chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received second dose of bnt162b2 on 24May2021; Patient tested positive for COVID following completion of the 2 dose series.; Patient tested positive for COVID following completion of the 2 dose series.; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient). A 33-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318, Expiration date: not reported) via an unspecified route of administration on 04Mar2021 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318, Expiration date: not reported) via an unspecified route of administration on 24May2021 (at the age of 33-year-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, patient tested positive for covid following completion of the second dose series and patient received second dose of bnt162b2 on 24May2021. Patient underwent lab test and procedure which included sars-cov-2 test positive on an unspecified date in 2021. The clinical outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Vomiting, high fever (103 F), resolved on own via Tylenol administration. 2 days post fever, diarrhea . All symptoms resolved within 4 days. We believe she had a stomach virus but was instructed by the CDC to report it anyway.
On June 23, 2021 three hours following COVID-19 vaccination patient complaints of face swelling with edema, palpitations, skin rash and respiratory difficulties. She visited the emergency room were symptoms were controlled and she was discharge home.
Received Pfizer vaccines on 1/29/21, 2/19/21, 10/14/21 Tested positive for COVID by PCR on 11/1/21 Admitted to Hospital on 11/1/21 , asymptomatic, admitted for other reasons
p/vax pt devel approx 3-4'' red & swollen area at inj site
Patient has erythema 1.5 cm x 1 in on left arm, since 07/21/2017. No other symptoms related.
The same day as vax, the pt developed flu-like symptoms. She also developed an injection site reaction characterized by redness and swelling described as "cellulitis". She recovered within 2 days.
Exhaustion from watching granddaughter.; Sore arm from covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm from covid-19 vaccine.) and FATIGUE (Exhaustion from watching granddaughter.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe).   On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 30-Aug-2021, the patient experienced VACCINATION SITE PAIN (Sore arm from covid-19 vaccine.). On an unknown date, the patient experienced FATIGUE (Exhaustion from watching granddaughter.). At the time of the report, VACCINATION SITE PAIN (Sore arm from covid-19 vaccine.) and FATIGUE (Exhaustion from watching granddaughter.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication reported.  The reporter's causality for the event(s) of Sore arm from covid-19 vaccine and Exhaustion from watching granddaughter with Humira was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Extreme muscle weakness in lower extremities, to the point of urinary incontinence., difficulty getting out of chair  (i?m an active person and never had problems like this before) I had this type of weakness with the 3rd vaccine but not this pronounced, which is why I'm reporting it now. Also had temp 101.1 ( usual temp is 97) nausea, headache and fatigue. Sx. Lasted about 24 hours. Feel perfectly fine today (4/12, 7am).
swollen left under arm-nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 10:00 (Lot number: EL3246) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 21Jan2021, for COVID-19 Vaccination, reaction(s): "Left Arm Red, Hot and raised", "Left Arm Red, Hot and raised", "Left Arm Red, Hot and raised", fine now. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 11Feb2021, outcome "not recovered", described as "swollen left under arm-nodes". The patient underwent the following laboratory tests and procedures: laboratory test: (24Feb2021) unknown results; ultrasound breast: (16Mar2021) unknown results, notes: Swollen lymph node (Have to go back in June). Therapeutic measures were not taken as a result of lymphadenopathy.  No follow-up attempts are possible. No further information is expected.
approximately 10 - 15 minutes after vaccine, person experienced audible wheezing, shortness of breath and "tightness" in the throat.
