chrisvoncsefalvay/vaers-outcomes huggingface dataset:
-Approximately 5 hours after injection, developed 12 hours of chills (no fever), diffuse aching, fatigue, and very low energy. -Approximately 3 days after vaccine noted difficulty completing usual daily exercise routine-stamina appeared low. -Approximately 3-5 days after vaccine noted difficulty completely taking in deep breath, with "catch" or discomfort in substernal area. -During early morning hours of day 7 after vaccine, was awakened with sharp, intense toothache pain right flank.  With change of position was able to get comfortable after which pain resolved.  This reoccurred the next two nights prompting ED visit. -First ED visit focused on right flank pain and CT Abdomen and pelvis was negative except for "atelectasis" right lung base -Due to more pleuritic symptoms, second ED visit occurred, and CT chest with contrast demonstrated bilateral PEs (approximately 5 on right and 2 on left) with evidence for RV strain -Hospitalized and started on anticoagulation (Lovenox SQ for one dose and then Eloquis). Echocariogram confirmed mild RV dilatation.  Interventional Radiology did not feel removal/lysis of clots necessary. -Completed exhaustive evaluation with Hematology--no underlying clotting disorder identified to date -Have returned to 100% activity without significant symptoms at present
pt recvd vax & exp pain @ the inject site which resolved; 2 days later exp a swollen painful upper eyelid; tx ATB ophthalmic & Tavist;
Broken out in hives; This case was reported by a other health professional via call center representative and described the occurrence of hives in a 17-year-old patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number J9F97, expiry date 30th June 2020) for prophylaxis.   In October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received Fluarix within the last week of reporting. The patient broken out in hives within 15 minutes after getting the vaccine and needed to go to the emergency room. The reporter also reported adverse event attributed to the quality defect of Fluarix vaccine. As per the reporter, syringe was affected which was purchased from wholesaler. The sample was not available for return for the investigation. The reporter consented to follow up. This is one of 3 cases, reported by the same reporter.
Information has been received from a male patient of unknown age referring to himself. The patient's pertinent medical history and concurrent condition were not reported. In 2014 (reported as "last year 2014"), the patient was vaccinated with a dose of RECOMBIVAX HB (lot#, expiration date, route and dose were unknown). No concomitant medication was reported. In 2014 (reported as "last year 2014"), a month after vaccination, the patient had an unspecified adverse reaction. The patient sought medical attention via contacting with physician. At the time of reporting, the patient was still suffering since receiving the vaccine. The causality was not provided. Additional information is not expected as there was no contact information provided.
tired, lethargy, rash which has spread to neck and arm area (started 48 hours post vaccination)
1) Severe swelling 5 hrs after shot - down to elbow. 2) Redness of arm shoulder to elbow & armpit. 3) Hardness of arm shoulder to elbow & armpit. 4) Extreme pain. These symptoms lasted 5 days - emergency room trip day following shot.
no advers event; temp excursion; This spontaneous report has been received from another reporter, concerning a 2-months-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 29-DEC-2022, the patient was vaccinated with the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, on left thigh (valid lot number W006596 [expiration date 11-OCT-2024]) and with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (valid lot number 1892784 [expiration date 03-DEC-2023]) (doses, vaccination schemes, and frequencies were not provided for both vaccines) for prophylaxis, after a temperature excursion of 47.9 degrees Fahrenheit (F) for 47 minutes that occurred on 01-DEC-2022 (product storage error).  No additional adverse events (AE) were reported.
Post vax, 5th and 6th doses of Anthrax, pt had approximately 15cm erythematous, edematous, local reaction in left upper arm.
About 48 hours post vaccine pt has injection site reaction. It looks like a hive red, warm and itchy. Patient is not planning to use analgesic or antihistamine as of now.
Swollen and painful armpit. Sharp stabbing pain on right side. Sharp tooth pulsing
On morning of 6 Feb 2020, Mother of patient noted increased redness, swelling, and warmth at vaccination sites. Reported area felt "firm" . Patient had no fever, chills,  headaches, body aches, and N/V/D. Seen in Medical Home Clinic on afternoon of 6 Feb:  Redness and swelling of right upper arm 2 days following vaccine receipt. Area warm to touch. Patient denies pain at site. Normal ROM and no numbness. On Exam: 12.5 x 8 cm on upper right arm.  Temp 97.6 Treated with antihistamines and NSAID Follow up on 8 Feb - symptoms at vaccination site almost completely resolved
Red, swollen at site, day after vaccine. Two days from vaccine site was red swollen and hot covers area about 6 inches diameter. Started to have hives on back - Mother treated with BENADRYL, and fever reliever. Temp 98.7
p/vax pt devel welt @ site, size of quarter;then pt devel a red 2" x 1"-warm & hard lump;
sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.            Concomitant product details was not reported.  Treatment details was not reported .
Given Pediatrix, DTaP-HepB-IVP combined, when she should have received DTaP alone.  No excessive symptoms noted by mom.  I will not give DTaP at this time, but will give routine 5 yo vacc.  Mom aware.
