chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inability to schedule a second Moderna dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inability to schedule a second Moderna dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer surgery (two cancer surgeries in 2020.) since 2020. Concurrent medical conditions included Hypertension (Patient reports PMH significant for hypertension, hypercholesterolemia, diabetes mellitus, and two cancer surgeries in 2020.), Hypercholesterolemia (Patient reports PMH significant for hypertension, hypercholesterolemia, diabetes mellitus, and two cancer surgeries in 2020.) and Diabetes (Patient reports PMH significant for hypertension, hypercholesterolemia, diabetes mellitus, and two cancer surgeries in 2020.).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inability to schedule a second Moderna dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inability to schedule a second Moderna dose) had resolved.            No concomitant medications were reported.  Treatment medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: The patient had received the second vaccine dose, action taken was updated to not applicable and patient denied consent for further follow up.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 21Aug2023 to 25Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Dry Skin Patches; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (Dry Skin Patches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis, COVID-19 and Foot drop.    On 28-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRY SKIN (Dry Skin Patches). At the time of the report, DRY SKIN (Dry Skin Patches) had not resolved.        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.   Patient's past medical history included Balance and Foot drop. On 28-DEC-2020, patient started therapy with Moderna Covid-19 Vaccine for unknown indication.  No concomitant medication were provided. No treatment details were provided.
Dizziness, Headache, Fever, NauseaVomiting, LOSS SENSE OF TASTE; ARM SORENESS; BODY ACHES; WEAKNESS; FATIGUE Narrative:  Employee (a physician)states: about 4 hours after vaccination his arm was sore about 6 hours after vaccination, he lost his sense of taste he was concerned and received a COVID test which was negative about 10 hours after vaccination he experienced body aches, frontal headache, and nausea. about 12 hours after vaccination had a fever which peaked to 102.7 F; and dizziness and generalized weakness. Most of the symptoms resolved the following morning including the loss of taste, with the exception of extreme fatigue. On 3/10 he states he awoke around 9:30am and by 11am had felt so exhausted that he went back to bed for a 4 hour nap after which seemed pretty much back to normal.  Other Relevant History:
About 5 hours after administration: light headedness- 2 episodes about a day apart, chills- intermittent for about 24 hours,  fatigue- about 2 days, nausea and inappetance- about 2 days, injection site pain- about 3 days
presented with chest pressure and difficulty breathing 4/15/21, eventually admitted 5/6/21 for pericarditis with atrial flutter. No PE on CT chest
8 minutes after receiving injection patient complained about feeling lightheaded and felt she was about to pass out.  Patient was assisted to lay down and cold compress was placed on her neck.  Vital were taken:  BP 100/60, HR 65, RES 20, OX 99%.  Patient stated she had anxiety and had not eaten.  At 10:18AM  patient stated she no longer felt lightheaded patient sat up; a bottle of water was given and vitals were taken.  BP 100/70, P 85, Resp 20, OX 98%, temp 96.8.  Patient refused emergency services and cleared.
Information has been received from a nurse concerning a 19 month old male patient with no pertinent medical history drug reactions or allergies who on 09-SEP-2010 was vaccinated with 0.5 ml single dose of PROQUAD (Merck upgrade process) (lot # reported as 666823/0071Z valid for MMR II). The patient also received a dose of PREVNAR and a dose of INFLUENZA (manufacturer unknown) at the same office visit on 09-SEP-2010. The nurse reported that "1 day after receiving the vaccine" on 10-SEP-2010, the patient experienced vomiting, crying, screaming and extreme fussiness. There were not laboratory tests or diagnostic studies performed. At the time of the report, the patient had recovered (date unknown). The patient sought medical attention by calling to the physician's office. Follow up information has been received via telephone call from a nurse indicating that the patient had swelling at injection site, fever, vomiting, crying, screaming, fussiness after he received PROQUAD (Merck upgrade process). The nurse said that the office no longer gave the first dose of PROQUAD (Merck upgrade process) in the younger patients, they only gave it to 4-6 year old patients now. This is one of several reports from the same source. Additional information is not expected.
