chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started getting profused rhinitis; I am got a little hoarse and it lasted all night long; I started getting profused rhinitis; I am got a little hoarse and it lasted all night long; I had enough Postnasal drip that I got a little bit of cough and no fever and didn't know if this was related to the vaccine; I had enough Postnasal drip that I got a little bit of cough and no fever and didn't know if this was related to the vaccine; This is a spontaneous report from a contactable physician who was also the patient. A 71-year-old male patient  received bnt162b2 (BNT162B2 lot: EK5730, expiry: Mar2021), intramuscular in left arm on 17Dec2020 at a singe dose for covid-19 immunisation. The patient's medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included olmesartan medoxomil (BENICAR) for hypertension and unspecified vitamins. On a unspecified date, the patient started getting profused rhinitis, he got a little hoarse and it lasted all night long. Patient actually had enough Postnasal drip (Captured as suspect conservatively) that got a little bit of cough and no fever and didn't know if this was related to the vaccine or not and needed to find out if that's the case. It was also reported that the patient took a rapid Covid test in the morning and whould like to know if that would to be 'false' positive because of taking the virus shot or Covid shot. It was reported that an RN administered the vaccine. The outcome of the events was unknown.
196 patients received 0.25mL of Moderna COVID-19; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up received wherein I narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:Master case
retinal hemorrhage; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0186) via an unspecified route of administration, administered in left arm on 12Aug2021 10:30 (at the age of 44 years old) as dose 1, single for COVID-19 immunisation. Medical history included Hypertension(controlled with  medication), Hypercholestremia (controlled with medication), and allergies with Mango fruit. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced retinal hemorrhage on 14Aug2021 08:00. The patient reported that she has not had one before to her knowledge. It has been examined and is resolving. There was no blunt force trauma. She was just sitting in a chair when the event occurred spontaneously. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment was given in response to the event. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovering.   Follow-up attempts are completed. No further information is expected.
62 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience funny taste in her mouth (somewhat metallic like).  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting.       ALLERGY REVIEW OF SYSTEMS   Previous Reactions: This is patient's first vaccine (Pfizer). Does report previous reaction to influenza vaccine many years ago, states it caused her to get really sick.     Objective    Vitals Vitals:   01/15/21 0932 BP: (!) 145/83 Pulse: 76 SpO2: 98%     Physical Exam Constitutional:      General: She is not in acute distress.    Appearance: Normal appearance. She is not ill-appearing or diaphoretic.  Cardiovascular:     Rate and Rhythm: Normal rate.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.  Neurological:     Mental Status: She is alert.          Assessment/Plan  Treatment included: antihistamines. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP.   Patient doing well upon discharge. Reports some improvement in change in taste prior to discharge/leaving. She was escorted out via wheelchair only due to reports of difficulty ambulating long distances due to being disabled but is otherwise at baseline.
Localized shingles outbreak in Left arm where vaccine was administered.  Left arm swelling, redness and pain.
First dose 12/30/2020 not able to read the lot number, no call back from the health department.  83-year-old man Patient received 2 doses of the COVID-19 vaccine is specifically Pfizer.  Patient is nonverbal, cannot walk.  He was brought to the hospital secondary to COVID-19 infection.  Specifically he was found with low oxygen saturation at the nursing home persistently for which they decided to bring into the hospital for further evaluation and treatment
Client reported fever up to 104.1, weakness, shortness of breath, and severe pain in limb where shot was given, extending into her shoulder. Was inst. to go to nearest ER- never went for evaluation.
Unilateral arm shaking. Mom reports after an episode of being upset, mom noticed left arm shaking which lasted about 30 seconds at 07:00 on 09/08/17. Later that afternoon Grandmother noted Right arm shaking, which lasted longer. Pt. remained afebrile, otherwise well. Mom contacted by our office 09/11/17 pt. had not had any further episodes of arm shaking.
No Adverse event; Greater than 35 days since the patient's first Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the patient's first Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No Adverse event) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 033B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the patient's first Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the patient's first Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No Adverse event) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant follow-up received on 03-Sept-2021. 2nd Dose details updated, race and ethinicity also updated.
