chrisvoncsefalvay/vaers-outcomes huggingface dataset:
01/05/2023 Provider Dr. ordered Pfizer Covid 5-11year initial series 1st dose. Nurse pulled Pfizer 5-11 year Bivalent Booster dose and gave vaccine in error. No adverse reactions. Monitored patient for 20 minutes and not reactions. Medical Director spoke with parents regarding next steps.   See below documentation on phone encounter with Medical Director and patient's mom.    "If a bivalent Pfizer-BioNTech vaccine is administered in error for a primary series dose: Do not repeat the dose. The primary and booster dosages are the same; the bivalent dose can be counted as a primary series dose. Continue with the recommended vaccination schedule (i.e., complete the primary series with a monovalent Pfizer-BioNTech vaccine, then administer a bivalent booster dose at least 2 months after completion of the primary series).  If a bivalent Moderna vaccine is administered for a primary dose: Repeat the dose immediately (no minimum interval) with a monovalent Moderna vaccine because administration of the bivalent Moderna vaccine will result in a lower-than-authorized primary series dosage. Some experts suggest delaying the repeat dose for 8 weeks after the invalid dose. After the dose has been repeated, continue with the recommended vaccination schedule (i.e., complete the primary series with a monovalent Moderna vaccine, then administer a bivalent booster dose at least 2 months after completion of the primary series).  Both situations are considered vaccine administration errors and should be reported to Vaccine Adverse Event Reporting System (VAERS).
2 days after vaccination right thighs and right leg started to have pain similar to pain I got with polymyalgia rheumatica that I have had in past and I though it was a flare up. A couple of days after that right leg started to swell and was warm. Went to ER on 1/29/2021 and had doppler which showed blood clots from groin area to below the knee. I was placed on Xarelto at that time. Got 2nd dose and about 24 hours latter back of thighs started to hurt again. Called doctor and applied heat and elevation and had no new swelling but I remain on Xeralto. Not sure if it was related but I have had no history of blood clots. 2 years previously broke my right patella and was with brace and no weight bearing for about 8 weeks and brace for 12 weeks without clot issues. Traveled by car a couple  thousand miles last year and no issues.
Constant itching about 4 inches from each direction from the vaccination site. keeping me up at night.  benadryl does not help. have contacted my doctor for further instructions.
The (BUD) refrigeration date  on 27-Jul-2022 and vaccine was adminstered on 29-Jul-2022; The vial had undergone temperature excursion; Administered the vial  which had undergone temperature excursion; No adverse event; erroneously vaccinated clients with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated clients with expired vaccine), PRODUCT STORAGE ERROR (The (BUD) refrigeration date  on 27-Jul-2022 and vaccine was adminstered on 29-Jul-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial had undergone temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Administered the vial  which had undergone temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 52-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 017B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated clients with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The (BUD) refrigeration date  on 27-Jul-2022 and vaccine was adminstered on 29-Jul-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial had undergone temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Administered the vial  which had undergone temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated clients with expired vaccine), PRODUCT STORAGE ERROR (The (BUD) refrigeration date  on 27-Jul-2022 and vaccine was adminstered on 29-Jul-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial had undergone temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Administered the vial  which had undergone temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated clients with expired vaccine), PRODUCT STORAGE ERROR (The (BUD) refrigeration date  on 27-Jul-2022 and vaccine was adminstered on 29-Jul-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial had undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered the vial  which had undergone temperature excursion).    Concomitant medication was not reported.  It was reported that the patient was administered dose after 30 days use by date which was 2 days past expiry date. The vial was kept in refrigerator on 27-Jun-2022 and the (BUD) refrigeration date was 27-Jul-2022. The size of the vial was 5.5 ml.   Treatment medication was not reported.   This case was linked to MOD-2022-681319 (Patient Link).
a male received an expired Ipol without side effects; Initial information received on 05-Dec-2019 regarding an unsolicited valid non-serious case received from a non healthcare professional.  This case involves a 65 years old male patient who was vaccinated with an expired 0.5 mL dose of vaccine IPV (VERO) [IPOL] (lot N1J45, expiry date: 05-Oct-2019) via intramuscular route in the left deltoid on 03-Dec-2019.  Medical history included stem cell transplant. Past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA), HIB VACCINE CONJ (TET TOX) (ACT-HIB) ; HEPATITIS B VACCINE (HEPATITIS B VACCINE)  and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation.  It was a case of actual medication error due to Expired vaccine used.  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 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.
