chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INJECTION SITE DISCOMFORT; SWELLING AT INJECTION SITE; REDNESS AT INJECTION SITE; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies and no previous medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 03-APR-2021 to left arm 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 07-APR-2021, the subject experienced injection site discomfort. On 07-APR-2021, the subject experienced swelling at injection site. On 07-APR-2021, the subject experienced redness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling at injection site, and redness at injection site, and the outcome of injection site discomfort was not reported. This report was non-serious.    I
On 11/27/2022 in the morning around 8:00AM. I woke up with a Sinus drainage and cough. I couldn't sleep because of the cough. So on 11/30/2022 I called my doctor and she prescribed me with cough medication which didn't help. On 12/05/2022 I called my doctor again since the cough medication wasn't helping at all. She then prescribed me an antibiotics called amoxicillin. I just started taking it from yesterday. I have to take it for at least 10 days.
Inflammatory local reaction with erythema in her upper arm, below the injection site; Inflammatory local reaction with erythema in her upper arm, below the injection site; This spontaneous case was received on 27-Oct-2020 from a physician with additional information (being processed together) received on 28-Oct-2020 via Med Communications (reference number: SEQW20-04351) and concerned a female patient of unreported age.  The patient's historical condition included history of allergies in the childhood for which she received injection therapy. The patient's concurrent condition included allergy to cats, pecan, sulfa drugs and ampicillin. The patient's vaccination history included vaccine with a severe local reaction with swollen arm and induration, erythema in arm, a knot, that may had been an axillary node. It was also reported that the patient had ''it'' the time before that prior vaccination. The patient's concomitant medications were not reported.  On an unspecified date in Oct-2020, the patient was vaccinated with Fluad (TIV) (Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; anatomical location: upper arm, dose: 0.5 ml and route of administration: intramuscular) for influenza prophylaxis. The batch number was not reported.  On an unspecified date in Oct-2020, unknown amount of time after vaccination with Fluad (TIV), the patient had a severe inflammatory local reaction with erythema in her upper arm, below the injection site.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment:The patient developed inflammation and erythema on an unknown date after vaccination with the suspect product, Fluad (TIV). Although onset date was not provided, narrative suggested plausible temporal relationship. The patient's concurrent condition included allergy to cats, pecan, sulfa drugs and ampicillin. The patient's concomitant medications were not reported. Considering all above mentioned, causal relationship for both events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed inflammation and erythema on an unknown date after vaccination with the suspect product, Fluad (TIV). Although onset date was not provided, narrative suggested plausible temporal relationship. The patient's concurrent condition included allergy to cats, pecan, sulfa drugs and ampicillin. The patient's concomitant medications were not reported. Considering all above mentioned, causal relationship for both events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
He received the vaccinations on 12/7. On 12/8 he had an erythematous area on his left thigh which was non tender. On 12/12 he developed fever to 103 and was seen in the office. He had pharyngitis and a cough. Rapid strep testing and viral PCR were negative. The fever to 103 persisted until 12/15. On 12/14 he went to the Emergency Department where he had a chest xray that was normal. On 12/15 the fever resolved and he developed a maculopapular rash on his face and trunk. The rash resolved on 12/17 and on 12/18 he was seen back in the office and he was back to his baseline.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 15-JAN-2016, the patient was inadvertently vaccinated with an expired dose of PROQUAD (Merck) (dose and route of administration were not reported, lot # K009470, expiration date 03-JAN-2016). This dose had no history of being stored improperly. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history or concurrent conditions were not provided. In November 2015, reported as between 04-NOV-2015 and 09-NOV-2015, the patients were vaccinated with improperly stored doses of GARDASIL, lot # K011492, expiration date: 22-JUN-2016 and Lot#: L007531, expiration date: 04-NOV-2018 (route, anatomical location and dose were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a pharmacist via a company representative, concerning an elderly male patient with unknown age. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot#: N032092, expiration date: 12-SEP-2019) one dose, once, for pneumonia prevention and FLUAD (strength, dose, route, frequency, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient experienced redness and swelling at the injection site that went from shoulder to elbow, the skin at the injection site was painful to touch, had trouble lifting the injected arm and was feeling under the weather with flu-like symptoms that persisted for 3-4 days. At the reporting time, the outcome of injection site pain, flu-like symptoms, injected limb mobility decreased, injection site erythema and injection site swelling were reported as recovered on an unknown date. The causality between PNEUMOVAX 23 and FLUAD and injection site pain, injected limb mobility decreased, flu-like symptoms, injection site erythema and injection site swelling were not assessed. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1810USA004434: US-009507513-1810USA004364.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date in September 2014, the patient were vaccinated with doses of (Oka/Merck) VARIVAX injections (lot# J004160 with expiry date: 05-APR-2015; doses, routes of administration and indication unspecified), that underwent a temperature excursion, on unspecified dates between 03-SEP-2014 -30-SEP-2014. No concomitant medications were reported. No adverse experiences were reported. This is one of several reports from the same source. Additional information has been requested.
