chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Armpit was very swollen and hurt; Armpit was very swollen and hurt; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female 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 27Apr2021 at 16:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included panic disorder, depression and blood pressure high. Concomitant medications included citalopram (MANUFACTURER UNKNOWN), topiramate (TOPIMAX) and amlodipine (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously received latex, morphine (MANUFACTURER UNKNOWN), nickel and BUSPAR on an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. 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 COVID-19 vaccine. On 29Apr2021 at 03:00, the patient armpit was very swollen and hurt on the same arm were shot was administered. The patient armpit was so swollen and was unable put the arm down all the way. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken for the reported events and included treatment with acetaminophen (TYLENOL) every 4-6 hours, ice and ultrasound examination. The clinical outcome of the event lymphadenopathy axillary and axillary pain was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Hot flushing feeling. Faint, chills, tingly lips and face. Arm pain with numbness.
Soreness in left upper arm and neck. The next day also had a 100.2 temperature with fatigue and nausea.
Moderna covid 19 vaccine was thawed and refrigerated on 05/13/2021. Per Moderna, vaccine is does not expire until 30 days have passed.  The vaccine was mistakenly given to the patient 1 day past expiration date on 6/13/21.  RPh reached out to Moderna manufacturer which stated that they did not have any evidence to support administering  another dose.
This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients. On 24-JUN-2014, the patients were vaccinated with PNEUMOVAX 23 (dose, route and lot # not provided) that was improperly stored. The product was supported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, since the reporter does not want to be contacted.
Developed itching to r upper arm, redness and slight hive to injection site 8 days later
Her daughter received a third Prevnar 13 dosage on 27Nov, after that she was notified that the administered vaccine expired on February (10 months ago)/the shot given had expired; Still has redness and soreness at injection site; Still has redness and soreness at injection site; This is a spontaneous report from a contactable nurse. A 16-year-old female patient received the third dose of meningococcal group b rlp2086 (TRUMENBA, Batch/lot number S5887, Expired date Feb2019) intramuscular in the muscle of right upper arm on 27Nov2019 at 3pm at single dose for routine vaccination. The patient medical history was not reported. Concomitant medication included unspecified birth control medication. The patient received first two doses of meningococcal group b rlp2086 on an unspecified date for immunization. The mother reported that her daughter received a third dosage vaccine on 27Nov2019, after that she was notified that the administered vaccine expired on February2019 (10 months ago), which was considered as serious (medically significant) per reporter. She still was very sore and there was some redness at the injection site on 27Nov2019, which she was told to expect. The reporter considered the events "very sore and there was some redness at the injection site" were non-serious. The outcome of events "very sore and there was some redness at the injection site" was not recovered. The reporter considered events were related to vaccination of meningococcal group b rlp2086.     The information on the batch/lot number has been requested.  Follow-up (04Dec2019 and 05Dec2019): New information reported from a contactable Nurse included the case was upgraded to serious, patient data (age), suspect vaccine (updated to meningococcal group b rlp2086, route, anatomical location), concomitant medication, reaction data (new events very sore and there was some redness at the injection site), reporter's assessment (serious, related).; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Six days after injection developed induration that was red hot and itchy,  the induration encircled the entire upper by day 8, and then a sporadic, itchy rash to torso.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 13-OCT-2014 the patient was inadvertently vaccinated with an expired ZOSTAVAX (lot # J007301, expiry date: 20-SEP-2014, dose, units, route of administration, anatomical location were not reported). No adverse effect reported. Additional information has been requested.
Guillain-Barre syndrome with respiratory failure.  Mechanical ventilation with tracheostomy for six weeks.  12/23/2008 MR received for DOS 11/25-12/21/2007 with D/C DX:  Guillain-Barre Syndrome.  Respiratory Failure.  Tachycardia.  Neropathic pain.  polymicrobial pneumonia resolving. Pt presented with 2 day hx of progressive weakness, numbness and tingling.  Started in his feet and neck and progressed up to legs, trunk and arms. Having difficulty walking due to unstable gait and disequilibrium. PE (+) for facial tic, 3/5 strength upper and lower, difficultly lifting head and sitting upright, decreased sensation upper and lower, absent reflexes and diminished sensation x4. Tx with IVIG. Functional vital capacity was decreasing with increased respiratory secretions unable to be cleared. Placed on BIPAP, then CPAP. Intubated 11/29/07. pt developed fever 2' to polymicrobial pneumonia and started on abx. PEG tube and trach placed. Pt d/c still intubated to long term care facility.
