chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the long-term prevention of singles and zoster-related conditions. Subsequently on an unknown date, the patient was treated for hearing loss. As a direct and proximate result of the patient's receipt of zoster vaccine live (ZOSTAVAX), the patient continued 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 medical losses and costs included care for hospitalization, physical 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 was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event hearing los was considered to be medically significant.
Patient states that adverse event began 6 hours post vaccination. Patient states she was unable to get out of bed even to use the bathroom. Patient states that her legs hurt so bad that they felt "broken". Patient experienced extreme fatigue in addition to the lower limb pain. Patients right arm did become red from shoulder to elbow and has recovered to approximately 2 inch diameter redness at 1 week post vaccination. Patient denies any fever post vaccination. Patient did not take any pain medication during event.  Patient did not follow up with doctor or vaccination clinic regarding  these events until 5/12/22, seven days post vaccination, where she discussed with pulmonologist at pre-scheduled appointment. Patients symptoms have resolved as of date of report. Patient states that previous doses of vaccine did not cause any adverse events. Patient has never had adverse event prior to this with any other vaccine.
inconsolable; pain; crying; body twitching; This case was reported by a physician via call center representative and described the occurrence of emotional distress in a 18-month-old female patient who received DTPa (Infanrix) (batch number 2C7F9, expiry date 9th February 2021) for prophylaxis.   On 15th October 2019, the patient received Infanrix. On 15th October 2019, less than a day after receiving Infanrix, the patient experienced emotional distress, pain, crying and muscle twitching. On an unknown date, the outcome of the emotional distress, pain, crying and muscle twitching were recovered/resolved.   It was unknown if the reporter considered the emotional distress, pain, crying and muscle twitching to be related to Infanrix.  Additional details were provided as follows: The patient received Shingrix and felt inconsolable, pain, crying and body twitching. The side effects lasted for 72 hours and resolved. The reporter consented to follow up.
the vaccines were "short dated" and a new expiration date of 6/30/2023 was given. She states that the products were labeled but still accidentally administered; vaccine with expipratio date 16-NOV-2022 administered on 30-JUN-2023; Caller reports that they had a temperature excursion 3/31/2023; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-JUN-2023, the patient was vaccinated with  "short dated"  and expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #W031816, expiration date: 16-NOV-2022, administered for prophylaxis (strength, and route of administration were not provided) (Product expiration date issue and Expired product administered). This vaccine underwent temperature excursion on 31-MAR-2023, for 4 hours in 6 degree Farenheit to 14 degree Farenheit, 4 hours in 14 degree Farenheit to 46 degree Farenheit and for 3 hours 57 minutes in 47 degree Farenheit to 77 degree Farenheit (Product storage error). No additional adverse event was reported.
Numbness approximately 4.5" inferior to the injection site. Still experiencing on 4/5/21. Warmth at injection site, still experiencing. Swelling, severe pain to the point of not wanting to use the arm of injection to open his car door, muscle spasms in arm of injection
Information has been received from a physician concerning a male patient who on 07-JUL-2008 was vaccinated with his first dose of VARIVAX (Merck) (lot # not reported). On 16-AUG-2011, the patient was vaccinated with his second dose of VARIVAX (Merck) (lot # not reported). On 22-MAY-2012 the patient was diagnosed with breakthrough varicella with less than 50 lesions. The patient had sought medical attention by visiting the physician's office. At the time of this report, the patient was recovering from the event. Follow up information has been received from an other health professional who concerning a 4 year old male patient with siblings of 2 who on 16-AUG-2011 (at 09:45 am) was vaccinated SC on right arm with the second dose of VARIVAX (Merck) (lot # 670180/0435AA). Other suspect therapy included MMR II, which was vaccinated SC on left arm with the second dose on 16-AUG-2011 (at 09:45 am). Concomitant therapy included KINRIX which was vaccinated IM on left arm with the first dose; and influenza virus vaccine (unspecified) which was vaccinated intranasally with the first dose. The concomitant therapies were vaccinated on 16-AUG-2011 (at 09:45 am). The reporter stated that the patient had breakthrough varicella with less than 50 minutes. There was no illness at time of vaccination. The patient required doctor visit. The patient was recovered from the event on an unspecified date. No further information is available.
Information has been received from a health professional concerning a female employee who on 7/24/97 was vaccinated with a dose of MMRII. The pt was also vaccinated with a 1st dose of MMRII as a child. Subsequently, in approx. 1997, the pt failed to sero-convert. Unspecified medical attention was sought. Additional info has been requested.
