chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with opioid and penicillin allergy. In March 2011 (reported as about three years ago), the patient was vaccinated with a dose of PNEUMOVAX 23 injection (lot number and expiration date not provided) (route, strength and dose not provided). On an unknown date the patient developed hives post vaccination. The patient sought unspecified medical attention. For treatment an BENADRYL orally was given. The outcome of hives post vaccination was reported as recovered/resolved. The relatedness between vaccination with PNEUMOVAX 23 and hives was not reported. Additional information is not expected.
Deep pain in upper arm/muscle spasms in back and neck for 2 weeks following shot. (no redness or visible swelling of arm) unable to sleep or move freely without pain. Negatively interfered with all aspects of life, including work (I am a sales rep who drives 900 miles/week).  From 4/28 to now, continuous deep ache in upper arm (feels like in bone area).  Also, neck and back has been stiff, achy and cracking (neck) since date of vaccination. Still cannot lay or lean on right arm - sore to touch.  Still taking pain meds multiple times during day.
Started with extreme soreness at shot site. Then are becamse swollen. Swelling continued on and stopped by the next day. Swollen so much that the skin was tight on my upper arm. The following day, my forearm became a little swollen. Around 18:00 I started getting chills. Chills worsed and had to go to bed. Chills so severe that I was literally shaking. Wrote Dr. an email the next day and about 2 hours later an advice RNP called. Described what was going on. No further action taken. Swelling disapated over the week and was gone by the next Friday.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored VAQTA (lot # L03600 with expiration date of 04-NOV-2016, lot# reported as L045713 with expiration date of 14-JAN-2017, dose, strength and route unknown). The VAQTA were stored at 9.9 Celsius degree for 1 hours and 23 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had COVID last December very mild and did not harm her; Patient had COVID last December very mild and did not harm her; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had COVID last December very mild and did not harm her) and DRUG INEFFECTIVE (Patient had COVID last December very mild and did not harm her) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In December 2021, the patient experienced COVID-19 (Patient had COVID last December very mild and did not harm her) and DRUG INEFFECTIVE (Patient had COVID last December very mild and did not harm her). At the time of the report, COVID-19 (Patient had COVID last December very mild and did not harm her) and DRUG INEFFECTIVE (Patient had COVID last December very mild and did not harm her) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported.  No treatment medications were reported.  Company Comment: This is a Spontaneous case concerning a 91-year-old female patient, with no medical history reported, who experienced the unexpected, non-serious, and AESI of COVID-19. The event occurred approximately 9 months after the second dose of mRNA-1273 vaccine, which was administered in an appropriate schedule of vaccination. Hence, drug ineffective was also captured. COVID-19 was very mild. SARS-CoV-2 test was performed, with a positive result. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 91-year-old female patient, with no medical history reported, who experienced the unexpected, non-serious, and AESI of COVID-19. The event occurred approximately 9 months after the second dose of mRNA-1273 vaccine, which was administered in an appropriate schedule of vaccination. Hence, drug ineffective was also captured. COVID-19 was very mild. SARS-CoV-2 test was performed, with a positive result. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 24-OCT-2018, the patient was vaccinated with PEDVAXHIB (lot # N003698 with expiry date 31-OCT-2019, dose, strength, route, vaccination site unspecified) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 47 degrees Fahrenheit (53.37 F) for 3 hours and 46 minutes, as recorded by a data logger. No previous temperature excursion. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA010362: Original Case: 1903USA004795; US-009507513-1903USA010363: Original Case: 1903USA004795; US-009507513-1903USA010364: Original Case: 1903USA004795; US-009507513-1903USA004795: Original Case: 1903USA004795; US-009507513-1903USA010360: Original Case: 1903USA004795; US-009507513-1903USA010365: Original Case: 1903USA004795; US-009507513-1903USA010358: Original Case: 1903USA004795; US-009507513-1903USA010359: Original Case: 1903USA004795.
received half volume; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 5-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 5AJ3B, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 23rd September 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient accidently received half volume of a Fluarix Quadrivalent vaccine, which led to accidental underdose. The reporter consented to follow up.
Breakthrough case admission after 2 vaccines  Moderna 3/2/21 lot# 008B21A;  Moderna 4/30/21 lot# 043B21A
ADMINISTERED EXPIRED VACCINE TO 3 PATIENTS; OPENED VIAL FOR PAST 24 HOURS; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced administered expired vaccine to 3 subjects. On 25-MAY-2021, the subject experienced opened vial for past 24 hours. The action taken with covid-19 vaccine was not applicable. The outcome of the administered expired vaccine to 3 patients and opened vial for past 24 hours was not reported. This report was non-serious.
