chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12-5-08  1530  Patient and her mother in office for meningococcal vaccine.  No contraindications noted and vaccine given IM in left deltoid.  Client stated she was "very nervous" and "hates getting shots" before vaccine administered.   No complaints after vaccine injected.  Client and her mother waited in waiting room for 10 minutes after shot administered.  1650  Mother of child telephones office reporting that patient came home from work and arms were shaking and had numbness/tingling bilaterally down both arms.  States she felt like she just "could not think."  Symptoms started about 1 hour after vaccine administered.  Mother of child inquiring if child's symptoms were common with meningococcal vaccine.  Nurse instructed mother of child that symptoms stated were not listed among common symptoms.  Encouraged mother of child to contact primary care physician or Emergency Room if symptoms worsened, or did not subside.  12-9-08  1200  Telephone call to mother of child.  States that patient's symptoms subsided later on the evening of 12-5-08.  States her "color came back and she ate supper well."  No other complaints since that time.  Mother of child states that she "thinks the ladies that patient works with got her too excited."  Nurse encouraged mother of child to contact office if any other or new concerns.
HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043821A expiry: UNKNOWN) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Second Moderna vaccine received on 1-28-2021 at about 9:00AM. Severe nausea vomiting and diarrhea began on 1-29-2021 about 7;00 PM, lasting several hours with temp to 100.5 at time of chills and rigors. Basically resolved in 12 hours but malaise and tiredness continued for several more hours.
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    No concomitant medication information was reported. Pharmacy intern reporting that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients.  No treatment medication information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
Rash erythema on face, left clavicle, abdomen around 4-5 days after hepatitis B injection. Saw doctor on 3/20/03; prescribed methylprednisoline 4mg dose pack.
L upper arm where DTaP given Golf ball size bruised area with redness from shoulder to elbow lateral side, Itchy but not painful, no drainage, pt did fight with vaccination, also nickel size red areas to right arm where MMR, IPV given.
Patient is 17 years and 11 months old at time of vaccination.  She is not 18 years old at time of vaccination.
MMR given 6/29/04. Developed rash on face 7/7/04, starting as erythematous papules on face, then spreading to trunk and extremities. No fevers or cold symptoms.
Itching on upper body (back, neck, shoulders, arms, hair line) and waistline, knees, back of thighs. Applying Triamcinolone acetonide ointment 0.1% with little relief.
SxS include SOB, fever, myalgias, cough, diarrhea, sore throat, >14 days after completion of vaccination series.
At 48 hours s/p vaccine pt had developed, 7cm x10 cm warm, tender, indurated area around injection site, no erythema noted, (left upper deltoid)Also had 1 cm, tender, mobile, left axilla was treated with Keflex 500 mg bid x 7d beginning 08/01/00
myalgia; This case was reported by a consumer via sales rep and described the occurrence of myalgia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was recovered/resolved.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were provided as follows: The reporter reported this case for the someone she knew. The age at vaccination was not reported. The patient had myalgia for 2 or 3 days after 2nd dose of Shingrix. The reporter refused to follow up as the myalgia was a known side effect of the Shingrix.
Mom took pt to ER 26JUL92 p/continuing to have fretfulness & t103 w/APAP; was told could be vax given 22JUL92, cont on APAP every 4 hrs was released from ER same evening;
Menactra was administered two days after the expiration date, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from an other health professional via agency (Reference number- 00495741) and transmitted to Sanofi on 26-Feb-2021.  This case involves a 24 years old female patient who was vaccinated 0.5 ml second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], solution for injection (lot number- U6543AB, expiration date- 23-FEB-2021) via intramuscular route in the right deltoid for prophylactic vaccination on 25-FEB-2021 and reported that Menactra was administered two days after the expiration date (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medications were given to the patient.  It was a case of actual medication error due to expired vaccine used (same day latency). Also reported that the caller would like to know how to proceed in caring for the patient. MIA (Manufacturing and/or importation activities) transferred Health Care Professional who asked for appropriate follow-up after expired Menactra was given.   It was not reported whether the patient had any adverse event.  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.
Lower extremity pain, limping, then moderate to severe R thigh and knee swelling and warmth, unable to walk/bear weight due to pain.
One day post vax, pt experienced local soreness, swelling, redness from deltoid to elbow.
