chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received on 06-OCT-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. It is complained and alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route and lot # were not reported) on or about 26-JUL-2010, as logged in the Immunization Registry, and recommended for routine adult health maintenance and for the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about  18-JAN-2016, the patient was treated at an Urgent Care facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 27-JAN-2016, the patient received subsequent treatment for ongoing and worsening symptoms of shingles outbreaks. The patient has been prescribed acyclovir, prednisone, hydrocodone-acetaminophen, and gabapentin for management of her painful condition. 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, pain and suffering and other damages. Additional information has been requested.
Case number PHEH2044US003650 is an initial spontaneous report received from a pharmacist on 21 FEB 2014 with a follow-up received on 25 MAR 2014. This case refers to an 11 years old female patient. She had no know drug allergies. Concomitant medication included clonidine. She was vaccinated with FLUCELVAX (batch number: 009031A and expiry date: JUN 2014), at a dose of 0.5 ml intramuscularly on 04 NOV 2013 at 7:30 PM. No adverse event was reported following this administration error.  Follow-up from pharmacist received on 25 MAR 2014. Concomitant medication and time of vaccination was updated.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 25 MAR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administered to child".
Pt recvd 3 doses of Engerix-B vax, 3rd dose given 21JUN90 & it was determined that pt did not convert to a protective surface antibody level;
No adverse reactions on any previous vaccine.  I have had all required vaccines during my childhood and the flu vaccine a couple of years ago.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's concomitant medications included MERCK STERILE DILUENT lot# M039200 expiration date 03-MAY-2019. The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On 07-FEB-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD  injection, lot # N022972, expiration date 19-FEB-2019, for prophylaxis (frequency, route and anatomical location were not provided). The administered dose of vaccine experienced a temperature excursion in the range between 6°F to 14°F during 6 hours as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA003986: US-009507513-1803USA007255: US-009507513-180 USA007256: US-009507513-1803USA007258: US-009507513-1803USA007259.
9/21/2016 Patient had a flu shot. (Pseudoephedrine). When he returned to his home by 3:30 pm he fainted and he had a temp of 102 and his head and body severely swollen. Some what better. 09/26/2016 Emergency room had trouble breathing. Patient was sick for 10 days.
3 chicken pox on face, shot site swollen small egg size and bright red around it, face swollen red with itchy blotches  itch was 8 on scale of 10. Extreme joint pain and muscle pain.
Fever 101.7F,  severe weakness, headache, body aches, chills, heat waves, burning eyes, painful (not sore) L arm at the injection site
APPROXIMATELY 15 MIN AFTER VACCINE ADMINSTERED AND BLOOD DRAWN, PATIENT GOT UP FROM CHAIR TO LEAVE AND WAS STANDING WAITING FOR MOTHER WHEN SUDDENLY FELL/FAINTING TO THE FLOOR. PATIENT HIT HIS HEAD ON FLOOR. NURSE ASSESSED PATIENT IMMEDIATELY ON IMPACT AND PATIENT RESPONDED SLOWLY TO VERBAL COMMANDS, ORIENTED X 3. PATIENT INITIALLY PALE AND COLD TO TOUCH. V/S:  B/P @ 100/60, HR @ 87, RR @ 24, O2 SAT @ 100%. HOSPITAL RESPONSE PROCESS INITIATED AND PATIENT SENT TO THE EMERGENCY ROOM OF THE HOSPITAL WITHIN 10 MINUTES WITH MOTHER ACCOMPANYING PATIENT. UPON FOLLOW-UP, PATIENT DISCHARGED FROM ER AND NO FURTHER ADVERSE EVENT/OUTCOME.
Loss of vision in left eye-partial loss in Rt eye. Sight is blurry but not good. Has not seen Dr yet. Additional information: Unaware that pt had RxN. No on e by the name works here to have reported this.
