chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Based on additional information received on 07 March 2016, this case became medically confirmed. Initial unsolicited report received from a consumer (Parent) on 06 January 2016. This case involves a 06 months old female patient who was vaccinated with a dose of Daptacel (Batch number, dose, dose in series and route were not reported) in the right thigh on 05 January 2016 and dose of Rotavirus (Batch number, dose, dose in series and manufacturer name were not reported) via oral route on 05 January 2016 and dose of (HIB) (Batch number, dose, dose in series, route and site of administration were not reported manufacturer name: Unknown) on 08 December 2015. At time of vaccination the patient had runny nose without fever. Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as not none. On 06 January 2016, one day following the vaccination, the patient had developed 9 millimeter area of redness and swelling at the injection site (right thigh) and a low grade temperature of 99 Farad. No any other laboratory test was done. Corrective treatments were not reported. The patient was not recovered from the event. List of documents held by sender: none. Follow up information received from a physician on 07 March 2016. Patient had received 0.5 ml dose of Pentacel (batch number H7599, expiry date 07 May 2017) intramuscularly, received 2 ml of Rotavirus (batch number 1020861, expiry date 25 January 2017) and also received a 0.5 ml dose of Acthib (batch number UI346AA, expiry date 03 February 2017) intramuscularly in left thigh. On 05 January 2016, same day following the vaccination, the patient developed red and raised spot at injection site, patient's leg was almost 2 inch in diameter bigger than left (right 11 inch and left 10.25 inch) temperature was 99.4 degree Celsius. Patient needed no treatment. Outcome of event was not recovered.
pt recv vax & reports soreness @ time of inj following day pt reported d x 6 days;pt also reports pins & needles type of numbness in lt extremity that began day p/vax;pt had diminished grip strength in lt hand;brachial plexus neuropathy;
Transverse myelitis with GAD enhancing lesion on MRI C3-C5. Strength was 5/5 symmetrically in the lower extremities, but he had significant weakness in the upper extremities left worse than right. Generally 4-/5 proximally on the right, 4/5 distally; left deltoid, biceps, triceps were 2-3/5, 4-/5 at the wrist and hand. Sensation is largely impaired on the right in a patchy distribution to light touch, temperature, pinprick, vibratory (impaired significantly on the right) and proprioception. Romberg testing was positive.
Weak; Light headed/ Dizzy; Tired; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a week after receiving Shingrix, the patient experienced weakness, light headedness and tiredness. On an unknown date, the outcome of the weakness, light headedness and tiredness were unknown.   It was unknown if the reporter considered the weakness, light headedness and tiredness to be related to Shingrix.  Additional details were provided as follows: The batch number and expiry date of Shingrix was not reported. One week ago, from the date of reporting, the patient received Shingrix and felt weak, light headed and tired. The reporter consented to follow up.
Red, warm, raised area at vaccine site for one week. 2.5cm in length. Denies fever, pain, or other symptoms. Treatment given, tylenol and benedryl.
12/18/22 presents to ED for "fever, shortness of breath". PMHx of " PE/DVT, factor 5 leiden on coumadin, morbid obesity"
Vasovagal Syncope - seated talking immediately after vaccine. Suddenly stopped and fell off chair onto gym floor. Regained consciousness after 30 - 60 seconds and was light headed and was diaphoretic. No SOB, swelling, itching, hives, difficulty speaking or swallowing, hoarse voice, palpitations, CP,  headache. AO x 3. No hives or rash. Ambulance called but patient declined export. Driven home by a friend. Advised to call 911 if further symptoms.
07/10/21 Sore arm muscle, headache. 07/10/21 - 07/14/21 Sore/stiff arm muscle. 07/14/21 Dormant Eczema activated. 4 blisters, duration 3 days.
Nausea/abdominal discomfort on Sa 27Mar; Nausea/abdominal discomfort on Sa 27Mar; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation.  The following information was reported: HEADACHE (non-serious) with onset 26Mar2021, outcome "recovered" (28Mar2021), described as "Headache"; NAUSEA (non-serious), ABDOMINAL DISCOMFORT (non-serious) all with onset 27Mar2021, outcome "recovered" (28Mar2021) and all described as "Nausea/abdominal discomfort on Sa 27Mar". Therapeutic measures were taken as a result of headache, nausea, abdominal discomfort.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
12 years old  got the Modena COVID-19  vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 years old  got the Modena COVID-19  vaccine) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 years old  got the Modena COVID-19  vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 years old  got the Modena COVID-19  vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.
