chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Product storage error; No Adverse Event; 13 patients administered an expired Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 patients administered an expired Moderna vaccine), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No Adverse Event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (13 patients administered an expired Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (13 patients administered an expired Moderna vaccine), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (13 patients administered an expired Moderna vaccine) and PRODUCT STORAGE ERROR (Product storage error).    Concomitant medication was not reported. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vials went from freezer to room temperature on days of administration. Dates of administration of vaccine were 14Apr2022, 21Apr2022, and 28Apr2022. Vial did not undergo any temperature excursions. 13 doses total given from 3 vials. Multi dose vials of 5.5mL. Age group of patients were mostly over 65 and they did report all of them in the VAERS website.  This case was related to patient number 1 out of 13patients.  Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697081, US-MODERNATX, INC.-MOD-2023-697097, US-MODERNATX, INC.-MOD-2023-697115, US-MODERNATX, INC.-MOD-2023-697138, US-MODERNATX, INC.-MOD-2023-697140, US-MODERNATX, INC.-MOD-2023-697170, US-MODERNATX, INC.-MOD-2023-697183, US-MODERNATX, INC.-MOD-2023-697200, US-MODERNATX, INC.-MOD-2023-697201 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697097: US-MODERNATX, INC.-MOD-2023-697081: US-MODERNATX, INC.-MOD-2023-697138: US-MODERNATX, INC.-MOD-2023-697140: US-MODERNATX, INC.-MOD-2023-697115: US-MODERNATX, INC.-MOD-2023-697201: US-MODERNATX, INC.-MOD-2023-697183: US-MODERNATX, INC.-MOD-2023-697170: US-MODERNATX, INC.-MOD-2023-697200: US-MODERNATX, INC.-MOD-2023-697213:Master case US-MODERNATX, INC.-MOD-2023-697333:Master case US-MODERNATX, INC.-MOD-2023-697284:Master case
Shingrix shot - second dose. Severe muscle pain at site of injection. Flu-like symptoms the following day. Lethargy, queasy stomach, slept 12 hrs. night of injection then napped 1-1/2 hrs., slept 12 hrs. following night. After 1 day of symptoms, felt great the next day. First injection I had no side effects whatsoever.
10/11/00, generalized rash and itching. Pt never followed-up with PCP.
COVID-19 breakthrough. Initially it was extreme fatigue. I never felt that tired before. Later I had the chills, they lasted just right before I fell a sleep. I also felt like I sinus drainage. The next day I felt much better.
I started having normal flu symptoms-- body aches, fever, congestion, and coughing. I took an at-home COVID-19 on New Year's which came back positive. I was prescribed Paxlovid on the 01/02/2023 and began the treatment. On Friday, the 5th, I was unable to keep any food or drinks down and became delirious. My husband called the ambulance and took me to the hospital where I was admitted. A full panel of bloodwork and cultures were taken, and my blood pressure was extremely elevated with severely low sodium levels. I was in the hospital for 2 days and was released after. My blood pressure remained elevated for a couple of days later as my sodium levels slowly began to rise. My blood pressure prescriptions were changed slightly to help regulate my blood pressure better and faster.
Headache, sore arm, body aches, fever of 100.5 day after 1st shot.  Second day still had a very mild headache.  Advil helped symptoms
Nausea; low grade fever; cold chills; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), PYREXIA (low grade fever) and CHILLS (cold chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Multiple sclerosis and Celiac disease.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced NAUSEA (Nausea), PYREXIA (low grade fever) and CHILLS (cold chills). On 27-Feb-2021, NAUSEA (Nausea), PYREXIA (low grade fever) and CHILLS (cold chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 14-MAY-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 and lot number J009689 with expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 59.9 Fahrenheit (F) Degrees (15.5 Celsius) (highest recorded temperature) for a total of 2016 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
PATIENT RECEIVED 1 DOSE OF JANSSEN  ON 08/18/2021 AT ONE LOCATION AND RECIEVED ANOTHER DOSE OF MODERNA ON 08/24/2021 AT HEALTH DEPARTMENT.
01/27/2021 was feeling unwell, with pressure in your head, eyes, face and teeth and ear and throught a sinus infection and was advised to get a COVID test, went to see PA  on  01/28/2022 Dr. visit  was tested PCR and received the results on 01/30/2021.  No fever was ever presnt.
