chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via sales rep and described the occurrence of shingles in a female patient who received 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 shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she never had chickenpox but pharmacist recommended SHINGRIX anyway. The patient broke out with an active case of Shingles after she received the vaccine.
Migraine; A spontaneous report was received from a nurse, 42 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a migraine.   The patient's medical history included migraine. No relevant concomitant medications were reported.   On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27 Dec 2020, within 24 hours of vaccine administration, the patient developed a migraine. The patient stated that she had an appointment with her neurologist for a botulinum toxin injection on the day of the event but was advised by the doctor to report her side effects. The consumer stated being treated for migraines, but they have been cyclic/hormonal. Treatment information included sumatriptan, ibuprofen and caffeine, "all the usuals".    Action taken with mRNA-1273 in response to the event was not reported.  The event, migraine, was considered not resolved.; Reporter's Comments: This case concerns a 42-years-old female patient, with past medical history of migraine, who experienced a non-serious unexpected event of migraine. The events occurred 2 days after first dose of mRNA-1273, lot # 025J20A-2A. Treatment included sumatriptan, ibuprofen and caffeine.  Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. Additional information has been requested.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021 at 4:42 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 4:42 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 46.51 for dose administered on 27-Apr-2021.  No concomitant medications were reported.  Batch number 007C21A underwent temperature excursion on 27-Apr-2021 with temperature 35 degrees Fahrenheit on 9 AM. This vial was moved to fridge on 19-Apr-2021 and beyond use date for the vial was reported as 19-May-2021. Product moved to clinic on 27-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.  This case was linked to MOD-2022-566976 (Patient Link).
severe right upper extremity pain/weakness/absent reflexes, pt underwent an extensive rheumatology/vascular surgery/neurology consults with no findings on any tests whatsoever to explain his symptoms, nothing on MRI despite his swelling in arm and right chest, negative angiogram/EMG and multiple labs. Per follow up report-Patient continues to complain of right upper extremity and breast pain.  Right had slightly edematous and discolored.  Neurologist suggest idiopathic brochial plexus neuropathy, likely autoimmune mediated.
Reportedly the patient was seen by a physician 4 days later, the patient had developed a large local reaction, red/purple area that was warm to the touch from elbow to shoulder. Further information requested. From additional correspondence received on 28 Jan 2000, additional patient, vaccine, concomitant medications and responsible physician information was provided. No further information expected, this case is closed.
mom phoned clinic 915AM to stat pt felt warm & took temp w/thermoscan using rectal t107.5;mom called back temp 101.4;
cellulitis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (cellulitis) 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 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (cellulitis) outcome was unknown.            The patient developed two lumps on arm and on the face. Dermatologist thought they were cellulitis, but medication did not work. No Concomitant medication information was provided. Treatment medication information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. Very limited information regarding this event has been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected.
Kinrix - Inappropriate age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On 05-JUN-2023, the patient received Kinrix. On 05-JUN-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix - Inappropriate age). 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 Information: GSK Receipt Date: 22-JUN-2023 The reporter asked for recommendations on this situation. The reporter consented to follow up via email. The reporter reported that the administration of Kinrix to a 12 month-old patient, which led to inappropriate age at vaccine administration.
Admitted to hospital for three weeks; Memory issue/ it effects your memory; Diagnosed with autoimmune encephalitis; This spontaneous case was reported by a consumer and describes the occurrence of ENCEPHALITIS AUTOIMMUNE (Diagnosed with autoimmune encephalitis), HOSPITALISATION (Admitted to hospital for three weeks) and MEMORY IMPAIRMENT (Memory issue/ it effects your memory) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced ENCEPHALITIS AUTOIMMUNE (Diagnosed with autoimmune encephalitis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced HOSPITALISATION (Admitted to hospital for three weeks) (seriousness criterion hospitalization) and MEMORY IMPAIRMENT (Memory issue/ it effects your memory) (seriousness criterion hospitalization). The patient was hospitalized on sometime in March 2021 due to ENCEPHALITIS AUTOIMMUNE. At the time of the report, ENCEPHALITIS AUTOIMMUNE (Diagnosed with autoimmune encephalitis), HOSPITALISATION (Admitted to hospital for three weeks) and MEMORY IMPAIRMENT (Memory issue/ it effects your memory) outcome was unknown.            After Moderna vaccine patient ended up with auto immune disease. The patient was admitted to hospital in March for three weeks and was diagnosed with autoimmune encephalitis. The patient was diagnosed by a neurologist and reported it affected memory.  Treatment information was not provided.  Company comment: This case concerns a 61-year-old female patient with no relevant medical history, who experienced the unexpected serious events of hospitalization, autoimmune encephalitis and memory impairment. The events occurred unknown number of days after the second dose of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine. The rechallenge was not applicable, as the event was reported after the second dose and no additional dosing will be given. The benefit-risk relationship of vaccine is not affected by this report.; Sender's Comments: This case concerns a 61-year-old female patient with no relevant medical history, who experienced the unexpected serious events of hospitalization, autoimmune encephalitis and memory impairment. The events occurred unknown number of days after the second dose of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine. The rechallenge was not applicable, as the event was reported after the second dose and no additional dosing will be given. The benefit-risk relationship of vaccine is not affected by this report.
