chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccines were exposed to a lowest temperature of -55°C for 4 minutes/administering these vaccines to patients.; This case was reported by a nurse via call center representative and described the occurrence of product storage error in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Havrix, Engerix B and Boostrix. On an unknown date, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Havrix, Engerix B and Boostrix, the patient experienced product storage error. On an unknown date, the outcome of the product storage error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 8-JUN-2022 Reporter's Comment: The case was reported for group of people. The vaccines Boostrix, Engerix B, Havrix, Infanrix and Kinrix were exposed to lowest temperature of minus 55 degree C for 4 minutes due to equipment malfunction. The temperature went back in range and the vaccines were not frozen and were viable. These vaccines were administered to patient's and would be continued to administer as this was only a program issue. The reporter consented to follow up.
Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a 62-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 19th May 2020, the patient received Shingles vaccine. In May 2020, less than a week after receiving Shingles vaccine, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was not recovered/not resolved.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After receiving shingles vaccine, the patient experianced side effects. The patient had asked, how long the side effects normally last. The patient cannot do much of anything and had got a family that needed him/her.
Developed new onset migraine headache syndrome after Anthrax #2 in Aug '11. Headaches were reproduced and worsened in frequency and intensity after Anthrax #3 in Feb '12. Headaches occur randomly and patient often has to go to ER to receive abortive treatment. Given permanent exemption to Anthrax vaccine unless exposed to the Anthrax Bacillus. The VHC has had multiple cases of new onset or worsening headache syndromes after Anthrax. The immunologic mechanism is unknown.
itching on her back, hands and wrists (severe), and behind her ear by her hairline; delayed types of reactions; dizzy whenever she lays down; rash going up her arm.; exhausted, fatigue, and couldn't get out of bed.; pulmonary fibrosis was also exacerbated.; A spontaneous report was received from a consumer, concerning a 78 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pulmonary fibrosis was also exacerbated(Pulmonary Fibrosis), exhausted, fatigue, and couldn't get out of bed( Fatigue), itching on her back, hands and wrists (severe), and behind her ear by her hairline(Pruritus), rash going up her arm(vaccination site rash),dizzy whenever she lays down(Dizziness), delayed types of reactions(Skin Reactions).  The patient's medical history had pulmonary fibrosis.No relevant concomitant medications were reported.   On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) intramuscularly in the Left arm for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experience exhausted, fatigue, and couldn't get out of bed, pulmonary fibrosis was also exacerbated and On 03 Feb 2021 ,the patient experience itching on her back, hands and wrists (severe), and behind her ear by her hairline,rash going up her arm, dizzy whenever she lays down,delayed types of reactions.  The patient was treated with lidocaine for itchiness on her hands and wrists.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, pulmonary fibrosis was also exacerbated(Pulmonary Fibrosis), exhausted, fatigue, and couldn't get out of bed( Fatigue), itching on her back, hands and wrists (severe), and behind her ear by her hairline(Pruritus), rash going up her arm(vaccination site rash),dizzy whenever she lays down(Dizziness), delayed types of reactions(Skin Reactions) were considered as unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. The pulmonary fibrosis and dizziness events are probably related to the patient's comorbidities. Based on the current available information and temporal association between the use of the product and the start date of the events vaccination site rashes and fatigue, a causal relationship cannot be excluded.
Case received from a healthcare professional in the USA on 24-OCT-2005 via MIS/VIS under the reference number 05-0568. A 64-year-old female patient with a medical history of hypercholesterolemia, diabetes mellitus and hypertension had received a dose of FLUZONE, batch number U1828AA, in the right arm and a dose of PNEUMOVAX, batch number 0055R, in the left arm on 17-OCT-2005, and 24 hours post-vaccination, i.e. on 18-OCT-2005, she developed fever at 101, which reached 103 36 hours post-vaccination, dry heaves, chills and redness at the injection site extending under her arm. She did not present with any illness at time of vaccination. Her symptoms were resolved on unspecified date except the redness which was decreased to size of 50 cent piece. The patient was receiving concomitant treatment as diuretics, LIPITOR, ZEDIC, LISINOPRIL and GLIPIZIDE. The patient required a doctor visit. Patient outcome was not recovered. Further details were requested. Follow-up information received on 03-FEB-2006 from a healthcare provider. There was no illness at the time of vaccination. Concomitant medication is corrected from ZEDIC to ZETIA. Additional information is not provided.
ct reports having fever, body aches, stomach pain with nausea and diarrhea, palpations, rash on her face, vision problems
Cellulitis, fever > 103, warmth at the infection site, possible staph infections.
th epatient received Rotateq vaccine on 9/28/07 at 4 month WCC.  Mom brought patient into the office today stating that since she received vaccines she has had diarrhea and vomitting.  pt was adnitted to the hospital.  11/7/07 Received vax record from pcp which confirm lot #s. 11/30/07 Reviewed hospital medical records which reveal patient experienced diarrhea since 9/29 & vomiting x 2 days w/dehydration & weight loss.  Admitted 10/5-10/07/2007.   FINAL DX: Rotavirus diarrhea, dehydration.