This is a spontaneous report from a contactable consumer who reported the same events for herself and for her mother. This is the first of two reports (patient case). A female patient of unspecified age received a single dose of PREVNAR 13, in arm on an unspecified date for immunisation. The patient medical history was not reported. Concomitant medication included influenza vaccine (FLU SHOT) given on the other arm for immunisation. Since an unknown date, the patient lost her appetite (she did not eat from 1 o'clock in the afternoon until 7 of the day after) and it was hard to sleep for her. The outcome of the events was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016509530 different patient same drug/event.
Pfizer-BioNTech Covid-19 Vaccine EUA- received injection at 09:10 in morning  4/30, At 0200 5/1 woke up with chills, severe headache and pain thru entire body. All day was extremely tired, con't with fever, extremely cold. No appetite, nausea. Con't all day into Sunday, along with some SOB. Monday felt better, no fever, injection sight now is red, swollen, and itching. Pain in left axilla area radiating into left side of breast. Also had increase in SOB and needed to use nebulizer treatment.  Had Covid in November and these symptoms were like those.
Didn't feel well that night, headache, fever (101) next morning, stomach muscles hurt.
Central Retinal Vein Occlusion; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 26Jan2021 (Batch/Lot Number: EL-1283) at the age of 62 years as single dose for covid-19 immunisation. Medical history included osteopenia. Concomitant medications included alendronate sodium (FOSAMAX); levothyroxine; meloxicam; atorvastatin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced central retinal vein occlusion on 12Feb2021. Adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received included injections in left eye, ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events were not recovered.
Lymph node swelling unilaterally in the armpit on the side of the injection; Sore arm; some fatigue; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EL3246) via an unspecified route of administration at left arm on 06Jan2021, at 04:30 PM (dose number: 2) for COVID-19 immunization. Medical history included depression and anxiety. No known allergies. Historical vaccination included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, Lot number: EH9899) via an unspecified route of administration at left arm on 17Dec2020 at 04:45 PM at a single dose (dose number: 1) for COVID-19 immunization. No other vaccine in four weeks. Other medications in two weeks included fluoxetine, ibuprofen, acetaminophen, cefixime (FLEXERIL). Facility type vaccine was at hospital. The patient was not pregnant. The patient experienced adverse events included lymph node swelling unilaterally in the armpit on the side of the injection, sore arm and some fatigue. The adverse event start date was reported as 08Jan2021 at 04:45 AM. No treatment received for events. The outcome of events was resolving. No COVID prior vaccination. No COVID tested post vaccination.
received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   According to HCP , the patient is not on ay medication. Treatment information does not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-162156, US-MODERNATX, INC.-MOD-2021-162176, US-MODERNATX, INC.-MOD-2021-162133, US-MODERNATX, INC.-MOD-2021-162303 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-162156: US-MODERNATX, INC.-MOD-2021-162176: US-MODERNATX, INC.-MOD-2021-162133: US-MODERNATX, INC.-MOD-2021-162303:
Information has been received from a physician assistant concerning a 67-year-old female with a history of shingles who on 08-OCT-2007 was vaccinated with a dose of ZOSTAVAX.  On 26-OCT-2007 the patient experienced pain in her jaw area and went to the local emergency room and was diagnosed with shingles.  The patient sought medical attention via a phone call.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Follow-up information was received on 12-NOV-2007 from a physician assistant.  The PA reported that the patient had trigeminal neuropathy which he felt was related to dental work or dental anesthesia.  He said that he recently saw the patient and she had no rash, just pain.  He felt that it was not appropriate to consider the patient's trigeminal neuropathy an AE.  The PA indicated that should the patient develop a breakthrough rash he would contact us.  He wanted to tentatively close the case and asked that no further correspondence be sent.  Additional information is not expected.
Mom called 12/21/09-states child received 3rd HPV vaccine on 12/17/09 8 AM-that night child was taken to ER with H/A, lethargic, numbness and tingling in (L) arm and leg and chest pain (L) side, vision blurred. States had CT scan that was neg. and bloodwork. Then sent to another hospital-was there about 12 hrs then sent home. Pt. had been having H/A's for the last 2-3 months.
sore arm; little bit fever; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore arm) and PYREXIA (little bit fever) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ARTHRALGIA (sore arm) and PYREXIA (little bit fever). At the time of the report, ARTHRALGIA (sore arm) and PYREXIA (little bit fever) 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.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. On uspecified dates, the patients were vaccinated with improperly stored injections of PROQUAD lot # M038227 expiration date 06-MAR-2018 (dose and route of administration were not provided) for prophylaxis. In a addition, the vaccines were reconstituted with properly stored STERILE DILUENT. The patients' concomitant therapies were not reported. On an unspecified date, the data logger registered a temperature ranges between 6° Fahrenheit (F) and and 14F during a time frame of 2 hours 15 minutes with no previous excursion. Adverse effects were not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007410.
Pt received shot on Wed 7/29/9. On Thurs. called to say redness, swelling & itching at injection site. Counseled on proper procedure (BENADRYL/TYLENOL). Pt did not take any meds. Called again 8-1-9 called MD (doctor) told her to do BENADRYL.
