chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had worsening of underlying chest pain with episodes lasting longer, but still intermittent in nature. Happened throughout the weekend until patient came to the ED on 5/24/2021.
started feeling upper arm aching/ left arm is still hurting; started feeling upper arm and shoulder aching; loss of range of motion; Itching; red and purple dots all over his; red and purple dots all over his; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 29Jan2021 (Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Feb2021, he started itching, red and purple dots all over his body. He was advised by his healthcare professional (HCP) to take Benadryl as treatment which took care of the symptoms. A week later, on 05Feb2021 he started feeling upper arm and shoulder aching and loss of range of motion. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 26Feb2021 (Lot number was not reported) as dose 2, single for covid-19 immunisation. His left arm was still hurting on the day of reporting. The patient was wondering if maybe the first dose wasn't effective and if he should get a third vaccine. The outcome of pain in arm was not recovered and outcome of all other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left was swollen and still is sore where shot was give. Left arm a week later has brokne out in hives and has a hot feel to it (bad sunburn).
tenderness and pain over his arm until his fingers / in the forearm distal / mid arm inferior superior tendons all the way to tips of all 5 fingers; swollen /  in the forearm distal / mid arm inferior superior tendons all the way to tips of all 5 fingers; not able to close his fingers properly; tiny bit of edema around it; went to put hand on knee and lit up / Every tendon was on fire / mid arm inferior superior tendons all the way to tips of all 5 fingers; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 542MY, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included influenza vaccine with an associated reaction of no adverse event.   On 17th December 2020 11:00, the patient received FluLaval Tetra 2020-2021 season (intramuscular). On 17th December 2020, the patient started Flulaval Tetra Pre-Filled Syringe Device. In December 2020, 60 hrs after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced pain in arm, swelling arm, mobility decreased, edema and tendon pain. The patient was treated with methylprednisolone (Medrol). On an unknown date, the outcome of the pain in arm, swelling arm, mobility decreased, edema and tendon pain were recovering/resolving.   It was unknown if the reporter considered the pain in arm, swelling arm, mobility decreased, edema and tendon pain to be related to FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was also a physician and had reported the case for himself. The age at vaccination was not reported. The patient received vaccine on left arm upper deltoid muscle and sixty hours later he started experiencing symptoms such as tenderness and pain over his arm until his fingers that became worst.  The symptoms were at the mid arm inferior superior tendons all the way to tips of all 5 fingers. The patient stated that he was not able to close his fingers properly and at the time of reporting he was keep recovering. On Saturday night, patient went to put hand on knee and lit up, it wasn not hot to the touch, every tendon was on fire and there was a tiny bit of edema around it. On Sunday morning, it was worse and patient started on Medrol dosepak and 12 hours later it was 80 percent gone. Next morning, the patient could close his hand and by mid day he could touch his fingers and palm. The patient stated that, he never had a reaction before, after an Influenza vaccine and that he was not an allergic patient. The reporter consented to follow-up.
On 6/17/21 community resident came to clinic with parent to obtain Covid Vaccination. Individual is not a patient of the health center. The nurse administered 1st Dose from Pfizer lot EW0185. Patient did not exhibit or complain of any adverse symptoms during observation period.    On 6/25/2021, back office identified that recipient's birth date. This makes the recipient only 11 yrs and 2 months old; ineligible for Pfizer vaccination for which minimum age is 12 years.   Phone call to parent on 06/25/2021 confirmed DOB.
Peripheral neuropathies: right arm radial nerve, right leg femoral nerve followed by muscle weakness (finger extensors, hip flexor) . Uveitis. Resolving after getting prescription prednisolone eye drops.