Not sure if this is the right place to report this, but I had an anovulatory menstrual cycle after my booster (cycle started a week early). I know there's currently research being done, so if you read this and decide not to dismiss it, I hope I'm helping. I still support getting the vaccine
Denies redness or pain at injection site.  T 102 oral.  No nausea or vomiting.  Father states he gave child Ibuprofen for elevated temperature. Recommended that child be seen by PCP if no improvement in next 48 hours.  Encouraged to continue with Tylenol or Ibuprofen for discomfort and to maintain good fluid intake.
Patient only had one dose; asthma was acting out despite having Nucala; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) powder for injection for eosinophilic asthma.   Previously administered products included Shingles vaccine (Patient had 1st dose a years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On 14-JUN-2023, the patient started Nucala. On an unknown date, an unknown time after receiving Shingles vaccine and an unknown time after starting Nucala, the patient experienced incomplete course of vaccination (Verbatim: Patient only had one dose) and lack of drug effect (Verbatim: asthma was acting out despite having Nucala). The action taken with Nucala was unknown. The outcome of the incomplete course of vaccination and lack of drug effect were unknown.   It was unknown if the reporter considered the lack of drug effect to be related to Nucala.     It was unknown if the company considered the lack of drug effect to be related to Nucala.   Additional Information: GSK Receipt Date: 07-JUL-2023 The patient stated she started Nucala on June 14th by a nurse.  Patient had the vial presentation of Nucala.  Patient stated that last week she felt like her asthma was acting out despite having Nucala (lack of drug effect).  During the conversation patient stated that she had a shingles vaccine years ago but she only had one dose.  Patient could not remembered the presentation of the vaccine and whether it was a GSK vaccine.  Filed reported of underdose of shingles vaccine.  Patient did not want to be associated with this report and wanted to file it as anonymous. The reporter did not consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Felt like I had the flu; 102 degree fever, extremely tired, insomnia (rare for me), injection site swelling and redness, it was painful to touch but not pain is just standing there. I took ibuprofen and alternated with TYLENOL. Fever went down to 101 after 4 hours. Fever continued from 100-101 for the next 20 hours. Still tired and had swelling for 48 hours total after symptoms appeared.
Client c/o feeling light headed and shaky, also itching to site left deltoid and throat tightness. P 70 B/P 120-90 R18. Lung sounds clear. Cardiac monitor normal sinus rythm. O2 sat 97%. Client refused to go ER.
Chest pain, rapid heart rate, very high blood pressure 220/90. Severe head ache, arm swollen at inj site chills (no fever) body aches worse than flu weakness, dizzy (no prior BP meds).
First Moderna vaccine given on 03/18/21. On  4/13/21 her left eye was red and she had a headache, but 4/14/21 she was unable to see clearly out of the left eye. She saw an ophthalmologist on 4/15/21 and the eye started improving on 04/16/21. On 04/16/21 she received her second moderna vaccine and the next day she had another headache and was unable to see out of her right eye. She had an emergency appointment with the ophthalmologist on 04/19/21 and a recheck on 04/19/21. By 04/20/21 the right eye started improving.
on 10/26/20  at 10:53am, patient came by pharmacy complaining of discomfort and redness and swelling at both injection sites on left and right upper arms.   Boostrix site was still about .75" radius from injection site and the flu shot site had slight redness.   Patient said she never had this much discomfort nor side effects in the past.
Patient was vaccinated with the COVID 19 PFIZER Monovalent vaccine instead of the COVID 19 PFIZER Bivalent vaccine.
On 9-19-2013 client developed swollen and stiff joints including the fingers, wrists, knees and ankles - Sx are very painful at time with limited movement. Cli states she was not vaccinated previously with MMR and does not recall having had Rubella disease. Per cli, her mom stopped immunization at 6 mos of age. Advised cli sx could last up to 3 weeks, to take an inflammatory med for sx and will call client in 3 weeks to asses health status. Advised cli to see MD if sx worsen or if interfere with work activities. 10-10-13 T.C. client states sx resolved within 2 weeks. No further f/u.
