chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756525A, A0756527A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUACA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Patient returned to pharmacy 5 days post-vaccination with large red itchy rash around injection site and reported that it had been spreading for several days. I advised her to seek medical treatment with her primary care physician or an urgent care.
Patient called to report a vaccine adverse reaction. He received the second dose of the Moderna on 05/07/21 and started to have mild fever (under 100F), body aches, headache, and weakness on 5/8 PM. He took once 600 mg Tylenol that day and symptoms felt better, but still some weakness at the time of call. ED precautions provided to patient
1030 am - MMR; VARIVAX, PREVNAR given. 2 pm - awakened from nap screaming and shaking and grunting lasting about 15 hours. X-ray - abd - negative except mod amt. fecal matter throughout colon - no distention. Temp 100.8 degrees @ 5:00 pm.
Mother reports: in the month after vaccination child went from saying about 30 words to saying only 2-3. He also quit having eye contact with family members.
Dizziness, Sweating, Tingling in fingers. Onset was approximately 35-40 minutes after administration. Effect was transient lasting 1-2 hrs. No treatment needed
Client became dizzy 15 minutes after getting vaccine. Denied all other symptoms. Waited total of 30 minutes, not other symptoms began. Instructed to go to ER or call 911 if symptoms return or worsen
Developed chest tightness, throat tightness after the vaccination. No fever, no hives. Prescribed antihestamine and steroid dose pack.
Patient reported dizziness following first dose of vaccine. Patient states she was nervous about the vaccine. Took vitals to find them stable. Patient refused transport to ED
Patient received 2nd dose of Pfizer COVID-19 vaccine on 6/16/21. She reported having myalgia, injection site pain, and some breathlessness following the dose. The following day, she noted sharp chest pain worse when she took a deep breath. She went to bed she woke up on 6/18 with worsening sharp chest pain worse with deep breath, worse with laying back and better with sitting up: 8/10 intensity without radiation.  She did feel short of breath when having the pain.  Patient's ESR was elevated at 30. hs-CRP was 69. Patient was given IV morphine and Toradol for symptomatic treatment. Troponins trended up with values of  0.029, 0.070, and 0.546ng/mL. Echocardiogram was performed, which showed normal pericardium and  normal LV and RV size and function. Patient was discharged with prescriptions for colchicine and ibuprofen.
A female patient was administered an expired vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A female patient was administered an expired vaccine.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (A female patient was administered an expired vaccine.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A female patient was administered an expired vaccine.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was unknown if the patient ever had tested COVID positive or diagnosis.   No concomitant medications were reported.  No treatment information was reported.
Treatment of covid-19; Treatment of covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 03May2021 as dose 3 (booster), single (Lot number: EW0161) at the age of 39 years, in right arm 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's relevant medical history included: "GERD" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Unknown results; (02May2022) Negative, notes: He tested negative for COVID via rapid antigen on day 6; (06May2022) Positive, notes: He tested positive via rapid antigen on day 10; (26Apr2022) Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: If vaccine received: Yes, Other medication in 2 weeks: No. Adverse event: Patient tested and Covid-19 via rapid antigen and PCR on 26Apr2022, he completed Paxlovid on 01May22. He tested negative for Covid via rapid antigen on day6. Symptoms reoccurred on day 10 consisting of nasal congestion, headache, and diarrhea, he tested positive via rapid antigen on day 10. Known allergies: No. Other medical History: GERD; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
CHIEF COMPLAINT:   Pt had blood work done today for chronic fatigue, H&H was 6.7/26.8. Pt denies bloody/black stools. Denies blood thinners.  Pt reports fatigue at time of triage   HISTORY OF PRESENT ILLNESS:     44-year-old female with history of PTSD, no history of GI bleed or anemia, comes to the ER for evaluation of chronic fatigue and low hemoglobin.  Patient says for the past several months she has been very fatigued, and she attributed this to being the mother of 4 children.  She tells me that her menstrual periods are not heavy, she has light spotting for 5 days.  No chest pain nausea vomiting fevers chills.  Otherwise asymptomatic.
