chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BREAST CANCER; This spontaneous report received from a consumer via a company representative via social media (J and J Corporate) concerned multiple patients (5 women). The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients experienced breast cancer 3 months after covid jab. It was reported that "Natural remedies only. Those covid jabs hurt a lot of people. I know 5 women 3 months after covid jabs got breast cancer". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breast cancer was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221242169-breast cancer. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.
Approximately 1 month after my 4th dose vaccination I contracted COVID-19 and had the following symptoms: cough, sore throat, shortness of breath and fatigue. I took an at home test and it was negative. The next day I went to an urgent care and they thought I was just having a respiratory problem and gave me an antibiotic then my daughter called me to say that I probably was exposed to someone with COVID-19 because we had a gathering last time and someone from there was positive for COVID-19. I got re-tested and the result was positive. I called my primary care and she prescribed me to take PAXLOVID and I started taking it on 05/24 and continued taking it for 4 more days. It did help me feel better, my symptoms have gone away and as of today 06/14 I'm still occasionally coughing but starting to feel back to normal.
This case was reported by a healthcare professional and described the occurrence of low grade fever in a 6-month-old male subject who was vaccinated with HAVRIX 720 for prophylaxis. The subject's medical history included allergic rhinitis and reflux unspecified. Previous and/or concurrent vaccinations included PEDIARIX; unknown given on 18 November 2008; PREVNAR; unknown given on 18 November 2008 and ROTATEQ; unknown given on 18 November 2008. On 18 November 2008 at 10:00, the subject received 1st dose of HAVRIX 720 (.5 ml, unknown, left thigh) and experienced drug use for unapproved indication. At an unspecified time after vaccination with HAVRIX 720, the subject experienced low grade fever. A 6-month-old subject received HAVRIX as ordered by a physician. The subject's mother was concerned about safety since the product is not recommended for 6-months of age. At the time of reporting. the events were unresolved. Follow-up information was received on 9 December 2008, via healthcare professional who reported the events resolved and were possibly related to vaccination with HAVRIX. The reporting healthcare professional associated the events with sinus congestion noted at the exam and erroneous administration given at 6-months of age.
redness to (R) thigh x 1 day. She was painful & warm yesterday 05/02/18, no  pain today. Denies fatigue or fever.
Injection site reaction - redness, warmth, and itchiness widespread over upper arm around injection site.
"Whole left upper arm turned red and swollen, all the way around" and was tender to touch, as well as pruritic. 20 Sep 2017, exam showed erythematous region that was indurated on the left shoulder measuring approximately 6 x 8 cm in diameter. Patient treated with anti-inflammatories and BENADRYL with resolution of symptoms within 4 days.
4 days after 2nd shot, started experiencing tingling/ numbness on left leg up body and face. Went to urgent care. Said it would pass. Now three weeks after experiencing more tingling, extreme fatigue and weakness. Face and down left side.
Found unconsious, vomiting in bed following a very normal day CT scan revealed catastrophic cerebral hemhorrage on both sides of the brain  Intubated at hospital, withdrew care from ventilator the next day due to unrecoverable diagnosis Booster vaccine given 9 days prior to incident.  Died 10/27/2021
Very high fever, chills, partial loss of sight, stiffness in both arms and hands, he could not move his fingers, at the moment he did not know where he was, loss of strength even to walk. Acetaminophen and Benadryl were administered, and I had to take a cold water bath for approximately 10-15 minutes until my body began to react. And fever monitoring throughout the day.
general erythematous rash; went away 8 hrs; treated w/DPH;
pt recv 4JAN99 & 10FEB99 numbness in rt leg;to MD then to orthopedic &  to neurologist;had MRI showing white plaque on upper part of spinal cord affecting nerves on rt side;dx acute transverse myelitis possible first stage of MS;
Diarrhea, fever, sore throat, major aches and chills, nausea, dizziness
Pt. states that after receiving the 1st dose of Moderna 01/11/2021, started experiencing symptoms of severe headache, fever (lasting 4 days 102.0), body ache, and fatigue. Self-treated with Advil and Tylenol, Primary communications recommendation Observation. 02/11/2021 2nd dose of Moderna resulting in Similar symptoms lasting 4 days. No noted Primary visit/communications.  Arthritis symptoms have worsened since initial dose of Moderna 01/11/2021.
