chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sweating on his pillow/sweat; Dopiness/dopey; Feeling bogged down; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating on his pillow/sweat), SEDATION (Dopiness/dopey), FEELING ABNORMAL (Feeling bogged down) and CHILLS (Chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029LZOA and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweating on his pillow/sweat), SEDATION (Dopiness/dopey), FEELING ABNORMAL (Feeling bogged down) and CHILLS (Chills). At the time of the report, HYPERHIDROSIS (Sweating on his pillow/sweat), SEDATION (Dopiness/dopey), FEELING ABNORMAL (Feeling bogged down) and CHILLS (Chills) had resolved.            Concomitant medications included Cellselfazine 500 MG and 2 Drops for Glaucoma. No treatment medication was provided.   This case was linked to MOD-2021-037232 (Patient Link).
Pt developed a rash on right side of her body the day after receiving the ZOSTAVAX vaccine it started in her armpit and ran down the side of her body to her wrist not painful but, very itchy.
Redness, itching, and pain at injection site.  Patient also reports having had a fever which has resolved.
This spontaneous report as received from a consumer refers to a 72 years old female patient with asthma, arthritis, osteoporosis, ulcers, drug hypersensitivity to LYRICA and CYMBALTA. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # and dose not reported) on 06-JUL-2012. No other co-suspects were reported. Concomitant medications included levothyroxine sodium, NEXIUM, SKELAXIN, acetaminophen, PERCOCET and COUMADIN On 08-JUL-2012 the patient developed a red soreness at the injection site, 3 days after onset of therapy. The patient did not seek medical attention but was going to check with her physician, no treatment was given for the reported events and no lab diagnostic tests were performed. The outcome of red soreness at the injection site was unknown. The relatedness for red soreness at the injection site was not provided for ZOSTAVAX. Additional information has been requested.
I contracted COVID-19 a few months after booster dose. It started out like a had a bad sinus infection and I was really achy. It felt like it was in my entire sinus cavity. I went to the doctor on the 3rd of July 2022 and tested negative. I went home and took a at-home test the next day on the 4th of July 2022, and it came out positive. I was prescribed medications to help with the COVID-19 symptoms. PAXLOVID, helped I think, I have existing respiratory issues, so I was concerned. I am still having lingering breathing issues I am now seeing a pulmonologist now.
14 years old received adult dose; 14 years old received adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 14-year-old male patient who received HAV (Havrix adult) (batch number ek59b, expiry date 26th February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In January 2021, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. In January 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The registered pharmacist reported that, the patient of 14 years old received adult dose of Havrix in January 2021 as first dose & realized once the patient arrived to the facility to receive the 2nd dose of Havrix, which led to overdose and adult product administered to child.  The reporter consented to follow up. The health care professional did not mentioned if the 2nd dose of Havrix was given.
Fever(102.4)(101 with medication), shaking/chills for 48 hours, nausea and vomiting; dizziness, confusion for 48 hours; loss of appetite on 2nd day; fatigue; pt used tylenol and ibuprofen for 48 hours; lingering fatigue since shot
the vaccine is not working; high sedimentation rate; high CRP levels; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, batch/Lot number was not reported) via an unspecified route of administration on 24Mar2021 as dose 2, single for covid-19 immunization. (Age at the time of vaccination 60 years). Patient medical history and concomitant medications were not reported. On 03Mar2021 patient had first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunization (at the age of 60-year-old). On an unspecified date he explained that he went to see his HCP for a Covid-19 antibody test results were given back with a value of 1.13 and indicated a titer result of 1.14 or higher would indicate a positive result. He reported his interpretation of his results as negative and a drop off of the IgG antibodies. No further AE details provided post vaccination. He voices his concern that his interpretation is the vaccine is not working and that within a period of 4 months he expected his antibodies to be higher. Patient reported annual physical examination and his laboratory result came with high sedimentation rate - He mentioned that he never had high CRP levels. Patient visited to physician's office for the event. The patient underwent lab tests and procedures which included CRP level: high, annual physical examination: high sedimentation rate, sedimentation rate: high (all on unspecified date), and COVID-19 antibody test were negative on 28Jul2021, 1.13. If the value is 1.14 or higher, then it is considered positive. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.
