chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received a medication error described as getting a double does of DTap-IPV due to the consumer was, given a dose of Pentacel and Tripedia with no AE; Initial information regarding this unsolicited valid non-serious case from via Medical Information (Reference number- 00496166).  This case involves a 15-months old female patient received a medication error described as getting a double dose of PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) [PREVNAR] (batch number: unknown and expiration date: unknown), DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE [DTAP-IPV] (batch number: unknown and expiration date: unknown) due to the consumer was, given a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/ IPV(MRC5)/ HIB(PRP/T) VACCINE [PENTACEL] (batch number: UJ402AAA and expiration date: 09-Oct-2021) at a dose of 0.5 ml via intramuscular route in the right thigh and concomitant medication Tripedia (extra dose administered) for prophylactic vaccination.  Medical history, past medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the extra dose administered (latency: unknown).  At the time of reporting, the patient had no adverse event.  Disclaimer: 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. 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.
CURED PSORIASIS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced cured psoriasis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cured psoriasis was not reported. This report was non-serious.
Pt. states that after receiving the 1st dose of Phizer 02/25/2021, started experiencing 03/01/2021 of a lump at injection site for 3 days (itchy and hot). Intense shoulder pain still continuing.
fatigue; myalgias; This is a spontaneous report from a contactable physician (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm, on an unspecified date in Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. Patient has no known allergies. Patient is not pregnant. Patient did not have Covid prior vaccination. Patient did not have other vaccine in four weeks. Patient had fatigue and myalgias for 3 days after the 1st dose in Dec2020. No treatment received for the events. Patient did not test Covid post vaccination. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sharp sciatic nerve pain along right lower extremity beginning at buttocks region and radiating down right thigh. Exacerbated by lying down (supine and prone), standing upright (when weight was on the right leg), and sitting crossed leg. At times the pain was pulsating in the thigh area, but remained constant in buttocks. Sitting upright with legs hanging off the bed alleviated some of the pain. Lasted from 11:00PM until time of falling asleep (2:47AM). Stretching, cold compress, naproxen 500mg temporarily eased the pain, but did not stop it. Woke up the next morning (~10:00AM) with no pain, and it has not been back since the time of writing this.
Swelling below injection site 5-6 inches long and 5 inches wide, redness and soreness. Advil given last night, still swollen and sore this am.
Patient was administered an expired MENACTRA vaccine on 04/30/2015. Vaccine expiration date 04/25/18. Patient has not had any side effects from vaccine.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. The reporter considered the injection site erythema and injection site swelling to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left arm deltoid (closer to the triceps muscle). The healthcare professional did not have the lot number and expiration date of the SHINGRIX available. The time of symptom development was not reported to the healthcare professional. The patient presented to the pharmacy on the third day after vaccination. This case has been linked with US2018057886, reported by same reporter for same events. There had been no further follow-up with the patient at this point.
Pt. returned to office approx. 48 hours after receiving VARIVAX 6-16-15 to post Rt. upper arm. Site became itchy, red and warm to touch 24 hours after admin. Red, warm, mildly swollen circular area measured 30 mm diameter. Advised to seek tx if swelling or redness increase.
Well the adverse event was that on that evening of my first dose I had fatigue and the next morning, March 18 2021 I had extreme all body joint pain which made it very difficult to walk, which lasted basically all day, then had more nausea and a low grade fever. The next couple of days the body aches eased up a little bit but the nausea, fever, etc lasted for about three days.
Very dizzy so I sat down and have felt totally off balance ever since.  The room does not spin and I am not nauseous but I am very unsteady on my feet. Then there are times when I feel fine. But off balance on a daily basis.
lt leg turned blue, pt began coughing & choking, became very pale, eye didn't appear to focus, screamed loudly;
From injection on. Two days (10/15th-10/16th) redness, itching, painful, swelling, rash. Unsuccessful in getting pharmacist to talk to me via pharmacy telephone. Prescribed (3) new prescriptions. Instructed to see PCP/or return to ER.
Employee began feeling lightheaded and dizzy and very hot.  Employee layed down on stretcher and stated she felt better, but was quite dizzy and lightheaded.  Employee reported tingling in her fingers and toes and a bad headache.
Left deltoid.  Left lateral deltod. 2in by 2 in area of swelling, erythema, painful to mild deep touch. Area is warm to the touch. No exudate, swelling is not hard, no steaking. Pt feels that the site is improving.  Pt advise to take OTC pain meds prn, warm compresses.
As above plus stiff neck  no treatment and I?m reporting on same day as I received the 2nd dose
Dizzy; Headache; Lots of anxiety; Elevated heart rate; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 29Mar2021 at 10:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus, hashimoto's disease, depression and anxiety. The patient received unspecified medication within two weeks of vaccination. The patient had no allergies to medications, food, or other products. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 07Mar2021 at 15:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 07:00, It had been 2 weeks passed her second shot. She had no affects after the first or second shot immediately after. But now, the patient experienced dizzy, headache (small), lots of anxiety, elevated heart rate. She was type 1 diabetic in good control (5.5 A1C). The evets resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events and included treatment with hydration. On an unknown date, the patient underwent HbA1C and the result was 5.5. On 14Apr2021, the patient underwent nasal swab rapid test and the result was negative and heart rate and the result was elevated. The clinical outcome of the events dizzy, headache (small), lots of anxiety and elevated heart rate were not recovered.  No follow-up attempts are needed. No further information is expected.
