chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible 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. No adverse reactions were reported by patient. No treatment medications were reported.
First symptom few days after boasters was starting my period 3 days earlier and lasted 3 days longer. Endometrial Ablation previous to having the shot and then had to redo it since having the shot. Period returned and lasted longer and much more painful.
the vial was initially stored in the refrigerator  26May2022; Vaccine administered 3 days after beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 3 days after beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator  26May2022) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 vaccination.     The patient had never diagnosed or tested positive for COVID-19. It was reported that patient had no acute illness at the time of vaccination and up to one month before. No chronic or long standing health conditions were reported.     On 29-Jun-2022 at 11:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 3 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator  26May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 3 days after beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator  26May2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided.  No other vaccines were given to patient when Moderna vaccine was administered. No other vaccines were received within one month prior to any dose of Moderna Covid-19 vaccine.  On 26-May-2022 vial was initially moved to refrigerator. The vial did not undergone any temperature excursion.  No treatment medication information provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-601207 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-601207:
Pt LOC. Patient denies thinners. No deformities /head trauma noted. VSS. Patient a&ox4 upon discharge.  Pt received pfizer vaccine at 1:50 hours and discharged at 2:15. Patient stable and no complaints at discharge. Guardian- Father was present.
Fatigued; Achy muscles; Chills; A spontaneous report was received from a 35-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulted in fatigue, ache muscles, and chills.  The patient's medical history was not provided. Concomitant medications were not reported.  On 30 DEC 2020, the patient received their first of two planned doses of mRNA-1273 with unknown batch number for prophylaxis of COVID-19 infection.  On 31 DEC 2020, the patient experienced fatigue, ache muscles and chills.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of fatigue, ache muscles, and chills, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the  reported events, a causal relationship cannot be excluded.
Diarrhea, upset stomach, extreme stabbing pain on left side and pain on back, sensitive skin (burning sensation) from left waist to back, then on 10/10/15, visible rash appeared on front. Then spread over days to back. Shingles diagnosed by doctor on 10/10/15.
Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; This is a spontaneous report from a non-contactable consumer (Patient).  A 63-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732), dose 1st via an unspecified route of administration, administered in Arm Left on 01Apr2021 08:00 as single dose for covid-19 immunisation. Patient medical history and concomitant medications were not reported.  On 01Apr2021 11:15, the patient experienced Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack. The patient had other medications in two weeks of vaccination. Patient did not took any treatment for adverse event. Patient did not had covid prior vaccination and not tested for covid post vaccination. She did not have any Known allergies and had other medical history.    No follow up needed. No further information is excepted.
Patient called reporting that she has a long history of fybromyalgia and that she is usually itchy. The day after her vaccination, she was experiencing a rash between her shoulder blades from her neck to her mid-back. Patient asked if she could take her hydroxyzine 10 mg. I advised patient to take the hydroxyzine to help with itching, use hydrocortisone ointment/cream for the rash, and to keep an eye on it. If it got drastically worse, to go to urgent care or ER and if it wasn't getting better to contact PCP on Monday. (Tonight is saturday night)
After second shot very sick for three days, began to experience increased fatigue excessive sweating, increased dizziness; vison blacked out; nausea would linger; chest pressure and pain; elevated pulse; shortness of breathe; sleep was interrupted; body aches and pain. Diagnosed with ischeminia.
Approx. 4 1/2  weeks after 2nd dose:  Severe Headache,, numbness, and right side facial paralysis. DX:  Bell's Palsy. Given decadron IV, and Methylprednisolone pack.  As of this time, still has full right side facial paralysis.  I was unaware of the correlation of the vaccine and Bell's Palsy but upon further education I learned that there were several reports in the case studies, although this incident did not occur within 36 hours of the second dose, I still feel it needs to be reported.
arm pain at a 2 at rest arm pain at an 8 if try to lit it. Driving, dressing, sleeping, hair washing cause extreme discomfort
This spontaneous report was received from a registered nurse referring to a 4 month old male patient with no known drug allergies, gastrooesophageal reflux disease, autism spectrum disorder (ASD), pulmonary valve stenosis and ventricular septal defect (VSD). Concomitant therapies included ZANTAC. On 06-JAN-2017, the patient was vaccinated with a dose of ROTATEQ, oral for prophylaxis (Lot No reported as: M038728; expiration date: 25-APR-2018). The registered nurse reported that on 06-JAN-2017 the patient vomited the dose of ROTATEQ after administration. No further side effects were noted after the incident. There was no treatment given for the event. In January 2017, the patient recovered/resolved from vomiting. There was no product quality complaint involved. The primary reporter did not assess the causality between vomiting and ROTATEQ. Additional information has been requested.
Left arm shoulder pain. Limited mobility. Unable to raise arm standing upright with arm at side any further than approximately 90 degrees perpendicular to arm. Time course continuous shoulder pain and discomfort since day after administration of vaccine.
