chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received second dose of Pfizer vaccine and was waiting in the observation area when she fainted and was held to chair by Security Guard and mother. Patient reports that she had not eaten and that she has a history of fainting with other injections/blood draws. Patient was given orange juice and a snack and reported feeling better. RN remained with patient in observation until patient and mother left.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 16-SEP-2016, the patient inadvertently received a dose of ZOSTAVAX(dosing details not known) with lot # L021612 that had expired on 10-SEP-2016, No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
(Vasovagal Response)  Fainted as walking to court yard.  Parent was able to assist w/o fall. Pt laid down and elevated feet. No additional treatment needed.  (Initial BP 80/62 ?  BP 96/68)
On day 3/4 I felt minimal pain in my left armpit at a specific point.  On 3/5 I felt itchy at the site of the vaccine and had a rash, the area quite red. The pain in the armpit had almost disappeared but a small ball (size of a pea) was felt swollen (swollen lymph node).  Nothing serious.
Rash on bilateral arms, neck and face, at approx 12:30 given 25 mg Benadryl denies SOB, no respiratory stridor, no swelling of mouth, lips or tongue, Per doctor would like lab order of Tryptase
TIRED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious.
Injection area is warm, swollen, reddened and slightly bruised in a 1 1/2 x 2 inch oval area at the site. Advised to take her pain med of choice - TYLENOL, ibuprofen, apply ice packs, elevate arm.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild
The day after receiving the vaccine i had a couple of swollen lymph nodes in my neck, and i had a slight headache. I went to the the doctor for an appointment not related to the vaccine and about six weeks later they gave me results and it was said that i was diagnosed with shingles.
I had all the symptoms they mentioned could happen plus some that started the next day and continued for months. The passing tingling and numbness is still occurring today when I sleep. Here's a list of symptoms that occurred in the following days, weeks and months after the shot:  heavy legs and arms (dropping things, unable to do house work, instability, left leg felt paralyzed or weak, entire  body felt week mussels went loose starting in my legs first left then right then arms one after the other then my face. Tingling, numbness, and burning sensations were occurring through out the day and at night. Had to go to urgent care for bruising on inner thigh then for a vein check they said my femoral vein was not working  (venous insufficiency ). Bruising continued on the right leg inner thigh but not as big. I could not walk up stairs the heavyness in my legs was so bad. I had stabbing back pain while walking. Face, arm and leg tingling, numbness and burning continued to the point that I got an MRI with negative results. Cheeks were flushed for weeks after the shot. My period was 16 days early after the shot. The right side of my neck was often stiff and my right arm still cannot bend all the way backwards with out crippling pain that feels paralyzing (it comes and goes) .
Pain/soreness in injection site area lasting around 4 weeks. Patient didn't report till 10/29/16.
arm itching; rash on arm /rash under both arms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm itching) and RASH (rash on arm /rash under both arms) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN POTASSIUM (COZAAR), CARVEDILOL (COREG), ATORVASTATIN and VITAMINS NOS for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PRURITUS (arm itching) and RASH (rash on arm /rash under both arms). At the time of the report, PRURITUS (arm itching) and RASH (rash on arm /rash under both arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment details include cold cloth
Gave HAVRIX #1 in (L) arm and patient said she felt light headed and started to fall, I lowered her to chair.
Had all 3 shingle shots / Light Case of the shingles/ Suspected vaccination failure; Shingles after getting his second Covid-19 shots; Had all 3 shingle shots; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis, Herpes zoster (Shingles vaccine) for prophylaxis and COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine, the 3rd dose of Shingles vaccine and the 2nd dose of COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The patient had all 3 Shingles shot and he got a light case of shingles after getting his 2nd Covid 19 shot. The patient received 3 doses of Shingles vaccine, which led to extra dose administered. The reporter stated that, no vaccine was 100 percent. This case was considered as suspected vaccination failure as details regarding the laboratory test confiding shingles and time to onset for shingles were unknown at the time of reporting. It was unknown if the reporter considered the shingles to be related to Covid 19 vaccine.
This spontaneous report as received from nurse practitioner refers to a 57 year old female patient with multiple sclerosis and not drug allergies. On 22-MAR-2014 the patient was vaccinated with ZOSTAVAX (lot # J003483 exp date 29-JUN-2014), subcutaneous. Concomitant medication were not reported. On 24-MAR-2014, the patient experienced redness and swelling that extended down the right arm from the site of injection. She also developed a headache. The outcome of redness and swelling that extended down the right arm from the site of injection and headache was reported as not recovered. The patient sought medical attention at the physician and nurse office, and no lab were performed. Additional information has been requested.
