chrisvoncsefalvay/vaers-outcomes huggingface dataset:
minor sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (minor sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia lymphocytic chronic.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (minor sore arm). At the time of the report, PAIN IN EXTREMITY (minor sore arm) outcome was unknown. Not Provided   No concomitant information provided. No treatment information provided  This case was linked to MOD-2021-433326, MOD-2021-408990.   Reporter did not allow further contact
my underarm is very swollen; I don't feel good; I don't feel very well; lymph node or swelling under the arm; it's just hurting, it's just very swollen; lymph node or swelling under the arm; it's just hurting, it's just very swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), administration date: Aug2022, for Covid-19 immunization. The following information was reported: MALAISE (non-serious) with onset 2022, outcome "unknown", described as "I don't feel good; I don't feel very well"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 2022, outcome "unknown" and all described as "lymph node or swelling under the arm; it's just hurting, it's just very swollen"; PERIPHERAL SWELLING (non-serious) with onset 2022, outcome "unknown", described as "my underarm is very swollen". Additional information: The patient just got the Pfizer Bivalent that is the second booster and the underarm was very swollen and the patient had 1,2, the original shots then had a booster last August and then this was the second booster, the new of the new strain and the patient read on the paper, did not see anything about lymph node or swelling under the arm and the patients was just very, it's just hurting, it's just very swollen.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Ringing in ear, dizzy, loud ringing.  Have gotten MRI, saw specialist ear nose and throat, cardiologist
Patient received Moderna dose #1 on 3-28-2021 and Moderna dose #2 on 429-2021. I do not have the immunization location or injection site information. He developed right side facial numbness, right side tinnitus and hearing loss on 5-19-2021. He was evaluated at  Hospital ER where a CT of Head was apparently normal; I do not have access to this report. No medication was given and he was discharged from the ER. He present to our (ENT) office on 5-6-2021. At this time he reports right side tinnitus and right side subjective hearing loss. He no longer had facial paresthesia. His ENT/Neuro exam was normal. An audiogram was performed and right sensorineural hearing loss was noted, the  acoustic reflexes were consistent with the SNHL. He was administered high dose Prednisone
Tested COVID Positive; Tested COVID Positive; got sick; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported for herself that:     A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection;), dose 1 via an unspecified route of administration on 09Feb2021  as SINGLE DOSE for covid-19 immunisation  The patient medical history was not reported.  The patient's concomitant medications were not reported.The patient experienced tested covid positive, tested covid positive on Feb2021  got sick on Feb2021   The patient underwent lab tests and procedures which included sars-cov-2 test: positive   on 2021 Received the first dose on 29Feb2021 then got sick after 5 days, caller took the rapid test and Tested COVID Positive. 2nd dose will be on 02Mar2021 (21st day). Caller is asking if the Vaccination date can be moved due to having a weak body for still being sick due to COVID.The events were assessed as serious (medically significant) by health authority and outcome of the events was unknown.  Information on the lot/batch number has been requested.
A few minutes after vaccine administration, while sitting down for post-vaccine monitoring, she became dizzy and diaphoretic.  Ice packs were given and the dizziness improved over about 5-10 minutes.  Vital signs were taken and were normal:  BP 125/80, Pulse 86, O2 Sat 100%.   After symptoms resolved she went back to work.
Patient received Pfizer booster at 2:16pm and went to go sit down to be observed for 15 minutes. Patient returned to vaccinator 5 minutes later saying that he felt faint and nauseous. Then vaccinator went to sit patient down and patient fainted. Staff caught patient and lowered him to the ground.  Patient was verbally unresponsive for 4 seconds. Patient opened eyes, while he was resting on the floor. Had patient bend his knees with head resting on the floor. Took initial BP; 110/66 HR 63. Patient denies any pain and stated his arms felt tingly, which also occurred with previous covid19 vaccination. Patient stated he did not sleep well or eat before coming to be vaccinated. He also stated that he was anxious because he is scared of needles. Had patient sit up on the floor after 5 minutes, assessed patient to see if he was dizzy patient denied. After several minutes had patient sit on chair. Offered water and observed patient. Retook Vitals ; 126/84, HR 80, SpO2 98%, RR 16, Temp 98F. Patient stated tingling in arms resolved. Let patient rest in chair for additional 15 minutes to be observed. Patient appeared stable, advised him to let his doctor know what occurred today and with future vaccinations to let vaccinators know as well. Patient left with friend after appearing stable.
Post vax, the pt developed fever and a diffuse, discreet, papular rash on abdomen and trunk. Fever to 104F.
