chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feel all the side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 50-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2019, the patient received Shingrix. On 23rd July 2019, 1 days after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The patient had the vaccine 22nd July 2019 and feel all the side effects 23rd July 2019. The patient asked that is it ok to take ibuprofen and will help me feel better.
pt recvd vax 22OCT93 & 3 days later pt exp a swollen ankle, wrist, & joint pain, h/a, & a fever; No further details were provided;
Employee states that evening, her arm became red, swollen lymph nodes under arm into armpit, with pain radiating to her neck and shoulder. Still sore the following day.
11/09/22 presents to ED for "respiratory distress". PMHx of "complex past medical history significant for spastic quadriplegic cerebral palsy 2/2 to HIE, Global Developmental Delay, scoliosis s/p spinal fusion (05/22), mild persistent asthma, acute respiratory failure, restrictive lung disease, airway clearance impairment, dysphagia with G-tube dependence, underimmunization, and seizure disorder s/p VNS placement
Robust 8X10cm erythema, swelling, warm reaction at R deltoid - shot.
Severe vertigo so that I could not walk or stand  without falling.   Any movement of the head led to  feeling the need to throw up.
Received vaccine did not feel like any other vaccine I had ever received. Pain was a. It more excruciating. Felt shot was administered a bit higher in deltoid than usual and thought the pain at the site would subside after a couple of days. Noticed left arm weakness in the evening of vaccination, which has been present until now. Weakness in left arm and difficulty lifting arm or moving arm in certain positions. Still feel similar pain felt when I received vaccine.
administered only the diluent portion; administered only the diluent portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 6-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA673A, expiry date 30th March 2023) for prophylaxis.   On 11th July 2022, the patient received Menveo. On 11th July 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-July-2022 Reporter's comment:  The reporter asked how to proceed if by accident they administered only the diluent portion of Menveo. The reporter consented to follow up. Additional supportive information: Menveo was not reconstituted, only the diluent portion was administered which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Both of them are positive (confirmed as COVID positive); Both of them are positive (confirmed as COVID positive); This is a spontaneous report from a contactable consumer (Parent) reported for her daughter. This is report received from a Pfizer-sponsored program regulatory authority Support.  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced both of them are positive. The patient underwent lab tests and procedures which included COVID positive: positive on unspecified date, Both of them are positive (confirmed as COVID positive). This was the second case out of 2 cases (For daughter). Today (unspecified date) was her second dose she had asked as if she could take it. By the way it was for her and her daughter. The clinical outcome of events was unknown.   Follow up attempts are needed. Information on the lot/batch number has been requested.
Large knot on arm that lasted greater than 2 weeks, throat swelling and wheezing- patient administered BENADRYL and EPIPEN. Symptoms were resolved after doing this.
1st Pfizer dose 2/28/21 EL9266 , 2nd dose 3/16/21 EN6206 both at site for Hospital. On 6/18/21 me and my family noticed circle bruises all over both of my arms and they were hurting me so I went to Hospital Emergency Room. I have those records in Chart . The Dr's couldn't understand why I was bruising in perfect circles and they watched bruising appear on my arms. July 12, 2021 I was referred to a specialist but by that time they was gone. On 1/19/22 I had my 3rd dose FD7218 @ nursing home. I went to the Dr on 4/2022 with wrist pain, 6/2022 with wrist pain and in August 2022 they defray and found Keinbocks disease of my right wrist. No Blood flow to lunate bone.
Bexsero as 1st dose and Trumenba as 2nd dose; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 18-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 6th July 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. In November 2022, the patient received TRUMENBA. In November 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 8-Nov-2022 Reporter's comment: The nurse called in and reported that the patient received first dose of Bexsero and last weekend received a dose of Trumenba in another pharmacy. The reporter consented to follow-up. Additional supportive information: The patient received Bexsero dose and then Trumenba, which led to interchange of vaccine products.
First two days after shot, extreme chest pressure/tightness, extreme shortness of breath, heart palpitations- began 12 -14 hours after 2nd dose of Pfizer vaccine.  Improved a little over next two days but still chest pressure/tightness, palpitations, and shortness of breath.  I get winded just talking.  I have never had these problems before..Went to Urgent care  on 5/26/21.
