chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient says at insertion of syringe into arm she experienced what she says is an electrical current in her arm.  The injection hurt immediately and thereafter.  that afternoon and night 48 hrs patient could not lift her arm above her waist and was in significant pain in her shoulder.  Patient has had previous bursitis in both shoulders.  Patient claims that injection site location may have caused her bursitis to flare up.  patient used cold compresses for 48 hrs and then switched to warm.  as of 48 hrs patient still in pain and cannot lift arm above waist.  Arm was also sore at injection site.  Patient did not feel it was neceassary to go to dr but would monitor symptoms over next couple days.
Rash down the arm/Rash around injection site; allergic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of rash 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, unknown after receiving Shingrix, the patient experienced rash and allergic reaction. On an unknown date, the outcome of the rash and allergic reaction were unknown.   It was unknown if the reporter considered the rash and allergic reaction to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's comment: Pharmacist reported that the patient had an allergic reaction following the first dose of Shingrix and experienced a rash on around the injection site and down the arm. Pharmacist called to inquired for Shingrix and asked what level of protection the patient would have after only receiving the first dose. The reporter unable to provide any vaccine or patient details. The reporter did not consent to follow-up.
Throwing up. Approximately 12 times between 1:00 a.m. and 7:00 a.m. Then threw up again around 4:00 p.m.
slept in p/leaving clinic; still sleepy/lethargic when brought to home 15 mins p/leaving clinic; pt got up & fell-eyes rolled back, shook all over for 25 seconds & slept p/til next afternoon; didn't eat til 9PM the following noc & was nl;
This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. Since 17-FEB-2015, the patients were vaccinated with ROTATEQ (strength, dose, lot# were not reported) oral which were stored improperly. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
Patient presented to the ED immediately after receiving COVID vaccination. Patient had shortness of breath, swelling to cheeks and lips, and it felt like her throat was swelling. Per nurse's note: Epi pen used to Right thigh and brought to the ER for further evaluate and monitoring. Epi seemed to help and by the time reached ER throat tightness was gone and breathing easier. Patient was prescribed and EpiPen, prednisone, and Pepcid. Epi pen was used a second time while in the ED. she was discharged home.
had two vaccines then this Thursday, went to the hospital and tested COVID positive; had two vaccines then this Thursday, went to the hospital and tested COVID positive; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history included COVID-19 last October 2020. The concomitant medications were not reported. On an unspecified date her mother had COVID last October and recovered and had two vaccines but then this Thursday, her mother went to the hospital and tested COVID positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Case number PHEH2014US018226, is an initial spontaneous report received from a medical assistant on 09 Sep 2014. This report refers to a 17 years old female patient. Her medical history and concomitant medications were not reported. It was reported that MENVEO vaccine was at 47 F for 10 minutes on 29 Aug 2014. On 04 Sep 2014, the patient was vaccinated with 0.5 ml intramuscular MENVEO (batch number: not reported) which underwent temperature excursion. No adverse event was reported following this administration error.
Injection site is sore to touch; a red bullseye is on the arm after more than 4 days following second shot; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via unspecified route on the left arm on 12Mar2021 at 11:00 AM as 2nd dose single for COVID-19 immunisation. The patient's medical history included possible atrial fibrillation from an unknown date. There were allergies to medications, food, or other products; however, details were not reported. Concomitant medications included other drugs used within two weeks. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via unspecified route on the left arm on 19Feb2021 as a single dose for Covid-19 Immunisation (at the age of 75 years).The patient received did not receive any other vaccine within 4 weeks prior to the vaccination. The patient had no symptoms associated with COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 12Mar2021 at 21:00, the patient experienced injection site soreness and a red bullseye on the arm in Mar2021 after more than 4 days following second shot. The patient did not receive any treatment for the reported events. The clinical outcome of vaccination site pain and vaccination site erythema were reported as not recovered. No follow-up attempts are possible. No further information is expected.
