chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a 2nd dose of Shingrix vaccine on 4/21/2020. Extreme pain as shot was given, swelling, extremely hot and extreme itching even though I took antihistamines starting 24 hours before injection to mitigate reaction. Very uncomfortable to sleep that night due to the pain and swelling, headache, shivering (very chilled) and irregular heartbeat. . The next morning I was in more pain in my arm the hive was 3" wide, 5" long and 3/4-1" high, I continued to take antihistamines, applied topical antihistamine and numbing ointments. Applied ice. By the afternoon I had a small hive on my face and 3 inside my mouth along with numbness, I had to immediately evacuate my bowels. Fever of 99.2. Very tired, I started needing naps and could hardly make myself get up from the nap. On the 26th I had extreme pain in my left little finger and could not use it. Ibuprofen did not help much. I did not have joint pain on this finger or hand before the injection It is now 7 days after the injection and I am still very tired. The injection site is still red, but not as swollen or itching. I am still fatigued and finger joint still hurts. Up until the injection I felt terrific and had plenty of energy, did not need daily naps, nor did I have hives or any other health issues.I have not been ill. This has been awful. It is not quite noon and I need to go lay down.
improperly stored vaccine in use; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-SEP-2020, the patient was vaccinated with improperly stored vaccine, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot#: T013540 has been verified to be a valid lot number, expiration date 17-OCT-2021, albumin status rHA (formulation, strength, dose, frequency and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of (6 to 14 Fahrenheit degree (11.7 F)) degrees Fahrenheit for 25 minutes. Data logger was involved. There were no previous excursions reported.
02/18/22 direct admit "for drainage from her LLE Taylor spatial frame with concerns for sepsis". PMHx of "anxiety, depression, COPD, OSA, HTN, HLD, morbd obesity, T2DM, and fall with left ankle fracture 10/2021 s/p ORIF at OSH c/b osteomyelitis and hardware failure s/p Ex-fix and multiple I&Ds and wound vac placements"
Information has been received from a physician concerning a 4 year old female patient who on 20-AUG-2005, was vaccinated with the first dose of VARIVAX (Merck) 0.5 ml subcutaneously. On 23-AUG-2008, the patient was administered her second dose of VARIVAX (Merck) (lot#659740/0165X) 0.5 ml subcutaneously. The physician reported that on 25-AUG-2008, the patient developed a 3 inch by 3 inch area of swelling at the injection site. The patient was treated with BENADRYL and ice compresses and the symptoms were improving. At the time of the report, the patient was recovering. This is one of two reports received from the same source. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the center and was released. No further information is available.
Since the vaccine I have had 2 miscarriages and have been suffering with secondary infertility. I also have noticed changes in my menstrual cycle and am worried that the vaccine has affected my ability to get pregnant and carry to term. I of course do not know if it is related to the vaccine or just coincidental, but my health and fertility issues have me very concerned. I hope that more studies are done to look into this issue.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 at 15:45 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 28Feb2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic pain" (unspecified if ongoing); "TBI" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "recovering from surgery of hand" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: MS CONTIN, start date: 01Mar2022. Past drug history included: Keflex, reaction(s): "known allergies: Keflex"; Codeines, reaction(s): "known allergies: codeines"; Nickel, reaction(s): "known allergies: nickel". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (25May2022) Negative, notes: I tested negative on 25May-4 days after I completed the full doses of placovid; (27May2022) Positive, notes: This morning I tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Rebound case of covid. She tested negative on 25May-4 days after she completed the full doses of placovid. On Day 7, she started having symptoms of congestion and fever last night. That morning, she tested positive again. Fever, cough, congestion, body aches and headache.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
high fever after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever after second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (high fever after second dose). At the time of the report, PYREXIA (high fever after second dose) outcome was unknown.            Concomitant and treatment medications were not provided by reporter.
Information has been received from a registered nurse concerning her 10 year old son who on an unspecified date was vaccinated with the first dose of VARIVAX (Merck). The nurse reported that the her son developed 4-5 lesions after the first dose of VARIVAX was given. On 21-MAR-2008, her son was vaccinated with the second dose VARIVAX (Merck) (Lot#659000/1491U) subcutaneously. The nurse reported that her son on 28-MAR-2008 developed approximately 2 lesions after receiving VARIVAX; on 29-MAR-2008 he developed 5-6 lesions and on 30-MAR-2008 he developed 2-3 lesions. The lesions had a duration of approximately 7-8 days. At the time of the report the patient had recovered. Additional information is not expected.
