chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I  have a lump in my throat; chills; soreness in arm; fatigue; headache; earache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in arm), EAR PAIN (earache), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness in arm), EAR PAIN (earache), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills). On an unknown date, the patient experienced PHARYNGEAL SWELLING (I  have a lump in my throat). At the time of the report, VACCINATION SITE PAIN (soreness in arm), EAR PAIN (earache), HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills) and PHARYNGEAL SWELLING (I  have a lump in my throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Flu shot was administered into her left arm. It swelled up around injection site and it became red and hardened. It stayed like that for about 2 wks. Patient also experienced flu-like symptoms as well.
Patient present to Urgent Care for treatment after receiving his COVID immunization at the Health Department. He states he received his vaccination on Friday in his left upper arm on Friday February 26th and felt fine on Saturday, Sunday began to have some fatigue and his arm was slightly sore and turning pink and itching. He began taking ibuprofen on Sunday by Monday the redness had increased and he added Benadryl. He came in today for enlarging redness of upper left arm, swelling and puritis.
Pt recvd 1st dose of Engerix-B 21AUG92 & 22AUG92 pt exp extreme nausea, rt upper quad pain, facial edema around eyes & abdo discomfort;
Headache (4/10). Fear of needles, with history of fainting. O2 sat 100%. BP 91/74 (pulse 63).
Got Shingrix twice, got shingles anyway/Suspected vaccination failure; got the shingles; Flu, very unpleasant; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and influenza. On an unknown date, the outcome of the vaccination failure, shingles and influenza were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and influenza to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received Shingrix vaccine twice and got the shingles anyway. The patient also came down with the flu which was very unpleasant. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Site: Bruising at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
This spontaneous report was received from a registered pharmacist referring to a 25 year old male patient. The patient's concurrent conditions included seasonal, penicillin and sulfa allergies. The patient's medical history was not reported. Concomitant therapies included FLONASE. On an unknown date in 1990 (at one year of age) and on an unknown date in 1994 (at five years of age), the patient was vaccinated with the first and second dose of M-M-R II, subcutaneously (strength, dose, anatomical location, lot number and expiration date were not provided), for prevention of measles, mumps and rubella, respectively. Then, on an unspecified date in 2011 for an unknown reason, the patient was administered a third dose of M-M-R II, at the same dosage regimen of the first dose, also for prophylaxis. Subsequently, on an unspecified date in 2011 (also reported as two months later), the patient received a fourth dose of M-M-R II, at the same dosage regimen of the first dose, also for prophylaxis. On an unknown day in January 2015, the patient had titers drawn, which showed he had positive titers for mumps (mumps antibody test positive) and rubella (rubella antibody positive), but had low titers for measles with a level of 0.2 (units not provided) (measles antibody negative). On an unknown day in March 2017, the patient was vaccinated with a fifth dose of M-M-R II, at the same dosage regimen of the first dose, also for prophylaxis. However, on 01-JUN-2017, the patient had titers drawn again, which showed his titers for measles were still low at 0.4 (units not provided). The patient did not receive any treatment. At the time of reporting, the outcome of mumps antibody test positive and rubella antibody positive was unknown. As of 01-JUN-2017, the patient had not recovered from the measles antibody negative. The causal relationship between all above mentioned events and the M-M-R II was not reported. Additional information has been requested.
Pt had MMR and ATD on 06/02/05, RTC 06/09/05 Left upper arm (bicep) was swollen, hardened, and red. Pt stated she didn't remember which nurse gave injection. site approx quarter size, warm, hard, and reddened.
the syringe broke and the diluent leaked out; the syringe broke and the diluent leaked out; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), PRODUCT LEAKAGE (non-serious), outcome "unknown" and all described as "the syringe broke and the diluent leaked out". Additional information: when they twisted the cap off the diluent, the syringe broke and the diluent leaked out.  Causality for "the syringe broke and the diluent leaked out" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Approx 15 min after reciving injection pt states her left hand felt tingling. Sensation good to touch, pulse present and strong, color good and equal to right. C/O flush feeling down lower arm following. No obvious swelling. Movement intact. Flushing resolved after approx 5 min. Pt waited 30 min prior to leaving.
Site: Pain at Injection Site-Severe, Additional Details: pt stated about 3 hours after vaccine. He had intense pain on left arm. He could not lift his arm up to 1 day later. pt advised to continue with tylenol and hot/cold therapy. will follow up with patient on 1/7/22 to see if they need further medical attention
63 year old complained of headache and sweating. She ate breakfast took her medications this morning . Onsite EMS was called Vitals BP 176/82 HR 73 released to go home.
Mom states that the pt was in a car seat carrier and she went very pale. She also noted that the pt seemed to be gasping for air. Mom described the event as "shock-like". This lasted approx. 2 minutes. After picking her up, she "pulled out of it". No treatment was sought.
