chrisvoncsefalvay/vaers-outcomes huggingface dataset:
throat felt very tight; although I could swallow, it felt difficult to do so; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old female patient (non-pregnant) received first dose of BNT162B2 (Pfizer BioNTech Covid 19 MRNA VACCINE BIONTECH, Solution for injection) (Lot no: 5318) via unspecified route of administration at right arm on 29Jan2021 at 16:30 as single dose for COVID-19 Immunization. Medical history included high blood pressure and high cholesterol. Concomitant medications included Lisinopril, Amlodipine, Pravastatin, ergocalciferol (Vit. D). On 29Jan2021 after 15 minutes of receiving first dose the patient felt that her throat was very tight and although she can swallow, it was difficult to do so. This lasted between 10 to 15 minutes and gradually subsided and did not return afterward. Since the vaccination, the patient had not been tested positive for Covid-19. No other therapeutic measures were taken. Patient did not receive any other vaccine 4 weeks prior to COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient was not tested for COVID-19 since vaccination. The clinical outcome for the events throat felt very tight, difficult to swallow was recovered on 29Jan2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's First Name added; Postal Code added; Patient's Ethnic Group captured. Patient's Age/Units captured as 80 years per event's onset=29Jan2021. For Relevant Med History: Verbatim "Blood pressure high" updated as "high blood pressure" per source reported. For suspect vaccine: Indication "COVID-19 immunization" captured twice, removed one. All Con-Meds were re-coded to remove from "Obtain Drug Country/Drug Authorization Country" since both fields should be Blank for con-med per SOP.  6. For all events: "Treatment Received?" captured as "No" per verbatim "if treatment ae: No"; Onset updated from "29Jan2021 00:00" to "29Jan2021 16:45" per source reported. Event term "difficult to swallow" updated as "although I could swallow, it felt difficult to do so" per source reported. "None" removed from Concomitant Therapy field since con-meds already coded in Product tab. Initial missed information "administration date=29Jan2021, administration time=04:30 PM", "adverse event start date: 29Jan2021, adverse event start time: 04:45 PM", "known allergies: No"
Patient came in on 1/24/23 and stated that she did not have the bivalent booster previously and received Moderna bivalent dose. Later, it was discovered that the patient received the first  Moderna bivalent 9/15/22. Patient was observed for 15 minutes post vaccine administration and did not experience any adverse event.
73-year-old female with a PMH significant for HTN, HLD, diabetes, factor 11 deficiency with recent cochlear implants (1 mo ago), vaccinated with Pfizer x2 and outpatient+ covid-19 test on 9/21/2021 who presented to the ER after experiencing a syncopal episode. . She reports experiencing malaise and symptoms for around 2 weeks, had an outpatient negative test 1 week ago, testing positive this Tuesday; Today, while she was in the bathroom, she felt dizzy, screamed for help and her son came and found her sitting at the edge of the tub. Then, called the ambulance and she was transported to the ER. As a side note, the patient's son who lives in another area and has been caring for her during postop process, tested positive covid-19 over a week ago, vaccinated. The patient's husband is negative covid 19 as of Tuesday, also vaccinated.   In the ER, VS temp 99.4 F, BP 115/57, HR 97, RR 20, O2 sat 100% on RA. EKG read as NSR, rate 90bpm, no STEMI, T wave inversions in V1, V3. Lab significant for mild AKI, dehydration, mild transaminases, D-dimer 2683 .She was given IV fluids, a CTA was attempted but patient declined as she had a prior anaphylactic shock after iodine injection. V/Q scan pending at this time. She is admitted to telemetry with a cardiology, Hematology and Infectious Disease consultations.
vaccine was expired, no temperature excursions occurred and moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration".  Patient reported no adverse reactions.
subcutaneous injection for 1st dose; This case was reported by a consumer via interactive digital media and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine (subcutaneous). On an unknown date, unknown after receiving Shingles vaccine, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 28-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. Additional supportive information: The patient got 1st dose subcutaneous injection, which led to intramuscular formulation administered by other route. The follow-up could not be possible as no contact details were available.
Information has been received from a receptionist at a physician's office concerning a 11 year old female, who at the age of 12 months was vaccinated with a dose of MMR vaccine live (lot unknown). The morning following vaccination, the patient had a rash. Medical attention was sought. It was unknown if any treatment was required. It was unknown if the patient was on any concomitant medications or if any labs were performed. The patient's past medical history was unknown. Additional information has been requested.
