chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given after 48 hours of a punctured vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given after 48 hours of a punctured vial) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006821A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given after 48 hours of a punctured vial). On 09-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given after 48 hours of a punctured vial) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-077668, US-MODERNATX, INC.-MOD-2021-077928, US-MODERNATX, INC.-MOD-2021-078057 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up received on 01-JUN-2021 and patient details, product details was updated.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 006821A)  with no associated AEs. US-MODERNATX, INC.-MOD-2021-077668: US-MODERNATX, INC.-MOD-2021-077928: US-MODERNATX, INC.-MOD-2021-078057:
Erythema to R thigh, site warm to touch- Day (1) 3"x3" (8/30/16). Day 2 (8/31/16) spread outside of original markings and wraps around posterior to thigh.
Hives appeared on back and shoulders the day following vaccine administration.  He reports that hydrocortisone cream helped some with the discomfort.
information has been received from a physician concerning a 16 year old female who on 08 Dec 2006 was vaccinated in the arm with a pre filled syringe of HPV Vaccine. There was no concomitant medication. On 08 Dec 2006, immediately following the vaccination, the patient turned white and nearly passed out. The patient was not hospitalized and was not pregnant. Subsequently, the patient fully recovered. The physician felt that the events were not a result of the vaccine, however a result of the patient being afraid of injections. Additional information has been requested.
afebrile-very fussy, hard lump to lt leg @ inject site; rx APAP;
APPROX. 10 HOURS AFTER VACCINATION, PT. DEVELOPED MOTTLED BRUISING AND TENDERNESS OVER BOTH FOREARMS AND A LOW GRADE FEVER.  BY MORNING, THE BRUISING HAD SPREAD, MOM BROUGHT PT. IN TO SEE DR. AND I AND IT WAS RULED A TD REACTION.
This spontaneous report as received from a pharmacist refers to multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 lot # K021030, expiration date: 22-JUN-2016 (dose, route and site of administration were not reported). No adverse effects were reported. Follow up information has been received from the pharmacist on 09-NOV-2015. On 10-SEP-2015, the patient was vaccinated with dose of improperly stored PNEUMOVAX 23. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Patient details, suspect therapy, event data and narrative were updated.
Area of redness with swelling 1 cm X 1 cm RUT where Pentacel was given.
Moderna 6/15/21, 7/13/21. Positive on 8/22/22
Within 10 minutes of receiving a flu shot, the patient got lightheaded and allegedly had a seizure.
(1) Itching at site that resolved after 1 week. (2) Knot in arm occurring after 2/5/21 injection and still on prominent 3/5/21. Nurse at facility said resident had not seen the physician for this condition.
pt stated the night after the covid vax she had chills, headache, nausea, fever, weakness.  Pt stated in bed next day since she was unsteady on her feet and had 101 fever.  Pt called PCP to let them know and will FU with regular scheduled appt.
Broke out with very itchy rash one week after shot. It was just my left arm, then it spread to other arm (upper arm and forearm). It has now spread to parts of my upper legs and buttocks.
Patient complained of burning sensation and achiness from left deltoid up to left side of neck and behind left ear. Patient complained of left ear clogged, numbness, swelling, with swelling and tingling of lips. Patient took ibuprofen. Went UC and ED, was prescribed prednisolone.
Information has been received from a pharmacist via a company representative, referring to a elderly female patient "in her 60's". The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (administration route, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unspecified date in May 2017 (reported as "about 5 months ago"), the patient developed an injection site reaction after receiving ZOSTAVAX. It was reported that the patient's injection site "was swollen and also very raw". The reporting pharmacist stated that the patient went to the doctor, but the doctor did not give her anything in terms of treatment. The outcome of all the events was reported as recovered and the causality between the vaccination with ZOSTAVAX KEYTRUDA and the events was not reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1710USA010523: US-009507513-1711USA003883.
