chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 9/19/2022 Patient was given 0.5 mL dose of the first shot in the primary MODERNA COVID-19 series, and then it was realized that the lot was expired on 9/10/2022. Director of Nursing at the Health District notified, and this nurse was instructed to contact the manufacturing company, Moderna on 9/20/2022. Moderna gave me a reference case number of MOD22-024062 and said their team would perform a lot assessment that would take 3-5 days to complete that would provide further instruction(s) on how to proceed. Moderna emailed the Director of Nursing with the lot assessment findings on 9/23/2022 and these results were then discussed with Dr. our medical provider and our Health Commissioner on how to proceed. I attempted to contact the patient on 9/26/2022 but they did not answer, so a voicemail was left asking them to call me back. Will continue to attempt at contacting the patient to let them know they were given an expired dose and to tell them how important it is for them to get their second dose for full protection.
This spontaneous case reported by a consumer, describes the occurrence of malaise (did not feel well), vomiting (all night until today), myalgia (body aches), pyrexia (fever of 101.3ºF) and terrible headache in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 009C21A) for COVID-19 immunization. No medical history reported. On Jun 22, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 22, 2021, patient experienced malaise (did not feel well), vomiting (all night until today), myalgia (body aches), pyrexia (fever of 101.3ºF) and terrible headache. At the time of the report, malaise (did not feel well), vomiting (all night until today), myalgia (body aches), pyrexia (fever of 101.3ºF) and terrible headache outcome: unknown. Diagnostic results: On Jun 22, 2021, Body temperature: 101.3ºF (inconclusive). No concomitant medication or treatment information provided. This case linked to MOD-2021-233019 (patient link).
Client states she developed back pain several days after vaccination, then big toe became numb progressive to feet and legs up to hips. By day 10 was unable to walk. continues to need a cane for stability. regained ability to walk approximately 2 weeks ago.
Information has been received from a physician concerning an 8 week old female patient who in January 2011, was vaccinated with a first dose of ROTATEQ (dose, route and Lot# not reported). The nurse stated that 21 days (in approximately January 2011) after receiving her first dose of ROTATEQ, the patient developed diarrhea and tested positive for rotavirus (stool sample). At the time of the report the patient had recovered. It was unspecified if the patient sought medical attention. No further information is available.
Red area, warm to touch on upper right thigh at injection site. Red area was the size of a softball and swollen.
Patient came to counter approximately 5 minutes after receiving vaccine stating he felt like he may pass out. He was instructed to have a seat in the waiting room and the pharmacist was notified. Pharmacist immediately went to the waiting room to check on the patient and observed the patient drop his paperwork and lean back in the chair and his eyes rolled back. Within 30 seconds he sat up and began talking to me. He was able to tell me about feeling light headed and sitting down. We gave him water and he immediately began to feel better. He stayed in the store with supervision for approximately one hour before going home.
Immediate swelling of injection site after receiving first dose Pfizer. Denied any other symptoms. Transferred to Observation for further monitoring .Completed by: RN, April 9, 2021.
Patient presented back to the clinic with angioedema, flushing, full body urticaria, stridor, and difficulty breathing.
No adverse effects were reported; An expired dose of Vaqta was administered to the patient; This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender.   There was no information about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or medical history provided.  On 17-JUN-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 50 (units not provided), lot # R013859, expiration date reported as 14-JUN-2019 (expired product administered) intramuscularly, for prophylaxis (strength, not reported).  No adverse effects were reported.
This spontaneous report as received from a consumer refers to a 23 year old male patient with seasonal allergies. The patient reported that as a child, on an unspecified date the patient was vaccinated with VARIVAX (merck) (dose and route, unspecified). Concomitant therapies included fexofenadine hydrochloride. The patient stated that on 17-MAY-2013, he had varicella titers drawn for Emergency Medical Technician (EMT) School, and the titers came back negative. Patient's outcome was unknown. Additional information has been requested.
Within 10 mins of receiving vaccine pt developed diffuse hives. Was assessed by MD at clinic who advised trip to ER. At ER x 5 hrs with IV and medication therapy. Also was given Benadryl PO by mother. Has recovered.
Breakthrough case admission after 2 vaccines Moderna 2/16/21 Lot# 031M20A;  Moderna 3/16/21 Lot# 040A21A
Patient passed  out after receiving both vaccines, Patient regained consciousness within a minute. EMS was called, patient was checked out and sent home.
Patient has not had any adverse reactions. What happened is that the vaccine was punctured the previous day and the vaccine was administered to the patient the following day past the 12hrs when the vaccine should be given. There was not any temperature excursions and Moderna was notified of the error
Post vax, the patient developed swelling and erythema of the left deltoid region approximately 3"x3" in size.
