chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received via search of the literature on 16 April 2013. This case contains information for 1 of 22 patients whose clinical data were provided. Information regarding the other 21 patients is captured in case numbers 1995-00224, 2003-02926, 2006-03086, 2006-03230, 2011-03827, 2013-02288, 2013-05188, 2013-05251-05259 and 2013-05261-05263 and 2013-05268-05269. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 inactivated influenza vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. This case involved a 76-year-old female patient who had received Trivalent inactivated influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and 35 days later reported the onset of GBS. No further information was provided. Outcome was not reported. Documents held by sender: None.
Severe chills fever at 3 am April 9. Responded to Tylenol. Fever and bodily aches and fatigue prevented normal daily activity.  Metallic taste in mouth 9pm April 9 continuing April 10.
neurological symptoms,bilateral upper extremity neuropathy; numbness; tingling; trouble with her gait  patient stated to have fallen 3 or 4 times, unsteady; muscle weakness in lower and upper extremities; coordination is quite off; feels her arms weight a ton; unable to lift arms; This spontaneous case was reported by a nurse and describes the occurrence of NEUROPATHY PERIPHERAL (neurological symptoms,bilateral upper extremity neuropathy) in a 67-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 Hypothyroidism, Breast cancer (survivor) and Vitamin D deficiency. Concurrent medical conditions included Coronary artery disease, COPD, Hypertension and Diabetes. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D NOS, CEFIXIME (FLEXERIL [CEFIXIME]), ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]), LEVOTHYROXINE SODIUM (SYNTHROID), METFORMIN, MONTELUKAST SODIUM (SINGULAIR) and PRAMIPEXOLE for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (neurological symptoms,bilateral upper extremity neuropathy) (seriousness criterion medically significant), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling), GAIT DISTURBANCE (trouble with her gait  patient stated to have fallen 3 or 4 times, unsteady), MUSCULAR WEAKNESS (muscle weakness in lower and upper extremities), COORDINATION ABNORMAL (coordination is quite off), LIMB DISCOMFORT (feels her arms weight a ton) and MOBILITY DECREASED (unable to lift arms). At the time of the report, NEUROPATHY PERIPHERAL (neurological symptoms,bilateral upper extremity neuropathy), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling), GAIT DISTURBANCE (trouble with her gait  patient stated to have fallen 3 or 4 times, unsteady), MUSCULAR WEAKNESS (muscle weakness in lower and upper extremities), COORDINATION ABNORMAL (coordination is quite off), LIMB DISCOMFORT (feels her arms weight a ton) and MOBILITY DECREASED (unable to lift arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Inhalers, Cholesterol lowering med and Blood pressure medication were taken by the patient as concomitant medications.  No treatment information was reported.  Company comment: Very limited information regarding this event has been provided at this time. Details from the neurology examination, date of vaccination, and date or onset of events are required for further assessment.; Sender's Comments: Very limited information regarding this event has been provided at this time. Details from the neurology examination, date of vaccination, and date or onset of events are required for further assessment.
SWEATING; REDNESS AT SITE OF  INJECTION; HEADACHE; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and  expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced sweating. On MAR-2021, the subject experienced redness at site of injection. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the redness at site of injection, fever, headache and sweating was not reported. This report was non-serious.
Dizziness, sweating for 60 min., 3.5 cm erythema at site of injection painful to touch.
develop shingles after completing two dose of Shingrix/Suspected vaccination failure; shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and 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 and Shingrix.  Additional details were reported as follows: The patient was in her 70's. The age at vaccination was not reported. The patient developed shingles after completing two doses of Shingrix. This case was considered as suspected vaccination failure as details regarding the time to onset for target disease and laboratory test confirming shingles were unknown at the time of reporting.
pt recv vax 9JUN95 & 12MAY97 pt devel chickenpox;
approx 23AUG96 pt broke out in a rash which began on face & upper trunk & progressed over a few days time to cover entire body;25AUG96 mom took pt to MD who told her pt had german measles;no lab work done;2SEP96 pt to ER t105.8 R;
near immediate lump at injection site.  minimal bleeding when withdrawing needed.  lump measured at injection site 18 mm x 13 mm.  no active bleeding, no erythema or bruising.  Spoke to patient for 8 minutes during which time no additional signs or symptoms were noted. Discussed next steps.  Will call to check on status in 4-5 hours and again in 20-24 hours.  Advised to contact our clinic or PCP with any additional questions or concerns.   Has appt with PCP 6/3/21 for annual PE.  Advised to monitor site periodically.
