chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately after the shot, I felt fine and the only side effect I had was a sore arm.  On 3/30/21 (day 4) I woke up to various red blotches on my hands and feet which were intensely itchy.  The ones on my hands had 2-3 small hives.  As the day went on, the red spots would move from the hands to the chest to my neck and back to the hands.  I took a Benadryl tablet and the itching and rash was better.  After it wore off, however, the spot/rash and intense itch was back.  I still have it and if I don't take Benadryl the itch is overwhelming.  I have no other symptoms.
Initial and follow up information has been received from a certified nurse midwife concerning a 26 year old female hispanic patient who on 11/14/02 was vaccinated with a dose of MMR (second generation) (lot number not reported). The reporter indicated that the patient was pregnant. It was reported that the patient received the vaccine 3 weeks (also reported as 4 weeks) after her last menstrual period. This was the patient's first pregnancy and the pregnancy was confirmed by a urine test and positive heart tones. The patient's last menstrual period was on 10/20/02. The patient experienced a yeast infection 27 weeks from her last menstrual period. It was reported that the patient had not taken any prescription drugs during the pregnancy. Lab evaluation on an unspecified date revealed Rh negative. The patient had received globulin, immune. Her expected date of delivery was 8/1/03. The patient did have diagnostic tests during pregnancy (unspecified). Lab evaluation on an unspecified date revealed Rh negative. The patient experienced cephalopelvic disproportion and required a cesarean section on 8/1/03. The patient delivered a normal male baby via cesarean section 40 weeks from the last menstrual period. The baby's birth weight was 9 pounds and 7.4 ounces. The baby had no congenital anomalies and no complications. Upon internal review, cephalo-pelvic disproportion was determined to be an other important medical event (OMIC). No further information is expected.
On 2/5/12 (L) eye started to droop & will not completely close. (L) side of face numbness. When raises eyebrows only (R) eyebrow raises. (L) facial droop. When smiles only (R) side of lip turns up.
Extreme muscle aches/pain over entire body, severe rash in area of vaccine shot, Fever, Extreme exhaustion/fatigue and lethargy, some loss of appetite, some sinus congestion, head ache  [Please note that I was diagnosed with a severe "virus of (then) unknown origin" in November 2019. My doctor tested me for everything known to him at the time and could not confirm what it was. I had ALL of the symptoms of Covid 19 - Loss of taste and smell, high fever, lethargy, severe cough and respiratory congestion, etc.  My doctor now confirms that there was extremely high likelihood that it was Covid, although he can not be 100% certain. I suffered lingering after effects for several weeks.]
I experienced a severe headache that day following the immunization and the skin on my stomach started itching intensely that night for about fifteen minutes then I developed a sore throat on the right side the same night. It felt like strep and the pain started easing up Saturday morning. It's still sore but at least I can swallow today. I had no fever through this. I also did not see a doctor.
8 days after the injection my arm started to hurt.  Rash itch hard at I ejection site.  Headache . Today is day 9 still have symptoms.
Fever, Sluggishness , Muscles Aches, Headache, loss of smell and loss of taste...
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On unspecified dates in February 2016, starting on or after 04-FEB-2016, patients were vaccinated with an unspecified number of improperly stored doses of RECOMBIVAX HB (lot # L027733 and expiration date 13-SEP-2017, dose and route of administration were not reported). The temperature of the excursions was 46.9F with the time frame of 16 hours. There was no previous excursion and it was not a data logger. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
That evening about 6:30 PM he got upset about something because he wanted a cup of coffee and his wife said no and he got really upset about what was on TV, then became anxious and confused then got very depressed. The next day he remembered what happened and described it as feeling like a zombie.
Apart from the normal side effects that lasted about 30 hours, I have been experiencing dizziness since June 15.
Immediately after injection the injection site was red, swollen and sore as was expected based on the information provided from the nurse. After 3 days these symptoms subsided. Nine days later a larger area surrounding the injection site appeared red, swollen, itchy and slightly tender to the touch - the pain was not at all like the initial 3 days after the injection. The redness, swelling and itchy conditions persisted days 10-12, but the tenderness subsided. Day 13 and Day 14 (today) the only remaining symptom is the itchy condition. No treatment was necessary.