Patient started to get a bald spot on her head after getting the second Meningitis B vaccine in the middle of January. Dad thinks it is the Bexsero vaccine causing it. She did have fever and nausea and dizziness after both of the Meningitis B vaccines. She has seen a Dermatology PA under MD and they gave her steroid shots the beginging of March. At first it started to get better but now it is getting worse again. She is not having any hair loss elsewhere on her body. She has been taking her thyroid medication as prescribed. Her weight has been stable. Mom wants to check blood work to look for possible causes.
Erratic hypertension, muscle weakness ,  Back pain, Guillain-Barré syndrome
Information regarding PREVNAR 13 was received from a nurse regarding an unknown number of patients who experienced severe pain during injection of vaccine and high fever lasting for a long time as compared other vaccines. The patients received a dose in 2010. The patients experienced severe pain during injection of vaccine and high fever lasting for a long time as compared other vaccines in 2010.  The outcomes are unknown.  No additional information was available at the time of this report.
On April 22, 2022, symptoms started early in the day, gradually getting more severe: sinus congestion, runny nose, headache.
This spontaneous report was received from a pharmacist refers to a 41 year old female patient. On 03-MAR-2014, the patient was vaccinated with ZOSTAVAX lot # J011882 (Expiry: 04-JAN-2015) (dose and frequency were not reported) subcutaneous. On 03-MAR-2014, a small amount of ZOSTAVAX leaked out from the injection site. The pharmacist reported that the patient was less than 50 years of age at the time of vaccination with ZOSTAVAX. No adverse reaction reported. No further information was provided. Additional information has been requested.
PT CAME INTO PHARMACY TODAY, STATING THAT ARM WHERE SHE RECEIVED FLU VACCINE STILL BOTHERS HER. SHE SAYS IT DID NOT HURT FOR A COUPLE DAYS AFTER VACCINCATION, BUT THEN STARTED HURTING AND SHE HAS TO ICE IT EVERY NIGHT.
Experienced tenderness in arm first few days.  3 days later experienced severe lower backpain across my entire back (crippling) in early morning and had to take advil to assist with the pain.  The next morning had severe charley horse in my right calf.  I have never experienced the intensity of these types of symptoms in the past.  It has taken over a week to recover (back and calf).  Today, 3/6/21, I notice that the injection site is sensitive and hard to the touch.  There is also redness around the injection site approximately 4" x 4".   I am not yet fully recovered but feel I am improving.
Patient presented to ED via EMS with a severe headache. Has history of seizures. Admitted to our inpatient medical unit. Has Covid 19 vaccine listed on her allergies. Note states patient developed unspecified shock requiring vasopressin support after the vaccine administration.
5/12, 5/13 and 5/14 - Arm Pain, specially when trying to lift anything. 5/15, 5/16, 5/17 - noticed shortness of breath, very sleepy, throat clearing, heavy post nasal drip. Weird taste in mouth. 5/18 - Neck Pain 5/19 - Felt a small moving ball on top of the left side of my collarbone, closer to my throat, it is painful and tender to the touch. My neck feels in pain, actually more like a burning sensation
This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included ongoing Ankylosing Spondylitis and ongoing canker sores oral. Concomitant medication included etanercept (ENBREL) taken for Ankylosing Spondylitis from 2017. The patient received his first dose of COVID-19 vaccine and his next dose would be on 19Mar2021 (next Friday). Subsequently, the patient stated that he could feel that some of his Ankylosing Spondylitis symptoms were coming back. He added that right now he had a canker sore break out and it had brought back the absolute misery this condition could bring. No treatment information was received. The outcome of the events ankylosing spondylitis, aphthous ulcer were reported as not recovered/not resolved. No follow-up attempts are possible; No further information expected; information about lot/batch number cannot be obtained.
Information has been received from a woman in a doctor's office concerning a 5 year old male who in March 2001 was vaccinated with a dose of varicella vaccine. In July 2001, the pt did not have a titer. The pt sought unspecified medical attention. Additional info has been requested.
on each anterior thigh there is an area 4-5cm in diameter;rt thigh more indurated w/a thick feeling, plaque like sensation to palpation;nl voice & cry;neck supple;no red streak going up leg;
swollen knees, effusion in both knees w/pain;needed pain meds & ace wraps;unable to bend either knee for 2wk;nuprin & seen by MD;
Symptoms began as heavy sweating during the night, followed by severe throat inflammation (non-airway obstructing).  Difficulty talking and swallowing, extreme pain.