Chills at 5:00p.m 3/4/2021.lasting for about 10 minutes.         Two sessions of diarrhoea  at 7:00p.m same day;   chills at 11:00p.m. lasting for about 20 minutes.    Diarrhoea on 3/6/2021 so far for two sessions and continuous urge to go again at 6:30p.m.
STATES ON DAY 9 POST VACCINE, RT ARMM 'GOT HARD, RED & SWOLLEN (APROX. 4" TO 5" LONG).  RESOLVED AFTER 1.5 DAYS WITH 'ICE AND BENADRYL PO'.  DID F/U VIA TC TO NURSE SAME DAY. NOW , 3-9-21, ALL S/S RESOLVED; DID NOT HAVE ANY OTHER S/S.
1 of 2 pts vaxed from the same vial, who exp an adverse event w/in 24 hrs of vax; pt also seen in ER for fever & resp problems (unspecified); pt recovered; no further clinical details available;
Post COVID infection: Ongoing/persistent headaches. Some carry into the night. Will wake with headache.
pain, redness & swelling @ inj site;low grade fever;tx DPH;
Sore arm/ injection site, body chills, no fever, headache. Took Tylenol. Started morning of 2/6/2021 lasted until 2am of 2/7/2021
Patient is fine and happy to be able to get the vaccine, but he is 17 and not 18 yet
Fatigue; dizzy; very slight change in breathing; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), DIZZINESS (dizzy) and RESPIRATION ABNORMAL (very slight change in breathing) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included Muscle disorder since an unknown date, Asthma since an unknown date, Type 2 diabetes mellitus since an unknown date, Anaphylactic reaction and Bone marrow transplant.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced DIZZINESS (dizzy) and RESPIRATION ABNORMAL (very slight change in breathing). On 21-Mar-2021, the patient experienced FATIGUE (Fatigue). On 20-Mar-2021, DIZZINESS (dizzy) and RESPIRATION ABNORMAL (very slight change in breathing) had resolved. At the time of the report, FATIGUE (Fatigue) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: normal Normal. On an unknown date, Respiratory rate: normal Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient experienced serious anaphylaxis in the past brought on by oral medications and sometimes injectables, but never before to a vaccine. No information on treatment was provided.
Severe back pain; Hip pain; Leg pain; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533) via an unspecified route of administration in the right arm on 01Apr2021 at 10:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included liver transplant, kidney transplants "(3)", spinal fusion, bilateral mastectomy, hypothyroidism, steroid-induced diabetes, glaucoma, osteoporosis and pancreatic cysts (IPMN). Concomitant medications included prednisone (MANUFACTURER UNKNOWN), tacrolimus (PROGRAF), lisinopril (MANUFACTURER UNKNOWN), carvedilol (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN). The patient previously received tetracycline (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the right arm on 04Mar2021 at 14:30 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 22:00, the patient experienced severe back, hip and leg pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events severe back, hip and leg pain were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient was given 0.5ml instead of 0.25 ml. Patient called on 1/19/2022 and denies any problems since vaccinations. Letter was also sent
Information has been received from a consumer concerning her daughter, a 14 year old female with a history of mononucleosis and no drug reaction who in March 2008, was vaccinated with the first dose of GARDASIL. Concomitant therapy included LOESTRIN FE. The patient experienced headache, muscle spasm, muscle pain and muscle aches ever since she received her first dose of GARDASIL. It was noted that the patient had received two doses of GARDASIL. At the time of report the patient was not recovered. The patient did not seek medical attention. Additional information has been requested.
Rash developing 3 days post vaccination with report from parent of rash appearing to area of elbows and down the back of patient's arms and behind the knees with complaint of itching with rash per parent.  Fever of 100 degrees or less appearing 5/22 and lasting for 3 days. Parent reported rash 5/24/2010 with parent stating rash still present, but decreased in severity. Parent states use of OTC Benadryl for child's rash. Strongly encouraged parent to follow up with primary care physician of child to review/examine child and rash.  Parent verbalized understanding of need for follow-up for rash and for future vaccinations.
Janssen Covid 19 Vaccine EUA   Numbness on arms Pain and soreness over the body
A 20-year-old female, with no concurrent illnesses or pre-existing medical conditions, and who was taking "birth control", had received a second dose of MENACTRA, and a dose of TET TOX ADS USP on 02 August 2007. The routes and sides of administration were not reported. The patient had previously received a first dose of MENACTRA on 21 June 2007. This is not a recommended dosing schedule by the manufacturer. Two days after the second dose of MENACTRA on 02 August 2007, the patient began having severe headache located in the "frontal lobe". The headache was not relieved by MOTRIN or EXCEDRIN. The patient is able to sleep at night, and wakes without a headache but later on in the day the headache begins. She was evaluated by a physician and prescribed ZOMIG, but she did not take it as it was too expensive. An MRI was completed that was "negative", and testing for Lyme disease and thyroid function were "negative". The patient had not received any other vaccination within four weeks of the Menactra and TET TOX ADS USP on 02 August 2007. At the time of this report, the patient had not recovered. Follow-up information received on 24 September 2007 from a health care professional: the patient received first dose of MENACTRA (lot# C2770AA) on 21 July 2007. The patient received on 02 August 2007 a dose of ADACEL (Lot# U2377A) and a second dose of MENACTRA (lot# C2770AA). The patient was negative for Epstein-Barr Virus (EBV).