"Big patches of painful itching that moved from site to site every day. The itching was different than any I'd had before: it itched but it also burned. I could not sleep and Gold Bond or Bactine didn't help. My sister (the nurse) said to try athlete's foot cream, which did help a little. There was no rash."  The symptoms are almost resolved four weeks later. "I also had flu-like issues - chills (but no fever), nausea, cramps, for example, for several days." "I had daily headaches for the first couple of weeks that reminded me of the ones I get when I don't drink coffee.  Aleve did help with the headaches." "Finally, I had strange muscle pains, oddly they were mostly in my left arm, but with my arthritis and the headaches, I just figured it was a new normal."
itching and large pink oval rash  on right arm where injection given.  Betamethasone cream on arm twice a day and Claritin per dermatologist.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 14-MAY-2016, the patient was vaccinated with a dose of ZOSTAVAX which had a lot # L036822 (expiration date 24-DEC-2016), with a dosage of 0.65 ml, subcutaneously, in the deltoid (unspecified side), (concentration was not provided). Concomitant medications were not reported. On an unspecified date in May 2016, the patient experienced swelling at injection site and up to the submandibular glands. According to the reporter, on 16-MAY-2016 swelling had "gone down some" compared to how it was on 15-MAY-2016. No laboratories were performed. It was also reported that there was no intervention to prevent serious criteria; significant disability or hospitalization and the events were not considered life threatening. There was no product quality complaint (PQC) involved. At the time of reporting, the outcome of swelling face, injection site swelling and local swelling was unknown. Additional information has been requested.
This case was reported by a nurse via other and described the occurrence of passed out in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 26th June 2018, the patient received SHINGRIX .5 ml. On 26th June 2018, several hours after receiving SHINGRIX, the patient experienced chills, headache and insomnia. On 27th June 2018, the patient experienced passed out (serious criteria GSK medically significant and other: as per reporter), nausea, light headedness, fainting and fever. The patient was treated with paracetamol (Tylenol) and ibuprofen. On an unknown date, the outcome of the passed out, chills, headache, insomnia, nausea, light headedness, fainting and fever were unknown. The reporter considered the passed out, chills, headache, insomnia, nausea, light headedness, fainting and fever to be probably related to SHINGRIX. Additional details were provided as follows: The vaccine was not discontinued. The patient took product in the morning and that night experienced chills, headache and insomnia. On 27th June 2018, 1 day after vaccination, the patient woke up around 7 am, nauseated and lightheaded, went to throw up and passed out. On the same day the patient visited the nurse's office and was dressed too warmly and had temperature of 102 degree F. The patient had to take more medications to control fever (given Tylenol and Ibuprofen). The patient was also advised to increase fluids and rest. The details of the pharmacy was provided. The other seriousness criteria's (death, hospitalization, disabling, congenital anomaly, and life-threatening) were not associated with the reported events.
The next morning (6/15) he woke up in a euphoric and giggly mood. Altered balance, had a hard time standing up straight. Often falling over. Change in behavior and balance has lasted all day.
I have no idea if this is even where I should ask or mention this but I can't find anywhere else to do so. I just wanted to find out if there have been any reports of people having previous ailments exacerbated after getting the vaccine. I've had various muscle or tendon issues the last 5 years and every single one of them have progressively gotten worse since the vaccine which seems odd to me. Ive had on and off gum infections in the same spot the last 4 years and I'm now getting them every other week and the periodontist has no clue as to why. My previously partially torn rotator cuff is now bothering me fairly regularly when it was non-existent before. I've had throbbing pain in my big toe for decades but it literally happened twice a year maybe and not this is the third bout I've had with it in the last 3 months. I've had extremely bad neck issues to the point of barely being able to move it. My knee has been an issue for years and it has gotten progressively worse as well. The last one is a wrist issue I've had for 5 years and as long as I didn't bend it back too far was never an issue and now it's throbbing on and off on certain days and a ton more sensitive. I'm aware I'm 42 and things in the body just get worse as time goes on but having all this happening at the same time out of nowhere just seems a bit off to me. I've done a little research on the mrna vaccines but have a very basic understanding of what they do. Just thought I would submit this in case it merits some inquiry about any possible connections. I'm assuming since there's no going back this is just stuff I'm gonna have to live with, which sucks, but I suppose maybe knowing why would make some sort of difference? I don't know. Anyways thanks for taking any time to read and possibly consider this. Have a nice day.
