chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 by 3 inches of warmth around the injection site; 3 by 3 inches of redness around the injection site; 3 by 3 inches of rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (3 by 3 inches of warmth around the injection site), VACCINATION SITE ERYTHEMA (3 by 3 inches of redness around the injection site) and VACCINATION SITE RASH (3 by 3 inches of rash around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE WARMTH (3 by 3 inches of warmth around the injection site), VACCINATION SITE ERYTHEMA (3 by 3 inches of redness around the injection site) and VACCINATION SITE RASH (3 by 3 inches of rash around the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (3 by 3 inches of warmth around the injection site), VACCINATION SITE ERYTHEMA (3 by 3 inches of redness around the injection site) and VACCINATION SITE RASH (3 by 3 inches of rash around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No relevant concomitant medications were not reported.  Treatment details included Tylenol and Benadryl cream and also antibiotic.
itchy rash x 3 days, maculopapular erythematous rash all over body;tx w/DPH, PRN;
during the wk following inj noted swelling @ inj site which progressively became worse till @ 1wk;went to ER for swelling & paresthesia to lt elbow w/hives noted;
Client left clinic about 1032 and mother stated he was confused, dizzy, and having trouble walking. The RN brought him back to exam room. VS: 50, 98%, 118/48. EMS called because of low heart rate. Client was diaphoretic, dizzy, disoriented, and stated he didn't feel well. Was having trouble seeing because of the dizziness. Client's pulse stayed in low 50s for about 5-7 minutes. Pulse started to rise to 70s when EMS arrived at 1041. Mother decided to take child to doctor to get checked out herself. Client's vitals totally stable-98 and 99% and oriented at 1055 upon discharge by mother's choice.
No additional AE/PQC details provided; temperature excursion that was intermittent beginning 28-JUL-2020, involving PROQUAD states that there has been administered doses/Administration of PROQUAD that was outside of recommended temperature storage range at the time of administration; This spontaneous report has been received from a registered nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  Since 28-JUL-2020, the temperature excursion of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) had been intermittent, and it was administered to the patient on 03-AUG-2020, at a dose of 0.5 milliliter, as prophylaxis, lot number S031882 has been verified to be valid, expiration date 07-APR-2021 (dose number, route of administration, and anatomical location of vaccination were not provided) (product storage error).  The temperature was reported to be between -14 degree Celsius (ºC) and -10 ºC (maximum -9.5 ºC) for 38 hours and 30 minutes. No previous temperature excursion was reported.  The call was placed because of a Digital Data logger report. No adverse effects were reported. ; Sender's Comments:  US-009507513-2008USA014709: US-009507513-2008USA014788:
pt recv vax 7JAN97 & w/rash on both thigh & lt thigh had several blisters;pt was seen by ARNP who thinks rxn caused by band aids;advised tx w/DPH w/good results;
Developed a shingles outbreak that has been getting better; This is a spontaneous report from a contactable consumer (patient). A 73-years-old male consumer patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot number: Not reported and Expiry date: 31Aug2021), via an unspecified route of administration on 03May2021 (at age of 73-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 04May2021 (1 day after vaccination), patient had developed a shingles outbreak that had been getting better. Treatment received was 7 days of tablets. Patients wanted to know if it was okay for him to receive the 2nd dose since his shingles have not healed completely. Patient mentioned that on the day reporting event (at 6:00), he had an appointment for the second dose. The outcome of event was resolving.  Information on lot/batch number was available. Additional information has been requested.
Patient received Moderna first dose on 1/14/21 second dose on 2/11/21, First booster on 11/2/21, second booster on 8/25/22  Bivalent booster on 10/27/22 and second bivalent booster on 12/7/22.
