chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8 patients got vx reconstituted w/wrong adjuvant; This case was reported by a other health professional via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 26-Aug-2022 Reporter's comment: The GlaxoSmithKline representative reported that a wrong solution used adverse event for Shingrix with limited information. The reporter reported that the office manager at one of his accounts stated that the Shingrix vaccine was reconstituted with the wrong adjuvant. He stated that instead of using the adjuvant that comes with Shingrix, an adjuvant specified for the Merck MMR vaccine was used to reconstitute the Shingrix antigen.   The reporter stated that office manager indicated that this event happened for 8 patients.   The reporter had no further information regarding patient demographics or the vaccine itself. No follow-up was requested. The reporter did not consent to follow-up. Additional supportive information: The patient received Shingrix vaccine which was reconstituted with wrong solution, which led to wrong solution used in drug reconstitution. This case was for 2 of 8 patients.; Sender's Comments:  US-GSK-US2022AMR124633:Same reporter. US-GSK-US2022AMR124632:Same reporter. US-GSK-US2022AMR124631:Same reporter. US-GSK-US2022AMR124630:Same reporter. US-GSK-US2022AMR124629:Same reporter. US-GSK-US2022AMR124634:Same reporter. US-GSK-US2022124281:Same reporter.
Next day post vax, the pt complained of swelling and redness from injection site down to the elbow.
Developed a raised rash at and around injection site. 2in x 4 in in size. Itchy. Localized only, not over entire body.
Extremely strong headache; Nausea; weakness; Some dizziness.; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 19Mar2021 at 10:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included CRESTOR and SYNTHROID, both for unknown indication from unknown dates. The patient did not had allergy to any medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 19Mar2021 at 16:30, the patient experienced an extremely strong headache for three days, nausea, weakness and some dizziness. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, nausea, weakness and dizziness was resolving at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Woke up following AM w/ extreme muscle soreness from foot, upper thigh, lower back and a little at point of injection. Took 2 ADVIL and felt better - when they wore off late PM, took 2 ADVIL PM's. Slept well and pain gone next day. Had felt like I'd been in a car accident. Get flu shot every year - never reacted before. Pharmacist said this year's flu shot is a considerably stronger one than prior years. No fever, sore throat, or anything else.
2 days later pt developed shortness of breath. Went to ER. Had mobitz 2 heart block and required emergency pacemaker placement
Pt was in for 2 mo WCC, Dr ordered a PREVNAR vaccine to be given, MA inadvertently gave pt 0.5cc of PNEUMOVAX 23 in left thigh. Notified Dept of health she let us know that infant would need to be revaccinated with correct vaccine.
5 min later a tightness in left jaw for a few seconds, small stabbing pains throughout the body here and there for 1 day.
At first, I started having trouble breathing after getting the vaccine. I went and got some water to try to relax and breathe. I tried to calm myself down, so I didn't have an asthma attack. I got a headache about 2pm that same day it was so bad I could not lift my head it was like a squeezing so tight at the base of my neck it felt like it was squeezing my brain. I had to call for help because the pain was so bad, they had to give me Tramadol, HCL (50mg, half tablet) up to every 6 hours but I only did 2 half tablets. The medication finally resolved the pain, and it went away.
Received first dose of Pfizer vaccine the morning of 8/16. The afternoon of 8/19 developed a sore throat. That evening, bilateral lymphadenopathy noted supraclavicular and along cervical chain. Other side effects included fatigue and chills. Sore throat resolved somewhat 8/20, was COVID tested and was negative. Enlarged lymph node noted supraclavicular on the right side (same side as the vaccine) which remains over two weeks after the injection.
Sensory/stimming (holding an item in each hand and meltdowns if let go), rigidity.
pt recv vax & broke out in hives 3min p/;recv DPH;hives faded, no resp distress;
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL. On an unknown date the patient had pain at the injection site post administration of the vaccine. The outcome of the patient was not reported. It was unknown if the patient sought medical attention. Additional information has been requested.
I had swelling under my left armpit with pain.  I didn't associate it with the vaccine and used Ice and heat in an attempt to reduce the inflammation.  Went to get mammogram because I thought I had breast cancer.  Test came back with an issue so I had to go back in for secondary test.  After reviewing the test results the radiologist determined it was a side effect from the pfizer vaccine.
period symtems; itching is around her waist with small red bumps like shingles; itching is around her waist with small red bumps like shingles; itching is around her waist with small red bumps like shingles; she has some pain also at the site.; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A 59-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included shingles. There were no concomitant medications.  The patient received the Pfizer vaccine on 06Apr2021, the 1st dose. She was scheduled to receive the 2nd dose on 27Apr2021. In Apr2021, the patient had developed issues, it felt like period symtems and sometimes similar to the feeling she had when she had shingles in the past. She had recently read of possible side effects that include the vaccine possibly stimulating previous auto immune issues. She asked if she should get the 2nd shot or visit with physician before receiving. The patient experienced itching from the first shot of pfizer covid vaccine. Itching was around her waist with small red bumps like shingles and she had some pain also at the site in Apr2021. The outcome of the events was unknown. The report was non-serious.  information on the lot/batch number has been requested.