Imm was given 7/21/10. She had a fever for 1 day and a headache for 12 days following the vaccine. No treatment was done.
Hospitalized 9/13/21; COVID-19 positive on 9/13/21; fully vaccinated. Admitted for Abscess , Lymphedema  and COVID-19
Inflamation; large, hard lump roughly the size of a 2-4 cm; a sensation in the chest as if the inside of the chest and back had united somehow, resulting in a pain in the left center side of the chest; painful; lingering soreness underneath the arm and throughout the upper chest; This is a spontaneous report from a contactable consumer (patient). A 63-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EP7534), via an unspecified route of administration, administrated in right arm on 18Mar2021 (age at the time of vaccination 63-years-old) as a single dose for COVID-19 immunization. The patient's medical history included Hypothyroidism, and high cholesterol. The patient's concomitant medications included Levothyroxine 100 MCG, Lisinopril 10 MG, and Atorvastati. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. On 20Mar2021, the patient experienced Inflammation; large, hard lump roughly the size of a 2-4 cm; a sensation in the chest as if the inside of the chest and back had united somehow, resulting in a pain in the left center side of the chest; painful; and lingering soreness underneath the arm and throughout the upper chest. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received as a result of adverse events. The outcome for all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Fever chills fatigue (12 hrs after)  Numbness and chills in toes, feet, finger, hands (2 weeks after)  Lost of taste due to numb tongue. Blurred vision  (3 weeks after)  Droopy/stiff left side of face, eyes, mouth, cheeks (4 weeks after)
I received the FLULAVAL QUADRIVALENT IM in my Right Deltoid thru my Tattoo on 1/5/2018. In the morning of 1/7/2018 about 6 am I awoke to a horrible Tendinitis type pain in my right arm. The pain started at the point of the injection down to just distal my Right elbow. I have never had Tendinitis or a pain like this in my arm before. I called the office of Dr. on 1/10/2018 to report the pain. I was instructed by the office to use ICE on my arm and to make a follow up appointment if the pain did not go away. As of 1/26/2018 the pain is no different.
A non-serious spontaneous report of pregnant patient inadvertently given the live vaccine was received from a registered nurse concerning an adolescent female. After vaccination of the patient, the nurse was informed that the patient was four weeks pregnant. The expected delivery date is approximately 11-Jul-2010. There was no adverse event associated with this pregnancy. Additional information was received on 05-Nov-2009: start date of adverse event, reporter's address and responsible physician's address. Additional information was received on 13-Nov-2009: Expected delivery date has been updated.
COVID-19; This case was reported by a consumer via other manufacturer and described the occurrence of covid-19 in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2022, the patient received the 2nd dose of Shingrix. On 16th November 2022, 2 days after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     Additional Information: GSK Receipt Date: 08 DEC 2022 Reporter's comment: The reporter stated that the patient had 2nd dose of Shingrix vaccine on 14th November 2022. Then on 16th November 2022 the patient had covid 19. The caller confirms that on 14th November 2022 2nd dose of Shingrix was taken.
had a seizure with the Men B vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a 17-year-old male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown.   The reporter considered the seizure to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by the parents of the patient. The age at vaccination was not reported. The reporter stated that, his or her 17 year old son had a seizure with the Meningococcal B vaccine. No further information was reported.
On 3/19/16 child received meningococcal vaccine. Within 4 hrs of vaccine child had fever and was unable to walk. Body aches.
Breakthrough case of the Covid 19 virus after receiving the Moderna Covid 19 vaccines; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Breakthrough case of the Covid 19 virus after receiving the Moderna Covid 19 vaccines) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 COVID-19 (Breakthrough case of the Covid 19 virus after receiving the Moderna Covid 19 vaccines). At the time of the report, COVID-19 (Breakthrough case of the Covid 19 virus after receiving the Moderna Covid 19 vaccines) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information mentioned.  Patient reported to Pfizer of their own experience then mentioned that their son had a breakthrough case of the Covid 19 virus after receiving the Moderna Covid 19 vaccines.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Company Comment: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of Breakthrough COVID-19. The reporter stated her son had a breakthrough case of the Covid 19 virus after receiving the Moderna Covid 19 vaccines. Exact date of vaccinations, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of Breakthrough COVID-19. The reporter stated her son had a breakthrough case of the Covid 19 virus after receiving the Moderna Covid 19 vaccines. Exact date of vaccinations, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
BODY/MUSCLE ACHES; WEAKNESS; TIREDNESS; FEVER; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, and non-alcohol user, and other pre-existing medical conditions included: The patient had no known allergies and no drug abuse or illicit drug, The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-AUG-2021, the patient experienced body/muscle aches. On 18-AUG-2021, the patient experienced weakness. On 18-AUG-2021, the patient experienced tiredness. On 18-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever on 19-AUG-2021, and had not recovered from weakness, tiredness, and body/muscle aches. This report was non-serious. This case, from the same reporter is linked to 20210938329.
