chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 4:14 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 4:14 AM, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Reported that facility had a temperature excursion for the Moderna Covid-19 vaccine.  The patient was given doses from a vial that were stored in an ultracold freezer which was colder than the required storage condition.  No treatment medication information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
had Td vax 17OCT95  & on 18OCT95 devel joint aches & aches in legs & knees; had chills afeb; still has aches @ present time;has minor soreness @ inj site;
expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vaccination facility  did not have a vial stay in the refrigerator for more than a week No concomitant medications was reported. Treatment medications was not provided.
12AUG96 rt arm severely swollen & red from shoulder to elbow next day;
abnormal mammogram, had to have breast biopsy which came back as benign fibrocystic calcifications (size smaller than a grain of sand) CDC recommended this form be completed
HEREDITARY PERIPHERAL NEUROPATHY 2/19/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
redness, swelling,  itching at injection site.  fever,  headache,  exhaustion
I had a kind of irritation on the skin surrounding my mouth and so I talked to the DR on 7/13/2021 to see what was going on and the DR said maybe it was a possible minor fungal infection. He suggested I use Hydrocortisone cream and an antifungal cream. I did that for about three days and now it is fine. The symptoms subsided and cleared up at about the 17th of July 2021.
Palpitations; Sore arm; Flaming red; Her arm was flaming red and itchy; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Flaming red) and PRURITUS (Her arm was flaming red and itchy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety (she has an extra heart beat with anxiety).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PALPITATIONS (Palpitations), PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Flaming red) and PRURITUS (Her arm was flaming red and itchy). On 13-Mar-2021, PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Flaming red) and PRURITUS (Her arm was flaming red and itchy) had resolved. At the time of the report, PALPITATIONS (Palpitations) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Initial additional, two new events and outcome added. On 23-Jul-2021: Outcome updated and end date removed for the event of palpitations.
This spontaneous report as received from a nurse (B.S.N.) refers to a 27 year old female patient. On 12-MAR-2013 the patient was vaccinated with her first dose of (merck) VARIVAX (dose and route not reported, lot # H013182, expired date: 05-JUL-2014). On 14-MAR-2013, it was reported that the patient experienced a 20mm by 30mm area of redness and induration at the injection site. The patient was given ice as treatment for the events. At the time of reporting, the outcome of the events was reported as recovered on an unspecified date. The patient sought medical attention by calling the clinic. Additional information has been requested.
Roughly ten to fourteens after each dose of the covid vaccine, I experienced significant dizziness and balance issues. After the first dose, I was experiencing falls and could not take on normal day to day activities due to the dizziness. I also found myself struggling with finding words and with word choice. The second dose was the same but to a lesser degree; the booster dose also brought dizziness but no falls and to a less extent.
21 yo female with no significant PMH who presented on 10/29 with 2 weeks of abdominal pain. Found to be COVID positive (asymptomatic, not hypoxic) and elevated LFTs. Extensive workup for abdominal pain done including pelvic U/S (showing simple cyst in the R ovary without torsion), RUQ U/S (without gallstones but focal fluid collecting abutting the right kidney), CT a/p (showing fluid-filled colon reflecting diarrhea with previously noted fluid collection on U/S corresponding with fluid filled colon), repeat pelvic U/S (showing normal bilateral adnexa). Further workup revealed acute porphyria (found to have high spot urine porphobilinogen). Hematology consulted and started on hemin infusions. Received 5 doses of hemin in house (last dose 11/10). Hospital course notable infusion related phlebitis secondary to hemin. Course also notable for urticaria with IV iron sucrose infusion (added to allergy list). Abdominal pain was an ongoing issue, but closer to discharge pt no longer requiring IV dilaudid. Pt to discharge home with pain regimen with close follow-up with hematology.   Patient Active Hospital Problem List:  ACUTE INTERMITTENT PORPHYRIA (11/6/2021)/ ABDOMINAL PAIN (10/29/2021)   Assessment: Pt presenting with abdominal pain. Several imaging studies including RUQ U/S, pelvic U/S unremarkable. CT a/p showing fluid filled colon reflecting diarrhea. Found to have porphyria. Query triggered by COVID infection.   Plan:  - appreciate heme recs             - s/p 5 doses of hemin (last dose 11/10) - encourage carb intake - continue pain control             - tylenol ATC, prn tramdol             - continue notriptyline, gabapentin             - lidocaine gel, voltaren gel, motrin prn for phlebitis pain Reason for Hospital Admission (Admitting Diagnosis):  Abdominal pain Acute porphyria
After my vaccine, I had the normal reaction. 2 weeks. Extreme fatigue, fever and chills came went, extreme fatigue did not stop, it lasted about 6 months and still haven't stopped completely. A month ago, I saw the doctor. I asked if I was dying. Shortness of breathe.
