chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Atrial fibrillation with RVR I woke up on 6/26/2021 in AFib. Went to the ER and they confirmed that I was in AFib. I was given Metoprolol through IV to lower my heart rate and they also doubled the Metoprolol prescription that I was taking. They added Eliquis to keep me from having blood clots and a stroke. I was admitted to the hospital overnight. The AFib began about 1:00 am on 6/26 and it went back to normal sinus rhythm about 10:00 pm on 6/26. I was released from the hospital the following day. I have an appointment with my cardiologist (listed above) on 7/9/21. I do not know if the AFib will return or how long I will need to remain on the new prescriptions.
Initial report receive from a healthcare professional on 09 October 2013. A 56-year-old male patient, whose medical history and concomitant medications were not reported, had received an intradermal dose of FLUZONE ID, batch number - UT4721BA dose number was not reported in left deltoid on 07 October 2013. On 08 October 2013, one days after vaccination the patient experience redness, mild swelling and discomfort at injection site. Patient received ice compresses, hydrocortisone cream and bacitracin ointment to the injection site as corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of the events was unknown. Documents held by sender: none.
PAIN IN ARMS AND HAND; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced pain in arms and hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in arms and hand. This report was non-serious.
sore arm; feeling run down; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm) and fatigue (Verbatim: feeling run down). The outcome of the pain in arm and fatigue were recovered/resolved (duration 2 days).   It was unknown if the reporter considered the pain in arm and fatigue to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and fatigue to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-APR-2023 The case was received from the patient via interactive digital media. The patient stated that the arm only hurts and felt run down the symptoms only last two days and she was telling us that you only need two doses your whole life.  The patient reported that make sure after getting the first dose that no longer than 6 months pass till the second dose within that timeframe you must get the second one otherwise the first dose loses its strength. The follow-up could not be possible as no contact details were available. The case was linked with case US2023AMR060553 and US2023AMR060554, reported by same reporter for her husband.; Sender's Comments:  US-GSK-US2023AMR060553:same reporter
Anaphylactic reaction; This is a spontaneous report from a contactable pharmacist. A 3-decade-old (in her 20s) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on Feb2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The pharmacist stated a patient in her 20's had first dose in Feb2021, resulting in anaphylaxis. HCP asking patient to receive an additional dose, followed by a second dose. The pharmacist was doing vaccines with patients and she was getting ready to restart the vaccine for a patient that had the vaccine done at another location and had a reaction back in Feb2021. The pharmacist stated she needed to find out if there has been any instances like that and what she should do. The pharmacist stated the patient had an anaphylactic reaction and had to be taken to the hospital. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile and temporal association, the causal relationship between bnt162b2 and the event anaphylactic reaction cannot be excluded.
Patient reports that shortly after the vaccine, hours to the next day she developed memory loss and confusion that lasted about 2 days. She then developed bilateral leg pain that is described as constant and aching with a sensation of weakness to the backs of calves. She was worked up for DVT and clotting issues, which were unremarkable. She also reported heart fluttering for about 6 weeks, evaluated by cardiology and Holter monitor were negative/unremarkable. She has now been seen by neurology for her continued complaint of bilateral leg discomfort.
Initial report was received on 30 July 2012 from a health care professional which involves a case of misuse. A two-year-old male had received on 22 May 2012 the second half of "1/2 dose (2.5ml)" of DTaP (manufacturer, lot number, route and site of administration not reported) and was observed for 1/2 hour without adverse effect. The patient had a history of reactive airway disease with wheezing, bronchiolitis with wheezing, respiratory distress, chest tightness and fever following the third dose of TRIPEDIA on 10 January 2012. The patient had experienced increased fussiness following dose one of IPV at three months. The patient was evaluated by an allergist where a prick skin test with DTaP was negative at 15 minutes and histamine control was 2+. The patient was given the first 1/2 dose DTaP (manufacturer, lot number and date of administration not reported) IM (intramuscularly) in the left quad (date not reported) and was observed for one hour without adverse effect. Follow-up information was received from a health care professional on 20 August 2012. The patient received the first 1/2 dose (0.25cc) of DAPTACEL, lot number C4002AA, via the intramuscular route in the left vastus lateralis on 16 May 2012 and was observed for about one hour without adverse effect. The patient received the second 1/2 dose (0.25cc) of DAPTACEL, lot number C4050AA, via the intramuscular route in the right vastus lateralis on 22 May 2012 and was observed for 1/2 hour without adverse effect. The patient has additional events captured in cases 2012-05165 and 2012-05169. Documents held by sender: none. Follow-up information received on 4 September 2012: On an unspecified date after vaccination, the patient developed pain in leg (unsure of which leg, both legs). Patient also seemed more tired and grumpy post Dtap vaccine. Outcome of the events was not reported.
