chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Registered Nurse and refers to a unknown patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored unspecified doses of PNEUMOVAX23 for prophylaxis (lot number  reported as M039201, with an expiration date of 20-MAY-2018) (strength, dose and frequency were not reported). No concomitant medications were provided. The doses of the vaccine experienced a temperature excursion from 32 degrees Fahrenheit (F) to 35 degrees F for 228 hours and from 47 degrees F to 77 degrees F for 18 hours and 20 minutes. The aforementioned temperature was identified due to a data logger. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA003224: US-009507513-1704USA003228: US-009507513-1704USA003226: US-009507513-1704USA003227: US-009507513-1704USA003223: US-009507513-1704USA003014:
PATIENT WAITED FOR 15 MINUTES THEN RELEASED AS SHE WAS FINE AT THAT TIME.  ABOUT 1 1/2 HRS LATER APPROX.  3:30 PM, SHE BEGAN TO HAVE TINGLING OF HER LEFT ARM AND FEELING NUMBNESS LIKE IT HAD FALLEN ASLEEP.  SHE ALSO HAD THE SAME SENSATION OF HER LEFT BUTTOCK AND DOWN HER LEFT THIGH.  A SHORT TIME LATER IT BEGAN AROUND HER MOUGH AND HER LEFT JAW.  SHE TOOK SOME "BHI" ALLERGY MED WHICH IS OVER THE COUNTER MED (HOMEOPATHIC) IT LASTED UNTIL ABOUT 11 PM THAT NIGHT.  SHE DID NOT SEEK MEDICAL ATTENTION.  IT WAS GONE IN THE MORNING.  THIS WAS NOT REPORTED UNTIL SHE CAME FOR HER SECOND COVID SHOT AND WE WOULDN'T GIVE IT UNTIL SHE CHECKED WITH HER DOCTOR.
hives & swelling @ inject site; ice applies & pt observed for approx 45 mins; DPH given;
This spontaneous report as received from a healthcare worker refers to a 6 month old patient of unknown gender. Concurrent conditions and medical history were not reported. On 05-JUN-2015, the patient was vaccinated with improperly stored dose of oral, ROTATEQ (lot # K015816 and expiration date 29-MAR-2016 (dose was not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
The patient received his vaccine just today.  DTaP in right leg and now has a swollen right leg, which is warm and nontender.  He has fever and cough and cold symptoms, which have started last night.
A 60 year old female pt, with no known past medical history, had received an IM, left deltoid injection of Fluzone SV 2006-2007, lot number U2195AA, on 10/4/06. Eight days post vaccination, the pts whole leg went numb. She began to fall, but the felling in her leg returned. Four days after that, she experienced no feeling from her waist down and from both elbows to both hands. She was subsequently admitted to the hospital on 10/16/06. the admitting diagnosis was rule out Guillain Barre syndrome or transverse myelitis. However, per the reporter, it was determined not to be Guillain Barre syndrome. The final diagnosis had not yet been determined. Relevant diagnostic testing included a MRI and lumbar puncture which were negative. The pt was discharged from the hospital on 10/18/06 and was scheduled to follow up with a neurologist and to have an EMG. A Medrol dose pack was prescribed upon discharge. At the time of this report, the pt had not recovered.
this was the second vaccine of Moderna for this person the first vaccine was Moderna given 1/3/2022  Lot Number 070H21A . Realized patient was under 18 at this visit. mother/grandmother stated there were no side effect that patient had
Patient was given Moderna at 0.25mL booster and not the bivalent.
Redness, warmth and tingling at site and right upper arm. No systemic symptoms.
Pharmacist immediately told me she "did not get needle in all the way". My L upper arm started hurting shortly after and has begun to get worse since. Feels worse than when I had a rotator cuff injury to R arm. Limited ROM, can't sleep.
approx 4 hrs p/vax recvd pt began a high pitched scram & unconsolable that lasted approx 3 hrs;
Patient described that she ?felt like she was going to die? and was confused while driving home. She denies any signs of anaphylaxis, fainting, or rash.
Pt developed parasitic rash, urticaria within 30 minutes of shot. 4 days after, pt seen for followup and treated with Zyrtec. (antihistamine)
Traumatic diarrhea; vomiting lasting for 24 hours. Low-grade fever; severe headache lasting for 72 hours. Caused outbreak of atopic dermatitis.
