chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/29/15 1:30 pm. Pt received vacc in clinic 1/28 at 10:30 AM. Went to school after visit and had dinner that evening. (L) deltoid site swollen at both inj sites with redness 2" diameter. No swell/redness on (R) deltoid. 1/29 woke up 7 AM but school closed back to bed until 9 AM. Woke up c/o dizziness, stomach ache, one episode of emesis small amt of fluid. No fever, napping this PM. To continue with fluids and progress diet as tolerated. (L) arm swelling resolving. To urgent care if sxs worsen.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 12:05 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 12:05 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 40.76.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: Not provided, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Mom stated that pt developed a rash to upper and lower torso. Rash appeared X 2 days.
found in bed unresponsive, CPR initiated, continued and assessment per EMT. EKG strip obtained - flatlined obtained
On the fifth day after vaccination I found myself disorganized in routine, everyday activities, such as washing & dressing, preparing meals, etc.; for example, I omitted washing my ears and forgot to put the kettle on.  In the afternoon I was troubled by a headache of a novel sort, not with indefinite perimeter, but more specifically delimited, with ragged edges.  Then that evening after ascending a flight of stairs, I heard a loud thumping, then suddenly realized that it was my own heartbeat that I could hear in my head.  These bizarre effects disappeared by the next day. On the seventh through fourteenth days after the vaccination, I experienced a soreness in my trunk below the rib-cage, at first toward the sides, but then becoming more insistent and less localized; this was accompanied by headache (normal dull sort), along with irritation at the back of my nasal passages, and a feeling of being tired already upon waking.
really really bad itching at the injection site; injection site was itchy; injection site was; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PRURITUS (really really bad itching at the injection site), VACCINATION SITE PRURITUS (injection site was itchy) and VACCINATION SITE ERYTHEMA (injection site was) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     no medical history reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LISINOPRIL for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site was itchy) and VACCINATION SITE ERYTHEMA (injection site was). On 17-Feb-2021, the patient experienced INJECTION SITE PRURITUS (really really bad itching at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (really really bad itching at the injection site), VACCINATION SITE PRURITUS (injection site was itchy) and VACCINATION SITE ERYTHEMA (injection site was) outcome was unknown.        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.   OTC vitamins were also  used as concomitant medications .  Treatment medication include Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: Treatment information, event updated
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with allergy to quinolones. Three years ago approximately in June 2010 the patient was vaccinated with ZOSTAVAX (dose, frequency, route and lot number were not reported). Concomitant therapies included levothyroxine sodium (manufacturer unknown) and alprazolam. On an unknown date, the patient was diagnosed with an unspecified cancer. The patient was treated with chemotherapy from October 2012 through January 2013. Laboratory test were performed, unspecified by the reporter. The outcome of unspecified cancer was reported as recovered on an unspecified date. Unspecified cancer was considered as life threatening event by the reporter. Upon internal review unspecified cancer was considered as an other important medical event. Additional information has been requested.
8-9 cm area of induration, erythema, warmth and tenderness around site of vaccination.
pt recvd vax & had sz; admitted to hosp several day after immun given; reporter did not know if sz was related to fever or vax rxn;
Approximately 36 hours post vax, pt developed fever, decreased activity, vomiting, transient rash. Pt was dxed with otitis media.
redness and swelling at the injection site; redness at the injection site; swelling at the injection site; Initial information was received on 21-May-2020 regarding an unsolicited valid non-serious case received from a non health care professional.  This case involves a 24 months old patient who developed redness and swelling at the injection site (vaccination site inflammation) with symptoms (vaccination site erythema), (vaccination site swelling), while he/she received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received fourth dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious redness and swelling at the injection site (vaccination site inflammation) with symptoms (vaccination site erythema), (vaccination site swelling) (Unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.  Details of laboratory data were not reported.  Final diagnosis was vaccination site inflammation.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not reported.  There will be no information available on batch number for this case.
muscle ache in his arm and muscle pain; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FA6780, NDC and UPC number: Unknown, Expiry Date: Unknown), via an unspecified route of administration on 19Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced muscle ache in his arm and muscle pain. Reporter stated, just have a question. My son was 19 (not clarified) he took Pfizer earlier today and he was experienced the muscle, you know the muscle ache in his arm. If he allowed to take Tylenol. Reporter was informed about Pfizer Medical Information Department. It was reported when asked for further probing, reporter stated, No, just called to ask, patient had muscle pain so reporter need to find out if he could take the Tylenol. Reporter think that's the priority right now. If you could call me back at another time reporter will be happy to answer any questions but right now the priority was to figure out if he can take something to alleviate the muscle ache. The outcome was unknown of adverse event.  Reporter was unwilling to provide further information hence limited information available over call.