Noticed abnormal fussiness and nursing problems beginning in early June.  Jerky seizure movements and abnormal fussiness which was later diagnosed as infantile spasms.  Spasms first noted on June 20, 1997 and diagnosed on June 27,1997.  Treatment began on June 27, 1997.  Treatment included valproic acid and vigabatrin followed by ACTH which was followed by Cortef.  Cortef was tapered until September 15, 1997. The 60 day follow-up states "seizures, severe mental retardation, autism, and visual disturbances." Also diagnosed with Autism and severely mentally retarded.
Received 4 mo. vaccines on 9/11/13. MOC called reporting increased sleep and fever 100.4 on 9/12/13 - early in day. In PM of 9/12 pt was projectile vomiting. Triaged in office by doc who sent to ER for eval/OBS. AGE dx - started on rehydration in ER. Abd. X-ray normal - ruled out intussusception.
Left arm with 7 1/2 x 5 1/2 cm induration; approximately 5 x 4cm erythema at small pastular site; (+) tender to touch
Shortly after receiving vaccine patient began experiencing dizziness, nausea, fatigue and headaches. Later that night started coughing and then woke up the next morning with a sore throat.
Covid19 breakthrough.  1st vaccine received on 06/17/2021.  36 y/o PMHx HTN, HA presents to ED for dyspnea on exertion, fatigue, body aches.  Pt was initially diagnosed with Covid 19 on Jan 23rd, 2022 and symptoms improved but in the past week have returned and pt feels much worse. Pt found to have elevated D-dimer, cardiac enzymes and LFT's.  No decadron or Remdesivir at this time per MD.
The morning after the immunization I felt "not well" which rapidly changed to being very ill. I quickly left work while becoming increasingly weak, afraid by legs would not be able to get me to my car. I was quite ill for 48 hours, with significant body aches, weakness, fever, headaches. After 48 hours the leg weakness and fatigue persisted for approximately 6 weeks.  I now experience intermittent fatigue and leg weakness that last weeks at a time. I am currently in week 7 of an episode of leg weakness and fatigue. I also experience stiffness in my spine and neck and headaches.
Client was given a PCV13 vaccine which was intended for the sibling.  No adverse effects were noted.
This spontaneous report received from a patient via a company representative concerned a 45 year old of unspecified sex.The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 and expiry: UNKNOWN) dose was not reported, administered on 19-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-NOV-2021, the patient experienced stomach pain. On 19-NOV-2021, the patient experienced left arm felt hot compared with rest of the body. On 19-NOV-2021, the patient experienced pressure in head. On 19-NOV-2021, the patient experienced left arm soreness. On 19-NOV-2021, the patient experienced headache.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The outcome of the stomach pain, headache, left arm felt hot compared with rest of the body, left arm soreness and pressure in head was not reported. This report was non-serious.
Patient felt nauseous, lightheaded, and with cold, clammy sweat. Patient was instructed to remain seated with head lowered in between his knees. EMT monitored his BP and it was not elevated per EMS.
Information has been received from a health professional concerning a unknown number of patients who on an unknown date were vaccinated with the first dose of VARIVAX. Subsequently, an unknown number of patient's developed chickenpox after received their first dose of VARIVAX. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. All telephone attempts to contact the reporter have been unsuccessful. The health Care Professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, lot number, date of event, recovery status, healthcare provider name and contact information. No further information is available at this time.
Hospitalization for bacteremia (also COVID-19 positive) on dates  8/17/2022-8/23/2022.  Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
25 week gestation infant of 4 months of age had 2nd set of vaccines on 9-13-07. He had a mild runny nose, loose stools, no fever, eating well. On 9-17-07 fever, fussy, decrease appetite. CBC showed platelets at 28,000 ---> then down to 14,000.  10/15/2007 MR received for DOS 9/16-19/2007 for D/C DX of Sepsis, Gastroenteritis, Thrombocytopenia most likely from sepsis.  Child initially presented with fever, fussiness, and intermittant diarrhea. Initial Platelets counts of 28,000 and 26,000 so pt was transfered to a higher level of care hospital.   No overt signs of bleeding noted. Heme/Onc consult with PE (+) for petechia on the upper extremities mainly around IV sites.  No other bruises or lesions noted.   Platelet transfusion given at transfer facility.  Diarrhea resolved during hospital stay.  Txd with abx and iron supplementation.
Approximately 9:00AM rec'd shot on 11/3/08. Around 4:00 started feeing sick, chills down spine, aching. Condition got worse with fever of 101. Called Dr, he said to take 2 Tylenol this was around 7PM-Had taken 2 Advil's around 5:00 too. Sick all night. Armpit started swelling, and hurting that evening too. Continued with Advil and Tylenol all day Tuesday. Wed AM went to Dr. office. He stated I was having a reaction to shot. Gave Cephalexin 500mg and Hydrocodone APAP5-500. Had fever of 102 deg through Thursday 11/6/08. With a lot of pain in armpit and redness and fever at shot site, area of redness size of palm of hand. Lack of energy and weakness continued through Saturday 11/8/08. Arm is still sore today 11/14/08.
