chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sweating; Injection site was sore; Fatigue; Chills; Nausea; Vomiting; Fever; Muscle pain; A spontaneous report was received from a consumer concerning a 51-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site was sore, fatigue, chills, nausea, vomiting, sweating, fever and muscle pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: B12M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced injection site soreness, fatigue, chills, nausea, vomiting, sweating, fever and muscle pain.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events injection site was sore, fatigue, chills, nausea, vomiting, sweating, fever, muscle pain were unknown.
Fainting; This case was reported by a pharmacist via call center representative and described the occurrence of fainting in a female patient who received HBV (Engerix B) for prophylaxis.   The patient's past medical history included fainting (when receiving injection).   On an unknown date, the patient received the 1st dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the outcome of the fainting was unknown.   It was unknown if the reporter considered the fainting to be related to Engerix B.  Additional details were reported as follows: The age at vaccination was not reported. The patient fainted after receiving dose of Engerix B. The reporter could not provide patient demographics, lot number, or expiration date of dose administered.
Pfizer COVID-19 Vaccine   A couple hours after the vaccination the patient experienced pain in the vaccine arm, headache,  and feeling ache.   Day 1 post vaccination patient experienced sore arm, headache, low grade fever, feeling ache, and GI symptoms with diarrhea.   Day 2 post vaccination patient experienced sore arm, Migraine, and diarrhea.   Day 3 post vaccine patient woke up with chest pain that radiated into her left arm and some weakness.  Patient's blood sugar was >500 and was admitted to hospital for DKA.
Rec'd PPSV23 at 3pm 2/8/11. At dinner itchy. At bedtime sore, difficult to lift, redness from site to elbow, sore to touch. No fever. Took ADVIL 2/9/11 am. 2/9 eve symptoms no better - went to ER. Dx cellulitis. Rx'd w/IV antibx, given po antibx to take at home 2/14/11 - slowly improving.
Received vaccine-Right side of tougue started to swell, then spread to my right foot and hand . Also both arms broke out in a rash This also happened to me twice when I was getting allergy shots in  2019.  I took two benedryl  at 4:30 P.M. - 2 more at 5:30 P>M-and 2 at 7:30 P.M.  My tongue by 9: P.M.was reducing in size
Significant painful body aches all over body, significant fatigue, malaise, lack of appetite, headache, symptoms lasted for about 3 days
This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender who on unknown dates were vaccinated with improperly stored doses of VARIVAX (Merck) (dose, route, lot number and expiration date were not provided). No adverse effects reported. Additional information has been requested.
FEVER, BODYACHES, NAUSEA AND HEADACHE. LASTED 1 DAY
Simple febrile seizure X 5 minutes on 9/1/10. To ER.
soreness when she got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness when she got the vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness when she got the vaccine). At the time of the report, VACCINATION SITE PAIN (soreness when she got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Patient reported dizziness, blurry vision and stomach upset. Followed up with pt hours later and father said she recovered. Maybe anxiety related.
Left arm became very sore, so painful I could not sleep all night. The next day, 24 hours, post vax, I could not move my arm due to severe pain and stiffness. Went to MD and he gave me a muscle relaxer and hot and cold treatment.
Tdap vaccine Aug 3rd, pain at site started 6 hrs later & has gotten progressively worse (8 on 1-10 scale). After 6 days pain to base of neck on (L) no rash, no nodules. Ibuprofen - helps some, heat helped. Poor sleep.
