chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 1:16 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided. Expiration date of vaccine was 22 Sep 2021. Patient did not experience any adverse events and did not require any medical attention. No problems reported from the patient.
tired after their second  dose; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (tired after their second  dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A, 002B and 033F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired after their second  dose). At the time of the report, FATIGUE (tired after their second  dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-406076 (Patient Link).
throat seized up twice/ throat tightening; Initial information was received on 28-Jan-2021 regarding an unsolicited valid non-serious case was received from a patient (consumer or non-healthcare professional) via global medical information (reference number- 00450721) and transmitted to Sanofi on 28-Jan-2021.  This case involves a 65-year-old female patient who experienced throat seized up twice, throat tightening (throat tightness), after she received FLUZONE.  Medical history, medical treatment and family history were not provided.  It was reported that, as past vaccination the patient received flu vaccines annually for many years and on 14-Dec-2006, patient was vaccinated with FLUZONE. List concomitant or no other vaccines was not asked at the time of reporting.   On 13-Dec-2007, the patient received a 0.5 mL dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On the same day, on the way on her way home after receiving the vaccine, patient experienced throat tightening.   It was reported that, her throat seized up twice, she could breathe, but her throat felt as if it was clamping shut. It was abrupt and sudden. Then her throat abruptly unclamped and she continued home. About 4 hours later at 21:00 her throat tightened again.  It was also reported that, patient checked with the pharmacy who checked their records and provided the national drug code (NDC) numbers from her vaccinations.  Health care professional stated that, it may be due to an ingredient, but patient was is not allergic to eggs also patient requests to know if she can take the corona virus disease (COVID) vaccine and wanted to know about throat tightening reactions to flu vaccine How could she find out the ingredients in the NDC's she was given.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, patient had recovered from the events.  There will be no information available on batch number for this case.
Experience extreme tiredness after each dose, after my booster shot which I received on 11/06/2021 I tested positive for covid on 12/03/22
For the 1st shot, I got a red blotch on my arm 2 days later that lasted for about a week. For this 2nd one the red blotch has spread down my left arm and is also on my right forearm. It has a slight/prickly itch feeling.  I have taken a video of my arms and sent it to my doctor. As long as it doesn't keep spreading I assume it will go away in a week.
Arm became red, swollen and sore with little pain at injection site. Patient broke out in about 7-8 blisters that have now drained and started to heal. He used peroxide solution for treatment.
Patient states that his resting heart rate was 105 the morning after his booster shot.  HIs normal heart rate is in the 70s.  Also, his blood pressure was elevated at 140/90.  The patient was advised to contact his pcp for evaluation.
While I had tinnitus for 12 years prior to the vaccine series, it was quiet, inaudible about 97% of the time.  About 2:30 am on April 6 2021 (approximately) I awoke and the tinnitus was screaming.  The tinnitus continued to be loud, with some fluctuation, to the point that I lost sleep, became anxious and depressed.  I saw an ENT and audiologist and they suggested trying hearing aids. I received hearing aids on June 24, 2021 and they helped make the noise quieter and softer, with some days being really quiet.  As of today the noise is constant but tolerable.  I believe the hearing aids have helped, and I have grown used to it.
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 79-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 15-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250795, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805520 was crossed linked to original cases 201804863 due to same reporter.
pt recvd series of 3 Engerix-B vax in 1989 & was found to be a non-responder; recvd 2 boosters in 1989 & a 3rd booster in 1992 & remains non-responder;
After second set of vaccines (given 12/28/12) child had high fever (over 103) x 3 day as well as fussiness. Gave infant TYLENOL that helped a bit but once it wore off her fever came back. After the three days she was back to her normal self. Mother in today 05/08/13 to get other vaccines per her child's NP schedule: Dtap and PNEUMOVAX today and others spread out.
