chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was fine in the morning her cognition was as normal was oriented to time place not date. 4 hours after Moderna booster was called by father in law. She could not feed herself nor open her mouth. This writer assessed her skin color normal BP Pulse rate and Respiratory rate all within normal limits. O2Sat was at 98% she was afebrile and did have output.  Her eyes were glossy she had no memory of myself her son or her husband. She would answer a question with maybe 2-3 words which had nothing to do with question followed by word confabulation. such as "Did you IIIIZZZZTTTZZZ"  always letters and no full sentances that made sense. this went on till 3 am.   They were going to take her to her  Physician today. (08/25/2021)   Caregiver got her up at 10 am. dressed her put her in the wheelchair( she is non-ambulatory).  She is normal.   No odd speech.She can answer questions and is fully aware of her surroundings.   It is amazing her come back! Please look into this. Thank You
pt recv vax 24MAR99 345PM & 5PM rash (hives) developed;no prior reaction to immunization;mom stated childs lips turned blue prior to arrival @ hosp;
Sore arm of injection site, dull headache, chills, low grade fever and lethargy
Patient c/o generalized  itching . Assessment revealed localized swelling in R arm (area of injection) and redness. Red bumps on extremities and back along face and neck. No dyspnea/LOC/or numbness.
One week post vax, the infant experienced a fever of 104. Mom gave the child Motrin and called the pediatrician. The childs face, neck, upper back, both arms and both legs were red. He was congested with some sneezing and very lethargic. The pt also had hives on both upper thighs, and experienced a loss of appetite. He was also given Benadryl. No other treatment noted. Pt's symptoms have resolved
Erythema, swelling, itching, 3 inch x 2 inch, 6 days duration
I had been feeling exhausted ever since receiving the vaccination. In March I had started an exercise program, I had also switched my blood pressure medication from lisinopril to losartan. I could not sleep because of pain in my back and chest. I went to my doctor. I had a chest x-ray that came back normal, a CT scan that came back normal, a stress test that came back normal. I then had a stress test with radiation that came back normal. My doctor told me to resume my exercise, increased my blood pressure dosage, so far, I have not had any other heart palpitations.
06sep90 pt vax hepta B. that evening, pt ex n/v/, chills, severe h/a, which persisted for five days.
Death Narrative: Patient was outpatient. There was no information or document notes about reactions, underlying or active conditions between the time patient came in for the first Pfizer dose and their death.
The patient noted that the reaction began the day after vaccination. A red circle appeared and spread down her arm, below the deltoid muscle where the vaccination had been injected. She said it started small, but spread larger (downwards and outwards). We had a ruler on hand and the circle measured 4 inches across left to right, and three inches top to bottom. It is red and warm to the touch. Patient also reported feeling off, but did not elaborate.
Patient over night was covered in bruises and red dots all over her body and in her mouth and a bloody nose. I rushed her to the ER and she ended up being diagnosed with ITP a blood disorder that they said was brought on by a virus but I have now realized it was from a MMR vaccination she received.
Covid arm; lumpy; feels like scar tissue; itchy; golf size knot; red; painful to the touch; joint pain; maternal exposure during breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), VACCINATION SITE MASS (lumpy), VACCINATION SITE SCAR (feels like scar tissue), MATERNAL EXPOSURE DURING BREAST FEEDING (maternal exposure during breastfeeding) and VACCINATION SITE PRURITUS (itchy) in a 35-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.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (maternal exposure during breastfeeding) and ARTHRALGIA (joint pain). On 13-Apr-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE MASS (lumpy), VACCINATION SITE SCAR (feels like scar tissue), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (golf size knot), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (painful to the touch). On 05-Apr-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (maternal exposure during breastfeeding) had resolved. At the time of the report, VACCINATION SITE REACTION (Covid arm), VACCINATION SITE MASS (lumpy), VACCINATION SITE SCAR (feels like scar tissue), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (golf size knot), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PAIN (painful to the touch) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  No treatment of events was reported.
Vaccine - skin rash - treated with Benadryl.  Rash looked 5-7cm - onset days after immunization.
At 2 am the patient felt like vomiting, so got out of bed to go to the bathroom. On the way, the patient began to black out to the point where she had to lay down on the floor and could not regain strength for a few minutes and would have fallen over if sitting down and then laying down did not occur. A few minutes were spent laying down and then the episode went away and she was able to get up. She then walked back to her bed and did began to feel light headed, dizzy, and began blacking out again. The patient layed down in bed and waited for the episode to pass again.
