chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was 75 y.o female with history of lewy body dementia and CLL who presented at local HCF with cough and shortness of breath. Pt was confused with her dementia at baseline and did not know where she was. Daughter stated she started having a cough with shortness of breath. She states she had a chest x-ray  done per her primary provider and was started on Augmentin. This caused some GI upset and was thus stopped.  Pt had some worsening shortness of breath and her oxygen saturation dropped down to the 70s. She was therefore transferred to here from the first HCF to be  evaluated in the ER. She was fully vaccinated against Covid-19 and had both her shot at the beginning  of this year.   Pt passed at 1913 on 10/13/2021 with family at side. breathing ceased and no apical pulse noted
Information has been received from a registered nurse concerning an 83 year old female with arthiritis, hypertension, gastrooesophageal reflux, anaemia, osteoporosis and Parkinson's disease and a history of strokes who on 09, Feb 2007 was vaccinated SC with a 0.65 ml dose of zoster vaccine live (Oka/Merck). Concomitant therapy included aspirin, acetaminophen (TYLENOL). docusate Na (COLACE), iron (unspecified), omeprazole (PRILOSEC), amlodipine besylate (NORVASC), carbidopa/levodopa (MSD), oxybutyninC1 (DITROPAN), calcium (unspecified), hydrochlorothiazide, alendronate sodium (MSD), paroxetine HC1 (PAXIL) and potassium (unspecified). On 11, Feb 2007 the patient experienced blisters on her lips and open sores on the sides of her tongue and roof of her mouth. She was afebrile and had no history of fever blisters prior to this. She was treated with nystatin for one week which was discontinued and she was started on acyclovir (ZOVIRAX) ointment. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. Additional information indicated that the patient developed blisters on her lips and inside her mouth. Her mouth was cleaned often, dentures were removed and ZOVIRAX cream was applied to her lips. The roof of her mouth was still sore, but physician does not believe it was from the vaccine. No laboratory tests were performed. The patieint recovered in March 2007. No further information is expected.
No adverse event; Medication error, 0.25ml dose administered instead of 0.5mL; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 18-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL).    No concomitant products reported.  It was reported that it had been brought to attention that the patient had been given 0.25mL of Moderna Bivalent booster vaccine. Asked for advise if the 0.25mL dose was enough coverage for the patient. Questioned if the patient need to receive another 0.25mL dose.  This case was for one of the patient among the 14 patients who received 0.25mL of Moderna Bivalent vaccine.   No treatment products reported.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A and 032BZIA) for COVID-19 vaccination.     Concurrent medical conditions included Spondyloarthropathy. Concomitant products included CELECOXIB and CITALOPRAM for an unknown indication.   On 04-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 26-May-2022 to 01-Jun-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has no known drug allergies. She felt better on May. Device date:03Jun2022  Company comment: This is a spontaneous case concerning a 63-year-old, female patient with no relevant medical history and with vaccine history of receiving unknown dose number of mRNA-1273 vaccine on 4 May 2021, who experienced the unexpected non-serious event of Covid-19. The event occurred approximately 6 months after the unknown dose number of mRNA-1273 vaccine administration on 11 November 2021. Allegedly the event was described as, approximately 174 days after the most recent unknown dose number of mRNA-1273 vaccine administration, patient took Nirmatrelvir + Ritonavir (Paxlovid) for treatment of Covid-19. No other information surrounding the event was reported. The outcome of the event was reported as not resolved from the time of last observation. The current Covid-19 pandemic remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 63-year-old, female patient with no relevant medical history and with vaccine history of receiving unknown dose number of mRNA-1273 vaccine on 4 May 2021, who experienced the unexpected non-serious event of Covid-19. The event occurred approximately 6 months after the unknown dose number of mRNA-1273 vaccine administration on 11 November 2021. Allegedly the event was described as, approximately 174 days after the most recent unknown dose number of mRNA-1273 vaccine administration, patient took Nirmatrelvir + Ritonavir (Paxlovid) for treatment of Covid-19. No other information surrounding the event was reported. The outcome of the event was reported as not resolved from the time of last observation. The current Covid-19 pandemic remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Fever at 101, severe chills and body aches withing 6 hours worsening for 24 hours. Then severe headache and nosebleed onset 12:45am day after vaccine. Symptoms resolved in 72 hours but tinnitus began in same time frame and has not resolved. No prior history of tinnitus
at 2:30 pm pt stated that he was felling dizzy and light headed. after checking his BP he reading was 83/54 heart rate 61. pt stated that the last time he ate was more than 12 hours. after eating some snacks and drinking some fluid he started to feel fine. at 2:53 pm his bp reading 110/73 heart rate was 69. Pt felt a lot better and he left the facility at 2:57 pm per his request
On January 12, 2021 I started to have headaches and not feeling good so I started to check my blood pressure and I realized my blood pressure was up high and I never really had a history of having high blood pressure. That's when I called the doctor but I don't remember the specific date and I told them I am having high blood pressure and I never had any issues so I thin it's the vaccine and my doctor said no, no.  I went to the doctor and I don't remember the specific dates , and she prescribe me Lisinopril 2.5mg and I had to take once a day.