1st dose vaccine 1/21/2021; seen at ICC on 2/1/2021 c/o: diarrhea, fever, body aches, runny nose x 4 days
I had a sinus infection and major headache including coughing off work from 03/17-03-23-2022
Information has been received from a 25 year old female consumer with allergy to penicillin and a history of leukemia, for the Pregnancy Registry for GARDASIL, who on 18-NOV-2009 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot No. not reported). There was no concomitant medication. The consumer became pregnant after receiving her first dose of GARDASIL. Pregnancy was confirmed through a "home pregnancy test". Her LMP was on 11-NOV-2009 and her EDD was estimated to be on 18-AUG-2010. There was no adverse event reported. Follow up information has been received from a receptionist in the physician's office concerning the female patient. It was reported that the patient was pregnant and miscarried on 24-FEB-2010 at 11 weeks of gestation. Upon internal review the patient's miscarriage was considered to be another important medical event. The patient subsequently became pregnant again after vaccination with GARDASIL (MSD, WAES# 1101USA00792). Additional information has been requested.
Pain in arm, numbness/pins and needles, and some weakness in right arm and hand. Pins and needles feeling occasionally in left arm as well.
Patient was given first dose of COVID Vaccine on 6/23/2021 and administered the second dose of COVID Vaccine 14 days later on 7/7/2021
This 51 y/o male with sudden onset left arm tingling/numbness 5 hours after flu shot. Felt jaw quivering, unable to talk. Was eating and unable to get food out of mouth -> used hard to remove. Awake/alert throughout; lasted approximately 5 minutes. Presented for eval 2 days after episode.
Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program, Pfizer First Connect. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the second of 20 reports.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
The injection was given in the front of her mid upper arm. It was given Intradermally. The pt stated that she watched them put it under the skin and it bubbled up like a PPD test does. Pt had and still does have a golf ball size lump, severe angry redness and warmth. It blistered up. Pt was concerned that it was not given properly. I called the pharmacy and made them aware of this. Patient wants to k now if the injection was given this way is it even effective?
Developed shingles-herpes zoster exactly 8 days post vaccine administration. While I know that this virus can develop at any time after having the chicken pox virus the timing is curious in relation to the vaccine.  Thought it may be a tooth abscess at first, went to the dentist and was diagnosed with sinusitis and was given antibiotics Amoxi/Clav 825mg.  After being on antibiotic for 36+ hours with no improvement worsening facial swelling and pain. Four days after initial symptoms of facial pain then swelling, blister/sores began to immerge and worsening of facial swelling and pain. The only reason that this was diagnosed was that other persons had developed shingles post vaccine, and friends and family stated that's what it looked like. Upon this went to the ER and was properly diagnosed with Shingles given IM Prednisone and Morphine unsure of dosage and prescribed Accylovir 800 MG 1 tablet PO 5x/7 days; Prednisone 50 MG 1 tablet PO daily/5 days; some PO pain medication.  No previous Shingle outbreak.
2:30 AM I woke up and had trouble sleeping deeply  In the morning around 8AM, I took my temperature and my fever was around 100.5 degrees when I usually run a little over 97 degrees.  This lasted through at least 3PM.  I had a slight headache lasting through the day.  Not extreme but present.    Fatigue all day that caused me to take a 2 hour afternoon nap   Body aches and stiffness   Heavy pain in my left arm that has continued into today, 2/24 but is getting better   All symptoms except for the arm pain lifted the following day
4/27 Itching, swelling & red at injection site; began earlier this week.  No streaks or swelling of axillary through nodes.                      4/29 Smptoms improved with Benadryl and cold compress, but still very itchy.                  5/1 Continues to improve, redness greatly reduced
He and his wife were getting vaccines. The TDAP was for her but given to him instead.
Pt vaccinated at 11:30 am with COVID-19 Moderna, 1st dose. While waiting in her car at the observation station of the drive-thru site for 30 minutes due to hx of anaphylaxis to an unknown substance, pt began to feel like her nose and lips/mouth were itching at 11:54. Alert and talking, no distress noted.  Pt given benadryl 25 mg tab at 11:56 am. Pt remained on site another 30 minutes. No worsening of symptoms and reported improvement.  Pt was discharged to home via her own car with husband driving at 12:30 pm. Called the next day to check on pt. She took another benadryl that night. No further problems.
A non-serious spontaneous case of dry throat, nasal congestion and drainage, diarrhea, headache, fever and abdominal pain characterized by cramps, discomfort and fullness has been received from a consumer for a five-year-old female.  No medical history or drug history information has been reported for this child.  The child received FluMist on 21-Nov-2007.  The child's mother who reported this case indicated the child received FluMist and the next day experienced a dry, scratchy throat.  Nasal congestion and drainage developed two to three days post administration.  Around 25-Nov-2007 the child developed diarrhea, stomach discomfort, abdominal cramping and fullness.  She also began complaining of a headache.  A low grade fever of 101 degrees started on 26-Nov-2007.  No outcome has been provided for this event.  Further dosing was not indicated.  The reporter did not provide a causality assessment for this event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. 03-Jul-2008: Follow-up information obtained and incorporated in above narrative information on child's physical condition on the day of FLUMIST administration.