0848 Pt arrived to observation area per RN. Per RN, no apparent signs of distress or complaints.  0902 Pt c/o sore throat to RN and began to cough. Pt coughing and c/o nausea. Pt states ?feels like my throat closing?. States her tongue feels swollen. 0903 Epi pen 0.3 mg administered to Rt thigh. 0904 Bilat lungs clear per RN. No wheezing noted per auscultation, air movement noted. EMT notified EMS of pt status and need for transport to ED 0905 Pt continued to c/o throat closing, con?t to cough, states she can?t breathe. Pt given Benadryl 50 mg IM to Rt deltoid per RN 0907 Pt states it usually takes 2-3 doses of epinephrine to treat her reactions 0909 Pt con?t to complain of difficulty breathing, cough con?t. Pt given Adrenalin 1mg IM to Lt Deltoid per, RN 0910 BP 122/82 HR 98 SPO2 92% per EMT. 2L of O2 NC applied per EMS. Pt vomited small amount of saliva. Pt?s husband called per Charge RN and will meet pt at ED. 0913 BP 124/palp, SPO2 99% on 2L NC, RR 24 per EMT. Pt continue to talk without difficulty, no vomiting noted 0914 SPO2 98% on 2L NC, 113 pulse. No coughing noted at this time. Skin dry, moist, appropriate. Lungs clear to auscultate.  0915 Pt states she feels like she is ?falling?. Pt laid supine and legs elevated. SPO2 86% on 2L, O2 increased to 4L per EMT. BP 122/88, HR 86 0918 SPO2 98% on 4L NC, no change in status 0920 Pt states she is feeling ?better?, denies complaint of cough, DIB, or nausea. No apparent distress noted 0921 BP 138/76, HR 85, SPO2 98% on 4L O2 NC, EMS arrived to scene. Report given to EMS per RN staff. Pt denies any complaints. Care transferred to EMS 0925 Pt assisted to stretcher without difficulty per EMS and transported to ED.
Aggressive vomiting, diarrea,  weakness, shortness of breath, chills, over sweating  and feeling faint 15hrs after vaccination.  911 came.  Low Blood pressure 89/57
The day of the vaccine the patient was very lethargic and couldn't walk. The next day he couldn't wake until evening time.
Pt. became anxious, cold and developed moderate shivering. Pt. sent to ER for evaluation and treatment.
Wheel noted left arm 1 inch below injection site.  Area erythema, elevation of skin noted with white center.  Advised patient to monitor.
Flu vaccine administered on 09/21/22. Patient developed pain to right arm, axilla and right cervical area with swelling. Treated in ER on 09/24 wuth dexamethasone 10mg IM and benadryl 50mg. Disharged with hydroxizine 50mg 1 tab TID and dexamethasone 4mg 1 tab BID x 3 days. Patient was re-evaluted in our office on 09/26/22. She reports improvement of pain to right axilla and right cervical area but still has swelling. Now developed pain and swelling to left side of neck yesterday. Tiny lymph mode palpated to left posterior cervical area. No axillary lymph nodes palpated. Patient advised to continue dexamethasone and f/u if lymphadenopathy does not resolve.
No additional adverse events.; patient received improperly stored dose of vaccine; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided. Concomitant therapy included sterile diluent (MERCK STERILE DILUENT).         On 02-JAN-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, vaccine dosage detail and route of administration were not reported, lot # S012536, expiration date 20-OCT-2020) for prophylaxis(product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). The storage temperature of the vaccine was 6 Fahrenheit degrees to 14 Fahrenheit degrees (-14 Celsius degrees to -10 Celsius degrees (5.5 Fahrenheit degrees) for 35 minutes. Previous temperature excursion was 6 Fahrenheit degrees to 14 Fahrenheit degrees (-14 Celsius degrees to -10 Celsius degrees (7 Fahrenheit degrees) for 35 minutes. No additional adverse events. Data logger was involved.
THREE DAYS AFTER RECEIVING VACCINE PATIENT DEVELOPED CHEST TIGHTNESS AND WENT TO THE ER.  THEY DID A WORK UP AND DIAGNOSISED IT AS PERICARDITIS
abdominal pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (abdominal pain). At the time of the report, ABDOMINAL PAIN (abdominal pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient developed increased shortness of breath 4/21/21.  Admitted to ICU via emergency with COVID pneumonia despite receiving 2nd COVID vaccination on 3/5/21
At about 10 minutes post injection I began feeling dizzy, lightheaded and hot. Left arm began itching. Discovered hives on my upper arm. 15 minutes later hives had spread to my left shoulder and neck. Paramedics on site gave me a fimotadine tablet and a benedryl injection, juice, water and monitored me. 20 minutes later there was no improvement, they gave another benedryl injection. Dizziness persisted. Hives began to resolve. 40 minutes later they permitted me to leave but said I could not drive, because the dizziness persisted. Advised me to take a benedryl tablet by mouth before bed and again in the morning and to follow up with my PCP.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 67 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursions identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
itchy rash on sight of injection for 1 week, swollen, red, painful, 8cm*10 cm
Information has been received from a physician concerning a 57 year old female patient with diverticulitis, depression and colostomy and no known drug allergies/drug reactions who in 1998 was vaccinated with the first dose of PNEUMOVAX (Lot # 660718/0551X). The patient received the second dose of PNEUMOVAX about 2-3 years ago, (approximately in 2006), and the third dose was given on 10-SEP-2009. There were no other vaccinations at the same time. It was reported that since the recent vaccination the patient had developed a fever as high as 101 F, a swollen injection site of about 4 cm, body aches, elevated blood glucose, tremors in her chest and arms and hallucinations. The patient sought medical attention in the office. It was reported that the patient was treated with TYLENOL, intravenous fluids and insulin. On an unspecified date a blood work was performed (results not provided). It was reported that the patient had not recovered at the time of the  report. The reporting physician considered that fever as high as 101 F, a swollen injection site of about 4 cm, body aches, elevated blood glucose, tremors in her chest and arms and hallucinations required intervention to prevent serious criteria. Additional information has been requested.
