chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; Abdominal pain; Very weak; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 29Apr2021 at 13:00 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on unknown date (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Prior to the 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 30Apr2021 at 16:00, the patient experienced nausea paired with abdominal pain that will not let the patient sleep, body is very weak. The patient had eaten nothing out of the ordinary but on her period. The clinical outcome of the events nausea paired with abdominal pain and very weak were not recovered at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Abdominal pain, distended abdomen, constipation starting in April 2021. Had an appointment with PCP in June 2021 due to recurring pain and an increase in symptom severity. PCP recommended the FODMAP diet for IBS (didn't get an IBS diagnosis) and to get another appointment if symptoms didn't improve within 2 months.
Cellulitis 9 days after smallpox vaccine. Redness, swelling, pain, streaky +TTP , Treated with one gram Keflex BID x 5 days. Resolved in 4 days.
Patient received a dose of Pnuemovax23 following a temperature excursion; no adverse effect; This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml unknown route and anatomical location; lot # T000702 expiration 01-OCT-2021, for prophylaxis) following a temperature excursion.  No adverse effects were reported.   The temperature excursion lasted for 31 minutes with a highest temperature above 47°F/9°C (8.8°C), due to a data logger issue.; Sender's Comments:  US-009507513-2007USA001492:
After the second dose her blood sugar sky rotted over 300; Became weaker/it linger; Lot of pain in the joint of her leg; Extremely fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (After the second dose her blood sugar sky rotted over 300), ASTHENIA (Became weaker/it linger), ARTHRALGIA (Lot of pain in the joint of her leg) and FATIGUE (Extremely fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02M20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN for Type 1 diabetes mellitus.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERGLYCAEMIA (After the second dose her blood sugar sky rotted over 300), ASTHENIA (Became weaker/it linger), ARTHRALGIA (Lot of pain in the joint of her leg) and FATIGUE (Extremely fatigue). At the time of the report, HYPERGLYCAEMIA (After the second dose her blood sugar sky rotted over 300), ASTHENIA (Became weaker/it linger), ARTHRALGIA (Lot of pain in the joint of her leg) and FATIGUE (Extremely fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: high (High) Blood sugar over 300.   It was reported that patient increased her insulin intake by 6 units since the second dose as her blood-sugar level was over 300. Patient stated she took lots medication.   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Follow-up received on 03-Dec-2021 contains non significant information.
Blister and rash on right arm where injection was placed, spasms of brachioradialis muscle right arm
Tightness and pain in right chest, sore throat, coughing, slight bleeding in left ear canal, itchiness on ball of right foot.
Koplick's white spots oral. Patient evaluated 06/02/2017 by Dr. "Rash and other nonspecific skin eruption-cutaneous reaction to measles vaccines. "Plan, follow up as scheduled, may use BENADRYL or calamine as needed. Return it worsening or new symptoms.
Light headed; Fatigued; Headache; Body ache; Diarrhea; This is a spontaneous report from a contactable healthcare professional, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Sep2021 at 12:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 09Sep2021 at 18:00, the patient felt light headed, fatigued and experienced headache, body ache and diarrhea. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with ibuprofen. On 13Sep2021, the patient underwent nasal swab test and the result was pending. The clinical outcome of the events light headed, fatigued, headache, body ache and diarrhea was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
J&J vaccine was dispensed and believed to not be expired. The expiration on the label only had the time of expiration and not the date. The vaccine actually expired the day prior. It was sent to the floor for administration and was subsequently given to the patient.  Patient was scheduled for revaccination
stomach pain; weakness; dizziness; chills; headache; slight fever; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), ASTHENIA (weakness), DIZZINESS (dizziness), CHILLS (chills) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 208523-2A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna (Lot number 1808609) on 23-Mar-2021 and Moderna (Lot number 213021A) on 19-Nov-2021; for Product used for unknown indication: RSV and Flu. Past adverse reactions to the above products included No adverse event with Flu, Moderna, Moderna and RSV.    On 12-Oct-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 12-Oct-2023 at 2:30 AM, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), ASTHENIA (weakness), DIZZINESS (dizziness), CHILLS (chills), HEADACHE (headache) and PYREXIA (slight fever). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Stomach pain, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), ASTHENIA (weakness), DIZZINESS (dizziness), CHILLS (chills), HEADACHE (headache) and PYREXIA (slight fever) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  The symptoms was lasted 12 hours.
