chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He then developed facial paralysis; he had Bell's Palsy; he had Ramsay Hunt syndrome; He then developed dizziness; He then developed weakness; This serious case was reported by a physician via sales rep and described the occurrence of facial paralysis in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced facial paralysis (Verbatim: He then developed facial paralysis) (serious criteria GSK medically significant), bell's palsy (Verbatim: he had Bell's Palsy) (serious criteria GSK medically significant), ramsay-hunt syndrome (Verbatim: he had Ramsay Hunt syndrome) (serious criteria GSK medically significant), dizziness (Verbatim: He then developed dizziness) and weakness (Verbatim: He then developed weakness). The outcome of the facial paralysis, bell's palsy, ramsay-hunt syndrome, dizziness and weakness were not reported.   The reporter considered the facial paralysis, bell's palsy, ramsay-hunt syndrome, dizziness and weakness to be related to Shingrix.     The company considered the facial paralysis, bell's palsy, ramsay-hunt syndrome, dizziness and weakness to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-MAY-2023  The reporter was a field staff employee. The first dose of Shingrix was received about a month prior to the reporting. The patient was with no comorbid conditions received a dose of Shingrix and then developed dizziness, weakness and facial paralysis.  The patient sought care from a neurologist and was told that he had Bell's Palsy or Ramsay Hunt syndrome. The Neurologist told it was caused by the Shingrix vaccine.  The patient had no other vaccines on the same day. The patient was now in physical therapy and his balance was better. The reporter agrees to follow up from GlaxoSmithKline.
thoracic radicular pain around right flank to right abdomen; abdominal pain; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 61-year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 17-APR-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed by a healthcare provided for the long-term prevention of shingles and/or zoster-related conditions. The patient suffered right sided abdominal pain and burning, intermittent radiating pain to the back and was diagnosed with shingles on 13-AUG-2013. The patient also suffered thoracic radicular pain around right flank to right abdomen area and was diagnosed on 26-SEP-2013. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
body pain; feeling like she had the flu; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 (Lot number: ER8727) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 26Mar2021, outcome "recovered" (28Mar2021), described as "body pain"; FEELING ABNORMAL (non-serious) with onset 26Mar2021, outcome "recovered" (28Mar2021), described as "feeling like she had the flu"; HEADACHE (non-serious) with onset 26Mar2021, outcome "recovered" (28Mar2021), described as "headache".  Additional information: Patient was not visited to emergency room or physician's office. Patient did not received any prior vaccination within 4 weeks prior to Covid-19 vaccination.The side effects from her first dose she believes only lasted two days. She had a headache, body pain and she was feeling like she had the flu but that only lasted two days. Confirmed she recovered completely.   No follow-up attempts are possible. No further information is expected.
Vaccines placed at vaccine clinic. Mom denied any complaints prior to vaccines. Same day as vaccines developed fever up to 104, improved with Tylenol but then returned. Temp of 104 daily since vaccines. Now day 5 of fever, fussy, seen 11/23/04 Dr. Labs ordered, Rocephin given.
Pt recvd 3 doses of Engerix-B vax 15FEB89, 17MAR89, & 17AUG89 & it was determined that pt did not seroconvert;
Left lateral upper arm with 11.5x9.5cm area of erythema, tenderness and warmth. Mild induration centrally. No postule, crusting or drainage.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 28-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 672 hours, the lowest recorded temperature was 20F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
On 11/20/2000 the patient experienced a strip of red above the infection site and 4 raised bumps. On 01/19/2001 (6 weeks after the vaccination) the patient developed roseola. Follow up information received from the physician's office indicated that they did not have any record of a reaction. No further information is available.
Groggy for 48 hours after. On 3rd day very sore, tender and inflamed/swollen under left armpit (same arm where 3rd Pfizer booster shot was administered).
Patient had facial droop on 9-2-14 and went to ER and was treated for presumed Bell's Palsy. Patient returned to ER on 9-8-14 with facial droop and leg weakness and was admitted to ICU for GUILLAIN-BARRE syndrome. She was then transferred to hospital.
