chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose number=1, Janssen; dose number=2, Pfizer; dose number=1, Janssen; dose number=2, Pfizer; is bivalent= False; rigors/ chills; extremely fatigued; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 2 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen (Dose number=1), for Covid-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "dose number=1, Janssen; dose number=2, Pfizer"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "dose number=1, Janssen; dose number=2, Pfizer; is bivalent= False"; CHILLS (non-serious), outcome "recovered", described as "rigors/ chills"; FATIGUE (non-serious), outcome "recovered", described as "extremely fatigued". The information on the batch/lot number for BNT162b2, BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Everything hurts; Sweats; Horrible fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Everything hurts), HYPERHIDROSIS (Sweats), FATIGUE (Horrible fatigue) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN (Everything hurts), HYPERHIDROSIS (Sweats), FATIGUE (Horrible fatigue) and CHILLS (Chills). At the time of the report, PAIN (Everything hurts), HYPERHIDROSIS (Sweats), FATIGUE (Horrible fatigue) and CHILLS (Chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Pyrexia: 92 (Inconclusive) 92F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Everything hurts), HYPERHIDROSIS (Sweats), FATIGUE (Horrible fatigue) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN (Everything hurts), HYPERHIDROSIS (Sweats), FATIGUE (Horrible fatigue) and CHILLS (Chills). At the time of the report, PAIN (Everything hurts), HYPERHIDROSIS (Sweats), FATIGUE (Horrible fatigue) and CHILLS (Chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Pyrexia: 92 (Inconclusive) 92F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Localized soreness (aching) pain on right deltoid. Occasionally refers distally down arm, half-way to elbow. No weakness. Using arm makes worse. Worse in morning or with pressure. Aleve helps. Symptoms improving during day, not upon awakening. Visit with PCP scheduled for 1/8/04. Somewhat
Tested positive for Covid-19 on 7/25/2021. Admitted to hospital for SOB.
This patient had severe joint pain, fever of 102 - 103, nausea, vomiting, and pulse of 120. Treated with Advil, Tylenol, Tamiflu, and Augmentin.
Noticed chest pain couple days after during the day randomly feels chest pain since then. Patient came to clinic for follow up on 04/18/2012 and was evaluated by Dr.
admitted 21 Jan  21for Chest pain; Elevated troponin; Hypokalemia; SOB (shortness of breath); Shortness of breath; Volume depletion   Dishcarged on 23 Jan 21
Information has been received from a physician concerning a 16 week male who on 09-MAR-2009 was vaccinated with the first dose of ROTATEQ via injection. There was no concomitant medication or relevant medical history and past drug history was unknown. On 09-MAR-2009 this physician reported that she misunderstood the package insert and administered the first dose of ROTATEQ to a 16 week old infant. There was no relevant laboratory data. As of 09-MAR-2009 it was unknown if the infant would continue to get the ROTATEQ and it was unknown if he was experiencing any adverse reactions. Follow-up information was received from the physician. The physician said the patient was doing fine. The physician further reported that she called for clarification as to when an infant should receive ROTATEQ not to report an adverse event. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mildly sore arm) and VACCINATION COMPLICATION (Non-specific report reaction to vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 031M20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Pantaprazole (oral) and possibly others in proton pump inhibitors (PPI) class), Hypothyroidism since 01-Sep-1990, Migraine since 01-Jul-1968, Anaphylaxis (Idiopathic anaphylaxis Improved from May 2015 when stopped Pantaprazole) since 01-Mar-2013 and Constipation. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 15-Mar-2013 to an unknown date and MONTELUKAST from 15-Mar-2013 to an unknown date for Anaphylaxis, DOCUSATE SODIUM (EQUATE STOOL SOFTENER) from 01-Apr-2007 to an unknown date for Constipation, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 01-Sep-1991 to an unknown date for Hypothyroidism. On 08-Mar-2021 at 11:50 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021 at 11:50 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION COMPLICATION (Non-specific report reaction to vaccine). On 05-Apr-2021 at 1:00 PM, the patient experienced PAIN IN EXTREMITY (Mildly sore arm). On 18-Mar-2021, VACCINATION COMPLICATION (Non-specific report reaction to vaccine) had resolved. On 07-Apr-2021, PAIN IN EXTREMITY (Mildly sore arm) had resolved. Treatment information were not provided.
