chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant concerning an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of GARDASIL (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The medical assistant reported that unspecified patients received improperly stored GARDASIL exposed to 49F for 35 minutes on an unknown date. No adverse effects were reported. This is one (1) of four (4) reports from the same source (MARRS 1408USA016198, 1409USA006389, 1409USA00638 and 1409USA006390). Additional information has been requested.
Patient was inadvertently given a Fluad vaccine instead of a Fluarix vaccine. Patient was informed of administration error and informed to monitor for side effects.
Mother called following day - claim pt could not straighten legs. Pt able to bear wt & move ft. No signs of infection, redness, streak, swell or drainage - advised to apply cool compress, acetamin q4h to call back if worsens.
Stomach upset; Period cramps; Bloating; Gas; Diarrhea (She goes to the bathroom 3-4 times a day); Muscle cramps; Headache; Fatigue; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), DYSMENORRHOEA (Period cramps), ABDOMINAL DISTENSION (Bloating), FLATULENCE (Gas) and DIARRHOEA (Diarrhea (She goes to the bathroom 3-4 times a day)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B26A and L031321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), DYSMENORRHOEA (Period cramps), ABDOMINAL DISTENSION (Bloating), FLATULENCE (Gas), DIARRHOEA (Diarrhea (She goes to the bathroom 3-4 times a day)), MUSCLE SPASMS (Muscle cramps), HEADACHE (Headache), FATIGUE (Fatigue) and LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset), DYSMENORRHOEA (Period cramps), ABDOMINAL DISTENSION (Bloating), FLATULENCE (Gas), DIARRHOEA (Diarrhea (She goes to the bathroom 3-4 times a day)), MUSCLE SPASMS (Muscle cramps), HEADACHE (Headache), FATIGUE (Fatigue) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.            No concomitant medications were reported.   This case was linked to MOD-2021-142570 (Patient Link).
Small intestines constricted mimicking pancreatitis / small partial bowel obstruction. Blood test ruled out pancreatitis. CT scan showed constriction/ causing obstruction. Morphine relaxed bowel and no more issues were there. They had engaged the on call surgeon, but he didn't examine till following day and he only put stethoscope to the chest in two places and released me/patient, suggesting no cause for pain other than vaccine. The on call doctor did a very thorough exam and talked to surgeon before he saw me/patient. There are no lasting effects. The small bowel didn't even hurt when examined the following morning.
Headache, Fever, NauseaVomiting, injection site soreness and swselling, fatigue, chills, acid reflux Narrative:
has been having headaches since that have not gone away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Oct2021, outcome "not recovered", described as "has been having headaches since that have not gone away". Additional information: Caller stated she was calling about the Pfizer Vaccine and had some questions about it; stated  she had the 1st vaccine last Thursday and had been having headaches since that had not gone away and wanted to ask if this was normal or at this point should she wait longer to go to the doctor or what to expect. Caller stated it had been a week and other than the headache she was fine and never really suffered from headaches so was pretty sure it was the vaccine and just wanted to see if this was normal; caller declined to complete the report. Since the vaccine dose she has had a headache everyday, back of head. How long will this last. She read it usually lasts for no more than 3 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was 12 years old at time of vaccination and should have received adult dose Pfizer.  Patient instead was dosed with pediatric dose.
This spontaneous case was reported by a physician and describes the occurrence of SWELLING (had some swelling, slight, size between a quarter and half a dollar), URTICARIA (had some hives in it), PRURITUS (it itched), PARAESTHESIA ORAL (internal mouth sensations, tingling) and ORAL DISCOMFORT (an unusual feeling inside her mouth) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation, ALLOPURINOL for Gout, LOSARTAN, METOPROLOL and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced SWELLING (had some swelling, slight, size between a quarter and half a dollar), URTICARIA (had some hives in it) and PRURITUS (it itched). On an unknown date, the patient experienced PARAESTHESIA ORAL (internal mouth sensations, tingling) and ORAL DISCOMFORT (an unusual feeling inside her mouth). On 07-Apr-2021, SWELLING (had some swelling, slight, size between a quarter and half a dollar), URTICARIA (had some hives in it) and PRURITUS (it itched) had resolved. At the time of the report, PARAESTHESIA ORAL (internal mouth sensations, tingling) and ORAL DISCOMFORT (an unusual feeling inside her mouth) outcome was unknown. 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. Treatment : benadryl (oral)
Narrative: Patient complained of difficult breathing following administration of 1st dose of covid vaccine. Patient with history of allergy to toradol. Patient verbalized without issue but O2 sats dropping to 93. Patient was transported to outside emergency department for evaluation.
Headache, redness, soreness, itching at injection site, temperature of 101.3, (temp lasted most of day night of day after vaccine), rash on chest (lasted a day), fast heartbeat that lasted about 30 - 45 minutes - this was second shot. First shot, I had a headache, sore arm, fatigue and chest rash that lasted several days.
