chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain all over her body,sore,muscle hurts,hurts to lift arm; high fever; arm is the size of a gulf ball; it is really hard and sore; weak,whole body is weak/ can barely walk,cant alone walk down stairs because it hurts to walk; not able to care for them now because she can't stand up long enough; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is the size of a gulf ball), INDURATION (it is really hard and sore), ASTHENIA (weak,whole body is weak/ can barely walk,cant alone walk down stairs because it hurts to walk), DYSSTASIA (not able to care for them now because she can't stand up long enough   ) and MYALGIA (pain all over her body,sore,muscle hurts,hurts to lift arm) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C214 and 00SC212) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced PERIPHERAL SWELLING (arm is the size of a gulf ball), INDURATION (it is really hard and sore), ASTHENIA (weak,whole body is weak/ can barely walk,cant alone walk down stairs because it hurts to walk) and PYREXIA (high fever). 22-Jun-2021, the patient experienced DYSSTASIA (not able to care for them now because she can't stand up long enough   ). On an unknown date, the patient experienced MYALGIA (pain all over her body,sore,muscle hurts,hurts to lift arm). At the time of the report, PERIPHERAL SWELLING (arm is the size of a gulf ball), INDURATION (it is really hard and sore), ASTHENIA (weak,whole body is weak/ can barely walk,cant alone walk down stairs because it hurts to walk), DYSSTASIA (not able to care for them now because she can't stand up long enough   ), MYALGIA (pain all over her body,sore,muscle hurts,hurts to lift arm) and PYREXIA (high fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2021, Pyrexia: 101 (High) high fever (an hour ago patient'stemperature was 101)..         No concomitant medication was provided. No treatment medication was given. Med info agent :  Warm transfer with Moderna Customer Care Number 00176281 Caller wants to know how long patient's  side effects  will last because patient has 4 kids to take care of and patient is not able to care for them now because patient can't stand up long enough, let alone walk down the stairs because it hurts to walk, muscle hurts. Patient has not taken anything yet because patient is scared. Patient to 27- years on 11-may-2021.Patient received both vaccines at the health department. Patient states she is not on any medications and not aware of any health conditions. Consent for safety to follow-up was received.   This case was linked to MOD-2021-231242 (Patient Link).
ARMS WERE IN PAIN; This spontaneous report received from a patient via a company representative concerned an 81 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination. It was unknown if the patient experienced any adverse event after vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date 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 an unspecified date, the patient experienced pain in arms (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arms were in pain was not reported. This report was non-serious.
Patient received ENGERIX-B immunization on 9-18-2017. Never returned for booster series #2 or #3. Contacted patient on 1/10/2018 about complete series and correct dosing. She refused and stated that she did not need the immunization any more, which was the reason she never returned for the booster.
p/immun temp elevated to 103, crying whining;  APAP given; short naps during noc;  unable to move arms & legs lifeless, feet tickled no response, stared @ ceiling would roll eyes from time to time when addressed otherwise unresponsive;
Adverse Reaction: Patient received her vaccine around 9am, around noon became dizzy and nauseated evaluated in ER and treated with Zofran and IV fluids, felt better and discharged home.
Redness, slight swelling and soreness in the arm where PNEUMOVAX was administered. Goes down along the inside of the upper arm but stops before the elbow, presentation is similar to those of other patients who got PNEUMOVAX and influenza vaccine at the same time.
Information has been received from a physician concerning a 15 month old female patient who was vaccinated with a dose of varicella virus vaccine live. In approximately February, 2003, "a couple of months ago", the patient developed "zoster in the arm post vaccination" and a "culture was taken". The patient was taken to the ER and was hospitalized. The outcome was unknown additional information has been requested.
Patient presented to local District Health Department to receive a Pfizer Bi-Valent booster vaccine. Patient was inadvertently administered a Pfizer Mono-Valent vaccine.
