chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tired; sore; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced tiredness and pain. On an unknown date, the outcome of the tiredness and pain were recovered/resolved.   It was unknown if the reporter considered the tiredness and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-Oct-2022 Reporter's comment: This case was self reported by the patient. The patient experienced sore and tired the day after receiving first Shingrix dose (adverse event sore, tired was recovered).  Nothing else was reported. The reporter did not consent to follow-up.
This case was reported by a nurse via sales rep and described the occurrence of pain localized in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain localized, erythema and swelling. On an unknown date, the outcome of the pain localized, erythema and swelling were unknown. It was unknown if the reporter considered the pain localized, erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 53 or 54 years. The patient received 1st dose of SHINGRIX and experienced more with local pain, redness, swelling but, systemically better tolerated as compared to 2nd dose. The reporter agreed to contact on follow up, if necessary. The case has been linked with case US2018GSK075483, reported by same reporter for same patient (for 2nd dose of SHINGRIX.
Admits to left arm swelling, neck pain, fatigue, headaches started 4/8/21
Broke out in rash with itching on chest and arms 30 minutes after Hep B injection.  Patient was observed at clinic 15 minutes after injection without any signs/symptoms of adverse reaction. Returned to work and developed symptoms there.  Returned to Clinic and examined by dr.- received SoluMedrol 125 mg IM and give Rx PO Benadryl.
her feet she can't walk on them; hands have a terrible sensation and tingling; pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "her feet she can't walk on them"; PARAESTHESIA (non-serious), outcome "unknown", described as "hands have a terrible sensation and tingling"; PAIN (non-serious), outcome "unknown". Therapeutic measures were taken as a result of pain.  Additional information: It was reported that, can she be told what poison went into the vaccine. The only reason she is saying that is because half of her body and her feet. Ever since she got the vaccine her feet she can't walk on them. Her hands have a terrible sensation and tingling. Her right arm and her right breast and her right side goes totally. They had to prescribe Gabapentin and Lorazepam for the pain she is enduring. It all started when she got the vaccine. She was the healthiest 70 years old that had been seen. Not everyone got a fever and an ache. Who is in charge. She is one of the people having severe side effect. She wants to know if other people called in with more severe reactions. She is getting an attorney after this call. She was a professional dancer. She can't get on her feet anymore. She is so opposed to you people. She was so pro vaccine. Now she feels bad because she has told a lot of people to take the vaccine and a couple people have died in the last few weeks. She is not sure if it is related to the vaccine because she moved from that place. This should not be given to children.  It was given before it was approved.  she will say that.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recv vax on 9/3/98; 15 hr post vax pt exp eyes rolled back, limp, lethargy
She felt numbness in the throat, the impression was that her throat was closing up. she was also dizzy/lightheaded. her heart beat was up. she felt her heart racing as she described.  Patient took self adminstered benadryl liquid, 20 minutes after the shot, 25 mg, then after 5 minutes she took another 12.5 mg.  EPIPEN administered after 40 minutes of vaccine administration. 911 was called.  She was shaky for 10-15 minutes after the epipen then the shakiness stopped.  paramedics checked blood pressure, was normal: 120/80 as I recall. paramedica checked her oxygen saturation and it was fine. Patient didn't want to go to the hospitals , I stayed for an extra 45 minutes after using the epipen, she was normal.
Hives broke out about 3-4 hours after shot, around corps. Treated with Benedryl.  Went away after a day or so.
CBC + DIFF drawn on 5/26/23 shows ABS lymph of 0.66k/ul No symptoms just abnormal lab result. All other values were normal
Woke up the morning of 10th, nausea, went to restroom and on the way back to bed I collapsed. Dehydrated and had a high fever. Unable to keep fluids down. I was knocked out the whole day of the 10th and most of the 11th.  I knew I was pregnant before getting my booster.  She advised her doctor that she has trouble after getting vaccines with passing out. She was advised to get the booster and take Tylenol for pain, fever. For the dehydration, I continued to drink water. I was not able to eat for 48 hours but tried to eat anything I could.
