chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching on my back; keeping me awake at night; This case was reported by a consumer and described the occurrence of pruritus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2020, the patient received Shingrix. On an unknown date, several weeks after receiving Shingrix, the patient experienced pruritus and wakefulness. The patient was treated with dermatologicals nos (Anti-Itch Lotions) and dermatologicals nos (Anti-Itch Cream (Medication Unknown)). On an unknown date, the outcome of the pruritus and wakefulness were not recovered/not resolved.   It was unknown if the reporter considered the pruritus and wakefulness to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. A few weeks later, the patient experience itching on back and was suffered from this itching, 24 hours a day. It was kept awake at night.  The patient apply some anti itch lotions and creams to it for relief, but only to have it wake up a few hours later to repeat. The patient had to also apply things to it all day to seek relief. The patient consulted with doctors as to the itching, and so far all they had been able to provide was information about ways to reduce the discomfort, but there had been no conclusions as to the cause. The reporter stated that, it was important to find the cause of this and even more important to find a solution to this constant itching. The reporter consented to follow up.
Information has been received from a 24 year old female patient with a history of papilloma viral infection (HPV) who was vaccinated with the first dose of GARDASIL (lot number not reported) in December 2010, and the second dose in March 2011. Concomitant therapy included "birth control". In March 2011, since she received her second dose GARDASIL, the patient had experienced hair thinning. The patient stated that she had always had very sick hair, and her hair dresser noticed recently that her hair was substantially thinner than it used to be. She said it was not "coming out in clumps", but she dried her hair in half the time she used to and when she touched it she could tell that it was much thinner than it used to be. The patient reported that she "devastated". She called her gynecologist and cancelled her third dose of GARDASIL. Her primary care physician ordered blood work which she had drawn on 20-APR-2011 and she would await the results before contacting an endocrinologist. Diagnostic laboratory tests "thyroid and cholesterol and other tests" performed, no results provided. The patient reported no other medical conditions and she took only "birth control". The patient's hair thinning persisted. Additional information has been requested.
Shortly after the administering the vaccine the person tensed up and became unresponsive. He appeared to be having a seizure. I was able to get the patient to the floor and he became responsive.  He said he "was ok".  We had contacted EMS.  We had the patient lie flat until the EMT's arrived.  He was very sweaty and tired but he insisted he was fine.  He refused to go to the ER and he was able to get a ride home.
Just after client received MPOX vaccine, client c/o dizziness and passed out for about 30 seconds. Emergency protocol activated, patient woke up diaphoretic, vital signs obtained, ice pack placed, elevated patient's leg, water given, patient AOX3. Patient stated to feeling much better. Patient to be observed for 30 mins more, patient called the partner. Symptoms resolved fully, patient ambulated with steady gait to observation area.
Patient complained of feeling "sick as a dog" with symptoms of headache, runny nose, worsening of asthma symptoms, cough, mucus in chest, feeling dizzy.
Pt recvd vax on 31MAR & the next day about 20 hrs later devel large hives all over body especially on trunk & lt arm; t101.6 ax; pt recvd pepto bismol;
Vaccine was given at pharmacy, not at clinic. General achiness, shivers, possible fever, stomach upset, nauseated.
COVID -9 Treatment; COVID -19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "COVID -9 Treatment"; COVID-19 (medically significant), outcome "not recovered", described as "COVID -19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1 1/2 weeks post MMR vaccine, rash appears on trunk and back.  Immunization clinic referred patient to responsible physician.  No treatment required.  Diagnosis: post MMR vaccine rash.
herpes zoster; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 24-MAR-2017, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and/or zoster-related conditions.   On an unspecified date, subsequent to patient's dose zoster vaccine live (ZOSTAVAX) inoculation, the patient presented shingles. As a direct and proximate result, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Chest pain, anxiety, difficulty breathing. This all started roughly a month after my second dose of the Pfizer vaccine in 2021. Symptoms persisted on and off for roughly a year. I got a booster dose on 12/28/21 and symptoms continued. I did not think about the connection at the time but I have not had any additional booster shots since 12/28/21 and in the last 6 months my symptoms have gone away. I have never had any chest pain before in my life and it started during the period of time when I was being vaccinated.
