chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LEFT ELBOW (ARM WHERE INJECTION WAS GIVEN) FELT SORE. IBUPROFEN TAKEN. SEEN DR. DECEMBER 11, 09. BECAUSE ELBOW BECAME INCREASING SORE, SWELLING, PAINFUL LIFTING OBJECTS AND OPENING DOORS. ICY HOT/HEAT PAD AND ICE USED.  CURRENT 12/16/09 USING ICE ONLY TO REDUCE SWELLING AND PAIN WITH SOME SUCESS.  STILL CAN'T LIFT OBJECTS WITHOUT DISCOMFORT OR SEVERE PAIN, DEPENDING ON HEAVINESS.
Headache Chills, redness and pain at injection site Narrative:  Patient reported headache, chills, redness and pain at injection site. Patient instructed to call her Primary Care Provider.
COVID-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications and treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Follow-up received on 24 Mar 2021 included no new information.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship is Unlikely. Based on the known causative agent of COVID-19 infection, the event is assessed as unlikely related to mRNA-1273. It is likely that the patient was already infected with the virus but asymptomatic before being administered with the mRNA-1273 vaccine.
Adverse event: 2 of 7 people received a more concentrated dose of the vaccine. One vial of two was diluted incorrectly with less Normal Saline than require. This error was not noticed until person mixing vaccine said they were out of vaccine and did not have enough to get 5 dosages of 0.3ml. Two people mixed one vial of vaccine together demonstrating to the other. It appears the person making the error did not notice they did not have 1.8ml of NS but must have had some air and did not realize it. The error was noticed when all the vaccines were given and one person had not completed pulling up the vaccine. So, 2 of 7 patients received the incorrect dose of vaccine and it could not be determined which two received the incorrect dose. Patient Reports: Sore arm for several days
20 minutes after vaccines, swelling of eyes, increased secretions, worker breathing. Seen in ED - improved with Epi very rapidly. "Anaphylactoid reaction"  9/2/08 Reviewed hospital medical records of 8/19/08. FINAL DX:acute allergic reaction & anaphylactoid reaction Records reveal patient experienced runny nose, congestion, red eyes & swollen, SOB, grunting, wheezing, rash, facial hives, irritability.  Tx w/steroids, epi & nebs.
had some pain down his neck; had trouble lifting his left arm yesterday; muscle weakness; This spontaneous case was reported by a pharmacist and describes the occurrence of NECK PAIN (had some pain down his neck), PAIN IN EXTREMITY (had trouble lifting his left arm yesterday) and MUSCULAR WEAKNESS (muscle weakness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 027L20A) for COVID-19 vaccination.     The patient's past medical history included Neck discomfort.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-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 NECK PAIN (had some pain down his neck), PAIN IN EXTREMITY (had trouble lifting his left arm yesterday) and MUSCULAR WEAKNESS (muscle weakness). At the time of the report, NECK PAIN (had some pain down his neck), PAIN IN EXTREMITY (had trouble lifting his left arm yesterday) and MUSCULAR WEAKNESS (muscle weakness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 24-Feb-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of NECK PAIN (had some pain down his neck), PAIN IN EXTREMITY (had trouble lifting his left arm yesterday) and MUSCULAR WEAKNESS (muscle weakness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 027L20A) for COVID-19 vaccination.     The patient's past medical history included Neck discomfort.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-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 NECK PAIN (had some pain down his neck), PAIN IN EXTREMITY (had trouble lifting his left arm yesterday) and MUSCULAR WEAKNESS (muscle weakness). At the time of the report, NECK PAIN (had some pain down his neck), PAIN IN EXTREMITY (had trouble lifting his left arm yesterday) and MUSCULAR WEAKNESS (muscle weakness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Pt recvd vax 6NOV91 & devel erythema & induration & tenderness adjacent to site of HIB; No fever; Seen by MD 11NOV91 dx local rxn vs infection;
Primary vaccinee.  Epicarditis 11 days after vaccination, beginning with substernal pleuritic chest pain, better when leaning forward. ST elevation precordial, 1, avL, PR depressed. No significant SOB. Treated with indomethacin 50 mg tid to relieve symptoms. Patient now feeling well, without symptoms since 7 Jul.  Nurse follow up on 05/27/04 states: "Per review of hospital records, diagnosis of pericarditis is confirmed (already coded). A second diagnosis of generalized vaccinia (GENERALIZED VACCINIA) is noted. (If you are not sure if this COSTART should be added, check) Pt had vesicular lesions on arm and opposite shoulder. Hospital staff did consult government agency and state health dept. It was determined pt did not require VIG treatments. Please also add to Box 7 fever (FEVER), chills (CHILLS), rigors (same as CHILLS) with myalgia (MYALGIA). Please add to Box 19 past medical history of Lyme disease (INFECT), Irritable Bowel Syndrome (can't find a suitable COSTART), and trench foot (can't find suitable COSTART)."
