chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacy technician refers to a 5 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 08-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Began with topical headache, 22 hrs post dose, quickly progressed to fatigue. Overnight stabbing pain migrating joint to joint, disorientation. Topical heAdache persists, now 17 days post . Intermittent nausea, anorexia, gi distress and diarrhrea persist 17days post. Mental fatigue and fog come and go randomly 17 days post.  Myalgia returned dramatically 17 days post. Sensory issues, specifically a Hightened and Distorted sense of smell and taste  intermittent  and worse when topical headache is most prominent.  Symptoms are debilitating at times , rendering inability to work as a healthcare provider.
Pt was treated 5/23/14 for possible cellulitis post ZOSTAVAX administration 5/20/14.
Allergic reaction; significant localized swelling; hot and hard to the touch consuming all of deltoid down to elbow; hot and hard to the touch consuming all of deltoid down to elbow; hot and hard to the touch consuming all of deltoid down to elbow; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: 30135BA) via an unspecified route of administration in left arm on 19Sep2021 (at the age of 35-year-old) at single dose for COVID-19 immunisation. Relevant medical history included asthma. The patient had no known allergies. Concomitant medications were not reported. On 20Sep2021 the patient experienced allergic reaction, significant localized swelling, hot and hard to the touch consuming all of deltoid down to elbow. The events were non-serious and treatment, if any, was unknown. It was reported that the patient had no COVID nor received COVID diagnosis prior to vaccination and was tested for COVID post vaccination through nasal swab on 17Sep2021 (as reported), resulting negative. The events were not resolved at the time of report.  Follow-up attempts are completed. No further information is expected.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Approximately 5 minutes after vaccine administration patient passed out in the waiting area of the pharmacy. She was unconscious for approximately 30 seconds to 1 minutes, regarding consciousness very quickly. Patient hit her head which resulted in minor bleeding. EMS was called immediately and arrived on site to evaluate the patient. Patient declined continuation of care and EMS left after full evaluating patient. The patient and her father remained at the pharmacy for approximately 15-20 mins after EMS left before going home.
Patient suffered two seizures, the first 18 days after vaccination, and the second 21 days after vaccination. She had no prior history of seizures or epilepsy. The two seizures were both short, approximately 1 minute to 1 minute 30 seconds in duration. They appeared to be tonic-clonic seizures. She was seen in the emergency room for both events. The second seizure changed her course of treatment, and is being currently treated with antiepileptic medication while waiting to follow up with neurology.
full body Urticarial rash starting on 4/7/21 ( at day 6)  post vaccination of Pfizer mRNA covid vaccine on 4/2/21. No other symptoms other hen itchy rash
Initially after the shot, my shoulder was tender and about 1 - 2 weeks after the shot, I started losing mobility and the shoulder was very painful. On Oct 31, I had an appointment with my primary care physician dr. She gave me a referral to a physical therapist in case my shoulder didn't get better. I started PT on Nov. 11 and continue with PT now for tendonitis.
