chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2022 at 2:51 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Jan-2022 at 2:51 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported  The patient received vaccine past its 30 day expiry date on 27-Jan-2022 at 14:51:37 , booster dose. Vaccine went into 2 to 8 degree Celsius thaw state on about 24-Dec-2021. The vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. No Treatment medication was reported   This case was linked to MOD-2022-542869 (Patient Link).
large area with red lesions at the injection site; Area at the injection site is very hot; area at injection site is itchy; large area with red lesions at the injection site; Arm was tender to the touch; dry mouth; arm was a little painful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm was a little painful) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical event reported). Concomitant products included METOPROLOL, DILTIAZEM (DILTIAZEM ER), ACETYLSALICYLIC ACID (ASPIRIN 81), MULTIVITAMIN [VITAMINS NOS], MAGNESIUM and VITAMIN D3 for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (arm was a little painful). At the time of the report, PAIN IN EXTREMITY (arm was a little painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment information was provided.; Sender's Comments: 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.
This spontaneous report as received from a physician refers to a female patient of unknown age. On an unspecified date in September 2011, "three years ago", the patient was vaccinated with a dose of ZOSTAVAX (route, dose and lot # not reported). The physician reported that on an unknown date, the patient experienced what it appeared like to be shingles, had a red, burning rash and eyelid on the left side of her body. The physician also reported that he thought the patient had sinusitis. The patient received anti-viral treatment. At the time of the report, the patient was recovering. Additional information has been requested.
Information has been received form a registered nurse concerning a 6 year old male with attention deficit disorder who on 09SeP1999 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. On 20JAN2004 the pt presented to the drs office with chickenpox. The child had an itchy rash with blisters and bumps, head to toe, for 3 days. The child was afebrile. Treatment was over the counter medication as needed. Subsequently, the pt recovered from chickenpox. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Extreme lower back pain, numbness in hands and feet, sharp pains on head, spasming in rectal and groin area, extreme sensitivity on lower spine and hips  Have been prescribed: norco, voltaran, diclofenac,  Currently taking: gabapentin
I took 600  mg Ibuprofen before the vaccine. About three hours after and I felt soreness in arm but it wasn't bad. 7:00 pm - body aches and softness; chills, shivering and a fever at 2:00 am and lasted until about 6:00 am. Next day, I couldn't move because body pain was bad, and I still had chills and shivering and fever and arm rash came back - but it was less itchy and red and less painful as first dose of vaccine - used the cream from first dose and Tylenol. Saturday symptoms started going away. Sunday I woke up with no symptoms.
I started noticing mild tinnitus shortly after my first shot of the COVID vaccine. It became much more severe after the second shot.
little bit of sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little bit of sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (little bit of sore arm). On 21-Feb-2021, PAIN IN EXTREMITY (little bit of sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported by the reporter.  Treatment medication for these events were not reported by the reporter.
Child very lethargic and experienced a fainting spell where he became very pale, skin very sweaty and slowed breathing. His body fell limp as he drifted out of consciousness. He also developed a fever of 99.4.
This spontaneous report was received from a pharmacist and refers to a 77-year-old male patient. The patient's concurrent conditions, concomitant medications and pertinent medical history were not provided. The patient had no drug reactions or allergies. On 05-SEP-2017, the patient was vaccinated with one dose of PNEUMOVAX 23 injection, intramuscularly, lot # N011305 with expiration date on 20-JAN-2019, for prevention of pneumonia. In September 2017 (reported as "a few days later"), the patient had to go to an unspecified hospital due to cellulitis in the arm that the PNEUMOVAX 23 was injected into. The patient was prescribed unspecified antibiotics for the cellulitis. The outcome of the event was reported as not recovered at the time of this report. The relatedness between the event and the suspect therapy was not provided by the reporter. The event was reported as life threatening. Upon internal review, the event of cellulitis was determined to be medically significant. A lot check was requested by the reporter. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA004760.
ACHY; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced achy, and headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from achy, and headache. This report was non-serious.
On 11/30/1988, the pt experienced a high fever of 104, irritability, and a maculopapular rash. The pt sought unspecified medical treatment.
An hour after he received his vaccine, he began breaking out in large welts all over his body and got a headache.  He has had a headache ever since he got his vaccine. He was seen at the pediatrician's office and was told he had an allergy to something in the vaccine and was not to receive the second dose.
Migraine and very high blood pressure began about 60 hours after 3rd (booster) moderna shot. Headache began Monday mid day, and lasted through Saturday mid morning. Went to urgent care on Friday 11/19.
