chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered improperly stored RECOMBIVAX HB; No additional; This spontaneous report was received from a Pharmacist, referring to a patient of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided.    On an unknown date, the patient was vaccinated with and incorrect stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (pediatric formulation) lot # T004378 with expiration date on 01-NOV-2022 (strength and route were not reported) for prophylaxis, however no adverse effects reported.    It was reported that the vaccine was exposed to temperature of 34.5 Farenheit grades range for a time frame of 30 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved.
4/25/04. Pt developed abdominal pain. 4/26/04 pt developed fever, t-100.6 and was lethargic with a headache plus a rash on trunk, head and extremities. Pt was seen in our office on 4/27/04 by Dr. with erythematous macules with fluid filled papules on trunk axilla, scalp, ear canal, ankle and webs of fingers- 50-60 lesions. Diagnosed with Varicella by Dr.
paramedics called to child school 255Pm d/t sz;hx fever 102-104;pt transported to ER T101;pt given APAP & child motrin;d/c w/family from ER 5PM;seen @ clinic 13OCT97 w/fever 102 sent home w/APAP;
Fever, fatigue, diarrhea. Fever and fatigue kicked in night/day after receiving the shot, and diarrhea started second night/day after
After my second dose I had a swollen throat; Caused me issues with swallowing; I also had a swollen lymph node; After that I have continuous struggles with this abnormal break out of hives and have been in a chronic state of itchiness and lifted skin since last receiving my shot; After that I have continuous struggles with this abnormal break out of hives and have been in a chronic state of itchiness and lifted skin since last receiving my shot; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 12Jul2021 at 18:30 (Lot number: unknown) at the age of 18 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any concomitant medication. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: Unknown, Anatomical site: Left Arm, Administration Time:18:00), administration date: 21Jun2021, when the patient was 18 years old, for COVID-19 immunisation.  The following information was reported: PHARYNGEAL OEDEMA (non-serious) with onset 16Jul2021 at 17:00, outcome "not recovered", described as "After my second dose I had a swollen throat"; DYSPHAGIA (non-serious) with onset 16Jul2021 at 17:00, outcome "not recovered", described as "Caused me issues with swallowing"; LYMPHADENOPATHY (non-serious) with onset 16Jul2021 at 17:00, outcome "not recovered", described as "I also had a swollen lymph node"; URTICARIA (non-serious), PRURITUS (non-serious) all with onset 16Jul2021 at 17:00, outcome "not recovered", and all described as "After that I have continuous struggles with this abnormal break out of hives and have been in a chronic state of itchiness and lifted skin since last receiving my shot". The events "After my second dose I had a swollen throat", "Caused me issues with swallowing", "I also had a swollen lymph node" and "After that I have continuous struggles with this abnormal break out of hives and have been in a chronic state of itchiness and lifted skin since last receiving my shot" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pharyngeal oedema, dysphagia, lymphadenopathy, urticaria and pruritus. Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. It was also reported that, the patient had never experienced this in her life until after receiving her second dosage of Pfizer and her body had not been the same since.   The lot number for BNT162b2 was not provided and will be requested during follow up.
On 12/20/20 i had received the Moderna covid vaccination.  3 days after i had recieved the vaccination i had felt like i had a stiff neck on the same side of my body that i receive the vaccination on. I had just ignored it until i noticed a "bump" on the side of my neck. I felt it and felt a large swollen lymph node. Again I had decided to ignore the reaction as i figured my antibodies were at work. I had decided to not get the second dose 28 days later as the lymph node had not gone down yet. It is now 06.04.2021 and the lymph node is still there, at this point it is causing an uncomfortable pain in my neck as it is growing.  I would like a letter stating i am medically except from receiving the second vaccination in order to fly.  Thank You.
headache; light-headed; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced headache and light headedness. On an unknown date, the outcome of the headache and light headedness were not recovered/not resolved.   It was unknown if the reporter considered the headache and light headedness to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-JUN-2022 Reporter's Comment: The patient reported this case via interactive digital media. The patient received dose of Shingrix vaccine and experienced headache and felt light-headed a week after the vaccine. The patient asked was it possible to still have a headache and feel light-headed a week after the vaccine. Additional supportive information: The follow-up would not possible, as no contact, details were available.