On day 3 post shot, I started having strong pain in  the area of my spleen, both front and back.  This was accompanied by occasional chills.  The pain was bad enough that I was not able to sleep on the Thursday, Friday and Saturday nights after the Tuesday shot.  However, during most of the day Saturday, I was almost pain free. But the pain returned on Sunday  afternoon and I had a difficult sleep .   Monday, the pain level was diminished but did increase by the end of the day.  I took 2 ibuprofin at bedtime and 2 additional when I was awake 4 hours later. Today, Tuesday the pain is minimal, but still present.
a slight throb at the injection site; Mild body aches that only started 27 hours after injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 09:30 (Lot number: EM9809) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing); "knee replacement" (unspecified if ongoing); "hpn" (unspecified if ongoing); "allergy to bromine in pools as skin irritant" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; BISOPROLOL; OMEGA 3 PLUS [FISH OIL]. Past drug history included: Ibuprofen, reaction(s): "allergies". Vaccination history included: Bnt162b2 (dose 1, single, Lot number: EN6202, Administration time: 12:45 PM, Vaccine location: Left arm), administration date: 08Feb2021, when the patient was 76 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 02Mar2021 12:30, outcome "unknown", described as "a slight throb at the injection site"; PAIN (non-serious) with onset 02Mar2021 12:30, outcome "unknown", described as "Mild body aches that only started 27 hours after injection". Therapeutic measures were not taken as a result of vaccination site pain, pain.  Additional Information: The facility where the most recent COVID-19 vaccine was administered was reported to be "other". Prior to vaccination the patient was not diagnosed with COVID-19. The patient's concomitant medication included "Micro Dail". Since vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
back started aching/felt like somebody stabbed her in her back next to her ribcage and vertebrae; back was spasming every 10 seconds and lasted 48 hours; felt like somebody stabbed her in her back next to her ribcage and vertebrae; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back started aching/felt like somebody stabbed her in her back next to her ribcage and vertebrae), MUSCLE SPASMS (back was spasming every 10 seconds and lasted 48 hours) and BACK PAIN (felt like somebody stabbed her in her back next to her ribcage and vertebrae) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Bone disorder.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (back started aching/felt like somebody stabbed her in her back next to her ribcage and vertebrae), MUSCLE SPASMS (back was spasming every 10 seconds and lasted 48 hours) and BACK PAIN (felt like somebody stabbed her in her back next to her ribcage and vertebrae). At the time of the report, BACK PAIN (back started aching/felt like somebody stabbed her in her back next to her ribcage and vertebrae), MUSCLE SPASMS (back was spasming every 10 seconds and lasted 48 hours) and BACK PAIN (felt like somebody stabbed her in her back next to her ribcage and vertebrae) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications, Muscle relaxers, NSAID, narcotics, anti-inflammatory, anxiety meds, lidocaine patches on back.
Fever ranging from 99 to 103 degrees F onset 2 days after vaccination shot and last for 4 days, chills, muscle aches, headache, nausea, constipation
This case is 1 of a cluster of 2 patients who experienced similar adverse events following vaccination with DAPTACEL. The event for the second patient was captured in case number 2011-00816. Initial report received from a health care professional on 23 February 2011. A 2-month-old male infant received on 29 December 2010 an injection (route and site not reported) of DAPTACEL, sanofi pasteur lot number C3577AA. On 29 December 2010, the patient developed inconsolable screaming for 3 hours after the vaccine. The outcome was reported as recovered. Follow-up information was received from the health care professional on 05 April 2011. In additional to DAPTACEL, the patient also received his first dose of the following vaccines on 29 December 2010: ACTHIB (sanofi pasteur inc lot number UH253AB, sanofi pasteur SA lot number E0990-1); IPOL (lot number E0123-1); PREVENAR (other manufacturer, lot number 915066); and ROTATEQ (other manufacturer, lot number 12667). The reporter of this case was the same as case 2011-00816. Documents held by sender: None.
