chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the second dose, patient became very hyperactive. Was physically and mentally hyper. He calmed down after several hours, but it seemed like his heart was skipping a beat upon listening. Took him to an Urgent care.
No adverse event; Expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine).    This case contains information for the 3rd of 5 patients described by the reporter.  Concomitant medication was not reported. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712703 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Feb-2023: No new information received. On 02-Mar-2023: Non significant information received. Reporter added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712703:1st patient case (Master case)
This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 12-JUN-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2014) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. Addtional information has been requested.
Since getting my vaccination my arm has been sore at the injection site. Two days ago around my injection site I noticed that have a red rash that is a bit swollen. It is a little bit warm to the touch.  It is a little itchy.
Within 15 minutes of patient receiving the above four vaccines (HPV, Covid bivalent booster, MCV, and TDaP), the patient developed lip swelling, subjective weakness, headache, abdominal pain, and felt "shaky." She briefly felt itchy over the right calf muscle and around the eyes. No hives. Vital signs normal - no hypotension. No wheezing or throat swelling. She received Benadryl and ibuprofen and symptoms resolved within one hour.
Information has been received from a nurse through a representative concerning a female patient who was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced immediate reactions including chills and muscle pain, The muscle pain lasted for about 2 weeks. It was unknown if the patient sought medical attention. At the time of report the patient recovered from chills and muscle pain. Additional information has been requested.
Narrative: COVID infections following completion of COVID vaccine series 02/03/2021 COVID vaccine dose #1 02/22/2021 COVID vaccine dose #2 04/19/21 Presented to ED for hypoglycemia 05/18/21 Pt presents to PCP for  cellulitis on left index finger; denies fever chills 07/20/21 Pt present to ED reporting productive cough with green sputum, sore throat, congestion x2 days; denies SOB, fever nausea, vomiting, and pain; discharged home; CXR wnl; COVID POSITIVE 07/22/21 Pt reports cough, headache, runny nose; given rx for acetaminophen, DM/guaifenesin 07/23/21 Pt reports fatigue but is improving  07/24/21 Pt reports mild, infrequent productive clear sputum cough, runny nose
After injection given, pt c/o of feeling dizzy. She then passed out and had a vagal response. Her mother was on one side holding pt in chair. Nurse was on the other side. Pt woke up within 20 seconds. Pt given cold compress and water. Pt placed in padded chair and observed for 15 minutes. Pt left with mom.
Parent called 8/25/05 stating child had slightly tender, silver dollar sized area of reddness and swelling in lft deltoid area.  Advised to apply cool compresses and give Motrin.
MASS VACCINATION CLINIC BEING HELD BY PUBLIC HEALTH AT PATIENTS WORK LOCATION. PATIENT HAD BEEN OBSERVED AND RELEASE BUT RETURNED AT 15:21 WITH C/O ITCHING TO LOWER LEFT ARM. REDNESS NOTED IN THE SIZE OF ABOUT A HALF DOLLAR ON LOWER LEFT ARM.THIS NURSE ADMINISTERED 25MG OF PO DIPHENHYDRAMINE. PATIENTS VITIALS TAKE AND ADDITIIONAL OBSERVATION. PATIENT DID REPORT A HISTORY OF ALLERGIES TO COCONUT AND ASA ON CONSENT FOR (HIVES). PATIENT WAS LET WITH SUPERVISING NURSE FROM WORK. I CALLED TO CHECK ON PATIENT THE NEXT DAY AND PATIENT REPORTED THAT SHE WAS DOING FINE. PFIZERBIONTECH COVID-10 VACCINE EUA
No additional AE/PQC reported.; RN reporting that a dose of GARDASIL 9 with a labeled expiry of 3/13/2023 was administered to a patient on 3/14/2023. Caller declined consent to contact. No additional information provided. No additional AE/PQC reported.; This spontaneous report was received from a registered nurse regarding a 17-year-old female patient. Information regarding medical history, concurrent conditions and concomitant medications was not reported.   On 14-MAR-2023, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)(lot number T029522 has been verified to be a valid lot number as well the expiration date, which was confirmed to be 13-MAR-2023) (expired product administered) at a dose of 0.5 mL. No additional adverse event was reported (no adverse event).
Patient was brought to vaccine clinic by parent/guardian. With claims of patient's birthdate being 03/13/2009.  Parent/guardian filled out medical information/consent forms stating that the information provided to us regarding the patient was true.  State records found that patient's birthdate was 03/13/2010, placing her outside the 12 year old minimum age for receiving the Covid-19 Pfizer-BioNtech vaccine.    Parent/guardian was contacted via phone and verbally stated that patient's birthdate was 03/13/2009.
Mother noticed that child started crying and scratching at skin. Red rash on trunk and extremities developed. This occurred in car on the way home after appointment in clinic. They turned around and returned to clinic for evaluation with treatment.
Pain, swelling, redness, and warmth at injection site  Day 1 -10 and ongoing  Headache and increased fatigue day 2-9  Hard bump at injection site, Day 1-10 and ongoing
Noticed swelling, pain, erythema in left lower axillary area sometime overnight (night of March 3 into March 4), radiated anterior and posterior. Resolved March 6/7.
