chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On or about 14-MAY-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route, lot number and expiration date were not reported) by a doctor for the long-term prevention of shingles and zoster-related conditions. On the same day, His healthcare providers including but not limited to the doctor (inoculated vaccine to him) relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risks of adverse effects. Subsequent to his zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by the doctor for shingles (onset date unknown). As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  The outcome of the event was considered not recovered.  The event was considered related to zoster vaccine live (ZOSTAVAX).
Left upper arm Red at the site hard and hot, about the size of a lime; Left upper arm Red at the site hard and hot, about the size of a lime; Left upper arm Red at the site hard and hot, about the size of a lime; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jun2022 at 11:30 as dose 3 (booster), single (Lot number: FJ4991) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "latex: allergy" (unspecified if ongoing). Concomitant medication(s) included: FAMOTIDINE; LEVOCETIRIZINE; LEVOTHYROXINE; OLMESAR. Vaccination history included: BNT162b2 (Dose 2, Batch/Lot No: FG3527, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 09Nov2021, when the patient was 53-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, Batch/Lot No: FF2590, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 12Oct2021, when the patient was 53-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE WARMTH (non-serious), VACCINATION SITE RASH (non-serious), ERYTHEMA (non-serious) all with onset 21Jun2022 at 12:00, outcome "not recovered" and all described as "Left upper arm Red at the site hard and hot, about the size of a lime". The events "left upper arm red at the site hard and hot, about the size of a lime" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site warmth, vaccination site rash, erythema.  Additional information: The patient had not received other vaccine in 4 weeks. Patient had other medications in 2 weeks with famotidine, levocetirizine, levothyroxine and olmesar. The patient was visited to doctor or other healthcare professional office/clinic visit for adverse event. The patient had no covid prior vaccination and covid tested post vaccination. Patient had latex allergy and no food allergies.  No follow-up attempts are possible. No further information is expected.
Pt started out with myalgias, headache, and fever of 102.  Fever continued to climb despite ibuprofen around the clock.  On day 2, pt with 104 fever.
Shot blocker was applied to child's leg, and vaccine was administered using standard procedure with a VanishPoint retractable needle. During the retraction process, the needle made a slightly different sound than is usual, and when the shot blocker and needle were withdrawn from the child's leg, a drop of clear liquid - presumed to be vaccine - was seen on the child's leg. A needle puncture mark with a small amount of blood was also observed. This RN, together with the child's father, examined the site and determined that the amount of vaccine observed to be lost was likely much less than the 0.2 mL that was intended to be delivered. Father expressed that he would not like the vaccination to be re-administered at this time.   Nurse contacted nurse manager, and manager consulted supervising physician and received recommendation to revaccinate the patient, considering a half dose. Nurse manager informed this RN of the updated/confirmed recommendation this morning.     Father was informed, and he stated he will consult with the patient's mother, and they will schedule online for an upcoming clinic if they decide to proceed with revaccination. Father was informed that last clinic will be 6/17/23.
nervous, sweating, lightheaded;pulse & BP & breathing nl, pt laid down & felt better;no tx needed;observed
SkinRash, Rash, NauseaVomiting, Palpitations, Feeling "hot" and "clammy" Narrative: Employee received vaccine around 10:30am. At around 10:45 employee reported palpitations, nausea, headache, and feeling "hot" and "clammy". BP 193/119 with a HR of 95. After 15 mins of rest, employee continued to feel poorly reporting a slight worsening of symptoms. Face appeared very flushed. BP on recheck 193/112 with a HR of 105. Employee escorted to ED for evaluation at this time. In ED, employee developed full body rash. Was given 50mg IVP benadryl and 125mg IVP methylprenisolone  in addition to 1L of Lactated Ringers- all with symptom improvement. Allergy/Immunology consulted. Recommend serum tryptase level. If elevated, advised that employee should not receive second vaccine dose. Employee discharged home with RX for epi-pen, prednisone, and cetirizine. Of note, employee reports a history of Thalassemia. Has a hx of hives with PCN and a rash with cipro.
