chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. The nurse reported that on an unspecified date, unspecified number of patients were vaccinated with improperly stored RECOMBIVAX HB injection (lot # L001626, expiry date: 06-OCT-2016) (dose, strength and route were not reported). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recv vax on 3/24/98; on same day pt exp severe arm pain.  Pt was unable to move arm.
The Moderna administered to the patient had an expiration date of 07/10/2022 but a Beyond Use Date of 05/07/2022.
Septic Shock Hypertensive disorder Chronic obstructive lung disease Cardiogenic shock Cardiac Arrest COVID19 Pneumonia
This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a patient of unknown age and gender. The patient's medical history and drug allergies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored ROTATEQ vial (route of administration default to oral, lot # K011952, expiration date 17-JUL-2016, dose and frequency were not reported). The patient's concomitant medication was not provided. No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
local reaction such itching after the 1st shot; local reaction such tenderness after the 1st shot; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (local reaction such itching after the 1st shot) and TENDERNESS (local reaction such tenderness after the 1st shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No medical history provided by the patient.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, MULTIVITAMIN [VITAMINS NOS] and ZINC for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 02-Apr-2021, the patient experienced PRURITUS (local reaction such itching after the 1st shot) and TENDERNESS (local reaction such tenderness after the 1st shot). On 09-Apr-2021, PRURITUS (local reaction such itching after the 1st shot) and TENDERNESS (local reaction such tenderness after the 1st shot) had resolved. Not Provided      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.   This case was linked to MOD-2021-114226 (Patient Link).
Tight swelling and heat as well as softball sized rash at injection site. As well as aching in the arm.
Loss of taste; Loss of appetite; Could not use restroom; Smells like something is burning, or oil; has a metallic taste in her mouth; dizzy; tachycardia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAROSMIA (Smells like something is burning, or oil), DYSGEUSIA (has a metallic taste in her mouth), DIZZINESS (dizzy), TACHYCARDIA (tachycardia) and AGEUSIA (Loss of taste) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cold, Blood pressure, Type 2 diabetes mellitus and Palpitations (Heart palpitations). Concomitant products included METFORMIN, LEVOTHYROXINE, AMLODIPINE BESILATE, OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL), BISOPROLOL FUMARATE and ALISKIREN for an unknown indication.    On 04-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PAROSMIA (Smells like something is burning, or oil), DYSGEUSIA (has a metallic taste in her mouth), DIZZINESS (dizzy) and TACHYCARDIA (tachycardia). On an unknown date, the patient experienced AGEUSIA (Loss of taste), DECREASED APPETITE (Loss of appetite) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not use restroom). At the time of the report, PAROSMIA (Smells like something is burning, or oil) and DYSGEUSIA (has a metallic taste in her mouth) outcome was unknown, DIZZINESS (dizzy) had not resolved and TACHYCARDIA (tachycardia), AGEUSIA (Loss of taste), DECREASED APPETITE (Loss of appetite) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not use restroom) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow up received on 27-APR-2021 and it contains significant information including concomitant medications, new events and change of event outcome. Other information updated include reporters information, patient demographics and patient medical history.
22DEC97 temp 101.5-103.7 axillary giving too little APAP-called 9AM 24DEC97 discussed dosage for weight-called mom 3PM temp 100.2 7PM 23FEB97 went to ER for T103 ax;sl elevated WBC MD advised alternating APAP & Motrin;
administered with expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-314567, MOD-2021-314793, MOD-2021-314468, MOD-2021-314545, MOD-2021-314540, MOD-2021-314570, MOD-2021-314517, MOD21-141641, MOD21-141642, MOD-2021-314555, MOD-2021-314573, MOD-2021-314805, MOD-2021-314810, MOD-2021-314573 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow-up information included no new information On 15-Sep-2021: Follow up information contains no new information.