No additional AE; both VARIVAX and PROQUAD were involved in a temperature excursion on 9JUN2022.; This spontaneous report has been received from a certified medical assistant, regarding an unknown number of patients of unknown ages and genders.  The patient's pertinent medical history, previous drug reactions or allergies, and  concomitant medications were unknown.   On 09-JUN-2022, the following vaccines were involved in a temperature excursion: varicella virus vaccine live (oka/merck) (VARIVAX) as prophylaxis (lot number U008180 had been verified to be a valid number; expiration date reported and established as: 12-DEC-2023; (scheme, dosage and anatomical site of injection were not provided) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA)(PROQUAD) as prophylaxis (lot number W007744 had been verified to be a valid number; expiration date reported and established as 04-SEP-2023.  The vaccines were exposed to a temperature of 8.6 Fahrenheit degrees for a time frame of 13 minutes. No previous temperatures excursion were reported. On an unknown dates in 2022, the vaccines were administered to the patients (product storage error). No adverse events reported.   This was a non-valid case due to lack of patient's identifiers.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 24-MAR-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5 mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius) for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
broke out into hives everywhere; hives extremely itchy; lip swelling; night sweats; dermatographia; skin swells up; angioedema; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (angioedema), URTICARIA (broke out into hives everywhere), PRURITUS (hives extremely itchy), LIP SWELLING (lip swelling) and NIGHT SWEATS (night sweats) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, the patient experienced URTICARIA (broke out into hives everywhere) and PRURITUS (hives extremely itchy). In December 2021, the patient experienced ANGIOEDEMA (angioedema), LIP SWELLING (lip swelling), NIGHT SWEATS (night sweats), MECHANICAL URTICARIA (dermatographia) and SKIN SWELLING (skin swells up). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ANGIOEDEMA (angioedema), URTICARIA (broke out into hives everywhere), PRURITUS (hives extremely itchy), LIP SWELLING (lip swelling), NIGHT SWEATS (night sweats), MECHANICAL URTICARIA (dermatographia) and SKIN SWELLING (skin swells up) outcome was unknown.            No relevant concomitant medications were reported. Treatment information included Zyrtec at least every 2 days or else the hives came back like clockwork. Patient reported she thought she was not pregnant because she had an IUD.   This case was linked to MOD-2022-445506 (Patient Link).
w/in 1 hr p/getting vax pt had high pitch crying for approx 4 hrs; pt given APAP; did not call MD;
I have had a fever, chills, all over body aches, headache, and stomach upset.
Information has been received from a registered nurse concerning a 7 year old male who on 12-JAN-2001 was vaccinated with Varivax. The registered nurse reported that on 05-JAN-2007, the patient reported to the office with a 2 day history with a lesion under the nose that was spreading and itchy. The patient had 4 to 5 lesions on the face that were crusted over and also had a couple of lesions on the arm. The patient had a total of 20 lesions on the torso arms, and legs. The patient outcome was reported as recovered. It was also reported that the patient's sibling had an AE after vaccination with Varivax (WAES# 0701USA04731). Additional information has been requested. 02/11/2010 In follow-up information it was reported that the patient presented to the office (21-DEC-2006) with a 2 day history of red, raised rash. There were 10 lesions on the chest and back. The lesions on the upper back were crusted over. The patient currently had 30-40 lesions on chest, back and inguinal area. The patient received supportive care. The outcome was reported as recovered. No further information is available.
COVID infection. Specimen collected on 7/21/2021. Patient died on 8/21/2021.
Information has been received from a registered nurse concerning a 41 month old male who on 08JUL2001 was vaccinated with a first dose of varicella virus vaccine live. On 12JUN2003 (also reported as 11JUN2003), the patient developed chicken pox with small vesicular bumps over his body. Medical attention was sought and the patient was not treated with any prescription medication. The reporter was not sure if the patient had recovered; he had not been back to the office since 11JUN2003. Additional information has been requested.
I had chest pain, racing heart, high heart rate. I went to the ER where I receive fluids, but no diagnoses. I continue with the symptoms for 2 months intermitting, I was put on a heart monitor for 2 weeks. The results were inconclusive.
Dry mouth; Diarrhea; Sleepy; Joint aches and pain; Headache; joint aches and pain; A spontaneous report (United States) was received from a consumer concerning a 44-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dry mouth, diarrhea, sleepy, joint aches and pain, headache.  The patient's medical history was not provided. Concomitant medications reported were laxatives for drug use for unknown indication.  On 13 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the events dry mouth,diarrhea, sleepy, joint aches and pain, headache. Consent given to follow up No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 16 Feb 2021 the outcome of events, joint aches and pain was resolved. The outcome of events, dry mouth, diarrhea, sleepy, headache were unknown.
