chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not experience any adverse event.  No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-395985.
Upon administering both vaccines, patient stated her arm was itching already. Patient agreed to only 25mg of benadryl instead of 50mg. She was given 25mg of benadryl at 2:57pm.  Blood pressure was 157/85. Pulse was 68 at 3:06pm. Blood pressure was 146/83 with a PR of 73 at 3:20pm. Patient had no other symptoms and felt well enough to leave. Upon speaking with the patient at 7:28pm, she had taken another 25mg of benadryl when she got home to make sure it didn't progress any further. She was doing fine by 7:28pm.
2nd vaccine om 1/8/21 : left arm pain within 5 to 10 mins of  injection  with burning , pain and tingling ,  headache  and feverish  feeling and chills started within 2 hours , severe myalgia  and  body ache and  headache   day 1 and day 2 ,    on round the clock tyelenol every 6 hours ,  temp max recorded 100.6
I had the normal chills, aches, fever symptoms and night sweats the night after I got my vaccine and I spent the whole day Sunday in bed. I still wasn't feeling well Monday or Tuesday. Then I went to work Wednesday and noticed an itchy burning sensation on my side. I went to urgent care that night and was diagnosed with shingles. I was prescribed a cream that I picked up from the pharmacy that night. The symptoms continued for about 2 weeks and lessoned while the shingles healed after about 3 weeks.
0.5cc vaccine administered IM, immediately child's color became pale, child started to moan, began to fall, child was eased to floor, feet elevated, ammonia spirits revived child immediately. Child was transferred to 3 chairs to lay down off of floor, B/P was 80/48 then after 5 minutes was 82/60, child rested. Juice administered. Child left with father to go to MD.
Flu shot received 10/7/19. Had fever achiness x1d. Rode mountain bike, x 2 days in a Row. 10/10/19 developed severe myalgias; started proximal arms & legs; proceeded distally. 1st visit 10/13 hematuria increased + on dip stick; initial CPK 682 10/16/19 CPK decreased to 260 symptoms improved. Next F/U 2-3wks 10/19/19 phone call. Pt feels great; walking Normal Reasons for CDC Consultation Presentation Compatible with Rhabdomyolysis. Is this common after flu shots? Recommendations regarding Future Flu shots. Please advise
approx 24 hours after injection, reported indection site tenderness x 2 days. Reported diarrhea and chills on day 2. reported fatigue days 4-7 after vaccine administration. Reported evening chills on days 8, 9, and 10 after vaccine.
Chest tightness and shortness of breath. Presented to ER following morning. After battery of tests was determined all was normal (chest xrays, covid test and EKG).
spine pain is more localized to the area of injury; brain fog, was a little bit disoriented; muscle jumping a little bit in my hands; A spontaneous report was received from a nurse concerning a 65-year-old, female patient who received Moderna's COVID-19 vaccine and experienced brain fog, a little disoriented, muscle jumping in her hands, spinal pain was more localized. The patient's medical history, as provided by the reporter, included frozen shoulder, inability to raise her arms up, broken right shoulder (2015), shoulder surgery (2016), severe arthritis in her spine, back surgery, spinal pain and spinal injury (2000). Concomitant medications reported included levothyroxine, pravastatin, apixaban, hydrocodone/acetaminophen and hydrochlorothiazide.  On 29 Dec 2020 at approximately 11:00AM, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 29 Dec 2020, approximately one and half hours after receiving the mRNA-1273 vaccination, the patient experienced brain fog and was a little disoriented at lunch and her muscles were jumping in her hands. So much so that she "knocked my drink over" at lunch.   On 30 Dec 2020, the patient noticed an improvement in her movement and agility. She was now able to raise her arm about 70 degrees and lean down to pick up toys. She stated her back leg raised up, like kids do. She noticed an improvement in the spinal pain. It was more localized now, rather than involving her whole spine. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events, brain fog, a little disoriented, muscle jumping in her hands, ability to now raise her arm about 70 degrees, ability to lean down to pick up items, spinal pain was more localized, and improvement in her arthritic pain, movement and agility were unknown.  The reporter's assessment of causality of the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The patient's medical history of severe arthritis in her spine, back surgery, spinal pain and spinal injury remains confounder.
