chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Intern gave the patient this vaccine and a Shingrix vaccine. About a minute after administering the shot, the patient passed out in the chair. She was passed out for about 90 seconds and then insisted she was fine and started to walk to the chairs in the lobby and then began to pass out again. The intern caught her so she did not hit the ground. She was then passed out for about 90 more seconds. She woke up and began hyperventilating, was very cold and her hands were turning light purple. Store management was with her at this time and brought her a blanket and pillow. She passed out again during this time. Within 10 minutes, ems arrived and patients blood pressure was around 210/140. They monitored her for around 45 minutes and then she caught up and went shopping for her groceries. The patient was still monitored by store employees on camera. The patient called the intern about an hour after she left to ensure she was home safe and feeling okay.
This is a serious spontaneous case from a nurse in the USA of involving CHICKEN POX. The reporter causality is not provided to FluMist. Case reference MEDI0002596 is a spontaneous case report sent by a nurse which refers to a female aged 27 years. The patient received FluMist on 12/9/04. The patient developed a red spot type blister rash that appeared on her face, chest and back on 12/11/04. The patient had complaints of lung pain and uncomfortable lesions in her mouth. The patient was examined by a physician on 12/13/04 and the physician suggested the blister rash could have been chicken pox. On 12/15/04, the patient required hospitalization for chicken pox. The patient's varicella IgM test was negative. The patient's chest x-ray revealed nothing active. The wound cultures from the patient's chest and head and urine culture had no growth. The wound culture from her face had light growth. The patient's sputum had normal upper respiratory flora. The patient was discharged on 12/16/04. No further information is available.
This case was reported by a healthcare professional and described the occurrence of low birth weight in a neonate female subject who was exposed to BOOSTRIX (GlaxoSmithKline) received by the subject's mother while pregnant. On 7 April 2011 the mother of the subject received unspecified dose of BOOSTRIX at 0.5 ml in the left arm. The mother's estimated date of delivery was September 2011.  The baby experienced maternal vaccine exposure. It was reported that the female neonate subject was delivered on 24 August 2011, at 37 weeks gestation via normal vaginal delivery. The neonate weighed 4 lbs and 9.1 ounces at birth, with a length of 16.75 inches and a head circumference of 16 inches. No defects were noted in the neonate at birth; however, low birth weight was noted. At the time of reporting the outcome of the event was unspecified.
Immediately after injected there was bruising and darkness around the injection site.  On day eight my arm beneath the injection site had welts and was red and warm to the touch. On day nine the welts all connected together and the area was still inflamed and warm. By day 12 the redness and swelling had subsided.
BODY ACHES; HEADACHE; FEVER; This spontaneous report received from a patient via a company representative 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 experienced unspecified adverse event (dose number in series: 1) when received covid-19 vaccine ad26. cov2. s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported for prophylactic vaccination.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable  The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on OCT-2021 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 had body aches, headache, and fever. (Dose number in series: 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the headache, fever and body aches was not reported.  This report was non-serious.  This case, involving the same patient is linked to 20211165877.
hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.    On 15-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOT FLUSH (hot flashes). At the time of the report, HOT FLUSH (hot flashes) outcome was unknown.            Concomitant medications were not reported. Treatment information in response to events was not provided.
so sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced sickness (Verbatim: so sick). The outcome of the sickness was not resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023 The patient got his/ her first vaccine and less than 12 hours later he/ she was so sick. It had been 3 days and he/she still sick. The follow-up would not possible as no contact details were available.
Patient accessed Walmart.com to schedule an immunization appointment and create a patient profile. When the profile was created the date of birth was entered as 11-4-2002. The patient reported for the immunization appointment and signed the attestation of phase form and filled in the date of birth as 11-4-2002. Patient stated she had no insurance coverage so no insurance was billed for the immunization. On Monday, 3-30-21 It was reported to Walmart that the patient had an immunization record on file with a date of birth of 11-4-2003. We called the phone number on file and the patient was unavailable but the person that answered the phone gave the date of birth of the patient as 11-4-2003.
Mom noticed head tilting to left after shots. Recheck arm torticollos with spasm of left sternoderomastoid muscle. Local warm compresses and Tylenol recommended.
Left arm extremely sore. Muscle aches, headache and chills beginning approximately 3 hours after vaccine injection and resolving after 24 hours. Symptoms consistent with typical flu symptoms.
