chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No medical history was provided by the reporter.  Concomitant products included DICYCLOVERINE HYDROCHLORIDE (BENTYL) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was extremely painful/ couldn't move arm for 4 days). On 04-Mar-2021, the patient experienced ABDOMINAL PAIN LOWER (cramping in lower right abdomen.), VACCINATION SITE WARMTH (Injection site hot), SWELLING (Swelling), RASH (Rash), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Injection site red), PYREXIA (Low Grade Fever) and FATIGUE (Extreme Fatigue). At the time of the report, PAIN IN EXTREMITY (arm was extremely painful/ couldn't move arm for 4 days), ABDOMINAL PAIN LOWER (cramping in lower right abdomen.), VACCINATION SITE WARMTH (Injection site hot), SWELLING (Swelling), RASH (Rash), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Injection site red), PYREXIA (Low Grade Fever) and FATIGUE (Extreme Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 99.9 to 100.1 High.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was reported.   This case was linked to MOD-2021-040722 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up information received on 04-MAY-2021 was updated with event details.
shakes; sore left arm; chills; redness at injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TREMOR (shakes), PAIN IN EXTREMITY (sore left arm), CHILLS (chills) and VACCINATION SITE ERYTHEMA (redness at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20AH) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced TREMOR (shakes), PAIN IN EXTREMITY (sore left arm), CHILLS (chills) and VACCINATION SITE ERYTHEMA (redness at injection site). At the time of the report, TREMOR (shakes), PAIN IN EXTREMITY (sore left arm), CHILLS (chills) and VACCINATION SITE ERYTHEMA (redness at injection site) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-660555, MOD-2022-660557, MOD-2022-660560, MOD-2022-660563 (Patient Link).
2/5/03 - local swelling to arm and redness. Remained swollen - with gradual decrease in edema and redness - left arm. 2/11/03 slight edema and slight redness to local area left arm.
She got the vaccine and within 3-4 hours both arms started hurting, and got worse as the day went on.  After about 6-8 hours later she could not move her arms without unbelievable pain, and could not move her arms up towards her shoulder without extreme pain and could not move then sideways.  She could not put her arms on the recliner and had to keep them besides herself.  Could not move her arms to brush her teeth or put a drink on the table due to the pain.  She had to sleep in the recliner as she could not lay in bed without her arms hurting.  I slept for about 12 hours to escape the pain and by the next evening about a day and a half later the pain started easing up a little bit, and got more range of motion in her arms.  She could lift them up a little bit more and a little sideways.  She did not take anything for it, just slept.  The first day and a half was bad.  She could move her fingers and hands, but not the arms themselves.  She has a push button recliner and could not use that and then tried her unvaccinated arm and could not move it as it felt like the muscles were twisting.  She was extremely tired and slept another 12 hours, and then 2 days later the pain and the range of motion got better and progressively improved.  She was able by Monday to dress and undress herself and the toothache type pain was gone.  The pain and symptoms lasted for about a total of 4-5 days and then had soreness.  By the time she received the 2nd vaccine she was okay.  She did have normal reactions to the 2nd vaccine, was sore and felt that her lymph nodes were swollen, and feels that sometimes it may still be.
Patchy rash on forehead and swelling/redness in right arm  where she received vaccine about 7in length and 5in wide.  Saw doctor 1/19/21 no pain, occasional itching.
This spontaneous report as received from a pharmacist (Pharm. D.) refers to a female patient of unknown age. The patient's concurrent condition included diabetes and high blood pressure. On an unknown date the patient was vaccinated with first dose of ZOSTAVAX (dose, route, lot#, injection site not provided). On an unspecified date the patient was vaccinated with the second dose of ZOSTAVAX (dose, route, lot#, injection site not provided). Since receiving the second dose of ZOSTAVAX she had had increased sweating, "jitteriness", and headache. The patient went to see the pharmacist. The outcome of adverse events was not recovered. The patient did not specify who administered the ZOSTAVAX and it was not administered by the pharmacist. Additional information has been requested.
