chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported.; Caller is an office manager reporting that an improperly stored dose of M-M-R II and VAQTA were administered to the patient on 27MAY2022 after experiencing a temperautre excursion.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-MAY-2022, the patient was vaccinated with improperly storage hepatitis a vaccine, inactivated (VAQTA) (valid lot #U033212, upon internal review expiration date was 07-NOV-2022 [also reported as 28-OCT-2022]) (strength, anatomical location and route of administration were not provided); and  measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (M-M-R II) (valid lot #T033814, expiration date: 05-OCT-2022) (strength, and route of administration were not provided) both administered for prophylaxis. Temperature excursion was at 54.5 Fahrenheit (F) for 11 hours. No additional information or adverse event was reported. ; Sender's Comments:  US-009507513-2208USA006720: US-009507513-2208USA006883: US-009507513-2208USA006520: US-009507513-2208USA006700:
I am allergic to preservatives which trigger migraines.  This vaccine gave me the second worse migraine i have ever had - severe pain and vomiting, nausea.  Should have gone to emergency room , but too afraid of the high volume of covid at the time
Patient was doing fine during the shot. Shortly after the shot (about 10 minutes), patient felt sweaty and walked over to subway next door to get some water and on the way back to the pharmacy, he collapsed but another customer, and his wife caught him so he didn't injure himself. Patient was laying on the floor for approximately 20 minutes. He reported that he did not eat before coming in. Cold compress and water were provided. 911 was called. Patient reported he never had this type of reaction before, but he also barely ever get vaccinations. He reported that he always feel a little anxious every time he goes to see his doctor. Shortly after medic arrived, patient felt better and he could sit up. We also provided him some protein bars. Medic walked him out to the car. We also let his wife know to call us if extra support is needed.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX. Concurrent medical conditions included artificial cardiac pacemaker user. Concomitant products included Aspirin and Propranolol. On 9th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 9th May 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, fatigue, fever and headache. The patient was treated with ADVIL. On 10th May 2018, the outcome of the pain in arm, fatigue, fever and headache was recovered/resolved. The reporter considered the pain in arm, fatigue, fever and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received the shot in the morning and on that evening, he experience extreme pain in the arm, headache, felt tired and run down and was feverish. These events lasted until the following day and then resolved. The patient used ice pack on his arm and took ADVIL for the headache. The patient was unable to provide full demographics for the pharmacy, where he received SHINGRIX or for his physician.
Shingles start to develop on the second day after receiving the 2nd dose of Pfizer/BioNTech COVID-19 vaccine. The Shingles are on the belly and also on the back.
Tinnitus has continued, other symptoms like fever, headache etc subsided after several days.
Onset of fever, chills, muscle aches/joint pain, headache 11 hours after injection. Fever, chills, and severe muscle aches/joint pain lasted for about 24 hours. Milder muscle aches and headache lasted for about 36-48 hours.
Pt's vaccine was administered at approx 9am.  Pt returned to the office at 11:35am c/o feeling "light headed, dizzy, and that her capacity to breath is diminishing".  Injection site was checked.  No swelling, redness, or warmth to touch was noted.  Pt was advised to go to PMH ED for further evaluation of symptoms.
Patient took the second dose past the 42 days mark; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took the second dose past the 42 days mark) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took the second dose past the 42 days mark). On 08-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took the second dose past the 42 days mark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
6cm x 5cm red, swollen, hot and painful area around injection site. Axillary lymph nodes are swollen.  Continued for greater than 9 days.  Treatment included warm and cold compress.
This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patient (age and gender not reported). Information regarding patients drug reactions or allergies and medical history was not reported. On an unknown date unspecified number of unspecified patients were all administered ZOSTAVAX, (0.65 ml, subcutaneous, anatomical location, lot#, expiration date were not reported) that underwent post supported excursion. Concomitant therapies were not reported. No adverse effects were reported by any patients. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reproter. Additional information has been requested.
