chrisvoncsefalvay/vaers-outcomes huggingface dataset:
breakthrough covid-19 infection; breakthrough covid-19 infection; Dose number 3; BNT162B2, administration date 04Nov2021/FLU VACCINE VII, administration date 04Nov2021; BNT162B2, administration date 04Nov2021/FLU VACCINE VII, administration date 04Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Nov2021 14:00 (Batch/Lot number: unknown) at the age of 45 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 04Mar2021 13:30 (Lot number: unknown) as dose 2, single and intramuscular, administered in arm left, administration date 11Feb2021 13:30 (Lot number: unknown) as dose 1, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 04Nov2021 13:30 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: LABETALOL; LEVOTHYROXINE; VITAMIN D 2000; BABY ASPIRIN; FISH OIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022 22:00, outcome "recovering" and all described as "breakthrough covid-19 infection"; IMMUNISATION (medically significant) with onset 04Nov2021 14:00, outcome "unknown", described as "Dose number 3"; PRODUCT USE ISSUE (medically significant), OFF LABEL USE (medically significant) all with onset 04Nov2021, outcome "unknown" and all described as "BNT162B2, administration date 04Nov2021/FLU VACCINE VII, administration date 04Nov2021". The patient underwent the following laboratory tests and procedures: covid-19 immunisation: (09Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The lot number for bnt162b2 was not provided and will be requested during follow-up.
1 wk later I had a fever, headache, achiness & tireness for 36 hrs. 3 wks. later I woke up with my Rt. eye sticking shut, eye lid red and puffy,sensitivity to light & pain in the eye. I was Diagnosed with Blepharitis, kero conjunctivitis, stye & chalizon. i was treated with antibiotics orally & via eye drops along with a ste riod in the eye drops. It took 2 wks to clear up and I still have the Stye & Chalizon. I saw 5 Dr's and am  n ow taking a prescription Omega 3 supplement. I guess the Stye & Chalizon are permanent markers for  t he COVID vaccine. I learned from a friend that she knows someone with exactly the same symptoms   b ut he has the stye & Chalizon in both of his eyes!! He got  the J$J vaccine also.
The day after receiving the shot, I started using fluorouracil 2% solution; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT PRESCRIBING ISSUE (The day after receiving the shot, I started using fluorouracil 2% solution) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Keratosis. Concomitant products included FLUOROURACIL from 23-Jan-2021 to an unknown date for Keratosis.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PRODUCT PRESCRIBING ISSUE (The day after receiving the shot, I started using fluorouracil 2% solution). At the time of the report, PRODUCT PRESCRIBING ISSUE (The day after receiving the shot, I started using fluorouracil 2% solution) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient called the pharmacy and said she has experienced severe pain on her arm from the Shingrix shot.  The pain which started on Thursday was so bad that she almost went to the ER.   Now, it has radiated to lymph nodes in her armpit  and  inside of her arm.
Lump/mass, swelling, warm, erythema, bruising at injection site. Symptoms infiltrated skin surrounding injection site.
SYRINGE MALFUNCTION. GUEST RECEIVED <50% OF DOSE. REDOSED W/O ISSUE
102.0 degrees temp. Muscle, skin, and joint aches. Nausea. Mild abdominal cramping and diarrhea. Felt weak.
Extreme Fatigue, shortness of breath, chills, redness and pain on site of shot, generalized body ache and joints, low grade
Pt recvd series of 3 Hep B vax 18DEC89, 17JAN90, & 14JUN90; titer 13SEP90 showed HBSAB neg; 2 booster doses given;
Information has been received from a physician concerning a 43 year old male (weight 172, height 71") with a history of exercise induced asthma who on 16-OCT-2006 was vaccinated with the first dose of Pneumovax 23 (lot #651404/0325F), 0.5 ml, IM. Concomitant therapy included FLOMAX and finasteride (MSD). On 17-OCT-2006, the patient experienced soreness in arm, red quarter sized spots on arm, chills and sweats. The patient sought unspecified medical attention but did not come in to the physicians office. The physician reported that the patient did not have a fever, no shortness of breath and did not experience wheezing. On 20-OCT-2006, the patient recovered from the soreness in arm, red quarter sized spots on arm, chills and sweats. Additional information is not expected.
