chrisvoncsefalvay/vaers-outcomes huggingface dataset:
loss of taste; 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 AGEUSIA (loss of taste) 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 20-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (loss of taste). At the time of the report, AGEUSIA (loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information and concomitant medications were reported.
I RECEIVED THE FIST DOES OF THE MODERMA VACCINE ON FEB 12 BETWEEN 10 AND 10:30 AM   I HAD NO PAIN OR SWELLING THAT DAY.    ON THE 19TH IN THE EVENING MY ARM WAS ITCHY BUT I NEVER EVEN LOOKED AT IT    BY MORNING A PATCH ON MY ARM WAS HOT AND RED.  A RASH TWO INCHES IN DIAMETER AND ABOUT 3 INCHES LONG  WAS OBVIOUS.  TWENTY FOUR HOURS LATER THE RASH FADED AND THE PAIN DISAPPEARED    I DID NOTHING TO RELIEVE THE PAIN OR REDUCE THE SWELLING
Blood pressure low; Paleness; weakness; Tiredness; Headaches; Nausea; throwing up; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-May-2021 and was forwarded to Moderna on 02-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Blood pressure low), PALLOR (Paleness), ASTHENIA (weakness), FATIGUE (Tiredness) and HEADACHE (Headaches) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced HYPOTENSION (Blood pressure low), PALLOR (Paleness), ASTHENIA (weakness), FATIGUE (Tiredness), HEADACHE (Headaches), NAUSEA (Nausea) and VOMITING (throwing up). On 19-Apr-2021, HYPOTENSION (Blood pressure low), PALLOR (Paleness), ASTHENIA (weakness), FATIGUE (Tiredness), HEADACHE (Headaches), NAUSEA (Nausea) and VOMITING (throwing up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment included ibuprofen for headaches.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: additional information events and contact information updated
High blood pressure, irregular heart beat, enlarged heart, reduced ejection fraction of left ventricle. Medication and two ablations have, so far, failed to eliminate irregular heartbeats and have had only minimal effect on increasing ejection fraction.
This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a male patient who received Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Hepatitis B vaccine. Additional information was reported as follows: The age at vaccination was not reported. The patient received hepatitis B series in childhood, the vaccine brand for hepatitis B was unknown. The patient had to have his titers done due to matriculating at school, however it was unsure if it was a medical, nursing or a pharmacy school. The serological titers were less than 10mlU/ml. Lab Comments: On an unknown date, the serological test for Hepatitis B were carried out, which showed titers as less than 10 mIU/mL.
Information has been received from a nurse concerning a patient who was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) at the lower arm. On an unspecified date, the patient developed mild shingles. The patient's shingles persisted. No lab tests were performed. The patient was seen in the office and sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered product to patient of inappropriate age (a patient under the age of 18 received the first dose of the Moderna vaccine) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 005C21A) for COVID-19 immunization. No medical history reported. On Sep 29, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 29, 2021, administered product to patient of inappropriate age (a patient under the age of 18 received the first dose of the Moderna vaccine). On Sep 29, 2021, administered product to patient of inappropriate age (a patient under the age of 18 received the first dose of the Moderna vaccine) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine):  unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information.
HAV #1 given at Health Div 1/28/05 at 10AM. By 12PM that day, ct felt hot, face became red and slightly swollen; itching started 1/29/05 morning. Redness, itchiness, slight swelling has remained constant (increasing in evening) through today. Today skin peeling. No difficulty breathing. Used Desitin x 1 with improvement. 2/8/05 TC Pt who visited PP 2/4/05 was diagnosed allergic reaction; not to receive HAV #2.
ER 9-27-2012 SOB, with chest heaviness, abnormal HR, eyes bloodshot red with heavy crusting, numb lips, tongue, severe headache, swollen eyes. Raspy voice-to point of not being able to talk. Neck stiffness. Lately, leg spasms going into feet light sensitivity.
4 hours or so after the shot, exhaustion such that I had to lie down and slept for 3 hours, Tuesday afternoon.  Wednesday I began running a low grade fever of 101 with muscle aches, controllable with acetaminophen, Thursday (today - still running a fever.)
6/8/21 Pt was admitted to the hospital from ED with acute gastritis without bleeding.  Per EUA guidelines, hospitalization is to be reported regardless of connection to vaccine.
Patient has rather severe pain in arm where vaccine was injected, patient cannot lay on said arm due to pain.  There is no knot or raised area.