60-90 minutes after the shot my muscles in my legs and arms became extremely tight and began to hurt
injection site pain; knotting muscles; Started with swelling at shot location; Throbbing muscles; joint pain up and down left arm, back, shoulder, up neck; headaches and stiffness of left side; headaches and stiffness of left side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 09:15 (Lot number: EW0202) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot Number: EN6203, prev dose vaccine location: Arm Left, prev dose administration time: 06:15 PM), administration date: 09Mar2021, when the patient was 78 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Lot Number: EL9265, prev dose vaccine location: Arm Left, prev dose administration time: 07:15 PM), administration date: 09Feb2021, when the patient was 78 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 01Oct2021 10:00, outcome "not recovered", described as "Started with swelling at shot location"; DYSKINESIA (non-serious) with onset 01Oct2021 10:00, outcome "not recovered", described as "Throbbing muscles"; ARTHRALGIA (non-serious) with onset 01Oct2021 10:00, outcome "not recovered", described as "joint pain up and down left arm, back, shoulder, up neck"; HEADACHE (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 01Oct2021 10:00, outcome "not recovered" and all described as "headaches and stiffness of left side"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "injection site pain"; MYALGIA (non-serious) with onset 01Oct2021 10:00, outcome "not recovered", described as "knotting muscles". The events "started with swelling at shot location", "throbbing muscles", "joint pain up and down left arm, back, shoulder, up neck", "headaches and stiffness of left side", "headaches and stiffness of left side" and "injection site pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dyskinesia, musculoskeletal stiffness, myalgia.  Additional Information:The patient had not received other vaccine in four weeks.. Prescribed muscle relaxer a week after Booster shot was ineffective.Patient had no known allergies.The patient provided information regarding the reported adverse event(s) with the use of the product and consider the Pfizer product had a causal effect to the adverse event.NSAIDS, Msk relaxerwere  given as a treatment.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history and concomitant conditions were not reported. In approximately 2016 (reported as "unknown dates starting on or after 14-MAY-2016"), the patients were vaccinated with PNEUMOVAX23 injection (lot # L048265, expiration date 10-JUN-2017, dose, route and anatomical location of administration were not reported) where were improperly stored at 53.2 F for 73 hours. There was no previous temperature excursion. The temperature excursion was detected by a digital data logger. No adverse effect was reported and no product quality complaint was involved. This is one of two cases received from the same source. Additional information has been requested.
Breakthrough case admission after 2 vaccines Pfizer 4/27/21 Lot# EW0172;  Pfizer 5/18/21 Lot# EW0183
HPI: This patient is a 31-year-old male presenting with chest pain for 1 hour. Pain started gradually. It is described as dull and aching, radiating into left arm.  Pain is described as moderate upon onset and is currently moderate.  No history of the same.  Pain is not worse with exercise. Patient has no decrease in exercise tolerance recently.  Patient states he received his COVID-19 vaccination in the left arm 2 days ago.  Left arm has been hurting since.  Just today intermittent chest pain has begun and radiates down to the left arm.  Denies any shortness of breath at this time
Pt was had sudden loss of hearing 28 days following the booster shot of Pfizer vaccine.  Complete hearing loss on the R side, with tinnitus and near complete hearing loss continues on this side and not able to be corrected with hearing aid.
It was reported that a pt (1 of 10) received a Fluzone SV '00-'01 on 9 Oct 2000. Reportedly within 48-72 hours post vaccination the pt complained of pain, redness, swelling and induration at the injection site. No specific provided, further information requested.
Information has been received from a physician concerning a 2 month old patient who on 09-FEB-2007 was vaccinated within oral dose of Rotateq (lot # 655866/1110F). On 09-FEB-2007 the patient developed diarrhea. The patient sought treatment for the diarrhea on 09-FEB-2007, 12-FEB-2007, 15-FEB-2007 and 19-FEB-2007. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.  This in in follow-up to report (s) previously submitted on 3/14/2007.  Information has been received from a physician concerning a 9 week old patient with a history of formula intolerance, colicky disposition and ventricular septal defect who on 09-FEB-2007 at 11:45 am was vaccinated with an first oral dose of ROTATEQ (lot # 655866/1110P).  There was no illness at the time of vaccination.  On 11-FEB-2007 (previously reported as 09-FEB-2007) the patient developed diarrhea.  The patient sought treatment for the diarrhea on 12-FEB-2007, 16-FEB-2007 and 19-FEB-2007 (09-FEB-2007 was previously reported as a treatment date).  The patient's diarrhea was described as non-specific without emesis.  There was no blood or mucous in the stool.  There was no weight loss.  On 21-FEB-2007 a stool culture was positive for enterovirus.  On 28-FEB-2007 the patient recovered.  There was no product quality complaint involved.  Additional information is not expected.
