chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient ahs been revaccinated on 03/19/21 and has since received dose 2 on 04/09/21
Cellulitis; redness surrounding the injection site; streaking red, resembling a thick red line up the arm; Rash; This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABX795AA, expiry date 31st August 2020) for prophylaxis.   On 16th August 2019, the patient received Bexsero. In August 2019, less than a day after receiving Bexsero, the patient experienced cellulitis (serious criteria GSK medically significant), injection site erythema, injection site streaking and rash. The patient was treated with Antibiotics (Brand Names Not Known). On an unknown date, the outcome of the cellulitis, injection site erythema, injection site streaking and rash were recovering/resolving.   It was unknown if the reporter considered the cellulitis, injection site erythema, injection site streaking and rash to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero on right arm and experienced redness, rash, cellulitis, and streaking following dose of Bexsero. The reporter described the redness as surrounding the injection site, streaking as red, resembling a thick red line up the arm. All events began less than 24 hours after dose administration, no exact time frame provided. The patient was prescribed antibiotics to treat the events. As of 18th August 2019, the events were beginning to resolve. The reporter consented for follow up. This case has been linked with case US2019151259 (for same reporter).
Injection site pain; pain travels from injection site up to neck; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and neck pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the neck pain was unknown.   It was unknown if the reporter considered the injection site pain and neck pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine on left arm. The patient experienced injection site pain that lasted really bad for 3 days. The pain travels from injection site upto the neck. The patient had an X-ray and it showed nothing. The patient said that shw will not be taking 2nd dose.
After the 1st inoculation of the Pfizer vaccine for covid 19 my daughter who has had all normal periods and cycles experienced break thru bleeding followed by an additional full menstruation cycle within a short time frame. Her menstruation cycle has always been normal and followed a regular schedule. At this time we have been advised that we should proceed with the 2nd inoculation and will have to wait and see if after this her menstruation cycle returns to normal or further medical review and intervention become necessary.
Sudden sensorineural complete hearing loss in right ear.  Followed with a number of hearing tests and ENT visits, MRI, CT Scan and a course of prednisone injections.  No other cause found. Hearing has not returned in right ear.  Considering cochlear implant.
Patient was sitting in observation chairs and was observed leaning over the side of the chair.  Pharmacist went to check on patient who regained consciousness and was able to talk. Patient requested emergency services when asked. He then proceeded to lose consciousness again for a few seconds and was held in his chair.  He regained consciousness and was lowered to the ground. He continued to report dizziness, sweating, and shakiness. He remained conscious and talking until the paramedics arrived and assessed him. He was able to leave on his own and did not require any medical intervention.
I began having abdominal pain, nausea, cramping in the morning. It became progressively worse throughout the day. By the afternoon, I was having 6/10 pain, especially when standing or walking.  I went to the walk-in clinic, and they took me to the emergency room next door. I was given fluids by IV, The Comprehensive Metabolic Panel was noted only for elevated Carbon Dioxide (21), with all others normal. Urinalysis specific gravity was <1.005, Bacteria Occasional, and they said no infection. CBC with differential, Lipase, GFR-EST Glomer, all that was normal.  CT of Abdomen Pelvis with Contrast showed no acute abnormality.  All labs "WNL".   The Estrace cream was new to me that morning, but they said it would not produce this - and has not done this to me in the past, and has not done this since I have been using it since that day. No problems whatsoever with it, and I haven't stopped using it.  I used it before, without anything ever happening, so I don't believe that was the issue.  The PA said it is a very rare side effect, but doubts this to be the problem.  (PA's name is (name), APRN, FNP, at Medical Center,  she may be able to help more than the physician who oversees her - your form does not ask for this information but she is the person who was most involved in my care, and very knowledgeable).  No pain medication, at hospital that I recall. Nothing prescribed. They really didn't find anything "wrong".
Information has been received from a healthcare professional regarding an unspecified number of patients of unknown age and gender. On an unknown date, unspecified patients may have received improperly stored M-M-R II (dose, route and lot number were not provided). No adverse effects reported. Additional information has been requested.
they have used the refrigerated unpunctured Moderna COVID-19 vaccine beyond 30 days in the refrigerator; Circumstance or information capable of leading to medication error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they have used the refrigerated unpunctured Moderna COVID-19 vaccine beyond 30 days in the refrigerator), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (they have used the refrigerated unpunctured Moderna COVID-19 vaccine beyond 30 days in the refrigerator), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they have used the refrigerated unpunctured Moderna COVID-19 vaccine beyond 30 days in the refrigerator), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (they have used the refrigerated unpunctured Moderna COVID-19 vaccine beyond 30 days in the refrigerator) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    Concomitant medications were not reported.  Treatment information was not provided.   This case was linked to MODERNATX, INC.-MOD-2023-699020 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-699020:Bivalent Product
This spontaneous report has been received from a nurse (L.V.N.) refers to one of twin sisters who in February 2010 was vaccinated with first dose of GARDASIL. The patient's mother said her draughts might have received the second dose of GARDASIL on March or April 2011 but the office could not provide official documentation and twins might received additional dose of GARDASIL. Vaccine for second dose again. No adverse effects reported. At the time of report, the outcome was unknown. This is one of several reports received from same source. Additional information has been requested.
