chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives on chest, neck, arms; Red/itchy chest/neck; Body aches; Itchy neck/chest; Pregnant at the time of vaccination? Yes; Sore arm; This is a spontaneous report from a contactable consumer (patient). This is a maternal report. A 33-years-old pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration, in the left arm on 25Feb2021 at 16:00 (at the age of 33-year-old) as single dose for COVID-19 immunisation. Medical history included chronic hypertension and pregnant both from an unknown date and unknown if ongoing. Known allergies not reported. Concomitant medications included labetalol, loratadine (CLARITIN), low dose aspirin [acetylsalicylic acid] and prenatals all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EM9810) via an unspecified route of administration, in the left arm on 04Feb2021 at 16:00 as single dose for COVID-19 immunisation. Facility type vaccine reported workplace clinic. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 25Feb2021 at 04:00, the patient experienced pregnant at the time of vaccination, vaccine on Thursday on 25Feb2021 afternoon sore arm, on 26Feb2021, Friday morning had tchy neck/chest, body aches progressed through the day, on 27Feb2021, Saturday experienced red/itchy chest/neck and on 28Feb2021, Sunday experienced hives on chest, neck, arms. Patient had received treatment for event was Benadryl. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The mother reported she became pregnant while taking bnt162b2. The mother was pregnant at the onset of the event. The mother was due to deliver on 21Apr2021. Gestational period reported 32. Outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Testosterone levels went to 700 prior to the vaccine to 353 after the vaccine.  I feel tired, can't get enough rest regardless of how much I'm sleeping.   My estrogen levels are practically ZERO
This spontaneous report as received from a nurse practitioner refers to a 6 week old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 20-JAN-2015, the patient was vaccinated with the dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
He got his vaccine, he didn't have any reactions on Wednesday or Thursday or for most of the day Friday.  Then around 6:30 he felt weakish, stood up in a restaurant, tried to get to his car and fainted and was caught by somebody.  He was set down in the chairs and waited about an hour and then drove home.  He did not contact his doctor.  He was out of state and so he did not go to an UR or seek medical attention.  He felt sick for about 6-8 days after that.  He did not take anything for his symptoms.  He was OK following that.    He did get two other Pfizer vaccines and did not have any reactions to those.
UPON INJECTION, NEEDLE BENT AND VACCINE LEAKED OUT. PT DID NOT RECD ANY VACCINE. SECOND ATTEMPT WITH PFIZER VACCINE GIVEN ON THE SAME ARM.
as having a headache for a couple of days after receiving Flu shot; within 5 minutes, the "nail beds on her left hand turned blue".; Initial information received on 06-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 67 years old female patient who experienced within 5 minutes, the "nail beds on her left hand turned blue". and as having a headache for a couple of days after receiving Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history included Arteriovenous fistula operation with in her left upper arm. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Renal disorder NOS.   On 11-Oct-2023, the patient received a 0.7 ml dose of suspect Influenza Quadrival A-B High Dose HV Vaccine (lot UT80726A, expiry date: 06-Jan-2024 with unknown strength and form) via unknown route in the right deltoid as prophylactic vaccination.  On 11-Oct-2023 the patient developed within 5 minutes, the "nail beds on her left hand turned blue" (nail discolouration) following the administration of Influenza Quadrival A-B High Dose HV Vaccine . On an unknown date the patient developed a headache for a couple of days after receiving (headache) (unknown latency) Influenza Quadrival A-B High Dose HV Vaccine.  It was reported "Caller reports that her "fingers turned black and blue like she had been beaten up". Caller informed the staff, and they came to sit with her to monitor her condition. After 30 minutes, the bed of fingernails went back to normal. The discoloration on fingers looked like bruises and returned to normal after some time. The only other thing she reported was having a headache for a couple of days after receiving Flu shot, but she is not sure if that was contributed by the flu shot."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovered / Resolved on 11-Oct-2023 for the event within 5 minutes, the "nail beds on her left hand turned blue". and was Unknown for the event as having a headache for a couple of days after receiving flu shot.
p/receiving vax begin severe screaming @ 4PM unable to console; large swelling @ inject site & hard knot; seen by MD 25APR94; dx react to DTP;
Patient had syncopal episode & fell to ground in office after immunizations with VARIVAX. BP decreased pulse decreased not cyanotic or pale had had no breakfast in AM. Patient known Hx seizure disorder. In past has had syncopal episode to blood draw.
