chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a female with a history of a tonsillectomy who was vaccinated with her first dose and second dose intramuscularly in her left arm with Gardasil (dates not reported).  In August 2007, she was vaccinated subcutaneously in her left arm with her third dose of Gardasil.  Subsequently, after each of the three doses the patient experienced "hypopigmentation" within a week or two after she received Gardasil.  "She said that in three separate areas of her left arm, there is a square-shaped area which is lighter in color than her normal skin color."  The patient's hypopigmentation persisted.  The patient sought unspecified medical attention.  No further information is available.
Redness in patch on skin at injection site. Mild sensitivity to touch. Did not appear until one week after injection.  Size of patch has increased over time. Presently 3 inches x 1.25 inches.
Patient was given expired Hep A vaccine expired on 2/6/23. Provider notified and he stated that he would notify the patient's parents of error once he reviewed the CDC recommendations.
TIENT REQUESTED A FLUBLOK QUADRIVALENT IMMUNIZATION(INFLUENZA VACCINE). PATIENT WAS COUNSELLED ON POSSIBLE ADVERSE EVENTS AND GIVEN IMMUNIZATION AROUND 2:35PM THEN SAT FOR 15 MINUTES ON MONITORING. ONCE THE 15 MINUTES WERE COMPLETE THE  PATIENT LEFT SATISFIED.  PATIENT RETURNED WITH MOTHER TO THE PHARMACY AROUND 3:55PM STATING THAT HIS ARM WAS RED.   THE PATIENT RAISED HIS SLEEVE TO SHOW A REDNESS UNDER THE IMMUNIZATION SITE.  I ASKED THE PATIENT IF THEY HAD ANY TROUBLE BREATHING OR ITCHING AROUND THE AROUND OR INTERNALLY. PATIENT STATED THEY ONLY HAD THE REDNESS. THE PATIENT NOTICEABLY SCRATCHING  WITH HIS NAILS I ASKED IF HE WOULD PLEASE HAVE A SIT AND LET ME ADMINISTER BENADRYL. PATIENT REFUSED STATE HE JUST WANT TO INFORM ME.
PATIENT TESTED POSITIVE FOR COVID ON 05/05/2021.  PATIENT DIED ON 05/10/2021.
1 day after flu shot developed pain in ear for 2 weeks. Then rash on face and scalp. Over eye. Developed shingles.
Medical Assistant reporting the administration of PEDVAX HIB to a 12 year old Patient.; No additional adverse events reported.; This spontaneous report was received from a medical assistant concerning a 12-year-old patient of unknown gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 31-MAR-2022, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 milliliters, lot number U024489 expiration date 02-NOV-2023 (route of administration were not provided) administered as prophylaxis (Product administered to patient of inappropriate age.)  No adverse symptoms were reported.
Patient states she began to experience "COVID arm- a red rash that keeps getting bigger and spreading throughout my upperarm now going to my elbow area"  Patient was followed up by healthcare office on 4/22/2021 and did not report additional or worsening symptoms. No systemic symptoms where reported y patient.  Patient was advised by healthcare office to seek medical follow up care if symptoms continue or get worse
Lump in my right breast. Spoke with Radiologist and he stated that, a recent vaccination can swell up you lymph node. Radiologist was not surprised that this happened. I have an appointment coming up for this symptom even thought the swelling went down.
pt recv vax last yr & devel a raised red welt @ the inj site, which resolved in 1 or 2 days
On 5/11 patient developed headache and was nauseous. On 5/13 in the evening, patient  developed itching of face, neck, and stomach.
Pt c/o red, very swollen upper right arm. 11/26/03 in the evening, sometimes itching and sore. Dr advised her to apply cold packs and ordered Triamcinolone 1.1%. Pt given 40mg Depo Medrol IM
Pt had what mom stated "as a few chickenpox" on and off for over 2 months, post vax.
Left arm with slight pinkness; Left arm has been painful at the injection site and continues to be painful even after 9 days; Left arm is itchy; Redness at the injection site; Left arm was swollen at Injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Left arm with slight pinkness), VACCINATION SITE PAIN (Left arm has been painful at the injection site and continues to be painful even after 9 days), VACCINATION SITE PRURITUS (Left arm is itchy), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Left arm was swollen at Injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Left arm with slight pinkness), VACCINATION SITE PAIN (Left arm has been painful at the injection site and continues to be painful even after 9 days), VACCINATION SITE PRURITUS (Left arm is itchy), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Left arm was swollen at Injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (Left arm with slight pinkness), VACCINATION SITE PRURITUS (Left arm is itchy), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Left arm was swollen at Injection site) outcome was unknown and VACCINATION SITE PAIN (Left arm has been painful at the injection site and continues to be painful even after 9 days) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.
