chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left arm throbbing; feels like she had been hit by a train; left arn is burning; after my second shot my left arm is now hurting, left arm is sore,both arm hurts; feels crappy; back of her head, neck and back hurts; back of her head, neck and back hurts; bad headache; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (left arm throbbing), MALAISE (feels like she had been hit by a train), BURNING SENSATION (left arn is burning), PAIN IN EXTREMITY (after my second shot my left arm is now hurting, left arm is sore,both arm hurts) and FEELING ABNORMAL (feels crappy) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medication history reported).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (left arm throbbing), MALAISE (feels like she had been hit by a train), BURNING SENSATION (left arn is burning), PAIN IN EXTREMITY (after my second shot my left arm is now hurting, left arm is sore,both arm hurts), FEELING ABNORMAL (feels crappy), NECK PAIN (back of her head, neck and back hurts), BACK PAIN (back of her head, neck and back hurts) and HEADACHE (bad headache). At the time of the report, PAIN (left arm throbbing), MALAISE (feels like she had been hit by a train), BURNING SENSATION (left arn is burning), PAIN IN EXTREMITY (after my second shot my left arm is now hurting, left arm is sore,both arm hurts), FEELING ABNORMAL (feels crappy), NECK PAIN (back of her head, neck and back hurts), BACK PAIN (back of her head, neck and back hurts) and HEADACHE (bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: no blood clots were observed in the vein..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2021: No specific follow-up information recorded.
Fever of 100-102; Hot area at injection site; Swollen area at injection site; Headache; Body aches; Chills; Fatigue; Pulse of over 200; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, injection site warmth, injection site swelling, headache, general body pain, chills, fatigue and blood pressure reading high. On an unknown date, the outcome of the fever, injection site warmth, injection site swelling, headache, general body pain, chills, fatigue and blood pressure reading high were recovered/resolved.   It was unknown if the reporter considered the fever, injection site warmth, injection site swelling, headache, general body pain, chills, fatigue and blood pressure reading high to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever of 100 to 102 degree F for more than 3 days. The patient experienced hot, swollen area that kept getting larger as days by at injection site for 3 days. The patient experienced headache, body aches, chills, fatigue for more than 3 days. The patient experienced pulse of over 200. The reporter spoke with pharmacist twice about side effects and he said it was fine but to report to manufacturer.      Lab Comments: On an unknown date, the patient's body temperature was recorded as 100 to 102 degree F and pulse was over 200.
STARTED ON 12/3 WILL SORENESS AND EXHAUSTION.  THE PAIN WAS IN THE AREA OF MY LYMPH NODES ON THE RIGHT SIDE.  THIS LASTED FOR ABOUT 1 WEEK, AND THEN AROUND 12/13 I STARTED TO HAVE SINUS TROUBLE & COUGH.  ON 12/18 I HAD A TERRIBLE MIGRANE, AND EXHAUSTION.   STARTED TO HAVE MORE SINUS TROUBLE AND COUGHING.
Info has been received from a female consumer with no underlying disease who on approx. 2/11/02 was vaccinated with a 3rd dose of Hep-B. On approx. 2/16/02, the pt noticed that her eyes looked yellow. It was noted that she has an appt. with her physician. Unspecified medical attention was sought. Additional info has been requested.
Noticed Left Deltoid was itching today while at work (1-9-21), Lifted sleeve and Left Deltoid was noted to be red, warm to touch and in center of Deltoid it was noted to be a white patch about a quarter size in diameter slightly raised. (hive like white patch). Redness extending around the same area of full deltoid muscle.  Itching about 6/10 level, ice pack placed to relieve some irritation. Notified employee health covid team.
Initial report received from a healthcare professional on 08 OCTOBER 2012. A 68-year-old female patient, whose medical history and concomitant vaccinations were not reported, had received a dose of FLUZONE HD (lot number U4499A) intramuscularly in deltoid (dose number not reported) on 17 SEPTEMBER 2012. On 08 OCTOBER 2012 i.e. 21 days post vaccination, the patient developed   with swelling, inflammation, yellow discoloration, general weakness and joint pain. Laboratory details and corrective treatments were not reported. The patient's outcome was unknown. Documents held by sender: None.