Is a fever a normal side effect; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Is a fever a normal side effect) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Is a fever a normal side effect). At the time of the report, PYREXIA (Is a fever a normal side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Vaccinated in left arm 12/29 ? initial soreness Wed 12/30 -Headache onset; pain 5 (out of 10) Thursday 12/31- some pain/soreness in arms and legs; no HA Friday 1/1- pain worse (7 out of 10); temp 99.8;  Sat 1/2 cough in the morning, soreness; in the evening pain worse; cough resolved;  Sunday 1/3  extreme pain 10 out of 10; presented to the ED; prescribed Toradol and excedrin Numbness and pain in upper and lower extremities, particularly in R arm; 10 out of 10 pain; 101.0 temperature Monday 1/4 temperature down to 99.5 this am (has been taking Tylenol); still experience significant pain Headache that she describes as migraine worsens with standing up, walking, talking Pain in legs, if stands for more than 10 seconds she experiences extreme pain Denies SOB, wheezing, coughing  The ED advised her to take Toradol for 48 hours and contact a PCP for follow up.
vaccine leaked on administration; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION ERROR (vaccine leaked on administration) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION ERROR (vaccine leaked on administration). At the time of the report, VACCINATION ERROR (vaccine leaked on administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication and treatment information provided.
Information has been received from a Registered Nurse concerning an 11 year old female patient with diabetes and no drug reactions or allergies who last week on approximately 24-AUG-2010 was vaccinated by an unspecified route with an unspecified dose of VARIVAX (Merck) (Lot# unknown). Concomitant therapy included insulin. The school nurse reported that the patient on 31-AUG-2010, presented with an elevated blood glucose level, ketonuria and a stuffy nose. The school nurse reported that the blood glucose levels on 31-AUG-2010 and 01-SEP-2010, where both in the 400s, and that the patient tested positive for ketonuria on both days. No specific values were available. The school nurse stated that she conferred with the patient's parents and physician and reported that the patient's physician ordered an increase in the quantity of insulin. At the time of the report, the patient was recovering. The patient sought medical attention by seeing school nurse. Follow up information has been received from a Registered Nurse who indicated that the patient was a student who on 09-AUG-2010, was vaccinated with a dose of VARIVAX (Merck) into her right arm. Secondary suspect vaccination included a dose of GARDASIL (Lot# 663451/0216Y) given IM into her left deltoid. It was reported that on 31-AUG-2010, the patient's blood sugar ran high for several weeks. Illness at the time of vaccination included increased blood sugar and body spilling out ketones in urine. According to the reporting nurse, the physician thought that it might be an insulin per mal function and the patient had improved with using insulin syringes again. Additional information is not expected.
ringing in both ears; Trigeminal Neuralgia exacerbated; mentally more dull; Dizzy; severe pain on the right side of my face; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (mentally more dull) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Trigeminal neuralgia. Concurrent medical conditions included Allergy to chemicals (patient had a problem with chemicals). Concomitant products included TOPIRAMATE (TOPAMAX) for Trigeminal neuralgia.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced MENTAL IMPAIRMENT (mentally more dull) (seriousness criterion medically significant), DIZZINESS (Dizzy), FACIAL PAIN (severe pain on the right side of my face) and TRIGEMINAL NEURALGIA (Trigeminal Neuralgia exacerbated). On 23-Apr-2021, the patient experienced TINNITUS (ringing in both ears). At the time of the report, MENTAL IMPAIRMENT (mentally more dull), DIZZINESS (Dizzy), FACIAL PAIN (severe pain on the right side of my face), TINNITUS (ringing in both ears) and TRIGEMINAL NEURALGIA (Trigeminal Neuralgia exacerbated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.  Company Comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No specific follow-up information recorded.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.
Eyes red, fatigue, muscle pain, joint pain, ringing in ears, hard of hearing, memory loss, numbness in hands, feet, face, HBP, rashes, allergic reactions, headaches, chest pain, sleeping problems - no treatment yet. Follow up 02/10/05: I still have not recovered from the adverse event. I now have angioedema with EpiPen assistance, medication every day. I also have myastenic gravis syndrome, for which I take medication 4 times a day, extreme high blood pressure for which I take 3 medications twice a day. I also have to use a sleep apnea machine at home.
patient tested positive for COVID with mild cough.; patient tested positive for COVID with mild cough.; This is a spontaneous report from a contactable consumer.   A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient received Covid vaccination in Feb2021. On Apr2021 after travel, patient tested positive for COVID with mild cough. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Was weak about 6 hours, post vax. Would not use right arm and had no muscle control; could not hold anything in right hand. Shot was given in legs.
Day after 2nd dose, what the CDC site refers to as COVID arm. Swollen at injection area with a red, warm, itchy rash. Lasted about 3 days.
pain at injection and lymphedema under R arm  Narrative:  No treatment, resolved on own
does not think that he ever got his second dose of SHINGRIX; This non-serious case was reported by a consumer via call center representative and described the occurrence of social problem in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 15th August 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim:does not think that he ever got his second dose of SHINGRIX).  The outcome of the social problem was unknown.   Additional Information: GSK receipt date: 19-Sept-2023 The patient did not think that he ever got his second dose of Shingrix because it was right before the covid pandemic and when everything was shut down. Did not consent to follow-up. The patient did not receive the second dose of Shingrix due to covid pandemic, which led to social problem.
