chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician via a company representative referring to two patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the patients were vaccinated with ZOSTAVAX (strength, frequency, lot number and expiration date were unknown), 0.65 ml, subcutaneously. On unknown dates, the patients developed shingles after being vaccinated with ZOSTAVAX. The outcome of the event was unknown. The causal relationship between ZOSTAVAX and the event was unknown. Additional information has been requested.
Initial report received from a healthcare provider on 25-OCT-2005. A cluster of three patients experienced a "black dot" at the injection site after receiving an intramuscular deltoid injection of FLUZONE, lot number U1819AA, on an unknown date. The patients' ages, names, and dates of birth were not reported. Per the reporter, the black dot was noticed after injecting the FLUZONE. The reporter states the black dot wouldn't wipe off, and that she felt that it was an impression or outline from the diameter of the needle, not really a black mark on the skin. One inch 25 gauge needles and safety glide syringes are the devices used. This event occurred three times, and then the staff began using new needles for injection. There have been no additional occurrences since. They routinely use alcohol to prep the vial stopper. No adverse events have been reported from the three patients, and no patients have called back concerning the black dot at the injection site. The status of the patients' "black dot" was unknown. Follow-up information received on 22-FEB-2006 and 27-FEB-2006. Per reporter there is no additional information available. To the reporters' knowledge none of the patients had any adverse event except for the black dot at the site of administration. No further information expected.
Does not want to get out of bed; unable to eat; Stomach pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Does not want to get out of bed), FEEDING DISORDER (unable to eat), ABDOMINAL PAIN UPPER (Stomach pain) and FATIGUE (fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced ASTHENIA (Does not want to get out of bed), FEEDING DISORDER (unable to eat), ABDOMINAL PAIN UPPER (Stomach pain) and FATIGUE (fatigue). At the time of the report, ASTHENIA (Does not want to get out of bed), FEEDING DISORDER (unable to eat), ABDOMINAL PAIN UPPER (Stomach pain) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.
ROUGHLY 30SECONDS AFTER THE DOSE WAS ADMINISTERED THE PATIENT STATED HE WAS DIZZY.  HE BEGAN SWEATING AND BECAME VERY PALE.  I GAVE HIM SOME WATER.  HE THEN PROCEEDED TO PASS OUT AND WAS STRUGGLING TO BREATH.  I CAUGHT HIMM BEFORE HE FELL AND ANOTHER PERSON HELPED ME HOLD HIM THE THE CHAIR.  I ADMINISTERED AN ADULT DOSE 0.3MG OF EPINEPHRINE WHICH REVIVED HIM AND ALLOWED HIM TO RESURE BREATHING.  911 WAS CALLED AND HE WAS TAKEN TO THE HOSPITAL
uncontrollable crying; Initial information received on 06-Apr-2022 regarding an unsolicited valid non-serious case received from other health care professional via call center.  This case involves a 2 months old male patient who experienced uncontrollable crying while receiving vaccine Diphtheria-15/Tetanus/5 AC pertussis vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Jun-2021, the patient received a Dose 1, 0.5 ml total of suspect Diphtheria-15/Tetanus/5 AC pertussis vaccine (formulation, route: unknown) (lot C5765BA, expiry date unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious uncontrollable crying (crying) (unknown latency) following the administration of Diphtheria-15/Tetanus/5 AC pertussis vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (uncontrollable crying).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event uncontrollable crying.
sore arm the next day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm the next day) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm the next day). At the time of the report, PAIN IN EXTREMITY (sore arm the next day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.    Reporter did not allow further contact
hives all over; This is a spontaneous report from a non-contactable Nurse. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration on 21Dec2020 at single dose (dose 1) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received her first dose of the COVID vaccine on 21Dec2020; she woke up on 04Jan2021 (2 weeks later) with hives all over. Patient stated that she know this can happen right after injection, but it has been 2 weeks. Patient stated that she is due for the 2nd dose soon and was concerned. Event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
generalized spasm of shoulder approximately 4 inches proximal to injection site, starting 2 days after injection and persisting as of 4/13/23.
1-2 days later, he started having soreness around lymph node in the armpit of left arm. He also had discomfort in the left chest. No pulpitation noticed.  The symptoms lasted for 1 week. He did not need to seek any medical treatment.  He did not take any medications.
This case was reported by a consumer and described the occurrence of blood pressure fluctuation in a female patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced blood pressure fluctuation, palpitation, unwell, unable to swallow and hyperacidity. On an unknown date, the outcome of the blood pressure fluctuation, palpitation, unwell, unable to swallow and hyperacidity were unknown. It was unknown if the reporter considered the blood pressure fluctuation, palpitation, unwell, unable to swallow and hyperacidity to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. Colleague reported that she was informed of an adverse event with a flu vaccine by her sister-in-law, who herself was informed by the patient (who was also her sister, living in another country). On the reporting date, the patient had to go to the physician because she could not swallow any food anymore. The physician prescribed something for acid in the stomach and if it was not going better, then the patient had to go back the next week. The patient was not well. The patient experienced heart palpitations and varying blood pressure. The patient wanted to know whether a flu vaccine can give such adverse events, because according to her everything started after administration of the flu vaccine. She had mailed some general information regarding flu vaccine to her sister as well. The colleague stated that the patient did not want to give any further information to GSK. The reporter only had the data mentioned in her mail and did not know which flu vaccine was concerned and did not have any details about the doctor.
