chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VOMITING (vomiting). The patient was treated with METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]) for Vomiting, at an unspecified dose and frequency. At the time of the report, VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information included do not tolerate Zofran.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/12/21 2nd dose02/05/21 Diagnosed covid positive:08/17/21 Symptom onset:08/16/21 Exposure: Symptoms:Muscle aches, fatigue, runny nose,HA, sorethroat.
receiving expired Hiberix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old male patient who received Hib (Hiberix) (batch number KP24R, expiry date 24th October 2021) for prophylaxis.   On 25th October 2021, the patient received Hiberix. On 25th October 2021, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient self-reported this case. Patient received Hiberix which was already expired on 24th October 2021.  The reporter consented to follow up.
Approximately 20-30 minutes after vaccine given pt c/o dizziness, throat swelling, hard to breath. Had hives/rash on head, neck and upper chest.
15 month old got Kinrix; Patient received Kinrix as their 3rd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   Previously administered products included Pentacel (dose received on 22th April 2022) and Vaxelis (dose received on 23rd February 2023).   On 24-MAR-2023, the patient received Kinrix. On 24-MAR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 15 month old got Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Patient received Kinrix as their 3rd dose). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were 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 14-APR-2023 The reporter reported that the 15 months old patient received Kinrix vaccine due for DTaP and IPV as their third dose. The reporter did consent to follow up. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The patient received Kinirix as a third dose of DTaP and IPV series which led to inappropriate schedule of vaccine administered.
Patient received Covid 19 vaccine at 4:00 PM. She has a history anaphylactic reaction from a bee sting.  She was advised to wait in observation area for 30 minutes after receiving vaccine.  After 20 minutes she complained of being light headed and dizzy.  She was given apple juice to drink.  Declined crackers.  States she ate lunch about 2 hours ago. 4:39 PM VS taken by personnel. BP 126/73, HR 58, pulse ox 100%, Blood sugar 101. 16:45 PM BP seated 110/65, HR 62, 16:46 BP standing 113/60 HR 58. 16:50 PM.  Patient states she is feeling better and is fine to drive a short distance home. Advised to return if she has any dizziness while leaving the building. Lead RN, was consulted regarding this patient.
Chest pain, sore throat, nasal congestion, fatigue, sore right arm, loss of appetite.  Normal cardiac exam with no friction rub or pain when leaning forward.  Treatment included aspirin 81 mg QD and rest., avoid sports. Patient recovered by 9/21/21 (13 days).
Later on in the day, arm really hurt as expected; it hurt for about 10 days. There was pain at site of injection and a red band 2 x 1 inch below site. The pain was bearable but definitely achy; did not take any medications. Within that week vomited for about 30 minutes, which was very strange. Patient went to scheduled appointment with endocrinologist on 1/14. Patient went back on 1/17 to receive results; labs were clear. Patient reports that heart started pounding and there were vibrations in torsothey were strong so it was scary. On 1/22 patient went to pulmonologist because she thought symptoms were related to lung condition and got an  EKG; doctor commented that they looked like heart palpitations and to follow-up with a cardiologist. Patient had scheduled an appointment with cardiologist for 2/8; however, on 1/30 she was feeling so bad with palpitations and vibrations that called cardiologist and was encouraged to go to the ER. The labs/tests (EKG, blood work, sonogram, chest x-ray) showed palpitations so patient was referred to follow-up with cardiologist. On 2/8 patient went to cardiologist and got an EKG and heart monitor for 8 days. Patient has allergy to adhesive on pads so could not use heart monitor for longer. On 2/21 also patient was sent for an Echocardiogram. On 3/6 patient reviewed results with doctor and told that palpitations/vibrations were not heart related. On 3/7 went to follow-up with PCP for palpitations/vibrations and provided a referral to neurologist. On 3/18 went to see neurologist and was scheduled 2 MRIs (cervical and thoracic) on 3/21. On 3/26 patient received results, per neurologist, she did not see any connection to vibrations. On 3/28 patient went back to the primary and she mentioned that she thought it was related to the vaccination. Doctor did not provide any other treatment/test; patient told to give it a few weeks. In the last week patient reports having vibration for 4 daysthey come and go even at night. Vibrations not as strong but still there. Vibrations come even when patient is at rest (sitting down)-- not doing anything physical; it is not something that she you could control.
Wheezing, eye watery, barely breathing, gave epinephrine, Benadryl and steroid
Severe vertigo, nausea, vomiting starting the morning of 5th day after vaccination. Bedridden for 24 hrs. Vertigo slowly resolving over 4-5 days. Nausea/anorexia x 3 wks. It is now 5 wks post vaccine & I still have dizziness when trying to turn my head in bed & with any sharp movements of head.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX)(lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUENT. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
8/4/21 @ 1539: Within 5 mintues after received the vaccine, pt c/o feeling nauseated and with pallor noted. Offered bottled water; however, prior to pt being able to drink offered water, he had syncopal event while sitting in chair. He did not leave the chair and head was held by this NP until pt woke up. Entire LOC/syncopal event lasted less than 30 -40 seconds. Pt noted to be pale post event; however, interacted appropriately and able to start drinking. VS heart rate 100 bpm, O2 sat 96, clear breath sounds, regular Heart rhythm ausculated.   Due to this event, I had pt drink 2 bottles of water and remain in clinic for 30 min. Pt's color returned and VS remained stable. Pt states he has never had vaccine syncopal event and only prior episode was r/t anxiety. Thinks current episode was r/t anxiety.   Pt states he felt back to normal and skin color noted to be pink prior to leaving clinic.
