chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Fatigue; This case was reported by a physician via  call center representative and described the occurrence of headache in a 60-year-old male 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 headache and fatigue. On an unknown date, the outcome of the headache and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the headache and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had headaches and fatigue after vaccination. The reporter described the headaches and fatigue had not gotten any better or worse since they began. The reporter did not provide demographics for the patient and did not had lot number or expiration date of dose of Shingrix. The reporter consented to follow up. No additional information was provided. For tolerance with 2nd dose refer case US2021094723. This is 1 of 4 cases reported by the same reporter.  Note-It was not clear from narrative that the patient experienced event after which dose 1st or 2nd or both hence as conservative approach 1st dose case was kept valid.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094723:case for husband,same patient, same reporter 2nd dose US-GLAXOSMITHKLINE-US2021094725:same reporter, different patient, wife case US-GLAXOSMITHKLINE-US2021094721:same reporter, different patient, wife case
Information has been received from a licensed visiting nurse concerning a 12 year old male pt who, in either November or December 1999, was vaccinated the Hep-B vaccine recombinant (yeast), In February 2000, the pt experienced fulminent hepatitis, con A, B, C and aplastic anemia and was hospitalized. Additional information has been requested.  Follow up on 10/25/2000: "Report was voided.  Patient did not receive this manufacturer's product."
mom stated she noticed a quarter size, red, raised, bruised area on her upper left thigh on 08/24/2005 in the am. She gave the toddler Motrin in the afternoon before shots. she repeated dose 2x the next day. Now mom stated the size of swollen area is the size of a small pancake, toddler is still complaining about pain, area is still swollen and re. Mom gave her Tylenol this am. Encouraged mom to call doctor.
None-CDC stated that Tdap should be given right away to assure he is covered. Client was given Tdap that had expired 10-19-07.
Tingling all over, sweaty, thirsty Narrative:  Patient started to experience theses symptoms and was sent to ER for further evaluation.
Diagnosed with A-Fib in June due to uneven heart rhythm.  I am not totally attributing it to the vaccine, but did recall that there were some blood / clotting issues with the J&J vaccine.   I just wanted you to be aware of this new diagnosis to see if others that had the J&J vaccine also started showing symptoms of heart disease.  I am still in the process of undergoing various heart tests to see if a cause could be found.
4 patients got the first dose of the Moderna vaccine more than 6 weeks ago and did not get the second dose yet.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (4 patients got the first dose of the Moderna vaccine more than 6 weeks ago and did not get the second dose yet.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, 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 (4 patients got the first dose of the Moderna vaccine more than 6 weeks ago and did not get the second dose yet.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (4 patients got the first dose of the Moderna vaccine more than 6 weeks ago and did not get the second dose yet.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment medications were reported
accidentally administered to someone under 65/no AE; accidentally administered to someone under 65/no AE; Initial information received on 19-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves less than 65 years old female patient for whom it was reported that quadrivalent influenza vaccine (Fluzone high-dose quadrivalent) was accidentally administered to someone under 65/no AE (adverse event) (inappropriate age at vaccine administration and overdose).  The patient's past medical history and family history were not provided.  The patient did not receive any other vaccinations or medications   On 19-Oct-2020, the patient received quadrivalent influenza vaccine (Fluzone high-dose quadrivalent) (batch number: UJ491A and expiration date: 30-Jun-2021) the left deltoid by staff person for prophylactic vaccination.   On 19-Oct-2020, same day after initiation of quadrivalent influenza vaccine, accidentally administration of quadrivalent influenza vaccine to someone under 65 with no adverse event (AE) was reported.   Disclaimer: 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.  It was a case of overdose and also a case of actual medication error due to inappropriate age at vaccine administration (latency was on same day).  No other relevant information was reported.
Presented on the evening of 8/28/2021 following a fall with bilateral leg pain as well as weakness and deconditioning.  She was also noted to be bradycardic with heart rates in the 50s.  Unfortunately her COVID-19 PCR test on 8/31/21 came back positive.  This delayed her discharge as she was required to be placed on precautions for a period of time, despite her being overall stable and asymptomatic.  She was found to have require increased oxygen from her baseline of 2 L which she uses as needed at night.  She was requiring just a couple of liters, and imaging was consistent with potential pneumonitis, and she was treated for COPD exacerbation.  She was placed on IV steroids, scheduled nebulizers, as well as IV azithromycin.  She did show improvement throughout her hospitalization, and was ultimately able to wean off of oxygen.
