chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in back, thoracic region, predominately on right side; Burning sensation; Deep muscular pain, spanning both sides of spine; tender to touch; Short duration fever; Short duration chills; This case was reported by a consumer via call center representative and described the occurrence of back pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2023, the patient received the 2nd dose of Shingrix (intramuscular). On 7th February 2023, 1 days after receiving Shingrix, the patient experienced back pain, burning sensation, muscle pain and tenderness. In February 2023, the patient experienced fever and chills. On an unknown date, the outcome of the back pain, burning sensation, muscle pain and tenderness were not recovered/not resolved and the outcome of the fever and chills were recovered/resolved.   It was unknown if the reporter considered the back pain, burning sensation, muscle pain, tenderness, fever and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comment: The patient was calling to report pain occurring in her back at the thoracic region.  She described it as a burning, deep, muscular pain which occurred in the thoracic region of her back, spanning both sides of her spine.  This began one day after her Shingrix vaccine dose received in left deltoid. She also stated that the area was tender to touch.  She reported that, although the pain did span both sides of her spine, it was predominately on the right side of her back.  Other adverse event reported were fever and chills of short duration. The reporter said that the burning in the back, including deep muscular pain and tender to touch remained ongoing at the time of the call.  The fever and chills were resolved and lasted about a day.  Gave medical disclaimer, read from PI, referred to healthcare professional.  Offered after-call survey.  The reporter did not consent to follow-up.
received 2 doses in 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 40-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concomitant products included DTPa (Reduced antigen) (Boostrix).   On 10th September 2021, the patient received the 2nd dose of Boostrix. On 10th September 2021, unknown after receiving Boostrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional information was provided as follows: Registered pharmacist reported that a patient received 2 doses of Boostrix within 3 months, which led to drug dose administration interval too short. Reporter had provided limited information. The reporter did not consent to follow-up.
This spontaneous report as received from a other health professional refers to multiple patients of unknown age and gender. On unknown dates, those patients were vaccinated with improperly stored ZOSTAVAX lot # N014942 for prophylaxis. Concomitant therapies included sterile diluent. No adverse effects were reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA004523: US-009507513-1708USA005937: US-009507513-1708USA005935: US-009507513-1708USA005936.
pt recvd vax;numbness,partial paralysis of hands & everything from breast down;tight diaphragm,difficult breathing,migraines,tingling;sxs still occuring;dx w/ transverse myelitis;MD told pt adverse effect to vax;
Temperature Excursion. Vaccine was stored refrigerated (2-8 degrees Celcius) for greater than 10 weeks. Vaccine was stored for a total of 6 days past its beyond use date 10/13/22 in the refrigerator. Patient did not experience any adverse events.
Modera Covid vaccine shot one. "Covid arm" reaction. Redness, swelling, and itching around injection site began 8 days after shot
The day i had the shot (given by one of the front desk girls) i immediately felt nauseas and fever, when i was about to faint, staff and doctor helped me get on my feet. As days passed by my muscles started to hurt. A week later i was not able to do daily activities such as closing my bag, waiving arm while walking, lifting my arm or dressing. When i called the doctor office about this explaining the details, physican assistant advised that pain in muscle is normal since shot is given in the muscle i should allow 2 weeks for it to get better and go to ER only if i was not able to move my arm at all (physcian assistant also asked if there was swelling). I became more cautious as im not able to lift my arm at all. I researched some of the reasons this could happen and found out that it could happen if the injection was given too high; could cause rotator cuff injury/disability. I found out online that i could see an orthopedic doctor for this but i feel bad that i was not given this information by my doctor as this is something that could get worse over time. I am very frustrated and i want to make sure that i dont face any negligence with the office that gave me the shot. They seemed truly caring but I am not sure if something serious happened as i have school and work it may take time for me to see a doctor and i had too much stress not to report this now.
Severe pain at injection site both arms, min-mod inflammation, fever 102 F, headache all worsening in first 24 hours.
Aches and pains throughout body, severe fatigue, nausea. Moderate pain in right arm that extends into armpit which continues 3 days later.  Inability to do normal tasks - Friday evening and most of Saturday in bed. Aches and fatigue better by 12/15, pain in arm continues.
