chrisvoncsefalvay/vaers-outcomes huggingface dataset:
All over body rash and hives. Body aches and shivering, low grade fever initially. All over body hives were solid red and I experienced five pounds watch weight gain. All resolved except for itchy post hive dry skin in four days.
Blood pressure and heart rate sky rocketed immediately after shot-did not come down and after an hour went to the ER- was in the ER for 8 hours with continued symptoms. This is a young man with no precious hx of this. Hospital would not entertain the idea this was related to the vaccine. Was discharged with instructions to return if worse in the AM. Continued high blood pressure and heart rate  for another 24 hrs. Swollen lymph nodes by the next day. Blood work in hospital showed immune response happening but again hospital would not attribute to vaccine.
diluent portion administered alone; diluent portion administered alone; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2022, the patient received Shingrix. On 29th July 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 1-Aug-2022 Reporter's comments: Medical assistant lead reported that the patient received the Shingrix diluent alone. The consented to follow up was granted. The follow up requested by postal. Additional Supportive Information: As patient received the Shingrix diluent alone, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Fever, fatigue, no energy or strength, could not get a full breath, progressed throughout  the day, temp 100.4 heavy sweat until the third morning from onset.  By fourth day all clear.
inject was given @ 1PM @ approx 120 mom states pt fainted & as was trying to revive pt; started kicking legs & throwing arms; anxiety attack;
Tested positive for COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, SARS-CoV-2 test positive: COVID-19 Positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment details were provided.
Hair loss; This is a spontaneous report from a contactable consumer (Patient).  A 43-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date (age at the time of vaccination was 43 years old) as dose 1, single, second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date (age at the time of vaccination was 43 years old) as dose 2, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no other vaccine within 4 weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. On 01Apr2021, the patient experienced Hair loss. After first shot and 2nd. Still loosing hair 3 weeks after 2nd shot. No treatment was received for the event. The clinical outcome of the event was not recovered.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information expected.
severe pain all over the body,whole body was in severe pain"; lack of sleep; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (severe pain all over the body,whole body was in severe pain") and INSOMNIA (lack of sleep) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN (severe pain all over the body,whole body was in severe pain") and INSOMNIA (lack of sleep). At the time of the report, PAIN (severe pain all over the body,whole body was in severe pain") and INSOMNIA (lack of sleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2020, COVID-19: positive (Positive) positive. On 05-Mar-2021, Blood pressure systolic: 190 (High) 190. On 05-Mar-2021, Heart rate: 135 to 140 (abnormal) 135 to 140bpm. On an unknown date, Blood pressure systolic: 140 (normal) 140. On an unknown date, Heart rate: 110 (normal) 110.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       EKG, X-ray of heart and chest has done and started infusion.  Concomitant product use was not provided by the reporter. Treatment information was provided infusion drip at ER.
We gave 3 doses of expired Moderna bivalent; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna bivalent) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna bivalent).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This case contains information about patient 3rd out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730168 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730168:Master Case(Patient 1)
Child was noted to be swollen day after immunizations at office periorbital and pedal edema noted weight gain from 16-12oz to 17-3oz. Urinalysis, serum electrolytes, BUN, creatinine, protein & albumin normal. Weight & edema decreased next day.
Patient reporting post injection pain/soreness in arm.  Shoulder pain and throughout body (wrist, ankles, hip).  Headache.
Sore scratchy throat, hard and painful to swallow.  Inflamed and red throat with small white bumps on tonsils.
Guillain Barre (GBS) Syndrome; This case was reported by a other health professional via call center representative and described the occurrence of guillain barre syndrome in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter had patient with a history of Guillain-Barr syndrome following an influenza vaccination.  The patient received Shingrix on 13th November 2019. The reporter asked was it safe for this patient to receive the Shingrix vaccine. The reporter was consented to follow up.
PATIENT COMPLAINED ABOUT DIARRHEA, CHILLS, NAUSEA AFTER 3 HOURS OF RECIEVING THE VACCINE.
Patient received her COVID Moderna booster vaccine. Per the technician giving the vaccine, she was reportedly feeling anxious and nervous prior to the dose because she does not like needles. Patient reported feeling warm but was able to walk out of the vaccine room without issues. About 5 minutes after, other techs heard her mom ask if she was okay and she was reportedly twitching/shaking and her eyes were going back and forth. Pharmacist on duty checked her blood pressure and it was normal. Mom requested to call 911 and paramedics arrived. She was given water and ice. Ultimately, she did not leave with the paramedics and was okay to go home with her parents.
Redness, swelling of entire L deltoid area. Tympanic temperature 103 on 8/12/03. Seen in emergency dept at hospital on 8/13/03. Diagnosis ? cellulitis vs reaction to DTaP started Augmentin antibiotics 8/13/03.