Information has been  received from a physician concerning a 23 year old female student with an allergy to CEFZIL who on 30-AUG-2007 was vaccinated IM with a first dose of GARDASIL at 08:30 am. Concomitant therapy included PROZAC and KARIVA. There was no known illness at the time of vaccination.  On 31-AUG-2007 at 7:00 pm the patient developed swollen eye lids, chills, body aches, temperature of 102.5 a low wbc and a headache. She was seen in the emergency room and subsequently, she was feeling better and the patient recovered on 20-SEP-2007.  It was reported that her sister had an experience following vaccination with GARDASIL (WAES # 0711usa01667). Additional information is not expected.
Fever of 102.2 starting 18 hours after vaccination and continuing for 12 hours.  Severe injection site swelling and soreness for 4 days.  Severe weakness and shakiness for 3 days after injection.  Headache starting 18 hours after injection and continuing for 3 days.
arm burning; pain joint; muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8730) via an unspecified route of administration in the left arm on 29Mar2021 at 17:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included coronary artery disease (CAD) since unknown date and heart bypass on an unknown date. The patient reported an allergy to flagyl and sensitivity to blood thinners. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and carvedilol (MANUFACTURER UNKNOWN), all received within two weeks of vaccination for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021, 8 days later, the patient experienced arm burning, pain joint and muscle pain. The patient did not receive any treatment for the events. The clinical outcome of the events arm burning, pain joint and muscle pain was recovered with sequelae on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Severe nosebleeds on 10/8/2021 and again on 10/16/2021 probably unrelated to the vaccine
Fever, cough, body aches for 5 days. Starting a few hours after receiving flu vaccine.
very sore and swollen UPPER LT. ARM very PINK AND WARM UPPER FOR 8 days 2 FIFTY CENT SIZED bletches oN my chEST no itcHING, chesT site
Extreme muscle soreness in upper arm where immunization was administered; interfered with daily activities; treated with Vicodin.
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 26th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm and swelling. On an unknown date, the outcome of the pain in arm and swelling were unknown. It was unknown if the reporter considered the pain in arm and swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm at a pharmacy. The patient was referred by her physical therapist to the office since patient experienced arm pain and swelling. No further details were provided.
Pain in (R) arm that radiated to right jaw x 3 days after injection - resolved - no treatment.
Eyes redness and tearful eyes, joint and muscle pain, pain in the injected arm, pale skin, severe lower back pain, feeling extremely tired and weak, headache, and dizziness.
Ten days after shot I felt chills, tired. Twelve days later I had chills and fever (101.3) followed by headache. More headache the following day. Went to get tested for COVID-19 (rapid test). Negative. More headaches. Visited doctor on Thursday. Blood work revealed no infection. Friday night fever. Saturday urgent care. Another COVID test (negative). Flu test (negative). Saturday fever. (all fevers low grade between 100-101). Sunday, two fevers. Monday (April 13) early morning fever. Chills precede fever. Headache follows fever.
Patient received FLUZONE HD on 9/25/2018, the next morning on 9/26/2018 she noticed a rash about the size of a baseball around the injection site that was still present on 9/27/2018. She did not report fever, pain or flu like symptoms. She did not have a rash at any other site on her body.
Severe gastroenteritis resulting in severe dehydration, hyponatremia, hypokalemia, hypochloremia, prolonged QT interval, acute kidney injury, and acidosis.  Required hospitalization for rehydration.
Shingles, including any and all of its sequelae; shingles; Information has been received from a lawyer concerning a case in litigation and refers to a 66-year-old male patient. On 12-APR-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administation, lot # and expiration date were not reported) at age of 63 years old (also reported as 66-year-old). As a result of his receipt of zoster vaccine live (ZOSTAVAX), on 21-SEP-2018, patient was caused to suffer shingles, including any and all of its sequelae. As a result of his receipt of zoster vaccine live (ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions the patient requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. Patient is informed and believes and further alleges that patient  will in the future be required to obtain further medical and/or hospital care, attention, and services. The outcome ofthe events was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
I started being really short of breath and felt pain/inflammation in lower body. I remember telling my brother I hurt everywhere below my waist; was just home from work where on my feet unless I sit down to rest. It all culminated with increased breathlessness and went to emergency at hospital at 8:30 pm on April 22, 2021.  Diagnosis was MANY pulmonary embolisms, some large. I have taken week long road trips for the past several years with  hours and hours at the wheel with no problems.   It just seems like a real strange coincidence of the vaccine and subsequent symptoms.
weakness in legs, collapsed onto floor, unable to control bladder, headache, Legs continued to give out while walking, fatigue
received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medication were reported.             No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live non-significant follow up received with age group updated.