Feeling bad; body aches; Nausea; Fever; Headache; muscle soreness; Soreness at the site of injection; A spontaneous report was received from a consumer concerning a 66-year-old,  female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle soreness/myalgia, nausea, headache, soreness at the site of injection/vaccination site pain, body ache/pain, fever/pyrexia and feeling bad/feeling abnormal.  The patient's medical history as provided by the reporter included COVID-19. No relevant concomitant medications were reported.  On 08 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 08 Feb 2021, the patient experienced the events, muscle soreness, nausea, headache, arm sore at the site of injection, body ache and fever which she had through the night.  On 09 Feb 2021, the patient reported waking up in the morning feeling bad. T  reatment for the events included prednisone.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, muscle soreness, nausea, headache, arm sore at the site of injection, body ache, fever, and feeling abnormal were unknown.
Full-body hives and rash for 16+ days starting a week after the booster dose. Most medicines are not effective in relieving itchiness, such as Benadryl and Xyzal.  Methylprednisolone did not help, only made the symptoms worse.
I felt like passing out tunnel vision . everything was black except center of vision. Unable to focus or stay attentive while driving "zoned out" multiple times. Felt like my head was detached from my body unable to shake it for 2 and a half days.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (dose and route were not reported, lot # K008334 with expiration date: 09-JUN-2016; lot # K022265 with expiration date: 22-OCT-2016) which were exposed to temperature outside of the recommended range. No adverse experience was reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a health professional concerning a 66 year old male with gout, cholelithiasis and elevated cholesterol levels and no known allergies who on 06-DEC-2006 was vaccinated SC with a 0.5 ml dose of varicella-zoster (lot # 652965/0622F). Concomitant therapy included probenecid (BENEMID), diazepam (VALIUM), vitamins (unspecified) and "triclor". Approximately one week later (also reported as 22-DEC-2006) the patient presented to the physician with a 2 inch red area at the injection site and 12-15 lesions were noted on the leg and shoulder. The patient was diagnosed with chickenpox pustules by the physician. It was reported that a lyme titer was done (results not provided). There was no product quality complaint involved. Additional information has been requested.
Fever of 103.8, red, hot, swollen area of the injection site malaise and fatigue. Injection site was right deltoid.
1:45PM: Fever and loud screaming. Patient had never screamed before.  2:30PM: After much soothing (sucking a finger, rocking, singing), soothed to sleep. 4:00PM: Felt less warm than earlier. Took temperature: 99.4.  Continued to be miserable for the rest of the day, but no more screaming. Diarrhea for three days afterwards. Blood in stool one week later. Patient had never had blood in stool before, and has not since, even though she has strained to defecate at other times. No straining was apparent at the time of the bleeding. Neither parent nor physician could find a fissure. Bleeding cleared up within 48 hours.
Patient reported experiencing extreme bruising and warmth at the injection site. Patient could not sleep on right side due to pain.
Hospitalized twice: 8/23-9/7 and 9/20-9/28. Patient died due to COVID-19. Patient was fully vaccinated.
In was reported that 8-10 pt, 5 years of age developed swelling, pain, redness and warmth from their shoulder to their elbow approx 24 hours after receiving in the injection route not reported, of Daptacel, dose five lot numbers included C20506AA and C2253AA, in the deltoid and the SC injection of Ipol, lot number Y1051 administered in the same arm as Daptacel on an unspecified date. Specific arm vaccinations were given in was not reported. Needle was 5/8 and 25 gauge. It was not reported if this needle size was used for Daptacel or Ipol. Per reporter the pts had no illness at the time of vaccination. At the time of this report the pts had not recovered.
fever of 101 degrees, rubbing @ head, increased fussiness There is a question of secondary viral illness
At first just pain in arm .  About a month later I started having unusual symptoms such as extreme tiredness, occasional sore throat, mouth sores that lasted at least three weeks, occasional headache, pains in my legs.  On Memorial day weekend I had a fever on 102 but it only lasted a day and a half.  My doctor gave me a Z-pac and it went away. I am not sure if these symptoms' are related to the vaccine but they are not usual to me. I am still unusually tired and lack energy.
Severe sore throat and severe phlegm. Gagging and choking me. Diarrhea.  Began day after vaccination and throat still sore and feels like mouth sores on roof of mouth. Still phlegm but not as severe.
I noticed 2-3 days after the H1N1 vaccination unusual amounts of my hair starting falling out and have continued to do since then.  Never noticed this kind of shedding/hair loss before the shot.
