chrisvoncsefalvay/vaers-outcomes huggingface dataset:
THE VACCINE WAS KEPT IN THE FREEZER AFTER DELIVERY AND THAWED OVERNIGHT AND KEPT IN THE FRIDGE TILL VACCINATION; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 28 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-MAY-2021, the subject experienced the vaccine was kept in the freezer after delivery and thawed overnight and kept in the fridge till vaccination. On 30-MAY-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of the the vaccine was kept in the freezer after delivery and thawed overnight and kept in the fridge till vaccination and poor quality vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210605104, 20210605120 and 20210605009.
Patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (Patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) 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 UNDERDOSE (Patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. Treatment medications were not provided. This case was reported for patient 8 out of 17.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient 1
discomfort in chest, dizziness,  wheezing, jumping left eye, swollen eyes, dark circles under eyes
Right Vastus Lateralis with redness and mild swelling.  Mother reported to health department morning following vaccinations (4/4/2012). Right Vastus Lateralis with redness approximately 5 cm in length by 2-3 cm width.  Mild swelling and warmth noted.  Instructed mother to follow up with primary physician for assessment.  Mother saw NP and was given Bactroban to apply to site and told to report if sx worsen or persist.
Jan. 28, I'm fine, just some bearable site pain. Took tylenol before getting vaccine, and the next day around 4 in the morning started having malaise, pain, fever, chills. (fever around 102), and went 104 around midafternoon, and 106 around 10. Chills, pain, weakness. Next day I was feeling well. I started noticing small dots on knee and shoulder. And then I started noticing bruising on my hands and legs. Felt fine on Sunday. I started noticing the bruises were becoming more pronounced. On Monday when I woke up the bruises were worse, and I went to the ER. The doctor checked CBC and platelets count was low around 28 thousand and was admitted into the hospital and they treated me with solumedrol 100 mg. Platelets count went back up.
Pentacel series given in error.  The DTaP-IPV component was given alone, rather than reconstituted with the ActHib component. There was no adverse reaction, no medical treatment needed for this event.
Elderly woman came in for booster dose of Pfizer. She had very thin arms and when the immunizing technician went to administer she hit bone. While depressing the syringe the technician tried to pull back from the bone and the needle came out of the patient's arm. The was liquid that then continued to come out of the syringe and run down the patients arm. It was determined after speaking with the immunizing technician that she believed about half the dose was administered to the patient. Per CDC guidelines the dose was considered complete and not re administered
Patient stated that his arm/underarm had  a knot on it at the injection site and was extremely sore.  He was concerned because he had no issues with his 1st dose.
per pt 4hr post vax heart racing, h/a, wirey felt like jump out of skin, not able to sleep;hosp 3 days for diarrhea & dehydration;pt states MD does not believe sx are vax related;pt has hx of anxiety & panic attacks;
pt recv vax 20DEC96 & that evening & next morning fever of 105 devel, would not decrease;parents ended up taking pt to ER 21DEC96;pt given rectal suppository for fever, blood tests & CXR;
Pt reported feeling lightheaded; escorted pt to first aid station; assessed pt, medical history, vital signs, gave juice box, monitored pt while she recovered.
day p/inject devel redness warmth, swelling @ site; to apply local warm compresses (@ DTP site is where react was rt lat thigh);
Information has been received from a medical assistant concerning a 90 year old female who on approx 10/31/05 was vaccinated IM with 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650084/0605P). The pt was also vaccinated separately with influenza virus vaccine unspecified. Concomitant therapy included metoprolol succinate Toprol XL tablets, aspirin and prednisone. On 10/31/05, the pt developed cellulitis. The pt was treated with antibiotics. The pt was reported as not recovered. Additional information is not expected.
Patitent felt like he was going to faint. He started sweating  and blood pressure was 175/95
Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. Other Case identifier(s): 2022NVX-US-000003241 (Novavax).  A female patient received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Lot number: FM9992) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  PQC results: This is a notification generated from the system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252. Refer to the below table for details. For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 7142695 (see File attachment in this investigation record) The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FM9992. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. The company concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or ADR were identified as the complaint was not confirmed. PR ID of Previously Completed Inv: 7142808, PR Link (Previously Investigated CR): 7142605.
This spontaneous reprot as received from a pharmacy student refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On an unknown date in 2015, the patient received another dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). No adverse effects reported. Additional information has been requested.
