chrisvoncsefalvay/vaers-outcomes huggingface dataset:
legs hurt; sweating; dizziness; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs hurt), HYPERHIDROSIS (sweating), DIZZINESS (dizziness), CHILLS (chills) and FATIGUE (fatigue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (legs hurt), HYPERHIDROSIS (sweating), DIZZINESS (dizziness), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (legs hurt), HYPERHIDROSIS (sweating), DIZZINESS (dizziness), CHILLS (chills) and FATIGUE (fatigue) had not resolved.            No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Approximately four weeks after second shot developed stiff joints and weak muscles throughout whole body, fatigued, body would feel very heavy when lying down, could hardly move and when I did was very painful/ache, especially at night.  Was very hard to get out of bed. The symptoms came up suddenly.
I did not have an adverse reaction to the vaccine. I started to not feel well 02/25/2023 with fever and chills. I tested positive for COVID-19 on 02/28/2023. I contacted my doctor and got a prescription for molnupiravir. I tolerated the medication and was able to complete the medication. As of today, I feel much better.
Patient had a very large bruise about 6 inches from below her deltoid to her elbow and what looked like a hematoma above the elbow. The bruise was not at injection site but rather below it by about an inch. The hematoma had disappeared by 9/14/17 but the large bruise was almost all the way around her arm. Patient didn't report pain or heat at injection site.
About an hour after immunization, patient broke out in hives all over her body (redness and tiny bumps) and the following morning woke up with swollen eyes.
Pt c/o difficulty swallowing, tongue tingling, and feeling "fuzzy overall" 25 min post vaccination. EMS called. Transferred to local hospital.
Weakness; Swelling; Joint pain; Fever; 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 ASTHENIA (Weakness), SWELLING (Swelling), ARTHRALGIA (Joint pain) and PYREXIA (Fever) 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 ASTHENIA (Weakness), SWELLING (Swelling), ARTHRALGIA (Joint pain) and PYREXIA (Fever). At the time of the report, ASTHENIA (Weakness), SWELLING (Swelling), ARTHRALGIA (Joint pain) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications were reported.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
No additional AE; HCP reported vaccines were administered after a temperature excursion.; This spontaneous report was received from a nurse referring to a 13 month old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 18-JAN-2023, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot # W008711 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and established as 14-MAR-2024) (strength, dose, route of administration and anatomical location were not provided), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and hepatitis a vaccine, inactivated(VAQTA) (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided).  The temperature of storage and time frame of the excursion were -10.5° Celsius (C) for 1 hour and 34 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.; Sender's Comments:  US-009507513-2301USA010765:
This spontaneous report was received from a female patient of unknown age referring to herself. She was 6 weeks pregnant at the reporting time. There was no information about patient's concomitant medications or pertinent medical history reported. On 18-MAY-2018, the patient was vaccinated with a first dose of Oka/Merck VARIVAX (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis. On 09-JUN-2018, the patient was vaccinated with a second dose of Oka/Merck VARIVAX (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis.
Patient began complaining of leg pain where injection given.  Leg was red and warm.  Patient started running fever the evening of the injection.  Advised warm compresses and tylenol and return if no better. Presented to the ED 9/5 and received IM and IV antibiotics and sent home with PO antibiotics.
Headache chills, fatigue, arm soreness Narrative: A woke next morning with headache, chills, fatigue and arm sorness.
Vaccination adverse reaction/Patient has been 4-5 months without working because of the symptoms she has been experiencing; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction/Patient has been 4-5 months without working because of the symptoms she has been experiencing) 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 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 VACCINATION COMPLICATION (Vaccination adverse reaction/Patient has been 4-5 months without working because of the symptoms she has been experiencing). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction/Patient has been 4-5 months without working because of the symptoms she has been experiencing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by the reporter. No treatment medication provided by the reporter. Patient was performing a test with her neurologist that if that came positive it wouldn't had a cure.
Patient instructed by doctor to stop xeljanz 4 days prior to and 4 days after covid vaccine.states that during that time she hurt more and developed a baker's cyst behind one knee.; Booster; This is a spontaneous report from a Pfizer-sponsored program A contactable Other health care professional reporting for a female (patient). A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE1, SINGLE for covid-19 immunisation. The patient's concurrent conditions included ongoing rheumatoid arthritis and lupus. The patient's concomitant medications were not reported. The patient reported that she hurt all the time. xeljanz was helping both the rheumatoid arthritis and lupus." The patient had less pain. The patient was instructed by doctor to stop XELJANZ 4 days prior to and 4 days after covid vaccine. The patient stated that during that time she hurt more and developed a baker's cyst behind one knee. Patient reports having increased pain in knee, getting injections in knee, and will re-evaluate effectiveness with md in the next 'couple of months.' no further details given. MD aware. Xeljanz XR 11mg once daily. The patient was unaware if MD was aware. Patient reports stopping Xeljanz 7 days before and 7 days after receiving covid vaccination doses MD instructions, last time was around booster dose about 1 month ago. Patient states noticing increase in pain during the time of missed doses, then back to baseline when taking Xeljanz again. Patient agrees it's hard to cope with rheumatoid arthritis and sometimes feels discouraged, also states she 'feels things more' with cold weather. no change in frequency since taking Xeljanz. md aware. The clinical outcome for the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Follow-up (10Aug2021&14Dec2021): This is a follow-up spontaneous report from a Pfizer Sponsored Program. A contactable other HCP and a contactable consumer (patient) reported that. New information received, includes 2 dosage regimens and booster event was added. narrative was added.  Follow-up attempts are completed. No further information is expected.
