chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Medication error:  Identified that this named 11-year-old patient received a booster dose of Adult Pfizer 0.3ml intramuscular/ left deltoid by Nurse; based on age, this 11-year-old patient, qualifies to receive the Pediatric Pfizer 0.2ml intramuscular dose. No adverse reaction or signs/ symptoms have been reported.
Patient developed a large (3x4in) erythematous, warm, pruritic area at vaccine site within 24hrs of vaccine administration. Advised treatment with Zyrtec and warm/cold compresses and return to office if increased erythema, pain, or fever.
Patient had the first dose and experienced rashes on nose like she had the second dose; This is a spontaneous report from a contactable consumer (patient) reported for self. A male patient of an unspecified age received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported as he had the first dose and experienced rashes on nose like he had the second dose. The outcome of the was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.Sender's Comments: Linked Report(s) : PFIZER INC-2021517224 same reporter/patient/product, different dose/event.
tines on chest (feels there something in there); sore arm; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tines on chest (feels there something in there)), PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and MYALGIA (body aches) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 031A21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS], VITAMIN B COMPLEX and MAGNESIUM for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021 at 8:00 PM, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and MYALGIA (body aches). On 15-Apr-2021, the patient experienced CHEST DISCOMFORT (tines on chest (feels there something in there)). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (tines on chest (feels there something in there)), PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant medications also include unspecified birth control medication.
I received the first Covid-19 vaccination 3/29/21.  A few weeks later my grandkids (who previously had a covid-19 positive illness months prior) came to visit from out of state for a few days.  They were sick with colds.  After they left, I got (presumably) the cold that they had and was sick for about a week.  I postponed my 2nd dose of the Moderna Covid-19 vaccine until it had been 10 days of feeling better (although I did have mild headaches that ibuprofen seemed to quell).  After receiving the the 2nd dose of the Moderna vaccine I began to have severe pain in one or two of my teeth, ear, and eye.  I assumed it was dental related and spoke to my dentist who put me on amoxicillin and scheduled an appointment a week later.  The pain and headaches intensified and I was taking a lot of ibuprofen and acetaminophen (max doses of each) to reduce the pain.  At the time of my dental appointment my symptoms had lessened a bit and the dentist took x-rays that were inconclusive.  She referred me to another dentist specialist who did the same thing and it was also inconclusive which tooth was bothering me or if there was even decay (under 2 crowns).  The second dentist wanted me to come back after NOT taking any pain meds to make a definitive diagnosis.  So, I stopped taking pain meds and the dental pain wasn't coming back.  What DID come back though were the headaches which now I believed were migraine headaches that were treatable with Fioricet (a migraine med).  Eventually, after maybe 14 days after the 2nd Moderna shot, the headaches finally disappeared...and my teeth are fine.
Information has been received from a physician concerning a 70 year old male (not his patient) who "2 weeks ago", on approximately 27-AUG-2008 was vaccinated with a dose of ZOSTAVAX. There was no concomitant medication. Subsequently the patient experienced encephalitis and was hospitalized. At the time of this report, the patient was still at the hospital. Additional information has been requested.  10/10/08  Reviewed PCP medical records of 5/29-9/22/2008. FINAL DX: encephalitis Records reveal patient experienced usual state of health on 6/12/2008 day of Zostavax vaccination, no lot number provided.  Developed HA, fever, decreased appetite, weakness, axillary & inguinal lymphadenopathy, frequent urination, chills, rash on flank, confusion, weight loss, excessive sleep 8/08.  Seen in ER 8/17 & dx w/muscle tension HA.  Condition worsened & seen by PCP 9/2 w/fatigue x 6 weeks, fever/chills x 4 weeks, right hand weakness/clumsiness, eye floaters, loose stools.  LP & labs done.  Tx w/oral antibiotics & antivirals.  Continued to worsen w/shakiness, gait disturbance, extreme fatigue & tiredness, HA & neck pain.  RTC & sent to hospital for admission 9/4/08 for possible viral meningitis & diagnosed w/encephalitis.   10/1/08 Reviewed hospital medical records of 9/4-9/16/2008. FINAL DX: no d/c summary available.  H&P states meningitis, indolent course; varicella-like rash across right chest wall & abdomen. Records reveal patient experienced feeling ill for approx 6 wks prior to admit.  Had been seen in ER on 8/18/08.  CT scan at that time c/w sinus infection.  Seen by PCP 9/3/08 w/HA, neck pain & intermittent fever & chills, weight loss x 2 weeks. Rash cultured.  LP done in office & when received results sent to ER for admission.  In ER had fever 101.7 w/severe HA, neck pain, fatigue, cough, rash across right chest & abdomen.  Tx w/IV antibiotics & antivirals.  ID consult done.  1/8/09 Reviewed D/C summary for 9/4-9/16. FINAL DX: aseptic meningitis; DM II; HTN; low testosterone. No other new information obtained.
