chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed a 2.5cm x 2.5cm area of induration/cellulitis adjacent to injection site. Improved with ROCEPHIN & course of OMNICEF. Injection site, area of induration (L) thigh.
Discharge Provider: DO Primary Care Provider: FNP Admission Date: 5/19/2022 Discharge Date: May 22, 2022  PRESENTING PROBLEM: Hypoxia [R09.02] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   HOSPITAL COURSE: Very pleasant 85 y/o WF widowed community dwelling patient of NP was admitted to CCU hypoxic with bilateral pneumonia consistent with COVID 19 infection.  The patient also had a right sided effusion.     The patient received IV Remdesivir and IV steroids and improved very quickly.  She is vaccinated from COVID 19.  Her oxygen requirements were RA at discharge.  Home oxygen evaluation was negative for supplemental oxygen needs.  Cultures were otherwise negative.     Her pleural effusion resolved with Lasix.     Patient was also treated for a recurrent Klebsiella pneumoniae and Aeromonas UTI  Which was treated with Rocephin and Fosfomycin.  She will continue her suppressive Keflex at home and will complete a 7 day course of Bactrim SS 1 PO BID.  Will recheck a CBC and BMP in 4 days.     Physical Therapy saw patient and thought that she was at her baseline and was safe to go home with her daughter and husband.     She is medically stable for discharge this afternoon.  She is asked to follow up with her PCP in a week.     Thank you for the privilege of taking care of Patient.
No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a certified medical assistant (C.M.A.) referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 09-JUN-2021, the patient was vaccinated with one of following incorrectly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route were not reported) for prophylaxis: lot # T024283 has been verified to be a valid lot number, expiration date reported as 14-JUL-2022, but upon internal validation established as 15-JUL-2022; lot # T032930 has been verified to be a valid lot number, expiration date reported as 27-SEP-2022, but upon internal validation established as 28-SEP-2022 (incorrect product storage). The vaccine underwent a temperature excursion as it was stored at 47.2 Fahrenheit (F) (above 46 F) for 52 minutes, recorded by digital data logger. There was no previous temperature excursion. No additional adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356:
Information has been received from a RN concerning a 42 year old white female diabetic mellitus counselor with diabetes, asthma, and hypothyroidism and no known drug allergies who on 06/09/03 was vaccinated SC on the outer aspect of her left upper arm with a second dose of pneumococcal vaccine 23 polyvalent (643249/0358M). It was noted that the pt had been vaccinated with at least one previous dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy on 06/09/03 included tetanus toxoid (Batch # Td88)(manufacturer unknown) administered in her left deltoid. There was no known illness at the time of vaccination. On the afternoon of 06/10/03, the pt developed swelling and redness at the injection site, a headache, pain, a fever and localized edema. On 06/11/02 (during today's visit) she was seen and treated for cellulitis. It was reported that upon exam in clinic her temperature was 99.2 degrees F with an 11cm in diameter erythema and general swelling extending several centimeters beyond the erythema. The area was soft and warm. Lab data included: WBC 12.4, neutrophils 80.2, lymphocytes 11.0, eosinophils 0.9, and a blood culture showed no growth. ON 06/12/03 the pt recovered. There was no product quality complaint involved. Follow up information received on 07/08/03 from a RN indicated that she was diagnosed with cellulitis. She was treated with cephalexin (Keflex). The pt recovered within one to two days. The reporter initially indicated that the cellulitis was an other important medical event because the pt received antibiotics which was a medical intervention. However, upon follow up, the reporter indicated that she did not feel that cellulitis required medical/surgical intervention to prevent death, life-threatening illness, hospitalization, or a significant disability/incapacity.  No further information is expected.
This is a spontaneous report from a non-contactable consumer. An 84-year-old male patient of an unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm hurt real bad, it is swollen, real swollen puffy, red down 3 inches, passed his elbow. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.
Shot date 3/16/21. About eighth day after injection got large red, swollen upper arm rash around injections site, irregular shape, spread to upper arm near shoulder and towards inner arm.  Site after several days become more and more hot.  By 3/27 , went to urgent care due to skin tight, red, swollen, itchy and hot.  I suspected cellulitis, but also suspected it must be from injection.   Nurse Practitioner prescribed Cephalexin and Prednisone.
