chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seriousness criteria other medically significant (OMIC). From initial information received on 1/21/06 from a literature report. a report of three cases, it was reported that three pts were evaluated at the neuromuscular clinic from 2001 to 2005, All pts underwent detailed history, general and neurological examinations, electro diagnostic and lab studies, including spinal fluid, complete blood count, metabolic panel, serology for autoimmune disorders, Lyme serology, VDRL, serum immune fixation, thyroid studies glucose and HBA1C, and MRI for brain and spine. The other two pts from this literature report are reported in cases 200603299 and 200603300. A healthy 89 year old man had received a dose of Influenza vaccine sometime in 2001 to 2005. The date of vaccination was not specified. The trade name, manufacturer, lot number, route and site of administration were not reported. The pt did not have any acute illness or systemic infections prior to the vaccination. He did not have any history of diabetes mellitus, alcohol abuse, exposure to any known neurotoxins, and there was no family history of neuropathy. The pt developed tingling in the hands two days post immunization, followed by progressive weakness, which progressed over two weeks, in his arms and legs. CSF showed 127.3. The pt improved after a05 day course of IVIG over 4 weeks, a month later, the pt experienced more gradual worsening of weakness over 6 weeks, the pt was unable to walk or stand, even with support. Examination showed marked weakness in proximal and distal muscles of all extremities, with absent muscle stretch reflexes. Vibration and diminished in the toes, and other sensations were intact. Electro diagnostic studied showed widespread abnormalities, indication a demyelinating polyneuropathy. Needle EMG showed fibrillation potentials, and loss of motor unit potentials, in the distal upper and lower extremity muscles. Pt was treated with monthly IVIG 1g/kg monthly) and oral mycophenolate 1000 mg bid. IVIG was discontinued after 6 months, at the 16 month follow up, the pt showed normal gait and only mild weakness of intrinsic hand muscle (grade 4 MRC). Pts status at the last follow up indicated that he was ambulating with a cane, and had mild weakness in his arms. The authors conclusion is that this pt , who was other wise health, developed CIDP with rapid onset in close proximity to influenza vaccinations, suggesting a plausible relationship between the immunization and the induction of CIDP. It is possible that antecedent events such as immunization are more likely in such pts,  but has not been systemically evaluated. In contrast to GBS, which is a monophasic illness, how a single event such as immunization may trigger induction of a relapsing or chronic immune mediated disorder such as CIDP is not known. The reporter for this case is the same as for cases 200603300 and 200603298.
Patient  described 6/10 pain in right arm. 12 lead _NRS, 120/79, 76,16, 100% RA, Patient wanted to go to hospital . Taken via Ambulance
Information has been received from a mother of a 9 year old female who in May 1995 was vaccinated with varicella vaccine. On 01/13/2002, the child was diagnosed with chickenpox. The child's mother reported that the chickenpox was, in her opinion, a mild version. At the time of this report, no further info was provided, and the outcome of the event was unknown. No further info is available.
chills. fatigue, temp 100-103 for six days Tylenol 500-1000 mg every 6 hours decrease in appetite
This spontaneous report as received from a nurse practitioner refers to a 64 year old female patient with osteoarthritis, hyperlipidemia, hypertension, gastrointestinal reflux, allergic rhinitis and no drug allergies. on 18-JUL-2013 the patient was vaccinated with one 0.65ml dose of ZOSTAVAX, in the "back of the arm", in subcutaneous region. The lot number and the expired date were not available as the patient was vaccinated in another pharmacy. Concomitant therapies included CELEBREX, ZOLOFT, ZOCOR and ADVAIR and "PROAIR". On 20-JUL-2013, 3 days after onset of therapy the patient contacted office with complaints of induration, redness going down patient's arm, tenderness and vesicles that developed near injection site. The patient was seen in the office on 22-JUL-2013 and started on antibiotics KEFLEX with cellulitis being diagnosis. The nurse practitioner stated "I was afraid to give antiviral so as not to diminish response to vaccine".The patient was "cultured", a viral culture was requested yet a "HSV culture was performed" which showed negative results. The nurse practitioner spoke to the patient on 29-JUL-2013 and reported "arm was doing better, still a little sore, vesicles and redness nearly gone". Additional information has been requested.
hypotonic-hyporesponsive collapse 6 hr p/vax; no fever; required full septic work up-neg;
This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender who "three years ago" in approximately August 2009, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number not reported) and was in the office today, on 24-AUG-2012, to received the second dose of GARDASIL. No adverse effects were reported. Additional information is not expected.
After getting the shot on Friday at 6:00 pm. I did not have any issues with the shoulder.   Sunday evening around 11pm I have started to have shoulder pain.  The pain is around the area of the injection.  The pain  is generally in the deltoid muscle  and has spread some to the bicep muscle as well.   Uncertain if this is common to the injection process but it caused concern as its onset had been  over 48 hours post injection.
Patient went to ER, cellulitis started around injection site. Doxycycline 100mg twice daily started 2 days later.