I received the Pfizer Bivalent booster for COVID-19 on 9/27/2022. I developed a sore throat on 10/30/2022, and it persisted for several weeks. Shortly thereafter, I also developed nasal congestion and a cough, both of which also persisted for several weeks. On 11/18/2022, I then also developed fatigue, body aches, and a low-grade fever of 99.9. During this entire time, I tested myself for COVID-19 3 times a week, as it is a requirement at my workplace. None of my tests yielded a positive result until 11/18/2022. On that day, I took a home antigen test and got a positive result. I spoke to a doctor on the phone afterwards, and he did not believe that I really had COVID-19. He asked me to undergo a PCR test for confirmation of the positive result on the home test, which I did, and it also yielded a positive result. Afterwards, I spoke to a doctor through an online service, and I was prescribed PAXLOVID, benzonatate, and an albuterol inhaler. I continued to feel sick afterwards, and I didn't begin to feel better until 11/26/2022. By then, my cough had greatly diminished, and I no longer felt winded whenever I moved around. It was also the first time since the onset of illness that I was able to get out of bed and resume some of my normal activities. I took another home antigen test on 11/25/2022 and got a negative result. My symptoms have continued to improve ever since. I still sometimes have a slight cough and a little bit of phlegm, but they're nothing major.
Information has been received from a consumer concerning her 16 year old daughter with no known drug allergies who on 11-MAY-2007, 06-AUG-2007 and 13-NOV-2007 was vaccinated with the first, second and third doses of GARDASIL (lot# not reported). Mother reported that in "April 2008", the patient became pregnant and delivered a normal baby in "December 2008". Mother reported that "2 weeks ago" approximately on 22-SEP-2009 during a regular Pap smear checkup, the patient was tested positive for HPV (strain type unspecified). Mother noted that the patient was not hospitalized when the patient was tested positive for HPV but mother did not specify if the patient was hospitalized when the patient delivered her baby. At the time of the report, the patient had not recovered. Additional information has been requested.
pounding pain on left side of her breast again; punching pain; tightness under her left breast; chest pains; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 10 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 07Jan2022 11:15 (Lot number: FK5618) at the age of 10 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "chest pain", start date: Oct2021 (unspecified if ongoing), notes: Back in October she had chest pain; "tightness under the left breast" (unspecified if ongoing), notes: Back in October she had tightness under the left breast; "obese" (unspecified if ongoing), notes: HCP contributed the pain to being obese; "heart surgery" (unspecified if ongoing), notes: had heart surgery at 8 months. Family history included: "4 silent heart attacks" (unspecified if ongoing), notes: Caller states that she, herself, has had 4 silent heart attacks; "heart issues" (unspecified if ongoing), notes: Caller states that there are heart issues in their family. Concomitant medication(s) included: PROZAC; CLONIDINE; CLARITIN [LORATADINE]; FLONASE [FLUTICASONE PROPIONATE]; VIT D [VITAMIN D NOS]. The following information was reported: BREAST PAIN (non-serious) with onset 07Jan2022, outcome "unknown", described as "pounding pain on left side of her breast again"; PAIN (non-serious) with onset 07Jan2022, outcome "recovered" (Jan2022), described as "punching pain"; CHEST DISCOMFORT (non-serious) with onset 07Jan2022, outcome "unknown", described as "tightness under her left breast"; CHEST PAIN (non-serious) with onset 07Jan2022, outcome "unknown", described as "chest pains". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain.  Additional Information: The parent stated that shortly after the vaccine, within a couple of hours later, the patient began experiencing the pounding pain on left side of her breast again. In Oct2021, the caller's daughter was experiencing some chest pains and because of heart issues in their family, the caller states she chose to take her to get an EKG and and ECHO everything came back fine. Caller states they told her the chest pain may be coming from her daughter being obese, she was about 170 pounds and is 10 years old. Her daughter had not had any chest pains since then. Caller states that about 2 days ago, around Tuesday or Wednesday, her daughter was having a little bit of tightness under her left breast. Caller states that when they told them all of this at her daughter's appointment for the Covid vaccine, they told her to wait before getting the vaccine. They told her pediatrician, primary care physician, who gave the go ahead for her to have it. They told her to wait 30 minutes after getting the vaccine, to make sure the patient was ok and then she was cleared to go home. About an hour or so after coming home, her daughter started talking about the same punching pain, felt under her breast.
