chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of injection site pain in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (details unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced injection site pain and muscle pain/aches. The subject was told by her primary care provider that the events were a "chemical reaction from the vaccine" and that she should not receive the vaccine again. The subject was treated with Steroids. At the time of reporting, she had finished "2 packs" and was currently being treated with a 3rd pack. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported that 2 employees experienced adverse events including muscle pain and aches after receiving FLUARIX. See case ID A0899572A for details of the other report.
Information has been received from a registered nurse concerning a 77 year old female with high blood pressure and penicillin allergy who on 06-NOV-2006 was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (Lot # 651406/0620F).  Concomitant therapy included NORVASC.  The patient reported a red, sore injection site arm later in the evening of 06-NOV-2006 and was told to ice the arm and take ZYRTEC.  The patient was examined in the office on 08-NOV-2006 and the injection site arm was swollen and bright red from the shoulder to the hand.  The patient was hospitalized on 08-NOV-2006 with cellulitis and was expected to be there for at least one week.  At the time of this report, the patient recovered from the cellulitis and was discharged from the hospital (date unknown).  Cellulitis was considered to be disabling, immediately life-threatening and an other important medical event by the reporter.  The reporter requested a lot check to be performed on Lot 651406/0620F.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
She woke up extremely lethargic and weak, almost unresponsive.  Was extremely pale, almost gray. Finally got up out of bed, and vomited in the hallway.
At approximately 1318, security guard alerted facility staff that medical personnel are needed outside. At approximately 1318, 2 nurses responded to security and ran patient to outside. RN saw patient sitting inside vehicle in driver's seat. Patient's eyes were closed. Patient was unresponsive to verbal and physical stimuli. At approximately 1318, RN notified Lead RN. At 1319, RN  activated EMS. Lead RN arrived on scene and assessed patient. Patient was responsive to verbal and physical stimuli. Patient was oriented to person, place, and situation. Patient denied itchiness, rashes, and difficulty swallowing. Patient's husband reported patient was driving out of parking space and patient asked "do your muscles hurt". Patient then parked car. Patient's left and right hands started "cramping" and "shaking". Patient then closed eyes and became unresponsive to verbal stimuli. Patient's husband alerted security guard and said he "needs to see a nurse". RN educated patient's husband on signs/symptoms of when to seek care, to follow up with primary care provider, and to sign up on v-safe. At approximately 1322 patient vomited on asphalt. At approximately 1325, paramedics arrived on scene and assumed care. At approximately 1345, patient transported to hospital for further care. At approximately 1345, patient left facility via ambulance.
Legs being numb; Back and top of her head is killing her; 5 days of pain and misery; 5 days of pain and misery; Migraine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "Mild headache" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 05Oct2022, outcome "not recovered"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Legs being numb"; HEADACHE (non-serious), outcome "unknown", described as "Back and top of her head is killing her"; PAIN (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "5 days of pain and misery". The events "migraine", "legs being numb", "back and top of her head is killing her" and "5 days of pain and misery" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine.  Additional information: Patient asked how long the migraine will last, as she is planning a trip with her grandkids. Her HCP told her to take 2 Aleve 220mg every 12 hours, been taking two Aleve and only lasts for 3 hours or not even. Aleve did not help at all. She also called her pharmacist and was advised to drink a lot of water. She stated that she has never had more than a mild headache in her life, and that she is otherwise in very, very good health.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report as received from a nurse refers to a 58 year old male patient. The patient's concurrent conditions and medical history were not reported. On 18-MAY-2015, the patient received an adult dose of RECOMBIVAX HB lot # K021581 (unknown strength and route) but on 15-JUN-2015, the patient was vaccinated with pediatric dose of RECOMBIVAX HB lot # J013394 in error, as his second dose of his Hepatitis B vaccination series. Concomitant medications were not reported. The patient did not experience any adverse effects. The outcome of the event was unknown. There was no product quality complaint involved. Additional information has been requested.