Information has been received from a nurse concerning a female who in May 2007 was vaccinated with GARDASIL. It was reported that the patient has been experiencing weakness since she was given the vaccine. The patient contacted her physician. At the time of this report, the patient's weakness persisted. Additional information has been requested.
Case number PHEH2012US022481 is an initial spontaneous report received from a medical assistant on 09 Nov 2012. This report refers to a male patient whose age was not reported. It was reported that he received only the MenCYW-135 liquid conjugate of MENVEO (batch number: X10133, expiry date: Sep 2013) intramuscularly and did not receive the MenA lyophilized conjugate vaccine component on 08 Nov 2012. No adverse reaction was reported.
Vaccine dosage incorrect. Patient received 0.3mL instead of 0.2mL.
RED, ITCHY RASH AROUND AND BELOW INJECTION SITE. DECREASED BLOOD PRESSURE REPORTED BY PATIENT'S MOM TO BE 105/66.
Injection site of right arm became inflamed over 72 hours period; swelling and erythematous area extended from site of injection to elbow. It was treated with a MEDROL dose pack and cold compress to resolution. Patient advised not to receive pneumonia vaccine in future.
Pt reports that in the L arm (arm vaccinated), her arm began to feel "heavy and sleepy" a few minutes later. Vitals obtained:  BP 121/82, HR 71, 98%. Pt denies feeling this with her first vaccination or ever before in the past. pt denied numbness but did report tingling in the vaccinated arm. pt denies a hx of HTN, DM2 or past injury. Full ROM and neurological assessment intact to  LUE. pt encouraged to continue to rotate and massage arm, to take tylenol or ibuprophen for pain and to contact MD if issue persists. encouraged to go to ED if the inability to move arm occurs or symptoms gets worse. pt verbalized understanding.
This spontaneous report as received from a health worker refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of MMR II (lot # H009578, expire date 07-May-2014) (dose, strength, route and indication not reported). The healthcare worker (immunization official) reported that over last 4 months, MMR II doses were stored in a freezer in a plastic container, out of original carton and were exposed to light each time freezer door was opened. One dose of MMR II that might have been exposed to excessive light was administered to unspecified patient. No adverse effects reported. It was unspecified if the patient seek medical attention. Additional information has been requested.
Pt. stated her left arm swelled up and she had fever and cellulitis in the arm.
Patient reported having dizziness and lightheaded ness and nervousness Provided water and seen by medical team Patient refused medical transport and signed AMA form, Symptoms resolved Patient will be driven home by spouse
Information has been received from a vaccine manager (healthcare worker) referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were inadvertently vaccinated with (Oka/Merck) VARIVAX (lot number, dose and route were unknown)  that had been improperly stored. No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Moderna COVID-19 Vaccine EUA: 10-15 minutes after receiving vaccination, patient felt "Like I just got anesthesia". From chest down felt "Like it's going numb". Also stated she felt very tired. Was transported to ER via EMS. Vital signs were stable before transport. BP 143/73, HR 92, O2 sat 92%, Blood Glucose 132.
Redness, itching, swelling, tenderness (L) upper arm. Near syncopal episode 4 days post vaccine.
Pt felt freezing cold could not get warm.  Joints ached. Excruciating pain in shoulder.  Pt could not lift arm above shoulder due to the pain. Red swollen rash looked like an intense sun burn.
Son diagnosed with autism by 20 months. Eye contact diminished, speech diminished, neurological issues.
This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in a 74-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 2nd April 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 2nd April 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On 3rd April 2018, the patient experienced feeling unwell and fatigue. In April 2018, the patient experienced erythema and swelling. In April 2018, the outcome of the erythema and swelling were recovered/resolved. On an unknown date, the outcome of the feeling unwell and fatigue were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the feeling unwell, fatigue, erythema and swelling to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX subcutaneously on 2nd April 2018 at 15:45 in right arm (back of arm near tricep), which led to Incorrect route of drug administration. The health care professional stated that patient reported redness and swelling after vaccination but was unsure when it occurred, other than that it did no occur immediately. These symptoms had since resolved but health care professional was unsure of when they resolved. Additionally, patient reported fatigue and not feeling well the next day. The health care professional was unable to provide further details regarding the patient not feeling well. These symptoms had since resolved but health care professional was unaware of when they resolved. The health care professional stated that patient did not put a call into her physician but did not, to his knowledge, visit her physician.