Rash starting Friday and worsened, now on face and arms, is very itchy. apply aloe vera and helped. no new products. started Vyvanse. states fell and scratched left hand, washing well. prednisone 20 mg tablet (prednisone) 1 tablet by mouth twice a day, Decadron injection Dermatology Consult  urticaria, neoplasm of uncertain behavior Zyrtec 10mg tablet, Cimetadine 200mg Benadryl 25mg Continue oral steroid Failed multiple IM rounds of Celestone ER visit 2/18/23 Facial swelling throat tightness Rash Worsened Famotadine  IV Decadron IV Diphenhydramin IV Epinephrine HCI 0.3mg IM
Feels really weak, cannot grip anything; Feels really weak, cannot grip anything; Tightness in the arm; Fever; Loss of appetite; Loss of taste; taste just feels messed up or nothing tastes right; Skin feels like burning; This is a spontaneous report from a contactable consumer reported for a female patient (wife).  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EW0178, Expiry date was not reported), via an unspecified route of administration on 23May2021 as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: ER8735, Expiry date was not reported), via an unspecified route of administration on 02May2021 as dose 1, single for COVID-19 immunization. The patient received a first dose of our COVID-19 vaccine last 02May, and received the second dose last 23May, which was exactly 21 days apart, on an unspecified date in 2021, after the second dose his wife felt really weak, could not grip anything, had fever had loss of appetite and loss of taste and her skin felt like burning. They don't know what to do with the patient. Reporter stated, like tightness in the arm and then still today, she said her taste just felt messed up or nothing tastes right. Reporter stated, no, it says the date that you received it. There was no expiration date. Reporter stated, she was not taking any medication. Reporter stated, there was no medical condition or lab test. The patient did not received treatment for the events. The clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. The patient was treated with antivirals for systemic use. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient diagnosed with shingles by her physician and that the patient's physician had prescribed an antiviral therapy. The reporter had no further specific details. The reporter called to inquire if GlaxoSmithKline (GSK) had reports of patient's getting shingles following vaccination with SHINGRIX and hypothetically if a patient gets a rash that was not truly shingles and begins taking antiviral therapy how that would affect things. This caller was transferred to the GSK medical information team regarding her inquiries upon request. The reporter gave consent for contact for further related questions. The reporter declined to answer camel form questions during the call, commenting that her pharmacist partner had actually spoken with the patient and already completed a VAERS form.
little itching; rash located on left side between shoulder and neck around two weeks after/as mosquito bites localized on left side; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), PRURITUS (little itching) and RASH (rash located on left side between shoulder and neck around two weeks after/as mosquito bites localized on left side) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concomitant products included FLUTICASONE, AZELASTINE, SALBUTAMOL (ALBUTEROL HFA) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 22-Apr-2021, the patient experienced PRURITUS (little itching) and RASH (rash located on left side between shoulder and neck around two weeks after/as mosquito bites localized on left side). On 09-Apr-2021, PAIN IN EXTREMITY (arm soreness) outcome was unknown. At the time of the report, PRURITUS (little itching) and RASH (rash located on left side between shoulder and neck around two weeks after/as mosquito bites localized on left side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication information was provided.
In employees own words "Received a flu shot 10-8-10, when receiving flu shot felt a zing or electric type of sensation into my left shoulder and neck that is con resolved over the couple of weeks, had more pain and limited mobility esp. at week 2-3, saw MD and he thought it probably was from the injection must of hit a nerve or a tendon".
Patient came back to pharmacy about hands shaking and turning red. She ended up having a seizure in the store and hands were worse and turning purple. Emergency was called and patient was taken to ER
Patient received Moderna vaccine on 01/22/21 and 2/23/21. Found to be COVID positive on 12/30/21. Presented to ER on 12/30/21 and was admitted.  Presented to the ER with complaints of feeling weak and tired for the past few days. She has been having covid like symptoms since 12/25. She feels like she has been confused as well lately. Upon arrival to ER she was saturating in the 80s on room air. She was initiated on oxygen via NC which has since had to be turned up to 60% optiflow. Patient saturating well now. Initial ABG showed po2 of 46.9. Other labwork reveals she also has an aki. Patient admits to decreased appetite past few days. Patient has also had some mild vomiting and diarrhea. CXR shows pneumonia L >R consistent with covid. Dimer was normal after age adjustment. Receieved dexamethasone, ceftriaxone, azithromycin and remdesivir. 1/21/2022 - Oxygen was dropped to 3 LPM and she did walk with OT she did desaturate to 85% after ambulating approximately 50 ft and required approximately 2 minutes of PLB to return to 90%. Discharged on 1/22/22
I'm no longer symptomatic. Very recently, in the last 4 days, I had a COVID test that showed positive; Pneumonia; This is a spontaneous report from a contactable consumer (Patient) reported for self. This 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection, Lot: EN6203, Expiration date: unknown) via an unspecified route of administration in left arm on 24Mar2021 at 17:30 at single dose for Covid-19 immunization. Patient relevant medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021, (as reported) patient experienced lot of coughing, low energy, fever with sweating then would feel extremely cold, Loss of taste, Hot and intense chills and pneumonia on 02Apr2021. Patient underwent lab test to the hospital and got a CT scan. The patient received cough drops and cough suppressant medication for cough with outcome of recovered. Patient took the antibiotics (Advil) for a week or 5 days for Pneumonia till 09Apr2021 with outcome of recovered. Patient underwent lab test and procedure which included COVID test positive (symptomatic) on 02Apr2021.The outcome of event was recovered.  Follow-up (12Apr2021): This is a Follow-up spontaneous report from a Pfizer-sponsored program.