Pt received routine Pneumovax to deltoid area in AM. Returned approximately 51/2 hours later with complaints of swollen, warm, tender right upper arm. Pt also complained of nausea. Slight pain remains at site on 08/15/2001.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapies were not reported. On 18-OCT-2015, the patient was vaccinated with an expired dose of VARIVAX (Merck) lot # J012375, expiration date: 03-OCT-2015 (dose and route were not provided). The reporter asked if the dose needed to be re-administered. Nurse also wanted this provided as feedback since the dating of the vaccine shows as "03-OCT-2015" and this created confusion for the nurse administering the vaccine. No product quality complaint (PQC) was reported. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like flu) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21-A and 032M2oA) for COVID-19 vaccination. The patient's past medical history included Crohn's disease. 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) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like flu). On 03-Apr-2021, INFLUENZA LIKE ILLNESS (Felt like flu) had resolved. No relevant concomitant medications were reported. No treatment details were reported. This case was linked to US-MODERNATX, INC.-MOD-2021-128189 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Additional information received included no new significant information. On 28-Jul-2021: Additional information received included no new significant information.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-128189:Case for wife
Extreme headaches lasting about an hour +  Sleepy Migraines  Ever since up to December of this year, I?ve had headaches, sore throat, congestion, and minor  heart pain. Ive had aches and pains in past around heart maybe due to stress or lack of sleep but I?ve never had these prolonging headaches before in my life. I was forced to get shot to meet requirement by army and military to be shot complete by 15DEC. Receiving my second dose tomorrow 13DEC to fulfill requirement although concerned about side effects. I?ve only waited this long because I had shoulder surgery on 6OCT21 for my left shoulder and was unable to receive second dose.
The student came to the health room at school at 1420 c/o 4 rash/welt marks (2 on Rt. cheek; 1 under chin; 1 on neck). Assessed: P-100 R-22 lungs CTA T-98.2. Recommended mother give BENADRYL.
A week after receiving my 1st shot , had redness, swelling, fever at sight and muscle fatigue, Sunday redness got worse and had some itching
Patient's mom insisted on getting Moderna booster instead of Pfizer booster for her 12 years old kid. The intern gave the patient 0.25ml of Moderna vaccine but upon re-checking administration guideline, that has not been approved.
0.5mL Moderna COVID19  vaccine inadvertently given to individual under the age of 18. Vaccine administrator immediately notified patient and assessed for any adverse reactions (none noted). Provider also called to follow up with patient the following day and patient stated he was not experiencing any negative side effects.
This spontaneous report was received from a medical assistant and refers to a 23 years old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported. On 22-SEP-2017, the patient was vaccinated with an expired dose of GARDASIL 9 (dose not reported) (lot # L028083 and expiration date 03-SEP-2017) intramuscularly for prophylaxis. No adverse effects were reported.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Patient administered with the vaccine that underwent temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered with the vaccine that underwent temperature excursion) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 3:52 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered with the vaccine that underwent temperature excursion). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered with the vaccine that underwent temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature.  The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit.  No treatment medications were provided.
Approximately twenty minutes after administering the vaccine the patient experienced symptoms consistent with her prodrome.  The prodromal and ictal phases each lasted less than 5 minutes.
tenderness in left armpit and left inside elbow/palpate lymph gland/lymph gland in armpit still tender and more pronounced; Tingling down left arm, across shoulders and back of neck; Achy in same area; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: 4145741-16036), via an unspecified route of administration, in arm left on 25Feb2021 at 09:15 (at the age of 61-year-old) as dose 1, single for COVID-19 immunisation. Medical history included Raynaud, Hashimotos hypothyroid, sinusitis, achalasia, undifferentiated connective tissue disease, osteoarthritis and known allergies: penicillin, sulfa drugs and Mastisol surgical glue. Concomitant medications include allergy shot weekly (3 days prior on 22Feb2021) and plaque. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior to vaccination and was not tested for COVID post vaccination. On 25Feb2021, 8-10 hours after the shot, the patient experienced tingling down left arm, across shoulders and back of neck and achy in same area. The patient took 2 Tylenol as treatment. On 27Feb2021 at 08:00,  the patient experienced tenderness in left armpit and left inside elbow, can palpate lymph gland and 4 days later (on the day of reporting), lymph gland in armpit still tender and more pronounced. The patient took 2 Tylenol. The outcome of all the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Developed a fever and rash for 2 days and then was hypothermic at 95.4 on 9.11 went to the ER and was found to be profoundly neutropenic, ANC 100. Admitted for fever/RO Sepsis/RO Covid but AB test was negative
Patient called at 11:00AM 10-18-18 and asked to speak to a pharmacist regarding the pain in her left arm that has occurred since the administration of her flu shot on 10-7-2018. The patient states that her arm is extremely sore and painful to the point of causing restricted mobility and loss of sleep. Stated she thinks pharmacist may have hit a nerve when administering the vaccination. Patient had tried TYLENOL and ibuprofen OTC with no effect. Patient was advised to contact and discuss situation wit her personal physician and informed that a report would be file describing her condition.
Patient came into pharmacy on 9/20/13 and  asked what to do. Her arm was very red, slightly swollen and itchy. Told to try Benadryl and contact MD.
Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 73-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 73-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
Patient and his son arrived to the pharmacy on 2/19/20 for second dose of Shingrix. They stated the patient developed hives and severe itching on his right shoulder/back after receiving the first dose on 10/02/19. They were unsure of the time of onset, but stated symptoms lasted over one month. Patient picked up topical steroid for treatment on 10/08/19, which he stated provided minimal relief.
This case was reported by a healthcare professional, via sales representative, and described the occurrence of Guillain Barre syndrome in a male subject of unspecified age who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline) for prophylaxis. Medical history and concurrent conditions were unknown.  It was also unknown if the subject had experienced any adverse events following previous vaccinations.  In November 2007 the subject received 1st dose of Flulaval (unknown).  At an unspecified time after vaccination with Flulaval, the subject developed Guillain Barre syndrome which was reported to include paralysis.  It was reported that the paralysis occurred approximately five minutes after vaccination with Flulaval.  The subject was hospitalized and his status was unknown.  The reporter considered that the events were disabling.  At the time of reporting the outcome of the events was unspecified.  The reporter considered that the Guillain Barre syndrome was unrelated to Flulaval.
Patient arrived with wife to receive booster shots. Upon entering vaccine room, patient's wife asked if patient still felt alright. Patient expressed if he stands for too long that he feels dizzy. Pharmacist asked several times if patient wanted to wait to get the vaccine if he felt dizzy or unwell in any way. Patient was adamite that he felt fine and wanted to receive the vaccine. Pharmacist inspected patient for any color or pallor changes in skin, assessed physical being to best of ability and asked one more time if patient felt well enough to receive vaccine. Patient insisted he was fine to get vaccine. Vaccine was administered in the Left Deltoid at 12:45 PM. Pharmacist escorted wife and patient to sitting area to sit for 15 minutes after vaccination. At 12:51 PM patient wife alerted pharmacy that the patient had lost consciousness. Pharmacist attended to patient to check for pulse and perform CPR while 911 was contacted to have paramedics arrive. Patient regained consciousness at 12:54 PM  and was alert and oriented with pharmacist and never lost consciousness again. Patient was evaluated by Paramedics and escorted to a nearby hospital.
was intended to administer but it was discouraged; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product storage error in a patient who received HAV (Havrix) (batch number H4H53, expiry date 31st January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient did not receive Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error 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: 17-OCT-2022 Reporter's Comment: Pharmacist reported that a Havrix prefilled syringe was activated on the previous day and was stored on refrigerator until the day of reporting.  The pharmacist was intended to administer the vaccine one day after the Prefilled syringe was activated, however practice was discouraged. Additional supportive information: As product was not stored properly and practice was discouraged, which led to intercepted product storage error.
After 1st injection on 4/30/2021, injection site pain, slight headache for 3 days.         After 2nd vaccination on 5/21/2021:  arm pain, flu-like symptoms body aches, slight headache, loss of appetite, some dizziness, chills, slight rise in body temperature,  injection site swelling , redness and very hot, nausea, body rash,  fatigue, joint pain.  Side effects gradually decreased over the following 6 days.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. In 2013 (exact date unspecified, reported as about one year ago) the patient was vaccinated with a first dose of PNEUMOVAX 23 (intramuscular, dose, units, anatomical location, lot number was not reported). On 10-NOV-2014, the patient was inadvertently vaccinated with a second dose of PNEUMOVAX 23 (intramuscular, dose, units, anatomical location, lot number was not reported). No adverse effects were reported. Additional information has been requested.
(L) lateral thigh erythema, induration and temperature of 100.2F.
Moderate to severe Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 02May2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications of the patient was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 05Apr2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 12:00, after the second shot, the patient experienced moderate to severe headache, which lasted longer than a month. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event moderate to severe headache was recovered on an unknown date in Jun2021.   No follow-up attempts are possible. No further information is expected.
Pt.came into Health Center c/o reaction to PPV23 vaccine. Area assessed by RN, CHN. Area very red, inflammed and warm to touch. Redness starts from area of injection and has spread down to antecubital area - 7.5 inches in length. It has encompassed the arm and has spread 7 inches in width. Area marked and dated. Instructed pt. to go to PCP 02/28/13 to have arm evaluated. Pt. verbalized understanding per RN.
Arm very sore, swole from site, down to elbow which was very large to midway down arm. Bright red in color Lots of pain. Swole in cheek and eye on same side. 103 fever for 2 days. Didn't itch until swelling went down on the 7th day. Could not eat (nauseated). Didn't feel well, sleep. (I only weigh 74lbs).
Mom calls and reports that patient experienced a swollen, hot to touch, 12 cm circle on the right arm. Reports giving patient TYLENOL and Ice on injection site. Mom reports that swollen circle has grown in the last 48 hours. Recommended to contact physician.