Information has been received from a physician and a nurse concerning a "17 or 18" year old female who on 09-AUG-2007 was vaccinated with the first dose of Gardasil (0.5 ml).  It was reported that following vaccination, the patient felt lightheaded and dizzy.  The patient also felt her throat tightening and was rushed to the emergency room and released.  At the time of this report, the outcome of the events was unknown.  Additional information has been requested.
10-6-08 red hot spot at injection site- no fever- Temp 98.8 degree F oral. 1545 measure of red spot on Left arm 55mmx50mm. gave BENADRYL 25mg orally- employee already took Ibuprofen. Instruct to take another BENADRYL tonight and return tomorrow for evaluation 10/7/08 1500 employee returned area of erythema now 10cmx5cm. Sent to OCC HLTH for evaluation. Per Dr continue BENADRYL and Ibuprofen. Return tomorrow for evaluation.
This spontaneous report was received from an health professional, referring to 2 unspecified patient of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On 21-MAY-2016 or after, the patients were vaccinated with a dose of improperly stored ZOSTAVAX lot # L035505 with expiry date on 16-DEC-2016 (strength, dose, frequency, route, and anatomical location were not reported). Concomitant medications were not reported. No adverse effect reported and no product quality complaint involved. Temperature: 43F. Time frame: 65hours. Was it administered (AE)? Yes. Previous temperature excursion? No. Was call because of a "data logger": Yes. Additional information is not expected.
sore throat; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 21Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported, "I received my vaccine on Monday the 21st and on Tuesday (22Dec2020) I had a sore throat. I don't see on the fact sheet this as a commonly reported side effect. Should I get tested?" The outcome of the event was unknown.  Information about Lot/Batch number has been requested.
Standard vaccine side effects (including dizziness) began to subside, but dizziness started to get worse on 11/21. The dizziness continued and progressed to vertigo, nausea, and vomiting. I went to the ER on 11/27 and was prescribed Zofran and Meclezine. Saw an ENT on 12/6 and was diagnosed with Vestibular Neuritis. Stopped Zofran and Meclezine despite minimal symptom improvement. Started Vestibular Rehab Therapy on 2/21 after continued daily dizziness, nausea, headaches, eye pain, and imbalance. Began seeing a neurologist on 7/6 after no improvement. Prescribed 10mg of Paroxetine to help with VN. Continued rehab therapy. Began seeing a behavioral ophthalmologist and was prescribed prism glasses and vision therapy. After 8/15 neurologist appointment, prescribed as needed Rizatriptan to treat dizziness flare-ups. Symptoms have slowly begun improving, but dizziness is still present every day. Both ER doctor and neurologist mentioned seeing several people with vestibular issues post-vaccine.
Patient came in with CDC Card with record of first two doses of Moderna (2nd dose received 5/26/2021) for a Moderna booster dose. Patient was screened by a nurse and the dose was administered. As they were being documented in the state registry, it was discovered that she received her booster dose five months after their 2nd dose instead of six months. The nurse reports that the patient felt fine after their 15 minute waiting period and left the clinic.
Information has been received from a nurse practitioner concerning a 16 year old female patient with a history of epstein-barr virus infection and lymphadenectomy on 8-JAN-2009 who was vaccinated with the first dose of GARDASIL on 01-MAY-2009 (lot#: 662300/0100Y). When the patient woke up on 02-MAY-2009 she experienced tremors. The nurse practitioner reported that the patient was still experiencing tremors periodically and is coming into the office on 4-MAY-2009. No further AE information provided. Unspecified medical attention had been sought. Additional information has been requested.
Starting 03/17/2022, I was out with my friends and my heart started racing. It is not 100% out of the ordinary since having Covid and it went down, then went back up again. Normally I'm in the 90s or low 100s but it was hovering higher than that. I called my mother who came and took my BP which was really high, so she took me to the ER. They gave me fluids which brought my HR down and my BP down a tiny bit (enough to discharge me) but told me to start metoprolol until I saw my cardiologist. I called a Cardiology office and they told me to check my BP randomly over the next few days and then call back after the weekend. I did that and they made an appointment on 03/23/2022. They did an EKG and took my BP. They adjusted my BP meds and told me to come back in a week for a check (since I was going on vacation). Luckily everything was normal and I am doing well on the meds at this time. However, if I stop them, my BP will go back up.
