chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she had Shingles as she felt like it was burning and stinging; she had Shingles as she felt like it was burning and stinging; she had Shingles as she felt like it was burning and stinging; Initial information was received on 02-Mar-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (Inquiry Number: 00500312).  This case involves a 71-year-old female patient who experienced she had shingles as she felt like it was burning and stinging (herpes zoster, burning sensation and pain), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious she had shingles as she felt like it was burning and stinging (herpes zoster, burning sensation and pain) unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome is unknown.  There will be no information on batch number for this case.; Sender's Comments:  2021SA073715: 00500312:
Influenza vaccine administered 12/2/13. 12/3/13 at 1AM woke up with headache, lip edema, tight throat, eye edema with watery eyes. Rx with BENADrYL at home - seen in employee health 12/5/13.
Patient reported "shingles-like rash" on inner left thigh. Redness, pain to the touch, and eventual blistering. Does not remember specific dates, but it started in early October and lasted a "few weeks".
Patient is 16 years old, and Janssen/Johnson and Johnson covid-19 vaccine is not approved unless you are 18 years or older.
had a little side step/unbalance moment; left hand started tingling/tingling in left foot and left side of face; neck on left side felt like someone had hit it; injection site and whole deltoid was numb.; Left side of face, left foot and left ear all felt numb but with tingles; This is a spontaneous report from a contactable other HCP (patient). A 48-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL0140), via an unspecified route of administration in Left arm on 28Dec2020 16:30 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at workplace clinic. Medical history included known allergies to food - vegetables, berries, shellfish, environmental. Concomitant medication in two weeks included desogestrel, ethinylestradiol (MIRCETTE), fluticasone propionate (FLONASE), iron, multi vitamin, elderberry w/z. The patient previously took benzoyl peroxide and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient waited 20min, went up to leave and while walking out had a little side step/unbalance moment. The patient thought nothing of it and went to car and was waiting in car for an extra 10 min. Her left hand started tingling, same tingling like if it was asleep and was waking up. Then she started to drive home, on the way home, noticed tingling in left foot and left side of face, neck on left side felt like someone had hit it. About 50 min after receiving injection, was at home, injection site and whole deltoid was numb. Left side of face, left foot and left ear all felt numb but with tingles. She had stopped timer after 2 hours. Tingling and numbness subsided sometime after 2 hours of receiving vaccine. Today (29Dec2020), everything felt fine. Injection site just felt like I got a shot, can barely notice it. Adverse event start date provided as 28Dec2020 05:15 PM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on 29Dec2020.
Fatigue, joint pain, fever/chills x 24 hours starting 04:00 on 01/22/2021
I developed a rash, redness, bumps, severe itchiness.  The rash has lasted for over 2 months, will come and go, on and off again.  Will be all over the body in different places, then will go away and go somewhere else on the body.
Event: Shingles Signs: Rash and pain from left thigh through left groin area and left hip Treatment: Valacyclovir HCL and Meloxicam Time Course: Rash cleared by 04/22/2021 but pain continued
2 days after taking 2nd pfizer shot my dad woke up saying something was wrong with his legs.  He said they were like noodles and he had no strength in them.  He had trouble walking as they were giving away on him.  He continued to have good days and bad days.  Bad days gradually worsened.  He had to stop driving as he doesn't know when his legs will give out.  In fact, 2 men had to carry him back from the gas station restroom to the car where my mom was waiting as his legs totally gave out on him one day in September 2021.  He went to his primary care dr but he did not do anything to help and refused to report the vaccine injury.  My parents  pushed primary care dr more and he finally sent my dad to physical therapy.  Physical therapy did not help very much.  My mom decided he needed to see a neurologist.  She made the appointment directly as his primary care dr approval was not required.  He went to neurologist, Dr, on 9/27/21.  She ran lots of tests.  Results of wrap up visit to Dr in Jan 2022 -  Dr said he should have plenty of strength in his legs and she is not sure why he is having problems given nothing unusual in his test results.  She said she could send him to Hospital for further testing but he refused as it is too hard on him to get around to doctors offices and hard on my mom to take him.  He still has problems walking and we feel this needs to be reported as a vaccine injury.  Dr did say his heart rate was low so he is going to a cardiologist now for further help with his heart.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient with diabetic. The reporter was not certain regarding the patients medical history. On 04-NOV-2014 the patient was vaccinated with ZOSTAVAX (lot # K008881, expiry date: 20-SEP-2015, 0.65 ml, subcutaneous posterior right upper arm). Concomitant medical history was unspecified by reporter. On 05-NOV-2014 the patient began to experience being light headed and just not feeling right. The reporter stated that the patient called on 06-NOV-2014 to ask her if she should consult her physician about these events. The reporter stated that the patient has felt like this in the past. The reporter also stated that the patient called her while at work, and she has not experienced any loss of consciousness. The reporter did not notify her physician about this adverse experience also did not think that the patient was experiencing a rash. No treatment was given for the events. The outcome of the events was reported as not recovered/not resolved. The causality was unknown. Additional information has been requested.
