chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Temperature excursion with AE; No adverse event; Temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with AE) and NO ADVERSE EVENT (No adverse event) in an adult 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. 066H22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In March 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with AE) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with AE) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with AE).    Concomitant medication was not provided.  It was reported that lost power the next day in the middle of the day at 12:00 PM and placed all vaccine into a frozen bag. Booster vaccines were then transported to another clinic.  Treatment information was not provided.  This case contains information for the 16th patient out of 26 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:Master case
Patient had vasovagal response after receiving HPV-9 and MCV4 in the left deltoid. Patient was assisted by both this RN and MD to ground, no injuries noted. VS checked and WNL. Patient A&O x3.  Was observed for 15 minutes in clinic.  No episodes of emesis, urination or BM. Denied HA, NV, dizziness, visual changes, or other complaints. Ambulating independently with steady gait upon discharge.
Couldn't move the arm for a couple of days; pain; Sore arm; Emphysema COPD; Emphysema COPD; dry unproductive cough/it's just cough cough cough cough cough, and then I cough cough cough and you can't breath/up for half an hour and cough and cough; barely breath; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Couldn't move the arm for a couple of days), PAIN (pain), PAIN IN EXTREMITY (Sore arm), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Emphysema COPD) and EMPHYSEMA (Emphysema COPD) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Couldn't move the arm for a couple of days), PAIN (pain), PAIN IN EXTREMITY (Sore arm), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Emphysema COPD), EMPHYSEMA (Emphysema COPD), COUGH (dry unproductive cough/it's just cough cough cough cough cough, and then I cough cough cough and you can't breath/up for half an hour and cough and cough) and DYSPNOEA (barely breath). At the time of the report, LIMB DISCOMFORT (Couldn't move the arm for a couple of days), PAIN (pain), PAIN IN EXTREMITY (Sore arm), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Emphysema COPD), EMPHYSEMA (Emphysema COPD), COUGH (dry unproductive cough/it's just cough cough cough cough cough, and then I cough cough cough and you can't breath/up for half an hour and cough and cough) and DYSPNOEA (barely breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment medicines were not provided.
Pain at injections sight and swelling to shoulder. 2 lumps on collar bone tender to touch and pain. Swelling.
Red allergic urticaria L upper arm "1.5 x 7/8" at site of of IPV vaccine.  We start cream BID to skin and oral Benadryl.
Myalgia inj site sore, inflammed, abcess like better after Abx, fatigue Narrative:  Day 2 soreness and inflammation of injection site, fatigue, mild body aches; Day 4 inj site is abcess like, better after Amoxicillin
Case number PHEH2014US010817 is an initial spontaneous report received from a nurse on 27 May 2014. This report refers to a 12 year old male patient. His medical history and concomitant medication were not reported. On an unknown date, he was vaccinated with MENVEO (batch number: M13014) via intramuscular route. It was reported that, before administration the vaccine was stored under 02 degree Celsius (between 33 to 36 degree Fahrenheit) for 28 hours on 05 May 2014. No adverse event was reported following this medication error.
This spontaneous case reported by a consumer, describes the occurrence of pruritic rash (itchy) and rash (rash on her back, arms and legs) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Sep 23, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 24, 2021, patient experienced pruritic rash (itchy) and rash (rash on her back, arms and legs). At the time of the report, pruritic rash (itchy) and rash (rash on her back, arms and legs) outcome: unknown. No concomitant medication or treatment information provided. This case linked to MOD-2021-330419, MOD-2021-330408 (patient link).
11/06/2021  I started experiencing around 2-3:00am in the morning I  had  a flu like symptoms except fever. My left arm was swollen and was very painful.  I discover a  pea size lymph node under my arm pit and it was hurting.  It was uncomfortable I couldn't sleep on that side.  After 3 months all my symptoms were gone but the pain from lymph node was still there. I went to see my doctor she checked me and said that a pea size lymph node which was swollen and she told me to monitor it. she told me to go back in 3 months if it didn't go away. I took Advil but it didn't help.