Received DTAP #5 on 05/03/04.  Mom called 9:15am 05/04/04, arm red, swollen.  Progressed as day went on, seen in our office 7:00.  10cm erythema, warmth, and induration. Diagnosis with cellulitis.  Augmentin 400mg twice daily for 10 days.
sore arm; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (mild headache) and VACCINATION SITE PAIN (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HEADACHE (mild headache). On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 04-Mar-2021, HEADACHE (mild headache) had resolved. On 06-Mar-2021, VACCINATION SITE PAIN (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Pt felt light headed, common vaso-vagal response. PT stabilized AOx4, ambulates appropriately (BP 95/54; HR 67; RR 16; O2 sat 99%) & released home
LLQ abdominal pain. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
About 1 hour after the shot I felt very tired . 3 hours after the shot I have severe body ache and headache lasted for 4 hours.
PATIENT WAS GIVEN PHARMAJET.  THE MORNING AFTER THE INJECTION, A RASH DEVELOPED ON THE FRONT OF THE ARM (NOT AT THE SITE OF INJECTION), SPREAD TO THE PATIENTS BACK, THEN MID-DRIFT, THEN DOWN THE PATIENTS THIGHS.  RASH WAS REPORTED ON 10/14/2011 BY PATIENT.  PT SAID THEY HAD RECEIVED THE VACCINE IN THE PAST WITH NO KNOWN REACTIONS.  PT TOOK BENADRYL AT ONSET OF RASH WITH NO RELIEF.  PT IS ONLY ALLERGIC TO DEMEROL AND LEAVES.  PT HAS CONTACTED HER PHYSICIAN ABOUT ADVERSE REACTION.
This case was reported by a nurse via sales rep and described the occurrence of fatigue extreme in a 55-year-old female patient who received SHINGRIX. Previously administered products included SHINGRIX with an associated reaction of chills (For tolerance to 1st dose, refer to case US2018GSK077927). In April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a month after receiving SHINGRIX, the patient experienced fatigue extreme, chills and malaise. In April 2018, the outcome of the fatigue extreme, chills and malaise were recovered/resolved. It was unknown if the reporter considered the fatigue, extreme, chills and malaise to be related to SHINGRIX. Additional details were provided as follows: The patient experienced more extreme fatigue, chills and malaise after 2nd dose compare to 1st dose, the events lasted for 2 to 3 days.
CHILLS; HEADACHE; BODY ACHES; FATIGUE; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported.  On 03-MAY-2021 17:30, the subject experienced body aches. On 03-MAY-2021 17:30, the subject experienced fatigue. On 04-MAY-2021, treatment medications included: paracetamol. On 04-MAY-2021 01:00, the subject experienced chills. On 04-MAY-2021 01:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 04-MAY-2021 06:00, and headache on 04-MAY-2021 08:00, and was recovering from fatigue, and body aches. This report was non-serious.
Case was hospitalized for Covid 7 months after receiving the Janssen vaccine. Pneumonia due to COVID-19 virus Presented with SOB, fever, fatigue in the setting of known Covid-19 diagnosis. Symptom onset 10/11 with rhinorrhea. Subsequently developed hypoxemia. Required 2L at time of admission. CXR with bilateral patchy infiltrates, right>left. No chest pain or GI symptoms. Received Covid-19 vaccine ( J&J 3/21). Completed course of remdesivir Started dexamethasone 10/19 to complete 10- day course. Worsened 10/23 with increased O2 requirement- CTA negative for PE. Did not meet criteria for tocilizumab and given his history of factor V Leiden and risk of thromboembolism with barcitinib, did not order this agent. By 10/27 (HD #8) he was sufficiently improved to permit discharge home with supplemental oxygen.   Acute respiratory failure with hypoxia (HCC) Due to Covid pneumonia. Not entirely resolved at discharge, still need 2 lpm.