Entire left side of my bod y, from head to foot,  became numb and tingly very suddenly.  I called 911 to make certain I was not experiencing a stroke. EMT assured me I was not. This was Saturday night.  It is now Monday morning, January 25, and the numbness has not gone away.
INJECTION SITE PAIN AND HOT TO TOUCH. ARM PAIN RADIATING TO NECK AND HAND. WORSENING OF TENDINITIS IN SHOULDER AND ELBOW. WEAKNESS IN LIMBS. TENDINITIS IN KNEES. GENERAL WEAKNESS. FEELING AS IF ARMS AND LEGS ARE TOO HEAVY.
After the first shot, I had a lot of swelling in my joints on my hands and legs.    After the second shot, I  was "sick" the next day with fever of 100.4F and body aches and chills.  This lasted about 2 days.  About 10 days later, I broke out in shingles on the left side of my body, on my torso.  This was also on the left side, the same side that I received my shot.
Mom reports that patient had vomiting, shaking, and having trouble breathing when they got home from the office.
I am having very bad throbbing pain in my thighs. It os constant and can only be slightly contained with Over the counter medication. I also have headaches, and fatigue.
Ache: Bones, Joints and muscle, Aches Whole body Acid relux: Mood: anxiety, Blood pressure high, Blood: High Cholesterol, Concentration: trouble, Depression, gastritis, Hypetension, memory loss, trouble remembering information, memory:short term memory loss, Mood swings, Mood Anxious, mood angry, mood irritable, nasal runny nose, pain legs, pain lower back, pain knees and hips, pain lower back, pain back. Respiratory problems, sinusitis, sleep problems, tendon disorder, vision poor tolerance of bright light, weigh gain.
47 yo male p/w fever, body aches, rash, and mild angioedema x 2 days s/p varicella vaccine on 2/8/23. Rash appeared this morning and it's not itchy but burning. Denies any SOB, vision changes/loss, CP, GI symptoms, or respiratory difficulties. Vitals were all stable except for a temp of 102F  During visit, new rash is seen on bilateral upper extremities that patient claims wasn't there before. Administered tylenol 1000mg, benadryl 25mg, pepcid 20mg immediately. Monitored patient for 2 hours after.  According to guidelines, patient was placed into isolation in Trailer #5 and wellness checks will be performed on him QD
No symptoms first 12 hours after vaccine, but when woke up her lips were swollen, she had headache for multiple days, cried/very emotional for 4 days, aches in joints, brain fog.  Did not require ER  and was advised to take Benadryl after called MD but symptoms were resolving.  She did see PCP and 2 separate allergists. 2nd dose was not given.  Took 4+ days for symptoms to fully resolve.
Pt got the rash and itchy skin at the site of injection on Wednesday. It spread down to her elbow and below and showed a physician. Per doctor she has a bacterial infection and was prescribed cephalexin on Friday.
unconsciousness x2 devel into what appeared to be several sz lasting approx 10-15sec each time;
Myalgias at onset, then chill that night, next day low grade fever to 100.5, then continuous malaise, severe fatigue, mild nausea and profound weakness. On day three a mild non-productive cough gradually improving after day 5 but persisting to day 7. Difficulty sleeping, Mild pharyngitis.  A rather severe viral like illness! No adenopathy,
red raised; painful lump at site of shot about the size of a quarter; itchy; This is a spontaneous report from a contactable consumer (Patient). A 73-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 10:00 (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. Medical history included, Slight asthma and high blood pressure (Slight asthma and high blood pressure) from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (LEVOTHYROX), bupropion hydrochloride (WELLBUTRIN), liothyronine sodium (CYTOMEL), olmesartan medoxomil (BENICAR) and silicon taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine, nitrofurantoin, Silvadene and varenicline and experienced drug hypersensitivity (Allergies to medications, food, or other products: Codeine, nitrofurantoin, silvadene, varenicline). The patient experienced red raised, painful lump at site of shot about the size of a quarter and itchy on 30Jan2021 16:00. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was recovering.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Received shot at 10:00  Felt strange almost immediately. No specified symptoms just brain fog and difficulty  holding conversations. Noticed my chronic back pain (L5 fracture) was very bad, but didn?t initially connect it to the vaccine.   By 4:00 I was running a fever, fatigue, shivering, sweating, could not eat due to lack of appetite / nausea. Could not think straight.   The night of the 22nd (day I received 2nd dose of vaccine) I had difficulty sleeping, heart palpitations, and extremely strange dreams when I did sleep. The next morning (23rd)  I felt much better, even walked around for a bit, but by noon I was back to having sever symptoms. My fever spiked, my energy was drained, and my back pain was unbearable.   This progressed over the afternoon into unbearable tooth pain along with the back pain and other symptoms. Back pain did not recede with rest as it normally does. Ibuprofen did not seem to mitigate symptoms much.  Brain fog was intense and I could not focus on anything.   Managed to sleep last night and had more vivid dreams. Woke up feelings fine but symptoms seem to be slowly returning.