Patient presented to Medical Center with chief complaint of headache, urinary incontinence, bilateral paresthesias of lower extremities.   He states that he was in his usual state of health until last night when he states that he had numbness of his penis and urethra and could no longer sense when he was urinating; admits to some urinary incontinence.  This morning, he woke up with sudden onset bilateral foot numbness, worse on the left.  He states that the numbness is primarily in the bottoms of his feet and when touched sends shooting electrical shocks up his legs to his back. He was admitted with BLE parasthesias with progressive ascending numbness/weakness and loss of reflexes. Patient had acute worsening of his numbness/paresthesias up to rib cage with new onset arreflexia.
Per Mom - "swelling of whole upper arm, redness, fever. She forgot to mention child had chicken pox at age 2".
The morning of 03/27/2022 around 08:00 scratchy sore throat went away that morning and by afternoon around 1:30PM it came back suddenly. I ran an at-home test and positive within a minute and I did another immediately one and positive again. By that evening I wasn't feeling well and within 24 hours I had symptoms of headache, cough, chills, sinus congestion, fatigue, GI Symptom that included nausea, vomiting, and loose stools. I contacted my PCP and  I was able to press an option to reach their Covid Program that was aligned with the hospital to speak to a team. They called me back an hour later and they contacted my PCP to recommend Paxlovid. I did not end up taking that. I had a few more conversions with my physician's office because the pharmacy did not have Paxlovid so I gave them another pharmacy that did. I was able to get it and because I was vomiting anytime I tried to take any pill I ended up not taking it at all. I felt like it was more important for me to stay hydrated and not vomit anymore. I did not take the medication. Today, April 5, 2022 is the first day I feel better. I am a nurse so I did not feel like I needed any additional intervention and just did saline wash for my sinuses, walk-around, and stay hydrated. I did take another government at-home Covid test today and results were also positive. I would say yes that I recovered but I still don't feel 100% because I do have some congestion and I did test positive still today.
Information has been received concerning a female who in August 2008, was vaccinated with the first dose of GARDASIL. Medical history, drug reactions and allergies were all unspecified by reporter. In approximately February 2009, "6 months after receiving GARDASIL vaccination", the patient's hands were trembling and shaking. On 10-OCT-2010 the patient experienced seizure. The patient sought unspecified medical attention, her present status was unknown. Upon internal review, seizure was considered to be on other important medical event. No further information was available.
Dose Number: 5: Pfizer/Dose Number: 4 :Moderna; Paxlovid as COVID 19 Treatment which started on 23Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27May2022 as dose 4 (booster), single (Lot number: 038A22A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Dairy" (unspecified if ongoing); "known allergies: avoid corticosteroids" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (non-serious) with onset Sep2022, outcome "not recovered", described as "Paxlovid as COVID 19 Treatment which started on 23Sep2022"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 20Sep2022, outcome "unknown", described as "Dose Number: 5: Pfizer/Dose Number: 4 :Moderna". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19 including Paxlovid given on 23Sep2022 to 28Sep2022.  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.
SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and CALCIUM ACETATE for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 12-Jul-2021. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 16-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that she learned she was pregnant on 03-Nov-2020. Her due date reported to be 12-Jul-2021. She reported her pre-pregnancy weight as 165 lbs and current weight as 170 lbs.    Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: NNI
0.25 ml fluviron given to patient.  Vaccine meant for 74 yrs.  Marked on box but not actual vial.  No reaction.
"Later that evening after Tdap shot, redness, swelling, pain, hardness at injection site. Also had numbness in arm and tingling in both hands. Injection site reaction resolved but still experiencing numbness/tingling in both hands."
I started developing a chronic cough that was bringing up phlegm that was from light green to opaque white in color. I took a COVID test that was negative. I was given a nasal spray, azithromycin, montelukast. The cough went away but still persists a little bit till this day. It's intermittent and cold air seems to trigger it and then it lingers for a few hours.
Patient was accidently given 0.2 mL of adult Prizer 30 MCG/0.3 mL instead of peds Pfizer 10 MCG/0.2 mL. There have been no known adverse events reported, or treatments needed that facility is aware of.
