chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 77 year old female patient with contrast dyes allergy, reporting on herself. The patient had no medical history. On 13-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, intramuscularly (lot#, expiration date and dose were not reported) as recommended vaccine. The patient had no concomitant therapies. On 13-OCT-2017, 6 hours after vaccination, the patient develop soreness in the left arm (where the vaccine was provided) . An hour after the soreness started, she developed a cold sweat and her arm from her shoulder to just below the elbow was red, inflamed, painful, and swelled to almost twice it's size. During the night, she could not sleep because of the pain and attempted to ice the arm. On 14-OCT-2017, the swelling started to go down, the arm became pink, and she slept on and off through out the day. She only drank fluids all day. On 15-OCT-2017, the patient developed canker sores in her mouth and on 16-OCT-2017, her arm was sore. No laboratory diagnostic tests were performed. The patient sought medical attention by talking with her physician. Unspecified treatment was give for the events.  On 17-COT-2017, the patient was completely recovered (also reported as recovering) from the events except the canker sores in her mouth from which she did not recover at the time of this report.  The causality between the events and PNEUMOVAX 23 was not provided. Product quality complaint was not involved.
Headaches, joint pain, muscle pain up to time of next  Vaccine.  99.3 fever for 3 days. Called doctor, but did not see her in person.
now its turning slightly yellowish color; heavy, thick post-nasal drainage; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (heavy, thick post-nasal drainage) and NASAL DISCHARGE DISCOLOURATION (now its turning slightly yellowish color) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023A20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RHINORRHOEA (heavy, thick post-nasal drainage). On an unknown date, the patient experienced NASAL DISCHARGE DISCOLOURATION (now its turning slightly yellowish color). The patient was treated with IPRATROPIUM ongoing since an unknown date at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) (nasal) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (heavy, thick post-nasal drainage) and NASAL DISCHARGE DISCOLOURATION (now its turning slightly yellowish color) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable  Concomitant product use was not provided.
Pt recv vax on 12/22/98; approx 2 hr post vax pt exp itchy hands, feet & head; swollen, red eyes; red, swollen hands; wheezing; difficulty breathing; tx=oxygen, Kenolog injection, Ativan, & AeroBid inhalers & Zytec
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-JUN-2016, the patient was vaccinated with an expired, properly stored dose of PNEUMOVAX 23 lot # K019561, expiration date 20-APR-2016 (dose and route of administration were not reported). There was no adverse effect reported. Additional information has been requested.
give 5 months old Bexsero; give 5 months old Bexsero; This case was reported by a consumer via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 5-month-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and BCG VACCINE for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device and BCG VACCINE. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced circumstance or information capable of leading to medication error and inappropriate age at vaccine administration. On an unknown date, the outcome of the circumstance or information capable of leading to medication error and inappropriate age at vaccine administration 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 reported as follows: The age at vaccination was not reported. The reporter asked could Bexsero and BCG vaccines be given at the same day for a 5 months old baby. As follow up could not be possible conservatively captured Bexsero was given to 5 months old baby, which led to circumstance or information capable of leading to medication error and inappropriate age at vaccine administration. No contact details were available.
Patient received a vaccine that had been drawn up with expired solution. Patient was then given correct vaccine that wasn't expired
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, 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. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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 (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  No adverse event was reported for patient.  Treatment medications were not reported. This case contains information for patient 06 out of 25 described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live significant follow-up received: Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:Patient 1 (Master Case)
Headache: Initially lasted several days, then recurred after 1 to 2 weeks and have been fairly constant since that time, though fluctuating in intensity.  He has no significant prior history of headaches.
Stated that she can hardly walk and she does not know what she has.; possibly having cellulitis; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 31Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer Covid-19 on 31Mar2021, and she is scheduled for the second dose today at 9:40, but she had CT scan yesterday and she is taking antibiotics for possibly having cellulitis. Stated that she went to see two doctors and one of them just told her that it was inflammation and the other one prescribed her the antibiotics. Stated that she can hardly walk on an unspecified date in Apr2021 and she does not know what she has. She would like to know if there are any similar reports for the vaccine. Patient would like to know if she should reschedule the second dose of the Pfizer Covid-19 if she is currently taking antibiotics for possibly having cellulitis. The outcome of the events was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Medium, Additional Details: Paramedics were called in. Patient's mom insists he visits the ER. Patient is conscious throughout, just weak, dizzy, flushed. Color came back to normal after lying down for 5-10 minutes.
Information has been received from a physician concerning 5 patients who were intended to be administered ZOSTAVAX (Merck) were inadvertently administered VARIVAX (Merck) subcutaneously 0.5mL. No adverse symptoms reported. The physician confirmed this was human error and not product confusion. Additional information has been requested.
