chrisvoncsefalvay/vaers-outcomes huggingface dataset:
booster dose; has pain in his shoulder blade and in his neck a little bit; has pain in his shoulder blade and in his neck a little bit; Caller added that he has loose bowel which is not totally diarrhea but it's close.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose, nausea on the second day), for Covid-19 immunization, reaction(s): "I had some big time nausea with that second shot on the second day"; Bnt162b2 (2nd dose), for Covid-19 immunization, reaction(s): "general malaise", "some fever". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster dose"; NECK PAIN (non-serious), MUSCULOSKELETAL PAIN (non-serious), outcome "recovering" and all described as "has pain in his shoulder blade and in his neck a little bit"; DIARRHOEA (non-serious), outcome "unknown", described as "Caller added that he has loose bowel which is not totally diarrhea but it's close."  Additional Information: Patient stated that he got mobility and can swing his arm like throwing a baseball but it does hurt as he got the shot in his arm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
life threatening illnesses; This spontaneous report was received from a person told a friend who then told the employee's wife referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date (reported as in the past), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot# and expire date were not reported) for prophylaxis.   On an unknown date, the patient experienced life threatening illness. The outcome of the event was unknown.  Causality assessment was not provided.  This is one of two reports received from the same reporter (link case # 2108USA004631).; Sender's Comments:  US-009507513-2108USA004631:
Profound chills/shivering/shaking - uncontrolled; headache, whole body pain.
Chills, fever, muscle cramping, complete renal shutdown, violent diarrhea, hospitalized x 3 days. Peritoneal dialysis 3 months post vaccination.
Patient was inappropriately given the shingles vaccine by pharm on 05/26/2017. It was discovered on 5/27/17. Pt uses different pharmacy and did not have his history. Pt unable to tell you what he takes.
The day after the shots were administered the baby developed a rash on her chest, stomach, and back. The rash was red, inflamed, and scaly. Over the next several days, the rash appeared on the chin, neck, arms, and legs as well. The next well visit was at 4 months and she was diagnosed with intrinsic atopic dermatitis and we were told to use hydrocortisone on it twice daily. The eczema still persists despite treatment. The baby also started blinking and shaking uncontrollably as if startled or surprised several times a day. This is with no provocation.
Paralysis, extreme fatigue, insomnia, bacterial infection, Irregular heartbeat, headache, loss of voice
Headache, fatigue, body aches, sore throat, ear pressure  COVID 19 Swab-Neg.
patient stated she got a large red rash at injection site which spread to her entire arm then her entire body
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 05-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 288 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a female (approximately 4 years of age to 15 years of age) who on 01-AUG-2007 was vaccinated with Zostavax (Oka/Merck, lot # 657558/0461U) instead of Varivax (MSD).  Subsequently no adverse experiences have been reported.  Unspecified medical attention was sought.  This is one of several reports received from the same source.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 9/24/2007.  Information has been received from a licensed practical nurse concerning a female (approximately 4 years of age to 15 years of age) who on 01-AUG-2007 was vaccinated with ZOSTAVAX (Merck), lot # 657558/0461U) instead of varicella virus vaccine live (MSD).  Subsequently no adverse experiences have been reported.  Unspecified medical attention was sought.  The nurse reported in follow-up that the packaging for the ZOSTAVAX (Merck) and VARIVAX was similar and the 2 vaccines were stored in the same freezer.  The VARIVAX had run out and the ZOSTAVAX (Merck) was picked up mistakenly.  The nurse hoped to avoid this event in the future.  There have been positive results noted from the parents of the vaccinated child.  This is one of several reports received from the same source.  Additional information is not expected.
Around two weeks before receiving my vaccine, I was experiencing an upper respiratory infection. However, I had finished my round of antibiotics and was feeling better. After receiving the vaccine, I did notice a bit more of a cough but by the following Wednesday, my cough was really bad again. The cough was not productive at that point. I was very congested in my sinuses and very fatigued. I was trying to treat my cough with over-the-counter medication, but I continued to not feel well. Friday, I traveled out of town to see family, but I was feeling so bad by Saturday afternoon that I had to go home. I went to the local emergency room since none of the urgent clinics were open. When I arrived at the hospital, my blood pressure was extremely high. I had no chest pain, but my cough was uncontrollable. They did blood work to check my heart, kidney, and liver function. All of that came back normal. They did chest x-rays and found nothing. I also tested negative for COVID-19 and Flu. The doctor prescribed a medication for my blood pressure and advised that I continue using my inhaler and discontinue using any over the counter medication for fear of raising blood pressure. They also prescribed a cough medicine, Prednisone, and Flonase. I wasn't able to begin those until late in the afternoon on Sunday. I followed up with my doctor on Wednesday, who increased the blood pressure medication and then advised that I increase my inhaler usage as well. He also prescribed Teflon Pearls for coughing. By Friday, I was still coughing some, but it was more productive. After increasing the medications, I have begun to improve a lot more quickly.
