chrisvoncsefalvay/vaers-outcomes huggingface dataset:
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported. It was reported that there was a failure to change the expiration date of Moderna Lot 012H21B when it was shipped. The original was kept -15 to -25 and then shipped and kept refrigerate. This lot was shipped on 06-Dec-2021,The error was caught on 11-Jan-2022 when a new shipment was received.   This case was linked to MOD-2022-449524 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2022: Significant Follow up received included , reporter details and suspect expiration date was updated.
pt presented to clinic for 1st time covid vaccine. incorrect vaccine was given to pt as should have given Pfizer ages 5-11  monovalent vaccine instead of  Pfizer 5-11 Bivalent booster  vaccine. pt's mother was informed via phone the next day. pt did not have any side effects or  reactions to getting Bivalent vaccine other than sore arm.
TINGLING IN THE LEGS FROM KNEE CAP TO FEET AND IN HANDS; PAIN IN LEGS AND IN HANDS; BAD HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced tingling in the legs from knee cap to feet and in hands, pain in legs and in hands, and bad headache. The action taken with covid-19 vaccine was not applicable. The outcome of the tingling in the legs from knee cap to feet and in hands, bad headache and pain in legs and in hands was not reported. This report was non-serious.
Egg shaped Lymphnode in armpit of Left Arm and Lymphnode  Swelling in neck. now getting  same feeling in Rt Arm Pit.
These are the following symptoms that she has complained of since getting the shot.  Not all of them are every day but she's had them throughout this past winter and now:  Fatigue-especially after exertion ie:  tennis, phyed, snowmobiling, wakeboarding, snowboarding, she's been checked for anemia, ekg, mono, liver test, kidney test, blood counts etc.. all come back normal.  It is hard to wake her during some of these episodes.  She doesn't want to drive, instead tends to sleep in car if it's more than a 20 minute ride.  Headaches in the last month have been most everyday now.  Vomiting- when not "feeling right"  as she puts it she will vomit once and then will sleep alot.  Light sensitivity- was complaining of this when she'd walk out of school also says her vision is worse.  Stomach gets very nauseous and sometimes cramping pain.  Shaky at times then feels better later.  Gets a rash that comes and goes on her chest.  Complained of arm hurting and burning for a few days after the shot. Back ache and leg pain.  Cramping more with periods, periods are very heavy, which she was put on the pill in Feb. for.  About a month ago she had an episode at mass that her fingers/hand was numb.  The feeling did come back though.
pt recv vax 17JUN95 & had t102, poor appetite, was lethargic & irritable but mom able to console;T controlled w/ apap;19jun95 pt had jerky movements;to er;t106.1;adm to hosp; tx w/ IVs, apap, meds;
4/1/21 Patient developed breathlessness, it progressed until she presented to local ER 4/13 with hypoxemia, tachycardia due to Submassive pulmonary emboli, also found to have R pulmonary infarct and asymptomatic DVTs in R femoral and popliteal, L popliteal veins.  Patient was admitted to hospital, treated with IV UFH, doing well.  Anticipate discharge in 1-2 days. Note hospitalization data below is tentative as pt is still in hospital
I received my 3 dose of the Pfizer vaccine, then I positive for COVID 5 months later.
Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-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 CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported.
Information was received from a pharmacist concerning a 69 year old male patient with allergy to CIPRO (unspecified reaction), high blood pressure and hypothyroidism. The patient had received ZOSTAVAX (lot number and dosage not provided) approximately 4-5 years ago. The patient reported that he experienced a rash on the right arm, near the hand and thumb, after receiving a second dose of ZOSTAVAX 0.65 ml, subcutaneously (lot # L007222, expiration date 03-JUN-2016) and FLUZONE in the left arm on 25-SEP-2015. The patient informed the pharmacist of the event on 06-OCT-2015. Concomitant therapies also included SYNTHROID and losartan potassium (manufacturer unknown). The outcome of the rash is unknown. No treatment was given. The relatedness of the rash to ZOSTAVAX was not provided. Additional information has been requested.
02/12/22 presents to ED as a transfer for "recurrent seizure activity" "COVID Infection".  PMHx of "cerebral palsy, epilepsy, hydrocephalus status post VP shunt"
Patient received first dose of Pfizer on 1/16/2021, and second dose of Moderna was administered 10 days later on 01/26/2021.