Patient's words: post injections patient fell, hit head and then had a seizure. The patient is a 6 year old male who presents with a complaint of loss of consciousness. The onset of the loss of consciousness has been acute and has been occurring for 30 seconds. The course has been decreasing. The symptoms have been associated with abnormal movements, convulsions and trauma, while the symptoms have not been associated with bleeding, fever, focal neurological deficit or history of neurological disease. Patient received influenza immunization x2.  When standing to leave, lost consciousness.  Hit forehead on counter.  Proceeded with tonic clonic seizure lasting approximately 30 seconds.  Patient was very pale.  No postictal period.  Alert and oriented minutes after fall.  No prior history of seizures or epilepsy.
On May 19, 1999 the patient was dx with chickenpox following a MD visit.
Moderna COVID-19 vaccine was administered to patients past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions  Concomitant medication use was unknown Treatment information was unknown
10 year old was administered Kinrix vaccines; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 22-Sep-2022 Reporter's comment: The registered nurse reported that a 10 year old patient was administered Kinrix vaccines.  At the time of call, the nurse did not had the patient details, date of administration, or the information of what vaccines were given.  The reporter did not had the lot number/expiration date information of the doses. The vaccine administration facility was the same as primary reporter.   The consent to follow up was granted. Additional Supportive information: The registered nurse reported that a 10 year old patient was administered Kinrix vaccine, which led to inappropriate age at vaccine administration. This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022136453:Same reporter US-GSK-US2022136446:Same reporter US-GSK-US2022136451:Same reporter US-GSK-US2022136455:Same reporter US-GSK-US2022136456:Same reporter US-GSK-US2022136459:Same reporter US-GSK-US2022136461:Same reporter US-GSK-US2022136463:Same reporter US-GSK-US2022136465:Same reporter US-GSK-US2022136466:Same reporter
FELT REALLY TIRED; Headaches; Nausea; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (FELT REALLY TIRED), HEADACHE (Headaches), NAUSEA (Nausea) and PAIN IN EXTREMITY (Sore arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On an unknown date, the patient experienced FATIGUE (FELT REALLY TIRED), HEADACHE (Headaches), NAUSEA (Nausea) and PAIN IN EXTREMITY (Sore arm). At the time of the report, FATIGUE (FELT REALLY TIRED), HEADACHE (Headaches), NAUSEA (Nausea) and PAIN IN EXTREMITY (Sore arm) had resolved.            No concomitant and treatment medications provided. There was no reasonable possibility of events with Humira. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Patient experienced dizziness,  blurred vision, felt faint, and threw up after receiving the vaccine. We gave her some chocolates and water and after a couple of minutes she was feeling better.
Constant continuous crying despite comforting and trying all measures to get crying to stop lasted from 6pm-11pm then infant finally went to sleep and was fine through the night and there after.
Headache, CoughWheeze, HA,Nasal Congestion, and Cough day after COVID 19  Narrative:  HA,Nasal Congestion, and Cough day after the vaccination that caused work loss X 1 day  Other Relevant History:
Patient started to feel dizzy.  He was laid back in a supine position. He was given a pillow. We also gave water and offered graham crackers. We came back with a ice pack and He was sitting up.  He started to sweat and convulse. He was throwing up. We ran and grabbed an emesis basin. Then a medical emergency was called and urgent care staff ran and tended to patient. Patient had two blood pressure checks after a medical emergency was called. The blood pressure was 100/60. Then the BP was taken again 15 minutes later and it was 101/60. An EKG was also ran. After a while patient felt better and was allowed to go home.
This case was reported by a nurse via sales rep and described the occurrence of shingles in a adult male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 6 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The patient was the reporter's neighbor. The age at vaccination was not reported. The patient had no health issues and received SHINGRIX due to his age. The patient broke out in the worst case of Shingles his physician had ever seen. The reporter knew it was not a live vaccine but that was just a little too coincidental. The patient refused to get the second dose. The reporter asked if GlaxoSmithKline of any other weird scenarios like this.