chrisvoncsefalvay/vaers-outcomes huggingface dataset:
exposed to 30F, some doses could have been given; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Havrix, Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Menveo and Boostrix. On an unknown date, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Havrix, Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Menveo and Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-Jul-2022 Reporter's comment: The medical assistant reported that Kinrix, Pediarix, Havrix, Engerix-B, Infanrix, Bexsero, Menveo, and Boostrix were exposed to 30 Fahrenheit and some doses had been given to patients after the excursion occurred. This was currently being investigated as of the time of this call and no further details were available.  The reporter consented to follow up from safety. Additional supportive information: The  Kinrix, Pediarix, Havrix, Engerix-B, Infanrix, Bexsero, Menveo, and Boostrix were exposed to 30 Fahrenheit and some doses had been given to patients after the excursion occurred, which led to incorrect storage of drug.
Moderna Dose 1 1/19/21 (041L20A) Moderna Dose 2 2/15/21 (011M20A) COVID Positive 1/6/22 COVID Positive 1/10/22  1/10/22: Patient is a 53-year-old female, with a history of schizoaffective disorder, chronic respiratory failure on 3 L of home oxygen, severe pulmonary hypertension, right-sided heart failure, mild-to-moderate tricuspid regurgitation, asthma, and sickle cell trait, who presented to the ED via EMS on 1/10/2022 with weakness and lethargy.  Patient currently resides at the facility and tested positive for COVID Thursday 1/6.  EMS was called today due to altered mental status and hypoxia.  Per EMS, patient was noted to be 75% on 3 L.  She was placed on 10 L and saturations improved greater than 90%.  She was noted to be hypotensive, 3 L saline was given however no significant improvement therefore she was started on Levophed infusion.  Blood cultures were drawn.  EKG showed normal sinus rhythm QTC 469. Potassium elevated 5.8, BUN and creatinine elevated, creatinine 3.03.  ED staff attempted to place RIJ central line yet was unable to advance guidewire, RN attempting to place midline. Patient was admitted with COVID pneumonia, acute kidney injury, hyperkalemia in septic shock.  At this time Pulmonary/Critical Care consultation is being requested  Records received from Dr.'s last office visit during last hospitalization.  Records revealed that her last sleep study was in 2007 and she has had significant weight gain since that time, Dr. recommended a repeat sleep study for titration of her Bipap however she refused this as well.  Following a hospitalization in 4/2019 she was discharged with 3L NC which she has been using.  His note mentions she has a home Bipap with settings of 24/20 and she has been wearing consistently at HS.  His note mentions that her psychiatric comorbidity has complicated her Pulmonary care.   Patient was seen while in the ED.  ED staff had medicated her with Versed prior to attempting to place a central line therefore patient was difficult to arouse and could not answer questions or verify information.  1/28/22: This patient from a long-term care facility was admitted on 01/10 for weakness, shortness of breath and hypoxemia.  She tested positive for COVID-19, required supplemental oxygen and IV anti viral medications.  She did not require intubation.  She is considered COVID recovered at this time.  She has a history of schizophrenia and bipolar disorder.  We had continued the valproic acid during the hospital stay, but because of hypotension had held the intramuscular haldol and oral ziprasidone.  We have been tapering the prednisone and restarting her psychiatric medications.  She was on metformin and Januvia for diabetes before the hospitalization, she is currently on Lantus, Humalog and correction dose.  Her PCP will need to monitor the medications and make adjustments once she returns the long-term care facility.  Her oxygen requirements are improving every day.
After the shot the next morning I had pain in my front jaw area, top and bottom. First thought was tooth ache. Then the next day the pain was in around my eyes and my jaw/cheek area.  I looked up the nerves in that area and it seems to be the Trigeminal nerves.  The pain would throb, then itch and burn.  Now, 10 days later I have some jaw pain but lots of pain around the eyes...burning and itching. You can't see anything which makes me think it is nerves....maybe a sort of bells palsy?  I visited the doctor yesterday and said the Trigeminal nerves usually is just one junction of the nerve not all of them.  I would say it is 30% better so at least is getting better. The odd thing about it my husband is experiencing the SAME THING!! That is why we think it is from the Covid booster as we got it the same time. His is more around the top of his eye and front of ear. It is only one side of the face.
Pain in left shoulder with abduction following flu vaccine administration. Pain estimated at level 6 or 7 (out of 10) with abduction. After 5 weeks, pain is improving but still present. Physician recommended anti-inflammatories prn, rest, warm and moist heat.
Approximately, 25 seconds after administering the MMR vaccine, the patient fainted and fell from the chair that she was sitting on. she then gained consciousness after 1 minute.  she told me and the pharmacy staff that she was only very anxious, and fainted.
Tinnitus. Lightheadedness.  One week after shot, both continue.  Lightheadedness is subsiding.  Tinnitus is worse as the day goes on (have experienced it before but this is a recurrence).  Tired for the first three days.  These events have continued.
Information has been received from a health professional concerning a 17 year old female who on an unspecified date was vaccinated with one dose of varicella vaccine. Concomitant therapy included hep A vaccine. Subsequently, the pt expereinced numbness in the limbs. No other adverse experiences were reported from this pt and it was reported that she has since recovered. Additional info has been requested.
