chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Four hours after receiving my vaccine I started to feel a cramp in my right leg and it went down to my toes. There was tenderness in my calf muscle and numbness at my toes. I called for an appointment. We had a telehealth call. I was told to go to XL Urgent Care to get an ultrasound if the pain continues.
Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 59 years old patient of unknown gender who received a dose of previously frozen vaccine FLUZONE QUADRIVALENT (Batch number, expiry date, dose, dose in series, route and site of administrated were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication were not reported. It was a case of actual mediation error due to incorrect product storage. It was also reported that Recently, our organization had a portion of 2018-2019 FLUZONE QUADRIVALENT vaccines inadvertently frozen and a patient received one of the previously frozen vaccines. It was not reported that if any adverse reaction was experienced or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
On 7-20-07 He started vomiting appropriately 10-12x/ day. No diarrhea still was vomiting on 7/22 and started screaming and crying inconsolably. His abdomen moved get tight and extremities, would get stiff. Had Pedialyte for 2 feeding vomiting decrease but still fussy and irritable. By 7-23-07 was keeping 1/2str and Full str breast milk down and vomiting had stopped, but was still irritable.
Information has been received from a patient's mother concerning a 36 month old female who on 22-JUL-2008 was vaccinated with GARDASIL vaccine (yeast) by a human mistake. Concomitant therapy also given on 22-JUL-2008, included hepatitis A virus vaccine (unspecified) (manufacturer unknown). On 22-JUL-2008, the child seemed more tired than usual after the vaccination. The mother called the physician. At the time of reporting, the child was recovering. Additional information has been requested.
fever; headache; fatigue; This non-serious case was reported by a physician via sales rep and described the occurrence of fever in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fever (Verbatim: fever), headache (Verbatim: headache) and fatigue (Verbatim: fatigue).  The outcome of the fever, headache and fatigue were unknown.   It was unknown if the reporter considered the fever, headache and fatigue to be related to Arexvy.     It was unknown if the company considered the fever, headache and fatigue to be related to Arexvy.   Additional Information: GSK receipt date: 25-Aug-2023 A physician stated that a patient in her 70s (date of birth and exact age were not reported) received Arexvy vaccination recently (date unknown) at a local (unknown) pharmacy and developed fatigue, headache and fever.  Onset, duration and outcome were not reported.  Nothing else was reported. May follow up with health care professional/reporter for details that were not provided to GlaxoSmithKline field representative. The reporter consented to follow-up.
diagnosed with Arrhythmia almost 2 weeks after the booster shot.  Assigned a specialist.  Appointment forthcoming
A non-serious spontaneous report of administration of expired dose was received from a health professional concerning a six-year-old male. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 11-Dec-2011. On 27-Dec-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and causality assessments are not applicable, and the event is considered resolved. Additional information was received on 21-Mar-2012: It was reported that the patient was fine and his mother did not want to re-dose him.
About 12 hours post vaccination, I developed body aches and fever and chills which persisted for another 48 hours. I had taken Tylenol 1000mg q6 hours about 14 hours after the vaccine for until Saturday. 72 hours post vaccine, body aches and chills are gone, only intermittent headaches that come and go.  As of 1/3, 4th day post vaccination I have a red bump under the injection site, it is not raised but it is red and warm to touch and it still hurts while moving my left arm.
Developed chest pain, arm pain and back pain post covid19 Pfizer vaccine. All the pain is on the left hand side and it is continuous since then. Had numbness in the left hand and it became cold on 3rd May. Went to Emergency room on 3rd May and gone thru all the blood tests, xray, ecg, cardiac scan (using dye). Symptoms still persisting
It swelled up at the injection site and it started feeling really feverish. The injection site itself got really hot. It swelled up right around it. It got really red and inflamed. It started off about an inch and a half right around the injection site in diameter and, then, it kept getting bigger. It was really tender and it hurt to move my arm. My lymph nodes in both of my armpits swelled up. They were really sensitive and hurt to touch. By the time I decided to go to the doctor, it was hurting and kept swelling. It wasn't getting any better, it migrated down. The swollen red area that was feverish migrated down about 2 inches below the injection site. I thought that was also really odd. When I went to the doctor, she told me to try to put ice packs on it. I already did that. She told me to take some Benadryl. I had already been taking Benadryl .She told me to take Claritin or Zyrtec which I had already been taking for seasonal allergies. She told me to try taking anti-inflammatory like ibuprofen and Tylenol. I told her I was already on prescription anti inflammatory. She said this is pretty common and it should go down. She didn't really help me at all. My lymph nodes in my armpits stayed tender and swollen for almost a month after the injection. The swollen red hot spot took about 2 weeks before it went away.