Hives, scratchy throat/mouth/lips, burning/stinging eyes and body, hard to swallow. Went to the ER to received treatment. Pt recovered from reaction.
G47.33 OBSTRUCTIVE SLEEP APNEA 8/14/2023 CHEST PAIN
Pt developed scratchy throat and tingling to his tongue approx 20 mins after vaccination. Monitored in obs then transported to local ED via EMS. Stable vitals, BP 148/108, pulse ox 98% RA, P87; ED Update: don't see any notes in patient chart
-headache (24 hrs) -severe chills (4hrs) -fever (24hrs) -cold sweating (24hrs)  i took tylenol to help put off some of the side effects, but I was in a lot of pain between the chills and the headache.
Facial flushing and heart palpitations after first dose of vaccination lasting approximately 2 weeks.   Palpitations onset approx  5 minutes after receiving second dose of medication.
DETAILS OF HOSPITAL STAY: ADMISSION DIAGNOSES: 1. Intrauterine pregnancy at 37+5 weeks gestation 2. Induction of labor 3. gHTN 4. COVID in pregnancy   The patient is a 23 y.o. female who presented to L&D at 37+5 weeks gestation as a G1P0 for induction of labor for gHTN. Her pregnancy was complicated by diagnoses listed above. Labor course included cytotec, FB, pitocin, and AROM for induction and intrathecal for pain management. Delivery was uncomplicated.   FINDINGS: NEWBORN STATUS: Living  NEWBORN SEX:  boy    WEIGHT: 3.28 kg
Developed adenopathy that did not resolve following vaccine.  Biopsy confirmed follicular lymphoma (Non Hodgkins) 9 weeks after 2nd dose of vaccine
NEXT DAY AFTER BOOSTER DOSE, PATIENT DEVELOPED COUGH, ENLARGED LYMPH NODE BY ARMPIT. PAST 2 MONTHS AFTER BOOSTER SHOT PATIENT COUGH WORSENING, NOW IN HOSPITAL 1/13/22 FROM SPIKED FEVER.
Bad joint and muscle pain; Bad joint and muscle pain; Get a pins and prickling sensation on her left shin; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was unknown) via an unspecified route of administration, administered in left arm on 27Mar2021 (at the age of 51 years) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer COVID vaccine on 27Mar2021, ten minutes after receiving the first dose of the vaccine she started to get a pins and prickling sensation on her left shin and she received the vaccine on her left arm. She rubbed her leg, and it went away but it still comes back off and on, three days later (30Mar2021) she had really bad joint and muscle pain. Caller would like to know if these side effects are normal and what she should do about her side effects if they don't go away. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
reaction on 11DEC92-12DEC92 lt arm very swollen, red from shoulder to elbow; body aches 2-3 days, felt miserable, sl temp by 16DEC92 no signs of reaction;
Flexeril, Mobic , Motrin, medrol given. Right arm..Worsening nerve pain at injection site that started to radiate a few days after the vaccine. Right arm. Sharp throbbing, shooting pain in the entire  arm. Tingling, pins and needle sensation at finger tips, cluster of pain with intensity  at injection site, elbow, under biceps, radiating pain to right shoulder. Spasm of fingers. Severe edema and bloating  in  right leg and knee.  Constant Traveling shooting pain scale 0-10 at ten level.
Onset of numbness/paresthesias of feet bilaterally. 10/27/98; onset fasciculations of calves bilaterally. On 10/29/98, onset exacerbation of carpal tunnel-like symptoms, bilaterally. In 1/99, Weakness/fatigability, low back, buttocks, and hip flexors noted.; 5/99, Motor abnormality of left foot noted; 8/00, Intrinsic muscle atrophy/weakness in both feet noted. Course: Numbness/paresthesias of feet progressed to proximal anterior legs by May/99; noted improvement in legs/feet sensory reactions in 3/00; intrinsic muscle atrophy/weakness in feet persists; have clawfoot-type deformity of left foot; weakness of low back, buttocks-essentially resolved. Note: At time of onset of neurologic symptoms in 10/98, still had tender SQ nodule from AVA.
after I received the vaccine I had a dizzy spell. I went home and was fine but the next morning I couldnt walk. I had excruciating pain in my right leg down to my foot. the strongest pain was coming from my hip. It took about  a day for my leg to stop hurting and then my right arm started hurting. I had pain in my right shoulder, over and down in to the front of my arm. I could not lift my arm. the pain resolved by the end of the next day.