11/07/21 presents to HCF triage "with complaints of worsening contractions since 0200 this am, G1P0 at 39w2d" "No pertinent past medical history"
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 13-year-old female patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 06-DEC-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
This spontaneous report as received from a nurse refers to a 18 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 02-MAR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 2, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Began with irritability in the PM of 2/5/02. Had extreme lethargy at 05:00 on 2/6/02. Resolved at 11:00 on 2/6/02. Also had marked pallor.
I went to bed early due to being tired. I awoke at 12:01 with severe pain in my left jaw. it felt as if I was punched and it was swollen. I could also feel a quarter size swollen disc. It was very painful to move jaw.  I put ice on location and took 3 Advil.  It didn't feel better until noon, both swelling and pain gradually went away. No I didn't take Benadryl.
fever, disorientation, fatigue for 3 days stayed home from work for 1 week recovered and returned to work
I am experiencing left leg pain from my thigh down to my shin. It has gotten progressively worse over time. I had an x-ray and a nerve conduction test which verified I had a pinched L4 and L5 nerve due to inflation. My primary doctor sent me to an orthopedic doctor who wants to conduct an MRI. My orthopedic doctor prescribed me an anti-inflammatory drug. I also caught COVID-19 in November of 2022. I experienced all upper respiratory symptoms. I lost my taste and smell but slowly regained them both over time.
This spontaneous report has been received from a pharmacist and an employee referring to a 62 year old female patient with asthma. Concomitant medication included unspecified thyroid medication. There were no drug reactions/allergies. On 16-JUL-2017, the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous, lot # N012492 with expiration date 17-MAR-2018) for preventing against shingles (prophylaxis). On the same day, within five minutes of being administered the vaccine, the patient experienced a rash at the injection site. On 17-JUL-2017, the patient "developed rash all over her body". On an unspecified date in July 2017, patient also experienced a rash on her neck and bruising at the injection site. The patient went into pharmacy on 19-JUL-2017 and reported the events. No laboratory diagnosis was performed. Unspecified treatment was given to the patient. At the time of the report, the patient did not recover from the events. The causality between ZOSTAVAX and the events was unknown. The pharmacist accepted the offer to receive the varicella zoster virus identification program (VZVIP) packet. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA003459:
Right shoulder pain noted a few days after the immunization, then weakness.  A neurologist diagnosed right brachial plexopathy.
vertigo when getting up in the morning; numbness and tingling in toes; numbness and tingling in toes; A spontaneous report was received from a 61 year-old male patient who received Moderna's COVID-19 Vaccine and experienced vertigo when getting up in the morning, numbness and tingling in toes.  The patient's medical history was not provided. Relevant concomitant medications included lansoprazole, cyanocobalamin, and nicotinamide.   On 29 Dec 2020, the patient received the first of two planned doses of mRNA-1273 intramuscularly in the left arm for COVID-19 for infection prophylaxis.  On 04 Jan 2021, the patient started having vertigo when getting up in the morning. He also stated he had numbness and tingling in his toes.   On 05 Jan 2021, the patient's vertigo continued more severely. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events numbness and tingling in toes was unknown and for vertigo when getting up in the morning not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of vertigo, hypoesthesia and paresthesia, a causal relationship cannot be excluded.