I had my vaccination on 09/26/2022. On 10/08/2022 started to feel unwell with sore throat. Then on 10/09/2022 I tested COVID-19 positive. I contacted my doctor on 10/09/2022 and was prescribed PAXLOVID. I have slight amount of residual congestion on 10/26/2022.
Positive for Covid-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Positive for Covid-19) in a 75-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 033K212A) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy.    On 22-Feb-2022 at 3:34 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 06-Dec-2022, the patient experienced COVID-19 (Positive for Covid-19). At the time of the report, COVID-19 (Positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Dec-2022, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-731472 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731472:Bivalent case
mouth and throat broke out in blisters; mouth and throat broke out in blisters; Tongue is broke out with white sores; tongue is swollen; breathing problems; cough; constantly clearing throat; malaise; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6207), via an unspecified route of administration in left arm on 21Apr2021 10:00 (at the age of 51-years-old) as 2 nd dose, single for covid-19 immunisation. The vaccination facility type was a reported as other. No other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of bnt162b2 (lot: EP6955) on 31Mar2021 at 10:00 in left arm (at the age of 51-years-old) for COVID-19 immunization. Medical history included asthma, Ehlers Danlos Syndrome, postural orthostatic tachycardia syndrome (POTS), immune disorder, Medium-chain acyl-coenzyme A dehydrogenase deficiency (MCAD), Irritable bowel syndrome (IBS), Chiari-decompressed, anxiety and depression. The patient had no known allergies. The patient's concomitant medications were not reported. The reported adverse events were mouth and throat broke out in blisters; Tongue was broke out with white sores, tongue was swollen, breathing problems, cough, constantly clearing throat and malaise on 24Apr2021. The events resulted doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included prednisone, z pack, valacyclovir hcl, nystatin. Prior to vaccination, patient was not diagnosed with COVID-19 and since vaccination (post vaccination), patient has been tested for COVID-19 (nasal swab) on 29Apr2021 with result of negative. The outcome of the events was not recovered.
PATIENT EXPERIENCED SYNCOPE IMMEDIATELY AFTER VACCINATION UPON STANDING FROM VACCINATION POSITION (SITTING). HE SHOWED LOW BLOOD PRESSURE IMMEDIATELY AFTER FAINTING, BUT REGAINED CONSCIOUSNESS WITHIN SECONDS OF FAINTING. AFTER A FEW MINUTES HIS BP RETURNED TO NORMAL AND AFTER A FEW MINUTES LONGER OF LAYING DOWN HE WAS ABLE TO SIT UP. AFTER ANOTHER FEW MINUTES HE SAT IN A CHAIR BEFORE FULLY STANDING AND WALKING. HE WAS RELEASED WITH HIS PARENT AT 3:55 TO EXIT CLINIC.
Reported nausea, feeling hot and sweaty.  Observed for 15 minutes.  Symptoms resolved.
Heart problems; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISCOMFORT (Heart problems) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Autoimmune disorder (Has an auto immune disease and a couple of other things.).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISCOMFORT (Heart problems). At the time of the report, CARDIAC DISCOMFORT (Heart problems) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
became fretful early evening w/temps of 104.5-105; seen by MD who advised sponge bath, APAP; temp down in 24 hrs w/o further problems;
Within 5 min of vaccine developed LEFT chest & neck rash / hives. Within 10 min entire neck / chest rash / hives with palpitations, tachycardia, flushing, & itching occurred. Took Benadryl 25 mg with no improvement. Monitored in ER for 2 hrs with additional dose of Benadryl 25 mg given.  Rebound rash occurred about 24 hrs after injection, but no further rash / hives. Left supraclavicular lymph node swelling noted 3 days after vaccine administered. Saw PCP 01/08/2021 with persistent lymph node swelling. Starting Medrol dose pak to see if improvement occurs.
bronchospasm & resp distress w/in 20min of vax;given epi, DPH, pred w/improvement;peds ER for observation;
Pediatric patient was given dose of adult Pfizer COVID booster (gray cap)- 0.3mL instead of pediatric child booster (orange cap)-0.2mL.  No adverse events were reported as a result of this error.