Patient received vaccines (IPV #4, MMR #2, VZV #2, DTaP #5, ppd test) on 10/17/08.  He had a febrile seizure on 10/18/08, was taken to the ER and kept for 2 days.  He has a VP shunt since 2005 and a history of other febrile seizures.  CT scan revealed the shunt was working properly.  01/26/2009 MR received for DOS 10/18-20/2008 with D/C DX: Acute symptomatic seizure, h/o febrile seizure, macrocephaly, expressive speech delay, s/p SDH evacuation 2005, h/o subdural peritoneal shunt placement 2005, URI. Pt presented after episode of shaking, followed by sleep, then trembling in sleep. One episode of shaking in ER. Neuro consult-no clinical signs of shunt malformation. Concurrent URI, likely tactile fever noted by EMS. D/C for outpt f/u by PMD.
cough; congestion; Scratchy Itchy Throat; chest cold; Head Cold; dizziness; nausea; This is a spontaneous report from a contactable consumer reported for herself. This 30-year-old patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 27Apr2021 13:30 (Lot Number: ER8735) at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were none. No prior vaccinations within 4 weeks. The patient felt a little bit of dizziness and nausea on 27Apr2021 (3-4 hours after vaccination), from which she recovered after 2 days. Currently, she is experiencing head cold 16May2021 18:00-19:00, chest cold, congestion, cough, and scratchy, itchy throat which started 16May2021 18:00, which she stated she got from her daughter. The event dizziness and nausea required a visit to Emergency Room. No Physician Office required. She would like to know if she may receive the 2nd dose of the covid vaccine although she currently has symptoms of a chest cold. She stated the congestion has worsened but they can still eat food, no nausea. Treatment for events chest cold, congestion, cough, head cold and scratchy, itchy throat included Vitamin C Pills, Drinking Vitamin C. The outcome of chest cold was unknown, outcome of dizziness and nausea was recovered on 29Apr2021, outcome of other events was not recovered.
I am doing better now.  Received the vaccine on Saturday about 2:30 pm, and felt fine until later that night when I had serious muscular pain.  The following morning I felt fairly well, until about noon or 1 pm, when I had chills, low grade fever and fell into a very serious mood swing/ depression which is very unusual for me (almost suicidal depression).  Monday, I had more muscular pain and had trouble with my right wrist.  I continued to have serious low mood but by Tuesday morning was better (not as seriously depressed).  I still have low to mid level anxiety, but I am starting a new job which might be part of that.  All other symptoms are now gone, including the serious depression.  I simply thought it should be noted.
admit for weakness, loss of appetite, cough, SOB and chest pain.  tested + for COVID 7 days ago. acute respiratory hypoxia COVID pneumonia. Zinc and IV steroids, pt refused remdisivir and actemra. able to wean O2 from 3 L to RA by discharge. PT discharged home on steroids and antibiotics - will self-isolate
18NOV91 mom stated on the 12th day p/immun pt got a full blown case of measles, pt also ran a t100 ax x 3 days; 10DEC91 investigator called concerning MMR rx vs measles outbreak; stated was not measles but typical MMR reaction;
fever about 5-7 days a/rash; pt given APAP; eat nl;
Red, swollen, painful knot the size of a quarter where shot was given in the left arm. Advised warm compresses to area and give Benadryl. Call office if area becomes infected.
Information has been received from a physician concerning a 17 year old  female patient who on 15-MAR-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included traxodone HC1 and citalopram. On 15-MAR-2007 the patient experienced generalized hives. Treatment included diphenhydramine HC1 (BENADRYL), and at the time of the report the patient was reported to be recovering. Additional information has been requested.
Slight headache; Feeling tired; Slight blood on her nose; A spontaneous report was received from consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced slight blood on her nose, slight headache, and feeling tired.    There was no medical history or concomitant medications provided.  On 24 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Dec 2020, the patient, experienced the non-serious event of slight blood on her nose. Additionally, she was experiencing the non-serious events of slight headache and feeling tired on unknown date. It was noted the patient wiped her nose with a tissue and saw the slight blood. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events slight blood on her nose, slight headache, and feeling tired was unkown.; Reporter's Comments: This case concerns a female patient of unknown age, who experienced an unexpected non-serious event of Epistaxis and expected non-serious events of Headache and Fatigue. The event of Epistaxis occurred approximately two days after receiving first dose of mRNA-1273, (lot # unknown). The events of Headache and Fatigue occurred at unknown date after receiving first dose of mRNA-1273, (lot # unknown). Treatment information was not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Several minutes after vaccines given, patient is brought to staff by by family member. She states he is passing out. Client is seated in chair, eyes closed, white, diaphoretic and body tensed. He remains unconscious for 15-30 seconds and then regains consciousness and requests fluids. Given two juice boxes, cool compresses and fanned. Regains full function within minutes and states he feels better. Monitored in waiting room for 10 further minutes. Family member also noted he fell in waiting room against window but he broke his fall with his hands and did not hit his head. Family member and client agree that he is uninjured.