chronic headache; ocular/sensory migraine symptoms; Visual snow syndrome; tinnitus; nausea; occipital neuralgia; pain; migraines with aura; scalp is numb to touch; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 27-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 4 (booster), 0.3 ml single (Lot number: GJ2524) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 , Manufacturer Unknown), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "headache", "migraines and migraine symptoms"; Covid-19 vaccine (Dose 3 , Manufacturer Unknown), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "chronic headache"; OPHTHALMIC MIGRAINE (non-serious), outcome "not recovered", described as "ocular/sensory migraine symptoms"; VISUAL SNOW SYNDROME (non-serious), outcome "unknown"; TINNITUS (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; OCCIPITAL NEURALGIA (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown"; MIGRAINE WITH AURA (non-serious), outcome "not recovered", described as "migraines with aura"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "scalp is numb to touch".  Additional information: Dealing with chronic headache and ongoing ocular/sensory migraine symptoms and migraines with aura. Visual snow syndrome and tinnitus being the most intense sensory symptom. With nausea, occipital neuralgia, and pain being the most intense physical symptoms. The pain has been chronic enough that scalp is numb to touch in certain areas. The migraine symptoms come and go, but the headache and occipital neuralgia has been chronic and consistent for about half a year. Noticed, after second dose of the COVID vaccine, headache within the hour and it induced a migraine within the same day. That migraine lasted a few days. Also noticed an increase in frequency and duration with my migraines and migraine symptoms since after receiving the second since after receiving the second dose, and all boosters of the COVID-19 vaccine. Supposed to get an MRI as soon as possible, but recently unable to continue seeing my out of network Neurologist who I was established with. So no EEG scripts until 05Nov.
Patient had a syncopal episode less than 3 minutes after recieving injection. Eased pt down to the floor. Fanned patient off and gave her soda to drink. Took patient to room to lay down for 15 minutes. BP 98/58. Patient voiced no signs or symptoms of any further abnormal/adverse reaction 15 minutes after Gardasil injection.
Itching, redness, inflammation just below injection site on left arm.  Treated with antibiotic.
patient mom came in to get shot with daughter. mom had print out of daughter's shot history but didn't have her own.  While Pharmacy was looking up mom's shot history nurse administered shot to daughter. Pharmacy noted mom was too soon and then noticed daughter too soon too but was too late and nurse already administered shot. daughter received booster only after 3 months instead of 5 months. mom said daughter needed booster for school and school told them to come get shot.
The Patients leg gave out and he fell.  Per doctors at hospital, he did not hit his head.  He could not get up and he vomited.  Ambulance was called and he was taken to the Hospital.  The family was told that he had a brain bleed near the thalamus.  A few hours later the patient was unresponsive.  He was intubated and taken to neuro ICU.  Within less then 24 hours from first symptom the patient died.
It started with a minor reaction and started getting redder and warm to the touch and spread down from the injection site to my elbow and half in my inner arm. And a lump under my shoulder. Sore throat, congestion, cough, headache, fever.
I was achy after the vaccine and had some soreness. On July 25th I went with a lot wheezing and congestion and body ache. I also had fatigue. They treated me with antibiotics. I was tested for COVID and it came back positive. I did have an infusion to help with my breathing. I battled with extreme fatigue. I had diarrhea and loss of appetite. I also have extreme pressure it is uncomfortable to shallow. I was also swollen in the rectal area. They prescribed a hydrocortisone cream for the rectal. I believe I am having an internal inflammation response. The most frustrating part is that I haven't been able to find a clinic that can do follow-up care that does not require hospitalization. I still have some internal inflammation, extreme fatigue, and still the pressure.
Left arm began aching one hour following my flu vaccine, after that it has progressed into a sharp pain throughout my muscle. I have extreme difficulty moving my arm side to side or up and down and I have decreased strength in that arm as well.