On March 25 2022 Discomfort begins in the eye (inflammation, redness and pain). March 28, 2022 visit to the hospital emergency room at 8:00am, they stabilize him and send him by ambulance to the Hospital. He is discharged with a diagnosis of Headache and acute sinusitis. March 29, 2022 visit to ophthalmologist and sends him by ambulance to the Hospital. In the hospital he has rashes and inflammation on the nose, left eye, forehead and head by the left side. On March 29, 2022 was admitted to the Hospital to be stabilized again, studies and diagnosis in the emergency room were conducted for 7 days. April 5, 2022 he was discharged from hospital with a referral to an ophthalmologist for treatment and treat blindness due to Herpes Zoster.
FLU LIKE SYMPTOMS, BODY ACHES, EXTREME FATIGUE, SWOLLEN AND RED ARM FROM ELBOW TO SHOULDER. Symptoms lasted for three days.
I started with a fever (103) and chills the first night Arm hurting so bad,  could barely move it. Took some Tylenol. Second day, I was extremely tired with a fever. I couldn't work for the remaining day. I noticed a small rash on my right leg which was not there before. I was itchy. fever went down to 100. I've taken over the counter medication. I'm still exhausted. I experience some numbness last night. it has subsided but my arm is still extremely soar. I'm still exhausted.
I received the Pfizer second dose on May 5th and started to have an allergic reaction on May 6th at 02:32. I was not able to attend classes due to muscle pain, headache and nausea. I was having some sort of fever where I felt hot but my body was cold. I slept for the majority of the day.  Around 16:35, when I woke up, I noticed a rash and that my body was feeling swollen. I took 2 Benadryl gel pills at 18:03. I felt some difficulty breathing, and itching sensation all over my body and still had a lot of tension on the left side of my jaw.  I went out to eat with my boyfriend, because we had plans and he had also complained of having some cold chills from the vaccine, and he noticed that I had red marks on my hands.  By May 7 10:05 I called off of work to go my doctor, because I had massive splotches of raised itchy hives all over my body.  It was confirmed that I was having an allergic reaction and I received a steroid shot in my upper gluteal muscle, as well as Famotidine 20mg twice daily for 5 days and Prednisone 20mg twice daily for 5 days.
Rash on neck and back. Treatment: Zovirax 800mg 1 tab tid times 5 days.
neck pain; jaw pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious), outcome "unknown", described as "neck pain"; PAIN IN JAW (non-serious), outcome "unknown", described as "jaw pain". Therapeutic measures were taken as a result of neck pain, pain in jaw. Additional information: The patient took 3 Advil 200mg a total of 600mg a day and Tylenol 500mg for the events. The patient wants to know if that will interfere with the Pfizer Covid-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hospitalized for confusion, fatigue, weakness and hypoxia.  On 5 L nasal oxygen.
Chills - violent shaking for 3 hrs Headache - 3 days weakness - 3days
One week after shot there site swelling, pain, warmth and itching. Also very tender in armpit on injected arm
Ongoing severe side effects from first vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of VACCINATION COMPLICATION (Ongoing severe side effects from first vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (Ongoing severe side effects from first vaccine). At the time of the report, VACCINATION COMPLICATION (Ongoing severe side effects from first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Initial misuse report received from a healthcare profession on 11 November 2013. On unspecified date at 3 year patient received 0.25 ml of FLUZUNE instead of 0.5 ml. Incorrect dose was administered. No adverse event was reported. List of documents held by sender: none.
I got my third booster at about 10AM. That night at about 3 or 4 in the morning, I woke up feverish. I tested about 103 fever. I took ADVIL and TYLENOL, and it would drop for a little bit and come back. I would have chills, I could not get warm at all for about a week. I had a cough, nasal congestion. After about day 8 I called my PCP, they gave me a tele-visit appointment. They prescribed some medicine that I got the next day. I was still having issues with my fever so he instructed me to continue taking ADVIL or TYLENOL throughout the day instead of just to make it go down. I've also had some nasal drainage, which I took ZYRTEC for, and some fatigue. I've been using my inhaler to help me breathe a little easier. I had a cough at some point but that's gotten better as well, I no longer have to take cough syrup to sleep. I had the fever up to a few days ago, around 12/12/22.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Medium, Systemic: Urinated in the event of fainting-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe
Chest pain, dizziness, headache. Received fluid and pain meds via IV at Hospital ER. Not admitted.
