chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse regarding an unspecified number of unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown dates between 26-SEP-2016 through 29-SEP-2016, the patient were vaccinated with improperly stored PEDVAXHIB lot # M010440/expiration date-09-DEC-2018 and lot no. M020101/expiration date- 07-MAR-2019, intramuscular. No adverse events was reported. No concomitant medication was reported. Temperature of excursion was 35F for 38 hours 50 minutes and call was because of data logger. There was no previous temperature excursion. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
This spontaneous report as received from a nurse refers to an 11 months 1 day old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Rash that looks like chicken pox / Vesicular rash; This case was reported by a physician via sales rep and described the occurrence of varicella-like rash in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2019, the patient received the 1st dose of Shingrix. On 26th September 2019, 1 days after receiving Shingrix, the patient experienced varicella-like rash. Shingrix was discontinued. On an unknown date, the outcome of the varicella-like rash was unknown.   It was unknown if the reporter considered the varicella-like rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 61 or 60 years old at time of vaccination. The physician reported the patient developed vesicular rash one day after first dose of Shingrix. The dermatologist at practice biopsied site and believes it could be chicken pox. The adverse event was reported on 26th September 2019 at 12:17pm. Upon speaking with physician morning, physician stated that they would not be administering the second dose of the Shingrix series. The reporter was agree to follow up from GlaxoSmithKline.
ActHib portion of Pentacel was reconstituted with Quadracel / no adverse event; Initial and follow information received on 19-Aug-2019 and 20-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 4 months old female patient who received dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number and Expiry date unknown) via unknown route in unknown administration site, that was reconstituted with only ActHib portion of Pentacel by mistakenly.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate reconstitution technique.  At a time of reporting, no adverse reactions occur.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  Information on the batch number was requested.  List of documents held by sender: none.
vaccine was expired,  no temperature excursions occurred and moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration".  Patient reported no adverse reactions.
16 year old was given a pediatric dose. Second dose of .1ml was administered per medical authorization, Doctor to complete a full adult dose of Pediatric vaccine. Patient has no adverse effects. Pt mother is present and consented to Medical control authorization of second dose.
Patient received the expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Nov-2021 at 11:35 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021 at 11:35 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine). On 18-Nov-2021 at 11:35 AM, EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that upon delivery of each vaccine order (021B21A- feb-2021  and 021B21A- MAR-2021. the vaccines were placed into the freezer the same day they were delivered. The vial from the freezer was removed and was put it in the refrigerator the day before it was used. Thus, vaccines were not in the fridge for more than a day unless patients did not appear for their vaccine.  No concomitant medication details was provided. No treatment medication details was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Dec-2021: Follow-up received on 06-DEC-2021 included suspect product and patient demographics details.
pt recvd vax;felt fatigue then restless,n,back,chest,stomach pain;began to throw up w/ severe chest,neck,stomach pain;elev T & pulse;adm to hosp;
Tested positive for COVID on PCR test; A spontaneous report was received from a pharmacist concerning a female patient in her mid 40s who received Moderna's COVID-19 Vaccine and then tested positive for COVID-19 on PCR test.   The patient's medical history included lupus. No relevant concomitant medications were reported.   On 24-Dec-2020, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On the 26th or 27th of December 2020, the patient was swabbed via PCR test for COVID-19 which was positive.   Treatment for the event was not reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, tested positive for COVID on PCR test, was considered unknown.; Reporter's Comments: This case concerns a female of unknown age, with medical history of Lupus, who had a nonserious unexpected event of COVID-19 (SARS-CoV-2 test positive).  Event onset 3-4 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Severe pain in neck beginning within 8 hours of injection.  Taking Flexoril, Tylenol, and Motrin with no relief of pain.  Severe burning skin sensation throughout shoulder and neck beginning 72 hours post injection.  No rash present.  Taking Benadryl and rubbing aloe on area with a slight amount of relief from Benadryl.  Headache beginning 48 hours post injection. Currently 96 hours post injection with symptoms continuing to worsen.
Patient received first dose of Pfizer COVID-19 vaccination last evening. This morning, she awoke and went to the bathroom at approx 0700 and noticed the red, raised rash throughout her lower extremities. She further noticed the same pattern distributed throughout her entire body including scalp. She endorses only very  mild to no  pruritis and denies associated pain. She does endorse mild chills and malaise noticed last PM following the shot. In addition, at her office visit this morning, she had a low grade fever of 100.2 measured. She given ibuprofen in clinic, as well as recommended ibuprofen, acetaminophen and prescribed famotidine,  loratadine, and diphenhydramine for her symptoms and instructed to follow back up at the clinic tomorrow. Photos were taken of the rash and sent by patient to appropriate contact.
Patient previously had Pfizer Covid 19 vaccine  on 4/21/21 but was given Moderna shot today. So far, there are no symptoms, signs or treatment.
Narrative:  Patient is a 56 year old male who reported to primary care team that he received COVID vaccine in 2/2021, was hospitalized x 3 days, was told to not take any more COVID 19 vaccines. Record of this administration with remote data was not found.