102.3 TEMPERATURE THE NEXT MORNING ALONG WITH NAUSEA AND A SEVER HEADACHES, COLD SWEATS, FATIGUE AND DIZZY SPELLS.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Oct2021 at 09:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Apr2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "fibromyalgia" (unspecified if ongoing). Other medical history included fibromyalgia and patient had no known allergies. The patient took concomitant medications. Patient received the vaccine. Patient received other medications in two weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 12Sep2022 to 17Sep2022 for treatment of COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
dizziness; Sensation loss; Sensation loss; Sensation loss; fatigue; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), the first episode of SENSORY LOSS (Sensation loss), the second episode of SENSORY LOSS (Sensation loss), the third episode of SENSORY LOSS (Sensation loss) and FATIGUE (fatigue) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced DIZZINESS (dizziness), the first episode of SENSORY LOSS (Sensation loss), the second episode of SENSORY LOSS (Sensation loss), the third episode of SENSORY LOSS (Sensation loss), FATIGUE (fatigue) and VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, DIZZINESS (dizziness), the last episode of SENSORY LOSS (Sensation loss), FATIGUE (fatigue) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details not provided. On 24Mar2021, he started experiencing fatigue, dizziness, decreased sensation not quite numbness or tingling, a sensation in between on the left side of face. Vaccine was administered on the left arm. Roof of his mouth and around his lips had decreased sensation as well. His left arm was swollen but not red at the injection site. He did not use anything to treat his symptoms.   Caller provided consent to follow up with her.
37 year old needed Tdap given Dtap. Per public health nurse no need to revaccinate with Tdap.
during administration about half of the dose leaked out from where the needle attaches to the tip of the syringe; had attached the needle to the syringe, it seemed as though the needle did not "lock" firmly onto the syringe; Initial information received on 21-Dec-2021 regarding an unsolicited valid non-serious case from a Pharmacist via Agency (Reference number- 00907132).  This case involves a 51-years-old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], (syringe issue) and (underdose).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication included booster Coronavirus disease-2019 (COVID-19) VACCINE (On 17-Dec-2021).  On 17-Dec-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7356MA and expiry date: 30-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  It was reported that when she had attached the needle to the syringe, it seemed as though the needle did not "lock" firmly onto the syringe; she had administered Fluzone Quadrivalent syringes to other patients, using syringes from the same box and the same lot number, and she had felt the needle "lock" more securely onto those syringes.   It was a case of syringe issue and underdose (same day latency).  It was unknown if the patients experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.  It was not reported if the patients received a corrective treatment.  At time of reporting, the outcome was unknown for all the reported events.
C/o worsening insomnia/anxiety after 2nd dose COVID-19 vaccine administered 03/26/21.  Per HCW, anxiety presents at night when trying to sleep and is unsure if anxiety is causing insomnia or vice-versa.  Per HCW, she slept well this weekend after taking herbal supplement "Ashwagandha" on night of 04/17/21 and 04/18/21.  Unsure if insomnia/anxiety is resolved. Reported fever, chills, joint pain, difficulty breathing and insomnia/anxiety approx.  24-48 hours post 1st dose of COVID Vaccine on 12/28/2021. Per HCW, she missed 4 days of work after initial dose.  Initial symptoms resolved using rest and Tylenol. Per HCW, her PCP felt s/s were consistent with Flu. Per HCW, PCP approved her to take 2nd  COVID vaccine dose.
Patient presented to the ED for ureterolithiasis. Patient presented to the ED and was subsequently hospitalized for ureterolithiasis. These visits are within 6  weeks of receiving COVID vaccination.
No other AE details available at this time; Temperature excursion; This spontaneous report has been received from a registered nurse concerning a 4 years-old patient of unknown gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.       On 04-DEC-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml,  Lot # T021638, expiration date reported as 21-FEB-2021 but upon internal validation established as 21-DEC-2021 for prophylaxis.  The temperature was reported to had been at -13.3°Celsius(C) for a period of 4 hours and 15 minutes.  No other adverse events details were available at this time.  There was digital data logger involved and no previous temperature excursion was reported.
This case was reported by a consumer via call center representative and described the occurrence of pruritus in a elderly female patient who received SHINGRIX. Concurrent medical conditions included food allergy. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was not recovered/not resolved. The reporter considered the pruritus to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported. None of the concomitant medicines were started recently. The patient was a pharmacy technician received the 1st dose of the series of the SHINGRIX vaccination into her upper left arm at a pharmacy sometime last week before the date of reporting. The reporter did not know the exact dosing or other dosing related details. Later that same night the patient experienced itching symptom. The patient was still itching all over her arms and back at the time of reporting. The patient obtained a prescription for SHINGRIX from her health care professional but was told that she did not need a prescription at the pharmacy because she was over 50 years of age. The patient routinely took blood pressure medicine and other medicines whose exact names the reporter could not now recall. The reporter called GlaxoSmithKline on the day of reporting to inquire on his wife's (the patient) behalf if SHINGRIX contained any soy, because his wife is she was allergic to soy. The reporter's inquiry had been submitted to the GlaxoSmithKline response center team lead for further research. The reporter was advised that someone from the GlaxoSmithKline response center would be calling him back after further research of his inquiry. The reporter requested that his wife be contacted back by GlaxoSmithKline and provided her phone number. The reporter was referred to the prescribing healthcare provider during the call.