Tingling in lower extremities from the waist down, which began 4-5 days after receiving my 1st dose of the Moderna COVID vaccination.
shingles until I received the shot / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had another shingles. The patient reported that he or she did not have any shingles at all for 2 year's until he or she received the shot. Therefore the patient asked why did he or she showed signs without ant prior outbreak to the shot. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Within 2 minutes of receiving vaccine, patient became hypotensive, diaphoretic, pale, altered consciousness. Recovered within 35 minutes after monitoring
On the coast of the right upper lip, there is a small central lesion that looks like a mall abrasion, surrounded by a approximately 1.5 x 0.5 cm area of ecchymosis.- very deep purple in color Only slight edema present.  No ulceration. No pain, No fever, No bleeding or drainage.  After 24 hours, listerine mouth wash twice, ice packs, swelling is reduced - less blister like. But, still very dark, purple discoloration
no adverse event; Non case: No stability data available in temperature excursion case no adverse event with no medication error case.
This spontaneous report has been received from a pharmacist via Pfizer (Company number 2016144687) on 14-MAR-2016 concerning a female patient of unknown age. The patient's medical history and concurrent conditions were not provided. On unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (lot #, expiration date, dose, frequency, strength and route of administration were not provided). Concomitant or co-suspect therapies were not provided. On an unspecified date, the patient experienced rash and itching all over after get PNEUMOVAX 23. At the time of this report the action taken with PNEUMOVAX 23 and the outcome of rash and itching all over were not reported. Additional information has been requested.
12 hours after injection developed fever, chills, body ache, loss of appetite, sweating and headache.
Itchy red rash to (L) arm. Pt. given clindamycin 75 mg/5 ml 2 tsp. BID x 10 days.
Initial report received on 03 April 2012 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 14-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance database. The subject had received 3 doses of PENTACEL; first dose received on 23 February 2011 (lot number unspecified), second dose received on 11 May 2011 (lot number C3590AA) and third dose received on 25 July 2011 (lot number C3633AA; routes and sites of administration not reported). The subject developed a cough on 01 March 2012, approximately seven months after the last dose. On 15 March 2012, patient developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 15 March 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 22 March 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 29 March 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 28 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-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 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      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 POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case included information of patient 100th out of 100 patients.  No concomitant medication was provided by reporter.  Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, date of administration 11 Jan 2023, lot numbers unknown to the HCP.  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:case
pt vax hepta B. aft 3 doses pt failed to seroconvert. pt vax 4th hepta B. anti-HBs titer was 6.5. pt ex gen malaise.  07aug90 pt vax 5th hepta B.  seroconversion on 20sep90 was 3.8 RU.
COLD SYMPTOMS (SORE THROAT, NASAL CONGESTION AND SNEEZING); This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 150 pounds, and height was 57 inches. The patient's concurrent conditions included: high blood pressure, and post partum preeclampsia, and other pre-existing medical conditions included: The patient and her son had not done covid-19 test. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included metoprolol tartrate for post partum preeclampsia. On 24-SEP-2021, the patient experienced cold symptoms (sore throat, nasal congestion and sneezing). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cold symptoms (sore throat, nasal congestion and sneezing) was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000194835.
I had a low-grade fever on 11/18/22 with chills going to the bathroom every five minutes. The next day I felt bad, no fever or chills, started feeling better on 11/20/22. By 11/21/22 the symptoms came back, I called the doctor's office and got an appointment with the nurse practioner the next day. During the telehealth visit she diagnosed me with an UTI and prescribed Macrobid, I am feeling
they said he had Covid; he couldn't walk on the 17th; He is like bed ridden; his hips was bothering; a pain from both sides of his hip; This is a spontaneous report from a contactable Consumer (wife) via call center. A 72-year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot Number: EN6199) as single dose for covid-19 immunisation.  Medical history included blood cholesterol from an unknown date and unknown if ongoing and he takes a pill for cholesterol.  The patient's concomitant medications were not reported. The patient's wife reported that "he had the shot on the 5th of this month and he couldn't walk on the 17th and she had to get the ambulance to take him to hospital where he was tested and they said he had Covid." The reporter also mentioned that they took X-ray because he was complaining about his hip, he had a pain from both sides of his hip. They also gave him Tylenol. The patient was discharged from the hospital on 17Mar2021. The reporter stated that the patient has been home upstairs in bed and that "he is scheduled for another shot on the 26th of this month" and inquired as to what to do with second dose appointment. Hospitalization date was 17Mar2021. Seriousness criteria for vents Covid-19 was hospitalization and medically significant, for gait disturbance and musculoskeletal discomfort was hospitalization. Events arthralgia (pain in hip) was reported as non-serious. The patient underwent lab tests and procedures which included sars-cov-2 test positive for covid on 17Mar2021 , x-ray: no result provided on unknown date .  The events outcome was unknown. Therapeutic measures were taken as a result of event musculoskeletal discomfort.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient said after she got moderna she started experiencing fewer a few hours later and the she had shivers, heart fluttering , tires and shortness of breath.
w/in 24hr low grade temp lasting 4wk-cut consumption of formula by 50%;Annual follow-up dated 02/15/01 states that the pt still has trouble regulating body temp.