Fever of 100.5 Nausea and vomiting Headache Sore arm Aches all over body (it hurt to move) Extreme dizziness  Sore eyes Had difficulty sleeping that night because symptoms were so severe (even after taking Tylenol)
Starting 1/13 at 1100 developed severe abdominal pain, unable to get relief even with taking tums and pepto bismol. No nausea or diarrhea.
Hot to the touch; Hardness, redness hot to the touch; Redness hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE INDURATION (Hardness, redness hot to the touch) and VACCINATION SITE ERYTHEMA (Redness hot to the touch) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were 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 VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE INDURATION (Hardness, redness hot to the touch) and VACCINATION SITE ERYTHEMA (Redness hot to the touch). At the time of the report, VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE INDURATION (Hardness, redness hot to the touch) and VACCINATION SITE ERYTHEMA (Redness hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Fatigue on the day of and day after. Increasing difficulty breathing starting the day after the dose, continuing into the present time. Minor but insistent in lungs, difficulty taking or holding deep breaths.
On March 20th, the patient demonstrated mild cognitive impairment and was advise by friends to seek medical attention.  Upon evaluation the patient had an unsteady gait and was inarticulate in his responses. He was sent off the base to a local hospital for a stroke workup. The CT scan was negative and sent back to the base afterwards. The following day, he continued to have impairment as was sent to medical facility where he was evaluated by a neurologist and an MRI was obtained at that time which demonstrated an ischemic stroke. The patient had a completion workup for the stroke and his tests were all negative for an etiology. He was placed on limited duty status and blood thinners
2005: pt self reported new onset of visible rash - both arms. More pronounced on R side. Pt reports history of serious anaphylaxis to latex - resulting in intubation. Benadryl 25 mg offered. Pt Education brochure offered. No change in color, respirations. Pt reports felling well otherwise. Pt encouraged to remain an additional 30 min.  2014: no change in status. Pt stable. 2024: No change in status. Pt stable. No further progression of rash.  2040: Pt stable, no further progression of rash. Pt self discharged from OBS to home, stated feels fine.
7/16/18- only mild soreness in arm after injection. 7/17/18- headaches throughout the day. 7/18/18- woke up with elevated blood pressure and pulse. Very sore neck and shoulder muscles. Neck and shoulders feels very painful, stiff and swollen. Pain unrelieved by TYLENOL or FLEXERIL. Unable to sleep due to pain. 7/18/18- pain continues to neck and shoulder area. PCP notified, requested I take BENADRYL and if no improvement go to E.R. Took BENADRYL with no improvement. Went to E.R. around 9pm. EKG sinus tachycardia. B.P 187/110. IV started. IV TYLENOL given. Diazepam 5mg given to me by mouth for muscle swelling/spasm. Doctor ran labs and took xrays. Mentions that my left shoulder muscle is very swollen. WBC count normal, decides not to do spinal tap. E.R. doc gives me the option to stay overnight in hospital for observation or go home. He sends me home with a prescription of valium for muscle spasm. Still leave the E.R. in pain and discomfort. 7/20/18- Woke up in am with continued pain to neck and shoulder. Feels ache and stiff especially when I move or turn my head. Throat now very dry. Coughing up very thick yellow mucous and now voice is very hoarse. Hurts to talk, feels like is straining my vocal cords
Pfizer booster dose given Wednesday 10/13/21 on 10/14/21 patient was not feeling well unsteady gait, Nausea, Vomit, poor appetite, shivering. 7pm patient was unresponsive with poor vitals, emergency service transported the patient and CPR initiated. Patient pronounced deceased around 750pm.
Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EL9267), on 12Mar2021 as dose 2, single (Lot number: EN6198) and on 10Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "High bp" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: On 06 Aug 2022 Paxlovid treatment was started. No known allergies.  No follow-up attempts are possible, information about batch number cannot be obtained.
Rash on right arm above wrist; 2.5 inch area, blotchy.
