chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling of injected right upper arm w/redness. Progressively got worse & became warm & sensitive to touch. Became painful to lift arm & weak; ultimately got so bad I couldn't use arm. Pain spread to the entire length of arm, yet the shoulder joint itself was not. Put ice packs on it which helped some. Had been told by pharmacist who administered the shot that I needed to stay around for at least 30 minutes to an hour to see if I would have a severe allergic reaction, as I'd had one to the Tetanus shot many years before & was told I could never have the Tetanus shot again, whether live or killed virus. He said all they would do is call 911 & notify my doctor if I did react. So, the arm got worse & worse over the next several weeks. I probably would have gone to dr sooner, except my husband fell & broke several bones and we had all that to deal with. I did finally go to my primary care dr & got blood work to rule out infection, as all the pain seemed to be in the "meat" of my arm, not joints. That was all sent with me to the orthopedist 12/22/2015 for xrays. Nothing obvious was found to explain it. Was told it should improve over the next couple months. Still having problems today. None better.
Narrative:  1st dose moderna 2-11-21 2nd dose moderna 3-12-21 booster dose moderna 12-6-21 covid positive 1-9-22 resulting in hospital stay
Not adverse event, but medication error. Pt received 4 Covid vaccines in all. Pt had the 2-dose Moderna series at A Clinic, then presented to the A Vax clinic for the complete Pfizer Series. He reported that he thought a booster was indicated, and thought it was going to be Moderna.
About 3 hours after vaccine (4:30pm) my pulse elevated past 100 even though I was doing nothing but laying around. I started getting stabbing chest pain that took my breath. I went to the hospital and my bp was 135/95 which is high for me. My venous blood gas deficit was high. My ekg showed an ST abnormality. They sent me home due to being immune compromised and home was better. I made it until Saturday morning then almost passed out and went back to the ER. Had another abnormal EKG and my bp was low this time at 85/60. My pulse is staying up with palpitations.
The caller said her eye doctor had myocarditis after the modern vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (The caller said her eye doctor had myocarditis after the modern vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (The caller said her eye doctor had myocarditis after the modern vaccine.) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (The caller said her eye doctor had myocarditis after the modern vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Myocarditis, which occurred on an unknown date after a dose of mRNA-1273 vaccine. Consumer reported her eye doctor had myocarditis after Moderna vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-594678, MOD-2022-594696 (Patient Link).; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Myocarditis, which occurred on an unknown date after a dose of mRNA-1273 vaccine. Consumer reported her eye doctor had myocarditis after Moderna vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report.
muscle weakness; fatigue; nausea; headaches; fever; This was a 17 day interval between doses; This was a 17 day interval between doses; This is a spontaneous report from a contactable consumer (patient). This 28-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported.  The patient previously received first dose of BNT162B2 on 21Dec2020 at single dose for COVID-19 immunisation. She received her first dose of Covid vaccine on 21Dec2020 and second dose of Covid vaccine on 06Jan2021. This was a 17 day interval between doses. After receiving second dose of COVID vaccine, she has been experiencing muscle weakness all over, fatigue, nausea, headaches, and fever. The outcome was unknown.    Information on the lot/batch number has been requested.
Child was inadvertently given a 0.5 ml dose of FluZone instead of the age appropriate 0.25 ml dose for age.
Child had fever 100-101 (04/01/04) and had grand mal seizures. Child has had 8 seizures since 4/1/04 always accompanied by fever.
No additional AE; improperly stored VARIVAX was inadvertently administered; This spontaneous report was received from a nurse and referred to a patient with unknown age and gender. The patient's concurrent conditions, concomitant medication, pertinent medical history and drug reactions/ allergies were not provided.  On 07-MAR-2023, varicella virus vaccine live (oka/merck) (VARIVAX) was improperly stored (product storage error). Temperature was 5.8 Fahrenheit degree (F). Time frame was 2 minutes. Previous temperature excursion did not occur. On an unknown date in March 2023, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # W016746 has been verified to be a valid lot number, expiration date was reported as 23-MAY-2024, dose, route and anatomical location were not provided) for prophylaxis. No additional adverse event (AE) details (No adverse event).  This was one of the two report due to the same reporter.; Sender's Comments:  US-009507513-2303USA005125:
Fourteen hours after receiving vaccine, I awoke from sleep with chills and a fever of 104.4.