Patient became light headed and dizzy, patient stated often reacts this way after injections.  Minimal po intake prior to immunization.  Patient laid flat on the floor, drank 10 ounces of water, 4 oz. Orange juice.  BP went from 94/50 to 108/62  ten minutes after first measure.  Prior to leaving BP was 110/64, pulse 64 and patient reported no symptoms.  Patient refused transfer to ED and felt fine prior to leaving after 30 minutes of observation.  She left in care of two co-worker RNs feeling asymptomatic and ambulating independently.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with the ZOSTAVAX vaccine at a clinic as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 27-FEB-2014, she was treated at a dermatology clinic for a persistent vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed VALTREX for the management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
First dose 1/30/2021 within one hour became extremely fatigued, lasting 12-16 hours. Fatigue in weeks to follow.   Second dose 02/20/2021, 12 hours to follow, extreme muscle pain all over body, seeing flashing lights in eyes and headache. Major body chills and fatigue. Difficulty walking without holding on to wall or doors. Extreme fatigue to follow, on and off, current fatigue.
After the first shot his arm was a little sore, nothing else. After the second shot around 16 hours later he ached all over, his joints hurt, and  a dull headache, he was nervous and ran a temp of 99.3°. Had a restless night sleeping 20 minutes then waking up them sleep 20 more minutes through the night. He had a temp of 100.8° temp at 12:30 p.m. He had taken 1,000 mg Tylenol every 6 hours from the time he got the second vaccine. I called his dr. and he relaid the message that he should take 500 mg Tylenol every 4 hours. also since we had a z pac to start that also. At 4 p.m. his temp is 97.8° Still has the headache and muscle weakness. Dr. will call tomorrow.
About one week after vaccination, the patient developed symptoms of enlarged cervical LN, sinus pressure, fevers. This progressed to develop rash and eventually SIRS. She was admitted several times over the course of April and May to determine a diagnosis and had extensive workup for infectious, autoimmune and hematologic malignancy. The ultimate diagnosis was macrophage activation syndrome/HLH but it is unclear if this was triggered by the COVID vaccine or not.  She is responding to steroids in taper and Anakinra and still recovering in the hospital at this point.
At site check, Day 7, c/o some nausea, 2 episodes of vomiting. Told to go to hospital ER if couldn't keep fluids down over weekend. Nausea & vomiting worsened next 24 - 48 hours.  Sought treatment at hospital ER. Seen by ID & ER doctors. 1.5 liters IV fluids, antiemetics, started on KEFLEX po for possible cellulitis (large area of erythema full extent of arm.) Much improved now, 24hr. Border of erythema, shrinking, No nausea/vomiting.  Continues on PHENERGAN 10 & KEFLEX 500 mg given.
Adverse Event: As the provider started to inject the vaccine into the patient,  leakage occurred around the barrel of the syringe. Treatment: None  We did not give her another dose. Outcome:  We did a safety huddle and retrained vaccinators.   The same thing happened again. Each remaining syringe  was checked by the Pharmacist who found that the connection between the syringe barrel and the needle was loose and unable to be tightened,  This was determined to be a defect with the needle device.  We changed out all the remaining vaccines with our own supply of needles and had no further problems.
Pt came to clinic to receive his 1st Anthrax vaccination. Pt was also to receive Typhoid and Flu Mist. Anthrax was given in L arm subQ. Approx. 1 minute later pt stated he felt like he was going to pass out. He then passed out. I took him to the floor, treated for syncope along with physician. Pt evaluated in clinic and return to duty.
; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023, They were to be used within 24 hours but administered to 17 patients on unknown dates.), PRODUCT TEMPERATURE EXCURSION ISSUE (Nurse manager reporting that Bivalent Vaccine underwent temperature excursion started on 21-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.