Syncope immediately after Menactra & Adacel. (+) dizziness & headache headache persistent 4 days after episode
I received my first dose of Pfizer COVID vaccine on 16AUG2021, LOT FD8448 without any issues. I received my second dose of Pfizer COVID vaccine on 06SEP2021, LOT FC3184 and did not have any issues initially. On or around 20SEP2021, I noticed a small dry patch on my right upper thigh close to my hip bone. I did not think anything of it and assumed it was just an eczema flare up and would go away on its own. The next week, I started noticing small red bumps on my chest and upper stomach. The bumps started to spread to my lower stomach and onto my arms and I decided to see a doctor. I went to a local Health Center on 13OCT2021. I was diagnosed with a rash and given a prescription for Medrol. I completed the 7 doses of the Medrol and the bumps only got worse and were spreading to my back and neck. I went to a Dermatology office on 19OCT2021 and was diagnosed with pityriasis rosea. The doctor explained to me that it is viral so it will need to run its course and typically takes about 6-10 weeks. He prescribed me 800 mg of Acyclovir, 5 times a day, for 7 days as he had seen it help with heal time with some patients. During this time the rash did spread to my arms, hands, pubic area, and upper legs. The rash was much more aggressive and very itchy which was to be expected based on my diagnosis. I have since completed the Acyclovir and my skin does appear to be healing. The bumps are no longer raised. They are red, dry patches now.
Case number PHEH2015US002937, is an initial spontaneous report received from a nurse on 09 Feb 2015. This report refers to a 17-year-old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with MENVEO (batch number M14030) intramuscularly at a dose of 0.5 ml on 24 Nov 2014. It was reported that before administration, the MENVEO was stored at a temperature greater than 45 degree Fahrenheit for a total of 35 hours. On 17 Nov 2014, it was stored at 55.1 degree Fahrenheit for unknown period of time. No adverse event was reported following this administration error.
Patient broke out in rash all over body after complaining of chest tightness the day before. Patient will be visiting doctor
Patient was asymptomatic at the time of hospitalization.  Testing only completed for pre-procedural screening.
Flush, tingling, palpitations. Observed for 2 hours. 150/90, pulse 72, SPO2 99% -> 140/90, 68, SPO2 99%.  Felt better, sent home.
Mom called-child had fever 104; Seen by MD dx ear infect, throat infect, asthma; On APAP & Antibiotic;
He says that since he got the flu shot (a month ago) he has not been able to lift his left arm up at the shoulder. He can bend the elbow, but no flex in left upper arm. Has tried some warm water (in shower) with little relief. Looking for some help. Has not seen MD.
LOW TEMPERATURE 97F; FATIGUE; COLD SWEATS; TEETH CHATTERING AND FREEZING; SORE ARM; This spontaneous report received from a consumer concerned a 51 year old male. The patient's height, and weight were not reported. The patient's past medical history included coronavirus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 in Left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 97 F. On 26-MAR-2021, the subject experienced sore arm. On 27-MAR-2021, the subject experienced cold sweats. On 27-MAR-2021, the subject experienced teeth chattering and freezing. On 27-MAR-2021, the subject experienced fatigue. On 28-MAR-2021, the subject experienced low temperature 97F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, cold sweats, teeth chattering and freezing, and fatigue, and had not recovered from low temperature 97F. This report was non-serious. This case, from the same reporter is linked to 20210356641.
Myocarditis recurred one month after 2nd vaccine shot. Going to see the doctor this week.
Chills, fever, chest pains, muscle aches, headache, exhaustion, slightly elevated white blood count.
On 9/25/2020, client vaccinated per standard protocol in clinic. No complaint after immunization and was released home with mother. In telephone call with mother on 10/9/2020, mother reported client complained of arm pain, redness and swelling of left arm the evening of 9/25/2020. The morning of 9/26/2020 the left arm swelling was hard and hot to the touch. Client complained of difficulty moving it. Mother took client to the ER for evaluation. ER physician stated there was fluid in the left muscle which suggested possible infection in the muscle. ER physician prescribed client PO antibiotics. Mother claimed limb returned to baseline after initiating antibiotic therapy.