eyelid red and whelps rt eye, Then, under breast and on, side of face, ear, neck, shoulder, chin, under and on,  nose - tip of & under & hands  very itchy & red mostly on right side
positive for covid but has no symptoms; positive for covid but has no symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 71-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (not ongoing), notes: He had covid in the past before getting the vaccine and had headache and diarrhea.; "headache" (not ongoing), notes: He had covid in the past before getting the vaccine and had headache and diarrhea.; "diarrhea" (not ongoing), notes: He had covid in the past before getting the vaccine and had headache and diarrhea. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant), outcome "unknown" and all described as "positive for covid but has no symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: He has tested positive for covid but has no symptoms; Positive, notes: He stayed home for 7 days and is still testing positive. Clinical information: Caller states her 71 year old husband had 4 Pfizer covid vaccine doses(the 2 doses and 2 boosters) and had no reaction to the vaccine. He has tested positive for covid but has no symptoms. He stayed home for 7 days and is still testing positive. He doesn't want to infect anyone so is wondering how long does he have to quarantine and does he have to keep testing. He had covid in the past before getting the vaccine and had headache and diarrhea. A friend's daughter tested positive. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Shingrix was accidentally giving sub-q instead of IM and pt has Redness irritation on injection site.
Red rash left thigh and swelling left thigh down to left knee (Red, warm, confluent rash - swelling, slight pain
pt recv vax;31oct95 devel fever of 106 & exp sz lasting over 1 hr;adm to hosp;exp "oth sz & coma intermittently";this resulted in "3/4 brain damage per grandma;devel encephalopathy & hydrocephalus per MD;
arm was sore; redness which circles all the way around her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore) and VACCINATION SITE ERYTHEMA (redness which circles all the way around her arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was sore) and VACCINATION SITE ERYTHEMA (redness which circles all the way around her arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (arm was sore) and VACCINATION SITE ERYTHEMA (redness which circles all the way around her arm) outcome was unknown.            No concomitant medications were reported.  No treatment related information was reported.
localized tenderness @ site, generalized systomic-flu-like sx-joint pain, ache all over, fever;
p/vax mom reported pt starting wetting bed @ noc;pt started losing weight, total of 12lbs w/in 3wk period;pt had an inc in thirst & look dehydrated;pt hosp x 1wk & dx w/juvenile diabetes;mom felt could be r/t vax MD felt not r/t vax;
TDaP- 0.5 ml Boostrix dose was given to 9 year old male in 2017; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 9-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix .5 ml. On an unknown date, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The patient received Boostrix vaccine at 9 year's old age in 2017 year, with no side effects or adverse events seen but below recommended age indication, which led to inappropriate age at vaccine administration. The office manager asked if patient should receive another TDaP for 7th grade school requirement. The patient was 12 years old at the time of reporting, but had only been less than 4 years since last TDaP and was given to him. The reporter consented to follow-up.
Uterine Shredding- Extremely, extremely heavy menstrual bleeding that occurred outside of my normal menstrual cycle which are very regular.  This was the first booster shot.  This heavy bleeding also occurred with my 2nd dose in April of 2021 but I did not report it because I was not completely sure if was from the vaccine.  Now that the heavy bleeding occurred again with the booster I KNOW it was related to the COVID vaccine.  I heard others also experienced the same heavy periods once I expressed my experience with some of my female co-workers.
Left arm muscle soreness (ongoing) Full body chills alternating with sweating/overheating - flu-like symptoms
Patient experiencing pain from immunization, no redness/inflammation reported. PCP does not note any damage in the ligament/does not suspect frozen shoulder. Patient states they increased exercise intensity after receiving immunization with hopes of helping soreness with no success. Pain is felt after strenuous exercise located in the lower arm by the bicep.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 29-JUN-2015, the patient was vaccinated with an improperly stored dose of VAQTA 10 Pk 25U/0.5 ml SD Llok w Cap Ped, which had the lot # L001445, with expiration date 15-FEB-2016 (dose, dosage number and route of administration were not reported). No adverse effects were reported and no product quality complaint was involved. On an unspecified date the vaccine experienced a temperature excursions of 64 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius degree). The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator (R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Left arm swelled to 1 and 1/2 times normal size. Our pharmacy was closed so he went to an open pharmacy and was advised to take Ibuprofen and diphenhydramine and ice the arm. He didn't call us to report event until 10/7/13 at 5:16PM, by then swelling was down but not completely and he still had pain. Pain was also on Rt side and lower rib cage. Phoned pt again for PCP info. He finally returned call 10/10/13 at 5:35P. His arm is no longer swollen and all pain has resolved.
Lightheaded, slurred speech, difficulty forming or saying words, headache, chest pain, shortness of breath, fatigue, couldn't remember how to do things at work that I do everyday, abdominal pain, chills and fever.
