chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient has an injection site reaction. Her upper arm is badly bruised and painful upon touch. The patient says she has been getting flu shots for many years and has never experienced anything like this.
Left deltoid redness, with warm to touch left arm pain down to Lt. wrist. Lt. deltoid swelling at site of injection. Pain occurred 5/13/11 noticed a raised red area.
The decedent had the first Covid vaccine in February 2021 and he was set to have his second vaccine 3/3/2021.  It is unknown which Covid vaccine he received.  He complained only of a sore arm after receiving the first vaccine.
he vomited twice; nausea; diarrhea; Weakness was reported as worsened; has been sick ever since/He feels bad; He has flu like symptoms, but no temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 16Oct2021 09:30 (Lot number: FC3183) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: He has been taking medication for years. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Lot ED8448, expiration is unknown. This was injected on right arm in the muscle), administration date: 18Sep2021, for COVID-19 immunisation. The following information was reported: NAUSEA (non-serious) with onset 17Oct2021, outcome "not recovered", described as "nausea"; DIARRHOEA (non-serious) with onset 17Oct2021, outcome "not recovered", described as "diarrhea"; ASTHENIA (non-serious) with onset 17Oct2021, outcome "not recovered", described as "Weakness was reported as worsened"; VOMITING (non-serious) with onset 18Oct2021, outcome "recovered" (19Oct2021), described as "he vomited twice"; ILLNESS (non-serious) with onset Oct2021, outcome "not recovered", described as "has been sick ever since/He feels bad"; INFLUENZA LIKE ILLNESS (non-serious) with onset Oct2021, outcome "unknown", described as "He has flu like symptoms, but no temperature". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported patient was feels bad. He wanted to know if this was normal. he stated he had lost every day that weak. He was weak, blah and cannot do anything. He provided his weight was between 150-155 lbs. He had been trying to eat and drink fluids and stay hydrated but was still weak. He was not one to get sick and never had the flu. Patient stated Nausea occurred at Evening, Diarrhea at morning, usually had it in the mornings lately. He had not eaten any spicy foods and was not drinking his coffee because it makes him nauseous. Patient experienced Weakness at Morning and Vomited at morning. Patient not administered additional Vaccines on Same Date of the Pfizer covid-19 vaccine. Patient had not taken other vaccinations within four weeks prior to the first administration date of the Pfizer covid-19 vaccine.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101430182 same reporter/product/event, different patient
Soreness, tenderness, swelling, and ache in left shoulder and arm; Soreness, tenderness, swelling, and ache in left shoulder and arm; Soreness, tenderness, swelling, and ache in left shoulder and arm; Soreness, tenderness, swelling, and ache in left shoulder and arm; Flu like symptoms; Slight fever; Overall body aches; The initial case was missing the following minimum criteria: specific number of patients. Upon receipt of follow-up information on 23Feb2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable consumer (patient) reported that a 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302, Expiration Date: 30May2021), via an unspecified route of administration in left deltoid, on 20Jan2021 at 10:30 AM (at the age of 76 years), as dose 1, single, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received influenza vaccine between the 1960s and 1970s (unspecified) for immunization and experienced swelling and pain at the site, stiffness in the arm, feeling feverish, and feeling sick. On 20Jan2021 in the morning, the patient experienced soreness, tenderness, swelling, and ache in left shoulder and arm; no treatment was received for these events. It became more painful during the day so that 10 hours later it was very painful to lift the patient's left arm. Also, as day progressed on 20Jan2021 (evening), the patient developed mild flu like symptoms (slight fever and overall body aches) that persisted for approximately 24 hours; the patient self-medicated for this as treatment. These adverse events after COVID-19 first shot was very similar to their reaction the patient used to have to his annual flu shot in the military when they were still using live-virus vaccines. The patient had no reaction to the second shot of this series (COVID-19) 23 days later (12Feb2021; Lot Number: EL9264, Expiration Date: 30May2021). The patient was not admitted to the hospital for these events. The patient recovered from the events in 2021.  Follow-up attempts are completed. No further information is expected.
Arm pain immediately following injection. "Feels like Tendonitis". Affecting daily activities. Advised on 10/29 to: take 600-800mg Motrin every 8 hours x 3 days. Cold compress to the affected area 1 hour 3-4 times per day. Avoid use of extremity x3 days.
pt hosp on 11NOV95 w/focal sz p/several episodes;released 15NOV95 w/phenobarb & orders from neuro that all future vax will exclude pertussis;pt has 6 to 7 sz per day;no meds controlling sz;
Booster dose given to 16 YO at our COVID Vaccine Booster site. No adverse reactions reported at this time.