Following the first dose on 01/15/2021 an allergic reaction happened requiring 2 injections of Benadryl to stop escalation of allergic reaction (tingling of lips swelling of tongue, and  in mouth). Two additional doses of Benadryl were taken by mouth. By evening a painful raised red rash began to develop across the upper chest, just below the below collar bone. A different type of rash (red, itchy and scaly) developed on right forearm. Both rashes persisted for 7 months.  Following the second dose on 08/23/2021 an allergic reaction happened requiring 1 injection of Benadryl to stop escalation of allergic reaction (tingling of lips swelling of tongue, and  in mouth).  Two additional doses of Benadryl were taken by mouth. On injection arm a lymph gland is painfully swollen, it is now causing a tingly sensation in the lower arm.
3/31/10 pt called to report-Fever of 102, sore arm- inj site achiness. Hives on torso, fatigue. 4-1-10-Pt seen much worse, groggy/severe urticaria, skin very red & warm. Tx with prednisone. 4-5-10 much improved.
Client state almost immediately experienced left hip pain, no swelling. She sought medical attention on 09/11 and was placed on Darvocet. On 9/12 she conveyed to the medical personnel that this medication was not helping. She was then placed on 600 mg Ibuprofen. Dosage was increased to 800 mg on 09/15. She states only minimal soreness remains as of 09/18.
nausea, diaphoresis, pallor, dizziness, cold cloth to head, juice, rest.
my arm was swollen up; red; extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (my arm was swollen up), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (extremely itchy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING (my arm was swollen up), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (extremely itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CORTICOSTEROID NOS for Adverse event, at an unspecified dose and frequency. On 18-Mar-2021, PERIPHERAL SWELLING (my arm was swollen up), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (extremely itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concominant medications were not reported.
The patient was scheduled for 4 vaccines, the shingrix, pnuemovax 23, fluad 65 and covid 19 booster. The fluad and pnuemovax were predrawn vaccines and required only a needle. The needles were attached to the predrawn syringes. I drew up the Covid 19 in a syringe appropriate for the patient.  I then mixed the dilulent into the powdered shingrix  and swirled. I picked up the predrawn syringes with needles attached and secured. I then proceeded and picked up the covid-19 booster. I didn't draw up the shingrix because I wanted to able to discern between the covid 19 and shingrix syringe. I grabbed what i thought was the shingrix vials along with the covid 19 and the two predrawn syringes and approached the patient for administration. I administered the Covid 19 to upper left arm and Pneumonia lower left. I then went to administer the shingrix but I noticed the vial was empty so I drew up from what I thought was Shingrix but it was actually Covid 19. I administered the vaccine. I thought it was Shingrix but I inadvertently brought out the covid 19 vial not the mixed Shingrix vial consequently administering a double dose. I gave the fluad lower right. When I returned to vaccine station in the back I saw the Shingles vaccine filled and realized I had taken out the wrong vial.
Whole body became sweaty; Gets cold; Feels miserable; Nausea; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Whole body became sweaty), NASOPHARYNGITIS (Gets cold), FEELING ABNORMAL (Feels miserable), NAUSEA (Nausea) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Significant medical history).    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced HYPERHIDROSIS (Whole body became sweaty), NASOPHARYNGITIS (Gets cold), FEELING ABNORMAL (Feels miserable), NAUSEA (Nausea) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). At the time of the report, HYPERHIDROSIS (Whole body became sweaty), NASOPHARYNGITIS (Gets cold), FEELING ABNORMAL (Feels miserable), NAUSEA (Nausea) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicines include Extra Strength Tylenol
fatigue; This is a spontaneous report received from a contactable consumer. This contactable female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 imuunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient experienced fatigue after getting the 1st dose of the vaccine. The patient stated her husband completed the 2 doses of PFIZER-BIONTECH COVID-19 VACCINE and did not have any side effects. She asked if she could take Tylenol after I received the 1st dose. Outcome of the event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
flu like sx/vomiting;soreness in chest, shoulders & back;terrible aches & pain all over torso;hurt to breath deeply;ears  clogged;pneumonia suspected;weak/tired; movement dec d/t pain; muscle spasms; diff sleep; final dx: TB w/ skeletal
Approx 4-5 min post vaccine administration, pt became dizzy while standing; mother assisted her to chair, body stiffened. Pt observed to have symmetric tonic-clonic movement of arms / legs for approx 10 sec. with loc seizure activity observed by ARNP.
