chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shoulder ache; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (The patient got over acute shingles about a year ago after losing 2 months out of his/her life). Concurrent medical conditions included pruritus (the patient had some minor itching at times).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 6 months after receiving Shingles vaccine, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was recovered/resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingles vaccine.  Linked case(s) involving the same patient:US2022AMR127392   Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient still had some minor itching at times. About a month after the acute phase he/she got the first shingles vaccination.  The patient stated that, all the vaccinations he/she had for overseas travel, etc.  The patient stated that, it was the worst. The patient took about 2 weeks before his/her shoulder did not ache.  The patient stated that, still far better than getting shingles. Additional Supportive Information: The follow up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2022AMR127392; Sender's Comments:  US-GSK-US2022AMR127392:2nd dose
Redness across arm, about 2in x 3in slight pain at area of injection swelling for 2 days now. Patient was told by pharmacist to apply cold compress and hydrocortisone. She said it seem better now.
This was second shot (first was 1/13/2023).  Right away within an hour he was hunched over in pain, had tingling skin on his torso, shivers and couldn't eat.  Went to bed and awoke the next morning completely fine.
Rash formed on shoulder. Within one week is spread across stop of back. Within 10 days rash was on full back and spots on chest.
After the second dose, I was in the waiting area and my heart starting racing (Heart palpitation).  I approached one of the Nures and told her what was going on and the medical personnel immediately took my blood pressure which was over 233/143.  I was losing my site and began to tremble. I was rushed to the emergency room at the Hospital where I received both the 1st and 2nd dose of the Pfizer Vaccine.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On 14-NOV-2015, the patients were vaccinated with doses of M-M-R II, lot # L020189, expiry date: 03-JUN-2017 (dose and route of administration were not reported). The nurse reported that the doses had been reconstituted with sodium chloride instead of sterile water diluent. She stated that the sodium chloride diluent was manufactured by Sanofi and there was 0.6 ml in each dose of diluent. No adverse events were reported. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
On Tuesday the right arm at the injection site was sore by that afternoon, by the evening the joints became painful more so in the right arm to the point of a 9 on the pain scale 1-10. The pain was enough to prevent sleeping the night of the injection. On Wednesday afternoon a fever of 100.8 F developed which continued until approximately 9:00pm. On Thursday the only remaining side effect was soreness at the injection site continuing through Friday.
Maroon cap pfizer vaccine (age 2 to <5) was not diluted prior to administration. Patient received 0.2mL of undiluted vaccine. Followed-up with parents today and she has had no issues/side effects
Very strong a-fib attack, blood pressure spiked. From 3/19 on shortness of breath when walking and pressure in head and blood pressure rise. Heart ultrasound  3/26 ok. Stress test with ultrasound 4/30 ok. Bloodwork, chest x-ray 6/4 ok. Drs. don?t know what?s going on. ER said people coming in with problems from the vaccines.
Pain at the injection site and entire arm became progressively weak where it is difficult to lift a coffee cup and cannot lift arm over his head. Saw his primary physician who advised him to see an Orthopedic MD, but does not have an appointment for 3 weeks. Took Ibuprofen for the pain.