Vaccine expired on 01-Apr-2022, vaccine placed in refigerator on 04-Apr-2022, vaccine administered on 08-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, vaccine placed in refigerator on 04-Apr-2022, vaccine administered on 08-Apr-2022) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, vaccine placed in refigerator on 04-Apr-2022, vaccine administered on 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, vaccine placed in refigerator on 04-Apr-2022, vaccine administered on 08-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. It was reported that the pharmacist thought that the expiry date of the vaccine was Jun-2022, however the vaccine expired on 01-Apr-2022. The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo temperature excursion. No treatment medication was provided.
previously injured biceps tendon flared up with extreme pain; doctor believed it could have been an immune response leading to frozen shoulder; doctor believed it could have been an immune response leading to frozen shoulder; extensive calcification of the biceps tendon; range of motion was extremely limited; unable to work, drive, get dressed by herself, or care for her children; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 29Apr2021 at 09:45 AM at the age of 50 years old (Batch/Lot number and Expiration date were unknown) as the 2nd dose, single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the pharmacy or drug store. The patient was not pregnant at the time of vaccination. The patient previously received the 1st dose of BNT162B2 on 01Apr2021 at 09:30 AM (Batch/Lot number and Expiration date were unknown) in the left arm for COVID-19 immunization. Relevant medical history included injured biceps tendon, biceps tendonitis, and known allergy to Penicillin, all from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Following the vaccination on 30Apr2021 at 07:00, a previously injured biceps tendon flared up with extreme pain. The patient's doctor believed it could have been an immune response leading to frozen shoulder. Urgent care took x-rays, which revealed extensive calcification of the biceps tendon. The patient's range of motion was extremely limited and pain was difficult to manage with over the counter medication. The patient was unable to work, drive, get dressed by herself, or care for her children. Prednisone was prescribed and brought the pain level way down. The patient later had an ultrasound (US) guided needling and barbitage procedure as well as a cortisone shot in her shoulder to manage the pain. The adverse events started date on 30Apr2021 at 07:00 AM. The adverse events did result in both doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures, which included ultrasound guided needling and barbitage procedure with unknown result on an unspecified date. Therapeutic measures were taken as a result of all the events, which included prednisone, Us guided needling & barbitage, and a cortisone shot, hydrocortisone sodium succinate (CORTIS). The patient was recovering from all the events.  Information on the batch/lot number has been requested.
on 3/19/21  This is a 38yo female with the medical history as mentioned below presents to  Emergency Department today by ambulance complaining of right leg pain. Patient states she was walking on the parking lot and a car was backing up, and struck her in her right leg. Vehicle was not driving fast, possible <10-15mph COVID-19 tested positive and this was an incidental finding -- she is asymptomatic - No s/s of coughing, fever, SOB or GI at this time. No treatments were given. Diagnosis: Closed tibia/fibula fracture S/P being struck by a car Due to the severity of the fracture - patient transferred to trauma hospital
Pt had allergic reaction with hives and swelling that was similar to her allergic reaction she has to shellfish
Pt fainted about 2 minutes after I gave the vaccine.  She came to right away.  Gave her water and a cool rag and ice pack.  She left 30 minutes later.  She stated that she has fainted before but not after receiving a vaccine.
redness & swelling & soreness @ site & extends down arm 31MAY94 aching & inc @ pain w/turning arm; could not lift pain w/o severe pain in upper arm; took 2-3 month for pain to subside;
Numbness, tingling legs, feet, hands, diarrhea. Reported in incidence report on same day. All follow up with docs basically dismissed as non-existent until diagnosis MS in 06. 1/4/07 Received medical records from parent/reporter which reveal patient seen 8/30/04 for diarrhea & mild but constant abdominal pain for approx 1 mo.  Had just returned from deployment to Iraq on 7/12/04. Tx w/cipro, labs & rest.  Returned to clinc 9/16/04 with continued diarrhea.  Prior labs were neg.  Tx w/lomotil.  Returned to clinic for knee pain, ankle pain, back pain.  To ER 4/15/06 for N/V/D with abdominal pain for 6 days.  On 6/6/06 seen for numbness in arms & legs.  EMG/NCS were ordered.  Dx w/campylobacter jejuni enteritis & tx w/prednisone. 6/15/06 seen in Neuro clinic for numbness in hand, arm & legs when leans head forward for approx 4 weeks. Dx w/cervical radiculopathy & sent for MRI of brain & c spine.  Seen in ER 6/21/06 for LP to r/o MS or ADEM.  Return to ER with HA, nausea, dizziness, & photophobia since LP.  Tx medically & referred to Neuro clinic.  Seen in Neuro clinic 7/14/06 for IV steroid infusion for ADEM treatment & given rx for oral tapering steroids.  Returned to Neuro clinic on 9/11/06 & symptoms had resolved.  Was OKd for deployment to Kuwait. FINAL DX: ADEM. 1/19/07 Received medical records from 1st hospital which reveal patient admitted 10/28/06-11/6/06.  Just prior to deployment to Kuwait 10/06, the numbness started to return & progressed while deployed. Received additional steroids & was transferred to Germany, then back to US.  Weakness continued to deteriorate to being unable to ambulate.  Had headache, sweats & nausea for approx 5 days. Consult by neuro & dx w/MS & optic neuritis.  Tx w/steroids & interferon & transferred to ICU for possible intubation.  Gradually improved & was transferred to inpatient rehab facility to continue PT, interferon, prednisone, neurontin & to be followed by neuro. FINAL DX: Multiple sclerosis; hyperglycemia secondary to high dose steroids; & rash probably related to dog tags. 1/25/07 Received medical records from Rehab hospital which reveal patient admitted 11/6-11/10/06 & then transferred back to first hospital prior to transfer to another rehab facility closer to patients family. FINAL DX: tetraplegia, incomplete secondary to MS with myelopathy; MS; neuropathic pain; myofascial pain; acne secondary to long term steroids; & dysarthria. Per information received from annual follow up, patient is in a remitted state (of MS) at this time. He has undergone extensive medical therapy. I have submitted a request by his neurologist to update your records. He still suffers from nerve damage & diarrhea. He is on a monthly infused medicine and interferon. He has made huge progess but everything is tenuous at best and he truelly goes one day at a time because he never knows what his health will be tomorrow.