Arm soreness , fever & chills , body malaise x 2 days Took OTC Tylenol , rest & increase fluid intake
**fatigue 9/13/2021, ongoing** 9/13/2021: left arm pain, chills 9/14/2021: left arm pain/soreness **no symptoms/side effects 9/15/2021-9/18/2021** 9/19/2021-9/21/2021: sudden left arm pain beginning @4:15pm (throbbing every 10-15 seconds) 9/20/2021: indigestion 9/21/2021 hot flash with heart racing (HR in 100s) on the way to work @6am (especially worse on left side of body), dry cough mid-day, indigestion 9/22/2021: left upper/mid back pain (left neck/jaw pain off occasionally), indigestion **menstrual cycle 9/23/2021-9/28/2021** 9/23/2021: heart racing (HR in 100s) with chest tightness on the way to work @6am, indigestion 9/24/2021: heart racing (HR in 90-100s) with chest tightness on the way to work @6am, indigestion, lower abdominal cramps 9/25/2021: congested in the morning (had to clear throat), left chest pain/tightness, left upper/mid back pain, coughing fit @7pm (chest pain worse), indigestion 9/26/2021: congestion/cough, left arm pain/weakness, left knee pain, left upper back/shoulder pain, headache, indigestion 9/27/2021: cough/shortness of breath in the morning HR consistently 90-100 from 7am-3pm **no symptoms/side effects 9/28/2021** 9/29/2021: cough, chest pain with left arm pain @6:20am (O2 sat 92-96%), left arm/chest/back pain throughout morning until 2pm with left arm/leg weakness 9/30/2021: cough/congested with chest tightness on the way to work @6am, left mid/lower back pain mid-day through the evening, left breast/chest pain @8pm 10/1/2021: left chest pain/lump in throat @8pm 10/2/2021: left chest pain in the morning cough from 8am-12pm, headache mid-afternoon, left arm weakness, sneezing 10/3/2021: left chest pain/tightness, headache and dizziness mid-day  **symptoms ongoing - appointment with doctor/NP scheduled for 10/20/2021**
Shot given 11/26/2001. Cellulitis developed 11/28/2001.
I received first dose of vaccine on 08/13/2021 at pharmacy. Later that evening after all expected symptoms i felt extreme pain in my right eye and then my right eye went black for a moment and when i checked mirror my eye had burst blood vessels everywhere and my eye is turning yellow. I am still suffering from pain behind the eye and blurred vision
Nurse did not mix the proper diluent with the powder. No treatment needed. Mother notified. No signs of any complications from client. Will plan on administrating MVC4 again at next months appointment.
Blurred or double vision especially after slight exertion or going up/down stairs, constant fatigue and low-level headache (this has been for more than a week now),  mild spatial disorientation  (as would be evidenced with --one symptom--incorrect typing of keys on keyboard), lack of proper bowl movement (more than 1 week), enhanced appetite (hungry).
Heaviness in chest and slight shortness of breath. I went to my doctor who though I might be having a heart attack. So I went to the ER who said I wasn?t. Chest X-ray showed enlarged heart and decreased lung capacity. Symptoms continue now, 8 days after vaccination.
Excursion in the refrigerator with maximum 49.3 F and minimum 45.8 F temperature/ the refrigerator door was left open for 10 minutes; 5 patients were administered the Moderna Covid 19 vaccine after it suffered a temperature excursion; No adverse reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion in the refrigerator with maximum 49.3 F and minimum 45.8 F temperature/ the refrigerator door was left open for 10 minutes), POOR QUALITY PRODUCT ADMINISTERED (5 patients were administered the Moderna Covid 19 vaccine after it suffered a temperature excursion) and NO ADVERSE EVENT (No adverse reaction) in a 51-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion in the refrigerator with maximum 49.3 F and minimum 45.8 F temperature/ the refrigerator door was left open for 10 minutes), POOR QUALITY PRODUCT ADMINISTERED (5 patients were administered the Moderna Covid 19 vaccine after it suffered a temperature excursion) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion in the refrigerator with maximum 49.3 F and minimum 45.8 F temperature/ the refrigerator door was left open for 10 minutes), POOR QUALITY PRODUCT ADMINISTERED (5 patients were administered the Moderna Covid 19 vaccine after it suffered a temperature excursion) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion in the refrigerator with maximum 49.3 F and minimum 45.8 F temperature/ the refrigerator door was left open for 10 minutes) and POOR QUALITY PRODUCT ADMINISTERED (5 patients were administered the Moderna Covid 19 vaccine after it suffered a temperature excursion).    No concomitant drug information was provided.  Reporter reported that the refrigerator door was left open for ten minutes. Maximum and minimum temperatures reported were 49.3 degree Fahrenheit and 45.8 degree Fahrenheit respectively. There were 2 Unpunctured and1 punctured VIAL Lot number 060A22A and MFG Exp. Date: 28-AUG-2022 and 1 Punctured vial Lot number 013B22A and MFG Exp. Date: 22-NOV-2022. Vials were moved from freezer to refrigerator on 25-Jul-2022. It was further reported that the unpunctured vial was still in the refrigerator and the punctured ones were discarded.   No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-627779 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2022: Follow-up received, lot number and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-627779:
Vertigo, vestibular neuritis  vomiting tinnitus 2.5 months
Three days after receiving the vaccine, I have a 5 x 5 cm patch of erythema, tenderness, and induration about 5 cm below the injection site. The pain came on suddenly, over a five minute period. My entire arm was also very painful for about 30 minutes. I took Tylenol and the pain diminished. It has now been about an hour and a half since the symptoms started, and the redness and induration persist.