Temperature 105 started right after injection lasted x 4 days of temp > 101 increased lethargy fatigue. Excessive tearing, nasal congestion and sore throat. Swollen glands, fussiness and moodiness.
zoster related hearing loss; zoster related hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information regarding the pt's pertinent medical history, drug reactions or allergies, and concomitant medications was provided. On or about 01-OCT-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions.At the time of the pt's vaccination, the pt relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX), and the information relayed through the pt's healthcare providers that the zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the pt to be vaccinated. On an unknown date, reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for zoster related hearing loss. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies;diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.The outcomes of the events were considered as not recovered. The reporter assessed that the events were related to the zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of zoster related hearing loss was considered to be medically significant.
Pt vaccinated with DTP developed high fevers resulting in progressive hearing impairment. Had frequent assoc rx w/local induration & swelling of injection site. elevated temp noted w/progressive deterioration of hearing abilities.
It was reported that a female patient received a Menomune A/C/Y/W-135 vaccination on 07/07/00 at 2:00 PM. Reportedly 30 hours after the injection the patient became severely nauseated, pale and developed shaking and jerking of her arms and legs, eyes were open but rolling, no loss of bladder or colon. When the patient came to she could see but not hear, could sit up but couldn't move legs. The patient experienced muscle fatigue for the rest of the day. Patient recovered from this experience and was okay the following day. From additional correspondence received on 10/10/00, the county were the vaccine was administered was provided. No further info is expected, this case is closed. *F/UP report 3/4/03: ....It was deemed necessary to amend the report by updating the adverse event coding - added Pallor, Nystagmus, Paralysis.*
her arm is very achy; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MYALGIA (her arm is very achy ) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 29-Jan-2021, the patient experienced MYALGIA (her arm is very achy ). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Jan-2021, PAIN IN EXTREMITY (Sore arm) had not resolved. At the time of the report, MYALGIA (her arm is very achy ) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Reporter did not allow further contact
This is a spontaneous report from a contactable physician via Pfizer Sales representative. This physician reported for a female patient (infant). The patient's mom reported that at 2 months in the NICU initial PREVNAR 13 vaccines were given and she had an apneic episode. She gave the 4 month vaccines separately and within 48 hours from the PREVNAR 13 administration the patient had an apneic episode at home where she turned blue. At 6 months the vaccines were given separately again and she was on an apnea monitor this time, the monitor alarmed but the patient did not turn blue within 48 hours from the PREVNAR 13 administration. Follow-up (13Dec2013): Follow-up attempts completed. No further information expected.
I received my Pfitzer shot and had my heart rate increased, my throat felt like it was swelling(not closed), my nose became stuffy, and extreme fatigue hit. I did not tell the pharmacist due to the fact I felt like I was overreacting/it was in my head. I ended up being just feeling fine after getting home and taking a long nap.
red, swollen outer lt (upper) 15 x 13cm palpable axillary, lymph nodes;tx w/ATB for poss cellulitis-allerg component ? dad reports pt recovered 24APR96
presented @ 3dasy w/ 2day hx inc red & swelling 6x7cm of inj site;hard, warm, red;
fatigue, headache, cough, sore, tired, chills, heart fluttering strong heartbeat
got the flu every time; Initial information was received on 18-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves adult male patient who experienced got the flu every time (influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got the flu every time (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  It was reported "My dad got the flu shot for 20 years got the flu every time ten years he didn't hasn't got it sense."  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case'
Tinnitus (ring in ears) for 5+ days. Initially Moderate and persisting over time.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 15-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017. This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Addition information has been requested.
On April 15, 2021, stiffness in my right shoulder, it has gotten worse over time, until recently they put me on prednisone. It spread to all my joints, wrist, knees, fingers, hips, elbows, shoulders it took a couple of months to spread that far. On 08/01/2021, Dr. diagnosed it as polymyalgia rheumatica. He referred me to a rheumatologist. I have an appointment 09/15/2021 to see the rheumatologist. I am doing well with the Prednisone. I mainly still have pain in my wrist and fingers, but I am doing better than I was.