Normal vaccine booster given.  No blood at time of injection.  Patient went to waiting area and sibling came in for her dose.  I came out of area to find patient on the ground due to fainting
received a box of expired Fluzone high dose for Jun 30, 2022 and gave all 10 doses with no reported adverse event; Initial information received  on 21-Sep-2022 regarding an unsolicited valid non-serious case received from health professional.   This case involves unknown gender (over 65 years) elderly patient who was given expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] for with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA392579, 2022SA400367, 2022SA400987, 2022SA400369, 2022SA400371, 2022SA400976, 2022SA401056, 2022SA400981 and 2022SA401104.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ772AA, exp date: 30-Jun-2022) via unknown route in unknown administration site for Immunization.  On an unknown date the patients developed a non-serious "received a box of expired Fluzone high dose for Jun 30, 2022 and gave all 10 doses with no reported adverse event" (expired product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever 101F, within 1 hour, post vax. Pt was "floppy and limp" with decreased responsiveness.
I had Flu-like symptoms and severe muscle aches about 12 hours after the second dose. I was very fatigued. I had redness, swelling and pain at the injection site. It lasted for two days. After they subsided I had much more fatigue than I normally had with my condition. I have also had a lot of Brain Fog and I have trouble articulating. I feel like I have a sore throat and congestion every day.  I have had Chronic Fatigue since I had Epstein Barr Virus. It has been 15 years but I was able to work and do normal household activities. It has been eight months and my Fatigue is still debilitating. I can only stand for about one minute without feeling weak. I am unable to stand to shower. I can no longer do housework and I cannot work. Any kind of exertion makes me think I am going to faint. I was diagnosed with Hypothyroidism within three months of getting my second dose and I am taking Levothyroxine for that. I have been unable to get my EBV symptoms and fatigue under control.
Information has been received from a consumer concerning her 8 year old daughter, with allergies to cats and feathers and a mild case of asthma, who on 08/28/2001 was vaccinated SC in the left arm with the first dose of varicella vaccine. Concomitant therapy included albuterol. One minute post-vaccination, the pt passed out and experienced twitching in her right arm. On an unspecified date, the pt developed a three inch red spot at the injection site. Follow-up info received from a registered nurse indicated that the pt appeared anxious before administration of the vaccine. The nurse reported that the pt was pale and sweaty during the syncopal episode. Her pulse remained strong, but no nausea was noted. The pt and her mother remained in the office until the pt recovered. No medical attention was sought. No further info is available.
Information has been received from a nurse concerning an 18 year old female who on 30-JAN-2008 was vaccinated with Gardasil (lot# 659657/1487U). There was no concomitant medication. On 30-JAN_2008 the patient "received her first dose of Gardasil (lot# 659657/1487U) and sat down for a couple of minutes (not 15 minutes as recommended in the guidelines) and when she tried to get up and leave, she fainted. The patient did not eat lunch prior to the vaccine." Unspecified medical attention was sought. Subsequently, the patient recovered from the fainting episode. No product quality complaint was involved. Additional information has been requested. Follow-up received 04/16/2008. No further information is available.
son came in contact with 3 other people that got the shot and still got COVID-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (son came in contact with 3 other people that got the shot and still got COVID-19) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced COVID-19 (son came in contact with 3 other people that got the shot and still got COVID-19). At the time of the report, COVID-19 (son came in contact with 3 other people that got the shot and still got COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Patient's spouse states that approximately 1.5 hours after receiving vaccine patient was at home and found to be confused and non- verbal. Unable to verbally express what was wrong. Spouse called into the clinic was triaged via phone and advised to go to the ER for further evaluation.
I experienced chest pain, weakness and a hypertensive issue that has not resolved. I had stomach issues, nausea, gassy, and different. BP that day was 168/110 and later was down to 148/98. It has gone down but still hovers in the 130's to 140s and this is very high for participant.