This spontaneous report as received from a physician refers to a 4 month old patient. On 22-APR-2014, the patient was vaccinated with second dose of expired ROTATEQ, lot # H013539, expiry date 28-MAR-2014, dose (unknown) and route of administration (unknown). No concomitant were reported. No product quality compliant was involved. The outcome of events was unknown. No other information was reported. This report is linked to 1405USA001639 and 1405USA006753 by the same reporter link. Additional information has been requested.
It was reported in a published article, that a female pt's mother was vaccinated with a dose of rubella virus vaccine live II in 1984. Subsequently the pt, who was born in 1988, and who was breast-fed developed severe dyslexia, learning disabilities and ADHD. It was also reported that "in spite of its limitation, this study suggests that an autism/vaccine connection may exist." Upon internal review, ADHD was considered to be an important medical event (OMIC). It was unknown if medical attention was sought. Follow up: A copy of the published literature article is attached as further documentation of the patient's experience.
Immediate pain in right arm with administration of vaccine. 30 mins after administration noticed shooting pain in to elbow. Shooting pain has continued through today. Also reports palm sized hardness at injection site.
Adverse Event: Redness (circle of around 2.5 inches in diameter), pain, swelling at injection site, abnormal amount of bleeding from injection site immediately after administration (not normal for this writer), bruising and itching at injection site.  Treatment: None  Outcome: Redness is dissipating as of 9/20/22, site is still painful, bruising is still present.
Extreme dizziness when waking up Thursday morning, and very tired. Could barely walk a straight line without holding on to something. Like I was drunk but not nauseous. 2nd day just as bad. 3rd day a bit better. Finally 4th day no dizziness but still a bit tired. My wife felt the same way, but 4th day still a little bit dizzy.  Good friend near us woke up with the same dizziness. She too had the Pfizer shots.
Initial information and additional information received on 28-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 18-months-old patient (gender unknown) who received a dose of QUADRACEL batch number, dose and expiry date not reported via intramuscular route in the left thigh on 01-Feb-2019. The patient's past vaccination(s) included was PEDIARIX on 08-JAN-2018. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant vaccination included a dose of INFLUENZA VACCINE (QUADRIVALENT) (batch number, dose and expiry date not reported via unknown route in unknown administration site) on 01-Feb-2019. It was an actual medication error due to inappropriate age at vaccine administration. A 18 months old patient was inadvertently administered QUADRACEL by a physician PA. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Took oral TYPHOID 10/2/09.  Took #2 pill on 10/4.  Noted puffy lips & itchy tongue which subsided after a "while".  Took dose #3 @ 3 am 10/6.  Swam at the health club & at 10 am noted puffy lips & itchy tongue returning.  Sent to ER.
Shoulder soreness and flu-like symptoms within 24 hours, post vax. Has had residual pain of right hip, thigh down to ankle since vaccine was given. This causes a limp with walking. Pain continues daily; ongoing problems. Is followed closely by a physician every 3 months.
Information has been received from a registered nurse concerning an approximately 16 month old male who on 10/26/2004 was vaccinated with a dose of varicella virus vaccine live.  Concomitant vaccination included the influenza virus vaccine.  Subsequently, in 2004, the patient developed a rash, erythema multiforme.  Unspecified medical attention was sought.  At the time of this report the patient's status was unknown.  No product quality complaint was involved.  Additional information has been requested.
Upper arm redness, swelling from top of shoulder to elbow. Evaluated 11/13/2002. Chart states reaction to immunization. Benadryl q 6 hour, Duracef x 10 days
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 2:46 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.   Patient received vaccine which was stored in an ultra cold freezer at minus 82 degrees Farenheight. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.
Chest pain started on the day of the 2nd dose along with chills, myalgias and 'tactile temp'. The other symptoms resolved but the chest pain persisted. Worse with exertion, and also worse with leaning forward and also lying flat. Went to PCP who drew troponin, which was elevated, sent the pt to the ER. Troponin was elevated in the ER, ECG was normal, echo also normal. Admitted for trending of labs, work up for infectious causes of myocarditis sent. cMRI showed LGE in small area of the inferolateral wall of the LV. Symptoms resolved with Tylenol prior to arrival at the ER, discharged after ~24 hours observation on ibuprofen RTC with close follow-up planned. Restricted from strenuous activity.
threw up, and was concerned if the vaccine leaked out; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (threw up, and was concerned if the vaccine leaked out) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided). Concomitant products included Acid Suppressants and PANCRELIPASE (PANCREATIC ENZYMES) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VOMITING (threw up, and was concerned if the vaccine leaked out). At the time of the report, VOMITING (threw up, and was concerned if the vaccine leaked out) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided; Sender'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.
