chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EN5318) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Clinical depression" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "Known allergies: Compazine". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".  Additional Information: No reactions to vaccinations other than sore arm.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231836 same patient, different vaccine dose/event;US-PFIZER INC-202300232002 same patient, different vaccine dose/event;US-PFIZER INC-202300232003 same patient, different vaccine dose/event;US-PFIZER INC-202300232004 same patient, different vaccine dose/event;US-PFIZER INC-202300232005 same patient, different vaccine dose/event;
PT EXP PAIN AND STINGING AT SOI AFTER RECEIPT OF ENGERIX-B.  TREATMENT:  PT COUNSELING.  DOSE #2 ON 09Jan90 PT EXP SIMILAR PAIN AT SOI.
Red swollen blister - arm swelled drastically- fever chills - itching - oozing blister at sight of injection- pain - given antibiotics.
Reactions started at approximately 6 PM 11/21/2019.  Increased pressure in head (possibly intercranial hypertension (IH)), shaking, fever, diarrhea,  severe muscle and joint pain,   IH lastetd until approximately 9 AM 11/22/2019,   Muscle and joint pain lessened to normal arthritic level on 11/24/2019.  Diarrhea lasted until approximately 9 AM 11/26/2019.
Fatigue, low grade fever, spitting up some clear cough, sputum, cough 4-5 times a day. starting 12/25/21
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ep7533), in left arm, on 28Apr2021 as dose 2, single (Lot number: ew0171), in left arm and as dose 3 (booster), single (Lot number: fj8757), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient was not Pregnant. The patient had received the vaccine. No other medication in 2 weeks taken by patient. The patient has no known allergies. No other medical history was there. Took full course of Paxlovid and had a rebound infection 9 days after testing negative and stopping treatment.
Patient received covid #2 vaccine and developed a lump above the collarbone area with swelling and painful to touch. Diagnosed as left supraclavicular lymphadenopathy.
It appears it was given very posterior (possibly sub Q).  Has a large knot, large area of warmth and erythema, appx 15 cm
As of today, 10/28/2020, I have had chronic pain and in my left shoulder at the injection site of the Shingrix vaccination ever since I had the shot 9/11/2020. I was sitting in a chair when the nurse, who was standing, gave me the shot which was also very painful. It is very painful when I lift and lower my left arm in a certain direction. I told my physician about this on 10/16/2020.
Leg issues/leg pain; Joint pain/joint issue; This case was reported by a consumer via call center representative and described the occurrence of leg pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced leg pain and joint pain. On an unknown date, the outcome of the leg pain and joint pain were unknown.   It was unknown if the reporter considered the leg pain and joint pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced leg issues and joint pain after the Shingrix vaccination. The patient disconnected the call abruptly and did not provide any additional information.  The reporter did not consent to follow-up.  Note- there was discrepancy in reported events. Leg issues mentioned in narrative but in event sections leg pain was reported, so event was coded as leg pain as seems appropriate. Same for joint issues/joint pain.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 58-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 30-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023AMR055743:same reporter
A 67 y.o male with PMH with parkinson, TIA and pseudogout found to be +COVID-19 no signs of sepsis or SIRS. No leukocytosis. Labs unremarkable. No hypoxia. CXR with infiltrate vs atelectasis independently reviewed. Could be post COVID but given patient symptoms will cover with bordered broad-spectrum antibiotic with vancomycin and Zosyn for possible superimposed infection.  Will monitor renal function with labs in the morning to evaluate for side effect. Urinalysis was negative for UTI.  Will order blood cultures.  No indication for therapy for COVID-19 given the onset of symptom in more than 2 weeks and not being hypoxic
No further AE reported. No PQC. No additional AEs reported; A patient was administered expired PROQUAD.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 24-AUG-2021, the patient was vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter, lot #T005406 was confirmed to be valid, expiration date 12-AUG-2021, for prophylaxis (route and site of administration were not reported). No additional adverse event was reported.
Well child visit 30May91 /x for a slight cough-afebrile.2nd PEDVAXHIB given that day.APAP given prophylactically.That evening T rose to 104-105F.Seen again on 4Jun91 for F/U-no focal signs of infection found.
Developed pain (R) shoulder after flu shot - Was seen by PCP & orthopedist for evaluation. Currently getting therapy for shoulder ordered by the orthopedist.
This is a spontaneous report from a contactable pharmacist, reporting for herself, via Pfizer Sales Representative. A 65-year-old female patient received PREVNAR 13, on an unspecified date at single dose for immunisation. The patient medical history was and concomitant medications were not reported. On an unspecified date, after pneumococcal 13-val conj vaccination, the patient's arm swelled up and was very painful and patient  could not work the next day. Outcome of the events was unknown. Information on the batch number has been requested
This is a spontaneous report from a contactable consumer from a PFE PAP SP Lyrica. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization; pregabalin (LYRICA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient past Medical history included spinal operation and two back surgeries. Concomitant medication included pregabalin (LYRICA) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; hydrocodone (MANUFACTURER UNKNOWN), via an unspecified route of administration, on an unspecified date at unknown dose and frequency for unknown indication. On an unspecified date in 2021, the patient experienced my arm itched, headache. The patient reported drug is miracle for him the generic doesn't work for him. He would like to get off hydrocodone and increase his Lyrica. He will have spoken with his doctor about increasing his Lyrica. He had the Pfizer vaccine too. After the shot his arm itched and he had a headache on an unspecified date. The clinical outcome of the my arm itched, headache were unknown. Information on the lot/batch number has been requested.
