chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in her ear; hearing loss; Information has been received from a lawyer regarding a case in litigation referring to a 66-year-old female patient (pt). Information about concurrent condition, medical history and concomitant medication was not reported. On 06-DEC-2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) in a pharmacy for prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), in December 2013, the pt was caused to suffer pain in her ear and hearing loss, including any and all of its sequelae.  As a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt was caused to suffer serious and dangerous side effects including pain in her ear and hearing loss, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications (also reported as a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages). In addition, the pt required and would continue to require healthcare and services. The pt had incurred and would continue to incur medical and related expenses. The pt also had suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The pt's direct medical losses and costs include physician care, monitoring, and treatment. The pt had incurred and would continue to incur mental and physical pain and suffering. The outcome of the events was not recovered.  Upon internal review, hearing loss was determined to be medically significant. The lawyer considered both events to be disability.
Fever; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 24Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, patient received the first dose of the Pfizer COVID Vaccine yesterday, 24March2021 (later confirmed). And it said you might have as a side effect have a fever on an unknown date. How high a fever should I be concerned about. The outcome of the event was reported as unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
After receiving the vaccines, I awoke on the morning of the 19th unable to walk. I seemed paralyzed from the waist down, except that I could feel everything -- the base of my spine was excruciatingly painful when I tried to roll out of bed. It took me 45 minutes to fall out of bed and push myself (using my arms) to the phone. An ambulance took me to Medical Center. An ER diagnosis was lumbosacral strain (a muscle injury due to inflammation, tearing or bruising within the muscle) and spasms It looks like I was given Motrin, Robaxin and Percocet. Subsequent testing was performed the following year(s) and found lumbar neuritis, a herniated disc (L4-L5), degenerative disc disease and osteoarthritis. Here is further information on the vaccines:  Meningococcal A,C,Y,W-135 Diphtheria Conj  VIS Version(s): 1/28/08 Tdap  VIS Version(s): 07/12/06    My symptoms were similar to Guillan-Barre Syndrome. I couldn't drive for a long time, and it was difficult to walk. I didn't report this sooner because medical providers said my symptoms weren't related to the vaccines. And I only heard of VAERS/Guillan-Barre during the Covid pandemic. Since I finally found the lot numbers, I'm reporting a potential adverse event... in case it's of significance.
Infection; Took only one capsule of Vivotif and doctors made the patient stop the vaccine; Took only one capsule of Vivotif and doctors made the patient stop the vaccine; A spontaneous report was received from a patient of unknown age and gender on 07NOV2023 who "took only one capsule of Vivotif and doctors made the patient stop the vaccine" (PT: Incomplete course of vaccination and PT: Therapy cessation) for an "infection" (PT: Infection). The patient took Vivotif (typhoid vaccine live oral Ty21A; lot number: 3003851) for an immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient started the Vivotif vaccine protocol and took only the first dose and then had an infection. Reportedly, the treating physician made the patient stop the medication.  The outcome for the event "took only one capsule of Vivotif and doctors made the patient stop the vaccine" was not applicable and for event "infection" it was unknown.  The action taken with Vivotif with respect to the event "infection" was withdrawn and it was not applicable for event "took only one capsule of Vivotif and doctors made the patient stop the vaccine".  No additional information was reported.  Company comment: This case concerns a patient of unknown age and gender who took only one capsule of Vivotif and doctors made the patient stop the vaccine (incomplete course of vaccination and therapy cessation) for an infection (infection NOS). This case lacks information on the event of infection, start date, and relevant medical history of the patient. Hence, the causality for the event of infection NOS is not assessable until further information is received.  The causality for the events of incomplete course of vaccination and therapy cessation is assessed as not applicable considering the nature of the events.; Sender's Comments: This case concerns a patient of unknown age and gender who took only one capsule of Vivotif and doctors made the patient stop the vaccine (incomplete course of vaccination and therapy cessation) for an infection (infection NOS). This case lacks information on the event of infection, start date, and relevant medical history of the patient. Hence, the causality for the event of infection NOS is not assessable until further information is received.  The causality for the events of incomplete course of vaccination and therapy cessation is assessed as not applicable considering the nature of the events.
