chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Infanrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-year-old female patient who received DTPa (Infanrix) (batch number XG942, expiry date 22nd August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd January 2023, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 23rd January 2023, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 13-FEB-2023 Reporter's comments:  A medical assistant called in to asked for information regarding the administration of an expired Infanrix dose to a 6-year-old patient. The reporter had asked if the patient had to be, re vaccinated. The reporter had consented to follow-up. Additional supportive information: The patient had received an expired dose of Infanrix vaccine, which had led to expired vaccine used.
I got my first Pfiser Vaccine on 2/9/2021 The second Pfiser shot on 3/2/21 A Pfiser booster 9/28/21  My symptomswas severe sore throat, congestion, and cough. it lasted two or three days and then started to get better, however it took about three weeks to clear completely.  I was tested at the doctors on 01/24/2022
On 09/01/2022, I woke up with severe pain and swelling in my arm, hand and wrist, from the tip of my fingers all the way up to my elbow. I used Aspercreme for a week, then I went to urgent care.  They sent me for an XRay of my hand. They found Arthritis and swollen soft tissue. I saw a hand specialist two weeks ago and he said the bone is growing and I have soft tissue. I take an anti-inflammatory cream now. I need an MRI, but I cannot afford it right now.
Initial case received from a consumer, who is also the patient, on 15 April 2014. A 68-year-old female patient, with a history of Crohn's disease and allergies to sulfa and morphine, received an intramuscular left arm injection of FLUZONE HIGH DOSE (lot number U4759AA) on 21 October 2013. At the time of vaccination, she experienced pain at the vaccination site. Approximately one week later, on 28 October 2013, her left arm pain became worse, described as "variable from a 6 to 9 with 1 being the lowest on the scale". The patient stated that the pain radiated down to her wrist, and that she had limited range of motion (ROM) in her left arm. She underwent an MRI, which showed that the "bursa is affected". The patient had been seen by her primary physician and a shoulder specialist on three occasions, and had undergone therapy. According to the patient, she was now looking at possible shoulder surgery. At the time of the report, the events were ongoing. Documents held by sender: None.
On 1/4/21 at around 1:30 pm, I was getting ready for work when all of a sudden I started to feel really terrible. My heart was racing, body and face was sweating, externally nauseous, dizzy, blurred/fuzzy vision, body shaking, the room was spinning,  and I was unable to stand up. This would happen every time I got out of bed and stood up. Lasted about 2 hours.
day of vaccination pt noted swelling/soreness of left arm. tremors, chills, dizziness, blurred vision. inability to raise left arm. pt called dr and was seen 12/16/19. dr reported no fever. pt given rx for prednisone that afternoon.
7AUG91 7 wk old PT recd 1st Hibtiter/DTP/OPV; 5SEP91 PT presented w/szs & was hospitalized; dx: HIB meningitis confirmed by positive lumbar puncture; pt has significant brain damage; ongoing outpt rehabilitation; hosp summary available;
Same day: Acute stinging; red swelling; hot to the touch; quite sore. 1 day later: Asthma attack with asthma cough and wheezing; red swelling 3 in. diameter; hot feverish at site; quite sore. Queasy and mild nausea. Strong flu-like fatigue. Slept 15 hours. 2 days later: Sore and swollen. Feverish at site. Mild headache. Sleepy again. 3 days later: Swollen and feverish at site. Less sore. 4 days later: Swollen but receding, Warm at site. Less sore. 5 days later (today): Swelling gone, but still warm at site. Only slightly sore. NOTE: Patient had ZOSTAVAX shingles vaccine August 31, 2012 with no adverse effects.
Lethargy; Sore arm; Headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Tiredness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2019.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced LETHARGY (Lethargy), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Tiredness). At the time of the report, LETHARGY (Lethargy), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
mistakenly received a second dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Kinrix (On an unknown date 1st dose received .).   On 29th September 2022, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 29th September 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered 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: 18-OCT-2022 Reporters comment: The medical assistant reported that a child mistakenly received a second dose of kinrix. The date of the first dose was unknown. Nothing else was reported. The vaccine administration facility was same as primary reporter. The reporter consent to follow-up. Additional Supportive information: The child mistakenly received a second dose of kinrix, which led to Inappropriate schedule of vaccine administered.