Pt recvd 2 doses of Engerix-B & devel stiffness in lower back 3-4 hrs p/2nd dose; has improved;
Information has been received from a nurse concerning a patient who in 1998 was vaccinated with a dose of VARIVAX (Merck) (lot no., route and site of administration were not reported).  The patient experienced a mild chicken pox outbreak two weeks after VARIVAX (Merck) was given.  The patient called physician's office and sought unspecified medical attention.  On unspecified date the patient recovered from chicken pox.  No product quality complain was involved.  No further information available from the nurse.  Additional information has been requested.
Injection site itching, redness, swelling, hot to the touch beginning 22-36h after vaccination. Swelling lessened after 2 days; itching and redness in area 4x5? in size remained on third day after vaccination
I began to have fatigue/ was very sleepy the evening I got the Tdap vaccine. By at least 2/10/13 I had an elevated temperature (I didn't take my temperature right away), and a fever through 2/14/13 (at highest, 102.1). At my doctor's direction I took Tylenol to reduce the fever.  I had severe chills and times when I was very hot/sweaty.  I had a rash from my chest down from about 2/12/13 until 2/18/13, which my dermatologist stated was very likely from the vaccine.  For several days I had very achy joints (it was hard to walk at one point) and neck pain and headaches.  I did not have any cold/respiratory symptoms or stomach symptoms.
Information has been received from a physician concerning a 63 year old female patient with upper respiratory tract infection at the time of vaccination and hypertension and glaucoma who on 29-DEC-2008 was vaccinated from her primary care physician with a dose of ZOSTAVAX. Concomitant therapy included Lisinopril (manufacturer unknown), Xalatan, Diazepam, Amoxicillin, Aleve and Tylenol. On 31-DEC-2008 the patient experienced vertigo. The patient was seen in the office and underwent balance testing (results not reported). The physician stated that the patient had gotten better regarding her symptoms. Experienced vertigo was considered to be disabling as the patient was unable to drive. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromise" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient did not received other medication in 2weeks. Anti viral details: product: COVID 19 treatment, Brand: Paxlovid, treatment start on 22May2022, stopped on 26May2022, Lot number: fx8140 Indication: Treatment of COVID-19. Covid vaccine details: Vaccine brand: Pfizer / BioNTech, Vaccine brand unknown: False, Vaccine administration date: 11May2022, Vaccine lot unknown: True, Vaccine lot unknown reason: Not available/provided to reporter at the time of report completion, vaccine dose number: 4, vaccine dose number unknown: False, vaccine location: Left arm. Adverse event: After reducing symptoms, symptoms returned in full 1 week after taking Paxlovid. If patient recovered: Not recovered. If treatment ae: No. Known allergies: No. Other medical history: immuno-compromised.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Bells Pals half of face, numbness, weakness, headache, fever, diarrhea, nausea, chills, body aches, fatigue., tics and then a few days later had a gran mal seizure, forgetfulness
BUD was 11/17/21. Vaccine administered 11/19/21. Vaccine was refrigerated until 1:00pm when it was mixed and given at 2:30pm.
2 days of high fever, delirium, extreme fatigue, sweats, followed by diarrhea & dehydration.
This case was reported by a physician via sales rep and described the occurrence of pain in arm in an unspecified number of adult patients who received 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient experienced arm pain.
This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received BNT162B2 (COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at the age of 26-years-old as single dose, dose 2 via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) at the age of 26-years-old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She already got the 2 doses of the covid vaccine, being the second dose administered on 22Apr2021. She said that after getting the first dose she got her period a couple hours after it was administered and that was strange for her since she is very regular and the same happened after getting the second dose. She wanted to know if this something normal from the vaccine. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
COVID 19, numbness in knees,/ankles, sore spots on feet feels like electricity running through hands/feet, extreme pain in chest
7 days following the vaccination I came down with shingles.  In 65 years prior to vaccination I had not had shingles.  The shingles occurred on the right side of my body and were diagnosed by dermatologist.   She prescribed Valacyclovir HCL 1 Gram--3 times daily for 7 days to counteract the shingles.
