chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Increasingly larger red spots on upper arm between injection area and elbow.  Began one day after vaccination,  Red spots are hot to touch.
Pt vaccinated with Engerix-B developed HBSAG positive. F/U Reporting nurse indicated lab test were incorrect.
Pt states that next AM noted lt arm swollen around site & red; no temp 3 days ago, on 5APR hard knot approx size of quarter appeared (looks like an abscess?) area around warm, red & tender;
This is a spontaneous report from a contactable nurse communicated to a sales representative.  A female patient of an unspecified age and race/ethnicity received  the second dose of TRUMENBA, via an unspecified route of administration at single dose in Dec2017 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a red rash around the shot area in Dec2017 with outcome of unknown. The information on the lot number has been requested.
patient called stating she was experiencing full body pains/aches that began 8 days after receiving booster dose of moderna. States pain starts in left side, and radiates down side, leg, and hip. She states she has taken extended release acetaminophen and it does not help, and she has been unable to sleep. Called primary care doctor and was prescribed prednisone. No other symptoms reported prior to aches.
palpitations, chest tightness/heaviness, scratchy throat/frequent throat clearing, head heaviness, blurred vision, elevated blood pressure.  Evaluated in ED received solumedrol, benadryl.  Discharged home and returned to hospital as direct admit due to continued symptoms.  Pertinent labs reveled AKI, elevated LFTs.  AKI and LFTs improved with IVFs.
Arm started to leak a clear liquid; Arm started to leak a clear liquid; Arm was sore; Arm was red; A spontaneous report was received from a consumer who was also a 68-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced sore arm (injection site pain), redness (injection site erythema) and her arm leaked a clear liquid right after getting the vaccine (vaccination site discharge/ incorrect dose administered).  The patient's medical history was not provided.  No concomitant medications were reported.  On 20 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) in the left arm for prophylaxis of COVID-19 infection. After the injection, the patient's arm started to leak a clear liquid.  Her arm was also sore and red. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the events was not reported.  The outcome of the event, arm leaked a clear liquid, was considered as resolved on 20 Jan 2021.  The outcome of the events, sore arm and redness, was unknown.; Reporter's Comments: This concerns a 68-year old female patient who experienced injection site pain, redness, and her arm leaked clear liquid after mRNA-1273 administration.Based on the current available information and temporal association between the use of the product and the start date of the events (redness, site pain), a causal relationship cannot be excluded.
Patient received the second dose of the COVID vaccination on 2/15/21; She developed a migraine with vomiting, and body aches/cramps that evening, still present on 2/16/21; Patient was advised to remain hydrated, rest, and use Excedrin and ibuprofen as needed and to call if worsening.
pt complained of bruising and site of injection and pain going down arm. Also had body aches and runny nose for 1 week. pt instructed to ask doctor and apply ice for bruising
On 07/14/2001 the patient developed erythema. The patient awoke on 07/15/2001 with edema and severe pain in the right upper arm and shoulder. The patient was seen in the ER and treated with Ceclor. The patient had a low grade fever 07/15/2001 through 07/17/2001.
Admit hospital with fatigue and syncope, orthostatic hypotension for several days. Large hematoma in chest wall from previous fall causing anemia
pt recv vax; lab eval revealed varicella antibody .03 following 2 doses of varicella vaccine;lab eval revealed varicella antibody .09.
She had heart palpitations; The opposite arm was swollen up; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in left arm on 17Feb2021 (at the age of 65-years-old) as single dose for COVID-19 immunization. The patient's medical history included palpitations and she takes medicine for it. The patient's concomitant medications were not reported. The patient previously experienced known allergies to lot of medicines and things. On 19Feb2021, the patient experienced swollen up in the opposite arm when she woke up. The patient also experienced heart palpitations the last night. The patient noticed the opposite arm was swollen this morning. The patient was trying to figure out why it was feeling so tight and she got out of the shower and she was lotioning up and she noticed it and said oh that was why. The patient said the injection was given in the left arm but this was the right arm that was swollen. The right arm and it was swollen in the fold of the arm like where the crease was between arm and elbow. The patient said it was swollen in the bend of her elbow and was ongoing. The outcome of the opposite arm was swollen up was not recovered. The outcome of heart palpitations was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 29-DEC-2015 at 17:28, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.3 and 5.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
developed headache, myalgias, fatigue.   The headache resolved however the myalgias, "exhaustion", fatigue persisted for 2 weeks
Fatigue; shaky feeling; Feeling of slightly increased heart rate; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 28Mar2021 at 12:00 (at the age of 31-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma and known allergies to peanuts, tree nuts, shelfish and trees. Concomitant medications included fluticasone propionate (FLONASE), fexofenadine hydrochloride (ALLEGRA) and fluticasone furoate (ARNUITY); all for unspecified indication from unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the patient experienced fatigue and shaky feeling and feeling of slightly increased heart rate. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab for COVID-19 on an unknown date and tested negative. The clinical outcome of the events fatigue and shaky feeling and feeling of slightly increased heart rate was not recovered at the time of report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Stiffness on the local area, bone pain 1 day after the vaccine injection. Arm pain from Should all the way down to the fingers. Wrist pain, elbow pain and Bone pain
Information has been received from a registered nurse concerning a 4 year old male who 14-APR-2006 was vaccinated with a 0.5 mL SC dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot # 650104/0828R). There was no concomitant medication. On 28-APR-2006 he presented with fever and a morbilliform, itchy, red rash over his entire body including his mouth. At the time of the report, the patient was recovering. Unspecified medical attention was sought. There was no product complaint involved. Additional information has been requested.