Started menstrual cycle while perimenopausal; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2593) via an unspecified route of administration in the left arm on 03Nov2021 at 18:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, high blood pressure (HBP) and high cholesterol. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included first dose of influenza vaccine (FLU) in left arm on an unknown date for immunisation and metformin (MANUFACTURER UNKNOWN), rosuvastatin calcium (CRESTOR), venlafaxine hydrochloride (EFFEXOR), losartan potassium (LOSARTIN) and dapagliflozin propanediol monohydrate (FARXIGA), all for an unknown indication from an unknown date and unknown if ongoing. The patient received other vaccine within four weeks prior to COVID vaccine. The patient previously received doxycycline (MANUFACTURER UNKNOWN) and experienced drug allergy. On 05Nov2021 at 11:30, the patient started menstrual cycle while perimenopausal. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event started menstrual cycle while perimenopausal was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Approx 3 hours after immunization pt cried for 4 hours, mom gave pt Motrin, then pt got stiff eyes rolled back. Mom took pt to ER possible seizure, febrile 99 deg, pt brother has has of febrile seizures.
It started on the day before memorial day with swelling in right foot. I went to the urgent care and they did an x-ray and was unable to determine the cause. They thought that it was gout but they were unsure. They told me to see a podiatrist who put a boot on my ankle. I did that a few days but then y left foot started swelling. I was unable to walk at all or wear any shoes. I went to the ER at the hospital and they did a full blood panel, and multiple x-rays of my feet and my knees. They also did an ultrasound to check for DBT but everything came back normal. They were only able to determine that there some type of inflammation in the body, I ended up going to the ER at least five separate occasions. I was admitted to to the hospital for 2 days. I was released with pain medication. I was also having difficulty breathing and tachycardia in a resting position. They were still unable to determine the issue but I was out of breath from just walking to the bathroom. I was referred to a rheumatologist who did a chest x-ray and located a nodule on my lung and did a biopsy on the lung and determined it was sarcoidosis. I was given prednisone which actually helped with the heart rate and the swelling. I still experience occasional tachycardia from time to time. I am still seeing rheumatologist, cardiologist, pulmonologist from time to time.
On 03/29/2021 reaction started at injection site, gastrointestinal moderate to severe, abdominal pain, body aches, no temp. This continued throughout the week of 03/21/2021. Extreme fatigue to the point that I had to stay in bed and sleep. Reaction site swelled to the size of a small child's Nerf football with weals and severe itching. Coughing and nasal congestion started on  04/01/2021. Severe fatigue continued. Was able to do small chores, but my husband took care of most responsibilities. Poor appetite and severe nausea developed 04/02/2021. Time course approximately 14 days. Today, 04/08/2021, swelling is gone at site, still fatigued, but not severe. Will rest and continue to recover.
Information has been received from a Physician Assistant concerning a 12 year old female with unknown drug allergies and unknown medical history who on 04-JUN-2009 was vaccinated with the second dose of VARIVAX (Merck) (lot #662473/0044Y).  Concomitant therapy included MENACTRA.  On 04-JUN-2009, the patient passed out after receiving the second dose of VARIVAX (Merck) (lot # 662473/0044Y).  He fell forward in the chair and hit her face on the floor.  Unspecified medical attention was sought and facial bone X-ray was performed.  The X-ray of the patient's face showed there were no broken bones.  At the time of the report, the patient had recovered on 04-JUN-2009.  Follow up information was received from a Physician Assistant concerning that a 14 years old female with Rhunt allergy and no illness at the time of vaccination who on 05-JUN-2009 was vaccinated with the second dose of VARIVAX (Merck) (lot #662473/0044Y) intramuscularly in the left deltoid region at 10:30 am.  She received the first dose of VARIVAX (Merck) on 08-DEC-1997.  Concomitant therapy included the first dose of MENACTRA (lot # 62917AA, Sanofi Pasteur) at 10:30 am on 05-JUN-2009.  The patient had syncopal episode immediately following vaccination.  She smashed her face off a stool in the treatment room and had immediate swelling of her nose.  But the facial bone X-ray was performed, with negative result.  Unspecified medical attention was sought.  On 05-JUN-2009, the patient recovered.  No further information is available.