Pt reports to clinic on 10-29-09 stating that he experienced rash several days after injection on 10-23-09.  Impression is that skin anterior chest with papular erythematous eruption extending into upper abdomen.  No treatment was given.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT).   No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source.; Sender's Comments:  US-009507513-1801USA005992:
Woke up next morning with noticeably extreme soreness, unable to lift left arm; Woke up with chills; Noticeable soreness started around 6 hours after the vaccine administration,/ Woke up next morning with noticeably extreme soreness, unable to lift left arm.; This is a spontaneous report from a contactable pharmacist, the patient. A 36-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Mar2021 at 08:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Feb2021 at 08:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 13Mar2021 at 14:00, around 6 hours after the vaccine administration the patient experienced noticeable soreness. On 13Mar2021 at 22:30, the patient woke up with chills. On 14Mar2021 (also reported as next morning) at 11:00, the patient woke up with noticeably extreme soreness and unable to lift left arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events noticeable soreness started around 6 hours after the vaccine administration, woke up next morning with noticeably extreme soreness, unable to lift left arm which included treatment with 2 doses of acetaminophen (TYLENOL) 650 milligram on 13Mar2021 around 23:30 and on 14Mar2021 at 13:30 and symptoms reduced drastically by 22:00. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event woke up with chills was resolved on an unknown date in Mar2021; while that of the events noticeable soreness started around 6 hours after the vaccine administration, woke up next morning with noticeably extreme soreness, unable to lift left arm was resolved on 14Mar2021 at 22:00.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
I received an MMR vaccine as a recommendation from my fertility doctor.  Few days ago I noticed that the area in which I was shot was inflamed.  It looks pink and a it is more warm the the other areas of my arm.   It hurst, but not too, much.  I don't know if it is normal.  I am concern about.  I don't know if I have to go to the doctor, or if I have to postpone my fertility treatment to avoid other problems.    Can you please advise.
Left upper shoulder redness, warmth, swelling and itchiness. Complains of lethargy and sensitivity to light.
no adverse event; needle fell of the syringe; vaccine began leaking out of the syringe; Poor quality vaccine administered; the patient received a smaller than recommended dose; patient with another dose of PNEUMOVAX 23; dripped on the patients arm; This spontaneous report was received from a pharmacist referred to a 68-year-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 27-MAR-2023, the patient was vaccinated with a smaller than recommended dose pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, also reported as 0.5 milliliter/ once, lot #U032086, expiration date: 29-AUG-2023, for prophylaxis (strength, and route of administration were not provided). The reporter stated that while the patient administered this dose of PNEUMOVAX 23 (Pre-filled syringe) the vaccine began leaking out of the syringe while reporter was pushing on the plunger to administer the vaccine. A lot of the vaccine leaked out (Syringe issue). The reporter said when she went to put the cover on the needle the entire needle fell of the syringe (Needle issue). The reporter confirmed no defects to the prefilled syringe were noted. The reporter said thought she had secured the needle on correct. The reporter discarded the syringe and so the product was not available for retrieval. No pictures were available, so no pictures were being sent. The syringe needle was attached to the syringe tip before the leaking occurred. The needle able to be attached securely to the syringe. the leaking occurred from the tip of the syringe, and between the syringe hub/Luer lock and syringe needle. When the plunger rod was being pushed forward this defect was noticed.  Thus, the patient received the smaller than recommended dose, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), dripped on the patient's arm, and the reporter then revaccinated the patient with another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, lot #, expiry date, and route of administration were not provided) due to the PFS leaking in the same visit. The product was not available for retrieval so no mailer was being sent. (Poor quality device used; Product administration error; Exposure via skin contact). There was no additional adverse event reported (No adverse event).
