chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hypoxia 2/2 COVID pneumonia Onset date: 1/14/22  test POS, admitted to hospital 1/21 -presented with: N/V/D, HA, body aches, loss of sense of taste and smell, body aches, shortness of breath, and cough  -Recent exposures: many family contacts.   -CXR with bilateral multifocal infiltrates -Remdesivir and dexamethasone 1/21 -O2 ambulatory challenge:  She did not require oxygen at rest or ambulation on the day of discharge -incentive spirometry
BlurredVision, Dizziness & HYPOtension Narrative: Patient experienced blurred vision, dizziness, and hypotension within minutes of receiving the vaccine at the same time the employee across from her getting the vaccine was having a similar reaction.
Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER87337) via an unspecified route of administration in the right arm on 01Apr2021 at 13:30 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported.  Concomitant medications included vitamin C (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN), all taken from unknown dates for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 11Mar2021 at 13:30 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. On 02Apr2021 at 14:00, after the second dose, second day following vaccination, the patient experienced fever and chills. Therapeutic measure taken as a result of the events experienced included aspirin (MANUFACTURER UNKNOWN). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever and chills was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Narrative: COVID infection following COIVD vaccine series 05/06, Pfizer, dose #1 06/03, Pfizer, dose #2 12/30 COVID swab, result: detected 12/28 pt cc: sinus congestion and dry cough exposure: unknown 12/30 CXR impression: No acute abnormality. 12/30 pt admit ED cc: sinus congestion and dry cought dx: COIVD LOS: 1 day
This subject is a 74 year old female, who died while enrolled in a comparative randomized study of safety and immunogenicity of a non-adjuvanted respiratory syncytial virus vaccine versus an RSV vaccine adjuvanted with Aluminum Phosphate when administered concomitantly with a Licensed Influenza vaccine in High-Risk > or = 65 years of age. The subject received a dose of RSV vaccine or placebo and influenza vaccine on 9/30/02. The subject died, 444 days post-immunization. The cause of death was not reported. The patient's has a history of lung mass, dyspnea, pleural effusion, smoking, asthma, and COPD. The death was reported by the investigator as unrelated to the study vaccine. THe death certificate received on 2/3/04 states metastatic lung CA. The medical record received on 2/9/04 states pain, anorexia, blood oxygen decreased, decreased mobility, respiratory distress, weakness, hemoptysis, and chest pain. Additional information received January 12, 2004 death certificate cause of death: metastic lung cancer.
By 2:30 PM the day of the vaccine, he looked tired, fatigued, sleepy. Placed him in his crib. He did not get up & looked lethargic. By evening, he was running a fever of 103.3. The fever peaked at 103.5 the next day; and by evening  the fever fell. However, by Sunday evening into Monday morning, he developed a red rash all over his body: arms, torso, groin, legs, and red spots appeared on right ear. The rash disappeared within 48 hrs.