MENVEO given SubQ when it should have been given IM. Patient experienced warmth and pink coloration spreading at injection site. No induration, pus, fever, or chills noted. Patient to monitor for fever, chills, and to monitor site if it gets red or hot and if so needs to be seen.
itching and scaling on his head; rash of some sort; scaling on his head; difficult to move his arm; 10-JUL-2019 first dose; arm pain; headache/lasted 2 months; This case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included migraine.   On 10th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 10th July 2019, several hours after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm. On 11th July 2019, the patient experienced headache. On an unknown date, the patient experienced pruritus, rash, skin scaly, mobility decreased and incomplete course of vaccination. On an unknown date, the outcome of the headache, pruritus, rash, skin scaly, mobility decreased and incomplete course of vaccination were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the headache, pain in arm, pruritus, rash, skin scaly and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had headache and lasted 2 months.   The patient had arm pain and it was difficult to move his arm.  The patient started to had some itching and scaling on his head and recently noticed that it may be a rash of some sort. Till date the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
loss of consciousness; respiratory distress Narrative: Patient tolerated his 1st dose of the COVID-19 vaccine well, on 12/16/2020, and received his 2nd dose on 1/6/2021. Patient had some mild clinical decline the past few days prior to 2nd vaccination, with a decreased appetite and some increased fatigue per nursing report, but no significant changes. He experienced nausea on the evening of 1/6/21, which was effectively managed, but by early morning he spiked a fever of 102.9 with a sat of 86.1%. He continued to deteriorate from that point on and died 1/7/21 @13:20. Clinically, the presentation was most consistent with an aspiration pneumonia.
headache - moderate continuing to date arm pain - severe  neck pain and stiffness - severe continuing to date
A few female students at a middle school had bad reaccions in their whole body and physically were not feeling good after getting Gardasil 9; A few female students at a middle school had bad reaccions in their whole body and physically were not feeling good after getting Gardasil 9; This spontaneous report was received from an administrator and refers to a few female patients of unknown age. Patients current conditions, medical history, concomitant medications, drug allergies or reactions were not reported.       On an unspecified date,  the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, dose number, lot number and expiration date were not reported) for prophylaxis.        On an unspecified date (reported as "after getting hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)"), the few female patients experienced a bad reaction in their whole body and physically were not feeling good (feeling abnormal).  It was reported that the patients get better over the time and had recovered, it was unknown if the patients sought for medical attention or if any treatment was given. The reported did not assess the causal relatedness between the events and vaccination  with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).
12 mo ex 32 week with gross motor delay and S/P hypospadias repair. NICU x 25 days at birth. Received 12 mo vaccines and had complex febrile seizure. Admitted 24 hrs for work-up.
Tiredness; Lack of energy; I felt I knew that I couldn't go all the way I was afraid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EP7534) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "Glaucoma" (unspecified if ongoing), notes: Verbatim: Glaucoma; "Low thyroid function" (unspecified if ongoing), notes: Verbatim: Low thyroid function. Concomitant medication included: SYNTHROID taken for thyroid hormones decreased. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; ASTHENIA (non-serious), outcome "unknown", described as "Lack of energy"; FEAR (non-serious), outcome "unknown", described as "I felt I knew that I couldn't go all the way I was afraid". Patient stated, "I had the shot approximately two weeks ago and I have noticed tiredness, lack of energy and it's just been just not real big but today I did work in a yard, I worked in yard for a bit and I felt well and I was going to, I live about a miles from a restaurant that I sometimes bicycle too and weather was nice I thought I will bicycle to the restaurant well I only got about half a mile and I felt I knew that I couldn't go all the way I was afraid so I turn around and came home and I was just wondering that is that too serious should I see a medical assistance because of this."  No follow-up attempts are possible. No further information is expected.