Raised reddish-purple rash with blisters on both hands that felt like I was scalded in hot water for 7 days.  It is now scaly and purplish brown (week 3).  Appears to be lichen planus, treating it with OTC hydrocortisone 1% topical cream
DIZZINESS, SHAKING, FAINT  AT 12:05PM FOR 10 SECONDS
I had fever, chill and muscle aches and was very tired for two days after the injection.
Pt. came to visit doctor at clinic 01JUN07 stating that she has been feeling fatigues, having chills and tenderness in arm since last night. Assessment revealed: 3.5 circular erythema on right tricep area. BP: 112/74 P:88bpm. Pt was instructed to take ibuprofen, apply cool compress to area and notify doctor if there is an increase in symptoms by doctor.
Rash, ErythemaMultiform & UrticariaPruritus CEPHALEXIN 500 MG QID
Myopericarditis - patient with chest pain.  Elevated troponin, elevated CK,  ECG with elevated ST segments.
Dizziness, Headache & Sedation Narrative:  Other Relevant History:
Pt experienced migraine type headaches the day after receiving 4th dose, retroorbital pain, asymmetric, associated with nausea. Also had similar headaches after 3rd does, reported by pt. Treatment continues.
EXTREME FATIGUE, BODY ACHES, UNABLE TO WORK 1/31/21
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 10th December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, headache, shivering, fever and general body pain. On an unknown date, the outcome of the fatigue, headache, shivering, fever and general body pain were recovered/resolved. It was unknown if the reporter considered the fatigue, headache, shivering, fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter received SHINGRIX vaccine on left arm sometime in the afternoon. The patient reported that within 12 to 14 hours she began to experience fatigue, headache, shivering, fever and general body aches. All symptoms resolved within 12 hours. The reporter consented to follow up. The reporter gave permission for her physician to be contacted. The reporter was unable to provide additional information.
Initially had typical injection site soreness, fatigue and nausea. Patient reports 2 day later began developing, nasal congestion, periorbital edema and urticaria like skin eruption on  bilateral UE, trunk and LE's.  Evaluated in clinic 6 days later still having similar symptoms with no worsening or improvement despite OTC benadryl. No respiratory distress, fevers, or abnormal blood pressure.
Information has been received from a health authority concerning a 15 month old male birth twin with a family history positive for febrile convulsions in childhood (mother) who on 23-Jan-2006 was vaccinated SC with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. It was reported that on 01-Feb-2006, the patient presented with fever and tonic-clonic convulsion lasting <10 seconds. The patient was taken to the Emergency Room (ER) and treated with diazepam and admitted to the hospital during the post-critical phase. On 02-Feb-2006, a chest x-ray showed slight parenchymal density. A follow-up chest x-ray showed hyperinflation of the lung design without visible lesions. On 03-Feb-2006, a sleep electroencephalography (EEG) was within normal limits. Lab work performed revealed a white blood cell count (WBC) of 11,700, neutrophils at 67%, lymphocytes at 25% and a C-reactive protein (CRP) of 9.8 mg/L. At the time of this report, the outcome was unknown. Other business partner numbers included E2006-00741, 63663 & IT047/06. No further information is available. The case is closed.
Information has been received concerning a pt who was vaccinated with varicella vaccine and Prevnar on 06/30/00. On 07/08/00 the pt developed an apparent varicella rash, low grade fever, and small reaction at the injection site. The pt's mother noted pox all over his body, but the reporter noted less than 50. The pt sought unspecified medical attention.
Pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0250L20A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy (Mild latex allergy).    On 05-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 08-Oct-2020 and the estimated date of delivery was 15-Jul-2021. On 05-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant information  provided. No Treatment information  provided   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: No new information was received.