Chills; Shaking so hard; "I" could barely walk; Headache of massive pain; Body aches like "I" have never before; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on an unknown date in Feb2021 at 12:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included nebivolol hydrochloride (BYSTOLIC), hydrochlorothiazide, olmesartan medoxomil (OLMESARTAN/HYDROCHLOROTHIAZIDE) and levocetirizine (MANUFACTURER UNKNOWN); all for an unknown indication from unknown start date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 04Feb2021 at 16:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. On 26Feb2021 at 00:30, the patient symptoms were as described on line, but very severe. The patient experienced chills with shaking so hard that she could barely walk, a headache of massive pain, body aches like she had never had before, so much worse than flu.  Shaking lasted for 1 hour, the other symptoms for 18 hours. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent antibody test (Blood test) and the result was negative. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events shaking was recovered on 26Feb2021 at 01:30 and chills, so hard that she could barely walk, a headache of massive pain, body aches like she had never had before, so much worse than flu was recovered on 26Feb2021 at 18:30, after the duration of 18 hours.  No follow-up attempts are needed. No further information is expected.
lipoma on the left arm; got very sick; fever "and all that"; This spontaneous case was reported by a consumer and describes the occurrence of LIPOMA (lipoma on the left arm), ILLNESS (got very sick) and PYREXIA (fever "and all that") in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C2VT and 939902or9399oZ) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIPOMA (lipoma on the left arm), ILLNESS (got very sick) and PYREXIA (fever "and all that"). The patient was treated with STEROIDS for Adverse event, at an unspecified dose and frequency; VALACICLOVIR HYDROCHLORIDE (VALTREX) for Rash, at an unspecified dose and frequency; GABAPENTIN for Pain, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, LIPOMA (lipoma on the left arm), ILLNESS (got very sick) and PYREXIA (fever "and all that") outcome was unknown.            Concomitant medications were not reported. On an unknown date, Patient had computerised tomogram: of head: No result reported.   This case was linked to MOD-2021-347551 (Patient Link).
Per patient 2 hours after shot severe swelling of face, coughing, watery eyes. Called pharmacy at 5:28 (personnel took the call) then called back to ask what to do complained at that time of cough/some swelling told to go to ER. She went and got better but claims to be having a continuing rxn. Says she has coughing/congestion when she is off prednisone. She says a rash/hives did develop.
This spontaneous report as received from a consumer refers to herself, a 72 years old female patient. Consumer report no pertinent medical history, drug reactions or allergies. On 21-SEP-2007 the patient was vaccinated with ZOSTAVAX (lot # and exp date 658208/0886U, 02-DEC-2008, respectively) (dose and route reported as 1 vaccine, injection). There were no concomitant medications. Consumer stated that she came down with shingles on 05-APR-2013 after receive ZOSTAVAX on 21-SEP-2007. Consumer stated shingles lasted until 05-MAY-2013. The patient did not received treatment for shingles. No labs or diagnostics studies were performed. Additional information has been requested.
Information has been received from a licensed practical nurse and a physician concerning a 66 year old white female with hypothyroidism and allergies to rofecoxib (WAES0503USA033462) and celecoxib (Celebrex) who at 10:30 on Jul 23 2004 was vaccinates intramuscularly in the upper left arm with a first dose of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P). Concomitant therapy included medroxyprogesterone acetate (Provera), estradiol (Estrace), and levothyroxine NA (Synthroid). The patient had no illness at the time of vaccination. Around dinner time on Jul 23 2004, the patient began to develop pain in the arm in a circumferential distribution around the injection site. The pain had progressed through the night with accompanying redness and swelling. The patient reported that the arm felt much heavier than the right. there was significant pain, and ice was applied. On Jul 24 2004, the patient presented to the emergency room in no distress with a temperature of 97.6F. She had an erythematous area in the left upper arm that was most prominent over the lateral deltoid and down toward the elbow though not all the way  to the joint. There was obvious swelling noted, and the skin was somewhat tense. The entire area of involvement with erythema was probably approximately 7 inches long by 3 to 4 inches wide, The assessment was localized reaction to pneumococcal 23v polysaccharide vaccine, left upper arm. the physician believed the patient was brewing a secondary cellulitis. the patients arm was elevated and ice packs were applied. The patient was treated with diphenhydramine HCL (Benadryl) 25 mg, acetaminophen hydrocodone bitartrate 5/500 (Lortab), and cephalexin (Keflex) 500  mg 4 times daily for 1 week. The patient recovered on Jul 26 2004. No additional information is expected.