Left arm and quad soreness, nausea, headache, light headedness, light sensitivity, dizziness, body aches. No fever nor respiratory symptoms.
Pt adm'd exp'd vax.  Discussed with Merck who indicated vax if stored in fridge would maintain potency and pt did not require additional vax.
no adverse effects; administered a dose of improperly stored varivax; This spontaneous report was received from a medical assistant refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, allergies/drug reactions and concomitant medications were unknown.   On an unknown date in July 2019 (reported as within the last 2 weeks), the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, strength and route of administration were unknown) (lot # R019235 with Expiration date: 04-JUL-2020 or lot # S005084 with Expiration date: 19-FEB-2021) for prophylaxis which was reconstituted with properly stored sterile diluent(STERILE DILUENT) (Lot # N028746, Expiration date: 17-MAR-2020). It was reported that the varicella virus vaccine live (oka/merck)(VARIVAX) was stored at -14 degree celsius to -10 degree celsius (-14.17 celsius) for 30 minutes (product storage error). There was no previous temperature excursion. It was reported that digital data logger was involved. No adverse effects were reported.
This case was reported by a consumer via sales rep and described the occurrence of rheumatoid arthritis in a 17-year-old female patient who received BEXSERO. Concurrent medical conditions included acne and anxiety disorder. Concomitant products included CYMBALTA and Acne Medication. On an unknown date, the patient received the 1st dose of BEXSERO (intramuscular). On an unknown date, 14 days after receiving BEXSERO, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant and other: serious as per reporter), swollen joints, fatigue and eye swelling. On an unknown date, the outcome of the rheumatoid arthritis, swollen joints, fatigue and eye swelling were recovering/resolving. The reporter considered the rheumatoid arthritis, swollen joints, fatigue and eye swelling to be unrelated to BEXSERO. Additional details were provided as follows: The age at vaccination was not provided. The patient's mother reported to a field representative that her daughter experienced swollen knuckles, swollen eyes and fatigue starting at least 2 weeks after receiving BEXSERO. The patient had seen her pediatrician and she was tested for rheumatoid arthritis since there was a family history. it was also decided to discontinue her acne medication. The rheumatoid arthritis (RA) titer came back mild, but the patient would be seeing a rheumatologist. The patient was an equestrian and the mother was going to insist that she needs to be tested for Lyme disease. The reporter did not want any of her information to be shared.