No additional AE reported; accidently administered PROQUAD and V ARlV AX concomitantly; a 14 year old patient accidently administered PROQUAD; accidently administered PROQUAD and V ARlV AX concomitantly; This spontaneous report was received from a licensed practical nurse referring to a 14 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 19-AUG-2021 the patient was accidently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) concomitantly (both: 0.5 milliliter; route, lot# and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration, product administered to patient of inappropriate age, accidental overdose). No additional AEs were reported.
Patient has unraised red circle around injection site. No pain, slight itch. About the size of an orange on left arm.
Parent reported child has a low grade fever with bumps on his face.  ARNP saw child in her office and informed parent that the bumps on his face were mild chickenpox from the vaccine.
arthritis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 19Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arthritis on an unspecified date. Patient asked is it okay to have the knee injection for arthritis before the second dose appointment. Outcome of event was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Muscle tightness and soreness; Muscle tightness and soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Mar2021 09:00 (Lot number: EL3247) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; GIANVI; BIOTIN; VITAMIN D NOS. Vaccination history included: Bnt162b2 (dose 1, lot number: EL3247, administration time: 09:00 AM, vaccine location: Right arm), administration date: 01Mar2021, when the patient was 37 years old, for Covid-19 immunization. The following information was reported: MUSCLE TIGHTNESS (non-serious), MYALGIA (non-serious) all with onset 22Mar2021 20:00, outcome "recovered" (24Mar2021) and all described as "Muscle tightness and soreness". Therapeutic measures were not taken as a result of muscle tightness, myalgia. Additional information: That patient had no other vaccine in four weeks. The patient had no covid prior vaccination and was not tested for covid post vaccination. It was reported that the events lasted only for another 24 hours as the patient woke up on Wednesday, 24Mar2021, like normal.  No follow-up attempts are possible. No further information is expected.
I had headache, body ache, serve fatigue, low grade fever, nausea, and difficulty breathing.  I went to the Urgent care.  They did a Covid-19 test, which came back negative.  I did have a repeat of the same symptoms two weeks later.
pt recvd vax & 72 hrs p/vax pt exp migratory arthralgia (shoulder, hands, elbows & legs), myalgia in the deltoid region as well as major joints; pt was treated w/Motrin;
runny nose; chill; Extreme fatigue; This spontaneous case was reported by a nurse and describes the occurrence of RHINORRHOEA (runny nose), CHILLS (chill) and FATIGUE (Extreme fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced RHINORRHOEA (runny nose), CHILLS (chill) and FATIGUE (Extreme fatigue). At the time of the report, RHINORRHOEA (runny nose), CHILLS (chill) and FATIGUE (Extreme fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jul-2021: Follow-up document received on 04-july-2021. Events outcome was added as Recovered/resolved
COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 26March2021 at 14:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included birth control (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN): all from unknown date for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation and sulfa meds on an unknown date for unspecified indication and experienced a sulfonamide allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27March2021 at 03:00, the patient experienced muscle aches and chills as expected and her lymph node in her armpit of the arm injected to harden and the area to swell to a visible level. It was still very tender and swollen. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event muscle aches, chills, swollen lymph node and lymph node tenderness was not recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
DIZZY, NAUSEOUS, LIGHT HEADED, CHILLS, BLURRY VISION
weak; sensation of throat closing; mild tachycardia; shaky; nausea; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weak), THROAT TIGHTNESS (sensation of throat closing), TACHYCARDIA (mild tachycardia), TREMOR (shaky) and NAUSEA (nausea) in a 21-year-old female patient who received mRNA-1273 (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Obesity and Anxiety. Concurrent medical conditions included Penicillin allergy (Allergies to Penicillin and Sulfa).    On an unknown date, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weak), THROAT TIGHTNESS (sensation of throat closing), TACHYCARDIA (mild tachycardia), TREMOR (shaky) and NAUSEA (nausea). The patient was treated with EPINEPHRINE (intramuscular) at a dose of 0.03 mg; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency and FAMOTIDINE at an unspecified dose and frequency. At the time of the report, ASTHENIA (weak), THROAT TIGHTNESS (sensation of throat closing), TACHYCARDIA (mild tachycardia), TREMOR (shaky) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter considered ASTHENIA (weak), THROAT TIGHTNESS (sensation of throat closing), TACHYCARDIA (mild tachycardia), TREMOR (shaky) and NAUSEA (nausea) to be possibly related.    This case was linked to MOD-2021-055838, MOD-2021-029012, MOD-2021-032365, MOD-2021-055838 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: No new information was received.
Patient states that her arm got extremely sore the pm of the vaccine. She said that she couldn't move it and is still in that same pain today.