No reactions until one week later which was a rash/redness/itching at injection site.
Pt recvd measles vax during 1st wk of pregnancy; In MAY90 pt underwent a therapeutic abortion; no further details were provided;
Afvacine i had no period and these two/Menstrual cycle is disruptive/skipped a period/ I noticed a change in my menstrual cycle; Ive never had such heavy long menstrual cycles/Menstrual cycle is disruptive/then the following 2 months my menstrual cycles are heavy/ last 2 more than normal/ I noticed a change in my menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (Afvacine i had no period and these two/Menstrual cycle is disruptive/skipped a period/ I noticed a change in my menstrual cycle) and HEAVY MENSTRUAL BLEEDING (Ive never had such heavy long menstrual cycles/Menstrual cycle is disruptive/then the following 2 months my menstrual cycles are heavy/ last 2 more than normal/ I noticed a change in my menstrual cycle) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the Reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMENORRHOEA (Afvacine i had no period and these two/Menstrual cycle is disruptive/skipped a period/ I noticed a change in my menstrual cycle) and HEAVY MENSTRUAL BLEEDING (Ive never had such heavy long menstrual cycles/Menstrual cycle is disruptive/then the following 2 months my menstrual cycles are heavy/ last 2 more than normal/ I noticed a change in my menstrual cycle). At the time of the report, AMENORRHOEA (Afvacine i had no period and these two/Menstrual cycle is disruptive/skipped a period/ I noticed a change in my menstrual cycle) and HEAVY MENSTRUAL BLEEDING (Ive never had such heavy long menstrual cycles/Menstrual cycle is disruptive/then the following 2 months my menstrual cycles are heavy/ last 2 more than normal/ I noticed a change in my menstrual cycle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jul-2021: Follow-up received on 04-JUL-2021 and Patient's Age and Event information was updated.
Information has been received from a physician concerning a 9 month old male patient with a history of birth weight low, who on 28-JUL-2008, was vaccinated with the first dose of ROTATEQ vaccine, orally, and on 02-OCT-2008 with the second dose of ROTATEQ, orally. The physician reported that the "fragile" preemie received 2 dosed of the vaccine and tested positive for rotavirus recently. The patient received the vaccine on 02-OCT-2008 and tested positive on 22-DEC-2008. The patient developed symptoms of gastroenteritis around 20-DEC-2008. The C-diff test was negative, rotavirus test positive and still waiting for the culture. At the time of the report, the patient had not recovered. The patient sought medical attention and was seen at the physician's office. Additional information has been requested.
Bleeding when I had the injection; Right arm hurts; Not feeling good; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding when I had the injection), PAIN IN EXTREMITY (Right arm hurts), MALAISE (Not feeling good) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding when I had the injection), PAIN IN EXTREMITY (Right arm hurts), MALAISE (Not feeling good) and PYREXIA (Fever). At the time of the report, VACCINATION SITE HAEMORRHAGE (Bleeding when I had the injection), PAIN IN EXTREMITY (Right arm hurts), MALAISE (Not feeling good) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
swelling of L arm's inner aspect; tenderness in entire arm especially around the inside elbow; some red areas that have diminished; fatigue.  continues.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: en6200), in left arm, on 11Mar2021 as dose 2, single (Lot number: 6206), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: fc3180), in left arm and on 15Mar2022 as dose 4 (booster), single (Lot number: fk9895) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Probably Cutaneous Lupis that has been in remission for 20 years" (unspecified if ongoing), notes: Probably Cutaneous Lupis that has been in remission for 20 years; "known allergies;Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) Negative; (18Jun2022) Positive; (20Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: The patient was Tested negative on Monday 13Jun after 5 days of Paxlovid treatment. The patient still had very mild congestion. On 17Jun the congestion and coughing was increasing and tested again in the morning of 18Jun and tested positive. The patient experienced fever in the evenings and continued coughing, sneezing and fatigue. The patient still testing positive today 20Jun. The patient daughter and her boyfriend stayed with patient and came down with Covid the day they left. The patient got it two days later. The patient daughter and her boyfriend also took Paxlovid. The patient daughter did not get a rebound, by her boyfriend did. His experience has been identical to patient. Treatment start date was 07Jun2022 and stop date was 12Jun2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