Pt recvd 2 doses of Hep B vax & recvd 1st dose 8 wks ago & 2nd dose 2 wks ago; 1 wk p/2nd dose exp arthritis-like pain in hands; also had pain @ the base of the skull;
A mother reported that her 6 year old daughter received an injection of Prevnar on 05/01/2000. The mother indicated that child experienced five episodes of pneumonia over one year. On 05/01/2000, the child developed an injection site reaction characterized by a hard, red lump lasting a "few days." Per follow up: Cancelled-duplicate of HQ1648605APR2002.
This spontaneous report was received from a physician concerning an 18 month old patient of unknown gender. No medical history or concurrent conditions were reported. On 24-FEB-2014, patient was vaccinated with MMR II (dose, route and strength not provided). Co-suspect or concomitant therapies were not reported. On 06-MAR-2014, patient experienced generalized measles rash. At the time of the report, the outcome of the event was unknown. The causal relationship between MMR II and the event was unknown. Additional information has been requested.
I have pain in my right arm when moving my arm up and down, as well as reaching back to scratch my neck or put my hair in a ponytail. I am having neck and shoulder pain related to my arm soreness. I am also having many more headaches after the vaccine, due to the soreness in my neck and shoulder as a result of the arm pain. I also have tenderness, and at times, extreme soreness in my right heel, something I have never had in my life. Please note that I am still having these symptoms 5 1/2 weeks after receiving my 2nd dose of the vaccine.
Patient complained of fever, chills, lethargy, soreness at the injection site and the patient passed out at home.
PT GOT FEVER, CHILLS AND NAUSEA DAY AFTER, BUT THEN 1 WEEK LATER HAD SEVERE CHILLS, NAUSEA AND FEVER, HE BELIEVES THEY WERE RELATED TO VACCINE
Administered expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  HCP administer expired vaccine to patients, after the manufacture date of expiration and wanted an assessments on the case. Expiration date was: 09-NOV-2021. Number of doses/vials:168 doses. Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
Arm trouble; This case was reported by a consumer via call center representative and described the occurrence of arm discomfort in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was unknown.   It was unknown if the reporter considered the arm discomfort to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments: Reporter was the patient, who stated that after receiving her Shingrix dose, she started to experience arm trouble. Call was disconnected before any demographic information could be collected.  The reporter did not consent to follow-up.
Patient Seen on 3/14/07 for complaints of pain and swelling at the site of the Gardasil vaccine given on the left upper arm. Injection administered on 3/8/07
Information has been received from the father of an 8-year-old male who in October of 2007, was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 658586/1272U, product circular# 7999916). The father reported that "my son has been having fevers since his second dose of varicella virus vaccine live (Oka/Merck) in October". Unspecified medical attention was sought. The outcome was not reported. No product quality complaint was involved. Additional information is not expected.
Initial and follow-up information has been received from a physician and nurse concerning an approximately 67 year old female who in approximately November 2007, "within the last month" was vaccinated SC with a dose of ZOSTAVAX (lot# 658395/0966U).  In approximately November 2007, the patient developed a localized injection site reaction with redness and yellow crust around the area.  The patient sought unspecified medical attention.  Subsequently, the patient recovered.  There was no product quality complaint.  This is one of several reports from the same source.  Additional information has been requested.
Syncopal event, no injury accorded, accompanied with mother. Vital signs stable, AAO x 4. Able to stand and walk unassisted
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID]), VITAMIN D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID], ZINC, SELENIUM and Turmeric for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported taking Tylenol liquid children's for symptoms. Patient also reported having blood titers antibodies checked 3 weeks ago and they are over 10. It is reported as patient takes 20 mg once a day simvastatin to lower cholesterol and also healthy supplements for immunity   This case was linked to MOD-2021-364741 (Patient Link).
Began feeling dizzy shortly after receiving the vaccine. I notified the workers. They took my blood pressure  and found it was hig. They took it several times and when it was 210/110 they called an ambulance to take me to the emergency room.