12 hours after injection noticed injection site reaction - incrased pain, redness, swelling at injectin site 2 days after receiving influenza vaccine (L thigh).
pt recv vax 12JUL95 & on 4FEB97 pt exp a healthy case of chicken pox w/a papular rash on face & trunk & no fever;
pt recv vax & 5-6hr post vax pt exp an urticarial rash all over body which was blistering hive type rxn;pt seen by MD 9AU96;hives were treated w/pred;
High fever at 102.3 degrees F; fatigue, mild muscle aches, mild joint pain.  Fever reduced  over three day period of time; side-effects lasted three full days through Monday, October 4th in the afternoon.  Right arm painful at injection site and knot formed.
Info has been received from an RN concerning a 7 year old white female with seasonal allergies and no pre-existing allergies, birth defects or medical conditions. and no known drug allergies who on 6/8/99 at 14:00 was vaccinated SC in the left arm with a 0.5ml, 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination. There was no concomitant medications. On 8/19/05, at 09:00, also reported as 8/20/05, the pt presented to the physician's office with a 102 fever, a papular vesicular rash and complained of not feeling well and feeling "very lethargic". It was noted that the child was exposed to chickenpox and shingles in the community. No treatment for chickenpox was given, but the child was placed on Zyrtec at the time of the visit. Unspecified events following prior vaccinations. The outcome was reported as recovered on 8/27/05. No additional info is expected.
Immediate onset of pain at time of injection. Never got any better. Progressed to Impingement syndrome and frozen shoulder. 3 other people in clinic also affected but their pain resolved after 4 months.
Injection site reaction (erythema at site of injection approximately 4-5 cm in diameter).
Weakness - was in bed for 36 hrs; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness - was in bed for 36 hrs) and CHILLS (Chills) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced ASTHENIA (Weakness - was in bed for 36 hrs) and CHILLS (Chills). On 06-Feb-2021, ASTHENIA (Weakness - was in bed for 36 hrs) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-028005 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-028005:Crosslinked case
Swelling at site. temp 100.2, headaches, chills and body aches
Redness, tenderness and swelling at the site of injection. Was given KEFLEX 500mg % po q 12 hours at hospital.
Very bad itching at the injection site; Which now is red and swollen; Which now is red and swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Very bad itching at the injection site), VACCINATION SITE ERYTHEMA (Which now is red and swollen) and VACCINATION SITE SWELLING (Which now is red and swollen) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Lung cancer.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Very bad itching at the injection site), VACCINATION SITE ERYTHEMA (Which now is red and swollen) and VACCINATION SITE SWELLING (Which now is red and swollen). At the time of the report, VACCINATION SITE PRURITUS (Very bad itching at the injection site), VACCINATION SITE ERYTHEMA (Which now is red and swollen) and VACCINATION SITE SWELLING (Which now is red and swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included medicine for diabetes and lung cancer.  Treatment information was not provided.
Could not breath; Tired; Very bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Could not breath), FATIGUE (Tired) and VACCINATION COMPLICATION (Very bad reaction) in a 92-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Could not breath) (seriousness criterion hospitalization), FATIGUE (Tired) (seriousness criterion hospitalization) and VACCINATION COMPLICATION (Very bad reaction) (seriousness criterion hospitalization). At the time of the report, DYSPNOEA (Could not breath), FATIGUE (Tired) and VACCINATION COMPLICATION (Very bad reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not reported. Treatment medication information was not reported.  This is a spontaneous  case concerning a 92-year-old patient of an unknown gender, with no relevant medical history reported ,  who experienced the serious  unexpected events  of  DYSPNOEA , FATIGUE and VACCINATION COMPLICATION leading to hospitalization after receiving a dose of Moderna COVID-19 vaccine. Very limited information regarding clinical course of these events has been provided, and patient declines to further contact for follow up. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous  case concerning a 92-year-old patient of an unknown gender, with no relevant medical history reported ,  who experienced the serious  unexpected events  of  DYSPNOEA , FATIGUE and VACCINATION COMPLICATION leading to hospitalization after receiving a dose of Moderna COVID-19 vaccine. Very limited information regarding clinical course of these events has been provided, and patient declines to further contact for follow up. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
loss of smell for a week; loss of taste for a week gone; no appetite; no strength; tired since she got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of smell for a week), AGEUSIA (loss of taste for a week gone), DECREASED APPETITE (no appetite), ASTHENIA (no strength) and FATIGUE (tired since she got the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Past medical history  was provided.     On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (loss of smell for a week), AGEUSIA (loss of taste for a week gone), DECREASED APPETITE (no appetite), ASTHENIA (no strength) and FATIGUE (tired since she got the vaccine). At the time of the report, ANOSMIA (loss of smell for a week), AGEUSIA (loss of taste for a week gone), DECREASED APPETITE (no appetite), ASTHENIA (no strength) and FATIGUE (tired since she got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment information was provided
URINARY TRACT INFECTION N30.01 - Acute cystitis with hematuria
swelling, itching , rash 1 week after injection.  Lasting x1 week or more
Donor phoned center on 8/25/07 at 1235 stating that she had gotten Tetanus shot on 8/27/07 and had felt fine until 0600 8/25/07 when she awoke with nausea and vomiting. Donor sent to work fitness for eval.