No additional adverse effect reported.; Caller reported that VARlVAX that experienced a temperature excursion was administered (minus 10 C to 8C (minus 3.7C) for 22 hours ).; This spontaneous report was received from another health professional (nurse) referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Lot # T022315, expiration date 30-JUN-22) for prophylaxis (dose and route of administration were not provided).    On 17-FEB-2021, the suspect vaccine underwent a temperature excursion of -10-degree Celsius (C) to 8 C (average of 3.7 C) for a period of 22 hours. The vaccine did not undergo a previous temperature excursion. The excursion was called by a digital data logger. The patient did not experience any adverse event.
Arm immediately started hurting after injection ~11Am on a Saturday (knew that was normal), later that evening ~5:30PM after waking up from a nap, started to develop fever of 101 and severe pain in mostly arm, rest of body was aching (again, knew that was normal). Took following day to fully rest (Sunday). Starting  Monday left leg started to have throbbing pain. Arm was still hurting. Throughout week, left leg and arm were hurting. A week later my leg ?throbbing? turned into a sharp pain. A week later I took myself to ER in concern I had a blood clot. Medical personnel took a blood sample for D Dimer test. My results came back within normal range. Later that evening after hospital visit, throbbing /sharp pain, turned into pins and needles sensation in both legs. Then it made its way throughout entire body. Pins and needles sensation in chest, legs, both arms, calfs. Took Asprin to sleep. Left arm continues to feel pins and needles sensation and like I have a flood pressure cuff around bicep. Called my primary care on Wed 12/22 and they had me come in for another blood test. I told her I had visited ER days prior in concerns pain in leg was blood clot (testing came back negative as mentioned above). Had my blood taken at a local healthcare facility  around 1pm. Dr (NAME) said she was looking specifically liver and kidney functions. I was told everything looked great in terms of blood work. Dr suggested to me that I may have had an allergic reaction and recommended a combination of Claritin / Benadryl over the next several days.
Complex tic/movement since receiving vaccines. He purses his lips & extending arms/legs quickly - lasts few seconds - episodes occur every few minutes.
Caught covid/Covid test Nasal Swab positive; Caught covid/Covid test Nasal Swab positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in Dec2021 as dose 1, single (Batch/Lot number: unknown), in Jan2022 as dose 2, single (Batch/Lot number: unknown) and in May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 12 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Allergic reaction only to covid vaccine - previously reported" (unspecified if ongoing), notes: Other medical history: None. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" and all described as "Caught covid/Covid test Nasal Swab positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300309499 same reporter/patient, different dose number/event;US-PFIZER INC-202300309500 same reporter/patient, different dose number/event;US-PFIZER INC-202300309498 same reporter/patient, different dose number/event;
No symptoms on the day of the shot. Had a fever that reached 103.8 by 1pm the day following the shot. Also had a severe migraine all day. The fever started to subside towards the end of the day but remained over 100 until the next morning. On Saturday, 2nd day after the shot, fever was gone and only a mild migraine remained.
The patient is 12 years old and inadvertently received Pfizer pediatric (PEDS) (5-11, orange cap) for their second dose, instead of the adult Pfizer vaccine. The patient didn't report any AE's within 15 minutes of administration. Based on CDC guidelines, the patient will not need to repeat a dose.
Evening after receiving YF/HAV & Flu vaccination patient states developed fever & chills.  Contacted me the following morning and described a temperature of 37.4 C - "feel better".  Did attend classes the morning following immunizations but would have stayed home if had a choice.  Also c/o "mild" headache - described it as a normal headache for her.  Pt was self treating with rest, fluids, and Tylenol prn. Refused provider appointment.  Advised to seek emergency care if status deteriorated.  Pt stated her husband would be home with her this evening.  Also advised her of the availability of a 24 hr nurse triage line if she had further concerns and we were closed.  She is suppose to check in with me via e-mail this AM.
Ringing in ears, lightheaded "head feels tight" No reports of respiratory distress. Mother called at 2:50 pm pt informed to go to ER if resp distress occurs.
Within the first 5 minutes post vaccination, the patient began experiencing itching and tingling of the lips. I instructed patient to remove her mask and inquired about any changes to her tongue, throat, skin, vaccination site. Her lips were physically normal in size. After verbal consent, I administered 50mg of diphenhydramine to the patient and continued to observe her. The itching decreased over the next several minutes and was completely gone after approximately 10 minutes. I continued to observe the patient for another 20 minutes and instructed the patient on repeating diphenhydramine if symptoms return at home and to seek 911 care for any difficulty breathing  or swelling of lips/tongue/throat.