I skin turned grey and was red and swollen, I had severe breathing difficulty, I felt like knives were stabbing me all over my body, I had a fever, chills, severe fatigue, severe headaches, blurred vision, heart was out of natural rhythm, paralysis, muscle twitches, (clear/blood/green) mucus poured non-stop out of my nose for a week straight, dizziness, fever was 102.7 degree's  Fahrenheit, vomiting, brown urine, and diarrhea, etc.  I had a very severe adverse/allergic reaction after I received the Anthrax Vaccine, which required me to have to take a very powerful antibiotic pill that the hospital only carried one of those types of pills. They could only save one out of a total of 13 dyeing.
This spontaneous report was received from a nurse referring to an unspecified number of patients of unspecified demographics. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On unknown dates, the unspecified number of improperly stored doses of PNEUMOVAX 23 lot # M026317, expiration date 11-JAN-2018 (dose, route of administration and anatomical location were not reported) were administered to the unspecified number of patients. No adverse effects have been reported. The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 10 degrees Celsius for 4 hours and 17 minutes before administration to the patients. The previous temperature excursion was reported (time and temperature unknown). No adverse effects were reported. The product quality complaint was not reported. Additional information has been requested.
Started with nausea at 1AM Fri. morn woke up with diarrhea vomiting stomach pains went to hosp. at 3:30 AM.
severe body aches, headache, chills, diarrhea, sweats, hot, red, and swollen injection site
Day of vaccine and day after- elevated heart rate, 100 bpm. Approximately 8-10 days after vaccine, bruising on left and right legs, and inner thighs, and persistent itching all throughout body without rash.
Drug ineffective; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Jan2021 as dose 1, single (Lot number: 04l20A), in left arm, on 26Feb2021 as dose 2, single (Lot number: c01az1a), in left arm, on 04Nov2021 as dose 3 (booster), single (Lot number: 014F21A), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: 06911214), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NABUMETONE; SULFASALAZINE; AMLODIPINE; HYZAAR. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Oct2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient received Paxlovid treatment for Treatment of COVID-19 from 20Feb2023 to 24Feb2023. Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300097285 Same reporter and patient, different product and event;
he was given an expired Fluzone HD, no AE; Initial information was received on 03-Mar-2020 regarding an unsolicited valid non-serious case from a consumer.  This case involves Adult male patient who experienced he was administered an expired  INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number not reported) (expiry date-Jun-2019) via an unknown route at an unknown administration site for prophylactic vaccination in Dec-2019.  Medical history, past medical treatment, vaccination and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on batch number was requested.
swelling in knees/it is in ankles; swelling on my back; knuckles on her hand are swollen, and it is in hands; extreme body aches; swollen under the arm/(kind of swollen)/it continued to get worse; swollen into the breast area (on left side)/it continued to get worse; arm was really painful (left) and kind of throbbing; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen under the arm/(kind of swollen)/it continued to get worse), BREAST SWELLING (swollen into the breast area (on left side)/it continued to get worse), JOINT SWELLING (swelling in knees/it is in ankles), SWELLING (swelling on my back) and PAIN IN EXTREMITY (arm was really painful (left) and kind of throbbing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076F21A, 048A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis. Concomitant products included SIMVASTATIN, BACLOFEN, OMEGA-3 [OMEGA-3 NOS], COLECALCIFEROL (VITAMIN D3) and LISINOPRIL for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm was really painful (left) and kind of throbbing). On 12-Oct-2021, the patient experienced PERIPHERAL SWELLING (swollen under the arm/(kind of swollen)/it continued to get worse) and BREAST SWELLING (swollen into the breast area (on left side)/it continued to get worse). On an unknown date, the patient experienced JOINT SWELLING (swelling in knees/it is in ankles), SWELLING (swelling on my back), PERIPHERAL SWELLING (knuckles on her hand are swollen, and it is in hands) and MYALGIA (extreme body aches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and HYDROCODONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swollen under the arm/(kind of swollen)/it continued to get worse) and BREAST SWELLING (swollen into the breast area (on left side)/it continued to get worse) had not resolved and JOINT SWELLING (swelling in knees/it is in ankles), SWELLING (swelling on my back), PAIN IN EXTREMITY (arm was really painful (left) and kind of throbbing), PERIPHERAL SWELLING (knuckles on her hand are swollen, and it is in hands) and MYALGIA (extreme body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs included Sulfodene.