chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; LEG CRAMPS; This spontaneous report received from a patient concerned a patient of unspecified gender, age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and Expiry: Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-AUG-2021, the patient tested positive for Coronavirus disease (COVID-19), (suspected clinical vaccination failure, suspected covid-19 infection). At the time of the report the patient still had been feeling very sick for the last 5 days. The symptoms include leg cramps, chills, chest tightness, coughing and extremely tired, the breathing felt okay. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and leg cramps, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210815211-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
tinnitus; This is a spontaneous report from a contactable consumer (patient's friend). A patient of unspecified age and gender received bnt162b2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tinnitus on an unspecified date with outcome of unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever 101.3 no appetite low energy unable to keep awake no waking up for feedings stiff neck diarrhea white spots or balls in the liquid stool vomiting crying for more then 6 hrs not acting normal.
PT BEGAN HAVING REDNESS AND FEVER TO INJECTION SITE THE DAY AFTER HE WAS GIVEN THE VACCINE. MOM WAS ADVISED TO GIVE TYLENOL AND MOTRIN ALTERNATING EVERY 4 HOURS AND USE ICE PACK. 2 DAYS  LATER MOM CALLED SENDING US PICTURES SHOWING THAT THE CELLULITS  HAD GONE ALL THE WAY DOWN HIS ARM TO HIS ELBOW. WE PRESCRIBED BACTRIM SUSPENSION, BENADRYL, AND MUPRICION OINT.
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication provided. No treatment information mentioned.  Patient experienced fatigue.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unspecified gender and age. On unknown dates, the unspecified number of improperly stored doses of the GARDASIL 9 lot # L037554, expiration date 25-DEC-2017, lot# M013636, expiration date 15-FEB-2018, lot # M034780 expiration date 15-APR-2019 (formulation, dose, frequency, route of administration and indication were not reported) were administered to the patients. On unknown dates, the doses were stored in the temperatures between 32 degrees Fahrenheit and 35 degrees Fahrenheit for 284 hours. Data logger was involved. There was no previous excursion reported. No adverse effects were reported. Additional information is not expected as there is no correspondence contact information.; Sender's Comments:  US-009507513-1703USA009116:
Received COVID vaccine on 12/18/2020. On 1/2/2021 started to note inflammation of superior auricular and superior cervical nodes. Rash on left side of head appear around 1/3/2021. On 1/7/2021 diagnosed with shingles.
This spontaneous report refers to an approximately 56 years old male patient reporting on himself. The patient reported allergy to certain type of adhesives like on band-aids, tape and patches; his concurrent conditions included hand-foot-mouth disease, since his early 30s. The patient's medical history included hand-foot-and-mouth-disease. In approximately July 2016, (reported as "about four months ago"), the patient was vaccinated with a dose of ZOSTAVAX (injection, lot#, expiry date, route and site of injection were not reported). Concomitant therapies included lisinopril (+) hydrochlorothiazide (manufacturer unknown) and XIAFLEX. Since receiving ZOSTAVAX the patient had not had an outbreak of his hand-foot-and-mouth disease. He stated that he had had the condition since his early 30s and used to get water blisters on feet and fingers. The patient was surprised with his unexpected result, but did not discuss this reaction with his physician. The patient did not receive any treatment and no lab diagnostic studies were performed. The outcome of the event was unknown at the time of the report. The relatedness between the event and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
injection site reaction 8 hours after vaccine was administered; rash; pain; This spontaneous report was received from a pharmacist refers to a 77 year old female patient. Concomitant therapies included verapamil, azathioprine, aspirin, fluticasone propionate(FLOVENT), atorvastatin, hydroxychloroquine sulfate, sertraline hydrochloride 100 mg, albuterol sulfate(VENTOLIN) and insulin glargine (BASAGLAR). Information on pertinent medical history and drug reactions or allergies were reported as none. On 22-JUL-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S002582, expiry date: 10-AUG-2020, route, dose and anatomical location was not reported) for prophylaxis (reported as vaccine). On 22-JUL-2019, 8 hrs after vaccination, the patient had injection site reaction. The patient used warm compresses until the rash and pain went away (injection site reaction, injection site pain and injection site rash).The reporter had requested for lot check (Reporter concern). On 25-JUL-2019 (reported as 3 days after the vaccine was administered), patient was recovered from the events injection site reaction, injection site pain and injection site rash. Causality assessment was not reported.
C/O (L) arm red and warm approx 4" diameter (she stated) around injection site. "Redness started late Friday and lasted until Sunday morning. It moved from site down my upper arm midway between elbow and shoulder".