Myopericarditis/ myocarditis; a reduction in my LVEF to approximately 35%-40%; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Apr2021 12:15 (Lot number: EW0176) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose 1; LOT# EP7533; Anatomical site of administration of vaccine: Left arm), administration date: 05Apr2021, for Covid-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant) with onset 30Apr2021, outcome "recovering", described as "Myopericarditis/ myocarditis"; EJECTION FRACTION DECREASED (hospitalization, medically significant) with onset 30Apr2021, outcome "recovering", described as "a reduction in my LVEF to approximately 35%-40%". The patient was hospitalized for myocarditis, ejection fraction decreased (hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: echocardiogram: 35%-40%, notes: reduction in my LVEF; 50%, notes: LVEF has returned to 50%; magnetic resonance imaging: 35%-40%, notes: reduction in my LVEF. Therapeutic measures were taken as a result of myocarditis, ejection fraction decreased. The patient stated that he had an adverse reaction to his second dose of the Pfizer covid vaccine, involving myo-pericarditis and a reduction in his LVEF to approximately 35%-40% (echocardiogram and MRI, respectively). After 8 months of recovery, the patient felt fine and his LVEF has returned to at least 50% (echocardiogram). The patient stated also that he would say that he was still recovering from the myocarditis. Although, he would say he was about 90% recovered. When he had a follow up appointment about three months prior to this report, his left ventricular ejection fraction have recovered from 35 to 50 percent which was still suboptimal. He will have a follow up appointment next month for when he would be able to say he would have recovered 100% but he would say that he had at least 90% recovered. The patient specified that the outcome of the events was "Certainly, improved". The patient had a two-day hospital stay where he was monitored and given cardiac drugs. So, he took both a beta-blocker and ACE-inhibitor on the direction of his cardiologist (not clarified further).  No follow-up attempts are possible. No further information is expected.
five minutes or so after the two shots, pt informed us her stomach felt weird and pressured and she felt some strong heart beats and she was seeing stars. pt was red all over so i gave her 1 capsule of  benadryl 25mg generic 00363-0190-51 lot #p123115 exp:12/2022 and a bottle of poland spring
Pfizer-BioNTech COVID-19 Vaccine EUA.  After receiving the vaccine on 8/6/21 at 12:22 pm I experienced a slightly sore arm and fatigue throughout the first several hours. As the evening progressed I began experiencing flu like symptoms which included but not limited to body aches, joint pain, stiffness. Between 9 pm and 12 midnight the pain progressively got worse. I could not sleep due to my skin hurt so bad and my joints and muscles were in so much pain I could not lay down without pain. This lasted from midnight until 5 am. Tylenol and Advil did not help. After finally falling asleep from exhaustion for a few hours, I awoke to extreme pain and stiffness which made it difficult to move or walk. The arm I had received the shot in had decrease range of motion and hurt to move at all with shooting pain around my elbow. The body pain, joint pain, and stiffness did not subside for the next 36 hours (8 am 8.7.21 through 8 pm 8.8.21). Fever and chills were throughout the entire 2 day time frame. 8/9/21 I was able to move and walk some but still had lower back pain with more pronounced pain on the left side of the back. Energy was non existent throughout. On 8/9/21 when I attempted to go on a slow walk around my block, my heart was pounding and my body felt like I had just climbed a mountain.
At injection site: Fever, Lump, Soreness, Significant rash covering more than 120 CM2.
Patient stated that he did feel some soreness after injection (on a Sunday), but didn't see any real symptoms until the following (Wednesday). He said he felt a fever and his arm get sore and red and hard to the touch. The inflammation was substantial in his opinion, but only on his left arm.  He said the left arm also got a little red, but not as bad as the left arm in his opinion. He went to the pharmacy and spoke to the pharmacist on duty (the following  Saturday), at which point he was referred to a doctor for further evaluation. He then came back on the following Sunday, and presented with an rx for an antibiotic. In a follow up conversation with the patient by the vaccinating pharmacist, he stated his arm is looking much better, and the redness and swelling have gone down. He stated he no longer felt a fever or pain, but stil felt sore.
pt recvd vax; devel giant hives, rash on face & anxiety; large local rxn; tx w/ DPH & methylprednesolone; hives resolved but still had blotchy rash after 2 hrs;
Myalgia , weakness of legs and of left arm (injection site) Narrative: Per employee report: "took 2nd dose of Moderna on January 20th and states took off on January 21st-22nd due to states had weakness and aching lower extremities. Also c/o left upper extremity weakness"
Right side breast has been feeling pressure/pain - close to armpit.  No lump but feels a bit swollen and hurts when there is pressure; Right side breast has been feeling pressure/pain - close to armpit.  No lump but feels a bit swollen and hurts when there is pressure; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on right arm on 11Mar2021 at 14:45 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were reported by the patient. Prior to vaccination, the patient was diagnosed with covid 19. Since the vaccination patient had not been tested for COVID-19 virus. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No relevant past drug history was reported by the patient. On 13Mar2021 patient experienced right side breast pain and breast swelling. The patient also reported that her right-side breast was feeling pressure or pain- close to armpit and no lumps, but felt a bit swollen and hurt when there was pressure. No therapeutic measures were taken for the adverse events. The clinical outcome of the events breast pain and breast swelling were not recovered at the time of this report.   No follow up attempts are needed. No further information is expected.
a few hours after felt fatigue and chills.  Around 8:30pm 4/20/2021 same day as 2nd dose, fever, body aches, headaches.  Fever persisted overnight and into the morning.  Fever went away around 10am 4/21/2021, but headache continued until morning of 4/22/2021.