Rash at injection site eight days after shot. Mild itching. Taken antihistamine and using topical steroid to treat.
Information has been received from a nurse concerning a patient who was vaccinated with a 0.5 ml dose of Pneumovax 23 (lot # 654982/0675F). Subsequently the patient experienced severe localized reactions which included welts and a rash on the extremity that was vaccinated, but not necessarily at the injection site. The reaction was reported "from the shoulder to the elbow." The patient sought unspecified medical attention. It was reported that the lot # would not be used and there was concern expressed regarding the lot number. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Office of Biologics Research and Review and was released by the regulatory agency. Additional information has been requested.
Patient was given Moderna Bivalent Pink cap, as second dose.  No known symptoms. Patient will be revaccinated. Primary care provider called and advised parents of the incident.
After the vaccine, I felt tired and sore arm and then when I got COVID-19, I had a home test, and it was positive. I was tired, congestion and sore throat.
Fever, headache, are swelling and redness, general body aches, sore throat, nausea.
1) Body aches start around 10pm day of injection (4/21) 2) Woke up with body aches, headache, and fatigue the next day (4/22) 3) Developed low fever of 100.1 (ear thermometer) in afternoon and lasted through rest of day.  Also became nauseous in afternoon and vomited. Developed sores in mouth/mouth felt swollen. (4/22) 5) Woke up next day without fever but still had everything else. Vomited after lunch. Left ear clogged and painful (4/23) 6) Clogged ear and pain (likely ear infection?) has lasted until at least today. Mouth less painful today. (4/27)
12-24 hr after vax, pt devel neck pain, stiffness and "hot rashes" at the inject site. This is 1 of 6 pts at this site which after vax had similar rxn.
I break out in a hot to the touch, itchy red rash every time I am in the sun for any amount of time.
Right foot pain/swelling, redness.  could not walk, could not tolerate any weight on foot.  Today is 5/3 and still have slight pain.
next day- soreness with red skin distal to injection site but still above elbow. second day- 99.8 temp (self reports 97 her normal). swelling between injection site and elbow - patient took APAP otc for symptoms third day- swelling progressed, itch developed - patient continued APAP and began otc hydrocortisone cream for symptoms 6th day- yellowish/bruising skin 1 week- still has intermittent fever
Swelling of throat and ears with severe tinnitus in left ear which was followed by tinnitus in right ear. The right is still "ringing" as of 11/13/08.  3/5/09 Received vaccine records & PCP medical records for 10/29/2008. FINAL DX: tinnitus Patient reported via phone call that he developed tinnitus same day as vaccine & then developed nasal/head congestion & chilld on 10/29.  No reaction to previous flu shots. No MD visit. 02/01/2010 Tinnitus especially bad in the right ear (in both ears).
Chest pain; This is a spontaneous report from a contactable consumer (Patient's parent). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced chest pain on an unspecified date. The outcome of event was unknown.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Intensely painful skin on upper right leg (neuropathic pain) from hip to knee; Intensely painful skin on upper right leg (neuropathic pain) from hip to knee; Felt like the skin was burned; sleeplessness: woke at 5:30 am after going to bed at 12:30pm on first night; Very sensitive to touch; This is a spontaneous report from a contactable consumer, the patient. A 45-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 02Apr2021 at 10:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic. The patient had no known allergies to medications, food or other products. Concomitant medications included Primadphilus (probiotics) (MANUFACTURER UNKNOWN) and an unspecified B-Complex 12 (MANUFACTURER UNKNOWN) all for an unspecified indications, from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 20:00, the patient experienced intensely painful skin on upper right leg (neuropathic pain) from hip to knee, felt like the skin was burned, very sensitive to touch and sleeplessness (The patient woke at 5:30 am even after going to bed at 12:30 on first night of vaccination) (Not the patient's typical 8 hour sleep pattern)). 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  intensely painful skin on upper right leg (neuropathic pain) from hip to knee, felt like the skin was burned, very sensitive to touch and sleeplessness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
pt recv vax 21OCT97 & hot red arm very sore-soreness retained for 1 wk however lesser degree;approx 8cm swelling remains-some evidence of hematoma below area resolving;
Pt received FLUZONE HIGH DOSE vaccine morning of 10/07/2018. Pt called pharmacy at around 4:30PM same day to report adverse event experienced with flu shot. Pt tongue was swollen and she gave herself an epinephrine shot at around 4:00PM. Pt stated she has not gotten worse after given herself the epinephrine shot. Pt just turned 65 this August and therefore was given the high dose flu vaccine. Pt stated not allergic to latex or egg. Unclear what might have caused the allergic reaction. Pt was encouraged to call 911 if condition worsen or having trouble breathing.