This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 69-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received when patient was 60 years of age) and SHINGRIX with an associated reaction of injection site pain (1st case refer case US2019GSK064202 ). On 6th February 2019, the patient received the 2nd dose of SHINGRIX. On 6th February 2019, less than a day after receiving SHINGRIX, the patient experienced injection site muscle pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. It was unknown if the reporter considered the injection site muscle pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX on left arm. The patient experienced deep significant pain in the muscle where the vaccine was administered, since receiving the 2nd dose of SHINGRIX. The patient had received 1st dose on 14th December 2018. The patient was evaluated by physical therapist and it was found that there was no bubble. The pharmacy manager who administered the vaccine informed the patient that he utilized correct technique for administration. The patient was not able to lift her arm. The pain was deep, achy throbbing pain like the pain which gets during shingles. The patient also had some pain with 1st injection. The patient has used all kinds of balms and arnica on the site. The patient also exercises and tries to move the arm as much as possible but it hurts to even lift it.
The 9th day after my 1st vaccine I had woke up in the morning and saw that my  left arm had developed a red spot 1 inch long and 1/2 inch wide, it was at the injection site and below it to the right. It didn't swell, itch or hurt and no numbness in my arm. No signs of any other side effects. I went back to the Health Dept. where I received the injection and had one of the nurses on site to check it on  the 4th day after it appeared. She told me if it started hurting or swelling to use a cold compress & if it itched to use an anti-itch creme, and if my arm went numb to go to the doctor. Today  is March 7, 2021 and it is still a light pink. It is day7.  I am scheduled to get my second injection on March 19, 2021.
mild bi-lateral numbness and tingling of hands and FINGERS during morning of 2/11 (3 or 4 on a scale of 10); does not interfere with ADL - right side: Becoming interment  during the afternoon and disappearing on the right by evening. - Left side: tingle and numbness lasted longer.  became intermittent during the evening of 2/11 Day of 2/12: experienced occasional tingling on right and more frequently on left. 2/13: tingling mostly gone However, will still occasionally notice a small bit of residual tingling and numbness 2+ weeks later.  low frequency, 1 or 2 on a scale of 10
Developed a red Itchy rash on the outside of the arm 10 days after the injection.  Rash is on the outside of the left arm from the elbow to the middle of the upper arm.  Started on 2/15/21.  Still present on 2/18/21.
Complaining of being severe fatigue/extremely tired; Muscle pain/Muscles aches in the back; Muscles like her legs hurt a little bit; She has pain in her lower back like muscle pain; back pain; This is a spontaneous report from a contactable consumer (parent). A 34-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FA7484), via an unspecified route of administration on 29Jul2021 (age at the vaccination 34-yer-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Lot Number: FW0198) on o6Jul2021 for COVID-19 Immunization. Patient took the vaccine at night, for last few days she has been complaining of being extremely tired/Complaining of being severe fatigue. This was her second shot of the Pfizer vaccine for COVID. So now she is complaining of being, starting from like Tuesday or Wednesday severe fatigue and her muscles aches in the back in her back like her legs and her muscles in her back, her back pain and like and her muscles like her legs hurt a little bit and she travels for business and she is away right now. She has pain in her lower back like muscle pain, back pain and like her legs hurt a little bit on an unspecified date in 2021. Therapeutic measures were taken Tylenol as a result for all events. The outcome of the event back pain was not recovered and unknown for another events.
axillary lymphadenopathy on the left side (same as shot site) approx 48 hrs after 1st dose
This spontaneous report was received from a the patient's mother and refers to a male patient of unknown age. The patient's current conditions and medical history were not provided. In approximately 2013 (reported as: "two years ago") the patient was vaccinated with the first dose of MMR II (dose, LOT and batch numbers were not provided, therapy type was not specified, route of administration was not specified by reporter), for prophylaxis (also reported as: immunization). Subsequently the patient broke out in hives, which his mother described as: big red bumps all over his vaccine arm. It was not specified if the patient received any treatment. On unspecified date, the patient had not recovered from the event. The patient's mother stated that he was due to his next dose of vaccine and she took him to have titers drawn. She stated that he showed positive titers for measles and rubella, but showed negative immunity for mumps on unspecified dates. Action taken with therapy with MMR II was not applicable. It was not reported if the events were related to MMR II. Additional information is not expected, as consumer declined to provide any additional information.
VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins); This non-serious spontaneous report with reference numbers 02197725 / 02197588 was received by partner on 05-JUL-2022 and forwarded on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.   FOLLOW-UP INFORMATION was received by a partner on 01-AUG-2022 and forwarded on 03-AUG-2022, from a HCP. The case is maintained as non-serious.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins)" and Vaxelis remained not applicable.  For reference purposes this case is linked to MCM-003725, MCM-003726, MCM-003729, MCM-003734, MCM-003735, MCM-003737, MCM-003738, MCM-003739, MCM-003740, MCM-003741, MCM-003724, MCM-003743, MCM-003744, MCM-003747, MCM-003749, MCM-003751, MCM-003752, MCM-003753, MCM-003757, MCM-003759, MCM-003760, MCM-003761, MCM-003763, MCM-003766, MCM-003767, MCM-003769, MCM-003770, and MCM-003772, due to same reporter.  No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on 5th or 6th April 2018. The patient experienced soreness in her arm. In 2018, the event was resolved. This is 1 of 2 cases, reported by the same reporter.
A report was received from a health care professional on 11/02/03 concerning a 55 year old female vaccinee who inadvertently received expired Fluvirin on 11/1/03. the vaccinee had experienced no adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/02/2004: A follow up report was received from a health care professional indicating that the vaccinee inadvertently received 1 ml of expired Fluvirin on 11/01/03. No adverse events were reported at the time of the follow up report. No follow up pending, all information received. See ref.: PJP200300969 and PJP200300970.
Patient had an apparent seizure (shaking, eyes rolled back, unresponsive). He did not have a fever when his temp was taken at the ER about an hour later (was 99.2 rectally). They did not think further testing was necessary sent us home to follow up with neurology.
I am breaking out in cold sweats and the right side of my forehead is numb as if I have been to the dentist and received a shot of Novocain.
Patient passed out less than 1 minute after receiving the shot - she said her arm begin to tingle and her vision went out.  She hit her head and elbow on the floor.  We called emergency services and provided first aid till they arrived.
Initial report received on 27 October 2008 from a health care professional. A 3 year-old male patient received on 22 October 2008 an intramuscular vaccination with Fluzone, into the left deltoid. A day after vaccination on 23 October 2008, the patient's arm was swollen. He was seen by a doctor on 27 October 2008, and was diagnosed with "significant local reaction, cellulitis of the left arm"' which was described as 4 inches long redness from shoulder to elbow. The patient was treated with KEFLEX and BENADRYL. The recovery status was unknown. Previous vaccinations were given on 2006-2007 and 2005. The patient had no allergies or medical conditions. The patient had no illness at vaccination time and he was not taking medications. Follow-up information received on 24 November 2008 from a health care professional. The patient had not received any other vaccination within four weeks of 22 October 2008. At the time of this report, the patient had recovered; however a recovery date was not provided.
March/April 2021 began having palpitations and shortness of breath. EKG at PCP office confirmed new onset atrial fibrillation. Stress ECHO and Holter  monitor confirmed a reduced ejection fraction and mild cardiomyopathy. Cardiac angiography confirmed suboptimal ejection fraction
COVID-19 Vaccine EUA: I got the vaccine at 11 am on 2/15/21. There were not immediate adverse effects.  By 3:00PM, my arm was becoming very sore. By 8:00 PM, my right arm was extremely sore and overall body aches ensued as I began to feel weak. By 9:00 PM, I felt the need to get into bed and had chills, a severe headache and pain over my whole body, accompanied by shooting burning sensations down both arms into my palms and fingers. I had not taken any medication for the discomfort up to this point.  As time went on, my pain became excruciating, I never felt this kind of pain in my entire body. I had pain in areas I never felt pain before like my arms, hands and toes.  I also had extreme pain in the back of my neck, both shoulders, both arms, my hips and knees. The pain was so intense and throbbing, my headache was severe at my temples and I had chills.  I did not take my temp, but I am sure I had a fever, although I was not sweating. I could not sleep at all and finally broke down at 1:30 am and took an Advil.  There was minimal help with the Advil and I slept on and off over the next 4 hours. Throughout today, the headache, chills and pain continued, but slightly less and I was able to take a 2 hour nap.  I think it important to note that I had more of a reaction to the first COVID shot that most others I talked with and felt an ongoing weakness after the first shot over the course of the month.  I understand that some of my symptoms are part of my body's reaction to building antibodies, but  with the intensity of my reaction, I have to wonder if there is more going on.
Information has been received from a female consumer who in July 2007, was vaccinated intramuscularly with the first dose of Gardasil.  Per the patient, she has been diagnosed with an ovarian cyst since receiving the Gardasil.  The patient had no physician information and requested prescribing information.  The patient sought unspecified medical attention.  No further information is available.