Patient reported the day after injection: muscle soreness at injection site, fatigue, nausea, upset stomach, low pulse rate and dizziness that subsided after 1 day. After 3 days, patient reported developing severe joint swelling in right knee, right ankle, and pain hip. Patient also developed shingles type rash on back, buttock, and down right leg. Patient went to urgent care on Day 8 post injection and PA diagnosed rash as shingles.
hot sensation near injection site; Itchy feeling; rash bigger than the palm of the hand on back of leg; redness, bumps on back of leg; Swollen under injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot sensation near injection site), PRURITUS (Itchy feeling), RASH (rash bigger than the palm of the hand on back of leg), ERYTHEMA (redness, bumps on back of leg) and INJECTION SITE SWELLING (Swollen under injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot sensation near injection site), PRURITUS (Itchy feeling), RASH (rash bigger than the palm of the hand on back of leg), ERYTHEMA (redness, bumps on back of leg) and INJECTION SITE SWELLING (Swollen under injection site). At the time of the report, VACCINATION SITE WARMTH (hot sensation near injection site), PRURITUS (Itchy feeling), RASH (rash bigger than the palm of the hand on back of leg), ERYTHEMA (redness, bumps on back of leg) and INJECTION SITE SWELLING (Swollen under injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Shoulder pain still feels like right after vaccination even though so much time has passed. If left arm is down by my side it's fine but if I lift it up it is painful. I do have an upcoming appoint with Dr. on January 4th, 2023.
High fever, injection site pain, redness, swelling, pain in eyes Instructed to see physician
no additional adverse event reported; an unspecified 5 year old received a dose of PROQUAD that expired on 10/20/2020; This spontaneous report was received from a medical assistant and refers to a 5-year-old patient of an unknown gender. Information about pertinent medical history, drug reaction/allergy was not provided.  On 30-OCT-2020, the patient was vaccinated with dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live with albumin status rHA (recombinant human albumin) (PROQUAD) injection, lot # S012533 for prophylaxis (dose and route of administration were not reported) that expired on 20-OCT-2020. The vaccine and sterile diluent used for reconstitution of vaccine (lot # and expiration date was reported as unknown) had been stored at the appropriate storage condition, specified in the product label, through the date of administration. No confusion or product quality complaint (PQC) human error was reported.  No additional adverse events were reported.
Pt complained of pain in right arm. On 03/18/2002 mother noted indented area in right arm.
1 of 2 pts immunized from the same TETRAMUNE lot who exp an adverse event; pt vaxed 29MAR94; approx 4hrs later, began to cry unconsolably in high pitched tone x 1.5hrs; would not eat or sleep; the following morning 30MAR, all sx resolved;
I received my second Moderna vaccine at 10:00am on 4/13, 28 days after my first one. On Fri, 4/16 at 4:00am, I woke up to use the restroom and voided my bladder. Shortly thereafter, I felt very nauseous and cold clammy. I had a sip of water, than sat down next the toilet since I thought I had food poisoning and needed to throw up. Instead, I passed out and fell from a sitting position against the wall. I woke up a few seconds later, to find my right ear cut and with quite a bit of blood (not sure what I cut it on, maybe my own thumb nail?). I stood up and walked to the sink, so I could bleed over it while apply pressure so I wouldn't make a mess. My wife had woken up at this point, and shortly after I got to the sink, I passed out again while standing (fortunately she caught me) and started twitching for a few seconds before coming to (I came to while still standing up). At this point, my wife drove me to the emergency room and we were admitted. In the ER from 4:15am-7am, they did a CT scan on my head without contracts, blood work, and an EKG. All three tests came back normal and I was diagnosed with vasovagal syncope. I have no history of any prior vasovagal event. At the ER they also sewed my ear up with 6 dissolvable stitches, gave me a big of IV fluids, a tetanus shot, and then sent me on my way, discharging me at 7:00am on 4/16. I then saw my primary care doctor that afternoon at 1:00pm on 4/16 who reviewed by medical records/test results from the ER, concurred with their vasovagal syncope diagnosis, checked my stitches, and said I could go back to normal activity largely unrestricted. I haven't had any issues since; so not overly concerned (other than the >$2,500 of ER hospital bills that are piling up), but just reporting this so you have the data.