No adverse event; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On 02-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 an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On 20-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as Solution for injection in pre-filled pen. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-619780.   Reporter did not allow further contact
throat pain and chest tightness that began shortly after 2nd covid vaccine; sx started 5 minutes after vaccine administered.  Given 50mg of IM Benadryl in office but O2 sat was still 89%.  Clinic called EMS to transport pt to ER.  Upon arrival to ER, patient discovered she was pregnant.  She presented with sore throat and feeling of pressure and palpitations but denied any chest pain, lightheadedness, etc to ER physician. Pt was released home.
More than 3 months away from first dose and now scheduling the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 3 months away from first dose and now scheduling the second dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 3 months away from first dose and now scheduling the second dose). On 15-Jul-2021, PRODUCT DOSE OMISSION ISSUE (More than 3 months away from first dose and now scheduling the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported.  No treatment information provided.   This case was linked to MOD-2021-257992 (Parent-Child Link).   See case MOD-2021-257992 for details regarding the child case.
Eye disorder; Injection site rash; Nasal stuffiness; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal stuffiness), EYE DISORDER (Eye disorder) and INJECTION SITE RASH (Injection site rash) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form. and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. In November 2021, the patient experienced NASAL CONGESTION (Nasal stuffiness). On an unknown date, the patient experienced EYE DISORDER (Eye disorder) and INJECTION SITE RASH (Injection site rash). At the time of the report, NASAL CONGESTION (Nasal stuffiness) and INJECTION SITE RASH (Injection site rash) had not resolved and EYE DISORDER (Eye disorder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2022: live follow up received suspect drug Humira drug details updated and new event Injection site rash added On 21-Jun-2022: live follow up received new event eye disorder added
Patient called and states she has had arm pain since receiving infuenza shot 10/16/2008.  Has seen MD X2.  Was put on NSAIDS TID X 1 week w/ no relief. Is now on steroids.  States pain comes and goes and is a burning feeling.
a fever 99.6; severe lower back pain; she can hardly move/she can hardly sit; very hard to get comfortable; a very intense pain; caller received 2nd dose on 03Apr2021 (1st dose was on 30Jan2021); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller received 2nd dose on 03Apr2021 (1st dose was on 30Jan2021)), PYREXIA (a fever 99.6), BACK PAIN (severe lower back pain), HYPOKINESIA (she can hardly move/she can hardly sit) and MALAISE (very hard to get comfortable) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller received 2nd dose on 03Apr2021 (1st dose was on 30Jan2021)). On 05-Apr-2021, the patient experienced PYREXIA (a fever 99.6), BACK PAIN (severe lower back pain), HYPOKINESIA (she can hardly move/she can hardly sit), MALAISE (very hard to get comfortable) and PAIN (a very intense pain). On 06-Apr-2021, PYREXIA (a fever 99.6) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller received 2nd dose on 03Apr2021 (1st dose was on 30Jan2021)), BACK PAIN (severe lower back pain), HYPOKINESIA (she can hardly move/she can hardly sit), MALAISE (very hard to get comfortable) and PAIN (a very intense pain) outcome was unknown.            Concomitants: Levothyroxine 88 mcg, Venlafaxine, Pravastatin 20 mg Treatment Pain medicine. Ibuprofen.   This case was linked to US-MODERNATX, INC.-MOD-2021-071215 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071215:
Fever for 2 days following vaccine. Soreness, redness around vaccine site for at least 4 days.
Immunization administered at left deltoid on afternoon of 6/18/07, within 2 hours, began to have redness and swelling at injection site. Arm was painful down arm from site, into neck, and left hip. By 6/21, left arm pain, redness and swelling got worse, moving arm was increasingly painful - arm felt tight. "knot" formed on arm at site at time of injection. Alternating ice and heat to arm did not decreased symptoms. Saturday 6/23, site oozed pus-looking fluid drained from site when scratched. On Monday, 6/25, symptoms unchanged. NSAIDS did not decrease pain. 6/27, knot on arm persists, arm is painful to touch. Continues to have pain in left arm, neck and back.
No adverse event, but vaccine was found to be expired. Removed from freezer on 7.20.2021 expired  on 8.20.2021 and given on 8.24.2021.
muscle aches, heacache 5 hr after shot. lasted 36 hours.  legs felt paralyzed.