Body malaise, sore throat, productive cough, headache and fever of 99.2 degrees F manifested 2-3 days after vaccine was received. Medications taken as follow: Paracetamol 2 tabs every 12 hrs, ROBITUSSIN DM 5ml every 6 hrs.
Initial unsolicited report received from a nurse on 19 November 2015. This case involves a 44-year-old female patient who was vaccinated with a dose of Flu VACCINE (batch number, dose, dose in series, expiration date, route and site of administration were not reported) on an unspecified date. It was reported that patient received Fluzone multiple times and had an increasing site reaction each year. Illness at time of vaccination was unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Concomitant medications were unknown. On an unspecified date, following the vaccination, the patient experienced an increasing local red hot raised reaction at the injection site. Lab data was reported as none. Corrective treatments were not reported. The patient was recovered from event. List of documents held by sender: none. Follow up information received from a nurse on 28 January 2016. Patient received Flu Vaccine on 15 September 2014. It was reported that patient had received vaccines for the conservative past three years. On an unspecified date, following vaccination, patient developed site was red, swollen and pruritic. The area was indurated to the size of an orange. Patient was referred to an allergist which patient did not pursue.
This is a spontaneous report from a Pfizer-sponsored program from a contactable pharmacist. A female patient of an unspecified age received PREVNAR 13 (lot number: S74424, expiration date: Dec2019), via an unspecified route of administration on arm on an unspecified date at a single dose for immunization at a pharmacy. The patient's medical history and concomitant medications were not reported. A pharmacist gave a patient pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and patient experienced red swelling on her arm. Outcome of the events vaccination site erythema and vaccination site swelling was unknown.
Pt vaccinated with DTP/OPV developed unconsolable, continuous crying for more than 3 hrs.
Eczema; Injection site rash; This spontaneous case was reported by a health care professional and describes the occurrence of ECZEMA (Eczema) and INJECTION SITE RASH (Injection site rash) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GLIPIZIDE, LOSARTAN, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE and DOXYCYCLINE for an unknown indication.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ECZEMA (Eczema) and INJECTION SITE RASH (Injection site rash). The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, ECZEMA (Eczema) and INJECTION SITE RASH (Injection site rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.
Pt was administered 0.3 mls of a Pfizer Bivalent vaccine Lot #GL1990 as a first dose in their primary  vaccine series. Supervisor notified immediately. Per CDC guidelines, continue w/ current dosing schedule for pt to receive next dose of Monovalent in 21 days. Pt notified and monitored for s/s of adverse reactions w/ none noted. Monitored for 30 minutes. All questions/concerns addressed. Pt verbalizes understanding of vaccine symptom management. .
Onset Temp > 102 with nausea, myalgias, headache. Local reaction injection site.
This spontaneous report as received from registered nurse refers to a male patient of unknown age. No concurrent condition or medical history reported. On an unknown date in 2014 (reported as year ago), the patient was vaccinated with 2 doses of (Oka/Merck) VARIVAX. On an unknown date in 2015 (reported as recently), the patient was determined to have negative antibody titers to varicella. No treatment was given for the event. The patient sought medical attention and had an office visit. Action taken with (Oka/Merck) VARIVAX was not applicable. The outcome of the event was unknown. The causality was not provided. No product quality complaint reported. Additional information is not expected as the reporter did not wish further contact.
This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 64-year-old male patient who received Flu Seasonal TIV Dresden. Co-suspect products included VALTREX unknown for herpes nos. On 12th September 2016, the patient received Influenza vaccine unspecified and VALTREX 1000 mg once daily (1000 mg dailey). On September 2016, 3 days after receiving Influenza vaccine unspecified and VALTREX, the patient experienced dizziness and sickness. In September 2016, the patient experienced tingling and numbness. The action taken with VALTREX was unknown. In September 2016, the outcome of dizziness and sickness were recovered/resolved. On an unknown date, the outcome of the tingling and numbness were not recovered/not resolved. It was unknown if the reporter considered the dizziness, sickness, tingling and numbness to be related to Influenza vaccine unspecified and VALTREX. Additional details were provided as follows: The patient was experiencing dizziness, sickness, tingling and numbness after receiving flu vaccine (unknown manufacturer) and generic VALTREX (unknown manufacturer).