Approx 48 hrs after Pt. was given QUADRACEL and PROQUAD vaccines in (L) lateral thigh, she developed large area of redness (7x9cm) warmth and pain around the inferiorly placed PROQUAD vaccine. Also with moderate thigh swelling. (+) Fever by mom's report. Starting Pt. On KEFLEX to treat for possible cellulitis. Will return in 48 hrs if not improving.
h/a, ached all over, joints ached, sores that looked like chickenpox size of erasers on arms & legs;few on rest  of body, fingers drawn unable to use hands;taken to MD referred to specialist Feldene taken for months;
Chest ache, fatigue, nausea, dizziness, red and swollen at injection site, Headache
Excruciating pain from left deltoid radiating downward to wrist; Left hip pain/Bilateral knee pain; Shivering; Headache; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), intramuscular in the left arm, on 28Dec2020 at 16:30 (at the age of 55-years-old) at a single dose for COVID-19 immunization. Medical history included insomnia, gastrooesophageal reflux disease (GERD), anxiety, mitral valve replacement (MVR) on an unspecified date, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. Concomitant medications, taken within two weeks prior to vaccination, included atenolol (MANUFACTURER UNKNOWN), omeprazole (PRILOSEC), sertraline hydrochloride (ZOLOFT), eszopiclone (LUNESTA), krill oil (MANUFACTURER UNKNOWN), linum usitatissimum oil (FLAXSEED OIL; MANUFACTURER UNKNOWN); ascorbic acid (VITAMIN C; MANUFACTURER UNKNOWN), and calcium (MANUFACTURER UNKNOWN). The patient previously took erythromycin (MANUFACTURER UNKNOWN) and experienced allergy, nitrofurantoin (MACRODANTIN) and experienced allergy, and loracarbef (LORABED) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced excruciating pain from left deltoid radiating downward to wrist, left hip pain/bilateral knee pain, shivering, and headache on 29Dec2020 at 07:00. The events were reported as non-serious. The excruciating pain from left deltoid radiating downward to wrist woke the patient up from her sleep. Therapeutic measures were taken as a result of the events, which included treatment with hydrocodone bitartrate, paracetamol (VICODIN) and heat application. The clinical outcome of excruciating pain from left deltoid radiating downward to wrist, left hip pain/bilateral knee pain, shivering, and headache was recovered with sequel in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Right arm hurt immediately after injection with increasing pain, heat and on day 3 painful to move arm and has a hot 4 inch lump at injection site. Constant pain, heat and difficulty using arm. Left hand joints swollen the next day and hand remains swollen. Knee joints swollen and painful. Worst side effects are the right arm and left hand.
sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to MOD-2022-445539 (Patient Link).
Knot on the back of her head; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Knot on the back of her head) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008b21a) for COVID-19 vaccination.     Concomitant products included IMMUNOSUPPRESSANTS and IMMUNOGLOBULIN HUMAN NORMAL (PRIVIGEN) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced SWELLING (Knot on the back of her head). At the time of the report, SWELLING (Knot on the back of her head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: follow-up was received on 11-may-2021, contain no significant information
Body rash.  Abdomen, legs, back. Still in progress  Spreading. Like hives.   No itch presently   All started the following morning   03/20/2021
Fatigue, Fever, chills, sore throat, muscle aches, coughing, sneezing, diarrhea. NAUSEA. HEADACHES.
Itchy. Swelling. Pink/reddish area 1-2" x 3-4". Today - smaller pink area.
Flu like symptoms on 4/21 and 4/22 ( muscle/body aches, severe fatigue, headache, chills, night sweats), plus tingling sensation in hands - heat/sweating in hands as well, especially right hand.  Fatigue, dizziness and tingling in the hands has persisted through today ( 4/24)
Pain/Redness at site, sore and difficult to move d/t nodule underneath skin at injection site specifically.