Menningitis not sure if viral or bacterial; Massive headache on a scale of 1-10 it is a 10; Chills; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of MENINGITIS (Menningitis not sure if viral or bacterial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced MENINGITIS (Menningitis not sure if viral or bacterial) (seriousness criterion medically significant), HEADACHE (Massive headache on a scale of 1-10 it is a 10) and CHILLS (Chills). At the time of the report, MENINGITIS (Menningitis not sure if viral or bacterial), HEADACHE (Massive headache on a scale of 1-10 it is a 10) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No medical history provided. Lab test for viral versus bacterial meningitis being done. No results provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
expired vials were used to provide 38 doses; Sore arm; some identified common side effects after the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses), PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (some identified common side effects after the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses). In November 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (some identified common side effects after the vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) had resolved. In November 2021, PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (some identified common side effects after the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No vial went any temperature excursions.  On 12-Nov-2021, all vaccines were administered within 2 hours.  Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. Till 19-Nov-2021, there were no adverse reactions to the vaccine.  As of 19 Nov 2021, there were no adverse reactions to the vaccine reported by the list below. We spoke with some that received the vaccine during these dates and some identified common side effects after the vaccine (ex: sore arm, etc.) and only lasted for a few hours but no more than 24 hours for 1st dose, 2nd dose and Booster.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: The additional information included suspect administration date. On 19-Nov-2021: Follow-up information included about patients details On 19-Nov-2021: Significant FU appended (Second reporter Information was updated)
Information has been received from a health professional concerning her 5 year old son who in October 2005, was vaccinated with a booster dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live.  Concomitant therapy included montelukast sodium (MSD).  In October 2005, after vaccination, the patient's throat started to hurt, he was vomiting and he turned red.  He was treated with diphenhydramine hcl (BENADRYL) and cetirizine hydrochloride (ZYRTEC).  As a result of the vomiting, the patient lost weight.  He recovered on 02-OCT-2005.  Unspecified medical attention was sought.  No product quality complaint was involved.
My son broke into hives the night after he received the vaccine. It started in his abdomen with welts that were about nickel sized and spread throughout his body. We kept a close eye on him all night to make sure it was not getting worse. He slept through the night but the next morning had a fever of 101 and was very tired. He missed his baseball camp for the day and slept all day. The rash had spread to his legs, arms, and his back. Although the next day his fever had subsided and he was feeling better (day 2 after the shot), his rash spread to his face and continued to move around his body for 10 days.
NAUSEA,DIAPHORESIS,FACIAL THINGLING, NUMBNESS IN LEFT LEG AND HAND Narrative: Summary by ED provider - 37 yo FEMALE with a history of depression, bipolar disorder, HLD, and H pylori presented to the ED after coronary destination with complaints of facial tingling and left hand and leg numbness. (Vaccine notes also indicated she had nausea, dizziness, and diaphoresis post vaccination) Patient received her first dose of Pfizer COVID vaccine this a.m. around 9:30 (3/24/2021) in the ambulatory clinic. A few minutes after that while in the waiting area, she started noticing tingling sensation in the face which progressively got worse and she also experienced numbness and tingling in the left hand and left leg. Due to concerns of possible stroke like symptoms she was sent to the ED. On the addition to the ED, she reports that she has had allergic reaction to several drugs in the past and had a similar episode like this when she received lidocaine for local anesthesia in the past. She never had an allergic severe enough that warranted hospital admission or intubation. Complete neurological examination done at bedside failed to reveal any sensory deficit, decreased strength or cranial nerve deficit. #Numbness and tingling -Symptoms are likely die to anxiety VS minor allergic reaction to drug. - Patient reports similar complaint in the pat and quick improvement with Benadryl. We will go the dose of IM Benadryl 25 mg in the ED. -We will observe the patient for a short while to rule out potentially worsening allergic reaction. No labs or imaging mandated this point.
PATIENT DIED OF ACUTE HYPOXEMIC RESPIRATORY FAILURE SECONDARY TO COVID 19 PNEUMONIA AFTER BEING FULLY VACCINATED FOR COVID 19
Patient presented to our office on 5/14/09 with a 2.5in circular swelling @ the injection site.  She was diagnosed with either cellulitis of the injection site or a vaccine reaction.  Patient was treated with Keflex 500mg TID for 10 days. Mom reports improvement after 1 day of antibiotics.
On 07/06/18, pt presented to Clinic for evaluation of nocturia. During visit, pt reported that she received the SHINGRIX vaccination (varicella zoster vaccine) on 06/29/18 (vaccine location not disclosed or documented). Pt reported that after injection she developed soreness in left arm with a rash at injection site as well as fever (which may or may not have been related). Symptoms completely resolved without incident. No further information is available. Per the SHINGRIX prescribing information: "The most common side effects are pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach". This appears to have been the first of the 2 injection series.
