chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 67 year old female with mitral valve prolapse, elevated lipids, diverticulitis, irritable bowel syndrome, reflux, osteoporosis, penicillin allergy, sulfonamide allergy and allergies to erythromycin, fluoroquinolones, dicyclomine, "statins" and ACIPHEX who in 1999 was vaccinated with the first dose of PNEUMOVAX vaccine (lot# not reported). On 16-FEB-2009 the patient received the second dose of PNEUMOVAX vaccine (lot# 663012/1163X). Concomitant therapy included NIASPAN, estrogens, PREMARIN, aspirin (manufacturer unknown), ezetimibe, DITROPAN, PREVACID and NASONEX. On 16-FEB-2009 the patient developed injection site reaction on her left arm. She had warmth and swelling that was 6 inches long and 5 inches wide. There was redness inferior to the injection site and it looked like cellulitis. There was no itching. The patient was given an injection of DEPO-MEDROL 60mg on 17-FEB-2009. The patient's symptoms persisted. The patient sought medical attention in the office. In follow-up, the registered nurse reported that the patient with fatigue, osteopenia, hypolipidaemia and allergies to LEVAQUIN, BENADRYL and CIPRO received her first dose (previously reported by the same nurse as the second dose) of PNEUMOVAX vaccine (lot# 663012/1163X) into left deltoid on 16-FEB-2009. On 16-FEB-2009 the patient developed redness at injection site with no itching. On 17-FEB-2009 the redness had spread inferior to the majority of the dorsum of the lower upper arm. The patient also had a swollen and warm left deltoid. On 17-FEB-2009, the patient was given OMNICEF 300mg BID #20 and DEPO-MEDROL 60mg IM for treatment. Subsequently, the patient recovered. The reporter considered the events to be non-serious. Additional information is not expected.
I had a sore throat, congestive, body ache, fatigue, and running nose. These lasted for about few weeks. On Jan 11th, I was tested positive for Covid-19.
Redness and swelling at site 3/26/14 - Showed Infection Prevention Coordinator pic taken. Vist by her to use warm packs and BENADRYL. 3/27/14 16:10 I spoke w/patient on phone. She said she never used BENADRYL; did warm packs. Swelling and redness has gone down on it's own. Denies fever.
Pt. noticed local injection site pink and itchy the following day. It got larger the next day after on 6/10/16. Patient went to md and he prescriber her antibiotic for 7 day. It has gotten better as of 6/13/16.
(Moderna COVID?19 Vaccine EUA)   Chills, sweats, nausea, and migraine headaches. Also, respiratory congestion and cough. Symptoms started 24 hours after vaccination (not all at once) and persisted for 9 days total. Loss of appetite and loss of taste for certain foods. I lost 8 lbs. during this period.
Patient describes tongue swelling 20min post vaccination and requested Benadryl (history of allergic reaction with spices).  staff provided diphenhydramine liquid. Patient reports feeling better, no swelling or itching 8min later. At 9:40am patient was discharged from clinic feeling normal.
Temp started 8MAY92, has been up & down since then usually between 102-104, eyes watery, hurts to touch; seems to hurt to move;
Complained of pain immediately - no visible redness or swelling. Saw PCP and was given MEDROL dose pak.
Refrigeration excursions identified/vaccines have undergone several temperature excursions; No Adverse Event; vaccines undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No Adverse Event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Sep-2022 at 11:48 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 16-Sep-2022 at 11:48 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient).    No concomitant medication was provided.  The patient had ever been diagnosed with/ tested positive for COVID-19 was unknown.  Patient took first, second and third dose through intramuscularly at deltoid region. Dose 4 vaccine administered at deltoid region.   Date vial was moved from freezer to refrigerator on 7-Sep-2022. The 2 unbroken cartons 20 vials.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022. It was reported that no adverse reactions were reported to their knowledge for any patients.  Treatment medication was not provided by the reporter
I am the epidemiologist reporting on behalf of 73-year-old male LTCF patient. The patient received their first dose of the Pfizer vaccine on 1/06/21. The patient tested positive for COVID-19 on 1/26/21 via PCR (20 days post dose 1). The patient received their second dose of the Pfizer vaccine on 5/26/21 and their third dose of the Pfizer vaccine on 10/27/21. The patient tested positive for COVID-19 a second time via PCR on 11/16/21. On 11/27/21 (one-month post dose-3 and 11 days post positive test) the patient expired (listed as COVID-19 death). The cause of death listed on the death certificate is atherosclerosis (3 years). Known patient history includes cardiovascular disease. This is the first instance I have observed within my home county of a person with a repeat infection, fully vaccinated + boosted, passing away with COVID.
