chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Terrible migraines; Vomitting; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 11:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021, (also reported with the start date as 10Mar2021) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 11Mar2021 at 13:00, the patient experienced terrible migraines and vomiting. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of vomiting and included treatment with unspecified pills (reported as pills for nausua). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events terrible migraines and vomiting was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial information was received on 14 October 2008 from a health care professional.  A 12 year old female patient with a history of acne, bronchitis, and pneumonia developed pain in the right arm after receiving a right deltoid intramuscular injection of MENACTRA (lot number U2643AA), left deltoid intramuscular injection of ADACEL (lot number C3027AA), and a second left arm subcutaneous injection of VARIVAX also reported as "VARICELLA" (manufacturer Merck, lot number 0430X) on 20 August 2008.  On 14 October 2008 the patient presented to the doctor's office with sharp shooting pain in the outer right arm.  The patient reported that the pain occurred several times a day for the past two months.  An exact start date of the patient's symptoms and the recovery status was not reported.  Documents held by Sender: None.
Splitting headaches, chills, fever, nausea, vomiting, soreness in left arm
Weakness, headache, chills, fever (sweats), severe nausea and abdominal pain started approximately 10:30 pm and lasted until 4:00 am although the headache lasted till after 9 am the next day 3/28.  Utilized Advil and Pepto Bismol to alleviate symptoms.
Sterile abscess on left arm 5 cm induration non tender site of DTaP & IPV. Child unaffected symptomatically.
Wife reports about a week after the vaccine he passed out for about 15-30 seconds. She didn't think anything about it, maybe he had tripped. Then a few weeks later, end of Nov/beginning of Dec he has passed out several more times. Wife reports vitals are always perfect. Beginning of Dec he went to dr related to sinus issue. MD advised to report the reaction.
Pain in both eyes, light sensitivity, body aches, chills, fever, coughing. When looking at anything, if I moved my head at all, whatever I looked at seemed to pause for half a second. Like when your WiFi slightly pauses. Leg, arms and back pain severe headache. Pain and swelling in the area of injection . Trouble raising that arm above my head, really hurts.
I experienced tachycardia on 2/6/21, 2 days after my 2nd Moderna vaccine. I have experienced a total of 11 episodes since then. They last from 2 minutes to 7 hours. My cardiologist diagnosed me with atrial tachycardia. He put me on Metoprolol. I am still being monitored.
approx 15min p/vax devel SOB, severe itching, hives, diaphoresis, feeling like throat closing;given epi & DPH, & Solucortef
Pt was signed up for an appt for her first dose. Multiple calls were made to administration regarding her appt including Dr. Direction had been provided earlier that week that clinical concerns could be channeled to Dr. for determination. It was discussed that she was 17, and active EMT and had a parent present at time of vaccine. It was discussed that we were not supposed to be vaccinating minors but she had a appt and met criteria. Approval was given to vaccinate pt. Upon the pts second dose, administration was again contacted and it was determined pt should not be given the second dose. This writer spoke both with pt and mother.
They began as red bumps on both arms when I woke up the following morning.  The majority of the red bumps/hives were on the left arm where I got the shot.  The left arm was sore and slightly swollen.  They bumps/hives became itchy and some spots spread and were raised up with a leathery appearance.  I took Benedryl capsules for the first week, but became disoriented and dizzy, so stopped taking it.  Used calamine and aloe vera as topical treatments.  It is now 11 days from the first vaccine and I'm down to only 6 red hives on the left arm and 3 on the right arm.  The right arm does have a large rash where I have scratched the hives and there is a quarter size rash has developed.
She claims she had an asthma attack - couldn't breathe, felt that her BP was high a few hours after leaving the clinic.  She went to the Emergency Room at 10:51 pm the same day.
Shortness of breath. Lasted 2 weeks. No prior history of heart or lung  problems.  Family history of TIAs.  Mother had stroke after 1st shot and died.