Eyes have been bothering me like I want to keep closing them; Strained; Lightheadedness; Dull headache; Fatigue; Chills; Slight headache over my eyes; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (Eyes have been bothering me like I want to keep closing them), MUSCLE STRAIN (Strained), DIZZINESS (Lightheadedness), HEADACHE (Dull headache) and FATIGUE (Fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 072A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN, AMLODIPINE and LEVOTHYROXINE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Slight headache over my eyes). On an unknown date, the patient experienced OCULAR DISCOMFORT (Eyes have been bothering me like I want to keep closing them), MUSCLE STRAIN (Strained), DIZZINESS (Lightheadedness) and HEADACHE (Dull headache). At the time of the report, OCULAR DISCOMFORT (Eyes have been bothering me like I want to keep closing them), MUSCLE STRAIN (Strained), DIZZINESS (Lightheadedness), HEADACHE (Dull headache), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Slight headache over my eyes) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Ophthalmological examination: normal (normal) normal.         No treatment medications were reported.  Action taken with the drug in response to events was not applicable.      Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: On 26-May-2021, follow up document was attached which states the event have resolved.
POSSIBLE ALLERGIC  REACTION  VISIBLY BEGINNING ABOUT ONE INCH BELOW INJECTION SITE. READ AND WARM TO TOUCH,  ITCHY AND MILDLY PAINFUL TO PATIENT. CONTINUED DOWN LEFT ARM  AND STOPPED AT MID FOREARM. PATIENT NOTICED REACTION 11/20/2020 ABOUT 25 HOURS AFTER VACCINATION.
1/17/21 pt presents to ED with diarrhea, nausea, hx of a fall within last few days where he hit his head; unsure if lost consciousness; found to be positive for COVID; on 2L O2 via NC; AKI; AHRF secondary to COVID pneumonia; CT of head is negative for acute pathology; COVID treatment protocol followed; pt's overall condition worsened; worsened respiratory status; status changed to comfort measures only and pt expired in the hospital
This spontaneous report was received from a medical assistant and refers to a 7 months old patient of unknown gender. No information about the patient's medical history and concurrent conditions was provided. On 17-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M044397 with an expiration date in 20-JUN-2018), orally, for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown), that underwent a temperature excursion from 9 degrees Celsius to 25 degrees Celsius during 20 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1801USA001570: US-009507513-1801USA001571: US-009507513-1801USA001565: US-009507513-1801USA001566: US-009507513-1801USA001567: US-009507513-1801USA001568: US-009507513-1801USA001569: US-009507513-1712USA003377:
24 hrs p/vax pt devel redness, warmth, swelling @ inject site w/chills & fever (temp not taken) as reported by client-dizziness; localized sx persisted through Wed & Thurs & Friday; seen by MD 9APR93 treated w/DPH;
Hives/rashes like Hives; Body pains; Allergic reaction on my skin; This spontaneous case was reported by another health care professional and describes the occurrence of URTICARIA (Hives/rashes like Hives), PAIN (Body pains) and HYPERSENSITIVITY (Allergic reaction on my skin) 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 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives/rashes like Hives), PAIN (Body pains) and HYPERSENSITIVITY (Allergic reaction on my skin). At the time of the report, URTICARIA (Hives/rashes like Hives) and HYPERSENSITIVITY (Allergic reaction on my skin) had not resolved and PAIN (Body pains) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient experienced body pain for two to three days.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Sore arm; After the first two doses of the Pfizer covid vaccine is that the caller got lightheaded like she got unplugged and plugged back in; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Lot number: ER8737) at the age of 56 years as dose 2, single and administration date 18Mar2021 (Lot number: ER2613) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Food intolerances" (unspecified if ongoing), notes: The caller has food intolerances like gluten, dairy, and corn; "The caller has food intolerances like gluten" (unspecified if ongoing), notes: The caller has food intolerances like gluten, dairy, and corn; "The caller has food intolerances like dairy" (unspecified if ongoing), notes: The caller has food intolerances like gluten, dairy, and corn. Family history included: "Genetic blood clotting" (unspecified if ongoing), notes: Family Medical History Relevant to AE(s): genetic blood clotting, the caller only has one of 2 genes. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Sore arm"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "After the first two doses of the Pfizer covid vaccine is that the caller got lightheaded like she got unplugged and plugged back in".  Additional information: Adverse event, product problem or error: Adverse event checked. Date of events: 2021. Suspect product name: BNT162B2, Manufacturer: Pfizer. Start date: 1st dose: 18Mar2021 (Lot: ER2613, Exp: Unknown): 2nd dose: 08Apr2021 (Lot: ER8737 Exp: Unknown). The only thing that happened after the first two doses of the Pfizer covid vaccine is that the caller got lightheaded like she got unplugged and plugged back in. This happened 3 days after getting the vaccines and that was the only thing that happened other than the sore arm. Family Medical History Relevant to AE(s): genetic blood clotting, the caller only has one of 2 genes.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101686099 Same reporter, patient/ different dose and events
I went to bed at  9:00 pm last night, shortly thereafter my husband came into the room to see who I was talking to.  Unfortunately,  from the on-set of me talking in my sleep with  understandable phrases and/or complete sentences throughout the entire night until 5:45 am this side effect occurred.  Each frequent episode occurred  after I would fall asleep, then talk and my husband would wake me.  I recall several times being awakened and I felt like I was enduring a ping-pong ball bouncing around from event to event like a Rolodex flipping through events.  However, I don't ever talk in my sleep.  In addition, today 4/11/2021 at 3:30 I took a nap. The talking in my sleep happened once again. Therefore, this is a huge concern for my health. Has this been a side effect from anyone else?
