chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose 12-jan-2020, the 2nd dose on 26-jul-2021 and 3rd dose on 17-sep-2021; 1st dose 12-jan-2020, the 2nd dose on 26-jul-2021 and 3rd dose on 17-sep-2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix b (received 1st dose on 12th January 2020).   On 17th September 2021, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 26th July 2021, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 26th July 2021, not applicable after receiving Engerix B and Engerix B Pre-Filled Syringe Device and unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On 17th September 2021, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were provided as follows: The patient received Engerix-b  outside recommended schedule. The patient received the second and third dose late which led to lengthening of vaccination schedule. No knowside effect reported. No LOT number and expiration date provided. The reporter consented to follow up.
Left Axilla Lymph node swelling and pain , improving over time . Almost resolved at this time . Lasted about 3 months .
77 yr old male with medical hx of history of DMII, HTN, MI, Afib on AC, coronary artery disease, status post CABG x4 in 1996 and stents who reports feeling weak the past couple days with increasing dyspnea. Patient came to the ER this evening noted to have hypoxia 84 percent on room air the patient was placed on oxygen improved to 90%.   The pt found to be covid +. CXR bilat infiltrates. Labs are also notable for severe anemia 6.3 , the patient takes Eliquis and aspirin. he has AN elevated lactic acidosis 7.22 likely from resp. hypoxia and noted INR 3.07. HE has a normal platelet count and WBC. Trop elevation 0.12, EKG is notable for atrial fibrillation rate in the 90s
Administer 0.5ml dose to the patient instead of the indicated 0.3mL dose. Patient noted feeling like he had the flu for 5 days after his Pfizer booster- bad headache and fatigue. Before had only mild symptoms after #2 dose for 1 day.  No residual symptoms.
fever, chills, nausea, aches, joint pain; fever, chills, nausea, aches, joint pain; fever, chills, nausea, aches, joint pain; fever, chills, nausea, aches, joint pain; fever, chills, nausea, aches, joint pain; This is a spontaneous report from a contactable consumer reporting for self. A 65-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included covid-19. Concomitant medication included celecoxib. The patient experienced fever, chills, nausea, aches, joint pain on 08Jan2021. Outcome of events was recovered.   Information on the lot/batch number has been requested.
ACUTE NON ST ELEVATION MI 12/9/2022 &  12/6/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient received PNEUMOVAX 23 and FLUZONE HD at around 2PM on 09/18. Patient came back to the pharmacy at around 10AM on 09/19. They stated they had an injection site reaction (redness, swelling, spreading erythema) and trouble breathing at 2AM. They sought medical attention and were subsequently given a dose of BENADRYL injection. Upon return to pharmacy, patient was counseled to take BENADRYL, Ibuprofen and apply a cold compress and to report any additional adverse reactions.
Temp ranging fr 100.6-103.6 24hrs period p/immun; Periods of inconsolable crying & screaming followed by hyporesponsive periods; Seen by MD; No tx indicated; local rxn lt leg redden swollen initially no abscess;
Fainted at 1000 AM, *lost consc. < 1 min, no seizing VS- Lying 110/68, HRR, LCTA at 1010 AM - sitting 110/78, HRR, LCTA at 1020 AM - standing 112/72, HRR, LCTA at 1030 AM.