tiredness; Chills; Fever; generalized aches; could hardly sleep through the night; This is a spontaneous report from a contactable Physician (patient). A 64-year-old male patient reported received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176  and expiry date: Mar2021) via an unspecified route of administration on 10Jan2021 08:45 at a single dose for COVID-19 immunization. Medical history bypass surgery (10.5 years ago, in June it will be 11 years ago) and hard of hearing. Patient said he used to be 5'7" but right now he is 5'6" or 5'5". He says that change in his height happened before he got the vaccine, that is effects of being short. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and simvastatin. It was reported that the patient had been healthy all his life, he doesn't have any medical conditions which could have contributed to side effects. He does not think they would have contributed but he takes Simvastatin and Baby Aspirin. The patient got the vaccination, the first one (BNT162B2 for COVID-19 immunization, on unspecified date) he did not have anything happen, no side effects or nothing. It was as if he didn't receive any vaccine. The second dose he received it at 8:45 AM on Sunday (10Jan2021) and Sunday night he began experiencing tiredness and then chills, fever, generalized aches and could hardly sleep through the night. It was reported as the worst night in his life and then, fortunately during the day on Monday, gradually, the intensity and severity of the symptoms began to subside but he was not able to do any of his normal functions. Then last night Monday night (11Jan2021) he slept well and today on Tuesday (12Jan2021) he was okay, this morning everything was fine. On Tuesday night he took Acetaminophen for pain, he clarified that was Sunday night after he had gotten the vaccine he took Acetaminophen and he still had the problems then Monday night he thought it would be the same so he put the medicine next to the bed on the night stand but he did not need to take it. He slept and woke up this morning and his back to work. Now it is like nothing has happened. He has recovered completely from all effects. The outcome of the event could hardly sleep through the night was recovered on 11Jan2021 and all the other events recovered on 12Jan2021.
pt recvd vax 19DEC95 & devel 2 pox-like lesions on lt arm on 11JAN96 where vax was given;no temp or itching noted;devel 2 other questionable lesions to other arm
About a week after the vaccine, I noticed my lips was tingling and half of my mouth was swollen. The swelling started to increase to both sides of my mouth. This continued daily until I went to urgent care. I did not take any medication. On 3/10/2021, I went to urgent care and the swelling had increased to my tongue and my throat became itchy. I was prescribed prednisone, EpiPen, Claritin, and Benadryl. He also consulted with an allergist and took blood work. I took the medications and after a couples weeks of taking prednisone, the swelling did resolve but I also developed hives all over my body. It started on my wrists and spread throughout. I took Benadryl and was prescribed prednisone again which help to resolve the hives. I followed up the allergist who ordered an allergy test which showed an allergy to nickel.
injection site became sensitive; been shaky; neck pain; shoulder pain; back pain, worse on left side; This case was reported by a consumer via call center representative and described the occurrence of injection site hypersensitivity in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th February 2023, the patient received the 1st dose of Shingrix. In February 2023, 3 days after receiving Shingrix, the patient experienced neck pain, shoulder pain and back pain. On an unknown date, the patient experienced injection site hypersensitivity and shivers. On an unknown date, the outcome of the injection site hypersensitivity, neck pain, shoulder pain, back pain and shivers were not recovered/not resolved.   The reporter considered the injection site hypersensitivity to be related to Shingrix. It was unknown if the reporter considered the neck pain, shoulder pain, back pain and shivers to be related to Shingrix.     Additional Information: GSK receipt date: 27-FEB-2023 Reporter's comment: The patient self-reported this case. The patient stated that she got their 1st Shingrix vaccine and about 3 days later, she started to had pain in her neck, shoulder, and back.  She stated, that the pain was worse on her left side.   She also stated the injection site became sensitive and she had been shaky (did not know at what point these 2 symptoms started after the vaccine).   She was still experiencing all of the symptoms. The reporter did not consent to follow up.
