chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival; Total duration of the excursion refrigerated temps for max of 4 hrs; They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.    No concomitant medication were reported.  Vial was moved to fridge on 19-Jan-2022.Temperature was fluctuated Frozen-refrigerated and again re frozen. Frozen vails removed and transported ate refrigerated temperature and refrozen at time of arrival. Total duration of excursion refrigerated temperature for max 4 hours. Temperature reached to 8 degrees Celsius. Vials size was 5.5 mL and 7.5 Ml. Partially thawed liquid state at the time of excursion.  No treatment drug were reported.
BODY ACHE; CHILLS; FEVER; FATIGUE; This spontaneous report received from a consumer concerned a 36 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180095, and expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced body ache. On 20-MAY-2021, the subject experienced chills. On 20-MAY-2021, the subject experienced fever. On 20-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, fever, and fatigue on MAY-2021. This report was non-serious.
Tremors in the right and left hand for 2 days. Pain in hand for several weeks. Pain in hands about 3 to4 times a week now. Continuous muscle pain and muscle spasms in left and right arms including lower and upper arm muscles for  three weeks. Pain in right and left arms continued intermittently for months and even continues now.  Continuous muscle pain and intermittent  spasms in right and left upper leg muscles for three weeks. Intermittent pain in legs still at times. Once about every week, a muscle spasm will occur in either the left or right arm or leg muscle.
Got the swine flu; Initial information received on 03-Jan-2023 regarding an unsolicited valid social media serious case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age and unknown gender patient who experienced got the swine flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   Patient got the shot of INFLUENZA VACCINE produced by unknown manufacturer in the beginning of Oct-2022 (strength, formulation, route, dose, lot number and expiry date: unknown) in unknown administration site for prophylactic vaccination (Immunisation).  Patient got the swine flu (H1N1 influenza) the beginning of Dec-2022. In the hospital 3 days with it. So, there was no guarantee the shot will keep you well. Patient have gotten a flu shot every year for years. Only had the flu once when he/she was very young. It's horrible!   It is unknown if the patient experienced any additional symptoms/events. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Got the swine flu).  At time of reporting, the outcome was Unknown for the event got the swine flu.; Sender's Comments: Sanofi company comment dated 06-Jan-2023: This case involves an unknown age and unknown gender patient who experienced got the swine flu after receiving vaccine INFLUENZA VACCINE. Additional information regarding concomitant disease or risk factor, medical treatment and lab investigation excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Patient states redness happen later on during the same day. Started having swelling, soreness, pain and the redness.
The patient had COVID-19 positive test or diagnosis on 08Jun2022; The patient had COVID-19 positive test or diagnosis on 08Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MDLA22-00100 (Moderna).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 12Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Sep2021 as dose 2, single (Lot number: 024D21A) for covid-19 immunisation; covid-19 vaccine nrvv ad26 (gam-coviD-vac) (SPUTNIK V), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient did not have any allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Jun2022, outcome "unknown" and all described as "The patient had COVID-19 positive test or diagnosis on 08Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jun2022) Positive.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
*ADMINISTRATION ERROR - PATIENT UNDER 18 YEARS OLD*  Patient received first dose of Moderna Covid vaccine on 05/31/21 with previous pharmacy manager. Patient filled out Prevaccination Checklist with no reported allergies, medical conditions, or adverse events with other vaccines. Patient came back to pharmacy on 06/28/2021 for second Moderna dose, accompanied by father. Because patient came in for second dose, new pharmacy manager focused on going over Prevaccination Checklist with patient without realizing patient age. Patient reported no adverse events or allergic reaction after getting first dose or second dose.
Red and warm hard knot at injection site. (Right side). Right side joint pain and body felt heavy. Currently still knot and painful to touch/itchy but not as bad today (10/29).
I have a slight and running, Just a very slight temp not very much.; Little bit of chills, Off and on.; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 21Aug2021 10:00 as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization. Patient had second Covid shot yesterday morning (21Aug2021) at 10 O'clock and was taking elderly mother to an appointment today (22Aug2021) and patient was having just a couple side-effects. It was nothing bad. Just need to know, if should be around other people. Had a slight and running, just a very slight temperature (slight fever) not very much and a little bit of chills, off and on, that was it on an unspecified date in Aug2021. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient reported swelling in right arm from injection site down to  right hand (noting increased swelling around elbow). Patient stated he could not bend arm to touch face as arm was so swollen. He reported icing arm and taking Advil which reduced some swelling, but still reported pain and swelling 24 hours post vaccines. He reported inability to attend golf tournament he was in due to swelling. He reported no shortness of breath, no chest pain or tightness, and no swelling or tingling anywhere else. Advised patient to seek medical attention if swelling got worse or if he developed any symptoms previously reported as negatives.
