chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vccine was stored in the refrigerator for more than 30 days; No adverse event; Dose was given one day after 30 days beyound use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given one day after 30 days beyound use date), PRODUCT STORAGE ERROR (Vccine was stored in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No allergies to medication, food and other products.     On 15-Sep-2022 at 1:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Sep-2022 at 1:20 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given one day after 30 days beyound use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vccine was stored in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given one day after 30 days beyound use date), PRODUCT STORAGE ERROR (Vccine was stored in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose was given one day after 30 days beyound use date) and PRODUCT STORAGE ERROR (Vccine was stored in the refrigerator for more than 30 days).    The site of vaccination was left deltoid arm. No concomitant medication were reported.  It was reported that the date they removed the vial from the freezer on 16-Aug-2022. They administered the vaccine to 2 kids on day 31 of its storage in refrigerator. It was reported that the reporter had slight confusion as the day the reporter reported the incident the reporter was informed by 2 people that the vaccine was not considered expired based on date it was received and placed in refrigerator. Per their calculation expiry would be 15-Sep-2022 but reporter wanted to know if it was now considered the vaccine was expired on 14-Sep-2022.  Patient had no adverse events, patient was fine. The event had not caused patient to seek medical care. The patient had not experienced a similar event in the past.  No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654885 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2022: Follow up received contains no new information. On 04-Oct-2022: Significant follow-up information was received: Patient demographics updated, suspect product details updated, onset time of event was added, reporter details added and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654885:Case for C-D(second pt)
The reaction occurred all at the site of injection. It was swelling, hot, red, hard, and it hurt. As of now, the patient will be going to the doctor tomorrow if swelling has not gone down.
1508- Patient complains of itching on arms and face, red palms, red watery eyes, and mild clearing of throat.  RN x3 at patient's side.  Pulse: 60BPM,  Resp: 20, O2 Sat 100% RA.   1510- Benadryl 50mg PO given.  Pt anxious and crying at present.  Itching and redness of face, arms, and chest continues.  Denies Shortness of breath, trouble swallowing, or itchy throat.   1516- Pt sipping on water with fan blowing on patient.  Resp.18, O2 Sat 100% RA, Pulse 48-50BPM.    Palms remain red and pt. continues to complain of itching on arms and chest.  Denies trouble swallowing, itchy throat, or shortness of breath.   1528- BP 158/92, Pulse: 50, Resp. 16.  Pt is calm and states is "feeling much better".  Denies itching of face or arms, shortness or breath.   1535- BP:138/96, Pulse: 52.   1540- Respirations even and unlabored at 16 BPM.  No acute distress noted at present.  Denies shortness of breath or itching.  Pt released from the vaccination clinic and returned to her department walking with another RN.  Instructed patient to seek medical attention or go to the emergency department immediately if symptoms return.
PT did not have any adverse reactions during observation. PT did receive the Moderna COVID 19 vaccine booster however, he was only 17 at the time of vaccination. Not in the approved 17+ age range.
This spontaneous case reported by a consumer, describes the occurrence of illness (felt sick after second dose) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient developed illness (felt sick after second dose). At the time of the report, illness (felt sick after second dose) outcome unknown. No concomitant medication or treatment information provided. This case linked to MOD-2021-395796 (patient link).
Patient reports constant pain since receiving the vaccination. Also reports she has had swelling and redness since the vaccination. She is only experiencing these symptoms in the arm she received the Shingrix shot.
A few hours after the shot: arthritis type aching in my hands (disappeared by morning) A few days after the shot: random stabbing/shooting pain in my vaccine site and also back/neck/shoulder tightness/pain (seems to be getting worse)
This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored (Oka/Merck) VARIVAX, (strength, dose, frequency, and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Mother states that within a few hours of the vaccines he started running a high fever to 101 (with ibuprofen), was agitated (he is non-verbal), appeared uncomfortable and moaning. Fever lasted for 5 days and was then back to his self. Also had a rash that started on the arm of the vaccines 72 hours after injection which spread across chest. Lasted about 3 days.