Left upper arm and shoulder pain, deep, continuous. Limited ROM. Extreme fatigue, heart palpitations much worse
Thirty minutes after shot was administered I vomited in the bathroom at work. I suddenly felt dizzy, tingly and very strange. My eye sight was off. I don't know how to explain, not exactly blurry but just cloudy. Felt drowsy and blah all the rest of the day. My arm was very stiff the rest of the day as well.
Case number PHHY2013US010827 is an initial literature report received on 02-FEB-2013: This report refers to multiple patients whose identifiers were not reported. On an unknown date, 3327 pregnant patients were vaccinated with H1N1 (manufacturer and batch number: not reported) at on unknown dates. The author concluded the article stating that pregnant women who received H1N1 were less likely to give birth preterm, and gave birth to heavier infants.
Patient received an extraneous dose of varicella. Patient had been reported as up to date on vaccinations for her age. No side effects or complications have been reported.
Swelling & redness increasing at site of (R) thigh injection of PREVNAR 13. Non confluent erythema about 5.5-6 cm in diameter - warm to touch.
Anaphylaxis.   The COVID shot was given, no reaction then. After 7 minutes, congestion, severe cough, vomiting phlegm, feeling like throat closing started happening. Code was called, Benadryl was immediately given intramuscular in the left arm, blood pressure, pulse ox was taken, and then was taken to the Emergency Department. In the ED, I was given prednisone, one EPI, anti-nausea medication all through I.V. and many more medications given to me via I.V. that I don't sincerely remember. I was under observation for 4 hours. I was discharged after all symptoms dissipated and was given Prednisone 20 MG (3 tabs a day) to take to help my lungs. Management followed up almost immediately, everyone from the moment I had the anaphylactic reaction was quick and prepared.
kicked my butt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: kicked my butt). The outcome of the feeling abnormal was recovered/resolved.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR060431   Additional Information: GSK receipt date: 23-Apr-2023 The case was received from the patient via interactive digital media. The patient got the jabs year ago and kicked his or her butt for a few days. The follow-up could not be possible as no contact details were available. For tolerance of 2nd dose, refer case US2023AMR060431.; Sender's Comments:  US-GSK-US2023AMR060431:Same patient/same product
69 year male presented to vaccine clinic, scheduled for a Moderna booster. Reconciled past immunization records on multiple databases, pt had received 1st dose (2/12/21) and 2nd dose (3/12/21) of Moderna and indicated to proceed with administration of 3rd dose. Pt received 0.5cc of Moderna on 10/21/21 @ 14:40, double the recommended volume of 0.25cc for booster.  Pt did not have any allergic reaction or adverse event during 15 min monitoring period nor upon leaving.    Moderna Lot #11F21A, exp 1/19/2021
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 06Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "GERD" (unspecified if ongoing); "migraine" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: PROZAC, start date: Aug1989; PEPCID [FAMOTIDINE], start date: Aug2017.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that Paxlovid with lot no 2815223 was given as COVID-19 treatment from 25Jul2022 to 30Jul2022. It was reported that the other medications used by the patient in 2 weeks of vaccination are Fluoxetine (Generic Prozac) with start date as Aug 1989 and Famotidine (Generic Pepcid) with start date as Aug2017.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient got the vaccine in left deltoid and seemed fine.  She stayed in waiting area and suddenly developed symptoms of light headedness difficulty breathing and sweating.  Benadryl was given and symptoms monitored.  Blood pressure, heartrate were monitored.   Husband took her to ER where blood panel and EKG were done.  EpiPen was not admistered.  She recovered and went home.  ER told her not to get 2nd shot and to contact her PCP for followup.
I am itchy on my belly/chest, armpits and knee areas. I have been taking Benadryl every 4 hours for the past 5 days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Lot number: Elo140), on 10Jan2021 as dose 2, single (Lot number: El1283) and on 24Sep2021 as dose 3 (booster), single (Lot number: 301358a) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 31Mar2022 at 12:00 as dose 4 (booster), single (Lot number: 025l21b), in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: OMEPRAZOLE, start date: Feb2020; WELLBUTRIN, start date: Nov2021; CYMBALTA, start date: Oct2019; ESTRADIOL, start date: Dec2017; MIRENA, start date: Dec2017; TESTOSTERONE, start date: Dec2018; MELATONIN, start date: Dec2017. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Rebound covid on 21Jun2022 at 20:00 with no treatment plus initial antigen test plus on 05Jun2022, 5 days of paxlovid and negative antigen tests. Recurrence of symptoms started 22Jun2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (unspecified date) Negative, notes: 5 days of paxlovid and negative antigen tests; (05Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid (start date- 04Jun2022, stop date- 09Jun2022).; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, vaccination failure  and the administration of the vaccine cannot be excluded.