itching and rash on forehead and cheeks, beginning 2 days after vaccine, pt took benadryl , benadryl helped, reported event today, pt continuing benadryl
Vaccine : Pfizer BioTech COVID-19 Vaccine EUA.  Symptoms : Chills, Body Aches, Slight Fever  Time Course : About 2 hours
Information has been received from a medical assistant referring to a 4 week old male patient without pertinent medical history and drug reactions/allergies. On 15-JAN-2015 the patient was vaccinated with the first dose of RECOMBIVAX HB 5mcg/0.5 ml (0.5 ml, intramuscular in the right leg, lot# was unspecified) and on 13-FEB-2015, the patient was vaccinated with the second dose of RECOMBIVAX HB 5mcg/0.5 ml, lot# K012875, expiration date unspecified, 0.5 ml, intramuscular in the right leg (inappropriate schedule of drug administration). There was no concomitant therapy. On the following day of second vaccination, 14-FEB-2015, the patient developed symptoms on his hands, feet and face. Symptoms included rash, oedema and swelling. The patient was taken to the emergency room where he had blood work and cultures done (results were not provided) but the emergency room did not provide any treatment. He was not hospitalized. When the patient returned to the physical's office on 16-FEB-2015, the physician determined that the patient had recovered from his symptoms in February 2015. The medical assistant said the physician would like a lot check for lot # K012875. Additional information has been requested.
On 6-10-2022, I went to the doctor's office to be tested due to spouse having a positive Covid test. I did not have any symptoms. I was tested and had positive results as well. The doctor ordered Paxlovid. I started taking it that day. I am well today with still no symptoms. I am reporting a breakthru case of Covid.
Cluster headaches, drooping of face, inflammation of left side of body. Left pupil constricted. All on left side of body only. I now have to take regular medication which I may not can continue to afford to be able to function with daily living activities.   I went in healthy and now seem to have a permanent neurological disorder.
Patient complained of large red swelling on left arm near where vaccination was given. Patient and pharmacist do not remember if was given IM or SQ, but large swelling area located on the back of upper left arm. Area was warm to the touch. Patient complained of slight pain, but nothing severe enough to interfere with daily activities.
Nose and part of cheeks became flushed, almost "like a bad sunburn". nose felt warm to touch. Resolved after 1 hour. Felt restless that night and unable to sleep well. No tx.
Severe chills, shaking, sweating, vomiting, nausea, injection site pain, head pain, fatigue, fever
Red itchy rash approximately 3 inches in diameter in a circle surrounding the raised, painful, hard knot site of the injection.
Bumpy itchy rash the began with a few bumps on right thigh 4 days ago and has progressed to bumpy itchy rash covering entire leg hip to ankle bilaterally
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concomitant condition and concomitant medication were not reported. Since an unknown date in November 2015, the patients were vaccinated with improperly stored dose of ROTATEQ, orally (strength, dose, lot number and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
General malaise from booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "General malaise from booster shot".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Spoke with doctor's office whom mother reported to that client reported to her on 08/23/06 in the am that the night before when he was at a friend's house he had when he woke up around midnight dizziness and difficulty breathing did not seek medical attention in the am had temperature 101 and a headache felt under the weather.  Reported 8-24-06 left for college in no apparent distress.  Spoke with mother.
Information has been received from a physician concerning three patients who on unspecified dates was vaccinated with the dose of ZOSTAVAX (Merck) (LOT# not reported). On unspecified dates, the patients experienced shingles. The physician did not report the patients' outcomes at this time. It was unspecified if the patient sought medical attention. Follow-up information has been received from the physician who stated that he did not consider the adverse experience but considered them part of the 48% of patients who could potentially got shingles after receiving ZOSTAVAX (Merck). He said that no vaccine was 100% and that at least the cases of shingles that patients got after ZOSTAVAX (Merck) were milder. The physician reported that he could only remember one patient's name (had captured in WAES # 1009USA01617), starting the patient for this report and other patient (WAES# 1106USA04323) were not his patients but were patient's of other people in the practice. Follow-up information has been received on 14-SEP-2010 from the physician who on 07-SEP-2010 reported that the occurrence of this episode of shingles occurred 1.5 to 3 years after ZOSTAVAX (Merck) vaccination so the physician did not consider this to be reportable adverse event. Follow-up inconsistently information has been received from the physician who stated that the patient had no adverse reaction. This is one of several reports received from same source. No further information is available.
Left anterior thigh swelling, warmth, tenderness with 2 papules surrounding possible injection site and reactive left inguinal lymphadenopathy. Swelling started on 16th and had evaluation at ER on 16th. Came to office today. He was placed on Augmentin to return for follow up of cellulitis on Mon. 6/20/05.