This spontaneous report has been received from consumer a mother who was referring to her son, 17 year old male. It was reported that the patient has always been very healthy, usually he has showed zero absences maybe year. In August 2011, we went for his yearly check-up, the doctor commented the fact we was all muscle (no other results or details provided). And then the doctor said the patient should get GARDASIL series of shots. When the patient's mother hesitated, the doctor insisted so the patient's mother agreed and he got the first shot. On unspecified date in August 2011, the patient was vaccinated with the first dose of GARDASIL (dose, route, indication not reported). Information on concomitant medication was not provided. On unspecified date, reported as about two weeks later, in September 2011, the patient got a cold, the reporter stated that he was so wiped out that, when he did not recovered after a week, he was taken to the doctor and inquired about Mono as the symptoms were unusual for the patient. The patient seemed to be recovering when he got another cold on unspecified date reported as in early October 2011. The reporter stated that the patient life has never been the same. He had a fever and cough for weeks and was totally debilitated in a way never seen, the patient could barely function or stay awake. On unspecified date the patient recovered from fever and cough. In April 2013, reported as a year and one-half later, the patient was remaining debilitated with constant headaches- at 3:00 in the morning. The reporter stated that the headache pain was so bad that either he could not sleep or it awakened him. The patient had trouble concentrating, reading, focusing (dates unspecified). The reporter stated that her son life has been irrevocably altered. It was reported that the patient seen seven doctors: his pediatrician, ear nose and throat doctor, an infectious diseases group specialist, an adult neurologist, a pediatric neurologist, a Lyme Disease specialist (who ruled out Lyme) and, chronic fatigue specialist. It was reported that there was no relief for him, aspirin or MOTRIN, even at prescription dosages, did not help the headache pain. It was reported that the exhaustion and debilitation was continued. The patient's mother reported that she was searching for answers and noting the timing of the onset of my son's illness. She researched GARDASIL on-line and she was shocked by the stories I found (unspecified). When the patient's mother suggested the connection between her son's condition and GARDASIL to his doctor, he said those stories were anecdotal. The outcome of another cold, trouble concentrating, reading, focusing, the event reported as it's too late for my son whose life has been irrevocably altered / his life has never been the same was unknown. The reporter suggested the connection between her son condition to GARDASIL. Upon internal review reported the patient's event reported as it's too late for my son whose life has been irrevocably altered / his life has never been the same was considered to be disabling. Additional information has been requested.
Information has been received from a consumer concerning a 71 year old female consumer with a history of renal cancer (about 3 years ago), and no drug allergies, who on 07-JAN-2008 was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (Lot#, dose and route not specified) to the right arm. Concomitant therapy included simvastatin (MSD), alendronate sodium (MSD), baby aspirin, SYNTHROID, and triamterene. The patient reported that after receiving the pneumococcal 23v polysaccharide vaccine she developed swelling below the shoulder blade and her entire arm was sore. The patient reported receiving pneumococcal 23v polysaccharide vaccine every ten years (dates unspecified), and she never experienced any bad reactions. The patient visited her primary physician and was sent to the hospital, she was not admitted into the hospital and was later released the same day (date not specified). No treatment information was provided. The patient reportedly recovered "one week after 07-JAN-2008" (about 14-JAN-2008). No product quality complaint was involved. Additional information is not expected.
Pt c/o rash - neck, arms 1-2 wks after all six anthrax shots, lasting 2-3 wks.  c/o bumps on his skin, flesh colored, reddish after scratch - pruritic but not hives.  Reports only after Anthrax shots - he gets this rash - 6-7 times, not only 1-2 wks after Anthrax shots.
Pediarix was given in error instead of DTAP only. There was no adverse event, the error was appreciated by the nurse who gave the shot, parents were notified and they were counseled appropriately. This
Rash on inner wrists, upper thighs and scrotum along with 100 degree fever awoke me around 3:00am Feb 6. At 7:06 am I noticed  left side facial swelling and slightly obstructed throat.  Swelling worsened only slightly from 7am to 9am. At 9am I took 100mg Benadryl and withing 45 minutes swelling was subsiding and breathing was normal. Arrived at ER at around 11:am. Was treated with EPINEPHrine, methylPREDNISolone and saline IV. Released after a few hours
Symptoms: Chills, body aches, nausea, light headed. Treatment: fluids PO & rest
Case number PHEH2013US009125, is an initial spontaneous report received from a medical assistant on 19 Apr 2013. This report refers to a 12-years-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: M120127 and expiry date: Dec 2014) at dose of 0.5 ml intramuscularly on 18 Apr 2013. On the same day after vaccination, he experienced redness and swelling at the injection site on left arm. These symptoms were subsided on the next day. The outcome of the events was reported as completely recovered. The seriousness and causality of the events was not reported.
Beginning on August 4th I started feeling a heavy chest with pressure. That continued until the 6th of August when I developed shortness of breath as well. Extreme fatigue, the feeling of a fluttering heart, and skipping beats developed on the 7th as well as the extreme chest pressure still being present. I have been seen at the hospital twice now due to these very worrisome and scary symptoms.
WE CALLED PATIENT ON 3/2/21 BECAUSE HE HAD NOT SHOWED UP FOR HIS 2ND DOSE.  THE PERSON WHO ANSWERED THE PHONE NOTIFIED US THAT PATIENT PASSED AWAY AT MEDICAL CENTER ON 2/13/21.