Vaccine BUD was reported 02-Sep-2021 which was administered to patient on 22-SEP-2021; No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine BUD was reported 02-Sep-2021 which was administered to patient on 22-SEP-2021) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine BUD was reported 02-Sep-2021 which was administered to patient on 22-SEP-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine BUD was reported 02-Sep-2021 which was administered to patient on 22-SEP-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and PRODUCT STORAGE ERROR (Vaccine BUD was reported 02-Sep-2021 which was administered to patient on 22-SEP-2021).    Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up received contains narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
The patient has had no known side effects; Extra dose of Varicella being given; Extra dose of Varicella being given; Proquad and Varivax were administered to a patient today, istead of MMR-II and Varivax; This spontaneous report has been received from a medical assistant, concerning a 12 month old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies, and concomitant medications were not reported.       The reporter stated that on 22-NOV-2021, the patient was vaccinated with an extra dose of varicella (Overdose), since she/he received a dose of varicella virus vaccine live (oka/merck)(VARIVAX), 0.5 milliliter, subcutaneous (lot # T021825, which has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date of 25-JUN-2022), and also was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 milliliter, subcutaneous (lot # U014143, which has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date of 31-OCT-2022), both as prophylaxis; instead of being vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX).  The patient had no known side effects.
Partial seizures; dizziness; can't concentrate; loosing my tastes; loosing my tastes and smell; wobbly as I walk; bad balance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 06Sep2021 as dose number unknown, single (Batch/Lot number: unknown) and on 27Sep2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARTIAL SEIZURES (medically significant), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "can't concentrate"; AGEUSIA (non-serious), outcome "unknown", described as "loosing my tastes"; ANOSMIA (non-serious), outcome "unknown", described as "loosing my tastes and smell"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "wobbly as I walk"; BALANCE DISORDER (non-serious), outcome "unknown", described as "bad balance".  Clinical course: Patient Assistance: Patient just want to leave a complaint, that after patient got the Pfizer shot 06Sep21 and 27Sep21 at Pharmacy and beside all the other symptom, of loosing patient's tastes and smell patient also had very bad dizziness. The patient was diagnosed with Partial seizures on both patient;s frontal lobs of patient's brain. The patient feel wobbly as patient walk, can't concentrate and patient had bad balance while walking as well. This was hindering patient from working as a normal human being. Hope the was compensation.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
8 days p/vax pt devel itching @ the site of inj;on the 9th day localized redness devel @ the site of inj & pt described a knot under the skin;pt was seen by occupation med MD & was advised to apply ice packs to the site on 9th day;
Approximately 15 hours post vaccine administration long term care facility resident was found in her room stating she "felt terrible". When nurse was repositioning patient the patient moaned and went unresponsive. SpO2 was 69%. When EMS arrived resident was responsive stating she "felt terrible". Report from ED stated that upon arrival to ED patient had no pulse and was intubated and admitted.
Right Elbow pain- can't lift anything.  MRI shows tendonitis.  I'm left handed.
Information has been received from a physician with unspecified drug allergies and pertinent medical history who on an unspecified date was vaccinated with a single dose of Zostavax (Oka/Merck).  Subsequently, he experienced electrical pulsating feeling every "once," for about a week in the arm that he received the injection.  At the time of this report the patient's outcome status is unknown.  No product quality complaint involved.  Additional information has been requested.
On 10/22/18 patient was administered another dose of FLUZONE HD. The patient previously received a dose on 09/18/2018.
The vanishpoint syringe needle was reportedly stuck in the patient's right arm upon receipt of the Pfizer COVID-19 vaccine.  Retained needle was confirmed via x-ray when patient was sent to the ED.
Immediate swelling at site of injection of flu vaccine. Swelling gradually resolved with ice and time.
This spontaneous report has been received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. Beginning on 23-MAY-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # M048203, expiration date 07-DEC-2018 and lot # M047662, expiration date 02-DEC-2018 (dose and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). There was no symptoms reported. Administered doses of vaccines experienced the temperature excursion of -10 degrees Celsius for 2 hours and 50 minutes. Digital data logger was not involved. There were no previous excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA010478:
Initial unsolicited report received from physician on 23-Feb-2018. This case involves a male patient (age not reported) who was vaccinated with a dose of TDAP Vaccine (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history revealed that, the patient had penicillin allergy. Concomitant medications includes Albuterol, ADCAL, FLONASE, Aspirin, Glipizide, metformin, simvastatin, trazodone and LYRICA. On an unspecified date, following the vaccination, the patient experienced rash. Lab data and corrective treatment were not reported. The patient's event outcome was not reported. List of documents held by sender: none.
