chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HAD TINGLING SENSATION (LT) FRONTAL SCALP AREA THE END OF WEEK (8/2/10), REDNESS AND BUMPS PRESENT 8/9 ALONG WITH SENSITIVITY TO (LT) SCALP AND LEFT UPPER QUADRANT OF FACE.  EYE RED AND SWOLLEN WITH DRAINAGE.  WENT TO PCP ON 8/11 WHO DIAGNOSED CLIENT WITH SHINGLES.  REFERRED HER TO OPHTHALMOLOGIST TO BE EVALUATED D/T EYE INVOLVEMENT.  DR. REFERRED HER TO EYE SURGEON D/T INVOLVEMENT WITH EYE.  CLIENT STATED DR DID SWAB EYE.  UNSURE IF CULTURES WERE OBTAINED.  SHE WAS SEEN BY ALL 3 DRS ON 8/11.  WAS PRESCRIBED VALTREX TID X 7 DAYS-TOOK 1ST DOSE 8.11.  TAKING OTC PAIN RELIEVERS FOR THE DISCOMFORT.  TODAY STILL HAS SENSITIVITY TO AFFECTED AREAS AND SWOLLEN, DRAINING EYE.  EYE SURGEON INSTRUCTED CLIENT ON HOW TO CARE FOR EYE AND TO RETURN IF IT WORSENS.  CLIENT AND MOTHER RECEIVED VACCINE ON 2/4/09.  MOTHER HAD SHINGLES SUMMER 2009 SAME AREA OF FACE/SCALP.  INSTRUCTED CLIENT TO CALL IF CONDITION WORSENS.
Information has been received from a consumer concerning her 77 year old mother with a history of pneumonia, bronchitis and vaccination who on 11/13/03 was vaccinated with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included hydroxyurea. The reporter noted the patient had received a dose of pneumococcal 23v polysaccharide vaccine in  March 2003 and was erroneously re-vaccinated. Subsequently, the patient developed severe pulmonary trauma. Soon after the vaccination, the patient developed high fever and emesis. Medical attention was sought and treatment was required. On 11/21/03, the patient was admitted to the hospital and subsequently admitted to an intensive care unit. While hospitalized, the patient exhibited chills, headache, emesis, fever, tachycardia and pneumonia. The patient was intubated multiple times to remove fluid in her lungs before a tracheotomy was performed to facilitate intubation. Toxicology screening was performed. At the time of the report, the patient had not recovered. The reporter indicated an onset date of 11/17/03. The reporter noted that therapy with pneumococcal 23v polysaccharide vaccine was discontinued. A product quality complaint was not involved. The reporter considered the patient's experience to be disabling and life-threatening. Additional information is not expected.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 19-OCT-2012 13:11, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old female patient who received Shingrix (batch number M77B4, expiry date August 2019) for prophylaxis. On 8th August 2018, the patient received the 1st dose of Shingrix (intramuscular). On 8th August 2018, less than a day after receiving Shingrix, the patient experienced pain in arm. On 10th August 2018, the patient experienced tingling and numbness. On 11th August 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the tingling and numbness were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, tingling and numbness to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the right deltoid. Two days, after receiving Shingrix, the patient had developed numbness and tingling that was progressed from her midsection down to her toes. The patient had an appointment with her physician on Friday and all of her reflexes were fine. The patient called back and provided lot number and expiration date. The patient also called her previous physician and he told her that numbness and tingling were the top 5 side effects for Shingrix and that he was aware of 3 nurses that had the same side effect. This case was 1 of the cases, reported by same reporter.