Patient is homeschooled and has a history of good memorization skills.  Problems with memorization started during her mock trial study in April 2020.  These issues escalated until mid-May when her personality started changing drastically for the worse.  We took her to two local emergency rooms in mid and late May.  She then had about two weeks of "coming back to normal" before her personality went bad again.  She was admitted to Hospital on June 14 and stayed there for 25 days.  While there, she underwent multiple tests every day and was treated for autoimmune encephalitis even though blood and spinal fluid antibodies didn't match those known at the Clinic.  After steroid and IVIG treatments, patient had a stroke and was admitted to the intensive care ward.  The time in intensive care was about 10 of the 25 days.  We have continued to give patient LOVENOX shots 2X/Day since mid-July and have been weaning her off of Valium which she now takes once/day (Diazepam 10-mg).  She still takes a blood pressure pill once/day (Amlodipine Besylate - 10mg).  The LOVENOX is for clotting so her brain clot doesn't grow and so her brain bleed behind the clot doesn't get larger.
Patient reported redness and swelling of left arm where the injection of the Moderna vaccine occurred. She came to the pharmacy and the locale looked red. She said it was swelling much worse before. She said it is itchy. Advised patient to go see a doctor. She can take an antihistamine for the symptoms.
Swollen lymph node in armpit of injected arm; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8020) via an unspecified route of administration in the left arm on 13Oct2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. On an unknown date in Oct2021, the patient had swollen lymph node in armpit of injected arm. The event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph node in armpit of injected arm was resolving at the time of the report.  No follow-up attempts are possible. No further information is expected.
herpes zoster; Information has been received regarding a case in litigation from a lawyer, and  female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2014, at age 73, the patient was administered the zoster vaccine live (ZOSTAVAX) by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a nurse practitioner for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Local swelling, redness up to the shoulder, warm to touch, 3 inch rash in a curve around the arm, temperature of 100.6, pain that radiates.
A lot of bleeding at injection site when given the shot. The day of began 102 degree fever. Severe chills. Body aches. Sore throat. Fatigue. Swollen arm. Pain in arm.  Nausea. Lasted about 5 days.   3 weeks later still have tingling and pain in right arm.
had tonic clonic sz 10 minutes p/recvd MMR; hx of sz in family;
Administered flu shot IM ((L) deltoid) 9/23/15, still experiencing pain in (L) shoulder radiating down/aching down towards () hand. Hurts to lift arm and event in use visited primary care MD and suggested may have hit a nerve when administered.
1st dose administered October 6, 2019, LATE 2ND DOSE; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 6th October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that, the patient received 2nd dose late than the recommended time interval, which led to lengthening of vaccination schedule. No reactions reported. The reporter consented to follow up.
The vaccine was expired and the patient has already had two MMR vaccines in the past. No adverse reaction to date.
Information has been received from a medical assistant to multiple unspecified patients. The patient's concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (dose was unknown, lot # L013204, expiration date on 28-JAN-2017) orally. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Breakthrough COVID-19 case with symptom onset 9/3/2021:Fever, Cough. Patient was admitted because he could not walk. He was also diagnosed with pneumonia and required oxygen. He admits to still having trouble with his feet. He is back at the facility where he and wife lives. He states he spent 21 days between the hospital and a Rehab facility.
Pain in arm at injection site but to include full upper arm. Pain radiating up to shoulder  and neck and to base of head on right side only. Shot was given in right arm.
Immediately following injection pt stated she felt pain at the site, tingling, and lightheadedness. Waited a few minutes and left. Stated pain x48 hours then OK.