This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 25th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic reaction, shingles, fever, general body pain, eye dryness, excessive eye blinking and hearing decreased. SHINGRIX was discontinued. On an unknown date, the outcome of the allergic reaction, fever, general body pain, eye dryness, excessive eye blinking and hearing decreased were unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the allergic reaction, shingles, fever, general body pain, eye dryness, excessive eye blinking and hearing decreased to be related to SHINGRIX. Additional details were provided as follows: At 17:30, the patient received SHINGRIX on left arm. The patient had an allergic reaction. Within a few days the patient experienced low grade fever and all over aches. The patient experienced shingles and stated that hers being worse than her husband (refer case US2018151992). The patient had shingles from bottom of her feet up and had them in her ears that caused her reduced hearing. She had them in her throat and down her esophagus. The patient also had low grade fever. She stated that she was diagnosed by a physician but was not able to give any specifics. She disconnected from call when more specific questions about events was asked. She was threatening law suit against GlaxoSmithKline. The name of the physician was provided.
I had numbness and tingling to my face. That got worse after a week and it traveled through my whole body.
Headache, Myalgia, Arthralgia, Flu-like symptoms, chills, fatigue Narrative:
A sub optimal response to Haemophilus influenza Type B vaccine was noted;    This literature marketed report has been received from authors of the literature article entitled as stated above. Acute Otitis Media (AOM) was one of the most common reasons for antibiotic use in early childhood. The article explored the challenges when AOM fails traditional therapies and immunologic evaluation did not identify a commonly described immunodeficiency.  This report referred to an 18 months old male patient, who presented with 12 episodes of AOM and recurrent purulent otorrhea requiring intravenous antibiotics. Laboratory evaluation revealed a normal complete Blood Count (CBC), normal immunoglobulins (IgG 588 (unit unknown), IgA 76 (unit unknown), IgM 63 (unit unknown), IgE 12 (unit unknown)) and IgG subclasses. Lymphocyte subset panel was normal. Initial responses to diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (DTaP) and pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) boosters were normal, however, there was rapid decline to tetanus and pneumococcal antibody titers.   On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (dose, strength, route, lot# and expiration date were unknown) for prophylaxis.     On an unknown date, a sub optimal response to with haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) was noted (vaccination failure). Mitogen response to phytohemagglutinin (PHA) was normal with decreased responses to concanavalin A (ConA) and pokeweed and no detectable tetanus nor candida responses. Further investigation revealed decreased non-class and class switched memory B-cells. The patient was recently vaccinated to Pneumococcal Vaccine, Polyvalent (23-valent) and at the present time has protective titers.  The outcome of vaccination failure was unknown. The reporter considered vaccination failure to be related to Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown).   A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports obtained from the same literature (link # 2007USA011356).; Sender's Comments:  US-009507513-2007USA011356:
Narrative: Timing ERROR, too soon- 2nd dose given 4 days too early.
She passed out right after receiving the vaccine.  She regained consciousness almost immediately.  She was laid supine and a cool towel was applied to her forehead.   She rested for several minutes and felt better so she was given a glass of water and released to go home.
This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A 19-years-old male patient received TRUMENBA, via an unspecified route of administration on 04Sep2018 for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced vomiting on an unspecified date with outcome of unknown.
27 y/o accompanied by provider upstairs to HC with concern regarding pt's "reaction at SPV site" (LUE). Pt received primary SPV (LUE), AVA #1 and Typhoid IM (RUE) on 17NOV11. Today is day #22 s/p receipt of these vaccines. Pt denies any malaise, chest pain or SOB. He is concerned that a new lesion is developing below the central lesion on his LUE. Reports positive take at approximately 7 days post SPV, with no axillary LAD or lymphangitis endorsed. Central Jennerian pustule with small 7mm oval scab, which is almost completely dry now. About 8-10 cms below and medial to central Jennerian pustule, there is another erythemic, raised, papulo-pustular oval area. There are multiple smaller papulo-pustular lesions lateral to and below the central Jennerian pustule. If you step back and visualize the surrounding lesions, you can appreciate a faint erythemic rectangular shape (more visible on bottom right), where tape came in contact with pt's skin to secure dressing.
Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.  The vaccines were stored in freezer and everyday, one or two vials were taken out and placed in fridge each day as needed.
Pt claims light headache, mild loss of appetite, fatigue. The site of injection was clear, no sign of infection a small bruise to visual inspection. Axilla of injected arm has a swollen gland and the sign of infection. Pt was advised to seek the medical treatment. Practitioner diagnosed the symptom as a severe infection, but not related to, or caused by the vaccination. Patient was prescribed SEPTRA DS (1 BID X 10d).