PT STATES THAT LATER ON THE SAME DAY SHE WAS HAVING THROBBING PAIN AND LOSS OF FULL ROM IN HER RIGHT ARM.  IBUPROFEN AND ICE WERE NOT EFFECTIVE.  SHE STATES THAT IT FELT BETTER WHEN PLACED IN A SLING.
pt had pneumonia vaccine @4PM & last evening devel RUE warm, itch & swelling @ site of inj; pt was seen 19OCT95 1115 & prescirbed Atarax;pt was seen 19OCT95 1115 & prescribed Atarix
Chills, aches, muscle pain, difficulty breathing, sleeping 24 hours, exhaustion.
Rash on abdomen, face, back, arms and legs. Macular and papular erythematous rash-10 days after vaccine-resolving in about 2 days.
This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever), CHILLS (chill) and MYALGIA (body ache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced PYREXIA (fever), CHILLS (chill) and MYALGIA (body ache). At the time of the report, PYREXIA (fever), CHILLS (chill) and MYALGIA (body ache) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided.
Chills beginning that evening - woke up about 1:45 a.m. and off and on a few more times with chills Chills weren't as bad the day after the vaccine (4/15), but then had very slight headache, general soreness of muscles, joint pain in left elbow, fever ranging up to 100.9 degree F, and extreme fatigue.  Got hot and sweaty around 1 p.m. (n 4/15) - fever had broke and began feeling better from then on, just tired recovery-wise Back to normal 4/16
4 year old patient was given expired quadracel with no reported adverse event; Initial information received on 09-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 4 years old female patient who was given expired quadracel (DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.)with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine for Immunisation.  On 02-Dec-2022, the patient received an unknown dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.(formulation, strength:unknown) lot C5778BA , expiration date: 07-Oct-2022, via intramuscular route in the left deltoid for Immunization.  On 02-Dec-2022 the 4 year old patient was given expired quadracel with no reported adverse event (expired product administered) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (4 year old patient was given expired quadracel with no reported adverse event).  At time of reporting, the outcome was Unknown for the event
A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning a 12-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. On 09-Feb-2012, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. The patient did not develop any late occurring adverse events.
This spontaneous report as received from a pharmacist refers to an approximately 20 year old female patient with no pertinent medical history and not known drug allergies. In approximately 2013, reported as "around one year ago", the patient was vaccinated with first dose of GARDASIL (dose and lot number not reported). Two months later in 2013, the patient did not get the second dose of GARDASIL because she was sick (unspecified type of sickness). The pharmacist stated the patient now (on 08-APR-2014) wanted to receive the second dose of GARDASIL. The patient's outcome was not reported. Relatedness between sickness and GARDASIL was not reported. Additional information is not expected.
Chronic pink eye, blurred vision, vision loss, sore throat, earache,  sinus pressure, trouble breathing with chest pain, nasal issues, fatigue, muscle/joint pain
vaccine was administered and the patient had some bleeding, then a small lump form where the vaccine was administered. Bleeding stopped and patient said dr was monitoring his platelets since his bloodwork 6 months ago. Referred patient to PCP and recommended new bloodwork
Pt had rash & t104 & was treated @ hosp w/DPH & APAP suppositories; Pt was going to be admitted but rash went away;
Bilateral papular rash on hands and feet; This spontaneous case was reported by a physician and describes the occurrence of RASH PAPULAR (Bilateral papular rash on hands and feet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 RASH PAPULAR (Bilateral papular rash on hands and feet). At the time of the report, RASH PAPULAR (Bilateral papular rash on hands and feet) 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.   No relevant concomitant medications were reported  No treatment information was provided.