Itchy; Sore; ears on fire; Mouth on fire and lips burning/ Mouth on fire was reported as worsened/ Lips burning was worsened/ burning; Tingling lips; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 15:00 (Lot number: 30130BA) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, Lot: EW0181, Exp: unknown , Lot Number / Expiry Date: EW0181/UNKNOWN), administration date: 18Aug2021, when the patient was 30 years old, for COVID-19 immunization  The following information was reported: PARAESTHESIA ORAL (non-serious) with onset 09Sep2021, outcome "unknown", described as "Tingling lips"; BURNING SENSATION (non-serious) with onset 10Sep2021, outcome "not recovered", described as "Mouth on fire and lips burning/ Mouth on fire was reported as worsened/ Lips burning was worsened/ burning"; PRURITUS (non-serious), outcome "unknown", described as "Itchy"; PAIN (non-serious), outcome "unknown", described as "Sore"; EAR DISCOMFORT (non-serious) with onset 10Sep2021, outcome "not recovered", described as "ears on fire". Therapeutic measures were not taken as a result of paraesthesia oral, burning sensation, pruritus, pain, ear discomfort.  Additional information: It was reported that, she was calling to report reactions. She did not have these reactions after the first dose. She just got the second dose. Mouth and ears on fire. Her lips were burning. It was like a spicy taco. Her lips started tingling, but now were burning. The burning was getting worse. It is the whole area around her lips going a quarter all the way around. The patient did not require emergency room and physician office visit. Prior Vaccinations (within 4 weeks) were reported as none.   No follow-up attempts are possible. No
Per administering nurse, vaccines ordered were Varicella, MMR, Hep A, and Kinrix. Administering nurse gave Varicella, MMRV, Hep A, and Kinrix. Patient received 2 doses of Varicella.
I received my second dose of the COVID Vaccine at 9:10am. On or about 7pm that same day I started having pain and occasional itching around injection site. Upon assessing area I noticed a 1/2 dollar sized redness, warm to touch that was raised and very tender to touch. Later that night around about 2:40am I was awakened with a headache that has been constant since then. Around or about 5am I started feeling generalized malaise and aching joints including eye sockets. Aching is mild to moderate about a 4-5 on pain scale.  Low grade temperature of 99.7F
Dizziness, vertigo 2 hrs after administration, vertigo continued on & off for 10-12 days. Flu symptoms, fever, body aches, cough, dizziness - no green mucous drainage noted. Earache also.
ADMINISTERED VACCINE TWICE; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.   No concomitant medications were reported.  On 12-APR-2021, the subject experienced administered vaccine twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered vaccine twice was not reported. This report was non-serious.
This spontaneous report was received from an unspecified reporter referring to a 23 year old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On 30-JAN-2018, the patient was vaccinated with incorrect storage PNEUMOVAX 23 lot # N027624, expiration date on 11-MAY-2019, for prophylaxis and (wistar ra 27-3) M-M-R II, expiration date on 01-AUG-2019. The vaccine's strengths, doses, routes of administration and anatomical locations were not reported. Both vaccines were stored at 34.30°F during 0.17 hours; however, they were in good conditions when were administered.
I was notified of vaccines administered outside age range. Report showed 5yr old given 12yr+ covid vaccine documented on 1/20/2022. It also showed historical covid vaccine on 11/21/21
ADVERSE REACTION; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported 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 an unspecified date, the subject experienced adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reaction was not reported. This report was non-serious.