chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 66 year old female patient who was reporting on herself. The patient did not have pertinent medical history nor drug reactions or allergies. Concomitant therapies included SYNTHROID, vitamin D (unspecified), vitamin B complex, probiotics (unspecified), amethrosol (unspecified) and fish oil. On 23-JUL-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (administered intramuscularly in the left deltoid, dose, lot # and expiration date were not reported). On 26-JUL-2015 (reported as 3 days after vaccination), the patient experienced warmth and burning sensation at the injection site. On an unknown date, liquid profile, hemoglobin A1C, thyroid stimulating hormone and amylase lab tests were performed (results not provided). The patient did not seek medical attention and did not receive any treatment. The patient's outcome was reported as not recovered/not resolved. The relatedness between the events and therapy with PNEUMOVAX 23 was not provided. Additional information has been requested.
This spontaneous report as received from a female consumer refers to a female unspecified nurse of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The reporter heard that on an unknown date, the patient developed a chicken pox rash after receiving ZOSTAVAX. No treatment information was reported. The patient's outcome of chicken pox rash was unknown. The relatedness for chicken pox rash was not reported for ZOSTAVAX. It was unknown whether the patient sought medical attention. Additional information has been requested.
4/7/2022 incident 1608 onset time Client presented to the clinic for her second dose of Pfizer (FM0698) received to her LD at 1548. Shortly after vaccination, at 1609, the client complained of itchiness of scalp, and left arm near her elbow.  Visual inspection revealed no rash/hives to her arms, back, neck, face, head/scalp, legs. No swelling to lips or mouth or difficulty with swallowing was noted. There were no breathing changes or change to LOC or AMS noted. At 1614 her SPO2 was 98% on RA and HR was 89.  1615- The client was offered Benadryl, but she declined. She was also offered juice and water and also declined.  1618-No hives were noted upon extensive visual examination. At 1626 again no hives, redness or swelling to lips and tongue were noted. Her SPO2 was 100% RA and HR was 88. Patient was alert and oriented and breathing normally. She reports that she often has allergic reactions of unknown cause, and this incident is similar to reactions she had had in the past.  She then reported that her throat felt slightly sore. Visual examination of her mouth/throat showed no changes to her oral mucosa. She also reports that she did have a sore throat the previous day, but she did not have it today. Upon questioning, she states that she ?feels fine? and will have people to monitor her at home. She was educated about anaphylaxis/allergic reactions, what to watch for and when to seek medical care and she verbalized understanding. At 1636 her SPO2 was 100% on RA and HR was 76. She then reported that she had ?the beginning of a slight headache?.  Signs and symptoms of anaphylaxis were reiterated and she was offered additional observation time, but she declined, reporting that she felt well enough to leave. During the entirety of the incident, she did not exhibit any symptoms beyond an itching sensation and showed no hives, rashes, swelling, changes to mental state, or difficulty breathing. She exited the facility at 1642.
w/in 24hr of vax several pt from this facility devel an inj site rxn characterized by redness, swelling & tenderness;
16 days post 2nd Moderna shot in left arm- developed a severe ringing in left ear- several days later ear felt clogged as well. Continuous ringing. On day 6 contacted PCP who prescribed steroid ear drops. No relief. Seen by doctor on day 10 of ringing. Prescription for oral steroids (4 days) and Amoxicillin (5 days)  given.  No relief following medications.  Followed up w PCP on day 15, referral made to ENT. Waiting for appointment. Continue with ear ringing, ear clog/pressure and weird feeling in head. Becoming very static like and buzzing. Taking Zyrtec/Flonase and Advil past  3 days to assist with sinus pressure. Some mild relief but ringing is persistent.