G62.9 PERIPHERAL NEUROPATHY 6/27/2022 GAIT ABNORMALITY I82.441 ACUTE DVT OF RIGHT TIBIAL VEIN 8/28/2022 GAIT ABNORMALITY G62.9 PERIPHERAL NEUROPATHY 6/27/2022 HYPOXIA I82.441 ACUTE DVT OF RIGHT TIBIAL VEIN 8/28/2022 HYPOXIA G62.9 PERIPHERAL NEUROPATHY 6/27/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I82.441 ACUTE DVT OF RIGHT TIBIAL VEIN 8/28/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED G62.9 PERIPHERAL NEUROPATHY 6/27/2022 C DIFFICILE COLITIS, RECURRENT I82.441 ACUTE DVT OF RIGHT TIBIAL VEIN 8/28/2022 C DIFFICILE COLITIS, RECURRENT G62.9 PERIPHERAL NEUROPATHY 6/27/2022 WEAKNESS OF RIGHT LEG I82.441 ACUTE DVT OF RIGHT TIBIAL VEIN 8/28/2022 WEAKNESS OF RIGHT LEG G62.9 PERIPHERAL NEUROPATHY 6/27/2022 COMPLEX PARTIAL EPILEPSY I82.441 ACUTE DVT OF RIGHT TIBIAL VEIN 8/28/2022 COMPLEX PARTIAL EPILEPSY
Migraine headache beginning within 10 minutes of the injections, recurring for over a week. Visual changes worsening over time. Urgent Care visit on 10/14/2023 for migraine. Received Torodol. Right occipital infarct confirmed on MRI with hospitalization on 10/17/2023.  Persistent, but improving left temporal hemianopsia.
Information has been received from an office manager concerning a patient over 65 years of age, who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not specified). It was reported that the patient experienced adverse reactions on an unspecified date after receiving the PNEUMOVAX 23. The patient complained of redness and little bumps. The patient sought unspecified medical attention. It was given Y-cold compress as a treatment for the adverse event. It was unspecified if the any lab diagnostic studies were performed. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Pt. C/O feeling light-headed and nauseated while sitting at the observation hall. She vomited some undigested food particles after sipping some fruit juice offered  by her mother. Writer to her in a wheelchair to the cubicle in the observation hall for further observation. V/S T. 97 degrees fahr. b/p 97/68, rr 14, h rate 85, O2 98% RA. Pt was verbal, A&Ox4. No c/o pain or respiratory distress. At 3:10 p m pt. said she felt well and okay to leave. v/s - b/p 100/77, heart rate 80, O2 98% RA. She left the observation hall in the company of her mother unassisted
sneezing; headache; extreme runny nose; head cold symptoms; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 08Mar2021 17:15 (Batch/Lot number was not reported)(at age 62-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. There were no other vaccine within 4 weeks. The patient previously took aspirin and experienced drug hypersensitivity.  About 15-16 hours after the vaccination on 09Mar2021 09:00, patient began repeatedly sneezing and having head cold symptoms (extreme runny nose, headache). It felt like a peak day during allergy season. There were on treatment for the events. Outcome of the events was recovering. Patient was not diagnosed with covid prior to vaccination and had not been tested post-vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tenderness on injection site - felt like a pinch nerve, shoulder pain (Shoulder fatigue).
Head acheItchy bite marks on mid chest and under left armpit.  Severe pain on left side of torso.
Employee notified this nurse of suspected reaction at 6:58 pm by text. She reported scratchy throat, cough and tight feeling in her throat. She reports having a reaction 10 years ago to a flu shot but not since; she has had one every year. This nurse directed her to take benadryl and if symptoms persist or  worsen to go to ER. Symptoms improved upon administration of Benadryl but returned at 11:19 pm and she went to the ER. She was released at 2am.