This spontaneous report was received from an approximately 63 years old female patient regarding herself. The concurrent condition included the gastrooesophageal reflux disease. The patient stated that she has suffered from the herpes simplex virus for over 45 years. It was reported that on an unknown date in 1970 (reported as 45 years ago) the patient received a special Smallpox vaccine to provide immunity for the herpes simplex virus and after the injection of the smallpox virus (45 years ago) she has suffered mild and manageable symptoms of sores on the mouth as a result of herpes simplex virus. The patient had no known drug allergies. On an unknown date in February 2014 (approximately 1 year ago) the patient was vaccinated with ZOSTAVAX 1 injection. Concomitant therapies included ESTRATEST, VIROXIN and unspecified stomach medication. On an unknown date in October 2014, (also reported as in the last 4 months i.e. October 2014, November 2014, December 2014 and January 2015) the symptoms of the sores from herpes simplex virus certainly worsened possibly as a result of the ZOSTAVAX. The patient had no other symptoms or new symptoms appeared but simply the fact that the symptoms ha gotten worse after receiving the ZOSTAVAX to the point where it was becoming unmanageable. The patient did not seek any medical attention. The patient took over the counter medications, BLISTEX and others. No lab tests were performed. The patient enquired if this was possibly caused by the fact that she vaccinated with smallpox vaccine and then received ZOSTAVAX. The outcome of symptoms of the sores from herpes simplex virus certainly worsened was reported as not recovered/not resolved (reported as not improved). The causality was not reported. Additional information has been requested.
Extreme daytime Sleepiness, couldn't arouse from sleep, napping uncontrollably during day, while driving, etc. Fell over repeatedly numerous times; couldn't move one foot when awakening; vivid dreams; widespread pain, debilitating fatigue; cognitive decline, forgetfulness, inability to concentrate.
Severe  whole body pain, fever ,chills, fever blister on lip after first day, by day3 had trouble walking, I was sick for about 7 days . Have been not feeling well sence then , about 4 weeks later a rash looking like shingles showed up on my left forearm  and apparently  6 weeks after the shot my whole body is covered  in blisters that resembles chickenpox both the rash and pots are still  present. I have also had a headache  since the vaccine.
Child received Hib & PREVNAR at 15 mnth visit on 2/22/2012. Had small rings, then on 3/28/12, seen for (L) thigh swelling. Sono done on 3/28 c/w with abscess, sent to ER -> surgery evaluation.
Headache, Fever, swollen lymph nodes, unable to elevate arm above head Narrative:
Per patient, he experienced elevated heart rate, breathing issues, fever, nausea, and delirium
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration and dose was not reported, batch number: unknown) administered on 07-APR-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 APR-2021, the patient experienced suspected immunological vaccine failure. On unspecified date patient went to the doctor to do Laboratory test for detection of antibodies which was found as negative. Patient was upset about it and wants to know about how this was happened. Patient also states that company would contact with her to know the details of event occurred. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious. (Other Medically Important condition) This report was associated with product quality complaint: 90000177573.; Sender's Comments: V0:20210448211-Covid-19 vaccine ad26.cov2.s-suspected immunological vaccination failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/  expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/  expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/  expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  The vial did not undergo any temperature excursions.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up document contains no additional information.
Felt dizzy; This is a spontaneous report from a non-contactable consumer. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 06Apr2021 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient did not have allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021, the patient felt dizzy about 3 hours after the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the event. The clinical outcome of the event felt dizzy was recovered on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a female in her twenties or thirties who on 14Nov05 was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine. On an unspecified date, the pt had a reaction at the injection site. The area was raised, red, and painful. Subsequently, on an unspecified date, the pt recovered. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Pt got a rash on arms, chest, and back.  I gave him Diphenhydramine 25 mg to take 1 to 2 tablets to take by mouth every 4 to 6 hours. He will call his doctor.
said she experienced "flushing" from her chest up to her neck about 3 hours after her vaccine. It resolved on without treatment after a few hours. She also had "covid arm" about 10 days after her vaccine. She had a hot, red welt near the vaccination site. This also resolved without treatment after a couple of days.
For my pain I was put on steroids-prednisone-muscle-spasm-my doctor said I have a bruise muscle. I am also wear a elbow wrap to suppress pain. I went to DR. for pain, as to this day I have pain in my left arm.