Covid-19; A spontaneous report was received from a 65-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced COVID-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient reported he was admitted to the hospital a week ago because he was positive for COVID-19. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, COVID-19 was not provided.; Reporter's Comments: This case concerns a 65-year-old male who was hospitalized with a serious unexpected event of COVID-19.  The event occurred with unknown latency after the first dose of mRNA-1273. Treatment was not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Pt received Flumist and it is not indicated for her age. Patient had a few sores in her nose which promptly cleared up.
This event occurred today, 25 Jun at approx. 1400 hours. 22 y/o f patient received the 2nd dose of COVID vaccine. Pt had some previous history that rendered her high risk for the vaccine with a 30 min wait time. However, she did not have any contraindications for the vaccine. Pt was advised by her PCM and screener that her reaction may be worse this time and she may not wish to get it. However, pt insisted on completing the series.    At around 1400 hrs on 25 Jun, pt complained that she could not feel the arm she received the injection in (left). Pt was brought into the sick waiting area to be escorted to the immunizations area for further evaluation, but pt stated she began to feel weak and lightheaded while walking. Pt was sat down in a reclining chair where she then began to hyperventilate. She was given 2 tabs- 25mg of Benadryl at approx 1405. Approx 3 min later, pt states she felt worse and was having trouble breathing. At approx 1409, pt received, 1 autoinjector of Epinepherine (0.3mg). After the dose of epinephrine pt began to feel nauseous and stated she felt pain when touched. Pt stated it was painful when provider proceeded to take radial pulse to the point pt was shouting in pain. EMS protocol was activated immediately following the epi dose. Approx 1415, Security arrived on scene followed by Fire Dept a few minutes later. Pt was placed on NRB at 8 lpm. At approx 1420,  pt was given second dose of 0.3mg of epinephrine. At approx 1425 EMS services arrived on scene. Pt was then transferred to EMS personnel and pt was taken to ER with spouse.
Information has been received from a medical assistant referring to a 17 year old patient of unknown gender. Information about concomitant medication, drug reactions/allergies and pertinent medical history was not provided. On unspecified dates, the patient received 3 doses of GARDASIL 9 (strength, route, lot# and expiration date were not reported) for prophylaxis. Then on 12-NOV-2018 the patient received the 4th dose of GARDASIL 9 (intramuscular, lot# R016971, expiration date was 22-MAR-2021; strength was not reported) for prophylaxis (extra dose administered). No adverse effects reported.
Iniatial and follow-up information has been received from a physician concerning a 16 year old female with no known drug allergies or illness who on 18-MAY-2007 was vaccinated with the first dose of Gardasil (Lot # 0389U/657769).  Concomitant therapy included diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid.  On 18-MAY-2007 a few minutes post vaccination the patient experienced an episode of syncope.  No injury was noted.  Subsequently, the patient recovered from the episode of syncope.  Unspecified medical attention was sought.  Additional information has been requested. This is follow-up to report (s) previously submitted on 7/16/2007.
Both hands, palm side and fingers, swollen with bumpy rash. Very itchy and sore.
pt recvd immun 15NOV91; mom reported irritability starting 5PM; pt had no reported fever, had persistent crying (not high pitched) for greater than 3 hrs but would calm down; poss pain in thighs;
Patient fainted after receiving shots.  He left health room and sat down in waiting area and fainted then.  Was very pale and felt nauseated.  Was able to walk on his own eventually.  Gave him water and some orange juice and he first laid down for a while, then sat down on floor, then on the chair.
This 35 year old female patient received Pneumovax vaccine, 1 adult dose, to right arm on 23Sep2009. On 25Sep2009, this patient called and left a message for her primary care provider. Her call was returned by a triage nurse. On 25Sep2009, this patient complained of pain and rated her pain 9 out of 10. She also reported difficulty moving her right arm and rash to the area of vaccination. She felt feverish but had not taken her temperature. The area of vaccination was not red or warm to touch. No other signs and symptoms to the area. It is unknown if the patient had a previous allergy or reaction to the Pneumovax vaccine. On an unknown date, she tried over-the-counter ibuprofen for pain and an ice pack for 10 minutes every hour for swelling. The patient was instructed to come in to be seen if her signs and symptoms worsened, but she did not do so. As of 25Sep2009, it is unknown if the patient continues to receive Pneumovax vaccine and it is unknown if her symptoms continue.
rash began on 6OCT95 & last for 2 wks;mom described rash is bumpy, pink about 20 raised dots around diaper area;applied Desitin q diaper change, 6-7 times a day
Admit 7/1-7/4. Re-Admission 7/11. Expired 7/14.
