chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extremely fatigued; Reduction in energy level; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 14Apr2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, type 2 diabetes and asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:ER8727) via an unspecified route of administration in the right arm on 23Mar2021 at 14:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 09:00, the patient had been extremely fatigued and had a noticeable reduction in energy level since the day after receiving second dose. She was unsure if it is related or merely coincidental but felt that she should report it just in case. No therapeutic measures were taken as a result of the events. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely fatigued and had a noticeable reduction in energy level was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
administration of an expired product with no reported adverse event; Initial information received on 22-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA235929(CLUSTER), 2023SA257557(CLUSTER) and 2023SA258504(CLUSTER).  This case involves a 1 years old male patient who was administered with an expired product DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB) for Prophylactic vaccination.  On 16-Aug-2023, the patient received 0.5 ml dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE with no reported adverse event (expired product administered) (latency: same day) (Suspension for injection) Frequency = Once, Strength = Standard (lot C5893AA and expiry date: 21-Jun-2023) via intramuscular route in the left thigh for immunization.  It was reported that "Caller with question on whether dose needs repeating. Caller also requesting standard to be re-sent regarding expired dose of ACTHIB previously reported."  Action taken: Not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Too young.  Mom reports child experienced body aches and tiredness starting the evening after getting vaccinated and ending the afternoon the day after vaccination.
Mild dizziness and nausea. It's extremely mild but what gives me pause and made me decide to report it is that I've now had these symptoms for almost a week, and received the shot exactly one week ago.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 22-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
pt recvd vax & pt devel a knot, & redness @ the inject site, & a fever;
Fever and chills 8-10 hours after receiving the injection. Significant reduction in breast milk supply (from 30+ ounces pumped per day to less than 2 ounces).
With C/O chest tightness 10 days post primary SPV. The tightness progressed to "constant pains across his anterior chest" that worsened gradually (5-6/10) with lying down, walking and deep breathing. NO F/C/N/V/D. Mild SOB. No radiation of pain. Pain mid chest. No numbness or tingling. Pain worsened a lot today. Went and had ST elevations inferiorly and laterally. Troponin 1.95. Medivac'd. Given LOVENOX, LOPRESSOR 10 mg, but BP 100/70 after 4 liters of fluid.
11 year old patient received adult Pfizer dose (0.3 mL). Both the child (patient) and parent were untruthful about the patient's age and verbally stated that patient was 12 years old. However, upon processing, it was discovered that this patient was actually 11 years old and parents confirmed that after pharmacy called to follow up. Patient is 3 days from turning 12 years old but not 12 yet.
Patient passed out in the middle of the night...not at site and hours after the dose was administered.
I received my booster vaccine and unlike my previous vaccines my arm was sore within hours of receiving the shot, my entire arm remains sore for several days. The other adverse event I experienced was the overall feeling of malaise and fatigue that lasted more than 24 hours. I did not experience this with my first two doses of the moderna covid-19 vaccine. I had a sore arm for a day or two, had mild fatigue and headache the next day. I received my booster on a Sunday and today is Friday and I'm finally starting to feel like myself again.
Pt went to ER with complaints of headache, hives, slight shortness of breath.  Please review attached ED report.
3/8/2023 felt like getting sinus infection.  3/10/2023 Rapid and At Home COVID-19 Tests positive.  Doctor proscribed Paxlovid and cough syrup, and to treat symptomatically.  3/11 started to have symptom improvement, mostly feeling gradual lessening of sinus pressure and pain.  Fully recovered by  3/16.
Upon awakening on 10/16/09 the resident was noted to have bilateral orbital and mild facial edema with faint hives on face and neck.  The resident had an uncomplicated dental extraction earlier that day and also rec'd one tab of Tylenol #3 (Tylenol 300mg/Codeine 30mg), which he does not recall ever having before.  It is unclear which event lead to the allergic reaction.
Pt developed a blistering rash on neck and shoulder/back on left side of body. It developed 2 days after vaccine was given. Pt went to his doctor who prescribed Valtrex 1gm 1 tablet every 8 hours for 7 days. Patient is to follow up with doctor in about 3 weeks to see how the rash progresses and to see if he should get the 2nd dose once the rash clears.
Patient was not feeling well, had dizziness, fever, headache, nausea, loss of appetite, discomfort, redness and swelling the vaccine inj. site 1st 2 days, on 3rd day swelling of legs also.