TESTED POSITIVE FOR COVID-19; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-JAN-2022, the patient experienced tested positive for covid-19. Laboratory data included: COVID-19 rapid POC test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Vaccination given- Janssen, 03/15/2021, right deltoid c/o fever day of vaccine, subjective lasted 3 days 03/18/21,onset of upper abdominal pain,left arm pain, left foot sweeling, ankle to toes,  currenlty swelling to foot has resolved,  continues to have left arm pain, tingling sensation to left arm and abdominal pain with intermittent SOB "It is not related to my asthma" abdominal pain is intermittent, happens at random times, currently abdominal pain 4//10, best 0/10, worse 9/10, Acetaminophen relieves the symtoms, not sure what is exacerbating the pain  >denies pain, swelling to injection site, fever, chills, fatigue, bodyaches, leg pain,  hives, n/v, diarrhea, neurological deficits, change in level of consciousness, seizure activity, visual disturbances
PATIENT HAD NO ADVERSE EVENTS. VACCINE WAS ADMINISTERED OUTSIDE OF STATE SUPPLY TERMS AND CONDITIONS
Shortness of breath several days in a row, nausea several days, headaches several days.  Went to emergency room on June 2, 2020 to be treated for symptoms.
No additional AE details were available; Caller states they gave VARlVAX with 0.9% sodium chloride instead of the sterile diluent.; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On 26-MAR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) as prophylaxis (route of administration and anatomical location were not provided; dose, vaccination scheme frequency, lot number and expiration date were unknown by the reporter), however, the reporter stated that they gave varicella virus vaccine live (oka/merck) (VARIVAX) with 0.9% sodium chloride instead of the sterile diluent (product preparation error). No adverse event was reported.
The product was placed in refrigerator on 26 OCT2021 beyond expiration date 13 OCT 2021and administered; 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 placed in refrigerator on 26 OCT2021 beyond expiration date 13 OCT 2021and administered) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-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 placed in refrigerator on 26 OCT2021 beyond expiration date 13 OCT 2021and administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (The product was placed in refrigerator on 26 OCT2021 beyond expiration date 13 OCT 2021and administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No adverse events were reported. No temperature excursion was reported.  Treatment information was not provided.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 31-DEC-2010, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-MAR-2017, the patient was treated by a nurse practitioner for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 28-MAR-2017, she sought subsequent treatment from the nurse practitioner for ongoing and worsening symptoms of herpes zoster infections. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report as received from an 81 year old female consumer refers to herself with no pertinent medical history and no drug reactions/allergies. On 16-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, strength, dose, route and site not reported). Concomitant medication included blood pressure medications and baby aspirin (also reported as treatment). On 16-APR-2013, the patient experienced redness, swelling, tenderness and 2 pin sized brown "spots" at the site of the injection after receiving the dose of ZOSTAVAX. The swelling was about 2 inches in diameter. Aspirin was given for treatment. No laboratory diagnostics studies were performed. The outcome of the events was reported as not recovered/not resolved. The patient saw a pharmacist for medical attention. This is one of several reports from the same source. Additional information has been requested.
My menstrual cycle has been REGULAR since I was about 25 years old, every 28-29 days, without fail, until I was pregnant.  2021 cycles 1/1, 1/29, 2/26.  My 2nd dose was 3/11/2021 and then did NOT have my period until 5/7. I had not been sexually active for over 1 year prior to that date. So no Chance of pregnancy.  6/27 was next period.  Have not had my period since 6/27. I recently read in news that some females menstrual cycles became off after the vaccine. My dr checked for pregnancy and menopause only 9/7/2021 during woman wellness exam. I only checked my period dates after I viewed news article & seen my period dates are nowhere near regular.
Red circle at injection site. Redness is about 4 inches in diameter and warm to the touch. Patient denied any itching or pain at injection site. No other symptoms noted.