Began to have itching all over body. No airway compromise. Seen 9/9/15 3:15pm. Give IM Benadryl. Prescription for Medrol dose pak and take OTC Benadryl as needed. Had follow ups qd. Resolved as of 9/14/15. No hospitalization.
Right arm swollen; Right arm red; This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (Right arm swollen) and VACCINATION SITE JOINT ERYTHEMA (Right arm red) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included Breast tumor benign (Breast tumor removed a year ago under the right arm.).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PERIPHERAL SWELLING (Right arm swollen) and VACCINATION SITE JOINT ERYTHEMA (Right arm red). On 25-Feb-2021, PERIPHERAL SWELLING (Right arm swollen) and VACCINATION SITE JOINT ERYTHEMA (Right arm red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
02/22/22 presents to ED for "Altered mental status". PMHx of "atrial fibrillation, Cardiomyopathy, frequent falls, CHF, and COVID-19".
pt recv vax 26FEB96 3 days later devel chest heaviness,cough & shoulder pain;MD dx flu upon returning from a trip on 3MAR96 pt c/o inc resp distress;pt hosp;CXR revealed a large lt-sided pleural effusion;dx myocarditis,pericarditis,CHF
Fevers, Nausea, vomiting, diarhea, headaches, body aches, chest pain and shortness of breath
Three weeks later patient noted petechia along posterior/medial calves and scattered along lower extremities, intermittent pain and edema of lower extremities. This worsened over the next four weeks. Ultimately diagnosed with Henoch Schonlein Purpura by Rheumatology in June. Biopsy prior to that had been nonspecific and only ANA positive noted on extensive lab workup.
back started killing him; soreness at injection site; muscle ache; Felt woozy; A spontaneous report was received from a Consumer concerning a 72-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced woozy, soreness at injection site, muscle ache, and back started killing him.  The patient's medical history include psoriasis, high blood pressure, gout, shattered collar bone, multiple degenerative disks, bad back and AMD. Concomitant medications reported were lisinopril, Lipitor and alopurinol were reported.  On 8 Jan 2021, prior to the onset of the events the patient received his first of two planned doses of mRNA-1273 (lot/batch: 011J20A) for prophylaxis of COVID-19 infection.  On 8 Jan 2021, the patient experienced the events felt woozy. soreness at injection site, muscle ache and  On 22 Jan 2021, the patient experienced the events back started killing him.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, felt woozy, soreness at injection site, muscle ache, and back started killing him was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Moderna Booster: Patient is reporting extreme itching in scalp. Itching in hands, and  Itching in mouth.
Shoulder pain, decreased mobility in arms, swelling at injection site, shortness of breath, fever 3 hrs after, body aches, and headaches. Had symptoms for 3 days and did not receive treatment.
LOSS SENSE OF SMELL; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced loss sense of smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of loss sense of smell was not reported. This report was non-serious.
Noticed a "full" feeling in head about a week after vaccine but nothing major. Not a headache sufferer, so felt like getting a cold or maybe sinus issue. Ears feel like a "roaring" at times, no ache or anything else, just noise (started days after head) Intermittent not being able to taste food (noticed last week) Smelling is noticeably off (noticed last week)  Had just passed it off as generally thinking I was getting a cold, but today made French toast with cinnamon, and could not taste that it even had cinnamon in it. I usually have an acute sense of smell & taste
Case number PHEH2012US016213 is an initial spontaneous report received from a nurse on 15 Aug 2012. This case refers to an 18-year-old female patient. This patient was vaccinated intramuscularly with MENVEO (batch number: M10131/M11064/M11054A) that had reached 23 degree Fahrenheit and the vaccine was not frozen. No adverse event was reported following vaccination. No other information was available.
Diarrhea  Stomach pain Nausea Body Aches Headache Chills Swelling in face  Swelling in arm
Appearance red, raised warmth at injection site with red streak noted. Painful, cellulitis.
20 cm area of redness, tenderness, edema at injection site. Muscle soreness at injections site
Heart pain and off beat, numbing in my arms and legs for time to time, and weird heart palpitations.
Onset of dizziness, shortness of breath, nausea, headache. Symptoms lasted App 30 minutes without resolution. Pt transported via ambulance to hospital.