After receiving a FLUZONE HD, the site of injection progressively became red, sore and warm to touch. The symptoms got worse over time and was referred to see the Dr. Patient took a BENADRYL and MOTRIN.
Hypertensive crisis; Elevated systolic pressure; Headache; Anxiety; This case was reported by a pharmacist and described the occurrence of hypertensive crisis in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 8 weeks before receiving 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced hypertensive crisis (serious criteria GSK medically significant), blood pressure systolic increased, headache and anxiety. The patient was treated with antihypertensives nos (Antihypertensive). Shingrix was discontinued. On an unknown date, the outcome of the hypertensive crisis was recovered/resolved and the outcome of the blood pressure systolic increased, headache and anxiety were unknown.   The reporter considered the hypertensive crisis, blood pressure systolic increased, headache and anxiety to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix 8 weeks apart from 1st dose. After receiving Shingri, the patient was repeatedly reporting elevated systolic pressure (more than 3 readings) in 180's at home and was symptomatic- headache, anxiety. The patient was taken to emergency room for hypertensive crisis, which resolved after treatment with an antihypertensive. The reporter was consented to follow up.      Lab Comments: Lab test performed on an unknown date
Several days after receiving the immunization, the patient called the pharmacy complaining of arm pain and jaw pain. She explained that she could barely chew her food or flip a light switch because the pain was so severe. We advised the patient to contact her physician for an examination. The patient was seen by her primary physician, who stated there was nothing imminently wrong, but it may have been a result of the flu shot administration or that her jaw pain may be from the patient tensing up on the side that she received the shot. The patient called back two weeks after receiving the shot still complaining of mouth and arm pain, but now is experiencing chills, nasal congestion, and a raspy voice.
WAS TOLD THAT MY ARM WOULD BE MORE SORE AFTER THIS SECOND SHOT BECAUSE i CHOSE TO GET IT IN THE SAME ARM AS THE 1ST DOSE.   WHILE I DIDNT FEEL THAT SORE IN MY SHOULDER on 2/3  THE FOLLOWING DAY AFTER A HIGH FEVER AND GENERAL/ALL OVER  MUSCLE ACHE, CHILLS   my left armpit began to hurt like I'd pinched or been punched in it, today my armpit is swollen with a knot under the skin and very sore to the touch and slightest movement (injection site is red and swollen with a knot in that area as well.    *my son also received his second shot on same day & he is reporting to me the exact same issue.*   icing the area is not helping.
Started having cough, sinus drip, and lost my voice completely, started having tingling in chest area with cough, fatigue, leg weakness, by Jan 2, was having serious cough, and called doctor.  Symptoms stopped by Jan 4 with exception of voice.
The patient is still experiencing arm soreness even now, a month after the injection. He happened to be visiting his doctor for another issue and his doctor mentioned that the injection may have been given up too high on the arm. The patient is currently only using over the counter remedies like ICY HOT.
For 1 month after 2nd shot I cinsistentlly woke up with a dull headache. During the days I experienced waves of severe chills. And extreme fatigue. After a month the symptoms remain, but not every day. I called my doctor and my appointment is in May. I had a Covid test on march 18,2021. Results negative.
This case was reported in a literature article and described the occurrence of multiple sclerosis in a unk subject who received Hepatitis B vaccine. On an unknown date, 90 days after receiving Hepatitis B vaccine, the subject developed multiple sclerosis. Serious criteria included GSK medically significant. The outcome of multiple sclerosis was unknown. It was unknown if the investigator considered the multiple sclerosis to be related to Hepatitis B vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of multiple sclerosis in a subject of unknown age and gender who had been vaccinated with an unspecified hepatitis B vaccine (manufacturer unknown). No information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, from 1999 onwards, the subject received a dose of either ENGERIX B (GlaxoSmithKline; dosage, administration route and site unknown; batch number not provided) or RECOMBIVAX HB (Merck Sharp and Dohme Corp; dosage, administration route and site unknown; batch number not provided). On an unknown date after 1 January 2000, 90 days after receiving the vaccine, the subject developed new onset multiple sclerosis. Treatment was unknown. The outcome of the events was unspecified at the time of reporting. The authors did not comment on any causal relationship between the vaccine and the events. The authors concluded that "Findings from the present study show no long-term association of vaccines with an increased risk of multiple sclerosis and other central nervous system demyelinising diseases. In younger subjects, a short-term increase in risk after vaccination of any type was observed, which suggested that vaccines (like infections) could accelerate the transition from subclinical to overt autoimmunity in subjects with existing disease. The authors found no association between hepatitis B vaccination and an increased risk of multiple sclerosis or other central nervous system demyelinising diseases up to 3 years after vaccination. The results for human papillomavirus vaccine were inconclusive given the small number of cases and the paucity of previous studies on the topic. The findings reconciled the anecdotal clinical reports of a central nervous system demyelinising diseases onset shortly after vaccination with the larger body of epidemiologic literature showing no long-term increased risk of multiple sclerosis or other forms of central nervous system demyelinising diseases following vaccination. The findings do not warrant any change in vaccine policy". This case is 1 of the 9 valid cases reported in the same literature article.