PATIENT SATES THAT HER MOTHER NOTICED A RASH ON HER FACE ON 1/7/11. DENIED DIFFICULTY BREATING OR ITCHING. STATES SHE BEGAN TAKING BENADRYL 1/7/11 AND THE RASH RESOLVED
Shot was in left arm on 10/25/21. Followed by soreness in upper arm for 1 day and numbness in entire left arm  started mid day 2 days after shot on 10/27/21 around 1 pm
Could not stand; Body aches; Neck pain; Headache; Felt very unwell; This is a spontaneous report from a non-contactable consumer reporting for a patient. A 93-year-old male patient received unknown dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection), via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not available/provided) (age at vaccination: 93 years) as single for covid-19 immunization was administered at health clinic. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient was not diagnosed with COVID-19. On 02Feb2021 (same day patient received vaccine), patient awoke from sleep with body aches, headache, neck pain.  Patient felt very unwell, could not stand, sat on edge of bed for approximately 1 hour until the symptoms passed and patient was able to get back to sleep. When patient woke in the morning, felt well and had no further symptoms. It was unknown if patient received any treatment for the adverse events. The case was reported as non-serious. The outcome of all the events was recovered on an unknown date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sore at injection site day one and on day two much more pain and the beginning of limited movement - by day?s end was unable to move right arm at all. Currently can move with great pain, limited range, and inability to lift even small objects if arm extended.
The patient called and the chief complaint was redness at the area. She said one was about a quarter size round and the other about the size of two half dollars. The area was swollen, red, and hot to the touch.
This case was reported by a healthcare professional and described the occurrence of leg rash in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 30 October 2008 at 12:00 the subject received a dose of FLULAVAL, the subject experienced leg reach and itching. Rash on ankles was also reported. The subject was treated with CORTICOSTEROIDS and ANTIHISTAMINES. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. The reporter stated that 6 subjects in an employee flu clinic developed a rash on their legs and ankles approximately two days after receiving the FLULAVAL vaccine. The subjects describes the rash as appearing as a heat rash. Two of the subjects were females and were treated by a physician with CORTICOSTEROIDS and ANTIHISTAMINES. Some of the subjects were males, but exact details were not known. The healthcare professional reported additional cases see: A0757694A and A0757715A - A0757718A. Follow-up information was received on 09 December 2008, via healthcare who reported she was not sure if the event was related to the vaccine or not. The reporter stated she was told that two females and three males had a rash. As of this report, the healthcare professional had not received further information. She did state that two subjects saw their private physicians.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 05-JUL-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L037924, expiration date 22-JUN-2017, orally; exact dose was not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of 45 Fahrenheit degrees for cumulative 14 hours and 50 minutes before administration to the patient. No adverse effects were reported.  This is one of the several reports received from the same source. Additional information has been requested.
Arm very sore, red with raised knot and hot to touch, general aches and pains primarily legs, back and hip. Generally not feeling well but not severe. Shot was given more than 48 hours ago, still have symptoms.
Pt received vaccine and waited in the store for 15 minutes.  She felt fine.  After leaving the store and going out to her car she took her mask off and noticed her face was red under her mask.  No swelling or difficulty breathing.  She went home and took some diphenhydramine and her issue resolved.
4 hours post vax, the pt broke out with flat red blotches on trunk. !2 hours post vax and the blotches had increased and spread to limbs. The pt was afebrile and fussy. Has not seen MD.
I have had three flare up episodes from my lupus since this injection and I have recently been diagnosed with carpal tunnel in both might right and left arms/hands.  I do not attribute this to the vaccine, but rather my lupus but it was suggested that I complete this form.  On July 6, 2021 I was prescribed prednisone for my lupus flare-up.  On August 11, 2021, December 13, 2021 and Feb 10, 2022 I had follow-up visits with my lupus doctor.  Prior to 2021 I can only recall 2 flare-ups in about 20 years.
Patient states she had cold like symptoms, fever over 100 degrees, says she had seizures and went to ER (ER did not feel it was related to vaccine but patient did).
Vaccine 2/7, 3/4. Admit 3/23. MD notes state wife reports pt tested COVID + right after his first shot and has tested + several times since Feb. Physician note states pt not showing any signs of COVID +, however other documentation states CXR and inflammatory markers suspicious for COVID, and COVID PNA. Treated with abx, steroids, and fluids for respiratory infection. Family opted for comfort measures and patient eventually expired.
Approx. 2 hrs. aft. rec. flu shot c/o itching, cough, SOB; increased HR, increased B/P, eyes red- went to Hosp. ER - Dx - Allergic react. Rx. Albuterol and Prednisone.