My initial symptoms were extreme fatigue, body chills, body aches, body fever occurring around 10pm on 10/14/2021 which lasted through 6am on 10/15/2021 at which time the fatigue, chills, aches, and fever subsided and I first noticed the loose stool. I have had loose stools since 10/15/2021 through today 10/20/2021 accompanied with a slight nausea, and stomach discomfort. I feel a general discomfort (difficult to explain) but its stemming from my stomach and radiating outwardly. The loose stools are most noticeable in the morning and evening but I have also had loose stools mid day.
This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. Medical history was not reported. The nurse practitioner informed that on 28-AUG-2014 the patient was vaccinated with PROQUAD (Merck) injection, 0.5 ml, subcutaneous, which expired on 22-AUG-2014 (lot number were not reported). No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
pt recv vax; approx 20-30 red spots; started breaking in eve; itching of spots, slightly irritable; no known exposure to chicken pox; no fever
Blood and fluid that leaked out on to arm; Did not get the full dose; A spontaneous report was received from a consumer concerning a 59--year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced when the needle was pulled out she felt that there was blood and fluid that leaked out on to her arm and she thinks she did not get the full dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (BATCH # 029L20A) on 15 Jan 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient received their second of two planned doses of mRNA-1273 (BATCH # 006M20A) on 12 Feb 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Reporter stated that she had her second dose of the Modera COVID-19 vaccine 12 Feb 2021, at a drive in vaccination clinic. She had it on her left arm. When the needle was pulled out, she felt that there was blood and fluid that leaked out on to her arm and she thinks that she did not get the full dose. Lot number 006M20A, expiration date unknown. The first dose was administered through the same site on 15 Jan 2021 on her left arm with unknown dose and route of administration. Lot number 029L20A, unknown expiration date. Reporter wanted to know what the protocol was for vaccine leakages, if she should get another dose and if she got the full protection from the vaccine. No further information was reported.  No treatment information was provided.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the events was unknown.; Reporter's Comments: This is a case of 59--year-old, female patient who was administered mRNA-1273 and experienced when the needle was pulled out she felt that there was blood and fluid that leaked  (Injection site leaking ) out on to her arm and she thinks she did not get the full dose ( incomplete dose administered) batch # 006M20A. There was no associated adverse event reported for the events of injection site leaking and incomplete dose administered.
STARTED WITH HEADACHE, CLOSELY RESEMBLED A MIGRAINE AS IT WAS JUST IN ONE EYE.  BECAME SICK TO STOMACH, THEN BEGAN WHAT COULD BE IDENTIFIED A SEIZURE.   BODY BECAME RIGID, A LOT OF PAIN, COULD NOT SPEAK, JUST MAKE SCREAMING TYPE NOISES,.   LASTED ABOUT 3 MINUTES,  THIS WAS REPEATED THREE MORE TIMES.   FOLLOWING DAYS HAD OVERALL BODY ACHES, STILL HAVE TROUBLE WITH CONCENTRATION, EXTREMLEY TIRED.
I tested positive for Covid-19 on May 01, 2023 my symptoms are runny nose. sore throat, fever of 100.4 I was taking Tylenol and Ny Quil and was also prescribed Paxlovid for my symptoms.
Pt Reports following the vaccine, numbness in arm, followed by pain.  Early in the morning following the vaccine, arm pain became unbearable.  Pt consulted his physician who advised pt to go to hospital.  X-rays and lab work were completed without finding.   Only notable issue, per PT, was elevated uric acid levels.  Pt. was given Colchicine ? (Pt believes it was colchicine).  Pain has since subsided mostly.
Stated had B-12 1 week ago in LD. Received flu vaccine left deltoid 10/5/04. Immediately soreness. Swelling started in PM. Redness and raised rash started 10/6/04 at 9am. Felt cold and hot since flu shot. Patient called MD office. They advised her to put cold compress to arm and take Tylenol q 4 hours prn.
Vaccination site pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 046321A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 4 UNK. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Ultrasound Doppler: all clear (normal) was all clear.         No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter.
