chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 12 hours after the injection, vomiting and diarrhea for approximately 12 hours.  Used Lomotil for diarrhea (which would come without warning), and sipped sparkling water for hydration.  Sometimes the vomiting occurred every 15 minutes.   All of this was on Thursday, 1-28-21.  Continued with sparkling water and began saltines on Friday through Saturday, plus bit of toast for breakfast on Saturday, and yogurt Saturday noon.  Saturday, 1-30-21, watery diarrhea, about every 15 minutes, 5:00 pm until 8:00 pm, 9 times.  Took 2 Lomotil shortly after 5, and one more at 8:00 pm;  Sunday, 1-31-21, watery diarrhea beginning at 6:00 pm, every 15 to 30 minutes, until around 8:00 pm; Took a Lomotil.
No adverse effects reported. FDA approved the 2023-2024 Monovalent COVID-19 vaccine and no longer authorized the Bivalent COVID-19 vaccine on 9-11-2023. Meeting for approval was 9-12-2023. Patient was given the Bivalent COVID-19 vaccine on 9-13-2023, prior to knowing of the official change in recommendations. Patient notified by nurse to return in 2 months for the new monovalent 2023-2024 COVID-19 vaccine.
Patient approached me and said the Zostavax vaccine was given in her upper left posterior arm on Friday, 1/9/15.  She said approximately 36 hours after (very early Sunday morning) the injection the site was warm, very red, itchy and somewhat painful.  There was an area of swelling/induration and redness  2 inches by 4 inches at the injection site.  Around this area the skin was slightly pink.  It was a raised rash.  Uncomfortable rash but painful to touch.  Only used comfort measures  warm compresses and a oatmeal based lotion which helped relieve itching. Wednesday (14th), rash is pink, flat, with some itchiness. Today (16th) itching is gone, hint of pink to the injection area approximately 2" in diameter.
body aches; Joint Pain; This spontaneous case was reported by a physician and describes the occurrence of PAIN (body aches) and ARTHRALGIA (Joint Pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (body aches) and ARTHRALGIA (Joint Pain). At the time of the report, PAIN (body aches) and ARTHRALGIA (Joint Pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were provided.
Vaccine (2nd dose) received 12:45pm on 4/22/21. Beginning around 1:00am 4/23/21, fever developed and lasted until 10:00pm on 4/23/21, reaching a peak of 102.0 degrees Fahrenheit. Beginning at 6:00am 4/23/21, headache developed and lasted until 11:00am 4/23/21. Beginning at 6:00am 4/23/21, nausea developed and lasted until 1:00pm 4/23/21. Beginning at 5:00pm on 4/23/21, redness (1 inch circle) developed at injection side on arm, and was hot to the touch. Injection site redness continued to grow in size and become splotchy, reaching a size of 5 inches on upper arm. This redness began to decrease on  4/25/21, but did not fully disappear until 4/27/21.
3MAY93 pt had swelling behind both ears; pt had no elevated temp; no irritability & no interuption of sleep or appetite pattern;
Right arm is red and hot below the area of her shingles vaccine she got 3 days prior.  It is also tender. MD recommended  trying Benadryl for a local reaction and if redness continues to spread or if she develops SOB, recommend they go to ER.  Patient ended up going to the ER 2 days later (2/10/2020) complaining of pain, itching, swelling and rash. ER workup was negative for any major concerns.  They gave her an Rx for Prednisone and Keflex to cover for possible early infection.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of improperly stored PNEUMOVAX23 injection, lot # M040804, expiration date: 20-MAY-2018 (dose and route of administration were not reported). Temperature excursion ranged from 32 to 35 degrees Fahrenheit (from 0 to 1 degrees Celsius) for 2 hours and 40 minutes. There was no previous temperature excursion. Digital data logger was used. Product quality complaint was not involved. Additional information has been requested.; Sender's Comments: US-009507513-1703USA005103: US-009507513-1703USA010599:
Approximately 5 to 7 minutes after vaccine patient said he felt sleepy and started to collapse.  Pharmacist helped him lay down and he became unresponsive.  While checking for pulse and trying to get him to respond he did wake up
This is a spontaneous case, initially received from other health professional on 16-Nov-2018, concerning a 23-year-old, adult male patient. On an unspecified date, vaccine was exposed to 56 Fahrenheit for 3 hours and 20 minutes which was considered as first-time excursion. On 15-Nov-2018, the patient was administered FLUCELVAX QIVc which underwent temperature excursion (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252678 and expiry date: 30-Jun-2019). The patient did not experience adverse effects. The reporter assessed the case as non-serious.