large mass under the armpit. possible swollen lymph nodes. muscle pain,  fatigue, tingling feeling on the lower lip left hand side,
I had a Spontaneous Coronary Artery Dissection leading to a heat attack in my LAD. I had an emergency stent placement to save my life. Before the heart attack but after the vaccine my pregnancy became medically complex. I developed gestational diabetes. I then proceed to have a placental abruption at 34 weeks leading to an 11cm blood clot in my uterus. I at that time also was diagnosed with pre-eclampsia and spent a week in the hospital for the placental abruption. I was sent home on bed rest, but my water broke early at 35 weeks and baby was born 5 weeks premature and spent 3 weeks in the nicu. Delivered July 7th birth weight 5 lbs 10 oz
I had the flu shot on 10/14/19 at my workplace.  My arm starter getting sore and I was manipulating my arm to help the vaccine absorb around 6 pm.  By the time I got home at 7 pm I was in excruciating pain when trying to abduct my left arm.  This abduction pain has continued for the duration of this episode.  I took pain medication before going to bed hoping to alleviate some of the pain.  I have had aching from my shoulder to my elbow and shoulder to wrist at different times.  it seems to worse at night.  I didn't initially do anything specific because I thought it would get better "on its own".  I sought a physician consult on 11/13/19 after continuing to have mobility issues with my arm.  His recommendation is physical therapy.
Pt received 4 mos vaccines of DTaP, IPV, Comvax on 8/7/02 developed diffuse macular papular rash over entire body associated factile fever. No other symptoms.
Client stated this will be his first covid vaccine ever. I gave the vaccine to the patient and when I looked at his vaccine record in his chart there was three doses of moderna already administered. Fist one 04/15/21, second one 5/13/21, and third one on 11/15/21. When asking the patient about it, he stated that he has never gotten it before. His demographics were verified, he remembers the address on file but says that it is old. His ssn is correct but the  id number is different. Client has no memory of going to the clinic but states that because of his brain injury that he may have forgotten. He is 45 years old, and not considered immunocompromised. He doesn't meet the requirements for the 4th booster dose. Client waited the time for observation with no complications observed or reported.
Will bring in all discharge papers. Patient hospitalized after emergency room visit 8/31/17. Given antibiotic therapy 9/9/17.
low potassium; low sodium; chills; started throwing up; felt very nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKALAEMIA (low potassium) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (patient had covi1-19  on last march and was hospitalized.).  On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced CHILLS (chills), VOMITING (started throwing up) and NAUSEA (felt very nauseous). On an unknown date, the patient experienced HYPOKALAEMIA (low potassium) (seriousness criterion medically significant) and HYPONATRAEMIA (low sodium). At the time of the report, HYPOKALAEMIA (low potassium), HYPONATRAEMIA (low sodium), CHILLS (chills), VOMITING (started throwing up) and NAUSEA (felt very nauseous) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment information was not 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 events, a causal relationship cannot be excluded.
Initial report received from consumer on 19 December 2013. A 69-year-old female patient whose medical history and concomitant medications were not reported received FLUZONE HD (lot number and expiration date were unknown) intramuscularly in left deltoid (dose number not reported) on 16 December 2013. On 16 December 2013, the patient got a bright red rectangular 2x3 inch mark to the left and below injection site. It was sore if she presses on it. On 19 December 2013, the area was pink. The injection was given on top of a biceps tear by the pharmacist. Laboratory investigation and corrective treatment were not reported. As of this report, the patient had not recovered from the events. Documents held by sender: none.
