chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     It was unknown if the patient had acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.    On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 12-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On 12-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml).    No concomitant medication was reported.  The age of the patient was reported as over 65 years.  Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event was unknown.  On 10-May-2023, 27 patients received 0.25ml of the Moderna bivalent vaccine instead of the 0.5ml booster dose. On 11-May-2023, 26 patients were contacted. On 12-May-2023, 18 patients received additional 0.25ml.  No treatment medication was reported.  This case contains information for the 9th of 27 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case
After the 2nd dose, I have constant pain from my deltoid and into my shoulder, limited range of motion, could not sleep on left side, and difficulty reaching to grab items.
can't exercise daily like she usually does; she did not feel great; weak; her arms were swollen; her feeling "crappy"; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 85-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 85 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "pericarditis", start date: 2017 (unspecified if ongoing), notes: pericarditis with fluid around her heart in 2017; "Fluid around around her heart Said that it took a week to drain.", start date: 2017 (unspecified if ongoing), notes: Fluid around around her heart Said that it took a week to drain. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, Lot number: Unknown), for COVID-19 Immunization, reaction(s): "she did not feel great". The following information was reported: FATIGUE (non-serious) with onset 22Sep2023, outcome "recovering"; FEELING ABNORMAL (non-serious) with onset 22Sep2023, outcome "recovering", described as "her feeling "crappy""; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "can't exercise daily like she usually does"; MALAISE (non-serious), outcome "unknown", described as "she did not feel great"; ASTHENIA (non-serious), outcome "unknown", described as "weak"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "her arms were swollen". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Caller on the line calling about the Comirnaty 2023-2024 vaccine for adults formulation and reported that she got a dose of the product a week ago Thursday,. The first day after her shot she did not feel great, but she expected it. Just like the reaction she had from the other shots, which were all Moderna. This is the 9th day of her feeling crappy. Only had one symptom which is fatigue and she can't exercise daily like she usually does. She did blood work, a chest x-ray, EKG, and urinalysis. Caller has a history of Pericarditis and fluid around her heart in 2017. They were wanting to make sure that the pericarditis did not come back and the urinalysis to was to make sure that she did not have a UTI. Everything came back normal and they could not find anything wrong with her. She was calling to find out if anyone had this happen before. Caller was referred to her physician. She was reporting it not as a complaint, but reporting this to find out if it was a normal thing. Her symptoms today are a little better. She was so weak previously that she could not get in the shower. She was able to take a shower today. This is a sign to her that she is doing a little better.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Metal taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 25Mar2021 at 09:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no past medical history. The patient had no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 10:00, the patient experienced metal taste in mouth. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event metal taste in mouth was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Itchy rash at the site of injection; Itchy rash at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Itchy rash at the site of injection) and VACCINATION SITE PRURITUS (Itchy rash at the site of injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE RASH (Itchy rash at the site of injection) and VACCINATION SITE PRURITUS (Itchy rash at the site of injection). At the time of the report, VACCINATION SITE RASH (Itchy rash at the site of injection) and VACCINATION SITE PRURITUS (Itchy rash at the site of injection) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