Information has been received from a physician concerning a 12 year old female patient who on unspecified date was vaccinated with the first dose of GARDASIL. It was reported that the patient had flu like symptoms a few days after receiving her first dose of GARDASIL. The symptoms lasted 6 weeks and the patient is now recovered. The patient did not seek medical attention. No further information is available.
Information has been received from a physician concerning a 2-month-old patient who on approximately 23-JAN-2007 was vaccinated PO with the first dose of Rotateq. There was no concomitant therapy. The physician reported that on approximately 23-JAN-2007, immediately after the first dose, the patient "turned red" and developed a rash over most of their body. Unspecified medical attention was sought. The patient subsequently recovered. The physician noted that the patient would not receive the second dose of Rotateq. Additional information has been requested.
Mild dizziness beginning in late afternoon on day of vax.  Mild dizziness morning after vax lasting 3-4 hours only. Minor soreness in upper arm muscle at site of vax lasting a day and half after vax.
Initial case received from a nurse practitioner on 03 December 2009. A 48-year-old female patient received a left arm injection of H1N1 (lot number UP019AA) on 06 November 2009, and four days post-vaccination developed generalized hives. On the day of vaccination, the patient also received immunotherapy for tree and grass allergies, and concomitant medication included FLONASE. At the time of the report, the hives were still ongoing. Documents held by sender: None.
Headache, Myalgia, NauseaVomiting, headache, chills, fatigue, nausea, body aches Narrative:  Other Relevant History:
Awoke with temperature of 101, fussy, did not act like she felt well.  Taken to MD on 3/6/12 and prescribed Augmentin for "red ear and red throat". On 3/9/12 fever 104 and red rash appeared on chest, abdomen, faintly noted on extremities.  Febrile seizure x1.  Taken to ER for evaluation.  Advised to continue Augmentin.
Patient woke up next morning with arm so stiff she couldn't lift it. Upper arm became hot, red, and wrapped around entire arm circumference. Dr informed by patient who initiated BENADRYL and ice. Stayed the same for 3 days, began to resolve on the 4th day. Much better on 5th day.
Severe Rash around waist and hip area and along the inside leg area of the knee  the  rash is still present and has not cleared as of today
19 hours post vaccine, overcome with  exhaustion, slurred speech, balance instability, hot flashes, red faced which felt bloated.  I obtained transportation home from work. Caffeine seemed to ease symptoms but exhaustion and balance issues remained the next day. Persistent headache remains.
Developed fever 102.7 F; Chills; Extreme weakness; This is a spontaneous report from a contactable healthcare professional who reported for himself, a 62-year-old male patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL0140) at the hospital, via an unspecified route of administration in the left arm on 07Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included CVA no residual, patent foramen ovale and known allergies to iodine. Concomitant medications included apixaban (ELIQUIS) and atorvastatin (ATORVASTATIN). Patient did not receive other vaccines in four weeks. On 08Jan2021 at 06:00 AM, the patient developed fever 102.7 F, chills and extreme weakness. Treatment for the events included Tylenol, tepid bath and "cleep". Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious. The outcome of the events was not recovered.
Severe depression; Emotional reaction; Severe anger; A spontaneous report was received from a consumer concerning a 37 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced emotional reaction, severe depression and severe anger.  The patient's medical history included hysterectomy. Products known to have been used by the patient, within two weeks prior to the event included ondansetron, pantoprazole, vitamin B complex, probiotics.  On 26 Mar 2021, approximately one day prior to the onset of events, the patient received their first of the two planned doses of mRNA-1273 (Lot number: 019B21A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Mar 2021, the patient experienced severe depression and severe anger, had emotional reaction and no physical reaction. The patient reported that it was not normal for her as she experience this when she has PMS (Premenstrual syndrome) and after taking steroids. However, the patient does not have PMS and did not take any steroids. The patient felt better later. The event severe depression was considered medically significant. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events emotional reaction, severe depression and severe anger was resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
p/vax pt awoke 11JUL97 w/rt arm red, swollen indurated @ inj site w/intense pain preventing movement of arm, fingers & weakness in rt leg as well;c/o resolving somatic flu-like sx w/sharp, shooting pain in rt ear as well;muscle weakness;
Vaccine was administered at 8:03 AM. Patient was monitored at clinic until 8:33 AM at which time the patient left the clinic site. At 10:56 AM, the patient reported back to the clinic with concerns over hives on left arm and face. At 10:57 AM, patient was given 50 mg oral diphenhydramine.
fever of 102 6 hrs p/vax, screamed x 2 hrs, hard to settle down, fever again the next day & cried alot;
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 12-month-old female patient who received KINRIX (batch number PY3DZ, expiry date 31st May 1926). On an unknown date, the patient received the 1st dose of KINRIX (unknown). On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received on 13 November 2014: A one year old patient was inadvertently given a dose of KINRIX as the 4th dose of DTaP. No adverse event was reported.