Chest pain (central and left started Dec 24th and still experiencing slight central pain), left arm numbness and tingling on the inside (Dec 25- 26th lasted 2 days), swollen lymph nodes in left armpit, shortness of breath when sharp chest pains (24th-26th). I went to ER on Dec 26th for symptoms. They did an EKG, said everything looked normal and told it was likely a reaction to booster. It was effecting my musculoskeletal system. I was told to take ibuprofen and keep an eye out. Called PCP to follow-up with persistent chest tightness. Scheduled to be seen tomorrow, December 31st, to get a second look.
Within 5 minutes of receipt of vaccine patient reported nausea, dizziness, sharp pain in head and then syncope. Muscle stiffness observed during syncopal episode. He was also pale and diaphoretic.  He was unconscious approximately 10 to 15 seconds. Patient was placed in Trendelenburg position. Zofran was given sublingually for the nausea around 10AM. He had a general feeling of nausea until late in the evening. Patient did not report feeling "normal" until around 10:30 PM.
There is a movable bump under the skin on my left clavicle area. My left lymph node under my left armpit is swollen and painful. I also had body aches and felt very hot yesterday but the painful bump and my swollen lymph node are what concerns me the most.
Information has been received from an administrator referring to a few patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. The administrator reported "a few" of their patients (no demographics provided) had been non-compliant with the dosing regimen for GARDASIL (dose and frequency: three dose series; route: Intramuscular injection) (product use issue). No adverse effect was reported. Additional information has been requested.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (318 patients received dose from vials beyond 30-day use by date) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (318 patients received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Date of refrigeration of vaccine was reported as 07-May-2021.
Kidney pain on right-side of back. Treated with 7-day course of Nitrofurantoin Mono 100mg. 3 days later, same pain returned. I took another 7-day course of Nitrofurantoin. These prescriptions were provided by my primary doctor for travel. I finished second course same pain returned again 4 days later. I went to urgent care; urine test done; culture sent. I was prescribed ciprofloxacin HCL 250mg twice a day for 7 days. Just took the last dose on Thursday March, 3rd. I am hoping it won't return.
2 days after administration, patient noted bilateral epistaxis with a platelet count of 30,000 on 3/30/18. Dropped as low as 23,000 on 4/1/18.
Employee received the flu vaccine on 10/19/2018 and the next day had a headache to the back of head. Employee was seen in Employee Health on 10/30/2018 where she complained that she had a headache every day since receiving the vaccine, the pain was dull and located to the back of head, and complained of a pulling sensation to her eyes. She stated the headache was so bad on 10/29/2018 that it caused tunnel vision when turning her head to the left. She was seen by Dr. and he ordered FLEXERIL 10mg PO at bedtime PRN. On 11/13/2018, employee returned to Dr. complaining that she continued to have headaches every day since receiving the vaccine. Dr. ordered ROBAXIN 750mg PO Q6H PRN and a MEDROL Dose Pack taper.
Fever, sore arm, flu like symptoms, overall just didn't feel well. Temp at 106F. Took Tylenol and cool bath. Within 48 hours I felt better.
Arm sore 3 days, then cough, severe sore throat, hot, cold sweats, headache.  11/25th vomiting, went to MD, had bronchitis, low grade fever, sick at stomach, spitting up yellow phlegm.  Gave me antibiotic and cough syrup.  11/30/2003, feel better but not 100%.  Been sick 11 days, more questionable.
MUSCLE ACHES; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches. This report was non-serious.
I received a senior dose injection of Fluzone HD 0.7 ML INJ SANO, about 4 PM on October 8, 2022. The injection was into my left deltoid, in a location that seemed higher than previous such injections. About 2 hours later, the left side of my neck became extremely stiff and sore, so that I was unable to turn my head to the left, look down or tolerate any forward tension on my neck, such as when trying to remove a T-shirt. The pain was very intense, and felt like a severe spasm in the left neck tendon which connects to the base of the skull. I took acetaminophen 500 mg and Tizanidine 4 mg (prescribed by my physician) about every 12 hours. I performed gentle stretching exercises and massage of the area and applied heat twice a day, and stayed as active as possible by walking, to stimulate general circulation, all of which kept the pain just barely tolerable. It started to abate after about 60 hours. It has now been 4-1/2 days, and the pain is about 95% resolved.
