chrisvoncsefalvay/vaers-outcomes huggingface dataset:
52 year old male had a Fluzone HD, no side effects; 52 year old male had a Fluzone HD, no side effects; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 52 years old male patient who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (dosage form: prefilled syringe) lot UJ241AB expiry date: 18-Apr-2020 via unknown route in the left deltoid on 18-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given.  It is an actual medication error case due to inappropriate age of vaccine administration and overdose.   It was reported that the patient did not had any side effects.  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.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) and on 01Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 22 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: Other medical history: Lupus. Concomitant medication(s) included: PROZAC; HYDROXYCHLOROQUINE; LAMICTAL; WELLBUTRIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication taken in 2 weeks was Ventura Birth Control Pill. Therapeutic measures taken was Paxlovid from 30Sep2022 to 05Oct2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Child vomited app. 6 times between 10:00 pm and 01:00 am.
Febrile seizure, believed to be 2 hrs to Dtap. Hospitalized for 24 hrs in PICU. Had complex seizure lasted ~ 1hr. 6/20/06 Received medical records from hospital which reveal patient admitted w/status epilepticus secondary to febrile reaction from MMR vax. Temp 100.4.  Had recently completed rx for OM & had been back to PCP for recheck which revealed OM had cleared.  PMH: asthma & frequent OM.  No prior or family hx of seizure./ss 7/10/06 Medical records received from PCP which reveal patients febrile seizures felt to be secondary to DTap vax/ss
10:20am Post vaccination reports feeling light headed, dizziness and numbness @ vaccination site; medical monitoring x 30 min, vitals assessed BP123/87 P76 RR18; 11:00 "feels better" post rest/ laying down; BP 115/70 P68 RR18 T98.6. Released from facility home w/husband
Chills, fever, muscle pain, swelling around injection, headache and body aches, upset stomach, diarrhea
Pfizer-BioNTech COVID-19 Vaccine  5 minutes after receiving vaccine she experienced the following symptoms: rash/hives (rash on chest, back, around hair line, injection site and behind ears), dizziness, numbness and tingling of tongue.  Pt taken to ER as rash and tingling of tongue is persisting after taking Benadryl 50 mg and zyrtec 10mg at 0920. Epipen provided at discharge from ED.
Initial report was received from a healthcare professional on 29 September 2011. A 31-year-old female patient had received an Intramuscular (IM) injection of ADACEL; lot number U4104AA (sanofi pasteur Ltd. lot number C3962) in left deltoid and a Intradermal (ID) injection of APLISOL in right arm on 13 September 2011. On 14 September 2011, the patient developed symptoms of coughing spell leading to vomiting and urinary incontinence. No further information was available at the time of the report. The patient outcome was reported as unknown. Documents held by sender: none.
Pain at injection site of left shoulder after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site of left shoulder after 2nd dose) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site of left shoulder after 2nd dose). At the time of the report, VACCINATION SITE PAIN (Pain at injection site of left shoulder after 2nd dose) had not resolved. Not Provided          concomitant medicines was not reported by reporter   treatment information was not provided   The action taken with mRNA-1273 with the events was considered as not applicable   This case was linked to MOD-2021-055237 (Patient Link).
Loss of taste; a metallic taste; Swollen tongue; This is a spontaneous report from a contactable pharmacist. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 26Feb2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient developed loss of taste and swollen tongue that has persisted post first dose of the vaccine on 26Feb2021. The loss of taste started as a metallic taste and couple of days later progressed to a loss of taste. The patient has been tested twice and both negative for COVID-19 on unspecified dates in 2021. As of 14Mar2021, the symptoms have started improving, which is about 3 weeks post dose and it is mostly gone now. The clinical outcomes of swollen tongue loss of taste and a metallic taste were resolving.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
My sister and I were traveling internationally. I had congestion, stuffy nose, body aches. It felt like a very bad cold that just wouldn't go away. I used a home COVID-19 test that came back positive. We isolated for a day and then branched off from our tour group until we tested negative.