This spontaneous report as received from a registered nurse refers to her son, a currently 18 year old male patient with no drug reactions or allergies. The patient's concurrent conditions included Langerhans cell histiocytosis with a low absolute neutrophil count and a low overall white blood cell count. Information regarding concomitant medications was not reported. In approximately September 1999 (reported as "at 15 months of age"), the patient was vaccinated with M-M-R II (therapy type, dose, route of administration, lot # and expiration date were not reported) as routine vaccination. On an unknown date, the patient developed a measles rash, conjunctivitis, pneumonia and a fever of 104 Fahrenheit degrees "for over a week". The reporter stated that her son had multiple visits with the pediatrician following development of these symptoms, and he received acetaminophen (manufacturer unknown) and ibuprofen "altering every 2 hours around the clock". He was also prescribed unspecified antibiotics during this period of time. She stated that the pediatrician said this was the second time they had seen this in 25 years of practice. On unknown dates, the patient also suffered long-term neurological damage from the events described above, and he had sensory-processing issues, difficulty with memorization and fine-motor control issues. The outcome of the events was unknown. The relatedness between the events and M-M-R II was not reported. Upon internal review, the events of measles and pneumonia were considered to be medically significant. Additional information has been requested.
extreme swelling, redness, itching, hives, all over  face, eyes, ears, neck
Right arm sore, itching, swollen, bright red, hot to touch, very painful to touch, restricted motion. lasted approx 1 week.
Neuropathy in feet and thighs after 1 week following vaccination. Dizziness, nausea, vertigo, weakness after 2 months following vaccination.
On the evening of 2/10/07 she noted swelling of 2 lymph nodes. She saw the doctor on 2/14/07. On 2/16/07 pt notes decreased in size of lymph node.  Tenderness at site resolved. No redness.
itchy rash all Over body; This is a spontaneous report from a contactable patient. A 63-year-old non pregnant patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history of the patient included breast cancer, psoriasis and rosacea. The patient was allergic to Senna laxatives. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 16Mar2021 13:30 as a single dose for COVID-19 immunisation. Concomitant medications include Anastrazole (MANUFACTURER UNKNOWN) and Synthroid (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. Prior to the vaccination the patient was not diagnosed with COVID-19.  Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Feb2021, 3 days after the first dose of vaccination, the patient experienced itchy rash all over body, thought it was hives. Rash continued and second shot was received. Rash became worse on an unknown date, and 2 weeks after second rash and with 6 days course of steroids, rash was still present and worse as steroids tapered. The adverse event led to doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken for the adverse events and it included treatment with Zyrtec and steroids from an unknown date. The clinical outcome of the event itchy rash all over body and rash became worse was not resolved at the time of reporting.   No follow-up attempts are possible; information about lot number cannot be obtained.
Back pain in lumbar vertebrae.  Several months later I still have this and now have severe knee pain in my left knee.
Red band on Biceps measured 6.5" X 3" today; Stiff Injection Site; Burning/Stinging sensation at the injection site; Sore Injection Site/Burning/Stinging sensation at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red band on Biceps measured 6.5" X 3" today), VACCINATION SITE MOVEMENT IMPAIRMENT (Stiff Injection Site), INJECTION SITE WARMTH (Burning/Stinging sensation at the injection site) and VACCINATION SITE PAIN (Sore Injection Site/Burning/Stinging sensation at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced ERYTHEMA (Red band on Biceps measured 6.5" X 3" today), VACCINATION SITE MOVEMENT IMPAIRMENT (Stiff Injection Site), INJECTION SITE WARMTH (Burning/Stinging sensation at the injection site) and VACCINATION SITE PAIN (Sore Injection Site/Burning/Stinging sensation at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Red band on Biceps measured 6.5" X 3" today), VACCINATION SITE MOVEMENT IMPAIRMENT (Stiff Injection Site), INJECTION SITE WARMTH (Burning/Stinging sensation at the injection site) and VACCINATION SITE PAIN (Sore Injection Site/Burning/Stinging sensation at the injection site) outcome was unknown. Not Provided          No concomitant medications were reported.
