chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 10 month old son who in 2002 was vaccinated with a first dose of Engerix. In April, 2002, late on a Friday afternoon, the patient was vaccinated with a second dose of Engerix. For the next couple of days, the patient was crabby, excessively sleepy and had no appetite. When they tried to wake him, his eyes fluttered. By Monday, he had a rash over his face and appeared to be in pain especially when laying on his back. No fever was noted. He was taken to the emergency room of a hospital and was released the next day and his symptoms got better. On 06/03/02, it was reported that the patient is now due for more vaccines and his mother is concerned about possible reactions, but she feels that her pediatrician is not appropriately concerned. Additional information has been requested. Follow-up information from a nurse at the physicain's office indciated that the patient was vaccinated with a first does of hepatitis B vaccine recombinant (yeast lot# 1669K-invalid for this product) on 10/1/01. It was reported that the patient was not seen again until 10/11/01, however "somewhere between 10/1/01 and 10/11/02 the patietn was admitted to the hospital. The nurse reported that no where in the chart was the hospital admission documented nor is there any documentation of an AE in the chart after the vaccination with the heaptits B vaccine recombinant (yeast). The nurse reported that she spoke with the physician who reported that he did make rounds on the patient and that he was convinced that the hospital admission was not related to the hepatitis B vaccine recombinant (yeast) that the patient received on 10/1/01". The patient was vaccinated with a second dose of hepatitis B vaccine recombinant (lot#0657C-invalid lot) on 11/29/01. On 4/26/02 the patient was vaccinated with a third dose of hepatitis B vaccine, recombinant (Engerix-B). Additional information has been requested. Additional follow up information from a health care professional reported that the patient did not receive hepatitis B vaccine recombinant; however the patient did receive a first and second dose of haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (lot # 636642/1669K) on 10/1/01 and (lot # 639446/0659L) on 11/29/01, respectively. Additional information has been requested.
Patient with 2 Moderna COVID vaccinations who admitted and subsequently died of COVID complications.  Provider H+P:  "  HPI: The patient is a 64 YO female patient with a past medical history of CLL and Covid pneumonia.  She has developed acute respiratory failure 2/2 post covid pulmonary fibrossis.   She had been hospitalized wit end stage pulmonary fibrosis developed after Covid pneumonia.  Her symptoms progressed to the point that the patient elected for hospice care    The hospice service was asked to evaluate the patient for uncontrolled tachypnea   The hospice team reviewed the above case and determined that inpatient admission to the hospice service was required to gain control of the patients symptoms prior to any possible discharge."  Patient died on hospice services on 08/10/22.
Slight swelling in (R) underarm - fever, rash - started new medication at same time - swelling moved to (L) groin - golf ball sized but better - was having pain and difficulty walking d/t swelling.
Rash on thighs, began 11-13-03 also itching, became progressively worse on 11-17-03.
received the first /2018 / 2nd dose until today (received the dose); This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 9727R, expiry date 27th January 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2018).   On 16th August 2021, the patient received the 2nd dose of Shingrix. On 16th August 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of the vaccine schedule. The reporter consented to follow up via email.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm warm to touch), VACCINATION SITE WARMTH (arm became a little warm), PAIN IN EXTREMITY (arm became very sore, couldn't sleep on it that arm), VACCINATION SITE PRURITUS (arm became a little itchy) and VACCINATION SITE PAIN (arm soreness) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE WARMTH (arm warm to touch) and VACCINATION SITE PAIN (arm soreness). On 08-Apr-2021, the patient experienced VACCINATION SITE WARMTH (arm became a little warm), PAIN IN EXTREMITY (arm became very sore, couldn't sleep on it that arm), VACCINATION SITE PRURITUS (arm became a little itchy), VACCINATION SITE ERYTHEMA (arm became very red), VACCINATION SITE SWELLING (arm became raised) and LYMPH NODE PAIN (a little tenderness in the lymph nodes). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. On 02-Apr-2021, VACCINATION SITE WARMTH (arm warm to touch) and VACCINATION SITE PAIN (arm soreness) had resolved. At the time of the report, VACCINATION SITE WARMTH (arm became a little warm), PAIN IN EXTREMITY (arm became very sore,couldn't sleep on it that arm), VACCINATION SITE PRURITUS (arm became a little itchy), VACCINATION SITE ERYTHEMA (arm became very red), VACCINATION SITE SWELLING (arm became raised) and LYMPH NODE PAIN (a little tenderness in the lymph nodes) had not resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication provided. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Further follow up consent denied.
