chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vials stored in the refrigerator were exposed to temperatures below 36°F; vaccine that had experienced a temperature excursion was given as 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vials stored in the refrigerator were exposed to temperatures below 36°F) and EXPIRED PRODUCT ADMINISTERED (vaccine that had experienced a temperature excursion was given as 2nd dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Vials stored in the refrigerator were exposed to temperatures below 36°F) and EXPIRED PRODUCT ADMINISTERED (vaccine that had experienced a temperature excursion was given as 2nd dose). On 23-Sep-2021, PRODUCT STORAGE ERROR (Vials stored in the refrigerator were exposed to temperatures below 36°F) and EXPIRED PRODUCT ADMINISTERED (vaccine that had experienced a temperature excursion was given as 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No Treatment medications were provided.
3 hours after receiving the vaccine, the patient had radiating pain from the injection site down to her hand and up to her head causing a headache. She was in bed for 2 days after receiving the vaccine, unable to get up to do anything other than go to the bathroom. She felt like she had an increased urge to urinate, going about every 2 hours. When she woke up on the third day after receiving the vaccine, she was feeling much better.
Information has been received from a registered nurse concerning a 42 year old female patient with a history of cerebral artery occlusion and pneumonia who on 15-SEP-2009 was vaccinated with the first dose of PNEUMOVAX 23 (lot# 663486/0507Y). Subsequently, the patient experienced pain, redness and swelling. It was reported that the patient received the vaccine because she had pneumonia a few months ago. The nurse stated that the patient developed "more of a reaction than you would expect". The office would like a lot check on lot# 663486/0507Y. Follow-up information has been received from a registered nurse who provided the patient's name and date of birth. It was reported that on 15-SEP-2009, the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot# 663486/0507Y). The patient complained of swelling, redness and pain. The patient was treated with "ADVIL and heat". The patient was not hospitalized. The registered nurse stated that the patient's adverse events were not considered life-threatening and not considered disabling. At the time of the report, the patient recovered. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information has been received from a registered nurse concerning a 42 year old female patient with no illness at the time of vaccination who on 15-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot# 663486/0507Y) in the right upper arm. Concomitant vaccination administered on the same day included a dose of FLUZONE (lot# U3199AA) in the left upper arm. Subsequently, the patient experienced pain, redness and swelling in the right upper arm, which lasted for 4-5 days. It was hard to move his arm. There were no relevant diagnostic tests performed. At the time of the report, the patient recovered. Additional information is not expected. This is one of several reports from the same source.
Arm pain, not at injection site. Not constant but continues to happen two weeks later. Weakness, difficulty raising arm over head.
About 7 hours later, abdominal pain constant vomiting. Telehealth call was prescribed Zofran. Symptoms last about 2 weeks. Same symptoms with the booster.
Patient had first two COVID vaccines that were Moderna. Booster vaccine is Pfizer. Patient present to ER on 12.8.2021 with shortness of breath, dizziness and palpatations.
Arms are sore; This is a spontaneous report from a contactable consumer (patient's wife). A 50-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 19Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced arms are sore on 20Apr2021. It was reported that both patient's wife and 50-year-old patient received their first dose of the Pfizer-BioNTech COVID-19 vaccine yesterday (19Apr2021), at a drive-through . She explained both of their "arms are sore" this morning. She asked if it's true that pain medication cannot be taken post-vaccination. Outcome of the event was unknown.
Swollen & painful lymph node, left armpit occipital neuralgia pain Extremely painful joints, painful to bend Dactylitis Painful to walk
This spontaneous report as received from a physician via an unspecified reporter through a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 15-OCT-2014, the patient was vaccinated with VAQTA "25U/.5ML 10x1(ped), lot # J000985 with expiration date 20-AUG-2015 (route of administration unknown), which was stored at 1 Celsius Degrees for 48 hours. The storage criteria and the type of excursion was refrigerator (R) and the vaccine status was reported as "in excursion". There were no concomitant therapies and adverse effects reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Received vaccine at 0930... was checked on and feeling well ?. at 0950, she raised her hand and stated she was having tachycardia, "not feeling right" and c/o numbness and tingling in legs.   METs team called and pulse was 130 and was taken to ER here at MC via wheelchair.
Red welt at injection site. Firm, warm, and painful to the touch. Welt is approximately 2 inches in diameter.
This spontaneous report was received from a register nurse concerning a 19 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The register nurse reported that two patients (MARRS 1409USA012034) received improperly stored GARDASIL, exposed to 1C for 24 hours, on an unknown date.  Additional information has been requested.
Shortness of breath; chills; Pain at injection site; Redness at injection site; Itching at injection site; Swelling at injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath), CHILLS (chills), INJECTION SITE PAIN (Pain at injection site), INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE PRURITUS (Itching at injection site) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 10-Feb-2021, the patient experienced CHILLS (chills), INJECTION SITE PAIN (Pain at injection site), INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE PRURITUS (Itching at injection site) and INJECTION SITE SWELLING (Swelling at injection site). On 11-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), CHILLS (chills), INJECTION SITE PAIN (Pain at injection site), INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE PRURITUS (Itching at injection site) and INJECTION SITE SWELLING (Swelling at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication was not provided.