Gave shot, she sat timer for 20 minutes to watch for adverse reactions but then went to sit in car. she said her chest got tight and her hips hurt and she noticed she could not stand up. Her friend came to pharmacy and got me and I took the emergency kit outside to her car. When I got out there she stated she was much better and wanted no treatment from me. I called the ambulance on the way out to her car and when they arrived she refused to go. The EMT's took her in the ambulance and took her blood pressure. They said it was slightly elevated and she was up and walking and told me she was fine, probably just got nervous. She then drove herself home.
This spontaneous report was received from a pharmacist refers to a 72 years old male patient with no known drug allergies who was vaccinated subcutaneously into upper left deltoid with a dose of 0.65 ml ZOSTAVAX (lot # 672563/1649AA, expiration date 21-JAN-2013) on 19-JUL-2012. No other co-suspects were reported. Concomitant medications included lisinopril, COUMADIN, spironolactone and carvedilol. Pharmacist stated she read in the local paper and found out that client was died at her home residence on 24-JUL-2012. Cause of death was unknown. It was unknown if autopsy was performed. Pharmacist stated the patient did have health conditions, unspecified, but she wanted to make sure that no problem existed with this ZOSTAVAX lot number. This event (death) was considered to be life-threatening and disabling. This is one of the two reports from the same reporter. Additional information has been requested.
Got sore throat, congested, red face, could hardly swallow, I took TYLENOL and NYQUIL and feel very run down.
Hand started itching, color of hand changed to a black color all over, painful, when scratching it starts to bleed.  Both arms are affected.
SHINGLES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shingles. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
After receiving flu vaccination - in the evening became nauseous, had headache, achy and fatigue.
Pfizer pediatric monovalent primary series dose #2 wasn't properly diluted for this patient's dose. he was given more vaccine then required for his second dose.
1 day post vaccination began with redness and vesicle, redness became much larger and developed another vesicle on/near injection site. No fever.
First injection on 01/21: mild pain at injection site (left arm) Second injection on 02/18: mild pain at injection site. After 4 hours, experienced fever 105F. After 7 hours, experienced headache, post and frontal area.  Still experience sore arm till present.
Waxing and waning axillary lymphadenopathy and axillary pain possible breast mass right breast
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter. The vaccine was stored in freezer and the HCP had taken out 1 or 2 vials and place in the fridge each day as needed.
Patient presented with severe heart burn symptoms and was found to have inferior ST elevation on the EKG as well as 3AVB in the ER. She was taken emergently to the cath lab by Dr. and had PCI of the RCA on 5/22/2022. Her CHB resolved - there was no recurrence. 2 days later on 5/24/2022 she underwent staged PCI of the ramus branch. Echo showed EF 55-60% with no WMA. The second cardiac cath was complicated by a groin hematoma. Pressor support with Levophed was added and she was kept in the CCU. SQ heparin was held. Her Hgb dropped from ~ 11.4 to 9.5, likely because of continuous IVF being given at 75 mL/hour.  See procedure notes for complete details.  Her groin was stable with significant bruising, but no firmness or swelling.  On day of discharge, she was feeling well with no cardiorespiratory symptoms and was ambulating without difficulty. Vitals were stable and she was maintaining SR / ST; no recurrence of CHB. She was also incidentally found to have COVID - supportive care was recommended. She had no symptoms directly attributable to COVID during her hospitalization.  The remainder of her hospital course was unremarkable.  """
This non-serious spontaneous case, initially received from non-other health professional (consumer) on 12-Oct-2018 (combinedly processed with follow up received on 17-Oct-2018), concerns a 62-year-old, adult male patient. The patient's historical vaccine FLUCELVAX (batch number: 195227 and administered in 2017). The patient's historical procedure included thyroid removal (thyroidectomy). The patient's concomitant medication included SYNTHROID for an unknown indication.  On 10-Oct-2018, at 7:45 am, the patient was administered FLUCELVAX QIV [dose: single dose, batch number 252676, route of administration, anatomical location and expiry date: not reported). On the same day, after vaccination, in evening between 9:30 to 10:30 pm, the patient noticed (redness) on the upper arm and by the time he took shower, it spread to upper quadrant of his body. It was like glowing red over the patient's body. On 12-Oct-2018, the patient had recovered from the event. The reporter considered the causality of the event as not related to the suspect vaccine. Non-significant follow-up report received from reporter on 19-Nov-2018: The reporter's wife confirmed that the patient was feeling better at the time of the report and no new information was available. No changes were done in the narrative.