chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 11/09/2021- vertigo when turning over in bed, vertigo when bending over, general dizziness. 15 years ago, I had vertigo it was occasionally and at times it was pretty severe and it resolved with medication. This time the symptoms were not as bad as after the 2nd dose. (The vertigo symptoms returned with the 2nd dose of Moderna.) The treatment- I was seeing a Physical therapist for balance issues, they did maneuvers for the vertigo that have helped it diminished. but I am still having minimal symptoms. I will probably need another treatment like that because I am still having some symptoms.
This spontaneous report was received from a certified medical assistant, referring to a patient of unknown age and gender. The patient concurrent condition and medical history were unknown. On 30-NOV-2015 the patient was vaccinated with an improperly stored dose of PEDVAXHIB (Lot # 1014427, expiration date 09-MAR-2018) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Our nurse inadvertently gave a Moderna COVID vaccine to a person under age 18 - patient is 16 years old.
COULDN'T WALK; FLARE OF AUTOIMMUNE REFLEX SYMPATHETIC DYSTROPHY (RSD) SYMPTOMS; SPLITTING MIGRAINE; INJECTION SITE UNCOMFORTABLE; WAS VERY UNCOMFORTABLE; REDNESS GREW DOWN ARM TO ALMOST ELBOW; INJECTION SITE SORE; HEADACHE; HOTNESS AT INJECTION SITE; REDNESS AT INJECTION SITE; DIFFICULTY MOVING ARMS AND LEGS; This spontaneous report received from a pharmacist concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included: sympathetic nerve cut, and surgery, and concurrent conditions included: multiple autoimmune disorders, reflex sympathetic dystrophy, penicillin allergy, lymphoma, allergy to dye/filler in generic medications, pet allergy, oak and pine trees allergy, and outdoor allergens, and other pre-existing medical conditions included: The patient experiences allergy with things around the house, anything that blooms. The patient experienced stomach problems when treated with gabapentin for reflex sympathetic dystrophy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: 11-APR-2022) dose was not reported, administered on 02-DEC-2021 for prophylactic vaccination (dose number in series 1). No concomitant medications were reported. On 02-DEC-2021, the patient experienced difficulty moving arms and legs. On 02-DEC-2021, the patient experienced hotness at injection site. On 02-DEC-2021, the patient experienced redness at injection site. On 03-DEC-2021, the patient experienced splitting migraine. On 03-DEC-2021, the patient experienced was very uncomfortable. On 03-DEC-2021, the patient experienced redness grew down arm to almost elbow. On 03-DEC-2021, the patient experienced injection site uncomfortable. On 03-DEC-2021, the patient experienced injection site sore. On 03-DEC-2021, the patient experienced headache. On 04-DEC-2021, the patient experienced flare of autoimmune reflex sympathetic dystrophy (rsd) symptoms. On 04-DEC-2021, the patient experienced couldn't walk. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from splitting migraine, and headache on 04-DEC-2021, had not recovered from redness at injection site, difficulty moving arms and legs, couldn't walk, flare of autoimmune reflex sympathetic dystrophy (rsd) symptoms, injection site sore, and hotness at injection site, and the outcome of was very uncomfortable, injection site uncomfortable and redness grew down arm to almost elbow was not reported. This report was non-serious.
This case was reported by a physician via sales rep and described the occurrence of polymyalgia in a 60-year-old female patient who received SHINGRIX. Concurrent medical conditions included rheumatoid arthritis (prior to SHINGRIX vaccination). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced polymyalgia and joint pain. On an unknown date, the outcome of the polymyalgia and joint pain were unknown. It was unknown if the reporter considered the polymyalgia and joint pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The GlaxoSmithKline field representative was notified today by the reporter. The patient experienced general myalgia and specifically greater joint pain than her usual joint pain associated with her preexisting rheumatoid arthritis, after having received the SHINGRIX vaccine. The reporter said the vaccination was administered at the patient's rheumatologist's office and that the reporter is not the responsible doctor but was the patient's primary care physician. No further details were provided by the reporter to the GlaxoSmithKline field representative. It was unknown if the reporter gives permission to be contacted by GCSP.
Patient came into the clinic to receive her 4th PENTACEL. The shot was given too early. Both the PHN; contract RN thought it was dose #2 going to dose #3. So 4 weeks would be appropriate. 6 months is the correct span. Called mom: re-scheduled 4th dose for Feb 3rd 2015.
Day 3 (4/4/2021): Nose bleed, R nostril. Likely prompted with nose swipe. Resolved within 2 hours. Day 15 (4/13/2021): Nose bleed, mainly R nostril, Seemingly unprompted (just started gushing). Took 24 hours to resolve, likely would have been faster to resolve if proper decongestant was available. Day 15, approximately consistent with 2nd nose bleed, some malaise.
unable to raise left arm; he had sore left arm; had sore in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (unable to raise left arm), MYALGIA (he had sore left arm) and ARTHRALGIA (had sore in shoulder) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced MOBILITY DECREASED (unable to raise left arm), MYALGIA (he had sore left arm) and ARTHRALGIA (had sore in shoulder). On 21-Apr-2021, MOBILITY DECREASED (unable to raise left arm), MYALGIA (he had sore left arm) and ARTHRALGIA (had sore in shoulder) 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.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Non significant follow up received on 26-MAY-2021, no new information
Fourteen days after injection developed a red rash near injection site; Rash is warm and swollen; Rash is warm and swollen; Fourteen days after injection developed a red rash near injection site; Seven days after injection i had a marble size knot form at the site; Seven days after injection ihad a marble size knot form at thesite and itching lasting about a day; When vaccine was administered there was a stinging/burning sensation; mild soreness in the arm for 3-4 days after; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8730) via an unspecified route of administration in the arm left on 25Mar2021 at 12:00(at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included morbid obesity. Concomitant medications included vitamin d nos (VITAMIN D) and multivitamin(manufacturer unknown) both from an unknown date for unknown indication. The patient previously took Azithromycin on an unknown date for unknown indication and experienced drug allergy. The patient previously took Flagyl on an unknown date for unknown indication and experienced drug allergy. 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 vaccination. On 25Mar2021 When vaccine was administered there was a stinging/burning sensation. In mar2021on an unknown date she had mild soreness in the arm for 3-4 days after. On 01Apr2021 at 18:00 Seven days after injection she had a marble size knot form at the site and itching lasting about a day. On 08Apr2021 Fourteen days after injection developed a red rash near injection site. Rash is warm and swollen, but not painful. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events when vaccine was administered there was a stinging/burning sensation. She had mild soreness in the arm for 3-4 days after. Seven days after injection she had a marble size knot form at the site and itching lasting about a day. Fourteen days after injection developed a red rash near injection site. Rash is warm and swollen, but not painful were not recovered.   No follow-up attempts are needed. No further information is expected.
Swelling of the lymphnode in the left armpit; pain can be felt there; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Mar2021 09:00 (Lot number: EN6206) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Lot: EC9266, Administration time: 03:00 PM, Vaccine location-Left arm), administration date: 23Feb2021, when the patient was 44 years old, for Covid-19 immunization.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 14Mar2021 22:00, outcome "not recovered", described as "Swelling of the lymph node in the left armpit"; AXILLARY PAIN (non-serious) with onset 14Mar2021 22:00, outcome "not recovered", described as "pain can be felt there". Therapeutic measures were not taken as a result of lymphadenopathy, axillary pain.  Additional information:Swelling of the lymph node in the left armpit within 24hrs of receiving the 2nd shot in the left arm. it's been 48hrs at time of writing this and the armpit is still swollen and pain can be felt there. Patient not diagnosed with COVID 19 prior to vaccination and no other medications the patient received within 2 weeks of vaccination and Since the vaccination. The patient has not tested for COVID-19, since vaccine. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Started getting a rash of small red bumps on my face on Friday 3-27-09. Saturday rash had spread to neck and chest. By Sunday it had spread to arms, back, stomach and legs. It was itchy with small red raised bumps. Monday went to doctor received steroid shot. Been taking BENADRYL and 10mg ZYRTEC. Also have small knot on arm.