Vasovagal event, approximately 2 min after administered. Came to approx. 2 min, went home after 15 min.
feeling dizzy; trouble breathing; I do continue to have periods of being very tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling dizzy), DYSPNOEA (trouble breathing) and FATIGUE (I do continue to have periods of being very tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030M20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-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 DIZZINESS (feeling dizzy), DYSPNOEA (trouble breathing) and FATIGUE (I do continue to have periods of being very tired). At the time of the report, DIZZINESS (feeling dizzy) and DYSPNOEA (trouble breathing) had resolved and FATIGUE (I do continue to have periods of being very tired) outcome was unknown. Not Provided          No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant FU-NewAE and Outcome provided
Received injection 10/02/2008 that eve I had 100.4 temp, my arm had hard, swollen area.  That progressed to my elbow.  Range of motion was limited.  My arm by 10/3 was hot, red swollen & painful to the elbow.  Location Lf. Deltoid to elbow
p/vax pt devel a rash, sought medical attention & dx w/chickenpox;
I am reporting these adverse events for my booster shot of the Moderna vaccine.  I had extreme injection site pain and redness that lasted for 4 days, including the partial loss of mobility of my left arm.  Projectile vomiting and diarrhea started 3 days after the booster, and it persisted for over 5 hours.  When I thought the episode was done, I was able to get some sleep, but was awoken at 4:30AM on 2/27 with a bowel urge.  But when I tried to evacuate my bowels, only blood came out,  mixed with some type of membrane?  This continued every 15 minutes or so for the next several hours.  By Sunday night, the bowels urges stopped and so had the bleeding.  Please note I am a vegetarian for 44 years and must eat gluten free food.  On Friday, I had 2 slices of gluten free pizza with my own homemade pizza sauce, so there was no unusual food introduced to my diet prior to the vomiting/diarrhea.
Pt was inadvertently given I ml dose of FLUZONE instead of correct 0.5m. dose.  Pt reported no skin reaction and no adverse events.
Cardiologist:  He got his vaccine, was feeling fine, and then had uncontrollably shivering from midnight Saturday night until 6:00 Sunday morning.  He was very very weak, could not get to the bathroom.  Then when he woke up at 11:00 he seemed to be okay for an hour, and then it came back, weak to get to the bathroom, very hard to get out of bed.  At 3:00 PM she gave him Tylenol and said to give it a half an hour.  She gave it an hour and he still had the chills.  She called the ER and the fire department came and he went to the hospital as he was weak and she was not able to get him in the car to take him.  He went to Hospital.  They did a lot of testing, would not give him any water.  They found out he had a sinus infection, and gave him a broad based antibiotic and he did not get into a room until 9:00 PM.  He was admitted for the uncontrollable shivering and the extreme weakness.  He had been in the bed all day and was having trouble urinating.  Then they found out that he had a UTI.  The doctor told her that it may have been bad timing that the RSV shot may have increased whatever was in his body and make things worse.  He was urinating prior to being hospitalized on Saturday.  His shivering stopped at around 6:00 AM, but then started again at 6:00 PM and in the middle of the night he got hot and needed the blankets off of him, and then started shivering again. After about 8:00 AM yesterday the shivering stopped and last night he had no shivering.  They had questions as they did a blood culture and there was a gram negative bacteria in one of them, but they have to wait for the other three cultures, but they have not grown anything yet.  He thought there was a chance that he might be released today, but he is scheduled to see a nephrologist, and may be released tomorrow or tomorrow on oral antibiotics, but is on IV antibiotics at this time.    He usually has a sore arm after vaccines, but othewise no problems other than the Shingrix vaccine which he had sore arms for 36 hours.
On the right hand between the thumb and the index finger there were itchy bumps under the skin/Subsequently more of the itchy bumps on torso, arm, back, neck and the rash kept building up; Lips were swollen; Right nipple was irritated and the skin around it dried up; This is a spontaneous report from a non-contactable consumer.   A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 27Feb2021 16:00 (Batch/Lot number was not reported) at single dose (at the age of 63 years old) for COVID-19 immunisation.  Medical history included hypertension, hyperlipidaemia, retinal tears and known allergies: Penicillin. Concomitant medications included ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE]), colecalciferol (VITAMIN D [COLECALCIFEROL]), acetylsalicylic acid (BABY ASPIRIN), all taken for an unspecified indication.  The patient previously took NIASPAN and experienced known allergies.  At 19:30 pm on the day of the vaccination, on the right hand between the thumb and the index finger there were itchy bumps under the skin. Patient assumed it was insect bite. Subsequently more of the itchy bumps on torso, arm, back, neck and the rash kept building up. Patient started taking OTC Benadryl and Claritin on 4-5 days after consultation with PCP. However, reaction continued and the lips were swollen as well. Patient was prescribed steroids 4mg tapering blister pack by a separate physician since the rash had progressed to the chest. Right nipple was irritated and the skin around it dried up. Patient went to a dermatologist on 10Mar2020 and got a biopsy. Condition has not improved. The patient underwent blood test on Mar2021 for COVID and the result was negative. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events were not recovered.   Information on the lot/batch number has been requested.
Child received Varivax 2-1-01. On 10/1/01, child broke out in "full blown" case of chickenpox per mother. Child was taken to PP for verification.
