chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sick; fever; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received 1st dose on a unknown date and experienced shingles, refer case US2021AMR194382).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness and fever. On an unknown date, the outcome of the sickness and fever were unknown.   It was unknown if the reporter considered the sickness and fever to be related to Shingles vaccine.  Additional details were provided as follows: This case was self-reported by the patient. The age at vaccination was not reported. The patient received 2nd dose and felt sick with high fever. This case is linked with the case US2021AMR178318 and US2021AMR178307, reporter by same reporter.
No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 20-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Patient states that 5 days after getting the vaccine he developed severe diarrhea which has persisted. He has not been able to eat much as every time he eats he has diarrhea, sometimes to the point he can't make it to the toilet. He has not sought medical attention. Upon arrival for 2nd vaccine dose today he asked to speak with someone and it was noted he had lost 30 lbs in the last 4 weeks. He was advised to contact his regular physician immediately for complete evaluation and told this may or may not be vaccine related. Second dose was held today as precaution and once cleared by regular physician he can call us to get the 2nd dose. Patient did admit to history of "bacterial infection" causing diarrhea many years ago from drinking well water but doesn't drink well water currently. He also had body aches, headache after vaccine but these resolved and also complained of his hands swelling up like arthritis.
Stomach pain/cramps. Fever. Chills. Body aches. Headache. Fatigue
A non-serious spontaneous report of FLUMIST administered to an 18-month-old and wheezing has been received from a pharmacist, subsequent to FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  Neither past medical history nor concomitant medication were reported.  The patient received FLUMIST intranasally on 30-Oct-2008.  The 18-month-old patient was given FLUMIST inadvertently. The patient returned to the clinic on 15-Nov-2008 and the the mother reported wheezing.  The patient has an appointment to be evaluated by a health care professional.  The outcome for the events is unknown.
Information has been received from a physician concerning an approximately 9-year-old child who was vaccinated on an unspecified date with a dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccination included a dose of influenza virus split virion 3v vaccine inactivated (FLUZONE (influenza virus split virion 3v vaccine inactivated) (Sanofi Pasteur). Subsequently the patient experienced a possible anaphylactic reaction which included wheezing, shortness of breath, facial edema and facial mottling. The patient was stabilized and transported to the nearest hospital. No other information was available. This event not occur at the reporting physicians office. This is one of several reports from the same reporter. Additional information has been requested,
Received Janssen on 04/10/2021 filed VAERS report, report ID -1654072 . With 1st dose started having serve reactions, that were controlled with injections. After booster shot, the symptoms restarted, including swelling, itching, redness (hives) all over entire body. Followed up with PCP,  and Allergist.
Eyes swollen and red, ears red, some wheals one hour after shots. Zyrtec 10mg chewable given and Rx. for Prelone 15mg.
scab at the injection site; light headed/woozy; tingling in her legs; tenderness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness), DIZZINESS (light headed/woozy), PARAESTHESIA (tingling in her legs) and VACCINATION SITE SCAB (scab at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (Type 2). Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA) for Diabetes.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced TENDERNESS (tenderness). On 22-Mar-2021, the patient experienced DIZZINESS (light headed/woozy) and PARAESTHESIA (tingling in her legs). On 23-Mar-2021, the patient experienced VACCINATION SITE SCAB (scab at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Pain in extremity, at a dose of UNK dosage form. At the time of the report, TENDERNESS (tenderness), DIZZINESS (light headed/woozy), PARAESTHESIA (tingling in her legs) and VACCINATION SITE SCAB (scab at the injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
Administration of an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter. On 01 Sep 2021,the vial was initially stored in the refrigerator with a use by date of 01 Oct 2021.
Very bad pain in my salivary glands at end of my jam bone in my neck on both sides and down my neck and into my ears and I still am having these symptoms since the day of the shot. My doctors nurse said take Tylenol on day it started and it keeps coming the bad pain!! So I?m taking Tylenol every day almost 3 months later and nurse said it?s my responsibility to report it not my doctor.
Severe chills and shivering.  Lasted about 6 hours.  Wore ski hat, gloves and winter coat indoors to control.
Pt recv vax on 1/13/99; on same day pt exp fatigue, weak, pallor, irregular pulse; pt to E.R.
Abrupt onset of Dizziness and vertigo, unable to walk straight and feeling like I was going to pass out. Exactly 96 hours after second dose. No history of vertigo/ENT conditions or anything similar ever happening. Feeling that something is off is lingering, and dizziness is persisting.
