stood up saying he had to use the bathroom. He proceeded to faint and was caught. He passed out and then came around seconds later. BP check and pulse were normal. Had him lie down with legs raised. Gave water and cookie. He stayed about 45 min. He was driven home later. Called his home at end of day and said he was sleeping but fine.
12-24 hours after receiving dose #2 - I experienced a migraine throughout the day. It peaked around the 24-hour mark. I do not typically get migraines.
pt recv vax & devel an inj site rxn characterized by redness & swelling w/pain radiating from site down the arm;pt has recv pneumococcal vax in the past;this is one of ten pt who exp above rxn p/vax;
Mother stated that on 10/15/02 the injection site was "hard and swollen," on 10/16/02 the injection site was "hard, swollen and red," on 10/17/02 the injection site was "red, hot and tender to touch," on 10/18/02 the L thigh had a "reddish bruised area measuring 3" by 4", but that the pt had no difficulty walking.
I started having extreme fatigue and brain fog about 2 hours after receiving the first dose of the vaccine. I began having problems concentrating and finding words when speaking some days after that. I started having muscle aches and a weird ringing in my ears two days after the vaccine, 03/25/2021. The second dose was pretty similar with heavy fatigue. I began having tinnitus in between the first and second doses. The ringing in my ears began disrupting my balance and I couldn't ignore it anymore. I called my PCP who referred me to an ENT afterwards that I've been seeing since last March. It hasn't subsided and I was suggested to begin blood pressure medicine that could aid the ringing and buzzing in my ear; but because the medicine could drop my blood pressure, I wasn't prescribed the medication. Now, I go to an acupuncturist regularly to aid the tinnitus. Still until this day, I still have constant ringing in my ears.
red, swollen warmth at site.  Redness into armpit and rt breast.  Tylenol and cold compress. No further treatment yet. Awaiting response from occ med
10.5 to 11hrs after injection developed shaking rigors, severe diffuse joint pain preventing ability to ambulate normally, worse than after first series, fatigue, fever
pt recvd vax & w/in 1 wk post vax exp an upper body rash, stiffness in finger joints;seen in ER;tx aristocort cream for rash;
p/last shots in the evening vomited, would not take bottle, fever not measured; vomited & fever for 1 wk; irritable;
Developed headache within a couple hours of vaccination, put cool cloth on his head and was found dead on his bed a couple hours later. CPR initiated. Resuscitation suspended after approximately 20 mins when EMS arrived (to respect the wishes of his Advance Directive).
Administered expired vaccine to patients/ Dose 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 (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) in a 66-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The vial did not undergo any temperature excursions Date the vial was initially stored in refrigerator was unknown. Total of 173 doses were given from LOT 070H21A.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-Significant live follow-up was received.
Rash painful and tender started 7 days after shot.   Itching all over 3/10.  Arm painful and rash spread over upper arm.  Matched look of covid arm that was on news.  Dr prescribed  Benedryl.
Patient stated her tongue felt tingly. She took a dose of 25mg of liquid benadryl. Within a minute, the atient stated it was no longer tingling. She also stated she gets nervous with shots and may just be worked up. She stated she had the initial moderna series and had no problem. The patient waited an additional 15 minutes and stated she felt nothing concerning at that time. She denied any oral swelling or difficulty breathing.
On Sunday 04/11/2021 started with a diarrhea until Thursday 04/15/2021, when I  had convulsions at home and then 110 degrees fever, I stayed  15 hours in the ER, since that time the diarrhea has stopped, then  on 04/22/2021 I had a rectal bleeding and needed to be hospitalized until 04/24/2021. Also I showed positive for Influenza type B, I will like a explanation please.
Fatigue; Chills; Sinus pressure; Cold; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills), PARANASAL SINUS DISCOMFORT (Sinus pressure) and NASOPHARYNGITIS (Cold) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to Severe).   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Fatigue), CHILLS (Chills), PARANASAL SINUS DISCOMFORT (Sinus pressure) and NASOPHARYNGITIS (Cold). At the time of the report, FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown and PARANASAL SINUS DISCOMFORT (Sinus pressure) and NASOPHARYNGITIS (Cold) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment details were reported.  The reporter's causality for the event(s) of fatigue, chills, sinus pressure and cold with humira(adalimumab) was no reasonable possibility  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Seen in our office on 1/22/09 and reecieved 4 year old boosters. Woke up 1/23/09 with red and swollen left arm.  Diagnosed with cellulitis left arm treated with augmentin.