Information has been received from a physician concerning a patient who on 02-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The patient is currently experiencing Shingles. The patient has not experienced any known symptoms. At the time of the report, it was unknown if the patient had recovered from the event. Additional information has been requested.
Adverse reaction noted approx. 12 hours post injection. Redness, itching, hot to touch, edema noted at site of injection to left upper arm. Area today measures 4cm x 4 1/2 cm. Today serious red but not hot or swollen.
Pt had paresthesia in right forearm, right calf, as well as right hand and foot. Began 5 minutes after injection and has progressively improved over the last 48 hours.
Swelling in upper arm, very hot to touch, bruised feeling. Started on day 9 after injection.  Tylenol and antihistamine eased symptoms
Client c/o muscle soreness, congestion, increased fever x 1-2 days. Stated missed (3) days of work. Seen by M.D., taking CIPRO 500 mg 2 tabs daily x 10 days. October 27,2009 Caller states he got H1N1 flu shot at Health Dept on Fri. On Sunday, c/o runny nose, congestion, myalgia site of injection L arm. Rec fever reducers if becomes febrile, antihistamines, decongestants if not allergic. Advised effects can last 2-4 days.
Patient did not receive the 2nd dose between 25-35 of the1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose between 25-35 of the1st dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-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 PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose between 25-35 of the1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose between 25-35 of the1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported.
9 days later red itchy patch at injection site as well as itchy bumps on back of hands, elbow, knees and feet.
Arm pit area swollen/ inflamed lymph nodes; Arm pit area swollen/ inflamed lymph nodes; This is a spontaneous report from a contactable Health Professional reported for herself. A 36-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number Ek9231) at right arm 14:30 on 20Jan2021 for Covid-19 immunization. Patient received her first shot at right arm 02:30 PM on 30Dec2020. The patient was allergic to penicillin. Concomitant medication was none. The patient had not received any other vaccines within 4 weeks prior to the Covid-19 vaccine. On 22Jan2021, the patient experienced arm pit area swollen/ inflamed lymph nodes. No treatment was received. The events did not resolve at the time of reporting. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Hepatitis B #2 immunization give 1/3/07. 1/4/07 patient developed .5cm blister at injecito site-which he noticed after removing bandaid on 1/4/07.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient received dose 2 of GARDASIL (lot#, expiry not reported) on an unspecified date several years ago and this patient was currently in the office on 25-MAR-2014 and would receive dose 3. No adverse effects reported. No PQC involved. Additional information has been requested.
Pt received vaccine. She was sitting in the observation area after vaccine. About 10 minutes after vaccine, Pt reported feeling numbness in hands and feet, chest tightness and slight difficulty breathing. Pt was offered and ingested diphenhydramine 25mg at 1230 and another 25mg at 1238. Pt continued with same symptoms (not better and not worse). 911 ambulance was called. Pt remained conversing with full sentences with one breath during observation. Radial pulse was strong and regular. No rash. No apparent swelling. Respirations were quiet (no stridor). Ambulance arrived and took over care and eventually transported pt to the ETC.
seizure; headache; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Nov2021 10:30 (Lot number: FH8028) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Ulcerative colitis" (unspecified if ongoing),  "hypertension" (unspecified if ongoing).  Concomitant medication(s) included: METOPROLOL; AMBIEN; LIALDA. Past drug history included: Known allergies: Amoxicillin, Lisinopril, Contrast Dye, Zithromycin. Vaccination history included: Bnt162b2 (Previous dose number: 2, Previous dose lot number: EW0151,, ), administration date: 12Apr2021, when the patient was 48 years old, for Covid-19 immunization; Bnt162b2 (dose number: 1, ), administration date: 15Mar2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "booster"; SEIZURE (medically significant) with onset Dec2021, outcome "unknown", described as "seizure"; HEADACHE (non-serious) with onset 27Nov2021 21:00, outcome "unknown", described as "headache". The events "seizure" and "headache" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (2021) showed as clear, notes: The CT scan and EKG that were done at the ER didn't show presence of mass, clot, aneurysm or stroke. The CT scan showed as clear; electrocardiogram: (2021) normal, notes: The CT scan and EKG that were done at the ER didn't show presence of mass, clot, aneurysm or stroke; sars-cov-2 test: (01Dec2021) negative, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of seizure, headache.  The patient stated that she had not suffered from headache and seizure before receiving the vaccine.   No follow-up attempts are possible. No further information is expected.