On 3/31/99, the pt experienced hives on her face, jaw line, and ears. The reporting physician noted unknown gel given by school nurse. The hives resolved in 5-7 days with no nausea, vomiting, diarrhea, or breathing difficulties.
5/27 34y.o. G7P3033 at 38w1d by 7wk US who c/o vaginal bleeding since 0400. Has had a few small clots. States ctx have started getting more intense and frequent. +FM. Denies srom/lof. NOTE: Pt states she is fully vaccinated against COVID-19 but we do NOT have vaccination record for any details of when/which vaccine. 5/28 Pt delivered baby via SVD,
Site: Pain at Injection Site-Mild, Systemic: miscarriage-Mild, Additional Details: patient had miscarraige
"20 min. after flu injection employee reported numbness and tingling (Rt.) lateral aspect of palm/wrist that progressed to pain W/N 24 hours. MD note attached. Currently wearing splint to Rt. hand/wrist.
Pt developed petechial/purpuric lesions on bilateral lower extremities, starting at the sight of the injection, within 24 hours post vax, consistent with vasculitis. Hospitalized for 72 hours of IV antibiotics for monitoring and R/O sepsis.
p/vax face swollen (mouth, lips);lasted 24hr;took meds prescribed by MD for allergies;
This 51 y.o. male started Vivotif vax on 3/11/02. After ingestion of the 1st capsule at 6 p.m. he experienced diarrhea on 6 a.m. He again developed diarrhea after the 2nd capsule. The vax course was discontinued.
Patient turned pale about 2 minutes after shot administration but awake & warm; color got better with crying. Cardiac findings were normal; pulse oximeter registered 99/168. Patient wrapped in blanket given acetaminophen and bcd. Color improved gradually.
Information has been received from a registered nurse concerning her 12 month old son who on 8/23/04 was vaccinated with a dose of varicella virus vaccine live. Th RN reported that on 8/24/04, her son broke out in a rash. The RN indicated that her son continued to break out for three more days totaling less than 10 spots that were red, but not itchy and did not crust over. A large one on his chest was noted to be painful. The RN indicated that the spots looked like bug bites and when they disappeared left only a pin sized discoloration. Unspecified medical attention was sought, but no treatment was required. At the time of this report, the patient's events were almost completely resolved. Additional information has been requested.
Patient states that she is still experiencing intermittent pain in arm with pinching sensation on & off since vaccination.
Could not resume activities till 9/23/2019.  Fever as high as 101.8.  Headache, chills, severe stomach pain.  Malaise.  Sore arm.
Pain, half-hollar size redness, warm to touch at injection site starting on 11/08/2010. Pt. has applied ice and heat to area.  We recommended use ice compressed 3-4 times/day, Tylenol x2 tablets prn for pain q 6-8 hrs. x 48 hrs. Keflex 500 mg 1 po q8 hrs x 5 days if redness, pain continues after 48 hrs. or worsens.
covid test result=Positive; covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received bnt162b2 (BNT162B2), on 04Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in right arm and on 08Dec2021 at 09:00 as dose 3 (booster), single (Lot number: CUS2096) at the age of 56 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), on 25Mar2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "arhritis" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Oct2022, outcome "unknown" and all described as "covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient did not had covid prior vaccination. The patient had no known allergies.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
A report was received from a health care professional on 11/20/03 concerning an elderly female vaccinee who received Fluvirin on 11/10/03 and inadvertently received a further dose of Fluvirin on 11/20/03. On 11/10/03 the vaccinee received 0.5ml Fluvirin IM. On 11/20/03 the vaccinee received another dose of 0.5ml Fluvirin IM. At the time of reporting the reporter was not aware of any subsequent adverse events. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
suspected vaccination failure; got the shingles; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. About 2 months after receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided.
Inadvertently administered the vaccine 11 days after expiration date, to 16 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered the vaccine 11 days after expiration date, to 16 patients.) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 065F21a, 013M20A and 028L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered the vaccine 11 days after expiration date, to 16 patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered the vaccine 11 days after expiration date, to 16 patients.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Past medical history of the patient including allergies (medications, food and other products) was unknown.  Concomitant product use was not provided by the reporter.  It was unknown if patient ever had COVID positive test or diagnosis.  Medical history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination was none.  It was unknown if other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  On 19-Nov-2021, the patient received first booster dose.  On 27-May-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  On 31-May-2022, the patient received second booster dose.  Treatment information was not provided.
multiple bullae present on right ankle/foot 2 days after vaccine administration. Patient had similar event after second dose as well, with multiple bullae present on bilateral lower extremities.