A spontaneous report has been received from a medical rep concerning, female patient. No information regarding the relevant history, concomitant disease and concomitant drug was provided.  Medical rep stated that patient (doctor's daughter) had received FLUMIST QUADRIVALENT (intranasal) in October 2015. Agency reported patient has gotten Flu Type A (preferred term: influenza) around Christmas, and had a fever.  The outcome of the event of flu was unknown. Company physician considered the event of flu to be non-serious.
Patient called in to Health Department to report symptoms that developed after her first vaccination. She received her first COVID-19 Vaccination on 3/6/21. It was the Moderna Vaccine. Patient reported that around 5 am on 3/7/21 she started to develop fever (Tmax 100.4), chills, body aches, and headache. Symptoms lasted approximately 12 hours. She did not go to her physician and stated that she wanted to ?ride it out?. Patient reports symptoms resolved after 12 hours and that she has no symptoms currently.
Initial unsolicited report received from a nurse (patient herself) on 20-Dec-2017. This case involves a female patient (age not reported), who was vaccinated once with 0.5 ml HINI INFLUENZA VACCINE via intramuscular route (batch number: UP013AA; expiry date: 15-SEP-2010, dose in series and site of administration not reported) on 29-Oct-2009. Patient's medical history and concomitant medications were not reported. On an unknown date, few weeks following the vaccination, patient developed "progression of symptoms, numbness face and arms, blood pressure 200/100, fainted twice" seen in ER (emergency room) and diagnosed with H1N1 viral syndrome. On an unknown date, patient got hospitalized. It was also a case of suspected vaccination failure. Other lab test was not reported. Corrective treatment was not reported. On an unknown date, patient recovered from the events. No information reported on hospital discharge. Documents held by sender: none. Sender's Comments: The time to onset is few weeks post vaccination which needs further clarification. No PCR/serology results confirming the diagnosis was reported. No medical history, tolerance to previous vaccinations and condition at the time of vaccination were reported. Additional information regarding the same is required to completely assess the case. Based upon reported information te role of the vaccine can not be assessed.
soon after my 2nd shot, the following day, i got chills, low grade fever, muscle/bodyache, tiredness and nausea  now my period just started and i woke up with a severe cramping plus heavy flow
10 1/2 cm x 12 1/2 cm red, hot area at injection site - non tender. Afebrile - no pain.
my upper right side of my lip was feeling numb and weird; my speech was compromised; my left eyelid was twitching and it lasted for some time; I have felt changes in my mood and easily irritable; I have felt changes in my mood and easily irritable; feeling pain in my joints; Nassau; continue to feel lethargic and tired; chest pain; feeling tightness, spasms in my back; feeling tightness, spasms in my back; feeling lethargic; This is a spontaneous report received from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in right arm single dose for COVID-19 immunization on 18May2021 10:30 AM, at 49-year-old. The medical history included: acquired brain injury back in 2004. Concomitant medication was not reported. The patient started feeling pain in her joints by 19May2021 at 1:00 pm and feeling lethargic. The patient lied down and woke up around 6pm, between 6pm and 6:30pm her upper right side of her lip was feeling numb and weird, her speech was compromised, her left eyelid was twitching and it lasted for some time. She went back to bed to continue getting different side effects, chest pain, feeling tightness, spasms in her back, 'Nassau', and continue join pain. The speech had continued to be compromise, she had felt changes in her mood and easily irritable, continue to feel lethargic and tired. Doctor or other healthcare professional office/clinic visited. The treatment received included followed up with neurologist waiting on CT scan. Outcome of the events was not recovered.  Information about lot/batch number has been requested.; Sender's Comments: Based on the available information, a possible contributory role of vaccination with BNT162B2 to the reported events feeling lethargic, 'lip feeling numb and weird', 'speech was compromised' and chest pain cannot be excluded based on the temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
The patient has not experience and adverse event that I am aware of.  The patient was administered a Pfizer Bivalent Booster that was stored improperly in the freeze and administered to the patient past the beyond use day.