Confusion, Headache, Myalgia, Fever & Diarrhea Narrative:
Vaccines given at well child visit without immediate problems.  Infant had an episode consistent with seizure on the way home from the office, within 20 minutes on vaccine administration.  Parents describe eyes rolled backward, and right arm shook for about 5 seconds.  Infant sleepy for approximately 3 minutes after episode.  Normal exam on arrival to emergency department
Came down with influenza, after 5 days, never recovered from symptoms, had enlarged lymphnodes, extreme tiredness and painful knots all over body. I have been to oncologist and had CAT scans and blood work, was sent to infectious disease doctor who thinks that all of my side effects stem from flu vaccine that started a severe reaction in my body that has caused inflammation all over.  I still have swollen lymph nodes and sores in my mouth and swollen gums, weight loss, nausea, and abdominal pain.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-APR-2015, the patient was vaccinated with improperly stored dose of VAQTA pediatrician dose: 25U/0.5 ml (lot # J014584, expiration date: 16-JAN-2016; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 16 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius), second lasting for 64 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe pain and stiffness in ankles, knees, hips, wrists, elbows, shoulders, and wrists, lasting 3 days.
She got her vaccine, she had a sore arm, but otherwise had no reaction.   The next morning at 10:00 AM she felt extremely tired as if she had not slept in days. Then she got extremely cold and had to wrap up with a blanket.  She started making lunch for the children, and had made chicken nuggets for one of them, and the smell made her extremely nauseous and was throwing up 4 different times, and felt like she had morning sickness.  She had to call the parents to pick up the children, and went to bed at 4:00 PM yesterday and woke up at 6:00 AM this morning.  She has extremely aching of joints, low back in the waist area.  She had a temp of 100.0, and when she took it this morning it was 97.9.   She did not eat yesterday, and the smells again have given her dry heaves and has not eaten anything since the vaccine.  She is still having the nausea and the queasy feeling, as well as back aches.   She has been taking OTC Motrin for the symptoms.
Hard time breathing ,could not catch her breath; Her mouth was so dry; Could not swallow; Felt some constriction; GI problems; Heart was racing; Rash on her neck; Nausea; A really bad headache; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Hard time breathing ,could not catch her breath), DRY MOUTH (Her mouth was so dry), DYSPHAGIA (Could not swallow), THROAT TIGHTNESS (Felt some constriction) and GASTROINTESTINAL DISORDER (GI problems) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder NOS (Thyroid issues). Previously administered products included for COVID-19 immunization: Johnson & Johnson (First); for Product used for unknown indication: Miralax (Experienced the same events (Rash on her neck, a hard time breathing, couldn't catch her breath, her mouth was so dry, she couldn't swallow, felt some constriction, had GI problems, nausea and a really bad headache and her heart was racing) with MiraLax on an unspecified date); for Polyethylene glycol allergy: Zyrtec. Past adverse reactions to the above products included Adverse event with Miralax; and No adverse event with Johnson & Johnson and Zyrtec. Concurrent medical conditions included Polyethylene glycol allergy (allergic reaction to polyethylene glycol) and Autoimmune disorder.    On 26-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Hard time breathing ,could not catch her breath), DRY MOUTH (Her mouth was so dry), DYSPHAGIA (Could not swallow), THROAT TIGHTNESS (Felt some constriction), GASTROINTESTINAL DISORDER (GI problems), PALPITATIONS (Heart was racing), RASH (Rash on her neck), NAUSEA (Nausea) and HEADACHE (A really bad headache). At the time of the report, DYSPNOEA (Hard time breathing ,could not catch her breath), DRY MOUTH (Her mouth was so dry), DYSPHAGIA (Could not swallow), THROAT TIGHTNESS (Felt some constriction), GASTROINTESTINAL DISORDER (GI problems), PALPITATIONS (Heart was racing), RASH (Rash on her neck), NAUSEA (Nausea) and HEADACHE (A really bad headache) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported that the patient received a booster of the COVID-19 Vaccine (Moderna) at an unspecified dose and frequency as a COVID-19 precautionary.  Treatment information was not provided.
A report has been received from a health professional concerning a 39 year old, female subject, height: 69.0 inches; weight: 170.0 pounds, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST Quadrivalent started on an unknown date. It was reported that the patient was administering the FLUMIST Quadrivalent and she cut her finger on the applicator of the FLUMIST Quadrivalent. The event occurred approximately two weeks ago, Oct-2015 or Nov-2015. Her index finger and middle finger were bandaged. Patient also reported product quality complaint. The outcome of the event of she cut her finger on the FLUMIST applicator and product quality complaint is unknown. The company physician assessed the event she cut her finger on the FLUMIST applicator to be non-serious. The company physician identified the event product quality complaint from source narrative and assessed them as non-serious.