Fever, stomachache, head ache, neck ache, general soreness, sore throat, congestion.
Boil/rash on her left side of her face (3 bubbles); Right side upper thigh itchy/face itchy; right side upper thigh 3 bumps/left finger 2 bumps; This spontaneous case was reported by a consumer and describes the occurrence of FURUNCLE (Boil/rash on her left side of her face (3 bubbles)), PRURITUS (Right side upper thigh itchy/face itchy) and SWELLING (right side upper thigh 3 bumps/left finger 2 bumps) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced FURUNCLE (Boil/rash on her left side of her face (3 bubbles)), PRURITUS (Right side upper thigh itchy/face itchy) and SWELLING (right side upper thigh 3 bumps/left finger 2 bumps). At the time of the report, FURUNCLE (Boil/rash on her left side of her face (3 bubbles)), PRURITUS (Right side upper thigh itchy/face itchy) and SWELLING (right side upper thigh 3 bumps/left finger 2 bumps) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: No specific follow-up information recorded.
shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or about 18-NOV-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions, in a pharmacy. Subsequent to the patient's inoculation with zoster vaccine live (ZOSTAVAX), she was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was reported as not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Voice became hoarse, tongue felt like it was being stabbed with needles, and broke out in a rash on my stomach, became very lightheaded. I still have a knot on my arm almost five days later and arm still hurts very bad. Was given a shot of 50mg of Benadryl, and symptoms subsided.
fever of 100.1 23 hrs after vaccine. 8am on the 28th of july. broke out in hives all over face, behind ears, neck, back, chest. very irritatable
Coughing when I take full breath; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing when I take full breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    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 COUGH (Coughing when I take full breath). At the time of the report, COUGH (Coughing when I take full breath) outcome was unknown.
NASAL DRAINAGE; FEELING CHILLS; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: 25-MAY-2021) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-AUG-2021, the patient experienced nasal drainage. On 06-AUG-2021, the patient experienced feeling chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nasal drainage, and feeling chills on AUG-2021. This report was non-serious.
Anaphylactic response noted at 0955: Audible wheezing and dyspnea-Epipen 0.3mg administered to Left outer thigh. 0958 911 called. 1005 EMT on scene. SaO2 96 Room Air and HR 112. Taking sips of PO fluids (water).1015 Decreased audible wheezing 2LNC Sao2 98 and HR 115 States "feeling better".. 1020 Room Air SaO2 98 HR 111. States feeling better. Without audible wheezing. Spoke with Dr and gave report. Patient encouraged to go to hospital now but she refused. Explained risk of rebound respiratory event for next 6 hours. Patient acknowledged understanding but still refused transport to ER. 1025 Room Air SaO2 98 HR 105 Talking Alert Drinking water Offers no complaints. States she "feels better". Still refusing transport by EMT to hospital. Stated she does not regret having vaccine. Stated she "wanted to get the vaccine." No Chest pain No dyspnea. 1030 Signed AMA (a copy scanned into chart). Walked out of clinic with escort. No complaints. No dyspnea. Advised to call 911 immediately if any adverse effects. Verbalized she understands risks and recommended treatment needed. Called patient at 1412 and left VM inquiring about her and asked she return my call.
Information has been received from a registered nurse concerning a multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported.  Since 28-NOV-2016, the patients had been administered improperly stored doses of PNEUMOVAX23 lot # M020521, expiration date 17-NOV-2017, (dosages and therapy routes were not provided), for prophylaxis. No adverse experiences had been reported. The doses of PNEUMOVAX23 were exposed to a temperature >46°F but <77°F and were out of range for 21 hours. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA003203: US-009507513-1701USA003709: US-009507513-1701USA003711: US-009507513-1701USA003712:
History of Bell's Palsy. This type of  pain by R neck off and on for the first week. Also  Fatique 1/3 started. On  1/9/2021 started having  jaw/ neck pain. To ED where CT scan showed inflammation around parotid gland. The doctors had never seen this before, I was  told it was viral and to take ASA for pain, rest and fluids.   Swelling decreased with ice pack although not totally resolved on 1/10/2020. Still fatigue.
administered some vaccine that were expired a week ago. It was kept in the fridge.; patients were administered an "expired" vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (administered some vaccine that were expired a week ago. It was kept in the fridge.) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were administered an "expired" vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered some vaccine that were expired a week ago. It was kept in the fridge.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (administered some vaccine that were expired a week ago. It was kept in the fridge.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that the vaccines expired a week ago. The vial did not undergo any temperature excursions. Vials were stored in the refrigerator on 28-Feb-2022   This case was linked to MOD-2022-543471 (Patient Link).