Swelling under left armpit seven days after injection. Tenderness and discomfort and pain in armpit.
This is  a spontaneous report received from a cont actable physician via colleague. A patient of unspecified age ethnicity and gender received PREVNAR13, via an unspecified route of administration on unknown date. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient developed a reaction (red and purple rash) on the upper arm that was injected and fever as well. The outcome of the event was unknown. Follow up:(25SEP2014): Follow-up attempts completed. No further information expected.
Case previously recorded as MA2009-3708. A nurse reported the following information via MedCom on 5 NOV 2009: A 22-year-old pregnant patient was vaccinated i.m. with S-OIV-FLUVIRIN (batch no. unknown) on 4 NOV 2009. She developed flu-like symptoms on 5 NOV 2009. She had not recovered at reporting date. MedCom Ref. no.: NA09-007664.
Received shots (PENTACEL/PCV13/ROTATEQ) on 9-28-11. H/o bronchiolitis 9-15-11 --> better 9-20-11. NL exam on 9-28-11.
My shoulder/upper arm has been extremely sore since the vaccine.  At first, I figured I would give it a day or two, but almost three weeks later it's just as bad.  I experience pain when lifting or moving my left arm and it sometimes even wakes me up at night.  I will be calling my provider later today to report this and begin seeking treatment.
Erythematous papules on forehead a few on neck & ext. No school till 11/10/08 re check 2 days, fever.
Very thirsty, sore throat, then extreme dizziness when lie down or when get up with ceiling rotating.  12/27/2015 I woke up with severe stomach ache, vomiting twice, didn't eat until 4 pm.  The entire body hurt, vertigo.  12/28/2015  woke up with dizziness, vomited again, didn't eat until 2 pm.  12/29/2015 nose bled, ear bled, with a fever that continued for one week.  Severe headache, head felt numb, body in tremendous pain, worse than any flu.  Severe vertigo, dizziness when stand up, spilled water at dinner time last night 01/10/2015.  Still dizzy & my head hurts as I type this.  Have a tummyache & diarrhea ever since 12/26/15, which is about a week after the flu shot on 12/19/15.  I can't drive, and when I turn my head, it hurts & get dizzy.
11/20/09 at 1800 L delt immunized. 11/23/09 at 0730 full body rash, no fever. 11/25/09 Rash dissipating. Cheeks remain red apple like. Banana allergy: Hives, antibiotics: PCN, AMOXICILLIN, Augmentin.
Hives within 5 min of vaccine admin. TX with Benadryl PO no wheezing no angio edema.
9/5/13 - Mom called to report Sx began about 12:00p, 8/31/13. Red, itchy spots, quarter-sized, bilateral lateral thighs. 9:00pm, left lateral thigh had 4-5" of red splotches around injection site, center was raised slightly and hot. Mom administered BENADRYL oral susp. and cream daily, gradual decrease in Sx. Today, 9/11/13, very small pea-sized hardness noted by mom. No itch, pain, redness or swelling.
Information has been received from an office manager concerning a 17 year old female patient who on 02-JUL-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number not available). The office manager reported that after the patient was vaccinated with the three doses of RECOMBIVAX HB, all blood work (Hepatitis B surface antibody) came back negative (less than 5), "not immune", requiring a fourth dose of RECOMBIVAX HB. The patient did not develop hepatitis B. No other adverse events were reported. At the time of the report the patient had not had follow up laboratories. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow-up information was received from the office manager who reported that the female, non-smoker patient was vaccinated with the first dose of RECOMBIVAX HB (lot number not available) on 22-AUG-1992. On 17-SEP-1992, the patient received the second dose of RECOMBIVAX HB (lot number not available) and on 10-MAY-1993, the patient received the third dose of RECOMBIVAX HB (lot number not available). On 15-JUN-2010 an anti-HBs titer was performed which result was less than 5. The patient did not have immunity to hepatitis B virus at that time. On the same day, a varicella zoster virus AB (IGG) was done which result was 2.17 (positive). On 02-JUL-2010, the patient received a forth dose of RECOMBIVAX HB (lot # AHBVB789AA). On 10-AUG-2010, hepatitis B surface antibody test was performed which was 263. The patient now had immunity to hepatitis B virus. No adverse events were reported. It was unknown if the patient had any illness at time of vaccination. This is one of several reports received from the same source. No further information is available.
