chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got the shots got shingles/suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, [the patient experienced vaccination failure (Verbatim: got the shots got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles).The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-MAR-2023 This case was reported by a patient's wife via interactive digital media. The reporter stated that you could get still get shingles even after you got the shingles vaccine, it was not guaranteed. The reporter stated that the patient got the shingles shot last year and guessed he got the shingles last week from the day of reporting. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. Note: onset date not captured as last week could be February or March.
Rt arm swollen & red hot some blisters; pt given ATB & advised to take meds if gets worse go to Hosp;
Extreme chest burning/pain/tightness, shortness of breath, pressure in my neck around my throat. Persistent nearly 7 days after 2nd vaccine.
Caller reports vaccine was administered after experiencing temperature excursion //Names of vaccines involved (including lot/exp) VARIVAX  Lot: U02505 / Exp date: 8/13/2023        ?    Temperature -11.6C        ?    Time frame  0 hour 30 minutes; No additional AE details.; This spontaneous report was received from a consumer and concerning to a patient (gender not provided) who was 1-year-old at the time of reporting.  The patient's medical history, current conditions, drug allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX), administered subcutaneously for prophylaxis. Lot number [U02505] is an invalid lot number for (oka/merck) (VARIVAX) expiration date reported as 13-AUG-2022 (strength, and route of administration were not provided) (Product storage error).   The varicella virus vaccine live (oka/merck) (VARIVAX) was stored at a temperature of -11.6C  for the time frame of 0 hour and 30 minutes. There was no previous temperature excursion.  No additional adverse effects reported.
Patient received 1 st Moderna vaccine today. Within 5 minutes after receiving vaccine patient noticed redness, itching, pain in wrist- all on left side, and feeling light headed.  Vitals were 170/66 pulse 88 O2 98% and temperature 98.6.
This spontaneous report was received from a 56 year old female patient with drug hypersensitivity to AUGMENTIN and diabetes mellitus. The patient's medical history included 2 myocardial infaction (May 2006 and January 2014). On 14-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX in the left arm to prevent Shingles (administration route, lot number and expiration date were not provided). Concomitant therapies included EFFIENT, LIPITOR, ZESTRIL, SYNTHROID, omeprazole and clonazepam. On 15-APR-2015, the patient experienced rash, Injection site induration and skin warm. On 16-APR-2015 the patient experienced pruritus (reported as: "it was itching like crazy"). The outcome of the events was unknown. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers to two patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 19-MAR-2015, the patients were vaccinated with a dose of RECOMBIVAX HB intramuscular, which underwent a supported temperature excursion. Dose, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. No adverse effects reported. Additional information has been requested.
Rec'd 1st Pfizer shot on 4/14/21 1pm, by 3pm whole left leg was burning (large varicosities present) ruled out DVT 4/16/21, 4/19/21 itching ascending bilateral started in feet felt at different places all over my body but not body itching all over at one time. itching and burning persisted intermittently until 4/28/21 when burning got worse and traveled from feet to neck. no visible signs of rash or irritation.
Pt started a high pitched cry approx 1130PM; 27FEB92 cont the high pitched cry throughout the night; In the AM mom called pvt MD & whom stated pt had a serious side effect; mom gave APAP; fever 100.6 R;
rash; he could not walk; sharp pain in his groin; terrible pain everywhere; This is a spontaneous report from a contactable consumer or other non-Health Care Professional reported for an 89-year-old male patient (father). A 89-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318 and Expiry date: Unknown), dose 2 via an unspecified route of administration on 09Feb2021,at the age of 89-years-old as DOSE 2, SINGLE for covid-19 immunization. Medical history included chronic inflammatory demyelinating polyradiculoneuropathy from an unknown date and unknown if ongoing Concomitant medication: Reporter stated, "Yeah, but nothing new, newest thing is he was diagnosed with CIDP Chronic inflammatory demyelinating polyneuropathy about 8 weeks ago and he had his second infusion of IVIG so Intravenous, so you are a pharmacist so you know what I am talking about, so he has his immunoglobulin infusion, so we had the big thing about delaying or when to do his vaccine because this IVIG infusion that he had on Feb 1st, he had his second infusion of IVIG." , bone marrow transplant from an unknown date and unknown if ongoing Results and name of the test: Reporter stated, "They did everything BMT, it was a Dr.'s office, the neurologist that ordered the IVIG for him.". Concomitant medication(s) included immunoglobulins nos taken for chronic inflammatory demyelinating polyradiculoneuropathy, start and stop date were not reported. On 10Feb2021 the patient experienced terrible pain everywhere, sharp pain in his groin and he is getting a little bit better, but he started having the new symptoms this morning with this rash. On 11Feb2021 the patient experienced he could not walk, so basically, he lost his left leg and he has a sharp pain in his groin and basically he stayed in bed another. On 13Feb2021 the patient experienced rash. The patient underwent lab tests and procedures which included blood test: unknown results on Lab work: The last blood work would have been 4th when he had the IVIG infusion. February 1st, I think around then he had blood work. Treatment included doctor said to hold off, not take the Benadryl not to take anything like right now. The outcome of events terrible pain everywhere, sharp pain in his groin, he could not walk was recovering while the outcome of event rash was unknown.