Patient received Prevnar dose #2 and Hepatitis B #2.  Parents report that child was wobbly on feet, "floppy", and "disengaged for 2 weeks" following vaccine.
At 4:40 AM the morning after the first vaccination shot, patient experienced the onslaught of the first of  three epileptic seizures that day. Two more occurrences happened at 8:30 AM and 10:00 AM. At the beginning of each event I (husband & caregiver) administered prescribed prn 'breakthrough' medication to forestall a gran mal. After each administration of medication, patients symptoms subsided and she slept.  Also it should be noted: she experienced anxiety about two hours after the vaccination shot on 3/11/2021. We were near the vaccination site, away from home. She self-administered a pain management pill at that point and the symptoms disappeared. Sometimes anxiety episodes evolve into seizures.
Pt on chronic WARFARIN. INR was increase @ 4.3. Vaccine given in routine fashion 2-3 hours later, Lt upper arm began to hurt. Hematoma formed (5x7 cm) at & below inj. site. Ecchymoses spread down arm to elbow. Rx:Vit K given SQ ice & VICODIN recommended.
Unsure if related to vaccine, but wanted to report event of death due to brain bleed on evening of administration of the vaccination.
Staff member received vaccination @ 10:35 on 6/2/2021 @ Health Care Center from nurse . She awakened this morning with swelling and pain noted to the right index and middle finger on the right hand. She received her injection on the right arm. Staff member complains of all over joint pain. She does have a history of fibromyalgia. She has not other symptoms at this time.
Information has been received from a physician concerning a 2 month old male patient with eczema and atopy, who on 28-JAN-2010 was vaccinated with a 2.0 mL dose of ROTATEQ orally (lot# 664400/0616Y). On 28-JAN-2010 the patient "went completely limp" shortly after receiving ROTATEQ. Physician stated that office waited a few minutes before starting his route 2 month injections. When they went to give the 1st injection, his body went completely limp (needle never penetrated--unspecified which vaccine was in the syringe). His heart rate was stable, he was breathing slower, and the oxygen saturation was normal. He was taken to the hospital and given dexamethasone (MSD). Patient responded to dexamethasone (MSD). He was kept overnight in the hospital for observation. On 28-JAN-2010, a few hours after the patient went limp, the patient recovered from going completely limp and breathing slower. The patient sought medical attention through office visit. Additional information has been requested.
Swollen face and arm. Headache. Sinus pain. Tooth abscess. I do believe that the vaccine triggered immune problems from previous conditions.
fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: pollen" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 03Oct2023 at 15:00, outcome "recovering". Therapeutic measures were not taken as a result of fatigue. Additional information: The patient received flu vaccine within 2 weeks of vaccination. The event was reported as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 21Jun2021 at 10:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 31May2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 28Jun2021 at 06:00, the patient's left arm was hurting from top to fingers. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of left arm hurts from top to fingers which included treatment with unspecified nerve medicine and the treatment was ongoing (reported as still trying). The clinical outcome of the event left arm hurts from top to fingers was not resolved at the time of this report.
1. Stabbing abdominal pain lasting  60 hours (2.5 days).  It started about 13 hours after vaccine administration at 2 am 12 Feb 2022.  The pain woke me up.  Nausea is still present today but is intermittent.  It became intermittent on 16th February.   2. Double vision, headaches and dizziness.  Double vision and headaches lasted 24 hrs.  Lasting dizziness stayed until 16 February.  It became came intermittent since then.    12 February symptoms were the worst.  I was unable to walk straight, move more that 5 steps with out needing to sit/laydown.  I felt completely helpless and sick.  In addition to the above symptoms there were body aches that were 8/10 in severity and neck stiffness.  I also experiences the normal injection site pain at 6hrs post vaccination administration and mild headache.   17 February (today) I experienced onset of joint pain in knees that was aching (new symptom ).  I still have mild body aches and mild intermittent dizziness.  I was unable to complete daily life activities from 12 February until 17 February.  The symptoms were debilitating.  The worst one was the abdominal pain, which felt like knives were going into my stomach for close to 3 days.  It was hard to eat with that pain.  OTC pain medication did not help it.   Current symptoms as of 17 February 2022 are; Intermittent nausea & dizziness, body aches and joint pain.