Trouble hearing; Inflammation; Sinus issues/sinus infections; Possible vaccination effects/did not wake up for a week; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Possible vaccination effects/did not wake up for a week), HYPOACUSIS (Trouble hearing), INFLAMMATION (Inflammation) and SINUSITIS (Sinus issues/sinus infections) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    There was no reported medical history.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 08-Jan-2021, the patient experienced HYPERSOMNIA (Possible vaccination effects/did not wake up for a week). On an unknown date, the patient experienced HYPOACUSIS (Trouble hearing), INFLAMMATION (Inflammation) and SINUSITIS (Sinus issues/sinus infections). The patient was treated with PREDNISONE at an unspecified dose and frequency. In 2021, HYPERSOMNIA (Possible vaccination effects/did not wake up for a week) had resolved. At the time of the report, HYPOACUSIS (Trouble hearing), INFLAMMATION (Inflammation) and SINUSITIS (Sinus issues/sinus infections) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Company comment: This spontaneous case reported by a consumer concerns a 78-year-old male patient with no relevant medical history who experienced the unexpected non-serious AESI of Hypersomnia. The event occurred on same day after a dose of mRNA-1273 Vaccine. Other details are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Lab test: Inflammation was at a 50  Primary reporter contact for lot number information was unsuccessful.  The reporter's causality for the event of possible vaccination effects/ did not wake up for a week with Humira had no reasonable possibility. The reporter's causality for the events of trouble hearing and inflammation with Humira was not provided. The reporter's causality for the event sinus issues/ sinus infection  with Humira had a reasonable possibility.; Sender's Comments: This spontaneous case reported by a consumer concerns a 78-year-old male patient with no relevant medical history who experienced the unexpected non-serious AESI of Hypersomnia. The event occurred on same day after a dose of mRNA-1273 Vaccine. Other details are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Headache, Fatigue, very cold with shivers, body ache, soreness of arm at injection site.
Patient was administered 3rd dose of Pfizer 6m-4yr monovalent, rather that recommended 3rd dose bivalent. No adverse reactions were noted. Pfizer was notified, not specific recommendations and do not repeat thrid dose per CDC. Pfizer Safety Report/Case Number: PRIVATE.
Patient received her 3rd dose of the HPV vaccine and immediately reports sharp, shooting pain @ bilateral ears and jawline. Also, c/o lightheadedness. Pt sat for 20 min and symptoms resolved after 5-10 min.
Information has been received from an RN concerning a 13 year old female pt who in 1992 was vaccinated with varicella. About 12/29/99, the pt developed "a terrible pain on the scalp with a pink area on the scalp." There is also a rash on the left side of her face "which looks like contact dermitis." The pt's MD suspects herpes zoster. Follow-yp information reported that as of 1/4/00, the pt is doing "much better." She was started on acyclovir on either 12/30/99 or 12/31/99. Additional information has been requested. Follow up describes the rash as an erythematous papular rash on the left facial mandibular area and left scalp. Physician suspected herpes zoster however he was not able to obtain a sample of the lesions. It is noted the patient may have had chickenpox at 11 or 12 months of age.
rash at injection site that creeps down arm, size of a dollar bill; swelling in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at injection site that creeps down arm, size of a dollar bill) and VACCINATION SITE SWELLING (swelling in arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash at injection site that creeps down arm, size of a dollar bill) and VACCINATION SITE SWELLING (swelling in arm). The patient was treated with Corisone10 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (rash at injection site that creeps down arm, size of a dollar bill) outcome was unknown and VACCINATION SITE SWELLING (swelling in arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.
Four hours after receiving vax, child had severe allergic reaction, swollen itchy eyes, wheezing. Treatment Benadryl and Prelone
Patient felt dizzy and fainted after 4 minutes of receiving  the Pfizer COVID-19 vaccine.  Pt immediately woke up, no change in level of consciousness. Patient awake, alert, and oriented to name, place, time, and situation. Vital signs were within normal limits. BP 96/54,  HR 71, SpO2 99% in RA.  Patient left ambulatory with mother in stable condition after 40 minutes of monitoring  and observation.
Information has been received from a nurse concerning her 63 year old mother with no pertinent medical history who on 05-NOV-2008 was vaccinated with the first 0.65ml dose of ZOSTAVAX (Merck) (lot# not reported). There was no concomitant medication. On 29-SEP-2010 the patient "came back complaining of rib pain and ended up developing a full blown case of shingles. The patient was given acyclovir (manufacturer/description unspecified) to treat the AE. The patient was still experiencing nerve pain. At the time of this report, the patient was recovering. This is one of several reports from the same source. Additional information has been requested.