17MAR93 & 24MAR93 pt recvd vax & c/o morning stiffness in joints;
fever 103-104, crying & screaming x 3-4 days p/shot, listless, refused foods & formula;
Developed muscle aches and chills in the middle of the night post vaccine.  unable to report to work the following day.  symptoms resolved at this time
Narrative: Patient was hospitalized from 2/3/21-2/12/21 with new onset CHF and received COVID vaccine on 2/12. Patient states SOB seemed to worsen and is worse when lying down or with exertion and was wondering if it was due to  vaccine. Followed up with PCP and orthopnea/dyspnea on exertion is likely due to CHF
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unspecified demographics. Approximately on an unknown date in 2013 (reported as between 18-FEB-2013 and 11-JUN-2013), an unknown number of patients might have received dose of ROTATEQ (dose, lot number and expiry date was unspecified) that had been improperly stored. Concomitant therapy was unspecified. No adverse effects reported. No product quality complaint was involved. The outcome of patients might have received improperly stored ROTATEQ was unknown. No further information was provided. This is one of the several reports from the same source. Additional information has been requested.
Periodic outbreak of sores in my mouth. Occurs fairly frequently. Lasts a few days.  Continues to this day.
This spontaneous report as received from a physician via a company representative refers to a 69 year old male patient. No medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with ZOSTAVAX. No dosage information, anatomical location or lot number was reported. NO concomitant medication was reported. On an unknown date, three months after receiving the vaccine in his physician's office, the patient experienced shingles. It was unknown if the patient received any treatment for the adverse event. The outcome of shingles is unknown. No additional adverse event information was available. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers to a 63 year old male patient. The patient has no pertinent medical history and he had no known allergies. On 13-NOV-2014 the patient was vaccinated with his first dose of PNEUMOVAX 23 lot # K005797, exp. date: 21-MAR-2015, 0.5 ml, intramuscularly in the left deltoid. Concomitant therapies included lidocaine (manufacturer unknown) and DEPO-MEDROL, which were injection in the right knee trigger point. Approximately on 13-NOV-2014, 12 hours post the vaccination, the patient could not move his left arm and he sought medical attention by coming into clinic on 14-NOV-2014. During the visit, his left arm was so bad, patient had to use his right hand to pick up his left arm. No treatment was given for event, and none of lab diagnostics studies were performed. The outcome of event was reported as not recovered/not resolved. The causality was not reported. Nurse practitioner stated she was monitoring the client and some comfort measures might be recommended; such as ice. The event was reported as significant disability or incapacity. Additional information has been requested.
The patient was somnolent for over 5 hours.  On attempted arousal he vomited and became pale.  He aroused spontaneously after triage in the emergency room.  No treatment given.
modest diarrhea; Lumbar back pain problem; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 26-May-2021. The most recent information was received on 26-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (modest diarrhea) and BACK PAIN (Lumbar back pain problem) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A20A and 010M204) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (modest diarrhea) and BACK PAIN (Lumbar back pain problem). The patient was treated with Physical therapy for Back pain. At the time of the report, DIARRHOEA (modest diarrhea) had resolved and BACK PAIN (Lumbar back pain problem) was resolving.            No treatment and concomitant medications were reported. Patient reports that the diarrhea may or may not be associated with the two dosses of moderna. Patient is currently taking physical therapy which is helping.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-Up received on 26 Jul 2021, contains updated patient initials, event reported by primary source for the event  lower back ache changed to lumbar back pain problem, outcome of the event diarrhea updated from unknown to recovered, outcome of the event lumbar back pain updated from unknown to recovering and non-drug treatment for back pain.
Pt stated her arm became swollen and lasted several days. She applied allergy cream and it went away.
C/O "can't feel Lt. arm". (Injection site Rt arm). Observation x 15".
6th grade male was given MMR vaccine at a school immunization clinic. He was a bit apprehensive prior to injection but he had a typical day and evening following. His mother states that she had even forgotten about the immunization when he went to bed at a normal bedtime. She states that he woke up at 1:30am stating "I do not feel well." He told his mother that his stomach felt O.K. but his lips felt "hot and tingly." She states that when she turned on the light, she noticed a red pinpoint rash covering his chest and back to the top of his head. She states that it was red and blotchy and that she did not notice any on his arms or anywhere else on his body. He stated that he felt hot and when his mother took his temperature it was 102.4 deg F orally. She states that she gave him a usual dose of Tylenol and it really did not "break" the fever. In fact, later she states his temp rose to 102.6 deg F. She states that he really never developed any other symptoms other than what she described as "frequent urination" with normal drinking. She did take him to see a physian. She states that the physician recommended fever management and oral Benadryl for 24 hrs. The physician recommended that this be reported. The mother states that the rash subsided in less than 24 hours but that she continued the Benadryl for the recommended time. (Of note: there has(d) been a "virus" which presented with a fever greater and equal to 102 deg F for up to 4-5 days)/ This young man was back in school within a day or two and does not appear to have any other concerns relating to the MMR vaccine.