Patient described a frozen shoulder that she was seen for 8 weeks after the shot was given. She says that she is going to physical therapy now. She said that she did not notice anything different from a normal vaccination over the first week after the shot.
Approx 7-10 days after receiving my 2nd vaccine I developed asthma like symptoms-wheezing at night, difficulty breathing with exercise, chest tightness
Family member of pt approached observation nurse stating pt was complaining that left arm (site of injection) was tingling and numb. On-site EMTs transported pt by wheelchair to observation area outside ballroom. Pt was able to speak, appeared calm. Per family member, pt has history of HTN, which has been well controlled. VS taken: T WNL, BP 172/100(!), HR 93, SpO2 98% on room air. Pt and family were advised BP was well above normal limits and advised transport to hospital for assessment. Pt declined. Pt was observed for an additional 30 min w/ repeated VS monitoring. At 30 min, pt's BP had declined to 142/96, HR 83 bpm, SpO2 99% on room air. Pt and family were advised pt should still be evaluated for BP spike. Pt and family stated understanding and stated they would contact PCP when they reached home. Again declined transport to ED for eval. Pt verbalized feeling better, left with family.
she reported the arm was red-swollen and hurt- she use ice and ibuprofen- for 4 days
Approximately 6 months after taking her last HPV vaccine dose, my daughter began seeing blood in her stools accompanied by bouts of exhaustion. She was diagnosed with Ulcerative Colitis and her health has deteriorated since then. Even after trying numerous medications, GI doctors have not been able to bring her into remission since March 2020. She had an ileostomy in Aug of 2020 which ended up worsening her colitis and causing worsening symptoms. She also got perianal disease at this time, which was treated with multiple procedures and a skin flap surgery July 2021, but none of them worked. The surgery left her with wounds around and inside her anus that still have not healed to this day. The anal pain is so intense during the 8-12 stools she has per day that she requires narcotics to get her through them. The past few years have been consumed with pain, sickness, extended hospital stays, and emotional trauma caused by the relentless and unresolved nature of her illness. She missed her entire senior year of high school last year, attempted to return this fall only to repeatedly become sick causing her to take another medical leave. We are not anti-vaxxers. As there is no family history of IBD, we are still baffled by what could have triggered this reaction a once healthy girl. Because the HPV vaccine was the only thing new in her life, we want to be able to warn others in the event it may have had anything to do with this tragic outcome. my daughter has had numerous testing since her diagnosis in 2019. I cannot list them all here but can provide release of her medical records if it would help.
phlegm/when she coughs, mucus comes out from behind her throat//woke up with a lot of mucus/coughs; feels choked; coughs; same red blister for two days; burned; vaccine turned red; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (phlegm/when she coughs, mucus comes out from behind her throat//woke up with a lot of mucus/coughs), CHOKING SENSATION (feels choked), COUGH (coughs), VACCINATION SITE VESICLES (same red blister for two days) and VACCINATION SITE PAIN (burned) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE PAIN (burned) and VACCINATION SITE ERYTHEMA (vaccine turned red). On 04-May-2021, the patient experienced VACCINATION SITE VESICLES (same red blister for two days). On 24-May-2021, the patient experienced PRODUCTIVE COUGH (phlegm/when she coughs, mucus comes out from behind her throat//woke up with a lot of mucus/coughs), CHOKING SENSATION (feels choked) and COUGH (coughs). On 28-Apr-2021, VACCINATION SITE PAIN (burned) and VACCINATION SITE ERYTHEMA (vaccine turned red) had resolved. On 06-May-2021, VACCINATION SITE VESICLES (same red blister for two days) had resolved. At the time of the report, PRODUCTIVE COUGH (phlegm/when she coughs, mucus comes out from behind her throat//woke up with a lot of mucus/coughs), CHOKING SENSATION (feels choked) and COUGH (coughs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medication was not reported. No treatment information was provided.  On 24-May-2021, the patient had an appointment to receive the second dose. It was reported that the patient did not have a fever (temp 97.1).
On 8/2/ 2021 I received my 1st Moderna Covid 19 vaccine.  Within 24 hours I noticed my feet, ankles and shins on both legs itching. Within another day I notice my knees, thigh and hip were itching constantly. I tried to disregard it until I realized my arms, trunk, forearms, hands, back as well as lower extremities were all itching, and it was constant. I tried to mentally ignore and consciously avoid scratching.  I did not have a rash or any other skin irritation. I was on vacation and tolerated the continuous annoyance and on 8/25/2021 the itch was unbearable, and I went to urgent care to be assessed and get medication. I was diagnosed with Pruritus (unspecified) and given an injection of dexamethasone (4mg/ml)
12/16, slight itching, localized L/arm at vaccine, 12/17 more itching, hot, red, swollen, slight rash, no fever.