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     No medical history information reported.  Concomitant products included PRENATAL VITAMIN for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 08-Oct-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information was not provided.
administered a dose of improperly stored VARIVAX; No adverse effects were reported; Information has been received from an office manager referring to a patient of unknown age and gender. Concomitant therapy included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided.  On an unknown date, the patient was administered a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R033656, expiration date was 20-NOV-2020; strength, dose and route were not reported) for prophylaxis. The vaccine had temperature excursion of the range 15 Fahrenheit (F) degree to 46 F degree (26 F degree) for 6 hours. There has no previous temperature excursion. The call was due to the digital data logger. No adverse effects were reported.  This is one of five reports which have the same reporter regarding different patients.; Sender's Comments:  US-009507513-1905USA006861:
1-2 days later swelling of lymph node on back of neck. I?ve never to my knowledge had swelling in this specific lymph node area.
Joint Pain - Celestine shot and pain pills 1/7/08. Hospital - 1/28/08-1/31/08 with instructions to take 20 mg Prednisone. 2/21/08 Decrease Prednisone to 15 mg. 3/15/08 - Emergency Room visit and then transferred. Herpes breakout - mouth, lips, heavy rash breakout face, neck, chest, arms and hands, joint pain returned. Inflammation of pericardium and chest pain during hospitalization. Blood pressure dropped, blood became extremely thin and required a vitamin K injection. Since discharge from hospital, at times extreme pain in chest with shortness of breath at all times. Joint pain greatly improved with 40mg daily of Prednisone. Cardiologist placed on two additional medications due to pump function decrease and heart beating too fast. Required hospitalization on 2 occasions: 1/28-1/31/08 and 3/15-19/08. Permanent disability: Undetermined, still unable to perform as prior to vaccine. Physical abilities prior to vaccine equaled some 15-20 years his junior. 4/4/08-records received for DOS 1/28-1/31/08-DC DX: Chronic atrial fibrillation. Joint Pain/Inflammatory polyarthritis. Hypertension. Presented with lower extremity swelling. Week after receiving herpes zoster vaccine began to have diffuse arthralgias in knees, shoulders, hands and elbows which persisted and accompanied by lower extremity swelling for the last two weeks. Worsening fatigue over the same interval. 4/9/08-records received for DOS 2/21/08-Follow up visit after hospitalization, continues to improve after steroid therapy. Rash on face, chest and arms. Assessment: Inflammatory polyarthritis, stable.
Rash so bad, he could not sleep/ Itches a little bit but it does not severely; Rash so bad, he could not sleep; Rash going up his leg/ Rash going up his leg/ Rash going up his back/ Rash looks like chickenpox; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash so bad, he could not sleep/ Itches a little bit but it does not severely), INSOMNIA (Rash so bad, he could not sleep) and RASH (Rash going up his leg/ Rash going up his leg/ Rash going up his back/ Rash looks like chickenpox) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced INSOMNIA (Rash so bad, he could not sleep) and RASH (Rash going up his leg/ Rash going up his leg/ Rash going up his back/ Rash looks like chickenpox). On an unknown date, the patient experienced RASH PRURITIC (Rash so bad, he could not sleep/ Itches a little bit but it does not severely). At the time of the report, RASH PRURITIC (Rash so bad, he could not sleep/ Itches a little bit but it does not severely), INSOMNIA (Rash so bad, he could not sleep) and RASH (Rash going up his leg/ Rash going up his leg/ Rash going up his back/ Rash looks like chickenpox) outcome was unknown. Not Provided          Concomitant medication was not provided Treatment medication include Banophen 25 m and Mupirocin ointment USP 2%  .  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.     This case was linked to MOD-2021-114468 (Patient Link).
woke up from a nap and fell and my husband found e. said I was confused. I called my doctor with my symptoms headache, dizzy, stomach hurt, memory, confused. He thought I may had got covid getting the shot. Went to hospital and ran several test and doctor said it was depression. my liver enzymes were elevated. no memory of what happened.