Patient received second dose COVID Pfizer vaccine (LOT#: EW0172) on 8/19/21 at 1705. Patient came in with the instructions to stop at leads desk and ask about which vaccine she should receive for second dose due to her having an allergic reaction with the first dose. Patient was given benadryl with the first dose. Nurse did a medical consult. EMT took patient vital signs AT 1440. BP: 144/99, HR: 78, O2: 99%. EMT took a second set of vital signs st 1447. BP: 133/89, HR: 79, O2: 99%. Patient left vaccination site and came back two hours later when she was called by nurse to come back because the patient had been approved to receive second dose Pfizer with a 30 minute observation. Patient received vaccine at 1705. Patient went to sit in observation area. At 1728 the patient alerted EMT and stated that she felt itchy around her face and ears. EMT took patients vital signs at 1728. BP: 112/92, HR: 92, O2: 100%. EMT alerted nurse. Nurse offerred patient Benadryl. Patient agreed to take 50 mg of Benadryl. Nurse gave patient Benadryl at 1735. EMT reassessed and retook patients vital signs. BP: 154/99, HR: 92, O2: 100%. Patient stated that her ears were burning but the itchiness in her face was "getting better." Patient did not have any additional symptoms. Patient was given a juice. Patient drank the juice. EMT reassessed and retook patients vital signs at 1745. BP: 145/91, HR: 72, 02: 99%. Patient that her ears were "getting better" and that she was "not feeling as itchy" and that she "feels sleepy." EMT reassessed and retook patient vital signs AT 1750. BP: 150/96, HR: 75, 02: 98%. Patient stated that all her symptoms were improving. Patient stated that she "feels sleepy." Patient stated that her "ears are not as bad as before." RN reassessed and retook patients vital signs at 1800. BP: 136/90, HR: 68, O2: 99%. Patient stated that her itchiness had improved and that it was "gone" and patient stated she was "okay to drive home." Nurse educated patient on signs and symptoms of adverse reactions to the COVID vaccine and when to seek emergency care. Patient verbalized understanding of education. Patient left vaccination site at 1805 unassisted and with a steady gait.
Patient developed worsening breathing difficulty about 5 minutes after receiving vaccine, two doses of EpiPen were administered 5 minutes apart; patient's breathing improved. Paramedics arrived on scene and took patient to the hospital. I called patient later same day and she stated that she was feeling better and that she was leaving the hospital.
Information has been received on 05-FEB-2019 from a lawyer and a female patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) in 2013 at a medical center, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. The patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the vaccine ZOSTAVAX and/or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
ACUTE HYPERCAPNIC RESPIRATORY FAILURE 4/2/2023 ADENOCARCINOMA LUNG, UNSPECIFIED SITE CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 5/2/2023 ADENOCARCINOMA LUNG, UNSPECIFIED SITE
Patient reported feeling nausea, weakness, and shaking after receiving Moderna booster.  Patient was then placed in reclined position, offered water,  and monitored for 30 minutes. After monitor, patient reported feeling better, nausea, shaking, and weakness was much improved and felt normal.  Patient was able to walk independently.
itch; large red area about 2 inches below where the vaccine was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itch) and VACCINATION SITE ERYTHEMA (large red area about 2 inches below where the vaccine was given) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itch) and VACCINATION SITE ERYTHEMA (large red area about 2 inches below where the vaccine was given). At the time of the report, VACCINATION SITE PRURITUS (itch) and VACCINATION SITE ERYTHEMA (large red area about 2 inches below where the vaccine was given) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.  Patient gave consent to safety for Follow-up.
Pt recvd vax & exp pain in joint of ankles which has now spread through body; additionally, arthritis; Autoimmune connective tissue disease; pt is trying different meds;
PFIZER VACCINE- DOSE 1 -4/30/2021  5/7/2021- SUDDEN ONSET UTI- UNSPECIFIED HEMATURIA- SUGAR IN URINE LEG CRAMPING/PAIN FATIGUE SEVERE PELVIC PAIN SEVERE BACK PAIN SHORTNESS OF BREATH HEART PALPITATIONS DURATION- STARTING 5/1/2021- CURRENTLY  5/14/2021 SUDDEN ONSET- UTERINE/VAGINAL BLEEDING -PROFUSE!!! DURATION- 5/14/2021- 5/17/2021- PROFUSE/HEAVY 5/18/2021- 5/22/2021 (AS OF THIS SUBMISSON)- LIGHT SPOTTING (NOTE- LAST MENTRUAL CYCLE- 2/2021- DID NOT MENSTRUATE 3/2021 OR 4/2021) DIZZINESS/RACING HEART/LEG PAIN/CHEST PAIN/SHORTNESS OF BREATH/THIRST/EXTREME WEAKNESS AND FATIGUE
Early the next morning after the vaccine I woke up feeling like my chest was caving in.  Felt as if I had 30 bricks on my chest causing SOB.   6/10 I was transported to the ER where an EKG was performed resulting in having a combination of Peri and Myocarditis.  Various test and CBC was perfomed resulting in  my troponin levels being very elevated and never went down so I was admitted and more test were performed.  My BP was low during the entire stay but there wasnt much treatment d/t me being pregnant so I was monitored to ensure the symptoms didnt worsen and was released after 2 days.  EDD-1/27/2022
Erythema, induration, itching  and tenderness at the injection site  7 days after receiving injection.