I had two visits to urgent care and one visit to primary 09/16/2022 a visit urgent care due to full body rash, low level fever and body aches or joint pains. A low white blood cell count and NRBC was noted in a CBC test. Testing for rocky mountain spotted fever and influenza tests both negative. A second follow visit on 09/18/2022 was done with an additional blood draw, again low white blood count and presence of NRBC was noted. A visit to my PCP on 09/21/2022 additional CBC was done and all results at this point were normal. An unidentified virus was my PCP's conclusion and my symptoms are now gone.
patient could not got injections It was live injections give me the illness; Initial information received on 09-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer (patient) in United States.  This case involved a patient of unknown age who could not get injections it was live injections give me the illness (illness), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA 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, patient could not get injections it was live injections give me the illness (illness), (latency: unknown) following the administration of suspect vaccine.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the events were unknown.  There will be no information available regarding batch number in this case.
This report refers to an approximately 40 year old female patient enrolled in a program. The patient's current conditions included hepatitis c genotype 2 diagnosed in January 2005. On 10-JUL-2012, degenerative bone mass, problem walking and hip not good. The patient's medical history included tubes tied 12 years ago (2000). On 19-OCT-2012 the patient started therapy with PEG-INTRON and ribavirin (manufacturer unknown) for the treatment of hepatitis C (dose, frequency, route, were not provided). Other suspect therapies included Influenza Virus Vaccine (manufacturer unknown), pneumococcal vaccine (manufacturer unknown) pertussis vaccine (unspecified) (manufacturer unknown). No concomitant medications were reported. During a program phone contact, the patient stated that last weeks on an unknown date her arms were sore after taking Influenza Virus Vaccine (manufacturer unknown), pneumococcal vaccine (manufacturer unknown) pertussis vaccine (unspecified) (manufacturer unknown) (received vaccines due to new grandbaby who was born premature, so family advice to take the vaccines). She reported that after her first shot she felt awful, like was going to die, and clarified as flu symptoms and that she slept most of the day of first shot and on that Sunday not remember most of day, even going to church. She reported that after second shot, only had little chills. She reported her back had been killing her but had been using crutches to help her walk, when switched to a walker, pain improved. At the time of the report, the patient's outcome was not provided. Therapy for the hepatitis C medications was not stopped due to the events. Additional information is expected.
Hospitalization 9/2-9/9 for COVID PNA, hypoxemia, COPD.  Treated with dexamethasone 6 mg IV daily and REMDESIVIR.
This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced influenza-like symptoms, fever, general body pain, mobility decreased and lethargy. On an unknown date, the outcome of the influenza-like symptoms, fever, general body pain, mobility decreased and lethargy were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, general body pain, mobility decreased and lethargy to be related to BEXSERO. Additional details were reported as follows: This case was reported by a medical assistant. The age at vaccination was not reported. The patient had flu like symptoms, fever, body aches, couldn't move for an hour and was lethargic. The symptoms were lasted about 2 hours then subsided. The reporter agreed to be contacted by GlaxoSmithKline for follow up.
Pt c/o numbness in arm. States unable to use (R) arm. Went to ER 8/9/13. States was dx with Wrist Drop Splint applied per MD. Has movement in fingers.
T101 evening post vax;irritable, constipation w/fluid like BM;
Patient received a vaccine that had Expiration date Mar 06, 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine that had Expiration date Mar 06, 2021) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine that had Expiration date Mar 06, 2021). On 10-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine that had Expiration date Mar 06, 2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication is provided No treatment medication is provided  Reporter stated the vial was received on 19-Jan-2021 and on 10-Mar-2021 it was moved from  freezer to refrigerator.   This case was linked to MOD-2021-314646 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Updated reporter details, Patient information added, dose number added On 09-Sep-2021: Follow-up appended. Patient initials were updated..
Got Covid/Acute COVID-19; Got Covid/Acute COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 10Dec2021 (Lot number: D0809, Expiration Date: 28Jan2022) as dose 3 (booster), 0.3 ml single, administration date 01May2021 (Lot number: EW0164, Expiration Date: Aug2021) as dose 2, 0.3 ml single and administration date 10Apr2021 (Lot number: EW0153, Expiration Date: Jul2021) as dose 1, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "Got Covid/Acute COVID-19".
Immediate pain at injection site. Flu like (fever, chills, etc.) symptoms beginning about hour 12 after vaccine and lasting until hour 36 after vaccine.
Patient is under 18 years old and received the vaccine. The vaccine is recommended for 18 years and older.
10 minutes after shot neck itched on way out.  "Felt scratchy after drinking gatorade".  Lungs clear VS taken, pulse O2 100%.  Discharged per MD.
Patient had redness and swelling around injection area on Saturday evening, then on Sunday, the area became warm and hard. On Monday morning, she went to the Doctors office and they have her a shot and a Medrol Dosepak. That afternoon, she came to the pharmacy to show me.
Nagging headache and light sensitivity for the day following the shot. Tenderness, redness and itching at injection site subsiding now on day 3.
SHORTLY AFTER PFIZER BOOSTER (3RD SHOT) IN 11/2021 PATIENT EXPERIENCED POSSIBLE GOUT FLARE AND INCREASE IN URIC ACID LEVELS. HE IS STILL EXPERIENCIN GPAIN IN HIS ANKLE ALTHOUGH URIC ACID LEVELS HAVE RETURNED TO NORMAL.