Pt came for second Moderna Vaccine. A few minutes after receiving injection pt reported feeling dizzy, the room was spinning and she was nauseas. Pt ended up vomiting. BP was checked and was 180/120. Pt reported a hx of hypertension. She said she did take her medications this morning and had clonidine at work to take  PRN. Pulse was 91 and o2 sat was 99%. Pt was monitored 30 minutes after vaccine. We rechecked pressure and it was 160/110. Pt refused any EMT medical services to be called. She said she could just take her clonidine when she got to work. I called patient this afternoon at 12:33 to follow up. Pt reports feeling better. She said her pressure was down to 150/90 which she said was good for her.
Within 15 minutes of shot my arm felt like it had been burned by an iron. The burning pain was extreme, unlike any other shot and lasted for about 15 hours. Then the soreness - rather typical for a shot -  settled in. The doctor refused to suggest any manner of relief -  could ice or pain meds or antihistamine relieved this? The hand out did not include any relevant information. This vaccine only available in this area at this drugstore -  more information and concern for patient needed in this situation.
Patient called today on 10/23/22 to tell me that he believes the flu vaccine he received on 9/26/22 was administered subcutaneously instead of intramuscularly. I asked if he was experiencing any side effects at the moment that prompted this call several weeks after the event, and he said no, but he is concerned he would not be protected against the flu. He stated that he received another vaccine on 10/6 and informed the pharmacist at that time that he believed his flu shot was not given in the correct place. I told him I would document his concerns but at this time there is no way to confirm his antibody levels and we are not authorized to administer an additional flu vaccine.
FLU LIKE SYMPTOMS (CHILLS AND FELT TIRED EXHAUSTED); SORE ARM AFTER VACCINATION; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 130 pounds, and height was 61.5 inches. The patient's past medical history included foot surgery, and pain in injection site, and concurrent conditions included rheumatoid arthritis, auto-immune hives as a reaction to heat, alcohol user, no tobacco use, bone spurs got worse, hypothyroidism, dry eyes, chronic urticaria, calcium depletion, joint pain, morton's neuroma, limping, numbness, and weak ankle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 1808609 expiry: UNNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. Concomitant medications included amitriptyline hydrochloride for autoimmune disorder, omalizumab for chronic urticaria, ciclosporin for dry eyes, levothyroxine sodium for hypothyroidism, liothyronine for hypothyroidism, conjugated linoleic acid/linum usitatissimum seed oil/ubidecarenone for supplement, and calcium/colecalciferol for supplement, calcium depletion, and joint pain. On MAR-2021, the subject experienced flu like symptoms (chills and felt tired exhausted). On MAR-2021, the subject experienced sore arm after vaccination. Laboratory data (dates unspecified) included: X-ray (NR: not provided) No significant findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm after vaccination on MAR-2021, and the outcome of flu like symptoms (chills and felt tired exhausted) was not reported. This report was non-serious.
6MAR91 recvd immun; On 29MAR91 very hot & wouldn't eat; Taken to ER told ear infect given Amoxil, t104; Taken to pvt MD t106 back to ER; hospitalized 4 days;
Pt's dad reported on 5/5/22 that he lied about pt's dob on consent form at time of Pfizer vaccine primary series---pt was not 12+ y/o at the time of vaccine administration; this was prior to pediatric Covid-19 Pfizer being approved for EUA. No adverse event was reported, but Pfizer adult 12+ dose was administered to pt at time of vaccination in July and August, who was <12 y/o. We cannot confirm if said pt actually received vaccine series as dad is reporting dob was false on vaccine form at time of initial series, and we administered vaccine in good faith at the time of event.
