chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain on his neck; Chills; Headache; Pain on his shoulder at the same arm of injection site; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain on his neck), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain on his shoulder at the same arm of injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LOSARTAN and PANTOPRAZOLE for an unknown indication.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced NECK PAIN (Pain on his neck), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain on his shoulder at the same arm of injection site). At the time of the report, NECK PAIN (Pain on his neck), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain on his shoulder at the same arm of injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter.  No treatment information was provided.
This case was reported by a consumer via call center representative and described the occurrence of chills in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 15th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th January 2019, less than a day after receiving SHINGRIX, the patient experienced chills, fever, sleeplessness, cold and nauseous. On 16th January 2019, the patient experienced asthenia and pain. On an unknown date, the patient experienced sunburn-like rash and pain in arm. On an unknown date, the outcome of the chills, fever, sleeplessness, cold, nauseous, asthenia, pain, sunburn-like rash and pain in arm were recovered/resolved. It was unknown if the reporter considered the chills, fever, sleeplessness, cold, nauseous, asthenia, pain, sunburn-like rash and pain in arm to be related to SHINGRIX. Additional details were provided as follows: On 15th January 2019 at the night of the vaccine, the patient had horrible chills and fever and she could not sleep at all because she was so cold and also felt like she was going to vomit, though she did not. On 16th January 2019 the next day, she felt completely wiped out and achy. The patient's arm got really, really sore and a few days after the 1st dose, the patient's arm looked like it had a really bad sunburn. The patient gave consent to follow up. For tolerance of 2nd dose of SHINGRIX, refer linked case US2019GSK056680. Note: clarification has been raised regarding event cofirmation after each dose. For now, events are considered as per case narrative.
10/30/2009 Fatigue. 11/2/09 (L) side weakness, slurred speech, blurry vision, tingling numbness (L) face, (L) arm hand, (L) leg & foot, and (L) mouth drooping. 11/2/09 Seen in ER: CAT Scan & blood work stroke ruled out. Pain Rx given. Told to f/u with neurologist & primary care. 12/09 Saw neurologist. 12/09 Saw neurologist and primary care MD. Continues with these doctors. Dx'd with atypical migraine triggered by allergic reaction to H1N1. Guillain-Barre ruled out. Now on TOPAMAX x 4 days.
Terrible headache; Few chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Terrible headache) and CHILLS (Few chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced HEADACHE (Terrible headache) and CHILLS (Few chills). At the time of the report, HEADACHE (Terrible headache) and CHILLS (Few chills) outcome was unknown.            No Concomitant medications were provided No treatment medications were provided.
Child developed Henoch Schonlein Purpura. He is being treated symptomatically with ibuprofen as needed.
I26.99 ACUTE PULMONARY EMBOLISM 4/12/2023 DM 2 W HYPERGLYCEMIA I63.512 ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY 5/3/2023 DM 2 W HYPERGLYCEMIA I26.99 ACUTE PULMONARY EMBOLISM 4/12/2023 DM 2 W HYPERGLYCEMIA I63.512 ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY 5/3/2023 DM 2 W HYPERGLYCEMIA
8 days p/vax pt devel rash. MD dx pt w/otitis media, treated w/amoxicillin. addl info req
COVID 19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID 19) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy, Penicillin allergy, Asthma (borderline asthma) and GERD. Concomitant products included OMEPRAZOLE, FEXOFENADINE and COLECALCIFEROL (VITAMIN D3 1000) for an unknown indication.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 16-May-2022 for COVID-19 vaccination, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID 19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Relapse of Covid at 14 days after original symptoms and 12 days after original positive test..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the  Device Date is 24May2022  Relapse of COVID-19 at 14 days after original symptoms and 12 days after original positive test and starting Paxlovid. Tested positive after having had 4 negative tests over 6 days. Developed severe URI signs, malaise, exhaustion, etc. tested positive that evening. Still sick now at 2-3 days after relapse.  