Localized rash on site started day after immunization. No treatment needed other than ibuprofen for comfort.
Bell's Palsy was diagnosed by a physician on 10/4/13. Was prescribed Valtrex. Was seen by a neurologist on approximately 10/22/2013 who confirmed Bell's Palsy
Pt had a nodule for 2 days and reported bruising for 7 days and pain for 7 days that radiated up her neck.
Patient complained of severe headaches on days 2 to 6 following administration of Varivax. Also noted to have an increase in staring spells and periods where he did not seem to hear people speaking to him.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes & HBP" (unspecified if ongoing); "HBP" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 03Jun2022, latency 20 days after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course:No other medication in 2 weeks. Anti-viral Treatment of COVID-19 started on 14May2022 and stopped on 15May2022. Adverse event started on 03Jun2022 were severe cold/flu/covid symptoms. Sore throat, productive cough, asthma exacerbation & headache. No known allergies were reported.  No follow-up attempts are possible. No further information is expected.
Information has been received from a optometrist concerning herself, a 35 year old female with a sulfa allergy, who on 23-APR-2003 was vaccinated intramuscularly with a one time 1.0 mL dose of Vaqta (Lot # unknown). There was no concomitant medication. The doctor reported that she experienced a reaction to hepatitis A virus vaccine. The immediate reactions that occurred on 23-APR-2003 for about the first 24 hours were: felt hot, headache, loss of appetite, and tired. Fever occurred after 24 hours on 24-APR-2003 and lasted for approximately 72 hours. The doctor also experienced difficulty breathing, dizzy, nausea, hoarseness, paleness, weakness, fast heart beat, change in emotions, and feeling shaky off and on. The doctor also mentioned there was a rash on the torso and chest. Subsequently, 7 to 10 days, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No further information is available.
Left (indurated) arm became swollen (x 1 week) and site of injection was 6 x 4 inches hardened & had "fever" tx - cool compress, ibuprofen.
Within 2 days general malaise which lasted until 11/21. Within 2 days, skin hurt all over body; it felt bruised : hurt to touch it. 4 days after had a splitting headache that lasted for three days.
her right arm hurts; numbness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administered in arm right (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "her right arm hurts"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Low grade fever (99.6) for about a day, accompanied by chills, body aches and sore left arm/shoulder.  Then a hives-looking rash of about 2 inches in diameter, with a painful knot, developed about 3-1/2 inches below and to the right of the injection site. The rash and associated pain remained for the next five days. No other allergic reactions developed. As of today, 1/30/22, the rash is barely visible and the pain is almost gone.  I reported these side effects to my physician on 1/24/22 but did not feel that I needed to be examined. I also had a reaction to the Zostavax injection, in the form of a similar hives-type rash about the diameter of a quarter at the injection site that lasted several days.
Patient received his first dose on February 16, 2022 Pfizer Lot#FM0698 at Pharmacy. On February 22, Patient was seen at Hospital. for high blood pressure. His B/P was 151/104. Patient spent several hours in the ER and was released with instructions to follow up with his pediatrician and a cardiologist. On February 23, Patient saw Dr at Pediatrics. Patient's B/P was 146/78. Dr advised Patient not to receive another dose of the COVID vaccine, as he had not had any type of lifestyle, medical or physical changes that would cause his B/P to rise. Patient is an athlete who is in top physical condition and has never had high B/P before receiving the COVID shot. Patient is awaiting his scheduled appointment with cardiologist Dr. on March 23.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. Patient's medical history and concurrent condition were not reported. On 24-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # K003596, Expiry date: 12-MAR-2015), (dose was not reported), subcutaneous, that expired on 12-MAR-2015. No concomitant medications were reported. No adverse effects were reported. Additional information is not expected due to no consent for follow up.