Arm was heavy and Could not lift arm; Arm was swollen; Arm painful; Chills; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm was heavy and Could not lift arm), PERIPHERAL SWELLING (Arm was swollen), PAIN IN EXTREMITY (Arm painful), CHILLS (Chills) and FATIGUE (Extreme fatigue) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 28l201a) for COVID-19 vaccination.     No medical history information was provided by reporter.  Concomitant products included CHOLESTEROL for an unknown indication.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced LIMB DISCOMFORT (Arm was heavy and Could not lift arm), PERIPHERAL SWELLING (Arm was swollen), PAIN IN EXTREMITY (Arm painful), CHILLS (Chills) and FATIGUE (Extreme fatigue). On 12-Feb-2021, LIMB DISCOMFORT (Arm was heavy and Could not lift arm), PERIPHERAL SWELLING (Arm was swollen), PAIN IN EXTREMITY (Arm painful), CHILLS (Chills) and FATIGUE (Extreme fatigue) had resolved.            Treatment medications were not provided by reporter.  Patient stated that she had lymphedema in her left arm.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up received on 13-JUL-2021 contains non significant information. The reporter contact details were updated.
Itching, sharp pain, swelling, intense erythema,  superficial skin sloughing ~5 cm in diameter evolving over the course of a month.
Missed window for second dose; Moderna arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Moderna arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed window for second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced VACCINATION COMPLICATION (Moderna arm). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed window for second dose). At the time of the report, VACCINATION COMPLICATION (Moderna arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed window for second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
1.  sore and redness at shot site.   2.  Achy joints, similar to when have the flu.
No Additional AE; HCP called to report patient received expired dose of GARDASIL 9.; This spontaneous report was received from  a licensed vocational nurse and refers to a 12-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-MAY-2023, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #U008897, expiration date: 16-MAY-2023, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). No additional adverse event was reported.
A report was received from a health professional on 11/06/03, concerning approximately 30 elderly vaccinees who inadvertently received Fluvirin subcutaneously on 11/06/03. No other information was available at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Patient noticed 5 days post-vaccination a rash developing around the injection site. Before this, he had some soreness but did not notice any redness or discoloration
Pt reported redness and warm to the touch at site of injection on the left arm that started a few hours after injection. Pt came in 09/15/2018 to report adverse reaction. She was counseled on using BENADRYL and ibuprofen for symptom relief and rph recommended getting checked out by dr or urgent care.
10/19/2004 received IZs , that night mother states was crying all night. 10/21 brought in to clinic with crying, congested: given Benadryl, albuterol for URI. That night went to ER with fever 103, continued crying. CXR, labs done all WNL. 10/24 to ER again with fever, congestion told had ear infection, put on Amoxicillin . 10/26 seen in clinic, better.
I received the shot in my right upper arm that morning. Just thought I would be sore from vaccine (TDAP). It is has only continued to worsen. The mobility of my right arm is minimal with severe pain. There is no comfortable position with a constant pain. Minimal rotation and reaching ability. I worry as it is effecting my job and seems I can find no relief.  Very concerning.
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 25 out of 50 patients   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case
Intensely painful arm 10 days following vaccination.  Most intense at Deltoid, strong in Bicep and radiating down into lower part of extremity.
In the morning of 4/29 started having a bit of itching on my upper left arm later noticed a rash on the spot that was itching  I used over the counter anti itch gel
flu hit too hard; Initial information received on 07-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient).  This case involved an adult patient of an unknown age and gender who experienced flu hit too hard (Influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient had only taken 3 flu shot in lifetime. The flu hit the patient too hard last time (influenza), so the patient chose to try the shot again.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was reported as unknown.  There will be no information available on the batch number for this case.
Got Shingles shot/got shingles / Suspected vaccination failure; Got shingles; Painful blisters on the tummy; Pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got Shingles shot/got shingles / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got shingles), blister (Verbatim: Painful blisters on the tummy) and pain (Verbatim: Pain). The outcome of the vaccination failure was unknown and the outcome of the shingles, blister and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, blister and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, blister and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-JUL-2023 This case was reported by a patient via interactive digital media. The patient stated that he/she got the original Shingles shot 6 years ago from reporting which eased some of the pain when he/she got shingles 2 years ago from reporting. The patient had painful blisters on the tummy but not as bad as it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Fever 102, chills, headaches, dizziness, body aches, weakness generalized.