chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an unspecified health care worker via a company representative and refers to a male patient of unknown age. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On an unknown date in 2009, the patient was vaccinated with ZOSTAVAX, subcutaneously for prevention from shingles (dose, lot # and expiration date were not reported). On an unknown date, the patient was diagnosed with lung cancer, has half a lung (Lung neoplasm malignant) and had a pulmonary embolism (all at unspecified times since the ZOSTAVAX was administered). It was also reported that the patient had an appointment with the physician on 21-NOV-2017 because he "has a right side mid upper body zoster rash (Rash vesicular)". The patient was immunosuppressed. At the reporting time, the outcome of lung neoplasm malignant and pulmonary embolism was unknown and the patient had not recovered from Immunosuppression and Rash vesicular. No further information provided. The causality between the events and ZOSTAVAX was not reported. Upon internal review, the events Lung neoplasm malignant, pulmonary embolism and Immunosuppression were considered to be medically significant.
Pt. had inj. on 11/17/15. Started noticing redness and itching below site of inj. on 11/20/15. Today 11/24/15, pt. site of redness is 6 1/2 cm wide and 8 cm long down middle of upper arm. Pt. c/o little itching, no pain today. Has done cold compress and 1/2 BENADRYL last night.
Fever; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved.        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.   concurrent medication not provided. Treatment medication not provided. patient states that she received Moderna COVID-19 vaccine and had fever.
PT COMPLAINING OF A SORE SHOULDER ON 3/30/2020 AFTER GETTING A FLU SHOT ON 10/26/2020. Telephonic - pain on top of shoulder. No chronic dz reported but on f/u mentioned that he does have HTN.. Another pharmacist(son?) & his PCP said the shot was given too high, but unk. Pt had shoulder surgery 3-5 yrs ago. Intermittent pain, improvement w/ occ ibu & heat. Worsens when raising hand above head or inwardly rotating. Asking for options to help improve. Disc trying ice no more than 20' at a time, regular use of ibu x 7 days for poss inflammation, APAP, and/or slow gentle movement to strengthen & stretch. Emphasized the importance of pain free ROM. He reported that MD took imaging 1 mo ago, nothing seen. Seeing the MD that did the shoulder surgery could help, but with current COVID outbreak, minimizing elective contact w/ other pts & hcp would be rec. Rec taking ibu w/ food/antacids if chooses to take regularly. Disc poss s/e. Follow up with staff on 4/8/2020, he didn't try any of the things we talked about, confirmed that his shoulder hurt after the shot typical of most shots, but then never stopped. He has been doing a lot of remodeling that has also made it sore. Emphasized again the importance of pain free ROM, he will try the heat more often & ibuprofen more regularly w/ food.
Action taken: Pt brought to assessment tent 10 minutes after vaccination given c/o chest heaviness/feeling odd, along with the shakes and chills.  VS taken and doctor notified of patient arrival. Reviewed Pt. History and any medical problems.  Pt stated she is currently being treated for Sinus Problems and saw her doctor yesterday who encouraged her to get her vaccination today.  She is on a Prednisone taper, and takes HCTZ for BP, and had a cardiac procedure done last year for chest discomfort, and nothing was found.     Discussed with doctor the need to call EMS.  Pt resistant to this but explained that they would assess her and then she could decide what kind of treatment from there. Pt still resistant to having EMS called, but call placed as per protocol.   EMS Arrived and report given. Pt still resistant to being transported to hospital, after approx 15 minutes EMS convinced patient of the risks and needs of being transported versus the risks of driving there herself.  Pt transported via EMS hospital.
Vaccine was administered 7 days after vial expiration date. Parent notified by provider. Provider chosen not to revaccinate. Parent agreed, patient doing well.