Swollen right arm, spread with time from shoulder to elbow, redness, hot to touch and painful.
Information has been received from a pharmacist concerning a patient who on approximately 11-APR-2008 (also reported as two months ago) was vaccinated with ZOSTAVAX (Oka/Merck) by subcutaneous injection (lot number and injection site not reported). Right after the administration of vaccine the patient developed a rash at the injection site. Rash was elongated, and the reporter regarded it as an allergic reaction. Unspecified medical attention was sought. Subsequently, the patient recovered from the event. No complain of product quality was involved. Follow-up information was received on 07-JUL-2008 from the pharmacist concerning a 72 year old female with penicillin and sulfa allergies who on 26-MAR-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (Lot #659762/1874U). On 26-MAR-2008 upon administration, the patient complained of minor burning sensation which subsided within a few minutes. Policy required the patient to site down in front end of pharmacy for at least 15 minutes. Subsequently the patient developed red rash around injection site. The redness was oval about 2 inches long and 1 inch wide with some itching. The rash was not raised. The patient also had tenderness. The patient stayed in pharmacy for about 30 minutes after vaccination. After 30 minutes,the patient felt fine. The itchiness was subsiding and the rash was slightly less red. The next day the pharmacist called the patient. The patient reported that the rash was completely gone. Some tenderness still existed, but probably due to the soreness of receiving an injection. The pharmacist thought that no medical follow up required. The reaction was minor and resolved itself within a few hours. Additional information is not expected.
Hives, swollen face (especially around eyes), scattered pimple-type bumps on body (arms, legs, and torso).
Information has been received from a physician via a health science consultant referring to unspecified number of patients of unknown age and gender. The concurrent condition included autoimmune disorder. The physician reported that he read in the following medical journals that there had been cases. The cases were reported as on an unknown date the patients were vaccinated with ZOSTAVAX (strength, dose, route, lot# and expiration date not provided), then developed zoster keratitis and uveitis. No concomitant medication reported. At the time of reporting, the outcome of adverse events was unknown. The causality between adverse events and ZOSTAVAX was not provided. Additional information is not expected as the reporter did not wish further contact.
Intense itchiness  started on my scalp, which then progressed down my face, neck, and upper torso at approximately 9:15 am on 02/11/2021. By 9:30 am visible hives were seen on my neck, chest, and upper back; a generic Zyrtec was taken which helped relieve itchiness. By 2:00 pm the itchiness came back. I followed up with a health professional in person at 6:20 pm. Itchiness was still present. The hives were reduced but still visible.
Mother called at 2042 hrs as a child as been running fever this afternoon up to 104+ rectally.  The child did have two month immunizations given earlier today.  Physical exam at that time was normal.  Since then the child has been sleeping more than usual but is easily arousable to full awake, she is been tolerating p.o. feeds well, she is not excessively irritable, she had no vomiting or rashes.  Mother states the child is actually smiling a little bit this evening even though she is still running fever of 103 after having tepid bath.
approx 3 hrs p/vax administration, pt exp chills, malaise, SOB, etc; tx'd & released released from Naval hosp ER 21OCT94;
Patient woke up day after receiving Tdap boostrix with sore L shoulder pain 6/7. Unable to lift arm, throbbing, denies numbness or tingling. Tried hot packs and acetaminophen without effect.
Information has been received from a female who on unspecified dates, was vaccinated with the three doses of GARDASIL intramuscularly.  The patient reported that she developed mouth sores after receiving each of the three doses of GARDASIL vaccine.  The patient had also injection site pain.  The patient recovered on an unspecified date.  Unspecified medical attention was sought.  There was no product quality complaint. No further information is available.
I started feeling really tired. The next day I developed a sore throat, a fever of 102, cough, and body aches. I also measured my oxygen level and it went as low as 89. I took a COVID-19 test on 4/5/2022 that came back negative.  Over the next few days I started to feel worse. On 4/8/2022 I took another COVID-19 test that came back positive. That day I did a video visit with my doctor and they prescribed me Paxlovid. My symptoms lasted for about 10 days.