a rash underneath the arm pit where she got the shot; is burning; bright red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (a rash underneath the arm pit where she got the shot), VACCINATION SITE PAIN (is burning) and VACCINATION SITE ERYTHEMA (bright red) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 002F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. In September 2021, the patient experienced VACCINATION SITE RASH (a rash underneath the arm pit where she got the shot), VACCINATION SITE PAIN (is burning) and VACCINATION SITE ERYTHEMA (bright red). The patient was treated with ZINC OXIDE (BALMEX [ZINC OXIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (a rash underneath the arm pit where she got the shot), VACCINATION SITE PAIN (is burning) and VACCINATION SITE ERYTHEMA (bright red) outcome was unknown.            Patient was not allergic to any component of the vaccine. Patient had used cold compresses and lotion. Patient stopped using the remedies because it was burring. Concomitant medication use was unknown
arm soreness/Sore arm; fatigue; lightheaded; dizziness; headache; tongue swelling/her tongue swelled a little bit in the back. It changed her taste buds and she couldn't taste her food; loss of taste; inability to eat/loss of appetite; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 11:00 (at the age of 64-year-old) as single dose for covid-19 immunisation. Medical history included lung condition, allergic to penicillin (happened a long time ago when she was in her mid thirties), allergic to latex and fungal infection in her thumb (in June or July of last years). Concomitant medication was reported as none. Patient past drug included antibiotic NOS (in June or July of last years for fungal infection). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Mar2021, the patient experienced arm soreness/sore arm, fatigue, lightheaded, dizziness, headache, tongue swelling/her tongue swelled a little bit in the back. it changed her taste buds and she couldn't taste her food, loss of taste and inability to eat/loss of appetite. Patient reported that she received the first Pfizer Covid vaccine dose on 02Mar2021. The first day she experienced arm soreness, fatigue, lightheaded/dizziness, headache, and tongue swelling. She also reported loss of taste and inability to eat/loss of appetite. She stated that the 3rd day after receiving the vaccine, it was fine. She was concerned this was allergic. She wanted to know if she should get the second dose. After taking first dose of the vaccine and got a typical sore arm, but her concern was because her tongue swelled a little bit in the back. It changed her taste buds and she couldn't taste her food. It happened on the same day that she received vaccine about seven or eight hours later. The whole day sore arm got progressively worse and the next day as well. As of today, she has recovered completely. For the most part she had tongue swelled for the first day. She went to bed early because she was fatigued. She forgot to mention she also had fatigue. She couldn't eat. The next day she had a sore arm, fatigue, and the swelling of the tongue was a little better, but still bothering her. She couldn't eat. She could only drink liquid and eat yogurt. Her diet was light because she couldn't eat solids. She thought it was better by the third day. Patient did not require to visit emergency room or physician office. No relevant test was performed. The event arm soreness/sore arm, fatigue, lightheaded, dizziness, headache, tongue swelling/her tongue swelled a little bit in the back. it changed her taste buds and she couldn't taste her food, loss of taste and inability to eat/loss of appetite was recovered on 04Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Information has been received from a consumer concerning her 13 month old daughter with no pertinent medical history or drug reactions/allergies who on 29-DEC-2008 was vaccinated with the first dose of VARIVAX (Merck) (LOT# not reported). There were no concomitant medications. On 15-FEB-2009 the patient was diagnosed with herpes simplex. The patient developed a single lesion inside the lower lip on 15-FEB-2009. The patient was examined in a local emergency room and the lesion was diagnosed as herpes simplex. The patient was then examined in the physician's office because the "cold sore" lesion caused discomfort. No therapy was prescribed. The patient was recovering from the herpes simplex. It was reported that the patient sought medical attention: emergency room. Additional information has been requested.
Pt in on 2/2/01 for 4 month well check and received Comvax and Prevnar in right thigh. On 3/23/01, mom called the office and stated "bruising" on right thigh where shots were given along with 2 lumps. No tenderness or redness. Had 2-3cm bluish-purple discoloration on right anterior lateral thigh. Dx'd with resolving hematoma from immunization. In on 4/6/01 for 6 month well check and had worsening discoloration and now 4 lesions. Referred to surgery (letter included). Dx'd with a sterile abscess and had incision and drainage by surgeon on 4/7/01.
Client received HPV and Flu vaccine, within a minute of last vaccine she reported feeling dizzy, sweaty. Her father came over to provide support. While he was holding her she lost consciousness for approximately 15 sec. She was assisted to the floor on a mat and placed in the recovery position. Given crackers and juice. After 15 minutes was able to leave the clinic. No injuries were sustained
Hour 2: numbness in right jaw, numbness in right leg, and abdominal cramping Hour 5: continued numbness in right leg, groin pain Hour 8: chills, shakes lasting 45 minutes), followed by fever for several hours, highest recorded temp of 103.8, took ibuprofen to reduce fever, numbness on right side continued Day 2: numbness on right side, low grade fever, patient stayed in bed and continued taking fever reducers Day 3: numbness on right side, now including arm and back, and abdomen pain brought patient to primary care doctor; strength, pinprick, and vibration tests came back normal. Patient was instructed to return home.   That evening patient began experiencing numbness on left side in her ankles, and left calf. Numbness is described as electric pulsation, tingling, and dull feeling. Patient can walk, lift limbs, and control muscles.  Patient then experienced breathing difficulties, tightness in chest, sharp pains in chest. Abdomen pain intensified. Mouth numbness and difficulty swallowing. Dizziness grew stronger when patient sat or stood.  Day 4: breathing issues and chest pains resolved.  Numbness throughout body continued and is described as moving in intensity from one area to another. Often intense in the legs, ?feeling like weights?.  Day 5: patient goes to ER seeking answers.  ER preforms routine lab work and collects a urine sample to test hydration and electrolytes. Patient shows some signs of dehydration. IV is given. Referred to neurologist.