constantly cold and could not get warm; head felt like it had swelled up; sore arm; swollen arm; aches in her bones ,joints and muscles; constantly cold and could not get warm; dizziness; Headache; nausea; tired; chills; aches in her bones ,joints and muscles; aches in her bones ,joints and muscles; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (constantly cold and could not get warm), SWELLING (head felt like it had swelled up), PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen arm) and BONE PAIN (aches in her bones ,joints and muscles) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced NASOPHARYNGITIS (constantly cold and could not get warm), SWELLING (head felt like it had swelled up), PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen arm), BONE PAIN (aches in her bones ,joints and muscles), COUGH (constantly cold and could not get warm), DIZZINESS (dizziness), HEADACHE (Headache), NAUSEA (nausea), FATIGUE (tired), CHILLS (chills), MYALGIA (aches in her bones ,joints and muscles), ARTHRALGIA (aches in her bones ,joints and muscles) and VACCINATION SITE ERYTHEMA (redness at injection site). At the time of the report, NASOPHARYNGITIS (constantly cold and could not get warm), SWELLING (head felt like it had swelled up), PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen arm), BONE PAIN (aches in her bones ,joints and muscles), COUGH (constantly cold and could not get warm), DIZZINESS (dizziness), HEADACHE (Headache), NAUSEA (nausea), FATIGUE (tired), CHILLS (chills), MYALGIA (aches in her bones ,joints and muscles), ARTHRALGIA (aches in her bones ,joints and muscles) and VACCINATION SITE ERYTHEMA (redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
ATARAX 25 mg tab, one tablet by mouth four times a day as needed. Painful lymphnodes in neck and left armpit eight days after imm. Red rings on abdomen and arms two days after inoculation. Runny nose, sore, itchy throat for last five days. The patient is a 23 year old male. "I received the small pox immunization 1 week ago and about 24 hours ago these red pronounced rings just started popping up first showing up on my chest and abdomen." "I have had tenderness to the lymphnode's on my neck and left armpit for 2 days after the immunization." "I have had cold like symptoms for about 5 days recently and nothing other than a sore throat, runny nose and itchy throat." "I have an allergy to latex powder." "When I washed or showered I used my hand and soap rubbing over the immunization and over my whole body." Feeling tired. Neck pain and swollen glands in the neck. Itching of the eyes. Nasal discharge and sore throat. Cough. Rash.
Warm to touch at injection site; Redness at injection site about 2 inches long; Lump at injection site; A spontaneous report  was received from a consumer concerning a 58-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lump, redness at injection site about 2 inches long and warm to touch at injection site.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 02 Mar 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch: 014M20A) Intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 03 Mar 2021, the patient experienced lump at injection site (episode 1), redness at injection site about 2 inches long (episode 1) which was there over a weekend and went away. On 12 Mar 2021, the patient again experienced same redness (episode 2), lump (episode 2) little bigger and warm to touch at injection site. No treatment information provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events lump at injection site (episode 1) and redness at injection site about 2 inches long (episode 1) was resolved on 08 Mar 2021. The outcome of redness at injection site (episode 2), lump at injection site (episode 2) and  warm to touch at injection site was not reported.
Lymph nodes under arm swollen over 6" to convex, itchy at injection site, upper arm pain, chills.  This second shot was a walk in the park to the reaction of the first shot. Itchy went away for 24 hours after a workout. All of the reactions were gone in just a few days this time.
Initial report was received on 18 and 20 January 2011 from a health care professional. This case represents one of a cluster of 4 patients from the same reporter, same vaccine, same lot number, and who experienced adverse events requiring emergency room visits after receiving FLUZONE HIGH-DOSE on different dates. One patient was hospitalized. Information regarding the patient who was hospitalized is reported in case number 2010-01674; information regarding the other 2 patients are reported in cases 2011-00251, and 2011-00252. A 48 year-old female patient, who had concurrent illnesses of malaise and anemia had received an intramuscular left deltoid injection of FLUZONE HIGH-DOSE (lot number U3726AA) on 13 October 2010. At an unspecified amount of time later, she experienced extremely strong metallic taste, a scratchy throat, face felt a little numb, lips were tingling, she was "swelly", bottom of lip looked swollen, and her face was swelling. The patient required a doctor visit only (emergency room visit was not mentioned) and was advised to get evaluation for allergic reaction to flu shot. Treatment received was not reported. The patients medical history included: no known drug allergies, active menorrhagia, rheumatoid arthritis, major depressive disorder, recurrent episode, unspecified degree, fibromyalgia, fatigue and malaise, and hyperlipidemia (NOS). Patient had post-operative OBGYN appointment on 11 January 2011 (reason not identified). Patient stated she had 5 prior influenza vaccinations in the past with no reactions. The patient recovered, but a recovery date was not provided. Documents held by sender: None.
Pt recvd 3 doses of Engerix-B & titer neg for seroconversion p/33rd dose; pt recvd 4th dose of Engerix-B; titer pos;
Site for the injection was swollen, inflamed and very hard per patient the night of vaccine day. Upon inspection by me the next day the local site was extremely hard , swollen and inflamed above regular.
The night of the first shot I developed fatigue and chills. I felt relatively fine the next day. I felt more tired than usual in the days following the shot and overall felt "sick" for about 3 weeks.  After a few days and into the next few weeks I began to experience tingling in my lower arms, wrists and hands - both. It felt as though my circulations was being cut off. I later developed similar pain in my lower legs - calves and ankles and cramping in my feet. I feel worse after my second shot in terms of joint pain, fatigue - all over my body there is pain. I have been taking Tylenol for arthritis which seems to help somewhat - but there is always a level of pain and fatigue that remains even after the Tylenol.