Systemic: Bell's Palsy-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: droopy mouth, jaw pain, all symptoms on left side
Pain and redness after injection. 3 days after injection the injection sight started itching, like a really deep itch and sore to the touch
pt recv vax & was fussy, clear runny nose;5MAY96 t104.7;seen in ER put on ATB devel a rash 2 days later went away 1wk later but a fine rash cont;
warm and has some red color; warm and has some red color; My arm hurt; my arm is where I got my shot because it was discolored.; discomfort in my neck in my lymph nodes; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose, via an unspecified route of administration on 10Mar2021 (Batch/Lot number unknown) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. On 10Mar2021, the patient received the second dose of BNT162B2. The patient stated she haven't really had any real repercussions at all. On 10Mar2021, her arm hurt for the first two days.  In Mar2021, her arm was discolored and she has some discomfort in her neck and lymph nodes. On 15Mar2021, it was warm and has some red color. It's almost a week later after getting the shot. The outcome of events arm hurt, discolored, warm, red color and discomfort in neck and lymph nodes was unknown.      Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a physician refers to a 61 year old female patient. On 15-SEP-2013 the patient was vaccinated with ZOSTAVAX, (lot number, expiry date and route was not reported). Approximately on 15-SEP-2013, the patient developed wide spread petechiae. The patient had a complete blood count on 31-OCT-2013 and was diagnosed with thrombocytopenia. The patient then had a bone marrow biopsy on 01-NOV-2013 which revealed idiopathic thrombocytopenic purpura with no megakaryocytes. The patient sought medical attention (office visit). The patient has been treated with multiple platelet transfusions. The outcome of the reported events were not recovered. All the reported events were considered to be significant disability, life threatening and medically significant. Additional information has been requested.
Very sore , swollen , red arm below injection site. Headache and chills for 24hrs
Pt. reported a metallic taste in mouth immediately upon receiving vaccines. Patient later reported swelling of face and throat. Was treated with steroids.
Patient said he had swollen tongue at night around 8 pm the day he took his flu vaccine, he didn't take any new medication or ate anything different that he remembers of . He took a Benadryl tablet and swelling went down in about 2 hours , he didn't contact his doctor or pharmacy
Slightly sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a patient 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.  It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were reported as this patient self reported the case. The age at vaccination was not reported. The patient received shingles vaccine and experienced just a slightly sore arm for a  few hours. The follow-up would not possible as no contact details were available.
Pharmacist calls in to report administering the second dose of the Moderna Covid-19 vaccine to a patient 6 days early (day 22 based on second dose scheduled at day 28); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pharmacist calls in to report administering the second dose of the Moderna Covid-19 vaccine to a patient 6 days early (day 22 based on second dose scheduled at day 28)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pharmacist calls in to report administering the second dose of the Moderna Covid-19 vaccine to a patient 6 days early (day 22 based on second dose scheduled at day 28)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pharmacist calls in to report administering the second dose of the Moderna Covid-19 vaccine to a patient 6 days early (day 22 based on second dose scheduled at day 28)) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were reported. No treatment medication details were reported.
Around 10:00 PM on day of booster vax (12/21/21), she became extremely tired, too tired to stand.  At 5:00 AM on 12/22/22, I, her daughter, woke up to check on her.  Her temp was 102.1.  For the next three days she was too weak to stand, slept most of the time and had no appetite. She began to gain her strength back on 12/25/21.  Between 12/25 and 12/31, she was more tired than usual, and weaker than usual.  On 1/2/22, at approx. 10:15 PM, she collapsed and died, about 20 minutes later.  During those minutes, she had difficulty breathing and appeared to have two seizures.  Her death took place 12 days after receiving the J&J booster.
when patient sat up 15 minutes post vaccination she felt light headed. She sat for an additional 15 minutes with hydration and resolved
Information has been received from a health professional concerning a 4 year old black female with no pre existing allergies or medical conditions who on 13-Aug-2007 was vaccinated subcutaneously into the right arm with a first dose of PROQUAD (Lot #658132/0775U).  Concomitant vaccine therapy that same day included a fifth dose of DAPTACEL (Lot #CZ655AA) administered intramuscularly into the right arm and a fifth dose of IPOL (Lot #20872), administered subcutaneously into the right arm.  There was no illness at the time of vaccination.  On 14-Aug-2007 the patient developed a local reaction on the right arm, that included swelling and a quarter size red area that was hot to touch.  Treatment included cool compresses and ibuprofen.  Subsequently, the patient recovered from the events on an unspecified date.  Additional information is not expected.