Began as itchy red rash,  painful to touch, increasingly warm and swollen, increasing in size.  Went to urgent care on 3rd day and was told to use Benadryl and cortisone cream.  Began to fade 2/13 and gone on 2/15
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 20Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 30Jun2022 as dose 4 (booster), single (Lot number: FK9895), in right arm for covid-19 immunisation. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "SUSPECTED COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jan2023) Negative, notes: negative test (PCR) on the following Monday; (Jan2023) Positive, notes: tested positive (weakly) with home tests for about a week; (Jan2023) Negative, notes: tested negative on home tests; (02Feb2023) Positive, notes: with two home tests. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 12Jan2023 to 16Jan2023.  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.
I had initial soreness in arm for 2 days after shot on 3/11. Then, I had a delayed reaction on 3/19. I woke up on 3/19 with a knot/hardness in my arm at injection site as well as redness. I called health department where I received shot and they told me to submit this form and monitor arm, and contact my physician if it gets worse.
Noticed my Tinnitus  was worse during March after first vaccine (but didn?t even think of it as a side effect b/c I never heard of  that side effect) and then realized when I got the 2nd vaccine and my tinnitus got immediately worse right after the vaccine and it was then I realized it was a side effect of the vaccine that made my tinnitus worse.
arm was itchy; arm was swollen; arm was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (arm was itchy), VACCINATION SITE SWELLING (arm was swollen) and VACCINATION SITE ERYTHEMA (arm was red) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure (the patient taking  blood pressure medication) and Anxiety (the patient taking anxiety depression medication).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (arm was itchy), VACCINATION SITE SWELLING (arm was swollen) and VACCINATION SITE ERYTHEMA (arm was red). At the time of the report, VACCINATION SITE PRURITUS (arm was itchy), VACCINATION SITE SWELLING (arm was swollen) and VACCINATION SITE ERYTHEMA (arm was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included for blood pressure, depression and anxiety medication. Treatment details was not reported by the reporter.
red rash on both feet (top) & ankles & also on both arms fromthe shoulder to the hands (top), both ears also;Took Atarax; w/little effect;rash cont to present has moved on legs;given DPH;
Fever; chills; body aches; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 08Apr2021 at 09:45(at the age of 42-year-old), as a single dose for COVID-19 immunisation. Medical history included diabetic and hypertension. Concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 18Mar2021 at 09:45(at the age of 42-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 09Apr2021 at 06:00, the patient experienced fever, chills and body aches. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On an unknown  date the patient underwent lab tests and procedures which included COVID-19 (Blood test) test and the result was negative. The clinical outcome of the event fever, chills and body aches was not recovered at this time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever 99 F; Nausea; Chills again; Aches & Pain all over his body; vomiting; Fever 100 F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches & Pain all over his body), VOMITING (vomiting), PYREXIA (Fever 100 F), CHILLS (Chills) and NAUSEA (Nausea) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event reported).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced PAIN (Aches & Pain all over his body), VOMITING (vomiting), PYREXIA (Fever 100 F) and CHILLS (Chills). On 21-Jan-2021, the patient experienced NAUSEA (Nausea) and CHILLS (Chills again). On an unknown date, the patient experienced PYREXIA (Fever 99 F). On 17-Jan-2021, PAIN (Aches & Pain all over his body), VOMITING (vomiting), PYREXIA (Fever 100 F) and CHILLS (Chills) had resolved. At the time of the report, NAUSEA (Nausea) and CHILLS (Chills again) had resolved and PYREXIA (Fever 99 F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment Advil
horrific headache head pain and ear pain; horrific headache head pain and ear pain; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP), based on a report from Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), in Mar2021 as DOSE NUMBER UNKNOWN, SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), EAR PAIN (non-serious), outcome "unknown" and all described as "horrific headache head pain and ear pain." Therapeutic measures were taken as a result of headache, ear pain.  Additional information: Patient reported "Your vaccine COVID in Mar2021 w/ horrific headache head pain and ear pain I've tried every medication under the sun with my doctors The only thing that worked was "Nurtex," it's dollar 1,900 a month. I think the least you could do is send me this because I cannot afford it. I would like a script of this a month please can you help me since your vaccine did this to me, I feel that's the least you can do.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
A 3 year old female received an injection of Prevnar in 10/00 and subsequently, was admitted to the hospital with a dx of pneumonia and pleural effusion. As of 1/16/01, no further information was available. Fu info provides diagnosis of streptococcal septicemia.