This is a spontaneous case, initially received from pharmacist on 05-Nov-2018, concerning a 28-year-old, adult, female patient. The patient's medical history and concomitant medications were unknown. On 23-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252230 and expiry date: 31-May-2019). On an unspecified date in 2018, after vaccination, the patient experienced soreness in the shoulder joint lasting more than few days. At the time of this report, the outcome of the event was unknown. The reporter assessed the case as non-serious.
Tiredness, Swelling of gland above left clavicle in neck, fatigue, sore arm at injection site, painful arm movement with left arm
Gardasil administered to left deltoid IM. Client complained of feeling dizzy approx. 15 - 25 seconds later. Slight paleness to skin and hands clammy. 2nd nurse called to assist.  Feet were propped up, cold compresses applied, client stated approx 5 - 7 minutes later that she was feeling better. Client left office on own accord, with mother, after approx. 10 minutes of observation. When client presented to another clinic in health department she refused 2nd Gardasil shot with complaints of feeling weak for 2 days post vaccine. Further stated that injection site was itching and red.
Information has been received from a pharmacist concerning a 75 year old patient who on 20-Dec-2006 was vaccinated SC by the pharmacist with a dose of Zostavax vaccine (lot#654604/1406F). After vaccination, there was fluid leakage from the injection site. The pharmacist reported at a 45 degree angle. As of 02-Jan-2007, the reporter noted that the patient has not reported any adverse experiences. There was no product quality complaint involved. No further information was available. Additional information has been requested.
swelling; under her arm and in her arm pit started swelling and throbbing; under her arm and in her arm pit started swelling and throbbing; fever; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), PERIPHERAL SWELLING (under her arm and in her arm pit started swelling and throbbing), PAIN (under her arm and in her arm pit started swelling and throbbing) and PYREXIA (fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included HYDROCHLOROTHIAZIDE and NIFEDIPINE for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced SWELLING (swelling), PERIPHERAL SWELLING (under her arm and in her arm pit started swelling and throbbing), PAIN (under her arm and in her arm pit started swelling and throbbing) and PYREXIA (fever). At the time of the report, SWELLING (swelling), PERIPHERAL SWELLING (under her arm and in her arm pit started swelling and throbbing), PAIN (under her arm and in her arm pit started swelling and throbbing) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported. On 17-Apr-2021 she stated that under her arm and in her arm pit started swelling and was throbbing, she also stated that the pain has not increased since the symptoms began. She also experienced fever and more swelling. She also reported that she previously had COVID-19 back in December and wanted to know if this was a normal side effect and how she should be treating it.
Pt vaccinated w/1st dose of vax developed generalized pruritic rash which remitted spontaneously; On 29MAR90 adm 2nd dose 1wk p/vax developed pruritic rash; tx DPH, Atarax, Seldane; Dermatologist attrib rash to allergy & Hep B vax;
Patient woke up the morning after the vaccine and could not get out of bed. She felt horrible and disoriented. Her husband had to help her as she could not stand, was sweaty, nauseated and dizzy. BP 170/107. Did not feel well all weekend and was extremely fatigued and dizzy with a 10 on a scale of 1-10. Patient feels better today and is able to work.
arm pain; sleepless night; This is a spontaneous report from a non-contactable adult female consumer reported for herself that: A adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced arm pain and sleepless night. The patient received no treatment. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
General malaise beginning approximately 8 hours after injection.  Awoke at 3:30am (approximately 14.5 hours after injection) with severe body aches, fever, headache which persisted for 36 hours unabated.  Sore throat and severe fatigue on second day.  Symptoms began to abate two days after injection.  By third day post-injection, very mild symptoms including ear "fullness."  Hard subcatenous lump 3 inches below injection site, which was itchy and persists (although smaller) four days post-injection.
Patient presented to the pharmacy requesting her first dose of Shingrix. Prior to receiving the vaccine, the patient completed a consent form where she did not indicate that she had previously received the Shingrix vaccine. The pharmacist then confirmed the written information verbally prior to administering. The vaccine was then administered in her left deltoid and the patient was counseled on potential adverse effects. A few hours after leaving the pharmacy, the patient called to inform the pharmacy staff that she recalled receiving her first dose of Shingrix on 7/18/23.
No-itching Rash on both legs from ankles to hip and on back of both arms.  Started taking Benadryl PM 01/22.  Still visible AM 01/23.