Patient started temp 1:30 am 2/12/09. Mom gave MOTRIN temp was 100.8 at highest, no sore at injection site.
Throw up, rash, sleeping excessively, 05/10/2013-5/11/2013 2:00pm-8:00pm.
irregular heartbeat ( it slows down and comes up.); uncomfortable feeling; headache; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE IRREGULAR (irregular heartbeat ( it slows down and comes up.)), DISCOMFORT (uncomfortable feeling) and HEADACHE (headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included Anxiety. Concurrent medical conditions included Hypertension.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced HEART RATE IRREGULAR (irregular heartbeat ( it slows down and comes up.)), DISCOMFORT (uncomfortable feeling) and HEADACHE (headache). At the time of the report, HEART RATE IRREGULAR (irregular heartbeat ( it slows down and comes up.)), DISCOMFORT (uncomfortable feeling) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Anxiety medications and Blood pressure medications.  No treatment medications were provided by reporter.
This spontaneous report as received from a nurse refers to multiple unspecified patients. No information regarding the patients' concurrent conditions, medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, injection (dose and route of administration were not provided) with the following lot # and expiration dates: M026306, 30-APR-2018; M005714, 03-OCT-2017; L023230, 28-JUL-2017. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003300: US-009507513-1612USA003298: US-009507513-1612USA003299.
Feeling bad again; Diarrhea; Congestion; Fatigue; Body ache; Itchy feeling in throat; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion), FATIGUE (Fatigue), MYALGIA (Body ache), THROAT IRRITATION (Itchy feeling in throat) and DIARRHOEA (Diarrhea) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced NASAL CONGESTION (Congestion), FATIGUE (Fatigue), MYALGIA (Body ache) and THROAT IRRITATION (Itchy feeling in throat). On 13-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced FEELING ABNORMAL (Feeling bad again). The patient was treated with AZITHROMYCIN (Z-PAK) on 10-Mar-2021 at a dose of UNK dosage form; PARACETAMOL (TYLENOL) at a dose of UNK dosage form; GUAIFENESIN (ROBITUSSIN [GUAIFENESIN]) at a dose of UNK dosage form and GUAIFENESIN (MUCINEX) at a dose of UNK dosage form. At the time of the report, NASAL CONGESTION (Congestion), FATIGUE (Fatigue), MYALGIA (Body ache), THROAT IRRITATION (Itchy feeling in throat) and DIARRHOEA (Diarrhea) outcome was unknown and FEELING ABNORMAL (Feeling bad again) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable.  The patient started to feel better and now on last day of Z-pak was feeling bad again.
RA flare-up; rashes; This is a spontaneous report from a contactable consumer (patient). This unknown age female patient received first dose of covid-19 vaccine BNT162B2 on an unspecific date at single dose for covid-19 immunization. Medical history was rheumatoid arthritis. Concomitant drug was tofacitinib citrate (XELJANZ) for rheumatoid arthritis. After first dose from Pfizer, she was told to not take tofacitinib citrate for a week. She got off of tofacitinib citrate for 5 days after the first shot and on day 6 after the second shot, she had an RA flare-up and had to contact the rheumatologist who put her on a prednisone burst; 15 mg for 2 days, 10mg for 2 days and 5mg for two days. She did get a couple of rashes after the first covid-19 shot. This was reported and she went to the doctor for it as well. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Patient received a dose of Pfizer vaccine 0.2ml. The vaccine was not prepare correctly. The diluent was not added to the vial of the vaccine.  Patient full dose of Pfizer
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2022 at 4:28 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jan-2022 at 4:28 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. It was reported that the vaccine was administered 30 days past its expiry date. No treatment medication was provided.
Severe redness and swelling. Nausea still persisting as of 7/26. Other symptoms resolved with BENADRYL and warm compress.