C/o 2 red areas around injection site of hep B vaccine. Enc to seek care or ER or MD if needed. Enc to RTC to let RN evaluate arm. Pt did not return. Pt called arm ok 2/28/14.
Within a couple hours after, I was super super tired and by 05:30 am in morning, I had severe chills and a fever - 102.5. I had severe body cramps in my legs. My legs hurt so bad I could hardly work. Through my telehealth with insurance they said to: Drink water and taking a fever reducer and if that didn't help to go to ER. I took Advil and I took that every couple of hours and that helped. They suggested ice packs on my legs and alternate with heat - I drank tons of water and slept a lot. The next day, in the morning, was when the symptoms went away. I had that fatigue for a week and a half. On April, 28, I called my doctor again. I have migraines (from before I have chronic migraines - they are agitated by allergies - and by vaccines or any medications ) and my allergies were really, really bad and were having migraines and I had fatigue. They suggested that I do a sauna and try to get talk to my my system to get in somewhat in a balance. Those symptoms have resolved for the most part.
Headache, vomiting that lasted for a week.  Went to ER on day 4 and had I.V. and anti-nausea med.  Finally recovered day 10.
Vaccination adverse reaction; Pain; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction), PAIN (Pain) and HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction), PAIN (Pain) and HEADACHE (headache). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction), PAIN (Pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information was provided No concomitant medication was provided   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Adverse Event Added
Night sweats; chills; red rash on arm; This case was reported by a physician via sales rep and described the occurrence of night sweat in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced night sweat, chills and red rash. On an unknown date, the outcome of the night sweat, chills and red rash were unknown.   It was unknown if the reporter considered the night sweat, chills and red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had night sweats, chills, 3 days after injection, red rash on upper left arm. The reporter agreed to follow up.
48 hours of fever, severe body and bone pain, chills, headache, and weakness.  Severe pain at the injection site.
Erythema near right arm pit. appeared about a day and a half after immunization. Pt states it is not painful.
Fever 99-105 Muscle Aches Headache Fatigue Nausea  Lasted 24 hours. Fever responded somewhat to aspirin.
Body aches for 24h, starting about 12 hours after vaccination. Fatigue for 24hours.
pregnant was given Quadracel by mistake instead of Adacel -with no adverse event; pregnant was given Quadracel by mistake instead of Adacel -with no adverse event; Initial information received on 01-Mar-2021 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 23-years old female patient who was exposed to vaccines DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] in context of pregnant (exposure during pregnancy and wrong product administered).  The date of last menstrual period was not reported.  The estimated due date was not reported (she was 31 weeks pregnant).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot number: C5656AA and expiration date: unknown] at an unknown dose via intramuscular route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient who pregnant was given quadracel by mistake instead of adacel  (exposure during pregnancy and wrong product administered), (latency: unknown) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE and following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not applicable.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
A legal complaint was received from an attorney alleging that a male child received series of Tetramune, and Engerix B (GSK) vaccines as well as Hib-Titer, Acel-Imune, Pneumovax 23, and Recombivax HB (Merck) vaccines from 29-Nov-1995 through 20-Oct-1997 and subsequently "suffered devastating injuries through mercury toxicity and associated complications and sequelae and the aggravation of other conditions directly through exposure, via intramuscular injection of mercury" in the "thimersal-containing vaccinations. " according to the legal complaint, the child "was born a perfectly normal, healthy boy whose APGAR scores at birth were well within the normal range." It is alleged that at apprx. 16 months of age, the child "was neurologically devastated by the accumulation of Mercury in his body, having been exposed via intramuscular vaccinations, and suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior and the loss of language skills." According to the legal complaint, the child "suffered severe and permanent injuries" and "sustained and will sustain in the future a mental, intellectual, developmental and neurological incapacity and associated learning disabilities, affect disorders and impairments." Vaccination informatio ncontained in the legal complaint indicated that the child received Acel-imune, Hib-Titer, and Pnu-Imune 23 vaccines beyond 16 months of age.
Patient received the covid-19 booster (Moderna)  at 11:40 am; later that evening she experienced chills, weakness and loss of strength in her legs. The next morning she was able to take a few steps, then lost ability to walk for part of the day (about 1/2 day).  Symptoms resolved with rest.
Did not get sick at time of shot. Received 2nd shot 30 days after. Did not feel good at time of menstrual cycle, proceeded to get worse the months to follow shot. Heavy brain fog and cramping. Diagnosed with GBS June 2022.
12 hours After the second shot, i woke up with chills, shivering and aches.  16 hours later, I felt extremely exhausted.  18 hours later I developed a fever of 101.5.  This went on until 8 hours later, when  i experienced continued sweating, chills, aches and a fever of 103.  At 30-31 hours after the shot, I felt completely back to normal.  The next day I was tired, but nothing like the exhaustion felt the day before.