CHIEF COMPLAINT:   pt comes from group home; weakness; hasn't taken parkinsons meds in several days; no pain; doesn't know if he fell or not   HISTORY OF PRESENT ILLNESS:     pt fell at group home. unsure if he hit his head. no loc. History of present illness, ROS, and physical exam are all limited by patient's condition pt with hx of schizophrenia and new dx parkinson's dz.
Pediatric dose was given to adults mistakenly; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly).    Concomitant product use was not provided by the reporter.  It was reported patient received the error dose with instruction to re-vaccinate 2 months from the initial error doses.  Treatment information was not provided.
Information has been received from a nurse practitioner concerning a 41 year old female with no medical history or allergies who on 21-JAN-2008 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 659698/1770U). There was no concomitant medication. On 22-JAN-2008 morning, the patient developed a red and slightly swollen area at injection site of the deltoid. The next day, 23-JAN-2008, there was increased swelling, afebrile. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
12x12 cm warm/tight, erythematous, itching. BENADRYL.
Herpes Zoster; Post-herpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of currently 73 years old. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies.   On or about 24-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for the prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a healthcare provider for Herpes zoster and post-herpetic neuralgia. The outcome of herpes zoster and post-herpetic neuralgia was not reported. The reporter considered both events to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Patient received FluBlok on 10/1/2020 and received a duplicate flu shot for the season of Fluzone HD on 2/27/2021. I called patient and they were asymptomatic when I spoke with them and urged them to seek medical care should they begin to feel any worse.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-OCT-2013 the patient was vaccinated with M-M-R II (reported batch # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures for 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter link). Additional information has been requested.
Patient's arm is swollen at injection site, feverish, itching, painful to touch.  She has been taking Benadryl and applying hydrocortisone 1% cream to help with itching.
15 month old female child was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. It was noted that the child was in good health. Subsequently, ten days later, the child developed a crossed eye and head turn. An ophthalmologic exam was performed and revealed a 10-15 degree esotropia in primary position. a 15 degree esotropia in left gaze, and a orthophoria in right gaze. It was noted that the child had a 10-degree left face turn. It was reported that the left lateral rectus underacted by two to three on a scale of four. The child's pupils reacted normally, and the results of a dilated fundus exam were normal. A cycloplegic refraction revealed + 1.00 sphere OU. The child's vision was central, steady and maintained. A neurological history and examination disclosed normal development and no physical abnormalities except for sixth nerve palsy. A computed tomographic (CT) scan was normal, and during the next three months, the left abducens palsy gradually resolved. At the age of 22 months, the child had an upper respiratory tract infection and another left abducens palsy developed with a head turn to the left and a esotropia in primary position. Neurologic and ophthalmologic exams results were again normal with the gave normal or negative results: CBC, urinalysis, serum electrolytes, serum urea nitrogen determinations, spinal tap, edrophonium chloride test, viral titers for Epstein-Barr and enterovirus. It was reported that the sixth nerve palsy again resolved during the next two months. The authors noted that there have been reports of recurrent sixth nerve palsies, but that none were secondary to immunizations.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. In December 2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
The pt noticed swelling, redness, unable to move arm. Diagnosed with abscess/cellulitis. Treated with antibiotics.
After 5 days woke with itching and rash on chest. Itching became intense and rash was spreading under breasts. Also developed a rash on the left side thigh/torso area. Since then rash has continued to spread and spots on left arm have developed. Treating with anti-itch ointment, Benadryl and Ivy dry. Have determined that it is hives.