03/08/2021 (Symptoms began 45 minutes after shot): sore arm down to fingers, stuffy nose, watery eyes, headache, light headed, slight balance issues, malaise, no appetite, slight nausea, tight chest, arm soreness down to fingers became worst & was accompanied by arm swelling which included the fingers, 2 hives, tingle around mouth & nose, asthma feeling progressed to shortness of breath upon exertion, slight face swelling, Temp 102, chills. 03/09/2021 same symptoms as 03/08/2021 but minus the hives & the addition of the following symptoms: Temp 101, shaking so bad from chills couldn't hold anything, runny nose & eyes, extreme fatigue, small chest pain, skin cold like had been in freezer, lips & fingers slightly purple. 03/10/2021 same symptoms as 03/08/2021 & 03/09/2021   but minus the hives, slight face swelling, servere chills, lips & fingers barely purple  & the addition of the following symptoms: Temp 100. 03/11/2021 symptoms include: Temp 99.7, sore arm down to fingers, stuffy nose, watery eyes, headache, slight balance issues, malaise, no appetite, slight nausea, tight chest, shortness of breath upon exertion, runny nose & eyes, extreme fatigue, & small chest pain. 03/12/2021 symptoms include: Temp 98.7, sore arm down to fingers, slight headache, slight balance issues, malaise, no appetite, slight nausea, slight tight chest, shortness of breath upon exertion, runny nose & eyes, extreme fatigue. 03/13/2021 symptoms include: Temp 97.7 (my normal), sore arm down to fingers, malaise, no appetite, slight nausea, slight tight chest, slight shortness of breath upon exertion, runny nose & eyes, extreme fatigue. 03/14/2021 symptoms include: Temp 97.7 (my normal), sore arm down to fingers, malaise, slight appetite, slight nausea, slight tight chest, slight runny nose & eyes, extreme fatigue. 03/15/2021 symptoms include: Temp 97.7 (my normal), sore arm down to fingers, malaise, slight tight chest, slight runny nose & eyes, extreme fatigue. 03/15/2021- 04/10/2021 symptoms include: Temp 97.7 (my normal), fatigue & slight malaise  at times.
07/12/22 presents to ED for "vaginal bleeding and shortness of breath". PMHx of "anemia, right total knee arthroplsaty, pancytopenia, malignant lymphoma, arthritis, cellulitis, obesity, gait instability, MI, myelodysplastic syndrome, and coronary artery disease"
During the night (around 3 AM?), I woke in a lot of pain. My joints and my muscles hurt all over and I had a sharp headache on the right side of my head. The injection site hurt and I couldn't lie on that side because of it. The site itself did not appear swollen or red, just tender. My hands were so swollen, I couldn't make a fist. I tried to go back to sleep but only managed to doze on and off.  I felt better after a shower and started my day but found that I started feeling bad again. The swelling in my hands went down. I went to church but couldn't kneel because it hurt too much. I went to the supermarket (I only had a short list) but couldn't carry the bags in the house because I was too tired and achy. TYLENOL (2 extra strength) helped somewhat and I continued to take that during the day (every 4 hrs, total 6 pills). I spent the day laying down and did not have the energy to read or even to watch TV. I was able to sleep that night. I awoke with a migraine (MAXALT generic, needed the second pill 2 hrs after the first) and that resolved after ~5 hrs. The joint and muscle pains were still there but much less, although I continued to be very tired. I continued to improve. Today, I'm still tired and somewhat achy but overall much better. The swelling in my hands resolved.
pt recvd vax & @ an earlier age w/no apparent react devel redness in face & a wheal seven to eight mins following  vax w/measles virus vax live SC; pt moved arm during inject & only recvd 0.1ml;
>102 fever for over 24 hours, short-term relief with ibuprofen and then would return. Chills, body aches.  Fever finally broke and stayed gone at around 10am on 11/25/21. Hard, painful lump at injection site. Red, inflamed ring around injection site that extends out over 4 inches away from site. Swollen, painful axillary lymph node in same side as injection. Still have sore arm and pain at this moment.