Spontaneous Urticaria on and off all day, I?m taking Zyrtec and Benadryl
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-JAN-2015 the patient was vaccinated with an improperly stored dose of VAQTA 50unit/ml (lot # J001396, expiration date 02-AUG-2015, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 72 hours with the highest recorded temperature of 9 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 1 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax 28JUN95;4 of the six pt's tested neg post-vax titers, one had an equivocal titer & one had a post titer;
20 minutes after shot, tingling and numbness/swelling in throat and lips; did not feel any blockage in my airways and could breathe easily through my nose, but did feel constricted in my throat for about 40 minutes.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 85-year-old female patient who received SHINGRIX (batch number BF4J5, expiry date 5th July 2021) for prophylaxis. Concurrent medical conditions included chronic lymphocytic leukemia and shingles. On 2nd April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2019, 7 days after receiving SHINGRIX, the patient experienced shingles, swelling arm, erythema of extremities and pain in arm. The patient was treated with antivirals for systemic use. On an unknown date, the outcome of the shingles was unknown and the outcome of the swelling arm and pain in arm were recovering/resolving and the outcome of the erythema of extremities was not recovered/not resolved. It was unknown if the reporter considered the shingles, swelling arm, erythema of extremities and pain in arm to be related to SHINGRIX. Additional details were provided as follows: Less than a week after vaccination, the patient experienced swollen arm that was red and painful. The patient's arm had improved but was still red at the time of reporting. The patient also reported that about one week later she developed a shingles outbreak that was diagnosed by her dermatologist and treated with prescription antiviral. The reporter gave consent to follow up. The batch number of SHINGRIX was reported as BF4JB. However, based on a safety lot number review, the batch number was updated to BF4J5.
Moderna on 3/31 and 4/28. Positive on 11/9
Had a DVT Blood clot in the right arm / shoulder, currently taking blood thinners after diagnosis.
-burning at injection site. -redness of the face, arms & hands -symtoms began 20 min. after administration of the vaccine -Given Claritin 5mg/5mL, 10mL orally.
a red hot area under neck,around back of neck&down front of chest;not a rash-looked kind of like a sunburn-warm to touch
Initial: Cold sensation and tingling in left arm and hand Next 3-5 days mild tingling in Left arm, Left hand/wrist, Left fingertips and some on left side of face
Reports within 15 min of covid vaccine she had facial pressure, throat tightening, headache, light headed, increase in BP-179/123
Information has been received from a nurse, referring to an unspecified number of patients (ages and genders not reported). The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates in June 2017 (reported as "on 13-JUN-2017 and 14-JUN-2017"), the patients were vaccinated with improperly stored doses of ROTATEQ lot number reported as "M040367" with expiration date on 14-MAY-2018, administered orally (strength, dose and anatomical location were not reported) for prophylaxis. No adverse effects were reported and no additional information was provided. The vaccines had a temperature excursion of 0 Celsius (C) to 1 C during 30 minutes, it was also confirmed that the vaccines did not have previous temperature excursions and a digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA007354:
This spontaneous report was received from a pharmacist, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On 09-MAY-2018, the patient was vaccinated with an expired dose of GARDASIL 9, lot # L037339, expiration date 09-FEB-2018, intramuscular for prophylaxis (dose number was unspecified). No adverse effects reported.
I had no reaction to any of the COVID-19 vaccines. On 2/22/2023 I felt really bad, I had a sore throat, and I was just exhausted. The evening before I had a little bit of a sore throat. I tested with an antigen Home Test, and I tested positive. I immediately called the doctor because my husband has leukemia and he prescribed Paxlovid. I was given a Creatine test to make sure my kidneys okay before they gave me the Paxlovid. I isolated in my room for 5 days. I probably could have come out of lock down, but I was very concerned about my husband getting it.
Approximately 2 minutes after shot, sudden feeling all over body, felt possibly passing out. Notified staff, gave me water, waited additional time, then took blood pressure. I watched as others complained of the same symptoms. Staff indicated to me it was anxiety. I had not felt concern and had been checking my emails when this suddenly occurred. The following 2-3 weeks I had slight dizzy spells with a feeling of  quick tingling in head that lasted a few seconds.  Tingling in my feet and warm sensation was on and off started June 1 and subsided very slowly, ending mostly possibly by September  Ringing in ears started around 5/14/21 and is still an issue today 24 hours a day. Once it started it has not gone away.
Chills started by 2 pm on 2/9/21; extreme chills and shaking by 4 pm. Body aches , low fever, joint pain, and fatigue came after. By 7 pm, I had all of these symptoms, plus nausea and no taste. Today (2/10/21)  by 4 pm, the chills and low grade fever were gone but still have body aches, joint pain, and fatigue.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient experienced dizziness, light-headedness, profuse sweating, urge to vomit within 10 minutes of getting Moderna 0.25ml booster dose
NAUSEOUS; PULMONARY EMBOLISM; FELT LIKE TRYING TO GET SICK; FELT LIKE COMING DOWN WITH A COLD; This spontaneous report received from a patient concerned a 41 year old African American, not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and the patient did not have any history of previous clots and no medical condition reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: 05-AUG-2021) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, after vaccination, the patient felt like she was trying to get sick, and felt like she was coming down with a cold but did not really get sick. On 30-MAY-2021, the patient was working and ended up getting admitted in the hospital on 17-JUN-2021 night at 7 PM. On an unspecified date in JUN-2021, laboratory data included: chest X-ray (NR: not provided) multiple clots in both the lungs, and scan with contrast (NR: not provided) multiple clots in both the lungs and was diagnosed with pulmonary embolism. The physician were not sure if it was because of the vaccine. The patient was hospitalized until 28-JUN-2021 or 29-JUN-2021. The duration of hospitalization was 12 days. On an unspecified date, the patient felt like there was something sitting on her chest, was nauseous so she thought she had food poisoning. The patient had been a little short of breath, thought it was because she just started working out but it was not much noticeable.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism, and the outcome of felt like coming down with a cold, nauseous and felt like trying to get sick was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210713153-COVID-19 VACCINE AD26.COV2.S-Pulmonary Embolism. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210713153-COVID-19 VACCINE AD26.COV2.S-Nauseous. This event(s) is labeled and is therefore considered potentially related.