initially seen on 28JUL98 w/ 9x7cm area of erythema;painful to touch was started on ceftin;seen on 30JUL98 w/ a 9x13cm area of erythema, more painful;cont to be firm to touch;
After 1 dose, I started shaking with no body control. I Felt faint continuously. Experienced chills and shivers that last about 6 hrs. Very fatigue.
Increasing erythema/warmth x 2 days with max size 8 cm diameter stable the 3rd day with decreased erythema. (+) fevers the first 2 days.
I started developing chronic spontaneous hives about 12 days after my booster shot. (I had not experienced this after the first two Moderna shots, which I received in April and May 2021.) Starting on Sunday 12/19, I started having patches of hives come and go seemingly at random. At various points, they have appeared on my neck, my back, chest, breasts, stomach, armpits, hands, arms, legs, and feet. So, basically everywhere at some point. Some patches have been very itchy but others I just notice when I look in the mirror.  The base of my neck, scalp, and ears have also been consistently itchy. I did start to notice after ~1 week that they were appearing more regularly in areas where my clothing rubs, such as my waistline. The hives also get worse after I shower. I saw my dermatologist on 12/30/21 and she confirmed that I was experiencing chronic hives. We ran through a list of possible reasons, including new medications, new soaps and/or detergents, etc., but I've had no other changes besides getting the booster shot earlier in the month. I have now been experiencing chronic hives for approximately 3+ weeks. Per the recommendations of my dermatologist, I am currently taking Zyrtec and Pepcid AC twice daily to help manage them. I think is a delayed immune response to the booster.
Pt experienced shoulder girdle pain for 3 days followd by arm weakness and serratus muscle paralysis which has not resolved as of today. Pt had a similar symptoms after influenza shot in 2007 but only involved pain in the shoulder not weakness like this year.
pt recv vax 8NOV96 & exp a swollen rt occipital lymph nodes & 20 to 30 lesions;
Patient was 11 when given the first dose of the vaccine.  second dose was administered (Pfizer 5-11)  3 weeks later after the child had turned 12 .
Pt received 2 doses of Pfizer COVID-19 vaccine at unknown facility. Around 12/3/21, daughter noticed decreased PO intake and increasing confusion from baseline. Pt diagnosed with acute COVID-19 infection on 12/11/21. She only briefly required oxygen therapy, but does have an acute PE. Admitted 12/10/21. As of 12/20/21, still admitted. Possible discharge in next 24-48 hrs.
Vomiting and chills on first night.  Sore back. Fatigue. Headache. Loss of appetite. Pain in arm that had the shot. Skin redness surrounding injection site of FIRST moderna shot, worsening two days later. 2" diameter red spot
Pt. states that after receiving the 3rd dose of Moderna Booster 09/24/2021, started experiencing symptoms 09/25/2021 of severe chills, fever (100.5), fatigued, knot swollen at injection site with rash, and severe pain throughout the left arm. Self-Treated with extra-strength Tylenol, Symptoms lasting until 09/27/2021. Knot at injection site still remains and self-treated area with Topical Creams. No noted Primary visit.
This spontaneous report was received from a physician via field employee refers to a 16 year old male patient. Medical history was not reported. On 04-APR-2014 the patient was vaccinated with the first dose of GARDASIL (lot # J013324, expiration date 12-FEB-2016) injection, strength, dosage and route was not reported. On 06-JUN-2014 the patient was vaccinated with the second dose of GARDASIL (lot number J009788 expiration date 17-MAR-2016) injection, strength, dosage and route was not reported. There were not others vaccines administered. Concomitant therapy was not reported. The physician informed that on 04-APR-2014 after the first dose of GARDASIL the patient experienced syncope, while still in physician's office. Treatment was laying the patient down, giving him water, placing a fan on the patient and taking his blood pressure, the blood pressure was unspecified. The patient recovered fully after treatment in the physician's office. On 06-JUN-2014 after the second dose of GARDASIL the patient experienced being diaphoretic further described as he was so drenched and sweating that he drenched the table, hypotensive and vasovagal in the physician's office, treatment was laying the patient down, giving water and taking his blood pressure, the result of the patient's blood pressure was unspecified, the patient recovered fully after treatment was given. Additional information has been requested.