Sharp Left Testicle Pain,Sore, Dull, Pain in Left Ball; pain in Left Ball and Lower Abdomen; sharp pain in lower Back; it feels like having an hernia on the left testicle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Oct2021 13:30 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Previous dose number: 1, Previous dose Vaccine location: Right arm), administration date: 21Sep2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: TESTICULAR PAIN (non-serious) with onset 12Oct2021 06:00, outcome "not recovered", described as "Sharp Left Testicle Pain,Sore, Dull, Pain in Left Ball"; ABDOMINAL PAIN LOWER (non-serious) with onset 12Oct2021 06:00, outcome "not recovered", described as "pain in Left Ball and Lower Abdomen"; BACK PAIN (non-serious) with onset 12Oct2021 06:00, outcome "not recovered", described as "sharp pain in lower Back"; TESTICULAR DISORDER (non-serious) with onset 12Oct2021 06:00, outcome "not recovered", described as "it feels like having an hernia on the left testicle". The events "sharp left testicle pain,sore, dull, pain in left ball", "pain in left ball and lower abdomen", "sharp pain in lower back" and "it feels like having an hernia on the left testicle" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of testicular pain, abdominal pain lower, back pain, testicular disorder.  Additional information: The patient was not pregnant at the time of vaccination. The patient did not receive other vaccine in four weeks and no other medication received in two weeks. No covid prior vaccination and no covid tested post vaccination.  Follow-up attempts completed. No further information is expected.
UrticariaPruritus DIAPHORESIS Narrative:  PT SEEN BY EMPLOYEE HEALTH ARNP. V/S STABLE. SHE HAS NEVER HAD A VACCINE BUT HAD TO TAKE A MANDATORY COVID. ITCHING WITH IN 15MINUTES. SHE TOO BENADRYL 25MG PO OF HER OWN MEDS AND REACTION RESOLVED.
patient stated that she only received one dose of covid (JJ). she came in for a booster shot for moderna. after giving her the shot, we ran it through her insurance and it got rejected because it was too early. she received a pfizer booster on 8/8/21 @ pharmacy.
Vaccine given to left leg, there was surrounding erythema and the child was in pain with walking. Pt was admitted to the hospital for 23hrs with thoughts of cellulitis; was given IV antibiotics, switched to PO and sent home in less than 23hrs. Child seems to be doing fine 1 day after discharge.
No known adverse effects; an administered dose of V ARlV AX underwent a temperature excursion prior to being administered to 1 patient; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.   On 28-JAN-2020, the patient was administered an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, lot # R034396, expiration date 28-JAN-2020, (exact dose, route of administration and anatomical location were not reported) for prophylaxis.   The vaccine underwent a temperature excursion of - 14.6 degrees Celsius for 17 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.
Dizziness,  lethargy, weakness,  near syncope within 15 min of dose. Given 1liter of ns and discharged 1300  1/27. Full body aches continuing. Signifigantly worse am of 1/29/21, fever 101, fatuge, body aches, nausea, loss of taste.
48 hours following TD vaccine client began experiencing increase pain, redness, swelling and itching at inject site. Temp 100.5 72 hours.
POSITIVE TEST FOR COVID-19; This spontaneous report received from a consumer concerned a male of unspecified 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: 1805022, expiry: 23-AUG-2021) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-DEC-2021, the patient experienced positive test for covid-19. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of positive test for covid-19 was not reported. This report was non-serious.
the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 15-Mar-2022; dose of the Moderna COVID-19 vaccine was administered after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose of the Moderna COVID-19 vaccine was administered after the beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 15-Mar-2022) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2022 at 1:10 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Mar-2022 at 1:10 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose of the Moderna COVID-19 vaccine was administered after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 15-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose of the Moderna COVID-19 vaccine was administered after the beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 15-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Thaw expiration date was reported as 02-Mar-2022. It was reported that the HCP did not know that the vial should not be used past 30 days from thawing the vial. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-583132 (Patient Link).
Child presented to mother with hives 1 hour and 25 minutes following immunization; no SOB, no wheeze. 1/4 tabs Benadryl given by nurse per CB order upon arrival at 2:10 PM. Infant responded to Benadryl. Will continue with Benadryl 1/2 teaspoon every 4-6 hours for 48 hours. Refer to allergist.
Increased volume and new frequencies regarding existing tinitus; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199), via an unspecified route of administration in the right arm on 11Mar2021 at 18:15 (at the age of 51 years), as a single dose for COVID-19 immunisation. Medical history included tinnitus. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and LIPITOR for an unspecified indication. The patient was allergic to dilantin "Dylantin". Since the vaccination, the patient had not been tested positive for COVID-19. On 15Mar2021, the patient experienced increased volume and new frequencies regarding existing tinnitus. The patient did not receive any treatment for the event. The clinical outcome of the event tinnitus was reported as unknown.   No follow-up attempts are needed. No further information is expected.
Patient had fainted roughly 2-5 minutes after vaccination. Patient had been told to wait for 15 minutes after vaccination but was thirsty and went to her car to grab some water. When outside, patient felt dizzy and fainted, falling and hurting her head and leg. Ambulance was called but patient refused any care and wanted to go home. We had the patient call a friend/family to pick her up.  When asked, patient reported not having eaten today and vaccination was given approximately at 2:30 pm.