I had the shot but still had bad case of shingles / suspected vaccination failure; bad case of shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient received Shingles vaccine shot but still had bad case of shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact details were available.
This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 06-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), PYREXIA (elevated temperature), CHILLS (perspiring chills), CHILLS (shivering so bad) and ARTHRALGIA (aches on the joint) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (loss of appetite), PYREXIA (elevated temperature), CHILLS (perspiring chills), CHILLS (shivering so bad) and ARTHRALGIA (aches on the joint). At the time of the report, DECREASED APPETITE (loss of appetite), PYREXIA (elevated temperature), CHILLS (perspiring chills), CHILLS (shivering so bad) and ARTHRALGIA (aches on the joint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Breakthrough case. Just came back from overseas and came down with sore throat and cough, so I took 3 home tests and all were negative. Still wasn't getting better after a few days, so I went to the Dr to get tested and it was positive. Was prescribed Paxlovid. Took a home test and it was negative.
1. Pulse 106 2. Pulse 115 (5 minutes after first reading) 3. When patient stood up felt "wobbly"
On 12/18/21 I suddenly felt weak and was shaking. Felt like I was going to faint. I took my blood pressure It was very low:80/58 with pulse of 67. I also had a severe headache and a fever of 100.5, I was extremely fatigued and nauseated. Also had chills and sweating.
8/12/13 Vaccine administered. 8/13/13 Localized rxn injection site rash and welt right thigh. 8/15/13 Fever 102F. Few spots vesicular on trunk and face. 8/21/13 Fever and vesicles inc.
Case previously recorded as MA2009-4222. Initial case report received from a nurse via agency, on 11 NOV 2009. A patient under 4 year-old was vaccinated with 0.25 mL of S-OIV FLUVIRIN (batch no. 102046P1) i.m on 10 NOV 2009. No adverse events were reported. Agency reference no.: NA09-008010.
Pt woke up around 9pm crying. Parents tried to comfort her & she became tonic for about 1 min then had left arm & head jerking x 2 min. No evidence of post ictal state afterward. She was seen in the ER & had a CT scan & lab & everything was normal. Concern for reaction to pertussis.
4-5 days post vaccine. Tingling and nerve pains right side of body, hand, arm, foot leg. No weakness.
Pt developed a low grade fever (100), listlessness, malaise and decreased appetite the morning following receipt of vax. Later that day the pt developed large red blotches on each thigh, left 3-4 inches, right 4-5 inches, that were swollen and hot. Blotches still there, though improving.
Five hours post vax, the pt's hands began to itch, then arms, then all over. She took Benadryl that night and stayed home the next day. On 3/23/00, the itching got worse. Where she scratched she had large welts. Saw physician who dx her as having an allergic reaction and gave her an unspecified injection. Symptoms completely resolved by 3/26/00.
Stated she felt warmness going up left arm to neck and itching from left ear and down left arm. Given 50mg Benadryl IM, O2 at 5lpm/nc, BP 130/90, resp 20. very anxious. Started to feel pressure on airway and given 0.3ml epinephrine Subcutaneous. Squad arrived within 15 min of initial onset of sx and transported to hospital.
30 min after shot ches became heavy, throat seemed thick itchyness. Called doctor, he told her to take BENADRYL. Still feels strange-also recently had allergic reaction to peanuts and pecans.
Localized redness and swelling (hard knot like) approximately the size of a half dollar; Localized redness and swelling (hard knot like) approximately the size of a half dollar; Localized redness and swelling (hard knot like) approximately the size of a half dollar; pain the arm and shoulder; pain the arm and shoulder; This is a spontaneous report received from a contactable nurse (who is also the patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration in the right arm, on 11Jan2021 07:15, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19 prior to vaccination. The patient has no known drug allergies and is not pregnant. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING), omeprazole (PRILOSEC) and biotin. The patient did not receive other vaccine in four weeks. The patient experienced localized redness and swelling (hard knot like) approximately the size of a half dollar with continued pain the arm and shoulder on 12Jan2021. The patient was not tested for COVID-19 post vaccination. Treatment was reported as unknown. The outcome of the events was not recovered.