Scratchy throat, swollen bottom lip and high BP Note: twitching of bottom lip persisted daily for one month then occasionally for second month following vaccine
Headache; This is a spontaneous report from a Pfizer sponsored program (contactable female consumer (wife)). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 15Feb2021 as dose 1, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. On an unspecified date, the patient experienced headache. Patient stated that "My husband and I had vaccine 15Feb in (place name) last Monday, my husband started not feeling well on Tuesday with a lot of Covid side effects, our next schedule is 08Mar, do you think we need to get the Covid test before we get the next dose, I also had a little bit of headache." Outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Patient came in 9:40 AM to get his booster 0.25 mL Moderna vaccine. At 9:54 AM, patient came back describing feeling of throat swelling, restrictive, and back of throat feeling scratchy. Pharmacist checked on his pulse (120 HR) and O2 sensor (98%). Patient was able to talk freely and swallow water and feeling "freaked out", which explains his high HR. At 10:00, when arrived, I looked at his throat, tongue, pharynx, uvula, and mouth. No swelling was seen. No tenderness of throat. Patient mentioned it is still scratchy but does not feel restrictive anymore. At 10:05 AM, O2 sensor (99%) and HR (80%) were consistent with not having an anaphylactic shock, however due to throat scratchiness. Recommended to give 50 mg diphenhydramine and 20 mg famotidine (verbal order from ED doctor in  Regional hospital). Patient was able to swallow pills without issues. Recommended to monitor for 30 minutes. At 10:40 AM, Patient was doing well. Throat scratch was a little better. HR and O2 sensor were 80 and 99%, respectively. Advised the patient to go home and monitor himself. Give us a call if condition gets worse. Counseled that he could be drowsy and someone should take him home.   Called patient at home at 11:50 Am and he was doing really well breathing fine. Will call again before evening shift. Recommended to go to emergency department if condition gets worse.  Called patient at home 3:39 PM and he states full recovery.
redness, swelling, warmness @ site of inj devel 3 days post vax;? cellulitis lt upper arm;
Headache, Myalgia, Fever, fatigue, lympadenopathy Narrative:
Information has been received from a physician concerning a 5 month old male patient who was vaccinated with a dose of ROTATEQ on an unknown date.  The physician, who works in the emergency room, reported that she was aware of a patient who presented to the emergency room with possible intussusception in JUL-2008.  The patient's symptoms were vomiting, abdominal distention, and blood in the stool.  The emergency room performed an x-ray and determined that the patient had reduced airflow and suspected intussusception.  This adverse event occurred one week after a dose of ROTATEQ.  It is unknown if the adverse event occurred after the first, second, or third vaccination.  The patient was sent to another hospital that specializes in pediatrics but it is unknown if the child was admitted.  No product quality complaint was involved.  Upon internal review, intussusception was considered to be another important medical event.  Additional information has been requested.
gotten off track with schedule. The patient received first dose on 05Sep2023, and second dose was at day 14 on 19Sep2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 65-year-old female patient who received HAB (Twinrix) (batch number 2PG39, expiry date 19-SEP-2025) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 19-SEP-2023, the patient received the 2nd dose of Twinrix. On 19-SEP-2023, 14 days after receiving Twinrix and an unknown time after starting Twinrix, the patient experienced drug dose administration interval too short (Verbatim: gotten off track with schedule. The patient received first dose on 05Sep2023, and second dose was at day 14 on 19Sep2023).  The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 05-OCT-2023 The pharmacist had a patient that was going to do Twinrix accelerated dosing schedule, but has gotten off track with schedule.  The patient received 1st dose and 2nd dose was at day.  The patient was now (at the time of reporting) at day 30 and requested for 3rd dose, but has not yet been administered at time of call. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose less than the schedule time, which led to shortening to vaccination schedule. The reporter consented to follow up.