Bell Palsy; This is a spontaneous report from a contactable consumer (patient) reported that a 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration on the left arm on 17Feb2021 11:30 at a single dose for covid-19 immunization. The vaccine was administered at the hospital. Medical history included blood pressure, cholesterol, and gastrooesophageal reflux disease (GERD); all from an unknown date. Patient was not pregnant at the time of vaccination. Concomitant medications included benazepril, oxybutynin hydrochloride (OXYBUTININ ACCORD), ezetimibe, fenofibric acid, and esomeprazole; all were taken from an unspecified date for an unspecified indication. The patient experienced facial numbness then the patient went to the ER and was diagnosed with Bell's palsy on 17Feb2021 16:00. The patient underwent lab tests and procedures which included computerised tomogram: unknown result on an unspecified date. Therapeutic measures were taken as a result of bell palsy. The outcome of the event was not recovered.
COVID 19 Treatment; COVID 19 Treatment; 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 02Dec2022 as dose 5 (booster), single (Lot number: 656796), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EN6201), in right arm, on 08Mar2021 as dose 2, single (Lot number: EN6208), in right arm, on 09Nov2021 as dose 3 (booster), single (Lot number: 32030BD), in right arm and on 14May2022 as dose 4 (booster), single (Lot number: FM9992), in right arm for covid-19 immunisation. The patient's relevant medical history included: "borderline diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "obese" (unspecified if ongoing). Concomitant medication(s) included: REFRESH OPTIVE, start date: Apr2003; HYDROCHLOROTHIAZIDE, start date: Apr2005; METFORMIN, start date: Apr2010; RESTASIS, start date: Apr2010; LISINOPRIL, start date: Apr2019; ATORVASTATIN, start date: Apr2020, stop date: 16May2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received COVID 19 Treatment with Paxlovid from 17May2023 to 21May2023. Lot number: 6665318. Indication: Treatment of COVID-19. Adverse event: paxlovid didn't help much. finished last dose Sunday night and by Tuesday had temperature again (99.1) bad coughing that hurt chest. Slight headache.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300200912 Same reporter/patient, different product/events;
patient given expired dose of Menactra, no AE; Initial information received on 20-Apr-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient (unknown demographics) who was vaccinated with an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 16-Apr-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: not reported expiry date: 02-Apr-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that Caller does not have any information on the patient details for the questionnaire, so questionnaire not filled out. Provided caller with inquiry to call us with information once be obtains that from the site that gave the vaccine.   At the time of report no adverse event was reported.  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.
I did not have an adverse reaction to the vaccination. I contracted Covid-19 a little over 2 months from my 4th dose of the vaccine.
Information has been received from a physician concerning patients who were vaccinated with Gardasil. Subsequently the patients experienced fainting and nausea. The nurse indicated at least 5 patients experienced fainting and nausea. The nurse indicated at least 5 patients have had this experience. They did not eat before receiving the vaccination. The patient's sought unspecified medical attention and their outcome was not reported. Additional information has been requested.
1.) Fever,  2.) Loss of Appetite / Nausea 3.) Headache 4.) Body Aches 5.) Unable to standup
I recieved the first shot, and felt dizzy/lightheaded/blurry vision about 5 hours later.  That night i began having heart palpitations while trying to sleep.  It improved over the month, but i decided to report to vaccination site.  The doctor on site told me it heart palpitations was not a symptom being reported.  The injection nurse told me she had never heard that, but to report it, because ?this is so new, we are all guniea pigs right now?. On the drive home from second shot I had to pull over, because I felt like i was going to pass out.  I had chest pain/tightness intermittently throughout the day, worsening at night with palpitations.  I am (was) a healthy 30 year old man.  I exercise, hike etc.  i was scared and went to Urgent Care for an ekg, which was within normal limits.  They told me to go to hospital if it worsened.  I cant find good info on what to do, because I am treated like an antivaxxer, despite getting the vaccine.  Social media, etc blocks information on serious side effects.  I?m not antivax, i got the vaccine very early.  Everything I have read frol other people?s experience is that seeing a doctor is futile, because they can?t diagnos outside of myocardia and perocardia, and prescribe antiinflammitories.  My health insurance is not good. I have been taking NSAIDs to help.  It comes and goes, sometimes I feel like im going to have a heart attack.  My blood pressure spikes and dips.
Tightness in Jaw, severe pressure headache (Tylenol and ibuprofen )