48 hours post imm, hives on cheeks, neck, wrist and chest per maternal report via phone.
Cold sore type of reaction under my nose which has now spread to the ball of my nose with swelling
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: JARDIANCE; NUVARING. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) Positive, notes: Symptoms came back, and have confirmed positive test (antigen/rapid) on 27May2022; (unspecified date) Unknown Results, notes: indication: Treatment of COVID-19; (23May2022) Negative, notes: After completing the full 5 day course, tested negative on Monday 23May2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral product included Paxlovid for COVID 19 Treatment from 18May2022 to 22May2022. After completing the full 5 day course, the patient tested negative on Monday 23May2022. Symptoms came back, and patient have confirmed positive test (antigen/rapid) on 27May2022. The patient had other medication in 2 weeks included Jardiance and NuvaRing. No known allergies reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Breakthrough case admission after 4 vaccines Moderna 2/25/21 Lot# 010A21A;  Moderna 3/25/21 Lot# 018B21A;  Moderna 12/30/21 Lot# 060H21A;  Moderna 4/22/22 Lot# 056M21A
I had a red whelp at the vaccination site; Painful arm; rash; Fever 100.7F; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Mar2021 at 11:03 at single dose for COVID-19 immunisation at the age of 67-year-old. Lot number was EN6206. Medical history and concomitant medications were unknown. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Feb2021 at single dose for COVID-19 immunisation (lot number EL9267) at the age of 67-year-old. On an unknown date, body temperature resulted 100.7 F (97-98.6F). On unknown date, the patient experienced whelp at the vaccination site; in Mar2021, the patient experienced rash, fever 100.7F; on 14Mar2021, the patient experienced Painful arm. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
within hours of the shot, severe chills and vomiting. Vomiting all night and into next day. Pain in joints and nausea. No fever. Extreme fatigue. These symptoms lasted for days. Now after two weeks, still suffering from pain in my bones and lack of energy. Did not go to ER out of covid concerns. Monitored fever constantly. No cough. Second year in a row with the senior shot that I had a bad reaction, but this year is much worse than last year. I had my primary doctor add this to my chart via my chart on the internet.  At this point, I will never be willing to receive this vaccine again.
Patient said about 5 hours after receiving the vaccine he experienced swelling in arm, tongue swelling, tongue/mouth ulcers, was "swimmy headed", had shortness of breath, and his blood pressure was 161/135. He went to the emergency department.
COULDNT GET OUT OF BED; SEVERE HEADACHE; FEVER; This spontaneous report received from a consumer concerned a female 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: Unk) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 31-MAR-2021, the subject experienced couldn't get out of bed. On 31-MAR-2021, the subject experienced severe headache. On 31-MAR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 38.2 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't get out of bed, severe headache, and fever. This report was non-serious.
I had mostly nausea but no vomiting. I had bouts of diarrhea and anorexia. I lost about 8 lbs. already since this has been happening. It lasted for about 3 or 4 weeks. I am going to see a gynecologist. So far the doctors are saying that I have Gastroenteritis. I was prescribed PHENERGAN and PEPCID.
12 hrs after vaccine felt like she got  "hit by a bus" difficulty sitting ot lying down due to discomfort. Ankle, thigh, back felt achy, nauseated, weird feeling in center of chest.
Within 2 hours of receiving the flu vac she began to feel really exhausted. Within 2 days cold symptoms onsetted. Coughing, congestion, upset stomach, loose bowel movements, and gripping stomach pains. No fever. Saw her PCP at a regular scheduled appt on 10/28/2019. As of 11/16/2019 the gripping stomach pain and loose bowel movements continue and she is being followed by her PCP.
Following 1st dose vax experienced pain @ inject site; Following 2nd dose vax experienced prolonged pain & tenderness @ inject site;
no adverse event; ROTATEQ was administered to a patient after temperature excursions; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-SEP-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #W002561, expiration date reported and established as 07-OCT-2023 (strength, dose, vaccination schedule, site and route of administration were not provided) for prophylaxis. Prior to administration, the dose experienced temperature excursions of 1 hour at 9.13 degrees Celsius and 37 hours 15 minutes at minimum of -8.45 degrees Celsius (product storage error). There were no previous temperature excursions.  No additional adverse event (AE) information provided.
Patient received Covid vaccines and a booster and came to ED with decreased mental status.  Patient admitted to the hospital with UTI, Covid, and sepsis.
Did not receive 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose) had resolved. Not Provided      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 medications were reported.  No laboratory details were  provided.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: TCR received on 20 May 2021 and it contains no new information.
Significant redness & swelling w/in 24 hrs to entire (L) arm; treated w/ BENADRYL, KEFLEX, MOTRIN.
Patient reports left arm/shoulder pain that prevents her from moving her arm above her head and limiting daily activities. Patient is still experiencing this pain 6 weeks after vaccination. Patient also received Shingrix in right arm on the same visit and denies any pain in right arm. Pharmacist advised patient to contact and make appointment with PCP to get seen and rule out any other cause of the pain.