bilateral lymph node swelling in axilla. Resolved after 1 week. today (2/15/2021) requesting I report this
Swollen arm and very sore from injection site down to elbow. Soreness and redness started roughly one hour after injection. Pt took advil for pain.
On 4/15/2021 patient presented with chest pain and left lower extremity pain, which started about 2 days prior to admission.  CTA showed large volume multifocal bilateral pulmonary emboli throughout numerous right lower lobe, right middle lobe, right upper lobe, left upper lobe, and left lower lobe segmental branches.  Left lower extremity venous ultrasound showed no evidence of deep or superficial vein thrombosis; the right lower extremity was not scanned.  Patient denies personal or family history of VTE.  She states that she does not smoke and has no history of smoking.   Patient was treated with apixaban 10 mg po BID x7 d followed by 5 mg po BID.  Platelets were 295 on admission.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2016, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated at the same medical center (not specified if admitted; therefore considered an Emergency Room visit until follow-up is received) for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
fever greater than 102 degrees F chills fatigue body aches nausea swelling, redness and pain at injection sight
A report was received from a healthcare professional on 09/30/2003 concerning a 75 year old female vaccinee who experienced itching of both feet 3 days after, and swelling of the feet, blistering of the feet and weeping of the feet 4 days after receiving Fluvirin on 09/25/2003.  On 09/28/2003 the vaccinee developed itching of both feet, which progressed to swelling, blistering and weeping on 09/29/2003.  There was a mild improvement on 09/30/2003.  The vaccinee was self-treating with warm soaks.  The reaction involved the distal portion of both feet, (tarsals/metartals) and dorsal and plantar surfaces of both feet.  The vaccinee had not recovered at the time of the report.  There was insufficient information to determine the reporter's causality assessment.   Update 1, 10/07/2003: Follow up information was received from a healthcare professional on 10/07/2003, indicating that the vaccinee's feet had improved but were still itchy.  On 09/30/2003, the vaccinee was prescribed one Methylprednisone dose pack.  The vaccinee is currently taking Levothyroxine, Atorvastatine, Amlodipine besilate and Estradiol oral therapy.  The vaccinee has no drug allergies and no significant past medical history. Update 2, 10/20/2003: Further information recieved from a healthcare professional on 10/20/2003 indicated that the vaccinee experienced itching and blistering of both feet on 09/27/2003.  Additionally, the vaccinee was currently taking Omeprazole oral therapy.  No follow up pending, all information received.
Patient states that she started experiencing chest tightness, pain, and difficulty breathing. Patient got both Fluzone HD and Pneumovax 23 on the same day.