Pt recvd Engerix-B on 1OCT92 & had fever & rash (diffuse maculopapular); Reporter is considering kawasaki disease (not due to Engerix-B);
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 87 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Sep2021 (Batch/Lot number: unknown, Expiration Date: Sep2024) at the age of 87 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Sep2021, outcome "unknown", described as "legs started hurting"; BACK PAIN (non-serious) with onset 08Sep2021, outcome "unknown", described as "back hurts so bad I can just sit down and cry". Therapeutic measures were not taken as a result of pain in extremity, back pain. Additional Information: Patient stated, she got the vaccine last Friday. Her first shot last Friday and yesterday her legs started hurting and her back hurt so bad she could just sit down and cry. She just wanted to know can she take Tylenol. She really wanted to take some what she was supposed to. Patient stated on 03Sep2021. Well, that was the date written on here (Later 03Sep2021 Confirmed as date of vaccination of first dose). There was another date on the back side. On the back side there was another date. It says 24Sep (Further Clarification Unknown). She guessed that was when she got it. Last Friday, whatever Last Friday it was. Patient asked to see it on her card. That would be on her little card they gave her, (further not clarified, hence not captured in tab). Weight: Patient stated, "Probably 162."(not clarified further, hence not captured in tab). Scheduled Date of second dose: Consumer stated, "They had not that here, they said they will contact her." Anatomical site of administration: Patient stated that "In her right arm, upper arm." Other Medical Conditions: Patient stated, "No, it said on here if you have pain or something like this. No, her leg started hurting yesterday and then her back started hurting and I thought in case it was from the vaccine. I did not know whether to take something or not."(medical history was not appropriately clarified). Time of vaccination: Patient stated, "It was probably around 2 o clock at evening. Facility Type: Patient stated, "It was a premise of School. Patient stated that no prior vaccination (within 4 weeks of Pfizer vaccine). Patient stated that no Family Medical History relevant to AE. No lab tests were performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm hurt in the muscle around the injection site and arm felt hard for 4 days. I also felt achy and tired for about 4 days. I didn't need to take any pain relievers however.
The vaccine was given past its refrigeration expiration date, the date on the vial was still within date.  Patient was revaccinated.
This consumer (patient's daughter) reported that a 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown) at single dose for COVID-19 immunization on 13Apr2021 at 4:45-4:50pm. Relevant history and concomitant drugs were unknown. The consumer reported on Wednesday morning (14Apr2021), her mom woke up with the rash. It continued to worsen. The patient was on an antiviral, narcotic pain medication for the pain, and a lidocaine patch.  They took the patient to the emergency room Saturday. They said it wasn't a side effect. They first thought it was just a rash, but it continued to get worse and painful. It turned out to be shingles since 17Apr2021. They originally thought her mom was just having an allergic reaction so they gave her Benadryl. When they called in to report it on Friday, they told her to take her mom to the Emergency room. The patient went to the Emergency room Saturday morning. The outcome of event rash, and shingles was not resolved, the outcome of other events was unknown.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's medical history, concomitant medications and laboratory data were unknown. On an unknown date on "Friday", the patient was vaccinated with PNEUMOVAX 23 (Dosing details, route of administration, lot # and expiry date were unknown) for prophylaxis. On an unknown date in October 2018, the patient experienced numbness in his "pinkie" and ring finger and at the time of the report, a little bit in his middle finger (hypoaesthesia). The patient had not consulted a physician concerning the numbness. At the time of the report, the event was ongoing. Causality assessment was not provided by the reporter.
unexpected benefit; This case was reported by a nurse via call center representative and described the occurrence of unexpected therapeutic effect in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The reporter read studies that said shingrix helped patients decrease risk of stroke by preventing an inflammatory response. The reporter did not remember where she read it. The reporter consent to follow up.