19 yo otherwise healthy f c/o ongoing mild diffuse ha w/o visual changes, dizziness and nausea w/o vomiting x24hrs s/p J&J vaccine yesterday; Pt denies any cp, sob, rashes, dyspnea, abd pain/cramping, prior hx of vaccine rxn.
Dehydrated; Lost her electrolytes; Her lips were cracked; Eczema; exhausted and she couldn't leave the bed; Hallucinating; Violent dreams; Strange aches in one of her arms and one ear; Strange aches in one of her arms and one ear; Has not had the same energy; This is a spontaneous report from a contactable consumer (patient). A 90-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Feb2021 (Batch/Lot Number: EL9261; Expiration Date: May2021) at the age of 90-years-old as single dose for covid-19 immunization. Medical history included allergies to Shellfish, penicillin, sulfa, mercury, and latex, the patient has been tested positive on 08Jan2021 for covid-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot Number: EL9261; Expiration Date: May2021) on 26Jan2021 at the age of 90-years-old for covid-19 immunization and experienced exhausted, weak, so lethargic she could barely move, had chills, and she lost her sense of taste. For second dose: Most of these symptoms began on 16Feb2021 around 6:00 - 7:00 pm. The patient was exhausted and she couldn't leave the bed, started 16Feb2021, improved. The patient was hallucinating, started 16Feb2021, improved. The patient had chills, started 16Feb2021, improved. On an unknown date in Feb2021, the patient was dehydrated to the point to where her lips were cracked, the patient was so dehydrated and couldn't get enough water she drank so much water that she lost her electrolytes which was why she was hospitalized. The patient was hospitalized on 28Feb2021 and released on 01Mar2021, they gave her an IV for treatment. The patient had violent dreams, started 16Feb2021, improved. The patient had strange aches in one of her arms and one ear, started 16Feb2021, improved. The patient has not had the same energy since the shots on 16Feb2021, she's going to physical therapy for this. The patient had eczema, started 28Feb2021, ongoing. The outcome of the events eczema was not recovered, the outcome of the event dehydrated, lost her electrolytes and lips were cracked and 'has not had the same energy' was unknown, the outcome of the other events Hallucinating, Violent dreams, 'Strange aches in one of her arms and one ear', 'exhausted and she couldn't leave the bed' was recovering.
Cold sore; Cold sore started with tingling on both sides of mouth 7 days after vaccination; developed into full sore on right side; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 13:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included shingles in 2015. The patient did not receive any medication within two weeks of vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. 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 14Apr2021 at 17:00 the patient experienced cold sore, started with tingling on both sides of mouth 7 days after vaccination, then developed into full sore on right side. The patient had no cold sore in over 10 years. No therapeutic measures were taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event cold sore, started with tingling on both sides of mouth 7 days after vaccination, then developed into full sore on right side was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
everything started to echo/ He can hear himself; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (everything started to echo/ He can hear himself) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.    On 04-Aug-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021 at 3:00 PM, the patient experienced TINNITUS (everything started to echo/ He can hear himself). At the time of the report, TINNITUS (everything started to echo/ He can hear himself) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified blood pressure medication (2 types) and stomach pills (40 mg daily).  The patient reported experiencing noises like when you tap into a microphone. He reported he is a mechanic and ringing in ears is normal for him but he hasn't experienced anything like this previously.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: TCR received with No New Information.
arm hurt all the way to elbow; arm hurt all the way to elbow; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 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 pain in arm and pain in elbow. On an unknown date, the outcome of the pain in arm and pain in elbow were unknown.   It was unknown if the reporter considered the pain in arm and pain in elbow to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-OCT-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient asked was it a side effect after the shingle shot for arm to hurt all the way to elbow. Additional supportive information:  Follow up would not possible, as no contact details were available.
7-8 hours after the vaccine on (12/30/20) I started feeling tired and sluggish. Next day (12/31/20) at 9:30 am I started with body aches, chills and headache.  I got a fever of 100.2 at 4:00 pm.  I took 800mg of Ibuprofen at 4:00 pm and 9:30 pm and fever broke at 12:00 am. Next day (1/1/21) I still had a tiny headache and felt very tired.  I didn't start feeling better until Saturday (1/2/21).  On Sunday (1/3/21) I felt better and was able to go outside for some fresh air.