Itchy rash at shot site 9 days later.  Still present two weeks out from shot day.
I have the herpes simplex genital virus/But I had a breakout a couple days ago; This case was considered as invalid initially upon follow-up (14-APR-2021) case was considered as valid. This is a spontaneous report from a contactable consumer or other non hcp (patient). A 73-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 23Mar2021 as single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included aciclovir sodium (ACYCLOVIR ABBOTT VIAL). The patient stated, he had the herpes simplex genital virus and occasionally get outbreaks. He was not taking the suppression dosage daily while he was getting the vaccine. But on an unspecified date he had a breakout (viral test positive). He took 3 Acyclovir 800mg doses per day for 2 days. He had done that and would like to take the suppression dose which was 400mg to 600mg per day. Caller also questioned if he gets the second dose 4 weeks from the first dose, would the vaccine efficacy be compromised as time goes on. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Approximately 5 mins following the administration of the patient's second Pfizer COVID 19 vaccination, the patient, momentarily lost consciousness in the waiting area chair. Patient's eyes widened and rolled into his head and he started to sweat profusely.  Seconds later, patient regained consciousness and alertness and straightened up in his seat.  He was provided water and Kleenex in order to mop his sweat.  After approximately 20-25 mins he was able to leave the pharmacy under his own power with his female companion.
headache; Received Invalid dose; bodyache; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (headache), INCORRECT DOSE ADMINISTERED (Received Invalid dose) and MYALGIA (bodyache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced HEADACHE (headache), INCORRECT DOSE ADMINISTERED (Received Invalid dose) and MYALGIA (bodyache). At the time of the report, HEADACHE (headache), INCORRECT DOSE ADMINISTERED (Received Invalid dose) and MYALGIA (bodyache) outcome was unknown. Not Provided      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.   No concomitant medications were provided No treatment medications were provided   This case was linked to MOD21-075918 (E2B Linked Report).; Sender's Comments:  MOD21-075918:
1 and half hour after 1st shot on 2-10-2021 started legs aching, then felt pain everywhere  stomach and gallbladder burning  with acid, headache, chills, constant urination, no fever, tired, arm hurts, nauseous and a little hard to breath. lasted 2 days 3 hours after 2nd shot on 3-10-2021 started legs aching, then felt pain everywhere, stomach and gallbladder burning  with acid, headache, chills, constant urination, no fever, tired, arm hurts, nauseous and a little hard to breath. 24 hours still sick
On 10/3/06  started itching all over body around 2:30pm-3:00pm and Right eye swelling started called Dr.  Put on Prednisone 10 mg, taking 6 tablets one day and reducing down by one until gone.  Went to see Dr. on 10/05/06 had albuteral breathing treatment, advised to use Advair Diskus 100/50 1 puff twice a day until better.  Also told to get Benadryl 25mg 1 pill twice a day, and artificial tears to help with swelling of eye.
was being administered, it sprayed on my face and rolled down my arm. If I didn't get the full amount, should I get another dose?; syringe they are using is the BD Syringe attached with  25 Gauge, 1 inch needle; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (-PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 2 via an unspecified route of administration on 02Jan2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 02Jan2021, the patient stated when receiving the 2nd dose of the Pfizer covid vaccine, when it was being administered, it sprayed on her face and rolled down her arm. If she didn't get the full amount, she enquired, should she get another dose and or is there a way to test. The patient stated, she brought it up to infection control nurse several days ago. they said she had to talk to the Pharmacist. The Pharmacist spoke to nurse that administered and she said that she received the full dose. The nurse said she remembered giving it the needle came loose after administration, she was confident I received it. Patient stateds that the nurse said that the syringe they are using is the BD Syringe attached with 25 Gauge, 1inch needle, and that the biggest disadvantage is there is a lot of dead space, and that is why she felt this spray. The patient asked the Pharmacist why would it spray if it was under pressure, why would it spray at her. The pharmacist told her this information wasn't in his first report and he couldn't provide any more information. The patient stated, If it sprayed on her there was pressure on it and this was during administration, that is the way she felt. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
pt recvd vax 10AM on 9SEP92 & approx 330PM parents brought pt back to clinic rt thigh was swollen skin warm to touch; pt was crying & irritable; fever 101;
30Jun93 1000am T 101-was given APAP liq. 1100am T 103 continued to play, 130pm T 104 unable to breath, mucous draining from mouth, hot to touch, jerking motion-to ER, T 105, admitted to ICU 1 1/2 days. Dx:febrile convuls. Grand mal sz
I have a 23 year old hip prosthesis.  At the beginning of August, I had mild groin pain which I noted on the calendar wondering if it was the start of this prosthesis going bad.  However, after my initial calendar note on August 16, 2021, I did not experience any further groin pain.  Two days following the vaccination on August 29, 2021, I suddenly had groin pain, but only when standing or walking.  The pain was so severe, I was not able to stand for more than a minute.  The pain went away when I was sitting or lying down.  The groin pain while standing or walking continued unabated until I began a Medrol pack of prednisone the following Friday, with a 6 day course of treatment,  Within two days, of starting the Medrol Pack the pain was gone, and I have been walking up to 2 miles for the past few days.