Info has been received from a MT concerning a 38 year old female who was vaccinated with a dose of MMRII. In "the beginning of 2003", the pt's rubella titer was negative. Unspecified medical attention was sought. At the time of this report, the pt had not recovered. No product quality complaint was involved. Additional info has been requested.
Increased heart rate and blood  pressure,  dizziness, chest tightness, tingling  left arm , leg and foot,  left should heavyness.
606 doses were given after expiration date; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had no adverse effect after vaccination.  No temperature excursion issue was noted.  On 04-NOV-2021 Vaccine was placed in refrigerator.  No treatment medications were reported.
This spontaneous case was reported by a nurse and describes the occurrence of RASH (Raised Red Rash on bilateral Lower Legs and left Forearm), ARTHRALGIA (Joint pain), ARTHRALGIA (Ankle pain), BACK PAIN (Lower back pain) and FATIGUE (Fatigue) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (chantix), Anxiety and Depression. Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) and PERPHENAZINE for Anxiety, DULOXETINE HYDROCHLORIDE (CYMBALTA) and DESVENLAFAXINE SUCCINATE (PRISTIQ) for Depression. On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 28-Jan-2021, the patient experienced ARTHRALGIA (Joint pain), ARTHRALGIA (Ankle pain), BACK PAIN (Lower back pain) and FATIGUE (Fatigue). On 29-Jan-2021, the patient experienced RASH (Raised Red Rash on bilateral Lower Legs and left Forearm). On 29-Jan-2021, ARTHRALGIA (Joint pain), ARTHRALGIA (Ankle pain), BACK PAIN (Lower back pain) and FATIGUE (Fatigue) had resolved. On 08-Feb-2021, RASH (Raised Red Rash on bilateral Lower Legs and left Forearm) had resolved. Not Provided. 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. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: new events and co-meds were added.
This spontaneous report as received from a pharmacist refers to a 91 year old patient. Pharmacist reported that on 10-APR-2013 or 11-APR-2013 the patient was vaccinated with an expired 0.65 ml dose ZOSTAVAX (lot # 672606/1655AA, Exp date 21-JAN-2013) subcutaneously. It was unknown if the patient sought medical attention. At the time of reporting, the status of patient was unknown. Additional information is not expected.
This spontaneous report as received from a physician refers to a 65 years old female patient, who on unknown date was vaccinated with a dose of PNEUMOVAX 23 (lot # and dose not reported). On an unknown date, following the vaccination, the patient experienced arm swelling "from the deltoid down to the elbow like a long string of red reaction". The patient sought medical attention, she went to urgent care. No treatment was reported. The outcome of arm swelling "from the deltoid down to the elbow like a long string of red reaction" was reported as recovering/resolving. The relatedness for arm swelling "from the deltoid down to the elbow like a long string of red reaction" was unknown for PNEUMOVAX 23. Additional information has been requested.
Patient suffered swelling, numbness, and pain in arm where she received vaccination for more than one week.
a little sore at injection site; Muscles are so sore; Joints hurt; it hurts in the back of her leg from the bend of her knee up to her butt: it hurts real bad too; it hurts in the back of her leg from the bend of her knee up to her butt: it hurts real bad too; This is a spontaneous report from a contactable female consumer (patient) reported for herself that:  A 83-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6204), via an unspecified route of administration, administered in Arm Left on 04Mar2021; (Expiration Date: 03Jul2021) (At the age of 83 years) as DOSE 2, 0.3 ML SINGLE for covid-19 immunisation. Medical history included ongoing blood cholesterol and ongoing low thyroid. Concomitant medications included pravastatin taken for blood cholesterol, start and stop date were not reported; levothyroxine sodium taken for an unspecified indication from 1962 to an unspecified stop date; ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS) taken for an unspecified indication, start and stop date were not reported; vitamin b-complex, vitamin c, vitamin e (VITAMIN B-COMPLEX,VITAMIN C,VITAMIN E) taken for an unspecified indication, start and stop date were not reported. Patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration, administered in Arm Left on 10FEB2021; (Expiration Date: 31MAY2021) (At the age of 83 years) as DOSE 1, SINGLE for covid-19 immunisation. On 7Mar2021, the patient had experienced little sore at injection site, muscles are so sore, Joints hurt and it hurts in the back of her leg from the bend of her knee up to her butt it hurts real bad too. At the time of reporting, the outcome of the events muscles are so sore, Joints hurt, leg discomfort and Knee injury were not recovered whereas the outcome of the event a little sore at vaccination site was unknown.  No Follow-up attempts completed. No further information is expected.