Flu like symptoms; horrific cough; Feverish; I was so fatigue I could not get out of it; runny nose; I am blowing a lot, it is nothing but a clear mucous; armpit very bad soreness under the ''shot arm'' and it actually traced over to my right arm, which was not the ''shot arm''; soreness really bad on to my left armpit; got the Pfizer booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 60-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: 320308D, Expiration Date: 28Feb2022) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation; dulaglutide (TRULICITY), subcutaneous (Batch/Lot number: unknown) as 1.5 mg, weekly. Relevant medical history included: "Type II Diabetic" (unspecified if ongoing), notes: Verbatim: Type II Diabetic. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Mar2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): "I had no issue"; Bnt162b2 (Dose: 2), administration date: Mar2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): "I had no issue"; Flu shot (I got the Flu shot (Unspecified Flu shot) yeah in Oct2021.), administration date: Oct2021, when the patient was 60 years old, for Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "got the Pfizer booster"; AXILLARY PAIN (non-serious) with onset 18Nov2021, outcome "recovering", described as "armpit very bad soreness under the ''shot arm'' and it actually traced over to my right arm, which was not the ''shot arm''; soreness really bad on to my left armpit"; INFLUENZA LIKE ILLNESS (non-serious) with onset 19Nov2021, outcome "recovering", described as "Flu like symptoms"; COUGH (non-serious) with onset 19Nov2021, outcome "recovering", described as "horrific cough"; PYREXIA (non-serious) with onset 19Nov2021, outcome "recovering", described as "Feverish"; FATIGUE (non-serious) with onset 19Nov2021, outcome "recovering", described as "I was so fatigue I could not get out of it"; RHINORRHOEA (non-serious) with onset 19Nov2021, outcome "recovering", described as "runny nose; I am blowing a lot, it is nothing but a clear mucous". Therapeutic measures were taken as a result of axillary pain, influenza like illness, cough, pyrexia, fatigue, rhinorrhoea.  Additional information: Patient had received Robitussin cough syrup as treatment for the cough.  Follow-up attempts are completed. No further information is expected.
Within 8 hours (up to 25 hrs post vaccine) experienced somnolence, brain fog, GI upset, chest pressure/tightness, nausea and a migraine (hx of chronic migraines). Chest tightness continued for 3-4 days.  Vitals were WNL.
Arm still hurts and is slightly swollen from shoulder to elbow after a month. I also have had my period for two weeks now, which is not normal for me.
I am a breastfeeding month and haven?t had a cycle since July 2020. 24 hours after the vaccine I had back pain and cramping and bled for three days. Not a normal cycle, especially while bleeding. This is humiliating that I have to write this and tell people that this effected me. My milk supply dipped for 3 days I had to move my 4 month old to formula. My baby couldn?t eat because I got vaccinated.
The day I noted that I had sinus congestion and coughing. The next day I was still coughing and congested and I took a COVID-19 home test and it turned positive very quickly. Then I went to my doctor for a confirmatory test and it was positive. I was given a 5 day treatment of PAXLOVID. Within 24 hours my symptoms were slowly going away. By the time I finished my 5 day treatment I felt perfectly normal. I was able to continue working again when I was taking treatment but I was working remotely.
Information has been received from a physician concerning an 11 yr old female who on 04-MAY-2007 was vaccinated with a first dose of Gardasil. On the same day, the patient also received Vaqta and hepatitis A virus vaccine (unspecified) ("HEP A") in the other arm. On 04-MAY-2007 the patient developed a large ulcer on her arm. The ulcer was on the arm where the patient received Gardasil. The patient also developed swollen lymph nodes under her jaw. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested. Initial and follow-up informatoin has been received from a physician concerning an 11 year old female student with no medical history, allergies or illness at the time of vaccination who on 02-MAY-2007 was vaccinated in the left arm with a second dose of GARDASIL (lot # 654510/0962P). Concomitant vaccination included a second dose of VAQTA (MSD) (Lot # 652294/0249U) in the left arm (also reported as the other arm). Other concomitant vaccination included a first dose of DIP TOXIOD (lot # 41909M) in the left arm (also reorted as the other arm). On 02-MAY-2007, the patient developed a large ulcer on her arm. The ulcer was in the arm where the patient received GARDASIL vaccine. The patient also developed swollen lymph nodes undr her jaw. The patient was prescribed and treated with CEPHALEXIN 500 mg PO once a day for 10 days. On 04-MAY-2007, the patient had recovered from the cellulitis at the injection site. At the time of this report, the outcome of the ulcer on the arm and the swollen lymph nodes under her jaw was unknown. No product quality complaint was involved. Cellulitis at injection site was considered to be an other important medical event according to the reporting physician. Additional information is not expected.