10 hours 3 rd dose , I had fever 102. 3 , chills and severe headaches and lymph notes under arm right arm pits were worse, left also hurt and not as much. Didn't see my doctor.  the rash came after 36 hours later - on 24sep2021 I went to dermatologists. the rash was red, raised ichy , clammy hot feeling on my chest, back. Diagnosed yeast infection . Pills - Fluconazole and shampoo for rash - Ketoconazole
I developed left sided pleuritic chest pain without reason, as this seemed to resolve, a DVT to right leg developed.  As this resolved, a spontaneous left chest pleuritic chest pain developed 12/13/21, and is still active.  I do not wish to seek medical help.  I am taking large doses of ibuprofen for pain.  Concern for PE, is a concern.  I received the J and J vaccine.  I have no significant medical problems and was relatively active immediately prior to this starting in November.  As such sedentary activity was not a precursor when symptoms started.
Patient  inadvertently given mixed doses of COVID19 vaccine.  She received Moderna for her 1st dose and was given Pfizer for her  2nd dose.  There were no visible reactions and patient tolerated well.
9cm X4cm red, tender & warm, no fever or cellulitis, Keflex 125 mg qid was ordered by MD
severe hives/hives measured about 2 inches thick and 6 inches long in some places on my body/I just had hives that were itchy; severe hives/hives measured about 2 inches thick and 6 inches long in some places on my body/I just had hives that were itchy; My throat did not close; This is a spontaneous report received from a contactable consumer or other non hcp. A 26-years-old non pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot number: EM9809; Expiry date: unknown), via an unspecified route of administration in the left arm on 06Feb2021 13:00 (age at vaccination 26 years old) as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received other mediations in two weeks. Concomitant medication(s) included ethinylestradiol, norethisterone acetate (JUNEL) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 15xr taken for an unspecified indication, start and stop date were not reported. The patient did not have COVID prior to vaccination. On 09Feb2021 12:00pm the patient experienced severe hives 3 days after getting the shot. The patient did not have sensitive skin and had never broken out in hives like she did. The hives measured about 2 inches thick and 6 inches long in some places on her body. The patient throat did not close, and she didn't have any trouble breathing, she just had hives that were itchy. No treatment was received for the events. No covid tested post vaccination. The clinical outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Reporting a symptomatic positive COVID swab after the completion of Moderna Vaccine series. Became symptomatic  with nasal symptoms back in April  Per nursing note on 4/19/21: Pt is scheduled to have a septo, turbs, bil max/ethmoid on 5/13/2021.  States he is feeling miserable, blowing out yellow/green thick drainage, facial pain and pressure.  PCP has typically given him Doxycycline in the past, please send rx to pharmacy.  Tested preoperatively for Covid on 5/11/21- Positive  Vaccinated with Moderna vaccine 2/5/21 and 3/5/2
chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had enquired regarding the use of medicines to reduce chills.  No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.
Arm did swell where the shot went,now swelling gone down; Bit itchy every now and then; Feeling yucky; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In July 2022, the patient received the 2nd dose of Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced injection site swelling, injection site itching and feeling abnormal. On an unknown date, the outcome of the injection site swelling was recovering/resolving and the outcome of the injection site itching was not recovered/not resolved and the outcome of the feeling abnormal was recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site itching and feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-JUL-2022 Reporter's Comments: This case was reported the patient via interactive digital media. The patient got second Shingles shot about a week ago from reporting.  The patient was felt yucky for a day.  The patient's arm did swell where the shot went, now swelling gone down but a bit itchy every now and then.  The patient was glad to be done with shot. Additional supportive information: This case was linked with US2022AMR112122, received from same source. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR112122:Reporter-Patient of this linked case is tagged.
13 year old received the Jansen vaccine.  Spoke to parent on 7/19/2021.  Parent stated that he had a fever of 102 degree Fahrenheit for about 6 hours and felt achy for about 24 hours.  She stated he was doing fine and had been doing yard work.  Spoke to parent on 7/23/21.  I informed her that he did not need an additional vaccine.  She thanked me for calling.  She said he was still doing fine and was currently away at camp.
patient had a tonic clonic reaction within the first minute of receiving injection.  Patient regained consciousness within 10 seconds and was moved to father's lap on the floor.  A few minutes later a second similar episode occurred.  Paramedics found BG, EEG, BP, HR and other vitals to be normal and felt it was a pseudo seizure reaction to stress. Parents declined transport to hospital for observation.  11/21/21 parent reported that patient had no lingering effects and was back to daily living habits
At about 4 days of fever up tp 102, tons of sweating, chills, I would sweat so much through my bed linen. I had general malaise. Day 3 or 4, I started having nausea and vomiting, I was taking ibuprofen for fever and Zofran for nausea. I was taking Emergen-C . At night I was taking Nyquil to help me sleep. After fever let up I still had body aches, I went got a COVID test, I started having swelling in my lymph nodes in my throat. My toes started getting white, my toes went numb the only way I can describe it as Raynaud's phenomenon.