Patient came in with dad and sister all requesting first dose Moderna COVID vaccine. Moderna vaccine was accidently given to patient even though Pfizer is what is recommended for age 15. The patient had no adverse reactions and will come back soon as possible to receive her recommended dose.
ANAPHYLAXIS; HYPOTENSION; VOMITING; This spontaneous report received from a pharmacist concerned multiple patients (4 patients). 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 admin not reported) dose was not reported,1 total administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, upon the vaccination patients had string of events among which the one patient experienced anaphylaxis, three patients have experienced hypotension and vomiting. And seven patients were taken for further review. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anaphylaxis, hypotension and vomiting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210416852-Covid-19 vaccine ad26.cov2.s-anaphylaxis. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.
Swelling of right deltoid - redness around inj. site and spread down arm - 2 days. Seen on Oct. 6 - arm still slightly red around bicep.
I had 102 fever the next day about 24 hours later.  That was fine, however, a few days later, my right knee and calf were swollen and I could not walk. I contacted my doctor and was sent for a Doppler to rule out a blood clot.  Negative for. Lot.
pt recv vax 21JAN97 & found out she was pregnant on 7FEB97 by a blood test;LMP 24DEC96;estimated date of delivery is 1OCT97;ultrasound nl;pt devel cervicitis in approx JUL97 @ 28wk gestation & tx w/med;pt delivered healthy infant 8OCT97;
Site: Bruising at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: overall tiredness in body-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: Weakness-Mild, Additional Details: mild mucus production in the chest
Red, hot, and itchy at injection site, turned pale, fast, pounding heart beat, dizziness and weakness.
Information has been received from a nurse referring to an unspecified number of patients. On unknown dates the patients were vaccinated with improperly stored VAQTA (lot#, expiration date, dose and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
On the day of the vaccinations, my son developed an extremely high fever. Early the next morning (03/30/12 at approximately 7:00am), he was rushed to the hospital because of febrile seizures. Prior to the vaccinations on that day, my son was developing normally and speaking several words. After that time, he was no longer speaking. By age 2, I noticed his language still wasn't developing. I took him to his doctor and was referred to a program for speech therapy. After several evaluations, it has been determined that my son is on the spectrum for Autism. We have just begun the evaluation process. He is still non-verbal and has many red flags.
pulse is typically in the 60s-low 70 and it was racing to 100/bad reaction of her heart racing; mitral valve prolapse; heart murmur; aches; bad muscle aches; joint muscle pain; Aches and muscle pains and joint muscle pain was that bad she could not move; chronic sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "muscle aches"; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "pulse is typically in the 60s-low 70 and it was racing to 100", "chronic sweating"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "chronic sweating", "muscle aches"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "pulse is typically in the 60s-low 70 and it was racing to 100". The following information was reported: HYPERHIDROSIS (non-serious), outcome "recovered", described as "chronic sweating"; PALPITATIONS (non-serious), outcome "recovering", described as "pulse is typically in the 60s-low 70 and it was racing to 100/bad reaction of her heart racing"; MITRAL VALVE PROLAPSE (non-serious), outcome "unknown"; CARDIAC MURMUR (non-serious), outcome "unknown", described as "heart murmur"; PAIN (non-serious), outcome "recovering", described as "aches"; MYALGIA (non-serious), outcome "recovering", described as "bad muscle aches"; ARTHRALGIA (non-serious), outcome "recovering", described as "joint muscle pain"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "Aches and muscle pains and joint muscle pain was that bad she could not move". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, she had a bad reaction of her heart racing, really bad muscle aches and chronic sweating for a few days, resting pulse was typically in the 60s-low 70 and it was racing to 100. Aches and muscle pains and joint muscle pain was that bad she could not move. 3 days the achiness started to go away and heart rate started to come down. The sweating took one month to go away. Patient had mitral valve prolapse and heart murmur and are several medications including any medications that have phedra or phedrine at the end of the medication name, or any cough medications with a D or DM on the end of the medication name. No specific products mentioned and no additional information provided.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201139221 similar report from same reporter;US-PFIZER INC-202201139222 similar report from same reporter;
Blank thoughts, a feeling of brainwashed, slurred speech, drooling, loss of smell, unable to communicate
lost ability to grip the right hand; Pain descending down from scapula to hand; Parsonage-turner syndrome; This spontaneous case was reported by a pharmacist and describes the occurrence of GRIP STRENGTH DECREASED (lost ability to grip the right hand), NEURALGIC AMYOTROPHY (Parsonage-turner syndrome) and PAIN (Pain descending down from scapula to hand) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02521A, 025B21 and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced NEURALGIC AMYOTROPHY (Parsonage-turner syndrome). On an unknown date, the patient experienced GRIP STRENGTH DECREASED (lost ability to grip the right hand) and PAIN (Pain descending down from scapula to hand). At the time of the report, GRIP STRENGTH DECREASED (lost ability to grip the right hand) had not resolved, NEURALGIC AMYOTROPHY (Parsonage-turner syndrome) outcome was unknown and PAIN (Pain descending down from scapula to hand) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electromyogram: results are not reported Results are not reported. On an unknown date, Grip strength: decreased (Low) decreased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient consulted physicians from pain management to orthopedist to spine surgeon to neurologist to physiatrist, also went to several other physicians and it confirmed by the neurologist. Patient lost ability to grip the right hand. Pain descending down from scapula to hand. Pain is gone but have no grip strength. Went to occupational therapist given some exercises. Prior to having the booster shot was going to jujitsu and a lot of that is grabbing the other person and no longer have the strength to grip anything. This still hasn't resolved.  Patient stated that the Syndrome is rare and there is only like 10 cases in the literature.  No Concomitant medication was provided.
Pt started experiencing tinnitus one week after vaccination. Pt's wife reports progressively worsening Myasthenia Gravis symptoms since third vaccination. Pt has been stable with his MG for two years until after vaccination. It is now worsening at a rapid rate. Pt is losing balance.
Child received vaccine on 8/03/22. Mom noticed red, bumpy spot on child on 8/31/22. Spots continued to appear over next couple days. Was seen in office on 9/03/22 with spots covering whole body. Provider confirmed diagnosis of vaccine-induced varicella.
father states pt was hospitalized 2 days p/vax for viral synd w/a t107 & consequently convuls;
I did not follow-up with the doctor as I slept for two days with difficulty.  Severe allergic reaction. My right side lymph node became severely swollen disrupting my ability to breath and very itchy.  This lymph node on the front side of the neck was protruding making it difficult to swallow.  Used breathing inhalers.  Immediately leaving the vaccination site my temperature went high and I had to take off my shirt while I began to sweat profusely.  When I arrive home I checked my temperature it would fluctuate between 98.6 and 101.  My vision became extremely blurred for two days.  I could barely see so I had to lay down and close my eyes and rest as I thought I was losing my vision.  These symptoms were adverse while standing.  General feeling of be unwell.
this is 1 of 3 pt from this facility to develop an inj site rxn characterized by redness, swelling, warmth & a knot 1 day p/vax;pt was seen by MD;
Infant developed frequent vomiting 10/21-22/08 overnight to the point of dehydration.  He also had some diarrheal stools.  He did not require IV fluids or hospitalization but responded to oral rehydration with Pedialyte.
