chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT IS 3 YEARS POST MENOPAUSAL AND WAS VACCINATED 5-5-22. PATIENT HAD 102 FEVER DAY AFTER VACCINATION 5-6-22 AND THE 2ND AFTER VACCINATION 5-7-22.  SHE BEGAN BLEEDING/SPOTTING VAGINALLY.   WHEN PATIENT HAD 1ST 2 COVID VACCINATIONS SHE HAD NO SUCH SYMPTOMS.
right arm swelling, purpura/ecchymosis distal to injection site one day later
Injection @ 12 noon on 10/6/04.  12 hours later: Headaches, Chills, Shakes, Fever 102, Aches/Pains, Chest Discomfort, Extreme Tiredness.  Lasted for about 24 hours, then fine.
86 yr old male medical hx of DM, htn and afib comes in for eval of virallike symptoms, fever, chiolls, body aches, hemoptysis and hypoxia. Pt found to be covid positive. He is vaccinated. CXR revealed bilat pulm infiltrates. He was Hypoxic 85 rmbair started on NC 4L. EKG afib 160's started on cardizem gtt. Pt received IV solumedrol, rocephin and azithromax in ER as well.   During assessment in the ER the pt required additional oxygen now on nonrebreather 100% o2 sats increased to 97%, His hrremianed uncontrolled on 15 ml of cardizem gtt, pt to receive bolus will check stat cta rule out PE. Potassium replaced and will add on mag and ddimer. Pt admission upgraded to Step down
Heart rate dropped to 30 and BP dropped to 58/23. Was taken in the ambulance to hospital and given fluids and O2. Recovered to normal within a couple of hours. Nine days later injection site became red swollen and painful. This went away after three day. 14 days after the injection that arm again became red and warm to the touch.
This spontaneous report was received from the nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with VARIVAX (lot: R006221; expiry date: 29-FEB-2020) intramuscularly in the left arm instead of SHINGRIX (wrong product administered). No adverse effects reported.
Pt was accidentally given Moderna Primary Dose for 12+ and not 5-11 years of age
cried for 5 hrs inconsolable; sl fever >100; rt leg was red, hard, hot; fussy; didn't eat until now on 8DEC93; leg stayed hard for 3 days;
Pentacel was administered without reconstituting with the Hib portion, only administering the DTap/IPV,No AE; Initial information received on 30-Jun-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a two months old female patient was administered a 0.5ml first dose of  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACE] (lot number of (Hib): UJ229AAA, (diluent): UJ314AA and expiration date: 23-Apr-2021) without reconstituting with the HIB portion, the only part that was administered was DTaP/IPV, via intramuscular route in the left thigh for prophylactic vaccination on 30-Jun-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination on 30-Jun-2020.  It was an actual medication error case due to inappropriate reconstitution technique.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sore arm; Arm still hurts; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PAIN (Arm still hurts) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PAIN (Arm still hurts). At the time of the report, PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PAIN (Arm still hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
15 minutes after administration: began experiencing light headedness, nausea, and tightness in chest  1 hour after administration: began experiencing tightness in throat, irregular heart beat, and hypertension, anxiety/feeling of impending doom
Lymph nodes in my left arm have become swollen and painful.  Started about 40 hours after injection.
Approximately 24 hours post-vaccination, I developed dizziness (vertigo) which is ongoing twelve days later.
12 year old daughter ended up in emergency room with stroke like symptoms. Severe headache followed by numbness in right hand, upper lip and slurred speech. Previously healthy with no medical issues whatsoever. Hast to follow up with a neurologist for further care.
Patient went to bed feeling extremely fatigued, couldn't sleep all night because her body ached too much.  Next morning was very weak, entire body ached "even the skin", fatigued and slight fever.
Patient is 42-year-old female with history of muscle dystrophy, fully vaccinated for Covid admitted to the hospital for shortness of breath.  She was diagnosed with COVID-19 pneumonia.  Started on steroids.  Had been complaining of significant cough, much improved with the medical management.  A1c came back slightly elevated the 8.5.  Patient's blood sugars have been in the 400s range, covered by Insulin.  She was seen by diabetic educator and will be sending her home on the Lantus and I initiated Metformin. As pt. is not able to do fingersticks she was set up with freestyle libre2.  I do suspect the pt will need insulin for the time being on dexamethasone.  She is aware of the food restrictions.
After all of my COVID vaccinations I have experienced fever/severe body muscular pains,insomnia for 48 hours after the shot. Not able to do  anything.