fevers; chills; body aches; headache after 12-14 hours of vaccine which lasted 36hours total; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Jan2021 12:00 (Lot number: EL0142) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Psoriasis" (unspecified if ongoing); "depression" (unspecified if ongoing); "b12 deficiency" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA, administration date 27Sep2021; ZOLOFT. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Right, Vaccine Administration Time: 17:30 PM), administration date: 21Dec2020, when the patient was 37 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "fevers"; CHILLS (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "chills"; PAIN (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "body aches"; HEADACHE (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "headache after 12-14 hours of vaccine which lasted 36hours total". Therapeutic measures were taken as a result of pain. Additional Information: Patient received 3rd dose (booster) on 01Oct2021 at 12:30 PM on the right arm (lot No. EW0169). for booster on 02Oct2021 at 12:00 PM Patient had developed lymphadenopathy, swelling and pain at right axilla. Neck stiffness as well - still 48 hours post vaccine. Patient was not recovered and treatment received as otc ibuprofen. In the Public Health Clinic/Administration facility most recent COVID-19 vaccine was administered. On 27Sep2021 patient received Influenza vaccines on Right arm within 4 weeks prior to the COVID vaccine. patient received Zoloft within 2 weeks of vaccination. Prior to vaccination Patient wasn't diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. No Known Allergies. Ethnicity and Race information is available.  Follow-up (12Oct2021): Follow-up attempts are completed. No further information is expected.
Light headed, sleepy.  Monitoring for 1hr.   @1530 BP 112/78, SPO2 93%RA, Pulse 62. @1615  BP 110/80, SPO2 97%RA, Pulse 60. Patient wanted to leave at 1630, feeling much better.  States she will have a friend check on her at home but is now feeling good.  Informed patient to call doctors office and discuss second dose of vaccine.
It was reported that a 61 year old female pt received a Fluzone SV '01-'02 vaccination on 10/3/01. The pt was hospitalized on 12/7/01 for 12 days with a dx of transient brain swelling. The pt fully recovered.
2 days after the injection She started swelling on her cheek bones up high- like she got Botox. Still there currently today, called the Dr to let them know about it, but havent heard back yet
Pt. began feeling extreme fatigue and  had an unexplained loss of 15 pounds.  Also, for the first time, her lab tests--urinalysis--showed blood and protein in her urine which is an indication of kidney damage. From 2001 up until the time, she took the Pfizer booster, her urinalysis was always negative for blood or protein in the urine and her eGFR  was 120 which is well above 59 which is the reference point .  Her blood creatine was usually around 0.68.
A health care professional reported that a child received an injection of Acel-Imune vaccine on 5/16/96 at 4 years of age. At 10 years of age, the child developed pertussis. No further info was available at the date of this report. Pertussis was considerred medically important (OMIC).
105.3 rectal temperature. He was vomiting and not eating well. This was the evening that vaccines were given. The next day our office called for an update in the morning and afternoon. 8/27/2020 11:30 am- "Mom took him to ED last night at 8 pm as she thought he appeared lethargic and T was 105.3. Mom notes that they gave him Tylenol in ED, monitored him for a short while and was discharged to home.  Today T is 98.7. He is eating well. Interactive when mom talks with him and seems to be doing well." 8/27/2020  3:00 pm- "Mom said fever went to 102.8 today, and she gave tylenol. It has come down to 100.7. Patient is doing some better today. Instructed mother we will fill out a form for Vaccine reaction. Please let us know if fever goes above 103 again. Please continue to treat fever though. Also let us know if the fever goes longer than 72 hr."  Notes in chart on 8/28/2020 9:00 am - "101.2 rectal temp. Patient is alert and happy and eating without vomiting. Having adequate wet diapers. No rashes noted. T will go down to 99 with Tylenol. Mom denies any respiratory or other symptoms at this time, solely intermittent fever. "
Around 5am, my daughter woke up vomiting. She vomited 4 times within an hour and a half. All day, she has had fever on and off, and has vomited again at 6:00 pm. She was fine before receiving the vaccine and no one else in the family is ill.