Swelling of the wrists; Heart palpitations; Felt horible; This spontaneous case was reported by a nurse and describes the occurrence of JOINT SWELLING (Swelling of the wrists), PALPITATIONS (Heart palpitations) and FEELING ABNORMAL (Felt horible) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced JOINT SWELLING (Swelling of the wrists). On an unknown date, the patient experienced PALPITATIONS (Heart palpitations) and FEELING ABNORMAL (Felt horible). At the time of the report, JOINT SWELLING (Swelling of the wrists) outcome was unknown and PALPITATIONS (Heart palpitations) and FEELING ABNORMAL (Felt horible) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up information was received and events were added.
Began about 30 min after injection with numbness in the mouth, progressed to redness and swelling in face, increased blood pressure and tachycardia
4 Days after first shot my eye started twitching of and on; Then I got an ear ache towards the end of month for 4 days; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Jan2021 10:00 (Lot number: EN6201) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: B12-VITAMIN; HYDROCHLOROTHIAZIDE. The following information was reported: BLEPHAROSPASM (non-serious) with onset 14Jan2021, outcome "recovering", described as "4 Days after first shot my eye started twitching of and on"; EAR PAIN (non-serious) with onset Jan2021, outcome "recovering", described as "Then I got an ear ache towards the end of month for 4 days". The event "4 days after first shot my eye started twitching of and on" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of blepharospasm, ear pain.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: Women's Vitamins, B12, Hydrochlorothyazide. Reported Event: 4 Days after first shot my eye started twitching of and on, then I got an ear ache towards the end of month for 4 days. 11Feb received 2nd shot. Few days later my eye starting twitching again for a couple of weeks and toward the end of the month I got another massive ear ache. I do not get ear aches and was not sick. 15Mar I slept for a straight 36 hours. 17Mar felt better and then on 18Mar, at 10 a.m I told my sister to take me to emergency my face just fell and I got a headache. Went to clinic nearby, PA told me to go to hospital It looked like I got Bells Palsey and my heart rate was extraordinarily high. Kept me in hospital for 3 days brought blood pressure down and set me up with a neurologist, cardiologist and neurosurgeon. They found a meningioma that was about 10 years old (who knew). Neurologist was at a seminar and said they talked about vaccine waking up the Bells Palsy Virus. Booster is in question?. Did the adverse event result in any of the following?: Doctor or other healthcare professional office/clinic visit. Prior to vaccination, was the patient diagnosed with COVID-19?: No, Since the vaccination, has the patient been tested for COVID-19?: Yes. Covid test type post vaccination: Nasal Swab, Covid test date: 18Mar2021, Covid test result: Negative, Known allergies: No  Follow-up attempts are completed. No further information is expected.
Patient COVID + 9/18/2020 Patient received 2 doses of Pfizer 12/19/20, 01/19/21 COVID = 3/11/21
Vaccine storage temperature presumed to be between 7.5 C and 9 C; Vaccine has been administered to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine storage temperature presumed to be between 7.5 C and 9 C) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine has been administered to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine storage temperature presumed to be between 7.5 C and 9 C) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine has been administered to patients). At the time of the report, PRODUCT STORAGE ERROR (Vaccine storage temperature presumed to be between 7.5 C and 9 C) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine has been administered to patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Expired Vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Oct-2021, Body temperature: 97.9 normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided.
intractable vomiting; severe unusual for her headache; This is a spontaneous report from a contactable physician. A 46-year-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 04Mar2021 14:00 (Batch/Lot number was not reported), at the age of 46-years at vaccination, as SINGLE DOSE for covid-19 immunisation.  Medical history included   from an unknown date and unknown if ongoing.     There were no concomitant medications. The patient is not pregnant at the time of vaccination. The patient did not have COVID prior vaccination. On 11Mar2021, patient developed intractable vomiting and was not able to keep any fluid down for 24h. She had no any other symptoms at that time and no fever or headache. After her vomiting was stopped with high dose of Zofran, she developed severe unusual for her headache that lasted 2 days. The events required physician office visit. The events were assessed as life-threatening by the physician. MRI was done and it was normal. The patient has fully recovered and has no any residual symptoms. Interesting, that patient has a physically and mentally disable son that developed encephalitis at age 4month unclear etiology. No reason for his encephalitis was ever found and no virus was ever recovered. One of the versions of his encephalitis from infection disease team was post vaccinated encephalitis.  The outcome of the event was recovered. The patient was not tested for COVID post vaccination.  Information on lot/batch has been requested.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021301884 Same reporter, different patient/event