New Onset Mania With Psychotic Features; The initial case was missing the following minimum criteria: Invalid due to ICH-Unspecified product. Upon receipt of follow-up information on 16Nov202 this case now contains all required information to be considered valid.  This is a literature report for the following literature source(s):  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MANIA (hospitalization, medically significant), 1 day after the suspect product(s) administration, outcome "recovered", described as "New Onset Mania With Psychotic Features". The patient underwent the following laboratory tests and procedures: Angiogram: with out acute findings; Electroencephalogram: mild cortical dysfunction in the left temporallobe, notes: without evidence of epileptiform discharges or seizures; Labs: unremarkeable; Lumbar puncture: Negative, notes: for an infectious cause of symptoms; Magnetic resonance imaging head: without acute findings; Polymerase chain reaction: Negative. Therapeutic measures were taken as a result of mania.; Sender's Comments: Based on the available information in the case, the causal association between the event 'mania' and the suspect drug BNT162B2 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.
On 3/13/2021, I began having issues. At around noon, I began having more abnormal cardiac arrhythmias, and I felt very tired, so I went to bed. I continued having extreme fatigue and cardiac arrhythmias for the rest of the day. On 3/14/2021, I felt great. On 3/15/2021 at about noon, though, I began having severe vertigo and tinnitus. Not only that, but my entire left arm hurt intensely. Soon thereafter, I also experienced pain on the left side of my head and at the temple, pain in the left ear, pressure behind my left eyeball, and sinus pressure on the left side. The vertigo continued for the rest of the day and into the night, plus I had severe chills all night long that night. For about 6 weeks, I continued to have vertigo that interfered with my functioning. It was so bad that I couldn't even drive. I saw my PCP, neurologist, allergist, and ENT, and they all agreed that the vertigo and pain were autoimmune responses.
Difficulty breathing secondary to Zofran (After the Second Dose); Left Arm hurts  (After the Second Dose); Fatigue on and off (After the Second Dose); Nausea; Low grade Fever 99.3F  (After the Second Dose); Chills  (After the Second Dose); Swollen Lymph node in left side of the neck  (After the Second Dose); Inappropriate schedule of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left Arm hurts  (After the Second Dose)), DYSPNOEA (Difficulty breathing secondary to Zofran (After the Second Dose)), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine), FATIGUE (Fatigue on and off (After the Second Dose)) and NAUSEA (Nausea) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery since an unknown date, Diabetes since an unknown date, Blood pressure high since an unknown date and Sleep apnea.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine). On 28-Jul-2021, the patient experienced PAIN IN EXTREMITY (Left Arm hurts  (After the Second Dose)), FATIGUE (Fatigue on and off (After the Second Dose)), NAUSEA (Nausea), PYREXIA (Low grade Fever 99.3F  (After the Second Dose)), CHILLS (Chills  (After the Second Dose)) and LYMPHADENOPATHY (Swollen Lymph node in left side of the neck  (After the Second Dose)). On 30-Jul-2021, the patient experienced DYSPNOEA (Difficulty breathing secondary to Zofran (After the Second Dose)). The patient was treated with ONDANSETRON HYDROCHLORIDE (ZOFRAN [ONDANSETRON HYDROCHLORIDE]) for Nausea, at an unspecified dose and frequency. On 30-Jul-2021, DYSPNOEA (Difficulty breathing secondary to Zofran (After the Second Dose)) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Left Arm hurts  (After the Second Dose)), FATIGUE (Fatigue on and off (After the Second Dose)), NAUSEA (Nausea), PYREXIA (Low grade Fever 99.3F  (After the Second Dose)), CHILLS (Chills  (After the Second Dose)) and LYMPHADENOPATHY (Swollen Lymph node in left side of the neck  (After the Second Dose)) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) had resolved.            Reporter heard about pericarditis and myocarditis and she was afraid to get the second dose. Also thinks she makes more antibody this way by waiting longer between the two shots   This case was linked to MOD-2021-286712 (Patient Link).
Patient's DOB on the signup website and the consent form filled out by father and signed by mother stated a DOB and age of 12 however the patient's DOB was determined to be different with an age of 11. This was discovered after the insurance company rejected the claim stating invalid DOB.
Patient has a 1inch by 1inch red spot about 1/2 below the injection sight of the Shingrix after their 2nd shot in the series. Patient didn't take any course of treatment but this started a couple days after receiving the vaccine. The red spot has been slowly decreasing over time.