Fall on 1/21/2021 following first vaccination and fall on 2/18/2021 following 2nd vaccination. No falls since admit in 3/2020. Falls causing increase pain with head strike on 1/21/2021. Is recovering slowly from pain of events
Activated Hives, reacting to night shade family- tomato, green peppers, chili?s, paprika, potato. This was an old allergy that has resurfaced.
10/4/21 2:38 pm called patient, voicemail box not set up. Client received second dose on 9/8/2021. Client still needs a full dose of Moderna.  10/18/21 1:39 am v/m not set up. Text message and email sent via vaccine portal.  12/23/21 Message posted on vaccine portal - client needs a full dose of Moderna.
After vaccines he was noted to be coughing, a little puffy & pink in face. Had a couple wheezes. Got 2 puff albuterol and cleared. Also gave BENADRYL.
pt recv vax 16OCT95 & 17FEB96 pt devel chicken pox;pt brother was vaccinated w/varicella vax on 23FEB96 (WAES96031270); 5MAR96 2 1/2 wk p/devel chicken pox, vaccinated brothers devel chicken pox;
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6203), in left arm, on 29Mar2021 as dose 2, single (Lot number: EN6207), in left arm, on 17Nov2021 as dose 3 (booster), single (Lot number: FJ1620), in left arm and on 11May2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Skin cancers" (unspecified if ongoing); "allergies: Nickel" (unspecified if ongoing). Concomitant medication(s) included: MYLAN ATORVASTATIN, stop date: 24Sep2022. The patient experienced Covid 19 on an unspecified date. The patient received PAXLOVID as Covid 19 treatment from 25Sep2022 to 29Sep2022. The patient underwent the following laboratory tests and procedures:COVID-19 Virus test: Positive. The outcome of the event was unknown.
breakthrough infection with positive covid test on 3/1. Presented with symptoms of cough, SOB and fatigue on 2/21. Tested negative on  2/21. However due to persistent cough she was re-tested on 3/1 and was positive
No additional AE reported; VAQTA administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 2-year-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-DEC-2022,  doses of hepatitis A vaccine, Inactivated (VAQTA) underwent a temperature excursion of 47.9 Fahrenheit degrees for 47 minutes, a data logger was involved.  On 28-DEC-2022, the patient was vaccinated with an improperly stored second dose of hepatitis A vaccine, Inactivated (VAQTA) pre-filled syringe, administered intramuscularly on the left thigh, lot #W017343, expiration date: 13-DEC-2023 (strength and dose were not provided) as prophylaxis (product storage error). No adverse event was reported.  This is one of several cases reported by the same reporter. ; Sender's Comments:  US-009507513-2301USA009943:
Assessment: Received message from LPN that patient wanted to let  us know since receiving her covid vaccine she has had "bilateral elbow  pain, and upper respiratory issues" Pt. denied injury or strain to  elbow and states that she "feels it is a side effect of vaccine" and  wanted to report this. Also, reports that since receiving covid vaccine  she would only have 1-2 Upper respiratory infections each year, but has  had 6-7 since getting vaccine. Will submit information to VAERS.   Pt. reports that she previously reported her side effects to Dr.  Patient reports that this is her primary Care provider that she uses outside of facility.  Pt. thought that there was a possible connection with the  vaccine and her symptoms listed above.