Menstrual cycle is abnormal; Amount of blood is sparse, looks like spotting; Painful cramps; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Sep2021 at 16:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included unspecified iron supplement and fibre supplement; both from unknown dates for unknown indications and unknown if ongoing. The patient previously received sulfamethoxazole/trimethoprim (SEPTRA) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 26Sep2021, the patient experienced menstrual cycle was abnormal, amount of blood was sparse, looked like spotting and painful cramps. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events menstrual cycle was abnormal, amount of blood was sparse, looked like spotting and painful cramps was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Narrative:  Patient had Moderna COVID vaccine administered on 10/28/21. On 11/15/21 patient presented to office unscheduled reporting "intermittent left upper chest pain radiating into next, left shoulder, left arm" starting 3 days prior (11/12/21). Patient not interested in full work up and left office AMA when provider did not perform the requested test per clinical judgement. Patient scheduled for stress test which patient cancelled due to "upper respiratory infection", no documentation scanned in regarding infection. patient with a PMH of uncontrolled GERD. Patient eventually got stress test performed 2 months later which was negative. ADR added to patient's chart as "myocarditis" and "chest pain"
Irritable, crying inconsolable 10 p.m. to 1 a.m.
chills, night sweats  Narrative: Patient with PMH significant for multiple myeloma, ESRD on HD MWF, afib, patient presented to ER on 2/22/21 with acute worsening of cough associated with fever, chills, night sweats. Patient had received 2nd dose of COVID vaccine on 2/4. On admission, patient tested positive for COVID19 and was started on broad spectrum abx including azithromycin, vancomycin, cefepime for PNA. Abx deescalated to CTX and azithromycin to complete 7 day course. Patient was already on steroids for MM and remdesivir deferred d/t renal dysfunction. Patient did not require supplemental O2 during admission. Patient received HD during admission w/o issue and also started on anticoagulation for afib with CHADS2VASC score of 4 and in setting of possible hypercoag d/t COVID.
Redness around injection site descending down to the elbow.  Fluid filled blisters around the injection site.
patient received Janssen Primary dose 3/13/2021, received Pfizer Booster dose 7/14/2021. received an extra booster dose of Moderna 12/18/21. was not determined until after the vaccine was administered.
ROUGHLY 8 HRS POST INJECTION, SORE SHOULDER.  12 HRS POST INJECTION ACHY FLU-LIKE SYMPTOMS BACK, LOWER BACK, BOTH SHOULDERS, CHILLS, SHAKING, NO FEVER, GENERAL MALAISE.   IBUPROFEN HELPED SOME BUT AWAKE MUCH OF THE NIGHT.  MASSAGER IN THE MORNING HELPED SOME WITH MUSCULAR SORENESS BUT STILL FEEL LETHARGIC WITH SYMPTOMS.
Notes from discharge provider: "59 YO male with a history of HIV/ AIDS with CD4 count less than 35 on 12/07/2021, pneumocystis pneumonia, cryptococcal pneumonia, cytomegalovirus retinitis who presented to emergency department for complaint of right upper quadrant abdominal pain for the past three days. Patient ran out of his medications day prior to arrival and unable to get help or medications since his home aide got sick with COVID. In the ED, patient's vitals stable. He subsequently tested positive for COVID-19, not hypoxic. D-dimer elevated and CTPA revealed bilateral pulmonary emboli. Patient started on anticoagulation. He is to start Eliquis on discharge with medication arrangements with his primary provider. Infectious Disease was consulted and helped coordinate medications for patient with sotrovimab monoclonal antibody infusion during hospital stay. Patient received remdesvir for 3 days, though did not receive steroids as it was not indicated. He was additionally started on ceftriaxone and doxycycline for community acquired pneumonia prophylaxis. He is to continue doxycycline for 4 more days. He is current with LHC and will have home health. He is medically stable and ready for discharge in the afternoon of January 14, 2022."
(R) upper arm w/ warm, erythematous area about 4 cm diam, mild induration.
1/20: spot on back burning, right side only. 1/21: chest pain from burning 1/22: Lyrica and Valcyclovir started, spread to other dermotones. 1/23: burning face/arms. was seen by PCP 1/25: burning on other arm, right. Seen by provider in ED at place of work.
7 days post vaccination developed fever 1 day max 103 degrees/dx that lasted 36 hours and rash that lasted 3-4 days. Tx with Tylenol - All other children have the same reaction after MMR vaccination.