Redness started 6/17/04. 6/19/04 worse. The employee was referred to doctor. Doctor diagnosed as dermatitis, but wanted to cohort 13 babies in NICU until 7/15/04 where she worked. Treatment with Keflex and Mycolog.
soreness; redness; This case was reported by a consumer via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included intervertebral disc protrusion.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and erythema. On an unknown date, the outcome of the pain and erythema were recovered/resolved.   It was unknown if the reporter considered the pain and erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient after vaccination experienced soreness and it was really red. The patient refused to provide any additional details. This case has been linked with case US2019198548, reported by the same reporter.
Fever of 101-102, chills, severe swelling of injection site, burning hot, painful and hard to move or rotate right arm. This is still ongoing from 1/8/2022..was told it was an allergic reaction to the shot, this could be ongoing for up to 2 weeks.
Normal shot pain at site and small amount of normal swelling. After six days I noticed pain in arm that I had not previously experience and spoke with pharmacist who did the injection and read listed side effects. Decided to give it a few more days. On the night of the 8th day after vaccine I had much difficulty sleeping as I was having pain in left arm from shoulder to hand. I had never experience this type of intense pain before. It was like a tingle on steroids. Arm sore to touch. This continued to a lesser extent during the 9th daytime but was more intense during the next night. I tried during the days to fine more information online but did not find good, factual information online. On Monday 4/1/19 I made an appointment with my GP, at Family Medicine. Given two prescriptions to help me sleep and with pain, Hydrocodone and Prednisone. I follow up with her today 4/3/2019.
Rebound of Covid symptoms day 12 after taking Paxlovid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound of Covid symptoms day 12 after taking Paxlovid) in a 61-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Blood pressure high, Asthma, Pollen allergy, Allergy to animal dander (cat/dog dander) and Fruit allergy (drupes).   On 11-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 21-May-2022,  after starting mRNA-1273 (Spikevax), the patient experienced COVID-19 (Rebound of Covid symptoms day 12 after taking Paxlovid). At the time of the report, COVID-19 (Rebound of Covid symptoms day 12 after taking Paxlovid) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, SARS-CoV-2 test: positive (Positive) Rebound of COVID symptoms day 12 after taking Paxlovid. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medication information was provided.  No treatment medications were provided for Rebound of Covid symptoms. Company comment This regulatory authority case concerns a 61-year-old female patient, with medical history of Blood pressure high, Asthma and allergy, who experienced the unexpected non-serious AESI of COVID-19, which occurred after receiving the first dose of mRNA-1273 vaccine. Patient received second dose with TOZINAMERAN. Vaccination dates were not provided; hence, latency cannot be assessed. It was reported that patient experienced rebound of Covid symptoms the 12thday after taking Paxlovid (nirmatrelvir, ritonavir). No further information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This regulatory authority case concerns a 61-year-old female patient, with medical history of Blood pressure high, Asthma and allergy, who experienced the unexpected non-serious AESI of COVID-19, which occurred after receiving the first dose of mRNA-1273 vaccine. Patient received second dose with TOZINAMERAN. Vaccination dates were not provided; hence, latency cannot be assessed. It was reported that patient experienced rebound of Covid symptoms the 12thday after taking Paxlovid (nirmatrelvir, ritonavir). No further information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Flu Like Symptoms; Chills; Body ache; Difficulty sleeping; Fatigue; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms, chills, general body pain, difficulty sleeping and fatigue. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, chills, general body pain, difficulty sleeping and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, chills, general body pain, difficulty sleeping and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided. The patient received dose of Shingrix vaccine and experienced sore arm for 24 hrs. About 8 hours post vaccination she experienced flu like symptoms, chills, body aches, difficulty sleeping and fatigue.  The side effects resolved by lunchtime yesterday. No further details were provided. The follow up consent was not granted.