Rapid pulse between 121-133 while resting, dizzy and lightheaded, fever 101.3, body aches
Patient reported with severe chest pain and ended up going to the emergency room. Labs showed elevated troponin and thought to be myocarditis that was eventually ruled out. Patient to have check up with cardiologist every 3 months.
became very ill with swine Flu; weak; dizziness; Initial information received on 06-Dec-2020 regarding an unsolicited valid non-serious social media case eceived from a consumer (Patient).  This case involved adult patient who became very ill with swine flu (H1N1 influenza), weak (Asthenia) and dizziness, while patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient became very ill with swine flu (H1N1 influenza), weak (Asthenia) and dizziness, unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for weak and dizziness, as resolved for H1N1 influenza.  There will be no information available on the batch number for this case.
Patient presented with cough and shortness of breath on 01/06, his COVID-19 PCR was positive on 01/04, his symptoms started around 1/2.  Chest x-ray showed bilateral infiltrates.  He was hypoxic and was briefly on high-flow oxygen.  He was treated with on Remdesivir x5, Barictinibx  14 days, and Decadron till 1/23.  He also received intermittent diuretics in hospital. He improved with above treatment, was weaned to nasal cannula.  He will be discharged on 2-3 L nasal oxygen.  Continue CPAP at bedtime.  He remained afebrile for several days prior to discharge
Weakness in legs & trouble breathing lead to ambulance check. O2 levels in 80s so rushed to er. Blood tests suggested possible blood clots so ultrasound done for chest/heart/lungs. Multiple blood clots found in lungs putting pressure on heart, later tested legs & found multiple in both legs as well.
7/20/2021 12 am- Woke up hot and light headed. Went to is bathroom, had vasovagel while on toilet, was able to get into my hallway where I fainted and fell to the floor. Husband found me, I was sweaty and lightheaded but aware of what had happened.
4-25-21 9:45 PM - full body paralysis for 48 hours.  As of 4-30-21 9:40 am can walk, can move hands....still issue with balance and dexterity.  Approx at 90% capacity.
This initial spontaneous case received on 27-Sep-2017, reported by a pharmacist concerning a patient of unspecified age. Patient's medical history was not reported. On an unspecified date, the patient received FLUAD (TIV) (dose, route of administration, anatomical site, batch number, expiry date not reported) (explicitly coded as inappropriate age at vaccine administration). The outcome of the event was not reported. This report was considered as non-serious.
Redness and swelling of the left thigh. Parents brought child in for re-check. Called parents today 12/21/15, left message.
patient complained stomach pain, responsive but lethargy and slightly clammy. Vital Signs:  BP 112/45; pulse 41; O2 Sat 99 - 100%. Bradycardia patient put on gurney, heart monitor, started IV lock. transferred to ED for further evaluation.
12/16/2020 2:30 AFTER VACCINATION, STARTED TO FEEL INCREASE HR. STARTED TO FEEL WOOZY, UNABLE TO FOCUS. CHECKED VITALS IN ICU; HR 116. WENT TO ER, TRIAGE BP WAS 163/101; HR 115. GIVEN LITER SALINE, DREW LABS. BP AND HR CAME DOWN. TOLD TO REST COUPLE DAYS. WAS CONCERNED AS HX OF STROKE.  F/UP WITH CARDIOLOGIST 'DOESN'T THINK THE SECOND VACCINE WOULD BE HARMFUL' BUT 'I JUST DON'T KNOW'.  FAMILY HAS HX OF HEART DISEASE.  I KNOW ANXIETY BUT NEVER HAD HR DO 'WHAT IT DID'. DON'T FEEL LIKE IT WAS ANXIETY. I KNOW MY BODY. I HAD TAKEN CARE OF COVID PATIENTS THE WEEK BEFORE. I DON'T KNOW WHAT TO THINK.  TRYING TO LOOK AT ALL FACTORS.  12/17/2020 HEADACHE; FOLLOWING DAY I WAS FINE
supposed to vaccinate a patient with Adacel, however vaccinated her with Influrix instead, with no reported adverse event; Initial information received on 16-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non- health care professional via Medical Information (Reference number- 00773258).  This case involves a 51 years old female patient who was supposed to vaccinate a patient with adacel, however vaccinated her with influrix instead, with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On 01-Jul-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was 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 the guidelines. 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.