Sudden rapid heartrate upon even slight exertion, sudden blood pressure spike in the range of 165/100 to 225/110, headache, blurred vision, pain in right side intermittently
Swelling, redness and extreme pain at injection site, itching at injection site, headaches,  hot/cold flashes, bruising at injection site, tired.
Around 2 weeks after injection I began having inflammation, first in my prostate, then throughout my abdomen and diaphragm area. I started to have heart palpitations, and episodes of low blood pressure. I also began having tremors and difficulty digesting.
Swollen lymph nodes on inside of upper right arm.  First began on 3/26/21 and still can't raise my arm without pain as of 4/14/21.
patient was supposed to receive PENTACEL, however received QUADRACEL instead/ NO AE; 15 month old patient received QUADRACEL vaccine/ NO AE;Initial information regarding an unsolicited valid non-serious case was received from another health care professional via Medical Information (Reference number- 00792516) and transmitted to Sanofi on 30-Sep-2021. This case involves a 15 months old male patient who received a was supposed to receive DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] however received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead (wrong product administered and product administered to patient of inappropriate age).  Medical history, concomitant medication, past medical treatment, vaccination and family history were not provided.  On 30-Sep-2021, the patient received 0.5 mL DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (strength: standard, frequency: once, lot number: C5916AA, expiry date: 06-Jul-2023 via an intramuscular rote in the left thigh) instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) for prophylactic vaccination.  no other vaccines.  It was reported '' Caller stated nurse gave a 15 month old QUADRACEL. Wants to know about redosing? Is this sufficient as a dtap dose,. Call transferred. Nurse states that a 15 month old patient was supposed to receive PENTACEL, however received QUADRACEL instead. Nurse asks if if the QUADRACEL is a valid dose and if the patient just needs the ACT-HIB dose now. She also asks if the QUADRACEL will harm the patient since he is only 15 months old. Nurse states that the patient did not experience any adverse events (AE's) as a result of this. Compared components of QUADRACEL and PENTACEL. Explained the only missing component would be the ACT-HIB. Referred to healthcare professional (HCP). Additional Description of event Adverse events: Caller stated nurse gave a 15 month old QUADRACEL. Wants to know about re-dosing. Is this sufficient as a dtap dose.''  At the time of reporting, 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.
Client received PPV 23 11am 10/6 by evening L arm "shoulder joint" swollen and very painful. No redness, denies numbness or tingling. Difficulty sleeping related to pain. Enc ice/heat to arm. Taking motrin. Warm bath. Enc to seek medical care as needed. She did call her doctor. Call 10/8 States improvement of mobility, using ice and heat. Still quite painful
Localized redness about 3 inches around site administered with warmth, tenderness & hard per mom - mom gave Ibuprofen, BENADRYL & cold compresses & getting better per mom (L) arm.
Left arm inflammation and redness radiating to elbow. Made his left arm feel numb. Happened on next day or day after next. Pt had keflex course and inflammation reduced and had some sensation back.
Pt recvd vax 23SEP92 & 5 mins following vax c/o rush feeling w/h/a & palpitations, heaviness in chest, trouble breathing, feeling of warmth & was shaky; ECG revealed nl sinus rhythm; pt stated did not feel well & felt very strange; SOB;
Information has been received from a medical assistant and refers to multiple unknown patients of unknown ages and genders. There was no information about patients' concurrent conditions, medical history or concomitant medications. On multiple unknown dates, since 17-MAY-2017, the patients were most likely vaccinated with doses of improperly stored LIQUID PEDVAXHIB lot # L030868 and expiration date of 09-JUN-2018, (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 32 Fahrenheit degrees to 35 Fahrenheit degrees for 2 hours and a lowest recorded temperature of 30.2 Fahrenheit degrees for two cycles for a cumulative timeframe of 10 minutes). No previous temperature excursion was reported.  No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015824: US-009507513-1706USA001767: US-009507513-1706USA001766:
Information has been received from a consumer concerning a five year old female child with a history of premature delivery and no known allergies who on approximately 06/25/1996 was vaccinated with varicella vaccine. Concomitant therapy included Tylenol. The consumer reported that on approximately 06/01/2001, the pt developed chicken pox all over her body with a fever of 104 deg. F. It was unclear whether the pt had sought medical attention. Additional info has been requested.
Patient called today 12/19 stating that he is having a fever, shivering, and general body weakness. I explained to the patient that those are adverse events of the shingles shot and if symptoms are severe he can seek medical attention, patient has no itching or difficulty breathing.