Student apparently fainted few minutes after recieving the vaccine.  He was unresponsive for a few seconds but later recovered.  He gave his name & place where he's at.  He sustained a small cut (R) cheek area.  Neuro signs OK.  911 was called at 10:06.  Father was notified by phone.  Student taken to Hospital via Fire Department ambulance around 10:25 AM.
CLINICAL IMPRESSION 1. COVID-19  2. Acute UTI  3. Acute hypoxemic respiratory failure due to COVID-19  4. Diarrhea, unspecified type  5. Elevated bilirubin  6. Confusion  7. Complication, blocked Foley catheter, initial encounter  8. Acute urinary retention  9. Hypotension, unspecified hypotension type  10. Sepsis with acute renal failure and septic shock, due to unspecified organism, unspecified acute renal failure type  11. Panhypopituitarism
Pharmacist gave it to me in my SC rather than deltoid area of my arm; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of intramuscular formulation administered by other route in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th April 2021, the patient received Shingrix (subcutaneous). On 16th April 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The pharmacist administered the Shingrix vaccine subcutaneously(SC) rather than in the deltoid area of arm, which led to intramuscular formulation administration by other route. The patient wanted to know if another dose was needed because it was not absorbed as well in subcutaneous route(SC). The follow-up would not possible as no contact details were available.
Blood in ears; Swollen knee; This spontaneous case was reported by a consumer and describes the occurrence of EAR HAEMORRHAGE (Blood in ears) and JOINT SWELLING (Swollen knee) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 042L20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Atrial fibrillation, DUTASTERIDE (AVODART) and TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced EAR HAEMORRHAGE (Blood in ears) and JOINT SWELLING (Swollen knee). At the time of the report, EAR HAEMORRHAGE (Blood in ears) and JOINT SWELLING (Swollen knee) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received included no new information.
12/29/21 Patient is a 24-year-old female who presents to the ER with fever and cough.  Patient is vaccinated for COVID-19.  She has not been boosted.  Patient reports that starting yesterday she began having fever and cough.  She states that her fever made it up to 103.0 °F.  She reports that her fever and cough have continuously worsened.  Patient states that nothing makes her symptoms better or worse.  Patient took Tylenol this morning with symptom relief for short period of time.  Patient does not report any pain.  She states she has taken at home test which was positive for COVID-19 and wants a hospital COVID-19 test. 12/29/21  Review of Systems  Constitutional: Positive for fever. Negative for chills.  HENT: Negative for neck pain and neck stiffness.   Eyes: Negative for visual disturbance.  Respiratory: Positive for cough. Negative for chest tightness, shortness of breath and wheezing.   Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting.  Genitourinary: Negative for dysuria and flank pain.  Musculoskeletal: Negative for myalgias, back pain and arthralgias.  Neurological: Negative for dizziness, light-headedness and headaches.
Burning in (L) arm at time of injection con't x 1 wk, lesser degree. (L) arm pain - deltoid, persistent x 4 wk. No weakness or numbness (L) arm, hand.
Information has been received concerning a female consumer who on 6/6/01 and 7/16/01 (previously reported as 7/17/01) was vaccinated with the 1st and 2nd doses of varicella virus vaccine live, respectively (sites unknown). There was no concomitant medication. Subsequently, the pt found out she was 6 weeks pregnant on 7/19/01. The pt sought unspecified medical attention. Follow-up information received from the pt, on 8/15/01, indicated that she had a missed abortion. Additional information has been requested. F/U states: an adverse event onset date of ?/8?/01 has been added. This is a corrected report as amended.
pt stated she had swelling at the sight on the second day and then it spreas to the lymph notes under the arm. she was taking aleve for it
1 day after had body aches, fever, and chills,  also developed a small red rash at injection site.  Day 2 - body aches went away but rash became itchy and very sore - redness spread on arm.  Day 3 - continued redness and soreness with itchiness.  Day 4-5 - redness has subsided but still some soreness and itchiness.
SLEEPIER; This spontaneous report received from a patient via a company representative 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 MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. On MAR-2021, the subject experienced sleepier. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepier on MAR-2021. This report was non-serious.
Subsequent to receiving vax, pt developed profound pain in her arm, posterior neck, lower back and experienced difficulty walking. Pt was treated with Lodine which brought intermittent relief, however she feels worse in the morning.
p/vax pt exp chickenpox that consisted for 6-8 scattered itchy lesions;two of the lesions were scabbed while the rest were filled w/fluid;