chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concomitant products included SUMATRIPTAN, BUPROPION HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE (CONTRAVE), IRON, VITAMIN C [ASCORBIC ACID], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. In May 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            No medical history information was reported. On 02 Jun 2022, the patient had rebound infection after taking Paxlovid. Patient did not receive any treatment for rebound infection. COMPANY COMMENT: This is an spontaneous case concerning an 36-year-old female patient with  medical history of Concomitant products included SUMATRIPTAN, BUPROPION HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE, IRON, VITAMIN C, VITAMIN B12, VITAMIN D for an unknown indication and PAXLOVID for COVID-19 treatment who experienced the unexpected event of COVID-19 (AESI) unknown days after  3rd dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reporting.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an 36-year-old female patient with  medical history of Concomitant products included SUMATRIPTAN, BUPROPION HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE, IRON, VITAMIN C, VITAMIN B12, VITAMIN D for an unknown indication and PAXLOVID for COVID-19 treatment who experienced the unexpected event of COVID-19 (AESI) unknown days after  3rd dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reporting.
fever, cough, SOB, muscle aches, chills, congestion, runny nose, wheezing, poor appetite, fatigue, headache and constipation
Vomited on the way home after shots given. 6/26 decreased appetite noted, irritable. vomited again the following day (6/27) large amts, with a temp of 100. loose stools noted the night of 6/27 continued irritability noted the day of 6/28 with a poor appetite, MD eval on 6/29
pt recvd vax & 15 mins later exp h/a, inc BP, swollen tongue, dry mouth, sl unsteady on feet; addtl exp SOB, vomiting, nausea;
red circle of 3.5-4 in. big; Itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (red circle of 3.5-4 in. big) and INJECTION SITE PRURITUS (Itchy at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Blood pressure medicine for Blood pressure.    On 01-Feb-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 ERYTHEMA (red circle of 3.5-4 in. big) and INJECTION SITE PRURITUS (Itchy at injection site). At the time of the report, INJECTION SITE ERYTHEMA (red circle of 3.5-4 in. big) and INJECTION SITE PRURITUS (Itchy at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: Patient used cold pack Patient mentioned it was not as red as before may be its going away
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 06-APR-2017 and 01-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M016193, expiration date 24-APR-2018, intramuscularly (dose was not reported) in immunization series. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 34.5 degrees Fahrenheit for 1 hour and 53 minutes and of 34.7 degrees Fahrenheit for 1 hour and 25 minutes. There were no previous temperature excursions reported. A Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007705: US-009507513-1705USA007706: US-009507513-1705USA007708: US-009507513-1705USA007709: US-009507513-1705USA007710: US-009507513-1705USA007711: US-009507513-1705USA007712: US-009507513-1705USA000781.
Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 42 years old female patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE (batch number, expiry date, route and site of administration were unknown). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to inappropriate age at vaccine administration and overdose. It was reported that a 42 years old female patient received FLUZONE HD. It was unknown whether patient experienced any adverse reaction after the vaccination. 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. Documents held by sender: none.
I had a sore arm for a couple of days after the vaccine. I was 7 months pregnant at the time of the vaccine and I was due in June. I had to go to the emergency room on 08/08/2022 because I woke up with left side paralysis on my face.  At the emergency room they ordered blood work, tested for COVID-19, checked if I was having a stroke and checked if I had any feeling or moved in the left side of my face. I had difficulty closing my left eye and my smile was not correct. I was prescribed an antiviral medicine and a steroid and sent home. As of today, I am improving with closing my eye but it's still not correct.
Client passed away on 2/4/2020 at 0832 AM. Cause of death states hypoxia, respiratory failure, cardiac arrest and influenza. Unknown if the vaccines were linked to death in anyway. Reported due to close timing the vaccines were administered  to death.
Patient presented with fever and decrease activity. She was found to have pleocytosis in CSF and is being currently treated for meningitis. Today is Hospital day #2.
The patient developed 20 pox lesions on various body parts. The patient was afebrile. Follow up on 12/14/2001: "Transferred from our practice to another practice."
Info has been received from an RN concerning a 5 year old white male pt who "over the last three weeks", in approximately February, 2006, was vaccinated with a dose of MMRII (lot 644753/1231M). It was reported that the vaccine was expired. Unspecified medical attention was sought. There was no product quality complaint involved. It was also reported that on 9/25/00, the pt had been vaccinated with Prevnar and varicella virus vaccine live. It was reported that on 4/23/05, the pt developed a rash on his back, belly and under area. On 4/25/05, the pt was seen in the physician's office. It was reported that "more keep coming out very itchy". The events were reported as non-serious. The pt was started on therapy with acyclovir. At the time of this report, the pt had recovered. Additional info is not expected.
pt recv vax 10FEB99 & devel temp several hr later; prior to 12FEB99  office visit was 102.3 that AM; poor feeding & irritable;fever went acutely high on 12FEB99 106.9 R;
About ten days after, I noticed a rash on my lower left torso. I went to doctor and she diagnosed me with pityriasis rosea, and prescribed Prednisone 10mg tablet and Triamcinolone 0.1%  for 10 days. It cleared up before I reached the 10 days.