On 04/01/10 patient received the MMR vaccination along with DTaP, Varicella and Polio vaccinations.  After the immunizations mother states child ran a fever and was sleepy.  Mother states patient woke up in the morning of 04/02/10 with complaint of itching and pain to left arm where MMR was administered.  Mother noticed redness and warmth to immunization administration site.  Mother called health department.  Nurse encouraged mother to bring child to clinic.  Upon arrival around 11:00 AM, nurse noted upright triangle redness and swelling with the base of the triangle being approximately 2 inches wide.  For example, a half dollar coin would cover the area.  Child had no fever at that time.  Nurses encouraged mother to monitor child and immunization site closely.   Also, if symptoms or site worsened to follow up with primary doctor, Urgent Care clinic or ER.   On 04/03/10, mother states redness and swelling increased covering the back of her left upper arm.  She then took the child to the Urgent Care clinic.  On 04/04/10 child's redness and swelling had decreased significantly according to mother.  04/05/10 mother presented child to primary physician for follow up.
Received the J&J vaccine March 21, 2021 Took an antibody test in August (5 months after J&J vaccine) which reported NO DETECTIBLE ANTIBODIES Advised by physician to begin a full course of Pfizer or Moderna vaccine Pfizer vaccine dose #1  given 08/17/2021 Pfizer vaccine dose #2  given 08/08/2021
Swelling, redness, itching (L) SQ - day after varicella injection. Patient took BENADRYL OTC 1 cap. Wed night. Today Fri 11-22-2013 pt has a half dollar size reaction with slight itching. PA told patient till take BENADRYL for reaction.
My neck  and goiter swelled and is still swelled right now.  I still have a little neck pain on the left side from the bottom of the shoulder up my neck to my head  where the vaccine was done and I am still experiencing extreme fatigue.  I had a virtual visit with my doctor about my thyroid and the vaccine  and she thought it was the normal side effects of the vaccine but it still continues and it has about 2 weeks.  She wants to recheck my thyroid but not until 4 weeks after my second vaccine.
client complained of dizziness after receiving 1st Moderna. EMT responded and PHN  joined shortly. First vitals at 1419: blood pressure 145/92, pulse 92, oxygen 97%. Client sitting in chair, alert and oriented, slightly pale. Client stated sitting down at 1415, and felt "disconnected" for a few seconds and dizzy. EMT gave client water. Per client no headache, blurry vision, nausea, chest pain, shortness of breath. Client stated current medical history: migraines, no medications and no allergies. Client asked to stay 30 mins total for observation, client stated sat down at 1415. Vitals at 1428: blood pressure 143/92, pulse 94, oxygen 97%. Per client still dizzy, but improving. Client stated feeling a migraine was coming on. Vitals at 1437: blood pressure 140/90, pulse 90, oxygen 97%. Client stated dizziness improving, skin color normal, headache same. Last vitals at 1447: blood pressure 138/88, pulse 89, oxygen 98%. Per client dizziness resolved, headache same, but normal for his migraine. Per client felt fine to drive home. ER precautions given, advised to follow up with provider. Client left facility with steady gait at 1450.
Scattered erythematous molecules, several with clear vesicles and several new lesions today, 3/31/2000.
Shortly have the patient received the vaccination she began feeling dizzy and faint.  The nurse and EMT quickly attended to her and took the following vitals:   1. O2 99, HR 89, BP 126/78, TEMP 96 2. O2 99, HR 78,BP 119/70 3. O2 99, HR 83, BP 124/72 Patient was cleared by nurse in conjunction with other clinicians.  She was provided ice packs, food, and apple juice.  Per the patient she did not have anything to eat.  Patient left feeling better as per verbal communications physical signs (ie color in cheeks and walking and talking with a smile.)
pt recv vax 5MAY97 & 2 days later pt exp a local rxn consisting of a 10x10cm area of redness, 6x6cm area of induration, warmth & tenderness, no fever was reported;