Hive-type reaction starting in groin area several hours after vaccinations. Hives worsened today spreading to back, neck and chest area. Hives are identical to injection site urticaria.
While half way through eating a Lean Cuisine Butternut Squash Ravioli dinner I suddenly couldn't swallow. I coughed and threw up what I had eaten. My throat was extremely itchy and my head became very congested. I have never had a food allergy before but after searching that I found the symptoms to be similar. My face was not particularly swollen but I was unable to eat anymore and my throat continued to be very itchy on the right side.  I eat mostly on that side due to a dental problem on the left side.  I took an antihistamine, gargled with mouth wash, used a Netti Pot and sucked a cough drop. The itchiness was reduced by the next morning and gone by that afternoon.
Patient received moderna vaccine on 2/2/21 and 3/2/21. Also received pfizer vaccine on 12/30/21 and 5/25/22. Presented to ER on 7/11/22. FOund to be COVID positive on 7/4/22. Not admitted for COVID, but other reasons. Asymptomatic. Discharged on 7/15/22
Information has been received from a nurse concerning a female patient who was vaccinated with the Gardasil on an unspecified date. Subsequently, the patient developed a rash. The patient sought unspecified medical attention. The patient's outcome was unknown. This report is one of two reports from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007.  Information has been received from a certified nurse midwife concerning a female patient who was vaccinated with GARDASIL on an unspecified date.  Subsequently, the patient developed a rash.  The patient sought unspecified medical attention.  The patient's outcome was unknown.
elevated heart rate all night; aches; chills; Pain in arm; exhaustion; swollen lymph node in left armpit; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration in the left arm on 04May2021 at 09:00 as a dose 2 single dose (at the age of 36-years old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration on unspecified date as a dose 1 single dose (at the age of 36-year-old) for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient underwent lab test as heart rate and the result was elevated. On 05May2021 at 05:00, the patient experienced pain in arm, elevated heart rate all night, chills, exhaustion, aches and swollen lymph node in left armpit. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in arm, elevated heart rate all night, chills, exhaustion, aches and swollen lymph node were recovering at the time of this report.   No follow-up attempts were needed; Information about lot/batch number could not be obtained.  Amendment: This follow-up report was being submitted to amend previously reported information: Treatment received ticked no for all events. The patient did not receive any treatment for the event and the events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care added in narrative.
4-5 days after Hepatitis A & Influenza vaccines pt developed nasal DC, cough, fatigue and unusual speech. Stuttering and prolonged duration of sounds of speech. Improving symptoms after 2-3 days. Dx with URI and otitis media on 4/11/11.
Lingering headache for 6 days.  Hot flashes/night sweats and on-going chills.  Tiny mouth sores.  No appetite.  No libido.    All symptoms have lasted for 6 days.
