chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 22-OCT-2012 14:26, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
I woke up exhausted, chills, sinus infection, cough, upper respiratory congestion, and low-grade fever for 2 days. I tested positive for COVID-19. I went to the urgent care, and they did an x-ray to check for pneumonia and it was clear. She prescribed prednisone and antibody. I still have a cough and upper respiratory congestion.
Pt had a syncopal event. Vitals: 189/83, 61, 18 -- > @9:12 174/99, 65 -- > @9:20 153/84, 71 Pt stable and released from the vaccination site at 9:20
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. No Treatment information was reported. The vials were frozen, shipped in refrigerated temperature and then refroze for storage once arrive at facility. On 06-Oct-2021 vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 2C to 8C.
Change in smell and taste. Things taste and smell like they are rotting.  Symptoms lessened, but still present 2 months later.
pt recv vax;mom stated leg started to become red & swollen on 14jun95;swelling inc over noc;raised,red,warm area on rt upper outer thigh;area itches,tender;f/u: instructions were given per protocol;
stomach pain; symptoms have increased after I got the shot.; I'm not feeling good; slight headache; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ABDOMINAL PAIN UPPER (stomach pain), CONDITION AGGRAVATED (symptoms have increased after I got the shot.), FEELING ABNORMAL (I'm not feeling good) and HEADACHE (slight headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Schizophrenia (Bipolar). Concomitant products included VALPROATE SEMISODIUM (DIVALPROEX) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced DIZZINESS (dizziness), ABDOMINAL PAIN UPPER (stomach pain), CONDITION AGGRAVATED (symptoms have increased after I got the shot.), FEELING ABNORMAL (I'm not feeling good) and HEADACHE (slight headache). At the time of the report, DIZZINESS (dizziness), ABDOMINAL PAIN UPPER (stomach pain), CONDITION AGGRAVATED (symptoms have increased after I got the shot.), FEELING ABNORMAL (I'm not feeling good) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient developed painful red rash at injection site on 6/13/21.  Patient also said arm was swollen, hot and itchy.  Patient took ibuprofen and diphenhydramine and the pain, swelling, hot and itchiness has reduced.
This spontaneous report as received from a medical assistant refers to a 13 months old male patient without pertinent medical history and without drug reaction. The patient was vaccinated with the first dose of 0.5 ml MMR II (lot number 0288AE, expiration date 03-JAN-2014) subcutaneously on 10-AUG-2012. No other co-suspects were reported. Concomitant medications included: VENTOLIN nebulizer treatment. On 22-SEP-2012 the patient started vomiting when awake and on 24-SEP-2012 had circular small patches on his cheeks and on 25-SEP-2012 had a full body rash and itching from face to feet, no fever but elevated pulse and temperature. Medical assistant noted the physician suspects it may be signs and symptoms of possible rubella but not confirmed. No treatment was given for adverse event. No diagnosis studies were performed. The outcome of adverse event was reported as not recovered. The patient contacted physician for seek medical attention. Additional information has been requested.
This spontaneous report was received from a primary care physician (PCP), as part of a marketing research program, and refers to unspecified group of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX (lot #, expiration date, dose, route of administration and indication were not reported). The respondent told the patients, that some people who got the vaccination got a rash at injection site. The outcome of the rash at injection site was unknown. The relatedness between the event of rash at injection site and the ZOSTAVAX was not reported. Additional information is not expected, as the reporting physician did not wish to be contacted.
This spontaneous report as received from a health professional refers to a 23 month old patient. On 20-JUN-2014, the patient was vaccinated with a dose of (oka/merck) VARIVAX (lot # J013907, expiration date: 30-OCT-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
skin rash started on left arm, arm where dose was received. The rash was itchy and it spread along left arm. The eye sockets became swollen and skin became very dry and wrinkly after swelling reduced.
10/7/2015 at 15:30AM, received FLUCELVAX vaccination after leaving employee health nurses's office noted feeling of weakness tingling sensation traveling in an "L" pattern from left upper arm into neck and head. Took one tablet of MOTRIN about 10-15 minutes after flu vaccination was given. Headache, warm fever sensation and left arm discomfort subsided in 3 hours around 18:30PM. No further symptoms or discomfort noted.
She woke up the next morning was barely conscious, couldn't breathe, lips and face extremely pale , almost stopped breathing
pt began to get fussy about 530-6PM &  inc to non consolable crying through noc to about 5AM-slept 2hr;highest temp 101.9, whimpered then through next day;eating well;19FEB97 congested, cough, fussy;seen by MD-bronchitis;
This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX, GlaxoSmithKline. Previous and/or concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis vaccine; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated; manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose of FLUARIX (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with FLUARIX and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with FLUARIX (causality not provided for accidental overdose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as "Flumist" and administered intranasally. There were no other adverse events other than "bad taste."
Burning when vaccine received.  Injection site sore, bruised.  Fatigue and injection site soreness for about 24 hours.