Patient received a Pfizer vaccination which was his 4 th pfizer vaccination. He wanted the Pnumovax 23. He was okay with getting both vaccinations on the same date so we gave that as well. I explained that he may have an immune response to the vaccine like muscle aches, fever, or a headache and that he could take Ibuprofen or Tylenol tonight if needed. His pfizer vaccines were on 3-16-21,   04-12-2021, 11-07-2021, and 12-02-21
Swelling of hands, throat, and cheeks. Itching/tingling back of tongue. Resolved after 45 minutes. Took Benadryl 50 mg.
Patient received flu shot approx. 3:00PM. Left facility. Returned to facility at 4:08PM with c/o facial numbness and c/o tongue swelling 408 was given Epi 0.3ml 1:1000 I.M. 410pm Gave Benadryl 25mg BP 160/80 at 415/ BP 150/74 No swelling visible in throat or tongue 433/pm BP 126/70 450pm Friend have to take to E.R.
Arm swelling around arm; Itching at the injection site; Really really red around arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelling around arm), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Really really red around arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Heart disease, unspecified.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling around arm), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Really really red around arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Arm swelling around arm), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Really really red around arm) outcome was unknown.            Treatment details included warm compress, ice.   No concomitants were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: NNI
not feeling well; arm was crumping very bad; very very sick; whole body hurts; the arm, it seems like it's burning underneath the skin; sweating a lot; skin is on fire, have fire in hand; have really sharp pain in arms; knees started to shake uncontrollingly; cold sweat; can't barely stand up straight; It's almost like when you have the flu but worst; weak; feel like my whole body is controllingly shriving; body's been aching very very bad; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), MUSCLE SPASMS (arm was crumping very bad), ILLNESS (very very sick), PAIN (whole body hurts) and SKIN BURNING SENSATION (the arm, it seems like it's burning underneath the skin) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F11A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-2021, the patient experienced MALAISE (not feeling well), MUSCLE SPASMS (arm was crumping very bad), ILLNESS (very very sick), PAIN (whole body hurts), SKIN BURNING SENSATION (the arm, it seems like it's burning underneath the skin), HYPERHIDROSIS (sweating a lot), BURNING SENSATION (skin is on fire, have fire in hand), PAIN IN EXTREMITY (have really sharp pain in arms), TREMOR (knees started to shake uncontrollingly), COLD SWEAT (cold sweat), DYSSTASIA (can't barely stand up straight), INFLUENZA LIKE ILLNESS (It's almost like when you have the flu but worst), ASTHENIA (weak), CHILLS (feel like my whole body is controllingly shriving) and MYALGIA (body's been aching very very bad). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MALAISE (not feeling well), MUSCLE SPASMS (arm was crumping very bad), ILLNESS (very very sick), PAIN (whole body hurts), SKIN BURNING SENSATION (the arm, it seems like it's burning underneath the skin), HYPERHIDROSIS (sweating a lot), BURNING SENSATION (skin is on fire, have fire in hand), PAIN IN EXTREMITY (have really sharp pain in arms), TREMOR (knees started to shake uncontrollingly), COLD SWEAT (cold sweat), DYSSTASIA (can't barely stand up straight), INFLUENZA LIKE ILLNESS (It's almost like when you have the flu but worst), ASTHENIA (weak), CHILLS (feel like my whole body is controllingly shriving) and MYALGIA (body's been aching very very bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by the reporter.
Covid arm (about a week after first dose, developed redness, itching, and swelling at the injection site)
PATIENT CAME IN WITH MOM, GRANDMA, AND BROTHER TO GET THE COVID VACCINE.MINOR (16) GIVEN THE  JOHNSON AND JOHNSON VACCINE BY MISTAKE. BY STAFF. PATIENT WAS MONITORED FOR 30 MINS WITH NO ADVERSE REACTIONS. CALLED AGENCY WHO ADVISED TO HAVE PARENTS MONITOR FOR ANY SEVERE SIDE EFFECTS. DISCUSSED WITH PARENT WHO VERBALIZED UNDERSTANDING.