1. One hour after receiving second vaccination on Tuesday January 26, 2021 at 3:30, I became very confused and couldn't think clearly (brain fog).  The next day Wednesday January 27, 2021, I had to stay home from work due to not being able to think clearly again (brain fog). On Thursday January 28, 2021, I went back to work arriving at 0600 but still didn't feel right until around noon and then it was like the "fog" lifted and I was better. 2. On 2/5/2021, I noticed that I was starting to itch on my trunk and I  had a fine rash. The rash then went to my neck, back, arms, and legs. On March 23, 2021 i noticed that the rash was fading and the itching was much better.
The patient received 4 Moderna Covid-19 vaccines and on September 10, 2023 the patient caught Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (The patient received 4 Moderna Covid-19 vaccines and on September 10, 2023 the patient caught Covid-19) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 3) and Pfizer vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 12-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Sep-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (The patient received 4 Moderna Covid-19 vaccines and on September 10, 2023 the patient caught Covid-19). At the time of the report, COVID-19 (The patient received 4 Moderna Covid-19 vaccines and on September 10, 2023 the patient caught Covid-19) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported thatpatient had lower back pain for 4 days, and fever. The Covid-19 kicked his butt said by the patient. the worst symptoms that he had were nasal coughing sneezing runny nose, headache. Patient complains to the agent of pain that went straight to my back and he was in pain for 3 days. It was like sciatic nerve pain and was pretty miserable. It took 10 days for him to feel better.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-392112 (E2B Linked Report). This case was linked to MOD-2021-392112 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-392112:Master case
Approx 5-6 hours post flu vax, pt experienced generalized body itching and burning sensation, no rash. Itching and burning worsened during the night. Pt self-medicated with Benadryl PO. From 10/29 to 10/31 pt unable to attend work because itching worsened, especially palms and soles on "fire" with itching. On 11/1 pt developed rash on both arms and on back. Rash looked like chickenpox-type rash. Rash was very painful but resolved on evening of 11/2. Itching became intolerable on 11/3 (pt missed work) and pt developed joint pain in knees, wrists and hands (pt unable to drive). Pt went to ER on 11/4 and was given Prednisone (40mg) po for 5 days. 11/4 knees became swollen. On 11/8 and 11/9 right wrist pain. On 11/10 no meds, no itching.
Gave Patient a 40 mcg Dose of Heplisav-B; Initial Report Received on 10-Jun-2021  A registered nurse reported that a patient (age, gender, race, and ethnicity not provided) received a 40 mcg dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No relevant medical history was reported.  No relevant concomitant medications were reported.  On 04-Jun-2021, the patient received a 40 mcg dose of HEPLISAV-B (Lot #, expiration date, NDC #, serial number, route, and site were not reported) from the nurse. No additional information was provided.   Company Comment: The  company assessed the event as non-serious.; Sender's Comments: The  company assessed the event as non-serious.
This spontaneous report as received from a pharmacist refers to a 32 year old female patient. The patient's pertinent medical history included mitral valve regurgitation (prior to M-M-R). The patient's drug reactions or allergies were reported as none. On 15-JUL-2016 the patient was vaccinated with M-M-R II injection, 0.5 ml (lot # L041456, expiry date: 22-OCT-2017). On 22-JUL-2016, 7 to 10 days after the patient received M-M-R II the patient developed a large lump and pain at the injection site (injection site pain and injection site mass). The patient did not receive any treatment for the events. The outcome of the events injection site mass and injection site pain was not reported. The reporter did not provide the causality assessment between the events and the suspect therapy. There was no product quality complaint. Additional information has been requested.
AFTER GETTING THE SHOT CUSTOMER REPORTED VERY NAUSEATING AS WELL SHE VOMITTED. SGE DID REORTED TIGHTNESS IN CHEST AS WELL SHE BREAK OUT IN RASHES ON HER FACE
RED MARK ON ARM; This spontaneous report received from a consumer concerned an elderly male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced red mark on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red mark on arm. This report was non-serious. This case, from the same reporter is linked to 20211133810.
Patient received a third HPV vaccine in error.  No adverse reactions at the time or since that date.
Started with chills.  I was freezing for almost three hours. I could not get warm-with tons of blankets, heater, heat cranked up. Then I was seating. I had a fever and am still fighting this fever.  It was at 103 on Sat.  It was 101 this morning. I feel fluish-body aches, headache, eye sockets hurt, exhausted.   On sat, after the chills, my legs hurt and felt like they were 100 pounds.
This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 20-JAN-2016, the patient was vaccinated with (Oka/Merck) VARIVAX (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which improperly stored (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Pt experience swelling in feet, tiredness, weakness, mild SOB upon exertion (walking through a store), warmth, loss of appetite. Pt states that swelling and SOB had subsided but still feels mild warmth, tiredness. Continuing to monitor patient.
About 5 minutes after receiving both shots, she lost balance and fainted, or nearly fainted. She fell into a chair, then slid down onto the floor. She was given some food and water and began to feel better over about 20 to 30 minutes.