G3P1.  EDD 11/11/2022. Repeat C/S scheduled for 11/7/2022 Tdap given to the right arm. Patient states it was administered high.  Several hours after injection she had pain, (reports feeling similar to a fracture) and limited mobility to right arm. 17 days later in office, still unable to lay on arm at night and has continued limited ROM.
Arm pain, headache, fatigue, chills, diarrhea, lower GI pain, ringing in ears, hives, whole body itching
After 48hrs of immunization child had a seizure and was admitted for 24hrs. Observationwithout any further seizure during admission.
Experienced vertigo two weeks after first shot. I was improving but still had symptoms and was hit hard with vertigo again exactly 2 weeks after my 2nd shot.
shot given in shoulder bone; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (shot given in shoulder bone) 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 INCORRECT ROUTE OF PRODUCT ADMINISTRATION (shot given in shoulder bone). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (shot given in shoulder bone) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Redness, warmth to touch. Mild swelling. Plan to start warm compress if not better. Start cephalexin susp. 250mg/5 10mL PO TID x 8d.
After the vaccine my period became extremely irregular.  One month it lasted three weeks which is not typical for my body. The next month it started two weeks later and lasted over 14 days. The third month cycle was extended as well . This current month's cycle was one day. My cycle is normally very regular.  I have an appointment scheduled with my ObGyn this month.
Acute occlusive deep vein thrombosis noted in the left proximal and mid femoral and gastrocnemius veins. There is also evidence of acute partially occlusive deep vein thrombosis noted in the left common femoral and distal femoral veins.  Patient was initially started on enoxaparin transitioned to apixiban for discharge.
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative and from a contactable nurse. A 17-year-old female patient of an unspecified ethnicity received, on 06Aug2015 11:30, TRUMENBA (Lot# J29203, expiration date Jun2016), intramuscular at 0.5 ml single dose in the left deltoid. Relevant medical history and concomitant medications were unknown. On an unspecified date, in Aug2015, the patient experienced itchy at the site of injection, big rash red, sore and itchy. Treatment received included BENADRYL, ALLEGRA and ZYRTEC. The patient did not recover from the event, rash erythematous; while clinical outcome of the other events was unknown. There was a reasonable possibility that the events was related to TRUMENBA. Follow up (01Sep2015): 06 Aug 2015 New information obtained from a contactable nurse includes: lot# and expiration date, route of administration, dose, anatomical location and start date (updated) for TRUMENBA; patient's date of birth. Follow-up attempts completed. No further information expected.
After the 1st and 2nd vax, in 5/99, the pt developed swelling and pain in the middle finger-middle joint. The pt thought it was related to gardening and did not seek medical attention until 11/99 when it was diagnosed as osteoarthritis. The symptoms got better when the pt started taking Glucosamine, but it was never totally back to normal. The pt lost some function of the hand and had difficulty opening jars and packages and doing other fine motor activities. After the 3rd dose on 4/25/00, the pt experienced considerably worse swelling and pain in the middle finger. The pt would awaken at night with pain. The pt sought medical attention. The pt was diagnosed with Rheumatoid Arthritis and was placed on Celebrex and Plaquenil to help reduce symptoms. The swelling resolved except for the joint in the right hand was still enlarged and could be quite painful. A second opinion revealed the same diagnosis of RA. The pt also developed hypertension. Per doc 204328, patient continues to have to be medicated with plaquenil celebrex and cosaminds for rheumatoid arthritis symptoms.The RA has not progressed at this point plus medications seem to be keeping it in check. Patient has developed arthritis sumptoms in both knees and is currently in undergoing physical therapy to help improve flexibility and reduce the pain.  Follow up on 10/16/2000: "Received authorization for release of information." The follow up received on 2/3/03 states, "on this date at 10am I contacted subject pt. She provided an update regarding her condition and the adverse event she experienced following the Lyme vaccine. The pt stated that she was still experiencing pain and fatigue. She is still taking Plauenil and Celebrex. She still has pain and arthritis symptoms in her hands and in her affected fingers. Her hands are especially affected by the cold weather. She stated that she has not improved in the intervening time frame since her adverse event onset, VAERS report, or follow-up survey interview.