Patient fainted within 15 seconds of receiving the vaccine. Pt came too within 30 seconds after fainting. Pateint was observed for approximately 45 minutes by the pharmacy staff and the local EMS , which was contacted less than 2 minutes after the patient had fainted.  EMS checked patients BP and pulse and everything was normal. Patient refused to be transported to the local hospital and a family friend came and picked the patient up to take him home.
pt recv vax DEC96 & since then has been exp an allergy rxn manifested by sneezing, watery eyes, itchy nose & mild cough to clear throat;pt has not yet recovered;
This spontaneous report was received from a female patient of an unknown age concerning herself. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 injection (dosage and route not reported). On an unknown date, the patient was having "eye surgery on her right eye" for an unspecified reasons. The outcome of the event was unknown. The reporter did not provide any causality assessment between event and PNEUMOVAX 23. The reporter declined to participate in answering questions within this adverse event report. No further adverse event information was provided. Additional information has been requested.
While in observation area, patient said he was feeling a little lightheaded and then fell. Patient slightly stabilized his fall by grabbing onto a chair, but still fell on floor, hit his head. Patient was unresponsive for a few seconds as more help arrived, then was asked where he was, what vaccine he got, what his name was, he answered all questions correctly. Blood pressure was taken 3 times with blood pressure cuff pharmacy staff had on hand, readings were 171/76, 166/79, 151/91. EMS arrived took additional blood pressure 141/89, blood glucose 117, performed EKG. EMS said BP, EKG looked good.  Patient said he had one time passed out around needles as a kid. Today refused hospital, said he felt okay.  He did say his head was a little sore still, EMS said he was looking okay, EMS left. Patient stayed for about a half hour after event, then felt fine and went home.
Headache for 8 days; stiff leg unable to support her weight for 3 days; fever for 8 days (highest temperature was 104.8 for 2 hours; otherwise temperature was 100-103); extremely lethargic for 3 days, then continued fatigue for 5 more days.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient (encounter key# 413682) of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 16-FEB-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.7 Celsius) for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Moderna COVID-19 Vaccine EUA: patient presented to another hospital two days after vaccination with confusion, word finding difficulties, and fever. Diagnosed with septic shock and started on antibiotics. Less than one day after initiation of antimicrobials patient was noted to have skin pain, large blisters, and sloughing. Patient transferred to current facility for diagnosis of DRESS syndrome.
Swelling, itching, redness, heat at the injection site appeared over a week after the vaccine was received. The first few days following, I only had pain in my arm and bad headaches. The swelling, redness, itching, and heat started a week after. I have not received treatment. I was reporting my symptoms through the website that I was given by the hospital that administered the vaccine, but I cannot access it now. I am only reporting it for research purposes for you and the CDC. I do not think I need to seek medical attention at this time.
My arm swelled as big as baseball, turned red all down my arm. Cellulitis had set up, and spread through my body. Had to go to Emergency Room for treatment chest pains. I was hyperventilation and my leg jerking from the pain.
pt lifeless about 3-4 hrs p/shots; sleeps alot, perspires alot; has not been to MD; pt still has same sx on 29JAN93; suggested take to MD;
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.  A 68-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 01Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 04Sep2023 to 09Sep2023. Clinical course: Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300302352 Same patient, different drug and event;
Flushed feeling BP=110/62 HR=68 O2=97% Seen in medical screening by RN. Patient release at 12:15 p.m.