Information has been received from a medical assistant concerning three patient who in January 2009, were vaccinated with a dose of PNEUMOVAX (Lot # 659922/1667U). In January 2009 the patients developed swelling, redness, warm to touch, and soreness in the injection arm. As of 23-JAN-2009 the outcome of the patients were unknown. Attempts are being made to obtain additional information to distinguish the individual patient's. This is one report of 2 from the same source. Additional information has been requested.
On 8/19/99, the pt experienced injection site soreness with a feeling of "pin prick" when she uses her right arm for lifting. There are not signs of bruising or injury evident.
Pt vaccinated with DTP developed erythematoid papular eruption over injection site which spread over entire thigh.
Presyncope, shaking, supportive treatment, EKG. Did not resolve 40 minutes sent to ER.
all COVid shots were Moderna  1st 01/30/2021, 2nd 02/27/2021, 3rd 10/25/2021, and 4th 4/12/2022 the first 3 shots just made my arm sore and I felt a little tired the next day but this 4th shot made my arm really sore and red and painful. on the night of  4/13 the lymph nodes under my arm(the same arm that received the shot) were extremely swollen and huge and painful so the next morning I went to urgent care.  They explained that happens and is normal and means my immune system is working.  But later that same day a bruise started showing under the swollen area under my arm and now today the bruise is bigger and darker and there are also 4 or 5 smaller bruises by my inner elbow area of the same arm and the lymph nodes under my arm are still swollen though not as bad but it hurts.  I have never seen bruising like this before and haven't heard of this being a side effect of the shot so I thought I should let you know.
78 year old male with pmedhx significant for prediabetes, CKD, arthritis of knee, HTN.  Pt presented to the ER 2/3/2022 with shortness of breath, congestion, and cough x 1 week.  He has hx of Pfizer COVID vaccination x 2 with a Moderna booster over two monts ago.   SpO2 in ER is 92% on 2L NC.  Abbott COVID+ in ER. Pt admitted to  specialized CU for further care.  Required 1L of O2 transiently at rest but up to 3L with ambulation following admission.  He received dexamethasone and remdsivir during his stay. At the time of d/c on 2/6/2022, he was able to maintain O2 saturation in the 90%s at rest and with ambulation.  Stable for d/c home with close O2 monitoring.
rash from her head to toe that was itching; This is a spontaneous report from a contactable consumer. This 38-years-old female consumer (patient) reported for herself that:  A 38-year-old female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6200), via an unspecified route of administration on 28Feb2021 (at the age of 38 years old) as dose 1, single for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing Verbatim: High Blood pressure. Concomitant medication included esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for gastrooesophageal reflux disease, start and stop date were not reported. The patient previously took antibiotic as Bactrim and experienced allergic reaction to antibiotic, she broke out in hives. The patient previously took antihistamines and experienced hives (Was taking antihistamines when she broke out in hives). The patient experienced rash from her head to toe that was itching on 04Mar2021. Caller stated did not know if had actual possible side effects to the first Covid vaccine or that something else but caller was trying to find out who can speak to regarding this. When paraphrased the concern, Caller stated, "Correct, because of the situation that had with it could possibly be connected to the first shot but caller not sure." caller was calling because she wanted information on if it was safe to get her second vaccine. She concerned about getting the second dose. Wants to know who she could speak to see if it safe. Caller stated that she called earlier and spoke with Pfizer and reported this. Caller was unsure if it was her immune system or if had an allergy. Caller did not know if it was too soon after the allergic reaction to get the COVID vaccine and her immune system went into panic mode. Therapeutic measures were taken with antihistamines and steroid shot as a result of event.The outcome of event was unknown.  Follow-up (10Mar2021): The initial case was missing the following minimum criteria: -Unspecified AE. Upon receipt of follow-up information on 10Mar2021, this case now contains all required information to be considered valid. This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported for self that: event and case narrative was added.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from an unspecified reporter, as part of a marketing research program and refers to an unspecified number of male patients of unknown age. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with GARDASIL injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients (reported as "boys") were presenting new physical and physiological problems (details were unspecified). The outcome of the events was unknown. The reporter considered the events to be related to GARDASIL. This is one of several reports received from the same reporter. Additional information has been requested.