Client's family reports: Client experienced body pain and swelling of right arm and leg after vaccinations. H & P from hospital indicates client c/o pain the day before vaccination given. This is a 63-year-old male with a history of gout and left BKA with an open sore on the stump here with diffuse body pain for four days. He state that it started on Thursday four days ago, having pain all over his body. He then went to the clinic on Friday which is three days ago and did get four doses ( ) immunizations at the time. Since the immunization his pain has gotten worse. He is not sure if it is due to th immunization or that he is getting sick. The pain is diffuse on the extremity and also on the chest. He state that sometimes the pain is so severe that he feels feverish as well. He does have some swelling of the right wrist and ankle as well with extreme pain there too. He denies any URI symptoms such as runny nose, coughing or congestion. Denies any nausea or vomiting. Denies any constipation, diarrhea or melena. He state that he has been drinking and eating well.  12/28/05 D/C Summary reviewed. Final diagnoses were listed as 'septicemia, acute respiratory distress, chronic renal failure, hyperkalemia, dehydration, amputation of L stump with chronic ulcer on the L stump, gouty arthropathy, diabetes type 2 uncontrolled, anemia of unknown etiology, constipation'. (Appears likely that all but septicemia and acute respiratory distress were pre-existing.)
Patient was given varicella vaccine at health department per mom. Patient came to clinic with rash. Child was diagnosed with varicella. Date of initial vaccination is unknown.
11OCT98 noted local rxn @ site of inj, some soreness;12OCT98 area about size of a nickle, red applying ice to area;14OCT98 to MD given ATB;site still a little warm, most of redness gone, area flat;
SWOLLEN LYPH NODES ON THE RIGHT SHOULDER AREA AND ON MID NECK CAUSING THROAT IRRITAION
Pt recvd 3 doses of Engerix-B vax & 14OCT91 found to be a non-seroconverter;
This vaccine was accidentally reconstituted with 1.3ml of Normal Saline. Patient has no side effects from this error. Concerned about the efficacy of the dose she received and need to know when to re-dose her.
Full body red, raised rashes, fever >100F, vomiting, headache, loss of appetite Symptoms persisted for approximately 7 days.   Treated fever with acetaminophen and ibuprofen.  Treated vomiting with ondansetron.
Initial unsolicited report received from a consumer via social media and from other company (Merck) on 19 September 2016. This case involves female patient (age not reported) who was vaccinated with a dose of DAPTACEL (batch number, expiry date, dose, route and site of administration not reported) on unspecified date. Medical history and concomitant medications were not reported. On unspecified date, following the vaccination patient experienced severe reactions (not specified) and as result of reactions patient became blind. Lab data and corrective treatment was not reported. Patient was not recovered from event. Upon internal review the case was considered as serious because of important medical event blind. List of documents held by sender: none. Sender's Comments: This is a poorly document case. Patient who was vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE following which patient was blind. Time to onset is unknown, detail medical history, any recent CNS infection, ophthalmological disorder are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
rash starting day two on arm progessed to full body rash day 4 also headache red inflamed arm
Development of hives on upper arms, lower back and waist. For approx 3 wks. Treatment: Methylprednisolone 4 mg., SARNA 1% lotion.
From the second Pfizer vaccine, I noticed a hissing, whooshing sound, predominately from my left ear, although from both. After the booster shot (my third), the noise increased. It has not gone away.
She experienced weakness & aches shortly after midnight (10-12 hours after 2nd dose).  She fell in the middle of the night and was too weak to get herself up.  The weakness subsided, but tremors (she has had essential tremors her whole life) are significant & began the day after the shot.  She can "feel them from the inside," they are much more significant than she has ever experienced, and sometimes violent, involuntary convulsions.  She finds difficulty performing day-to-day functions such as eating or drinking.  She first reported about 5 days after the shot (not to this severity, and she complained more about the weakness) , now reports they still persist.  She is of good spirit.  Her doctor is doing telemedicine & knows of the events.  He was to get with her this afternoon after we talked.