EXPIRED PRODUCT ADMINISTERED; PREDRAWN AND LEFT OUT OVER NIGHT (ABOUT 12 HOURS); MEDICATION ERROR; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unkown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 05-MAY-2021, the subject experienced expired product administered. On 05-MAY-2021, the subject experienced inappropriate schedule of drug administration. On 05-MAY-2021, the subject experienced medication error. The action taken with covid-19 vaccine  was not applicable. The outcome of the expired product administered, inappropriate schedule of drug administration and medication error was not reported. This report was non-serious. This case, from the same reporter is linked to 20210513592.
Pain in left arm; fluid built up on muscle; loss of mobility was back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jan2022 14:00 (Batch/Lot number: unknown) at the age of 50 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. Past drug history included: Aspirin [acetylsalicylic acid], reaction(s): "Drug hypersensitivity", notes: Known allergies: Aspirin. Vaccination history included: Covid-19 vaccine (Primary immunization complete. Unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Jan2022, out-come "not recovered", described as "Pain in left arm"; PERIPHERAL SWELLING (non-serious) with on-set 03Jan2022, outcome "not recovered", described as "fluid built up on muscle"; MOBILITY DE-CREASED (non-serious) with onset 2022, outcome "not recovered", described as "loss of mobility was back". The events "pain in left arm", "fluid built up on muscle" and "loss of mobility was back" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, peripheral swelling, mobility decreased.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Serious, Seriousness criteria-Results in death, Seriousness criteria-Life threatening, Seriousness criteria-Caused/prolonged hospitalization, Seriousness criteria-Disabling/Incapacitating, Seriousness criteria-Congenital anomaly/birth defect all were reported as no. Facility where the most recent COVID-19 vaccine was administered: (withheld). Reported Event: Booster shot on 03Jan pain in left arm after a month still pain and fluid built up on muscle.  Dr. Gave a topical gel and that didn't help, than I was given an oral steroid for 5 days felt better for a week than pain and loss of mobility was back now on 29Mar a steroid injection into the muscle. Hospitalization Prolonged: No. What treatment received for the adverse event? Topical gel, oral steroids, and now shot in muscle  The lot number for bnt162b2 was not provided and will be requested during follow up.
patient received 2 flu vaccines in one day 1st shot was at pcp office 2nd shot was later that morning at the elementary school during flu clinic child not reporting any issues family notified pcp notified
soreness in right arm at injection site for 3 days could move arm with no problem.  Had redness at injection site for a week after injection then no issues. After the 1st injection, I had a burst of energy and felt great for a week.  Heard this from others of the same effect.  NO migraines at all and no mild headaches.   Interesting that I am hearing the same effect with energy in Type O blood types.  Curious as to why?
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 14:00 (Lot number: EL3247) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single on 03Feb2021 at 14:00 in the left arm), administration date: 03Feb2021, when the patient was 52 years old, for COVID-19 immunization.The following information was reported: CHILLS (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "Chills"; HEADACHE (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "Headache"; PAIN (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "bodyache"; PAIN IN EXTREMITY (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "sore arm". Therapeutic measures were not taken as a result of chills, headache, pain, pain in extremity.Additional information: The patient was vaccinated at the workplace clinic. No other vaccine in four weeks. No covid prior vaccination nor covid tested post vaccination. No follow-up attempts are possible. No further information is expected.
I am having a second period in the course of 14 days. My first period came as scheduled on June 20th and lasted 6 days and today, 10 days after my period ended for the month, I am having another period.
Patient was administered an IM injection from an empty syringe. the vaccine administration error was not realized until after the client left the clinic. Patient was called back to the clinic for administration of the Johnson & Johnson vaccine in the other arm. Contacted CDC to get guidance on any safety issues from receiving an IM injection  with empty syringe. CDC reported back " we are not aware that administration of an empty syringe of an IM injection would cause a safety problem." contacted client for follow up of CDC response. Patient responded no adverse side effects outside of normal signs and symptoms after vaccination with Johnson & Johnson.
Bump, or swelling at the injection site; This case was reported by a consumer via sales rep and described the occurrence of injection site swelling in a female patient who received Men ACWY-CRM NVS (Meningitis ACWY vaccine (potential Menveo)) for prophylaxis.   On an unknown date, the patient received Meningitis ACWY vaccine (potential Menveo). On an unknown date, unknown after receiving Meningitis ACWY vaccine (potential Menveo), the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovered/resolved.   It was unknown if the reporter considered the injection site swelling to be related to Meningitis ACWY vaccine (potential Menveo).  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced a bump, or swelling at the injection site which lasted 2 days and then resolved. The reporter did not consent to follow up. The exact name of the meningitis manufacturer or brand was not known.