There was no adverse event(s) patient ended up getting the second dose too early because his first dose was not entered into the system.
permanent pupil dilation; loss of peripheral vision - able to see straight forward but was fuzzy; extreme lightheadedness; severe headache/complicated migraines; Extreme aphasia; This is a spontaneous report from a contactable nurse, the patient. This 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200), via an intramuscular of administration in the left arm on 27Feb2021 14:30 (at the age of 24-year-old) as single dose for COVID-19 immunization. Medical history included mitral valve prolapse, asthma, attention deficit hyperactivity disorder, Crohn's disease, tachycardia and pernicious anemia. Concomitant medications included adalimumab (HUMIRA), propranolol (manufacturer unknown), escitalopram (manufacturer unknown), ethinylestradiol/ norgestimate (SPRINTEC) and amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL XR). The patient previously took ibuprofen and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 10:30, the patient reported experiencing "extreme aphasia, loss of simple understanding, inability to comprehend normally, permanent pupil dilation, loss of peripheral vision - able to see straight forward but was fuzzy, body felt fuzzy, extreme lightheadedness, frustration due to not being able to comprehend my own words, and severe headache afterwards. Checked hemoglobin and glucose through finger stick, both were normal. Symptoms subsided after a few hours but reoccurred for about an hour that same day. Since this occurred, I still have trouble at times finding the words to say. 4 days after this happened, I was hospitalized and put on stroke precautions: 4 MRIs and blood work show no sign of stroke and discharged with a diagnosis of complicated migraines." The patient was placed on prochlorperazine maleate and nortriptyline as events treatments. Since the vaccination, the patient had been tested negative for COVID-19 on the BINAX test via nasal swab on 04Mar2021. The patient was hospitalized for 2 days on unspecified dates in Mar2021. The patient had recovered with lasting effects.; Sender's Comments: The causal association between the reported events and vaccine administered cannot be excluded at this time. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
clusters of vesicles under the rt scapula & rt armpit following the dermatome (parallel to the rib);
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL (strengtth, dose, lot# and route not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
cold; Initial information received on 11-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced cold after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received suspect influenza vaccine (manufacturer, dose, lot number, expiry date, route, administration site: not reported) for prophylactic vaccination (immunisation).  On an unknown date the patient developed a non-serious cold (nasopharyngitis) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Headache, nasal drainage, loss of smell Narrative: tested positive by PCR for COVID-19 on 01/07/2021
Pain and erythema in her right deltoid--Nausea with reflux--Tachycardia--itching BENADRYL 25 mg IV push twice PEPCID 20 mg IV push once ZOFRAN 8mg IV push.
Headache, Myalgia, Arthralgia, Fever, Site swelling/discomfort,  Narrative:
So-called "Covid Arm" - itchy, hard, warm, red area appeared on Day 7 after vaccination. It was still present 2 days later (currently)
Just after I received dose 3 I realized my right breast was sore on the outer edge of my bra.  I could feel a lump.  It continued to be tendered and sore.  At first I didn't think much of it until I went to my next check-up and mammogram.  The lump had grown.  It is not malignant.  I go back to Dr. on Tuesday (my primary doctor) to discuss this further.
erythema around site @ inj;Tenderness & urticaria persists since 11JUl96 day p/inj;erythema-upper arm started p/2wk had 4x3cm, erythema & pruritus;
Delirium, started 2-1/2 hours after injection, admitted to the hospital, required IV sedation, Then, 20 hours after vaccine developed fever up to 100.9, and patient developed somnolence but no longer combative, then about 32 hours after vaccine improved to 50% of normal status, 48 hours after vaccine was 90% normal, and then slowly returned to normal over the next 2 weeks
Fluvac- hives, temp - given Benadryl, given epinephrine right thigh. Projectile vomiting, bronchospasms. O2 SAT decrease, Tachycardia. Information received from medical records includes irritability, rhonchi. msv
Pt recvd 3 doses of Engerix-B 18SEP90, 22OCT90 & 20MAR91; 28APR91 tested for Anti-HBS & found to be non reactive; 4th dose recommended; pt recd 4th dose 30APR91; 10JUN91 again tested & found to be non-reactive;
first dose after vaccine was open in refrigerator over 12 hour expiration time; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (first dose after vaccine was open in refrigerator over 12 hour expiration time) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (first dose after vaccine was open in refrigerator over 12 hour expiration time). On 14-May-2021, EXPIRED PRODUCT ADMINISTERED (first dose after vaccine was open in refrigerator over 12 hour expiration time) 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 medications were reported by the reporter. Treatment medications for this event was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-138655 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-138655:Crosslinked: Same Reporter