I had my 2nd dose of covid vaccine on 1/15, around 5 pm.  Next day when I got up about 7:20 I felt dizzy nausea and wanted to vomit.  Then I passed out, I fell down and hit my face on the floor.  My family called 911 paramedica.  They ,measured d my blood pressure and it was too low. The area around my right eyebrow was swollen and my neck hurt as precaution I went to the hospital.  I suspect the incident and its symptom are side effects of the vaccine given the timing.  Later on I had headache off and on and brain fog.
employee received the first COVID vaccine in her left arm.  The following morning she woke up with a rash on her left arm that spread to her neck.  She has been managing it with antihistamines, has not missed work and is contacting her PCP today
MMR Vaccine given on Jan 27, 2010. A few weeks later we noticed bruises but assumed she just had bruises. A few more weeks later the bruises were really bad and just when I thought it was time to go see her Dr about it she got a nosebleed. The next morning at the Dr office she was given a blood test that showed her platelet count was 4,000 and was sent directly over to the hospital. She spent 4 days there and now gets tests every 3-5 days. She still has bruising.
Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Mild
A report has been received from a Health Professional concerning an 11 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. It was reported that the patient received expired FLUMIST which started on 07-JAN-2016. The outcome of the event of received expired FLUMIST was unknown. The report was considered to be non-serious. The reporter and company physician considered that there was no causal relationship between received expired FLUMIST and FLUMIST QUADRIVALENT.
Case number PHEH2015US021296 is an initial spontaneous report from a nurse received on 16 Oct 2015. This report refers to a 16-year-old female patient. Concomitant drug included LO LOESTRIN FE. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported) on 08 Oct 2015 in the left deltoid. On 15 Oct 2015, the patient was vaccinated with RABAVERT (batch number: 578011A, expiry date: 30 Sep 2018) intramuscularly in the left deltoid. On the same date, 9 hours after RABAVERT vaccination the patient experienced severe myalgia, she felt like she was getting the flu, her skin sensitive to touch, had chills, nausea, feverish, severe headache and her arm hurt a lot. The outcome of the events reported as recovered on 16 Oct 2015. The seriousness of the events was not reported. The causality of the events reported as probable. Following an internal review on 22 Oct 2015, a significant case correction was performed for the information received on 16 Oct 2015: event skin sensitive to touch was recoded to increased skin sensitivity.
the baby was fussy all day yesterday and today; Crying; she had a baby and is currently breastfeeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 5 week-old female patient was exposed to bnt162b2 (BNT162B2), transplacental administered in arm left, administration date 07Dec2021 (Lot number: FD0809) as dose 1, single for covid-19 immunisation. The mother's relevant medical history included: "C Section" (unspecified if ongoing), notes: Mode of delivery (e.g. natural birth [i.e., vaginal delivery without medication or anesthesia], cesarean section: C Section; "Full term live birth" (unspecified if ongoing), notes: Pregnancy outcome: check one: Full term live birth. The mother was 1 weeks pregnant at the event onset. The mother is expected to deliver one baby(s). The mother's concomitant medications were not reported. The following information was reported: EXPOSURE VIA BREAST MILK (non-serious) with onset 07Dec2021, outcome "not recovered", described as "she had a baby and is currently breastfeeding"; IRRITABILITY (non-serious) with onset 08Dec2021, outcome "not recovered", described as "the baby was fussy all day yesterday and today"; CRYING (non-serious) with onset 08Dec2021, outcome "not recovered", described as "Crying". The baby was delivered live birth(unspecified), via cesarean route.  Additional Context: Caller reported having her first dose of the vaccine on 07Dec2021. Caller reported on 08Dec2021 having itchiness on her hands and feet. She had a baby on (#) and was currently a breastfeeding; the baby was fussy all day yesterday and today. Caller asked her HCP about the reaction and for treatment recommendations; her HCP recommended she call Pfizer. While reporting for herself, she mentioned she just had a daughter on (#) and she was breastfeeding.  She confirmed she was breastfeeding after she received the vaccine. This report was to capture information about her daughter. She normally does not get vaccines but got it because of her daughter. She then asked if you can pass antibodies through breast milk. She was breastfeeding her daughter. Since then, her daughter has been extremely fussy. She was crying all day yesterday and today. She then stated she cries all the time anyway.     No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101758869 maternal/child case
Very irritating unidentified smell always present,also very vivid dreams every night since about 2 days after 2nd vaccination.
Initial misuse report received from a healthcare professional on 22 March 2013. An 11-year-old patient had received DAPTACEL vaccine in error. No adverse event was reported. List of documents held by sender: none.