RED, SWOLLEN, HOT TO TOUCH, ITCHY, PAIN IN ARM, AND HEADACHE.
3mm nodular granuloma on right upper lung - trouble breathing - rapid and irregular heartrate.
fever of 101-h/a all muscles sore-heavy congestion of lungs, extremely tired & weak-noc sweats-chills-loss of appetite; MD gave pt Biaxin which pt is still on
gen sz lasting 1min w/in 48hr of vax;1st sz, no fever, no meds;
Patient had no reactions immediately after vaccination. Patient presented to the emergency room approximately 4 hours after vaccination with left sided chest pain that was radiating down the left arm. The pain was increased with inspiration, movement of his neck, arms, or chest.  Patient woke up from a nap with extreme left-sided pain that prevented him from not putting his shoes on or taking his jacket off.
Tenderness of left arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness of left arm) and FATIGUE (Fatigue) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Tenderness of left arm) and FATIGUE (Fatigue). At the time of the report, TENDERNESS (Tenderness of left arm) and FATIGUE (Fatigue) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-066085 (Patient Link).
acute muscle pain in legs, sides, abs; swollen gland on left side of neck causing pervasive and intense sore throat started day 2 and  still ongoing,; pervasive, relentless and strong headache started on day two and ongoing; inability to sleep (due to headache and sore throat) fever and chills on day 4; vomiting; no pain relief with OTC ibuprofen or tylenol.  No relief from dr prescribed norco and meloxicam either.
Unable to lift left arm fully to take off shirt, etc; unable to lift left arm, when sleeping-wakes me up; general soreness, cannot raise left arm in circular motion over head; seen by Dr. 3 times
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Patient fainted shortly after recieving the first dose of Moderna.
large painful lump in the my right armpit of the arm the shot was given; itchy; scaly rash outbreak on my shins, calves elbows, genital and anal areas, arms, thighs, inside left ear, back of left shoulder, lower back; scaly rash outbreak on my shins, calves elbows, genital and anal areas, arms, thighs, inside left ear, back of left shoulder, lower back; large painful lump in the my right armpit of the arm the shot was given; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A 56-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 12Jan2021 as dose 2, single (at the age of 56-years-old) for covid-19 immunization. Patient was not pregnant at time of vaccination. Previously the patient received first dose of BNT162B2, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administered in Arm right on 17Dec2020 (at the age of 56-years-old) as dose 1, single for COVID-19 immunization. The patient medical history was reported as none. There were no concomitant medications. No Other vaccines received in four and two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. There were no allergies. On 14Jan2021, the patient experienced large painful lump in her right armpit of the arm the shot was given, itchy, scaly rash outbreak on her shins, calves elbows, genital and anal areas, arms, thighs, inside left ear, back of left shoulder, lower back. New outbreaks were still appearing. It was not going away. Her dermatologist diagnosed it as psoriasis which was an overactive immune system. Therapeutic measures were taken as a result of all events; treatment included steroid and hydrocortisone creams were prescribed. AE resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient described tingling around mouth. No swelling of mouth or lip color change, nor were there any changes in speech. Patient accepted a Benadryl and 10 minutes later, the tingling subsided. Patient is waiting the full advised 30 minutes after shot and is doing well. Patient's wife will drive him home.\r\n
p/vax pt became SOB & had sx of wheezing & taken to hosp via automobile;while in car wheezing worse & mom stated passed out;noted to be hypotensive;devel petechiae & a spasmotic cough & urticaria;pt hosp in ICU;anaphyl rxn to vax per MD. Case, reference number 1998029981-1, is a spontaneous report from a medical assistant referring to a female patient aged 5 years. The patient's post medical history included a recent upper respiratory tract infection for which she was treated with amoxicillin and Naldecon DX. At the time of the event, the patient had allergic rhinitis and asthma with her triggers being excerise, strong fumes and animals. She was taking inital two puffs three times a day, and Proventil Inhaler on an as needed basis. On an unspecified date, the patient received her first injection with ENGERIX-B. On 08-Dec-1998, the patient received her second injection of ENGERIX-B 0.5 ml for prophylaxis for school regulations. She also received her MMR injection at the same time. Approximtely 15 minutes later the patient became short of breath and had symptoms of wheezing and was taken to the hospital via an automobile. While in the automobile, her wheezing worsened and her mother stated that she passed out. She was noted to be hypotensive upon arrival and developed petechiae and a spasmotic cough and urticaria. The patient was hospitalized in the Intensive Care Unit from 08-Dec-1998 to 09-Dec-1998. A hospital discharge summary is not available. The eventual diagnosis made on 08-Dec-1998 was an anaphylactic reaction. The patient was treated for the event with intravenous steroids, epinephrine and intravenous fluids. The most recent information received on 09-Dec-1998 reports the outcome of the patient as recovered and discharged from the hospital. Allergy consultation was performed with the opinion of the chief allergist that the patient had an anaphylactic reaction to either the MMR test or ENGERIX-B vaccination. Allergy testing of both these vaccinations was not to be performed at this time. If further doses were to be given, testing would be done at a future time. Skin testing was done and was positive for cockroach, dust mites, grasses, weeds and molds. Testing for egg by both RAST and skin was negative.