Patient began to be very itchy at site of administration immediately after receiving vaccination. Itchiness has continue for at least a week after injection.
Erythematous patch around injected site on 12/2/14 followed by generalized hives throughout body the next few days.
Pain at time of injection, got worse about 2 days after. Pain in left arm at the edge of the left side of deltoid muscle that radiates up to the posterior shoulder. Has some pain with movement on trapezius muscle. This pain on trapezius muscle hurts worse when sleeping on that side and feels that he has some numbness or tingling on that arm when he sleeps. Unable to feel any lumps or bumps. No swelling or changes to skin color. Slightly tender to the touch. No pain in AC joint. Full ROM, but complains of pain with abduction of the shoulder and external rotation of shoulder.  Took ibuprofen 800 mg bid for 4 days, helped, but then stopped. NP recommends naproxen 500 mg tablet 1 tablet 2 times a day for 14 days.
Information has been received from a licensed practical nurse referring to unspecified number of patients of unknown age and gender. Concurrent condition and medical history were not reported. On unknown dates the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose and route were not reported, lot # L034372, expiration date 08-SEP-2017). Temperature was 8.6 F. Time frame was 9.5 hours. There was no previous temperature excursion. No adverse effect reported. This is one of two reports from the same reporter. Additional information has been requested.
cough, diarrhea, cold symptoms starting on 9/25/21, son tested positive same day she did, recently attended wedding
About 12 to 18 hours after the second Moderno vaccine, I developed a low-grade fever, headache, malaise and eventually the fever rose to 101 with associated fatigue and chills. Loss of appetite also present. With the help of Tylenol and ibuprofen fever resolved  at about 31 hours post vaccination.
Had delayed allergic reaction in arm (redness and soreness). I spoke with my doctor and took one tablet of benedryl for 2 nights and it went away. Called pharmacy rite aid as well.
This spontaneous report was received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021935 expiry date 10-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the two reports received from the same reporter. Follow up information has been received from the C.M.A. via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) on 25-MAY-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics, therapy start date, event onset date and narrative were updated.
Information has been received from a mother referring to her son, a 14 year old male patient. The patient did not have pertinent medical history or drug reactions/allergies. On 03-AUG-2015 the patient was vaccinated with the third dose of GARDASIL 9 (lot#, expiration date and dose were unknown) intramuscularly. There were no concomitant therapies. On 03-AUG-2015, within 15 minutes of receiving the vaccine, the patient "broke out in hives." The patient was given an unspecified steroid injection and it was effective. Within 24 hours of August 3, 2015 the patient "broke out again with hives." The mother took the patient back to the physician on 06-AUG-2015 and the patient was given ZYRTEC and received an oral unspecified steroid. No lab diagnostics studies were performed. The patient was recovered within 7 days after his last physician's visit on an unknown date in August 2015. Upon internal review, the patient broke out in hives and was given an unspecified steroid injection was considered to be medical significant event. Additional information has been requested.
received the Tenivac(td) shot on the 30th of last month and her job needed her to get the Adacel(tdap) shot; Initial information received on 21-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA141943.  This case involves Adult patient who received DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS  It was of actual medication error due to  wrong vaccine administered..  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
At the time of examination on 07/19/2015 in the PM, of note was 12cm of well-circumscribed flat erythema to lateral/anterior left thigh. Warm to touch. No fluctuance or abscess formation. No drainage. Right thigh immunizations site unremarkable.  Area was marked and patient was given sulfamethoxazole-trimethoprim to take twice a day for 10 days.  Patient did return to ER on 7/20/2015 for further treatment.  No additional treatment known as of yet.
