chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 61-year-old female patient, reporting on herself. The patient's medical history included shingles on an unknown date in 2014 or 2015 (reported as "3 or 4 years ago"), again 2 months later and for the third time in September or October 2017. The patient's concurrent condition included allergies to an unspecified penicillin and DILAUDID. On an unknown date in November 2017, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot number and expiration date were not reported) to help prevent the recurrences of shingles. On 12-FEB-2018 the patient started to get rash on her leg and it was shingles again. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "after 5 covid Pfizer vaccines and my last vaccine was a bivalent, 2 months ago, and I'm covid positive now". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
2nd day after shot severe flu for 3 days, then multiple times during the month I have occasions of severe chills and puts me down for each day. This has happened at least 6 times this month and twice this past week.
After receiving my second dose, i started to feel very sick, by the second day after the vaccination, I had a severe headache, my eyes couldn't focus i was nauseous and i was vomiting, sever upper body pains,  it was the worst headache I have ever had in my life, my husband took me to the emergency room yesterday and i was there all day, I had a neurological exam, blood work and chest x-ray, everything came back negative, i was told my the attending physician that it was the side effects of the second dose of the Pfizer Vaccine.  I was given Motrin 600mg and  Metoclopramide via intravenous, several hours later, i was feeling a bit better and i was released from the hospital by 4:30pm.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe.
UPON ADMINISTERING VACCINE, ARM IMMEDIATELY BEGAN TO SWELL AROUND INJECTION SITE. A HARD KNOT APPEARED BENEATH THE SKIN. PATIENT'S ARM BRUISED WITHIN 30 MINUTES AND WAS SORE FOR A FEW DAYS. PATIENT SAT FOR 30 MINUTES TO ENSURE REACTION WAS LOCAL, ADVISED TO USE ICE PACK FOR SORENESS.
a 2 inch red round circular rash about 2 inches below injection site. Appeared about 10 days after injection. no itching & rash seems to be disappearing about 3 days after it was noticed. No fever or body aches noticed.
The  following lasted several days. The shortness of breath elevated heart rate and fatigue continued since injection. Chest pain Rapid and somewhat abnormal heartbeat  Shortness of breath, at rest and  during activity Swelling in legs, ankles and feet Fatigue Headache Body aches Joint pain Fever Sore throat Diarrhea
Patient was given the flu vaccine in her left upper arm at 08:30 on 12/08/2004. Reports the injection was more painful than usual. After returning to work had increasing radiating pain in shoulder, neck and chest. Not relieved with heat/cold, Ibuprofen or vicodin.
Received KINRIX and PROQUAD on 5/31/17. Developed dermatitis on (R) and (L) shoulders (Rx).
Pt reported on 4-12-21: after 1st vaccine dose 3/12/21 - 2 days later (3/14) had a large menstrual clot with bright red blood behind it. 3/15/21 blood flow stopped  After Dose 2 (4/9/21) started with menstrual bleeding 4/11/21 with large blood clots & (heavy) bright red blood. terrible uterine cramping has slowed to spotting 4/12/21 hx: Mirena IUD
It was reported in a letter to the editor that a 55 year old female patient with HIV infection was vaccinated with influenza vaccine 3 weeks prior to Herpes Zoster Vaccine (HZV). On an unknown date, the patient with CD4 count of 455 cells/uL, was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (lot number expiration date, dose, route were not provided). It was reported that pneumococcal vaccine (23-valent) (manufacturer unknown) (lot number expiration date, dose, route were not provided), was given concurrently. On an unknown date, 11 hours after HZV, the patient developed grade 3 injection site reactions (pain and tenderness, causing inability to perform activities). Then, one year after HZV, the patient developed rash consistent with dermatomal varicella zoster virus (VZV) infection and did not require hospitalization or treatment. The outcome of injection site reaction and VZV was unknown at the time of the report. The reporter considered injection site reaction and varicella virus infection to be related to Zoster Vaccine Live (manufacturer unknown). This is one of two reports from the same source (US-009507513-1604US004494).
Abdominal Pain in my entire abdomen.  It even hurt to walk or hit a bump.