RN experienced in COVID-19 vaccinations unable to remove final full 0.5mL dose from vial - about 0.1mL short
Began 8/5/2021 non-productive cough, nausea, vomiting, 8 lbs. weight loss in last 2 months, dyspnea, deconditioning, lower extremity weakness COVID Quad collected 8/9/2021 that was positive for COVID-19. She expired 8/17/2021
The pt developed a rash around right leg vaccine site and on cheeks approx. 15 minutes, post vax.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 17-NOV-2015 at time- 13:44, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 4.1 and 2.9 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
This literature marketed report has been received from the author of a published literature. BACKGROUND The effect of a third dose of the M-M-R II vaccine in stemming a mumps outbreak is unknown. During an outbreak among vaccinated students at the University, health officials implemented a widespread MMR vaccine campaign. The authors evaluated the effectiveness of a third dose for outbreak control and assessed for waning immunity. METHODS Of 20,496 university students who were enrolled during the 20152016 academic year, mumps was diagnosed in 259 students. The authors used Fisher's exact test to compare unadjusted attack rates according to dose status and years since receipt of the second M-M-R II vaccine dose. The authors used multivariable time-dependent Cox regression models to evaluate vaccine effectiveness, according to dose status (three vs. two doses and two vs. no doses) after adjustment for the number of years since the second dose. RESULTS Before the outbreak, 98.1% of the students had received at least two doses of M-M-R II vaccine. During the outbreak, 4783 received a third dose. The attack rate was lower among the students who had received three doses than among those who had received two doses (6.7 vs. 14.5 cases per 1000 population, P<0.001). Students had more than nine times the risk of mumps if they had received the second M-M-R II dose 13 years or more before the outbreak. At 28 days after vaccination, receipt of the third vaccine dose was associated with a 78.1% lower risk of mumps than receipt of a second dose (adjusted hazard ratio, 0.22; 95% confidence interval, 0.12 to 0.39). The vaccine effectiveness of two doses versus no doses was lower among students with more distant receipt of the second vaccine dose. This report concerned 2 patients of unknown age and gender. On unknown dates, the patients received the first dose of M-M-R II (dose, route, lot# and expiration date unknown) for prophylaxis. On unknown dates, the patients experienced mumps. The outcome of the events was unknown. The authors considered the events to be related to M-M-R II. This is one of the several reports that received from the same literature article. Sender's Comments: US-009507513-1709USA014639: US-009507513-1709USA014640.
Initial unsolicited report received from a nurse on 06-Jun-2018. This case involves a two-month-old patient (gender not reported) who was vaccinated with a dose of PENTACEL (batch number: C5370AA, expiry date: 04-Jun-2018, dose, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to expired vaccine used. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Arm pain; Temp 102; Tiredness; Headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PYREXIA (Temp 102), FATIGUE (Tiredness) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII (Taken on 8/11/21 Intramuscular at Right Arm). Concurrent medical conditions included Allergy to antibiotic (Allergy to Vancomycin.), Asthma and Bronchiectasis.    On 11-Feb-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021 at 3:00 PM, the patient experienced PAIN IN EXTREMITY (Arm pain), PYREXIA (Temp 102), FATIGUE (Tiredness) and HEADACHE (Headache). On 13-Feb-2021, PAIN IN EXTREMITY (Arm pain), PYREXIA (Temp 102) and HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (Tiredness) was resolving. Not Provided          No concomitant medications were reported. No treatments were reported.   This case was linked to MOD-2021-323610, MOD-2021-310473 (Patient Link).
Information has been received from a certified medical assistant concerning a child who on an unspecified date was vaccinated with a dose of Varivax (Merck). Subsequently the patient developed shingles after vaccination. It was reported that this occurred "a while ago." Unspecified medical attention was sought. On an unspecified date the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested. Follow-up information was received from the medical assistant on 09-NOV-2007. She reported that she did not have any further information because she cannot identify the patient. Additional information is not available.
admitted to hospital due to a fall, altered mental state, lethargy and hypotension; pt has dementia; found to have acute toxic and septic encephalopathy, pneumonia MRSA bactremia; treated per protocols; family desired pt to go into hospice care; pt tested positive for COVID prior to discharge to hospice; hospice not able to take COVID positive pts; pt stayed in the hospital where he passed away
The day after I have a fever of 100.6 managed by talking tylenol and advil after 6 hours fever went back up this continued for 48 hours.   Tired, headache, Very sore and weak arm.  Symptoms worse from 24 hr post shot to 48 post vaccine.  Tuesday (3 days post vaccine).  A larger red swollen hot area appeared around vaccination site 4" by 3".  This area is very sore, swollen and hot to the touch,
severe fatigue, dizziness, headache, shortness of breath,  itchy rash on lower extremities and buttocks
Reports on 3/9/15 that late in evening on 3/2/15 date of vaccine that began to have a "sore throat"; awoke at 2 am and had more discomfort and "Pain with swallowing". The pain continued through the next day, slightly relieved with Ibuprofen. Described the pain as being "only in the left side of the throat, pointing to below the chin and inner neck". On 3/10/15 Saw Dr. and was given an order to continue the series and take Benadryl prior to next dose.