exacerbated arthritis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ARTHRITIS (exacerbated arthritis) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (exacerbated arthritis). At the time of the report, ARTHRITIS (exacerbated arthritis) outcome was unknown.            Concomitant product use was not provided by the reporter. The patient received the primary series and the booster dose of the Moderna COVID-19 vaccine. The booster had exacerbated arthritis in the patient to the point where the patient had to see a HCP. Treatment information was not provided.  Company comment: This spontaneous case concerns a 85-years-old, male patient with no medical history, who experienced the unexpected non serious AESI event of arthritis (reported as exacerbated arthritis),which occurred unspecified days after third dose (reported as booster) of mRNA-1273 vaccine. It is reported that after booster patient had exacerbated arthritis, patient reports getting up in the morning is the task, patient was not treated for arthritis before she would take one ibuprofen and be fine, 4 to 6 weeks after booster arthritis has been unbearable. Patient does a lot of physical activity that she learned at physical therapy, but harder to do now. Patient consulted doctor received steroid shot in her back and her back is feeling better. Patient states the pain is residing, but still very stiff in legs. Shot helped her back a lot.  Elderly age is confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-604716 (Patient Link).; Sender's Comments: This spontaneous case concerns a 85-years-old, male patient with no medical history, who experienced the unexpected nonserious AESI event of arthritis (reported as exacerbated arthritis),which occurred unspecified days after third dose (reported as booster) of mRNA-1273 vaccine. It is reported that after booster patient had exacerbated arthritis, patient reports getting up in the morning is the task, patient was not treated for arthritis before she would take one ibuprofen and be fine, 4 to 6 weeks after booster arthritis has been unbearable. Patient does a lot of physical activity that she learned at physical therapy, but harder to do now. Patient consulted doctor received steroid shot in her back and her back is feeling better. Patient states the pain is residing, but still very stiff in legs. Shot helped her back a lot.  Elderly age is confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Large red, raised circular shaped rash underneath injection site. First noticed on the 12th. Rash has increased in diameter in the two days since. Arm pain had originally subsided but has slowly increased since the rash appeared.
Pfizer Vaccine received on 4/30/21.  5/4/21 at 2:40 am severe pain in lower abdomen, cramping - pain reduced but still present for over 12 hours.  Diarrhea for the next couple days. 5/11/21 approximately 3 am pain in lower abdomen, but subsided after a few hours.  Diarrhea for a few days.  5/21/21 2nd shot.  That same night some menstrual bleeding and spotted next 4 days.  I have not had a period since I went off the pill on 11/27/20.  My FSH test shows I'm in menopause.  6/6/21 - menstrual bleeding again. 6/21 & 6/22 spotting again. 7/2/21 sever cramping in the middle of the night again.  7/5/21 menstrual bleeding.  Ended on 7/9/21.  I have never in my life had cramping like this and haven't had a period this "heavy" in about 7 or 8 years.
Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/.1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 29-MAR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot # 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Got shingles, fever, pain and itching and blisters on right chest and right back
pt recv vax 13AUG96 & 25JAN98 pt devel a mild case of chickenpox;
No adverse effect; four year old received improperly stored VAQTA; This spontaneous report was received from a licensed practical nurse and refers to a 4-year-old patient of unknown gender. Information regarding patient's pertinent medical history, concurrent condition, concomitant medication and drug allergies/reactions were not reported. On 21-AUG-2019, the patient received improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (product storage error), lot # S007770, expiration date 24-JUL-2020 (dose, frequency not reported) for prophylaxis. No adverse effect was reported. The temperature excursion included highest temperature above 47 degree Fahrenheit (46.8 F) for a total time of 30 minutes . There was no previous temperature excursion. The call as due to data logger.
Did not mix the two vials; Only gave one vial; 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.   On an unknown date, the patient received 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: 09-FEB-2023 Reporter's comment: The reporter reported that the office manager contacted and said that the nurse in her office had given a Shingrix shot, but only gave one vial and did not mix the two vials before giving to patient. The office manager was contacting medical information regarding next steps for patient and office. The reporter did not agree to follow up from GlaxoSmithKline. Additional Supportive Information: The patient received Shingrix vaccines but only gave one vial and did not mix the two vials before giving to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Patient reported not feeling well 15 to 20 seconds after administration. Went limp and was caught by pharmacist. Awoke about 20 seconds afterwards feeling light-headed. Patient continued to sit and was monitored for 30 minutes afterwards. She fully recovered and left the store.
A non-serious, spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 14-year-old female. Neither past medical history nor concomitant medications were reported for this patient. On 29-Nov-2010, product expired. On 10-Dec-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Rapid heart beat for about 4 hours. The next day had same for about 1 hour. Fine after that.