Patient comes in with an adverse reaction to vaccination. She had several vaccinations done last Thursday, apparently reacting to varicella vaccine. She does have allergies to the MMR vaccine, although we do not know which component of the MMR. She apparently developed a fever within a day or two. Fevers were up to 104.0. They were running between 100.0-101.0 with medications. Is not running any fever of late. Has had some itching around the site where the injection was given, some redness there as well. Some kind of generalized itching. Also has been small rash that broke out under the breast. Also had a couple of spots on the abdomen. Dose not think she has rash anywhere else. The rash under the breast has resolved, but still has a couple of spots left on the abdomen. She is alert, orientated and pleasant. No acute distress. BP 110/76. P 64. R 10. T 98.6. WT 136. Allergic to MMR vaccine, varicella vaccine. Oropharynx is pink and moist, no lesions or exudate noted on the soft palate, pharynx or oral mucosa or buccal mucosa. Neck is supple, no masses. Skin with local erythematus lesion on the middle portion of the left arm. No tenderness over the area, slight warmth. Does blanch. No other rash is seen. No other skin changes are noted. Abdomen: Two small pink papular lesions on the abdomen, possibly resembling varicella. She has an infected hair follicle on her back, but really no other suspicious lesions on the back. Adverse reaction to varicella vaccine. Will report this. She is to try Xyzal for the itching. She is to keep the areas on the abdomen covered. Should clear up in the next couple of weeks. May scab over and once that happens, she should be fine. Did review the adverse reactions with her and she does seem to fit a lot of the symptoms that can occur. Fever seemed to happen a little earlier than what you would typically expect to see. Did recommend she not get the 2nd varicella shot. The first one should confer enough immunity to the virus. Also reviewed with her the lab report on her MMR titers. She is immune to the rubella and rubeola, but her mumps antibodies came back equivocal, which may simply mean she is not immune to mumps and if there is an outbreak, she needs to stay home until the outbreak is done. There is a chance she could get mumps. She is to watch for any acute changes. Patient will follow up if any other problems are noted.
Patient showed signs of light headedness and shortness of breath the day after vaccination. Lightheadedness resolved. Shortness of breath and waking up from sleep short of breath continued intermittently over the course of several months, worsening when patient had an upper respiratory infection in late June. Patient saw Dr. on August 4, 2021 and had an EKG as part of his physical examination. Atrial Fibrillation was noted. Patient was referred to cardiology. Shortness of breath persisted intermittently. Echocardiogram found a healthy heart with slight hypertensive changes. December 2, 2021 patient suffered minor strokes in the Thalamus and Temporal lobe, right side. On December 9, 2021 patient suffered a massive right hemisphere infarction and is hospitalized.
The next day of vaccine on 03/31/2021 I had a severe headache, nauseas, I had diarrhea. As the days passed I started getting worst and worst I was loosing mobility in my body my husband had to take me to the restroom. On 04/06/2021 is when I went to the Emergency Room. When I got to the hospital I could not breath my ribs hurt a lot & I had horrible back pain. They put me oxygen and gave me fluids but they said I had to get transfer to another hospital and they transferred me on an ambulance. In the other hospital us where they transferred me they kept poking my stomach when I asked them why they kept poking it they told me that it was to stop the blood cloths. I was hospitalized for 5 days. When I was sent home I was still not feeling good I was feeling sick still I've been trying to recover slowly but I am not the same. I'm still in a lot of pain I can't move my arms because of how much it hurts my back keeps hurting a lot as well. I want to go back to normal to how I was I can't do anything I can't even cook for my kids. I now have depression.
breach of implied warranty; shingles; products liability - defective design; products liability - manufacturing defect; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 02-MAY-2015, the patient was administered the Zoster Vaccine Live (ZOSTAVAX) vaccine by a pharmacist. The patient was treated by a physician for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: shingles. The patient claimed damages as a result of: Injury to themselves; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; punitive damages. The outcome of the event was not recovered/not resolved. Causality assessments were related.
The patient reported being nervous prior to vaccination but still wished to be vaccinated. About 2 minutes following vaccination, patient's partner reported the heart rate dropped to a concerning level. The pharmacist discovered the patient lucid in a car in the parking lot lying with her feet elevated on the dashboard. The pharmacist assisted patient; providing comfort and assurance,  while her heart rate and general feeling gradually improved. The patient reported losing consciousness; however deemed herself well enough for self-care after about 5 minutes.
The day after felt very fluish. Very fatigued and had swollen lymph node above right collar bone.
This spontaneous report as received from an unknown age male consumer refers to himself. On an unknown date the patient might be vaccinated with a dose of ZOSTAVAX (lot #< expiration date, dose, route, indication not reported) but wasn't sure. On an unknown date the patient experienced shingles but wasn't sure and the patient did not clarify whether his "shingles" occurred before or after he might have possible received ZOSTAVAX. The outcome of the event was unknown. Additional information is not expected.