Itchy, redness, hives, pain at injection site. Observed on 2/15/21, vaccine received on 2/5/21
I went for a year checkout, in October, the doctor sent me to the ER, in an ambulance; they kept me there for that evening. The Cardiologist gave instructions to transported me to another place. I was hospitalized for 4 days. I was diagnosed with atrial fibrillation; they gave me medicine. They gave me shot, that was in January. They schedule me to have in February a heart procedure,. My heart is functioning normally now, but I still being treated for a heart failure. I am taking a lot drugs.
Patient complains of pains in her lower back, shoulders, neck, and hands.  She describes the pain as being both  muscular and joint pains.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 67-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020) for prophylaxis. On 18th May 2018 10:30, the patient received SHINGRIX (intramuscular) .5 ml. In May 2018, less than a day after receiving SHINGRIX, the patient experienced fever, injection site pain, pain in arm and chills. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever, injection site pain and chills were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. The reporter considered the fever, injection site pain and chills to be probably related to SHINGRIX. The reporter considered the pain in arm to be unlikely related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. Within 24 hours, the patient developed fever, chills and soreness at the injection site. One week later, the patient reported that she had severe pain in the opposite arm she got the injection. The patient took ibuprofen and used a heating pad as treatment. On an unknown date, the patient's labs were drawn, however results were unknown.
Moderna Bivalent COVID vaccine use for COVID-19 under Emergency Use Authorization (EUA): Worsening Tinnitus after COVID vaccine - Moderna-Bivalent
Received vaccines on 12/18/08. Played basketball on 12/20/08 on the night of 12/20/08 noticed left arm swelling no pain/tenderness.
Rash, swelling and soreness on left arm one week after vaccine. 9 days after vaccine, severe migraine, nausea, back pain, fatigue.
Mild deep muscle pain with injection followed by full left arm pain and tenderness throughout night. Severe leg thigh cramping bilaterally at night.  Next day soreness but also upper shoulders and back muscle pain and burning. Transient joint pain, knees, fingers, elbows. Myalgias. Symptoms less today, two days after injection
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 11:07 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 11:07 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 70.12.  Concomitant product was not provided.  On 03-Nov-2021, excursion time was 10 AM, temperature was 35, total doses given for the day was 117, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 6 vials were sent to clinic. Vaccine BUD date was 05-Nov-2021.  Vial was stored on cooler 1, on 03-Nov-2021, Excursion duration At 8 AM: 36, 9 AM: 36, 10 AM: 36, 11 AM: 35, 12 AM: 36, 1PM: 37, 2 PM : 36, 3 PM: 36, 4 PM: 37 and 5 PM : 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medication was not reported.
Itchy; Felt as sword went in her shoulder blade; Injected arm was swollen; She had to call her husband to come and get her because she couldn't drive; Extreme heartburn; Throat felt like it was closing; Felt dizzy/felt like room was spinning; Thought she was dying so she got scared; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Extreme heartburn), OROPHARYNGEAL DISCOMFORT (Throat felt like it was closing), DIZZINESS (Felt dizzy/felt like room was spinning), FEELING ABNORMAL (Thought she was dying so she got scared) and PRURITUS (Itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 15-Apr-2021, the patient experienced DYSPEPSIA (Extreme heartburn), DIZZINESS (Felt dizzy/felt like room was spinning), FEELING ABNORMAL (Thought she was dying so she got scared) and HYPOKINESIA (She had to call her husband to come and get her because she couldn't drive). 15-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Throat felt like it was closing). On 16-Apr-2021, the patient experienced PRURITUS (Itchy), ARTHRALGIA (Felt as sword went in her shoulder blade) and INJECTION SITE SWELLING (Injected arm was swollen). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPEPSIA (Extreme heartburn), OROPHARYNGEAL DISCOMFORT (Throat felt like it was closing), DIZZINESS (Felt dizzy/felt like room was spinning), FEELING ABNORMAL (Thought she was dying so she got scared), HYPOKINESIA (She had to call her husband to come and get her because she couldn't drive) and ARTHRALGIA (Felt as sword went in her shoulder blade) outcome was unknown and PRURITUS (Itchy) and INJECTION SITE SWELLING (Injected arm was swollen) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included multiple sclerosis medicine, Blood Pressure medicine and bone medicine.