Vaccine that became too warm. Vaccine was administered on once occasion stated by the nurse; No PQC or additional AE reported; Information has been received from a nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA) injection, for prophylaxis, lot number S032055 with expiration date in 09-NOV-2020 (dose, route of administration, strength and anatomical location were not reported), that became too warm.  On 08-JUN-2020, the hepatitis a vaccine, inactivated (VAQTA) was stored at a temperature of 14.32 degrees Celsius (°C) and on an unknown date in July 2020 at 8.9 (°C) for the time frame cumulative of 2 hours and 18 minutes. There was no previous temperature excursion and the call was because of a data logger.   No additional adverse effects reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S032055; expirationdate: 09-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Presented with right arm redness and swelling.  Ultrasound evaluation reveal DVT.  Underwent heparinization and thrombolysis.  Underwent post thrombolysis venogram.   Patient is a 15 year old previously healthy female with unprovoked thrombosis located in right upper extremity, per the Admission Note specifically at the right distal subclavian through axillary vein as well as a DVT in the basilic and proximal brachial vein. Associated symptom was sensation of pressure on right arm "like blood pressure" cuff. Duration as of admission of these symptoms and presumably underlying clot was three days with onset of these symptoms was Sunday 7/18/2021. Timing was cyclical with discomfort in the arm worse in the morning than in the evening. Context of this thrombosis was healthy female who does not smoke, does not use hormonal contraception, is not active in sports where upper body workouts are emphasized, and was not injured.
Started to feel warm during Christmas Eve activities.  Checked temp at 7 pm - was 102.  Took Tylenol.  Went to crawl into bed noticed chills, body aches and the COVID headache.  Slept for 13 hours.  Woke up next morning, feeling good, except for injection site.  Injection site was warm to the touch, swollen and red.  Could see that it was swollen outside of my long sleeved shirt as well as feel the heat.  It was very sore and at times itched.  By the evening of 12/25 the redness was 3" by 3".  Had been taking Tylenol and icing it every couple of hours.  On 12/26, the redness spread to 3" by 3 1/2".  Did not seem to be as warm, so just continued to monitor.
Patient received duplicate High dose flu vaccine on 10/7/2021 and 10/20/2021.  Patient has also received duplicate COVID vaccines.  He completed the Pfizer series( 1/20/21 and 2/10/21), Moderna series (2/26/21 and 3/26/21)  and received a Pfizer booster (10/13/21).
"Nausea, fever, vertigo, then patient passed out and went to hospital." Stated by patient. She had to stay at the hospital for at least 1 night.
face and neck turned bright red with a rash,  body started shaking  felt wobbly or off center.  Treated with Benadryl.. Next day worse shakes feel lame with knee pain and joint pain.  Severe arm pain.  on third day still shaking brain for and joint pain
pt recvd vax; pain in lt arm extending down lt side of body; onset 4days p/ vax;tx w/ analgesics; 17may94 f/u:lower back pain & HA w/ fever; recovered;
This spontaneous report as received from a registered nurse concerning unspecified number of patients of unknown age who on an unknown date were vaccinated with COMVAX (doses, routes and Lot numbers not provided) that were exposed to 28F for an unknown period of time. No adverse symptoms were reported. Additional information has been requested.
Coughed 5 different times; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced coughed 5 different times on 23Jun2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Headache; I got small fever like 99.9; Muscle pain; Feeling unwell; Difficult breathing just a little bit just like a cough a little small cough; Difficult breathing just a little bit just like a cough a little small cough; Dizziness; Cold; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization. Medical history included diabetes, high blood pressure, and cholesterol. Concomitant medications included diabetes medication, medications for high blood pressure and for cholesterol. The patient stated that he got the Pfizer vaccine on Christmas eve that would be the 24th and today (30Dec2020) he was getting just small things like headache, fever (small fever like 99.9), muscle pain, feeling unwell, difficult breathing just a little bit just like a cough a little small cough, dizziness, and probably just a cold. There was no injection swelling, fast heartbeat, and rash. He doesn't know if he should go get tested for COVID or not because he just took the shot. The patient stated that he got to get the next dose of the vaccine on the 14th of January. The outcome of the events was unknown.
Severe headache; Fever/Low grade fever temp of 101 F; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache) and PYREXIA (Fever/Low grade fever temp of 101 F) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. J45) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Severe headache) and PYREXIA (Fever/Low grade fever temp of 101 F). At the time of the report, HEADACHE (Severe headache) and PYREXIA (Fever/Low grade fever temp of 101 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101 (High) low grade fever down to temp of 101 Fahrenheit.         No concomitant medications were reported No treatment information was provided   This case was linked to MOD-2022-436134 (Patient Link).
This case was reported by a consumer via call center representative and described the occurrence of headache in a71-year-old female patient who received SHINGRIX. Concomitant products included LIPITOR. On 1st may 2018, the patient received SHINGRIX. On 1st May 2018, several hours after receiving SHINGRIX, the patient experienced headache, muscle pain and chills. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the muscle pain and chills were unknown. The reporter considered the headache, muscle pain and chills to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the morning. On the same day, the patient started to experience adverse events in the evening. The patient denied permission to contact their physician. Some questions were not asked because someone came at the door during the call, and the patient ended the call.
Site: Pain at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Patient stated that they had pain with the arm where they got the vaccine. He said it was a 9 out of 10 initially but had reduced in intensity since then. He does not have a regular Dr that he sees. He had not taken any pain reliever since getting the vaccine. He was advised to start that to see if it helps.
Nurse administered frozen vaccine; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number C43KM, expiry date 10th April 2023) for prophylaxis.   In March 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: The nurse administered frozen Shingrix vaccine to the patient within 7th March 2022 to 31st March 2022. The healthcare professional provided consent to follow up. Information within adverse event report was all the healthcare professional provided at this time. Additional Supportive Information: The patient received frozen Shingrix vaccine which led incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061864:Same reporter. US-GLAXOSMITHKLINE-US2022061860:Same reporter. US-GLAXOSMITHKLINE-US2022061866:Same reporter. US-GLAXOSMITHKLINE-US2022061868:Same reporter. US-GLAXOSMITHKLINE-US2022061870:Same reporter. US-GLAXOSMITHKLINE-US2022061871:Same reporter. US-GLAXOSMITHKLINE-US2022061872:Same reporter. US-GLAXOSMITHKLINE-US2022061873:Same reporter. US-GLAXOSMITHKLINE-US2022061874:Same reporter. US-GLAXOSMITHKLINE-US2022061875:Same reporter.
Right hand swelled up, looked like a mitten; Fatigue; Nausea; Sore arm,achy all over,serious body aches; Cramping,muscle cramps in both hands; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramping,muscle cramps in both hands), PERIPHERAL SWELLING (Right hand swelled up, looked like a mitten), MYALGIA (Sore arm,achy all over,serious body aches), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A, 025A21A and 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sjogren's, Rheumatoid arthritis and Fibromyalgia. Concomitant products included CODEINE, TRAZODONE, ONDANSETRON HYDROCHLORIDE (ZOFRAN [ONDANSETRON HYDROCHLORIDE]), WARFARIN, CEVIMELINE HYDROCHLORIDE (EVOXAC), ALBUTEROL SULFATE, METOPROLOL, LIDOCAINE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), PREDNISONE, TORASEMIDE (TORSEMIDE), GABAPENTIN, LATANOPROST, ATORVASTATIN CALCIUM (LIPITOR), PANTOPRAZOLE, PROBIOTICS NOS, ERGOCALCIFEROL (VITAMIN D2), CALCIUM and ZOLMITRIPTAN (ZOMIG) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced MUSCLE SPASMS (Cramping,muscle cramps in both hands) and MYALGIA (Sore arm,achy all over,serious body aches). On an unknown date, the patient experienced PERIPHERAL SWELLING (Right hand swelled up, looked like a mitten), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, MUSCLE SPASMS (Cramping,muscle cramps in both hands), MYALGIA (Sore arm,achy all over,serious body aches), FATIGUE (Fatigue) and NAUSEA (Nausea) had not resolved and PERIPHERAL SWELLING (Right hand swelled up, looked like a mitten) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported by patient.  Patient reported that she was still experiencing symptoms, but hand was not as swollen.
Caller reported that a patient received PROQUAD that had undergone temperature excursion before calling the news station/Temperature: -14.0C for 5 minutes and 50 seconds and -14.1C for 5 minutes, Time frame: 10 minutes and 50 seconds; No additional AE reported; This spontaneous report was received from a nurse and refers to a 5-year-old at the reporting time, female patient. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On an unknown date, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) product quantity: 1, lot #: U002532, expiration date: 24-JUL-2022 (exact dose, strength, site and route of administration were not provided) for prophylaxis, that had undergone temperature excursion (product storage error) "before calling the news station". Temperature excursion information: -14 degree Celsius for 5 minutes and 50 seconds and -14.1 degree Celsius for 5 minutes; previous temperature excursion: yes. There was no additional adverse event reported.
Facial and eye edema on 11/29/05.  She went to the ER.  Benadryl 2 tabs. and Zyrtec daily for 14 days.  No itching or shortness of breath.
Patient received first vaccine on 6/26/21 and second dose 7/5/2021 , 9 days apart. We can't reach the patient to see if he had any adverse reactions
No additional AE reported; one dose of PEDVAX HB was administered to patient after temperature excursion; This spontaneous report was received from a physician and refers to a 2-months-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.    On an unspecified date, improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (Lot No. S031500 has been verified to be a valid lot number expiration date reported as 20-APR-2022, but upon internal validation established as 21-APR-2022), experienced an intermittent temperature excursion of 1.3 degree Celsius (C) for a period of 4 hours and 30 minutes with a previous temperature excursion of 1.13 degree Celsius (C) for a period of 3 hours. The excursion was called by a digital data logger.  On 09-SEP-2020, the patient was vaccinated with an improperly stored dose of of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, frequency and route of administration not provided) (Lot No. S031500 has been verified to be a valid lot number expiration date reported as 20-APR-2022, but upon internal validation established as 21-APR-2022), as prophylaxis. The patient did not experience any adverse event.