Shot 1: 3-31-21-5-4-21   Sore Arm, Migraines. 4-8-21 Acne  4-23-21-4-26-21 Rash on bend of left arm Shot 2: 4-28-21 Neck Pain, Migraine (treated with Sumatriptan), Arm Soreness, Frequent Urination. 4-29-21 Felt Hungover. Clammy. Chills. Migraine (treated with Sumatriptan). Bottom lip because purple around border and in the middle. Dry Mouth. 4-30-21 Fatigue. Brain Fog. Anxiety. Panic Attacks. Tongue became swollen and patchy.  Took Benadryl. Still purple lip. 5-1-21 Tongue now tingling.  Went to urgent care.  She prescribed a mouth wash and called it geographic tongue. High Heart rate so she did an EKG which came back normal.  Panic attacks.  Anxiety.  5-2-21 Tingling patchy tongue that is now painful. Panic attacks.  Anxiety. 5-3-21 Tongue is now scalloped. Mouth feels very hot.  Weird Taste.  Tingling sensation around mouth. Still purple lip. Panic attacks.  Anxiety. Light sensitivity developed. Facial Flushing. 5-4-21 Hot mouth. Still purple lip. Panic attacks.  Anxiety. Light sensitivity. Facial Flushing. Congestion.  Coughing.  Took a Zyrtec. Scalloped Tongue. 5-5-21 Scalloped Tongue. Fatigue.  Jaw Pain. Panic attacks.  Anxiety. Light sensitivity. Congestion.  Purple Lip. 5-6-21 Tons of canker sores develop, on my tongue. Took Advil, continuing to use mouth wash. Congestion.  Purple Lip. Panic attacks.  Anxiety 5-7-21 Mouth Pain.  Called Teladoc on Video.  He called me in a mouthwash with Lidocaine.  Also had him look at my lip and he didn?t think it was detrimental. Congestion.  Purple Lip. Panic attacks.  Anxiety 5-8-21 Mouth Pain.  Scalloped Tongue. Light Sensitivity. Tingling Feet.  Purple Lip.  Congestion.  Panic attacks.  Anxiety 5-9-21   Scalloped Tongue. Light Sensitivity. Tingling Feet.  Purple Lip.  Congestion.  Panic attacks.  Anxiety 5-10-21 Scalloped Tongue. Light Sensitivity. Tingling Feet.  Purple Lip.  Congestion.  Panic attacks.  Anxiety 5-11-21 Scalloped Tongue. Light Sensitivity. Tingling Feet.  Purple Lip.  Congestion.  Panic attacks.  Anxiety 5-12-21 Visited my family dr about the lip discoloration and tongue.  My vitals were fine so she felt my lip wasn?t detrimental to my health.  Nose became itchy.  Neck pain.  Lower back pain. Tingling Feet.  Purple Lip.  Congestion.  Panic attacks.  Anxiety 5-13-21 Neck Pain.  Dizziness.  Congestion. Tingling Feet.  Purple Lip. Panic attacks.  Anxiety. 5-14-21 Pain in Calf.  Felt like a cramp but turned into pain that went all the way to the inside of my leg.  Took ibuprofen. Congestion. Tingling Feet.  Purple Lip. Panic attacks.  Anxiety. Neck Pain. 5-15-21 Leg pain. Took ibuprofen. Congestion. Purple Lip. Panic attacks.  Anxiety. Neck Pain. 5-16-21 Acid Reflux. Congestion.  Anxiety.  Purple Lip.  Neck Pain.  Lower back pain.
Vaccine given on 5/9/06, MMRV and Hib. Febrile seizures on 5/13/2006. Admit to hospital, spinal tap, IV. Physical exam normal. 5/30/06 Medical records received from hospital which reveal patient admitted overnight w/dx febrile seizures.  Initially brought to ER w/ssizure & cyanosis.  Neg eval & was d/c home.  Later same day, recurrent seizure w/cyanosis & was admitted for observation.  All labs including CSF were WNL & final diagnosis was fever associated w/MMR/ss. 60 day Follow-up Information 02-AUG-2006: This patient has had another febrile seizure since the vaccination event. Working diagnosis common childhood febrile seizure.
Localized reaction- 10.4cm round, red, and  swollen Right deltoid. Patient verbalizes it only hurts when touched. Cool compressed TID x5days
No issue at time of vaccine. When patient went home she had some breakfast and shortly after breakfast she started vomiting. No reports of difficulty breathing, swelling, itching, etc.
12 hours following vaccination patient developed tremors in the hands and legs accompanied by weakness. This lasted for 5 days following vaccination before resolving spontaneously.
This is a new vaccine this year - patient said after she was given both shots she noticed difficulty swallowing upon each dose this is how she reported it down to the vaccine. No breathing problems.
pt recv vax 21FEB98 & two wk p/vax pt devel elevated liver enzymes;