Shingles Headaches dizziness pain in lower right side front very bad constant swelling in feet, toes, ankles, legs, and hands leg gave out
Injections of tDap and Flu shot were received at approx.  2pm.  Mom describes patient complaining of pain at site of injection at bedtime, so she layed with him.  Soon after, he became disoriented and scared.  Asked, "Mom, where am I?"  He also had blurry vision.  No fevers.  No seizures.  Patient was taken to ER.
pt recv 1 dose of varivax in 6/95 & in 4/98 pt devel ``20-25 bumps along the front hairline, torso & back of knee''.
Vesicular rash of lower abdomen and diaper area. Mild runny nose. HSV/VZV collected and pending.
Myalgia, Fever, SkinRash, NauseaVomiting, arm tingling Narrative:
Less than 1 week after immunization mom reports fever with 3-5 min. episodes of drooling, eyes rolling & tonic seizure.
4/6/12 ER HPI: 74 y.o. male who presents with complaint of shortness of breath that is worse after eating for 3 weeks.  Patient said he had received a his copied vaccine 3 weeks ago.  No cough, no chest pain,  no abdominal pain nausea vomiting, no palpitations and no fever or chills  Shortness of Breath: Started 3 weeks ago and getting worse. Received covid vaccine 3 weeks ago and started then. No cough. Dyspnea on exertion. No fever. Early am he has had runny noses. No inhalers or nebs. Not smoker
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (Arm became very irritated), VACCINATION SITE ERYTHEMA (Arm became red), VACCINATION SITE SWELLING (Arm became swollen) and VACCINATION SITE PRURITUS (Arm became very very itchy from the shoulder to the elbow) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 010A21A and 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL, MULTIVITAMIN [VITAMINS NOS], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), FISH OIL, METOPROLOL and MAGNESIUM for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, the patient experienced VACCINATION SITE IRRITATION (Arm became very irritated), VACCINATION SITE ERYTHEMA (Arm became red) and VACCINATION SITE SWELLING (Arm became swollen). On 22-Oct-2021, the patient experienced VACCINATION SITE PRURITUS (Arm became very very itchy from the shoulder to the elbow). On 25-Oct-2021, VACCINATION SITE PRURITUS (Arm became very very itchy from the shoulder to the elbow) had resolved. At the time of the report, VACCINATION SITE IRRITATION (Arm became very irritated), VACCINATION SITE ERYTHEMA (Arm became red) and VACCINATION SITE SWELLING (Arm became swollen) outcome was unknown.            No treatment was reported by the reporter.   This case was linked to MOD-2021-377059, MOD-2021-377032.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Additional information include no new information.
delayed cutaneous hypersensitivity reaction.  Narrative: onset 3 days post vaccination. duration 3 days. Left Arm.
Put completely down; Soo sick; Feel real bad; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (Put completely down), ILLNESS (Soo sick) and FEELING ABNORMAL (Feel real 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 24-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEPRESSED MOOD (Put completely down), ILLNESS (Soo sick) and FEELING ABNORMAL (Feel real bad). At the time of the report, DEPRESSED MOOD (Put completely down), ILLNESS (Soo sick) and FEELING ABNORMAL (Feel real bad) outcome was unknown.            No concomitant medication information was provided No treatment medication information was provided
Information has been received from a physician concerning his wife who on 8/27/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (641532/1353L) IM in the left arm. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. On approximately 8/29/02 the wife experienced a "severe local reaction," swelling from her elbow to her armpit, severe arm pain, redness, heat, arthralgia and malaise. The wife was treated with a Depo Medrol pack for 6 days. On 9/5/02 it was reported that the symptoms were subsiding. The reporter expressed a concern with the lot. Five other patients (WAES0209USA00016, 0209USA00030 and 0209USA01592 through 0209USA01594) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
I experienced a great head ache followed by weakness and then I experienced a great stomach ache and dizziness.