Received Tdap vaccine 9/10/12. Called 9/17/12 to state has experienced soreness x 7 days since adm. of Tdap vaccine. Denies any redness or streaks states warm to touch. S & S of mild-mod. reaction to Tdap vaccine reviewed per VIS. Encouraged to contact PCP.
rash in mid arm. pt stated injection was given too low. Dr and husband(rph)both stated based on rash site, the injection was given mid arm. pt came to pharmacy to show rash (mid arm). pt came back 2 days after injection and rash was getting better but still present
GARDASIL given No 1 shot, then Hep A and VARIVAX. Patient completely fainted (at least 1 min). After wakening, turn pale and almost passed out again. After giving blow by O2 and laying flat at least 5 min, felt better. Sat up, stood up took 2 steps, went pale again and needed to lie down again. BP 90/60. Bl. sugar 117. After 3rd epis given epinephrine 0.3mg.
diagnosed with cancer following receiving the booster dose; now immunocompromised and doctor wants them to get 0.5 mL dose; This spontaneous case was reported by a pharmacist and describes the occurrence of NEOPLASM MALIGNANT (diagnosed with cancer following receiving the booster dose) and IMMUNODEFICIENCY (now immunocompromised and doctor wants them to get 0.5 mL dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced IMMUNODEFICIENCY (now immunocompromised and doctor wants them to get 0.5 mL dose) (seriousness criterion medically significant). On an unknown date, the patient experienced NEOPLASM MALIGNANT (diagnosed with cancer following receiving the booster dose) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (diagnosed with cancer following receiving the booster dose) and IMMUNODEFICIENCY (now immunocompromised and doctor wants them to get 0.5 mL dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.   Pharmacist had a question regarding booster of the Moderna COVID-19 vaccine. Patient was not immunocompromised at the time; now immunocompromised and doctor wanted them to get a full dose (0.5 mL). Previously was not immunocompromised but diagnosed with cancer following receiving the booster dose. Received booster dose of 0.25 mL in Oct-2021.  Company comment: This spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced the unexpected serious (important medical event) events of Neoplasm malignant and Immunodeficiency, unspecified days after receiving the booster dose (dose 3) of COVID -19 vaccination with mRNA-1273 vaccine. No further information on clinical course and management of the events was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced the unexpected serious (important medical event) events of Neoplasm malignant and Immunodeficiency, unspecified days after receiving the booster dose (dose 3) of COVID -19 vaccination with mRNA-1273 vaccine. No further information on clinical course and management of the events was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient received the 2nd COVID vaccine Pfizer Lot #ER8736 exp. 07/31/2021 on 06/10/21 at 3:15 PM. Client returned to facility the following day, 06/11/21 with her boyfriend who was receiving a vaccine. The client alerted EMT at approximately 4:11 of a "rash on my left leg." RN and another RN responded. The client reported development of rash on her left leg approximately 2 hours following receiving her 2nd COVID vaccine. The client stated the rash was "itchy" and has been getting worse since it first appeared. RN noted hives along her left leg. The client also stated that she developed "shortness of breath" this morning around 10AM. She states this resolved after she "took a nap." The client also reported experiencing chills, body aches, and pain today. The client states she took Tylenol today. The client states she developed a similar rash about 1-2 hours following receiving the 1st COVID Pfizer vaccine on 05/20/21 at 2:51PM. She said the rash following her 1st vaccine was "not as itchy" as the current rash. Vital signs at 16:13 were as follows BP: 132/92, HR 106, Respirations 24. RN explained that our current protocol did not allow for administration of any medications. RN's provided education regarding signs and symptoms of anaphylaxis, when to seek EMS, to follow up with PCP as soon as possible, and V-safe. The client was provided a list of community clinics in the area. RN reiterated if the client experiences shortness of breath to seek EMS. The client voiced understanding of this. Vital signs repeated at 16:18 were as follows: BP 122/86, HR 82, Respirations 20. Client left the premises unassisted with a steady gait. The client was visualized getting into personal vehicle by EMT at 16:32.
Hives on arms, left side of face, severe swelling in left leg , nose bleeds, and chest pain.