Moderna COVID-19 Vaccine  Around 4 in the afternoon I started getting more intense pain in left arm.  By 5 PM I was starting to get mild nerve pain in the same arm, and the pain had spread from my left arm to include my neck and upper shoulder.  By 8 PM the nerve pain was getting worse and the muscular pain had spread to 2 inches bellow my shoulder blade (concentrated on the left side) and included the aforementioned areas. At 11 PM I noticed that my sense of touch was altered on the left side of my body, and the nerve pain was steadily getting worse.  I could feel pressure but not fine discriminative touch, and had little reaction to touch (I usually have a lot of hypersensitivity, and react very strongly to the slightest amount of touch). I tried going to bed around 12:30 AM but was not able to fall asleep until after 5:30 AM because the nerve pain was so sever at this point.  Positional changes and ice did not help, and I ended up taking Advil at 5:15 because I couldn't deal with the pain anymore.  This dampened the pain enough that I was able to go to sleep at 5:30 AM. The nerve pain was a 8/10 and went down my ulna to my 4 and 5th fingers.  This was some of the worst pain I have experienced in years. I have some lingering nerve pain in that arm (as well as dampened sensory sensation on the left side), but it is not as bad as it was the night of the vaccine.
fever of 102 x 2 days;presented to ER w/t104 & prolonged tonic-clonic gen sz >45min;required valium & Phenobarb for restoration;intermittent focality to sz w/posturing & opisthotonos;
Child developed a tight cough and progressive respiratory distress beginning 3-5 min after vaccination. On initial exam he has tachypneic tachycardia with O2 sats 92%. BP 82/42. Responded well to Pt neb. tx, DECADRON, BENADRYL, supplemental O2.
Local reation at left arm, injection site. Increase redness, warmth and swelling. Instructed to apply cool compress to area.
Father was notified Child received expired Pfizer. Explained Pfizer expired the day before administration. Father denies child having any adverse events.
pt started vomiting 2PM;temp elevation 102.4 R & very fussy;mom reports nursed w/o difficulty;had ecchymosis & marked tenderness around the lt upper gum line, sl edema of gum;tx in ER;dx acute rxn to DTP ? teething vs gingival infect;
Patient reported severe pain in shoulder, burning sensation, and difficulty/inability to move arm a few hours following vaccination. Patient visited ER and was treated with TYLENOL w/ codeine no.3 and ice compress. Patient reported still having pain a day later, but it was not as bad. Primary care continued RX for TYLENOL w/ codeine no. 3 for pain.
Rt leg 7x5cm red, swollen, hot area with 2cm firm area. Lt leg 15x11cm red, swollen, hot area with 4cm firm area at center.
Parents called on 1/15/16 and reported that on the morning of 1/11/16, the family found her in her crib, not breathing with congestion around nose and mouth. Taken by ambulance to hospital. Autopsy report pending per mom.
Patient received Monovalent COVID-19 vaccine. Recommendations from ACIP/CDC updated on 9/2/22 to discontinue Monovalent COVID-19 Boosters and to begin using BIVALENT COVID-19 Boosters.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Information on medical history was not reported. It was reported that the patient received GARDASIL injection (lot # not reported) 0.5 ml, intramuscularly series as followed: first dose was administered on 28-OCT-2009, second on 12-JUN-2013 and third on 23-AUG-2013. No adverse effect was reported. Additional information has been requested.
Localized, 5 cm x 9 cm zone of erythema w/ 4 cm central indurated area.
Patient developed fever 102.4, 12 hours after injection. Became fussy, unconsolable. Given Tylenol. T dropped 100.4 24-36 hrs after injection. Pt still has fever. Decreased PO, decreased UO, site red dime size.
bilateral pneumonia; transient ischemic attacks; Chronic Obstructive Pulmonary Disease; Bell's Palsy/right facial droop; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. In or around 07-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, injection anatomical location or route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Shortly after receiving zoster vaccine live (ZOSTAVAX), she suffered left facial droop, chest pain, discomfort, shortness of breath and was diagnosed with Bell's Palsy (facial paralysis) and chronic obstructive pulmonary disease. She was also diagnosed with bilateral pneumonia, right facial droop and transient ischemic attacks. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for all the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The above-mentioned injuries were assessed as disabling events by the reporter.  Upon internal review, the facial paralysis, pneumonia and transient ischaemic attack were considered medically significant events.
First signs of lupus started to appear. Rash on my face, loss of appetite, weight loss, fatigue, inflammation, pericarditis.
Hives on face, back of neck, top of back, orbital swelling left and right eye