RASH, PAIN AND ITCHING ON ARM BELOW WHERE SHOT WAS GIVEN
Vaccine administered to Left Deltoid 12/1/15. 12/2/15 injection site felt sore to patient. 12/3/15 patient noticed area was now red and warm, but did not hurt or itch. 12/4/15 patient presented to pharmacy and the above was seen by pharmacists. patient states they have an appointment with their doctor to address it.
Fever 101.3, pain in site, headache, swelling and redness in site, shivering.
Systemic: Body Aches Generalized-Severe, Systemic: cough, hand swelling & stiffness, hands warm to the touch-Severe, Systemic: Joint Pain-Severe, Additional Details: Pt already has diagnosed autoimmune disorders and vaccine aggrevated & enhanced her symtpoms and she had to go to her Doctor and they prescribed her a Prednisone dose pack to reduce hand swelling, stiffness, and achiness. She also had to use her rescue inhalers and oxygen more often because it aggrevated her lungs.
Had redness, induration and swelling on the lt. arm where IPV and MMR were given. No pain or fever. On antibiotics at present for possible cellulitis.
Pt. slept for a short time after vaxs then another child gave infant a cheetos snack piece which he ate, then rubbed on his face. No rash prior to vax or intake of cheetos. Rash appeared in exact places where cheetos residue contacted his
This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions. concomitant therapies or medical histories provided. Since 04-AUG-2016, the patients were vaccinated with improperly stored doses of VARIVAX lot # L029466, expiration date 06-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 16.7 degrees Fahrenheit for 4 hours and 20 minutes. The previous excursion was of 26.2 degrees Fahrenheit during 14 hours/ The cumulative excursion was of 26.2 degrees Fahrenheit for 18 hours and 20 minutes. Data logger was involved. This is one two reports received from the same source. Additional information has been requested.
Sore left arm and muscle , swollen arm down to hands, rash at injection site. Inside of cheeks swollen for 24 hours after shot.  Arm red and swollen for 4 days then all symptoms completely gone by day 8 and then day 9 after shot arm swollen again, injection site red and swollen and itchy.  Rash on scalp too, very itchy.
Sore arm and shoulder continuing five weeks later, chest discomfort, pins and needles feeling in arm
February 7, 2021 I started having chest pains. After it happening majority of the day I went to the ER. They ran test. The doctor said my left lymph node was swollen. About 7 or 8 months later my lymph node was still swollen. In September 2021 the lymph node was removed. The doctor and oncologist tested the sample of the lymph node, and they found out that there was nothing wrong with it. The doctor said the lymph node just had a reactive response after getting the vaccine.
No adverse event; Dose 1 and Dose 2 administered 40 days apart; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered 40 days apart) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 030A21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Shingrix (Lot number: E344C, Route IM and Dose number 2 of 2) on 16-Nov-2021. Past adverse reactions to the above products included No adverse event with Shingrix. Concurrent medical conditions included Mixed hyperlipidemia (onset more than 3 years), Hypertensive heart disease (without congestive heart failure more than 3 years), Gastrooesophageal reflux disease (without esophagitis, onset more than 3 years), Allergy to antibiotic (Cefdinir) and Sulfonamide allergy (sulfa). Concomitant products included HYDROCHLOORTHIAZIDE from 17-Aug-2022 to an unknown date, IRBESARTAN from 17-Aug-2022 to an unknown date, VITAMINS NOS (MULTIPLE VITAMIN) from 18-May-2022 to an unknown date, OMEPRAZOLE from 16-Nov-2021 to an unknown date, CITRIC ACID, POTASSIUM CITRATE (POTASSIUM CITRATE [CITRIC ACID;POTASSIUM CITRATE]) from 29-Aug-2022 to an unknown date, PRAVASTATIN from 17-Aug-2022 to an unknown date and PARACETAMOL (TYLENOL) from 11-Apr-2020 to an unknown date for an unknown indication.   On 08-Apr-2021 at 3:47 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-May-2021 at 3:12 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 18-May-2021 at 3:12 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered 40 days apart). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered 40 days apart) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered 40 days apart).    It was reported that there were not known or reported adverse events. No treatment medications were reported.   This case was linked to MOD-2022-645658 (Patient Link).
Extreme nausea, Headache, lightheaded,  loss of appetite that lasted for over a week.
