chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her glucose of 189 dropped to 70; having difficulty keeping her blood sugars up and it is dropping quicker than normal; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 28-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE DECREASED (her glucose of 189 dropped to 70) and BLOOD GLUCOSE FLUCTUATION (having difficulty keeping her blood sugars up and it is dropping quicker than normal) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus (since 14 years).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced BLOOD GLUCOSE DECREASED (her glucose of 189 dropped to 70) and BLOOD GLUCOSE FLUCTUATION (having difficulty keeping her blood sugars up and it is dropping quicker than normal). At the time of the report, BLOOD GLUCOSE DECREASED (her glucose of 189 dropped to 70) and BLOOD GLUCOSE FLUCTUATION (having difficulty keeping her blood sugars up and it is dropping quicker than normal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
3 days p/vax c/o chest pain in AM by afternoon severe: taken to ER by ambulance;fever 102 for approx 2 days off & on;neck hurt;palpitations;
Information was received from a physician concerning 5-10 immunocompromised patients over the age of 65 years. This report refers to the patients with asplenia. The physician revaccinated the patients with PNEUMOVAX 23 every 10 years. No adverse effects reported. This is one of the two cases received from the same reporter. Additional information is not expected as we can not contact the physician.
Rt. arm red, warm to touch, swollen hard size of my palm - itching, painful, almost hot to touch. Received injection at 10AM and symptoms appear 2 hrs. after lasted 3 days.
Patient did not feel well after the booster 11/21/21. 16 days later patient collapsed 12/7/21. Patient ruled out for everything. No stroke. No MI. Pacemaker rhythm checked the time of collapsed and no irregular heart rhythm identified. Thyroid levels within normal limits. CBC and SMA 20 normal. Patient with no signs and/or symptoms of  infection. Patient collapsed after a dinner but yet got up to walk around for 20 minutes. Patient walked to the bathroom to urinate. Patient decided it was time to leave and collapsed onto his wife while walking through the restaurant. Patient do not fall on anything. He had a syncope episode with no none origin. Patient was diagnosed with Central Cord Syndrome at Hospital. Patient was transferred to Hospital once a MRI was done to confirm a severe C 5 - 6 compression. Dr. the Chief of Neurosurgery operated on him 12/17/21. Patient had a Laminectomy of C 4 - 7 and a decompression of Cervical 5 - 6 with a Cervical Fusion. 10 1/2 months out of surgery patient requires 24-hour 7 day a week care in his home. He is unable to stand or walk with right sided weakness. Patient is AAO x 3.
Information has been received from a consumer concerning her 18 month old son with seasonal allergy, food allergy and allergic reactions to allergy shots (unspecified) and no other drug allergies who on 05-JUN-2005 was vaccianted with 0.5mL dose of MMR II. Concomitant therapy included DTaP. On approximately 15-JUN-2005, about 10 days later the patient developed a fever of 103 degrees and a measles-like rash that lasted several days. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. On an unspecified day, the rash cleared up, the fever broke and the patient was fully recovered. No further information is available.
Information has been received from an attorney regarding a 12 month old male. On 5/26/95, at 7 months of age, he received his third dose of Hib-TITER. He also received four doses of Tripedia, one dose of Tetramune, and three doses of Recombivax vaccines between the time period of 1/25/99 to 12/19/02. It is alleged that as a result of exposure to these vaccines, he experienced thimerosal-induced mercury poisoning. It is alleged that due to the accumulation of mercury in his body, he also experienced developmental delays including but not limited to becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior, loss of language skills, and loss of motor skills. Mercury poisoning is considered medically important.
Firm lump with redness & 2-3 tiny vesicles over lying it on (L) thigh developed 9 days after vaccine (same thigh as received varicella). Area involved about 2 cm. No fever; mildly itchy.