The day following the second Pfizer shot the patient developed a fever to 101.5 that improved with Tylenol and did not recur.  On that same day he felt tingling in the hands and feet and reported a floating sensation.  This too resolved with resolution of fever.  On the third day after the shot he developed chest pain, difficulty taking a deep breath.  He woke up the following morning with nausea which resolved but the chest pain and a feeling that it was hard to take a deep breath worsened.  The pain was significant enough that he went to the ER.  In the ER, he was found to have an ECG consistent with acute pericarditis and his troponin was elevated (2.75, upper limits of normal 0.03).  He was started on IV Toradol and admitted to the hospital.  His troponin kept climbing so he was also given IVIG (80 gm).  The following morning his Troponin started coming down and he no longer was reporting any symptoms.
Patient was given second dose one day too early. First dose given 8/25/2022 and second dose given 9/17/2022. Second dose given 23 days from first dose.  Patient did not report any adverse effects during 15 minute wait period post vaccination. Patient was notified of early vaccination and did not report any adverse reactions and the time of call (9/17/2022 @17:48. When called pt stated , " I feel fine." Pt was given information to health department.
On the left arm where they put the Pfizer vaccine, just under my armpit closer to the chest, it is swollen, right under the armpit, it is like between the chest and below the armpit; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EWV161), via an unspecified route on 14Apr2021 (at the age of 59-years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Apr2021, the patient experienced on the left arm where they put the Pfizer vaccine, just under his armpit closer to the chest, it was swollen, right under the armpit, it was like between the chest and below the armpit. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
vomiting, diarrhea, fever of 102, with vomiting resolving in 5-6 hours from onset, fever and diarrhea and fever resolving ~36 hours from onset
This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients medical history and concurrent conditions were not reported. On an unknown dates, the patient were vaccinated with improperly stored dose of GARDASIL (Lot#K011562, expiration date 08-APR-2017; Lot#K016966 and expiration date 10-MAY-2017) (dose and route of administration were not reported) or ROTATEQ (Lot#K007247, expiration date 17-MAR-2016; Lot#K011948 and expiration date 07-JUN-2016) (dose and route of administration were not reported). No adverse effect were reported. Additional information is not expected as there is no consent for follow up.
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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) with onset 19Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 19Dec2021, outcome "recovered" and all described as "tested positive for Covid". The event "tested positive for covid" and "tested positive for covid" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Dec2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Amendment: This follow-up report is being submitted to amend previous information: Amended new case 202200249864 only for event.
Received booster shot and now I have a huge swollen ball in my armpit that is very painful.
Received H1N1 on 11/30/2009; on 12/1/09 at 23:20 was found unresponsive, pulseless; was transferred to local emergency department for treatment.
Upper arm soreness started at about 8:30 pm, about 10 h after injection. Went to be like normal and arm was just sore, but nothing else at that time. At 1:10 am, patient woke up with horrible shakes, verging on convulsions, and the feeling of freezing to death. Uncontrollable shivers/shaking.  At around 1:40 am, patient was able to move enough to get out of bed to find a second blanket and extra strength Tylenol and took the Tylenol with some seltzer water and hid under blankets to get warmer. After about an hour, around 2:30 - 2:40 am, the shaking was reduced enough that the patient was able to relax and try to get to sleep. At 5;30 am, the patient woke up with much the same symptoms, but with the addition of the worst headache he had had since he stopped having migraines in his mid 20s and also his whole body ached like he had been hit by a truck (that [getting hit by a truck] had happened to him once about 15 years ago, so he has the actual reference to compare against).  This experience was worst overall body aches/pains ever experienced by the patient. He took additional Tylenol at 6 am and about 30 minutes later, the chills subsided and the pain was reduced enough that he could go to sleep again. Shortly before 10 am the symptoms started to get worse again and he took ibuprofen (400 mg) at 10 am, after the shakes started to come back. He has traded off every 4 hours taking tylenol and ibuprofen, which keeps the temperature perception swings to a minimum and overall body aches lower, but the headache does not go away. He feels exhausted, and has slept for spurts of 15 - 30 minutes on and off all day.  He was able to each crackers at around noon and some homemade chicken vegetable soup at about 1 pm as the nausea had subsided. Prior to that, he could only drink water and Gatorade. He is hoping that within 24 - 48 h he will feel much better, without having to take Tylenol or Ibuprofen.