EOA called in to report an adverse event. Attendee, DOB 05/28/2007. W/in 60 secs of receiving shot, she looked pale, felt dizzy, reported feeling lightheaded. Mom was there and reported this happens when she receives injections.  Didn't have time to get her to observation, so laid her down over 3 chairs w/head in mom's lap. First vitals:3:15p, BP 110/70, HR 86, resp 19, O2 100% room air, temp 98F. Kept an eye on her, w/in time she took vitals she was feeling better. 2nd vitals 3:20p, BP 102/70, HR 71, resp 16, O298% room air, temp 98.3. 1st dose of Pfizer, lot EW0217. Shot in L arm. Patient's sx subsided, she was released w/her mother, no further issues.
itching; mild rash; excessive mouth watering; This is a spontaneous report from a contactable consumer or other non hcp. A 62-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 23Mar2021 at 09:00 (at the age of 62-years-old) as dose 1, single for covid-19 immunisation. Medical history included coronary artery disease, known allergies: Penicillin and known allergies: Latex. Concomitant medication included celecoxib (CELEXA [CELECOXIB]), pravastatin sodium (PRAVACHOL), clonazepam (KLONOPIN), hydroxyzine (ATARAX [HYDROXYZINE]) and famotidine (PEPCID [FAMOTIDINE]). The patient previously took keflex [cefalexin] and experienced drug hypersensitivity, clindamycin and experienced drug hypersensitivity. The patient previously took Keflex and experienced known allergies: Keflex. The patient previously took Clindamycin and experienced known allergies: Clindamycin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On an unknown date the patient experienced itching, mild rash and excessive mouth watering. The outcome of all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is 16 years old.  the parents were not aware that the recommended age for moderna vaccine is 18.
Per phone call from mother. Child woke up from his nap and was crying for about 1/2 hours. Mother changed his diaper and noticed that he had started breaking out in hives. She called his PCP and was told to give him BENADRYL.
Pediarix to child over the age of 7; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number J9593N, expiry date 11th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th October 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 27th October 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: A dose of Pediarix was administered to the patient at 14 years of age, which led to inappropriate age at vaccine administration. The reporter consented to follow up. This case has been linked to US2021223564, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223564:same reporter
shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HERPES ZOSTER (shingles). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Dizziness; weakness; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 08Apr2021 at 12:15 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history included non-hodgkin's lymphoma, seasonal allergy, depression, anxiety and known allergy to penicillin. Concomitant medications included escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN), clonazepam (MANUFACTURER UNKNOWN), loratadine (LORATIDINE), tagetes spp. (LUTEIN) and unspecified multivitamin; all for unknown indications from unknown dates . The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 12:30, the patient experienced dizziness and weakness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events dizziness and weakness which included observation. The clinical outcome of the events dizziness and weakness were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Information has been received from a nurse concerning a female who was vaccinated with Gardasil. Subsequently, the patient developed Bell's palsy. Therapy with human papillomavirus vaccine was discontinued. The patient's Bell's palsy persisted. The nurse indicated that she was unsure whether the human papillomavirus vaccine caused the Bell's palsy. Upon internal review, Bell's palsy was determined to be an other important medical event. Additional information has been requested.
Follow up information received from the reporter on 05/03/04 provided updated patient demographics, medical history, additional vaccine, lot numbers, and name of patient's physician. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received from a pediatrician regarding a 3 year old pt who, at the age of 18 months, completed her primary series on 06/04/2002. On 03/25/04, the child experienced low titers. The child also received a dose of hib titer vaccine on 06/04/2002. Event Details: On 03/25/04, a pediatrician reported that a 3 year old pt having completed her primary series of Prevnar on 06/04/02 at 18 months of age, had titer test done which showed "low titers". Test Results: Antibody test (results : low titers) was done on an unspecified date.
Erythema, mild induration at (R) arm injection site 9 x 7.5 cm.
Immediately following vaccination the patient reported having a fever and feeling achy all over.  Her illness progressed over the next few day into a 'flu like syndrome'.  This never resolved and continued to progress.  Patient admitted to another hospital 17 days after receiving her annual influenza vaccination with total paralysis.  Patient was diagnosed by a neurologist with Guillian-Barre syndrome.  She received 5 days of IVIG and has experienced improvement in the paralysis.  12 days after hospital admission, she was transfered to an inpatient rehab unit.  11/16/06 Received medical records from hospital which reveal patient admitted 11/04/06 to acute floor of hospital with GBS.  She had developed cold & cough s/s, facial weakness & upper back pain approx 1 week s/p flu shot.  Speech with mild dysarthria & right 7th peripheral nerve impairment.  Dysesthesias in BLEs, DTRs areflexic in UE & LEs & decreased motor strength in RLE.  Patient also had complaints of N/V & RUQ epigastric pain.  Cardiac w/u was neg.  Consults by neuro, cardio & GI.  No D/C summary included with records.  Patient transferred to rehab unit for continued PT/OT/ST. PMH: HTN, migraine headaches, thyroidectomy,  Final Dx: GBS, mild per neuro consult./ss
Patient received 0.5ml of the (NDC 80777-0279-05) Moderna vaccine for 6 months to 5 years instead of the Moderna Bivalent 0.5 mL dose Since this wsa the monovalent vaccine at the appropriate dose (still 50 mcg), we are waiting 2 months and if the patient still wants, giving the Moderna Bivalent vaccine.  Patient reports that her arm hurts really bad.