smelling something that is not there/having a funny thing in her nose called phantosmia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), administration date 28Feb2021 (Lot number: EN6205, Expiration Date: 30Jun2021) at the age of 80 years as dose 2, single and administered in arm left, administration date 07Feb2021 (Lot number: EL9264, Expiration Date: 31May2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blockage in legs" (ongoing); "thyroid" (unspecified if ongoing); "esophagus" (ongoing). Concomitant medication(s) included: OMEPRAZOLE taken for oesophageal disorder (ongoing); ATORVASTATIN CALCIUM taken for limb discomfort (ongoing); BAYER CHILDREN'S ASPIRIN; NORVASC (ongoing). The following information was reported: PAROSMIA (non-serious) with onset Aug2021, outcome "not recovered", described as "smelling something that is not there/having a funny thing in her nose called phantosmia". Therapeutic measures were not taken as a result of parosmia.  Additional Information: She is calling about Pfizer covid shot. She does not think she has ever had covid. Two days ago she started having a funny thing in her nose called phantosmia, it is smelling something that is not there. It comes and goes. She was trying to read something that a doctor put into the oxford press, an article about the effects after the covid shot. Is there such a thing as phantosmia.  She called her primary's office and was told they never heard of it. States she might have got a breakthrough and thinks she may spread it if it is in her.  States she is having a time this morning when looking at the aspirin bottle. She takes a thyroid medication every morning and does not have it handy to provide the name, has been taking for a couple of years. She requested to be transferred for her question. States it may be nothing and wants to know if she is carrying covid and does not want to give it to anyone. She does not feel sick. She has this strange thing in her nose and does not know what it is. She does not know if she needs another test. She thinks the phantosmia started Monday or Tuesday, thinks it started Monday.  Treatment has been declines. She takes vitamins. States she is having a time this morning when looking at the aspirin bottle. She takes a thyroid medication every morning and does not have it handy to provide the name, has been taking for a couple of years. States she is having a time this morning when looking at the aspirin bottle. She takes a thyroid medication every morning and does not have it handy to provide the name, has been taking for a couple of years. She could not locate the strength on the Bayer Aspirin bottle. States everything is so small. There is so much written and did not see the strength at first, she was looking for printing and then was able to locate strength of 81mg.  No follow-up attempts are possible. No further information is expected.
Started with feeling a brick on my chest. Them my ribs hurt. Every breath hurt and I couldn?t take a deep breath. The pain spread all across my ribs and up my chest. It hurt to the touch.
Information has been received from Pfizer and was assigned manufacturer report number 2014360492 for PREVNAR 13. This was initially reported by a consumer and refers to a male patient of unknown age. No pertinent medical history was reported. On an unknown date the patient went to the pharmacy and asked for PREVNAR 13, since they did not have it, the patient was PNEUMOVAX 23 (wrong vaccine administered). There were no concomitant medications reported. The patient queried if the vaccines were the same. Thereafter patient was informed that PNEUMOVAX 23 was a different product and worked to stimulate the immune system differently. The outcome of wrong vaccine administered was unknown. It was referred to a physician to discuss if the patient had already received the vaccine. Additional information has been requested.
She went into SVT the next day and required adenosine and was started on a beta blocker.  Holter monitor was ordered and referred to cardiology.
1st Shingrix on 25May2018 2nd will be today (01Aug2022); This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in an unknown arm intramuscularly on 25th May 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 01-Aug-2022 Reporter's comment: The reporter reported that he and his wife both had received the 1st dose of Shingrix vaccine. The reporter reported that they were not told that they need a 2nd dose of Shingrix vaccine to complete the series. The reporter stated that they would go on the day of reporting for their 2nd dose. The reporter did not gave consent to contact health care professional, but welcome to contact him and his wife. This case was linked to the case US2022113789, reported by the same reporter for himself. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022113789:Same reporter
Shot given around 11:15 by 1pm was not able to move right arm. Swelling, redness, thumb and first finger went numb, pain in right breast and under arm, skin could not be touched so tender. Pain moved to left shoulder and client is still not normal.
Erythema(5 x 5cm) and swelling (2 x 2cm) at site;  ice pack applied.  MOC instructed to intermittently apply ice pack on 5-10 minute, off 5-10 minutes. Go to urgent care for dyspnea, or if swelling spreads rapidly.  Call for questions.
CHRONIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 12/19/2022 -- RECURRENCE OF SAME SYMPTOMS
pt had broken out in hives and rash. Pt went to the urgent care and took a steroid. Pt had hives and rash for 6 days.
Morning after receiving first dose had fever (99.6 with touchless thermometer), severe chills, lethargy, diarrhea.  That night had severe sweating.
pt recv vax; exp a rash at inject site; arm was also "red & painful"; sx subsided in 35 mins;
Hearing Loss; other zoster-related conditions; other zoster-related conditions; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions at a medical office. Subsequent to the inoculation (date not reported), the patient was treated by a physician for hearing loss and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event hearing loss and other zoster-related conditions was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, hearing loss was determined to be medically significant.