Nausea, fatigue, vomiting.  Pt observed initially in office; initially improved, then sx worsened at home - observed at home for several hours before recovering
my arm hurt quite a bit.  I felt a lot of pain; injection area was very hot and red and it felt sore; injection area was very hot and red and it felt sore; injection area was very hot and red and it felt sore; My arm also felt very heavy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete;, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "my arm hurt quite a bit.  I felt a lot of pain"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "recovered" and all described as "injection area was very hot and red and it felt sore"; LIMB DISCOMFORT (non-serious), outcome "recovered", described as "My arm also felt very heavy". Therapeutic measures were taken as a result of pain in extremity, vaccination site pain, vaccination site erythema, vaccination site warmth, limb discomfort.  Clinical course: Patient would like to report an adverse event after receiving the Pfizer booster shot on 07Apr22. I felt alright for several hours after the shot, but around 8 hours later, my arm hurt quite a bit. I felt a lot of pain, the injection area was very hot and red and it felt sore. My arm also felt very heavy and I could not even raise it without raising my shoulder. My husband gave me 2 tablets of Aleve and it continued to hurt until I went to bed. The next day, I experienced no pain or discomfort and did not experience any pain or discomfort after that. I am sorry I did not think to report it, I just figured it was an expected side effect. I had asked the healthcare professional that administered the booster shot if it would hurt like the last one and she said that it would hurt more and recommended I take aspirin.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Could  not get up from bed; Fell down to the floor when trying to go to the bathtub; Dizzy; Chills; Arm was sore; Arm was hot and sore; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Could  not get up from bed), FALL (Fell down to the floor when trying to go to the bathtub), FEELING HOT (Arm was hot and sore), DIZZINESS (Dizzy) and PAIN IN EXTREMITY (Arm was sore) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced FEELING HOT (Arm was hot and sore) and PAIN IN EXTREMITY (Arm was sore). On 07-Feb-2021, the patient experienced ASTHENIA (Could  not get up from bed), FALL (Fell down to the floor when trying to go to the bathtub), DIZZINESS (Dizzy) and CHILLS (Chills). At the time of the report, ASTHENIA (Could  not get up from bed), FALL (Fell down to the floor when trying to go to the bathtub), FEELING HOT (Arm was hot and sore), DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm was sore) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fatigue, headache, a bump or blister at injection site it?s squishy
pt recv vax 16AUG97 & 7SEP97 pt exp a rash that consisted of 10 to 20 lesions;
Pt was given her 2nd dose of COVID vaccine at 9:48 am. At 9:54 am pt was asked if she was feeling okay and pt reported that she had "tingling in her throat". Assistance called for and vitals obtained(157/74) pulse rate 83, sat o2 100%. Pt reported chest pain to RN. RN reported clear breath sounds and no labored breathing.  Dr. arrived besdie patient and pt was evaluated. At 10:02 am pts vital was (144/76) HR 76 and sat o2 on room air 100%. Dr.  provided samples of Xyzal to patient. Patient was clear of hives and at 10:05 am pt was reporting that she was feeling better and had no chest pain. At that time pts vitals was (142/76) HR 74 with sats 99% on room air, respirations 18. 1017- BP-143/76, HR-73, Res-18, sats- 100%   Patient alert and oriented at this time. No resp distress noted.  Patient reports she is feeling better and denies any chest pain at this time.  Will continue monitoring.   1029- BP-136/70, HR-68, Res-18, sats- 99%   Patient continues to converse in casual conversation.  No distress noted.  Instructions provided for patient to call 911 if displays signs and symptoms of anaphylaxis reaction.  Patient waiting for transportation (son).   1055- BP-156/73, HR-72, Res-18, sats- 100%   Patient walked out of room to check out.  No distress noted.
Pt recvd vax on 10FEB92 & 29JUN92 pt exp nausea & diarrhea; 28JUL92 nausea, vomiting & diarrhea for 3 days; 3SPE92 donated blood & was told had pos titer for anti-HBc; 10OCT92 retested by another lab & again was noted to have a pos titer
Patient reported fever & chills. He said the 3 days later he also had muscle aches but thinks that could be due to shivering from fever/chills.
systemic rash, t100-101 for 3+ days-irritable 1OCT to 5OCT;
Stomach bloating; Nausea; lightheaded; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration in the left arm on 08Mar2021 09:45 AM (at the age of 52-years-old) as first dose, single dose for COVID-19 immunisation at a Pharmacy or Drug Store. The patient has no relevant medical history. The patient has no concomitant medications. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient has no known allergies. On 08Mar2021, the patient experienced stomach bloating, nausea and lightheaded. No treatment was taken for the events. The outcome of the events was recovered on an unspecified date in Mar2021.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Headache, vomiting, severe arm pain for over 5 days,  swelling of the arm at injection site for over 5 days.