Developed non raised red rash 3/12/12, entire body, concentrated on trunk, MMR/VARIVAX 3/5/12. Fussy, afebrile. Right eye swollen/puffy, no discharge from eye. Diarrhea one time.
Moderna COVID-19 Vaccine EUA caused diarrhea beginning morning after second dose and continuing for at least 3 days. Also caused brain fog, fatigue, sore arm, and chills beginning evening after second dose.
During the night after I received the injection, I suffered chills. Felt tired and lack of energy the following day.
death I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) J18.9 - Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung
Fatigue and mild headache starting 24 hours after the injection. Approximately 30 hours after injection, headache progressed to severe headache with migraine features (sensitivity to sound and light) Symptoms resolved within 48 hours.
low grade headache, mild fever(100.7), body aches, extreme exhaustion. First began noticing adverse change within 20-24 hours following injection Tuesday injection. Was aware of not feeling quite right Wednesday afternoon. All day Thursday and into the evening was most challenging due to body aches and feeling of total exhaustion. By mid morning Friday a return to normalcy. Did not seek advice or treatment.
The child experienced a swollen left thigh from knee to hip with an onset of swelling. The pt had a good range of motion. Mom reports the child cries at night due to pain and limps when walks.
Severe diarrheia. 4 - 6 episodes day and night. Lasted for 4 1/2 weeks
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 56-year-old male patient received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Lot number: EW0191) at the age of 55 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Negative; (23May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid start on 12May2022 and stop date on 16May2022. Last dose of Pax was 16May2022. Negative home antigen on 20May2022. Patient felt fine then recurrence of sneezing,  congestion, fatigue on 22May2022and tested positive on 23May and outcome was recovered.No treatment, Known allergies and Other medical history.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded.
upper arm pain/lower arm pain; pain in hand; pain in fingers/thumb; numbness in fingers/thumb; numbness in wrist; numbness in hand; injection site soreness; elbow pain; pain in wrist; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (upper arm pain/lower arm pain), PAIN IN EXTREMITY (pain in hand), PAIN IN EXTREMITY (pain in fingers/thumb), HYPOAESTHESIA (numbness in fingers/thumb) and HYPOAESTHESIA (numbness in wrist) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (upper arm pain/lower arm pain), PAIN IN EXTREMITY (pain in hand), PAIN IN EXTREMITY (pain in fingers/thumb), HYPOAESTHESIA (numbness in fingers/thumb), HYPOAESTHESIA (numbness in wrist), HYPOAESTHESIA (numbness in hand), VACCINATION SITE PAIN (injection site soreness), ARTHRALGIA (elbow pain) and ARTHRALGIA (pain in wrist). At the time of the report, PAIN IN EXTREMITY (upper arm pain/lower arm pain), PAIN IN EXTREMITY (pain in hand), PAIN IN EXTREMITY (pain in fingers/thumb), HYPOAESTHESIA (numbness in fingers/thumb), HYPOAESTHESIA (numbness in wrist), HYPOAESTHESIA (numbness in hand), VACCINATION SITE PAIN (injection site soreness), ARTHRALGIA (elbow pain) and ARTHRALGIA (pain in wrist) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-143259 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-143259:First dose case
Pt received first Pfizer COVID-19 vaccine on 5/14. Pt was COVID positive three weeks prior to receiving the vaccine. Pt went to the ED on 5/15, c/o of chest pain. See below from initial consultation in the ED:  48-year-old female with a history of recently diagnosed COVID-19 approximately 3 weeks ago and subsequent COVID-19 vaccination yesterday presenting with chest pain. EKG reassuring and troponin negative. Chest x-ray without mediastinal widening or pneumothorax but with persistent bilateral pneumonia consistent with COVID-19. Considered PE but patient chest pain resolved following GI cocktail therefore less likely. No tachycardia or hypoxia. Plan for ACS rule out given HEART score 2. Patient signed out to the oncoming attending at shift change disposition pending repeat Trop/EKG but patient to continue to be primarily managed by PA.  Pt was prescribed famotidine and MOM and told to F/U with their PCP.