Administer initial Pfizer dose to pt at 11:40, pt advised to wait 30m observation d/t hx of anaphylaxis of unknown origin. Pt c/o itchy eyes, slight respiratory difficulty, and chest pressure at 12:25pm. Pt provided 25mg Benadryl Elixir PO at 12:25pm. Vital signs stable - BP 120/80, pulse 73, resp 16, SPO2 95%. Pt denied improvement of sx. EMS called at 1244 d/t c/o chest pressure. EMS arrivedat 1256 and took pt to ambulance at 1304.
About 9:00pm on 2/1/2021, started to have chills, moderate to severe body aches, and my temperature was 101.0. I took two extra-strength Tylenol, my body aches subsided a little, By around 3:00am, I started to have chills again, and moderate to severe body aches. By 7:30am, my temperature was still 101.0, and still having some chills and moderate to severe body aches,  I took a couple of Advil, after a couple of hours, my body aches subsided a little and my temperature went down to 99.0.
6 days post vaccination, noticed slight redness to site of injection, by the next day, the area became more of a red patch, 35 x 40mm, slightly indurated and mildly tender to touch
headache and feeling overheated; headache and feeling overheated; fatigue; GI symptoms; loose stool; gas; mild tightness but not so much like a cramp; This is a spontaneous report from non-contactable physician via a Pfizer Sales Representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache and feeling overheated, fatigue, gastrointestinal (GI) symptoms, loose stool, gas, mild tightness but not so much like a cramp in Dec2020. The clinical course was reported as follows: The patient was symptom free for the first 20 hours after vaccination, had mild symptoms from the 20-28 hour mark, and felt fine since then. The patient woke up at 3:30 in the morning one day (day of reporting) with a headache and feeling overheated. The temperature was checked several times on an unspecified date, with no fever. For the next 3-4 hours, there were a wave of symptoms; mostly a headache, fatigue, and GI symptoms. The symptoms responded pretty well to increasing water intake, taking an electrolyte supplement (MANUFACTURER UNKNOWN), and breakfast. The patient also had gas, loose stool, and mild tightness but not so much like a cramp. Therapeutic measures were taken as a result of the events as aforementioned. The clinical outcome of headache and feeling overheated, fatigue, GI symptoms, loose stool, gas, mild tightness but not so much like a cramp was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
spasms on his hand, like they are moving by their own; tendinitis on his hand; This case was reported by a pharmacist via call center representative and described the occurrence of spasms in a 83-year-old male patient who received Herpes zoster (Shingrix) (batch number 23B54, expiry date 25th September 2022) for prophylaxis.   On 27th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). In October 2020, several hours after receiving Shingrix, the patient experienced spasms and tendonitis. On an unknown date, the outcome of the spasms and tendonitis were unknown.   It was unknown if the reporter considered the spasms and tendonitis to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and few hours later experienced tendinitis on his hand and spasms on his hand, like they are moving by their own.  The patient was still had this symptom. The reporter consented to follow up. No further information was provided and agreed to follow up.
Increased sinuses about 2 days after the vaccine that won't go away. Strong cough. Headaches. My hip pain from a surgery I had 40 years ago is flaring again. It is still ongoing, not sure if it is vaccine related or not since I have a lot of sinus issues, however almost after every dose this happens. However this time I had a strong cough, but I also took a flu shot at the same time.
Patient developed hives and wheezing and chest pain. Patient seen in the emergency room and given an Albuterol neb, Benadryl and Zantac.