ER for headache; ER for dehydration; dizziness; rash; fever; chills; extreme headache; nausea.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEHYDRATION (ER for dehydration), DIZZINESS (dizziness), RASH (rash), HEADACHE (ER for headache) and PYREXIA (fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Traumatic brain injury (Patient was involved in car accident in 2012) and Orthopedic procedure (Patient has multiple plates throughout her body).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced DIZZINESS (dizziness), RASH (rash), PYREXIA (fever), CHILLS (chills), HEADACHE (extreme headache) and NAUSEA (nausea.). On 10-Mar-2021, the patient experienced DEHYDRATION (ER for dehydration). On 15-Mar-2021, the patient experienced HEADACHE (ER for headache). At the time of the report, DEHYDRATION (ER for dehydration), DIZZINESS (dizziness), RASH (rash), HEADACHE (ER for headache), PYREXIA (fever), CHILLS (chills), HEADACHE (extreme headache) and NAUSEA (nausea.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
On their way home from the facility, the patient "started to feel really bad; he told wife that she would have to take over the driving"; she stated that he received the flu vaccine yesterday while here at the facility; she stated that he came home and went to bed and has been up very little; she stated that at first he was freezing then he became hot and had a temperature of 102.3 last night at 1130; his temperature this am is 99.8, his bp is 114/76 with a pulse of 76; the patient stated that he has been sob and sweaty with a mild pain in his epigastric area, rated at "3", and weak; denied nausea/vomiting/diarrhea,  dizziness/lightheadedness, cough, chest pain, headache, visual changes; has not eaten since yesterday morning, but has been able to drink and has urinated;
Metallic taste in my mouth continues; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration in the right arm on 09Mar2021 16:45 (at the age of 65-years-old) as first dose, single dose for COVID-19 immunisation at a pharmacy/ drug store. The patient's medical history was not reported. Concomitant medications included calcium carbonate (CALTRATE) and vitamin C; both taken for an unspecified indication, start and stop dates were not reported. The patient was healthy. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient has no known allergies. On 09Mar2021 17:00, the patient experienced metallic taste in her mouth continued. No treatment was taken for the event. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Jansen COVID-19 Vaccine EUA - chills, fever temp almost 103, headache, stiff neck, for almost 48 hours
This non-serious initial spontaneous case was received on 11-Sep-2017 from pharmacist, concerning a male patient of an unspecified age. On an unspecified date, the patient was administered with FLUVIRIN THIOMERSAL (dose: 0.5 ml, batch number: 1720801 (as reported), expiry date: Apr-2018, route of administration: intramuscular and anatomical location: not reported). The administered vaccine reached 64.9-dgeree F instead of storing at 36-46-degree F for up to 12 hours, which was considered as incorrect product storage and drug administration error. It was reported that, no adverse reactions were observed. The outcome of the events was not reported. The reporter assessed the report as non-serious.
Patient received influenza vaccine without consent form signed. Patient signed  for and consented to receive Pfizer Booster dose. Patient was notified by RN that he received Influenza Vaccine instead of receiving the Pfizer Booster Vaccine he requested and consented to receive. Patient verbalized understanding of this. Patient verbalized and signed on Pfizer consent form that he had no allergies. Patient did not develop adverse symptoms from administered Influenza Vaccine.  Supervising personnel were notified of this event immediately after adverse event took place. Guidance was received from both RN and MD. Per guidance, patient was able to still receive the Pfizer Booster dose as he originally requested and consented for. After receiving education and guidance on the Pfizer Booster dose and signed consent to receive Pfizer booster dose,  patient was administered the proper Pfizer Booster dose as he requested and consented for.
Fibromyalgia/fibromyalgia pain in ankles; Patient took first dose on 01-Mar-2021 and second dose on 22-Mar-2021; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Fibromyalgia/fibromyalgia pain in ankles), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 01-Mar-2021 and second dose on 22-Mar-2021) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    There was no reported medical history.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In March 2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced FIBROMYALGIA (Fibromyalgia/fibromyalgia pain in ankles) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 01-Mar-2021 and second dose on 22-Mar-2021). In 2021, FATIGUE (Fatigue) had resolved. At the time of the report, FIBROMYALGIA (Fibromyalgia/fibromyalgia pain in ankles) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 01-Mar-2021 and second dose on 22-Mar-2021) outcome was unknown.      No concomitant medication details were provided. No treatment medication details were provided.  Formulation for HUMIRA was given as Solution for injection in pre-filled pen.  The reporter's causality for the events of fibromyalgia and fatigue was not provided with HUMIRA (ADALIMUMAB).  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.