This spontaneous report was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 19-JAN-2015, the patient was vaccinated orally with a dose of 2 ml of ROTATEQ 10 unit dose tube, lot # K000487, expiration date 27-SEP-2015. This vaccine was improperly stored exposed to three temperature excursions, one for a sum of 144 hours with the lowest temperature recorded as 31 degrees F (-0.555555556 degrees C); and other for a sum of 24 hours with a lowest temperature recorded as 33 degrees F (0.555555556 degrees C); and another for a sum of 216 hours with a lowest temperature recorded as 34 degrees F (1.111111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator(R)". No adverse effects were reported. There was no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient with red indurated elevated patch to injection site (2 cm) with surrounding light red flat area (10 x 15 cm). Mildly tender and mildly itchy. No fever, no body aches.
caller stated that there was a 2 month gap between both doses/ 1st dose received in Feb2021/ 2nd dose received in Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller stated that there was a 2 month gap between both doses/ 1st dose received in Feb2021/ 2nd dose received in Apr2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller stated that there was a 2 month gap between both doses/ 1st dose received in Feb2021/ 2nd dose received in Apr2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller stated that there was a 2 month gap between both doses/ 1st dose received in Feb2021/ 2nd dose received in Apr2021) had resolved.            No concomitant medications were provided by reporter. No treatment details were provided by reporter. The caller asked how he could obtain a vaccination card?   Reporter did not allow further contact
has lost a bit of his taste; has a temperature of 99.0 deg F; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (has lost a bit of his taste) and PYREXIA (has a temperature of 99.0 deg F) in a male 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-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced AGEUSIA (has lost a bit of his taste) and PYREXIA (has a temperature of 99.0 deg F). At the time of the report, AGEUSIA (has lost a bit of his taste) and PYREXIA (has a temperature of 99.0 deg F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Body temperature: 99.0 (High) temperature of 99.0 deg F..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: TCR attached- outcome updated
Complaining of pain immediately after deep into her shoulder. Thought it was just from the initial shot and would subside in a day. Pins and needles started next anytime she uses her hands to do small movements, followed by full shoulder numbness. Followed up with her PCP 6 days later and said it should go away within a couple weeks. No treatment was advised. Physical in 8/2021 and is still having the same pain, pins and needles followed by numbness when she uses her arm for anything. Referred to a neurologist. Appointment on 10/11/2021
Within 2 days after the vaccine: Soreness on arm at injection site, throat pain, chest congestion, body pain. This continued for 2 weeks. 2 weeks after the vaccine: Dull pain around right testicular region. I made an appointment to see the doctor, but by the time of the appointment the pain subsided (within 2 weeks). I plan to bring it up with the doctor at my preventive health checkup later this month.
Fever - 102.2 degrees F, large red, swollen oval shaped reaction just below inj. site approx 6 inches diameter. Muscle weakness at site of injection. ( right delt ). Patient had pain all day but really noticec Sx around 5 pm when he got home from work.
Red splotchy rash developed on both legs approximately 18 hours after vaccination. Rash was on tops of feet, around ankles, extended up calves and was also present on upper thighs. Rash did not itch. Treated by taking zyrtec every 12 hours and benadryl every 6-8 hours. Rash resolved 4/3/21.
This spontaneous report was received from a licensed practical nurse. The nurse stated that the name of PROQUAD sounded too similar to the name of QUADRACEL (manufacturer unspecified) and as a result, she placed her PROQUAD into the refrigerator, on an unknown date reported as "10 days ago", approximately on 13-JUN-2017.. The nurse did not report any labeling confusion for PROQUAD. No information about the diluent was provided. The PROQUAD was never administered to anyone. Additional information has been requested.
2nd dose administered from a punctured vial that was put back in fridge for a month/had been opened 30 days prior to administration, but kept refrigerated; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose administered from a punctured vial that was put back in fridge for a month/had been opened 30 days prior to administration, but kept refrigerated) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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) at an unspecified dose. On 17-Feb-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose administered from a punctured vial that was put back in fridge for a month/had been opened 30 days prior to administration, but kept refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose administered from a punctured vial that was put back in fridge for a month/had been opened 30 days prior to administration, but kept refrigerated) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information not provided by the reporter.   This case was linked to MOD-2021-027809, MOD-2021-027810 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Patient information was updated. Start date and batch number for mRNA-1273 was provided. Reporter stated no problems after vaccine administration. The client is still not having any problems as of 26-Mar-2021.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 013L20A)  with no associated adverse events. MOD-2021-027809:same reporter, same event, different patient MOD-2021-027810:same reporter, same event, different patient
Donor reported approx. three hours after vaccine that his face was numb on the left side from his eye to mid way down his cheek, He also reported numbness on the left side of his tongue and left neck. No swelling, pain, speech or swallowing difficulties. When donor called the symptoms had been present for approx. 45min not increasing or decreasing. Donor had eaten and drank well. Donor felt otherwise normal. Donor stated he has had this happen once or twice before when he has been active all day and not eaten.