A patient received Quadracel instead of Daptacel, no AE; A 3 year old patient received Quadracel, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00607334) and transmitted to Sanofi on 19-May-2021.  This case involves a three-year-old male patient who received 0.5 mL dose DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5763AA and expiry date: 26-Aug-2022) via an intramuscular route in the left thigh for prophylactic vaccination on 03-May-2021 (wrong product administered and product administered to patient of inappropriate age) instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (batch number and expiry date not reported).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination.  The healthcare professional (HCP) asked about potential side effects, and about comparison of the two vaccines. HCP also asked about the recommended dosing of the IPV (Ipol) component, about the dose being too soon if given at age 3 rather than age 4. The reporter stated that she had spoken to the patient's mother to notify her, and the patient's mother had told her that the patient was running around and seemed fine and was experiencing no side effects from it. Reporter did not know which dose in the series the intended DTaP was.    This was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency same day).  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.
no adverse event; bivalent vaccine was administered two days after the refrigerated 30 day beyond-use-date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent vaccine was administered two days after the refrigerated 30 day beyond-use-date) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 07-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (bivalent vaccine was administered two days after the refrigerated 30 day beyond-use-date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent vaccine was administered two days after the refrigerated 30 day beyond-use-date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (bivalent vaccine was administered two days after the refrigerated 30 day beyond-use-date).    No concomitant medications were reported.     HCP wanted to know if a dose of the bivalent vaccine was administered two days after the refrigerated 30 day beyond-use-date of the vial should the dose be repeated or not.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2023: Follow up contains no new information.
Vial initially stored in refrigerator on 23 Mar 2022, Vaccine beyond use date 17APR2022, Administration date was 20 Apr 2022; Past beyond use date Moderna Covid-19 vaccine given to 6 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past beyond use date Moderna Covid-19 vaccine given to 6 patients.) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 23 Mar 2022, Vaccine beyond use date 17APR2022, Administration date was 20 Apr 2022) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past beyond use date Moderna Covid-19 vaccine given to 6 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 23 Mar 2022, Vaccine beyond use date 17APR2022, Administration date was 20 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past beyond use date Moderna Covid-19 vaccine given to 6 patients.) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 23 Mar 2022, Vaccine beyond use date 17APR2022, Administration date was 20 Apr 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Vial was initially stored in the refrigerator on 23 Mar 2022. The beyond use date was 17 Apr 2022. Vial did not undergo any temperature excursion. No treatment information was provided.   This case was linked to MOD-2022-546559, MOD-2022-546563, MOD-2022-546567, MOD-2022-546561, MOD-2022-546566, MOD-2022-546561 (Patient Link).
Pt received her basic load of immunizations for entering the military.  Shortly thereafter she developed a "funny" sensation in her right cheek.  She went to sleep 8 hours later without problems, and awoke 18 hours after receiving her immunizations with inability to use her voluntary muscles on the right side of her face.  She was seen by the Urgent Care Clinic who diagnosed Bell's Palsy.  Treated her with prednisone without resolution of symptoms as of 30 June 2005.
Behavior change,breathing difficulty,hoarseness,low grade fever,fast heartbeat,runny nose,watery eyes,coughing & sneezing.12/18/99:had rash over some parts of body.12/19/99:had rash all over.
On 02/19/01 - This patient had Pneumovax and Flu vaccine given . On 02/20/01- She had a fever of 102, "feeling out of it", red local reaction at the injection site. On 02/21/01, more of the same very sick, rash on her arm 02/22/01 to sick to see a doctor. She went in to see the doctor on 02/23/01, severe rash, stared on Prednisone. On 02/24/01 reactions stopped , getting bigger. On 02/25/01 reaction much better, patient may stop medication. She wanted to keep taking the med. On 02/26/01, she saw the reactions again much better still recommend taking meds until Wednesday at least. Reaction at it's worse was red, itchy rash from shoulder to the elbow and half way around arm. Even blistered up with clear blisters. Later blood blisters evolved. As reaction started clearing up rash area turned yellow like bruising patient stated arm still stinging at the rash site.
Moderate headache, moderate joint and just all over pain, loss of taste and smell, mouth and tongue soreness, injection site extremely sore, weakness, and fatigue. Muscular cramping at time.
no additional AE information provided; VARIVAX that experienced a supported temperature excursion was administered to two patients on March 19, 2022; dose 5 mL; This spontaneous report was received from physician and refers to a patient of unknown age and gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 19-MAR-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 5 mL for prophylaxis (lot #U015689, expiration date: 18-MAY-2023; strength and route were not reported) (incorrect dose administered). The vaccine had a temperature excursion at temperature -14 degree Celsius up to -10 degree Celsius (-14.5 degree Celsius) for 5 min (product storage error). No additional adverse event information was provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA006498: