chrisvoncsefalvay/vaers-outcomes huggingface dataset:
child was nauseous; vomiting; had diarrhea; This case was reported by a nurse via sales rep and described the occurrence of nausea in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th April 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 27th April 2021, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced nausea, vomiting and diarrhea. On an unknown date, the outcome of the nausea, vomiting and diarrhea were unknown.   The reporter considered the nausea, vomiting and diarrhea to be unlikely related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by a Registered Nurse on behalf of patient. The patient received 1st dose of Bexsero a day before reporting and on the same day evening, experienced nausea, vomiting and diarrhea.  The reporter did not believe that the patient's symptoms were related because they had around 40 calls recently of patients having diarrhea.   The reporter also stated that it was unknown if the child has had the COVID vaccine. The reporter consented to follow up.
With 2nd dose experienced fever; chills; headache; diarrhea; nausea; This is a spontaneous report from contactable consumer (patient). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and batch no: not reported/lot number: EP6955) via an unspecified route of administration, in left arm on 30Mar2021 10:30 AM as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included as patient received her first dose of bnt162b2 (PFIZER-BIONTECH covid-19 vaccine, formulation: solution for injection, batch no: not reported/lot number: EL3247) via an unspecified route of administration, in left arm on 09Mar2021 10:30 AM as dose 1, single for covid-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination, the patient has not been tested for covid-19. On 31Mar2021 02:00 AM, patient experienced fever, chills, headache, diarrhea and nausea. Outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
No adverse event; Patient received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25ml instead of 0.5ml of Bivalent Booster) 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. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.  In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received 0.25ml instead of 0.5ml of Bivalent Booster).    No concomitant medications were reported.  The patient received booster in the end of Aug to middle of Oct-2022.     No treatment medications were reported.  This case contains information for the 12th of 20th patient described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662860, US-MODERNATX, INC.-MOD-2022-662881, US-MODERNATX, INC.-MOD-2022-663016, US-MODERNATX, INC.-MOD-2022-663014 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662871:Patient 12 US-MODERNATX, INC.-MOD-2022-663016:Patient 12 US-MODERNATX, INC.-MOD-2022-662860: US-MODERNATX, INC.-MOD-2022-662881:Patient 12 US-MODERNATX, INC.-MOD-2022-663014:
Information has been received from a physician and a 64 year old retired white male with coronary artery disease, psoriasis, hypercholesterolemia, arthritis, uses tobacco and alcohol and has no allergies who in 1994 and on 05/03/04 at 13:20 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine (Lot # 647797/0987N). There was no illness at the time of vaccination. Concomitant therapy included losartan potassium 50mg per mouth daily, simvastatin 80mg per mouth daily, Zantac 150 mg per mouth daily, aspirin 81mg per mouth daily, Allegra 180mg per mouth daily, Ativan 0.5mg per mouth daily, cyanocobalamin 1000mg per mouth daily, methotrexate 10mg every Wednesday, ezetimibe 10mg per mouth daily, pyridoxine 100mg per mouth daily, ferrous SO4 300mg per mouth daily, folic acid 5mg per mouth daily, nitroglycerin 0.4mg per mouth as needed, montelukast sodium 10mg per mouth daily, ascorbic acid 500mg per mouth daily, vitamin E 400 units per mouth daily, multivitamins one per mouth daily and calcium (unspecified) one per mouth daily. On 05/03/04 the pt developed swelling and pain at the injection site, elevated blood pressure of 200/100 and 220/120, headaches, stomach upset, pain in right flank (kidney), body aches, muscle aches, joint aches, nausea, throat tightness and dizziness. AT 1700 that day the pt was seen in his physician's office. He stayed in the office until his blood pressure went back down to 180/90. He also reported that he was given Benadryl and another antihistamine. Unspecified lab tests showed no significant abnormalities. On 05/17/04 the pt reported that the headaches, body, muscle, and joint aches and nausea continued. On 05/19/04 the pt recovered. It was noted that the pt had no adverse events following prior vaccinations. No product quality complaint was involved. No further information is expected.
very dizzied; headache; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 72-years-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 16Jan2021 11:30 as first dose, single dose for COVID-19 immunization. Medical history included Cholesterol, blood Irregular heartbeat and acid reflux (all ongoing). Concomitant medications included ezetimibe (ZETIA) taking for Cholesterol since 5 years and ongoing, amlodipine besilate (NORVAS) taking for blood pressure since 5 years and ongoing; omeprazole (PROTONIX [OMEPRAZOLE]) taking 2 twice a day for acid reflux since 8 years and ongoing and metoprolol succinate (TOPROL XL) taking 2 twice a day for Irregular heartbeat since 5 years and ongoing. On 16Jan2021, the patient experienced very dizzied and headache. Outcome of the events was unknown (stop in 30 minutes, as reported).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The patient who is 4 months old was administered the first dose of ROTATEQ / beyond 12 weeks of age; No adverse effects reported; This spontaneous report was received from a registered nurse referring to a 4 month-old-patient of unknown gender. Patient's pertinent historical and current conditions, historical and concomitant medications, previous drugs reactions or allergies were not provided.  On 08-NOV-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) first dose, 2 milliliter, for prophylaxis (lot number S000954 has been verified to be a valid lot number, upon internal validation the expiration date was established as 17-OCT-2020). According with the reporter, the patient was vaccinated beyond the 12 weeks of age (product administered to patient of inappropriate age), no adverse effect was reported.
Vaccine reaction after receiving meningitis and PPV23. 4 inch diameter in upper left arm with fever x 1 day after vaccine.
RN  is helping to enter from mass immunization event on 11/12/21  and realizes vaccine error.   This patient received a Janssen vaccine on 4/10/2021 and then a Pfizer booster on 10/22/2021. Patient put on on their sheet that they have previously received a dose of Pfizer but did not mention the previous Janssen so it was marked that this was his second dose of Pfizer. Extra dose given in error. Patient had no adverse reactions to the vaccine. This is being done to report the extra dose that was given.
His COVID is likely incidental as he is not requiring oxygen at this time and the pneumomediastinum is likely secondary to coughing from this. Rest of plan as
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 10:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 10:57 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the fridge on 09-Mar-2021, moved to the clinic on 20-Mar-2021 and proposed beyond use date was 08-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and at 10:00 A.M., the temperature recorded was 30 degree Fahrenheit that has been reached by the vial.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
A Women (Age 25 Moderna) Myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (A Women (Age 25 Moderna) Myocarditis) in a 25-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (A Women (Age 25 Moderna) Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (A Women (Age 25 Moderna) Myocarditis) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not reported.  Company comment:  This is a spontaneous case concerning a 25-year-old, female patient with no reported medical history, who experienced the expected serious (medically significant) event of Myocarditis after the administration of an unknown dose of mRNA-1273 vaccine. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-739860 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739860:Same reporter
LPN called AID - Guest reported itchiness in her throat, and was losing her Train of Thought in and out. Offered some water and she was checked out by the attending Medics. Patient felt fine and Left facility. She declined increased observation.
Administered vaccine to RD at 0830; at 0845, pt began c/o dizziness; BP 112/87, AP 71, R 16; skin W and D; pt stated BP normally decreased - systolic runs 98-100; dizziness cont to increase; BP taken 0850-122/90, AP 16, R-12 nonlabored; pt. began c/o headache and eyes burning; nausea; skin remained warm and dry; no flushing noted.
Approximately 5 minutes after receiving  vaccination patient reported feeling tightness on the left side of her jaw, then it spread to back of neck and up the face to below her eye. Patient reported no difficulty breathing and no movement issues (no drooping in face or arms), reported it felt like her lymph node was swelling when she palpated the area, reported she felt like her face was puffy. Patient declined ice pack, emergency services. Patient waited in pharmacy area and was observed for 30 minutes, then decided she wanted to get up and walk around. Patient reported her left foot felt numb upon standing up but that she has experienced that before with her herniated disc. Patient again declined emergency services. Patient reported pain in lymph node improved but still felt tightness in jaw, face, and neck. Patient chose to walk around store for a little bit, then returned to pharmacy to inform pharmacist she felt okay and wanted  to leave.
Pt developed large lump at vaccination site. Also developed redness and swelling. Vaccination site is painful to touch, also warm to touch.
No additional AE; 13 year old patient was accidently administered PROQUAD; This spontaneous report was received from a medical assistant referring to a 13-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 28-OCT-2022, the patient was vaccinated accidently with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliters once (lot #W007747, with an expiration date on 04-SEP-2023), administered for prophylaxis (strength, and route of administration were not provided) (product administered to patient of inappropriate age).  No additional adverse events were reported.
Chest pain, shortness of breath 1/20 Pulmonary embolisms 1/22 ER, 1/23-1/24 hospital stay, on eliquis
Presented to the ER on 8/14/13 with symptoms of bloating and crying/pain - diagnosed with intussusception. Treatment included a barium enema - resolved, and had f/u with Gen. Surgery on 8/29/13.
Second dose Moderna vaccination side effects I experienced are: 1. Fever 100.7 F -48 hours 2. A fast Heartbeat -5 hours  3. Dizziness -36 hours 4. Weakness- exhaustion -48 hours 5. Myalgia + athralgia - 48 hours
Patient began to notice her arm was extremely heavy, red, and swollen approx. 27 hours after the vaccination.  Ice and Ibuprofen were used to control the swelling and discomfort.
After receiving both doses of Moderna COVID vaccine in January 2021 and February 2021, my mother started becoming ill. Previous to this she was active, could drive, go to the store, the hair salon and family functions. She started not feeling well in March 2021 and May 2021. In July 2021 she was admitted to the hospital for 3 days having trouble breathing. August 2021 she was admitted again for 5 days with the same breathing issues. She was released and taken to the Emergency room again within 36 hours. She was admitted to hospital for 3 days and released to a nursing home August 25,2021. Her prognosis is not good and she will probably die soon. These COVID shots have seriously injured my mother.
I woke up the next day with a severe twitch in my right eye and had trouble speaking and getting words out.  The eye twitch lasted for 3 months and I am currently still have slight speech impairment.   I am basically waiting it out and seeing if it will improve.
Severe  myalgia, muscle cramp, headache, chills and fatigue.  Progressively worse. Severe restriction of rom in both arms. Right in particular. Unable to sleep 2/2 pain.
Pain immediately after, joint aching/pain from time of injection to present, unable to lift up all the way, unable to sleep on (L) side or hold my 2 year old with (L) arm, pain is at worst with lifting arm/turning to look at watch. I was in standing position when vaccine was given. When medication was pushed, burning sensation was much more than when I have had previous flu shots in past years. I have had pain in joint same day of administration and have noticed limited ability to raise my left arm. Pain worse when I sleep on (L) side or raise my arm and turn wrist as in when I look at my watch.
Initially reactive left axillary lymph node x 1 week then resolved, followed by diffuse urticaria to extremities, then torso, then neck, head and face. Angioedema. Itchy throat. Lip swelling. Symptoms persisted over the course of a week despite steroids, antihistamines and H2 blockers, in addition to multiple doses of epinephrine.
soreness; Nausea; fever; rash on arms, and back; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (soreness), NAUSEA (Nausea), PYREXIA (fever), RASH (rash on arms, and back) and VOMITING (Vomiting) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced ARTHRALGIA (soreness), NAUSEA (Nausea), PYREXIA (fever), RASH (rash on arms, and back) and VOMITING (Vomiting). At the time of the report, ARTHRALGIA (soreness), NAUSEA (Nausea), PYREXIA (fever), RASH (rash on arms, and back) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment was reported as Tylenol, wet towels and diclofenac.
2 days after receiving my first covid vaccine dose, I developed a knot on my right hand  and inch above my wrist. It is 11/10 and the knot has yet to go away.  Now I'm feeling slight hints of pain in the hand.
soreness in left arm; This is a spontaneous report from a non-contactable consumer, the patient. A 49-years-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 10Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation and 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 31Mar2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any concomitant medications. The patient did not have known allergies to food, medication or other product. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021, the patient experienced soreness in left arm with the first shot and it was reported that second shot resulted in much more soreness. The patient did not receive any treatment for the event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event soreness in left arm was not resolved at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccine Facility Information added.
1240 S/p vaccination reports complaints of SOB, tightness in chest; medical monitoring and after 10 minutes reports "feels better" with no additional complaints or incidence Vitals assessed BP 165/90 HR 78  O2 sat 98% RA; 1248 BP 130/76 HR 59 O2 sat 99% RA Released from facility w/husband
This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In 2013, the patient was inoculated with ZOSTAVAX (dose, route, and lot # were not provided) by a physician for routine adult health maintenance and for the long-term prevention. It was mentioned that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2013, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. At the time of the report, the outcome of the aforementioned adverse events was unknown. The relatedness assessment between the aforementioned adverse events and ZOSTAVAX was related.
On May 31, 2022 there was an Excursion that the temp went to 34.9 degrees F for 49 minutes. Then on June 12-13, 2022 the temp went to 34.9 degrees F for 6.5 hours. The Polio was in both of the Excursions and should have been thrown out.  Do we need to revaccinate the child?