Approximately 3 hours after injection, intense pain and numbness was felt from the shoulder all the way down through the fingertips, this intense pain lasted approximately 5 hours, ibuprofen was taken orally 2 hours after pain started and provided negligible relief. 12 hours after injection, gross pain had subsided, intense pain at injection site. 24 hours after injection all pain and soreness subsided.
2 hours post receiving dose experienced itching from head to waist, rash on stomach, and rash on same arm below elbow. Recommended to take BENADRYL and oatmeal bath. Patient contacted 3 days later and appeared to be fine and stated she is ok.
Red flat spot on left shoulder/ flat red itchy spots then got 3 on her butt next day (those are going away) 3rd day got on on her thigh (going away) her arm will fade then it will flare up again; After 24 hours of first shot she got bug bite looking clusters on her arm itchy and red bumps turned to flat red itchy spots; After 24 hours of first shot she got bug bite looking clusters on her arm itchy and red bumps turned to flat red itchy spots; Bug bite looking clusters on her arm; This is a spontaneous report from a contactable healthcare professional. An 18-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Sep2021 at 14:00 (at the age of 18-year-old), as a single dose for COVID-19 immunisation. Medical history included sometimes A Fib (Atrial fibrillation) and anxiety. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included citalopram hydrobromide (CELEXA) and unspecified multivitamins and birth control medications; all for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date in Sep2021, at 14:00, the patient had an immediate, not realized at the time, a red flat spot in left shoulder. After 24 hours of first shot, the patient got bug bite looking clusters on her arm, itchy and red bumps turned to flat red itchy spots, got 3 on her "butt" next day (those were going away) and on third day, got on her thigh (was going away). The spots on arm would fade, then it would flare up again. The events did not result in doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Sep2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were taken as a result of event itchy and red bumps turned to flat red itchy spots which included treatment with fexofenadine hydrochloride (ALLEGRA) and diphenhydramine hydrochloride (BENEDRYL). Therapeutic measures were not taken as a result of the reported other events. The clinical outcome of the events red flat spot on left shoulder after 24 hours of first shot she got bug bite looking clusters on her arm itchy and red bumps turned to flat red itchy spots then got 3 on her butt next day (those are going away) 3rd day got on her thigh (going away) her arm will fade then, it will flare up again were unknown at the time of report.  The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
This case was reported by a pharmacist via call center representative and describe the occurrence of headache in a 63-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). On 24th March 2018 10:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a week after receiving SHINGRIX, the patient experienced headache, skin warm and erythema of extremities. On an unknown date, the outcome of the headache, skin warm and erythema of extremities were unknown. The reporter considered the headache, skin warm and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to a physician. The reporter had a patient who received SHINGRIX in the right deltoid. On 26th March 2018, 2 days after vaccination, the patient went back to the administering pharmacy to report that she had a mild headache and a red circular area approximately 4 to 5 inches below the injection site. The red circular area approximately 4 to 5 inches below the injection site. The red circular area was at least 4 inches in diameter and it was warm to the touch. The patient indicated that the redness had moved down her arm.
I felt okay after the receiving the vaccine, besides I felt tired and just wanted to sleep. I woke up at 4AM and felt tired so I went back to bed, I woke up again about 7-8AM and I felt tired but I felt okay. Shortly after I developed chills, achy, dizzy, had a headache, sweaty, fatigued, no appetite and my temperature was 99.6. I took Ibuprofen shortly after and 6 hours later I switched to Tylenol. I tired to sleep, but I felt uncomfortable. This morning my fever was broke. I still feel achy , headache, tired feeling, no appetite as of today.  I am getting back to normal but only feel about 80% recovered.
Patient returned to pharmacy at 8:30 with extreme swelling and redness and pain at injection site. Site was ver warm to touch. This occurred in left arm when PNEUMOVAX was given. Patient was monitored over an hour. Strength test was done and even in both arms. Blood pressure and pulse were monitored and normal. Temp was 97.2 swelling was outlined for spreading followed up with patient at 10:30pm. Patient felt fine still swollen/red/pain and warmth had gone down and patient was feeling well.
Inflammatory issues:  sun-burn down the right thigh.  Visited gynecologist due to vulvadynia issues. Recurring rash in lower extremities.  Visited dermatologist Palpating heart:  wore a monitor.  saw a cardiologist.  Every time I have a Covid vaccination or booster, I have recurring issues.  May be the vaccine or long Covid.  Never had symptoms if I had Covid.  Antibodies test administered.
cut with a saw; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of WOUND (cut with a saw) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history information was provided by the reporter.  Previously administered products included for an unreported indication: TETANUS VACCINE (last tetanus shot was in 2014).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced WOUND (cut with a saw). At the time of the report, WOUND (cut with a saw) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information not provided.  Patient washed the wound & applied antibiotic cream.