Client moved his L arm away abruptly during vaccination and vaccinator  was unable to successfully vaccinate the client. There was no wasted vaccine but the needle broke the client's skin. RN wasted the vaccine dose and instructed the client's father that we can attempt to vaccinate on the opposite arm if he is able to help provide assistance with stabilizing the client's arm. Client's father verbalized understanding and RN provided the vaccinator with a new pediatric dose of Pfizer COVID vaccine. Client received 1st dose of pediatric Pfizer COVID vaccine (lot# FK5127) in the R deltoid at 0140. No adverse reactions were reported by client during observation. Client left the site at approximately 0200 with a steady gait.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of PROQUAD (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information was obtain during a telephone call to the licensed practical nurse, on 23-JAN-2015. The licensed practical nurse did not have lot numbers and expiration dates readily available for PROQUAD (Merck), and reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from the licensed practical nurse on 18-MAR-2015, concerning a currently 5 years old patient of unknown gender, who was vaccinated with a dose of PROQUAD (Merck) lot number K011313, expiration date not reported. This is one of several reports from the same reporter. Additional information is not expected, since all the information needed to complete the case has already been received.
Leg pain; Feeling abnormal; Sickness; Headache; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Leg pain), FEELING ABNORMAL (Feeling abnormal), ILLNESS (Sickness) and HEADACHE (Headache) in a 51-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 Psoriatic arthritis.    No Medical History information was reported.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Leg pain), FEELING ABNORMAL (Feeling abnormal), ILLNESS (Sickness) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Leg pain), FEELING ABNORMAL (Feeling abnormal) and HEADACHE (Headache) had not resolved and ILLNESS (Sickness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.
my chest was a little bit heavy; big rash around the injection site/ round rash; it was very itchy; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (my chest was a little bit heavy), VACCINATION SITE RASH (big rash around the injection site/ round rash) and VACCINATION SITE PRURITUS (it was very itchy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (my chest was a little bit heavy), VACCINATION SITE RASH (big rash around the injection site/ round rash) and VACCINATION SITE PRURITUS (it was very itchy). At the time of the report, CHEST DISCOMFORT (my chest was a little bit heavy), VACCINATION SITE RASH (big rash around the injection site/ round rash) and VACCINATION SITE PRURITUS (it was very itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment drugs were reported  Med Info Agent: I got the Moderna about 28 days ago. I called them because 8 days after receiving the first dose I had a very big round rash around the injection site. It was very itchy. I felt like my chest was a little bit heavy. Went to urgent care when rash appeared on my arm. Told me that before I get the second shot I should bring up this to the vaccination provider. She has called the vaccination provider who referred her to this number.  Caller disconnected prior to answering AE questions. Limited AE sent to safety.
pt recvd vax for prophylaxis;12 hrs later p/ recving dose 2,exp hives; event resolved;pt not seen by MD;was tx w/ dph;
Patient received vaccine at 0815L. Patient stated that he felt nauseous and dizzy.  Patient given emesis bag and ice pack placed on neck.  Patient reported some relief.  Patient remained in building for 1 hour. Vitals at 0920 as follows; HR 87, BP 135/91, SPO2 95%, RR 16. Vitals at 0927 as follows; HR 85, BP 133/87, SPO2 97%, RR 16.  Patient walked outside to determine stability.  Patient stopped and sat on bench and dry heaved 2 times. EMS called at 0933L and hand off given to paramedics at 0940.  Patient reported last time he at was at 0530L, blood glucose was 113 per medics.  Patient transported to  Emergent Care Center.
SWELLING, TENDERNESS IN INJECTED ARM, THEN PERSISTENT REDNESS.
Fever 101.6, headache, body aches especially in legs, chills, sweats, abdomin pain, pain in shot area up arm into sholder and neck.  This is going into my second day.
No other AEs or PQC reported; Vaccine administered after temperature excursion; This spontaneous report has been received from a registered Nurse referring to a 7-moths-old infant patient of unknown gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 18-OCT-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at the dose of 2 mL, as prophylaxis (frequency, strength, and route of administration were not provided; lot number T030458 has been verified to be a valid lot number with expiration date on 11-APR-2022).  Administered dose of vaccine experienced temperature excursion of 35 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. No other adverse event was reported. No additional information available.
Severe vomit/runs/chills/fever of 99.5 increasing to 100.2 at 8:00 PM. Cannot hold fluids down. Husband spoke to primary doctor on phone/ MD said give clear soup and gatorade / aspirin to lower fever.
Swollen, red, hot, induration at site of injection, lasted 7 days.  Not painful but tender and itched alot.
c/o itchiness in throat after receiving the vaccine. Given Benadryl 50mg IM. No SOB, dizziness, angioedema, or rash.  Felt better and went home after extended monitoring time.
15 yr old patient was given a dose of the intradermal influenza vaccine which is licensed for 18yr and older. Medication administered to or used by the patient: Yes. Patient counseling provided: Unknown. Patient's Age: Adolescent (13-17 years). Patient's Gender: Unknown. Relevant materials provided: None.
Initial report was received 28 August 2013 from a health care professional. A 60-year-old female patient had received an intramuscular right deltoid injection of ADACEL, lot number U4655AA on 24 August 2013, and two days later, the patient returned to the office to be evaluated for "cellulitis" at the vaccine injection site. She received corrective treatment with Cefotaxime. At the time of the report, outcome was unknown. Documents held by sender: None.