Weakness; Dizziness; Headache; No appetite; Really thirsty; Body aching; A spontaneous report was received from a consumer concerning a 65-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events weakness, dizziness, headache, no appetite, really thirsty, body aching.  The patient's medical history was not provided. Concomitant medications reported were Thyroid, Calcium, Metformin, Delaxitin, Melatomin, Low dose aspirn for drug use for unknown indication.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the event(s) weakness, dizziness, headache, no appetite, really thirsty, body aching.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), weakness, dizziness, headache, no appetite, really thirsty, body aching was unknown.
2/27. Spontaneous subdural hematoma.  Occurred 30 minutes into a flight.   Headache and dizziness began one week prior to 2/27, but not sure if they are correlated.
Case number PHEH2014US020734, is an initial spontaneous report received from a nurse on 13 OCT 2014. This report refers to a 56 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413201A) 0.5 ml intramuscular on 03 OCT 2014 (6 days later than supposed to get). Nurse stated that the person who opened the cooler stated that the gel packs were still mushy, but temperature unknown. No adverse event was reported. No further information was provided.
blacked out; Fatigue; fell; Dizziness; requiring more sleep than normal; This case was reported by a pharmacist via sales rep and described the occurrence of blackout in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th January 2020, the patient received the 1st dose of Shingrix. On 12th January 2020, 3 days after receiving Shingrix, the patient experienced blackout (serious criteria GSK medically significant), fatigue, fall, dizziness and sleep excessive. On an unknown date, the outcome of the blackout, fatigue, fall, dizziness and sleep excessive were unknown.   It was unknown if the reporter considered the blackout, fatigue, fall, dizziness and sleep excessive to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient felt fatigued, requiring more sleep than normal. The patient fall in the bathroom and blacked out. The patient also experienced dizziness. The field representative received an email and called in the information that the pharmacy sent to the representative. The reporter consented to follow up.
Following vaccination pt. not happy, groaning. Feeling warm at 4 PM so given Ibuprofen which allowed him to cope. At 9 PM developed uncontrollable crying. Developed at least 102 degrees fever. Pt. given TYLENOL at 12 midnight. By 1 PM calmed down & fell asleep 2:00-5 AM At 9:45 AM pt. cooing & babbling.
On April 25 did not feel well the next day had neck and shoulder pain and muscle muscle pains in arms and then the the muscles in the right upper arm did not function properly and lost mobility yes. At timesAt times had to support my right arm in order to lift it above my head or move it side to side there was some pain in the right arm. There has been improvement but still a lot of mobility lost.
injection site hurt/ injection site soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 88 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 02Mar2021 (Lot number: EL9267) at the age of 88 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood pressure" (unspecified if ongoing); "Gas" (unspecified if ongoing); "Sleep" (unspecified if ongoing); "Relaxation" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] (ongoing); ATENOLOL taken for hypertension, start date: 2020 (ongoing); OMEPRAZOLE taken for flatulence (ongoing); AMLODIPINE taken for hypertension (ongoing); MIRTAZAPINE taken for sleep disorder, feeling of relaxation (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 02Mar2021, outcome "recovering", described as "injection site hurt/ injection site soreness".  Additional information: Anatomical location - right upper arm. Indication - COVID-19 vaccination. Aspirin: Been on it for a while. Been on it for a long time, in conjunction with the Atenolol. Atenolol: Started taking it about a year ago, been on this dose for less than a year. Omeprazole: Started it about a year ago. Amlodipine: Been on it for about 6 months. Mirtazapine: Been on it for more than a year. Reporter is a consumer that was calling about the Covid-19 vaccine and stated that she received the first dose of the vaccine on 02Mar2021. She said that her injection site hurt kind of off and on and did not know if she should report it. Event: The reporter said that yesterday and today, her injection site soreness started to improve stated that her symptom is improved but is still off and on. Return date for her second dose is the 23Mar2021. Reporter said that she wanted to know what she could take for pain. It is not just pain and aching, she just knows it was there and was hurting a little bit. Time the vaccination was given between 1400-1500 on 02Mar2021. Vaccination Facility Type: Hospital. Prior Vaccinations (within 4 weeks) none.  No follow-up attempts are possible. No further information is expected.
Initial report was received from another manufacturer on 02 April 2012 (Service Request Number 1-5014135556). A patient (age, date of birth and gender not reported) had received an injection of FLUZONE, sanofi pasteur Inc. (lot number, date, site and route of administration not reported) and several hours later experienced shortness of breath. Past medical history and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Within minutes of receiving Moderna injection, I began to feel tightness in my throat, racing heartbeat, pale skin, burning sensation from neck up, shaking hands. I was immediately evaluated and given an injection of Benadryl and began to feel relief of symptoms. I was allowed to wait an additional 20 minutes and left after having another evaluation and had my blood pressure  checked.
SOB, DIZZINESS, CONFUSION, HIVES AT THE SITE ARM SWELLED UP, INCREASE PULSE RATE, WHEEZING.
Became very irritable, crying a lot, stumbling often 14 days after receiving the MMR and chicken pox shots.  15 days after much the same behavior and developed a red speckled rash covering her back and chest.  Dr. told us to give her 2, .8 doses of Tylenol.