While in observation area pt became diaphoretic, nauseous and lightheadedness.  EMS noticed pt fanning self went to assess noted pt very diaphoretic , and nauseous.  Vital signs done B/P 90/40 HR 54 o2 sat 92% RA.  EMS called for transport stayed with patient noted to be improving on own no hives/uticara no swelling noted to tongue or throat patent airway maintained.  Transport arrived B/P 100/60, HR 68 O2sat 98%RA. Pt alert and oriented translator present.  Pt in agreement to go to ED for evaluation pt ambulated independently to ambulance.
No reaction until on that Monday, I woke up with terrible itching on my back, I took a benadryl, and it went away.  It came back during the day.  They came in the inner part of my arm, my back, my arm , and my chest.  It'll come out in hives, and the itching, and then it will go back in.  Last night, I changed my sheets  thinking it was a reaction to my  sheets. There is no breathing problems,  just itching.
Td given on 06/24/05 following day, sore on 06/26/05 " turned red and swollen" better today pt applied cold compresses.
PT experienced a reaction post COVID vaccination  Vaccine brand (Pfizer) Type of reaction (allergic) Symptoms (tongue swelling) Vital signs:  See Vitals Medications given (Allegra 60 mg and Epi pen 0.15 mg) Was a code blue called (no) How long was patient monitored in observation area (911 called) Final outcome (transported to  Hospital)
Pt died in hospital on 3/10/22. He had several episodes of severe desaturation on 3/9.  Chest CTA was ordered but was never able to be accomplished as he was unstable.  After discussion with the patient and his wife, he desired to continue his DNR/DNI status.  He was placed on BiPAP and given comfort medications.  He tolerated the BiPAP well and looked improved on the morning of 3/10 but with attemp to put him back on high-flow cannula, he severely desaturated again.  He did not want to go back on the BiPAP and opted for comfort care and expired within a short time of coming off the BiPAP as above.
Throw up, diarrhea, nausea early on. 100 degree fever, chills, headache, sweating, delirium
It was discovered after vaccine (MMRV) was given that the freezer temperature was out of the correct storage range for the MMRV.  Per manufacturers dose was compromised therefore this MMRV dose is invalid.
Woke up the morning after receiving the second dose with nausea, body aches, headache, fever, chills, fatigue, arm pain, redness and irritation at site of injection on arm-hot to touch and some itchiness at site, which lasted all day, The following two days I continued to experience dizziness, weakness and fatigue, nausea, headache and body aches with the redness, heat and irritation at the site of injection. The next several days I experienced fatigue.
Information has been received from a physician via a company representative referring to a 13 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 16-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot # M016193, expiration date, route and dose not reported). In August 2016 (reported as "following administration of GARDASIL 9"), the patient developed a red lump at the injection site with a ring around it. The patient complained of sensitivity and pain. The patient was not hospitalized but sought care at physician's clinic for follow up. It was unknown if treatment was given for the events. The outcome of the events was unknown. The causality between GARDASIL 9 and the events was not provided. Additional information has been requested.
nodule; sterile abscess @ inject site; tx w/Duracef & warm compresses;
Feeling like she has a hangover; This spontaneous case was reported by a patient and describes the occurrence of HANGOVER (Feeling like she has a hangover) in a 51-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM (REMODULIN) injection for Pulmonary arterial hypertension.    Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included TADALAFIL and AMBRISENTAN for an unknown indication.   On 11-Dec-2020, the patient TREPROSTINIL SODIUM (REMODULIN) (IV drip) dosage was changed to at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and TREPROSTINIL SODIUM (REMODULIN) (IV drip) .08 microgram/kilogram. On an unknown date, the patient experienced HANGOVER (Feeling like she has a hangover). At the time of the report, HANGOVER (Feeling like she has a hangover) outcome was unknown.            On 11-Dec-2020, the patient had begun therapy with treprostinil sodium (Remodulin) of concentration 2.5 mg/ml for primary pulmonary arterial hypertension. The current dose was reported as 0.080 µg/kg, continuous via intravenous (IV) route. The reporter causality for the event hangover with COVID-19 vaccine was considered to be possibly related. The reporter did not provide causality for the event of hangover with Remodulin.  No treatment medications were reported.