mom states several hrs p/vax pt exp swelling around both eyes, w/itching & red raised areas over body;pt given DPH & APAP x 2 days;did not seek medical care;
Feverish; Chills; Shaking; her arm was hot, swollen and red; her arm was hot, swollen and red; her arm was hot, swollen and red; Feeling cold; This case was reported by a consumer via call center representative and described the occurrence of fever in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number KJ9N5, expiry date 1st October 2021) for prophylaxis.   The patient's past medical history included shingles (many years ago before first shingles vaccine several years ago). Previously administered products included Shingles vaccine (received 1st Shingles vaccine several years ago).   On 29th July 2019, the patient received the 1st dose of Shingrix .5 ml. On 29th July 2019, less than a day after receiving Shingrix, the patient experienced fever, chills, tremor, swelling arm, extremities hot feeling of, erythema of extremities and feeling cold. On 1st August 2019, the outcome of the fever, chills, tremor, swelling arm, extremities hot feeling of, erythema of extremities and feeling cold were resolved with sequelae.   It was unknown if the reporter considered the fever, chills, tremor, swelling arm, extremities hot feeling of, erythema of extremities and feeling cold to be related to Shingrix.  Additional details were provided as follows: The patient received vaccination on left arm. Post vaccination the patient's arm was hot, swollen and red. The patient also reported feeling feverish and cold, chills and shaking. The symptoms lasted approximately 2 to 3 days. Batch number was updated from AJ9N5 to KJ9N5 as per sales data sheet.  The reporter consented to follow up. For tolerance of 2nd dose of Shingrix, refer case US2019219253.
Scratchy Throat for 14 hours after dose 1 Fever at 4:30am after dose 1 Arm pain at injection site lasted for 36 hours after dose 1 Rash on left hand at 4:30am after dose 1 Diarrhea 12 hours later after dose 1
Moderna shot has messed me up I do not feel right ever since; head hurts really bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Moderna shot has messed me up I do not feel right ever since) and HEADACHE (head hurts really bad) 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 FEELING ABNORMAL (Moderna shot has messed me up I do not feel right ever since) and HEADACHE (head hurts really bad). At the time of the report, FEELING ABNORMAL (Moderna shot has messed me up I do not feel right ever since) and HEADACHE (head hurts really bad) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  No treatment medications were reported.
Noticed that her arm was huge, swollen, red, hot, skin hard and tight from shoulder to elbow. Called Health Dept. and was assured she would be ok. to give ibuprofen, cold compress and elevate arm.
Information has been received from a nurse practitioner concerning a 7-year-old female who was vaccinated on 06-Jun-2007 in her leg (laterality unspecified) with a dose of varicella virus vaccine live (Oka/Merck) (lot# 657408/0517U). Concomitant therapy included a dose of hepatitis A vaccine (inactive) (HAVRIX). Subsequently, on an unspecified date, the patient developed swelling and itching at injection site which lasted 3-4 days. Unspecified medical attention was sought. The outcome is reported as recovered. No product quality complaint was issued. Additional information has been requested.
Left side swelling and numbness from left elbow to top of head. Required hospitalization for  3 days.
Pt had fainting spell while standing in hallway approx 5-10 min after receiving vaccine. Unconscious > 1 min. Pt alert and oriented immediately after episode. Pt allowed to sit and sip Coke for 5-10 min after episode then sent home with parents.
Patient has lowered O2 levels of below 85% beginning on 2nd full day after vaccine [2nd dose].
Soreness at the Injection site; Redness at injection site that it is 4inch by 6inch; Swelling at injection site that it is 4inch by 6inch; Felt achy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the Injection site), VACCINATION SITE ERYTHEMA (Redness at injection site that it is 4inch by 6inch), VACCINATION SITE SWELLING (Swelling at injection site that it is 4inch by 6inch) and MYALGIA (Felt achy) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Felt achy). On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the Injection site), VACCINATION SITE ERYTHEMA (Redness at injection site that it is 4inch by 6inch) and VACCINATION SITE SWELLING (Swelling at injection site that it is 4inch by 6inch). On 06-Apr-2021, MYALGIA (Felt achy) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness at the Injection site), VACCINATION SITE ERYTHEMA (Redness at injection site that it is 4inch by 6inch) and VACCINATION SITE SWELLING (Swelling at injection site that it is 4inch by 6inch) outcome was unknown.            Concomitant medication list was not reported Treatment information was not reported.   This case was linked to MOD-2021-073334 (Patient Link).
Pt vax w/ MMR + DTTox on 16Oct90.  Immediately after DTTox vax pt exp sharp pain + tenderness.  Next day devel large bruise in deltoid muscle.  18Oct90 pt devel temp 102F; 19Oct90 fever 101F.