UrticariaPruritus two fingers on left hand became swollen & itched; right leg started itching Narrative:
I NEVER HAVE PROBLEMS WITH MY MUSCLES OR MY EARS, SINCE THE VACCINATION I STAR PRESENTING AND FEELING VOICES CLOSE TO MY EARS AND MY MUSCLES MOVE INVOLUNTARY.( I NEVER HAVE PROBLEMS WITH MY MUSCLE)
Pt recvd 3 doses of Engerix-B & 10OCT91 it was determined that pt did not respond to the vax series;
About 5 minutes after injection, patient got clammy,pale and started to twitch so we got the patient down on the floor and called EMS.  EMS came and took over situation.
Approx 2 weeks after receiving Hep B vaccine 1st dose into left deltoid, experienced pain in subscapular and scapular muscles. Subsequent pain in deltoid, triceps and shoulder girdle on left. Numbness, tingling, paresthesias in left forearm and fingers to present time.
PT was given 0.3 ml of undiluted Pfizer COVID-19 vaccine, enough for 6 doses.
NO ADVERSE REACTION REPORTED. A PFIZER VACCINE WAS ADMISNISTERED TO A PATIENT AFTER BUD OF 7/22/22. PATIENT, RECIEVED A PFIZER BOOSTER SHOT 3 DAYS AFTER BUD. The medical/safety team at Pfizer WAS CONTACTED AND indicated THE DISCOVERING PHARMACIST they do have stability but not efficacy data on the adult Pfizer vaccine beyond 72 days when stored in a refrigerator. They recommended that our rph contacts the CDC and inquires about repeating doses for these patients. Speaking with the CDC employees, our rph was given the same information as above and referred to the immunization division at the DOH.  Our rph contacted the DOH in the state, but she was asked to confer with Medical Doctor or the standing order physician. Our rph was able to interact with the latter, and she was given the guidance of re-vaccinating . In the context of the guidance from the standing order physician, the patient will need to repeat the dose. Regular schedules for series completion/booster doses will be observed if/when warranted.
101.5 fever for 2 days, body chills,  body aches, shaking, headache, really swollen around injection site, red ring, hot to the touch
temp elevation of 104.5 some evening as shot;given APAP & cool bath;leg red & swollen @ site;temp dec over next 2 days;
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 13-NOV-2015, the patient was vaccinated with an improperly stored dose of VAQTA 10 Pk 25 U/0.5 ml SD Llok w Cap Ped, which had the lot # L001445, with expiration date 15-FEB-2016 (dose, dosage number and route of administration were not reported). No adverse effects were reported and no product quality complaint was involved. On an unspecified date the vaccine experienced a temperature excursions of 288 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius degree). The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator (R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Slight pain in right back of throat; Looked like Marge Simpson, felt like Novocaine numbing; Hives on arms, legs, thighs, hips with lots of itching; Hives on arms, legs, thighs, hips with lots of itching; Nose and Upper Lip Angioedema; Right Eye puffy, closed, puckered, creased; Right Eye puffy, closed, puckered, creased; Right Eye puffy, closed, puckered, creased; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 21Apr2021 14:15 (Lot Number: EW0153) as single dose for COVID-19 immunisation. Medical history included seasonal allergies to pollen, grasses, weeds. The patient's concomitant medications were not reported. On 26Apr2021, the patient experienced right eye puffy, closed, puckered, creased, on 01May2021, nose and upper lip angioedema, felt like Novocaine numbing; hives on arms, legs, thighs, hips with lots of itching, on 04May2021, lower Lip Angioedema on right side, looked like an asymmetrical fat lip; continued Hives on arms, legs, thighs, hips with lots of itching, on 07May2021, left eye puffy, closed, puckered, creased; continued hives on arms, legs, thighs, hips with lots of itching. slight pain in right back of throat. The patient did not receive any treatment for events. The outcome of events was recovering.  Information on lot/batch number has requested.
Flu like symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment medications were not provided by reporter.
2-inch erythema at injection site. Warm and tender to the touch per aunt. Applied cool compress and water to the site. Acetaminophen given to the child. 8 hours later, symptoms are relieved. Mild redness and less tender, per aunt.