I received my first Moderna COVID vaccine shot on Saturday, around 3pm. No problems immediately and I felt fine. Went to bed late, around 4am. On Sunday, I was awoken at 1:30pm with a throbbing right testicle. The pain went away I thought. Then again it happened. Every 60 seconds my right testicle felt like someone was squeezing it. The testicle was not warm or painful to touch. The pain started soft at first and it would get stronger. The pain would start at a level 1-2, grow to 4-5. The pain would last 5-10 seconds then go away. This happened every 60 seconds. I had a stopwatch and timed it. Pain would come, go away, and then 45-60 seconds later, it would occur all again. This went on for the next 14 hours. I took nighttime Advil to try and sleep and eventually dozed off when the pain subsided around 4am. The next day nothing was wrong until around 8pm. Then the exact same scenario started. Pain, stop, 60 seconds, pain. This day, Monday, again I took nighttime Advil and the pain stopped. Today, Tuesday, as of 8pm, no pain yet. I do not have insurance so I didn't know whom to contact. After the second day of pain I called the pharmacist and then informed me to notify you.
Within 30 minutes of receiving vaccine on 12/31/20, I felt as if I had been given a "sedative."  Within 2 hours of receiving, I developed severe hip pain.  On 1/1/21, I felt "drugged" the entire day, with a severe headache.  On 1/2/21, I had fatigue, and developed sever lower extremity pain during night.  Severe fatigue continued through 1/4/21--I tested positive for Covid on 9/21/20--and I have struggled with lingering symptoms--fatigue, brain fog, and body aches.
No adverse symptoms reported; vaccinated with PNEUMOVAX 23 on 10/29/2018 and 10/08/2019; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 29-OCT-2018 and 08-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dosing details, lot number, expiration date, anatomical location were unknown) via unknown route for prophylaxis (inappropriate schedule of product administration). It was reported as on 24-OCT-2019, the event inappropriate schedule of product administration was identified. No adverse symptoms were reported. The outcome of the events was unknown. No product quality complaint (PQC) involved.
lost consciousness; went pale; chest pain; vomited; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 9-year-old male patient received BNT162b2 (BNT162B2), on 24Jun2022 at 13:00 as dose 3 (booster), single (Lot number: FL8094) at the age of 9 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 2, Single, Lot No: FK5618, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 01Dec2021, when the patient was 9-year-old, for Covid-19 immunization; BNT162b2 (Dose 1, Single, Lot No: FK5618, Location of injection: Arm Left, Vaccine Administration Time: 15:00), administration date: 10Nov2021, when the patient was 8-year-old, for Covid-19 immunization.  The following information was reported: CHEST PAIN (non-serious) with onset 24Jun2022 at 13:00, outcome "unknown"; LOSS OF CONSCIOUSNESS (medically significant) with onset 24Jun2022 at 13:00, outcome "recovered" (24Jun2022), described as "lost consciousness"; VOMITING (non-serious) with onset 24Jun2022 at 13:00, outcome "unknown", described as "vomited"; PALLOR (non-serious) with onset 24Jun2022 at 13:00, outcome "unknown", described as "went pale". The events "lost consciousness", "went pale", "chest pain" and "vomited" required emergency room visit. The patient underwent the following laboratory tests and procedures: Electrocardiogram: (Jun2022) Unknown results, notes: given an EKG. Therapeutic measures were not taken as a result of loss of consciousness, pallor, chest pain, vomiting. Clinical course: It was reported that, the other vaccine in four weeks and other medications in 2 weeks was None. Adverse event:  Moments after receiving the shot, he went pale, had chest pain then lost consciousness. Paramedics were called. He was unconscious for a minute of two and when he woke, he vomited. Upon sitting up, he vomited again. Under paramedic advice, he was taken to the ER where he was observed, given an EKG and sent home. Covid prior vaccination and Covid tested post vaccination was None. No Known allergies reported and other medical history was None.