Lymph nodes around the base of her neck, base of her skull and around her clavicle are hurting; muscle soreness; lymph nodes are tender; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes around the base of her neck, base of her skull and around her clavicle are hurting), MYALGIA (muscle soreness), LYMPH NODE PAIN (lymph nodes are tender), CHILLS (chills) and PAIN (body aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D30M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history).    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes around the base of her neck, base of her skull and around her clavicle are hurting), MYALGIA (muscle soreness), LYMPH NODE PAIN (lymph nodes are tender), CHILLS (chills) and PAIN (body aches). At the time of the report, LYMPHADENOPATHY (Lymph nodes around the base of her neck, base of her skull and around her clavicle are hurting), MYALGIA (muscle soreness), LYMPH NODE PAIN (lymph nodes are tender), CHILLS (chills) and PAIN (body aches) outcome was unknown.            no concomitant medication Patient has taken treatment tylenol
Covid vaccine documentation: PT admitted 12/11/21. POC SARS COV2 ANTIGEN POS 12/11/21. PT documented to have SOB, generalized weakness, dyspnea, HA. PT first tested positive 2 weeks prior to admission but was documented to have increased SOB. Moderna dose 1 received 2/10/21 Lot 031M20A. Moderna dose 2 received 3/10/21 Lot 026A21A. PT currently admitted.
The vial experienced excursion in the refrigerator on 03OCT2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes; No adverse event; 11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial experienced excursion in the refrigerator on 03OCT2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The vial experienced excursion in the refrigerator on 03OCT2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial experienced excursion in the refrigerator on 03OCT2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (The vial experienced excursion in the refrigerator on 03OCT2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes).    No concomitant information was reported. It was reported that excursion occurred in refrigerator on 03-Oct-2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes.It was the first time the excursion occurred. It was reported that some of the vials were used and some were discarded. Treatment medications were not provided. This case was reported for patient 1 of 11 adult patients.
The next day I had extreme fatigue to the point we couldn't even get off the couch. My left arm was swelling, hot, and red. It surprised me because I did not have any problems with the other two.  I recovered from this by the fourth day.
12 hours after my injection, by temperature shot up to 103.  I experienced tachycardia with my pulse ranging from 130-140. My heart rate went even higher.  My normal pulse range is 60-70. My resting heart rate is range is 50-60. Additionally,  I experienced chest pressure, chills.  I'm still experiencing sudden burst of tachycardia and chest pressure today, seven days after my vaccine.
C/o lightheadedness/slight nausea 5 minutes after vaccination. Reports this happened with 1st vaccine. States it is anxiety regarding vaccination and not adverse reaction to vaccine. Sat w/ feet elevated. At 1529, feeling better. No lightheadedness. 1535 patient states she is back to baseline. Standing up without symptoms. Discharged to self. Walked back to vehicle with friend
I experienced a red flushing and hives on my face as well as a tightening in my chest
pt recv vax; exp febrile sz lasting 1-3 min which resolved spontaneously;to ER & tx w/ acetaminophen for fever;
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 13-MAR-2017, the patient was vaccinated with an expired dose of PROQUAD lot # L034932, expiry date 03-MAR-2017 (dose and route of administration were not reported), which was reconstituted with sterile water diluent. No adverse effects were reported. Additional information has been requested.
10/6/15 noted lymphadenopathy left axilla. No other symptoms. 10/7/15 called PCP to report. Ok to keep already scheduled appointment 11/4/15 and not sooner.
I had chest pain after taking my 2nd dose. I also experienced a breakthrough case of COVID-19. I tested positive for COVID-19 on 10/18/2021. My symptoms included: sneezing, fever, loss of smell, watery red eyes, joint pain, and stomach pain. I was diagnosed with Pancreatitis on 11/01/2021.
Patient fainted about 1 minute after 2 injections were given.  She slumped to floor, hit head on rug and awoke spontaneously.  She remained nervous and fearful for 20 more minutes.  Blood Pressure 94/62.  Mother was with child and she was transported to home.  Patient walked to car.