I started to feel like I had a mild cold I sent my husband to the store to get some warm brownie's, I felt cold. I had a muscle cramp in my next which lasted for about a week
Infant was given PEDIARIX, ACTHIB & PREVNAR 13. She cried normally then in 3-5 min paled out & became unresponsive with poor peripheral circulation - low heart rate- not responding to stimuli. Gave 0.01/mg epinephrine 4x at 3-5 min interval to get a cry. She also vomited large amount. Transfer to hospital & there she had normal vital - took about 10-15 min.
Patient stated that the time of onset was that evening (10-3-18) and was painful overnight. She was not able to move her arm for the first 48 hours. Today (10-5-18) the pain is predominately gone, but the swelling is getting worse (started on 10-3-18). Swelling has now radiated down to her elbow and down her left arm. Patient stated she has tried OTC BENADRYL and ibuprofen.
This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A fifty-six-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 05, Apr2021 11:00 (at the age of thirty-six-year-old) as 1st dose, single for COVID-19 Immunization. The patient medical history, family history and concomitant medications were reported as none. The patient did not receive any prior vaccine within four weeks. No other vaccine administered on same date of Pfizer Vaccine. The patient reported that she received first shot of vaccine (yesterday). The patient stated that on 05, Apr2021 her "arm was sore last night and is more tender" this morning, she had been trying not to touch it. The patient started to feel some side effects on 06, Apr2021 (this morning). On 06, Apr2021, she had chills, was not feeling good, had aches and pains, and a headache. The patient stated that, on 06, Apr2021, the chills were gone but she was experiencing the other symptoms. She "feels like she was coming down with the flu". The patient wanted to know if it was okay to be around others (like an infant) and was, she contagious and could she be around other people if she was feeling side effects. She was asking because she kept her granddaughter on Tuesdays. The patient denied any labs, testing, or treatments. The patient had not been to the emergency room or doctor's office in response to the events. The patient enquired that could she take Ibuprofen for her headache. The outcome of the event chills was reported as resolved on 06, Apr2021. The outcome of other events was reported as not resolved. No follow-up attempts are needed. No further information is expected.
No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  It was reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707457, expiration date was reported as 22-FEB-2022 but upon internal validation established as 23-FEB-2022; lot # 1707460, expiration date was reported as 13-MAR-2022 but upon internal validation established as 14-MAR-2022) underwent a temperature excursion.  On 08-JUN-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were not reported) orally for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion 47.2 Fahrenheit (F) (above 46 F) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356:
The day I received the Janssen vaccine, I had pain at the injection site immediately, which was to be expected. My arm was very sore for over a week. I felt ill at dinnertime but was able to eat. Around 10:30 PM I started to feel like my skin was on fire. It was hot to the touch as well. However, I was freezing and couldn't get warm. My teeth were chattering. I started crying uncontrollably. I have never had tears run so hard down my face. The tears felt like they were burning my skin because my skin felt so hot. I awoke my husband to help me. He wanted to take me to the Emergency Room, but I wanted to wait. My muscles ached terribly. I had to pace back and forth because of the intense pain. My head also felt like it was going to blow off of my body. It wasn't like a normal headache. It felt like I had swelling in my brain. The left side of my head was sore for days afterwards. I then became terribly nauseated. I didn't throw up but felt like I was going to. I also felt extremely dehydrated. I was able to drink some water. It was a very long night. Looking back, I probably should have gone to the ER. My husband worked from home the next day so he could be available if needed. It took a long time for me to fully recover. I woke up exhausted and struggled with fatigue for a while and had extreme exhaustion in the evenings. My ears would turn bright red in the evenings and feel hot to the touch. I still have some fatigue now but am mostly better.