Changes to periods and unexpected vaginal bleeding. Anemia. Prescription for combined estrogen-progestin birth control pills and iron supplements.  Scheduled for hysterectomy
Have a palpable left neck lymph node noticed 2 weeks after 1st dose.  Node is still palpable not painful but neck is swore off left side. My period is late. I am consistently regular and have been since I was a teenager.
Intermittently feeling intense vertigo.  My vision will suddenly start spinning, similar to the feeling of being too drunk.   The feeling has come and gone twice, over the past two days.
Very painful at injection site for 4 days.  Red and swollen at injection site for 4 days, at least.  One day after injection, - muscle pain all over body,  sensitive to touch, feverish - just plain miserable.  Same symptoms but  milder on next day.  Gone by day after that,
Pt developed pain at injection site on day 1. Then developed redness and itching 2 day after injection. The itching became diffuse and pt noted redness at sites of itching (ie -legs). The itching is improving and is mostly at the injection site. On exam right deltoid area has 4-5 inch diameter area of mild, confluent erythema with palpable warmth and minimal tenderness. Recommended that pt take BENADRYL QHS to help with symptoms. Will refer to allergy/immunology given concern for type 4 hypersensitivity reaction and to help identify which vaccine component caused the reaction.
It was intense headaches, fever, chills, and achiness. I also had a loose stool all of which lasted three or four days. PRN with ibuprofen and TYLENOL, I was recovered from this event in four days.
Acute MI (Heart Attack) - treatment at Hospital- underwent Cardiac Catheterization and had stent placement in LAD, medications prescribed as further treatment, currently living
Patient reported limited range of motion of right shoulder since receiving her influenza and covid vaccines on October 14th.
Rash at the deltoid injection site; Rash feels like bubble underneath the rash; Fever; Cough; Mild hay fever type symptoms; Rash feels weird; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number E9Y5M, expiry date 31st May 2022) for prophylaxis.   On 16th November 2020, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, less than a week after receiving Shingrix, the patient experienced injection site rash, blistery rash, fever, cough, hay fever and weird feeling. The patient was treated with cough cold preparations nos (Cough Medicine (Nos)). On an unknown date, the outcome of the injection site rash, blistery rash, fever, cough, hay fever and weird feeling were not recovered/not resolved.   The reporter considered the injection site rash, blistery rash, fever, cough and hay fever to be related to Shingrix. It was unknown if the reporter considered the weird feeling to be related to Shingrix.  Additional details were provided as follows: The reporter who was a retail pharmacist reported that she had administered Shingrix to the patient at the left deltoid . The patient had a rash on her left arm at the deltoid injection site after the vaccination. The patient indicated that the rash felt weird because it felt like there were bubbles underneath the rash.  The patient had also reported to the pharmacist that she had experienced fever, cough and mild hay-fever type symptoms.  The patient was taking an unspecified cough medicine to treat the cough. These symptoms were mild but they had not resolved till the time of reporting. The pharmacist had called to inquire if a second dose of Shingrix should be given to the patient in 2 to 6 months or not and call was transferred to GSK-medical information. The reporter consented to follow-up. This case has been linked to US2020228575, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020228575:same reporter
Pt received vaccination and immediately afterwards syncoped.  Pt recalls receiving the inoculation and becoming acutely lightheaded before losing consciousness.  No preceding SOB or palpitations noted.
Mild reaction to injection noted 1 day after injection: redness, swelling, itching and soreness. Recommended BENADRYL PRN.
Post nasal drip sore throat; Muscle pain; Tired and Exhausted; Fever; Headache; Chills; Feeling sick; Lethargic; Sore throat; Running nose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), LETHARGY (Lethargic), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Running nose) and UPPER-AIRWAY COUGH SYNDROME (Post nasal drip sore throat) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]), LOSARTAN, AMLODIPINE, ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), LEVOCETIRIZINE, ESCITALOPRAM OXALATE (LEXAPRO) and LAMOTRIGINE for an unknown indication.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced MALAISE (Feeling sick), LETHARGY (Lethargic), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Running nose), MYALGIA (Muscle pain), FATIGUE (Tired and Exhausted), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills). On 10-Feb-2021, the patient experienced UPPER-AIRWAY COUGH SYNDROME (Post nasal drip sore throat). At the time of the report, MALAISE (Feeling sick), LETHARGY (Lethargic), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Running nose), MYALGIA (Muscle pain), FATIGUE (Tired and Exhausted), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) was resolving and UPPER-AIRWAY COUGH SYNDROME (Post nasal drip sore throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 100.7 (High) degree Fahrenheit.         No treatment information was provided.