pt recvd vax 4AUG93 & 5AUG93 devel redness @ the inject site which measured 3" in diameter was hot to the touch & sl swollen as well as pain in the shoulder; 7AUG93 had recovered;
Body aches, Body pain; swollen arm; dizzy; sweating; Sharp pain in my neck; shaking from head to toe; Light headed; Felt like I had Covid all over again; Felt violently ill; nausea; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches, Body pain), PERIPHERAL SWELLING (swollen arm), DIZZINESS (dizzy), HYPERHIDROSIS (sweating) and NECK PAIN (Sharp pain in my neck) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN (Body aches, Body pain), PERIPHERAL SWELLING (swollen arm), DIZZINESS (dizzy), HYPERHIDROSIS (sweating), NECK PAIN (Sharp pain in my neck), TREMOR (shaking from head to toe), DIZZINESS (Light headed), TYPE IV HYPERSENSITIVITY REACTION (Felt like I had Covid all over again), ILLNESS (Felt violently ill), NAUSEA (nausea) and PYREXIA (low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Body aches, Body pain), PERIPHERAL SWELLING (swollen arm), DIZZINESS (dizzy), HYPERHIDROSIS (sweating), NECK PAIN (Sharp pain in my neck), TREMOR (shaking from head to toe), DIZZINESS (Light headed), TYPE IV HYPERSENSITIVITY REACTION (Felt like I had Covid all over again), ILLNESS (Felt violently ill), NAUSEA (nausea) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
9/10/14 Student came into clinic to show immunization nurse (R) arm where received MMR et arm was sore, red, warm to touch at site. 5 cm x 3.5 cm reddened area. Area marked with marker and hydrocortisone cream applied. Use ice on and off next 2 hours et return to clinic to see provider as needed. 9/11/14 pt. returned to clinic to see provider and diagnosis of cellulitis of (R) upper arm. Given doxycycline 100mg caps (1 cap. BID x 7 days PO). Antihistamine, ice on and off. To return to clinic as needed.
Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 30-APR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 30-APR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Received injection.  On day of injection, patient experienced soreness and throbbing.  On Wednesday 4/19 night, saw increased redness with streaks below site of injection.  Lymp nodes started to enlarge. On Thursday 4/19, used warm packs throughout the day since arm very sore and red. Now, has raised, red, warm area the size of palm of hand about 12 mm below the injection site.  Injection site very hard and red.  Lymph nodes enlarged.  States has been febrile  releived by 3 doses of Ibuprofen since 4/17/2007.  Dr. notified and asked to refer to Dr.   Health Department for follow up.  Dr. and Health Dept notified employee enroute to Health Dept.  States has not taken Benadryl or any other over the counter or prescription meds.  Previous dose in PIMS 11/04/2005.  States forgot had this shot.
About one hour post inoculation my speech became jibberish. Cognitively, I could organize my thoughts and knew exactly what I wanted to express to my husband and our waitress, but when I opened my mouth to speak, only jibberish came out.  I couldn't say anything meaningful.  It lasted about 2+ hours and hasn't reoccured.   That night when I went to bed I was extrememly light sensitive.  We had the usual degree of light in our bedroom but with my eyes closed it felt like all the overhead lights in the room were on.  I had to block out the alarm clock, but that was the only adjustment that could be made.  Drapes were closed and no other lights of any kind were on.  That was bothersome for the first couple of nights. I'm still having a difficult time falling asleep when I go to bed and staying asleep all night.  My "fight or flight" response is highly charged.
7X7.5cm indurated erythematous area right upper arm. Afebrile, pruritic, non-tender.
Pt devel an area of erythema (5x5 inches) 1 to 2 inches below the inject site w/in 3 days of receiving Td; area was tender w/some induration noted; pt was treated w/Anaprox, Duricef, Topicort cream & cool compresses;
Contracted Covid; Contracted Covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 38-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 16Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 16Jun2022, outcome "recovering" and all described as "Contracted Covid". The event "contracted covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jun2022) Unknown Result, notes: COVID test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Serious, Seriousness criteria-results in death, Seriousness criteria-life threatening, Seriousness criteria- caused/prolonged hospitalization, Seriousness criteria- disabling/incapacitating and Seriousness criteria-congenital anomaly/birth defect reported as No. Report about COVID vaccine was Yes. If other vaccine in four weeks reported as Unknown. Adverse event Contracted COVID. If treatment ae reported as Yes. Ae treatment reported as Paxlovid. COVID prior vaccination reported as Unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
After receiving vaccine patient started shaking resembling Parkinson's like motion. Taken by ambulance to E.R. where she was given BENADRYL and prednisone. Went home after 4 hours in E.R.