Had the shingles shot, still get shingles\ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comment: This case was reported via interactive digital media. Reporter asked that people who had Shingles shot can still got shingles without rash did and was very painful. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Additional supportive information: The follow up would not possible as no contact details were available. This case has been linked to the US2022AMR118438 case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR118438:Same reporter
Pain, redness, swelling and firmness Rt 'upperarm' 3"x2 1/2". No fever or chills. Denies cp or SOB. No pruritus. ROCEPHIN gram + IM, KEFLEX 500 mg and BACTRIM DS. 4-1-09 Less redness, swelling, and pain - firmness gone - Tissue is softer. No fever
This spontaneous case, initially received from a pharmacist on 09-Nov-2018, concerns an 85-year-old, elderly female patient. On an unspecified date in the past, the patient had received FLUCELVAX vaccine for an unknown indication and had no adverse events. On 25-Oct-2018, the patient was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250794 and expiry date: 30-Apr-2019]. On 05-Nov-2018, 11 days after vaccination, the patient developed hives on the lower part of left arm which extended to her hand. The patient did not receive any treatment for the events. At the time of this report, the patient had not recovered from the event. The reporter assessed this case as non-serious.
Information has been received from a woman from a pediatric office regarding a 7 year-old female who, on 01-MAR-2001, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 12-MAR-2007, the patient's mother reported that she had developed 10-20 chickenpox spots. It was unspecified if medical attention was sought. Subsequently, the patient recovered from chickenpox. No outcome was reported. Additional information has been requested.
Pt is fully vaccinated and boosted. COVID positive on 5/3.  ED visit on 5/3. Pt presents with dizziness, nausea, vomiting, diarrhea, lightheadedness, cough and congestion.  Patient states that she had pneumonia approximately 1 week ago and has been off antibiotics for 2 days.  Labs reviewed, no significant abnormalities.  Hemoglobin stable at 11.5.  Chest x-ray negative.  EKG with sinus tachycardia, no signs of ischemia and no infarction.  Medications given in ED; fluids, zofran, tylenol, decadron. Discharged home.
This child had a fine rash on her arm , face, back, and neck the next day following immunizations.
This spontaneous report was received from a healthcare worker concerning an unknown number of patients of unknown age and gender. On an unknown date, the patients were possibly vaccinated with doses of an improperly stored ZOSTAVAX (lot number and expiry date reported as J000445 and 11-APR-2014 respectively, dose and route unspecified) that were exposed to -0.3 degree Celsius for 13 days. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
5/6/21 Presented to ED by EMS with SOB and CP, near syncope, N&V
19 days after my 2nd vaccine my period came 7 days earlier. I?ve been spotting blood for the past 7 days. This is not like my normal period, i have not had my normal flow since i began to bleed and  my period is always on time  and usually only last a maximum of 4 day. Im currently on birth control and have not missed any pills. I?ve been on the pill for 5 months and i also took a pregnancy test.
Varicella vaccine administered by subcutaneous route, in pt's left tricep. A 2mm wheal developed immediately afterwards about 1" above injection site which increased to about 10 mm with some redness and slight induration over the next 5-10 minutes. Liquid Benadryl 12.5 ml given PO per Dr and cold pack applied. Mom states symptoms resided readily.
Head nodding and awakening crying X 1 hour, starting 2 days after vaccination.
Left side supraclavicular/infraclavicular/axillary lymph node enlargement starting on Saturday evening after Monday vaccination. By Sunday left arm soreness in area where vaccination was given. No pain in other arm or swelling in right side.
No adverse event; Female patient received a dose of MMRII on 8/14/2020 that had been improperly stored; This spontaneous report has been received from a licensed practical nurse regarding a female patient of unknown age. Her concurrent conditions, known allergies/reactions, and medical history were not reported. Concomitant medications included steril diluent.   On 30-JUL-2020, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MRR II) (lot # S032826 with expiration date 16-OCT-2021; rHA albumin status) had a temperature excursion above 47 degree farenheit (F) (average temperature was 59.1F) for 225 minutes; and on 04-AUG-2020, above 47 F (average temperature was 51.36F) for 59 minutes. On 14-AUG-2020, the patient was vaccinated with the improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MRR II) (dose regimen and route of administration were not reported) for prophylaxis (product storage error), which was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot# and expiration date were not provided). The call was due to a digital data logger. No additional adverse events were reported.