8/13/23:  Fatigue, right arm painful, red, hot area 12 x 9 cm below injection site. 8/14/23:  Slightly less fatigue, right arm painful, red hot area 12 x 9 cm below injection site.  Bottom half of area darker red and itchy but no rash. 8/15/23: Fatigue subsided, only bottom half of affected area remains red and  has now extended another 3 cm down arm toward hand.  Itchy and painful but less hot, no rash. 8/16/23:  Redness mostly gone.  Area still tender and slight itch remains. 8/17/23 and beyond:  Symptoms continued to dissipate over the next several days.  Itchy sensation lingered for about 8/20/23.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 03Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications (No other medication received in 2weeks). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included Paxlovid from 22Jul2022 to 27Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mild rash on the arm where I had the shot/ Near the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (Mild rash on the arm where I had the shot/ Near the injection site) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Mild rash on the arm where I had the shot/ Near the injection site). At the time of the report, VACCINATION SITE RASH (Mild rash on the arm where I had the shot/ Near the injection site) outcome was unknown.            Concomitant medications were not reported. Treatment information was not provided.  The patient had the new Moderna booster with omicron and developed a mild rash on the arm where patient had the shot. It was not terrible but mild.
Patient said she had ringing in ear, and was nauseous immediately after immunization. Patient appeared pale, sweaty, and shaky. I told the patient to put her head between her knees. She regained color within minutes. She felt better but we called 911 just to be safe. The patient and the EMT decided the she would be driven home bu her mother to rest.
3 wk. history of progressive symptoms in arms and legs that started 3-4 wks after receiving flu vaccine Fine motor movements slow. Over last 7-10 days a persistent cold sensation, tingling, and weakness especially in hands. Diagnosis of Guillain Barre by MD. Pts was to received 1gm/kg/day of IVIG. Toward end of 1st infusion she developed headache and fever.  Infusion was discontinued.  Fevere and headache resolved. Given Neurontin 300 mg 1-2 po qhs for extremity pain along with ibuprofen 600 mg po tid x 5 days.  5/20/2008 MR received for OV 11/20/07 and admission DOS 11/29/2007 with DX: Guillain-Barre Syndrome. Aseptic meningitis 2' to IVIG. Dysthesias.  Pt initially presented with c/o weakness in the hands, most notable after running and intermittant numbness. Seen again 11/29/08 with c/o increasing progressive symptoms in pt's arms and now legs. Cramping and clumsiness noted in the hands with persistant cold sensation with tingling. PE (+) for muscle weakness of the bilateral APB, ADM, interossei and toe dorsiflexors.  Diminished reflexes at the biceps, brachial radialis and ankles. Sensory exam impaired to pin prick over fingers and ankles. Temp and vibration also reduced. Tx with IVIgG with development of h/a and fever suspected aseptic meningitis. 6/18/2006 Office records received from 11/12/2008-5/19/2008.  Initially seen with c/o abrupt onset of weakness of the R upper extremity as well as coldness of the extremities.  Unable to grip or start the ignition of her car. Referred to Neurologist. Seen again 2/5/08 with cold sx with recent hx of atypical Guillain Barre syndrome
Patient had low platelet and low red blood cells; Patient had low platelet and low red blood cells; Initial information regarding an unsolicited valid non-serious case was received from Consumer/non-hcp (healthcare professional) via Medical Information (Reference number- 00628775) and transmitted to Sanofi on 04-Jun-2021.   This case involves a female patient who had low platelet and low red blood cells (platelet count decreased) and low platelet and low red blood cells (red blood cell count decreased) while receiving vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (lot number and expiry date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient had a non-serious low platelet (platelet count decreased) and low red blood cells (red blood cell count decreased) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  The reporter states that she takes the Fluzone flu vaccine from Sanofi every year. she is aware of "many, many, many people" who took the mRNA vaccine and, in the future, don't want to take the mRNA vaccine as their booster. she is being inappropriately labeled as vaccine hesitant or an antivaxxer, but she is just waiting for a protein-based COVID-19 vaccine. She is asking that when Sanofi is finished asking for EUA status and makes its distribution decision to please set come vaccines aside for US consumers. She states that there are people with pre-existing medical conditions that are waiting for the protein-based vaccine because of side effects related to the nucleic acid vaccines. She states that she doesn't want thrombocytopenia, so she doesn't want to take the Johnson and Johnson vaccine.  Laboratory data was not reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the reported events.  There will be no information on the batch number for this case.