1hr p/vax numbness & tingling in both arms & legs;pain in spinal column ascending-felt tired-no energy;woke up felt fine;same rxn p/2nd dose but in 1hr of receiving vaccine;
On 4/1/15 AM patient experienced swelling 2-3 inches above elbow on administration arm (left arm). No sign or symptoms at administration site. Patient soaked arm in Epsom salt 2x and swelling went down. When patient notified us on 4/13/15 swelling is gone but area is still a little sore and sensitive.
This non-serious event was reported by a health care professional on 13 January 2009. Based upon additional information received on 13 February 2009, it was determined this case meets seriousness criteria. This patient is one of a cluster of 20 patients: the other 19 patients are captured in case numbers 2008-03509, 2009-00153 to 2009-001164, 2009-00166 to 2008-00171. SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. A female patient, had received an injection of FLUZONE SV 2008-2009 (lot number U2762AA) on 19 October 2008; however the route and site of administration were not provided. On 13 November 2008, the reporter recorded that at an unspecified amount of time after vaccination, the patient had a sore arm and the pain was up into her neck. The patient was seeing her primary care physician; however, it was not reported whether the patient required treatment for the events. Outcome was not reported. Follow-up information was received 13 February 2009 from a health care professional. The patient received an intramuscular left deltoid injection of FLUZONE and the left arm soreness began 24 to 48 hours post vaccination. The patient was seen by their primary care physician and an X-ray of her left arm was negative. The patient was prescribed VICODIN for pain and fully recovered in two to three months. It was further noted that the patient had a history of a pulled muscle in her left arm. Due to this new information received, this case has been upgraded from non-serious to serious. Documents held by sender: None.
Patient is a 53 year old going back to college and required a MMR booster since her measles and mumps injections were given to her prior to 1980. The physician had ordered a MMRV and the patient was given the MMRV. Patient had no reaction and did not need any additional treatment. The manufacturer for the MMRV was called and the patient must wait one month to receive a MMR if the provider feels she needs to get the MMR vaccine.
This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.  It was unknown if the reporter considered the unknown cause of death to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that what adults did not know about vaccines could kill them. Many adults were unaware that vaccines kill. The reporter's friend's dad died from a flu shot.  The reporter's friend's baby died from her 4 month vaccines (unspecified).; Reported Cause(s) of Death: Unknown cause of death.
Headache, Sedation, Myalgia, Arthralgia, Fever, Pain/redness/Swelling @ injection site
5min p/vax pt had sz episode;episode lasted for approx 1 min & didn't appear to be very severe;the pt appeared to be fine p/the event & has had no other problems since
Patient not feeling well after receiving vaccine. Patient advised to sit down and RPH tended to patient. 911 was called. EMS came and monitored patient. Patient taken to the hospital.
Still having slight pain on and off in my injection site of my left arm.  This has been continuing since I received my second dose.
Progressive weakness felt to be consistent with Guillain Barre Syndrome at this time he is still hospitalized so final outcome unknown.  MR received from ER admit for c/o progressive weakness in lower extremities.  Weakness began 1 ½-2 weeks prior to admission, which presented  as difficulty walking and progressed to inability to ambulate on the day of admission.  PE: WNL except diminished DTRs bilaterally in lower and upper extremities.  Decreased strength in lower extremities. The patient is noted to spontaneously move extremities, however is unable to upon request. Pt. was admitted and sent to acute rehab.  Was in hospital 22 days. DX: Guillain Barre Syndrome. Record also sent for re-admission for  altered mental status 2 days after discharge 2' to hypoglycemia and residual effects of narcotics.
Sudden headache, uncontrollable shaking, numbness in face, upper gastric pain, altered taste in mouth, severe itching, followed by skin rash Took 50 mg Benadryl, tylenol, drank water, Continued Benadryl 50 mg rested for several hours I am tiring easily and still have rash.