ITCHY RASH OR ITCHING ON ARM AND THIGHS; RED BLOTCHY HIVES ON THIGHS, BUTTOCKS AND ARMS; SORE ARM; MILD HEADACHE; This spontaneous report received from a patient concerned a 69 year old male. The patient's weight was 185 pounds, and height was 69 inches. The patient's concurrent conditions included copd, emphysema, smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies and no history of hives/rash ad did not have drug abuse history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin, levothyroxine sodium, metoprolol, and paroxetine hydrochloride.  On 05-MAR-2021, the subject experienced mild headache. On 06-MAR-2021, the subject experienced sore arm. On 13-MAR-2021, the subject experienced itchy rash or itching on arm and thighs. On 13-MAR-2021, the subject experienced red blotchy hives on thighs, buttocks and arms. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchy rash or itching on arm and thighs, red blotchy hives on thighs, buttocks and arms, and mild headache on MAR-2021, and sore arm on 07-MAR-2021. This report was non-serious. This case, involving the same patient is linked to 20210330252.
face was swollen; really hot; face was red; fever 104F; Fever of 102F; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face was swollen), FEELING HOT (really hot), ERYTHEMA (face was red), PYREXIA (Fever of 102F) and PYREXIA (fever 104F) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A,) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PYREXIA (Fever of 102F). On 08-May-2021, the patient experienced SWELLING FACE (face was swollen), FEELING HOT (really hot), ERYTHEMA (face was red) and PYREXIA (fever 104F). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (face was swollen), FEELING HOT (really hot), ERYTHEMA (face was red), PYREXIA (Fever of 102F) and PYREXIA (fever 104F) had resolved.            concomitant drug details not provided.
This case was reported by a physician via other manufacturer and described the occurrence of injection site swelling in a female patient who received BEXSEROL. Co-suspect products included BEXSERO. On an unknown date, the patient received the 1st dose of BVEXSERO .5 ml and the 2nd dose of BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO and not applicable after receiving BEXSERO, the patient experienced injection site swelling, injection site erythema, injection site pain, injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were recovered/resolved and the outcome of the injection site swelling, injection site erythema and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to BEXSERO. It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to BEXSERO. Additional details were provided as follows: This case was related via Merck National Service Center. This case was reported by a physician, who herself was the patient's mother. The reporter stated that the injection site reactions were worse with the 2nd dose of BEXSERO than with the 1st dose. The reporting physician agreed to follow up for information about the patient's injection site adverse events after the vaccination with BEXSERO. No additional information was provided. This case has been linked to case US2016GSK015758, reported by the same reporter.
photosensitivity reaction; redness 1x2 inches in size; injection site area was painful; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOSENSITIVITY REACTION (photosensitivity reaction), VACCINATION SITE PAIN (injection site area was painful) and VACCINATION SITE ERYTHEMA (redness 1x2 inches in size) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia. Concurrent medical conditions included Iodine allergy and Allergy (fish, beef, and seafood).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection site area was painful). On 31-Mar-2021, the patient experienced PHOTOSENSITIVITY REACTION (photosensitivity reaction) and VACCINATION SITE ERYTHEMA (redness 1x2 inches in size). At the time of the report, PHOTOSENSITIVITY REACTION (photosensitivity reaction), VACCINATION SITE PAIN (injection site area was painful) and VACCINATION SITE ERYTHEMA (redness 1x2 inches in size) 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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Like 15 hours after injection head started feeling very heavy, throat hurting hard to keep my eyes open,  freezing temp started at 101.3 took Tylenol at 2:30 checked temp again at 3;40 up to 101.7 and have been in bed
5MAR97 pt states had aches, stomach ached, h/a since inj on prev day;10MAR97 cont w/flu-like sx, now c/o inc BP 150/110, SOB, malaise, feeling bad;referred to MD;
still suffering itchy, Burning rash!!! ever since; Burning rash!!! ever since; This case was reported by a consumer via interactive digital media and described the occurrence of itchy rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced itchy rash and burning sensation. On an unknown date, the outcome of the itchy rash and burning sensation were unknown.   It was unknown if the reporter considered the itchy rash and burning sensation to be related to Shingrix.  Additional details provided were as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received the first dose of Shingrix 2 years ago experienced Itchy rash and burning. The patient refused the booster dose. The pharmacist sent the report which was never heard back from manufacturer.
