chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from pharmacist on 18-Sep-2018. This case involves a 57 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (Batch number: UI994AB, expiration date: 09-Apr-2019, route: intramuscular and site of administration: right deltoid) on 18-Sep-2018. The patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
nausea ,fatigue fever,swelling and extreme soreness at injection site.unable to use arm without extreme pain
pt described muscle pain as 1-2/10 a month later after getting flu shot. Pain comes off and on and has consulted PCP on proper steps to treat pain. Was recommended by pharmacy intern to trial APAP OTC and will return in 1 wk if pain consists.
This spontaneous report as received from a Nurse via Pfizer refers to a 68 year old female patient. The patient was preparing treatment for cochlear implant. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration date not reported), There was no concomitant medication reported. Nurse reported that on an unknown date orders came in for the patient to get PREVNAR 13 first and then for PNEUMOVAX 23 to be given 8 weeks later, but she received PNEUMOVAX 23 first. Nurse requested info regarding giving PREVNAR 13 second or if they could be given together. Additional information received. Patient demographics updated. Vaccine administration information updates. Pre-existing allergies, birth defects and medical conditions were unknown. Illness at the time of vaccination was unknown. On 24-MAR-2014 at 2:30 pm, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J004080, expiry 22-AUG-2014). Number of previous vaccines was nil. It was reported that the doctor ordered PREVNAR 13 to be given followed by PNEUMOVAX 23 8 weeks later. Patient was given the PNEUMOVAX 23 first, reported as vaccine given out of order. Relevant diagnostic tests and laboratory data were none. Additional information was received concerning the 68 year old female patient who on 24-MAR-2014 at 2:30 pm was vaccinated intramuscularly with a dose of PNEUMOVAX 23 into the left arm, instead of PREVNAR 13. There was no illness at time of vaccination. The patient had no prior medical history, relevant drug history, drug allergies or family history and no AE following prior vaccinations. No relevant laboratory tests were performed. Additional information is not expected.
Normally only have one or two episodes of Vertigo per month.  Since getting the second injection I have have 5 in the past six days including 2 separate episodes today.
Pt received vaccine 8/3/02, temp high 102, 7x4.5cm redness at injection site,warm to touch with swelling, no induration. Returned to office 8/5/04 with fever still 102. 8/6/04 redness increased in size, temp 99 orally.
muscle pain, severe headache, rapid resting heart rate normal is 58, but went up to 82 that night. Fever of 100.5. loss of appetite, shivering and extreme fatigue. started to feel better gradually the next day....but headache is lingering.
Early in February came down with Bell's Palsy. Doctors prescribed antivirals and antibiotics and I also did acupuncture. Symptoms have improved and I would say I am 99% recovered.
c/o dizziness-instructed to lay down waited for 15 min and sat up slowly.  No further problems.
Patient received PNEUMOVAX 07/29/2014. Developed pain, swelling, redness, and warmth around injection site that spread to elbow region.
40 days after vaccination, pt called to report redden blister area on L upper outer arm. Approximately 4 1/2" (shoulder), outer arm area, 2 large blisters developed & has continued to have area of tiny blisters, redness and pain to L arm from her shoulder to finger tips, pain from shoulder to back. Several areas of blisters, redness down arm continue.
pt recv vax & 4 months to 1yr p/vax pt devel rashes;pt reported that most of the rashes were mild;
Sedation, Myalgia, Arthralgia & Fever Narrative: Employee c/o needing to sleep all day long, called in sick on 2/2/21 due to fever, tiredness, body aches, muscle aches.
Breakthrough case admission after 3 vaccines Moderna 2/24/21NO LOT #;  Moderna 3/24/21 Lot# NO LOT#;  Moderna 11/10/21 Lot# 034F21A; THIS IS THE INFORMATION AS LISTED IN THE LOCAL STATE DATABASE
This spontaneous report was received from the patient's step mother and refers to her 17 year old daughter. The patient's pertinent medical history included back surgery and an unspecified extensive medical history. No information was reported about her concomitant medications, concurrent conditions and drug reactions/allergies. On an unknown date in 2012, the patient was vaccinated with GARDASIL 9, "1 x 0.5-mL dose at 0, 2 and 6 months", intramuscularly, for prevention of HPV (lot # and expiration date were not reported). On an unspecified date, the patient experienced warts on her toes (skin papilloma) after receiving her first dose of GARDASIL 9. At the time of reporting, the outcome of the event was reported as recovered (date unspecified). The causality assessment between warts on her toes (skin papilloma) with GARDASIL 9 was not provided. This one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA006397; US-009507513-1810USA006562.