Symptoms as described by patient: "arm is pulsing  and  sore with radiation down tricep" also "whole body weakness, had throbbing arm right after shot; unable to lift shoulder without pain. Had felt weak, SOB and nauseated for about 4 days. Missed 2 days of work." Treatment: none attempted at the time of report; first aid options described and encouraged Outcome: still complaining of arm soreness.
pt recvd vax;severe pain in arms & legs from about 6 hrs p/wards;also backpain,fatigue & facial rash;grand mal sz about 24 hrs p/ inject & 3 day ICU stay for encephalopathy;
AFTER HEP A AND HPV WERE GIVEN, CLIENT BEGAN TO SHAKE, EYES ROLLED TO THE BACK OF HIS HEAD, HIS BODY STIFFEND AND LEGS CONTRACTED. HE COULD NOT HEAR FOR A BRIEF TIME, HIS SKIN BECAME COOL AND CLAMMY AND THEN WARM. HE BECAME DIZZY AT THE ONSET AND TOLD US SOMETHING WAS WRONG. WE LOWERED HIM TO THE FLOOR, SUPPORTING HIS HEAD. APPLIED A COOL TOWEL TO HIS FOREHEAD, TOLD HIM TO BREATHE AND RELAX, STARTING TAKING VITALS. THE INCIDENT TOOK ONLY A FEW MOMENTS, BUT WE PLACED HIM ON OUR TABLE AT A 45 DEGREE ANGLE AS HE STILLED COMPLAINED OF DIZZINESS, NAUSEA AND FEELING 'WEIRD' WE OBSERVED HIM FOR ONE HOUR RECORDING BP AND PULSE LOWEST BP WAS 90/50 AND PULSE RAN IN THE UPPER 60'S.
5 mins after receiving Gardasil pt had vasovagal symptoms, lasted approx 5-10 min.
The night after the injection he started feeling chills for a week; The night after the injection he started feeling headaches off-and-one for a month; The night after the injection he  experienced vomiting; The night after the injection he started feeling soreness out the injection site.; Patient received the PNEUMOVAX 23 once "about 14 years ago", another "sometime last year", and just received an booster shot on 29-OCT-2020 .; This spontaneous report was received from a 67 year old male patient reporting on himself, with high blood sugar, and high blood pressure. The patient was allergic to Iodine, and some forms of plastic. Concomitant therapies included insulin and lisinopril. In approximately 2006 (reported as "about 14 years ago"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23).  On an unknown date (reported as "sometime last year"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown). Subsequently, on 29-OCT-2020, the patient received a booster shot of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) because it was recommended (prophylaxis).  The patient reported that the night after the injection, he started feeling chills for a week, headaches off-and-on for a month, vomiting, and soreness out the injection site. The patient did not seek for medical attention.  At the time of the report, the outcome of chills, injection site pain, vomiting and headache was reported as not resolved. The reporter did not mention the causality assessment between the events and Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) vaccination.
Case number PHEH2014US024994 is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 67 years old female patient. Past medical history and concomitant medications were not reported. The temperature excursion of FLUVIRIN (batch number: 145701) began around 16 Oct 2014 and the patient received the vaccine intramuscularly at a dose of 0.5 ml on 28 Oct 2014. It was reported that the vaccine administered was at 49F 12 times over a period of 34 days. There were 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46 to 49 F during each of those excursions. No adverse events were reported following the maladministration
Pt. experienced syncopal episode after receiving inj.-Pt. fell to floor and struck back of head on floor. Pt. c/o dizziness and head pain after.
Had 200  BPMS per EKG on ambulance and was treated intravenously by ambulance medic to stabilize heart rate. Felt dizzy, short of breath, shaking, like I was going to faint, heart beating super fast. Went to emergency room via ambulance.  Doctors say it was a heart arrhythmia, Specifically SVT. I was kept there for 24 hours for observation and additional testing. Not a stroke nor blood clot. I have been prescribed Metoprolol to control the arrhythmia going forward.
Patient was given a Moderna shot that had been in the fridge in for 35 days instead of 30, so it was 5 days past its BUD. The patient experienced no adverse effects. And Moderna stated the patient did not need to re-vaccinate.
A few hours after the dose, patient started to develop sore joints. The next day when she woke, she started to develop severe back pain, and pain going down both arms.  She also experienced nausea, severe stomach pain, and headache. These all have become less over time.
Erythematous maculo papular lesion noted over R lower jaw with pain within 3 days after Zostavax. Did not improve with Valtrex 1g ID Q 8 hrs x 7 days