Adverse reaction to Moderna covid booster with dyspnea, rigors, nausea and dizziness today. Had simliar symptoms with previous 2 covid vaccine doses. Prior 2 doses Pfizer vaccine. Known anaphylacitc reactions in the past to unclear triggers (gluten, mint, hibiscus, skin products). Notes allergist believes she may react to preservatives in food. Lungs clear to auscultation, good air entry on exam. - Observed in clinic until symptoms resolved; patient declined to be transported to ED - Vitals stable throughout reaction, oxygen saturation >95%, normotensive, intermittently tachycardic while in pain though recovers quickly - Completed albuterol nebulizer treatment with improvement - Declined epipen or prednisone; preferred to take own benadryl she brought with her - Encourage hydration given rigors and muscle pain - Discussed warning signs, when to present to ED, patient voiced understanding - Caution with further covid vaccines, has not had reaction to 3 of 3 doses, 2 different brands - Encourage follow up with allergist to narrow down potential allergens
injection site is red; injection site is swollen; injection site is hot to the touch; injection site is itchy; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site is red), INJECTION SITE SWELLING (injection site is swollen), INJECTION SITE WARMTH (injection site is hot to the touch), INJECTION SITE PRURITUS (injection site is itchy) and PAIN IN EXTREMITY (arm was sore) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL BETADEX CLATHRATE (YAZZ) for an unknown indication.    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 17-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site is red), INJECTION SITE SWELLING (injection site is swollen), INJECTION SITE WARMTH (injection site is hot to the touch) and INJECTION SITE PRURITUS (injection site is itchy). The patient was treated with BACITRACIN at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, INJECTION SITE ERYTHEMA (injection site is red), INJECTION SITE SWELLING (injection site is swollen), INJECTION SITE WARMTH (injection site is hot to the touch), INJECTION SITE PRURITUS (injection site is itchy) and PAIN IN EXTREMITY (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Red bump progressing to large abscess with associated fever of 105.8, cultured MSSA requiring surgical removal; pediatric PACU RN reporting this.
My teeth started to hurt before I even got home. This usually means a sinus headache is coming. The next day I had a sinus headache, chills, was very fatigued, and was achy. I had a knee replacement in December and that knee ached so much I could barely stand on it. The next day I was fine.
Patient's husband called day after immunization given and reported wife had layed in bed ever since she got immunization. Her left arm has a blue bruise and hurts.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 (BNT162B2), in Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID-19 Treatment included Paxlovid from 08Sep2023 to 12Sep2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns an 82-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 22-Oct-2018, the patient was administered FLUAD (TIV), [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805535 was crossed linked to original case 201804863 due to same reporter.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, sngle (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 19Oct2023 to 23Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350712 same patient, different drug/event;
2nd dose because she wanted to take the second shot and has been refused by healthcare providers due to her reaction to the first dose.; hypersensitivity; joint pain both knees; joint pain right shoulder/joint pain left hand; very tired/sleepy; blurred vision; Blood pressure high; flush left side of face; Light-headedness; back of head/neck soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VISION BLURRED (blurred vision), HYPERTENSION (Blood pressure high), FLUSHING (flush left side of face), DIZZINESS (Light-headedness) and NECK PAIN (back of head/neck soreness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Patient is allergic to Propofol which contains polysorbate (gets flu-like symptoms) and Allergy (Patient is also allergic to Demerol.).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VISION BLURRED (blurred vision), HYPERTENSION (Blood pressure high), FLUSHING (flush left side of face), DIZZINESS (Light-headedness), NECK PAIN (back of head/neck soreness), ARTHRALGIA (joint pain both knees), ARTHRALGIA (joint pain right shoulder/joint pain left hand) and FATIGUE (very tired/sleepy). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose because she wanted to take the second shot and has been refused by healthcare providers due to her reaction to the first dose.) and HYPERSENSITIVITY (hypersensitivity). On 13-Jan-2021, VISION BLURRED (blurred vision), HYPERTENSION (Blood pressure high), FLUSHING (flush left side of face), DIZZINESS (Light-headedness), NECK PAIN (back of head/neck soreness), ARTHRALGIA (joint pain right shoulder/joint pain left hand) and FATIGUE (very tired/sleepy) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose because she wanted to take the second shot and has been refused by healthcare providers due to her reaction to the first dose.) and HYPERSENSITIVITY (hypersensitivity) outcome was unknown and ARTHRALGIA (joint pain both knees) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Blood pressure measurement: 179/89 (High) shot up to 179/89, 172/89 (High) After 15 minutes172/89., 163 (High) After 30 minutes 163/8?. and 121/85 (normal) At 2:00 BP was normal 121/85..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information and concomitant medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Patient stated that she was allergic to vaccine and asked about the vaccine compounds and product dose omission was reported.Contact information updated.
Vial was shaken before administering; A spontaneous report was received from a health care professional who was also a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the vial was shaken before administered / wrong technique in product usage process.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On date unknown, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273, lot # unknown, intramuscularly in for prophylaxis of COVID-19 infection.    On 19 Feb 2021, the patient reported that the vial was shaken before it was administered to her.   No treatment information was provided.     Action taken with mRNA-1273 in response to the events was not reported  The event, vial was shaken before administered, was resolved on unknown date.; Reporter's Comments: This report refers to a case of Wrong technique in product usage process for mRNA-1273, lot # unknown with no associated AEs.