Patient is an 88 year old male with PMH of HTN, HLD, and lymphoma currently in remission who presents to the ED with complaints of chest congestion and coughing x1 day PTA. Patient also reports some vague chest discomfort associated with the congestion, unable to further describe. Patient states the congestion and coughing were continuous and he was unable to sleep. Patient also reports fatigue and sore throat. Patient denies nausea, vomiting, and diarrhea. Patient is vaccinated with Moderna, including booster received 11/2021.
Severe headache started about 3pm and lasted all night, better the next day lasted until 7pm. Both hips and back hurting most of the night. Pounding heart. Took Tylenol - hardly touched the pain.
Fever, arm with rash, pain, itching, (L) arm Depo Medrol 80mg IM given.
Patient developed DVT and pulmonary embolism 3 weeks after the vaccine was given.  Patient had no other risk factors.
Presented to Hospital ED on 6/14/2021 with self reported third episode of chest pain in past month. Troponin was elevated and EKG showed ST elevations. Pt was transferred to Hospital in another area.
WEAKNESS UNABLE TO WALK WITH OUR HELP CHILLS AND EXTREME HEADACHE...SECOND DAY ONLY INDICATION IS MY RED ARE SAME AAT THE FIRST INJECTION.
Patient said he couldn't hear.  He felt dizzy, nauseas, and was sweating.  Blood pressure was taken it was low.  Gave patient water to drink.  Took blood pressure repeatedly.  Gave patient something to eat (said he hadn't eaten & that could be cause of nausea).  Patient's blood pressure went back up to normal.  Patient felt fine before he left.  I had patient sit longer than the 15 minutes, it was at least 30 minutes.
Parotitis developing approximately 18 days post PROQUAD, started (Lt), then (Rt) side within 2 days, no treat.
Slight pain to her left arm after the shot; has chronic pain from sciatica and bulging/herniated disk; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Slight pain to her left arm after the shot) and PAIN (has chronic pain from sciatica and bulging/herniated disk) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Slight pain to her left arm after the shot) and PAIN (has chronic pain from sciatica and bulging/herniated disk). At the time of the report, MYALGIA (Slight pain to her left arm after the shot) and PAIN (has chronic pain from sciatica and bulging/herniated disk) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No adverse event. No concomitant medication.   Reporter did not allow further contact
Pt presents to ED by PD for altered mental status 2/8. Pt has occasional productive cough but denied any physical pain or complaints. COVID positive 2/8. 2/9 pt aox2 confused, on RA not in acute distress, denied pain or discomfort. 2/11 pt A&Ox3 with VSS on RA, still reporting no pain. 2/12 pt has a 5 out of 10 complaint of pain in his right arm, tylenol given per request. 2/14 pt a+o3-4 a bit confused about situation and complained of chronic back pain associated to arthritis. Pt discharged 2/14.
pt recv vax & w/in 2min site hard turned red & swollen & painful;no itching, no resp sxs, no other complaints;DPH given;sx dec w/in 40min;
Macular eruption in back that spread with itching and burning Ice pack controlled symptoms but rash was increasing in area so 10 mg prednisone prescribed as I am allergic to Benadryl and Claritin causing severe myalgia and arthralgia
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter asked if the chemical composition of the first dose of SHINGRIX identical to the second dose because his wife (patient) had a sore arm for 2 days after 1st shot, but got really sick after 2nd shot (for tolerance see case US2018GSK154791).
Develop milk allergy. My baby had diarrea up to 16 times a day. Before vaccinations she was never allergic to milk.Treatment: doctor switch her to Alimentum formula.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: pt also given icepack to apply to affected area of deltois or injection site
Pain, redness, swelling, arm fevered. Fluid collected around elbow. Swelling in the hands - not severe, meds - BENADRYL, TYLENOL, Prednisone (6 day regime) still have some dull tingling in fingers, left hand. Not present before injection. No N&V.
Pt got her first dose of Moderna covid vaccine on 3-3-21 at 3:45pm - was fine at pharmacy and waited 15 mins, then went to the next store and started to feel unwell, her bp was high after with high pulse, is now sick with sinus congestion, flu symptoms, and fatigue. She is now having incontinence issues after the vaccine as well, is on medication that was working just fine prior. Pt now has swelling, redness, and blood vessel flare ups in her left ankle that hasn't occurred in a long time. Feels like the vaccine has exasperated some of her medical conditions.
pink splotches that spread from left inner wrist to all over the body (arms, legs, chest, back, butt, feet, hands) over the course of 2-7 days after shot. 2 days post shot small red "bumps" appeared on inner left wrist (not raised skin, but looked like bumps). splotches continued to spread days 2-7, with a peak on day 5, before becoming darker & larger (almost like patchy skin) until they disappeared. Images available if helpful.
A few hours after we came home he was somewhat listless. He had a slight fever throughout the rest of the day and evening. His legs started shaking in the evening for about an hour within 5 to 10 minute increments.  He just was not himself at all.