Patient had no reaction immediately after vaccination. She came back the following morning (at 8:30a) and reported a diffuse, splotchy pink/red rash all over her body. She said it was itchy, and wanted to let me know. She was directed to take OTC diphenhydramine for the itching. Her doctor's office was alerted, and I suggested she tell her doctor as well.
June 17th 2022, woke with fever (103deg). Test positive  for Covid. Temp went down to 101deg. Called Oncology office and was informed to take a couple Tylenol and they would send a prescription of Paxlovid to my pharmacy. Fever reduced to 99.3 before family member returned with prescription. By next morning, I felt fine and tested negative the following week.
Other diseases of bronchus, not elsewhereclassified Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Acute respiratory failure with hypoxia Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Hypertensive heart disease with heart failure Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Heart failure, unspecified Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 ABG (arterial blood gas) abnormal Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Acute kidney failure, unspecified Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Polycythemia Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Hyperglycemia, unspecified Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 ARDS (adult respiratory distress syndrome) Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Shock Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Acute respiratory failure Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Aspiration pneumonitis Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Abnormal CXR Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Cardiogenic shock Onset: 17-Apr-202114:26 Comments: Onset Date: 20210417 Cardiac arrest Onset: 17-Apr-202114:26 Comments: Onset Date: 20210417 Pulmonary infiltrate Onset: 17-Apr-202112:23 Comments: Onset Date: 20210417 Acute respiratory failure with hypoxia Onset: 17-Apr-202112:23 Comments: Onset Date: 20210417 Aspiration into airway Onset: 17-Apr-202112:23 Abnormal EEG Onset: 25-May-202112:11 Comments: Onset Date: 20210419 Encephalopathy Onset: 25-May-202112:11 Comments: Onset Date: 20210419 Acute thrombosis of right cephalic vein Onset: 19-May-202111:49 Comments: Onset Date: 20210425 Cardiomegaly Onset: 30-Apr-20216:24 Comments: Onset Date: 20210426 Ventricular fibrillation Onset: 29-Apr-20212:21 Comments: Onset Date: 20210427 Coma Onset: 27-Apr-202114:09 Comments: Onset Date: 20210422 Postoperative hemorrhage involving circulatorysystem following circulatory system procedure Onset: 26-Apr-202112:27 Comments: Onset Date: 20210421 Personal history of ECMO Onset: 26-Apr-202112:23 Comments: Onset Date: 20210419 Presence of ventricular assist device Onset: 26-Apr-202112:23 Comments: Onset Date: 20210419 Frequent PVCs Onset: 24-Apr-202112:49 Comments: Onset Date: 20210424 Presence of other vascular implants and grafts Onset: 24-Apr-20215:43 Comments: Onset Date: 20210418 Obesity, unspecified Onset: 24-Apr-20214:58 Comments: Onset Date: 20210417 Body mass index [BMI] 45.0-49.9, adult Onset: 24-Apr-20214:58 Comments: Onset Date: 20210417 Hyperthermia Onset: 23-Apr-202121:40 Comments: Onset Date: 20210419 Ventricular tachyarrhythmia Onset: 23-Apr-202112:14 Comments: Onset Date: 20210423 This code is used to indicate to the billing staff thatservices have been rendered and the chargeneeds to be coded. Onset: 22-Apr-202113:08 Comments: Onset Date: 20210421 Cardiomyopathy Onset: 22-Apr-202111:48 Comments: Onset Date: 20210422
On 1/8/21 while at dinner I discovered a swollen area in my neck.  I went to an Urgent Care Center a few days later.   I was sent for an ultrasound.   It was a lymphnode.   Then my doctor sent me for a CT scan.   It showed additional lymphnodes, also in left axillary area.   I have an appointment to see a surgeon,  but in reading information and talking with a friend who is also a family doctor, I think it may be related to my vaccine.
Patient received HPV vaccine, then attempted to leave clinic after 10 minutes, and had syncopal episode, pale, low blood pressure - was back to normal in 15 minutes.
Raised red area on left arm underneath injection site appeared on day 10 post-vaccine. Warm to touch, no other symptoms. Dermatologist prescribed Clabetasol cream to apply 2 x per day. After first application of cream, red area appeared to be less inflamed and less red. On day 2 of application, arm appeared blotchy (as if applied sunscreen unevenly), on day 3 of application, the injection site is raised, red, warm to touch and appears larger than day 1 or 2.
An oval area about 2 by 4 inches became bright red, swollen and painful and nasal congestion.