About 30-40 minutes after patient received COVID-19 vaccine, she felt that she was having difficulty swallowing.  Denied respiratory distress.  Some swelling felt in middle of throat.  No fever, chills, pain, shortness of breath or wheezing.
pt recv vax 4JUL97 & the next day pt exp swelling in the lt axillary area which resolved w/o treatment;The site believes that the ID shot was given IM instead but they are unsure;
No adverse affects reported; improperly stored MMR II was administered; Information has been received from a pharmacy tech referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported.        On 15-AUG-2019, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R027063, expiration date: 20-SEP-2020; strength and dose were not reported) subcutaneously for prophylaxis. Data logger was involved. The vaccine was stored with temperature of 70 degrees Fahrenheit (F) for 4 days. There was not previous temperature excursion. No additional information reported. No adverse effects reported. No product quality complaint.
A nurse reported that a 62 year old female received an injection of Pnu-Imune 23 on 9/29/00. On 10/2/00, she was dx'd with cellulitis. The pt was treated with Keflex. The reporter indicated that 2 pt's experienced a "cellulitis reaction"; however, they are not presently identifiable. An additional report will be generated when identifying information is provided.
awfully sick; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves patient (unknown demographics) who experienced awfully sick (illness), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious awfully sick (illness) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for (illness).  There will be no information available on the batch number for this case.
Patient presented to oncologist on 3/5 with SOB, fatigue, increasing lymphadenopathy from chest CT on 3/4/21.  Patient was prescribed a pulse dose of steroids. Patient was admitted to the hospital, lymph node biopsy was performed demonstrated active disease. Patient also had active EBV virus. Patient was started on IVIG which resulted in an increase in platelet count. Patient will be initiated on rituxan therapy this is being treated as an EBV lymphoproliferative disorder. Brentuximab therapy will be held.
Patient had swelling of the eyelids, slight swelling of the throat and an overall 'funny feeling' that started about 1.5 hours after injection and lasted a few hours after initial presentation
Patient called us on 12/29/2020 and said she has had rash/itch/blisters in differing places on her body since she got second shot in November.  She has been treated by her doctor with antihistamines and steroids, but itch keeps coming right back (severely at times). She also had flu-like symptoms for a couple of days after dose, but those symptoms went away.
On the 5th day after the 2nd Moderna COVID19 vaccination my left arm, at the injection site, broke out into a rash the size of a softball that extended toward my elbow. It began to itch and sting while I was cutting my sister's grass. It is feverish and can be felt when rubbed across with my hand.  No other symptoms noticed.
COVID vaccine was given to patient under 18 years old.  Was unable to contact parent for further discussion
Information has been received from a pharmacy technician concerning a female with a history of premature who in January 2009, was inadvertently vaccinated with the fourth dose of GARDASIL (LOT# not reported). After vaccination, the patient experienced numbness and tingling sensations on her arm. The patient had one dose from the patient's Gynecologist and received two doses from the patient's pediatrician. The patient sought unspecified medical attention and the outcome was unknown. No further information is available at this time of report. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 13Oct2021 at 09:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Primary Sjogren's syndrome" (unspecified if ongoing); "dysautonomia" (unspecified if ongoing); "IBS" (unspecified if ongoing); "secondary inflammatory arthritis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "post concussion syndrome" (unspecified if ongoing); "Known allergies: Whey protein" (unspecified if ongoing); "detergent fragrances" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treated with Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Diluted with .9NS - new lot and no new instructions given to our clinic about new dosing preparation. No adverse symptoms reported by patient
INFECTED TOE; BRONCHITIS; This spontaneous report received from a patient concerned an adult female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe hidradenitis suppurativa. The patient received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, intramuscular, batch number and expiry was not reported) 1 total administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  The patient received non-company suspect drugs adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe hidradenitis suppurativa. No concomitant medications were reported.  On an unspecified date, the patient experienced infected toe, and bronchitis (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number and expiry was not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2.s. (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab non-company was withdrawn. The patient was recovering from infected toe, and bronchitis. This report was non-serious.
patient developed hives and itching the evening of receiving the dose. she followed up with a dr that told her to take an antihistamine. patient said she was stilling having some hives and itching and asked what else she could do to the pharmacy. suggested that she follow up with dr and continue to take antihistamine. if getting worse see ER