Ongoing muscle soreness/stiffness with onset approx 2 weeks after Tdap injection. Sx reported as bilateral muscle soreness and stiffness over much of her lower body and extending into shoulders and neck, with difficulty raising arms over her head. Taking Ibuprofen for pain. F/up 5/23 pt. has had cortisone injection through PCP and pain relief - will follow with neurologist soon.
Fatigue, generalized aching, Mild- moderate right side sore throat and slight soreness back and swelling back of  roof of mouth and tenderness neck glands unilaterally. Difficult/painfulswallowing -takes considerable  effort to swallow.
left arm warmth; left arm redness; swelling; Redness turned blue; left arm itching; Weeping left eye; left arm pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (Weeping left eye), PAIN IN EXTREMITY (left arm pain), SKIN DISCOLOURATION (Redness turned blue), FEELING HOT (left arm warmth) and PRURITUS (left arm itching) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A211A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced LACRIMATION INCREASED (Weeping left eye), PAIN IN EXTREMITY (left arm pain) and CHILLS (Chills). On 03-Mar-2021, the patient experienced SKIN DISCOLOURATION (Redness turned blue), PRURITUS (left arm itching) and PERIPHERAL SWELLING (swelling). On 08-Mar-2021, the patient experienced FEELING HOT (left arm warmth) and ERYTHEMA (left arm redness). The patient was treated with FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 02-Mar-2021, CHILLS (Chills) had resolved. On 04-Mar-2021, LACRIMATION INCREASED (Weeping left eye) and PAIN IN EXTREMITY (left arm pain) had resolved. On 06-Mar-2021, PERIPHERAL SWELLING (swelling) had not resolved. At the time of the report, SKIN DISCOLOURATION (Redness turned blue) outcome was unknown, FEELING HOT (left arm warmth) and PRURITUS (left arm itching) had not resolved and ERYTHEMA (left arm redness) had resolved.            No concomitant drugs were reported.  Treatment drugs for second dose include pepcid, Zyrtec and antihistamines used for Erythema   This case was linked to MOD-2021-037797 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received: Per reporter, she had "redness all the way to elbow" that lasted for 3 weeks after receiving first vaccine. She also reported that she experienced the same "redness" after the second vaccine but that it "wrapped around my arm". She states that this reaction lasted for approximately 3 weeks and resolved after taking antihistamines.
I have lot of testicular pain; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number& Expiry date not reported) via intramuscular route of administration on unspecified date (at age of 41-year-old) as dose 1, single for COVID-19 Immunization. Patient medical history includes blood pressure. Patient concomitant medications include Olmesartan 125 (units unknown) used for blood pressure from unspecified date and ongoing, lisinopril used for blood pressure from unspecified date and unknown ongoing.The patient did not receive any other vaccines within four weeks prior to the vaccination. On unspecified date consumer stated, I received my first vaccination yesterday about 14:00 and last night I am just starting but like this morning, I have lot of testicular pain. Patient enquired about is problem is a normal side effect. The outcome of event was not recovered.   Information about lot/batch number cannot be obtained. Additional information has been requested.
Pt c/o tongue feeling swollen and difficulty breathing.  Observed pt to be having dyspnea and face flushed. BP: 130/80, Pulse: 75. EMS notified.  Administered Epi Autoinjector 0.3mg x 1 IM (L vastus lateralis) at 10:02.  EMS arrived at 10:05 and assessed pt. Recommended to go to hospital but pt refused. Wanted to see his MD.