Stroke.  Began with full paralysis and no speech.  After 1 night at hospital and meds, has been extubated and can move right  side.  Some  speech has returned.
got shots and got shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got the shots and got shingles anyway. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
This spontaneous report was received from a Licensed Vocational Nurse (LVN), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength, dose number, dose and frequency were not reported) orally, lot number M041184, expiration date 31-MAY-2018, for prophylaxis.  On an unspecified date, the vaccine was exposure to a temperature excursion; the data logger registered a temperature of 70.7° Fahrenheit (F) during a time frame of 2 hours and 36 minutes. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA000593: US-009507513-1710USA011267: US-009507513-1710USA011269: US-009507513-1710USA011270: US-009507513-1710USA011271: US-009507513-1710USA011272: US-009507513-1710USA011273: US-009507513-1710USA011274: US-009507513-1710USA011275.
pt recvd vax on 22OCT92 & the next day herpes simplex recurred on the palm of rt hand; treated w/Zovirax; No further details were provided;
Did not feel good and joint pains getting a lot worse in the shoulders; Did not feel good; Feeling sick; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), MALAISE (Did not feel good), ARTHRALGIA (Did not feel good and joint pains getting a lot worse in the shoulders) and CHILLS (Chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 30-Aug-2021, the patient experienced MALAISE (Feeling sick) and CHILLS (Chills). On 31-Aug-2021, the patient experienced MALAISE (Did not feel good). On an unknown date, the patient experienced ARTHRALGIA (Did not feel good and joint pains getting a lot worse in the shoulders). In 2021, MALAISE (Did not feel good) and CHILLS (Chills) had resolved. On 30-Aug-2021, MALAISE (Feeling sick) had resolved. At the time of the report, ARTHRALGIA (Did not feel good and joint pains getting a lot worse in the shoulders) had not resolved.            No concomitant medication information was reported.  No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.
Pt tested POS for Covid 19 on 7/20/21 symptoms started on 7/19/21
had a cough; she was tired; she had body chills; she had some kind of upper respiratory infection; congestion; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient had no medical history and did not take any concomitant medications. On an unspecified date after dose 1 of BNT162B2 the patient experienced a cough, she was tired, and she had body chills. She was struggling for two weeks maybe. The patient visited an urgent care as a result of the events and she had some kind of upper respiratory infection. After almost two and a half weeks after the first dose, or maybe a little longer, she was struggling with cough and congestion but she doesn't think that she has completely recovered. Once in a while she will start coughing and she doesn't know if she is one hundred percent recovered. The outcomes of cough, she was tired, chills, upper respiratory infection, and congestion were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient was going to lay down on exam table but fell. Injury chin and braces injury mouth. Complain about being dizzy and body feeling shaky. Also shaking inside. Incident happen around 8:50 am. Dr assessment of situation. Gave fluids and cracker and check BP.
TEMPERATURE OF 99.4; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included RA. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced temperature of 99.4. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.4 F. Treatment medications (dates unspecified) included: celecoxib, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of temperature of 99.4 was not reported. This report was non-serious.
fever 7 days p/vax-ranged form 102-105.4 lasted 5-6days;
SORENESS AT INJECTION SITE, NAUSEA, HEADACHE, CHILLS, FEVER, JOINT PAIN, TINGLING SENSATIONS IN RANDOM SPOTS. TINGLING LASTED THE LONGEST
patient complained to pharmacist on duty on 9/27/19 of having welts on shoulder and torso that comes on and off, starting one day after having injection. He was advised to take benadyl  and follow up with his primary doctor.
7-8-09 receive injection - next day began developing local reaction - red, hot, painful R deltoid. That night developed flu - like Sx - exhausted, body ache's headache dizzy - today, 7-10 systemic Sx improved, but present. Arm still red, painful hot but no itch.
Patient had 1st shot of Gardasil yesterday 20 minutes after started wheezing and sore throat. No Ceoniad dyspnea. She has asthma, O2 96%. Today 5/16, she has a productive cough and wheezing.
Swollen glands in the neck, behind the ears, under the ears, in the head and, pain in the arms they started 9 days after the vaccination and are still present today. I went to a heath center near my home to be check.
5 minutes after flu shot, c/o tightness/thickness in throat. Rx with 0.3cc Epinephrine SQ, Benadryl 50 mgm IM and 0.2cc Epheph. Within next 45 minutes; evaluated by 911 but refused to go with them; transported by family to private MD. Pt states was better by next AM after 2 more doses of po Benadryl.
Per patient's physician: Supraventricular Lymphadenopathy.  Patient states her neck (clavicle) in very swollen and painful (size of golf ball). Should resolve itself in approximately 2 weeks.
Brother had mild case of chicken pox 1 1/2 weeks ago. 10/8/03 pt broke out with chicken pox, mild case, less than 20 spots. 2 spots look water filled, slightly itchy. No fever, not sick at all according to mother.
Rapid and irregular heart beat described in the ER as A-Flutter and possibly A-Fib
Vaccine expired 9/21/21 and was administered to patient prior to knowledge of expiration date. No adverse reaction noted. Moderna notified and will call back with any needed follow up.