After getting the second Moderna vaccine, 0.5 ml, Lot 031M20A  on Friday, Feb 26, 2021 at 1020, I got back home  without any problem.  That evening I had started to get a headache (don't normally get headaches) and felt very tired.  I went to bed about 8 PM after having some rice/tomato soup.   On Saturday, Feb 27,  I awoke about  0700 (7AM) and did not feel well.  I normally get 7 hours of sleep a night arising at 0630.  Stayed in bed until noon.  Came downstairs and laid on the couch.  I took my temperature at 1300 at 96.8.  Took my temperature  at 1700 and it was 100.4o.   Started to feel better by 8 PM.  Took my temperature at 20
Patient exhibits swelling and bruising that got progressively worse over the following two days.  Swelling and brusing were still significant at the time of reporting 3 days later.
fever 103, fatigue, sweating, sores in mouth, aches, confusion, memory loss HORRRIBLEEEE
Papular rash on bilateral thighs, not erythematous or swollen, no active drainage.
PATIENT REPORTED NUMBNESS AND TINGLING FEELING IN LEFT LOWER JAW APPROXIMATELY EIGHT MINUTES AFTER RECEIVING HIS VACCINE. PATIENT REPORTED NO DIFFICULTY BREATHING, OR ANY OTHER SYMPTOMS. PATIENT WAS GIVEN DIPHENHYDRAMINE 50MG AT 12:30PM. PATIENT STAYED FOR AN ADDITIONAL TEN MINUTES, AND REPORTED THE FEELING STAYED THE SAME. FOLLOWED UP WITH PATIENT ON APRIL 21, PATIENT REPORTS THE FEELING WENT AWAY AFTER A FEW HOURS.
p/vax pt c/o arthralgias, myalgias & fever;pt condition is unk;
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: this is not for a covid vaccine. only for flu shot
After administering the Janssen vaccine the patient began to have dizziness and difficulty breathing. The patient's airway did not completely close up as he was able to respond and talk to me. Called 911 and administered 10mL (25mg) of Diphenhydramine and gave the patient a bottle of water. He was already worked up as he was scared of needles. He continued to breath better but still had difficulty. The EMT arrived in under 5 minutes as they were already on a call close by and was rerouted. EMT administered breathing treatment and took vitals and eventually took the patient to the hospital as a precaution. (Technician administered vaccine)
her face, well more specifically her eyes, on the next morning had swelled and they have been swollen; her face, well more specifically her eyes, on the next morning had swelled and they have been swollen; racing heartbeat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administration date 24Aug2021 (Lot number: FC3181) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PALPITATIONS (non-serious) with onset 24Aug2021, outcome "recovered" (24Aug2021), described as "racing heartbeat"; SWELLING FACE (non-serious), EYE SWELLING (non-serious) all with onset 25Aug2021, outcome "recovering" and all described as "her face, well more specifically her eyes, on the next morning had swelled and they have been swollen". Therapeutic measures were taken as a result of palpitations, swelling face, eye swelling.  Clinical Course: She went to her doctor and he gave her steroids and she took the course and it still has not gone down.  No follow-up attempts are possible. No further information is expected.
pt recvd vax between 1985 & 1986 & was found to be anti-HBS neg & anti-HBC pos; lab eval on 12AUG92 revealed that pt was anti-HBS neg, HBsAg neg & anti-HBc neg; 15SEP92 was administered booster dose of vax;
LIGHT FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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 was not reported, administered on 12-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 12-JUN-2021, the subject experienced light fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of light fever was not reported. This report was non-serious.
After receiving the Moderna Booster, about 2 weeks later I experienced random itching that resulted in hives.   My skin has become sensitive (not painful) and turns red upon touch.   Hives develop in small places then expand when scratching or coming into contact with surfaces.   It appears to happen in waves.
ARM BRUISED, THROBBING PAIN FROM SHOULDER TO FINGERS, COULD NOT LIFT ARM ABOVE WAIST X 2 DAYS. THROBBING PAIN WITH NO RELIEF OF TYLENOL, ICE PACK, HEAT PACK, KEPT ME UP 2 DAYS STRAIGHT.