Fatigue, trouble standing, shortness of breath, weakness, body aches, low-grade fever, knot in the armpit, pain below where initial shot was given, and pain all the way down the left side to the hip area.
reconstituted with non-GSK diluent, then administered; reconstituted with non-GSK diluent, then administered; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA584A, expiry date 31st August 2022) and (batch number AMXA584A, expiry date 30th April 2023) for prophylaxis.   On 25th May 2022, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 25th May 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 25-May-2022 Reporter's Comments: The Pharmacy Technician reported that the nurse inadvertently reconstituted Menveo lyophilized powder component with a non-GSK diluent, then administered to a patient. The Pharmacy Technician asked how to proceed with dose? The reporter did not consent to follow-up. Additional Supportive Information: The Menveo lyophilized powder component was reconstituted with a non-GSK diluent, then administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Dermatology Provider, Dr., calls (24MAY10) to consult re possible vaccine related etiology of pruritic, papulo-vesicular rash of 3 days evolution on 20 y/o AD SM's upper arms & back of neck- predominantly on sun exposed areas- but has several isolated lesions on abdomen and legs bilaterally. No rash on trunk or back. Patient's tan lines from t-shirt mark the distribution on the upper body. (See digital photos attached in VAECS). The rash began, per Clinic Note (24MAY10, 11:26 EDT), as a "small patch located on the lateral aspect of SM's right upper arm...it was extremely pruritic and he scratched it excessively- about a day later, he noticed that it had spread. The SM was on detail pulling weeds and trimming grass last week." Other than the pruritic rash, the SM is asymptomatic. No recent colds or illnesses. NKDA.
Red rash welts over all of body. MD prescribed BENADRYL, lactate ringers.
Chills, body aches - lasted approx. 1 day Headache, fatigue - lasted approx. 2 days Injection site swelling and Swollen lymph nodes in right armpit - lasted approx. 5 days  Alternated Tylenol and Motrin to relieve head and body aches. All swelling reduced gradually without direct treatment.
w/in hr of vax pt fatigued & listless;pt had to remain lying flat; emotional affect was flat;by that noc pt fever 102.9;pt was shaking most of noc so could not sleep;screaming out in pain;neck stiff & painful;sx similar to meningitis;
This spontaneous report was received from a patient's daughter and refers to a 66 year old female patient. The patient's concurrent conditions included diabetes, depression, high blood pressure, anemia, high cholesterol. The patient's medical history was not provided. Her concomitant medications included quite a few diabetes medications, depression medications, high blood pressure medications and anemia medications. The patient had no drug reactions or allergies. On 26-SEP-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 subcutaneously or intramuscularly, lot # R012497, expiration date 08-JAN-2020. On 27-SEP-2018, the patient experienced injection site swelling, redness and pain. The patient put ice on injection site and took TYLENOL for the pain. The patient did not seek any medical attention. No diagnostic studies were performed. The patient did not recover from the events at the time of reporting. The relatedness between the events and PNEUMOVAX 23 was not reported.
mild pain in left elbow same arm as inflection) when arm is bent; Stiffness and mild pain in left elbow (same arm as inflection) when arm is bent; arm had significant pain; This is a spontaneous report received from a non-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 left, administration date 21Mar2021 12:00 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Erythromycin for Allergy. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "arm had significant pain"; ARTHRALGIA (non-serious), outcome "not recovered", described as "mild pain in left elbow same arm as inflection) when arm is bent"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "not recovered", described as "Stiffness and mild pain in left elbow (same arm as inflection) when arm is bent". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, musculoskeletal stiffness.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. It was reported that patient had Stiffness and mild pain in left elbow (same arm as inflection) when arm is bent. Her arm had significant pain within the first 24 hours after her first vaccination. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Shot given on 10/9/10. On 10/12/10 patient reports the place the shot was given felt like a persistent bee sting pain when reaching or raising his arm. Pt. contacted us on 10/17/10 and same pain sensation was being felt.
Immediately 10 minutes after the injection, my left arm got really hot. I got hot and turned red and itchy. Then the tingling started happening down the lower part of my spine. The redness and itching stopped after 4.5 hours. The tingling has lasted up until now, it's subsided but still there. My heart rate was a little fast. After the 2nd dose I contracted COVID-19 2 weeks later. With COVID-19 I had shortness of breath, fever, body aches and increased heart rate that lasted a 1.5 weeks. The cough is something the doctor can't tell if it's vaccine or COVID-19 related. The cough has not gone away and I'm seeing a Pulmonologist and taking medications.