Severe muscle aches and pain. Fever of up to 104 which did not come down with Tylenol or Motrin. Lasted 24 hours.
Excessive hair loss began; This is a spontaneous report from a contactable consumer. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Mar2021 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included Human Immunodeficiency Virus (HIV) positive. The patient was allergic to shellfish and Penicillin (PCN). Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Mar2021 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, about 1 week after vaccination, the patient experienced excessive hair loss. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with ketoconazole. The clinical outcome of the event excessive hair loss was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv vax 26APR96 & 11MAY96 pt exp easy bruising & petechial skin eruptions;pt recv exam 15MAY96;16MAYlab eval revealed low platelet count 26,000 & pt hosp;w/tx platelet count rose to 103,000;1wk later platelet count 563,000;
Pt had an episode of vomitting  while sitting down in the observation hall. She was taken to a cubicle inside the hall for further observation. The stomach content w as mainly water and undigested food particles. Pt. remained A&O x4 and verbal. She c/o no pain, dizziness or respiratory distress. V/S obtained was b/p 121/81, rr16, Hr. 97, temp 96.9, O2 98% RA.At 12:50 p m Pt.said she felt well and ready to go home. She left  unassisted in the company of her mom.
Soreness in the left arm where the shot was given but after a few days it did not go away. My left arm is still sore but today I started having some pain in my arm where the shot was given. I am going to call my new doctor tomorrow and make an appointment for this as well.
6/2/23 From client and reports that awoke on 5/31/23 after getting a Tdap on 5/30/23, with hives on both legs tht are itchy and also at the injection site it is swollen and hard and sensitive to touch. Reports that since then has not had any worsening or improvement. Planned to take Benadryl tonight. Denies any difficulty breathing, wheezing or any other issues. Discussed local reaction and to put cold packs on site regularly and ibuprofen for the discomfort. Explained that this can be a normal local reaction and should start to improve in a few days. Does not have a PCP and will speak to Dr. about recommendation for antihistamine. NKA. Discussed that in the future if needs a tetanus to speak to Dr. prior to getting and get it in a clinic that has a Dr. present in case of worsening reaction. Emphasized that if worsens or at all has any breathing problems needs to get to the ER immediately and v/u. VAERS completed.
Patient reports respiratory  difficulty. Pt attended by emergency medical personnel. Pt is anxious, sweaty, he presented hypertension and then hypotension. VS 160/100, P 64, Sat 92% without o2 P62, 99% sat with 02 was performed and Pt will be transferred to Hospital.
Temp 100, slept 2 hrs after taking ibuprofen then constant severe muscle pain/aches, chills, headache, extreme fatigue, queasy stomach the rest of the night & following day.
Being confused; having cold chills; fever; nausea; Lot of headache; Arm was hurting; I couldn't sleep all night; sweating a lot; Fatigue; A spontaneous report was received from a 62-years-old male patient concerning himself who received Modern's COVID-19 vaccine (mRNA-1273) and experienced arm hurting, couldn´t sleep at all night, sweating a lot, having cold chills, suppose  had a fever, nausea , chills and fatigue, being confused and having lot of headaches.  The patient's medical history was provided. as diabetes. No relevant concomitant medications reported.  On 19 Jan 2021, prior to the onset of the events, the patient received the first dose of two planned doses of mRNA-1273 (lot/batch:011L20A) via unknown route of administration and unknown anatomical location for prophylaxis of COVID-19 infection.   On 19 Jan 2021, the patient developed arm hurting, couldn´t sleep at all night, sweating a lot, having cold chills.   On 20 Jan 2021, patient experienced suppose had a fever, nausea, chills and fatigue, being confused and having lot of headaches.  Treatment information provided was Tylenol (acetaminophen).  Action taken with mRNA-1273 in response to the events was not reported.  At the time of the report, the outcome of events arm hurting, couldn´t sleep at all night, sweating a lot, having cold chills, suppose  had a fever, nausea , chills and fatigue, being confused was unknown and having lot of headache was considered recovered.