headache; body aches; pain in joints; chills; fatigue; This is a spontaneous report from a contactable consumer. A 37-years-old non-pregnant female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number EN6204) via an unspecified route of administration, administered in arm left on 13Apr2021 16:45 (age at vaccination:37 years and non-pregnant at the time of vaccination) as dose 2, single for covid-19 immunisation. The patient's medical history included none. There was no known allergies. The patient's concomitant medications were not reported. There was no other vaccine in four weeks. There was no other medications in two weeks. There was no COVID prior vaccination. There was no COVID tested post vaccination. The patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number EP6955) via an unspecified route of administration, administered in arm left on 23Mar2021 04:45 PM (age at vaccination:37 years and non-pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation and experienced headache after the first shot that lasted the entire day. On 13Apr2021 16:45 after second vaccination patient experienced headache, body aches, pain in joints, chills, fatigue. There was no treatment received for adverse events. The outcome of events was reported as resolved.  No follow-up attempts are possible. No further information was expected.
Breakthrough Case of COVID, I was coughing very bad, I coughed on and on and on, I had some congestions as well, a few days later, I had the chills, and a headache, and I had some pains in my body but I didn't really pay attention to that, then I got just really sick on my stomach, I almost fainted, I thought I was gonna die, I could not breathe at all, my oxygen levels were down, I was very fatigue, and still am. I can function pretty much during the day but around 4-5pm I am done for the day. The fatigue and the coughing are the hardest things to get rid of.
Large redness, hives, itching, swelling and pain of my whole right upper arm  where injection given occurring  2 days after the vaccine  and continues to spread.
Patient was vaccinated with COVID 19 vaccine at the age of 17 yrs and 11 month The recommended age is 18 yrs old  No adverse reaction was reported
Slight allergic reaction at the site of injection; little red - about an inch and a half wide; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HYPERSENSITIVITY (Slight allergic reaction at the site of injection) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE HYPERSENSITIVITY (Slight allergic reaction at the site of injection) with VACCINATION SITE ERYTHEMA (little red - about an inch and a half wide). At the time of the report, INJECTION SITE HYPERSENSITIVITY (Slight allergic reaction at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Patient reported experiencing no event.
Pain, bruising. She reported being sick from shot last yr and was contemplating if she should get it. She tensed up while I was giving her shot which may be causing the pain and bruising.
The day after the vaccine the patient reported fever and flu like symptoms: headache/achyness. The second day after the vaccine she reported injection site reaction of redness in about a tennis ball sized area and spread to her underam.
Mom reports in the evening time, when pulling band aids off, she noticed a small rash, fine bumps on both legs at vaccine sites: Rash same color as pt's skin. No redness or streaks noticed. Baby not scratching sites. Mom states rash occurred also w/last set of vaccines and lasted for approx. 2 wks. No fever or other symptoms noted.
This is a spontaneous report from a contactable consumer or other non hcp (patient). A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0196), via an unspecified route of administration on an unspecified date (at the age of 30-year-old) as dose 1, single; dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: FA74842) as dose 2, single, both doses for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced chills, fever, nausea, vomiting/feels like throwing up, feeling very bad, all on an unspecified date. Patient is a consumer. Patient had both doses of the Pfizer COVID 19 vaccine. Patient wants to know how long these symptoms will last and should she go to the emergency room. Patient went to the bathroom because she experienced nausea and vomiting. The patient was experiencing chills, fever, nausea, and vomiting. Patient says she was told if her symptoms of vaccine last more than 24 hours to call. Patient says she has had her second dose of Pfizer COVID-19 vaccine. Patient provides LOT for first dose EW0196 from her vaccine card, and second dose LOT FA74842, unable to clarify further. Patient says she may have to leave suddenly as she is feeling very bad and feels like throwing up. When call is joined unknown gentleman says patient has nausea right now, and chills, and fever and she wants to know is there something she can do to avoid it. Outcome of the events was unknown.