Patient reported swelling and pain at injection site and then developed nausea, vomiting, diarrhea, and headache 24 - 48 hours after injection. Began to feel better and then 4 days after vaccine reported swelling of left side of lips with mild facial droop and numbness left side of face.
04-20-09 - 04-24-09 = left arm, shoulder, neck and rib pain with muscle spasms. No treatment. 04-27-09 - severe pain in left side of my back, more painful with each breath. Went to ER and was diagnosed with blood clots in my left lung. Put on COUMADIN and LOVANOX.   9/17/09 Hospital records received DOS 4/27/09 to 4/28/09. Assessment: Pulmonary Embolism. Patient presented with sharp left-sided flank pain. Joint stiffness.   ICD-9 Codes: 415.19 Pulmonary embolism and infarction, 300.00 Anxiety state unspecified. V45.89 Postprocedural status.
The redness it was the size of an apple; it was very itchy; swelling; been having frequent headches lately; left a black shadowy bruising; pain on the site; had fever; chills; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (pain on the site), PYREXIA (had fever), CHILLS (chills), ERYTHEMA (The redness it was the size of an apple) and PRURITUS (it was very itchy) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ASCORBIC ACID (VITAMIN C ACID) and BIOTIN for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain on the site), PYREXIA (had fever) and CHILLS (chills). On an unknown date, the patient experienced ERYTHEMA (The redness it was the size of an apple), PRURITUS (it was very itchy), SWELLING (swelling), HEADACHE (been having frequent headches lately) and CONTUSION (left a black shadowy bruising). At the time of the report, VACCINATION SITE PAIN (pain on the site), PYREXIA (had fever), CHILLS (chills), ERYTHEMA (The redness it was the size of an apple), PRURITUS (it was very itchy), SWELLING (swelling) and HEADACHE (been having frequent headches lately) outcome was unknown. Not Provided      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.   No concomitant medications were reported.  No treatment medications were reported.
This case was reported by a health care professional and described the occurrence of transient loss of consciousness in a 22-year-old female subject who was vaccinated with Engerix B for prophylaxis. The subject is a medical assistant student who has exhibited fear of needles in the past. The subject received three hepatitis B vaccinations as a child without any problems. The subject has no history of allergy to yeast, foods, or medications. On 27 June 2007 at 10:10 the subject received 1st dose of Engerix B at 10 mcg in the left arm. This was considered to be an inappropriate dose of drug administered. The subject should have received an adult dose of Engerix B at 20 mcg. An unspecified amount of time following vaccination with Engerix B, the subject experienced lightheadedness, transient loss of consciousness, nausea, plus audible wheezing and shaking. The subject's blood pressure at the onset of reaction was 136/80. It then dropped to 108/50. Following epinephrine treatment, the subject's pressure increased to 142/62 and then to 166/76. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject as taken to the emergency room via ambulance. The wheezing was bilateral which resolved after epinephrine was given. The subject then regained full consciousness and was able to talk. Her vitals normalized by the time the ambulance arrived which was approximately 10 minutes. Shaking improved. The nurse used ammonia under the subject's nose to wake her up. Ammonia ampules were passed under nose 6 to 7 times. By the time the subject arrived at the hospital, she was generally improved, but had continued nausea and some shaking. Wheezing had ceased and she was stable, alert and oriented. The status of the subject at the time of reporting was not known. The reporting nurse questioned a potential quality issue (product complaint) with the lot of Engerix B used. She stated that the Engerix B product looked as it should have and that there were no perceivable quality issues. The nurse reported that the subject does have a history of a fear of needles that may have contributed to the events.
N/A - SHINGRIX was mixed with sterile water instead of the provide adjuvant - No adverse event to patient.