runny nose; This case was reported by a consumer via call center representative and described the occurrence of runny nose in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced runny nose. On an unknown date, the outcome of the runny nose was not recovered/not resolved.   It was unknown if the reporter considered the runny nose to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-Nov-2022. Reporter's Comment:  The reporter stated that her husband received the Shingrix shot recently and now the husband had a runny nose.  No other information reported to the agent by the reporter. The reporter declined for GlaxoSmithKline to store any contact information and declined to answer any more questions for the safety report. The reporter did not give consent to follow-up.
Mom noticed rash on thighs yesterday 11/14/12 2 days after shots were given. Also noticed rash under pt's neck.
After the first dose she experienced diarrhea.; This is a spontaneous report from a Pfizer from a contactable consumer (Patient).   A female patient of an unspecified age received bnt162b2 (PFIZER COVID 19 VACCINE), dose 1 via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The second dose was scheduled on 13May2021. Medical history included ongoing seizure and cardiac disorder, she was taking medications for them. After the first dose she experienced diarrhea in Apr2021 with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
p/vax pt began running 102 fever & had a few bumps trunk & arms; pt remained for next 10 days p/vax;crying, cranky, would not eat or drink, T102 daily;generalized rash, raised red bumps & whelps entire body;throat is red;sent to md;
only the Dtap-IPV being administered without HIB component with no reported adverse event; Initial information received  on 19-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had only the DTAP-IPV being administered without HIB component with no reported adverse event for diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UJ842AA, expiry date- 11-FEB-2024) (with an unknown dosage, strength) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date the patient developed a event of only the DTAP-IPV being administered without HIB component with no reported adverse event (single component of a two-component product administered) (latency- same day)) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  Reportedly, Due to patient safety concerns with the two different vials DTap-IPV (blue cap) and Hib (green cap) in one box with no attachment for administering staff to be alerted, we have always documented the lot numbers of both vials DTap-IPV and Hib separately to confirm both vials have been given in one dose. Now it has been noted both vials (blue cap and green cap) have the same lot number causing additional concerns for patient safety. Is there a reason for this change? Why are the vials not banded or shrink wrapper together? is Vaxelis going to soon replace the 15 month dose of Pentacel.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event   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 the guidelines. 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.
Within hours of receiving vaccine she developed rapid palpitations and dyspnea on exertion. Presented to my office 12/20/21 and found to be in atrial fibrillation with rapid ventricular response, a new diagnosis.  Treated with increasing metoprolol succinate and starting  Rivaroxaban. Referred back to her cardiologist, MD.
CVA occipital  lobe presenting with visual loss.  She recovered fully .  Symptoms occured suddenly   21 days post vaccination.   Stroke confirmed on  brain MRI. Treated with heparin.
Red area on upper left arm 2" by 2 1/2" with slight swelling.
lips and tongue started to get numb; Tired; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (lips and tongue started to get numb), FATIGUE (Tired) and CHILLS (Chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Allergic reaction (a year or two ago had injection in knee and had a very bad reaction). Concomitant products included NORTRIPTYLINE, OMEPRAZOLE, LEVOTHYROXINE and LISINOPRIL for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced FATIGUE (Tired) and CHILLS (Chills). On 25-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (lips and tongue started to get numb). On 25-Jan-2021, HYPOAESTHESIA ORAL (lips and tongue started to get numb) had resolved. At the time of the report, FATIGUE (Tired) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Cold; Achy; Fever blisters; Burning bottom lip; Fatigue/ Felt rundown; The patient experienced COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (The patient experienced COVID), NASOPHARYNGITIS (Cold), PAIN (Achy), ORAL HERPES (Fever blisters) and ORAL DISCOMFORT (Burning bottom lip) in a 62-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In January 2022, the patient experienced COVID-19 (The patient experienced COVID). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), PAIN (Achy), ORAL HERPES (Fever blisters), ORAL DISCOMFORT (Burning bottom lip) and FATIGUE (Fatigue/ Felt rundown). At the time of the report, COVID-19 (The patient experienced COVID), NASOPHARYNGITIS (Cold), PAIN (Achy), ORAL HERPES (Fever blisters), ORAL DISCOMFORT (Burning bottom lip) and FATIGUE (Fatigue/ Felt rundown) outcome was unknown.            No concomitant medication was reported.  Moderna's agency was reported as PRIVATE.  It was unknown if patient was enrolled in COVID-19 vaccine trial.  No treatment medication was reported.