First dose: only felt sore arms and lasted for a day and half. Second dose: after 12 hours of vaccination, experienced night sweat, nausea, body ache, fatigue. Symptoms after second dose lasted for a day and half.
Severe neck soreness and tenderness 2/27 & 28, took Tylenol Rash& Itching at injection area. 2/27 4:00pm. Itching stopped 2/28 however the rash is still present on 3/2. Took Benadryl.
Narrative:  72yo male patient died at home on 1/15/2022. Pt was in in home health care. Per notes pt was on home oxygen for pulmonary disease. See problem list below.  PROBLEM LAST MOD PROVIDER Heavy cigarette smoker (20-39 cigs/day) (SCT 08/13/2020 160605003) (ICD-10-CM F17.210) Secondary malignant neoplasm of intrathoracic 06/24/2019 lymph nodes (SCT 94351005) (ICD-10-CM C77.1) Coronary arteriosclerosis (SCT 53741008) 06/06/2019 (ICD-10-CM I25.10) Malignant neoplasm of lower lobe, bronchus or 06/29/2016 lung (SCT 187868006) (ICD-10-CM C34.31) Multiple nodules of lung (SCT445249002) 12/07/2015 (ICD-10-CM R91.8) (ICD-9-CM 716.90); Arthritis* (ICD-9-CM 716.90) 06/08/2010 (ICD-10-CM M54.2); Cervical radiculopathy 05/13/2019 (CT 54404000) (ICD-9-CM 278.00); Overweight * (ICD-9-CM 06/16/2009 278.00) (ICD-9-CM 780.52; Insomnia * (ICD-9-CM 780.52) 03/27/2008 (ICD-9-CM 724.2); LOWER BACK PAIN, 01/14/2002 CHRONIC/LUMBAGO (ICD-9-CM V62.9); PSYCHOSOCIAL PROBLEMS 01/14/2002 (ICD-I-CM 496.); COPD 01/14/220 (ICD-10-CM E78.5); Hyperlipidemia (CT 05/13/2019 55822004) (ICD-9-CM 443.9); PERIPHERAL VASCULAR DIS NOS 01/14/2002 Degeneration of cervical intervertebral disc 04/03/2000 (ICD-9-CM 722.4) Pt had received covid vaccines on 1/24/21 & 3/3/21 from facility. Pt had recently transferred care from elsewhere. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
15 month, old patient was given Quadracel/no AE; Initial information received on 10-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  It was reported that 15 month old female patient was given  DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL]./no AE (product administered to patient of inappropriate age) on 27-Dec-2019 for prophylactic vaccination [lot C5656AA; expiration date : 31-Aug-2021; dose: 0.5 ml; administration site: right thigh and route of administration not reported].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE [HEPATITIS A] and HIB (PRP/T) VACCINE [ACT-HIB]  It was a actual medication error case due to inappropriate age at vaccine administration.  At the time of reporting, no adverse event 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.
Information has been received from a vaccine provider concerning a 9 year old  female minor with no pre-existing allergies, birth defects or medical conditions who on 28-MAY-2008, at 3:30 p.m., was vaccinated subcutaneosly in the left arm with a second dose of VARIVAX (Merck) (Lot #658408/1177U). On the same day, the patient also received a first dose of concomitant vaccination HAVRIX (Lot #AHAVBZ35BA). There was no illness at time of vaccination. On 29-MAY-2008 the patient developed cellulitis in the left arm, left upper arm dorsal aspect erythema patch with induration around the injection site (from shoulder to elbow). On 05-JUN-2008 the patient recovered from the events. Additional information is not expected.
fever 101.1, chills, sensitive skin, muscle aches, headache, fatigue
This is a booster shot (Moderna) after the 2 initial doses of Pfizer (02/16/21 EN6200 and 03/09/21 EN6208). The urgent care Dr. that checked me suggested I fill this form. Besides the standard side-effect symptoms that I experienced on Saturday 20th (fever over a 100, joint and body aches, fatigue, headaches, etc) I have swollen eye that covers half of my eye and discomfort around the area. Additionally I have tenderness and a bit of pain under my arm-pit of my right arm (where the booster shot was administered). I was suggested to try Benadryl for the first few days, but if symptoms get worse, to return immediately.  I have a swollen eye that closes
Reporter was giving client influenza vaccine. When administering, vaccine shot backward out of hub of needle instead of through the needle into patient arm. Patient received less than 25% of vaccine. Was revaccinated.