BlurredVision, Headache, Myalgia, severe body and joint pain Narrative: 2nd dose 1/19/21 severe body and joint aches, tired, headache, blurry vision off work today 1/20/21. Self care at home with ibuprofen feeling better and vison better 1/21/21
Bell's Palsy; developed  flu like symptoms; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age (reported as 32-40) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in 2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient developed side effects side effects from first vaccine, Bell's palsy 4 days after vaccination (Dec2020) which lasted for 2 weeks and flu like symptoms (Dec2020) which also lasted 2 weeks. The events outcome was unknown. The patient was receiving 2nd dose on 06Jan2021, the reporter asked any information regarding this?  Information on the lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between event Bell's palsy  and BNT162B2 vaccine cannot be excluded. 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 and Investigators, as appropriate.
Patient said,"about 5 hours after injection her arm began to swell, turn red, and became warm to the touch. She also said she felt as if she was getting another shot as far a pain goes. She did not have a fever. She came into our pharmacy 8/28/18 to show me her arm. I told her to call her primary care physician. Her arm was quite swollen and very red. No fever, nausea, or vomiting.
On May 11, 1999 the pt developed a generalized vesicular rash which began as 10 lesions and spread eventually to about 40 lesions. Most of them were papulars and few of them progressed to the vesicular state. He had no fever and he is now recovered from his illness. The pts father feels the rash was caused by wild type virus.
Pt recv vax on 7/26/98; on 11/17/98 pt exp LA pain & atrophy at vax site; pt referred to neurologist
FLUBLOK leaked out around the hub of the needle where it is attached to the syringe/ no adverse event; FLUBLOK leaked out and patient received incomplete dose/ no adverse event; Initial information received on 20-Oct-2021 regarding an unsolicited valid non-serious case from pharmacist and physician via Regulatory authority (under the reference 00821115).  This case involves a 62 years old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] which leaked out around the hub of the needle where it is attached to the syringe and received incomplete dose (syringe issue, underdose).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 20-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (once, total, lot number: QFAA2110 and expiry date: 01-JUN-2022) via an intramuscular route in the left deltoid for prophylactic vaccination.  This case was a special situation due to (syringe leak, vaccine underdose) (latency: same day).  It was reported "While administering the vaccination, the FLUBLOK leaked out around the hub of the needle where it is attached to the syringe. The Pharmacist is unsure exactly how much of the FLUBLOK was received. The Pharmacist asks if the dose was valid or if she needs to be revaccinated. The needle was a twist on."  At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported event.
This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. The reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on unknown deltoid. The patient had flu like symptoms for longer than five days. The symptoms did fully resolve. The field representative had very limited information. All information described and reported in fields encompasses all information provided.
Mother says client woke up with a rash and itching was given Benadryl - woke up 2nd/ morning with welps - given Benadryl and rash & welps has cleared up - information reported to clinic on 10/27/2008
shortly after getting the first dose of Covid vaccine, patient started feeling lethargic, and sore arm.  The following day, patient was unable to attend work and feel out of the ordinary.  one week following the vaccine patient went to the ER due to feeling ill. Patient was told he had some swollen lymph nodes under his arm.  Patient was informed by his physician that it would be ok for patient to get his second dose. Therefore, on Nov. 6, patient came into the pharmacy to receive his second dose of the covid vaccine. Patient stated that within the next few days, patient fell ill and numbness and weakness throughout his knees and legs. Patient was nauseous, had loss of appetite as well as difficulty speaking.   He was unable to speak and articulate his thoughts. He informed us that he went back to the ER, and they diagnosed him with Guillen-Barr-Syndrome.  Patient was told he will have a follow up with his neurologist to determine if it is GBS or other medical conditions.  Patient will call us back to update with his medical situation
4-15-2021 - Bells Palsy affecting left side of face, CT Scan cleared Stroke.  Eye surgery on 4-26-2021 to partially close eyelid due to dry eye and cornea damage from bandage to keep the eye closed.   As of 11-12-2021, still experiencing nerve pain to left side of face and seeing eye specialist for continued dry eye and vision problems.