Fever or Chills  Cough  Fatigue  Muscle or body aches  Headache  Sore throat  Congestion or running nose  Diarrhea
Shortness of breath and chest tightness. Hospitalized for fluid volume overload after a couple weeks of having symptoms. Responded well to iv Lasix and was discharged on PO lasix. Has not had any heart issues since transplant 2009
Was sick when I woke up the next morning with the second shot. Thursday evening I started having a weird feeling on my left side woke up Friday with a rash on my left side torso. Little bumps on my lower back.
the use of FluLaval in patients over 65 and wanted to know if there was an issue; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 65-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 7ASC3) for prophylaxis.   On 29-SEP-2023, the patient received FluLaval Quadrivalent. On 29-SEP-2023, an unknown time after receiving FluLaval Quadrivalent, the patient experienced inappropriate age at vaccine administration (Verbatim: the use of FluLaval in patients over 65 and wanted to know if there was an issue).  The outcome of the inappropriate age at vaccine administration 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: 02-OCT-2023 The vaccine administration facility was the same as primary reporter The physician called in to request information about the use of FluLaval in patients over 65, which led to inappropriate age at vaccine administration.
Patient received a Novavax dose despite having previously had a Moderna dose. No effects reported.
4:10 PM: patient reported feeling "cold". Patient was clammy and upper extremities were cool to touch. Denies lightheaded, dizzy, nausea, other symptoms at this time. Brought back into exam room. Vital signs: BP 106/62, Pulse 62 bpm, Temp 97.1 F, O2 98%. 4:13 PM patient states that he is beginning to feel lightheaded. Lay patient flat on the exam table and propped up lower extremities. Pt lay for about 10 minutes and felt like sitting up, states he is having some improvement in symptoms. Gave him some water to drink and informed him to lay back for a bit longer so we can monitor him and not to get up too quickly because symptoms can return. After resting a bit longer, repeat vital signs at 4:30 PM: BP 120/78, Pulse 74, O2 99%, Temp 97.3 F. Pt reports full recovery from symptoms at 4:30 PM. Leaves the clinic without any distress, steady gait, and improved symptoms amd vital signs. Informed pt will report this and gave him instructions on what to do during next vaccination to prevent this from happening again. Pt verbalizes understanding. Go to ER if any symptoms return or if in any distress.
began fever 102.6 48hrs p/vax;then abd cramping,nausea & passed out 72hrs p/vax;saw MD-low WBC & elevated liver enzymes 8 days p/vax
Pt experiencing pain in arm, shoulder + neck since injection - pt confirmed not given high on arm near shoulder + pain started immediately after injection
He ran a loww-grade fever on the evening the vaccine was given, but the siezures, intense, uncontrollable crying and an inability to sleep without fits of unexplained crying and screaming began the next day, which is when I consider the adverse reaction to have begun. He continued to have seizures through the following Monday and his uncontrollable crying and sleep loss continues still.
This non-serious initial spontaneous case, was received from Other Non-Health Professional on 24-Oct-2017, concerning a 67-year-old elderly patient of unspecified gender. On 20-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: Intramuscular, anatomical location: left deltoid, batch number: 195218, expiry date: 30-Apr-2018). On 21-OCT-2017, after 1 day of vaccination, the patient experienced diarrhea. The subject was treated with PEPTO-BISMOL for the event. At the time of this report, the outcome of event was not recovered (reported as symptoms are ongoing). The reporter assessed the event as non-serious. Significant case correction received 24-OCT-2017: The listedness of the event Diarrhoea (changed from unlisted to listed) was corrected.
Patient states that she has altered sensation to her left arm and hand. She describes this feeling as a pins and needles sensation that occurs sporadically and reminds her of when her arm has "fallen asleep" and is regaining sensation. She states that she also has radiation of her symptoms from the shoulder to her midscapular area and neck to the base of the head. Physical exam of her arm reveals that she has decreased sensation in the distal C7 dermatome.  She has no loss of strength on exam. She had a 4cm by 8cm area of induration that was tender to palpation.