Acute dermatitis in the vaccine area Frequent and mild headaches (back of the head) Increased blood flow when menstruating
red indurated rash at the injection site; red  rash at the injection site; indurated at injection site; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th March 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st April 2020, 21 days after receiving Shingrix, the patient experienced injection site erythema, injection site rash and injection site induration. On an unknown date, the outcome of the injection site erythema, injection site rash and injection site induration were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site rash and injection site induration to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and reporting a red indurated rash at the injection site that began 3 weeks post vaccination and has not resolved.  The vaccination was given at a local pharmacy.  Limited information available.  Lot and expiration date unavailable. The reporter did not consent to follow up.
08/12/04 administred Td.  08/16/04 returned to office with itchy7x8 cm indurated firm area.  Gave antihistimines.
A non-serious spontaneous report of headache has been received from a registered nurse, concerning a 13-year-old male, subsequent to FLUMIST. The patient's past medical history and concomitant medications were not reported. The patient received FLUMIST on 23-Oct-2009. On the same day of vaccination, the patient got a headache. He complained of noise in the classroom and reported to the school nurse that he has does not get headaches. The patient was sent home. The adverse event resolved. The patient was back in class on 26-Oct-2009.
Within minutes of receiving her Hep-B #2 vaccine, the pt fainted and as she was lowered to the floor, her body jerked X 1. (She did not fall). She regained consciousness within a minute. When she went into the hall for fresh air, mom states that she fainted again. Mom concerned that she had a seizure. Paramedics were called and they examined her but found no problems. Mom took child to physician but he also found no problems. On Saturday, 3/31/01, the child got hives on her cheeks, neck and back of legs. Friday, she had worn new outfit (running suit). Mom unsure if hives from shot or something else.
Patient experienced nausea, abdominal pain, chills, emesis x1(unwitnessed) about 30 minutes post vaccine administration. Pt denies sudden weakness, SOB, hives, dizziness, changes in vision or speech. Pt reports she has experienced this with Covid vaccine and but not with Flu. School nurse present and evaluated patient immediately. VS taken and patient kept at nurses office for observation. See VS log. School nurse reports she will observe patient and update patient parent on incident. School nurse educated about call 911 if patient experiences difficulty breathing, swelling tongue, lips or throat, drop in blood pressure, increased HR.
Developed blood clots and then had strokes; Developed blood clots and then had strokes; This is a spontaneous report from a non-contactable consumer via a Pfizer sponsored program. This consumer reported similar events for 3 members of his family. This is the third of three reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on an unspecified date, as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The reporter stated that a member of his family received the Covid vaccine and then developed blood clots and then had strokes. The reporter was wondering about FDA approval and how many deaths happened from the Covid vaccine and also wondering about vaccine shedding. The outcome of the events was unknown at time of report.  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-202101211991 Different patients, same reporter/drug/events.;US-PFIZER INC-202101211992 Different patients, same reporter/drug/events.
Frequent arrhythmias; 20 point systolic BP rise; sense of oppression in breathing; vertigo on arising; brain fog; night sweating with normal temp; burning feet; trembling hands; weak muscles; fatigue; audible pulse in ears; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6200), via an unspecified route of administration administered in left arm on 19Feb2021 18:00 (at the age of 81-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The reported facility type was a hospital. No other vaccine in four weeks. The patient did not have covid prior vaccination and was not covid tested post vaccination. Medical history included Hashimotos Thyroiditis, irritable bowel syndrome (IBS), food and seasonal allergies, allergies Iodine isotope contrast, latex, cows milk protein. Concomitant medications included levothyroxine sodium (SYNTHROID); amlodipine and spironolactone. The patient previously took paracetamol (TYLENOL) and thiomersal and experienced allergies from these drugs. The patient experienced frequent arrhythmias day after; several days of 20 point systolic BP rise; audible pulse in ears; sense of danger; sense of oppression in breathing; vertigo on arising; brain fog; night sweating with normal temp; burning feet; trembling hands; weak muscles; fatigue all on 20Feb2021 at 13:00. After 20 days (in Mar2021), all has abated but muscle weakness and fatigue. Unwilling to risk the booster. There was no treatment for the events. The outcome of the events muscular weakness and fatigue was not recovered while for the remaining events was recovered with sequelae in Mar2021.