A nurse reported the occurrence of possible Lyme disease in a 40-year-old male who was vaccinated with Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. Additional information was received from the subject. The subject's medical history included anaphylaxis following bee stings, "mild" allergic rhinitis, asthma, and allergy to amoxicillin. Concurrent medications included triamcinolone inhaler (Azmacort), another unspecified inhaler, albuterol, epinephrine (EpiPen), a multivitamin, and calcium. The subject received his first two injections of LYMErix on 09 June 1999 and 08 July 1999, respectively. He reported "feeling slightly lightheaded" following the second injection. The lightheadedness resolved after an unspecified period of time. The subject received his third injection of LYMErix on 28 April 200. At an unspecified time post-immunization the subject began to experience joint pain and neck pain. Lyme IgG and IgM Western blots were positive on 15 April 2003, and a diagnosis of possible Lyme disease was made. The nurse practitioner prescribed cefuroxime (Ceftin). On day nine of the treatment course, the subject "broke out in severe hives". As of 21 May 2003, the subject was "becoming progressively worse." On 12 June 2003, the subject reported that he developed achy knees and shoulders, "severe" headaches, dizziness, and a food allergy after the third injection of LYMErix. he reported that all these events persisted as of 12 June 2003, and were "worse". The subject stated that the symptoms were "resistant to antibiotic therapy".
got deathly ill due to flu so bad; Initial information was received on 14-Oct-2020 and additional information on 23-Oct-2020 regarding an unsolicited valid non-serious social media case from the patient.   This case involves an unknown demographic patient who got deathly ill due to flu so bad (influenza), while the patient received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date (10 or more years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient got deathly ill due to flu so bad (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  After this the patient did not received flu vaccine and no flu experienced since then.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.
Dysautonomia, fatigue, inability to recover from strenuous activity, accelerated heart beat, fainting , automatic functions disorder
Pain, redness, swelling and numbness limb of injection.  MD dx = local reaction.  Tx = Motrin x 2 wks.  F/u  t/c on 3-31-2011.  Client states sx slowly resolving.
Redness/itchiness presented around day 4 after the shot. By day 8 the redness and itchy area had spread to 4? by 4?. Applied Benadryl cream.. Still waiting for it to subside.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 19-AUG-2014 the patient was vaccinated with an improperly stored (Oka/Merck) VARIVAX (lot # J009728, expiration date: 07-AUG-2015, dose , units, route of administration, anatomical location were not reported). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Pt sts feeling flush post receiving vaccinations.  Pt vital signs were within normal limits.  Pt refused treatement or tx.
No additional adverse experiences reported; Pharmacist calling to report administration of an expired MMR II dose; This spontaneous report was received from a pharmacist referring to a 46-year-old female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 18-OCT-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) single dose, lot number S031482, expiration date 07-OCT-2021 (exact dose and route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored PROQUAD (lot # M007965, therapy type rHA, expiration date 15-AUG-2017, and lot # L031603, therapy type rHA, expiration date 18-FEB-2018, strength, dose, frequency and route were not reported). The vaccine has been stored under temperature of -10.6 degree for 30 hours. Data logger had been involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
After I received my second dose on 3/26, my baby quit growing two days later at 8 weeks. One week later and her heartbeat became irregular and she had not grown from the 8 week mark. Within two days, her heart stopped beating. I had to have a d&c under anesthesia which has cost us a minimum of $1,200. Still waiting on the final bill.
Local erythema, tenderness to palpation over (R) deltoid at injection site with minor extension to neck and chest. NSAIDs rx'ed . Patient to follow up in 1-2 days.
Per mother of patient on 1/6/22 24hr after immunization patient began having painful swollen eyes. 1/7/22 eyes continued to be swollen and patient continued to have additional symptoms through 1/9/22 including headache, stomachache, lip swelling and sore throat and difficultly swallowing. On 1/10/22 patient had video appointment with urgent care and they advised them to take Benadryl. Symptoms improved and were resolved by 1/12/22.
Fully vaccinated with J&J, not boosted.   Symptomatic COVID infection with inpatient admit to ICU.
Swelling to the upper lip; This is a spontaneous report from a contactable nurse. A 28-year-old female patient received BNT162B2 (Pfizer COVID 19 vaccine), lot no. EL0142 with expiry date Mar2021, via an unspecified route of administration (left arm) on 03Feb2021 at a single dose for COVID-19 immunization. The patient had no relevant medical history and no concomitant medications. The patient got the COVID vaccine today (03Feb2021). She had an adverse reaction. She didn't have it within 15 minutes. She had it several couple of hours later. She had swelling to the upper lip on 03Feb2021. She took a Tylenol and Benadryl. The outcome of the event was unknown.
Upper arm soreness in left arm as expected with flu vaccine began shortly after injection, but did not subside. Pain/soreness continued without lessening for over one year. In January 2016, pain rapidly got much worse and spread to shoulder, resulting in inability to do much of anything with that arm followed by increasingly limited range of motion. Upon return home from trip, visited doctor in March 2016.  Doctor prescribed physical therapy.  Physical therapist identified pain as caused by combination of adhesive capsulitis combined with bursitis, which he noted he had not seen present similarly in 35 years of practice, and believed fit the profile of a flu vaccine injection injury. After 25 days of therapy and recommended daily exercises pain was still significant; health provider did steroid injection (triamcinolone acetonide 40mg) in bursa; pain was reduced significantly after a few days. Therapy course concluded, though some pain and limitations in range of motion remains as of June 13, 2016.