This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 28-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, (dose and frequency were not reported) lot # M044397 with expiration date: 20-JUN-2018 or lot# N003984 with expiration date: 19-NOV-2018, for prophylaxis. On 28-NOV-2017, the patient was also vaccinated with an improperly stored dose of PEDVAXHIB (dose, frequency and route of administration were not reported) with lot # reported as N047666 with expiration date 24-OCT-2019 or lot# M045206 with expiration date 27-JUN-2019 or lot # N001348 with expiration date 31-OCT-2019 with expiration date 31-OCT-2019 or lot # N008080 with expiration date 02-DEC-2019. The specific lots # of ROTATEQ and PEDVAXHIB administered to the patient was unknown by reporter. The ROTATEQ vaccine and PEDVAXHIB were stored in or above 32 degrees Fahrenheit (F) up to 35 F (35.4 F) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. This is one of seven reports received from the same reporter. The lot # N047666 has been verified to be not valid for PEDVAXHIB. Sender's Comments: US-009507513-1712USA002785: US-009507513-1712USA002197: US-009507513-1712USA002303: US-009507513-1712USA002524: US-009507513-1712USA002652: US-009507513-1712USA002696.
Broke out into hives immediately - within minutes. No issues with airway ever. I am still breaking out into hives daily. I also experienced cognitive function issues - memory gaps, brain fog, and could not walk a straight line. Those went away after the first week or so. I also had headache, body aches, fever, chills, dehydration, joint pain, and severe fatigue. This affected my daily life for about a week and half.
Small pink rash away from injection site, headache, soreness at injection site. Rash reported 12/12, headache and soreness 12/16. Referred to primary MD 12/16. Hydrocortisone helped rash temporarily.
This case was reported by a consumer and described the occurrence of increased aspartate aminotransferase levels in a 13 year old female relative who received hepatitis B vaccine recombinant.  A physician or other healthcare professional has not verified this report.  The reporter stated that the patient's past medical history included being fine prior to immunization with Engerix-B.  On an unspecified date, the patient received the first dose of Engerix-B.  On an unspecified date, the patient experienced an increased aspartate aminotransferase level, chronic pain, rash and fever.  Outcome was not specifically reported.  On an unspecified date in April 2003, the patient received the second dose of Engerix-B.  At an unspecified time following the second administration of Engerix-B, the events reocurred.  On an unspecified date, the patient received hepatitis B vaccine as the third dose in the immunization series.  It is unknown if the events reocurred following the administration of Recombivax-HB.  The patient was seen at a physician's office.  At time of reporting, the rash and fever resolved.  The increased asparate aminotransferase level and chronic pain were unresolved.
SUDDEN CHANGE IN MOOD/BEHAVIOR; VERY LABILE. IRRITABLE, CRYING FOR NO REASON, SOME EPISODES OF INCONSOLABILITY.  NOT ABLE OR NOT WANTING TO VOICE WHY SHE IS CRYING OR TELL US WHAT SHE WANTS.  APPEARS VERY FRUSTRATED.  THESE ARE ALL NEW/DIFFERENT BEHAVIORS.
Systemic: Headache-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Patient said she experienced left side numbness, slurred speech, severe neck pain, and a headache. She said she had stroke like symptoms but after being hospitalized for 3 days  and having a CT scan performed stroke was ruled out.
Pt presented with a feeling of "dizziness" 10 mins after receiving the vaccine, while pt was waiting in line to schedule second dose appointment. BP 120/74 HR 84 RR 22. Pt was taking in a private room to lay down after spouse reports pt has panic attacks after her injections. Informed of pt history of anxiety and depression, spouse was unsure if pt had taken her anxiety medication that day or not.  Instructed pt to began slow and deep breathing x 10 mins. Pt then reported she was feeling well and was ready to go home. Pt was ambulated to car. Pt was in the care of her spouse and both were aware if any more difficulties present to seek care.
Pfizer-BioNTech COVID-19 Vaccine EUA Facial rash over mouth and lips, itchiness, burning, swelling, followed by cold sores
Arm has been sore since shot given, currerntly 11/16/16 (21 days).
On 10/13 developed low fever and generally sick-acting, by 10/15 fever rose to 102 degrees F, on 10/16 fever gone but rash appeared on cheeks, 10/17 rash spread all over body and fever back up to 100 degrees.  Both rash and fever gone by 10/19.  Treated with infant Tylenol and fluids.  Dr. recommended ER visit because he claimed it had nothing to do with vaccine, but we kept at home due to information on vaccine insert about exactly this type of reaction. Child remained generally fussy until about 16 days after vaccine.