I was diagnosed with Lupus at 10 years old and experienced many symptoms between ages 10-20. In my early 20's, my symptoms lessened and I had not had a flare in over 15 years.  The first day after vaccination, mild soreness in my left arm...no big deal, just a vaccine.  By the third day after my vaccination, I realized I was having pain in multiple joints, left wrist, hand and shoulder.  As the days passed, the pain and swelling in my joints continued and spread throughout my entire body.  I tried to wait in out in hopes the issues would resolve themselves.  Finally, after 6 weeks, I realized I was having a flare and made an appointment with my doctor who said she had other autoimmune patients experience the same thing but since it had been so long, she could prescribe steroids (which I had used during other lupus flares in my childhood) and that should resolve things.  I have since had 4 rounds of steroids of varying doses and am on hydroxychloroquine but, as soon as the steroid round ends, the pain and swelling increase again.  I cannot open bottles, have difficulty sleeping due to pain, cannot perform many of my duties at work and am overall able to do minimal physical activity.  My knuckles have turned into dimples and my fingers are 2 ring sizes larger than normal.  Prescriptions listed below.  This is the most expensive free vaccine I've ever received and also has had the most negative impact.  I sincerely hope we can stop the Lupus which remained dormant for the last 15 years before vaccination.  This has the potential to have major long term health impacts.  4/29/21: 20mg prednisone for 4 days, 10 mg for 3 days 5/10/21: 20mg prednisone for 4 days, 10 mg for 3 days 5/28/21: 40mg prednisone for 5 days 6/8/21: 5mg prednisone for 14 days
The patient was supposed to get 0.25 ml booster dose and was given 0.5 ml dose, No adverse event was noted.
Developed general malaise, low grade fever, body aching which increased in severity until 10/24/2021. Seen in ER due to extreme swelling of left leg.  Diagnosed with Massive dvt left leg, 2 pulmonary emboli right lung. Required placement of IVC filter on 10/25/2021
Parent noted swelling at site of injection on 9/8/23. Approximately 48 hours after injection administered. Developed redness, pain and pruritis as well. Diagnosed with cellulitis Treated with oral antibiotic.
I received the flu shot around 9:15 am. I felt fine afterwards, just had some pain at the injection site. Within 30 minutes, I started to feel light-headed, my vision started to lessen, and I felt extremely nauseous. I sat down and let a pharmacist know that I felt like I was going to pass out. She commented on how I had no color in my face; I was really pale. It felt like my whole body was going numb and that I could vomit at any moment. I vomited once and felt better after doing so. Within seconds I had another round of lightheadedness and almost passed out, but vomited 5-6 times right after that feeling. It felt like I was going in and out of consciousness. My forehead was sweaty and my body felt cold. A pharmacist got me a glass of water to drink after the nausea went away, which was right after the last time I vomited. I proceeded to sit for at least the next hour and a half while drinking Pepsi. I also tried walking around, but I still felt lightheaded. I called my mom during that time to find out if I actually have received the flu shot before; I thought I had received it before. She told me she has never allowed me to have the flu shot, so this would've been the first dose of the flu vaccine I've ever received. I also talked with my dad about the incident and he said in the 1980s when he received the flu shot, he experienced nausea and vomiting as well, but stated that he no longer experiences nausea or vomiting after receiving the shot. I am reporting this very soon after the incident. It is almost 11:30 am and I still feel light-headed and not ready to walk around.
Total body aches - especially joints; feeling extremely tired. Impacted ADL - Significant Mobility impact. S&S started early morning 4/12,  unable to sleep due to pain. c/o S&S 4/13 - 4/16, unresolved as of this submission.  Son is a physician and advised to take Aspirin for pain.
44 days after 1st dose and no 2nd dose yet; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (44 days after 1st dose and no 2nd dose yet) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (44 days after 1st dose and no 2nd dose yet). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (44 days after 1st dose and no 2nd dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Unknown) with no associated adverse events.
Cellulitis reaction to R thigh, also urticaria - treated with BENADRYL PO and ice to area.
3cm induration left deltoid, red, warm, slightly edematous. Tenderness and itchiness according to patient. 6/13/06: Follow up telephone report from patient: Induration decreased to 1cm. Continues to itch, however improving.