This spontaneous case, initially received on 07-Nov-2016, was reported by a laboratory technician and concerns a female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA from Nov-2016 to Nov-2016 (either 02-Nov-2016 or 03-Nov-2016, the reporter was not sure of the dates). Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse reactions/events and outcomes: The next day, the patient experienced rash (outcome: unknown). It was unknown if any treatment was given for rash. Follow-up information received 11-Nov-2016: This case concerns a non-pregnant female patient. The patient had no concomitant medications at the time of vaccination. The next day after receiving the vaccine injection, the patient experienced an itchy patch of skin rash around the nose and forehead (outcome: reported as 'clear skin', stop date: couple of days). The overall outcome was reported as recovered / resolved for 'rash' and 'itchy patch of skin rash around nose and forehead'. Event abated after stopping suspect product: not applicable. Event reappeared after reintroduction: not applicable. Action taken with drug: reported as 'hydrocortisone'. Reporter comments: The reporter considered all events as non-serious.
Patient developed shortness of breath, tremors, chills, and tightness in the chest.  Treatment consisted of Benadryl 25mg IV and Solumedrol 20mg IV.
Administration in patients under 4 years; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 08-NOV-2023) for prophylaxis.   On 31-JUL-2023, the patient received Kinrix. On 31-JUL-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration in patients under 4 years). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-JUL-2023 They provided information about vaccine, event and patient. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter called to report that a patient received a dose of Kinrix while being below 4 years of age, which led to inappropriate age at vaccine administration.
Hepatitis A #1 given 3 weeks prior to 1st b-day. Per CDC, series to be restarted in 6 months.
Rash all over body. Started with the legs and then worked up to the back, chest and arms. Strong itching all over body. Rash would produce sores and scabs. Scabs seem to have a root that went into the body and could not be pulled off.  I have photos of the outbreak.
Information has been received from a physician concerning a 6 year old male, who was vaccinated with his second dose of varicella virus vaccine, live. Subsequently the patient experienced anaphylaxis, edema, itching, and mild angioedema. The physician administered BENADRYL, Epi and DECADRON. The physician monitor the patient for about one half hour. The patient was prescribed PERAZONE and released to home. At the time of this report the patient was considered to be recovering. There was no product quality complaint. Unspecified medical attention was sought. The events were considered to be life threatening and other important medical event. Additional information has been requested.
Swelling of lips and face that progressively got worse and spread to half of my nostril. Swelling started on the lower left lip with a heavy feeling on April 13th and spread to the whole upper lip on April 14th.  Pictures available with progression.
The patient was given 0.5 ml of moderna for the booster dose instead of 0.5 ml. the patients first series was jhnson and johnson. the patient has had no adverse reactions.
Information has been received from a medical assistant concerning a female who was vaccinated with Gardasil. Concomitant therapy included DTaP. Subsequently the patient "went to the hospital". Additional information has been requested.
Left SQ red area size of 1/2 dollar - vaccine give 2/26/09 - and 2/28/09 area turned red and hot to the touch and swollen. Cheeks had a red rash with warm to the touch on 3/3/09. All symptoms subsided 3/9/09.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 84-year-old male patient who received FLULAVAL QUADRIVALENT (batch number Y9H77, expiry date 30th April 2017). On 4th October 2016, the patient received FLULAVAL QUADRIVALENT. On an unknown date, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced pain in arm and skin warm. On an unknown date, the outcome of the pain in arm and skin were recovering/resolving. It was unknown if the reporter considered the pain in arm and skin warm to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The patient received FLULAVAL QUADRIVALENT in unknown arm. The patient experienced lingering soreness at the injection site, which had subsided slightly. The reporter explained that the local newspaper in his town had recently ran an article that explained that if a person experiences pain after receiving the flu shot it was because the shot was given incorrectly? This patient stated that, his arm was painful, hot, but it was subsided a bit since the date of the injection.