Information has been received from a physician concerning a 68 year old female who was vaccinated with ZOSTAVAX (Merck) (lot # not reported).  Concomitant therapy included doxycycline hyclate.  On 04-AUG-2008 the patient developed necrosis of the skin.  Subsequently, the patient recovered from necrosis of the skin.  The patient sought medical attention.  Additional information has been requested.
Initial unsolicited report received from a consumer on 10-Oct-2016. THIS CASE IS LINKED WITH 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (same reporter). This case involves a patient (age and gender not reported) who was vaccinated with INFLUENZA VACCINE (lot number, Expiration date, route of administration, site of administration and dose details were not reported) on an unknown date. The medical history and concomitant medications were not reported. On an unspecified date, following vaccination, the patient was very ill. The lab test and the corrective treatment was not reported. The outcome of the events was reported as unknown. Documents held by sender: none.
About 15 minutes after itchy eyes, rhinorrhea, itchy skin, hives, throat tightness, hard to swallow and evaluated in the ER
Rash at location of vaccine. Swelled to ~3" in diameter. Itchy and hot to touch, hives formed when scratched. Persistent at a reduced level for 3+ days, but with less swelling and itchiness.
CONFIRMED COVID-19 INFECTION; confirmed clinical vaccination failure; MIGRAINE; This spontaneous report received from a consumer concerned a 56 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had unknown drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-MAR-2021, the subject experienced migraine. On 24-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative. On 26-APR-2021, the subject experienced confirmed covid-19 infection. On 26-APR-2021, the subject experienced confirmed clinical vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on 13-MAR-2021, and the outcome of confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was non-serious. This case, from the same reporter is linked to 20210451939.; Sender's Comments: V0.20210452164-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 11:37 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:37 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Age of patient was reported as 66.80 for dose administered on 20-Mar-2021.No concomitant medications were reported.   Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 37 degrees Fahrenheit from 11:00 AM to 12:00 PM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-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.
on 18SEP92 pt devel fever of 102.5 & pt was taken to another medical ctr where was treated w/Amoxicillin for an ear infect & a rash that had devel on face; seen in our clinc on 21SEp & told to cont Amox;
pt called in 13 days post-vaccination to report her left arm injection site is red, warm to touch and itching, pt denies edema or red streaks, denies fever, pt advised to contact PCP is site s/s worsen or if patient develops a fever or site worsens, aware verbalized understanding.
HAIR LOSS/HAIR FALLING OUT/ LOST TREMENDOUS AMOUNT OF HAIR; HEADACHE; NAUSEA; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced nausea. On 18-MAR-2021, the subject experienced hair loss/hair falling out/ lost tremendous amount of hair. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and had not recovered from headache, and hair loss/hair falling out/ lost tremendous amount of hair. This report was non-serious.
Dizziness, Headache, 102 F fever, Stomach rash, moderate/severe arm pain
swelling in the hand of the injected arm, progressing to severe and disabling pain, unable to move fingers or elbow without severe and disabling pain
55-year-old female was getting mandatory influenza vaccination on 09/28/2020, where she felt the inoculation was inserted superior to customary landmarks developed pain rated 8/10 in her left shoulder during the injection. She reports that pain has since improved but continues to be present. On presentation she rates her pain 1-2/10 at rest which waxes and wanes. The pain is made worse with cross shoulder movement (up to 4/10). She has been using Ibuprofen 600mg po intermittently. She denies any numbness, tingling, redness or swelling. She denies allergies, PMH or possibility of pregnancy.
I was driving for work and in the middle of my drive I felt this weird tingling feeling in my left hand then I felt it in my right hand and they both felt numb and weak. Then I started to feel this weird bee sting type feeling in my legs so I safely pulled the car over and stretched my arms and legs incase Ive been sitting in the car to long. It went away after a few minutes but later that evening it came back. It comes and goes every day. My hands get weak almost daily now and my legs will still occasionally get the bee sting.
The adverse event was the patient received his second dose of Pfizer vaccine 15 days after his first rather than 21 days after his first.  It was adminstered 6 days earlier than the recommended 21 day wait period between the two doses.
Family member states pt was given 4 vaccines, 2 in each arm at the Health Department 1/2/2020. Since that day she has been dizzy, feverish, vomiting, with a cough and headache. She has pain in left upper arm at injection site with ecchymosis still present at site. She also has left ear pain.
Day 2-4 soreness, tired, chills, severe fatigue. Day 7 Swelling and pain in arm pit area. Felt like I had a golf ball in under my arm pit. Felt like a pinch nerve by my neck , resolved nu day 14.
vaccine administered to patient under 18; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to patient under 18) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to patient under 18). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to patient under 18) outcome was unknown.        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.   No concomitant medication were reported. No treatment information was reported