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Additional Details: pt said has fever but doesn't know what it is, also has chills
Symptoms started the following day after injection. To date almost daily dull numbness/pain occurs in upper left arm lasting 15-30 minutes periodically during the day but more so upon lying on the left side. Frequency of event has not subsided but seems to be increasing.
Within a few minutes of receiving the vaccine, tingling and pain to left arm, left side of neck. Then in the next few hours I developed tingling, pain and  weakness in left arm and left leg. The tingling and weakness resolved after a few days. But the pain became worse and over the next 2 weeks pain became worse until it was severe and all over body with deep pain and severe burning pain, also I had sensory changes  issue including changes in cold and heat sensation. In the last 2 years I had this type of pain and was diagnosed with likely small fiber neuropathy. However it had just gone into remission. But after the covid vaccine it returned just as severe as ever. It took several weeks to resolve.  My neurologist Dr stated that she thought the vaccine had likely caused a flare of the small fiber neuropathy.
Rxn to pneumonia shot. Left upper arm redness/swelling. Pharmacy: ATARAX 25 mg, MEDROL Dose pak, AUGMENTIN 875 mg.
The pt experienced seizure-like activity consisting of decreased awareness, symmetrical jerking or tremor over the whole body without breath holding, cyanosis or paleness. This happened during sleep, after she had been asleep about 30 minutes. This happened five days post vax.
10mins p/vax pt wasn't able to walk & had blurry vision, diaphoretic & tremors over entire body; BS 70; pt recv IVF observed;
This spontaneous report as received from an other health professional refers to patients of unknown age and gender. In August 2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # M035140 for prophylaxis reconstituted with sterile diluent (STERILE DILUENT). No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA001290: US-009507513-1709USA001288: US-009507513-1709USA001297: US-009507513-1709USA001045:
Vaccine expiration date was listed as 05/11/21022. Expired vaccine was administered on 05/17/2022.
Child's mother reports that he felt "crummy" for 3+ days after vaccination. On Day 3-4 after vaccination he felt light headed without fainting. He also 5-6 inches of redness at injection site with little swelling.
Received Tetanus booster to L deltoid on 8/2/02. Pt reports 8/8/02 continued pain, weakness, inability to fully use L arm. Ibuprofen prescribed.
mom reported daughter was 12 years old for pfizer vaccine and wrote 12 years old on consent form but birthday in patients profile does not match patients reported age. received second pfizer vaccine on 9.14.2021
Shot on Friday at 7pm, Immediate arm soreness (fairly severe), then I woke up at 4am sweating and shaking and vomiting. I threw Up 8 times between 4am and 3pm the following day (Saturday), and it is now Sunday morning at 9:30 and the sweating and shaking seems to be subsiding. I would Describe Saturday as ?violently ill?. These were not minor side effects.
Constant back pain. Middle back, Tylenol will only make it bearable, won't go away. 4 days straight now of back pain.