Vaccine administered 1/14... Day 2 (1/15): Experienced nausea and jitteriness for the day, had injection site  and muscle soreness that lasted 3 days Day 5-9: Felt fine but developed sore lymph node under left armpit day  5 (2/18) that lasted a few days Day 9 (1/18) : Injection site and surrounding muscle became spontaneously sore again Day 11 (1/24) : Developed headache, hearing issues (sounds are muffled), joint pain and stiffness, brain fog and fatigue which have persisted  through today (2/5) with bouts of tachycardia, jitters, and hot flashes Day  15 (1/28): Developed intense nausea which has persisted through today but has lessened since 2/3. Currently: Still have muffled hearing, brain fog, joint pain and stiffness, fatigue, headache, and intermittent nausea. Due for second dose 2/11.
Pt wa given DTP approx 2PM APAP given a/inject given; 5PM t101-12 MN t103.2; tepid bath given emp dec 102 would not go lower; APAP given thoughout noc; 6AM t103-sz occurred; pt taken to hosp fever brought under control sent home seen by MD;
Nausea, fatigue, loss of taste, facial tingling and numbness, pain in elbows, pressure to front of head and behind eyes, fogginess, memory loss, lack of concentration, muscle tingling in the middle of the night, numerous cysts in rt. arm, shooting pain in rt. thumb and hand, bone spurs and calciumafication of rt. elbow. No treatment. Schedule to neurologist and orthopedic doctor.
Swelling and redness of (R) upper arm measured 8x9 cms, non-tender. Advised to apply ice to the ares.
Information has been received from a registered nurse concerning a 7 year old patient who on 02MAY1997 was vaccinated with a dose of varicella virus vaccine live . On 12JAN2004 the patient was seen at the office with chickenpox greater than 50 lesions, head to toe. It was noted that the patient had a fever of 101.9F. Treatment included eye drops, diphenhydramine hydrochloride (Benadryl) and acetaminophen (Tylenol). As per follow up report: It was noted that the patient recovered. There was no product quality complaint involved. A patient from the same source had a similar experience (WAES0403USA03047). No further information is available.
This spontaneous report was received from a certified medical assistant, and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the unspecified patients were vaccinated with an improperly stored doses of GARDASIL 9 (which had a lot # of L007560 and an expiration date of 15-JUN-2017: however, dose, dosage number, route of administration and anatomical location were not reported). However, no symptoms were reported. The vaccines experienced the following temperature excursion: not less than 32F for 107 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Patient not responding, sm amount of blood on lip, snorous breathing. O2 97%.  Sternal rub administered and 911 notified.  Patient admitted to hospital with very low blood sugar and aspiration pneumonia.  11/30/09:  Discharge summary and  hospital records received for dates of service 11/12/09 to 11/14/09.  Final Dx:  Acute metabolic encephalopathy, resolved.  Hypoglycemia, resolved.  Acute respiratory failure, resolved.  Dementia, Hypertension, Depression, Anxiety, Gout, Benign Prostatic Hyperplasia, Hx. of TIA, Vit. D deficiency, GERD, Anemia, Skin cancer.   Assessment:  Presented with low blood sugars and altered mental status, after a fall in the nursing home, D50 given by EMS. Mild respiratory distress on admission.  IV Fluids initiated and oxygen supplementation and antibiotic therapy.  Had some difficulty finding words.  Impression was that pt. was inadvertantly administered oral hypoglycemics in the nursing home.  Discharged in stable condition.
infected with COVID; infected with COVID; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "infected with COVID".  Clinical course:He never received his booster and ended up becoming infected with COVID. He had symptoms for a week. His symptoms were high fever, mild dry cough, chills, and loss of taste. Symptoms resolved after a week.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Patient with shaking or "shiver" not jerking off and on x 30 minutes. Then few minutes of cyanosis of lips and extremities. Checked by EMT with then normal VS & Sats.
Reported headache soon after administration of vaccine. Reported increased pain after her 2nd shot at  a 9.5 out of 10 24 hours a day that still continues.
Induration and erythema at the injection site beginning within 24 hours after the injection and subsiding 4 days after the injection, though still present.  Low-grade fever to 100.7 from 24-48 hours after the injection, resolved 4 days post-injection.
This spontaneous report as received from a pharmacist refers to a 78 years old male patient with seizure disorder. The pharmacist was reporting that the patient was vaccinated with ZOSTAVAX on 17-JUL-2012 SQ (dose and lot# not reported). Concomitant medications included : KEPPRA. The patient fell at home on 18-JUL-2012 (also reported as 18-SEP-2012). The patient was evaluated at a local emergency room, and required 9 sutures to his forehead. The patient relayed to the pharmacist that, prior to the fall, he felt like he was walking too fast and fell when he tried to slow down. The patient received treatment. At the time of the report the patient was recovering from the events. Additional information has been requested.