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL3302), in right arm, on 19Feb2021 as dose 2, single (Lot number: EN6203), in right arm, on 04Nov2021 as dose 3 (booster), single (Lot number: FG3527), in right arm and on 06May2022 as dose 4 (booster), single (Lot number: EL9992) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; BUPROPION; FISH OIL; MAGNESIUM; ESTER C [ASCORBIC ACID]; TURMERIC [CURCUMA LONGA RHIZOME]; VITAMIN B-12; VITAMIN B3. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2022) Positive; (13Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient tested positive on 29Jun2022, mild symptoms, started PAXLOVID on 30Jun2022 (in the evening) and ended Paxlovid on Monday, 04Jul2022. Tested negative on 05Jul2022 (Tuesday). Symptoms were gone. Symptoms returned on 12Jul2022, 12:00 (event start date), tested positive on 13Jul2022 with mild symptoms at this time. Known allergies were none.   No follow-up attempts are required. No further information is expected
headache; soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 81 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TIKOSYN. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; PAIN (non-serious), outcome "unknown", described as "soreness".  Additional Information: Patient called regarding Tikosyn 0.125mg assistance again. During call patient explained She went off of Tikosyn she had some problems she had an ablation and all this and she called to see if Tikosyn is still available. Patient reported When she had some problems she was taken off the Tikosyn and put back on Pradaxa and at the time the doctor wanted her to go back on Tikosyn and when she called Tiksoyn was not available so she had to go back on Pradaxa . Later on call patient shared how got Pfizer vaccine and she really didn't have any side effects to speak of except a headache and maybe just soreness a little bit all over but she got over that. Date the event description was reported was 03Dec2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderate to severe ache/pain at the site of administration (deltoid) and extending down to the elbow.  Aches constantly and more severely to the touch.  Cannot lift arm presently.
tested positive for COVID19; Headache; Fever; Fatigue; Chills; Secondary bronchitis and bacterial infection; Sore throat; Sweats; And could not breathe through her nose; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Secondary bronchitis and bacterial infection) in a 48-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.     The patient's past medical history included No adverse event (No relevant medical history reported).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced BRONCHITIS (Secondary bronchitis and bacterial infection) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (Sweats), DYSPNOEA (And could not breathe through her nose), HEADACHE (Headache), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (Chills). On 14-Mar-2021, the patient experienced COVID-19 (tested positive for COVID19). On 14-Mar-2021, COVID-19 (tested positive for COVID19) had resolved. At the time of the report, BRONCHITIS (Secondary bronchitis and bacterial infection), OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (Sweats), DYSPNOEA (And could not breathe through her nose), HEADACHE (Headache), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, COVID-19: positive (Positive) positive.         This case was linked to MODERNATX, INC.-MOD-2021-074973 (E2B Linked Report).; Sender's Comments: Based on the known etiology of covid-19, , the event ofSARS-CoV-2 test positive and bronchitis is assessed as unlikely. Based on temporal association between the use of the product and onset of the other events of sore throat, headache, fever, fatigue, chills, sweats,  dyspnea , injection site as hot and she developed a large red oval rash on her shoulder, a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-074973:
The day after receiving my 2nd shot of Shingrix i had a slight fever, general malaise, an soreness at injection site.  Eleven (11) days after my injection i began to have severe itching at my right ankle, this proceeded to my right thigh, under my right arm ,lower back ,onto the top of my buttocks.  a rash developed shortly afterwards,  the rash was raised and resembled what shingles would look like.  There is no weeping from the rash.  here is however  severe bruise at the top of the crack of my buttocks.  My inner right thigh has also developed a rash as well as the area on my left rib cage..  Different patches become severly itchy at different times.  not painful but itchy.  looks terrible.  Looks if I have the shingles.
I developed a  splotchy red rash that spread quickly around my body.  It was mildly itchy and worsened in the evening.  After waking up it largely went away but came back again in different places the following night.
Low grade fever, headache, nausea and chills on 1/29, then on 1/30 developed injection site reaction that is red and swollen and about three inches in diameter
Pt had local reaction including a red hard lump and painful  axillary lymphadenopathy
9:30 AM that a patient who was in the post vaccination observation area was developing a reaction.  This was her first dose of vaccine (Moderna). She developed a rash over her trunk and extremities that was warm and pruritic. She was given 50mg po benadryl before I evaluated her. When I saw her she was not in extremis, respiratory distress or with audible stridor, but did appear uncomfortable. She denied any lip swelling, tongue swelling or throat closure, however did note that her heart was racing and she was having chest heaviness. The patient's lungs were clear and there was no audible wheezing or signs of cyanosis. Pulse ox was 100-110 HR, with O2 sat 97-100%.  Did not appear to be an anaphylactic reaction at this time.  She was brought to the ER for further observation
Patient started getting extremely dizzy and started getting cold sweats after vaccine administration and feels like she is going to faint
Patient was given vaccines on 11/22/2017, and came in for check up on 11/24/17 indicating that her left arm started swelling and becoming red the following day. Patient had also indicated that the right arm was very painful. Exam revealed that the left medial upper arm was noted to have a 4-5 cm circular, red warm swollen area. The left bicep was measured and noted to be 14 inches in circumference while the right bicep measures 13.5 inches in circumference. Left arm has mild pain on palpation. Right arm has no erythema and no pain noted. Diagnosed with cellulitis of left arm and given script for cephalexin 500 mg one tablet twice a day for 10 days and to return to the office on Monday 11/27/17 for recheck. Patient was seen 11/27/17 and there was improvement noted. Patient is to finish the antibiotics and call if problems reoccur or become worse.