24 hours after administration patient developed redness, warmth, itching and a bullae measuring 1 x 2 cm. Clear fluid. No induration. Did experience chills and fatigue for first 24 hours.
Itchy red rash to trunk and stomach. Pt said that he first notice rash on 1/24/2011. States he has a positive history of rashes and has sensitive skin. Per patient, "I always have rashes." Given 50 mg Benadryl po now today (1/27/2011).
Patient was brought to the local ER for complaints of a fall with injury to both knees , Left shoulder and face.  Placed in observation status for PT/OT evaluation and treatment.
Patient presented with redness on her left arm that went from her deltoid muscle to her elbow.  It was warm to the touch and patient claimed it was painful.
pt recv vax 6JAN99 & about 9 days p/vax pt devel six chickenpox like lesions;this was on 15JAN99;pt sibling devel forty lesion starting on 27JAN99;another sibling devel forty lesions on 8FEB99;siblings not immunized;
Nurse gave patient covid vaccine even though pt received monoclonal antibody therapy for Covid within the last 90 days
weakness, cough, sore throat Narrative:  59 yo male with PMH of HTN, CKD stage 3B, B-cell lymphoma, DM, neuropathy, HTN, chronic pain, sleep apnea, psychosis, history of substance abuse who reported not feeling well (pain 6/10, sore throat, nausea, vomiting, increased weakness) at the ED on 2/17/2021. This was attributed to covid19 vaccine that the patient received on 2/16/2021 (first dose, Pfizer). The patient denied any prior severe reaction to this vaccine or its components or a severe allergic reaction such as anaphylaxis to any vaccine or to any injectable therapy. Covid19 vaccine was administered without complications. of note, pt tested positive for covid19 on 12/31/2020. Patient felt better after receiving NaCl 0.9% fluid, 50mg of ketorolac IVP, 975mg of Tylenol and 0.5mg of hydromorphone. Pt was discharged the same day.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 1/25/21 (EN5318) Pfizer Dose 2 2/16/21 (EN5318) COVID Positive 8/31/21  9/1/21: Patient is 76-year-old female presented in ER with complaints of fevers, a positive COVID-19  and strep test on 08/31/2021 from urgent care.  She reports persistent fever and chills but denies nausea vomiting, abdominal pain, diarrhea, constipation and chest pain.  Upon arrival to the ER she was noted with fevers of 102 with oxygen saturation above 90% on room air.  Bilateral checks x-ray showed bilateral pneumonia and she was treated with IV antibiotic, 3 L IV fluid and Tylenol.   Emergency room blood work was unremarkable.  Currently she is able to keep her saturation above 90% on room air.  Will continue to monitor her lung function closely and assess the need to get pulmonology involved.  Explained the plan of care to the patient and she is agreeable to stay for further management.  Care coordination to provide information about the COVID-19 safe home return.  9/4/21: Patient is a 76-year-old female who was admitted on 9/1/2021 with bilateral COVID pneumonia, streptococcal pharyngitis, and sepsis, secondary to above.  Patient was admitted to the medical floor for closer monitoring.  She was started on clindamycin for her streptococcal pharyngitis due to multiple antibiotic allergies.  Her fever has resolved.  She has been fever free for 24 hours. Yesterday she did develop some hypoxia and was placed on supplemental oxygen.  She has been off of oxygen now for over 12 hours.  She reports that she is feeling much better.  She denies shortness of breath at rest, dyspnea on exertion, chest pain, palpitations.  She is quite insistent that she wants to go home today.