Hospitalized with a diagnosis of covid; A spontaneous report was received from a healthcare professional concerning a female patient of an unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and was hospitalized with a diagnosis of Covid-19.  The patient's medical history and concomitant product use was not provided by the reporter.  On 12-Feb-2021, the patient received their first of two planned doses of mRNA-1273  (Batch Number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, post the first dose of vaccination, she was hospitalized with a diagnosis of Covid-19. The patient was treated with monoclonal antibodies and her last treatment were on 01-Mar-2021. The physician understood that it is recommended to wait 90 days before vaccination and wanted to clarify that information before giving the second dose.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of event hospitalized with a diagnosis of Covid-19 was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Dizziness and chills body aches for first 2 days and dizziness hasn?t gone away-Vertigo with ear fullness and aches.
Rash at injection site, diminished for a few days,  then came back and spread all over my body.  Diagnosed as hives.  Have symptoms now for 6 months.  Not responding to treatment.  No allergies
Patient was achy and febrile (as is typical) but also did require advancement in diuretic dose for a few days after the booster due to worsening CHF and lower O2 sats.
Donor's L deltoid red with itching following injection. Also, 3cm bruise at injection site. Symptoms occurred after donor left facility.
Pt was found dead in her crib on the morning of 19OCT2004 Follow up: congestion of the lungs, liver and brain. Pending investigation and toxicology examination. Follow up: Coroner states that father of baby mentioned the bay was slightly more fidgety than usual the evening before this death.  - Review of well-baby progress note on 11/8/04 indicates baby was apparently healthy at time of immunizations. No additional symptoms.  - - 03/23/2005 autopsy report rec'd.  COD was SIDS.
This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for a patient (reporter's wife). A female patient of an unspecified age received bnt162b2 (BNT162B2, Batch/Lot Number: EW0185), dose 1 via an unspecified route of administration, administered in Arm Left on Jun2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was admitted in the hospital for 3 days after she got her first dose shot, 5 days later. Her left arm first got swelled up and got puffy, 4 days after that her elbow to wrist turned black and blue in side of her wrist. Later her whole left arm is swollen and bruised. Reporter stated that her left forearm is painful and the site she got the vaccine is her left arm. Outcome for event condition aggravated was reported as not recovered however for other all events it was reported as unknown. No follow-up attempts are possible. No further information is expected.
Pruritic rash on trunk, chest x 2 weeks and persisting.  Began the same day as vaccination.
Initially I had normal side effects of pain, swelling, redness at the injection site for three days from 12/31/2020-1/2/2021. The symptoms resolved. Then I experienced itching at the injection site late 1/6/2021 after reporting V-safe. On 1/7/2021 I woke up with itching, redness, swelling. As the day  progressed the injection site was red, indurated (6 cm x 4 cm), painful, itchy. I contacted my doctor's office and received antibiotics for cellulitis.
Suspected vaccination failure; Shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   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 details were provided as follows: The age at vaccination was not reported. The patient developed shingles after having gotten vaccinated with Shingrix. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.    The reporter did not agree to follow up with GlaxoSmithKline. This case is one of 3 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR233841:Same reporter US-GLAXOSMITHKLINE-US2021AMR233842:Same reporter
About 4 minutes after vaccination, patient began complaining of throat tightening and trouble talking. I called 911 and described symptoms and asked if I should administer generic Epipen - advised to administer so I administered. EMS came and took patient to ER.
starting on 8/3/21 she had numbness and tingling of her L arm and hand.  It made her feel she had to shake her hand at times. Finally resolved on 8/23/21
I was tested for COVID-19, RSV, and Flu and I ended up testing positive for RSV. I had loss of appetite, fever, cough, congestion, and body aches. My doctor told me that it should be gone in 5 days, but I still have a bad cough. It gets really bad when I lay down. I was prescribed benzonatate, 600mg ibuprofen, and a steroid injection while I was at the hospital.
DTP-Entire arm (shoulder to wrist) became swollen, red and warm to touch.