About one week AFTER receiving my first Moderna COVID-19 vaccine, my left arm (where I had gotten the injection) began to itch a lot. I didn't think anything of it, but the next day in the shower noticed a round, red area surrounding the area of the injection site. It is 4 days later now and it still itches and appears to be slightly raised. It feels different then my normal skin around it, almost smooth and "shiny". The arm is still sore, but not in any way that impedes my daily life.
Pt developed a fever (mom does not know how much) and a rash, starting at both thighs and spreading to the body, 1 hour, post vax. The fever was controlled with Tylenol per mom. Pt seen by MD on 7/10/01 and was prescribed Atarax.
12/26- bruising/discoloration and severe blister on 3rd left toe after running several miles in 30-40 degree weather  12/30- swelling index finger and middle finger of right hand, worse in am 1/7- bruising/painful blisters on 4 toes of right foot after I stood for 2 hours in 30-40 degrees wearing only socks and flip flops (was avoiding wearing shoes b/c of toe blister on 12/26)  1/14- swelling has continued each morning with only those fingers, but less. Index finger on right hand turned white, numb, cold tingling and painful after I drove home 25 min w/out gloves in 40 degree weather, episode lasted 20 min and returned to normal after heat application
Symptoms include severe headaches, fatigue, muscle pain, joint pain, numbness in feet, eye pain, chest pain, night sweats, loss of appetite, weakness, sensitivity to touch. Several tests have been run. Blood work, urine tests, EKG, EEG, CT scan, xrays. Symptoms have persisted for 3 weeks without relief or diagnosis.
2/23 Pain and redness at injection site. Body aches, nausea, fever 101 degrees x 2 d. Starting 2/25 feeling better, swelling and itching decreased and redness decreasing. Recommended Cephalexin - pt did not start recommended BENADRYL 50mg q 6 hr.
The inside of my arm was swollen by the morning after receiving the shot. This swelling was not around the site of injection, it was under my armpit. The area was extremely tender and somewhat itchy.  I felt it was my lymph node but it was hard to place my arm down flat. By Sunday (shot was on Friday), the swelling was starting to decrease.  The other symptom included burning sensation going down the inside of my arm to my elbow the first day and by the second day the burning and discomfort went to my forearm/wrist. I felt like I had a softball under my arm. There was no drainage or redness at the site. Today I still feel a small amount of discomfort and swelling but it has mostly subsided.
pt told me that he needed a 4th dose of vaccine and that he never had bivalent, however it turns out this was his 6th dose he didn't need and already had bivalent, he did not have his records with him 0 pt did not experience any complications and is doing well
This spontaneous report as received from a other health professional (Licensed practical nurse) refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date in 2014 (reported as since August 2014) the patients were vaccinated with GARDASIL injection for an unknown indication (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. Since August 2014, the patients were administered improperly stored GARDASIL. No adverse effects were reported. Outcome and causality assessment was not reported. Product quality complaint was not reported. No additional information reported. This is one of 2 reports received from the same reporter. Additional information has been requested.
Patient was admitted for chest pain 2-3 days following second dose of vaccine. No symptoms or close contacts that have been ill. Currently stable but admitted for elevated troponin and monitoring. Awaiting further imaging to confirm myocarditis. Chest pain resolving after ibuprofen x1.
Sore arm; Fatigue; Flu-like symptoms; Low grade fever; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration on an unknown date in Mar2021 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on an unknown date in Mar2021 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Mar2021, the patient experienced sore arm, fatigue, flu-like symptoms, low grade fever for several days after second dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the events sore arm, fatigue, flu-like symptoms, low grade fever were recovered on an unknown date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented to the ED on 3/10/21 and 3/11/2021 was admitted to the hospital. She also presented to the ED and was subsequently hospitalized on 3/29/2021.
Received first Pfizer shot on July 10, 2021. After shot immediate numbness in left arm and specifically fingers in left hand. Then subsided. Received second Pfizer shot on July 31, 2021.  August 8, 2021: Significant pain at site of injection and return of significant numbness in left arm and fingers in left hand (matching exact issue after receiving first shot on July 10, 2021).  August 2021: numbness and burning sensations spread to left arm, left hand, right arm, right hand, spine, buttocks, and left leg (specifically tightness in left calf), and left pectoral muscle and left side of face. September 2021-January 2022: Most symptoms from August 2021 still exist and have spread to numbness and pain in right foot and left foot, right thigh and left thigh, right hamstring and left hamstring. Occasional numbness in teeth and face and behind ears that comes less frequently and subsides.  As of this date, January 18, 2022, symptoms have not subsided and numbness and pain continue.