LITTLE PAIN AT THE INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced little pain at the injection site. The action taken with covid-19 vaccine was not applicable. The outcome of little pain at the injection site was not reported. This report was non-serious.
Patient claims felt pain in left arm that evening. Pain comes and goes, she cannot lift arm or move side to side. Pain radiates to fingers and to neck. No fever. Saw M.D. 11/10/05 received a shot and Meds (propoxyphene 50mg) claims pain still bothering her.
Swelling in muscle at vaccination site.  Pain shooting from muscle down the left arm. Very painful to extend left arm toward back, e.g. to scratch back or to insert arm into sleeve of jacket or shirt, . Also, intermittent pain in the arm at various times of the day, sometimes bad enough to wake me up.
Breathing difficult, fluid in lungs, flu like symptoms, edema - body. Symptoms 1 week flat of back.
Patient got vaccine and sat down. He felt tired, his vision and hearing was impaired, and his skin turned white.  He was still talking to us and somewhat alert but felt very tired and lightheaded.  After continuing to talk to him for about 5 minutes, he started feeling better and his skin color recovered.  He was able to drink water and his senses came back.  He kept sitting and staff member watched him longer till he was able to get up .
Patient complains of  itching and tingling. Benadryl was given patient stated feeling better and left.
Patient states she noticed a welt on her arm 3 days after receiving the 2nd dose of the vaccine. She tried applying ice on the most red part on the arm but the swelling continued to grow. Then she started applying heat in addition to applying HPR+ cream that she uses for urticaria. The only thing that the patient stated that helped a little was the ice pack. The patient ended up going to the emergency department on 1/14/2020 for the rash / welt that developed beyond her arm and to the neck and eyelid area which she described as itchy. The patient was prescribed a 4 day prednisone 50mg daily course along with Benadryl as needed and Pepcid 40mg daily which she states have helped alleviate the itchiness but has not completely resolved yet as of today 1/15/2020.   Per ED note, patient presented with mild erythema around the injection site and non-specific rash to the neck. Patient has clear speech and no oral swelling and no signs of anaphylaxis. Patient discharged home in stable condition and advised to follow up with primary care doctor in 2-3 days.
Patient became very lethargic and confused. She stated she felt pain on left arm and felt drunk. Vitals signs normal. Patient sent to ER.
No adverse effects were reported; patients received improperly stored vaccine; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided.  On 22-APR-2019, the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(rHA (recombinant human albumin))(PROQUAD) lot # R026351, expiration date 15-MAR-2020 for prophylaxis (dose detail, anatomical location and route of administration). The sterile diluent was stored according to the prescribing information. No adverse effects were reported.  The vaccines were exposed to temperature excursion in the range (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 13.7 degree C) for a time frame of 30 minutes with previous temperature excursion (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 12.6 degree C). Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA011917:
Red raised skin around the injection site on the left arm present for the past 6 days. Redness covers half of the upper arm up to the shoulder; Redness covers half of the upper arm up to the shoulder. Also itchy, but no pain or burning; chills; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Red raised skin around the injection site on the left arm present for the past 6 days. Redness covers half of the upper arm up to the shoulder), PRURITUS (Redness covers half of the upper arm up to the shoulder. Also itchy, but no pain or burning), CHILLS (chills) and FATIGUE (fatigue) in a 45-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 06-Apr-2023, the patient experienced VACCINATION SITE ERYTHEMA (Red raised skin around the injection site on the left arm present for the past 6 days. Redness covers half of the upper arm up to the shoulder), PRURITUS (Redness covers half of the upper arm up to the shoulder. Also itchy, but no pain or burning), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE ERYTHEMA (Red raised skin around the injection site on the left arm present for the past 6 days. Redness covers half of the upper arm up to the shoulder), PRURITUS (Redness covers half of the upper arm up to the shoulder. Also itchy, but no pain or burning), CHILLS (chills) and FATIGUE (fatigue) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had a doctor's appointment on April 11, 2023. It was unknown if the patient experienced any additional symptoms/events.   No treatment drugs were reported.