Pt received shingles vaccine at pharmacy next day itching, swelling, redness, pain.
21JUN91-23JUN91 parotitis, c/o tenderness below rt ear, redness, tenderness, swelling noted below rt ear; Taken to clinic; Tx; Pediaprofen;
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 25-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On OCT-2021, the patient experienced arm swelled under armpit really large. On 25-OCT-2021, the patient experienced as soon as got the shot immediately felt it went from arm to chest, then through sinuses and down legs and felt weird the entire night. On 25-OCT-2021, the patient experienced felt like going to pass out and had frequent days where dizzy. On 26-OCT-2021, the patient experienced cannot see straight for no apparent reason, so left work early and laid down. On 26-OCT-2021, the patient experienced had a headache. On 27-OCT-2021, the patient experienced woken by stabbing pain in left leg, feet and hands are in pain all the time. On 27-OCT-2021, the patient experienced numbness in both feet and hands and right arm went completely numb. On 28-OCT-2021, the patient experienced had nonstop severe chest pains. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from as soon as got the shot immediately felt it went from arm to chest, then through sinuses and down legs and felt weird the entire night, felt like going to pass out and had frequent days where dizzy, had a headache, woken by stabbing pain in left leg, feet and hands are in pain all the time, had nonstop severe chest pains, arm swelled under armpit really large, cannot see straight for no apparent reason, so left work early and laid down, and numbness in both feet and hands and right arm went completely numb. This report was non-serious.
This spontaneous report as received from a physician refers to an unspecified number of patients. On unknown dates an unspecified number of patients were administered with doses of RECOMBIVAX HB (lot#, strength, dose, frequency, route unknown) that were improperly stored. No adverse effects were reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
At first if felt like a really painful acid reflux and i kept taking deep breaths because it was painful and it was alarming since I had not felt this before. This continued for several days but I just didn't feel well. Not sick just my heart was hurting  and i was very nauseous
Swelling of left axilla, approximately baseball sized starting 2/3/2021 unresolved
Patient received flu shot at clinic. Presents with localized swelling and warmth approximately 5-6 cm reaction. Mild redness overlying.
Patient received a second booster of Pfizer bivalent Covid vaccine.  (First dose received 10/06/22).  That evening, he stated he experienced fatigue and chills which resolved the following day.  Patient stated he gets a similar reaction with other vaccines e.g.  flu. His personal physician was informed.
Arm pain at injection site that returned a week after the 1st dose.; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route in the left arm on 21Apr2021 at 11:30(at the age of 54-year-old) as single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient's history of known allergies was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 28Apr2021 at 12:00, the patient experienced arm pain at injection site that returned a week after the first dose. Therapeutic measures were not taken as a result of the adverse event. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event of arm pain at injection site was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt experienced pain and redness at injection site with a large localized rxn of 10x5 cm
Lots  of bleeding and it wasn't time for her period.  Severe back pain, pelvic abdominal pain and headache. Severe fatigue.  Not able to get out of bed.
Started to get tired and thirsty the evening of the 30th a few hours after the vaccine. Went to bed around 10:30 and woke up about 3 hours later at 1:30. Had chills and was shaking when I got up. Could not really fall back asleep. Chills turned into a fever. That morning I started to get a headache. I sounded congested at one point, but no runny nose. I also had body and joint aches.  I took Excedrin three times that day. Once in the morning, once in the afternoon, once before bed. I used zquil to sleep a little bit in the afternoon and again at night. I woke up Sunday and felt completely fine except for my arm still being sore.
Administered 0.25 ml instead of 0.5 ml to uncompromised adult/wrong dose for Bivalent Vaccine booster dose (underdose); No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Administered 0.25 ml instead of 0.5 ml to uncompromised adult/wrong dose for Bivalent Vaccine booster dose (underdose)) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Administered 0.25 ml instead of 0.5 ml to uncompromised adult/wrong dose for Bivalent Vaccine booster dose (underdose)) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Administered 0.25 ml instead of 0.5 ml to uncompromised adult/wrong dose for Bivalent Vaccine booster dose (underdose)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Administered 0.25 ml instead of 0.5 ml to uncompromised adult/wrong dose for Bivalent Vaccine booster dose (underdose)).    Concomitant medications were not reported.  Reported that patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster. It was reported when first administering Bivalent boosters. So, they assumed the same dose as the second booster, and they were administering 0.25 ml instead of 0.5 ml to uncompromised adults. It was reported that CDC had recommended to re-vaccinate the patient with a full dose of 0.5mL. It was reported that no adverse event was reported. Treatment medications were not reported.
Approximately 8 mins after injection, I began to experience lightheadedness and trouble focusing.  Began to feel dizzy, weak, was sweating, and had a flushed appearance in face.  On attempt to stand, felt like I could not take a step.  In ER vitals were normal except for blood pressure was high.  Was discharged after receiving IV fluids, lab tests, EKG.  About 5 hours later, I developed a low grade fever of 99.7, blood pressure 142/92, chills,  general malaise and body aches.  Symptoms started dissipating later in the evening.  Started feeling better as the day progressed the next day.