Patient was admitted to observation level of care on 8-6 with weakness and respiratory failure. Patient is noted to have tested positive for covid on 8-6 at the transferring hospital. Patient has a medical history that is significant for chronic pain syndrome on chronic opioids. Patient has been working with outpatient therapy prior to admission. Per inpatient PT/OT assessment, patient is not able to fully stand or ambulate at this time. Placement is recommended for continued therapy
After my second dose, one month later, my skin broken out with numerous squamous cells, pre cancerous cells, left side of my body. I had 5 squamous cells that were removed by dermatologist. I can also say that also my booster in August 2021, I again broke out with another 5 squamous cells that also had to be removed. Over the last ten years, I only had 3 squamous cells removed. I have auto immune hepatitis. I feel the Pfizer vaccine made my squamous cells worse and had to be removed by the dermatologist. I have another two squamous cells that have to be removed in two weeks.
Fatigue dry mouth dizziness but most troubling the injection site has a hard red hot circular area that developed today that is beyond painful to touch!
Fatigue; fever; aches; headaches; chills lasted on and off for 5+ days.
Within 24 hours severe congestion and cough.  Cough continually worsened into an allergic reaction as diagnosed by doctor.  To date the condition has become progressively worse with the child coughing at intervals of every 15 seconds, constantly.  Ventilation and allergy medication now presecribed by physician.  Follow up in two days.  If worsening or no progress - Specialst care will be required. Condition has now existed for 10 days and has increased in severity.
Headache, dizziness, chills, sweat, hot, chest pain, fatigue
Immediately upon receiving shot started to feel "funny". Then had episode of vasovagal syncope within minutes of receiving shot. Return to normal shortly after. Vital signs stable following the syncope.
Vaccine administered 10/12/12 approximately 11:00 AM, within 20-22hrs soreness, redness, swollen & black & blue bruising. Currently itching/hot. Currently taking ZYRTEC recommended BENADRYL & cold compresses.
Violent shaking, vomiting, fever of approx 99-100  varying,  extreme nausea , dizziness, feeling was about to pass out, body aches like hit by a freight train,  woke up in the middle of the night Thursday approx 3AM and was blindsided. Could not move from bed for the next 24 hours. The vomiting stopped and second 24 hours into Friday extreme nausea and migraine headache began. Headache and nausea continues to today 3/31/2021.
Pt recvd vax 16JUL92 & 10AUG92 pt awoke @ noc w/severe anxiety attack & broke out into cold sweat, felt flushed & had rapid heart rate; taken to ER also noted to be hyperventilating;
Itchy Hands were red Itchy at injection site 2 days later got a migraine.  from her elbows up everything was red, not hot or didn't break out in a rash.
This spontaneous report has been received from a medical assistant referring to a 5 year old female patient. The patient's concurrent condition and medical history was not provided. On 09-JUN-2016, this morning, the patient was vaccinated an expired M-M-R II RHA, lot # K007108, exp date 16-MAY-2016, subcutaneously in the child's right quad. Concomitant therapy was not provided. The reporter stated there was no know side effects or other problems after administering the injection. No treatment was given. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of VAQTA 50/1.0 U/ML (route, dose and lot # were unknown) in October 2012(reported as one month ago(unspecified date)). The patient received the second dose of VAQTA 50/1.0 U/ML (route, dose and lot # were unknown) today(12-NOV-2012) which was early. No other co-suspects were reported. No concomitant medications were reported. No symptoms reported. Additional information has been requested.