Immediate severe pain at time of administering of vaccine (L) arm. Numbness to (L) thumb for 1st day. Ongoing pain (L) deltoid persisting 9/9/11. No numbness, weakness, or swelling by 7/28/11.
No adverse reaction reported by customer.  We received communication from our home office that although dose was expired (as we were going by the beyond use date from when we received the inventory) that it was determined that the vaccine was in fact still viable at the time of administration- and that revaccination was not needed.
After receiving vaccines (4 mth), patient developed a localized rash at the injection site (on her right thigh) where the HIB vaccine was administered. She also had this reaction after her 2 mth vaccines. SX resolved shortly thereafter.
Pfizer-BioNTech COVID-19 Vaccine EAU Vomiting, Diarrhea, High fever, Chills, Body aches. Symptoms began approximately 24 hours after the vaccine was administered and persisted for approximately 6-7 hours. No treatment was sought .
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 07-AUG-2016, the patient was treated at a medical group for a blistering vesicular outbreak that was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
11/28/21 presenting today for Cough (SORE THROAT, LOSS OF SMELL, HEADACHE, BODY ACHE) He is complaining of a one week history of sinus congestion. Cough is mild and improving but loss of taste and smell have him concerned for COVID infection. He denies fever, chest pain or shortness of breath. No OTC RX yet. His wife has similar symptoms. .
Per patient via phone call 9/8/17, she had a knot, redness, and soreness on the left arm (where she got the injection). It is also warm to the touch. She said the redness started yesterday 9/7/17 and extends about an inch around. I told her the suggestions to ease the reaction-use a cold compress, TYLENOL or ibuprofen, or BENADRYL for the localized reaction. (Also told her about side effects for those). Told her what signs of a severe allergic reaction would be and told her that if the reaction continues to spread or worsen, to contact the doctor and if she has any signs of anaphylaxis, to go to the emergency room.
Reports that after having received Anthrax #5 on 8 July 2004 has been having sore arms (Tingling down lt arm) and he gets cramping on his left hand.  This has been a problem for him ever since. He states he has been having the problem since the beginning of the series back on 8 March 2003. First time complaint was reported was 10 Nov 2004.
7/1 at 6am. Rash on hands/palms. 10am. Rash spread to knees, feet. Went to urgent care received CLARITIN and BENADRYL. Later same day at 4pm. Swollen lips and eyes, hives/welts on arms, ribs. Called 911. Transported to ER. Received "IV cocktail". Prescription for Prednisone 40 mg for 3 days. 7/2: Hard to walk due to hives/rash on feet. 7/3: Went to urgent care difficulty breathing. Had xray, breathing treatment. Was given inhaler and EPIPEN. Also prescription for tapering prednisone for 3 more days. 7/5: Went to see my Dr. still having symptoms of rash/painful feet.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 13-FEB-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
This spontaneous case was received from a pharmacist and refers to unspecified patient of unknown age and gender. The patient's medical history, concomitant medications, concurrent conditions and drug allergies were not reported. On unknown date, the patient was vaccinated with a with M-M-R II rHA lot # R019687 with expiration on 09-JUL-2020 (strength, dose # and anatomical side of the injection were not reported) for prophylaxis. The dose was administrated intramuscularly. No adverse effects reported nor quality complain involved.
Headache, chills, weakness, myalgia, light headedness, nausea, severe pain and swelling around injection site starting May 23 PM and lasting until May 25 AM.  Hives around injection site starting May 24 AM and lasting until May 25 PM.  Took Benadryl, ibuprofen, acetaminophen.
A throbbing arm pain at the injection site; arm got pretty sore / extreme arm pain; Throbbing arm pain at the injection site was preventing her from sleeping; This case was reported by a consumer via licensee and described the occurrence of injection site pain in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced injection site pain, pain in arm and insomnia. On an unknown date, the outcome of the injection site pain, pain in arm and insomnia were recovered/resolved.   It was unknown if the reporter considered the injection site pain, pain in arm and insomnia to be related to Flu vaccine.  Additional details were provided as follows: The reporter was the patient herself. The age at vaccination was not reported. The patient was vaccinated with Flu shot and experienced pretty sore arm slightly. The patient also experienced throbbing arm pain at the injection site which prevented her from sleeping. The patient had also received the first dose of PFIZER-BIONTECH COVID-19 vaccine 3 to 4 days before the reporting date and experienced the same events for which she took Ibuprofen as treatment drug and applied cool packs. This case has been linked to US2021AMR087656, reported by the same reporter for Shingles vaccine.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR087656:Same reporter, same patient, different suspect