chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a little headache; a achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "a little headache"; PAIN (non-serious), outcome "unknown", described as "a achy".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from the patient's mother and refers to a 15 year old female non-pregnant patient. The patient had no medical history, concurrent conditions and drug reactions or allergies. She did not take any concomitant medications. On an unknown date in approximately July 2015, the patient was vaccinated with the first dose of GARDASIL injection (lot#, expiration date, dose ad route of administration were not reported) for HPV prevention. On the same day, couple hours after vaccination, the patient experienced severe headaches that were very permanent and they lasted for about 2 months before the finally subsided and the patient recovered in approximately September 2015. The physician thought that the patient might have had some inflammation occurred in her brain from the vaccine resulting in her bad headaches. No laboratory diagnostic tests were performed. The patient decided not to continue vaccination with GARDASIL due to the event. On an unknown date in March 2017, the patient received the first dose of GARDASIL 9 injection (lot#, expiration date, dose ad route of administration were not reported). The patient had no side effects after GARDASIL 9. The reporter inquired if the patient needed to start the series all over again because she said she's getting mixed advice from 2 different doctors. Product quality complaint was not involved. The causality between the event of brain inflammation and GARDASIL was not reported, the event was not related to GARDASIL 9. Upon internal review, the event of brain inflammation was considered to be medically significant. Additional information has been requested.
No adverse event; Nurse manager reporting that they accidently administered Monovalent dose to a patient from a lot that expired in February2023,; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse manager reporting that they accidently administered Monovalent dose to a patient from a lot that expired in February2023,) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     It was unknown that patient receive other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 03-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 03-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse manager reporting that they accidently administered Monovalent dose to a patient from a lot that expired in February2023,). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse manager reporting that they accidently administered Monovalent dose to a patient from a lot that expired in February2023,) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Nurse manager reporting that they accidently administered Monovalent dose to a patient from a lot that expired in February2023).    No concomitant medication details was reported. It was reported that Individual vials was used and vial size was 5.5ml. The vial was initially stored in the refrigerator on 03-Mar-2023.  The vial did not undergo any temperature excursions. No treatment medication details was reported.
Emergency Use Authorization (EUA): Injection Hard red swelling painful at injection site and migraine headache
Initial report was received from a pharmacist on 21 Dec 2009: This patient (3 year old child) was vaccinated with S-OIV FLUVIRIN (batch no. 101326) on 15 Dec 2009. No adverse event was reported.
temp of 101.7-102.9; chest tightness; stabbing chest pain; pulse was 118; This is a spontaneous report from a contactable other HCP (healthcare professional) who reported for herself. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 22Dec2020 at 15:45 (at the age of 44-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included high blood pressure from an unspecified date and unspecified if ongoing. It was reported that the patient had no known allergies to medications, food or other products. The patient was not pregnant at the time of vaccination. The patient was tested for COVID-19 on 21Dec2020, the day prior to vaccination, and received a positive test result on 23Dec2020, the day after vaccination. The COVID test name was reported. Concomitant medications included celecoxib (CELEXA), trazodone, potassium citrate and hydrochlorothiazid, all taken for unspecified indications from unspecified dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 15:00, the patient experienced temp of 101.7-102.9, pulse was 118, chest tightness and stabbing chest pain. The clinical course was reported as follows: "I was tested (mandatory) on Monday. I got the 1st vaccine on Tuesday. I found out my test was positive on Wednesday morning. I had no symptoms until 24 hrs. after my vaccine. I had a temp of 101.7-102.9, O2- 94-95, pulse was 118. I also had chest tightness and stabbing chest pain. My fever broke Wednesday at 11:00pm. I woke up today, Thursday, feeling a lot better. O2 is 97, pulse is 85. No chest issues today." It was reported that the events were non-serious and did not require hospitalization. The patient did not receive any treatment for the events. The clinical outcome of the event temp of 101.7-102.9 was recovered/resolved on 23Dec2020 at 23:00 and the clinical outcomes of the events chest tightness, stabbing chest pain and pulse was 118 were recovered/resolved on 24Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 28-FEB-2018, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The Oka/Merck VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Dose two of primary series was administered 1 week early by mistake. Vaccinator who administered the dose and lead nurse spoke with parents and let them know.
Fever of 100.8, tachycardia, severe headache, muscle aches, joint aches ( hips, shoulders ,knees), nausea, shakes, chills, short of breath, severe pain in the bottoms of my feet, injection site swelling, pain, redness, swelled up my shoulder into my neck.  I was sent to the Emergency room to be evaluated...possible AFib.
Gave Fluzone HD vaccine to patient who is under 65 years of age. Patient was fine with no adverse events noted.
improperly stored and administered Proquad; This spontaneous report was received from a medical assistant and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and cocomitant therapies were not provided.  On 27-MAY-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) lot # U002535, expiration date 24-JUL-2020 (dose and route of administration were not provided) for prophylaxis. The vaccine was improperly stored in temperature excursion of -14 degress Celsius for 35 hours and 43 minutes. There was no previous temperature excursion. Data logger was involved.   The report is linked to 2106USA001746, received from the same reporter.; Sender's Comments:  US-009507513-2106USA001746:
elevated heart rate (up to 135 while resting) beginning approximately 8-10 hours after receiving the shot. my heart also had strange, strong beats and did not feel right. I left the hospital before someone would read my EKG because it was crowded and I was worried about infection. The symptoms persisted for approximately 6 to 8 hours and mostly coincided with fever and chills.   about a week or ten days later, I had another episode of strong heart beats lasting about 6 to 8 hours. I went to Hospital and was told I had premature atrial contractions.   my other symptom has been louder tinnitus, which has not subsided since my shot.
Patient reports insomnia accompanied with GI cramping on night one. She reports an overall feeling of illness days two thru four with GI cramping and carotid artery pain. Has an appointment for a physical next week and is following up with her doctor if still not feeling well on day of visit.
Patient received PNEUMOVAX in (L) arm as noted (10) around 1500 that afternoon, patient's arm became tender, red, and warm to touch. Today 7/31/14, arm is swollen, red, and tender touch. Patient given BENADRYL and encouraged to elevate arm and ice as needed for comfort.
Narrative:  Patient with complex medical history took his usual morning medications (including carbidopa/levodopa, donepezil, gabapentin, metoprolol, and others) and experienced his "usual" dizziness which persisted after vaccination. BP was 140/90. In Trendelenburg position BP 177/79 P69, SPO2 97% on RA. Discharge VS sitting 164/76, P64, SPO2 97%. Ambulatory on discharge; no changes is baseline balance or coordination.
BRUISE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced bruise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bruise was not reported. This report was non-serious.
Patient received HPV, Covid 19 Pfizer Bivalent 5-11 and Tdap.  Thursday and Friday she had a sore arm, HA and fever. Saturday She had a HA, dizzy with movement and started with vaginal sores. Seen today in the office and started on antibiotics.
The COVID-19 vaccine administered through the vaccine administrator, between June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days.  A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
4MAR94 unconsolable pt p/DTP in AM crying time reported by mom as 5-6 hrs; 13MAY93 when mom brought pt in for immun; pt to recvd ped DT:
could barely get up; swelling about the size of an egg on the right side of her neck (the opposite side of the body from the injection site of the left deltoid); redness had spread across her chest, down the other arm, and up to her neck; within 2 minutes of the nurse administering the vaccine, her left arm starting itching on the inside and she had to scratch it; the left arm was red;Initial information regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Medical Information (Reference number- 00634722) and transmitted to Sanofi on 09-Jun-2021.   This case involved a female patient who could barely get up (dysstasia), swelling about the size of an egg on the right side of her neck (the opposite side of the body from the injection site of the left deltoid) (swelling), redness had spread across her chest, down the other arm, and up to her neck (erythema), within 2 minutes of the nurse administering the vaccine, her left arm starting itching on the inside and she had to scratch it (vaccination site pruritus) and the left arm was red (vaccination site erythema), while she received vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Medical history included latex allergy and allergy to vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On 11-Nov-2011, the patient received a dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UH454AC and expiration date: 30-Jun-2012) via intramuscular route in the left deltoid for prophylactic vaccination.  On 11-Nov-2011, the patient developed a non-serious, swelling about the size of an egg on the right side of her neck (the opposite side of the body from the injection site of the left deltoid) (swelling), redness had spread across her chest, down the other arm, and up to her neck (erythema), within 2 minutes of the nurse administering the vaccine, her left arm starting itching on the inside and she had to scratch it (vaccination site pruritus) and the left arm was red (vaccination site erythema), same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date, the patient developed a non-serious, could barely get up (dysstasia), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Patient stated that she was latex-sensitive, so that if she received a formulation that had latex she might have reacted to that. Because the patient experienced a bad reaction to a previous vaccine, she has been told she needs to confirm that certain ingredients in the Covid (corona virus disease)-19 vaccine she is planning to get were not present in the Sanofi flu vaccine she got back in 2011. This is on a Covid-19 checklist as something that must be done before she can receive the Covid-19 vaccine.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as unknown for the event difficulty in standing and rest of the events were resolved on an unknown date.
Itching in the body, in the body, petechiae on the tongue, itching on the tongue, respiratory distress, tachycardia. After more than 15 days I still have them and nobody gives me a solution to the problem
Acute onset fever, tremors, leukocytosis, vomiting,  marked swelling at injection site 3 hours post injection 11/4/08-records received for DOS 10/29-10/30/08-DC DX: Allergic reaction to pneumovax vaccine. Leukocytosis. Presented to ED with rigors, fever, swelling of arm and shoulder. Feeling cold. Requested that he be discharged.
Reconstituted with sterile water; Reconstituted with sterile water; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 20-MAR-2023, the patient received Menveo. On 20-MAR-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: Reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-MAR-2023 The reporter reported that lyophilized portion of Menveo was reconstituted with sterile water and administered to a patient. The reporter consented to follow up via email. Menveo reconstituted with sterile water instead of the supplied CYW-135 liquid conjugate, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
She died 5 days after her second vaccine; This is a spontaneous report from a contactable consumer.   An 83-year-old female patient (Not pregnant) received the second dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number not provided), via an unspecified route of administration in the left arm on 12FEB2021 at 03:00 PM (at the age of 83-years-old) at single dose for covid-19 immunisation. The subject had a history of Heart condition and thyroid.  Relevant concomitant medications included calcium, fish oil, multivitamin and potassium. The patient died on 16Feb2021 (12:00 PM), 5 days after her second dose of vaccine (as reported). The cause of patient's death was unknown. She had no adverse effects until her death. It was unknown if autopsy was performed.   Information on batch/lot number was requested.; Reported Cause(s) of Death: She died 5 days after her second vaccine
- Shingrix #1 2-27-2020 no issue  - Shingrix #2 6-9-2020 530p. During night arm hurt, nerve pain down to (L) elbow. Felt - very sick 6/10 - stayed in bed most of day. Temp 100.1 oral. (L) upper arm getting red.  - 6/11 increased red, induration /hard - pain/itch.  - 6/12 worse, thought I might have cellulitis, Redness extending medially around arm Temp 100.1, oral  - 6/13 red, painful, itchy, indurated but Better/ but some chills & HA  - 6/14 way better No fever  Chills & headache every day until 6/14, felt sickest June 10, June 12 arm the worst.
varivax were administered on 27-05-2021 and expired on 20-05-2021; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. No information regarding medical history or concomitant medications was provided.  On 27-MAY-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), 0.5 milliliters (ml), once, lot number S015460, expiration date 20-MAY-2021 (anatomical site of vaccination and route of administration were not provided) as prophylaxis (expired product administered). The reporter stated the vaccine had never undergone a temperature excursion.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA001328:
Information has been received from a physician concerning a 13 year old male who on 22-SEP-1997 and 30-Jul-2000 was vaccinated with the first and second doses of MMR II.  On 25-NOV-2009 the patient experienced mumps.  On 06-DEC-2009 the patient was diagnosed with mumps.  The patient was afebrile.  A sibling in the household also had mumps.  At the time of the report the status of the patient was unknown.  Follow up information from the physician indicated that the patient experienced mumps on 11-JAN-2010 (previously reported as 25-NOV-2009).  On 12-JAN-2010, the patient was diagnosed and had right parotitis.  On 12-JAN-2010, a first blood work was performed and showed that: IgM, <1:10; IgG, 10.72; serum amylase, 44.  Additional information has been requested.
AFTER INJECTION, THE INJECTION SITE BEGAN TO BLEED IMMEDIATELY. HELD COTTON BALL TO APPLY PRESSURE FOR A GOOD MINUTE AND STOPPED BLEEDING. AFTERWARDS, THE INJECTION SITE BEGAN TO BULGE AND FORMED A BUMP OF ABOUT A SIZE OF A QUARTER. THE SITE SEEMED BRUISED AROUND THE BUMP. PATIENT REMAINED IN PHARMACY FOR 15 MINUTES AND THE BULGE DID NOT GET ANY BIGGER.
A red, itchy, warm welt near the site of the injection which has not gone away. Additionally, I have felt somewhat itchy all over which started around the same time.
Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: numbness from neck to jaw.
pt with h/o generalized itching 15 min after first does of covid who received 2nd dose of covid a/w localized itchy of the left flank 5 min after the vaccination but no flushing, no hives, no pulmonary or cardiovasc sx no angioedema. symptom resolved with 25mg oral benadryl
Hives starting on face within 2-3 hours after receiving vaccination. Hives grew more wide-spread all over body and more sever with each day. Bad coughing for over 7 days, and hives lasted over 7 days.
Product storage error; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) 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 considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported.  It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vaccines were stored in the fridge on 30-Jun-2021, there were different administration dates, starting on 02-Aug-2021 until 20-Sep-2021 being the last one. Patients did not report any side effects.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master Case ID