Date of symptom onset ? 1/29/21 at 5:45 PM?  Symptoms ? EE reports approximately 1 hour after vaccine she began feeling dizzy, lightheaded and pain at injection site.  EE denies syncope.  + nausea without emesis  On Saturday, EE reports continued dizziness and lightheadedness, denies syncope.  + joint pain.  On Sunday, improvement in symptoms.  On Monday, + lightheadedness, no syncope.  EE denies fever, recent travel or exposure to COVID-19 without proper PPE. Last day of work and shift - ? 2/1/21 currently at work Home remedies? -   rest Any improvement? - yes Recommendation?  EE educated to increase fluid intake for hydration and to take ibuprofen as directed in the Medical  for joint pain.  EE educated to continue to monitor her symptoms and to contact vaccine support line for further questions or concerns.  EE educated to manage her symptoms per the TCH Illness in the Workplace Policy.  EE verbalized back understanding and denied further needs at this time.
?Covid arm?.  Very itchy, red around injection sight, swollen, raised ?rash?. Warm to the touch.
PLUGGED EARS; TOOK THE THIRD DOSE OF VIVOTIF A DAY LATE; This spontaneous case (PVX2019-964) was received from a consumer on 23-Apr-2019. It describes a female consumer who had plugged ears, while on oral Vivotif (one capsule every other day) for typhoid prophylaxis. She also reported that she took the third dose of Vivotif a day late.  Case report: The consumer took the third dose of Vivotif a day late. The doses were taken on 18-Apr-2019, 20-Apr-2019, and 23-Apr-2019 respectively. She stated that she took the third dose about 20 minutes to 8:00 am on 23-Apr-2019, against her schedule of 8:00 pm on 22-Apr-2019. She also reported that her ears were plugged when she woke up on 23-Apr-2019. Her ears were not plugged when she picked up Vivotif last week, but were plugged when she woke up in the morning on 23-Apr-2019. She stated that her ears do not hurt. She had not taken any treatment for the events.  The consumer's concurrent condition included head cold, (which she had off and on), and sinus drainage. She was unsure if she had a cold or if she had water in her ears. She explained it as this was something that happened to her quite a bit even before starting Vivotif.  The consumer did not have any other medical condition and was on no concomitant medication.  Action taken with Vivotif with respect to the event plugged ears was unknown while with respect to the event "took the third dose of Vivotif a day late" was not applicable.   The consumer had not recovered from the event plugged ears, while it was unknown for the event "took the third dose of Vivotif a day late"  Company's Comment: In this case, the patient reported that she had  plugged ears following administration of third dose of vivotif. The patient's concurrent condition included head cold which she had off and on type and sinus drainage which could have attributed to the event .h Hence, the causality has been assessed as unlikely for event "ears plugged". The causality of the event "took the third dose of Vivotif a day late" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, the patient reported that she had  plugged ears following administration of third dose of vivotif. The patient's concurrent condition included head cold which she had off and on type and sinus drainage which could have attributed to the event .h Hence, the causality has been assessed as unlikely for event "ears plugged". The causality of the event "took the third dose of Vivotif a day late" was considered as not applicable.
Received x2 doses of Pfizer  1st dose 05/3/2021 2nd dose 5/24/2021  tested positive for COVID 9/20/2021 , required hospitalization for acute respiratory failure (o2 SAT 88% on RA upon arrival).  Patient on 3 L of oxygen at hospital.
Vaccine received on 10/23/2001 at 3 PM. Arm became swelled at 6 PM. Nine PM pt had fever 105 F, chest congestion, cough, severe sore throat. 10/24/2001 pt called her physician. received Trimox 500mg antibiotic called in Rx. 10/25/2001 pt reported  reaction to HD. Stated the swelling out of arm on 10/24/2001 in the PM. Continues to have chest congestion and feels tired. 10/30/2001 phone conference with pt. Still has chest congestion and fatigue. No fever or sore throat. "Is some better" Has 3 more days of antibiotics. Pt will call HD if any other reactions occur.
Initial and follow up information has been received from a RN concerning a 12 month old male pt with no medical history, no allergies and who had no illness at the time of vaccination. On 13Jun03 the pt was vaccinated SC in the left leg with a first dose of  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). The vaccine was given at 12 months of age. There were no concomitant medications. Initially the RN reported on 26Jun03 that the pt presented to the doctor's office yesterday with a head to toe rash. No treatment was required. On follow up information the nurse described the rash as a full body rash and the onset date was 24Jun03. The pt recovered from the full body rash. No further information is available.