I got extremely fast heart rate 4 hours after receiving the vaccine. It lasted for about 24 hours and the rate went you to 140 resting. It resulted in me seeking medical care and getting an EKG. It was normal, but this event was extremely concerning and scary. My husband almost called 911.  Please add this side effect to the list because when you look for this online all you get is the inflammation of the heart. I think people should know this is also possible.
expired ACT-HIB was administered to a patient, with no reported adverse event; Initial information received on 04-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Patient of unknown age and gender who received expired HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of expired vaccine suspect HIB (PRP/T) VACCINE intramuscular (Frequency: once ) (Strength: standard) (lot number, expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination with no adverse event (expired product administered) (latency: same day).  Treatment: The clinic calling the manufacturer  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt had syncope episode approx. 15 minutes after receiving Gardasil injection. Pt verbalized fear of needles before receiving the injection. Crying after the injection and nurse sat with her in exam room for approx 10 min. Pt had syncope while on her way out to waiting room and hit her head on the edge of a door. No visible injury but went to hospital via ambulance. Her guardian decided at that time that she did not need to be seen and took her home.
Diarrhea started 1/15/2011 to 1/19/2011, Irritability 1/15/2011 to 1/18/2011, Vomiting 1/16/2011 to 1/19/2011
About 12 hours post vax, the pt's left arm was sore, hard to move and then developed redness, burning sensation and swelling. Improving now 72 hours later.
Terrible headache almost immediately which lasted off and on 2 days, Tylenol helped a lot. About 3pm on 2/11, started having severe chills, developed a slight fever (still below normal as I'm usually around 95}, ate small amount of popcorn for supper as I was not very hungry then threw up four times in about an hour. Next day I was fine so did not notify my doctor.
This infant had a red raised area at the site of injection 25 mm. The rash inferior aspect of the left ankle extending to the bottom of his foot. Additional rash on under toes of the left foot.
Developed erythematous papular rash on torso (98%) few lesion on upper arm and into groin area. Rash remains in same place daily, can be pruritic. Consulted with Dermatologist, sent photos, felt to be consistent with Pityriasis Rosea. (NOT urticaria) Difficult to control with topical corticosteroid and oral anti-histamines. Currently taking 6 day taper of oral prednisone with some rash improvement.
Pain, swelling, discoloration and achiness in  injection site. Feels like arthritis. Feels like it's cracking is the best way to describe it
No adverse reactions.  Immunization took place in Child Care Center.  Child care provider brought child to me to immunize and I administered inactivated H1N1 vaccine.  Received call from Child Care Provider approximately an hour later that she had "brought the wrong patient" and that there was a second patient who had given consent for the H1N1 vaccine.  I called patient's primary care provider who informed me that she had already received two doses of LAIV H1N1 - 10/15/09 and 11/11/09.
Sitting in the chair about 15 min after vaccine was administered and he had a seizure.
Patient received FLUVIRIN shot-shortly after developed rash about size of a silver dollar-sold her some HC 1% creme-called a few days later-rash gone. Feeling fine. Not allergic to eggs.
I usually have a bad day after the Covid shots where my whole body hurts, fever and headache. My left leg started hurting and hasn't stopped hurting. It's not joint pain. Its in the center of my left thigh and radiates out. In feels like a deep ache in the muscle. Not soreness but aching. It starts the moment I wake up and last all day long. When I was younger I would get what they called "growing pains in both legs." Stopped getting them at 18 and never had it since. Now I am 45 and the day after I get my second booster the same pain comes back. Now only in one leg and last all day long everyday for 4 weeks. Something is going on but not sure what.
Numbness, blood count platelets went very low.  April 11th. Swollen, migraines, inject in Left arm. Does not usually get side affects. Was given prednisone, did not lessen symptoms.
Within minutes of getting his vaccine, he felt his throat tighten with mild itching of his throat.  He was assessed with normal vital signs, no wheeze, no emesis, no rash.  He felt better quickly without intervention.   He was observed for 45 minutes and we practiced some calming visualization strategies.
pt recvd vax 6JUN93 & had severe vomiting & diarrhea; pt went to ER & was treated w/compazine;
Patient came in for a flu vaccine, but received a Pfizer COVID vaccine by mistake. Patient parent notified and recommended to be observed for 30 minutes. Patient doctor notified. Next day, pharmacy followed up with parents where patient had no ill feeling and just a sore arm.