Headaches started June 21, 2021 and continue. I've had blurred vision, double vision, I couldn't think of the words I wanted to say, and I tried to say words but they came out all jumbled.  On July 4, 2021 I went to the ER because my head hurt so bad .My BP was 200/95 upon arrival. The hospital did blood work and a brain scan.   It is now over 5 weeks later and by headaches are still very hurtful.
Within one hour post vax, this pt reports feeling dizzy, lethargic, developed fever 5 hours later, chills swollen glands in neck, stiffness of neck, aches, body pains, cough, mucous lasting 2 weeks. Reports continues to have stiffness in neck almost one month post vax. No treatment per client.
Pt broke out in hives/redness cheek area of face which progressed to pt back
Stiffening and pain in all major muscles including neck, shoulders, legs, upper arms. Began ADVIL, 2000 mg per day, muscle relaxers. After 2 months placed on prednisone for short course while on my trip.  Finally symptoms gone October 1/2, 2014.
even when try to lay down the arm ,i can not because of the pain, jumpmed on mysleep because I leaned on it; arm is pinkish,; her left arm very swollen; can not move left arm; it is so sore/ it hurts only when moving the arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (her left arm very swollen), MOBILITY DECREASED (can not move left arm), PAIN IN EXTREMITY (it is so sore/ it hurts only when moving the arm), LIMB DISCOMFORT (even when try to lay down the arm ,i can not because of the pain, jumpmed on mysleep because I leaned on it) and VACCINATION SITE ERYTHEMA (arm is pinkish,) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer (had cancer some years ago, and her doctor told her, not to have vaccines in that arm.).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PERIPHERAL SWELLING (her left arm very swollen), MOBILITY DECREASED (can not move left arm), PAIN IN EXTREMITY (it is so sore/ it hurts only when moving the arm) and VACCINATION SITE ERYTHEMA (arm is pinkish,). On 05-Feb-2021, the patient experienced LIMB DISCOMFORT (even when try to lay down the arm ,i can not because of the pain, jumpmed on mysleep because I leaned on it). The patient was treated with PARACETAMOL (TYLENOL) on 04-Feb-2021 for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (her left arm very swollen), MOBILITY DECREASED (can not move left arm), PAIN IN EXTREMITY (it is so sore/ it hurts only when moving the arm), LIMB DISCOMFORT (even when try to lay down the arm ,i can not because of the pain, jumpmed on mysleep because I leaned on it) and VACCINATION SITE ERYTHEMA (arm is pinkish,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken regularly included sleeping pill at night, iron pill and infusions every 3 weeks for the anemia   Reporter did not allow further contact
Information has been received from a company representative concerning her 13 month old daughter with no pertinent medical history and no drug allergy who on 06-AUG-2009 was vaccinated with a 0.5mL dose of VARIVAX (Merck) (LOT# not reported). Secondary suspect vaccinations included a dose of MMR II (MSD) on 06-AUG-2009. Concomitant vaccination included a dose of PREVNAR (manufacturer unspecified) on the same day. No other concomitant medications were reported. On 10-AUG-2009 the patient experienced a "chickenpox-like rash on her trunk" after receiving VARIVAX (Merck). No lab diagnostics was performed. The patient sought unspecified medical attention and she was recovering. No other information was available at the time of this report. Follow-up information has been received from the company representative concerning her 13 month old daughter who on 06-AUG-2009 at 03:30 PM was vaccinated subcutaneously into right thigh with a dose of VARIVAX (Merck). On 12-AUG-2009 the patient experienced rash. She had recovered on an unspecified date. This is one of the two reports from the same source. No further information is available.
Information has been received from a nurse referring to a 13 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 17-AUG-2016, the patient was vaccinated with a dose of PROQUAD (strength and frequency were unknown; lot number and expiration date were M004893 and 26-JUN-2017) 0.5 ml subcutaneously in error (inappropriate age at vaccine administration). No adverse effects were reported. Additional information has been requested.
(DOB 10/21/1962) - received second Moderna COVID-19 vaccine on 8/24/2021. Pt came to the pharmacy on the evening of 8/25/2021 to let the pharmacist look at a red rash at the right arm injection site of the second vaccine dose.  The area was red and she said it was hot to the touch and sore to the touch.  She was advised to take Tylenol and use a cold compress to help with the discomfort.  She was also experiencing low grade fever, headache and general malaise.  On 8/26/2021, Pt returned to the pharmacy to let the pharmacist look at the injection site.  On 8/26/2021, the red area had increased in size moving both up and down the arm and expanding toward the inner and outer portions of the upper arm. She stated the muscle was also very sore. Pt was advised to take Tylenol, apply a cold compress and monitor for additional spreading of the red area.  She was advised that if the area did not improve, she should seek medical attention.