Patient is fully vaccinated. COVID + on 12/2/2021. Hospitalized on 12/2/2021. Admitting dx: shortness of breath, hypoxia, dyspnea, COVID 19. Patient is a known case of high blood pressure hyperlipidemia and diabetes who presented to the hospital with acute respiratory failure related to COVID pneumonia. Patient is status post been treated with IV steroid and IV remdesivir patient condition improved. Breo inhaler daily and albuterol nebulizer. Patient continue Lovenox subQ b.i.d..   Patient will continue Levaquin daily. Patient weaned off from high-flow oxygen to nasal cannula plan for the patient have home O2 eval with discharge home. Discharged to home.
auto-immune response to vaccine; hair loss in splotches on head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDROXYCHLOROQUINE; FINASTERIDE; MINOXIDIL; PYRIDOX [BIOTIN;CALCIUM PANTOTHENATE;CHLORPHENAMINE MALEATE;GLYCYRRHIZIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;TOCOPHERYL ACETATE]; HYDROCORTISONE; BETAMETHASONE DIPROPIONATE topical. The following information was reported: IMMUNE-MEDIATED ADVERSE REACTION (non-serious), outcome "unknown", described as "auto-immune response to vaccine"; ALOPECIA AREATA (non-serious), outcome "unknown", described as "hair loss in splotches on head". The events "auto-immune response to vaccine" and "hair loss in splotches on head" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  clinical course: Patient shared that he experienced auto-immune response to vaccine. This according to his dermatologist (Dr. Name withheld). He had hair loss in splotches on head.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient was accidentally administered an expired Fluzone Quadrivalent with no reported adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 37 years old female patient was accidentally administered an expired Influenza quadrival A-B vaccine [Fluzone Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Oct-2022, the patient was accidentally administered an expired 0.5ml (total)  dose of suspect Influenza quadrival A-B vaccine (lot UT7356NA;Expiration Date :30-Jun-2022) via intramuscular route in the left deltoid for Immunization with no reported adverse event (expired product administered).  Action taken: not applicable.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
2 days after second dose my guts, large bowel, began cramping severely for hours at a time., with nasty diarrhea. And extreme fatigue.  I have never had this much pain with my guts even thou i have had microscopic colitis in the past.  This went on for at least 4 plus weeks during which time i attempted to make an apt w my gastro doc to no avail.  Went to urgent care, had ct scan w contrast, showed inflammation in lower bowel.  NP put me on prednisone.  Finally saw gastro nurse practitioner, was put on flagyl and cipro antibiotics.  Still very tired thru May 15th and ill feeling which could have been in part from the antibiotics.  Starting May 17 I finally felt fine.  One of my daughters also had very bad gut cramps off and on for 3 weeks after 2nd Moderna shot.   Also female friends reported very painful guts after 2nd Moderna shot.  Hope this is helpful.  Thank you
Received my flu shot on Tuesday. Tuesday night began having numbness, tinling in legs, feet, pain in back, hands, and shoulders.
Side headache; Fever; Slight Nausea; Soreness in injection site; This is a spontaneous report from a contactable consumer (patient) via a sales representative. A 25-year-old (reported as 20 - 30) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as second dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date. The patient experienced side headache, fever, slight nausea, and soreness in injection site after she got second dose of COVID-19 vaccine on an unspecified date. The outcome for the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Drive thru vaccine event.  The Health Department gave booster Pfizer vaccine from 9:00 am until 12 noon. Pharmacy was giving booster dose Moderna from 12 noon until 3:00 pm.  Patient arrived 15 minutes early for her appointment.  She got in the line for vaccine and was inadvertantly given Pfizer instead of Moderna.
Pt recvd vax & exp fever 100, w/lymphadenopathy, arthritis, & arthralgia; No pain in both thighs tired, fatigue;
pt recv vax 6OCT98 & w/in 30min pt devel neck stiffness, jaw tightness & nausea;pt was treated w/muscle relaxants & remained in clinic for several hr observation;3hr later pt neck & jaw stiffness had stabilized & nausea subsided;
This spontaneous report as received from a physician refers to a 11 year old female patient. On 23-OCT-2014, the patient was vaccinated with GARDASIL lot # K004205, expiration date 12-JAN-2017, 0.5 ml, intramuscularly. Concomitant therapies included meningococcal vaccine (unspecified), tuberculin purified protein derivative and 2 unspecified medications, TDAP, reported as KEYDAP and unspecified flu vaccine (Influenza virus vaccine), reported as BLUE vaccine. On 23-OCT-2014, 5 min after being vaccinated with GARDASIL, the patient fainted. The patient was in a sitting position and her head went back as she fainted. The GARDASIL was the last vaccine that was given that day. No other symptoms were reported. The patient did not seek medical attention. No treatment was given. The outcome of fainting was unknown. The relatedness between fainting and GARDASIL was not reported. Additional information has been requested.