High Fever, Chills, Body Aches, Low Energy Ibuprofen, Acetaminophen, Fluids 3 to 4 days of reaction
August through January I became severely ill. Extreme fatigue, nausea and vomiting. My coordination was off.. difficulties walking and vision problems. Extreme dry mouth and eyes. Pins and needles along with numbness that started with my feet and progressed up my legs, thighs and stomach. Finally my entire face went numb. I was hospitalized for 3 months. Diagnosed with Critical Illness Polyneuropathy and Guillain Barre Syndrome.
I received Shingles vaccine on 10-8-13 in my (R) arm. The next day my arm swelled got hot and red hard spot at injection site. Headache - blurred vision.
Redness, tenderness, and lymph node swelling 1 1/2 weeks post administration of TDAP. Dx. cellulitis, abscess formation and staph aureus infection.  BACTRIM DS BID x 10 days. NORCO 10mg po q 4 prn.
No additional adverse event reported; a dose of VARIVAX that was administered during a temperature excursion; This spontaneous report was received from a registered nurse concerning a 4-year-old patient.  The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 14-JAN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S025608, expiration date 18-AUG-2021), at a dose of 0.5 milliliter for prophylaxis (Strength, route, anatomical site and vaccination schedule were not reported), which had a temperature excursion of 0 Celsius degree for 2 hours and 11 minutes. The temperature excursion was detected by a data logger and the reporter stated that the vaccine had no previous temperature excursion. No additional adverse events were reported.  This is one of the two reports from the same reporter.
rash at the site of injection on her arm; at the site of injection on her arm that was painful; at the site of injection on her arm that was painful and warm to the touch; Armpit Pain; Arm Weakness; arm tingling; Hallucinating/Spacey Head Feeling; Low Grade Fever; Chills; Nausea; Fatigue; Headache; muscle/body aches; muscle/body aches; dizziness; not feeling herself; This case was reported by a consumer via call center representative and described the occurrence of hallucination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a week after receiving Shingrix, the patient experienced feeling unreal. On 18th August 2020, the patient experienced hallucination (serious criteria GSK medically significant), fever, chills, nausea, fatigue, headache, general body pain, myalgia and dizziness. On 22nd August 2020, the patient experienced injection site rash, injection site pain, injection site warmth, axillary pain, weakness of arms and tingling of extremity. On an unknown date, the outcome of the hallucination, injection site rash, weakness of arms and tingling of extremity were not recovered/not resolved and the outcome of the fever, chills, nausea, fatigue, headache, general body pain, myalgia, dizziness, injection site pain, injection site warmth and axillary pain were recovered/resolved and the outcome of the feeling unreal was unknown.   It was unknown if the reporter considered the hallucination, fever, chills, nausea, fatigue, headache, general body pain, myalgia, dizziness, injection site rash, injection site pain, injection site warmth, axillary pain, weakness of arms, tingling of extremity and feeling unreal to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose in left arm. After receiving Shingrix, the patient had low grade fever, chills, nausea, fatigue, "spacey head"/hallucinating, headache, muscle/body aches, and dizziness.  On day 5 from the date of receiving vaccine, the patient noticed there was a rash at the site of injection on her arm that was painful and warm to the touch and there was pain in her armpit.  The pain under the armpit had resolved and the rash on her arm had gotten smaller but had not fully resolved.  Caller confirmed all symptoms have resolved except arm weakness, arm tingling, rash, and the "spacey head" and just not feeling herself. The reporter consented to follow up. This case was linked with case US2020170268, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020170268:same reporter