Feeling cold / Freezing/Had to use Three blankets; Productive cough / Coughing up a little bit like had sinus drainage; Sleep decreased / Averages about four hours of sleep; Pain in arm / Arm sore with Humira; Stool odor abnormal / Odor in Stool/Poop Smells Bad; COVID-19; COVID-19; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4289655-00 (Agency).  A 56-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), at unk (citrate free), subcutaneous for colitis ulcerative. 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) all with onset 23Dec2021, outcome "recovered" and all described as "COVID-19"; ABNORMAL FAECES (non-serious) with onset May2022, outcome "unknown", described as "Stool odor abnormal / Odor in Stool/Poop Smells Bad"; FEELING COLD (non-serious), outcome "unknown", described as "Feeling cold / Freezing/Had to use Three blankets"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "Productive cough / Coughing up a little bit like had sinus drainage"; INSOMNIA (non-serious), outcome "unknown", described as "Sleep decreased / Averages about four hours of sleep"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Pain in arm / Arm sore with Humira". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Dec2021) Positive. The action taken for adalimumab was dosage permanently withdrawn. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of "covid-19", "feeling cold / freezing/had to use three blankets", "productive cough / coughing up a little bit like had sinus drainage", "sleep decreased / averages about four hours of sleep" and "stool odor abnormal / odor in stool/poop smells bad" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "pain in arm / arm sore with humira" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Gave Boostrix to a 5yr old instead of DTAP.  CDC was contacted Referrence #166798793.  Information was also located in pink book.  Nothing else done.
pt recv vax; 4 hr p/ vax, exp medicinal or fruity (persimmon-like) taste; bad taste in mouth lasted 3-4 hr & resolved w/o tx;
Patient states left arm is swollen, red and tender and patient is running a fever of 102 degrees.
Headache; the next morning followedby dizziness; sweating; 3 days afterhives on my legs, arms and face.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0150), via an unspecified route of administration in the left arm on 08Apr2021 at 15:45(at the age of 36-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any medication within two weeks of vaccination. The patient had no allergies to food, medication and other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 07:30, the patient experienced headache the next morning followed by dizziness and sweating and felt like had a fever, but did not; three days after experienced hives on legs, arms and face. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event headache, dizziness, sweating and hives was resolving at this time of report.  No follow-up attempts are needed. No further information is expected.
fracture; This is a spontaneous report from a contactable consumer reported for self. This 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 03May2021 12:30 at the age of 76-year-old as 1st dose, single for covid-19 immunisation. Vaccine Administered at Facility. Medical history included cancer. Concomitant drug included ongoing palbociclib (IBRANCE) by mouth take 1 DF, cyclic (one pill daily for 3 weeks then takes zero pills for 1 week) for Neoplasm malignant. She was supposed to schedule her second Covid 19 vaccine for 24May2021 but she forgot and when she went to schedule the appointment, there were no more appointments on that day of 24May2021. She was able to schedule her second Covid 19 vaccine for 26May2021 which is 23 days after the first vaccine. She is asking if this is ok. It is her fault, the people at the facility where she had the Covid 19 vaccine told her to schedule her second appointment right away but she had a doctor's appointment on 25May2021 and she received a bone infusion that day to help heal a bone from a previous fracture and she wasn't sure if she should get the Covid 19 vaccine with the bone infusion because she wasn't sure it would be effective. No emergency room and physician office visit. Outcome of the event was unknown.  information on the lot/batch number has been requested.
Fever 8/20 to 101F; then rash (diffuse, discrete, exanthem) on 8/21.
Headache, Myalgia, mild body aches, drowsiness and soreness at injection site Narrative:
The patients arms developed raised rashes above and below both elbows. He experienced itching and blisters. It presents like allergic dermatitis. Upon visiting his physician, he was told it could be related to the vaccine. His symptoms presented the same day he received the vaccine.
Feeling intense sharp pain in skin all over body accompanied with goosepumps whenever I feel hot or experience stress or excitement in a social situation.  The pain can be very very intense but lasts only a few minutes if controlled by somehow cooling down .  This has left me unable to exercise at all or go out in the sun and has made daily life really difficult. Doctors suspect the condition to be neurological. All kinds of blood tests, MRIs done on my brain and spinal chord have revealed nothing however and I continue to suffer greatly from this undiagnosed condition for several months now with no signs of its intensity reducing.