I experienced strong headaches in the morning and would occasionally last throughout the day. On the 2nd or 3rd day, i got a fever which only lasted a few hours at night.
Information has been received from a nurse practitioner referring to an unknown number of patients. Between 27-APR-2015 and 30-APR-2015, the patients received improperly stored doses (unspecified in series) of ZOSTAVAX lot # K009771, expiry date: 09-OCT-2015, 0.5 ml, subcutaneously. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Information has been received from a pharmacist via a company representative referring to unspecified number of patients of unknown age and gender. On an unknown date these patients were vaccinated with PNEUMOVAX 23 (dose, frequency and lot# were not reported). After vaccination, on an unknown date, the patients experienced injection site reactions. The outcome of injection site reaction was unknown. The relationship between the event and PNEUMOVAX 23 was not reported. It was unspecified whether these patients sought medical attention or not. No product quality complaint was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
tired; flu-like sympotom; headache; discomfort; cold/chill; cold/chill; illness; lost an appetite; weak; This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0171), via an unspecified route of administration, administered in Arm Left on 30Apr2021 12:00 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included dry eye and sinus infection (reported as every spring, have allergy (dry eye and sinus infection) during the flower blooming season around May time). There were no concomitant medications. The patient didn't take any medication 4 weeks prior to the 1st dose.   On an unspecified date in May2021, the patient experienced flu-like symptom, was tired, headache, discomfort, cold/chill. On an unspecified date in 2021, the patient experienced illness, lost an appetite, weak. It was reported that on 3rd week after the 1st dose (week may be 16 2021), the patient had headache, discomfort, flu-like symptoms, like fatigue, but didn't take any medication. These were mild symptoms which got resolved after rest and sleep. Prior to the 2nd dose during the week of 16-20May2021, the patient had experienced a flu like symptom, very mild, felt a bit under weather, cold/chill, tired.   The patient suspected the AEs related could an infection prior to the 2nd dose. Vaccine dose interval was too close, 3 weeks apart, could it be dose related accumulative side effect. If we look at the AE profile overall, after the 2nd dose, it triples the incidence rate: fever, chill and fatigue (>50-70%), which is very high, even it is mild. It was further reported that the patient didn't had a chronic condition that required for medical treatment. Every spring, the patient have allergy (dry eye and sinus infection) during the flower blooming season around May time. This year the patient took Claritin for 2-3 weeks in May (one tablet per day) and had an add-on of steroid nasal spray (sinus) for about a week during the peak. The patient used over the counter eyedrops to treat the eye itching and dry symptom (patient is an eye doctor) about 6 weeks (May-early Jun). On 16Aug2021, the patient underwent lab tests and procedures which included rapid test: false positive, on 19Aug2021, PCR test: negative. The patient did not received treatment for adverse events. The outcome of events lost an appetite, illness and weak was unknown and outcome of all other events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
experience a severe reaction after first dose underneath her arm.  It is a lymph node.; She complained about the pain under the arm a day later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 19 year-old female patient received bnt162b2 (COMIRNATY), administration date Aug2021 (Lot number: EW0178) at the age of 19 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Mar2021, stop date: Mar2021, notes: She was quarantined 08Mar2021 in her dorm. The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "experience a severe reaction after first dose underneath her arm. It is a lymph node."; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "She complained about the pain under the arm a day later".  Additional information: The caller was calling on behalf of her daughter who had Covid 19 in March, received her first dose of Pfizer covid vaccine Aug2021 and experienced a reaction with a lymph node under her arm that resolved with a few days. She complained about the pain under the arm a day later, about the lymph nodes, and it lasted a couple of days and went away. Caller stated her daughter is due for the second dose but isn't sure if she should get it  Follow-up attempts are completed. No further information is expected.