6 weeks old received Menveo; This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 6-week-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA466A, expiry date 31st March 2022) for prophylaxis.   On 7th October 2021, the patient received Menveo. On 7th October 2021, unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The 6 weeks old patient who received a dose of Menveo, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Body chills, cold sweats, fatigue, body aches and pain.  Took Acetaminophen Q6hrs for about 2 days. Symptoms went away after about 2.5 days
Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is related to case 2018SA200801 for patient and 2018SA200800 for patient, from the same reporter. This case involves a 4 years old male patient who experienced light headed, clammy and diaphoretic (sweaty), while he received vaccine QUADRACEL. The patients family history included Mom has a history of passing out with shots. The patients past medical history, medical treatment, vaccination was not provided. The patient did not receive any concomitant medication. On 19-Jul-2018, the patient received a first dose 0.5ml of suspect QUADRACEL lot C5497AA, expiry date 17 Jul 2020 via intramuscular route in unknown administration site. On 19-Jul-2018, the patient developed a non-serious light headed same day following the administration of QUADRACEL. On 19-Jul-2018, the patient developed a non-serious clammy (cold sweat) same day following the administration of QUADRACEL. On 19-Jul-2018, the patient developed a non-serious diaphoretic (sweaty) (hyperhidrosis) same day following the administration of QUADRACEL. Lab data was not provided. Final diagnosis was diaphoretic (sweaty), clammy and light headed. As a corrective treatment the patient was laying down. The patient outcome is reported as Unknown for light headed, as Unknown for clammy and as Unknown for diaphoretic (sweaty). List of documents held by sender- none.
Developed Pain & swelling @ inject site; headache; sore throat; malaise; rhinitis.
Post vax, at 10:10, pt's mother presented child with edematous area over IZ site and reddened area; ice was applied and PAC notified. Left lateral thigh had moderate erthema at IZ site. Rest, ice, compression and elevation. Observe and give Benadryl.
First dose administered on 17Jan2021/Secodn dose administered on 23Dec2020; Headache, hypertension, tachycardia; hypertension; tachycardia; This is a spontaneous report from a contactable Pharmacist. A 35-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3249), via intramuscular route on the left arm on 17Jan2021 as a single dose for COVID-19 immunization. The patient had no medical history. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical vaccine data included the firs dose of BNT162B2 (Lot Number EL0140; at the age of 35-years) via intramuscular route on the left arm on 23Dec2020 as a single dose. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Past drug history included known allergies to codeine and sulfamethoxazoletrimethoprim. On 17Jan2021, the patient experienced headache, hypertension, tachycardia. The patient was seen at the Emergency Department/ Department of urgent care. The patient was treated for the events headache, hypertension, tachycardia with acetaminophen and lorazepam. The patient was not tested for Covid-19 post vaccination. The clinical outcome of the events headache, hypertension, tachycardia was not recovered. The outcome of event, Inappropriate schedule of vaccine administered, was unknown.
16-year-old patient received the 1st Moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old patient received the 1st Moderna vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old patient received the 1st Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old patient received the 1st Moderna vaccine) outcome was unknown. Not Provided      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 provided by the reporter.   Treatment information was not provided.
When I was getting the shot it felt like a burning feeling but that quickly went away. The next day my lymph nodes in my neck and throat area were swollen,  it was in my neck and my front left side of chest area. I had a sore throat. I went to the ER on the evening of the 19th. They checked my vitals and they did not think it was a reaction to the vaccine, it was my body's response to the vaccine. They said I could take Tylenol or Ibuprofen and Benadryl if I needed to. As of today the swelling went down and I feel fine.
Patient states she developed hives 2 days after the shot. Shot administered 10/12 and hives developed 10/14. They lasted for 7 days. She went to an MD on 10/26 for some lingering hives.
a 56 year old patient that received the Fluzone High-Dose Quadrivalent/no AE; a 56 year-old patient that received the Fluzone High-Dose Quadrivalent/no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 55 or 56 year-old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number and expiry date not reported) via unknown route in unknown administration site on 01-Oct-2020 prophylactic vaccination (Product administered to patient of inappropriate age and Overdose)  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration (latency was same day).  Also, a case of overdose (latency was on same day).  No adverse event was reported to the patient at the time of reporting.  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.  There will be no information available on batch number for this case.
Fever (102.6' @ 0800 12-24-20), Body ache,  Injection site pain, chills, fatigue, slight headache.  Lasting until early morning hours of 12-25-20.