This case was considered medically important (OMIC). Follow up information was received regarding a 6 year old male participant enrolled in a study. The subject received a dose of Prevnar and a dose of Hepatitis B vaccine on 7/24/01 and experienced an allergic reaction, erythema, rash and an injection site induration. The patient's concurrent illness included HIV infection. Indication for Prevnar was immunization. Product was administered on 7/24/01. Dose regiman was 1 dose. Additional suspect vaccine included Hepatitis B vaccine. Concomitant therapy included Norvir, Epivir, and Zerit. On 7/24/04, a 6 year old male patient developed nausea, as did his mother, after dining out. On 7/25/01, he experienced an allergic reaction and rash. The patient's mother noted erythema to hands, trunk, and privates without fever or itching. The patient was evaluated in the clinic. Upon examination, temperature was 36.5 degrees C and erythema was noted on hands, trunk, and privates, along with plantar and palmar erythema. Swelling was noted on his left hand. The patient also had the following toxicities: erythema grade 3, induration grade 3, pain grade 1, rash grade 2, malaise grade 1, myalgia grade 1, allergic reaction grade 2, and injection site induration grade 3. Treatment included Benadryl and Tylenol. The investigator considered hypersensitivity, erythema, rash and injection site induration possibly related to the administration of Prevnar and Hepatitis B vaccines.
3 days after receiving vaccines, patient developed spasms.  Later diagnosed with infantile spasms.  Has done well on ACTH gel therapy.
Patient complained of a runny nose and headache that has worsened, she went to the ER on 04/15/2021 and was given medication that relieved her symptoms, patient not admitted
Pt was over vaccinated. Received dose of Kinrix and Proquad in 2019 at 4 years old. Received 2 dose of each on 11/23/2020. No adverse reaction.  Mom caught error when pt got home.
Legs cramped and body hurt for 5 days after first dose. Could hardly move. Pain level was around an 8  on a scale from 1-10 for those 5 days. After pain went away skin and muscles where tender to touch from being in so much pain
08/15/2008 2:20 pm Mom reported after child received immunization on 8/14/08 at 9 pm. She first had pruritus on the neck, back and posterior side of  bilateral palm then broke out in hives. She gave benadryl and problem resolved. on 08/18/08 9 am followup with Mom stated child broke out in rash seen at children med. center ER on 08/15/08 at 7 pm  treated problem resolved.
sudden onset of hemoptysis & hematuria;taken to hosp required ventilator;all testing negative;many specialist saw pt & non could explain episode;p/prolonged stay, child recovered w/o apparent permanent injury;
Received the Covid vaccine at the hospital on 1/13/2021.  Patient was feeling "run down" the rest of the day.  Woke up the next morning on 1/14/2021 with symptoms.  Symptoms included: Fatigue, headache, fever 100.2, chills, body aches, head felt heavy, dizziness, sore throat.  These specific symptoms lasted from Thursday to Saturday- 1/16/2021.  On Friday 1/15/2021, new symptoms started: red rash around injection site, painful.  Left axilla swelling/severe pain- felt like being stabbed in the area.  Pain lasted until 1/18/2021.  Sunday, 1/17/2021, had a headache with fatigue.  Monday and Tuesday, 1/18/2021 and 1/19/2021 headache only.  1/20/2021 symptoms resolved.   Patient took Ibuprofen and Acetaminophen OTC.
Her "calves started swelling and then progressively got worse"/While admitted was diagnosed with Myositis; This spontaneous report has been received from a pharmacist who is also the patient's father referring to a 14 year old female patient. The patient did not have pertinent medical history, drug reactions or allergies. Concomitant therapies included loratadine (CLARITIN) and cetirizine hydrochloride (ZYRTEC).       On 07-AUG-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly, for prophylaxis (lot # and expiration date were not reported).     On 30-AUG-2019, the patient's calves started swelling and progressively got worse, therefore, the patient went to the physician's office, then to urgent care and finally, on 07-SEP-2019, was hospitalized. On an unspecified date in September 2019, an ultrasound of calves, unspecified blood work, and urianalysis tests were taken but no results were provided. Afterwards, while being hospitalized, the patient was diagnosed with myositis and received furosemide (LASIX) intravenously for 3 days, as well as fluid and sodium restrictions. On 11-SEP-2019 (reported as 5 days later), the patient recovered from the event and was discharged from hospital.  The reporter's causality assessment between myositis and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Around 09/19/2021 shortness of breath, and heaviness in my chest, and irregular beat. I went to the ER and they diagnosed me with PAC with an EKG. I had 3 test stress test, echo test, and a heart monitor. I will have the results to those on 10/23/2021. The treatments have not been given yet. I have never had shortness of breath, and heaviness in my chest, and irregular beats in my life.