The person who administered the vaccine gave it to me like stabbing a knife. Immediately I left pain that ran down my arm into my hand. It hurt and I stated so.. . the next couple of days I felt my arm was not okay...not just the pain from the shot but the movement was different and some parts of my hand are in pain. I also felt my spinal cord was affected somehow and felt shocks in the spinal cord from time to time. My arm is still not okay and when I use it a lot in the garden it is sore and seems like there is nerve or tendon damage.
Erythema (4cm diameter), slightly raised at injection site. Pt brought copies of his records from the clinic that administered it.
The day before the vaccination (12/14/20) I was exposed to COVID. I even filed an incident report at work but they told me to receive the vaccine the next day (12/15/2020). I asked for a test before the vaccine and I was refused. The day after the vaccine (12/16/2020) I started with muscle ached and soreness. Talked to employee health who told me it was expected from the vaccine. I asked to be tested again and they told me no need to, it was from the vaccine. On the 3rd day after the vaccine, I stated with elevated temperature (99.9F and 100.1F) and also fatigue and not feeling well. Communicated with Employee health and once again, was refused the test. On the 4th day I started with cold symptoms and a cough - reported to employee health and once again, no test. All this time I have been working with patients at the hospital, I was not away from my duties. On day 7 I lost my sense of taste and smell and finally on day 8th t(12/23) they tested me after I insisted a lot. My result came back positive. I still had fever for another 3 days after the positive result and the sense of smell/taste and the fatigue were present for another 2 or 3 weeks.
pt had immun approx 11AM; took nap @ home until 2PM & woke up crying; cried for 3 hrs & could not be consoled or quieted; mom called MD & was told to keep giving APAP every 3 1/2-4 hrs;
both hands shaking a little bit; minor aches all over; pains all over; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (both hands shaking a little bit), MYALGIA (minor aches all over), PAIN (pains all over) and DIZZINESS (dizziness) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced TREMOR (both hands shaking a little bit), MYALGIA (minor aches all over), PAIN (pains all over) and DIZZINESS (dizziness). At the time of the report, TREMOR (both hands shaking a little bit), MYALGIA (minor aches all over), PAIN (pains all over) and DIZZINESS (dizziness) outcome was unknown. Not Provided          No concomitant medication was provided  Treatment medication was not provided by the reporter
- Painful upon receiving shot. C/O in the morning upon awakening of pain. Described as an aching pain (2) inch radius around injection site. Small bout of redness & swelling about the size of a silver dollar.
No symptoms until 8:30 PM on fifth night after injection.  Headache, unable to sleep fifth night after injection.  Dizziness beginning 9:00 AM and lasting all day sixth day after injection;  Nausea and shortness of breath beginning 7:00 PM on sixth after injection; able to sleep sixth night after injection.  Fatigue and shortness of breath beginning 8:00 AM and lasting all day seventh day after injection until 8:00 AM eight day after injection.  Side effects were moderate, subsided on their own.
Aching in arms & legs; After 2nd vaccine felt like I had the flu; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose on 15Dec2020 15:00 (lot EH9899, expiry date not reported) in the left arm, then second dose on 05Jan2021 (lot EL0142, expiry date not reported); both via an unspecified route of administration at a single dose as COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had other medications (unspecified) in the two weeks prior to vaccination. The patient was not pregnant at the time of vaccination. On 06Jan2021 02:00, the patient experienced aching in arms and legs, and reported that after 2nd vaccine felt like patient had the flu. The patient did not receive any treatments for the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The patient recovered from the events aching in arms and legs and felt like patient had the flu in Jan2021.
Received second dose at 3:30 pm.  Started feeling cold with minor chills at 8 pm (same day).  Chills lasted all night, abating around 11 am the next day.  Felt feverish about 1 hour after chills subsided.  Took 2 Tylenol and fever abated.  Felt cold but without chills later that day.  All side effects were gone by the next day, with the exception of a tender arm at the injection site for approximately 4 days.