Red, swollen area @ shot area ~2-3" in diameter. Getting bigger daily. Tx with BENADRYL & AUGMENTIN.
Mild wheezing and 101 fever that first evening, sore body and sensitive skin the next day followed by intense cough, pox developed by that evening, a total of 6-12 pox over the next day or two. Treated with toddler OTC cough medicine and ibuprofen.
Moderna Covid-19 vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022 and administered past its 30 day beyond use date; Pharmacy gave Moderna Covid-19 vaccine past its 30 day beyond use date to 21 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its 30 day beyond use date to 21 patients) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022 and administered past its 30 day beyond use date) in a 67-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its 30 day beyond use date to 21 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022 and administered past its 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its 30 day beyond use date to 21 patients) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was transferred from the freezer to the refrigerator on 24-Jan-2022 and administered past its 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. No treatment information was reported.  The pharmacist did not know which dose the patient received and on which arm it was administered. The pharmacist did not have any other adverse events or side effects to report. The pharmacist wrote an expiration date of 24-Mar-2022 on the Moderna Covid-19 vaccine instead of 24-Feb-2022.
Covid19 breakthrough.  1st vaccine received on 04/30/2021.  97 y/o PMHx HTN, COPD, HLD, CHF presents to ED with 1 week history of diarrhea and cough.  Pt has been on hospice x2 years at home.  Afebrile, Room air sat 96%,  CXR indicative of Covid PNA.  Started on IV ABX.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022).    No concomitant medications were provided by the reporter. Patient received half dose. On 04-Jun-2022 the vials were initially stored in the refrigerator. Vial did not undergone any temperature excursions. No treatment medications were provided by the reporter.
Possible GBS. While on vacation developed back pain, numbness & weakness in leg. Hospitalized. Currently undergoing physiotherapy.
Presented to hospital ER  on 12/21/2021 with 10 day history of shortness of breath. Upon arrival, diagnosed with acute COVID19 pneumonia with acute hypoxemic respiratory failure, with O2 sat of 84% on room air. Also reported weakness, fatigue, fever.  Was admitted to hospital and remdesivir and dexamethasone started. 12/22/2021 required increase from 2L O2 via NC to 8L mini-high flow O2. Placed on Baracitinib. 12/23/21 placed on high flow O2 35L/min with 100% FiO2. Patient refuses to prone as it is too painful. 12/24/21 placed on bipap 100% overnight with continued sat in 70s-80s. Only managed 2 hours prone. Transferred to ICU for monitoring and probable intubation. Rocephin and Azithromycine added for possible concomitant bacterial pneumonia. 12/25/21 placed on mechanical ventilation. Remdesivir 5 day treatment completed.. 12/27/21 patient paralyzed and proned. 1/1/22sedation stopped for weaning trial. 1/2/22 remains off sedation but no response yet. Now febrile with temp 100.9  Continued to decline and on 1/4/22 patients sister decided to withdraw care.  Expired 1/4/22.
Woke up with facial swelling a day after administration of influenza vaccine. No difficulty breathing and no fever. Seen 5 days later and still has lower eyelid swelling but facial swelling has subsided. Mother states this is the second such episode with influenza vaccine. Does not have this reaction with the intranasal vaccine.
Nausea; Diarrhea; Weakness; Vomited; This is a spontaneous report from a contactable consumer reporting for a patient (reporter's friend).  A male patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date in Sep2021, as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as DOSE 1, SINGLE for COVID-19 immunization and no events reported. On an unspecified date in Sep2021, the patient experienced nausea, diarrhea, weakness and vomited. Received call from consumer (patient friend) regarding the second dose of Pfizer COVDI 19 shot on Saturday. While reporting for himself, caller stated that he had a friend (patient) that said he experienced the same thing after his second dose. He did not have his friend information to complete a report on. He had his done two weeks before his. He received the Pfizer COVID vaccine as well. He is over his symptoms. No further details provided. Outcome of the events were recovered on an unspecified date in Sep2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101426803 same reporter/product/event, different patient
Tinnitus both ears.  Continuing 24/7 since September after vaccination . Wakes me In night and prevents return to sleep for hours.  Using noise continuously, TV, radio.  MD appt 11/29/22 to assess this
Information has been received from a physician concerning an 8 yr old male with no medical history who on 18May98 was vaccinated with a dose of varicella virus vaccine live (lot 625043/1567E). There was no concomitant medication. On 10Oct05 the pt experienced a mild case of breakthrough varicella with less than 50 lesions. Some of the lesions were crusted over. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Patient broke out in light rash on chest and abdomen after receiving varicella, MENVEO, and GARDASIL vaccine. Rash resolved a few minutes after onset. 2 tsp of BENADRYL were given as directed by Dr.
lymphadenopathy; Fused rash; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (lymphadenopathy) and RASH (Fused rash) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced LYMPHADENOPATHY (lymphadenopathy) and RASH (Fused rash). At the time of the report, LYMPHADENOPATHY (lymphadenopathy) and RASH (Fused rash) outcome was unknown. Not Provided      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. Treatment details included Tylenol, Antiallergy medication