Felt like crap; Pain in shoulder; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling abnormal (Verbatim: Felt like crap) and shoulder pain (Verbatim: Pain in shoulder). The outcome of the feeling abnormal was unknown and the outcome of the shoulder pain was recovered/resolved (duration 1 week).   It was unknown if the reporter considered the feeling abnormal and shoulder pain to be related to Shingrix.     It was unknown if the company considered the feeling abnormal and shoulder pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-MAR-2023 The patient was a friend of the reporter. The reporter stated the patient had pain in the shoulder that lasted for 1 week, and had felt like crap after the first dose of Shingrix. The reporter provided limited information. The patient did not consent to follow-up. This case was one of the three case reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2023033389:Same reporter US-GSK-US2023033387:Same reporter
Person stated she was itching and felt she was having difficulty breathing. Person was taken to the ED for evaluation.
dehydration; Fatigue; chills; headache; fever; nausea; body ache; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN5318) via unspecified route of administration in left arm on 26Jan2021 at 11:00 AM (at the age of 78-year-old) for COVID-19 immunization and other unspecified pfizer vaccine (Lot number EN538) in left arm on same date 26Jan2021. Medical history included blood pressure and covid. Patient had no known allergies. Concomitant medications included unspecified blood pressure medications (in two weeks). No other vaccine in four weeks. Patient experienced fatigue, chills, headache, fever, nausea, body ache on 26Jan2021 at 04:00 AM and dehydration on an unknown date. Adverse event resulted in emergency room/department or urgent care. Treatment was received for all events. IV treatment was received for dehydration event. Patient had covid prior vaccination, Patient did not test for covid post vaccination. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. On unknown dates the improperly stored GARDASIL was administered to the patients. No adverse effects were reported. It was unspecified if the patient sought medical attention. Additional information has been received from a registered nurse during a phone call on 18-MAR-2016. The registered nurse reported that the original reporter Medical Assistant was no longer at the facility. The registered nurse did not have the requested information (patient identifiers, dates of vaccination, lot numbers or reason for temperature excursion) available at the time of the call. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reported headache immediately after injection.  Within 5 minutes, reported headache radiating down neck and arms to elbows with tingling down arms lasting about 10 seconds.  30 minutes after injection, patient declined further care while complaining of persistent sharp frontal headache radiating down neck.  Patient was very anxious prior to receiving vaccine.
Sinus drainage; Cough; Warm; A little weak; Fatigue; Chilled; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Sinus drainage), COUGH (Cough), FEELING HOT (Warm), ASTHENIA (A little weak) and FATIGUE (Fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinusitis.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Sinus drainage), COUGH (Cough), FEELING HOT (Warm), ASTHENIA (A little weak), FATIGUE (Fatigue) and CHILLS (Chilled). At the time of the report, RHINORRHOEA (Sinus drainage), COUGH (Cough), FEELING HOT (Warm), ASTHENIA (A little weak), FATIGUE (Fatigue) and CHILLS (Chilled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Redness and swelling at injection site to (R) thigh; recommended ice packs, ibuprofen for discomfort.
This spontaneous report was received from a registered nurse referring to a 34 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a fourth dose of ROTATEQ orally, for prophylaxis (strength, dose, anatomical location, lot number and expiration date were not provided). No adverse events and no product quality complaint (PCQ) were involved.    Additional information has been requested.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX lot # L000454, expiry date 06-JAN-2017, lot # M004326, expiry date 25-JAN-2018, lot # L049535, expiry date 08-DEC-2017, lot # M006731, expiry date 09-FEB-2018, lot # L013395, expiry date 16-APR-2017, subcutaneously (dose and site of administration were not reported). No adverse effects were reported. Additional information has been requested.