10/26/18 3:00 pm eye irritation, felt sandy, used lubricating eye drops. 3:30 pm red eyes, yellow mucus discharge in eyes used cold compress. 4:13 pm difficulty breathing. Admit to E.R. E.R. treatment 25 mg BENADRYL, 40 mg famotidine, 60 mg prednisone, DUONEB nebulizer. 7:00 pm discharge.
swelling, numbness in arm, allergies, and hives around breast; swelling, numbness in arm, allergies, and hives around breast; swelling, numbness in arm, allergies, and hives around breast; swelling, numbness in arm, allergies, and hives around breast; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer reported for her wife. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: not reported), dose 1 via an unspecified route of administration, on an unspecified date, as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced swelling, numbness in arm, allergies, and hives around breast. The reporter confirmed that the side effects took place after the first dose of the Pfizer vaccine. The reported enquired to know that if the patient was okay to get the second dose of vaccine. The reporter has firsthand knowledge of the patient and was reporting on a specific patient. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Patient given mixed series mRNA COVID Vaccine in error. 1st dose Moderna on 4/29/2021 and 2nd dose Pfizer on 6/8/2021.
Event- miscarriage History- 5 weeks pregnant, previous miscarriage in May 2022
Congestion, cough, whizzing, headaches, joint and body  pain, loss of appetite, fever.  Saw PCP and he prescribed the Butalbital Acctaminoplen,.  Saw him a second time on 5/13/21 due to continued headaches and body aches.
None - patient was given MMR #3 and Varicella #3.  She didn't need either one.
Started itching 5/20/12, and started developing hives. 6-8 lesions - started BENADRYL. (-) fever. (+) soreness arm. No SOB, wheezing.
Seeing heart failure specialist soon to see if cause of heart failure was covid vaccine or chemo.; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE (Seeing heart failure specialist soon to see if cause of heart failure was covid vaccine or chemo.) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE (Seeing heart failure specialist soon to see if cause of heart failure was covid vaccine or chemo.) (seriousness criterion medically significant). At the time of the report, CARDIAC FAILURE (Seeing heart failure specialist soon to see if cause of heart failure was covid vaccine or chemo.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medication Information was provided.  No Treatment Drug was provided by reporter. Company comment This spontaneous case concerns 56-year-old patient of an unknown gender with no medical history reported, who experienced the unexpected, serious (due to medically significant) AESI of s Cardiac failure, which occurred on an unknown date. The patient received a dose of the mRNA-1273 vaccine on an unknown date. It was reported: "Seeing heart failure specialist soon to see if cause of heart failure was covid vaccine or chemo". The course of the event and treatment information was not provided. If "chemo" suggests medical history of cancer with chemotherapy, this could be a confounder for the event cardiac failure. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns 56-year-old patient of an unknown gender with no medical history reported, who experienced the unexpected, serious (due to medically significant) AESI of s Cardiac failure, which occurred on an unknown date. The patient received a dose of the mRNA-1273 vaccine on an unknown date. It was reported: "Seeing heart failure specialist soon to see if cause of heart failure was covid vaccine or chemo". The course of the event and treatment information was not provided. If "chemo" suggests medical history of cancer with chemotherapy, this could be a confounder for the event cardiac failure. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Hard to sleep; Not energetic; Not feeling well; Feeling a little bit down; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Hard to sleep), ASTHENIA (Not energetic), MALAISE (Not feeling well) and DEPRESSED MOOD (Feeling a little bit down) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Hard to sleep) and ASTHENIA (Not energetic). an unknown date, the patient experienced MALAISE (Not feeling well) and DEPRESSED MOOD (Feeling a little bit down). At the time of the report, INSOMNIA (Hard to sleep), ASTHENIA (Not energetic) and MALAISE (Not feeling well) outcome was unknown and DEPRESSED MOOD (Feeling a little bit down) had resolved.            Patient was taking medication for diabetes, high blood pressure and cholesterol. No treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2022: Follow up contains No New Information.
Information has been received from a Registered Nurse, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 28 year old female patient with no pertinent drug reaction/allergies and no medical history who approximately on 10-JAN-2012 was vaccinated with a dose of VARIVAX (Merck) (lot # 670329/0611AA, expired date 30-JAN-2014), one shot. There was no concomitant therapy. When the patient received the dose of VARIVAX (Merck), she was pregnant for "3 weeks and 5 days". Her last menstrual period was on approximate 20-DEC-2011 and estimated delivery is on 25-SEP-2012. No adverse event was reported. No treatment was given for this event. The patient sought unspecified medical attention. Follow up information was received from the registered nurse and she did not have any pregnancy outcome information and could not find the patient's record in the medical record system. Case is lost to follow up. Additional information is not expected.