voice box in her neck area, like another voice box. It has a chain inside like a massager machine; It is very painful.; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (voice box in her neck area, like another voice box. It has a chain inside like a massager machine) and PAIN (It is very painful.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high and Potassium low.    In 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (voice box in her neck area, like another voice box. It has a chain inside like a massager machine) and PAIN (It is very painful.). At the time of the report, FEELING ABNORMAL (voice box in her neck area, like another voice box. It has a chain inside like a massager machine) and PAIN (It is very painful.) had not resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the voice box in the neck area, like another voice box. It has a chain inside like a massager machine. The patient a sensation under the chin. And it does the thing a camera does around her gums and it twists the teeth and gum area, around the mouth. It was very painful. It was like the patient had another tongue and another mouth.The patient also felt  in her head. it's like someone was doing something with the body. There was a chip in the vaccine and the patient wanted to knowhow it can be taken away. Patient was out of the hospital for the reason mentioned above.  No treatment medication was reported.
Whole body hives  Worse at injection site  2 Benadryl; hives not improved 5 hours later
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 02/12/21pfizer,Lot#EM9810 2nd dose: 03/05/21,Pfizer,Lot# EN6202 Diagnosed covid positive:07/15/21 Exposure:Travel Symptoms:
12/19/2021 Injection @ 9:30am. Around 3:30pm I started aching in my joints and feeling mild soreness in the injection site arm. Around 7:30pm the aches became more intense and widespread as well as some chills. Around 10:00pm I started getting withdrawal symptoms of not taking my sertraline medication on time, which is an electric shock feeling through my body. Have only tried applying heat to areas, not much help. Symptoms still ongoing (currently 10:36pm). This all also happened after my second dose.
had a 102 degree fever for about 15 hours which started the evening of 1/5/21, which also included chills and muscle aches. The muscle aches lasted about 24 hours. The injection site was my left arm and I now have swelling in my left axilla which started the evening of 1/6/21 and is still currently swollen. I am an ultrasound technologist and was able to scan myself this morning when I came back to work. It appears I have a cluster of reactive lymph nodes in the area of swelling within my left axilla, the largest measuring 3.0 cm. It is very tender in the area of swelling and the pain radiates down my left arm. I had a lot of pain at the injection site that lasted for about 24 hours, it is now subsiding. However, for the last 24 hours it has been very painful to bend my arm. Any time I tried to bend my arm it sent a throbbing pain down to my left hand, it is still occurring today.
For the first 2 days after the shot I had minimal side effects (sore arm, sneezing).  The morning of Saturday, Sept 4 I woke up with back pain that progressed into the worst back spasms I've ever had and that didn't subside until noon on Sunday, Sept 5, which at that point the back pain and spasms were intermittent until the evening of Monday, Sept 6.  After Sept 6 the pain went away until I received my second COVID shot which will be in another report.
Caller reports after patient received a dose of VAXELIS,she had increased irritability for few days,doctor thinks patient may be allergic to pertussis component of vaxelis.Reports they had patients in past allergic to Pertussis with similar reaction; This non-serious spontaneous safety report, with reference number 2023SA271433, was received by the partner on 05-SEP-2023 and forwarded to company on 06-SEP-2023, from a health professional.  The reporter did not provide an assessment of causal relationship between Vaxelis and the event "Caller reports after patient received a dose of VAXELIS, she had increased irritability for few days, doctor thinks patient may be allergic to pertussis component of vaxelis. Reports they had patients in past allergic to Pertussis with similar reaction".  Further information is expected.
Muscle soreness all over, especially legs, lethargy, glands in throat swollen, sore throat, injection site bruised, red, swollen.
Pt reports experiencing itching, hives and rash symptoms 4 hours after receiving vaccine. Visit to ER was given cream and pills. Resolved within 2 days.
Fatigue adn nausea, fever. throughout night.  By 6am on Tuesday morning, EXTREME nausea, sweating, weakness, collapsed onto kitchen tiled floor, hit head and hip on kitchen tile floor.  Called ER, ambulacnce to hospital. .  Needed ctscan of head and neck, receiving excess radiation which should not have been needed if I had been fully informed of severity of possible effects.  Needed expense of ambulance, ctscan of head, neck, xray of chest and hospital ER stay..