Woken in early hours of 3/18 with fever, chills, body aches and pain at site of vaccine.  All symptoms improved within 48 hours of onset of symptoms.
After my first dose Moderna vaccine, I developed a rash in my upper right arm at the injection site, it was warm to touch and swollen. It was 1inch in a half to about 3inches in diameter.
Painful upon injection. Fever, chills, diarrhea, low blood pressure, fainted starting around 11pm.
Rigors, fever, swelling arm, redness, lethargic, headache.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: other medical history: High blood pressure, low thyroid; "low thyroid" (unspecified if ongoing), notes: other medical history: High blood pressure, low thyroid; "Strawberries" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Postive, notes: Tested positive again on Day 13. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with PAXLOVID.  Clinical Course:if vaccine received: Yes, other medication in 2 weeks: Yes, product=COVID 19 Treatment, brand=Paxlovid, treatment start date=01Feb2023, treatment stop date=06Feb2023, other medication details:other medication in 2 weeks product=Levothyroxine, other medication in 2 weeks product=Amlodipine, adverse event: Rebound covid. Tested positive again on Day 13 after feeling well from day 7-12 after initial symptom onset. Tired, headache, cough, fever. Milder than the first set of symptoms.  No follow-up attempts are possible. No further information is expected.
Throat began closing up, itching in face, especially nose and lips . The next day, sore throat, muscle exhaustion in entire body  and continued itching.
This spontaneous report as received from a medical assistant concerning to a patient with unspecified demographics. The patient's concurrent conditions, medical history, drug reactions and/ or allergies were not reported. On 09-MAY-2017, the patient was inadvertently vaccinated with an expired dose of GARDASIL 9 with lot # L010596 and expiration date on 06-APR-2017 for prophylaxis (the dose, rote, frequency, and strength were not provided). No adverse effects were reported. Lot number L010596 has been verified to be a valid lot number for GARDASIL 9. Additional information has been requested.
Erythematous, edematous left upper arm with tenderness and warmth, painful. Pt experienced high fever. Treatment with ibuprofen 800mg, prednisone, clindamycin.
No reaction occurred. The health care provider wanted to know if the child needed to receive a dose of PEDIARIX since he was given the wrong medication?
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; DIZZINESS; 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, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 05-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 17-APR-2021, the patient experienced dizziness and suspected covid-19 infection (cough and difficulty breathing) and suspected clinical vaccination failure. On 19-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) as Positive (units unspecified). Patient was referred to HCP to discuss further. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure and dizziness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: - covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
32 months old female inadvertently received the second dose of expired Moderna infant at around 9:30 AM on 9/6/22. The Moderna vaccine vial expired 34 hours from the manufacturer date (expire on 9/4/22).
Severe chills.   Moderate body aches.  Moderate headache.  Fever (peaking at 101.3).  Symptoms lasted approximately 30 hours.
Information has been received from a registered nurse concerning a 47 year old white female with no known allergies or illness at the time of vaccination who at 8:15 on 03/19/2004 was vaccinated subcutaneously in the left deltoid with a dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Subsequently, the patient experienced joint pain and stiffness in the same arm she had been vaccinated.  Additional information received indicated that the patient notified the employee health services that on 04/04/2004, approximately 2 weeks after receiving measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, the patient had numbness in her wrist, fingers, and thumb.  She complained of joints being sore.  She also reported that she had a rash following vaccination, but the rash had gone away.  It was reported that the joint, numbness, and pain persisted.  No additional information is expected.
Patient is only 15 and was given Pfizer in error due to age. Was given first doe on 4/14/21 and second dose was given today 5/12/21  ( due to approval coming through at this time from agency) Patient is not fully vaccinated, had no reactions to first dose.