After each vaccine she had a fever off and on for 2 weeks complete regression of speech and motor skills would get worse after each vaccine after the 6 month of age Used to say Momma & Dada at 6 month then stopped Both girls shared similar symptoms. They were meeting all developmental milestones until 6 months of age when we first saw a difference in their behavior. Days of fever, uncontrollable crying, and swelling at the injection site occured with each vaccination they recieved. Following their 3/20/2019 (MMR/DTAP/PCV13) vaccines, symptoms dramatically worsened. They stopped responding to their names, stopped letting people hold/console them, loss of eye contact, baby babble stopped even basic "ma ma" and "da da". Immune problems occured, sick more often, loose bowel movements, crying holding their abdomens, severe diaper rashes, banging their heads on the floor and walls, overwhelmed by noises (sensory issues), flicking of items with fingers. These symptoms prompted us to pursue speech and occupational therapy for the girls. at which time they were diagnosed with a developmental delay from medical professional
blood clot; lymphadenopathy; unable to walk without a cane; her left leg swelled up dramatically; painful leg; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (at the age of 69-years-old) as single dose for COVID-19 immunisation.  Medical history and concomitant medications were not reported. It was reported that patient received Pfizer shot a few weeks before reporting. Within 3 hours her left leg (she was inoculated on the left side) swelled up dramatically - - it was painful. Subsequently - a doctor discovered numerous blood clots in that leg; then a blood clot in one of her lungs. She was being treated but the lymphadenopathy has not subsided in her leg and she was now unable to walk without a cane. Lymphadenopathy was not resolved; the outcome of the other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
"Covid arm"   9 days after vaccine administered a small 2" red dot appeared at injection site with a larger patch of red on round part of shoulder,  in subsequent days the red patches merged to one large patch
Pfizer vaccine has 8 days past its beyond used date. BUD was 4/29 + 2 days allowed temperature excursion per pfizer drug safety representative. Administered on 5/9/22. Product was refrigerated at appropriate temperature for the 10 weeks and 10 days.
Skin rash - Hives  All over the body - Doctor prescribed  - Zyrtec twice daily and  use of Triamcinolone ointment  to the area where  redness or itching is observed.
Some malaise first week; ocular migraines-brief; woke up one day with rash on breasts for 2 days; usually get with fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Some malaise first week), MIGRAINE (ocular migraines-brief), RASH (woke up one day with rash on breasts for 2 days) and PYREXIA (usually get with fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Some malaise first week), MIGRAINE (ocular migraines-brief), RASH (woke up one day with rash on breasts for 2 days) and PYREXIA (usually get with fever). At the time of the report, MALAISE (Some malaise first week), MIGRAINE (ocular migraines-brief), RASH (woke up one day with rash on breasts for 2 days) and PYREXIA (usually get with fever) outcome was unknown.            No concomitant medications were reported. No treatment information was provided for the events.   This case was linked to MOD-2021-080820 (Patient Link).
Full body aches all night long, then fever of a 102.3 followed by chills, also headaches, feeling of low energy
Grandma noted moaning, jerking, & frothing @ mouth; Taken to ER-temp 104; child exam & blood work done & placed on cardiac monitor; Exam showed red throat rest of exam normal;
pt recvd vax 28OCT91 & on 28OCT91 pt exp pain, edema & erythema in lt elbow & lt upper arm; tx included PDH & ice pack & sling; no further details were reported;
Tingling hands, Feeling weak and tired Patient alert and oriented noted with tingling sensation in both hands at around 5:35 pm, 6 minutes after being vaccinated for 1st dose of PFizer CoviD 19 vaccine. Vitals signs taken BP 156/96, HR 115, RR 20, T 98, O2 sat 98% RA. Patient offered beverage and tolerated well. Patient was monitored, Vitals re checked as Follows: BP 129/80, HR 105, RR 18, O2 sat 99% RA. At around 6:05 PM Patient verbalized that tingling was gone, monitoring continues, pt. noted anxious at all times. Patient states that he is taking Citalopram 30 mg For 2 years. Vitals rechecked at 7 PM BP 148/88, P 134, RR 20 MD evaluated pt with recommendation to send pt to ER For Further (monitor) evaluation. EMS arrived at 7:22 pm and take over the pt. Patient left Ambulating with Wife and EMS.