Information has been received from a pharmacist concerning an elderly clinic patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649989/0579P). On approximately Mar 08/2005 two weeks ago, the patient experienced unknown adverse reactions. Unspecified medical attention was sought, the patients out come was unknown. No product quality complaint was involved. Additional information has been requested.
On 1/4/2023, patient presented to the emergency department for evaluation of shortness of breath cough, and tachycardia. He had a positive COVID-19 PCR test on 1/4/2023 in the ED; his chest x-ray showed progressive bilateral lung infiltrates suggesting infectious or inflammatory process. Based on the medical information provided by Medical Center to public health, it is unclear if the patient was discharged from the emergency department or admitted to the hospital. Submitter does not have access to further medical information on this case. If more information is needed, please contact the hospital  On 1/23/2023, patient presented to the emergency department for evaluation of shortness of breath. He was tested again for COVID-19 and had a positive COVID-19 PCR test on 1/23/2023 in the ED; his chest x-ray showed bilateral infiltrates which had increased over the previous exam and mild cardiomegaly. He was given a DuoNeb treatment and admitted to the hospital for further evaluation and treatment. During his hospital stay, the patient?s condition deteriorated; He was placed on inpatient hospice care and died on 2/2/2023 at the hospital. Submitter does not have access to further medical information on this case. If more information is needed, please contact the admitting hospital
Pain/swelling under right axilla, chest wall. Started on Wed. 9/20/17. Malaise 9/19/17. Treatment: ADVIL 400 mg TID x 5 days, low heat to area.
My arm was more sore than the first one. I also had water in one of my ear. I went to the doctor and she prescribed me nose spray for my ear. This affects my speech. This has never happened to me before. My doctor thinks it is allergies and doesn't think it has anything to do with the shot.
The father booked an appointed under his name and date of birth the father and son share the same name and an adult dose was given to the child. The error was discovered as the patient was still in the pharmacy and both were made aware of the mistake and is aware that the son will receive a pediatric dose for their second dose
Soreness and swelling on day 1 and 2 Redness/rash nine days later
High fever (102.4 F), body aches, chills, night sweats, mild nausea, mild sore throat, very strong headache
Varicella (3 lesions) destal to inject site - esp to VZV - attends daycare, playgroup - ???
Numbness and tingling/itching shooting down arm into fingers upon injection. Waited for the required 15 mins and no change. Drive home and in the next 30 mins (30-45 mins post injection) numbness spread to left side of face, neck, ear, jaw, and tongue. Contacted pharmacy and was advised to monitor and take Benadryl and treat as I treat other allergic reactions.
Vomiting 5 times at 8:30PM, 9:30PM; 10:30PM, 10:45PM and 11:15PM. No further symptoms after woke at 7AM the next morning.
Significant flare of PsO in surface area and thickness.  I have never been on biologic and only use nonsteroidal topical creams (3% salicylic acid).  The flare stared approximately Day 7 after 1st dose, and has continued to worsen exponentially.  2nd dose received today.
A non-serious spontaneous report of '29 patients received expired FLUMIST" was received from a physician concerning a eight-year-old female. The patients' medical history included no history of asthma. Concomitant medication were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are
About 20 minutes after the injection, I had numbness in my lips and cheeks (it felt like pins and needles).  Over the next 10 minutes, I noticed swelling in my throat (swallowing felt somewhat obstructed).  These persisted for an hour or so until I took Benedryl which seemed to ease the numbness but the swollen throat persisted..