Treatment of COVID-19; Treatment of COVID-19; Moderna: 17Aug2021; 14Sep2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EM9810), in left arm, on 25Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 14Jan2022 as dose 5 (booster), single (Lot number: Fj6369) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Aug2021 as dose 3 (booster), single (Lot number: 939902), in left arm and on 14Sep2021 as dose 4 (booster), single (Lot number: 058E21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "A-Fib" (unspecified if ongoing); "Prostate cancer" (unspecified if ongoing). Concomitant medication(s) included: TIKOSYN, start date: Nov2021. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Aug2021, outcome "unknown", described as "Moderna: 17Aug2021; 14Sep2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Patient died of COVID 8/29/2021. Had received 2 doses of Pfizer COVID19 vaccines. 1st dose was also Pfizer 12/29/20, 2nd dose on 1/19/2021. 83 yo F with sig comorbidities including chronic ischial wound, admitted for resistant PsA UTI and incidental covid. As such, the OSH didn't treat her for COVID 19, despite transfer document indicating the new, 1L o2 requirement at elevation. On DOA 4/5 she developed and O2 requirement, had b/l pna on CXR, and then over the course of 4 days progressive respiratory failure. Given RDV/Dex x 2 days and stopped as patient transitioned to hospice.  Pt died as mentioned.
Pain in arm (left) day 2 was swollen no longer swollen, no redness. Pain continues.
feeling sick; every bone in her body hurts; hurts to walk; low grade fever; Chills; Headache; no appetite; extremely thirsty; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), BONE PAIN (every bone in her body hurts), GAIT DISTURBANCE (hurts to walk), PYREXIA (low grade fever) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (she had COVID-19 in the end of January-beginning of February.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and SIMVASTATIN 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 04-Mar-2021, the patient experienced MALAISE (feeling sick), BONE PAIN (every bone in her body hurts), GAIT DISTURBANCE (hurts to walk), PYREXIA (low grade fever), CHILLS (Chills), HEADACHE (Headache), DECREASED APPETITE (no appetite) and POLYDIPSIA (extremely thirsty). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, MALAISE (feeling sick), BONE PAIN (every bone in her body hurts), GAIT DISTURBANCE (hurts to walk), PYREXIA (low grade fever), CHILLS (Chills), HEADACHE (Headache), DECREASED APPETITE (no appetite) and POLYDIPSIA (extremely thirsty) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included over the counter allergy pills and vitamins.
A couple days after the injection all arm soreness had done away. One week after the injection the injection site became red and itchy with a hard lump under the skin roughly the diameter of a golf ball.  I am not sure if it is infected or if I have "COVID Arm".