Chest tightness; Difficulty breathing; Voice is hoarse, voice changes; This case was reported by a consumer via call center representative and described the occurrence of chest tightness in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd February 2021, the patient received the 1st dose of Shingrix. On 2nd February 2020, less than a day after receiving Shingrix, the patient experienced chest tightness, difficulty breathing and voice alteration. On an unknown date, the outcome of the chest tightness was unknown and the outcome of the difficulty breathing and voice alteration were not recovered/not resolved.   It was unknown if the reporter considered the chest tightness, difficulty breathing and voice alteration to be related to Shingrix.  Additional details were provided as follows:  After receiving 1st dose of Shingrix, the patient experienced chest tightness, difficulty breathing, and his voice is hoarse, voice changes. The patient reported that he did not want to provide his health care provider's information. The reporter did not consent to follow up.
HCP reports that improperly stored vaccines were administered. HCP did not have specific detail regarding the administration date. Case Consent to contact was provided. No Additional AEs. No PQCs.          ?    Names of vaccines involved (including; No additional AEs; This spontaneous report was received from Medical assistant and refers to a patient of unknown gender and age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 1 time dose, lot #W028561, expiration date: 06-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, HCP reported that improperly stored vaccines were administered (product storage error temperature too high). Vaccine was stored in 7.7 degree Fahrenheit for 8 hours and 54 minutes. Vaccine had previous temperature excursion (7.7 degree Fahrenheit for 2 hours and 18 minutes). HCP did not have specific detail regarding the administration date. Case Consent to contact was provided. No Additional AEs. No PQCs.
Injection site red, raised and warm to the touch. Appeared 8-10 days after immunization received. Given ATARAX to treat reaction.
PT RECEIVED  FLU SHOT 2:15PM 10/4.  PT EXPERIENCED LARGE  BRUISING OF THE INJECTED ARM OBSERVED THE  MORNING  OF 10/6.   BY 10/8, BRUISING APPEARED A LITTLE BETTER.   RPH ADVISED ON 10/6 TO FOLLOW UP WITH MD.  PT CALLED MD ON 10/8 WHO THEN RECOMMENDED TO MONITOR AND IF IT GETS WORSE, TO VISIT ER.
about an hour after receiving flu vaccine, I developed left leg, left arm numbness as well as my lips feeling numb.  I consulted the next day with my family physician who requested I continue to take my allergy medication as they felt this could be an allergic reaction and also file a vaers form.  the symptoms did subside within three days.
Rash occurred over neck area.  Red, splottchy, raised areas with pruitus.  Relieved some with 50mg of Benedryl.  +hoarseness, neg SOB, n/v, fever, seizures or LOC. Rash continues to be present on day 8 from vaccine although pruritis has eased up.
10cm circumference swelling and redness. Complaining of hot and itching. Hard nodule in the middle. Went to pediatrician after 48 hours of no improvement.
Negative antibody test after receiving both doses of Covid-19 Vaccine; This is a spontaneous report from a contactable consumer. This consumer reported same event for three patients. This is third of three reports. A 70-year-old male patient received the first and second doses of BNT162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, Lot Numbers: UNKNOWN); both doses via unspecified route of administration on unspecified dates as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient tested negative for antibodies after receiving both doses of the Covid-19 vaccine. The outcome of negative antibody test after receiving both doses of Covid-19 vaccine was unknown.   The lot number for the doses of vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s): same reporter/drug/AE, different patient.; same reporter/drug/AE, different patient.