Woke up with every joint in my body aching like it does when I?ve had the flu. This lasted most of the day until about 9 pm
On the day the patient received the vaccine he experienced an increase in the frequency of urination to a level of urinating every 30 minutes for 2 days. After that the frequency decreased but remained above his normal level. The patient received a second dose on 10/15/2021. The lot was 048F21A at 10:47AM in the right arm by IM route. The frequency of urination increased again to every 30 minutes for 2 days then decreased to 10 to 12 times a day. He has remained at that level. On 11/30/2021 his visited his primary care physician. Per the patient labs were done and no issues were found. He also experienced a severe headache for 1 week after the second dose.
Significant other of vaccinated member developed a lesion on right knee, presented to Hospital ER 28 December with complaint of painful/itching lesion. Pt reported knee pain with groin and thigh pain/lymphadenopathy.
The  patient received dose from vial beyond 30-day use by date; The patient received dose from vial beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The  patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The  patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (The  patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2021-364543 (Patient Link).
24 hours post vaccine: mild fever, body ache, fatigue, nausea, diarrhea, injection site red, warm, sore.  All of that cleared up.  Day 8 post vaccine: injection site swollen, red, warm, spreading, very itchy, still ongoing
This spontaneous report was received from a pharmacist refers to an unspecified patient of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with PROQUAD (Merck) (dose, route, lot # were not reported) that was stored improperly. No adverse effects reported. Additional information has been requested.
Initial report received on 14 August 2007 from a health care professional. A 12-year-old male patient, with no illness at the time of vaccination, had received a left deltoid, intramuscular injection of MENACTRA, lot number U2286BA, on 13 August 2007. On an unspecified day in August 2007 post-immunization, the patient experienced a fever of 102.1 degrees Fahrenheit, headache, dizziness, and muscle aches. At the time of this report, the patient had not yet been evaluated by a physician and had not recovered.
15April2021 his wife tested positive for Covid; This is a spontaneous report from a contactable consumer. This consumer (husband) has reported for his wife (patient). A 64 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0180), via an unspecified route of administration in the left arm, on 14Apr2021 in the morning, as first dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The history of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient did not received any additional vaccines administered on the same of day. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 15Apr2021(also reported as: in a day or two), the patient was tested positive for COVID. It was reported that the patient was well and much better and back to work and on an unknown date she had tested negative. The reporter wanted to know if the patient would need to restart the vaccination again or she can just get the second dose. On 01May2021, the outcome of the event COVID-19 Positive was recovered.
Pt reports fainted in chair while waiting the 15 minutes after receiving the JJ vaccine and states hurt his right shoulder when he fell.
2 weeks after my COVID booster shot I developed a rash on my right arm. It continued to grow into a 10 in line on ulnar nerve. This was on RIGHT arm. It was diagnosed as Shingles and I was given an antiviral and was OK in about 7 days of treatment. Note- I had had my 1st Shingles vaccine in September - so not fully immune but kind of unusual I'd get shingles.
10FEB91 developed "whelps" on extremities; afeb, no malaise; 11FEB91 Seen by MD advised rxn to MMR & no further MMR;
Side affects for five days after receiving COVID-19 booster (Pfizer): Swollen at injection site (left arm); severe pain at injection site, enlarged and severely painful lymph node under left armpit; fever that reached 100.4 (for two days) and decreased with Advil every 4 hours.
At 2230 on 6/25/15 pt had hives/rash on bilateral arms, feet and legs. Parent administering BENADRYL 5mL q4-6h around the clock. Medication helping the symptoms.
hot rash 4" x 6"; soreness 8 days after shot;  headache;  chills;  tiredness
lip swelling; Facial swelling made me look like a chipmunk; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lip swelling) and SWELLING FACE (Facial swelling made me look like a chipmunk) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced LIP SWELLING (lip swelling) and SWELLING FACE (Facial swelling made me look like a chipmunk). On 08-Feb-2021, LIP SWELLING (lip swelling) and SWELLING FACE (Facial swelling made me look like a chipmunk) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications and No Treatment medications were reported. Patient states no derma fillers taken.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Updated Reporter details[Address, Email and Fax].
One day post vax, the child had two brief seizures. Taken by ambulance to hospital. Dx with a seizure disorder. Has cyst on brain per hospital.
I suffer from depression and anxiety, it feels like my depression is on overdrive. I began having a hard time going to work, feelings of worthlessness and hopelessness got more intense, and now I have all of that plus feeling like I could cry at any second. Everything seems to take so much effort to do, I feel so broken inside
noticed swelling under her right arm pit; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE SWELLING (noticed swelling under her right arm pit) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE SWELLING (noticed swelling under her right arm pit). At the time of the report, VACCINATION SITE SWELLING (noticed swelling under her right arm pit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. List of concomitant medication were not given.