Face race. Very dry skin with small raised bumps. This turned into very itchy and burning skin, particularly around eyes, temples and near jaw. I believe it started within 24 hours. It has been 13 days since vaccine and the rash has not gone away; Face race. Very dry skin with small raised bumps. This turned into very itchy and burning skin, particularly around eyes, temples and near jaw. I believe it started within 24 hours. It has been 13 days since vaccine and the rash has not gone away; Face race. Very dry skin with small raised bumps. This turned into very itchy and burning skin, particularly around eyes, temples and near jaw. I believe it started within 24 hours. It has been 13 days since vaccine and the rash has not gone away; Face race. Very dry skin with small raised bumps. This turned into very itchy and burning skin, particularly around eyes, temples and near jaw. I believe it started within 24 hours. It has been 13 days since vaccine and the rash has not gone away; Face race. Very dry skin with small raised bumps. This turned into very itchy and burning skin, particularly around eyes, temples and near jaw. I believe it started within 24 hours. It has been 13 days since vaccine and the rash has not gone away; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 05Apr2021 at 16:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included levothyroxine sodium (LEVOXYL) for unknown indication from unknown date. 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 05Apr2021 at 21:00, the patient experienced face race (coded to rash on face). Very dry skin with small raised bumps. This turned into very itchy and burning skin, particularly around eyes, temples and near jaw. The patient believed it started within 24 hours. It had been 13 days since vaccine and the rash had not gone away. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of face race; very dry skin with small raised bumps; this turned into very itchy and burning skin, particularly around eyes, temples and near jaw and included treatment with Antihistamine. The clinical outcome of the event face race; very dry skin with small raised bumps; this turned into very itchy and burning skin, particularly around eyes, temples and near jaw; the patient believed it started within 24 hours; it had been 13 days since vaccine and the rash had not gone away was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On AUG-2021, the patient experienced covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious. This case is associated with product quality complaint: 90000205505.
Fever, large red hot swollen bump at shot site, about the size of a small apple.
Vaccine administered to patient on 11/10/2022. It was identified in the days following the administration that the BUD out of the freezer for this vaccine was 10/18/2022. Patient lost to follow up. Manufacturer expiration date = 11/30/2022.
This case meets criteria for vaccine breakthrough review.   SxS include confusion, cough.  Known household exposure. Admitted after fall.
1.  Severe pain in hip/girth area..... unbearable; 2. fever 101.6, chills; 3. nausea; 4. pain at injection site; 5.  5 days after I had severe itching on palms of my hand mostly, other areas of itching and rash.
He got the vaccine, had a little pinch, did not bother him.  Then it got a little sore and went away.  A day or two later things would show up, got fatigued, headache seemed to be the main thing, nausea without vomiting, chills and no fever.  The symptoms are moving around the body with body aches.  This morning when he got up he was very nauseated, and not feeling well.  Did not go to work as not knowing if he had the flu or anything else.
Per mother, patient had severe headache within 3 hours of administration, then had tonic clonic seizure the following morning requiring rescue medication
Patient experienced aching and hot/cold spells with diarrhea. She also experienced swelling of the tongue as a delayed reaction.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE NARCOLEPSY, UNSPECIFIED ACUTE NON ST ELEVATION MI DEMAND ISCHEMIA 1/29/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Diffuse erythema within 60 minutes of injection fussy,12:45am Decadron 5mg administered IM 1 hour after vac inject. Benadryl 10 mg given PO.