This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site discomfort and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site discomfort and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was contacted by the pharmacy technician on Friday 23rd February 2018 to know that a patient who was also a nurse had a written prescription for SHINGRIX and got it filled at the Pharmacy. The patient took the vaccine offsite to have a friend that was a nurse administer the vaccine to her. There was no information on how the patient stored the vaccine or how long after picking up the vaccine it was administered. On 23rd February 2018 the patient called the pharmacy back complaining that she was having a reaction consisting of a three inch red circle around the injection site with some pain or discomfort. She wanted to check and see if that was a normal reaction. The pharmacy also did ask her to follow up with her physician as well. Upon speaking with the pharmacist on Friday February 23rd he informed the GSK vaccine account manager that the patient had SHINGRIX administered in the gluteus. The vaccine account manager reviewed proper dosing and administration, storage and handling for SHINGRIX with the pharmacist and contacted a medical science liaison to follow up with the pharmacy.
The patient received the vaccines around 4"15pm. 3 minutes after the patient complained of dizziness, BP dropped to 75/47 from a baseline BP of 123/82. The patient was seated down on a lower chair and leg elevation (trundleberg position) was performed. Patient asked for water, and was given. BP cuffs was repeated on both arms. BP eventually improved in 8 min to 100/61, HR 73 and monitoring. The patient was monitored further w/BP w/c slowly went up from 102/70 to 108/74, HR 67 and O2 saturation at 99%. The patient verbalized that she is feeling much better, able to stand up & ambulate and was discharged at 4:50pm.
A week after second dose I had chills, slight fever, headache and body aches for 24 hours. Today, I had my bi monthly allergy shot that I have been receiving for 2 years and had chills, body ache and headache one hour after shot for about 3 hours.
Flu like symptoms; Sore arm at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and VACCINATION SITE PAIN (Sore arm at the vaccination site) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and VACCINATION SITE PAIN (Sore arm at the vaccination site). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and VACCINATION SITE PAIN (Sore arm at the vaccination site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact
Fever up to 101.4, nausea, chills, redness, swelling and warmth to injection site. Sent to hospital for evaluation.
Moderna COVID-19 Vaccine EUA Rec'd Moderna COVID Vaccines on 1/21/2021, 2/20/2021, and 11/6/2021. Arrived to ED. Admitted for acute resp failure w/hypoxia, acute metabolic encephalopathy and dementia. Req'd intubation. Underwent bronchoscopy, PNA panel positive for Pseudomonas, E.coli and Klebsiella. Cont'd to deteriorate despite abx therapy and suffered from multi-organ failure. Continuous EEG with no seizure activity noted and CT head with no acute abnormalities. Pt w/AKI req dialysis. Given no significant improvement transitioned to comfort measures. Expired 7/22/2022. Tx'd cefepime, Zosyn, vancomycin, and dexamethasone.
2nd shot yesterday-now fever; 2nd shot yesterday-now body aches /sore; nausea; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (for tolerance of 1st dose refr case US2020AMR047401).   On 15th March 2020, the patient received the 2nd dose of Shingrix. On 16th March 2020, 1 days after receiving Shingrix, the patient experienced fever, general body pain and nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, general body pain and nausea were unknown.   It was unknown if the reporter considered the fever, general body pain and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaacination was not reported. The age group of the patient was not provided but selected as an adult as per vaccine indication. The reporter stated that, on the day of reporting, after vaccination the patient experienced fever, general body pain and nausea. The reporter stated that, the symptoms worse with 2nd dose.
I stated sneezing with upper chest congestion, headaches, body ache, no temperature, blood pressure was normal. No cough. On Jan 24th my wife was tested positive at the hospital, I came back from the hospital, and I took a COVID-19 test and it was negative, three days later when I took another test was Positive. On Feb 2nd I took another test, and it was clear.  On Jan 27th I went to the doctor and prescribed medication. My symptoms went away after three days. This morning I starting to get congestion. I will contact my doctor.
PT MOTHER CALLED, SAID AREA WAS LOWER ON ARM THAN FIRST DOSE, ARE WAS RED INFLAMMED TO SIZE OF A HALF-DOLLAR AND HOT TO THE TOUCH