COVID vaccine error noted 1/18/22 @ 1:30pm. Vaccine drawn up and given from expired vial mixed on 1/17/22 with 6 hour expiration noted for 9:40pm. Telephone call to manufacturer to check stability of vaccine and verify if patient needs to have repeated. Advised no stability information available. Per CDC guidelines if no stability information is available patient will need vaccine repeated with no minimum interval in the opposite arm. Telephone call to system to report error and findings. Practice manager spoke with patient and advised of error. Patient is going to call back to schedule repeat dose.
Information has been received from a nurse practitioner concerning a patient who was exposed through the mother on 07-JAN-2010 was intramuscularly vaccinated with a 0.5 mL dose of GARDASIL (Lot # 0669Y) instead of H1N1 flu vaccine. Concomitant therapy included prenatal vitamins (unspecified), FLONASE, BENADRYL and SUDAFED prior to realizing that she was pregnant. The nurse practitioner reported that at 17 weeks of gestation, on approximately 23-JAN-2010, a sonogram was performed which showed echogenic foci in the left cardiac ventricle of the fetus. The nurse practitioner felt that echogenic foci in the left cardiac ventricle was not related to therapy with GARDASIL. At the time of the report the patient's outcome was unknown. Follow up information was received from the nurse practitioner which reported that on 28-JAN-2010, the patient's mother had ultrasound done for screening which was within normal limits. On 25-FEB-2010, maternal serum alpha-fetoprotein (MSAFP) was within normal limits. The mother's experience has been captured in WAES# 1003USA00456. No further information is available.
sore arm about 3 days; Initial information was received on 28-Jan-2021regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (age and gender unspecified) who had sore arm about 3 days (pain in extremity), when received vaccine INFLUENZA VACCINE..  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sore arm about 3 days (pain in extremity), (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE..  it was, sore arm about 3 days, currently all gone, having his/her second shot 2/17 put an ice pack on for 15 minutes It was unknown if the patient experienced any additional symptoms/events.   No laboratory data was provided.  The patient received ice pack on for 15 minutes as a corrective treatment.  At the time of report, the patient was recovered form event.  There will be no information available on the batch number for this case.
6 hours of vomiting and diarrhea 12 hours after taking oral Typhoid #2. Pt. recovered and went to work next day.
104 fevers. Rash from head to toe. On 4th day of fever and rash has gotten worse and she still has a fever.
had a little bit of discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (had a little bit of discomfort) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced DISCOMFORT (had a little bit of discomfort). At the time of the report, DISCOMFORT (had a little bit of discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Fever for 3 days ranging as high has 101.9, extremely muscle pain in hips, legs,  and feet. Chili?s and neck pain.
Pt reports onset of intermittent neuralgia and numbness in both hands beginning the day following vaccination and continuing now 5 days later. No report of injection site reaction, erythema, swelling, or other systemic symptoms.
MMR and HIB given 10/4/02. 10/8/02 Mom reports fine rash. 10/13/02 Mom reports pin-point rash. 10/14/02 Physician visit- mixed rash/fine scattered papular and erythematous/hive-like on cheeks and trunk. Recommended soda baths, Benadryl syrup 1/4 to 1/2 teaspoon QID.
Provider preparing vaccine diluted it using a smaller volume of diluent (1.5mL) than recommended (1.8mL).  She injected 0.3 mL as indicated.  Pt. was observed for 15 minutes and reported no adverse reaction.  Consultation with Pfizer Safety Reporting revealed that this volume dilution would produce a concentration within the therapeutic range.
Fevers, rigors, skin sensitivity, muscle aches. Fever's to 102.5 up to 36 hours after injection. Symptoms of rigors, fever and muscle aches began 12 hours after injection. Rigor subsided at 18 hours after injection. All symptoms resolved at 48 hours after injection
flu shot 29OCT93; 30OCT93 about noon felt achy 31OCT93 woke up about 5AM w/severe abdo cramps, nausea & diarrhea; started getting better Sunday PM & felt OK by 5PM x/for weakness which lasted approx 5 days;