OTC medications to treat clinical symptoms  Company comment: This spontaneous case concerns a 37-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 11-May to 16-May. Patient tested positive again after having 4 negative tests over 6 days. She developed severe upper respiratory infection signs, malaise, and exhaustion. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 37-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 11-May to 16-May. Patient tested positive again after having 4 negative tests over 6 days. She developed severe upper respiratory infection signs, malaise, and exhaustion. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient is a 17 yo male with no hx asthma who presented to medical center ED as transfer from facility with pleuritic chest pain and fever x1 day. Recent history of second covid vaccine on Friday (5/14). Patient reported associated fatigue, headache and muscle aches late Friday into Saturday (5/15). Sunday patient reported a fever (101 F) and chest pain with deep inspiration. No associated SOB, increased work of breathing or abdominal pain. Was seen initially at urgent care and then referred to facility for "an abnormal EKG."    Pertinent findings at facility: troponin 0.31, EKG wnl, rapid covid negative, ESR 9, CK 134, D-dimer <150, WBC 12.4 w/ left shift. Transferred to medical center for further workup.   While in medical center ED, troponin 1.59. EKG rSR' leads V1-V3 w/o ST segment elevation. MISC tier 1 studies drawn. Cardiology consulted - admit for observation, myocarditis infectious workup, echocardiogram and  During his time in the ED, patient continued to have pain with deep inspiration as well as when he had to yawn. He other wise felt fine. Vital signs normal throughout out time in ED.  His troponin continued to rise, with max of 14, so decision was made to start IVIG and steroids. His troponin fell over the next day. He remained stable from a clinical standpoint, and symptoms had resolved by the morning of 5/18. At time of filing, patient is still hospitalized at medical center, with further labs and imaging pending.
rash; it seems to be fading; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) and SKIN DISCOLOURATION (it seems to be fading) 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 RASH (rash) and SKIN DISCOLOURATION (it seems to be fading). At the time of the report, RASH (rash) and SKIN DISCOLOURATION (it seems to be fading) outcome was unknown.            Treatment drug include Lotion. No concomitant drugs were provided
Received Expired dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) in an 18-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine). On 27-May-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) had resolved.        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 product use was reported No treatment information was provided; Sender's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot # 004C21A) with no associated AEs reported in an 18 year old Female. Further information has been requested.
within 5 minutes of shot, got nauseous and lightheaded?eventually vomited.  Felt better after that.
Severe muscle aches in both legs Left arm hurt to move Numbness in left arm to fingertips and both feet once muscle pain went away in extremities.
One hour after vaccination patient experienced Left facial and tongue numbness that impacted her ability to speak clearly (similar to experience with numbing for a dental procedure).  She was given 25mg diphenhydramine orally and taken to the ER.  Dexamethasone 10mg given intramuscularly in ER.
Vasovagal response: Vomiting, Diarrhea, nausea, sweating, narrowing vision Lasted strongly 20 minutes, mildly 10 hours.  Also happened one day after 2nd dose.
Information was received from a registered medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date between 08-AUG-2016 and 11-AUG-2016, the patient received unspecified dose of improperly stored VARIVAX injection (lot# L049533, expired date 08-DEC-2017) (dose, frequency and route unknown). The vaccine was previously exposed under -3.48 Celsius degree for 1 minute on 08-AUG-2016, and currently exposed under -14.16 Celsius degree for 2 hours 45 minutes. Digital data logger was involved. No adverse effect was reported. Additional information has been requested.
Approx 45 minutes after receiving vaccines; c/o (+) cough; difficulty breathing; noted: redness to facial area; (+) hives on both inner upper arms. Patient in exam room; at 1:48 Epi 0.3mg given; BENADRYL 50mg/1mL given at 1:59; Epi 0.3 mg x 2 given in clinic emergency room, followed by SOLUMEDROL 125 mg IM - albuterol treatment via nebulizer, O2 at 2L. ZANTAC to take at home.