This spontaneous report was received from a health care professional refers to 3 or 4 patients of unknown demographics. On an unknown date the patients were vaccinated with PNEUMOVAX 23 injection (dose, route, frequency and lot # unspecified). Concomitant therapy was not reported. On an unknown date, patient experienced extreme pain that was debilitating and achiness described as had decrease range of motion in the shoulder joint of the upper arm area. Nurse reported the pain was localized to the general area in the shoulder joint of the upper arm. Nurse reported she rated the pain as a 10 out of 10. Nurse reported patients also had localized edema in an unspecified location. Nurse also reported that these 3 or 4 other patients who experienced the same symptoms as the related case patient after taking PNEUMOVAX 23. Patient sought medical attention and spoke to nurse. The outcome of joint range of motion decreased, asthenia, localised oedema and musculoskeletal pain was unknown. Causality assessment was not reported. This case is linked to: 1506USA003505 (same reporter link). Additional information has been requested.
on and off pain especially on quad muscle; pain in right leg; pain in right side of body,pain all over body,soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in right leg), PAIN (pain in right side of body,pain all over body,soreness) and MYALGIA (on and off pain especially on quad muscle) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in right leg) and PAIN (pain in right side of body,pain all over body,soreness). On 11-Mar-2021, the patient experienced MYALGIA (on and off pain especially on quad muscle). At the time of the report, PAIN IN EXTREMITY (pain in right leg), PAIN (pain in right side of body,pain all over body,soreness) and MYALGIA (on and off pain especially on quad muscle) outcome was unknown.            No concomitant medications were reported. Treatment included Pain medications. Action taken with mRNA-1273 in response to the events was not Applicable
24 hours after immunizations pt developed 5x12cm local site reaction at Pneumovax site and fever up to 38.5 C.
Patients mother states that she has big circle on arm and underneath. Dr said it was blood poisoning.
Within 6-8 hours after receiving the vaccine I had the same side effects I'd experienced with the previous doses: fatigue, chills, fever, intense body aches, pain at injection, swelling of lymph node at left armpit.   Over the next 6 hours,  I  noticed a NEW and UNEXPECTED SIDE EFFECT:  I LOST MY SENSES OF TASTE AND SMELL.   Contacted doctor who suspected it was booster related but suggested a PCR test out of an abundance of caution and because I work with the public.  Appox. 48 hours after vax, taste and smell began to return and were fully back by 72 hours after vax.  PCR test results were negative, suggesting loss of taste and smell were a vaccine side effect.
On 09/10/2000 the patient developed a papular rash which became vesicles, the crusts. It was noted that the patient had approximately 50 lesions in total on the trunk and extremities. It was also reported that the patient developed impetigo and was treated with Keflex. On 09/25/2000 the patient recovered. Additional information is not expected.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 93-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 23-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805419 was crossed linked to original cases 201804863 due to same reporter.
Still feel off after a week/just not right yet; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Still feel off after a week/just not right yet) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Still feel off after a week/just not right yet). At the time of the report, FEELING ABNORMAL (Still feel off after a week/just not right yet) had not resolved.            No concomitant medications were reported. No treatment medications were reported.
Sore muscle at injection site (duration: 3 days, treated with ibuprofen), mild fatigue (2 days), higher temperature (not quite to fever level, but temperature reached 99.5 degrees, higher than my normal temperature; duration: 6 hours; treated with ibuprofen)
60mmx60mm round area, slightly raised, pink in color and warm to touch. Advised to use cold pack to area, Tylenol for discomfort and Benadryl for swelling. Return to office with no improvement.
Patient was seen in ED and dx'd with Cellulitis .  No treatment given, advised to follow up with pcp.
Red bump below injection site; Red bump below injection site; This case was reported by a pharmacist via call center representative and described the occurrence of local swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2019, the patient received Shingrix (intramuscular). In July 2019, less than a week after receiving Shingrix, the patient experienced local swelling and erythema. On an unknown date, the outcome of the local swelling and erythema were unknown.   It was unknown if the reporter considered the local swelling and erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The health care professional stated that patient noticed a red bump formed 2 inches below the injection site, after she got the vaccine. The case has been linked to the case US2019138559, reported by same reporter.
sore neck; This case was reported by a consumer via interactive digital media and described the occurrence of neck pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced neck pain. On an unknown date, the outcome of the neck pain was unknown.   It was unknown if the reporter considered the neck pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient received a dose of Shingles vaccine and experienced sore neck. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Pruritic rash on both elbows, right knee, and palms of both hands.  Elbows and knees had erythematous, non-scaling, coalescing plaques with satellite papules and vesicles; palms of hands had few scattered discrete dark red papules (2-3 on each palm).  Treated with topical Triamcinolone 0.1% gel TID for itching prn.