My daughter had a runny nose and cough on 8/5/22 prior to the vaccine. I did a home test and she was neg for COVID. She received the 2nd dose of vaccine on 8/6/22. That same day, around 8 hours later, she developed a low grade fever at home and had very rapid breathing (60-70 breaths/min). Took her to urgent care where she had a temp of 102.3 axillary. MD reported lungs were clear. O2 sats were 96%.
Within minutes of receiving immunization, arm began to tingle and itch. After 1/2 hour, itch progressed to chest, head and back. Had rash on face, arm and chest.
She sat for 15 minutes then left. 5 minutes later she returned to the pharmacy having difficulty breathing. She has COPD and is on oxygen and admitted to not breathing well before the vaccine. 911 was called as a precaution and after arriving and evaluating the patient she felt better and went home.
Information has been received from a woman working in a physician's office concerning a 9 year old white female who on 01/11/1997 was vaccinate with a subcutaneous first dose in the left arm of varicella virus vaccine live (Oka/Merck) (lot#620617/1105D). Subsequently the patient was diagnosed with chickenpox and has since recovered. Additional information has been requested.
This case was reported by a consumer via another manufacturer and described the occurrence of injection site pain in a female subject of unspecified age who was vaccinated with DTAP vaccine (manufacturer unspecified) for prophylaxis. A physician or other health care professional has not verified this report. On 28 December 2012 the subject received a dose of DTAP vaccine (unknown details). In December 2012, within days of vaccination with DTAP vaccine, the subject experienced injection site pain ("arm hurt"). On 12 January 2013, 15 days after vaccination with DTAP vaccine, the subject experienced shingles. No further information was provided. At the time of reporting the outcome of the events were unspecified.
had my first shot on April 22 and am scheduled for my second shot tomorrow June 4, 2021.  (six weeks later); 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had my first shot on April 22 and am scheduled for my second shot tomorrow June 4, 2021.  (six weeks later)) 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 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had my first shot on April 22 and am scheduled for my second shot tomorrow June 4, 2021.  (six weeks later)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had my first shot on April 22 and am scheduled for my second shot tomorrow June 4, 2021.  (six weeks later)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Patient reports fever over 102 - non-responsive to ibuprofen/tylenol.  All over body aches, severe joint pain.
5 days severe pain and inability to move arm?entire shoulder joint area inflamed?tried massage and CBD cream  nothing helped finally started to subside after 5 days?extremely uncomfortable and unable to dress myself properly
Severe shoulder pain; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A 65-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 31Aug2022 at 13:30 as dose number unknown, 0.5ml single (Lot number: FJ2598, Expiration Date: Jun2023) at the age of 65 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ARTHRALGIA (medically significant) with onset 31Aug2022, outcome "not recovered", described as "Severe shoulder pain". The patient couldn't lift arm. Asking how long that may last. Shoulder pain got a little better, but then returned to the same pain level.; Sender's Comments: A possibly contributory role of PREVNAR 20 in triggering the onset of ARTHRALGIA cannot be fully excluded, considering the temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Patient received smallpox vaccine on 3/19/03 on left arm.  Take read on 3/26/03; major take response.  Site proceeded to scab and heal completely.  On 5/5/03, patient noted fomration of blisters on scar.  Site assessed by a doctor on 5/9/03; reacttivation of smallpox vaccine "Day 6" according to the doctor.  Scar site had ~ 3 blisters - appear to have purulent substance inside blisters. Culture was sent to a lab.
nerve pain; numbness in the extremities; tingling in the extremities; painful blistering rash; Information has been received from a lawyer regarding a case in litigation concerning a currently approximately 78-year-old male patient (pt). No information was provided regarding the pt's past medical history, concurrent conditions and concomitant medications. On or about 26-OCT-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route of administration were not provided) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On an unknown date, reported as subsequently, the pt was treated by a provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: painful blistering rash, nerve pain, as well as, numbness and tingling in the extremities. The outcome of painful blistering rash, nerve pain, numbness and tingling in the extremities was not reported. The reporter considered the events of painful blistering rash, nerve pain, numbness and tingling in the extremities to be related to zoster vaccine live (ZOSTAVAX).
RASH STARTING BETWEEN FINGERS AND HANDS 12 HOURS AFTER VACCINE ADMINISTERED, PROGRESSIVELY CONTINUEING TO GET WORSE. NEW RASH AREAS AS NEW AS TODAY. IN HAIR, TORSO, FEET ALL EXTREMITIES; PRURITIS; NO PAIN.