Papular, itchy rash as on R knee and R elbow, also on R ankles and some on torso.
Patient self reported day after vaccine having an adverse reaction and taking benadryl.  He reported to work today.
2 minutes after vaccine was administered, patient developed palpitations and felt jittery, HR in 130s and BP 140/88, otherwise normal VS.  3-5 minutes later, she developed rash (flat red splotches, non-pruritic) on neck and chest. no difficulty breathing or angioedema. No GI symptoms. She was observed and symptoms resolved.  3-5 minutes later, symptoms returned (rash, HR in 130's). She was given Benadryl 25 mg x 1 and observed for 15 minutes. no improvement in symptoms. She received Benadryl 50 mg and albuterol.  She was then taken to ED from via ambulance. She was monitored in the ED until symptoms resolved. Normal EKG. Labs drawn for ARUP and complement per allergy consult.
PT RECEIVED ALL 4 VACCINES.  AFTER LAST VACCINE - MENACTRA- WAS ADMINISTERED PT.  FAINTED.  PT WAS SITTING IN A CHAIR AND SLIDE DOWN TO BOTTOM OF CHAIR.  PT DID NOT FALL ON FLOOR-  NO INJURY OCCURRED.   VITAL SIGNS IMMEDIATELY FOLLOWING AT 3:41- BP 80/47- HR 55- RR 16- PT IN AND OUT OF CONSCIOUSNESS .  EMS CALLED- PT STABLE
Patient received her COVID-19 booster dose fewer than 6 months after the 2nd dose of the COVID-19 vaccine series. No adverse event. Mild arm soreness.
10min after getting her first dose of Pfizer, patient started experiencing dizziness. No shortness of breath, no numbness/tingling. Stated she 'felt like she was drunk and that she couldn't read the paper in front of me." BP 132/86, P88, O2 on room air 99%. Patient was escorted to Emergency Room where she was evaluated by provider.
Vaccine given 11/14/02. On morning of 11/19, broke out in large, urticarial welts on 11/19/02 in area where injection was given which was swollen and red.
10 minutes after shot metallic taste in mouth, sore arm Wed 8/11 /2021 2am  Woke up both ears were ringing  Then immediately plugged Blocked ears  Breakthrough menstrual bleeding Headache Fever  Tired but couldn?t sleep  Wed  8/11/21 afternoon: Ears become completely blocked, couldn?t hear at all for a few seconds, ringing, whooshing sound like air is being blown into them and then they go back to being plugged  Low grade fever, headache, very sore arm, plugged ears  Very tired woke up 2am   Thur 8/12/21 Arm better Ears plugged  Extremely Tired Headache pm Pounding left side/tightness chest  Fri 8/13/2021 5am  Headache  If I Lay flat- get very nauseous, light headed Am: When Walking-pounding/tightness left side of chest Both thighs very sore  Saw my primary dr in the afternoon because of these symptoms   Saturday 8/14-Wednesday 8/18/21 Very congested, issues with left ear, dizzy at times   8/26/2021 Achey joints at night- knees, ankles, legs, still getting dizzy at times, left ear pain at times
When the shot was administered it bled a decent amount and immediately bruised. By the next day the bruise was much larger and a red rash surrounded it taking up about half of my upper arm. On day 3 the rash is spreading and my shoulder and elbow joint is achy. The rash is itchy hot and raised
5 people in his church got Covid after being vaccinated with Pfizer; 5 people in his church got Covid after being vaccinated with Pfizer; This is a spontaneous report from a Pfizer sponsored program. A consumer reporting same event(s) under the same suspect product(s) for five patients. This is five of five reports.  A patient of an unspecified age and gender received an unknown dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number and Expiry date were not reported) via unspecified route of administration, on an unspecified date, as an unknown dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter reported that 5 people in his church got Covid after being vaccinated with Pfizer. The patient asked whether he should wait to go to the dentist until he gets a booster. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache within 15 minutes  Super sleepy within two hours. Sleep for five hours.  Next morning injection site is warm to the touch, lump, red and sore.
Patient was given Pfizer covid vaccine 5-11 years old on 09/10/22 by an LPN who is under my supervision.  The nurse missed that there was a new expiration date on the vaccine and gave the vaccine which expired on 08/31/2022.  The patient's mother was called and offered revaccination. She states the patient had soreness to his arm after the vaccination and will wait for the date of his second dose.