pulse rate had increased; This is a spontaneous report from a contactable consumer (Reported for himself). A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9264/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 02Feb2021 at 10:00 (at the age of 47-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing (on medication). Concomitant medication included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. The patient previously took neomycin and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 at 10:45, the patient experienced pulse rate had increased. It was reported that, adverse event was very mild. Approximately 45 minutes after receiving the shot, patient noticed his pulse rate had increased. Normal RHR for patient during day is low 50s, patient fit and a runner. Patient took pulse and it was in 80s. Patient then took it every 5 min or so for another half hour and it began returning to normal. 2 hours after shot, pulse was back to normal RHR. It was not a big deal but it was something patient thought was related to response to the shot. All is well now. Dose 2 scheduled on 25Feb2021. The patient underwent lab tests and procedures which included heart rate: increased (during day is low 50s) and heart rate: 80s on 02Feb2021. No treatment was given for the events. The outcome of the event was resolved on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Sedation, Myalgia, Arthralgia, Arm soreness, Chills Narrative:
RIGHT DELTOID RED AND SWOLLEN WITH PAIN.  TREATMENT APPLY ICE AND TYLENOL PRN
This spontaneous report was received from a pharmacist refers to a 83 year old male patient. Pertinent medical history included hypertension and high cholesterol. Drug allergies/reactions were reported as none. Concomitant therapies included DIGOXIN, TOPROL, sacubitril, ENTRESTO and aspirin. On 21-JUN-2016, the patient was vaccinated with ZOSTAVAX, vial 19400 PFU, lot # L035506, expiry date 16-DEC-2016, subcutaneous. And then on 30-JUN-2016 the patient's physician, called the pharmacist to report that he saw the patient on 30-JUN-2016 in his office and the physician reported to the pharmacist that the patient has a "rash, that was diagnosed as shingles" that began on an unspecified date. Physician reported to pharmacist that the patient was now being treated with VALTREX. Lab diagnostic studies performed were reported as none. The outcome of the shingles was not recovered. Causality assessment was not provided. No product quality complaint (PQC) was involved. Call was disconnected before pharmacist provided tax  number to have VZV packet sent. No additional information was provided. Additional information has been requested.
I had a significant asthma flare up after done 1, within  24 hours and it continued for months. I ended up on an inhaled steroid. I went through 6 albuterol inhalers in 3 months and I normally only use it 1-2x a year.
After about 5 minutes patient became light headed and became prone on the floor. Patient became nauseated and vomited.
On 09/30/22 at approximately 3:30pm the provider ordered 0.25 ml Moderna Bivalent Vaccine to be administered instead of 0.5 ml. The nurse carried out the order as ordered and administered 0.25 ml to the patient.
PT FELT DIZZY AND FAINTED DURING POST VACCINATION OBESERVATION TIME. PT FALL DOWN AFTER MODERNA VACCINATION DONE.DIZZYNESS,FAINTING OCCURED RIGHT AFTER VACCINATION.
Acute hearing loss; This serious case was reported by a nurse via sales rep and described the occurrence of hearing loss in a 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 hearing loss (Verbatim: Acute hearing loss) (serious criteria GSK medically significant). The outcome of the hearing loss was recovered/resolved.   It was unknown if the reporter considered the hearing loss to be related to Shingrix.     It was unknown if the company considered the hearing loss to be related to Shingrix.   Additional Information: GSK receipt date:22-MAR-2023 The reporter reported that the patient complained of acute hearing loss after administration of Shingrix vaccine. Some resolve but some sent to specialty. The reporter agrees to follow up from GlaxoSmithKline. This case had been linked with US2023AMR044540 reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR044540:Same reporter
sore arm; Discomfort in arm after first shot; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 64-years-old male patient received first dose of bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 06Apr2021, the patient experienced sore arm and discomfort in arm after first shot. After 6 hours of the first shot, arm discomfort started and lasted for 3 days. Regarding treatment of events, the patient stated that he did not do anything. The outcome of the events was recovered on an unspecified date of Apr2021.  No follow-up attempts are possible. No further information is expected.
This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a2a2, and  expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced sore throat. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, headache, body aches, sore throat, fever, and chills. This report was non-serious.