Swollen "bump" about the size of a baseball at injection site. Picture available if needed! Over one week now.
Mild arm soreness; Nausea; Headache; Chills; Fatigue; This case was reported by a physician and described the occurrence of pain in arm in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2021, the patient received the 1st dose of Shingrix. On 31st August 2021, 1 days after receiving Shingrix, the patient experienced pain in arm, nausea, headache, chills and fatigue. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm, nausea, headache, chills and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in arm, nausea, headache, chills and fatigue to be related to Shingrix.  Additional details were reported as follows: The reporter was a GlaxoSmithKline employee and relative of the patient. The patient reported that he received received Shingrix vaccine and experienced fatigue, chills, nausea, headache and mild arm soreness. The patient took Tylenol. The patient does not have any symptoms. The lot number and expiration date are not available. The reporter consented to follow up.  This is one of the 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020148003:Same Reporter US-GLAXOSMITHKLINE-US2019089947:Same Reporter US-GLAXOSMITHKLINE-US2019137709:Same Reporter US-GLAXOSMITHKLINE-US2019158430:Same Reporter US-GLAXOSMITHKLINE-US2020113059:Same Reporter
muscle tension on his shoulder area up to his neck; pressure on his chest; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 10Apr2021 at a single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient received his 1st dose yesterday (10Apr2021) and experienced muscle tension on his shoulder area up to his neck and pressure on his chest in Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Pain on movement; Headache; Area of previous Shingles rash on left low back was irritated/burning; Pain across abdomen at waist; Low fever (100.2); Tight low back pain; Chills; Sniffles; This is a spontaneous report received from a contactable consumer, the patient. A 72-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E19267), via an unspecified route of administration in the left arm on 17Feb2021 at 13:00 (at the age of 72-years-old), and a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 10Mar2021 at 13:15 (at the age of 72-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included sleep apnea and shingles. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) 50mg and simvastatin (MANUFACTURER UNKNOWN) 40mg, from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any vaccines within four weeks prior to the COVID vaccine. On 18Feb2021 at 01:00, approximately 12 hours after the vaccination, the patient experienced sniffles/chills. On 19Feb2021 (Day 02), the patient had low fever (100.2), chills, pain across abdomen at waist and tight low back. The patient received paracetamol (TYLENOL). On 20Feb2021 (Day 03), the patient experienced significantly tight low back with pain on movement. Area of previous shingles rash on left low back was irritated/burning similar sensation to original rash. The patient had low fever/headache and received TYLENOL. On 21Feb2021 (Day 04), the patient low back pain and irritation continued with no fever. The patient received ibuprofen (MANUFACTURER UNKNOWN) then TYLENOL with no effect on pain, stiffness or irritation. On 22Feb2021 (Day 05), irritation lessened and stiffness also lightened. On 23Feb2021 (Day 06), the irritation was much reduced and low back movement was easier. On 24Feb2021 (day 07), irritation resolved and low back movement improved to negatable pain on movement. The clinical outcome of the events low grade fever was recovered on 21Feb2021, itchy rash was recovered on 24Feb2021 and chills, sniffles, headache, abdominal pain, pain upon movement and low back pain was recovering.   No follow-up attempts are needed. No further information is expected.
Patient did not receive his 2nd shot because he was advised to wait 90 days after his monoclonal treatments; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive his 2nd shot because he was advised to wait 90 days after his monoclonal treatments) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive his 2nd shot because he was advised to wait 90 days after his monoclonal treatments). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive his 2nd shot because he was advised to wait 90 days after his monoclonal treatments) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Positive.     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.   Concomitant medication were not reported .  Treatment medication were not reported .