Myalgia, Arthralgia, Fever, Fatigue, chills Narrative:
This case was reported by a consumer  interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of 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 provided were as follows: The patient self-reported this case. The age at vaccination was not reported but the patient was over 60 years old. The patient received a dose of Shingles vaccine and was only suffered with a sore arm for a few days. Follow-up would not be processed as no contact details available.
I had flu like symptoms after taking the 2nd dose. My symptoms included achiness, tiredness, headache, and chills. Then on April 2021, I developed Shingles. It affected the left side of my body. I was prescribed a steroid medication called prednisone.
Patient reported feeling drugged, speech slurred, mouth didn't work right. Felt like a car was sitting on him.
On 02/01/2001 the patient presented with chicken pox over her entire body, 75-100 crusty lesions. The nurse practitioner reported that 'no other symptoms were noted'. Additional information has been requested. Per F/U 6/17/02: Info has been received from an NP concerning a 10 year old female with no know drug allergies who on 8/10/95 was vaccinated with a dose of varicella. Concomitant therapy included Singulair 5mg qd. On 2/1/01, the presented with "chickenpox over entire body, 75-100 lesions". There were papular lesions over her face, head, neck, trunk, arms and legs and some lesions were open and crusty, all were pruritic. The NP reported that "no other symptoms noted". Subsequently, the pt recovered. No further info is expected.
Severe pain in arm from shoulder to hands and around injection site, itching at injection site. Swelling of arm. Pain did not respond to medication. Slight improvement with heat therapy and non usage of arm. Doctor suggest antihistamines and anti inflammatory meds.
Patient called and spoke to reporter and stated a painful rash has developed on her back she suspects shingles. Reporter instructed her to contact her physician. It was later discovered she was 49 years old.
15 minutes after receiving vaccine pt complained of tingling around mouth similar to reaction experienced after the first dose. Pt was monitored by EMS for 1 hour post vaccine. Vital signs remained stable with no worsening of symptoms, No difficulty breathing or swelling noted, lungs clear. Pt released to home after one hour with instructions to seek medical attention with any worsening of symptoms
sz lasting approx 20min;pt taken to ER & followed up the next day to peds clinic;23SEP97 ER; ped clinic 24SEP97;
1 week later onset of papular rash on the face which then spread to remainder of body which was pruritic
Pt was admitted to hospital from the ED with GI bleeding on 4/4/21 after receiving the 2nd dose of vaccine on 3/30/21. Per guidelines, all hospitalizations are reported.
Hospitalized for febrile illness/sp COVID19. Treated with dexamethasone IV daily and Remdesivir
Pt was administered the vaccine and developed a red bulls eye at inj site the pt was counseled to take BENADRYL. The pt contacted the pharmacy on 9/21/13 and reported a hard ball at the site the pt is going to f/u w/her PCP.
Information has been received from a RN concerning a healthy 22 month old female who on 02Jun04 was vaccinated with a dose of varicella virus vaccine live (lot645044/0207N). Concomitant vaccination on the same day included a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On approx 27May05, the pt experienced a skin rash on one side of her body. It appeared as red and raised above the skin with itching. Unspecified medical attention was sought. The pt was treated with diphenhydramine hydrochloride (Benadryl) for itching and calamine. At the time of the report, the pt had not recovered. A product quality complaint was not involved. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information on patient's pertinent medical history, drug reactions or allergies was provided. On 16-MAY-2016, the patient was subcutaneously vaccinated with a dose of expired dose of PROQUAD (Merck) (human serum albumin (HSA)) (lot # K022448, expiry date 13-MAY-2016) (dose was not reported). Concomitant medications were not provided. Additional information has been requested.
Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 06Aug2021 at 12:00 as dose 1, single (Lot number: FA7485), in left arm and on 28Aug2021 at 12:00 as dose 2, single (Lot number: FF2588) at the age of 63 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29May2022, outcome "recovered" and all described as "Tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Addition information: Covid prior vaccination was none. Covid tested post vaccination was none. Known allergies was none. Other vaccine in four weeks was none. Other medications in two weeks was none.  No follow-up attempts are possible. No further information is expected.
Gave pt a Pfizer monovalent vaccine instead of a bivalent pfizer vaccine as syring was labelled incorrectly