Information has been received from a physician concerning a 11 year old patient who on 10/18/1995 was vaccinated with a dose of varicella virus vaccine live (lot 610248/0446B). On 5/15/2005 the patient developed a rash. On 5/16/2005 the patient was diagnosed by the physician with breakthrough chickenpox with less than 50 lesions. The patient was afebrile. There were no complications. The patient has no prior history of chickenpox. The patients breakthrough was not confirmed by a laboratory test. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Eye pain, progressive vision loss Oct 30 '16 later diagnosed as optic neuritis (11-6-16). Was placed on high dose steroids and has slowly seen reduction of the optic neuritis and improvement in her vision.
Patient's body was found on May 1st. Since the shot , he was complaining of tinnitus, sore legs, dizziness (passed our several times), loss of bowel control, and unable to maintain a stream of thought, which are stroke symptoms.  He has had surgery for blood clots in the past. He seemed to get worse in the weeks following the Jansen shot.
Local swelling, pain, and itching developed 2 days after vaccination.   Ensuing excoriations (patient has autism and scratched uncontrollably) resulted in doctor visit 8 days after vaccination.  Local reaction treated with a topical steroid.
to ED c/o SOB, wheezing, TX: 5lpm O2, duo nebs, pulmicort, singulair, zithromax, rocephin, steroids, vit C, zinc, remdesivir. D/C'd home
pain behind rt scapula 19NOV92; x-rays neg 23NOV92 tx Lodine; 25NOV92 referred to Orthopedic MD injected steroids no relief; also loss of energy, loss of appetite & low grade temp;
Systemic: Confusion-Medium, Systemic: Weakness-Severe, Additional Details: patient reports "terrible" confusion, muscle weakness for 3 days.  Much better after 3 days but is still having "problems with movement and thinking clearly"
This case was reported by a consumer via call center representative and described the occurrence of nausea in a 58-year-old female patient who received SHINGRIX (batch number PK9BY, expiry date 19th March 2021) for prophylaxis. On 16th October 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 17th October 2018, 1 days after receiving SHINGRIX, the patient experienced nausea and weakness. On 23rd October 2018, the patient experienced chest pain and viral upper respiratory tract infection. On an unknown date, the outcome of the nausea and weakness were not recovered/not resolved and the outcome of the chest pain and viral upper respiratory tract infection were unknown. It was unknown if the reporter considered the nausea, chest pain, viral upper respiratory tract infection and weakness to be related to SHINGRIX. Additional details reported as follows: The patient's husband was pharmacist and he administered a dose of SHINGRIX to the patient at their home. The day after the vaccination, the patient experienced nausea and weakness. The patient had difficulty to getting out of bed. The patient went to a physician and diagnosed with a viral upper respiratory tract infection. The patient had denied permission to contact their physician. This case has been linked with case US2018195931 (vaccinated with same lot number and expiry date), reported by the same reporter.
1 WEEK OF INTERMITTENT HICCUPS, BIBASILAR INFILTRATES ON CXR (10/30)
Initial and follow up information has been received from a physician concerning a 79 yr old retired female pt who on 16Nov04 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 650084/0605P). On 16Nov04 the pt developed cellulitis at the injection site, including symptoms of severe pain, erythema, and induration at site. It was reported that the cellulitis was self-limited and resolved in 5-7 days. The physician also noted that the pt saw local doctor for follow up and there was no illness at the time of vaccination. No treatment was required other than ice, observation and analgesics (unspecified) for one week. It was also reported that the pt recovered on an unspecified date. The physician reported that this pt received a previous dose of pneumococcal 23v polysaccharide vaccine in 1992. Additional information is not expected.
11 hours after vaccine, chills started.  Fever, chills, severe headache and body aches, and fatigue over next 24 hours.  Bedridden, would not have been able to work or care for my children.  Left eyelid began twitching at that time and has continued to have intermittent periods of twitching over the 5 days since.
This spontaneous report as received from a other health professional refers to a 4 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N014371, expiration date 09-MAY-2019 or lot# 019133, expiration date 22-JUN-2019 (dose was not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees Fahrenheit for 1 hour and 45 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA009100: US-009507513-1710USA009099: US-009507513-1710USA009022: US-009507513-1710USA009098.