pt exp 1x1cm red area on thigh;pt was seen on 12/15/97;DPh was instructed to be given;pt reported to have recovered from this exp;
Patient received a flu shot previously. Patient was given another flu shot by accident when she came in for her second dose of shingrix. Patient also given shingrix on the same day. Patient called and let me know that she was very fatigued, weak, had a sore arm and felt ill the day after the vaccine. She is now back to 100%.
Patient called pharmacy on Tuesday, 11/13 stating that starting on Monday night she had hives all over her body. Her mouth and chin were also swollen. She took some allergy medication, which helped but she still had symptoms present in the morning. I directed her to go to her MD to get treatment. She went to emergency room, under the care of Dr., where she got PEPCID, BENADRYL and an EPIPEN.
Menstrual cycle started 3 weeks early; This is a spontaneous report from a contactable nurse, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158), via an unspecified route of administration in the right arm on 08Apr2021 at 10:45 (at the age of 33-year-old), as a single dose for COVID-19 immunisation. The patient had an unspecified medical history and had a history of allergies to food or medications or other products. The patient received unspecified other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 08:00, the patient experienced menstrual cycle started 3 weeks early after only 1 week of last cycle stopping. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcome of the event menstrual cycle started 3 weeks early was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
ADMITTED HER TO ICU; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. 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, and batch number and expiry date were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, 45 minutes post vaccination the patient was admitted to intensive care unit (ICU), and she was hospitalized there for 2 weeks. Reporter stated, "my friend took the shot and 45 minutes later they had to admitted her to ICU. She was there 2 weeks. She pulled through but her doctor told her to never take a COVID shot again." The number of days of hospitalization was not reported and it was unsure if the patient was discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from admitted her to ICU. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20221246595- Admitted her to ICU. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
12/24/2021- I had severe joint pain, body aches, headaches, fatigued, couple days later I was okay.
BREAKTHROUGH COVID: FULLY VACCINATED COVID POSITIVE. Severe proctocolitis in this patient who has been severely constipated; rule out Clostridium difficile colitis with severe leukemoid reaction. Colonoscopy path confirms Ischemic colitis 2. Coronavirus disease-2019, initially diagnosed on 08/14/2022. Leukocytosis. Remains with no particular treatment indicated for COVID-19 at this time.
No other adverse events reported; An improperly stored MMR II was administered to a patient yesterday; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.    It was reported that on 06-OCT-2021 (reported as yesterday), one improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) as prophylaxis (strength, formulation, dose number, route of administration, and anatomical location of vaccination were not reported; Lot No. T001211 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date was reported as 12-JAN-2022) was administered to the patient (product storage error). The temperature and time frame were reported as 47.6 °F (Fahrenheit) and 30 minutes, respectively; and the previous temperature excursion was at 47.1 °F for 30 minutes. No other adverse events reported. The outcome of the event product storage error was unknown.
in JUN95 p/vax pt devel progressive sensory neuropathy involving feet, legs, hands, arms, plus cardiac dysautonomia;pt required mult hosp in 95, 96 & is permanently disabled secondary to chronic neuropathic pain; Annual follow-up received on 10/2/00 states that the pt has chronic neuropathic pain in legs. Can only stand for 10 minutes and walk for 15. the pt has GI and cardiac disorder as well.
Various medical complications twitching, weakness, numbness, tingling, blue fingers, hand swelling, difficulty walking, head nodding and excessive sleepiness. Double vision, vibrations, extreme arm pain. Excessively biting lips while trying to eat, stumbling and tripping right arm and leg severe weakness, paresthesias of right arm and right leg. Difficulty walking, writing, thinking, uncontrolled gait/balance. Difficulty controlling bladder and extreme constipation. Decreased cognitive astuteness. Insomnia. Treatment at hospital ER visit. Outcome pending symptoms continue primary care visit. Each and every time I have an influenza shot I have some strange neurological symptoms of the sorts.
Swelling of area below injection site with pain. Then development of diffuse erythema continuing distally to antecubital fossa with both pain and itching.