Severe headache during the day after vaccine given. Then around midnight , woke up with extreme chills, body aches, weakness, nausea.. Got up to go to bathroom to throw up, at this time my husband was with me and when I got to bathroom, I passed out. He was holding me, stated my eyes were open and pupils very dilated.  He had to wake me out if it (maybe just under 1 min) When I woke up, I vomited a little. Then until about 4 am I continued to have extreme chills, body aches and threw up a few more times. Still currently (9:30 am) feeling very weak and have a bad headache .
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. No information about the patient's pertinent medical history, drug reaction or allergies was provided. On an unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (lot# L000610, expiration date 31-JAN-2017) (dose and route of administration were not provided). Concomitant medications were not reported. No adverse effects reported. This is one of several reports from the same source. Follow up information has been received on 19-NOV-2015 from a healthcare worker concerning a 25 year old patient. The patient was administered an improperly stored dose of GARDASIL 9 on 23-OCT-2015. Additional information has been requested. Patient's demographics, product information, onset date and narrative have been updated.
Patient returned for follow-up visit on 5/24/19 complaining of right shoulder pain since her immunization on 5/3/19.  Has pain over the proximal bicep that occurs constantly that feels sore when keeping it still, then has a burning sensation when she moves it especially across to left side of body and moving arm behind her back to put on bra.  Movement and pain has improved on 5/24 since 5/3, and ranges from 6-8/10.  No history of reaction to vaccines.  Patient is right handed.  Admits to having warmth initially after the immunization, but no redness or swelling.  No past injury to right arm/shoulder.  Admits to feeling a bump initially over the bicep that has since resolved.  Is on Plavix for history of Stroke.  Has some bruising on her right arm, which is normal for her as she bruises easily.
Pain in upper thighs; Groin Pain; One week later upper arms stiffness/ pain in the joints and upper arms; One week later upper arms stiffness/ pain in the joints and upper arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in upper thighs), GROIN PAIN (Groin Pain), MUSCULOSKELETAL STIFFNESS (One week later upper arms stiffness/ pain in the joints and upper arms) and ARTHRALGIA (One week later upper arms stiffness/ pain in the joints and upper arms) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 045B21A) for COVID-19 vaccination.     No medical history reported by the reporter.    On 31-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced PAIN IN EXTREMITY (Pain in upper thighs), GROIN PAIN (Groin Pain), MUSCULOSKELETAL STIFFNESS (One week later upper arms stiffness/ pain in the joints and upper arms) and ARTHRALGIA (One week later upper arms stiffness/ pain in the joints and upper arms). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in upper thighs), GROIN PAIN (Groin Pain), MUSCULOSKELETAL STIFFNESS (One week later upper arms stiffness/ pain in the joints and upper arms) and ARTHRALGIA (One week later upper arms stiffness/ pain in the joints and upper arms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       weight of the patient reported as 170 Concomitant medication was reported as pROTONICS at a dose of 25 milligram Patient reported that she work full time as an executive and do the treadmill 3to 5 times a week Patient reported that she did not have Arthritis   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up information received and contains significant information-Patient contact details and patient demographics details added. Concomitant medicine details provided. Treatment information added. New Events added- Groin pain, Mucoskeletal stiffness and Arthralgia. Event outcome updated for the event Pain in extremity from Unknown to Not Recovered/ Resolved. Dose 2  details added.
Right arm pain from shoulder to elbow limiting ADLs due to pain. Being treated with heat, ice, stretches. Ongoing for 2 months since injection, waxing/waning but not improving overall.
I noticed a runny nose. It was pouring for like 2 days. My symptoms progressed to coughing, headache, & fatigue. I was taking a nose spray called Afrin for 3 days. I also took Nyquil cold and flu medication. I reached out to the doctor once I tested positive. I was not prescribed any medication as my symptoms were not severe. I started feeling better by February 03, 2023.
Patient complained of red hands and blotchy neck. Says she feels okay, but taken to ED for evaluation
p/ pt recv vax approx 2 yrs later rpt low grade fever, pt presented to MD chickenpox, had maculopapular & vesicular lesions all over body.