Information has been received from a physician concerning a female patient with no pertinent medical history and no known drug allergies/reactions who was vaccinated with the first 0.5 ml IM dose of GARDASIL. Subsequently the patient experienced vasovagal reaction in the waiting room. The patient recovered and was sent home. On 24-MAR-2009 the patient was vaccinated with the second 0.5 ml IM dose of GARDASIL. There was no concomitant medication. On 24-MAR-2009 after receiving the vaccine the patient experienced not responding to their questions and acting strange. The patient was not conversing for about 2 minutes, but she did not pass out, The physician clarified that the patient did not have a seizure. The patient was observed at the office. No lab diagnostic studies were performed. On 24-MAR-2009 the patient recovered and was sent home. The patient would not get the third dose of GARDASIL. Additional information has been requested.
Swelling, redness, protrusion and itch at site of injection and down side of arm.
Altered mental status, moderate dehydration, nausea and vomiting; Addison?s crisis
A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on an unknown date. The patient experienced patient received expired FLUMIST quadrivalent. The outcome of the event of patient received expired FLUMIST is unknown. The report was considered to be non-serious.
pt recv vax 21AUG95 & JAN97 pt devel chickenpox w/more than 50 blistered & craters lesions;devel no complications, & recovered in JAN97;
Rash/hives started around site of vaccine injection. The hives continued to spread to the rest of the body. Rash resolved with hydroxyzine.
Pt given HIB vaccine instead of Hep B. Given a HIB and given in Pentacel. (HIB administed twice at same visit)
Information has been received from a 72 year old female, who on an unspecified date "couple of months ago", was vaccinated with a single dose of ZOSTAVAX (Merck).  After getting ZOSTAVAX (Merck) the patient experienced  shingles with complications.  She did not have blisters but experienced the nerve pain.  She visited multiple doctors before she was diagnosed.  In follow up received on 02-JUL-2009, the patient stated that she was hospitalized four times due to the severe chest pain that she was experiencing.  At no time, did she get a rash and felt that it made it harder for the physicians to diagnose her with shingles.  She had taken VALTREX and steroids but was still experiencing pain.  She stated it felt like "a hot blow torch on my stomach".  X-rays were performed (results not reported).  The patient was upset that she was not properly informed about the effectiveness of ZOSTAVAX (Merck) for her age group.  No further information is available.
she had "moderna arm". after her second Moderna Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (she had "moderna arm". after her second Moderna Covid-19) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE REACTION (she had "moderna arm". after her second Moderna Covid-19). At the time of the report, VACCINATION SITE REACTION (she had "moderna arm". after her second Moderna Covid-19) outcome was unknown.            No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2022-443243 (Patient Link).
Chills, sweats, muscle aches, skin sensitivity, fatigue, nausea, headache for 16 hours approximately. Ongoing headache and fatigue for a total of approximately 36hrs.   Rash on left forearm and lower back onset 2 days post injection and recurrent still (9 days post injection).
Right ear, skin on right cheek and jawline is numb...like a bells pslsey. No eye or mouth involvement this time. No treatment administered at this time...
N17.9 - Acute kidney failure, unspecified J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia
Left Arm went numb several hours  after injection. Numbness dissipated after a few days, however left hand joints were stiff for almost five weeks.  Cramping and menstrual cycle began hours after injection (after months of no cycle).  Sever cramping (very unusual) and menstruation continued with severe cramps and heavy cycle nonstop for months with fever and headache.
Tingling sensation; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021. The most recent information was received on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced PARAESTHESIA (Tingling sensation). At the time of the report, PARAESTHESIA (Tingling sensation) had resolved. Not Provided          No Concomitant medications were reported  No Treatment medications were reported   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Significant FU- AE outcome updated
Patient returned to pharmacy and revealed a large rash on the upper arm in which the vaccine was administered. She stated that it got worse over the weekend but has since improved. The pharmacist recommended ibuprofen and Benadryl (diphenhydramine).