1st dose Aug2019, 2nd not yet/patient had not received the 2nd Shingrix vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comments: The reporter reported a patient came in this weekend to get the 2nd Shingrix vaccines after receiving the 1st Shingrix vaccine in August 2019. It was reported that at time of call, the patient had not received the 2nd Shingrix vaccine.  The 1st Shingrix vaccine was not given to the patient at the pharmacy that called.  No lot number or expiration date were available. The reporter gave the consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Case number PHEH2014US024439, is an initial spontaneous report from a nurse received on 04 Dec 2014 with a follow up information received from a nurse on 17 Feb 2015. This report was initially reported as a multiple patients' case, but upon receipt of follow up, it became a valid single patient case. This report refers to an 11 years old female patient. Her current conditions included allergy to shellfish and rash on right cheek for years. Her concomitant vaccinations included human papilloma virus vaccine (other manufacturer, batch number: 14004205) at a dose of 0.5 ml intramuscularly in the right deltoid, tetanus diphtheria acellular pertussis vaccine (other manufacturer, batch number: C4497AH) at a dose of 0.5 ml intramuscularly in the left deltoid and influenza vaccine (unknown manufacturer, batch number: 379MY) at a dose of 0.5 ml intramuscularly in the right deltoid; all vaccines given on 05 Nov 2014. Her vaccination status was up to date and she required second dose of human papilloma virus vaccine. On 05 Nov 2014, she was vaccinated with an initial dose of MENVEO (batch number: M14030, expiry date: 31 Jul 2015) intramuscularly at a dose of 0.5 ml in the left deltoid after the temperature fell to 34.9 degree F for 12 hours at 9:48 am and for 12 hours on 06 Nov 2014. The vaccine had never frozen during the excursion. The nurse received the information only when an audit showed that the MENVEO went out of range. No adverse event was reported. The patient was referred on 05 Nov 2015 for cardiac echocardiogram (ECHO) and dermatology. No further information was provided. Follow up information received from a nurse on 17 Feb 2015: Updated reporter type, patient demographics (initials, date of birth, age and gender, height and weight), current condition, concomitant vaccination, MENVEO batch number, expiry date, dose, site and time of vaccination and narrative.
Patient received vaccine and stated she was itching really bad and noted scratches on stomach.  No visible rash noted.  Notified MD.  Patient's shift was about to end.  MD encouraged patient to go to store to get benegryl.  No reports of swelling.  Vital signs stable.  HR 80, RR 24, BP 154/90.  Stated that she was told she had HTN, but never followed up with it.
Burning, pain, numbness, swelling. I still have some pain and forearm weakness in both arms.
Patient's husband came the next day and stated that she had facial swelling and trouble breathing and went to the ER.  He brought a prescription for a Medrol dose pack.
FPIES allergy diagnosed 1 month following - severe allergy to banana; vomiting, lethargy DTaP "scream" for hours following vaccination
Immune system seems to be overreacting. Rash occurred on face, shoulders, arms, and top of hands, Could not longer use detergent that I had used for years. Moving to detergent helped.  Through my own trial and error testing, determined allergic reaction also occurs when I eat chocolate (dark ). Through current trial and error testing, I might also be allergic to soy butter.
Pt recvd 3 doses of Engerix-B & 1OCT91 found to be a non-seroconverter;
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K002036, expiration date 10-FEB-2016, 0.5 ml, subcutaneously (SQ)). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that on 10-NOV-2015, the vaccine was exposed to temperature of 55.9 Fahrenheit degrees (F) for 1190 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. Additional information has been requested.
Blotches were noticed on the back of Pt. several hours after MMR-V was given.
patient c/o nausea , monitored patient's vitals BP: 122/84 Spo2: 99 Pulse: 82  Monitored patient for 50 minutes, symptoms were relieved and was sent home.