On the date of the vaccination, my arm itched at the site of the injection.  However, one week later, the itch turned to a red spot and the red spot got larger and larger and redder over the next couple of days.  I called my doctor and he told me to take a Benadryl.  I did that for one night and it got a lot better.  But, it is coming back.  I will try more Benadryl.
This spontaneous prospective pregnancy report as received from a registered nurse refers to a 32 year old female patient. The patient had no pertinent medical history and no drug reactions/allergies. On 28-DEC-2015, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX lot # L026405, expiry date 15-JUL-2017 (route and site of administration were not reported). No concomitant medications were reported. The patient became aware of the pregnancy on 30-DEC-2015. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known. The pregnancy was pending. The patient reported she would be seen by her physician on an unspecified date. On an unknown date, chickenpox titer test was performed with unknown result. There was no treatment given for the patient. The patient did not seek medical attention.  Additional information has been requested.
Mild Hives on cheek and back Treated with Benadryl and Cetirizine Resolve in 70 minutes
Patient has red 2x2 raised hard inflammed area of skin at the injection site on her left arm. The left arm at the injection site is warm to the touch and  painful. Patient started having fever, chills, body aches, and general fatigue feeling about 12 hours after the vaccine was given and lasted for about 36 hours. Patient had same fever and body aches when she had the first injection.
Moderna vaccine administered to a 12 year old male.  No adverse reactions. Patient was not of age to receive Moderna vaccine, administration error.
This case was reported by a nurse and described a 36 yr old female pt who did not respond to immunization with hep B vaccine recombinant (Engerix B). The pt's medical history was notable for tobacco use. On unspecified dates, the pt received the full series of Engerix B (dose numbers not specified). At an unspecified time following the admin of the Engerix b series, on an unspecified date in Apr 2004, a hep B surface antibody test revealed a titer of zero. On 18Jun04 the pt received a booster dose of Engerix B (lot Eng5379A4). The expiration date for this lot of Engerix B is 18May04. No adverse event occurred following the 18Jun04 booster dose.
Headache, Myalgia, NauseaVomiting, HYPERtension, Tachycardia, chills, fatigue Narrative:
Red hot very itchy spot; Red hot very itchy spot; Woke up to a large swelling on same left arm about area 3X2 inches, red hot very itchy spot; Red hot very itchy spot; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Red hot very itchy spot), VACCINATION SITE PRURITUS (Red hot very itchy spot), VACCINATION SITE SWELLING (Woke up to a large swelling on same left arm about area 3X2 inches, red hot very itchy spot) and VACCINATION SITE ERYTHEMA (Red hot very itchy spot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (usually from skin product like makeup products or sunscreen). Concomitant products included VITAMINS NOS and BIMATOPROST (LUMIGAN) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Red hot very itchy spot), VACCINATION SITE PRURITUS (Red hot very itchy spot), VACCINATION SITE SWELLING (Woke up to a large swelling on same left arm about area 3X2 inches, red hot very itchy spot) and VACCINATION SITE ERYTHEMA (Red hot very itchy spot). The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) for Antibiotic therapy, at an unspecified dose and frequency and TRIAMCINOLONE for Rash, at an unspecified dose and frequency. On 11-Feb-2021, VACCINATION SITE WARMTH (Red hot very itchy spot) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Red hot very itchy spot) and VACCINATION SITE SWELLING (Woke up to a large swelling on same left arm about area 3X2 inches, red hot very itchy spot) had not resolved and VACCINATION SITE ERYTHEMA (Red hot very itchy spot) outcome was unknown.        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.
Pt was up and caregiver noticed she didn't look right. she stated to caregiver she felt like she was having a reaction. pt was assisted to the floor. RN assessed pt and noticed her tonge swelling and patient getting red and neck swelling. RN ran to get emergency kit EPI PEN.  EPI Pen administered Right thigh. EMS arrived. took patient to the ED for further treatment.