Rotateq given today and infant 13 weeks old. Since 1st dose of Rotateq is not indicated past 12 weeks, none further will be given. Note that immediately following administration infant vomited.
SICK; FEELING UNWELL; This spontaneous report received from a consumer via a company representative concerned a 20 year old male. 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, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced sick, and feeling unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick and feeling unwell was not reported. This report was non-serious. This case, involving the twin/triplet is linked to 20210403156.
Could not sleep last night; Worse pain last night; Left arm injection site hurt more; Whole left arm sore, Whole left arm in excruciating pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Whole left arm sore, Whole left arm in excruciating pain), INSOMNIA (Could not sleep last night), PAIN (Worse pain last night) and VACCINATION SITE PAIN (Left arm injection site hurt more) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Whole left arm sore, Whole left arm in excruciating pain). On 05-May-2021, the patient experienced VACCINATION SITE PAIN (Left arm injection site hurt more). On 09-May-2021, the patient experienced INSOMNIA (Could not sleep last night) and PAIN (Worse pain last night). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK UNK, q4h. On 06-Mar-2021, PAIN IN EXTREMITY (Whole left arm sore, Whole left arm in excruciating pain) had resolved. On 10-May-2021, INSOMNIA (Could not sleep last night), PAIN (Worse pain last night) and VACCINATION SITE PAIN (Left arm injection site hurt more) had resolved.            No treatment medications were provided. No concomitant medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-116483 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up information received and patient demographic was updated.
After thirty minutes of walking around the store, the patient's husband came to the pharmacy to report his wife was soaked in cold sweat and had diarrhea on herself. Patient was found slumped over a table in the food court with diarrhea on the floor, she was unable to walk and she was soaked in cold sweat. Paramedics were called and she went to the hospital for care.
Fatigue and arm soreness at injection site started around 7 pm. By late evening muscle soreness, body aches, headache, and fever of 101.2 emerged.  Fever lasted until 5/14/2021 at 4am. Woke with sweat fever was gone.  Red circle and warmth still visible on arm around injection site, some body aches are still present but mostly subsided.
Didn't feel great at all; Very weak; Had chills; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Didn't feel great at all), ASTHENIA (Very weak), CHILLS (Had chills) and PYREXIA (Slight fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Didn't feel great at all), ASTHENIA (Very weak), CHILLS (Had chills) and PYREXIA (Slight fever). At the time of the report, FEELING ABNORMAL (Didn't feel great at all), ASTHENIA (Very weak), CHILLS (Had chills) and PYREXIA (Slight fever) outcome was unknown.            No concomitant medications were reported. Treatment information was not provided.  Action taken with mRNA-1273 in response to events were not applicable.   This case was linked to MOD-2021-101483 (Patient Link).
Patient received Pfizer for Dose 2, however he got Moderna for Dose 1. No adverse events aside from sore arm.
A spontaneous report has been received from a pharmacist concerning a 30 year old, female patient. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. The patient was receiving FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The reporter administered almost the full dose of FLUMIST into one nostril of the patient which started on 16-Oct-2014. The outcome of the event of accidentally administered almost the full dose of FLUMIST into one nostril was unknown. The reporter considered the event accidentally administered almost the full dose of FLUMIST into one nostril as non-serious.
This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2108USA003026), concerning an currently 73-year-old male patient. Since an unknown date, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (manufacture unknown) injection yearly for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (inappropriate schedule of product administration). The patient didn't have any adverse reactions. This is one of two reports regarding the same patient.; Sender's Comments: US-009507513-2108USA003026.
arm pain; couldn't move; joint pain; nausea; headache; pain in knee and elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), HYPOKINESIA (couldn't move), ARTHRALGIA (joint pain), NAUSEA (nausea) and HEADACHE (headache) in a 72-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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain), HYPOKINESIA (couldn't move), ARTHRALGIA (joint pain), NAUSEA (nausea), HEADACHE (headache) and ARTHRALGIA (pain in knee and elbow). On 21-Mar-2021, HYPOKINESIA (couldn't move), ARTHRALGIA (joint pain), NAUSEA (nausea), HEADACHE (headache) and ARTHRALGIA (pain in knee and elbow) had resolved. At the time of the report, PAIN IN EXTREMITY (arm pain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter.  Treatment information was not provided.