Was fine immediately post vaccine. Drove home and proceeded with a normal rest of the day at home. Went to sleep around 10 pm. Woke up at 4 am with my arm very sore. Got up to take meds for my arm pain and once I got to the bathroom felt pale, sweaty, nauseous and had chills, very weak - an overwhelming sense of not feeling right and strong fatigue. I sat on the toilet and went to the bathroom (urination and defecation) but did not have the energy to wipe properly. I stood up and turned on the sink faucet, took my meds  with a few sips of water and next thing I remember is me laying on the bathroom floor confused and with my ears ringing. I figured I had laid down but then I realized the toilet was running and the sink faucet water was still running and I looked in the mirror and had a cut bleeding on my chin that I had no idea was there. Then I realized that I must have passed out while standing at the sink. I put a bandaid on the cut and went back to bed. In the morning when I was able to assess my self better, I realized during my fall/ fainting episode I had bitten my lip, cut my chin, had abrasions on my right thigh and left shoulder and bruised my right knee and some poop in my underwear I hadn't wiped properlyat the time, that's how out of it I was. I have never fainted or passed out ever before in my 31 years of life. I live alone and it was a very scary incident for me. Luckily my injuries were minor and I have recovered but I felt like I might die during the episode. My body had a very strong adverse reaction 12 hours post vaccine.
Moderna Covid-19 Vaccine EUA Almost immediate dizziness, lasted for about 3-4 hours.
Pt presented with 5 cm erythema to the L thigh. Area is the site of  KINRIX injection given 1/6/2010. Pt saw doctor 1/08/10 at which time was given orders for BENADRYL and PREDNISONE
?Numbness? like feeling in the little finger of the left hand. Finger is tender anytime I have my hand in water (washing dishes, taking shower etc.) Noticed symptoms shortly after having  the shut. It is not going away.  Initially, symptoms were present in the little finger and ring finger. Other initial  symptoms include  same feeling slightly on the left eye and left foot. Symptoms in the little finger (left hand) persist.
Information has been received from a physician concerning a 15 month old female who on 11-APR-2007 was vaccinated with 0.5 mL dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccinations included "all vaccines required at 15 months." On 25-APR-2007, the patient developed "asystematic bumps." The bumps were described as pink superficial papules with no pustules. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from the physician who stated that approximately 2 weeks after vaccination, the patient developed 5-6 erythematous papules at the injection site. The patient's experience was reported as "no adverse reaction" but a "normal reaction." The papules went away in 1 week. No further information is expected.
By evening of injection, got chills and fever and body ached all over for 2 days. Arm at injection site was very sore, red and swollen and still is as of today 11/7/03. Two days after, a productive cough began-seems to be subsiding a little now. Showed arm site to administering nurse today i srecovering. Arm still very sore and red.
Tingling and numb feeling in legs, itch associated with tingling. Also tight feeling in legs.
This non-valid spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose and route of administration were not provided) lot # N011305, expiration date 20-JAN-2019; lot # N013541, expiration date 23-JAN-2019 for prophylaxis. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided).  Concomitant therapies included sterile diluent (STERILE DILUENT). No adverse events were reported. The outcome of the events was unknown PNEUMOVAX 23 (lot number and expiration date not provided) was stored in temperature from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 6 days. Pneumococcal vaccine, polyvalent (23-valent) PNEUMOVAX 23 lot # N013541, expiration date 23-JAN-2019 was stored in temperature from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 13 days. PNEUMOVAX 23 lot # N011305, expiration date 20-JAN-2019 was stored in temperature from 32 degrees Fahrenheit to 35 degrees Fahrenheit for 144 hours. There were no previous temperature excursions. Digital Data Logger was involved. ZOSTAVAX lot # and expiration date were not provided, was stored in temperature from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 11 days There were no previous temperature excursions. Digital Data Logger was not involved.
pt recv vax & had sx of vomiting, nausea, aching in joints, sl inc in temp 99.7, felt extremely weak 1 day p/vax;
Patient received first dose of Moderna vaccine 08/17/2021. Patient received second dose of Moderna vaccine 09/08/2021. This made the two doses only 22 days apart. The second dose of this patients vaccine was NOT given at the Care Clinic. It was given at Pharmacy.
I tested positive for COVID-19 on 1/27/23. I had fatigue, body aches, chest tightness, sore throat. I just thought I had a cold but when I took an at home test it was positive immediately. I went to the doctor, and they tested me again and I tested positive immediately, was prescribed benzonatate. No other medications were prescribed. I requested PAXLOVID and he refused.
2-3 minutes after receiving vaccine pt. sitting up in chair and eyes rolled back in head and pt. started convulsing. Convulsions lasting approximately 10 seconds. Immediately following Dr.  entered the room, pt. came to, writer reported dilated pupils bilaterally and the convulsions. Pt. with no recollection of what happened. Pt. with stand by assist to exam table and lying flat on table. Pt. assessed by physician and RN took pt's vital signs: 120/60 HR= 60 Pulse ox 97%. EKG done and read by Dr.  to be normal. Pt. observed for 1/2 hour post vaccine in lying position. Pt. sat up and VSS checked 1 minute post sitting= 90/62 P=66 water given. Attempted to take BG x2 and unable to gain reading. A minute after 2nd BG poke, pt. fainted,  hit the back of his head, 911 called, placed flat on exam table b/P= 112/56 P=72 pulse ox of 97%. EMS arrived and pt. declined going to ED. Pt. wheelchaired to car  with mother driving.
patient had no adverse reaction - vaccine exp. 6-30-23 and was given in office 7-3-23.
48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported.  No Treatment informations were reported.  This is a case of Expired Product Administered concerning a 66-year-old male patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Expired Product Administered concerning a 66-year-old male patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Flu-like symptoms, low grade fever, body aches, headache, fatigue, lasting 24 hours. Ibuprofen.
Red swollen area about 6in lt arm with a 2in darker red area in middle with discomfort down to hand with some swelling, pt was given BENADRYL and PEPCID to take every 8hr x 2 days and instructed to use TYLENOL/ADVIL and apply warm moist heat to arm. And to contact family medical MD if needed or call 911.
After the shot I was having body aches and a severe headache.  It has been 2 weeks and one day and I am still having off and on severe headaches that get so intense I can't even function.  They come in waves and last about an hour.
On  the third day following the second dose, a Visible rash  of blotches, about the size of a dime appeared throughout the torso from the lower waist line to the armpit on the front and not sides of the torso.  The back was clear at almost clear. The rash as persisted. It is now day 9 following the second dose. The rash seemed  to fade o day 5 an 6, the the larger blotches became many smaller ones beginning day 7. There has been no sensitivity to the touch or itching. On day 9 a very mild sense of itch emerged
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA057733 (CLUSTER) and 2023SA057309 (CLUSTER).   This case involves a child of unknown age and gender and it was reported influenza quadrival A-B vaccine [Fluzone QIV] reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and Fluzone QIV NP PFS was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, it was reported influenza quadrival A-B vaccine suspension for injection (lot number: UT7683NA, UT7682JA; expiry date: 30-06-2023) reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error; latency: unknown) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  Action taken: Not applicable.  Outcome:  Unknown for both the reported events.  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 the 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.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
After 3 days of flu shot, patient developed muscle aches on the other arm, pain moved to the arm (flu shot) after 7 days. Pt had chest pain after 5 days of shot -> all tests came out -UE. After 1 week pt still has pain cannot grip anything with the hand (flu shot was given)
1 hour after receiving the vaccine, patient reported a large hive forming on the inside of her left bicep. It kept increasing in size and covered the entire inner bicep. She complained of slight itching, soreness and pain. She started taking loratadine and apply hydrocortisone. It has been slowly getting better and fading.