Aches; fever 100.3; tired; minor chills; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955) via an unspecified route of administration on 25Mar2021 at 14:00 (at the age of 57-years-old) in left arm as a single dose for COVID-19 immunisation. Medical history included being treated for atrial fibrillation since an unknown date. Concomitant medications included apixaban (ELIQUIS) and diltiazem (CARDIZEM) for an unknown indication and from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3241) via an unspecified route of administration on 04Mar2021 at 14:30 in left arm as a single dose for COVID-19 immunisation. The patient previously received BACTRIM and KEFLEX both from an unknown date for an unspecified indications and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 07:30 the patient experienced aches, fever when checked 100.3, and felt tired and minor chills. The patient did not receive any treatment for adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events aches, fever, tiredness with minor chills were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information expected.
Patient was given Gardasil vaccine this morning around 8:15 AM.  Around noon this day she to notice she was achy and having chills.  That evening she ran a fever over 100 degrees F orally taken by mother.  The next morning she was nauseated and threw up.  She continued to spike fevers in the evening/night time with generalized aches/chills, nausea, headaches through out the week.  On Friday March 1, 2013 patient was still febrile and noted to be itchy.  Her mother reported she had broken out into hives from her head, chest, trunk and decided to take her in the local emergency department.  Patient was febrile, tachycardic, noted to have swollen lymph nodes and was tested for MONO and German Measles (to my report).  She tested negative to both of these.  She also had labs drawn and was noted to have a low white blood cell count.  She was encouraged to take Benadryl for itchiness and started on an antibiotic with no sure cause of possible infection/hives rash.  I spoke with the mother today, March 5, 2013 and patient does not have any obvious hives but still itchy on her head.  She is still spiking fevers at night with malaise and fatigue.
Post Inj. day 3 swollen painful lymph nodes right axillary armpit. Day 9 pain has resolved but lymph is still swollen. Day 16- lymph nodes resolved.
Vaccine given left leg 1:15 PM. Call from mother 3:30 PM. Rash on face, trunk, back. Raised bumps. No fever, no itching. No Tx. Gone in 3 days.
Nauseated; head is spinning; right ear is ringing constantly; felt like she was going to fall; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 09:25 (Lot number: EW0179) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: NAUSEA (non-serious) with onset 01May2021, outcome "not recovered", described as "Nauseated"; TINNITUS (non-serious) with onset 30Apr2021, outcome "not recovered", described as "right ear is ringing constantly"; VERTIGO (non-serious) with onset 01May2021, outcome "not recovered", described as "head is spinning"; FALL (non-serious) with onset 2021, outcome "unknown", described as "felt like she was going to fall".  Additional information: The caller denies being sick at the time of vaccination. No relevant tests. No family medical history relevant to AE. No prior vaccinations within 4 weeks. No additional vaccines administered on same date of the Pfizer suspect. The caller wants to report that after the Pfizer vaccine she had events. The caller declines to provide her primary care physician information. She says she had the vaccine last Friday 01May2021 morning and at night her ear started ringing. She says she felt like she was going to fall. She corrects herself and says her vaccine was on 30Apr2021. She says it has worsened because she had nausea yesterday and could not work; she had to ask work to take her off and today still called in sick because of the nausea. She says the ringing in her ear still going. She says the ringing started 30Apr2021 at night. She says the nausea started, 01May2021 in the evening. She says her head is spinning as well. She says it started the same time as the nausea, she confirms 01May2021 in the evening as well. This spinning started little and then now it is like more heavier, she confirms it has worsened. She says her appointment was supposed to be at 9:25 am but she might have gotten it earlier than that. She says this was her first dose. The events did not result in emergency room or physician office visit. The caller says she is set to return to get the second dose. She says she has ringing in her ear and queried is she going to take the second dose or is she going to skip it. She queried will the ringing in her ear go away or she has to ask anyone else experienced this ringing.  No follow-up attempts are needed; No further information is expected.
Swelling to softball size, numbness, redness/hives, fever/sweating, nausea, migraine, uncontrollable twitching/muscle spasms for 28 hours after injection, paralysis of lower extremities/loss of mobility, loss of eye sight for 6 hours
pt was given DTP on Friday afternoon; devel a temp & extreme reddened area of the lt upper arm; dx as cellulitis & requiring ATb;