body pain; Muscles hurt; This case was reported by a consumer and described the occurrence of general body pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th December 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced general body pain and muscle pain. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the general body pain and muscle pain were recovered/resolved.   It was unknown if the reporter considered the general body pain and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and whole body hurt, muscles hurt and it was better the next day.  The patient took chewable Benadryl before going to bed. For tolerances of 2nd dose of Shingrix, refer case US2019AMR092823.
exposed to temperatures out of the recommended storage temperature range / no AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA301600 and 2019SA301601.  This case involves a 27 years old male patient who received 0.5 ml dose of suspect IPV (VERO) lot N1J45 (Expiry date 18-Nov-2019) via unknown route in unknown administration site on 24-SEP-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) ; HEPATITIS A VACCINE INACT, HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX); PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) ; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE)  and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) .  It was a actual medication error case due to incorrect product storage.  It was reported that temperatures out of the recommended storage temperature range.  At a time of reporting no adverse reaction reported.  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.
When woke up around 8:00 AM (1/30/2021) had low fever (99.4 °F) that lasted for about 5 hours, body aches (specifically prominent around both calves and knees), left arm (injection site) was sore, slightly swollen and warm to touch. At 12pm, small wave of nausea and abdominal discomfort that lasted for about 20-30 minutes. Stayed in bed and intermittently slept until 12pm when nausea started. Once nausea passed around 12:30 PM, took a singular Advil pill and returned to bed. Awoke a little after 2:00 PM and most of the aches in legs were gone, continued to stay in bed but did not sleep. Finally cooled down at 3:00 PM and checked temperature was normal again (97.8 °F). Arm was normal temperature at 3 PM as well, stiffness did not go away until 1/31/21.
Pt w/ allergy to turkey, chicken, pollen, and dust.  PMH significant for chronic urticaria and hives (been managed by immunology).  Current hives on neck and arm areas (pt reports that this is the best it has been in 1.5yrs).  Pt vaccinated at 16:01 and given PO benadryl 25mg @ 16:02 as a preventative measure.  BP 139/60, HR 69, RR 19, O2 Sat 100%  Pt observed for 33mins. At the time of D/C pt did not complain of any new hives/rash or puritis.  Pt did not appear in distress.  Pt stable and released from the vaccination site.  Recommended that pt follow up w/ thier healthcare provider.
Dose given beyond 30-day expiration date; Dose given beyond 30-day expiration date; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (Dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (Dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (Dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date) and PRODUCT STORAGE ERROR (Dose given beyond 30-day expiration date).    Concomitant products were not reported.  It was reported the vial was initially stored in the refrigerator on 13-Sep-2022 and administered on 18-Oct, 25-Oct, 01-Nov, 02-Nov and 08-Nov. The vial did not underwent any temperature excursion. It was unknown if individual vials or unbroken cartons were used. The vial size was unknown.  The vial did not undergo any temperature excursions.  No treatment medications were reported.
Vaccine #1- 4 hrs post injection- arm tenderness, 6 hrs post injection severe chills, severe body aches, severe headache, moderate nausea that lasted overnight.  aches did not respond to ibuprofen. Mod to severe  Headache fatigue and mild body aches remained day 2.  Woke day 3 with fever of 101.2 for half the day, and headache persisted for the next 5 days.  Large local injection site reaction on Day 4 that persisted for 4- 5 days. Vaccine #2-   4 hrs post injection- arm tenderness, 6 hrs post injection severe chills, severe body aches, severe headache, moderate nausea that lasted overnight.  aches did not respond to ibuprofen. Mod to severe  Headache fatigue and mild body aches remained day 2.  Day 3 large local reaction at injection site, very hot and tender to touch for 4 days.  no fever.  Headache was only 30 hours.
Pt has history of a reaction with the 1st dose of COVID 19 Vaccine with c/o SOB 4 hours after receiving the primary dose of COVID 19 Vaccine, and hives x 4 days after vaccination.  Patient stated that she had received her Depo-Provera injection the day before vaccine.  Pt given second (2nd) dose today @ 1450.    Physician on duty assessed patient 1505: Patient still non-reactive 1520 pt still denies any s/sx of allergic reaction 1530 Pt denies any signs and symptoms and plan of care was to have patient's boyfriend come and pick up patient to ensure that she was with someone to ensure if she had a onset of SOB she could have someone call or take her to receive follow up care.   Patient discharged home with boyfriend.
Awoke am of 03/31/2017 with pain in the left shoulder region. Seen by PMD on 04/01/17 prescribed Ibuprofen 600 mg.
Pt recv vax on 10/15/98; on 10/18/98 pt exp LA weakness/numb/ tingling