This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a 16-year-old female patient who received BEXSERO. Previously administered products included BEXSERO (1st dose received on an unknown date). On 5th July 2016, the patient received the 2nd dose of BEXSERO. O 7th July 2016, 2 days after receiving BEXSERO, the patient experienced injection site erythema, injection site warmth, injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site pain and injected mobility decreased were not recovered/not resolved. The reporter considered the injection site erythema, injection site warmth, injection site pain and injected limb mobility decreased to be almost certainly related to BEXSERO. Additional details were provided as follows: The medical assistant reported to Medical Science Liaison that, the patient had a coin sized red area around the injection site (left arm) that was hot to the touch. The patient's arm was painful and she cannot move it as a result. The parents had called the office, but the Medical Science Liaison (MSL) was not aware of the patient being seen by the office for this reaction.
The patient skipped day seven for the second dose of RabAvert; Case reference number US-BN-2022-002285 is a spontaneous case report initially received on 08-Sep-2022 from a health care professional (reference number: USBAV22-1310) and concerns a patient of unknown age.  The patient's relevant medical history and concomitant medications were not reported.  On 18-Aug-2022, the patient was vaccinated with the first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number: unknown) at an unknown dose, via unknown route of administration, at an unknown anatomical site, for pre-exposure for rabies.   It was reported that the patient was not vaccinated with the second dose of RabAvert seven days after the first dose (explicitly coded as 'Missed dose').  At the time of this report, it was unknown if the patient experienced any adverse events.  Non-significant case correction performed for information received from Bavarian Nordic on 08-Sep-2022 to include the local case ID.  The case is linked with cases no. US-BN-2022-002286 and US-BN-2022-002287 due to the same reporter.; Reporter's Comments: A patient of unknown age was not vaccinated with the second dose of RabAvert seven days after the first dose which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age was not vaccinated with the second dose of RabAvert seven days after the first dose which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
2nd dose: Got it the specified number of days later, probably like 90 days later; Headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose:1), administration date: 19Mar2021, when the patient was 75 years old, for Covid-19 immunization, reaction(s): "Headache". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "2nd dose: Got it the specified number of days later, probably like 90 days later"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headaches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 21 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL.  It was reported that the patient fainted immediately after receiving GARDASIL vaccine, she woke up shortly after.  It was reported that shortly after she woke up she vomited at least once, but perhaps two times.  The doctor kept the patient in her office for over an hour and after that she was ok to leave.  It was reported that GARDASIL was the only vaccine given at that time.  Additional information has been requested.
pt recvd vax & a few days later devel swelling & rash; No further details were provided;
Dizziness, Myalgia,  Developed chills, sore throat, ang myalgia day post 2nd vaccine. Then a week or two developed a HA and dizziness that has persisted. Narrative: Developed chills, sore throat, ang myalgia day post 2nd vaccine. Then a week or two developed a HA and dizziness that has  persisted. Missed 2 days of work.
breathing difficulties, congestive heart failure, admitted to hospital twice on oxygen now.... shakes and tremors.   She was never on any meds - just diagnosed with sundowners and was not fully on anti anxiety meds yet.  They forced her to take vaccine as we were pulling her out of the facility that day.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse by phone. This case is linked to cases 2018SA324603, 2018SA324602, 2018SA324605, 2018SA324604, 2018SA324607, 2018SA324609, 2018SA324596 and 2018SA324608 (same reporter). This case involves adult female patient (age not reported) was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UJ045AA and expiry date: 30-Jun-2019) via intramuscular route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because the refrigerator temperature dropped overnight to 29.1 degrees Fahrenheit and was out of range for 11 hours. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
First day after:  chills, fever, body aches, severe headaches and body pains (same as when I received second dose back in the spring).  But the next morning, and for 18 days since: fatigue, body weakness and brain fog 24 hours a day; intermittent mild headache, lightheadedness, rapid heartbeat, pressure in forehead, nausea; occasional bitter taste in mouth and muscle cramps.