24hours later redness, swelling at injection site for 24 hours. 9 days later it swelled larger with redness at injection site but less sore than the 1st time.
A report was received from a health care professional on 10/23/2003 concerning approximately 10 pediatric vaccinees less than 4 years old, of unknown sex, who were inadvertently administered Flurvirin vaccine between 10/08/03 and approximately 10/22/03. No adverse reactions were recorded at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/9/2003: A follow up report was received from a health care professional indicating that a 2 year old male vaccinee inadvertently received Fluvirin on 10/15/2003. On 10/15/2003 a 2 year old vaccinee inadvertently received 0.25ml Fluvirin. At the time of reporting the vaccinee did not exhibit any adverse symptoms. Cross reference with: PJP-2003-01263, PJP-2003-01264, PJP-2003-1265, PJP-2003-01266, PJP-2003-01267, PJP-2003-01268, PJP-2003-01269. No follow up pending. A information received.
Patient had a Moderna vaccine on 2/17/21. Provider unaware and pt had Pfizer on 7/22/21. Pt had no adverse reactions. Writer contacted patient 48 and 72 hours after event and patient stated that she only had a sore arm, no other reactions related to the vaccine.
pt devel t104 1 day p/vax 1hr of crying & temp;took pt to hosp ER;blood work was neg; & temp brought down to 99-100;MD stated pt had rxn to shot;problem resolved by next day;
Pt's wife called to report pt. developed cough w/shortness of breath about 4 hrs. after injection. Pt went to ER and had CXR and CT scan done which showed blood clot in RLL and mass in RUL as well as spot on liver.
Lips numb, restricted breathing, chills, sweating, temperature 102.1, severe body aches, Covid Arm
Initial reaction was pain in arm and along left side of body and face (same side as injection site).  This was followed by several days of symptoms of Bell's Palsy, which went away after 1 week, but now has resurfaced as of May 9th, 2021.
Currently 33 weeks pregnant, estimated due date 1/2/22. Experiences light headedness, dizziness, nausea within 20-30 minutes after receiving the vaccine.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with LIQUID PEDVAXHIB for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to LIQUID PEDVAXHIB.
Headache began evening of 2-3-05 and other symptoms started 2-4-05,  These included: very bad joint pain, fever w/ chills and night sweats, swollen glands in neck, sore eyes, runny nose.  Took Motrin for the pain & fever.  I was too ill to go to the doctor's office, but did call him. I began feeling better on 2/7/05.
Information has bee received from a registered nurse and a physician concerning a 15 year old female with no yeast allergy who in February 2003 was vaccinated with a second dose of hepatitis B virus vaccine. The reporter indicated that about a week to two weeks later the patient complained of muscle weakness, arthralgia, and pain in and around her neck area. It was noted that these events have been weaning and waning since that time. The patient visited an emergency room and a rheumatologist and the tests were negative. The reporter stated that the rheumatologist thought that the patient was experiencing fibromyalgia. The patient also saw an allergist ad it was determined that she was not allergic to yeast. The patient has not been going to school recently because of the pain. It was indicated that a prescription drug was required to treat the event. The event has not abated and the patient has not recovered. The reporter noted that it was unknown if the patient was pregnant. Muscle weakness, arthralgia and pain in and around the neck area were considered disabling. Additional information has been requested.
I got a rash on my left arm a week after the injection.  It was about 5 inches in length and 3 inches across and covered most of the top portion of my arm.
Within an hour of taking the injections I was in severe pain. My (R) shoulder, arm, and hand, as well as my (R) ribs and back, neck and face were swollen and very red and inflamed. Friday, I called my doctor's office, he was not in. I finally had to go to E.R. Saturday. Was given KEFLEX 500 mg. As of today 10-12-12 I still have a sore throat and nausea. I can explain a lot better when you call me.
Right upper arm hard, red, warm and swollen; radiating to elbow. Local reaction-symptomatic. Measures, to call office back if develops systemic symptoms.