A repugnant, putrid body odor reminiscent of garlic and onions emanating from all parts of my body, predominantly the under arm area. Symptoms began only hours after vaccine administration. Showered excessively with hypoallergenic fragrance free sensitive skin soap.  Odor returns within 2 hours after shower for first three days. I continued my excessive showering and now the smell has begun to fade and is only present once I begin to perspire. I still have the putrid smell on the daily basis. I am very concerned about receiving dose 2.
I didn't do too well either; I got the side effects like I had the shavers and all that kind of bunch stuff but then by Sunday night I was okay; I didn't do too well either; I got the side effects like I had the shavers and all that kind of bunch stuff but then by Sunday night I was okay; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), MALAISE (non-serious), outcome "recovered" (2021) and all described as "I didn't do too well either; I got the side effects like I had the shavers and all that kind of bunch stuff but then by Sunday night I was okay".  Additional information: Reporter had the Pfizer Covid vaccine and I just have I feel very important question to ask whether it can if you have high blood pressure if it can cause your high blood pressure to go havoc. It is really important because I have a 94 years old mother and it was happened to her when she had the shot. We both had the vaccine on Saturday. I didn't do too well either but I had it you know what I am saying I got the side effects like I had the shavers and all that kind of bunch stuff but then by Sunday night I was okay but she actually for her blood pressure drops drastically by Sunday morning we called the doctor please understand we were she is under in doctor's hand I just want it to hear for she called the doctor again today so there because I am not you know I know the best thing you to supposed to do but all that I am questioning is she also fainted so all that I am questioning is can it in very extreme cases can it cause the blood pressure to go havoc."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Transient ischemic attack/small stroke Requiring hospitalization for 4 days. Right sided numbness inability to walk, , confusion, loss of sensation for 2 months.  Numbness started 1.5 hours after vaccination.
In my 11th day after taking the Moderna Covit vaccine, a red, warm and puffy spot 2" x 3" appeared in the left arm near where the vaccination shot was given. Checked with Pharmacist who explained possible one of the reactions to the vaccine.  Recommended observation and report to doctor is spot stays longer than 24 hours or get larger with additional symptoms.
Case number PHEH2015US019754 is an initial spontaneous report received from a health care professional on 02 Oct 2015. This report refers to a patient whose identifiers were not reported. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 30 Sep 2015. It was reported that before administration the vaccine reached -3 to -4 degree Celsius for up to 8 hours which was its first temperature excursion. No adverse events were reported following the maladministration.
She received vaccine at 2:00 pm. Around 3 hours after injection began getting a rash on her face that spread to other parts of body.  Felt some tightness in her chest.  She took Pepcid and 50 mg of Benadryl.  Rash and tightness in chest improved.  Began to come back around 9pm.  Took 1 more 50 mg of Benadryl.  On 12/18 she reported to Employee Health.  Rash was still visable . 1-25 mg Benadryl was taken.  She reported she would take 50 mg of Benadryl at lunch.
Breakthrough case admission after 3 vaccines Moderna 4/22/21 lot# 002C21A;  MOderna 5/20/21 lot# 036C21A;  Moderna 12/10/21 lot# 045J21A
In the middle of may I started having light headed issues and I was very fatigued. It was on and off and on June it started to get worse. I had an incident and I ended up going to a walk in clinic. My sugar level was really low so they gave me juices to try to bring them back up. That day I had an incident were I just passed out and the ambulance came, and they did the same thing trying to bring my sugar levels back up. I am seeing an endocrinologist now and he started me on Acarbose. They did a whole blood panel and urine test. He said that he thought I might be prediabetic. Now I have to check my blood sugar 3 times a day.
Pt had diarrhea for several days. Other children at daycare also got diarrhea.