Squeamy cry and fussy for 2 hours (6-8 PM) evening of injection.  Low grade tactile temperature episode of throwing back left arm for several minutes.  Did not seem to regard parents normally.  Seemed normal after Tylenol at 8 PM.
Chills Body aches Headache Runny nose Metallic taste in mouth  Fatigue
COVID 19  Janssen EUA- patient was given 0.3ml dosage of vaccine. Correct dosage should have been 0.5ml.  No adverse side effects or symptoms noted at time of vaccination. No further treatment recommended at this time.,
high pitched cry > 3 hrs; choking when eating or drinking for 24 hrs;
This spontaneous report was received from a registered nurse and refers to a 25-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. On 05-APR-2010 and on 08-NOV-2010, the patient was vaccinated with the first and the second dose of GARDASIL (dose, route of administration, lot# and expiration date were not reported), respectively. On an unknown date in March 2017, instead of receiving the third dose of GARDASIL, the patient received a dose of GARDASIL 9 injection, lot# M035486, expiration date: 05-JUN-2019 (dose and route of administration were not reported). No adverse effects were reported. Additional information is not expected as there was no consent to contact the reporter.
3 Violent seizures; 3 Violent seizures; body aches; chills; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 15:00 at the age of 57-years-old (Batch/Lot Number: EW0161) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included chronic kidney disease, atrial septal defect, essential tremors in both hands, seizures, currently taking blood thinners, known allergies: Ampicillin, Penicillin, grapes, raisins. The patient previously took ampicillin and experienced allergy. The patient was not pregnant at time of Vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within 2 weeks of vaccination. The patient experienced 3 violent seizures, body aches and chills on 30Apr2021 21:00. For 3 weeks non stop, she went to emergency room twice and was tested for COVID in one of those times at the ER, tested negative. Records of ER (Hospital name withheld) 03May2021 and 21May2021. There was no treatment received. The patient underwent lab tests and procedures which included Nasal Swab: negative on 21May2021. The outcome of the events was recovered with sequelae.
Localized swelling, mass and lump neck, acute onset mass in left neck near clavicle.
From the beginning, I had extremely enlarged lymph nodes and felt fatigued. Every day my lymph nodes grew until they were the size of golf balls. On Tuesday morning at 2:30 AM, I began to have a fever and developed a mild full body rash. This severely escalated and by Wednesday, I developed full body hives and uncontrollable fevers as high as 105. Since then, I have been anti-histamines and steroids, which made my rash worse but helped the fever and lymph nodes. My hives are painful, itchy, and getting worse.
Patients  vaccines were administered and she was asked to wait for a 15 minute observation period.  She initially reported feeling light headed and like she felt she could pass out. She was pale, cold and clammy. She was also having a hard time forming words and completing a sentence. She was given water, 7 Up and ate a few peanut butter crackers and a cool pack was applied to her neck. This helped her feel a little better and she was asked to still sit and rest for a few more minutes. After about 5 minutes she started complaining that her head hurt, she was having trouble getting deep breaths, that her chest was hurting and her tongue felt numb and her lips were tingling. She was asked to focus on some breathing exercises and her feet were elevated. She was also saying if she looked up then she was dizzy and wanted to pass out so she kept her head looking straight ahead. We were not able to obtain her vitals because she could not handle the blood pressure cuff. After about 10 minutes she was not improving and continued to say her chest hurt and she could not breath. At this point a call was placed to 911 for ambulance services. They arrived within about 5 minutes and was transported to the hospital for evaluation of anxiety and possible allergic reaction due to some tongue swelling. She also mentioned she had been taken to the ED last week with similar symptoms of shortness of breath and chest pain and been given clonazepam for anxiety.
High pitched screaming for 8 hours. Infant would not sleep, just cried. Unable to calm infant. High fever for 3 days that was not helped by Tylenol. Vomiting.
PT STATES THEY HAVE LONG TERM TRANSIENT DERMALOGIC SIDE EFFECTS INCLUDING TRANSIENT LONG TERM HIVES, WELTS AND RASHES