Patient is a 66-year-old male who presents to the emergency department for evaluation of hives on his forehead, body as well as forearms, which patient states he developed a day after his second COVID vaccine.  Patient reports developing itchy rash few days following his first COVID vaccine and the end of May.  He states that his hives improved but never completely resolved.  Patient states that following his second vaccine on 6/17/21, his hives worsened. Patient reports experiencing intermittent flares of urticaria ever since.  He states that ongoing of hives prompted his ED visit today. Patient otherwise denies any respiratory symptoms.  No associated fevers, chills, headache, facial swelling, sensation of her throat closing, drooling, stridor, voice hoarseness, lip or tongue swelling, difficulty swallowing secretions, inability to tolerate p.o., blurred vision, open wounds, vesicular rash, chest pain, shortness of breath, wheezing, lightheadedness, or any other complaints.  Treatment: IV hydration (2 L) Methylprednisolone 125 mg IV x 1 dose Famotidine 20 mg IV x 1 dose Diphenhydramine 50 mg x 1 dose Cetirizine 10 mg PO x 1 dose
On 1/4/00, the pt received the first dose of Lymerix. The following day, she experienced pain in her shoulder and pain in the front of her legs in the muscles. She could not move the injection arm and has lost movement in that arm. She experienced fatigue and has had headaches which have lasted eight weeks so far.  She was seen by an MD on 2/14/00 and it taking Motrin. The pain is worse at night, Motrin does not help the pain. The MD's notes state that the pt still experienced pain in the outer upper left arm with certain motions, for example reaching for the car shoulder strap. She occasionally got pain in the thighs or in shoulder. She has also experienced gastrointestinal upset when taking Motrin and stopped taking it. Pain with movement of shoulder was experienced. Diagnosis is reactive arthritis, (very like from Lymerix), serum sickness and some prolonged soreness at the injection site.   The most recent information received on 3/15/00 reports the condition of the pt as ongoing. The headache persists and she has lost movement in her injection arm but all other symptoms have resolved.
11/2/2022 body aches everywhere, 10/10 all over. Test positive on at home COVID-19 test. For the next week I had pain in my body everywhere, and fever. The fever broke after about a week, but pain continued until time of reporting with weakness. Rheumatologist states that all tests show normal and stated this is likely Long Covid but diagnosed Fibromyalgia and PCP prescribed gabapentin to treat Fibromyalgia. Quality of life has drastically reduced because of infection.
Hives developed two days after receiving Tdap, Rabies, & Ty Vi. Pt managed s/s with BENADRYL.
After receiving Td vaccine, patient's arm became very swollen, patient experienced arm pain and minor fever. Patient was seen by the doctor for the adverse reaction. The reaction resolved within couple of days.
Baby woke up three days after vaccines were given with swelling on the forehead spreading, spreading over the left eyelid to left ear. Worsened a day after - spreading to the right side of face. + itching, no cough, no swelling of lips or inside the mouth. Treated with Diphenhydramine HCL liquid 0.2 ml orally every 6 hours as needed
Information has been received from a healthcare worker concerning a 14 year old female with penicillin, BACTRIM and CEFZIL allergies and a history of attention deficit disorder, who on 31-OCT-2007 was vaccinated with the first dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). No specific details on the vaccination, including dose or route are available. On 31-OCT-2007, the patient experienced shock, swelling all over, and a drop in oxygen saturation to 70 percent, following the vaccination. Healthcare worker reported that the patient was treated with an EPI-PEN, and then hospitalized at an unspecified facility for an unspecified time period. The patient recovered on an unknown date. Follow-up information received via telephone call from the medical assistant indicating that on 31-OCT-2007, the patient received the first dose of GARDASIL, Lot number 0530U and concomitantly received VARIVAX (Merck) (MSD), Lot number 658298/1107U. The M.A. stated that the patient's mother reported that the patient went to the Emergency Room and had been hospitalized. The M.A. stated that the patient was first seen in the doctor's office on 02-SEP-2010. Follow-up information received via telephone call from an office manager in the office where the patient administered the vaccines. The Office Manager confirmed that the patient received the vaccinations on 31-OCT-2007. The Office Manager stated that if the patient had an allergic reaction after she received the vaccinations there was no documentation to confirm this fact. The last time the patient was seen was in December 2007 and the reason given was the patient had an "Office Visit". The Office Manager did not have a date when the patient Medical Records were sent to another physician's office. Shock, swelling all over and a drop in oxygen saturation to 70 percent were considered to be immediately life-threatening. A lot check has been initiated. Additional information has been requested.