Patient  parent was asked how old was the child, he stated that he was 10 yrs old, proceeded to administer the vaccine  ( pediatric 5-11) .
she was very faint; Diarrhea; weakness; had a fever of 100 degrees; headache; Nausea; Loss use of right hand; sore arm; it was very painful like some stepped on her right hand, hand started hurting and continued to get worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (it was very painful like some stepped on her right hand, hand started hurting and continued to get worse), DIZZINESS (she was very faint), MOTOR DYSFUNCTION (Loss use of right hand), DIARRHOEA (Diarrhea) and ASTHENIA (weakness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014FZ1A, 012M20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Allergy to nuts, Fish allergy, Fruit allergy and Ulcerative colitis (In remission due to Entyvio infusions) since May 2019. Concomitant products included VEDOLIZUMAB (ENTYVIO), PREGNENOLONE, ESTROGEN NOS;TESTOSTERONE and PROGESTERONE for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021 at 10:15 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced PAIN IN EXTREMITY (it was very painful like some stepped on her right hand, hand started hurting and continued to get worse) and VACCINATION SITE PAIN (sore arm). On 09-Sep-2021 at 4:00 PM, the patient experienced MOTOR DYSFUNCTION (Loss use of right hand). On an unknown date, the patient experienced DIZZINESS (she was very faint), DIARRHOEA (Diarrhea), ASTHENIA (weakness), PYREXIA (had a fever of 100 degrees), HEADACHE (headache) and NAUSEA (Nausea). On 10-Sep-2021, PAIN IN EXTREMITY (it was very painful like some stepped on her right hand, hand started hurting and continued to get worse), MOTOR DYSFUNCTION (Loss use of right hand) and VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, DIZZINESS (she was very faint), DIARRHOEA (Diarrhea), ASTHENIA (weakness), PYREXIA (had a fever of 100 degrees), HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included Thyroid, Desiccated taken daily orally started in year 2011  No treatment information was not provided.  Patient reported to have taken an Entyvio infusion earlier that same week on 9/7/2021.   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow up received on 21-09-2021 contains significant information: Event information, Concomitant medication, Patient history updated, Batch number updated
Sore arm; Throughout the morning ''I'' developed a fever eventually hitting 102 by late afternoon; Shivering; Body aches; Headache; Generally not feeling well; Extremely gassy; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the right arm on 11May2021 at 17:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 19Apr2021 at 18:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 12May2021 at 07:00, the morning following the second vaccination shot, the patient started with a sore arm. Throughout the morning the patient developed a fever eventually hitting 102 (unspecified units) by late afternoon. Other symptoms included shivering, body aches, headache and generally not feeling well. The patient eventually became extremely gassy, which lasted through the night. The fever was down to 100 (unspecified units) by morning and after sleeping until nearly 14:00, the fever was gone. Some aching remained in the evening, but the patient was able to function nearly normal at the time of reporting. The events 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. No therapeutic measures were taken as a result of reported events. The clinical outcome of the event fever was recovered on 13May2021 at 14:00. The clinical outcome of the events sore arm, shivering, body aches, headache, generally not feeling well and extremely gassy were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient presents to clinic with entire body macular rash for two days, fever (102 F), irritability, eating less (but not refusing food), and intermittent vomiting. No diarrhea or sick household contacts. Parent denies decreased urination, tugging ears, and prolonged irritability. Advised hydration, antipyretics, antihistamine, and close monitoring.
Vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "Vertigo".  Additional Context: Consumer was experiencing side effects from the covid vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Common symptoms: feverish and tired within 30 mins to 1 hour.  Rare symptoms: chest discomfort/ache.  It was equal on both sides along the inner pec or breast and back.  However, next morning, pain was just on left side and moved more inward over heart.  These symptoms went away within  36 hours after vaccine was administered.
Information has been received from a physician concerning a 12 month old male with no known medical history or allergies who on 22-SEP-2006 was vaccinated with a 0.5 mL IM dose of MMR (lot # 654235/0615F). Suspect vaccination administered that day included a dose of Varivax. On 26-SEP-2006 the patient developed swelling of the lower cheek of his face and of his neck. The physician indicated that this turned out to be an abscess unrelated to vaccination with MMR (lot # 654235/0615F). On 27-SEP-2006 the patient had a temperature of 102F. Medical attention was sought. It was reported that there was "no treatment thus far". The patient's outcome was not recovered. There was no product quality complaint involved. Additional information has been requested.
Heart racing within minutes of the shot; Sporadic strong headaches; Sporadic fatigue; Blood pressure (BP); This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PFER8727) via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high (HBP), cardiovascular disease and gout. The patient had a history of allergy to sulpha based medications, penicillin and statins. Concomitant medications included aspirin (MANUFACTURER UNKNOWN), blood pressure (unspecified medication) and blood thinners (unspecified medication); all for unknown indications from unknown dates. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021, the patient had heart racing within minutes of the shot; she also experienced sporadic strong headaches, which lasted for about 60 seconds for 24-48 hours and had sporadic fatigue. On an unknown date in Mar2021, the patient had blood pressure (BP). The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure was taken as a result of blood pressure (BP) and included treatment with clonidine, the patient took extra clonidine 0.05 mg to lower BP. The clinical outcomes of the events heart racing, headache and fatigue were resolved on an unknown date in Mar2021 while that of blood pressure abnormal was unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.
Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Information has been received on 04-APR-2017 from a pharmacist who reported that  patient of unknown age and gender. The pharmacist reported that on 04-APR-2017, an expired dose of PNEUMOVAX 23 (Route and site of administration were not reported) was inadvertently administered to a patient for prophylaxis. The Lot number was reported as L029406 with expiration date of 26-MAR-2017. A Lot check was requested and it was reported that Lot number L029406 is an invalid Lot number for Pneumococcal Vaccine, Polyvalent (23-valent). No adverse effects were reported. No further information was provided. Additional information has been requested.
Headache, Sedation, Arthralgia, Fever &  NauseaVomiting Narrative:  Other Relevant History:
Dose 1 Pfizer 2/4/2021 Lot # EL3302, Booster Pfizer 10/13/2021 Lot # FC3184  Patient died from Covid 19 complications on 12/15/2021 at hospital.
EXPERIENCED NAUSEA AND VOMITING 5-6 TIMES DURING THE NIGHT; 6 PM, 8PM, 11PM - 3AM 6AM.
14 year old male with autism who has chest pain and ECG showing diffuse ST elevation (normal troponin) consistent with pericarditis. He also received his second dose of the Pfizer vaccine 5 days prior to onset of chest pain. Although it is difficult to know for sure if this is vaccine mediated, the timing makes it suspicious. Now hospitalized with observation and pending ECHO results. Symptomatic management with NSAIDS.
Information has been received from an aunt concerning her 17 month old niece, with no reported medical history and no known drug allergies, who in December 2004, was vaccinated with a dose of measles virus vaccine live, mumps virus vaccine live rubella virus vaccine live (lot # 648474/0314P); route of administration unknown.  There was no concomitant medication.  Subsequently, a few days after vaccination in approximately December 2004, the patient developed a fever of 100.4 degrees, swelling of the lymph nodes between her legs, redness underneath her eye lids, weakness in her legs and loss of balance, tilting to her right side.  It was also reported that the patient sought unspecified medical attention and that she had not recovered at the time of the report.  There was no product quality complaint involved.  Additional information is not expected.
Developed fever 101.2 on the day of vaccination. Next day, on 03/05/2011, developed seizure: eyes rolled up, shaking movement of the body, pallor, nonresponsive. Seizure lasted less than 5 minutes. Seen at ER the same day, observed and discharged home the same day.
first dose 4 years ago, would like the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 4 years ago, from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter inquired if the patient restart the series or get a second dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter unable to provide details on first dose. The reporter did not consent to follow up.
A rash with swelling on the left arm around the injection site. The rash first spread Friday morning, small in size and has grown daily since. The rash is red and hot around 10 x 10 cm in size.  Starting antibiotics. Cephalexin (KEFLEX) 500 mg Oral Cap and Mupirocin (CENTANY) 2 % Top Oint
tremor; affected her breathing; dizziness; cramping in legs; chills; bad headaches; temperature of 102; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramping in legs), DIZZINESS (dizziness), TREMOR (tremor), DYSPNOEA (affected her breathing) and CHILLS (chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 28-Jan-2021, the patient experienced MUSCLE SPASMS (cramping in legs), CHILLS (chills), HEADACHE (bad headaches) and PYREXIA (temperature of 102). On 06-Feb-2021, the patient experienced DIZZINESS (dizziness). On an unknown date, the patient experienced TREMOR (tremor) and DYSPNOEA (affected her breathing). At the time of the report, MUSCLE SPASMS (cramping in legs), DIZZINESS (dizziness), TREMOR (tremor), DYSPNOEA (affected her breathing), CHILLS (chills), HEADACHE (bad headaches) and PYREXIA (temperature of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: 102 (Inconclusive) Temperature-102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
HAD APPARENT VASOVAGAL EVENT AFTER IMM/ BLOOD DRAWING - CONTORTING MOVEMENTS AND EVENTUALLY FELL FORWARD FROM CHAIR-WAS LAID DOWN ON EXAM TABLE AND LEGS RAISED- EPISODE RESOLVED WITHING 5-10 MIN- SUSTAINED CONTUSSION TO RIGHT LOWER LIP TEETH INTACT- BLOOD PRESSURE WAS NORMAL.
No adverse effect; improperly stored vaccine administration; This spontaneous report has been received from a medical assistant referring to a 12-month-old patient with unknown gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.      On 04-SEP-2019, the patient received improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency and route were not reported) (lot # S002874, Expiration Date: 29-JAN-2021) for prophylaxis. There was no adverse effect. The stored temperature was 6 Fahrenheit (F) to 14 F (10.2 F, multiple) for 50 minutes and the data logger was involved. There was no previous temperature excursion. It was used to reconstitute sterile diluent (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The storage of sterile diluent was properly.
Moderate to severe left  arm pain/ tenderness.  Mild joint stiffness and mild joint pain in left hand.  Mild fatigue, mild mental fog.