Saturday morning my arm was swollen, red, warm and sore at the injection site with rash.  After using a warm compress on Saturday evening, I woke up on Sunday morning with hives, severe itching and a headache.  Mild chest congestion but no shortness of breath.  I took Benadryl for the rash and itching at regular 6 hour intervals on Sunday and Monday.   Tuesday morning the injection site was still slightly swollen, red and sore.  Still some itching and a mild headache.
Arm pain, Fever 102, body aches, chills, back pain, nausea/vomiting which began 3 hours following injection with both injections.
Hives - within 24 hours of immunizations.  Being treated with Benadryl.
Pt c/o severe body aches, congested, diarrhea 3-4 times since morning, headache. Reports dizziness and weakness in emergency screening. Pt was advised to call 911 or go to nearest ED for further treatment and evaluation,
Pt vax /w Meruvax II developed sore arm, seen in ER and sent home. on 3OCT90 the pt experienced blurred vision. At the time of the report, the pt remained under treatment.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapy were not provided.  On an unknown date, the patient was vaccinated with PNEUMOVAX 23 0.5ml, intramuscularly, lot # N022303 for prophylaxis. The reporting pharmacist stated that she attempted to remove the air from the syringe, prior to administered the injection, but the syringe leaked from the needle connection site.  Due to the pharmacy did not have another PNEUMOVAX 23 prefilled syringe to use for this patient, he did not receive their PNEUMOVAX 23 injection. No adverse effects were reported.
Narrative: 79 yo patient who has never received any care at clinic died on 11/12/2021. It was reported pt received one covid vaccine (pfizer) on 2/10/2021. NO info available to assess if vaccine is related to pt's death; likely is not given pt's advanced age & length of time from vaccine administration.
On Monday April 26, 2021, about about 4 hours after the second dose of the Pfizer vaccine, itchiness was felt all over the body then a rash started to break out. The rash continued to spread and gradually get worse for two days until I went to see a doctor. They gave me a steroid injection and prescribed  a Methylprednisolone pack. About 8 hours after the steroid injection the rash started to disappear but the itchy feeling still remains. My skin is still sensitive and flares up when slightly rubbed. mostly occurs on my arms, hands,  chest, feet, inner and back thighs, face, neck, and ears
Patient may have inadvertently been given 1cc of Moderna COVID vaccine instead of 0.5cc. Patient was notified. State of MD was notified
Received Flu vaccine on 9-17-12 then 3AM 9-18-12 mom noticed lip/face swollen, feverish, injection site pain, swollen, she didn't have trouble breathing, went to ER. Tx with BENADRYL 25mg.
Mild warm to touch at site (Right deltoid) where vaccine was given. Low grade temperature, Nurse contacted and patient was placed on sports restrictions with TYLENOL/Ibuprofen given every 4 hours if needed. Patient will be monitored.
Information has been received from a consumer concerning her friends' boys who on an unspecified dates were vaccinated with MMRII. "One week later", the children were diagnosed as being autistic. No further information was provided at this time. It was unknown if the patients sought medical attention or not. Upon internal review, autism was considered to be other important medical event. No further information is available.
pt recv vax; very irritable during noc w/ episodes of high pitched crying; would shake head when fell asleep;
Swollen on left deltoid, warm 6cmx8cm. Seen by provider.
Pt had hot, red and tender thigh at site of DTAP or HIB (left thigh) about 4 hours, post vax. According to parents, her entire leg was swollen but had improved by the time we saw her about 1 hour later. The pt was crying but neurologically normal and no fever. Treated with ice and Tylenol.
Pt reports mild soreness in deltoid as usually occurs with flu (IM) vaccine. Expired flu vaccine administered.
2 days after my 1st vaccine I felt no side effects except a sore arm. I did some exercise and checked my pulse afterwards, found the pulse elevated and missing beats. That night it returned to normal.  My resting pulse has been steady at 58 beats per minute for the 2 weeks after the first vaccine.  I checked it yesterday afternoon before going for my second vaccine and it was a steady 58 beats per minute.  This morning I have a fever of 100F and resting pulse is 93 beats per minute and skipping 3 to 4 beats per minute. I've never had this problem in the past
Because of COVID vaccine something horrible is happening in his body; This spontaneous case was reported by a non-health professional and describes the occurrence of IMMUNISATION REACTION (Because of COVID vaccine something horrible is happening in his body) in a male patient of an unknown age 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 IMMUNISATION REACTION (Because of COVID vaccine something horrible is happening in his body). At the time of the report, IMMUNISATION REACTION (Because of COVID vaccine something horrible is happening in his body) outcome was unknown.            No concomitant medications were reported.  It was reported that patient was not a participant of a Moderna clinical trial.  No treatment medications were reported.