Delayed reaction. Painful, itching rash/blisters from head to foot. Swollen finger joints.
This spontaneous report received from a patient (Health care professional) concerned an adult female of unknown race and ethnicity. The patient's height, and weight were not reported. Patient was health care professional. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018, expiry: unknown) dose was not reported, 1 total administered on left arm on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with first dose of Covid-19 vaccine ad26. cov2.s (dose number in series 1). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received non-company suspect vaccine Pfizer BioNTech Covid-19 vaccine (Tozinameran) (dose number in series 2) (form of admin not reported, route of admin, batch number: Unknown, expiry: UNKNOWN) dose was not reported, 1 total administered on 28-OCT-2021 for prophylactic vaccination. On an unspecified date, the patient experienced back ache (dose number in series 2). On 03-APR-2022, Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) negative. The action taken with tozinameran was not applicable. The outcome of back ache was not reported. This report was non-serious.
Patient had a low grade temp 99.6/chills/HA/achey eyes for 2 full weeks after the second Covid shot.It is still happening off and on.
tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, COVID-19: (Positive) tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
No adverse event; first dose more than 34 days ago. The pharmacist reports that a patient missed her second dose for a whole year. Her first dose of Moderna was on 28Apr2022. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (first dose more than 34 days ago. The pharmacist reports that a patient missed her second dose for a whole year. Her first dose of Moderna was on 28Apr2022.) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Apr-2022, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (first dose more than 34 days ago. The pharmacist reports that a patient missed her second dose for a whole year. Her first dose of Moderna was on 28Apr2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (first dose more than 34 days ago. The pharmacist reports that a patient missed her second dose for a whole year. Her first dose of Moderna was on 28Apr2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (first dose more than 34 days ago. The pharmacist reports that a patient missed her second dose for a whole year. Her first dose of Moderna was on 28Apr2022.).    No concomitant product was reported. It was reported that the patient missed her second dose for a whole year. Her first dose was on 28-Apr-2022. The patient had not received the second dose yet. The patient did not receive any vaccines in the last 4 weeks. No treatment information was reported.
Day 1 after vaccine administered,  chills, low-grade temperature,  sore arm, sweating, total exhaustion, dry cough.  Day 2  reduced but continued with chills, low-grade Temperature,  sweating, exhaustion, dry cough. Day 3 much better but the cough and night sweats have continued every evening/night through  Day 10. Day 11, middle of the night, sweating, chills, whole-body discomfort (not exactly aches), and pressure/tightness in middle of chest and back. Currently Day 11, chills, lower than usual temperature (97.3) and extremely tired.
Localized erythema around the injection site 5cm by 7 cm. Felt nauseated and discomfort in left shoulder.
Patient's father gave incorrect DOB for child. Father stated DOB but patient's actual DOB is different. Patient is 11 years old at time of vaccination.
As soon as I received the second shot I was unable to walk up a slight incline which I had done everyday for almost a year. This has gotten a bit better but I still cannot exert myself without becoming out of breath and need to stop for a short rest before continuing. Walking up stairs is a real difficult concern. The first flight is OK when walking very slow, but the second flight is almost impossible even after resting for several minuities.
Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 25-year-old male. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11 Jan 2009. There were no adverse events associated with this medication error: therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and patient demographics were provided. Additional information was received on 12-May-2009: Product Complaint Investigation results.
After client received her vaccine client stated she feels flushed and shaky.  Vital signs obtained.  BP 126/83, HR 93, O2 Sat 99%.
Routine Dr. visit. ? The shot as 64 age of cut off - Dr said OK to give if pt. in good health - Rec'd DTAP apx 10:30 AM felt bad went to bed, slept - 1 PM woke with temp of 102.5 oral - congestion (heavy purulent). Lungs clear on Dr visit B/P has increased & stayed some since Imm 160/94 usual B/P 140/70-80.
Swelling, pain and redness at injection site (Upper arm) as well as spreading onto the clavicle area, posterior shoulder, mid-upper arm.
Onset of lightheadedness shortly after vaccination. Brought to medical screening to lay down . No other interventions. Left in stable condition @9:38.  Recorded by, RN. Medic.
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 16-SEP-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at 0.55 Celsius Degrees for 200 hours, 1.11 Celsius Degrees for 208 hours, -0.55 Celsius Degrees for 32 hours and 0 Celsius Degrees for 152 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Shingles Valacyclovir antiviral Lyrica generic for nerve pain Symptoms lessened, but still apparent 8 weeks later
Joint pain for 1 day, all over muscle ache and fatigue for one day, and headache for one day; not resolved