Patient got Fluad QID PFS 65+ despite being younger than 65 years old at time of vaccination. Patient is only 53 years old. No issues have been reported.
Patient was admitted to the hospital for COVID-19 symptoms and received typical COVID treatments. They discharged to home.
A non-serious spontaneous report of "inadvertently gave expired FLUMIST" was received from a health professional concerning a 16-year-old male. Neither medical history nor concomitant medication was reported for this patient. The product expired on 29-Nov-2010. On 30-Nov-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Fever, chills, body aches, night sweats for nine days that started June 21, 2021 after vaccine.  Next day had severe panic attack.  Went to see Primary physician and he prescribed Xanax.  I?m taking a full Xanax at night and sleeping okay. During  the day panic attacks are continuous causing me to loose two weeks work. Still on Xanax and no relief.  Went to ER for this issue. Labs and ekg were fine, but still not feeling well. Prior to first dose of Pfizer, no issues with panic attacks.
a blood clot right below his lung on the left side; his chest was hurting; he couldn't breath; Second shot three weeks later; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (a blood clot right below his lung on the left side) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (a blood clot right below his lung on the left side) (seriousness criterion medically significant), CHEST PAIN (his chest was hurting), DYSPNOEA (he couldn't breath) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot three weeks later). At the time of the report, THROMBOSIS (a blood clot right below his lung on the left side), CHEST PAIN (his chest was hurting) and DYSPNOEA (he couldn't breath) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot three weeks later) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered THROMBOSIS (a blood clot right below his lung on the left side), CHEST PAIN (his chest was hurting) and DYSPNOEA (he couldn't breath) to be related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot three weeks later).    Patient was taken to the ER (Emergency Room). Treatment Xarelto was started.  Patient has Cardiologist appointment on 28-APR-2021.  Company comment:Limited information regarding the blood clot, chest pain and difficulty breathing has been provided at this time and a causal relationship cannot be excluded.  Inappropriate schedule of vaccine administered is unrelated to the vaccine and is not reported as specifically resulting in adverse events.   This case was linked to MOD21-076660 (Linked Report).; Sender's Comments: Limited information regarding the blood clot, chest pain and difficulty breathing has been provided at this time and a causal relationship cannot be excluded.  Inappropriate schedule of vaccine administered is unrelated to the vaccine and is not reported as specifically resulting in adverse events. MOD21-076660:
Rash on back and body. Onset 12 hrs after dose. This was 2nd dose. First dose had no reaction
I started menstruating after receiving shot and have not had a period over year. Lasted 5 days. Was not heavy but a light period. I had just seen OB/ Gyn  4 days before vaccine for my annual visit and everything was normal.
No additional AE reported; MMR II involved in temperature excursion on 01/01/2021; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not provided.     On 01-JAN-2021, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status recombinant Human albumin (rHA) (M-M-R II) vaccines experienced a temperature excursion at 47.01 Fahrenheit for 1 minute 30 seconds. There was no previous temperature excursion. The temperature excursion was detected by a data logger. On 25-JAN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status recombinant Human albumin (rHA) (strength, dose and route were not provided; lot# was S037500 and expiration date was 20-NOV-2021) involved in temperature excursion for prophylaxis (product storage error). No additional adverse event reported.   The administered dose experienced a temperature excursion at 47.01 Fahrenheit for 1 minute 30 seconds. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of the 16 cases received from the same reporter.; Sender's Comments:  US-009507513-2102USA007556: US-009507513-2102USA007557: US-009507513-2102USA007558: US-009507513-2102USA007559: US-009507513-2102USA007568: US-009507513-2102USA007562: US-009507513-2102USA007563: US-009507513-2102USA007564: US-009507513-2102USA005227: US-009507513-2102USA005228: US-009507513-2102USA005229: US-009507513-2102USA005230: US-009507513-2102USA005231: US-009507513-2102USA005232: US-009507513-2102USA003923:
PATIENT REPORTS: DIZZINESS 2 WEEKS POST-INJECTION, SEEING STARS ON SIDES OF VISION 2 WEEKS POST-VACCINATION, AND EXPERIECING FEELING OF "SHOOTING PAIN" OR "BURNING PAIN" INSIDE OF HEAD 2 WEEKS POST-INJECTION. NOT TYPICAL SYMPTOMS FOR PATIENT.