Patient developed a fever the evening of the 10th  (the day he was vaccinated) and continued to have a fever for the entire following day. It was difficult to take his temperature but at one point, it was 101.5 even after he had take Tylenol.  He also experienced pain at his injection site. He slept very poorly the evening of the 10th and was very tired the following day. By the morning of the 12th he appeared to be recovered, though he was still experiencing some tenderness at the injection site, as evidenced by him being afraid to put pants on because he didn't want anyone to touch his thigh.
102 fever, tired. Took acetaminophen for fever and slept a lot. Fever started 2 days ago. Still have fever and feel tired.
Poor quality vaccine administered with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2023SA129826.  This case involves Infant and unknown gender patient who had poor quality vaccine administered with no reported adverse event after receiving vaccine hib (prp/t) vaccine [act-hib].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 ml of suspect hib (prp/t) vaccine Powder and solvent for solution for injection (unknown strength), lot UJ756AAA, expiration date- 12-aug-2023  via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious poor quality vaccine administered with no reported adverse event (poor quality product administered) (unknown latency).  It was unknown if there were lab data/results available.  Action taken was not applicable.  Outcome: Unknown for the event poor quality vaccine administered with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA124713:
Patient reported waking up this morning around 5 am not feeling well.  Dizziness, perfuse sweating, headache, slight nausea and all over body aches.  He denied having any known issue with blood sugar or blood pressure.  He checked his blood pressure while at the store at is was 109/65.  I informed him that was a low normal but he did not know what his BP was normally.  He stated he was supposed to drive to Indiana to see family and then to a camp where he would be a counselor.  I told him that while he did not have any adverse reactions to the first two doses that his description  of symptoms could possibly be normal reaction to the vaccination.  He had not eaten or drunk much ( half a cup of water and part of a protein bar)when he came in to the store.  I gave him a bottle of water and advised him to go home, rest and try to eat and that if he felt worse to seek medical attention.  I attempted to call aroun 5:30 pm 07.16.22 but did not get an answer.
The product was refrigerated on 18NOV2021 beyond expiration date 3OCT2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (The product was refrigerated on 18NOV2021 beyond expiration date 3OCT2021) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The product was refrigerated on 18NOV2021 beyond expiration date 3OCT2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (The product was refrigerated on 18NOV2021 beyond expiration date 3OCT2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. No adverse events were reported. No temperature excursion was reported.
On Tuesday, October 9, 2018 I received a flu shot administered by our school nurse. It was approximately 3:15 pm. I worked until 4:00 pm and checked out. Instead of heading home I had a couple of errands to run. On my way, at approximately 4:15 pm, I began to sweat profusely, vision became blurry and I was confused. I kept driving because of the confusion I wasn't sure of what to do. I got to the intersection where there is a store on my left and another store on the right. From that point on I don't remember a thing. I was at that point anxious and confused. I kept driving and my driving became very erratic. There was an off duty detective behind me that took a video of my driving. It was a miracle that I did not kill someone or kill myself. I continued to drive until I ended up in a corn field. I do not have a copy of the police report yet, so I'm not sure exactly where I ended up. I believe I drove for 15/20 minutes. When stopped, two ambulances came and one of the respondents recognized my condition as a diabetic coma, low blood sugar. After checking the count he administered a glucose solution which he had to force down my throat since I was confused, scared and combative at this point. I was taken to the local hospital emergency room where I was treated. I was diagnosed with Hypoglycemia. Tests ran were CBC and Auto Differential, Comprehensive Metabolic Panel, Magnesium level, Metered blood glucose, Troponin 1 Ulta sensitive, Urinalysis and reflex Micro and Urinalysis Microscopic. After eating something and resting my blood sugar came back to the normal range. I was sent home with family supervision. I still have no recollection from the time I left until I stopped in the field. I followed up with more blood work on Thursday, October 11, 2018. Everything was in the normal range with slight dip in magnesium. I would like to add that there were 4 other staff members who got the shot out of the same vial that became ill. One staff member ended up in the hospital and one other was very affected by the shot. The flu vaccine that we received, I believe, needs to be tested to find out what was in it. The symptoms that I experienced would lead me to believe there was something, probably insulin, mixed with the flu vaccine.
Information has been received from a consumer concerning a 6 year old female, with no known drug reaction or allergies and born with a good APGAR score, who was vaccinated with a first, second and third dose of hepatitis B virus vaccine rHBsAg on 16-MAR-1999 (lot number "1799H'), 26-APR-1999 (lot number 629631/0195J), and 08-DEC-1999 (lot number 632215/0967J), respectively. Suspect vaccination on 07-MAR-2000 included a dose of MMR II (lot number 633599/1510J) and a dose of varicella virus vaccine live (lot number 632376/1684J). Post vaccination with hepatitis B vaccine, MMR II, and varicella virus vaccine live the pt developed mercury poisoning. The pt was diagnosed with autism and was not able to talk, she would only repeat back what was said to her. The pt could not chew and was on baby food until 5 years of age. It was reported that the pt was on chelation therapy and was improving somewhat. Unspecified medical attention was sought. There was no product quality complaint involved. The pt's mercury poisoning and autism were considered to be disabling. Additional information has been requested.