(B) numbness (no weakness) to LE which progressed up to chest. Started 2-3 days after injection. No F/C/SOB and pain/gait abnormalities/vomiting/diarrhea.
sz (infantile spasms) w/in 24hr involuntary screaming for min;to hosp 13JUL96 & in for a wk;no fever;given 50/50 change, could die from inj;
This spontaneous report was received from a pharmacist via a company representative refers to a patient of unknown demographics. On 01-MAR-2014, the patient was vaccinated with ZOSTAVAX (lot # J004310 expiry date of 12-JUL-2014), 0.65 ml, subcutaneous. On 03-MAR-2014, the patient experienced 3 inch by 5 inch red welt at the injection site. The patient sought medical attention by contacting pharmacy. The outcome of 3 inch by 5 inch red welt at the injection site was reported as recovered on 04-MAR-2014 without any medical treatment. Additional information has been requested.
persistent, inconsolable crying lasting 2 1/2hr then short periods w/no crying then crying off & on till 7PM;fussy through noc;pale face & hands;no appetite for 6 days;vomiting x 3;did not want to be held or to be touched;
It started in my right upper bicep. Pain and went to excruciating pain that went up into my right shoulder. Then it went to the left shoulder and my left bicep. It started the 13th of July. It went away and then 2 weeks later it started again on the 25th the same sequence. It was worse that labor with my son. I did a tele med visit and they said IVIG was the solution; which I was already receiving.
Abdominal pain, R/O intussusception - URI, cold and cough 1 week. Intussusception continued U/S. + Abd X-ray. Successful reduction by Barium enema. On Albuterol too, ? RAD.  Received flu vaccine 10/30/2007, SP lot # U2462AA, LAT.  12/20/07 Patient experienced runny nose, cough/cold symptoms x 1 week w/diarrhea x 3 days & vomiting x 1 day.  When seen in clinic, parent revealed patient had been in hospital 11/10-11/11/2007 for IS.  12/28/07 Reviewed hospital medical records which reveal patient experienced cough x 2 wks,irritability, colicky abdominal pain & vomiting x 1 day.  Family member had been ill w/gastritis 1 wk prior.  Admitted 11/10-11/11/2007.  Surgery consult done. Progressed well s/p reduction & d/c to home. FINAL DX: intussusception, enema reduced.
(L) arm became swollen shoulder to elbow - 2 days fter - not reported till a week later.
The vial was initially stored in refrigerator on 06-Jul-2022 with BUD as 05-Aug-2022 was administered to patient post use by date; No adverse event; Adult patient received expired Monovalent second dose of Moderna COVID-19 vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent second dose of Moderna COVID-19 vaccine.), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Jul-2022 with BUD as 05-Aug-2022 was administered to patient post use by date) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 051B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent second dose of Moderna COVID-19 vaccine.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Jul-2022 with BUD as 05-Aug-2022 was administered to patient post use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent second dose of Moderna COVID-19 vaccine.), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Jul-2022 with BUD as 05-Aug-2022 was administered to patient post use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent second dose of Moderna COVID-19 vaccine.) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Jul-2022 with BUD as 05-Aug-2022 was administered to patient post use by date).    Concomitant drugs were not reported.  It was reported that the monovalent individual vial of unknown size was administered to patients from 19-Sep-2022 until 09-Nov-2022. The vial was not exposed to temperature excursion. The vial was in the freezer and was moved to the refrigerator on 06-Jul-2022.  It was also reported that 6 patients received vaccine on 19-Sep-2022, 2 patients on 04-Oct-2022, 1 patient on 06-Oct-2022 and 1 patient on 09-Nov-2022. It was unknown if patients received full protection against COVID-19 virus.  Treatment medications were not provided.  This case contains information for the 2nd dose of 11th adult patient out of 12 as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-720531 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2023: Live Followup received, updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720531: