chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The client reported that she developed dizziness 24 hours after the vaccine which lasted 6-7 days. The client also reported development of left axillary lymph node swelling and pain that lasted one week. The client states the pain caused her to be unable to lift her left arm. The client reported development of itchiness in her throat and chest 1-2 days after the vaccine that is still present. Lastly, the client reported onset of a migraine 1-2 days after the vaccine which lasted 5 days. The client took Maxalt for the Migraine. The client has taken Claritin each night, but states this has provided no significant relief of her throat and chest itchiness. The client has not followed up with a PCPC or allergist. The client has a history of a hysterectomy 2.5 months ago and has had constant shortness of breath since. The client has seen her doctor regarding the shortness of breath without any conclusion on the cause of relief. The client takes oral birth control medication. She has a history of allergies to Tetracycline, Ciprofloxacin, and Toradol. The allergic reaction to these medications consists of nausea and vomiting.
The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 01-Mar-2022; inadvertently administered expired dose of the Moderna COVID-19 vaccine (dose administered more than 30 days after storage in fridge); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine (dose administered more than 30 days after storage in fridge)) and PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 01-Mar-2022) in a 51-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine (dose administered more than 30 days after storage in fridge)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 01-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine (dose administered more than 30 days after storage in fridge)) and PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 01-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The reporter reported that the staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 and were not in accordance with the EUA. The vaccine in question did not experience any temperature excursions.  The patient had not reported any adverse reaction.  No treatment information was provided by the reporter.
10/16/2022  Slight headache 10/19/2022 Headache moderate 10/20/2022 Intense presure in sinus area. eyes hurt.  Blurred vision in left eye. 10/21/22 Called PCP instructed to go to clinic.  Was given  Antibiotivc  ( Doxycycline) and to take Ibprofin/ This relaeves sinus pressure and eye pain but vision loss continued in both eyes. Symptoms: sensitivitty to light. Cou;d only see shadows.  Could not discern daytime : everything dark. 10/28.22  OV with Optometris.   Indstructed to go to ER ASAP  Went to a local Medical Center.   10/29/2022 Admitted to Hospital
No adverse event; Adult patient received expired Moderna Covid-19 vaccine for the second series of his primary series of the Moderna Covid-19 vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Moderna Covid-19 vaccine for the second series of his primary series of the Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Moderna Covid-19 vaccine for the second series of his primary series of the Moderna Covid-19 vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Moderna Covid-19 vaccine for the second series of his primary series of the Moderna Covid-19 vaccine.) 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 (Adult patient received expired Moderna Covid-19 vaccine for the second series of his primary series of the Moderna Covid-19 vaccine.).    No concomitant medications were reported.  The patient received his first primary series dose of the Moderna COVID-19 vaccine on 07-Sep-2022 lot number 082B22A expiration date was 22-Nov-2022 in the left arm. No adverse reactions experienced.  Vial size was 5.5ml. Vial was initially stored in the refrigerator on 12-Oct-2022. The vial did not undergo any temperature excursions.  No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2022: Follow-up received wherein patient demographics and suspect product indication updated.
received Janssen vaccine on 3/6/21 tested positive for COVID by PCR on 11/2/21 admitted to hospital on 11/3/21 d/t trochanteric fracture, COVID an incidental finding dismissed same day.
I had no AE to the vaccine. I had a positive COVID exposure a few days prior and on 1/12 I started having a cough and chest congestion developed which resulted in me taking a COVID test at home and it was positive.  On 1/14 I had a PCR test that was positive to COVID as well.
PT CALLED TODAY 9/3/20 AT 245PM THAT SHE RECEIVED VACCINATION AT 1030 AM, BUT HAD PALPITATIONS AND ELEVATED BP AND PULSE AT 1030PM 165/90 AND PULSE 78. SHE HAS LEFT A MESSAGE AT MD OFFICE
non tender, 1-2 inch node supraclavicular; This is a spontaneous report from a Pfizer sponsored program support. A contactable Physician reported that a 17-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via unspecified route of administration in left arm on 26May2021 (Batch/Lot number: not reported) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Patient's concomitant medication was not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 via unspecified route of administration on unspecified date (Batch/Lot number: not reported) as single dose for COVID-19 immunisation. On unspecified date the patient experienced a non-tender, 1-2-inch node supraclavicular, not painful. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER same reporter, product and AE, different patient
Shingles; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL1283), dose 2 via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for COVID-19 immunization. Medical history was none reported. The patient's concomitant medications were not reported (Other medications in two weeks). The patient was not pregnant at the time of vaccination. The patient previously received first dose of BNT162B2 (Lot number: EK9231), administered on Left arm on 11Jan2021 for COVID-19 immunization, received sulfur and experienced known allergies. Facility where COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. On 06May2021 20:00, patient experienced shingles. Patient visited doctor or other healthcare professional office/clinic visit for adverse event. Therapeutic measures (Antiviral) were taken as a result of shingles (herpes zoster). The clinical outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Flare of psoriasis that would not clear with medications that had been effective in the past.  Development of herpes2  supported by blood tests showing positive Herpes 1 and Herpes 2 exposure though never, ever, ever having an outbreak or episode prior to receiving this moderna booster. Treated with acyclovir pills and cream.