No adverse event; improperly stored vaccine administered; This spontaneous report was received from a medical assistant regarding a 4 year old patient. The patient's medical history, concurrent condition and concomitant medications were not reported. The reporter stated that on 26-SEP-2019, the patient was vaccinated improperly stored hepatitis a vaccine, inactivated (VAQTA) (product storage error), lot # S007770 and expiry date 24-JUL-2020, (strength, dose, route were not reported) for prophylaxis. No adverse event reported. It was reported the product was stored at below 36-degree Fahrenheit/2 degree Celsius for 10 minutes. There was no previous temperature excursion and no data logger.
Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st September 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 1st September 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 01-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used. The case was linked with case US2022126915 and US2022126898, reported by same reporter.; Sender's Comments:  US-GSK-US2022126915:Same reporter US-GSK-US2022126898:Same reporter
pt recv vax & became nauseated & head hurt; MD notified-titer drawn was 1:1200 on 6JUL95;
a 16 month old received an expired dose of Acthib with no adverse event; Initial information was received on 25-Jun-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves 16-month-old female patient who received expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ316AAA and expiry date unknown] via an intramuscular route in the left vastus lateralis on 24-Jun-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  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.
pt recv vax 28MAY98 & devel acute transverse myelitis w/motor skill difficulties in legs & was hosp x 3 days;attempted to go back to work part time but was told not to by neurologist;
Injection site pain; overall muscle aches; headache; nausea; dizziness; shivering; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2020 14:00, the patient received the 1st dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, muscle pain, headache, nausea, dizziness and shivering. On an unknown date, the outcome of the injection site pain, muscle pain, headache, nausea, dizziness and shivering were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, muscle pain, headache, nausea, dizziness and shivering to be related to Shingrix.  Additional details were provided as follows: The patient experienced injection site pain, muscle pain, headache, nausea, dizziness and shivering after receiving 1st dose of Shingrix. No further details were provided.
pt recv vax 11DEC96 & was given APAP again 9PM;10-1030PM pt started crying;pt shrieking in pain;refused to nurse (didn't eat from 530PM to 3AM) & was inconsolable;t97.8;slept almost constantly;not as alert, groggy;puffy bumps, rash;
swelling and itching at injection site; swelling and itching at injection site; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient (reported as 4) who experienced swelling and itching at injection site (vaccination site pruritus and vaccination site swelling), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  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 INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route and unknown site.  On an unknown date, the patient had swelling and itching at injection site (vaccination site pruritus and vaccination site swelling) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was vaccination site pruritus and vaccination site swelling.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for vaccination site pruritus and vaccination site swelling.  Information on the batch number is requested.  List of document held by sender: none.
My second menstrual cycle after receiving the vaccine my period was extremely heavy and painful. I have never experienced pain like that and my periods have been consistently heavy ever since. I do not take Aspirin or any blood thinners, nor have I ever. I was soaking through over 6 pads in a span of 24 hours the first 2 cycles post vaccine. I now go through an entire box every 2 cycles. Normally before kids after kids pre vaccine I would go through an average of 6 tampons total for 3 days total.  I am now going through over 8 tampons per day and my periods are still painful and last 5 days minimum and I will have had 2 periods per month which have a direct effect on me and my daily activities at work, school and with my children.
08/31/21 The patient presents with COVID-19 related symptoms x 2.5 weeks. Pt has tested positive for COVID-19. Pt measured O2 at 87% yesterday and 82% this morning. Her PCP told her to go to ED. Pt is 98% on room air here. Pt has had cough, diarrhea and loss of taste and smell. Pt denies any other sx.  The onset was 2.5  weeks ago.  Pt was here  8/21/21. Was tested COVID+. Pt still having SOB and cough. Pt also c/o diarrhea and body aches. 71-year-old female with a past medical history of CAD, hypertension, hyperlipidemia, diabetes mellitus type 2, hypothyroidism and obesity who presented the ED complaining of shortness of breath.  Patient states she was diagnosed with COVID-19 infection about 1-2 weeks ago and has been home however 2 days ago she started to have worsening shortness breath.  States she checked her pulse ox and it was down to the low 80s and hence she she was told by her PCP to come to the ED for further evaluation recommendation.  Patient denies chest pain, abdominal pain, nausea vomiting or dizziness.  She continues to have some shortness of, however denies any fevers/chills.
Severe muscle aches in legs and lower back, chills, shortness of breath and weakness occurred the night of the vaccination and lasted 6-7 hours. Slight muscle aches and slight chills the following day all day.
10/26/2006 Flu Shot was given at 2:00pm in left arm.  5:00pm sore swollen knees, could hardly walk. Sore right shoulder also.  By 7:00pm 101 degree temp.  8:00 102.3 temp. 10/27/2006 Still stiff and sore knees and shoulder.  By afternoon, hands and knuckles also swollen.  Temp was 101 degrees.  Much difficulty walking both days. 10/28/2006  Symptoms the same. 10/29/2006  Able to walk better and use arm better.