slight fever headache pain in arm by 4 am Feb 13, 2021: increased headache, aches and pains everywhere, swollen face and joints
About 6 hours after my second COVID vaccination, I started experiencing muscle and joint pain throughout my body that was severe enough that I didn't get much sleep. After breakfast, I took 3 Ibuprofen, which somewhat relieved the pain, which I would categorize as about 7 on a scale of 1-10. The pain continued and was uncomfortable but did not require medical attention. At midnight (36 hours after vaccination), I woke up and the pain was all gone. However, the next day (Monday 02-15-2021), I developed a rash and itching on the front side of my left arm (the injection was in the back at the top) that continued for a week, turning into a bruise about 4 inches above my elbow. It doesn't itch any more and the bruise is going away. I am reporting this adverse event to contribute to the knowledge base about reactions to this novel virus and these newly developed vaccines.
After about 3 hrs after vaccine hives in the chest, stomach and back. Baby was very itchy.
Flu vaccine at 1615. Went for a walk and had a "coughing fit" and SOB. Breathing tx given and helped. HO RAD and neb tx's. No distress at 2025.
Patient seen 12/4/02 for routine physical. Office administered DTaP (right thigh IM) and flu vaccine (left thigh, IM). Patient presented to office 12/6/02 with redness, swelling and heat at site on right thigh at DTaP site.
Pain in arm first week that migrated to my neck and then back. Second week my blood pressure went to 200/100 and took three months to get under control. To this day my joints still hurt, especially my back. I have gone to the doctors to discuss all these isuues and I am currently under diagnoses/treatment.
Arm hurt; This is a spontaneous case, initially received from other non-health professional (consumer) via The Agency (reference number: SEQW20-00318) on 17-Apr-2020, concerning an adult, female patient who was 64-year-old at the time of this report.   The patient's relevant medical history was not reported.  The patient's historical vaccine included an unspecified flu vaccine received on an unspecified date in 2017 after which the patient's arm hurt for 3 months.   The patient's concomitant medications were not reported.  It was reported that the patient was on unspecified antidepressants in the past (start and stop dates for antidepressants were unspecified) and none of them worked which was confirmed with a genetic test.  On an unspecified date in 2018, the patient was administered with INN Flu Vaccine Seasonal [influenza virus vaccine polyvalent; dose, route of administration, anatomical location, batch number and expiration date: not reported] for an unknown indication.  On an unspecified date, after vaccination, the patient's arm hurt.  On an unspecified date, 6 months later, the patient recovered from the event of pain in arm'.  The reporter did not provide causality assessment to INN Flu Vaccine Seasonal.  This case is linked to cases 202003111 and 202003113, due to the same patient and reporter.  Follow up information received from other non-health professional (consumer) via The Agency (reference number: SEQW20-00349) on 27-Apr-2020: It was reported that the patient was on antidepressants in the past. Indication for vaccine changed from influenza prophylaxis to ASKU. Narrative amended accordingly. Additional reference number added.  Non-significant follow-up information received from other non-health professional (consumer) from The Agency [reference number: SEQW20-00404] on 15-May-2020: Additional reference number added. No changes in narrative.  Company comment: The patient developed pain in extremity on an unspecified date, after receiving INN Flu Vaccine Seasonal. Chronology needs more clarification. The patient's relevant medical history and concomitant medications were not reported. With information available, causal role of the suspect product is unassessable.; Sender's Comments: The patient developed pain in extremity on an unspecified date, after receiving INN Flu Vaccine Seasonal. Chronology needs more clarification. The patient's relevant medical history and concomitant medications were not reported. With information available, causal role of the suspect product is unassessable.
pain at injection site; pain in the armpit; radiated down the arm outwards and went to the rib cage; radiated down the arm outwards and went to the rib cage; radiated down the arm outwards and went to the rib cage; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), in Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Sep2023, outcome "not recovered", described as "pain at injection site"; AXILLARY PAIN (non-serious) with onset Sep2023, outcome "not recovered", described as "pain in the armpit"; PAIN (non-serious), PAIN IN EXTREMITY (non-serious), MUSCULOSKELETAL CHEST PAIN (non-serious) all with onset Sep2023, outcome "not recovered" and all described as "radiated down the arm outwards and went to the rib cage".  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Chest pain radiating to back; Chest pain radiating to back; Nausea; Transient hypertension; This is a spontaneous report from a contactable pharmacist. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 01Mar2021 (at the age of 63-year-old) (Lot Number: EN6205) as dose 2, single for COVID-19 immunization. The vaccine was administered in a hospital. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 08Feb2021 (at the age of 63-year-old) (Lot Number: EM9809) as dose 1, single for COVID-19 immunization. It was unknown prior to vaccination, if patient was diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19. It was unknown if patient received other vaccine within 4 weeks prior to COVID vaccine. The patient experienced chest pain radiating to back, nausea, transient hypertension on 01Mar2021. The patient did not receive treatment for the events. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.
Redness/swelling to (R) upper arm. Patient treated w/ ROCEPHIN per PAC.