First evening-arm sore, some body aches, stomach ache Next morning and for 5 days-large red knot, very painful, warm to touch Day 8-COVID arm rash begins and continues to grow for 6 days then begins to resolve itself,  shoulder painful to move fully Day 15-begin to notice swollen and painful lymph nodes in armpit, left breast.  Lymph nodes began to reduce in size about day 21 Week 5-still trying to regain full movement, shoulder and left breast still painful, taking advil to sleep at night
Body ache; headache; vomitted; Fever; A report was received from a consumer concerning a 48-year old, female patient who experienced fever, vomiting, body ache and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, approximately 0 days hours prior to the onset of the events, fever, headache and body ache, and 1 day prior to the event vomiting, the patient received their first of two planned doses of mRNA-1273 (LOT# 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 30 Dec 2020 at 10:00 pm, the patient had a fever of 38.36 or 38.6, body and headache. On 31 Dec 2020 at 04:00 am, the subject reported vomiting. She took diclofenac when she went to bed the night of 30 Dec 2020, and Tylenol on the morning of 31 Dec 2020 after which she reported feeling better. Treatment for the event included diclofenac and Tylenol.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event were unknown.   The reporter did not provide an assessment for the events, fever, vomiting, body ache and headache.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Dad woke up one morning in February with a a pain in his groin so severe he could not swing the leg forward to walk.  He used a walk-behind walker to get around for several weeks.  Eventually he could walk without support, but only if careful.  The pain would also radiate down  the thigh of the same leg.   After the groin/thigh issue started to improve the pain changed to the buttock  and thigh of the same leg.  He had to use the walker again to  safely walk.  He also had difficulty lifting the leg up to get out of a recliner. He had to use his fists on  either side of the bad leg and lift himself with his arms because of too much pain if he tried to push up with his leg.  He has discovered that if he swings the bad leg behind him before he starts to try to walk, movement of the leg is less painful. He is using the walker to maintain balance because of the problems with  his leg. It just recently occurred to us that  these problems coincide with the  Covid vaccine doses and decided to report this.
With 1 or 2  minutes of getting vaccine patient started dry heaving. Patient had no signs of allergic reaction, no swelling or difficulty breathing. After giving a patient to feel better and not feeling better ambulance was called. EMS stated all vitals and breathing were good. Patient wanted to go to hospital and EMS took patient to the hospital.
Peripheral neuropathy in hands and feet (tingling, numbness). Began 36 hours post injection for Tetanus vaccine. Began in arms, spread to legs and feet. 3/26/08-records received for DOS 3/12-3/14/08-neurology consultation-seen in evaluation of C/O four extremity paresthesias. Symptoms began 2 weeks prior to visit when seen in ED for laceration to forehead. Day after tetanus shot C/O paresthesias in right arm from elbow to hand. Followed by numbness in toes of right leg, day later paresthesias in all four extremities especially in arms from elbows to hands and 4th and 5th fingers bilaterally. Two days later experienced symptoms of a cold with shortness of breath. Seen in ED for treatment of asthma. Developed hives on arms which occurred on three separate occasions for 48 hours at a time. Exercise increases symptoms in extremities. Positive Tinel's sign at left elbow otherwise, neurological exam normal. Laboratory tests unremarkable. She has developed an autoimmune or inflammatory neuropathy or mild case of Guillain-Barre syndrome but this can not be proven as peripheral neuropathy.
pt recvd vax & devel a rash on feet & lower legs 4-5 days p/vax; pt also devel a welt-like rash on any body surface exposed to cold temps; rash resolved 1-2 hrs p/pt was out of the cold;
joint pain; fever; nausea; stomach pain; This is a spontaneous report from a contactable physician (patient). A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at left arm, at single dose for vaccination. Medical history included ongoing diabetes. Concomitant medication included dulaglutide (TRULICITY) for diabetes. The patient the vaccine on 22Dec2020 and had developed joint pain, fever, nausea, and stomach pain on 22Dec2020. The patient had taken Pepto bismol and Tylenol in response to these events and what to know if these medications are safe to take or what recommendations to treat side effects. He called to ask if those products were safe to take relative to having gotten the COVID-19 Vaccine; and if there are any recommendations on medications to or not to take relative to having gotten the COVID-19 Vaccine. The patient stated his was also on Trulicity for diabetes and that medication can cause stomach pain too. He stated the pain is in the center of his abdomen. COVID-19 Vaccine next dose is scheduled in 3 weeks, no dose change made. The patient specified that there is no relevant information to provide regarding concomitant products or medications or other medical conditions. He took medication for diabetes but that was not relevant. The outcome of the events was not recovered.  Information about Lot/Batch number has been requested.
experiencing a twitching sensation in her shoulder blades after having first covid shot. The feeling is intermittent, throbbing and annoying. Sensation continues and has not subsided.