G47.33 OBSTRUCTIVE SLEEP APNEA 3/8/2023 BRAIN MASS G62.9 NEUROPATHY 9/22/2022 BRAIN MASS
Swelling and pain around injection site and radiating around. Unable to lift arm fully. Unable to sleep or lean on arm.
11-27-09 Office visit with MD for localized reaction deltoid area right arm. 6.2 cm firm, red, warm, mildly tender to palpation. Good ROM to right arm. No other signs or symptoms. TYLENOL, ADVIL, BENADRYL AND prednisone.
Patient stated that 24 hours after vaccination she developed low grade fever, stiff neck, muscle pains on the right side of her body. Symptoms continued for three days but were lessened by the use of ibuprofen.
9-16-11 patient went back to clinic, 2 days after pneu. injection received and reported redness, hard, mild itching, swelling and pain at injections site.  Follow up phone call with patient on 11-6-11, patient stated the symptoms lasted for approx 2 weeks. symptoms: swelling hard to the touch red 'not pink', 1" from injection site, to below her elbow. Pain rated as a 7-8 (Painscale 1<10). Patient denies fever.  Patient states she followed up with her PCP, and No treatment was rendered.
This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 62-year-old female patient who received FLUARIX. In October 2015, the patient received FLUARIX .5 ml. On 11th October 2015, less than a month after receiving FLUARIX, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was recovered/resolved. The reporter considered the vesicular rash to be probably related to FLUARIX. Additional details were provided as follows: This case was previously reported to a doctor. The doctor reported that the patient blistering red rash after receiving the vaccination. The date of vaccination and batch number of the vaccine was unknown. The doctor was unsure of the injection site and vaccine administration site was not available.
Scheduled for Moderna follow-up (second dose 0.5ml) received half dose (0.25ml). Patient called to come back for other half (0.25ml) of dose.
Gradual onset of allergic responses to diet (that previously was not a problem) including increase of GERD symptoms, weight loss, and eczema. Changed diet on 11/24/2016 to hypoallergenic formula and patient showed gradual improvement of symptoms. Allergy skin test was postponed until 3/23/2017 for accuracy. Skin test confirmed severe allergies to milk, eggs, peanuts, tree nuts, and soy. No genetic history of allergies.
Patient was immunized with vaccine that has beyond-use-date of 7/15/22; MFG: 11/2021; EXP: 10/31/22. No temperature excursion during this time period. We have reached out to Pfizer for additional information the vaccine viability past the Beyond Use Date, currently waiting on response.
Began bleeding; Began spotting; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Began bleeding) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Began bleeding) (seriousness criterion medically significant) and VAGINAL HAEMORRHAGE (Began spotting). At the time of the report, HAEMORRHAGE (Began bleeding) and VAGINAL HAEMORRHAGE (Began spotting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 16-year-old female patient of an unspecified ethnicity received TRUMENBA on an unspecified date at single dose for immunisation . The patient medical history and concomitant medications were not reported. The day after vaccination with meningococcal group b rlp2086, the patient had "a soar arm". Outcome of the event was unknown.   .
12/23/21 presents to ED EC for "syncope/ fall". PMHx of "HTN, CAD w/ CABG, CHF, anemia, CKD, GERD, multiple myeloma on chemo".
Reports developed redness, swelling and itchiness at injection site. Onset was 1 week after she received the vaccine. Referred to her PCP for evaluation.
This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided. On 02-OCT-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ 1 dose orally, lot number lot M043836 and expiration date 17-JUN-2018 (strength and frequency were not reported) for prophylaxis. No adverse effects reported. The vaccine was stored at a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit, time frame of 12 hours and no previous temperature excursion. Digital Data logger was involved. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1710USA001900: US-009507513-1710USA001694.
I had severe breakout of hives of full body and itching; went to the Dermatologist prescribed cream; a week for my symptoms to subside.
2-3  hours after the injection I developed a slightly elevated temperature, a headache and severe nausea which resolved approximately 4 hours later.  There was no vomiting.  12 hours later there was still a slight headache.