Vertigo; lightheadedness; Felt as though I would pass out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 11:00 as dose 1, single (Lot number: 2267330-04919) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "BPPV" (unspecified if ongoing); "balance problems" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 01Oct2023 at 09:00, outcome "recovering", described as "Felt as though I would pass out"; VERTIGO (non-serious), outcome "recovering"; DIZZINESS (non-serious), outcome "recovering", described as "lightheadedness". Therapeutic measures were not taken as a result of loss of consciousness, vertigo, dizziness.  Clinical information: Patient reported that 'Vertigo/lightheadedness. Had a little lightheadedness for several days. Today was the worse so far. Felt as though I would pass out twice today.' Prior vaccination, the patient did not get COVID and did not test covid post vaccination. Known allergies: None known. The patient did not receive any other vaccines within 4 weeks. The patient did not receive any other medications within 2 weeks.
the back and left side of her head hurts like she has a knot, but he doesn't feel anything there; the back and left side of her head hurts like she has a knot, but he doesn't feel anything there; the back and left side of her head hurts like she has a knot, but he doesn't feel anything there; getting the shakes; her arthritis got worse from the back of her hand to her neck and the back of her jaw; This is a spontaneous report from a contactable consumer (patient's husband). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID 19 VACCINE) via an unspecified route of administration on the left arm on 24Jun2021 between 12:10 and 12:15 PM (Batch/Lot Number: EW0187; Expiration Date: 31Aug2021) at the age of 65-year-old as 0.3 ml dose for COVID-19 immunization. Medical history included cardiac failure congestive from 2008, chronic obstructive pulmonary disease (COPD) from an unknown date, asthma from an unknown date, diabetes mellitus and it was diagnosed maybe 2 or 3 years ago, the reporter stated that the patient previously was prediabetic and now she was diabetic, pacemaker received in 2017, arthritis and the patient already had COVID and was hospitalization from 05Apr2021 to 10 Apr2021. Investigation assessment was none. The patient was on a wait list for the valve. The patient taken Pfizer BioNtech COVID-19 vaccine as her primary doctor wanted her to receive it because she already had underlying conditions. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional vaccines administration on same date of the Pfizer suspect was none. The patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. AEs following prior vaccinations was none. Family medical history relevant to AEs was none. Concomitant medication included warfarin for mechanical valve from 2009. On 24Jun2021 at 12:13 PM, a couple minutes later after vaccine, the patient started getting the shakes, the patient already had arthritis, and when they got home her arthritis had gotten worse from the back of her hand to her neck and the back of her jaw about an hour after they got home from the place. On 25Jun2021 at 03:00 AM, the patient started saying the back and left side of her head hurts like she had a knot, she could not lean on the left side of her hand because it hurts, but reporter doesn't feel anything there. Reporter states the shakes started a minute or 2 after the shot. The patient stated the shakes came and gone and she shakes really bad. The reporter was told by other people that shakes was one of the side effects. The second and dose of BNT162B2 for patient will on 15Jul2021. The events was not result in emergency room and visit physician office. Relevant test was none. The outcome of events was not recovered.
I had several adverse events, the most significant of which was at the time listed above. I developed pericarditis (and a mild fever of 99.4 F the next day) in the absence of anything else that could have contributed to it. In the full week after receiving the vaccination, my arm was red (about a 3" diameter red rash) and extremely itchy. I also had significant chills in the time between receiving the vaccine and the pericarditis appearing (so much so that I had them in 102-degree weather).
Soreness, redness, swelling around vaccine injection site, followed by generalized muscle aches in shoulders, neck.  Also with fevers up to 102F.  Treatment just supportive with Tylenol, cold packs, observation.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment details were not given.   This case was linked to MOD-2021-395985 (Patient Link).
The patient was admitted to Regional Health System on 02/07/2022 for SOB.  The patient was diagnosed with Covid-19 and progressively required more oxygen.  The patient gradually declined with mental status and respiratory drive.  The family decided to transition the patient to comfort care only and admit the patient to general inpatient hospice.  The patient expired at the facility on 02/18/2022.
Patient reports staring spells/decreased levels of consciousness without any abnormal movements, fecal or urinary incontinence or tongue biting occurring the evening after 2nd vaccination and occurring 10 times in the 3 days since.  She did not remember that she reported the same symptoms 11/2020.   She is an unreliable historian.
Information has been received from a physician concerning a 60 year old female consumer with sulfonamide allergy who on 02-APR-2008 was vaccinated SQ with 0.65mL zoster vaccine live (Oka/Merck) (lot # 659404/1826U). Concomitant therapy included PREVACID, SYNTHROID, EFFEXOR XR, ezetimibe (MSD), ACTONEL, aspirin and simvastatin. Several hours post vaccination on 02-APR-2008 the patient experienced an injection site reaction that included, induration, redness, burning and stinging. No other symptoms were noted. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.