No adverse event; Monovalent doses administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient).    No concomitant medications were reported.  It was reported that, the patient received monovalent dose after the beyond use-by date.  No treatment medications were reported.
About 24 hours after the vaccine, patient suddenly experienced incapacitating loss of muscle control and could barely walk with the help of walker and support from his wife. Prior to the vaccine, he had had five months of IVIG treatments and a subsequent long period without loss of muscle control.  He did not need a walker during this time. The onset of loss of muscle control was rapid, as if a switch had flipped. When he woke up the day after the onset of loss of muscle control, his walking had improved to the level of his baseline. He is walking without a walker and doing simple household chores.
Patient was given ADACEL into the left arm, then patient was given FLUARIX Q into the right arm. Almost immediately after the FLUARIX injection, patient stated that she started feeling lightheaded. Patient was responsive, she indicated that she can hear my voice, then she started leaning her head and her pupils started dilating. She was not responding anymore. Pharmacy technicians were instructed to call 911 and alert store management. Pharmacist stayed with patient and monitored her pulse, which was present. Then patient came out of the lightheadedness and stated she was feeling better. Soon after, she vomited. Soon after that she was getting lightheaded again. Soon after that she snapped out of her lightheadedness. Emergency response team arrived. They offered her ZOFRAN 4mg ODT and she took a few sips of water. She stated that she was feeling almost back to normal. Patient was advised to get checked at the ER, so she was taken to the ER on a stretcher. At that point patient was completely alert, talking and even joking about the event.
A 5 month old male infant with constant crying, irritability, no sleeping,with "body stiffening" noted by his mother. brought to the ER received Benadryl and Tylenol.
Fever, abdominal pain, crying (inconsolable for more than 3 hours), pale gray/clay colored stools (4).
I received the vaccine at 1:30pm on April 27. 2022, by 5;00pm that evening I was chilled, slept on the sofa. I awoke the next day with a dull headache behind my eyes, a fever of 99.9F, that is high for me, my arm was sore more than usual, I was extremely tired, I slept all day. For the next two days I slept off and, on all day, long I felt very lazy, I did not have any energy to do anything. I tested positive for COVID-19 in September 2022. I had a fever, sore throat, I was coughing a lot., I had rhinitis. I tested; it came back positive. I isolated for a week. I did call the doctor who advised me to isolate, to take something for the coughing I opted to take Mucinex.
I started having terrible Chest Pain, Palpitations, Shortness of Breath around 24 hours after my first dose. The events were on and off for two weeks. I was told by doctors that I was fine and to receive my second dose. I got my second, and the next day after that one I was worse. I went to the ER on April 22nd where they did an EKG & XRAY and told me my heart looked fine. I was in ER two more times following the next couple months as the pain never subsided. Finally in July, I had an episode of pain that I thought I was having a heart attack. I saw my doctor where he diagnosed me with Pericarditis. The following weekend I was admitted to the hospital for chest pain, and further tests showed fluid in my heart sac. I'm currently on three medications to help and have yet to feel relief. It is going on 5 months now. I have no quality of life, I can not even move from my bed because the pain in my chest is so terrible. Since my hospital admittance in July. I have been back 3 more times to ER for blood clot scares (blood work markers indicated Clotting) & excruciating pain.
nauseous; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Mar2021 (Lot number: EP7534) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTROGEN GEL taken for artificial menopause. The following information was reported: NAUSEA (non-serious) with onset 10Mar2021, outcome "not recovered", described as "nauseous". Therapeutic measures were taken as a result of nausea.  Additional information: The patient received her first dose on 08Mar2021 and the next day, 09Mar2021, she didn't have any symptoms. she felt a little nauseous on 10Mar2021 for the next three days and it was off and on. She stated that the nausea went away on 13Mar2021 and reoccurred this Monday, 29Mar2021 and wants to know if this is this related to the Covid vaccine and if she should be concerned. She reported that she works in the or as a sterile processor, she does the instruments. Patient reported she was feeling a little nauseous this morning, but it is improving at this time. The patient scheduled to receive her second dose on 08Apr2021. She received treatment with Pepcid AC, but clarified she took Pepto-Bismol. She wants to know if she should proceed with the next dose.  No follow-up attempts are possible. No further information is expected.