PATIENT REPORTS A SORE ARM FOR ABOUT A DAY AFTER RECEIVING 3RD DOSE
Redness, heat, tenderness, throbbing red area at 6" from inject site. Reaction noted at 1AM day of injection. Reaction to flu shot at 5 years old, prior pneumo shot no reaction.
Unknown exposure at the day prior to vaccine. Started having symptoms 12/24 tested positive 12/25
devel >50 vesicular lesions on red bases 3wk p/exposure to shingles;also w/fever;
Client presented to the local public health center for first dose of Pfizer COVID vaccine. Client reported he had COVID infection in February 1, 2022 and recovered. No known allergies and no medical history. Client received his first dose Pfizer COVID vaccine at 12:38 PM. At 12:48 PM, during the 15 minutes observation, the patient in sitting position with both his arms resting on his legs, was found with blank gaze, his head rolled on left side and then back, pale face and sweat beads on his forehead. Vital signs were taken: Blood pressure 122/72, respiration rate 18, heart rate 80. With speak arousal, the client was alert and able to state where he is and what happened. Client reported he felt dizzy and nauseous and added that he did not have any food since morning. Client was repositioned on anti-gravity chair. At 12:50 PM, client took sips of water and after two minutes he stated he is "less dizzy and nauseous." At 12:52 blood pressure was 112/72, respiration rate 17, heart rate 72. Client denied headache or any other symptoms. At 12:58 Vital signs were retaken: blood pressure 110/70, respiration 16 and heart rate 72. At 1:02 PM, client's face was no longer pale with even skin color and no longer sweaty. Client sat in observation for additional 30 minutes. Nurse informed client to follow-up with his primary care provider and educated on possible adverse effect, when to seek medical care and register on V-Safe. Client verbalized understanding. At 1:15 PM, Client complained of blurry vision. Client appeared with pale face, moist skin and stated he felt dizzy again. Vital sign was taken: blood pressure 96/66, respiration 17, heart rate 70. Nurse called for paramedic to call 911. At 1:17 PM, 911 call was made. Paramedic repositioned client to Semi-Fowler's position. Vital sign was retaken: blood pressure 98/68, respiration 16, heart rate 70. Client complained his muscles feel "stiff" and nauseous. At 1:22 PM vital sign was taken: blood pressure 110/70, respiration 17, heart rate 69. At 1:22 PM the ambulance arrived to the clinic waiting room. After the emergency medical team made their assessment, the client was transferred to a gurney and left the site at 1:25 PM.
The night of the vaccines- 3/13/07 (Pediarix, Hib, Prevnar, RotaTeq) the baby got a rash that I saw on 3/17/07 and recognized as Erythema Multiforme Minor.  The child's rash was resolved by 3/19 by history.  I am unsure how to give the 4 month old shots.
Pt reports that she develops vaginal bleeding and cramping starting after 2nd shot for COVID 19
See previous page. With the first shot, I developed Covid a room and was put on antibiotics eight days after the first shot. With second shot they developed fever, chills, severe shaking, body aches, massive headache, severe fatigue, and diarrhea. Was unable to get out of bed for 48 hours. After 36 hours developed a heaviness in tightening in my chest which made breathing feel restricted. Was very weak and fatigued and unable to go to work for a full five days after receiving the second dose of Moderna Covid vaccine.
8/30/2021 at approximately 3:30 pm I started sneezing and began having extreme sinus pressure and ear pressure. My nasal passages became inflamed. I was extremely fatigued. I was not running a fever.  I performed an OTC  COVID test and it was positive. I then went to and had a Sofia SARS Antigen test performed at 8:56 pm. The results were positive. On 8/31/2021 I list my sense of smell and taste.. My symptoms were that of an upper respiratory infection.  My oxygen level stayed between 96 to 99.  I never developed a cough and never had a fever. My highest temperature was 99.7.  I was prescribed the following: 325 mg aspirin 4000 IU Vitamin D3 1000 mg Vitamin C twice a Day 100 mg Zinc 500 mg Qucertin 10 mg melatonin   ZPac  Ivermectin for 5 days  Monoclonal Antibody infusion
Pt report small blisters at site of injection with 48 degrees, occurred with 1st and 2nd Hep B.