Fever of 101, body aches, severe ongoing headache, chills, rash, itching
Approximately 2 weeks after receiving the second Pfizer vaccination, I started to have multiple hot flashes per day. I have never had even one hot flash in my entire life. I thought I was coming down with something, but they have continued each day several times a day.  I did have severe fatigue, vertigo, and brain fog for at least 1. 5 weeks afterward as well, but those have dissipated at this time.
Fever for 24 hours (99, 100.6), sore arm, chills, discomfort, muscle aches/pains, sensitivity to light/eye strain, headache --- treated with Tylenol.
Received GARDASIL/HPV vaccine at our office approximately 11:00 am. Reported feeling well during day with only local pain at injection site. Experienced dizziness approximately 11 pm that night. Had syncopal episode in bathroom. Got up with assist. Felt dizziness/visual changes. Had second syncopal episode. Up with assist. Slept all night. Reported feeling well today (3/27). No treatment provided.
while withdrawing the needle a "lot of the medication shot out of the patient's skin" so they feel the patient didn't get much of the injection, no AE; while withdrawing the needle a "lot of the medication shot out of the patient's skin" so they feel the patient didn't get much of the injection, no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and while withdrawing the needle a "lot of the medication shot out of the patient's skin" so they feel the patient didn't get much of the injection.  The patient's past vaccination(s) included Flu vaccine in JUN-2015. The patient's past medical history, medical treatment(s) and family history were not provided.  On 30-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ211AB, Jun 30, 2020 via intramuscular route in the right arm. It was reported that while withdrawing the needle a "lot of the medication shot out of the patient's skin" so they feel the patient didn't get much of the injection.  It was a case of actual medication error due to vaccine underdose. It was also a case of exposure via skin contact  At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error  List of documents held by the sender: none
This spontaneous report was received from a healthcare worker referring to a 67 year old female patient who on 02-DEC-2013 at 10:24 am, was vaccinated with the 1st dose of ZOSTAVAX (lot # J006827, expiration date 14-SEP-2014 in the left arm. Concomitant therapies included fluconazole, VAGIFEM, vitamin D, NEXIUM, azelastine hydrochloride, BENICAR and SPIRIVA. On 28-OCT-2013, the patient received a dose of FLUZONE HIGH DOSE in the left arm too. On 06-DEC-2013, the patient experienced localized reaction of a large knot developing at injection site, redness and swelling of arm that spread to elbow from middle of upper arm. The patient required emergency room/doctor visit. She was treated with BENADRYL for itching and clindamycin. The outcome of swelling of arm that spread to elbow from middle of upper arm, redness and localized reaction of a large knot developing at injection site was reported as recovered/resolved on an unknown date. Additional information is not expected.
PATIENT PASSED OUT  AFTER RECEIVING VACCINATION. EMS WAS CALLED AND TOOK PATIENT TO HOSPITAL VIA AMBULANCE.
Patient felt better by 25Aug2022; however on 28Aug2022, Covid symptoms returned (Rebound; had Covid symptoms beginning 18Aug2022. Had Rapid Antigen Test 19Aug2022. Tested Positive and PCP; had Covid symptoms beginning August 18, 2022. Had Rapid Antigen Test August 19, 2022. Tested Positive and PCP; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EN5318), in left arm, on 19Feb2021 as dose 2, single (Lot number: EN6200), in left arm, on 26Oct2021 as dose 3 (booster), single (Lot number: FU8020), in left arm and on 29Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing), notes: Other medical history: HBP.; "Enlarged Prostate" (unspecified if ongoing); "Gastritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ultram, reaction(s): "Known allergies: Ultram", notes: Known allergies: Ultram. The following information was reported: VACCINATION FAILURE (medically significant) with onset 19Aug2022, outcome "recovering", described as "had Covid symptoms beginning 18Aug2022. Had Rapid Antigen Test 19Aug2022. Tested Positive and PCP"; COVID-19 (medically significant) with onset 19Aug2022, outcome "recovering", described as "had Covid symptoms beginning August 18, 2022. Had Rapid Antigen Test August 19, 2022. Tested Positive and PCP"; DISEASE RECURRENCE (medically significant) with onset 28Aug2022, outcome "unknown", described as "Patient felt better by 25Aug2022; however on 28Aug2022, Covid symptoms returned (Rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Aug2022) Positive, notes: Had Rapid Antigen Test August 19, 2022. Tested Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.