Every time I get the shot I come down with the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via agency through social media on 03-Dec-2020 .  This case involves a patient of unknown demographic who experienced every time got the shot came down with the flu  (influenza) , while the patient was treated with Influenza vaccine.  The patient's medical history, past medical treatment(s), concomitant therapy, past vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) at an unknown dose via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient experienced every time  get the shot came down with the flu  (influenza) according to doctor.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of the reporting , event outcome was unknown .  There will be no information available on batch number for this case .
arm was hot, and chills -sat 03/06/21 itching- Sunday 03/07/21 and it got bad on 03/08/21 pt. stated she took tylenol and benadryl at night  Recommendations:  Apply a cold compress to the area where you are experiencing itching to provide some comfort, please contact your PCP and let him/her know the symptoms you are experiencing for other recommendations. You stated you are having difficulty breathing so I recommend for you to go to your nearest emergency department just to make sure your airway doesn't close up and they could do a full workup.
After administration of vaccination, patient stated to be feeling dizzy, patient skin color was pale, he become diaphoretic and clammy, patient stated he wanted to pass a bowel movement, but instead patient vomited.
0815 Hep B vaccine administered. 0845 Client still in building came to my office stating her RT arm was breaking in rash and itiching real bad.  Denied any breathing difficulty. At 0847 administer diphenhydramine 1cc IM in LD.  0937 was taken home.
Flu and moderna injection: 1. Headache and light sensitivity 2. Nausea and constipation, but unable to vomit or move bowels resulting in extreme discomfort. 3. Dizziness 4. Exhaustion Severe symptoms lasted 20 hours, then leftover exhaustion.
Received H1N1 vaccine 11/16/09 at 11pm left arm where received vaccine felt heavy. Then tingling of muscles and arms, hives, difficulty breathing. Went to ED at hospital. 12/7/09 ER records received for date 11/17/09. DX: hives, allergic reaction, anxiety. Chief c/o skin rash, intermittent leg tingling. Pt states received H1N1 vax x1day ago. Assessment: mild erythematous, blanching skin rash located on chest.
Previous pneumonia - would wake up at night due to pain when rolled over on it. Swelling (3 welts at injection site).
Within 1 hour of vaccine, arm became red and a hard knot formed at injection site and a headache. By 2100 that evening I had a temp of 100.2F, slight muscle aching, chills and a headache. Sunday 1/6/2019 right shoulder and neck pain, injection site was hot to touch, redness and hard knot was larger. Muscle aches, fatigue remained. Temp was still around 100.2F. Monday, 1/7/2019 Muscle aches, fatigue were worse. Temp was 99.9, Tuesday, 1/8/2019 shoulder pain, neck pain and jaw pain began around 0500am. I went to the ER.
I am not sure which exact flu vaccine I received. Symptoms were: chills/sweats, sneezing, headache. This lasted for about 2 days.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 24-SEP-2013, patient was in the physician's office and would receive a third dose of GARDASIL (lot#, expiry not reported) today. The nurse reported that the first and second doses of GARDASIL (lot#, expiry not reported) were administered on unspecified dates about 4 years ago approximately in September 2009. No adverse effects reported. Additional information has been requested.
Inflamed Lymph Node under the left armpit, injection was given IM into left arm.The swollen node feels like a golf ball and quite painful, it developed ( started hurting) the day after receiving the vaccination
Started having chest pains, shortness of breath, and rapid heart beat that evening. Persisted for the next 2 weeks so I went to the doctor to have a D-Dimer test on 4/15/21. Test showed elevated D-Dimer.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Patient received a refreeze vaccine once thawed) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a refreeze vaccine once thawed). At the time of the report, PRODUCT STORAGE ERROR (Patient received a refreeze vaccine once thawed) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication details was reported. At first, a thawed shipment of vials of the Moderna Covid-19 vaccine was received at the facility. Once received, the shipment was placed on the refrigerator except for 1 vial, that was stored in the freezer. This particular vial was again thawed and then administered to the patient. On 07-Apr-2022, the vial was initially stored in the refrigerator at 41.6 degree Fahrenheit. Then the vial was moved to the freezer at -8.1 degree Fahrenheit but the healthcare provider did not know when it was moved to the freezer. Then, the vial was taken out from the freezer on the date when the dose was administered. The patient would have received either the first booster dose or the second booster dose. No treatment information was provided. This case was linked to MOD-2022-545266, MOD-2022-545272, MOD-2022-545270 (Patient Link).
Immediate AEs: Severe swelling, redness, itchy, and pain at injection site.  Nausea, extreme fatigue and headache, body and muscle aches. Approx 4-5 weeks post injection: severe itching along back which progressed to stomach after several hundred hard red, itchy and painful bumps appeared - predominantly along right back (upper more, less lower) but across spine and to left side (25% of total).  Progressed to stomach (about 20% of total).  Tingling, pain, neuropathy feeling (similiar to shingles but appearance more in line with chicken pox.). Remained and got worse over course of 10-14 days.  At 6 weeks now reduction in size/pain.
Bump on (L) arm warm to touch gave cefdinir 300 mg advise to put cool compresses to area.