Systemic: Pt developed (2) 1cm bumps on left elbow 1 week after 1st shot. Developed small 1cm lump on left should after 2nd dose-Medium, Additional Details: Pt developed (2) 1cm bumps on left elbow 1 week after 1st shot in left arm. Developed small 1cm lump on left should after 2nd dose shot in left arm.
Cold after first vaccine; Chills after first vaccine; Night Sweats after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night Sweats after first vaccine), CHILLS (Chills after first vaccine) and NASOPHARYNGITIS (Cold after first vaccine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022N20A) for COVID-19 vaccination.     No medication history was provided.     On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced NIGHT SWEATS (Night Sweats after first vaccine). On 07-Mar-2021, the patient experienced CHILLS (Chills after first vaccine). On 08-Mar-2021, the patient experienced NASOPHARYNGITIS (Cold after first vaccine). On 08-Mar-2021, NIGHT SWEATS (Night Sweats after first vaccine) had resolved. On 09-Mar-2021, CHILLS (Chills after first vaccine) had resolved. On 10-Mar-2021, NASOPHARYNGITIS (Cold after first vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was unknown Treatment information was unknown
Headache 5 hrs after receiving shots. nausea and vomiting the following day. abdominal pain only when vomiting.
Received both vaccines on the same day in error; This case was reported by a pharmacist via sales rep and described the occurrence of accidental overdose in a 5-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-SEP-2022 Reporter's comment:  Field representative submitted a request form on behalf of pharmacist.  The reporter had a medical question regarding Infanrix and Kinrix. Could you help him/her to obtain information regarding if a patient had received both vaccines on the same day in error. The reporter would like to have any documentation to support their variance and patient supportive care.  No further details available via form. The reporter had consented to follow-up. Additional supportive information: The patient had received Infanrix and Kinrix on the same day in error which had led to accidental overdose.
Limb heaviness within 5 minutes of second vaccination.  Subsided in approximately 25 minutes. Patient also reported that she experienced a similar reaction immediately after first vaccination plus the inability to visualize words (i.e. she couldn't read what was on the paper she was holding).
Within 5 min, developed >2cm wheal, extremely tender. 10cm area of surrounding erythema. Child crying and irritable. Given 5mL Benadryl and monitored for 15 min without worsening of sx. Referred to allergist for evaluation
Patient was seen at the local ER for c/o shortness of breath at rest for the past 5 days.  Patient was previously seen by PCP and diagnosed wth covid and started on paxlovid.  Patient was admitted with a Dx of pneumonia, acute kidney failure and hyperkalemia for further evaluation and treatment.
46 Y male with a PMHx of HTN, HLD, DM, hypoT, stage II NLPHL with concomitant low grade B-cell lymphoma (dx 5/19/21)  (5/2021, chemo scheduled later this month) presents with cough and SOB x6 days.    1) COVID Pneumonia, Acute hypoxemic Respiratory failure - Symptom onset on 7/15. COVID positive on 7/16. Pt was fully vaccinated on 4/1/21. Pt presented satting 88%. In the ED, he was put on 2L O2, solumedrol, remdesivir, and offer tocilizumab, which he refused at first. Pt took Tocilizumab at night. Pt now on 12L oxymizer. Offered tocilizumab again and increased methylprednisolone to Q6h. - 12L Oxymizer. Goal SpO2 >92%. Consider ICU evaluation if requiring >40LPM and 60% FiO2 for SpO2 >/= 90% - Self-proning as tolerated for O2 req >3L - Methylprednisolone 125mg IV Q6h for 5 days (7/21 - 7/25) and taper down - Remdesivir 200mg IV x1, followed by 100mg IV daily until clinical improvement or 5 days (7/21 - 7/25 )  - f/u daily LFTs. Hold Remdesivir if ALT >10xULN or CrCl<30 - CRP, D-dimer, LDH, ferritin elevated. Trend QOD - Lovenox 40mg SQ BID and hold for Plt <25k, Fibrinogen <100, active bleeding - Tocilizumab 600mg IV x2 - Tessalon for cough - Encourage IS - Isolyte 500cc x1