I had a pneumoia and flu shot in the same day one in each arm. A few hours later I got the chills, headache, tight in my chest, felt llike I was getting a sore throat felt like the flu. The arm I had the pneumoia shot in was really sore. The next morning on the 9th I noticed it was all red and swollen and just kept getting worse. The redness and tenderness is still there and I have noticed tonight the red is spreading even more. Over to my arm pit and now almost to my elbow. Im thinking I will go to the emergency room tomorrow if this isn't any better. Im not sure what one of the flu shots or the pnewmoia shot to check on your list. The pharmacist would have that I think, so I just guessed on which one to check. It as just the second year pneumoia and regular flus shot for the year.
Lady contracted covid after receiving 2 doses; Lady contracted covid after receiving 2 doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "Lady contracted covid after receiving 2 doses". It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Other medications in two weeks: unknown. Covid prior vaccination was reported as no and covid tested post vaccination was reported as yes. Patient other medical history and known allergies was reported as unknown.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt rec'd initial DPT/OPV/HIB developed fretful later the same day, rec'd APAP; Stools seemed loose; child voided more than usual; But looked OK next day, died unexpectedly in sleep;
Patient reports severe pain in arm where shot was given, especially when moving arm. It is 18 days since she received the shot and this is the first reporting of it. She said it started immediately after the shot, though she did not mention it at the time. She says the area looks fine, no swelling or redness.
mild virus-like symptoms; muscle aches; Shivers; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL INFECTION (mild virus-like symptoms), MYALGIA (muscle aches) and CHILLS (Shivers) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VIRAL INFECTION (mild virus-like symptoms), MYALGIA (muscle aches) and CHILLS (Shivers). At the time of the report, VIRAL INFECTION (mild virus-like symptoms), MYALGIA (muscle aches) and CHILLS (Shivers) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that, with the previous doses patient had experienced muscle aches, shivers, and mild virus-like symptoms for about a day. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745822 (Linked Report). This case was linked to MOD-2023-745834 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745822:Wife Case
This case was reported by a consumer via call center representative and described the occurrence of herpes virus infection in a 71-year-old female patient who received SHINGRIX for prophylaxis.  Concurrent medical conditions included herpes virus infection (history of herpes since childhood).  On 27th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced herpes virus infection, condition aggravated and cold sore mouth. On an unknown date, the outcome of the herpes virus infection, condition aggravated and cold sore mouth were unknown. It was unknown if the reporter considered the herpes virus infection, condition aggravated and cold sore mouth to be related to SHINGRIX. Additional details were provided as follows: The patient stated that, since getting SHINGRIX she had more problems with herpes outbreaks compared to before getting the SHINGRIX vaccine. The patient had a cold sore on her mouth about 3 weeks before the date of reporting and it took longer than usual to resolve even with medication. The reporter gave consent to follow up.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In April 2017, at age 66, the patient was administered the ZOSTAVAX vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated at a hospital for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Pt recvd MMR vax on 16JUL87 & on 27JAN91 pt had t102 secondary to OM; pt devel congestion & mough ulcers dx viral flu; 31JAN91 devel diarrhea, was lethargic & had red eyes; pt had not urinated for a couple of days; pt hospitalized;
fatigue; headache; This is a spontaneous report from a non-contactable consumer (patient) received via a sales representative.  A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history included COVID-19 from Oct2020 to an unspecified date.  The patient's concomitant medications were not reported. On an unspecified date, the patient experienced fatigue and headache. The patient outcome of the events was recovered (symptoms only lasted for about 24 hours).  No follow-up attempts are possible, information about batch number cannot be obtained.
Starting in the early hours of 02/19/2021, I experienced body aches, a severe headache and nausea/vomitting. I also had a fever. I called the adverse event number and they told me to take Motrin, drink fluids and rest. I ended up taking Motrin, drinking lots of fluids, resting and using a heating pad for my back. The symptoms lasted about 24 hours then resolved.