I  have an autoimmune disease, psoriatic arthritic and osteoarthritis. This caused my flare up. My knees and ankles swelled to the size of grapefruits. I could not move legs for about 18 hours. From Friday to Sunday, I could not get out of bed. Monday night, I really started feeling better and was able to take care of my kids again on Tuesday. I went back to my normal shift on Wednesday.  I was under the care of my PCP and Rheumatologist.
Took NSAIDs (Ibuprofen/Acetaminophen) 4/6 hours following vaccine. Continued as needed. No symptoms evident until Saturday at noon, when fever registered at low grade of 99.1, persisted for 2 hrs. All readings taken afterwards normal. Slight runny nose started same time, persisted until afternoon 4/5/21. Moderate (affecting life activities) fatigue started same time, persisted until midmorning of 4/5/21.
very dizzy; clammy; blood pressure drop; "face turned white"; "ready to vomit; nausea; headache; need to lie on the floor; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (very dizzy), COLD SWEAT (clammy), BLOOD PRESSURE DECREASED (blood pressure drop), SKIN DISCOLOURATION ("face turned white") and VOMITING ("ready to vomit) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 serology test negative. Concurrent medical conditions included Food allergy, Drug allergy and Drug allergy.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (very dizzy), COLD SWEAT (clammy), BLOOD PRESSURE DECREASED (blood pressure drop), SKIN DISCOLOURATION ("face turned white"), VOMITING ("ready to vomit), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (need to lie on the floor). On 15-Apr-2021, DIZZINESS (very dizzy), COLD SWEAT (clammy), BLOOD PRESSURE DECREASED (blood pressure drop), SKIN DISCOLOURATION ("face turned white"), VOMITING ("ready to vomit), NAUSEA (nausea) and FATIGUE (need to lie on the floor) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      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.   No concomitant medication details was reported. Treatment information includes Ice packs (to face and neck), Feet propped, BP monitoring.
Mom stated previous DTaP vaccines resulted in fevers -> 105 and child was seen by the ER. No medical intervention needed. Mom did not report this event until 6/5/2013. States no fever when child only got PREVNAR 13 and ACTHIB on 4/3/2013.
Information has been received from registered nurse concerning a 6 year old male with no pertinent drug reactions who on 24-MAY-2006 was vaccinated SQ with a dose of PROQUAD (lot #652328/0956R, expiration date unknown) and on 11-JUN-2010 was vaccinated SQ with a dose of PROQUAD (lot#02302, expiration date unknown). There was no concomitant medication. The nurse mentioned that on on 02-MAY-2012 the patient was diagnosed with "chickenpox". The nurse mentioned that there were three cases of chickenpox at his school. The patient sought unspecified medical attention. No lab diagnostics studies were performed. No treatment was given for adverse event. The patient's chickenpox persisted. Lot number [102302] is an invalid lot number for PROQUAD (Merck). Follow-up information has been received from a registered nurse concerning a 6 year old male patient with eczema and no known drug allergies who on 24-MAY-2006 was vaccinated in left thigh with the first dose of PROQUAD (lot#652328/0956R, expiration date unknown) and on 11-JUN-2010 was vaccinated in left arm with the second dose of PROQUAD (lot number 666755/0230Z, expiration date unknown). It was reported that on 11-JUN-2010 the patient was vaccinated with the first dose of concomitant therapy KINRIX (lot#AC20B158AA) in the right arm. The registered nurse mentioned that on 02-MAY-2012 the patient was diagnosed with breakthrough chickenpox by doctor of medicine assessment. On 02-MAY-2012 the patient had scattered vesicular lesion on abdomen, neck, face. Patient itched. The patient had sought doctor visit. At the time of the report, the outcome was unknown. The health care professional contacted during telephone follow-up could not supply the following; patient name, date of birth, dates of vaccination/therapy, dose number, lot number, date of event, recovery status, hospital name, healthcare provider name and contact information. Additional followup information has been received from registered nurse, initial reporter, refers to the 6 year old (also reported as 7 year old) male patient with not known drug allergies and eczema who on 24-MAY-2006 was vaccinated in left thigh with the first dose of PROQUAD (lot #652328/0956R, expiration date unknown) and on 11-JUN-2010 was vaccinated in left arm with the second dose of PROQUAD (lot number 666655/0230Z, expiration date unknown). It was reported that on 11-JUN-2010 the patient was vaccinated with the first dose of concomitant therapy KINRIX (lot#AC20B158AA) in the right arm. The nurse reported that the patient's mother stated that the patient was recovered (on 07-MAY-2012) from adverse event and went back to school (it was also mentioned that the patient required emergency room visit). No further information is available.
Felt itchy across back which progressed to hive like rash! Pt took benadryl-Rash responded - took about 2-3 doses. - duration of rash was 6 days- responded to benadryl-pt stop benadryl