Pt received vaccine, then within 1-2 minutes began having an apparent seizure .  The symptoms were mild & pt recovered in less than 30 seconds.  He was pale & clammy, but not other significant symptoms.  After drinking water, cold compress applied to back of neck & a lollipop, the patient was back to his usual self. Pt reported he had not eaten prior to vaccine, and he had experienced similar symptoms when giving blood.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain has been steady and consistent for the last four (4) months), INCORRECT DOSE ADMINISTERED (woman administering my second dose just jabbed the needle in one hand), PAIN IN EXTREMITY (severe pain in the left arm), VACCINATION SITE PAIN (Her arm is still sore  at the injection site) and CHILLS (The patient experienced chills the day of the vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036A1A) for COVID-19 vaccination. The patient's past medical history included Stent placement. Concurrent medical conditions included Thyroid disorder and Cardiac dysfunction (Long Q-t syndrome). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), FAMOTIDINE for Acid reflux (oesophageal), METOPROLOL and LISINOPRIL for Cardiac dysfunction, ATORVASTATIN for Cholesterol. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain has been steady and consistent for the last four (4) months), INCORRECT DOSE ADMINISTERED (woman administering my second dose just jabbed the needle in one hand), PAIN IN EXTREMITY (severe pain in the left arm), VACCINATION SITE PAIN (Her arm is still sore  at the injection site) and CHILLS (The patient experienced chills the day of the vaccine). On 01-Apr-2021, CHILLS (The patient experienced chills the day of the vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (pain has been steady and consistent for the last four (4) months), PAIN IN EXTREMITY (severe pain in the left arm) and VACCINATION SITE PAIN (Her arm is still sore  at the injection site) had not resolved and INCORRECT DOSE ADMINISTERED (woman administering my second dose just jabbed the needle in one hand) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment included a steroid, not otherwise specified. This case was linked to US-MODERNATX, INC.-MOD-2021-114379 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant FU- Event outcome, concomitant, Medical condition updated; Sender's Comments: US-MODERNATX, INC.-MOD-2021-114379:MOD21-088160.
Approximately 2 hours post injection, hives appeared on the left wrist of patient and remained for approximately 30 minutes.
Half an hour after vaccination at 16:30, R lip numbness (resolved) started. Led to inability to hold water in mouth, requiring a straw to drink water, and L eye numbness (resolved) by 22:00. She arrived in ED at midnight and developed R side neck and occiput tingling (resolved during admission), blurry vision (first L eye then both eyes, persisted past discharge), and impaired balance/dizziness (improved but persisted past discharge). The patient was admitted to neurology floor and presented with a R peripheral CNVII palsy (R forehead weakness, R lagophthalmos, smile does not extend to R, persisted past discharge), R face paresthesia (persisted past discharge), and tongue deviation to L (persisted past discharge).
Nausea, chest pain, tightness in throat 178/55  50mg Benadryl given IM. Pt stated improvement . Transported to  ER
Pt w fever to 103 and pruritic, urticarial rash to arms, flank & cheeks. Pt with rhinorrhea the next day. At eval resolution of rash, erythematous TM, but without effusion. No abx prescribed, but had CBC resulted from 8/18/15 with a WBC: 18, Rx for Omnicef given, but will not initiate unless child with persistent fevers, otalgia or protracted emesis.
Patient received what was her 2nd dose of Moderna and 5th Covid-19 vaccine altogether. Left and by next day experienced swelling and erythema with extreme enlarging of lymph node above elbow on inner part of left arm where vaccine was administered in deltoid earlier. Patient presented to Urgent Care clinic locally on 10/14/23 and received prednisone 50mg for swelling and inflammation. Stated prescriber advised it was the beginning of cellulitis, but did not give antibiotics at that time. Patient to follow up if no better after using steroid or if symptoms worsen. Redness wrapped around circumference of upper left arm accompanied by some general swelling with more extreme swelling of approximate 1.5"x3" area above inner/outer left elbow - presumed to be lymph node.