Extreme swelling, redness, itching at injection site.  Nausea, weakness, joint and muscle pain, fever 101degrees.  Headache, syncopal episode
Patient reported right arm swollen from shoulder to elbow (about 1.5 the size of other arm). Erythema Multiform and erythema, edema, pain at injection site. ETODOLAC.
Flu vax recvd 25OCT91 @ 1200 poss adverse reaction reported 29OCT91 pt states awakened from sleep w/blistering rash to rt arm had neck & face; Denied any SOB; PDh taken for itching; pt seen 29OCT w/ resolving red raised rash;
Pt was a homebound patient listed to receive 2nd Pfizer vaccine. Pt received Pfizer as second dose when his first dose was Moderna. when finished vaccinating, RN asked patient for CDC card. Pt did not have a card, did not know what vaccine he had received at his PCP. vaccine was already given upon verification via phone call back at vaccination service center.
Ongoing substernal chest pain, fatigue, decreased stamina, cyanosis of hands (mostly left),  elevated D-Dimer, EKG changes, pericarditis with fibrin deposits noted on cardiac sonography.
Dr states wanted this reported out as a vaccine related event that patient had reaction to his second pfizer shot and ended up with shingles.  He had his first dose of the vaccine in April then contracted COVID and didn't get his second shot until 8/4/2021.    Patient was admitted 8/25/21 for shingles to the face, Peri orbital Cellulitis, suspected superimposed bacterial infection.  Corneal abrasion secondary to fiberglass 8/21/2021.  He is currently on acyclovir IVPB x 14 days.
Patient reported hives-like reaction only covering the upper part of the arm in the vaccinated arm. She said it appeared the same as the hives she had in the past with a medication she's allergic to.  She's otherwise fine & okay to work & carry on as normal.
This spontaneous report as received from a physician refers to a 40 year old male patient with asthma (diagnosed prior to receiving VARIVAX (Merck) and no drug reactions or allergies. Within the past five years, the patient received two doses of VARIVAX (Merck) (dose, route of administration, lot number, interval were not reported), on unknown dates. Concomitant therapy included SYMBICORT. The physician stated that the patient had titers drawn on 24-JUL-2015 for "school" and the results of the titers were "insufficient". Outcome of the event was unknown. Causality assessment was not reported. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA  Woke up on Sunday morning after vaccine with very swollen lips.  By the afternoon I had a rash starting on my upper torso and it continued to cover my face.  I began taking Benadryl 25mg q6 and contacted my doctor to see if I should receive the second dose of vaccine.  She advised against it.  The swelling went down but rash continued.  Contacted my doctor on April 12th and began a regimen of a titrating dose of Prednisone 20mg for 12 days on April 13th.  As of today, I seem to be responding to treatment
Information was received from a healthcare worker via a company representative referring to a 14 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions, and allergies were not reported. In approximately 2017 (reported as about a year ago), the patient was vaccinated with first dose of GARDASIL 9 for prophylaxis (route of administration, lot number, and expiration date were not reported). On an unspecified date, the patient developed a wart on an unspecified location; the outcome of the wart was unknown. The relatedness between the event and GARDASIL 9 was not reported.
This spontaneous report was received from a other health professional refers to a patient of unknown age. On 25-AUG-2014 the patient was vaccinated with ROTATEQ vial, lot # K001935; expiry: 08-DEC-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 26-AUG-2014, it was reported that the patient was rex posed to temperatures outside of the proper storage range. No adverse effect reported. The outcome of were exposed to temperatures outside of the proper storage range and no adverse effect reported is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
p/vax pt exp back spasms (severe); lesions & blisters at spasm site; redness & swelling at inj site;approx 7cm;