Patient reported feeling dizzy, anxious, rapid heart rate, slight elevation of blood pressure, mild shortness of breath. Patient requested 911 assistance. Paramedics assessed patient and after 30 minutes directed patient to hospital. Patient was not transported via ambulance. Patients Mother drove him to hospital for further assessment. I tried to contact patient 3 hours later and there was no answer. I left message to follow up.
Information has been received for the pregnancy registry for GARDASIL from a master of science in nursing concerning a 26 year old female with no pertinent medical history and allergy to erythromycin who on 24-MAR-2008 was vaccinated with the first 0.5mL dose of GARDASIL IM (Lot No. 655604/0052X) and on 19-MAY-2008 was vaccinated with the second 0.5mL dose of GARDASIL IM (Lot No. 660389/1968U). Concomitant therapy included MOTRIN and vitamins (unspecified). The patient received her first two doses of GARDASIL and is now pregnant. The patient sought medical attention, seen by the practice. The last menstrual period was on 01-JUL-2008. On an unspecified date, was performed a urine pregnancy test and a serum pregnancy test resulting positive. Estimated date of delivery approximately on 07-APR-2009. The patient has not experienced any known symptoms. Follow up information has been received from a case manager in the office, concerning a 26 year old female who on 17-FEB-2009 "lost" the baby. However, the mother is fine. The office hasn't really followed her and doesn't have much more information. Upon internal review: the patient "lost" her baby, was considered as other important medical event. No further information is available.
Patient reported soreness of arm and injection site. He indicated no fever. He stated a rash had started to develop from the site of the reaction and spread down his arms and towards his chest. Patient had taken ibuprofen for pain relief which did lessen his discomfort. He also took diphenhydramine which did not seem to help. I advised the patient follow-up with his PCP and/or go to a urgent care for follow-up.
2 days after dose 1 and dose 2 of vax, pt had enlarged lymph nodes. States able to see with naked eye and slight stiff neck. Lasted 5-7 days, no problems with sore throat or swallowing.
low platelets; rash; possible case of Dengue Fever; Initial information received on 24-Aug-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who had possible case of dengue fever after receiving vaccine TETRAVALENT (CHIMERIC) DENGUE VACCINE [DENGVAXIA].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect TETRAVALENT (CHIMERIC) DENGUE VACCINE (strength, formulation, lot number and expiry date was unknown) via intramuscular route in unknown administration site for prophylactic vaccination.  On 15-Aug-2022 the patient developed a non-serious event of possible case of dengue fever (Dengue fever). No dengue fever test was performed. Patient had fever and rash (onset date: 15-Aug-2022, Latency for 6 days with no bleeding or significant pain. Hematology report had low platelets which returned to normal on Day 8 (platelet count decreased) (onset and latency: unknown). Patient last week became ill with what patient assume was dengue fever (based on low platelets from her hematology,  she don't think an actual dengue test was performed).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: Recovered / Resolved.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 10-SEP-2008, the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, exact dose and route of administration were not reported). On 07-JAN-2009, the patient received the second dose of GARDASIL (lot #, expiration date, exact dose and route of administration were not reported). On 24-MAR-2009, the patient was vaccinated with the third dose of GARDASIL (lot #, expiration date, exact dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Pt. states that after receiving the 2nd dose of Phizer 01/10/2021, started experiencing symptoms of itchiness, rash/hives. Showing up randomly throughout the body. Self-treating with Benadryl. Primary visit 09/2021 continuing to self-treat with Benadryl. Still experiencing symptoms.
10 days after J&J booster, reactivated neuropathy in feet, random muscle and joint pains, stiffness, built in intensity to 1 week hospitalization 5/2022 for pericardial effusion, plural effusion, hyponatremia, leukocytosis, anemia, CRP 12, ANA+, resting heart rate 130, SpO2 88%, pericardial effusion resolved 7/2022 and plural effusion reduced to minimal lung restriction 7/2022.  However, increased edema in hands, feet, wrists, ankles, joint pain everywhere, stiffness everywhere, jaw swollen, can no longer kneel due to knee pain, can't get to floor to sit, can't write or perform regular household chores because hands stuck in claw position with skin scaling and cracking due to stretching from edema, shortness of breath continues, chronic fatigue, constant sharp pain (like bee stings in finger joints), pain in hands, ankles, upper arms, jaw, head.
Patient received first dose of Pfizer COVID vaccine at 9:58 am.  Due to history of cardiac arrest with flu vaccine in 2008, patient was advised to remain in observation for at least 30 minutes.  At 10:12, patient was observed to be holding her throat.  When questioned, patient stated she felt like she was having difficulty swallowing.  She also started coughing violently at this time.  At 10:13,  VS were taken with B/P of 145/105, HR 132, and O2 saturation of 98%.  Patient had a levalbuterol inhaler and Epipen in her possession, she inhaled 2 puffs at 10:15.  911 was also called at this time.   At 10:20, she was observed to be having increased difficulty breathing and severe, violent coughing.  An injection of Epinephrine was given via Epipen in her left thigh by RN at 10:20 and VS were checked again with B/P of 156/121, HR 137, and O2 saturation of 98%.  At 10:22, 12.5 ml of diphenhydramine liquid was given orally by RN.  Patient was assessed by EMS and transferred to a ED facility for further observation and treatment.
Information has been received from a 24 year old female consumer patient with no drug reactions or allergies and no pertinent medical  history who in November 2009, was vaccinated with the first dose of GARDASIL (Lot number unknown). Concomitant therapy included ORTHO TRI-CYCLEN. The caller stated that on 13-JUL-2010 she received her third and final dose of GARDASIL and about one hour after receiving the shot she felt dizzy and her hands fell asleep and felt tingly. She noticed this in both extremities, as the opposed to just the left arm which she received the shot in. She called the doctor again and was told to take ibuprofen three times a day and call again on Monday 19-JUL-2010 if her side effects did not diminish. The caller stated that she no problems whatsoever with the previous two shots. There was no laboratory tests performed. At the time of the report, the consumer had not recovered from dizzy and tingling in her hands. The patient sought unspecified medical attention. Follow up information has been received from the physician's office. It was reported that the patient was vaccinated IM in the left deltoid with the third dose of GARDASIL (lot number 666118/1539Y). It was reported that immediately after injection the patient experienced muscle pain and numbness in bilateral hands. At the time of the report the patient's outcome was unknown. The patient did not seek medical attention. Additional information has been requested.
Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness at injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Soreness at injection site). At the time of the report, INJECTION SITE PAIN (Soreness at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Initial pain in back of head and extreme headache. Some vomiting.  At emergency, went into coma and was intubated.  Hole drilled in skull to relieve pressure.  MRI taken.  Lot of bleeding in brain - anuerism lead to death approximately 14 hours after initial symptoms.
I had heart palpitations that woke me up, I had a pulse of 180 my blood pressure was 164/90. I had my husband take me to the emergency room so that we could have the test run to rule out a heart attack. Once there they hooked me up to an EKG, bloodwork, Thyroid TSH test, all tests came back negative. They sent me home and told me to follow up with my physician. I went to see my cardiologist who had me wear a Holter monitor for seven days. The monitor showed one palpitation on a Tuesday during the night, but it did not last as long as the one I went to the hospital for. I was not prescribed any medication. I feel like I am getting back to normal.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R II (lot# reported as L003959, expiration date: 05-FEB-2017) (dose, route of administration and injection site were not provided). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 11.8 degrees Celsius for 40 hours. Data logger was not involved. The previous excursions were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Patient was found in waiting room during 15-min observation period. Pt was diaphoretic, pale, had loss of consciousness, hypotensive. Placed patient lying down with legs in air, vitals & appearance improved. EMS was activated and per paramedic & provider's discretion d/t some abnormality on EKG, recommended that patient be further evaluated at local hospital.
got 2 blood clots in my left leg; This serious case was reported by a consumer via interactive digital media and described the occurrence of thrombosis leg in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced thrombosis leg (Verbatim: got 2 blood clots in my left leg) (serious criteria GSK medically significant).  The outcome of the thrombosis leg was not reported.   The reporter considered the thrombosis leg to be possibly related to Shingrix.     The company considered the thrombosis leg to be possibly related to Shingrix.   Additional Information: GSK Receipt date: 21-SEP-2023 This case was reported by patient via interactive digital media. The patient reported that after 1 Shingles shot, she got 2 blood clots in her left leg. Patient states that she had friends who had shingles. The pain they described sounded unbearable and she educated herself about the risks and what she could do for prevention. The reporter thought that the event might had been related to the drug. Follow up was not possible as no contact details were available.
Patient reported the day after the vaccine, he started having increase heart rate (148-160), chest pain for 2 days, ringing in ears and headache. Still having headache today. Did not seek medical attention. Reporting today due to concern and if should take the 2nd dose.
Burning, pain down the arm, could not lift arm any higher then the waist.  Pain constantly.  Lasted for 6 months.
Patient received PREVNAR 13 on 10/3/18 on Left arm and developed redness at the site of injection (Left arm). She also received flu-shot same day on right arm - No reaction occurred.
Vial initially stored in the refrigerator on 06-Dec-2022/ Caller said when they received the vaccines they were refrigerated so they put them in the refrigerator; No adverse event; Patients received vaccine after 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 06-Dec-2022/ Caller said when they received the vaccines they were refrigerated so they put them in the refrigerator) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received vaccine after 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 06-Dec-2022/ Caller said when they received the vaccines they were refrigerated so they put them in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 06-Dec-2022/ Caller said when they received the vaccines they were refrigerated so they put them in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   This case included information of 3rd patient out of 7 patients. No concomitant product reported by reporter.  It was unknown if patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. Vial initially stored in the refrigerator on 06-Dec-2022. Caller said when they received the vaccines they were refrigerated so they put them in the refrigerator. Vial size was 2.5ml.  Dates of administration of vaccine were 12-Jan-2023 for 2 patients, 16-Jan-2023 for 2 patients, 20-Jan-2023 for 1 patient, 24-Jan-2023 for 1 patient and 01-Feb-2023 for 1 patient. Vial did not undergone any temperature excursion issue.  No concomitant product reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-708306 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-708306:Master case