Initial information received on 29-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown demographic patient who was vaccinated with an expired dose of TENIVAC (batch number, expiration date 7 Jan 2019, dose, route and site of administration was not reported for both vaccines) on 29-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to expired vaccine used. It was reported that the patient had expired TENIVAC vaccine (expiry date: 07Jan2019) on 29Jan2019. It was unknown whether the patient had any harm 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 and Module VI of the 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.
PATIENT REPORTED VERTIGO STARTED ABOUT 12PM. PT REPORTED FALLING DUE TO VERTIGO. SHE ALSO EXPERIENCE NAUSEA LASTING ABOUT 4 HOURS. PT HAD A SYNCOPAL EPISODE ABOUT 1 HOUR AFTER SYMPTOMS STARTED. PT REPORTED EXTREME ARM PAIN AND WEAKNESS PERSISTING THROUGH REPORTING TIME 2PM 10/18/2011.  PT IS EXPERIENCING EXTREME PAIN IN ARM AND HAS MISSED WORK DUE TO THIS EVENT.
Arm red and swollen hot to the touch started 01/082021 still 01/19/2021
Rash; swollen throat; Arm hurt for months, right arm never did come back to normal; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from a Social Media via consumer/non-health care professional.  This case involves a patient (unknown demographics) who had rash, swollen throat (pharyngeal swelling) and arm hurt for months, right arm never did come back to normal (pain in extremity) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed non-serious rash, swollen throat (pharyngeal swelling) and arm hurt for months, right arm never did come back to normal (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I would rather not get a shot that's gonna make my arm hurt for months breaking out in a rash with swollen throat and misery for a month or two. My right arm never did come back to normal. The doctor for. 10 years retired and nobody knows where my records are to prove that I'm allergic."  It was unknown if the patient experienced any additional symptoms/events  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the event pain in extremity was not resolved while outcome of other events were unknown.  The reporter did not report the causality of events with suspect.  There will be no information available on the batch number for this case.
patient called the office today 8/6/20. states that he received the tdap vaccination on 7/29/20, states a couple of days later 7/31/20. he noticed his arm began to hurt. he noticed lump  and redness at the injection site. he stated he did not think anything of it. he had showed his wife today and she had called our office to inform us of the issue. wife states the lump was redden about 2 in by 3 in around. patient denied fever or any difficulty breathing. patient denies taking anything for the reaction. patient reports the site is better today, no worsening in redness or swelling. patient was educated on vaccine reaction and supportive home care and to report to the ER or call office with any changes they voiced understanding.
Per patients email..."Vaccinated on 1/13/21 with Moderna #1. Shortly after, my entire upper arm was swollen and redness in entire left arm. 24 hours later I started having body aches, headache and fever of 100.1. 1/15/21 brain fog, left side facial tingling, nausea, diarrhea, and fatigue. 1/16/21 had severe headache with nausea, continued fatigue and nausea. 1/18/21 bilateral lower ext?s aching and tingling from knees down. 1/19/21 woke with severe headache with blood pressure 143/123, tingling legs and generalize  weakness. One hour later. Several labs were done, ultrasound of bilateral lower ext, chest xray, which were all normal. The ER physician strongly felt all of my symptoms were related to the vaccine. He prescribed Zofran, meclizine and fioricet. Advised me to return if symptoms persist or worsen. 1/25/21 facial twitching on left upper lip and below eye. I have had daily headaches and joint pain since the vaccine. All other symptoms have subsided"
Patient received IPV to L thigh 5/23/08.  Seen in ER 5/26/08 Dx post immunization cellulitis of L thigh.