pt recvd vax & that evening exp soreness & swelling @ the inject site, low grade fever (100), profuse sweating; could not lift arm over head; took APAP w/Codeine for these sx, applied ice packs to the affected arm;
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 28-NOV-2016, the patient received an improperly stored dose of M-M-R II (therapy type: recombinant human albumin, RHA) injection (lot # M015931 with expiration date at 30-MAR-2018; dose, route of administration and anatomical location were not reported). The administered dose of vaccine was exposed to a temperature of -14.4 degrees Celsius (C) for 54 minutes. Digital data logger was used to track the temperature. There was no previous temperature excursion reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
They have several friends who had adverse reactions; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a (RA). A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ADVERSE REACTION (non-serious), outcome "unknown", described as "They have several friends who had adverse reactions".  Additional information: No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Caller stated his wife, his mother in law and himself all received their 1st Pfizer dose on 27Feb and are scheduled to received their 2nd dose on Mar2020. They have several friends who had adverse reactions following their 2nd dose. Caller would like to have just one of them (himself/wife/mother in law) receive 2nd dose to see if they have a reaction and if they do not have a reaction, the remaining 2 will receive their 2nd dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt vaccinated with Influenza four days following injection, pt stated "I had red spots on my face", followed by a generalized facial rash on day five & swelling of the face on day six.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with VARIVAX (lot # K018960, expiration date: 15-OCT-2016, route and dose were not reported). Concomitant drug was not reported. The vaccines were at 6 F for 16 hours because of data logger issue. There was no previous temperature excursion. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Dizziness; Vomiting; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; VOMITING (non-serious), outcome "unknown", described as "Vomiting"; NAUSEA (non-serious), outcome "unknown", described as "Nausea". Additional information: Events occurred 2 days after the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My baby was NOT supposed to receive the PEDIARIX, however the nurse who was "in a hurry" accidentally grabbed the wrong vaccination and gave it. My daughter woke up with half of her face completely swollen and was unable to open one eye and was very lethargic. The nurse told me this was "due to a cold". And told me NOT to take her to the ER.
Delayed onset of menses by 7 days; low grade fever; small headache/small headache in the morning and by the afternoon went away; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (Delayed onset of menses by 7 days), PYREXIA (low grade fever) and HEADACHE (small headache/small headache in the morning and by the afternoon went away) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 0448A21A) for COVID-19 vaccination.     The patient's past medical history included Constipation. Concurrent medical conditions included Thyroid disorder NOS.   On 25-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PYREXIA (low grade fever) and HEADACHE (small headache/small headache in the morning and by the afternoon went away). On an unknown date, the patient experienced MENSTRUATION DELAYED (Delayed onset of menses by 7 days). On 25-Apr-2021, HEADACHE (small headache/small headache in the morning and by the afternoon went away) had resolved. At the time of the report, MENSTRUATION DELAYED (Delayed onset of menses by 7 days) and PYREXIA (low grade fever) outcome was unknown.            Patient reported headache was intense on 23-Apr-2021 which turned to small headache on 24-Apr-2021 and subsequently went away on 25-Apr-2021 Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments   This case was linked to MOD-2021-099054 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Added patient demographic, added medical history.
Per recovery RN notes: "At approximately 0841, patient stated feeling dizzy. Mother noted with patient. Patient anxious. Pt loss of consciousness for approximately 10 seconds. Rapid response called. Patient regained consciousness. Patient with emesis x1. Vital signs stable BP 109/70 HR 64. SpO2 at 99 on room air. Rapid response team arrived at scene. MD assessed patient. Per mother, patient has a history of syncope after vaccinations. Per MD, ok to go home once stable. Patient noted to leave facility at 0904, in stable condition.".
Severe arm pain within 30 minutes of administration. Pain radiates down entire left arm to fingertips and up to left side of neck. Range of motion is limited. With the first dose of Moderna my left arm was sore for 3 days after the injection, range of motion was limited by pain, however, I was still able to actively move my arm through all planes. With this 2nd dose active range of motion is limited due to pain, unable to achieve full range of motion without physically assisting with right arm. When actively assisting, the left arm is still limited due to pain. I did call Walgreens the same day that the dose was given at 3:13 PM to inquire about this reaction. I was told to take OTC for the pain.