This spontaneous prospective pregnancy report as received from a physician refers to an 18 year old female patient with no drug reaction/allergies. The patient's medical history included Bell's palsy. The patient became pregnant with LMP of 25-AUG-2013 and EDD of 01-JUN-2014. The first 0.5ml dose of GARDASIL lot # H017698, intramuscular was administered on 17-MAY-2007 and the second 0.5ml dose of GARDASIL lot # H017698, intramuscular was administered on 13-SEP-2007. The physician reported that a third 0.5ml dose of GARDASIL lot # H017698, intramuscular was administered to the patient on 25-SEP-2013 while she was pregnant. The next day, 26-SEP-2013, the patient reported having a headache and on 28-SEP-2013 the patient reported having a runny nose, cough and congestion. Laboratory studies performed included Beta serum HCG pregnancy confirmation. Patient sought medical attention by calling physician's office and was treated with TYLENOL and ROBITUSSIN. The outcome of events was unknown. Additional information has been requested.
Patient's R arm had redness & swelling from shoulder to elbow.  Fever of 100.  Duricef.
Within 5 hours post vax, the pt developed an injection site reaction characterized by warmth and an area of erythema measuring 3 cm in diameter. The area of redness developed within 24 hours of administration and lasted 4 days. The pt recovered without treatment.
On March 6 I woke up with an excruciating headache.  I took a couple Tylenol and felt a little better. The next day, March 7, I had a terrible headache all day. Around 6:00 pm, I suddenly felt pain in my arm at the injection site. It is red, swollen, and warm. I still have a terrible headache.
Patient returned to clinic 9/14/15 complaining of left arm being very sore & red with knot at injection site where TDAP was given.  States that on 9/11, she noticed a quarter sized red area that progressed to a silver dollar size firm and tender area at injection site.  Patient denies fever.
pt recvd vax &  became irritable, difficult to console, fever up to 103 started that evening persisted for next 48 hrs septic work-up w/LP performed, cult neg;
Fatigued, heaviness to vaccination site, chills, low grade fever, chest pain, heaviness, pressure and left upper arm pain that is still on as I am reporting this side effect today.
States had violent nausea and vomiting, high fever of 102-103, body and bone ache along with SOB. Then had headache from the 6th to the 9th. This was accompanied by hives and a rash over the entire body  which was worse under arms and breasts.
MASSIVE BLUNT FORCE TRAUMA; CAR ACCIDENT; BLEEDING PROBLEMS; FELT PUNK; POSITIVE COVID TEST/ CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned an 77year old male.  The patient's weight was 216 pounds, and height was 65 inches. The patient's concurrent conditions included pacemaker, and copd (Chronic obstructive pulmonary disease), and other pre-existing medical conditions included the patient was on respiratory medications and blood thinners. The patient was previously treated with warfarin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry :unknown) dose was not reported, 1 total, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not provided and has been requested. On an unspecified date in JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. The patient felt a little punk from the vaccine initially. On 18-MAY-2021, the patient was in a car accident. He was driving a truck and got T-boned by a car and pushed 40 feet into a ditch. He was hospitalized and had 2 negative rapid tests for COVID. He decompensated and was intubated. Upon intubation, another rapid COVID test was done and was positive. They did an additional test that was also positive. He passed away on 25-MAY-2021. An autopsy was performed on an unspecified date. It was reported that she believed the cause of death to be the massive blunt force trauma and bleeding problems. He tested positive for COVID with a 5 day test in JAN-2021. During that time, he had received the monoclonal infusion. She noted that he did not get ivermectin. He also got a physical examination done. Laboratory data included: COVID-19 virus test (NR: not provided) not reported, and SARS-CoV-2 rapid diagnostic test (NR: not provided) positive, positive. Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) negative, negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of massive blunt force trauma and bleeding problems on 25-MAY-2021, and the outcome of positive covid test/ confirmed covid-19 infection, car accident and felt punk was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20210554454-COVID-19 VACCINE AD26.COV2.S. Massive blunt force trauma, bleeding problems, car accident. This events is considered unassessable. The events have an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: MASSIVE BLUNT FORCE TRAUMA; BLEEDING
below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 17-year-old male patient who received HAV (Havrix) (batch number yl532, expiry date 9th September 2022) for prophylaxis.   On 19th July 2021, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: The physician reported that the patient was administrated with Havrix after a below freezing temperature excursion which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case is one of 28 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164795:Same reporter. US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164799:Same reporter. US-GLAXOSMITHKLINE-US2021164797:Same reporter. US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164798:Same reporter. US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter
feels a little warmth on the face; This spontaneous case was reported by a consumer and describes the occurrence of COLD URTICARIA (feels a little warmth on the face) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COLD URTICARIA (feels a little warmth on the face). At the time of the report, COLD URTICARIA (feels a little warmth on the face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Co-suspect included an unspecified allergy pills.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However the allergy medication the patient has been taking is a co-suspect
Patient said later the day of vaccination her hands, feet, eyes, fingers started swelling --NO issues breathing and NO tongue swelling.  Patient took benadryl.   Following day patient took benadryl again.  When she told pharmacist about it they suggested she been seen at an urgent care or hospital, they may want to prescribe steroid treatment.  Patient did go to hospital and reported they did put her on steroids.
woke up and it was like I was paralyzed. I could not move my arms/could not move my legs/couldn't put any pressure on my elbows/could not move my arms to get out of my shirt/couldn't brush my hair; tenderness to touch of arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (woke up and it was like I was paralyzed. I could not move my arms/could not move my legs/couldn't put any pressure on my elbows/could not move my arms to get out of my shirt/couldn't brush my hair) and VACCINATION SITE PAIN (tenderness to touch of arm at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PAIN (tenderness to touch of arm at the injection site). On 24-Feb-2021, the patient experienced HYPOKINESIA (woke up and it was like I was paralyzed. I could not move my arms/could not move my legs/couldn't put any pressure on my elbows/could not move my arms to get out of my shirt/couldn't brush my hair). On 13-Feb-2021, VACCINATION SITE PAIN (tenderness to touch of arm at the injection site) had resolved. At the time of the report, HYPOKINESIA (woke up and it was like I was paralyzed. I could not move my arms/could not move my legs/couldn't put any pressure on my elbows/could not move my arms to get out of my shirt/couldn't brush my hair) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication were not reported.  Treatment details were not provided.   This case was linked to MOD-2021-075451 (Patient Link).
Pain at injection site then because nauseous, warm feeling, sweating, rash on face and shoulders, facial swelling, throat tight, short of breath
3rd booster dose; Fever; Malaise; Headache; This is a spontaneous report from a contactable consumer. An adult female patient of unknown age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Oct2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if the patient was pregnant at the time of this report. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient previously received the first and second dose of covid-19 vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in Oct2021, the patient experienced fever, malaise and headache. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events fever, malaise and headache was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache; Dizzy; Front of her calves and into her feet felt a little like jello; Lightheadedness; Nausea; This is a spontaneous report from a contactable consumer reporting for herself.   This 45-year-old female patient received on 16Dec2020 around 7:30am first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730) intramuscular in the right arm for vaccination. Medical history was none. Concomitant medications were not provided. She sat there for the 15 minutes following administration of the vaccine.After that initial 15 minutes passed she had onset of side effects. On 16Dec2020, while walking to her car, she experienced what she described as dizzy, but it was more like feeling a little wonky like when you are coming down with the flu, where she did not feel right. She was ok to drive herself home, she took a shower. She worked the following night. She noted that mostly the front of her calves and into her feet felt a little like jello. She has brief moments of lightheadedness, a little bit of nausea and a tiny bit of headache starting. The room is not spinning, she is walking fine, bending over and does not seem to be struggling at all. Outcome she initially reported as having subsided, but then reported ongoing, further details unknown. Final outcome was unknown.
The patient had a painful arm. Could not raise above her head. Saw an orthopedic doctor who ultimately gave a cortisone shot and indicated it was related to the flu shot being given too high on the arm.
PROQUAD was administered after a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 22-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number U016976, expiration date 24-NOV-2022 (route of administration not reported) for prophylaxis (product storage error).  The vaccine underwent a temperature excursion of 10 degrees Farhrenheit fo 6 hours. No previous temperature excursions detected.