Extreme pain and swelling, hot to touch at injection site. Swelling subsided after 2 weeks. Contacted Dr. and was seen over 30 days later for same symptoms. June 3, 2015 still have inability to lift or use arm normally. Terrible pain, sore, stiff arm muscle, causing nausea and inability to sleep. Unable to do daily chores, my daughter helps me dress, she is only 8 years old.
Patient had tight chest, difficulty swallowing and hives all over face 30 minutes after vaccination
Covid19 breakthrough.  1st vaccine on 06/11/2021.  Pt with PMH of COPD, PTSD, Bipolar and anxiety arrived to ED by EMS from outpatient center, pt was having colonoscopy (due to bowel incontinence x2 months) and MD felt may have perforated bowel.  Pt denies fever, chill, nausea and vomiting.  Pt to emergent surgery- had intraop difficulty maintaining oxygentation-O2 sat 91-92@ 100%FIO2.  It was reported pt with persistent cough pre-op.  Covid test +.  Treated with IV ABX/Steroids and Remdesivir.  In ICU on vent.
Caller received her first dose of the Moderna vaccine yesterday at 9 am, today she woke up with chills, fatigue and a fever that is reading 100.1 after antipyretics. Pt denies diarrhea or vomiting and states she is able to keep fluids down. Advised patient to keep monitoring s/sx , rest and keep hydrated. Advised her to call her PCP if s/sx worsen and/or she is unable to keep food or drink down
SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On JUL-2021, laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. Patient had suspected clinical vaccine failure and suspected covid 19 infection. The action taken with covid-19 vaccine was not applicable. The outcome of the suspected clinical vaccine failure and suspected covid 19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189372.; Sender's Comments: V0;20210822908- covid-19 vaccinesuspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Wanted to put this on report in case others are seeing it.  My daughter started with menstrual bleeding 4 days after vaccine was administered, never had menses prior to this and per her physician her body does not match up to a child who should be starting with her menstrual cycle.  On the Tanner scale my daughter is only at a Tanner Stage 2 in her development.  This led to concerns by her pediatrician and we are following up with an endocrinologist.  This may be coincidental but I also wanted to make sure it was noted.
This spontaneous report as received from a registered nurse refers to a 11 year old patient (unspecified gender). On 23-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Within a few minutes, felt faint, unwell, did faint, came to, hot and sweaty, retching, heartbeat 110.
Patient was given only the diluent portion; Patient was given only the diluent portion; This case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-FEB-2023 Reporter's Comments: No additional details are available. Medical information agent returned to health care professional's call, no answer, left message on answering service and will update adverse event once additional details were available. Additional Supportive Information: The patient was administered only the diluent portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
was due to receive her the second dose of the Moderna Covid-19 vaccine   on   17Jul2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (was due to receive her the second dose of the Moderna Covid-19 vaccine   on   17Jul2021) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (was due to receive her the second dose of the Moderna Covid-19 vaccine   on   17Jul2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (was due to receive her the second dose of the Moderna Covid-19 vaccine   on   17Jul2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
20 min after injection the left side of my face went numb and felt heavy. My left eye lid was hard to open and the pressure in left ear was intense and painful.  It took three hours for the paralysis / numbness to subside. Resting heart rate continues to be ielevated  (between 120-188).  Other side effects (sore arm and headache seem reasonable).
Received Hep A vaccine on 04/09/2002 at approx. 1pm, pt developed nausea with vomiting at approx. 8-9pm and during the night. Headache on 04/10/2002. Complaints of achiness in fingers (rt) in am of 04/10/2002.
Pt was asked if she had received pneumovax in past. She stated "no". When reviewing chart found pt had shot in 2003. Pt received shot she did not need.
Initial report received from a consumer on 20 October 2014. A 74 year-old female patient with an allergy to antibiotics had received on an unspecified date in October 2013 an intramuscular dose of FLUZONE HIGH DOSE (lot number and site of administration not reported) and 24 hours later developed an extreme cough, widespread body aches and fever that lasted for 7 days. Then again in March 2014 the patient developed "the same symptoms" and was evaluated by a physician. The patient tested positive for the flu but strain was unknown. Treatment included Tamiflu. No further information was provided at the time of the report. Outcome was recovered. Documents held by sender: none.