I had a cyst on my backside, so I had to get some antibiotics and they discovered I was pregnant. I had been experiencing some cramping and noticed that they were worse than usual once I went home. On April 30, I called Urgent care and went in the next day. They checked my numbers and everything was good. The growth hormone was high (around 25k), which suggested that the baby's timeline was on target.  However, they did an ultrasound, but couldn't really see anything in the sac.  On May 9th, I had to go back for another ultrasound and, again, there was a sac but no fetus. I had another ultrasound on May 14th with the same results. After a 4th ultrasound on May 26th, I was diagnosed with a blighted ovum and had surgery two days later.
Progress Notes Nurse Practitioner Cosign Needed Expand All Collapse All       Patient:                                                                     DOB:  10/1/1947  Date:  2/4/2021                                                            Subjective Patient is a 73 y.o. male who was seen at COVID Vaccine Clinic today for his first  dose of the COVID 19 vaccination.    He was given the Pfizer vaccination in the right deltoid muscle.   During his 15 minute waiting period after the injection, the patient began to experience SOB and throat tightness and abdominal pain.  He denied rash, hives, welts, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and he was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting.   Pt is a diabetic ate last at 8 am.  Blood sugar 234 at 15:12.     ALLERGY REVIEW OF SYSTEMS:  Patient complains of shortness of breath and abdominal pain       Previous Reactions: None    Objective Vitals There were no vitals filed for this visit.    Blood Sugar 234 collected at 1512     Physical Exam Constitutional:      Appearance: Normal appearance. He is well-developed.  HENT:     Head: Normocephalic and atraumatic.     Right Ear: External ear normal.     Left Ear: External ear normal.     Nose: Nose normal.  Eyes:     Conjunctiva/sclera: Conjunctivae normal.     Pupils: Pupils are equal, round, and reactive to light.  Neck:     Musculoskeletal: Normal range of motion and neck supple.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Abdominal:     General: Bowel sounds are normal.     Palpations: Abdomen is soft.  Musculoskeletal: Normal range of motion.  Skin:    General: Skin is warm and dry.     Capillary Refill: Capillary refill takes less than 2 seconds.  Neurological:     Mental Status: He is alert and oriented to person, place, and time.        Assessment/Plan  Treatment included: no therapy Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Pt left at 15:28
patient got up and woke up on the floor; She never passed out. She got out of her chair, turned off the light and woke; Turned off the light and woke w a bruise to my right cheek; swelling to the right side of my head; This is a spontaneous report from a contactable emergency room nurse (patient).  A elderly female patient (also reported as age: 61; unit: unknown) received the first single dose of BNT162B2 (Lot number: El0249, exp date not reported), intramuscular (vaccine location: Left arm) on 21Dec2020 at 06:15 AM for immunization. Medical history included hypertension (HTN). The patient had no known allergies. Concomitant medication included meloxicam (MOBIC), levothyroxine sodium (SYNTHROID), lisinopril, and metoprolol tartrate (LOPRESSOR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Dec2020 at 08:45 AM the patient got up and woke up on the floor. She never passed out. She got out of her chair, turned off the light and woke with a bruise on her right cheek and swelling to the right side of her head. She was a bit freaked out just worked "another 12" with no side effects. No treatment was received for the adverse events. The events were considered as non-serious by the reporter. The patient did not receive prior Covid vaccination and was not tested for Covid post vaccination. The patient recovered from the events on an unspecified date in Dec2020.
(Comment on Item 17- not sure which of these 2 vaccines is was, I will obtain records if poss.) Hemorrhagic stroke in temporal-parietal lobe; hospitalized for 4 days; no treatment; aphasia and confusion for 1-2 months. Recovered after 1-2 years
patient came in on 12/03/2020 stating his left arm and shoulder were still sore from the vaccine shot he received over a month ago.
patient reported blurred vision, and facial redness and swelling around the cheeks. Blood pressure was also found to be elevated.
vomiting; temperature of 101 degrees Farenheight; Chills; fatigue; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events temperature of 101 degrees farenheight, chills, fatigue, vomiting.  The patient's medical history was not provided. Concomitant medications reported were Tylenol, Propranolol, Famotidine, Nitrofurantoin, Acidophillus, Aspirin for drug use for unknown indication.  On 17 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the events temperature of 101 degrees farenheight, chills, fatigue. On 20 Feb 2021, the patient experienced the event vomiting.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, temperature of 101 degrees farenheight, chills, fatigue, vomiting was unknown.
Chest tighten, palpitations, eyes felt dry, flushing, lightheadedness.
Pt presented with itching, swelling  and redness around the injection site in the upper right arm all the way to the elbow.
Flu vaccine was given but not ordered by provider. Mom was aware at time of service and discussed error with provider.