Patient reported bruise/sore/itchy at injection site on left arm and itchy/red left eye that started appearing about an hour after receiving the vaccine. Patient stated on 10/13/15 that the bruise/sore/itchy injection site and left itchy/red eye is slowly improving.
signs of an Herpes simplex on her upper left lip; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ORAL HERPES (signs of an Herpes simplex on her upper left lip) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 immunization.     No Medical History information was reported.   On 09-Mar-2021 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ORAL HERPES (signs of an Herpes simplex on her upper left lip). At the time of the report, ORAL HERPES (signs of an Herpes simplex on her upper left lip) outcome was unknown.      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 concomitant medications were reported. No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Non-significant follow up updated on 23-Jun-2021 and updated spelling of patient name and email address
Stated that he received the first dose then took the test and it came out positive/got vaccinated 29Dec2020/took the Covid test on 30Dec2020/found out that he was positive on Friday (01Jan2021); Stated that he received the first dose then took the test and it came out positive/got vaccinated 29Dec2020/took the Covid test on 30Dec2020/found out that he was positive on Friday (01Jan2021); This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect, received from a contactable consumer (patient). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 29Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he received the first dose then took the test and it came out positive. He was scheduled to take the second dose next Tuesday 19Jan2021 and wanted to confirm if he has to wait 90 days or still stick with the second dose since he has already had the first dose. Patient stated that he had got vaccinated on 29Dec2020. Stated that he took the Covid test on 30Dec2020 because someone tested positive and found out that he was positive on Friday (01Jan2021). He was cleared to return to work and he will tomorrow. He wanted to know if this will impede the vaccination process and wanted to know if he will have to redo the vaccination. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Both of his shoulders he started having pain in the muscles. He is having problems with putting on his jacket without being in pain.
At 45 minutes approx after the vaccine was given in my right arm, my lips and the area of my face around my mouth were tingling and felt "rubbery".  More specifically its as though a 2 inch wide circle around my mouth and my lips were affected. My tongue and throat were no affected at all. There was no constriction of breathing. There was no swelling or nothing discernable. This sensation stayed with me for about 1 hour. I want to note that the fist shot had slighter but similar symptoms. For the first shot I felt a much more mild version of what happened for the second shot.
Headache, Fever, HEADACHE, FEVER, CHILLS, FATIGUE Narrative: AROUND 6PM ON DAY OF VACCINATION, CHILLS AND FEVER (101.8/101.9 F), LIGHT HEADACHE WITH EXTREME FATIGUE. TREATED WITH TYLENOL ON 1/4/21 AND 1/5/21; STILL FATIGUE ON 1/6/21 BUT NO FEVER (LAST TYLENOL 7 PM ON 1/5/21)
Scratches on left upper arm; This case was reported by a consumer via call center representative and described the occurrence of scratch in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st April 2020, the patient received the 2nd dose of Shingrix (intramuscular). In April 2020, less than a week after receiving Shingrix, the patient experienced scratch. On an unknown date, the outcome of the scratch was not recovered/not resolved.   It was unknown if the reporter considered the scratch to be related to Shingrix.  Additional information was provided as follows: The patient received shingrix in his left upper arm last week and within a week he noticed four scratches on his left arm. He states that they are not rashes, they are scratches, they are not around the injection site, one scratch starts 4 inches below injection site and the others seem to go down his arm and stop at his bicep.  The reporter reported that the scratches did not itch, and nothing was coming out from them. He describes that one scratch was individual, another was separated like a dot that was not full connected and reported that it was possible that he scratched his arm unknowingly and possible that the scratches are unrelated to Shingrix. The reporter did not want this report to be submitted to safety department until he was certain that it was related to Shingrix.  The reporter did not want to be contacted by safety department. The reporter did not consent to follow up. The reporter stated that he changed his mind and did not want this report to be submitted to safety department until he was certain that it was related to Shingrix.  The reporter reported that if he thinks the scratches are significant and related, he would call back to report the adverse reaction.  The reporter did not want to be contacted by safety department.
Patient ran temperature for 5 days after vaccine administration.  Leg pain began 12/27/06 until present.  Muscle aches began 12/27/06 until present, as well as difficulty walking.  Patient has most recently 3/23/2006 been diagnosed via biopsy with polyarteritis nodosa which was confirm after a 3/27/2006 visit to the pediatric rheumatologist.  04/10/2007 MR received from pediatrician which includes a 5 yr well exam of 12/19/2006 which is WNL with some question of allergic rhinitis vs. perrenial rhinitis. Imms. received.   6 OVs beginning 1/2/07 for c/o fever, and leg pain. Pain in calves progesses with difficulty in walking.  Hospitalized 1/3-5/2007 for w/u. Developed sores on legs by 1/31/07, described as multiple dark macules from mid-thigh to feet. Dermatology consult with punch bx.   DX: Polyarteritis nodosa.   Corrected DOB is 01/21/2002.  Updated in VAERS. 04/23/2007 MR received from rheumatology consult of 3/27/2007 confirming above dx. 05/14/2007 Hospital record received for 2 night hospitalization (01/3-5/2007) for c/o pain in the lower extremities x several weeks.  Tenderness present in calves. (+) DTRs.  No weakness. Neurology consult r/o GBS.  Discharge DX:  Mild myositis lower extremities-resolved.
Patient having numbness to right pink finger. Having nerve pain to injection site. Injection site red and itching started two weeks after injection