General body pain / full body ache; Muscle pain / full body musclepains; Fever (100 degree); Nausea; Vomiting / Multiple vomoting; Joint pain; Chills; Tiredness; Feeling unwell; Swollen lymph nodes / Swelling of lymph nodes; Tight chest / Slight tight chest and heartbeat; This is a spontaneous report received from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on the left arm, on 18Mar2021 at 16:00 hours for COVID-19 immunisation. Medical history included myasthenia gravis. Concomitant medications included cellcept (MANUFACTURER UNKNOWN), mestinon (MANUFACTURER UNKNOWN), and 10mg steroids (MANUFACTURER UNKNOWN); all for an unspecified indication and unknown drug start date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 18Mar2021 at 18:00 hours, patient experienced events general body pain (full body aches), muscle pain (full body muscle pains), fever (100 degree), nausea, vomiting (multiple), joint pain, chills, tiredness, feeling unwell, swollen lymph nodes (swelling of lymph nodes), tight chest (slight tight chest and heart beat). No therapeutic measures were taken. The clinical outcome for events general body pain, muscle pain, fever, nausea, vomiting, joint pain, chills, tiredness, feeling unwell, swollen lymph nodes, tight chest were resolving at the time of reporting. The patient had not tested positive for COVID-19 since having the vaccine.  No follow-up attempts are needed. No further information is expected.
Whole body muscle aches, muscle fatigue, skin tingling, severe migraine,  fever (103°F)
SM was 5 wks pregnant when she received AVA #2. She was asked at time of vaccination if she was pregnant, but no testing was done. She found out later the same day she was pregnant when she was treated for a fainting spell. Symptoms: Amenorrhea.
After a few hours, he was unable to walk and put weight on it. He was in pain. His whole thigh was swollen and  bright red/pink red. It was also hot to the touch and hurt to touch. This lasted 3-4 days. This is exactly what happened the year before. This injection was preservative free, while the one from 2015 was not.
Fever (102.6 F), Joint ache, Headache, Shallow breathing, Tiredness. 10/19-23/2010 Fluids, Rest, Motrin, Aspirin
Pt. reports rash behind left knee day after vaccine received, then progressively worsened into hives on torso and face within next few days after rash noticed.  Seen by doctor twice.  Was given shot of prednisone and epinephrine on day 4.  Taking prednisone pills and hydroxzine PRN for itch.
upper abdominal swelling after getting the first dose; mottling on abdomen after getting the first dose; abdomen was kind of lumpy after getting the first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3248), dose 1, via an intramuscular route, administered in Arm Left on 03Mar2021 (61-years- at the time of vaccination), as dose 1, single for covid-19 immunization. Medical history included Type 2 Diabetes from 2018 and ongoing. Concomitant medication included valsartan taken for high blood pressure from 2018 and ongoing; hydrochlorothiazide taken for Blood pressure high from 2017 and ongoing; aspirin [acetylsalicylic acid] taken for prophylaxis from 2015 and ongoing; vitamin d nos taken for Vitamin D low from 2016 and ongoing; calcium carbonate taken for absorption of Vitamin D from 2019 and ongoing. On 04Mar2021, the patient experienced, upper abdominal swelling after getting the first dose, mottling on abdomen after getting the first dose and abdomen was kind of lumpy after getting the first dose. Outcome of the event abdomen was kind of lumpy after getting the first dose was unknown, other events was recovered on 08Mar2021.  Additional Context: Caller received the second dose of the Covid-19 vaccine. She is reporting that she experienced side effects. She received the second dose on 23Mar2021. Caller is a Pfizer employee reporting on herself. Caller states she had a lot of the common ones other people have reported. She experienced foggy feeling, was flushed, jaw ache, headache, sore neck, eye pain, low grade fever, chills, muscle aches and fatigue. She started feeling foggy 15 minutes later after getting the vaccine. She received the first dose on 03Mar2021. Lot: EL3248. NDC is not provided. The card doesn't indicate the expiry but there is a date of Apr2021 on the card. Caller assumes this is the expiry. It was given intramuscular in the left arm. She adds that after the first dose she had upper abdominal swelling. This lasted for 4 days. She saw her doctor for this. Her abdomen was also mottled and kind of lumpy for lack of a better word.   No follow-up attempts are possible. No further information is expected.