Body hurting all over - joint and muscles), eyes burning, completely exhausted, eyes burning, headache, stomach nausea and pain, cold symptoms, perennial cough worse.  No fever
The case was received on 21 March 2014 at GPV. Initial misuse report received from a healthcare professional on 16 September 2013. A 06-month old patient had received 0.5 ml dose of FLUZONE on an unspecified date. No adverse event was reported. List of documents held by sender: none
Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION FAILURE (Lack of efficacy) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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. On an unknown date, the patient experienced VACCINATION FAILURE (Lack of efficacy). At the time of the report, VACCINATION FAILURE (Lack of efficacy) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Patient year of birth reported as 1968.  No concomitant medications were reported.   It was unknown if the event cause the patient to seek medical care.  No treatment medication was provided. Company Comment: This is a spontaneous case concerning an adult male patient, with no reported medical history, who experienced the non-serious unexpected event of Vaccination failure (reported as Lack of efficacy), which occurred on an unknown date after a dose of mRNA-1273.214 (Original/Omicron BA.4/BA.5) vaccine (unknown COVID-19 vaccination schedule). No further information was disclosed. The benefit-risk relationship of mRNA-1273.214 (Original/Omicron BA.4/BA.5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-712903 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712903:cluster case for colleague
Patient experienced the following symptoms: paleness, chills, full body hives, vomiting, difficulty breathing, hoarseness/wheezing, 102.4 fever that wouldn't break, and rapid heartbeat. Also severe body aches and pains.
post vaccination, patient walked to restroom for urine sample to be taken. upon waiting outside of restroom door, patient fainted and hit her head against wall.  patient responded quickly and incident occurred for 1-2 minutes
Patient complaint of dizziness. BP 132/78, P 66, R 16, O2 95%. Head to assessment completed. Patient monitored for 15 minutes. Patient felt better after 15 minutes and left clinic.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 12-AUG-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # J001179, expiration date 31-JAN-2015, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Pt developed pain throughout right arm (deltoid injection) and contracture of right hand muscles at MCP and PIP joints.
broke out, 'looked scarier than what it was'; Hot feeling; redness; experienced adverse events; hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced adverse events), VACCINATION SITE WARMTH (hot to touch), URTICARIA (broke out, 'looked scarier than what it was'), FEELING HOT (Hot feeling) and VACCINATION SITE ERYTHEMA (redness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION COMPLICATION (experienced adverse events), VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE ERYTHEMA (redness). On an unknown date, the patient experienced URTICARIA (broke out, 'looked scarier than what it was') and FEELING HOT (Hot feeling). At the time of the report, VACCINATION COMPLICATION (experienced adverse events), VACCINATION SITE WARMTH (hot to touch), URTICARIA (broke out, 'looked scarier than what it was'), FEELING HOT (Hot feeling) and VACCINATION SITE ERYTHEMA (redness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No Treatment details was included.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Additional information was received on 21-May-2021, patient demographic details (sex) and event outcome updated.
12/24  felt horrible, experienced body aches, chills, dizziness, nausea, night sweats , possible fever , did not check, soreness at injection site. 12/25 felt the same until 12/27
Pt recvd recvd 3 dose of Hep B 1st dose 26JUL90, 2nd dose 26AUG90 & 3rd dose 27FEB91 following 3rd dose devel local rxn that appeared "hot, red, size of a fifty-cent piece;
Within the first hour after receiving the vaccine, I experienced a flushing warm sensation in my skin on my face and neck area.  About 2-3 hours after receiving the vaccine, I broke out in a skin rash on my face, neck, and upper body.  About 2 days later, the rash began to diminish.  Now (6 days later) it has continued to recede (although it is still somewhat visible).
approx. 5-10 minutes after the injection I went to the pharmacy in the same building...just down the hall a short distance.  went to the desk and a very sharp pain hit me in my lower back.  the pain was so severe I could hardly keep from screaming.  my feet would not move and I had to lean on the deck to hold myself up.  I told the clerk I had just received the injection and now I couldn't move my legs.  she just looked blank.  I stood there for a short span of time, gabbed the wall and scooted to a chair and sat down.  The pain was so intense!!!  a person sitting next to me went for help.  They brought a wheelchair and took me back to the clinic.  The LVN reported to an RN (who I never saw or spoke to), she called a doctor (who I never saw or spoke to).  They didn't know what was wrong.  I sat there for about 20-30 minutes and finally felt better.  stood and made it to my car and drove home.  my back was sore for about a day.  Questioning whether I can take other meds not knowing why this happened.  Can I take shingles injection without this happening again.  Was this a trigger for guillain-barre'?  it really scared me!