Developed swelling, erythema and heat at vaccine administration site right arm. Edema to elbow. Diagnosed with Cellulitis and given IV antibiotic and treated with Levoquin p.o.
day p/vax pt devel hives, swelling of the lips & diff swallowing & was seen by MD who prescribed med;pt became near non-responsive;MD dx anaphylaxis;vomited;adm to hosp ICU devel resp diff  then cardiopulmonary arrest;
Dizziness (started on the 20th, ongoing), nausea, vertigo (on August 21st), arm pain (gone by August 23).
Woke the morning of Friday, January 8th, 2021 with a slight cough, heaviness to my chest, and extreme fatigue.   Had to use my inhaler twice, get rest, and plenty of hydration for 24 hours then felt fine.
Fever of 101.6 had chills, headache, dizziness . Just like when i had covid.
From the 2nd day of my second covid shot, I have been experiencing anxiety related symptoms for last 6 months.  On 05/01/2021 around night 11PM est - I suddenly had racing heart beat for some hours that I never had. on 05/02/2021- I visited PCP on 05/02/2021 to understand the symptoms and to get treatment My TSH level, B12, D vitamin and Blood pressure was checked. TSH was around 8.5 and B12, D were very low. Blood pressure was above normal too on the day of the my PCP visit. To control my blood pressure, I cut down the salt completely from my food intake.I was taking Levothyorixine every alternative day, and was also taking medications for B12 and D.  But my symptoms were not gone. I still used to feel lot of uneasiness in the body and used to feel anxiety and tension all the time. If I was fine for one day, I used to be having anxiety symptoms for rest of the week. The symptoms continued for entire May month. I used to feel heavy headed sometimes. Light headed sometimes. Racing heart beat continued most of the time. PCP did complete blood tests CBC and Metabolic panel on 06/11/2021 and they all came out normal. PCP said it is general anxiety and will go away eventually after few months.  In a month of june and July, I had some kind of panic attacks which made me  visit Urgent care and Emergency care each time. They said I have some anxiety related symptoms.  My PCP gave hydroxizine HCL 25 mg to treat anxiety as needed but I never used that as I was trying to heal the anxiety on it's own.   But even after 6 months from my vaccination ,I have been experiencing anxiety symptoms every day.  No improvements.  This is impacting my daily activities a lot.
8/06/2021 2:15pm 12 yo patient received first Pfizer injection. 2:18pm patient had possible seizure, unresponsive to staff for about 10 seconds. Came to alert x 3, but having abnormal sx's per mother and patient unaware. EMS notified, came and monitored patient.  2:48 EMS left with patient and mother
Body aches, joint pain, malaise, viral rash extending from trunk up my neck and into my scalp, started the night of the vaccine and continuing today, two days post.
Received PCV 13 in (L) deltoid - some red tactile temp. Next day (L) arm red & swollen.
This spontaneous report as received from a consumer (patient's friend) via market research program, refers to a 55 year old female patient. The patient's concurrent conditions and medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency and route were not reported). Concomitant medications were not reported. From an unknown date, the patient experienced itching for 3 months, which occurred on and off. The outcome of the event was reported as recovered/resolved with sequelae. The reporter considered the event to be related to ZOSTAVAX. Additional information has been requested.
This case was reported by a pharmacist and described the occurrence of increased white blood cell count in a 2 month old female patient who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis.  The patient's past medical history included gastroesophageal reflux disorder.  Concurrent medications included Zantac.  On 05/12/2003 the patient received the 1st dose of pediarix.  One day post-immunization, on 05/13/2003, the patient experienced increased white blood cell and band neutrophil counts.  The patient was seen by a physician.  The outcome of the events is unknown.