Headache, Sedation, Myalgia, Arthralgia, FeverChills Narrative:
low blood pressure; tired; feel so crappy/feel poorly; really weak, like I have the flu; low blood sugar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for Covid-19 immunization, reaction(s): "low blood sugar", "tired every time afterwards, "I feel so crappy", "low blood pressure"; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), for Covid-19 immunization, reaction(s): "low blood sugar", "tired every time afterwards, "I feel so crappy", "low blood pressure"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: unknown), for Covid-19 immunization, reaction(s): "low blood sugar", "tired/feel so crappy:", "low blood pressure". The following information was reported: HYPOTENSION (non-serious), outcome "unknown", described as "low blood pressure"; FATIGUE (non-serious), outcome "unknown", described as "tired"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feel so crappy/feel poorly"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "really weak, like I have the flu"; BLOOD GLUCOSE DECREASED (non-serious), outcome "unknown", described as "low blood sugar". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller was asking how to limit side effects from the Pfizer booster vaccine, reported when the patient got the vaccine she had low blood pressure and wanted to know how to limit and if she should take another dose. The caller confirmed inquiry. Caller also referenced the booster dose she previously received and was considering getting the bivalent dose. Caller said she had 5 shots so far and was debating about getting the next dose. Caller was tired every time afterwards, she felt so crappy. Caller said specifically after the last bivalent booster that she felt really weak, like she had the flu. She said the first booster was brutal, she had fever, chills, aches and was really miserable. Caller also said that it may be lowblood sugar  that caused her to feel poorly after the vaccine dose.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
pt recv vax & 2 days later lt jaw started hurting when yawned or opened mouth to eat;went to family MD & sent to another hosp for blood test;lethargic, unable to eat, diff taking fluids;arteritis confirmed;short term memory loss;leg hurt;
Kinrix given instead of Infanrix; 2 YO received Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5AY2J, expiry date 10-JUN-2024) for prophylaxis.  On 21-MAR-2023, the patient received Kinrix. On 21-MAR-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Kinrix given instead of Infanrix) and inappropriate age at vaccine administration (Verbatim: 2 YO received Kinrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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: 22-MAR-2023 Nurse called to report with the intention of administering Infanrix for Dtap vaccine, mistakenly it was administered Kinrix. The reporter consented to follow-up via email. The 2 year old patient was given Kinrix instead of Infanrix, which had led to wrong vaccine administered and inappropriate age at vaccine administration.
Patient was there for a Covid vaccine, when vaccine called out it was misheard, and a flu vaccine was given inadvertently. Patient had received a flu shot on 10/27/23 at the pharmacy.   Patient still received the Covid vaccine.
Seizure like event, grimace tight jaw, eyes flickering rolling back, tensing up shoulders and neck, come in few second clusters of 3-5 at a time, 4-5 times a day every day since, rx phenobarbital 2x a day.
Constant numbness in hands and feet; started a few days later.   Multifocal ischemic strokes in November, 2021
Extensive swelling reaction in left arm after 5th dose of DTaP vaccine. One day after vaccination swelling= 80x90mm. Redness=80x90mm. Increase of mid-arm circumference of 5cm.
pt vax hepta B. pt ex rash, h/a, dizziness 30 min aft vax.  no addit vax.
Patient had redness that went from an 1/2 inch below shoulder to about mid arm, on the outside of the arm.  Denied any pain, itching, fever, swelling
Information has been received from a pharmacist reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 13-SEP-2017, the patient received an improperly stored dose of ZOSTAVAX lot # M040146, expiration date 26-DEC-2017, 0.65 ml for prophylaxis (dose number, anatomical location and route of administration were not reported), reconstituted with properly stored sterile diluent (STERILE DILUENT). On 04-SEP-2017, the administered vaccine was exposed to a temperature between 6 Fahrenheit degrees and 14 Fahrenheit degrees for 15 hours and 45 minutes. The pharmacist reported that there was no previous temperature excursion. The call was placed because of a Digital Data logger report. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1711USA008257:
Temperature started on March 4th (day 5 after the vaccination) and peaked at 101.7 on the 5th.  Body aches started on the 4th and got severe on the 5th.  Took about 3 days for aches to finally subside.  Slight fatigue for 5 days after the highest temperature. Only slightly cool.  Heating pad was sufficient for that.
Patient seen in the emergency department on 6/1 for generalized weakness and shortness of breath after having tested positive for Covid-19 at home. In the ED, patient found to be hypoxic, O2 sat was found at 87%. She was admitted from 6/1-6/4. Confirmatory Covid-19 PCR testing on 6/2 was also positive. This meets criteria for vaccine breakthrough case review.
severe pain up arm into neck, chills, fatigue, joint pain and diuressis x 3 days
Client was given a Janssen vaccine even though she was only 17 years old at the time. This was over a year ago. Client had no complaints of adverse reaction. I was not told about this incident until late last week when state brought it to our attention.
My son got a rash from head to toe (see attached photos) the day after getting vaccinations on 2 different occasions. Took 2 weeks for reaction to totally clear up.
My finger/toenail growth has slowed, hair getting thinner and my joints ache more than before getting both vaccine doses.