Approximately 12 hours after injection of vaccine, patient reported body aches, joint aches, fever, chills, abdominal discomfort. Temp of 103.0
a large blood clot, which has been removed from her leg; Right side paralysis; No speaking; Unable to walk, due to her paralysis; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (a large blood clot, which has been removed from her leg), HEMIPLEGIA (Right side paralysis), APHASIA (No speaking) and GAIT INABILITY (Unable to walk, due to her paralysis) in an 85-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (a large blood clot, which has been removed from her leg) (seriousness criteria hospitalization and medically significant), HEMIPLEGIA (Right side paralysis) (seriousness criteria hospitalization and medically significant), APHASIA (No speaking) (seriousness criterion hospitalization) and GAIT INABILITY (Unable to walk, due to her paralysis) (seriousness criterion hospitalization). At the time of the report, THROMBOSIS (a large blood clot, which has been removed from her leg), HEMIPLEGIA (Right side paralysis), APHASIA (No speaking) and GAIT INABILITY (Unable to walk, due to her paralysis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported. No concomitant medications were mentioned.  On an unknown date, the patient was hospitalized due to a large blood clot which was removed from the patient's leg. The patient, at the time of this report, was hospitalized in the stroke center. The patient had right sided paralysis and was unable to speak or walk.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
urticaria on inside of both arms; This is a spontaneous report from a contactable Physician. This physician reported for a female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunization. Medical history was urticaria. Physician stated that I have a female patient in good health with a history of urticaria. She got the vaccine and developed urticaria on inside of both arms - looking for information on whether this patient should receive the 2nd dose. Outcome of the event was unknown.  Information about batch/lot number has been requested.
Later that evening the patient experienced a seizure and he was taken to an unspecified hospital emergency room by ambulance; an unspecified 27 year old male patient was in the office to receive the 3rd dose of GARDASIL 9; This spontaneous report has been received from an osteopathy physician via a field representative, concerning a 27-year-old male patient. Information about the patient's past drug and medical history, as well as concomitant therapies and allergies were not reported.  On an unknown day in December 2019, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 3 dose series (concentration, frequency, administration route, anatomical location, lot number, and expiration date were not reported) as prophylaxis (reported as vaccination) (Inappropriate age at vaccine administration).  On an unknown day in December 2019 (reported as later that evening), the patient experienced a seizure and he was taken to an unspecified hospital emergency room by ambulance. A computerised tomogram (CT scan), magnetic resonance imaging (MRI), and 72 hours with continuous monitor electroencephalogram (EEG) were performed. The CT scan and the MRI were negative; and the EEG showed diffuse slowing consistent with seizures. He was seen by the physician since the occurred event and was recovered. No additional adverse events were reported. There was no overdose reported.  The causality assessment between of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the seizure was not provided.  Upon internal review, the event seizure was considered to be medically significant.
Entire body is extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Entire body is extremely itchy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Entire body is extremely itchy). At the time of the report, PRURITUS (Entire body is extremely itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  The patient stated that the itching started about 1-2 hours after vaccination. The patient did not use anything to treat her symptoms.
Patient spiked a fever and started having tremors.  Nausea.  Given Toradol, Benadryl and a dose of Reglan and 1liter of saline.
Localized inflammation occurred immediately after injection. Swelling did dissipate within 10 minutes. Patient was monitored for systemic reaction but no further reaction occurred and no further treatment was necessary. Patient was monitored for generalized reactions and none were observed.
5 days after recieving my second COVID Pfizer vaccine a rash developed and now three days after the rash started it covers my entire body. It is very red. Itches but not severely. There appears to be no other cause for the rash: no change in diet, no exposure to chemicals. no insect or other bites, no change in my regular routine. My vitals have remained normal although the rash does make me uncomfortable.
Swollen(bumps on arm around injection spot), red, itchy. Reaction comes and goes.
Felt dizzy - feeling like I'm going to pass out; Felt like she's going to fall; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt dizzy - feeling like I'm going to pass out) and FEELING ABNORMAL (Felt like she's going to fall) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007BZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS (Felt dizzy - feeling like I'm going to pass out). 25-Mar-2021, the patient experienced FEELING ABNORMAL (Felt like she's going to fall). At the time of the report, DIZZINESS (Felt dizzy - feeling like I'm going to pass out) and FEELING ABNORMAL (Felt like she's going to fall) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood pressure measurement: 166/93 (High) Blood pressure was 166/93..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.   This case was linked to MOD21-063129 (Patient Link).
t104 lt upper arm swollen, 2 inch area red, hard, hot w/intense itching; 1 hive above, 1 hive below; tx w/DPH; 29JAN95 area pink w//1 hive remaining-itching minimal, itching, swollen, throat; local react-red & itchy;
Extreme muscle weakness; required help to move. Noted to be using ancillary muscles for breathing at urgent care. Pt was hospitalized and transferred to Minneapolis.Dx of GBS.