This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. On 17-SEP-2013, the patient was vaccinated with a dose of ZOATAVAX (Lot number, expiry date, route and dose were not reported) vial. Approximately on 17-SEP-2013 (at an unspecified time shortly after receiving ZOSTAVAX), the patient developed rash on thigh groin and one testicle. The patient had developed a "zoster like rash" on testicles. Patient sought medical attention and went to see unspecified dermatologist and was diagnosed with herpes zoster and was prescribed Valtrex which had not yet been started. Physician stated that the dermatologist completed a "culture" on 26-SEP-2013. Valtrex had not been started and does not plan to start. The physician who advised patient takes Embrel and unspecified rheumatologist advised ZOSTAVAX vaccination would "be alright". The outcome of the report events was unknown. Additional information has been requested.
cranial nerve VII lt palsy p/1st dose of vax;treated w/steroids & antivirals w/minimal relief;some resolution of sx w/time;
Within two hours of getting vaccine I began to have heart palpitations and PVC?s that lasted about 4 hours.
Lump in neck with pain left side same side as injection, Fever low grade-100. On 10/04/02 symptoms persist seen by PMD today.
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 53-year-old female patient who experienced stuffy head (feeling like her head was packed with cotton), feeling achy, chills and sore throat. At 53 years of age, the patient received a dose on 11-Dec-2003. Medical History: The patient's concurrent illness includes unspecified allergies. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 11-Dec-2003. Dose regimen was 1 dose (intranasal). Concomitant Therapy: Concomitant therapy included Claritin (loratadine). Event Details: On 14-Dec-2003, 3 days post-immunization, the patient developed symptoms of stuffy head (feeling like her head was packed with cotton), feeling achy, chills, and sore throat. No additional information was available at the time of this report.
Acute HFrEF (35%) and dilated cardiomyopathy. Potential myocarditis. MRI cardiac obtained 24 days post vaccination neg for acute myocarditis. Other work up cardiomyopathy: ischemia (underwent left heart cath), HIV, TSH neg. No hx of alcohol,  meth, or cocaine. Not acutely infected.
Received both Tdap & Hep B (& PPD skin test on 9-25-06 as part of Immunization Program for new students).  Today when she returned for PPD reading, she reported significant swelling, tenderness, & redness at site of the Tdap.  Reports crescendo of symptoms beginning 12 hrs after injection for 1.5 days, then decrescendo to present time.  Also reports transcient "twitching of muscle", "crawling sensation of skin" & light touch sensitivity at site of injection at 1-2 days but since resolved. Felt warm (both locally & systemically) but did not document temp.  Denies any chills or shaking at any time.  On examination: 6 X 6 patch of mild erythema & edema on left deltoid, tender to touch.  Advised: ice, Tylenol as directed prn pain, & f/u if not continuing to resolve over next 1 week.
8 days after receiving vaccine, noticed a 2" red circular spot at the injection site that is swollen and warm to the touch
administrating only the diluent portion / administration of the diluent alone; administrating only the diluent portion / administration of the diluent alone; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received Shingrix. In July 2021, 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 details were provided as follows: The age at vaccination was not reported. The account manager from Glaxosmithkline called to report that he was informed by a third person, that an health care professional was administrating only the diluent portion of the Shingrix vaccine to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, the patient received Shingrix vaccine through 26th July 2021 to 29th July 2021. The reporter gave the health care professional contact information but did not specify if the health care professional agreed to be contacted for follow up or not. There was no further information regarding the date of the administration, nor lot number or expiration date of the vaccine. No further information was given to the account manager or to the agent. This case was 6 of 9 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165607:Same reporter US-GLAXOSMITHKLINE-US2021AMR167670:Same reporter US-GLAXOSMITHKLINE-US2021AMR167671:Same reporter US-GLAXOSMITHKLINE-US2021AMR167672:Same reporter US-GLAXOSMITHKLINE-US2021AMR167673:Same reporter US-GLAXOSMITHKLINE-US2021AMR167676:Same reporter US-GLAXOSMITHKLINE-US2021AMR167675:Same reporter US-GLAXOSMITHKLINE-US2021AMR167677:Same reporter
pt recvd vax & started temp elevation @ 4PM t102.1 gave pt APAP; was lethargic & slept most of day &wining; woke up 1230AM w/t103.1 had sz; turned blue;