hot at the injection site; big rash at the injection site; deep red at the injection site; a bit swollen at the injection site; incorrect schedule of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE PAIN (big rash at the injection site), VACCINATION SITE ERYTHEMA (deep red at the injection site), VACCINATION SITE SWELLING (a bit swollen at the injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (incorrect schedule of vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A, 011620A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (incorrect schedule of vaccine). On 21-Sep-2021, the patient experienced VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE PAIN (big rash at the injection site) and VACCINATION SITE ERYTHEMA (deep red at the injection site). 21-Sep-2021, the patient experienced VACCINATION SITE SWELLING (a bit swollen at the injection site). At the time of the report, VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE PAIN (big rash at the injection site), VACCINATION SITE ERYTHEMA (deep red at the injection site) and VACCINATION SITE SWELLING (a bit swollen at the injection site) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (incorrect schedule of vaccine) had resolved.            Patient got the flu shot the same day  as the 3rd dose but in her right arm and did not experience a reaction in that arm. No concomitant and treatment medication were reported.
- Felt like I had been twilighted before surgery the afternoon and evening of Apr 20th. Had also developed some ezchema on my face - Sometime after 2am while I was sleeping, cried out in my sleep a few times I was in so much pain and was also very nauseous - 10am on Apr 21st, I awoke and had shooting pain in my injection arm, knees, shoulders, stomach, and other muscles, it felt like someone was stabbing me intermittently in different places. My whole body was tensed up from the pain and I was breathing shallow (I think from the pain, unsure though). And I had an awful headache. - Got out of bed to take magnesium citrate to alleviate some of the muscle pain and almost threw up. Turned white as a ghost, felt extremel felt extremely flushed, and sunk to the kitchen floor until I could calm my stomach enough.  Finally was able to get the magnesium powder into my glass of water and drink it which did take the edge off of the pain. Then took Nux Vomica homeopathic to lessen the nausea so I could eat and keep my food down. Got a bucket and carried it with me wherever I went as I was that close to throwing up. Got breakfast and took my temp which was 98.9 when my normal temp is 97.9 or lower. Had the chills and sweats that comes with a fever. Went back to bed and ended up sleeping 20hrs that day (Apr 21st) as I was extremely fatigued. Apr 22nd was better, no fever, and was still having a lot of muscle pain, bad headache, bad nausea, it hurt to digest, and tiredness. Was only awake 6 hrs that day. Apr 23rd was much of the same and I was awake 8 hrs that day.  Apr 24th a lot of the muscle pain had passed, I was finally breathing normal again, and I could finally start moving around some though was still very tired and was feeling an internal shakiness in my chest.  Apr 25th I had an emotional meltdown from the pain and trauma I had just experienced from the vaccine over the past four days. Apr 26th tried to go for a walk and was walking much slower than normal, my stomach hurt from the jostling of the walking, my thinking was much slower than normal, and still felt a shakiness in my chest.  It took 8 days after my 2nd vaccine shot before I get through the day without anti nausea medication and the shakiness in my chest went away.  Evening of May 7th I had a nosebleed and I don't get nosebleeds so this was strange.  3-4 days before May 7th, had a bit of blood occasionally when I blew my nose.  It's now May 12th and my energy level still isn't where it normally is.
Second COVID shot Directly after  administration: Swollen arm for a few days, extreme tiredness for 3 days, swollen lymph node in clavicle area on right side for a few days.  12 days after administration:  unexplained purpura/petechiae near left shoulder in area about the size of a silver dollar (no injuries or medications). Rash is still present, but is likely to resolve in a couple days and is getting fainter.
Left thigh has 9-10cm diameter oval area of redness with minimal warmth. Right thigh has 8cm. diameter area of redness. He is afebrile. Treated with Cephalexin. Discussed with mother possibility of neomycin allergy
pt had immed anaphylactic rxn w/inc facial warmth & erythema;perioral/nasolabial edema;nausea;diffuse wheezing;rx w/epi, Solucortef, Proventil, axid, claritin
Fever, chills, severe muscle aches...legs, arms..sweats, upset stomach..difficulty walking...cough, dizzy....