Patient reported feeling nauseous and light-headed post-vaccination. EMS evaluated patient and gave him water.   6/1/21: 11:37am - TC to parent. No answer. left message to call back. - RN   6/1/21: 12:22pm - Mom returned call. Child doing fine. No concerns or questions. - RN
pruritus spreading erythema of inject site finally involves 10 x 5 cm area lt upper arm; rx w/ Hismanal;
sick; lethargic; This is a spontaneous report from a contactable consumer via a company representative This is the first report for one of two female patients. A female patient received Pfizer COVID-19 Vaccine BNT162B2 on an unspecific date at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient experienced sick and feeling lethargic. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021384159 Same reporter/drug/event, different patient.
extreme exhaustion; cannot get out of bed and is sleeping all the time; had normal pain at her injection site; slight fever; some joint aching; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 62-years-old female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number and Expiry date was not reported) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. It was reported that patient was experiencing extreme exhaustion. She had to call in sick to work as she was not able to get out of bed and was sleeping all the time. She wanted to know if this was normal and if it might be the same after her second vaccine. She states she had normal pain at her injection site, a slight fever and some joint aching like the flu, but not after the vaccine, but the exhaustion was so not like her as she normally had a lot of energy. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a consumer refers to her approximately 1 (currently 5 years old) years old daughter with no pertinent medical history and no drug reactions or allergies who about four years ago, in approximately 2008, was vaccinated with a dose of M-M-R II (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that about four years ago, in approximately 2008, when her daughter received M-M-R II, she turned purple had a bad rash and was sent to the hospital. At the time of the report, the patient's outcome was unknown. The relatedness for patient turned purple and had a bad rash was unknown for M-M-R II . Additional information has been requested.
Starts at 12 hour mark then I get fevers, then cold chills and then vomiting
A non-serious spontaneous report of received expired vaccine was received from a health professional concerning a 29-month-old female. Neither medical history nor concomitant medication was reported for this patient. The FLUMIST expired on 29-Nov-2010. On 12-Dec-2010, the patient received the expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Seen in office.  1 wk later 2nd HPV c/o, pain R arm and R side chest pain.  Pain with deep insp & cough.
Information has been received from an office worker who reporting herself. On 02-AUG-2011 she was vaccinated with ZOSTAVAX (Merck). 2 days after (on approximately 04-AUG-2011) she was given ZOSTAVAX (Merck), she developed a tremendous itching. On 16-AUG-2011 (two weeks after she was given the vaccine) she was still itching. Follow up information received on 26-AUG-2011, the 70 year old patient with a history of nymphectomy surgery in 1994 and ZYVOX allergy called to report that after receiving ZOSTAVAX (Merck) SQ on 04-AUG-2011 she experienced severe itching. Concomitant therapy included ZANTAC OTC. On 04-AUG-2011, 48 hours after the patient received ZOSTAVAX (Merck), the patient had been unbelievably itching and the antihistamine she was treated with had done nothing. It had been 4 weeks and the patient was still itching. The patient had had severe itching on her back, forehead and scalp. The patient had intermittent itching on other parts of her body, as well. The patient sought medical attention by contacting physician. Patient also reported that she had an unspecified severe reaction to ZYVOX (manufacturer unknown). She stated, "I had to be hospitalized and received IV treatment. It was terrible". Additional information has been requested. This is one of several reports received from the same source.
No additional AEs; Vaccine administered on 2/3/23 while improperly stored during temperature excursion; This spontaneous report was received from a nurse and refers to a 69-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 03-FEB-2023, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) formulation not reported however upon internal review established as pre-filled syringe, 50/1.0 u/ml, 1.0 ml, once, lot #W017819, expiration date: 27-DEC-2023 (administration site, and route of administration were not provided) administered for prophylaxis (product storage error). There were multiple temperature excursions on 03-FEB-2023. No additional adverse event was reported (no adverse event).  This is one of multiple reports received from the same reporter. ; Sender's Comments:  US-009507513-2302USA004298: US-009507513-2302USA004552:
Immediately after receiving my vaccine, I felt a burning in my lungs. I have had asthma my entire life, so I figured that was why. Within two weeks, I developed a severe outbreak of shingles on my face and my head. At the same time I developed pneumonia. I ended  up hospitalized Winter Haven Hospital in Winter Haven As of today, I still have shingles, but the pneumonia has cleared.