Initial report received from a consumer on 23 August 2010. A 60-year-old female patient, with a history of osteoporosis and on hormone replacement therapy, received on 22 August 2010 the 4th dose of intramuscular (IM) deltoid IMOVAX Rabies (lot number unknown). The patient had a cold and cough at the time of vaccination. One hour after receiving the 4th dose, she experienced neck stiffness and pain in the lower back, knees and both hips. She received IMOVAX Rabies (dose 0) and Immune globulin in the Emergency Room (ER) on 08 August 2010, IMOVAX Rabies (dose 1) on 11 August 2010 and IMOVAX Rabies (dose 3) on 15 August 2010. The outcome was reported as unknown. Documents held by sender: None.
This report describes the occurrence of Lyme disease in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant for prophylaxis. This report was received from the subject and has not been verified by a physician or other health care professional. The subject's medical history, concurrent conditoins and concurrent medications were not reported. On an unspecified date, the subject received his first injection of LYMErix. At an unspecified time post-immunization, an unspecified Lyme disease test reflected a "positive" result.
Injection at 10:00 by 4:00 pm she was dizzy felt like she was going to pass out. At 4:30 she started to have uncontrollable muscle spasms that quickly spread to tics over her entire body below the neck. She complained of nausea, severe stomach pains, fatigue, and loss of appetite. Tics continued in her arms, legs, and abdomen several days.
Information has been received from a nurse practitioner referring to an approximately 76 year old female patient with no pertinent medical history or drug allergies. On 16-APR-2007, the patient was vaccinated with 0.65 ml dose of ZOSTAVAX (lot# reported as 0015U, expiration date August 2015) via subcutaneous route. The patient was also on unspecified medications and supplements, described as "multiple pages of medications". Approximately in 2015 (reported as "8 years later"), the patient had a case of shingles. No lab diagnostics studies were performed. The nurse practitioner reported that the patient's present status was not "completely recovered", with a "a little bit of hypersensitivity in the areas" (unspecified which areas, event onset date not reported). Causality assessment was not reported. Additional information has been requested.
It started out with body aches and tiredness. Within a day or two I started having severe chills, and a fever. On the fourth day it turned into cold like symptoms. I started having a cough. I have never been as cold as I was that day with chills. I could not warm up. My teeth were chattering. I had two blankets on, a jacket, a sweatshirt, and my dog next to me and I still could not warm up. I did a virtual visit with my doctor on 11/1/2021, and she scheduled the COVID-19 test that afternoon. It came back positive on 11/4/2021. They just told me to take fluids, and Aspirin to control my fever. I still have a little bit of a lingering cough, but I am pretty much recovered.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 10-APR-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and time of excursion was 1.11 degrees C for 64 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
big circular rash showed up on my left arm at the exact injection spot exactly a week after the 1st dose vaccination. it was painful and itchy and red for about 4 days  then subsided after about a week
Child woke up on the morning of 5/2/13 with redness over the injection site of varicella given on the left thigh.  Looked like a small hive per mom.  Was observe and throughout the day seem to be getting a little bigger.  This morning are was more firm and red.  Maybe a little painful.  No fever.  In office found to have firm area beneath skin.  With superficial erythema and tenderness.  Still no fever.  As a precaution treated with cephalexin for possible cellulitis.  No vesicles present.
A report has been received from a Pharmacy concerning a 12 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 15-OCT-2014. The patient experienced multiple patients received FLUMIST Quadrivalent and tested positive for Flu A which started on 06-DEC-2014. The outcome of the event of multiple patients received FLUMIST Quadrivalent and tested positive for Flu A is unknown. The report was considered to be non-serious.
patient accidentally received FLUZONE QUADRIVALENT after an excursion with no adverse event; Initial information was regarding an unsolicited valid non serious case was received from a nurse via Medical Information (Reference number- 00813179) and transmitted to Sanofi on 14-Oct-2021.  This case involves a 56-year-old female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] that was reported in a past excursion was accidently used (product storage error).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 11-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (once, suspension for injection, lot UT7315JA, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to product storage error (latency: same day).  It was reported "FLUZONE QIV that was reported in a past excursion case was accidently used on two patients even though they were no longer suitable for use".  At time of reporting, no adverse event reported.    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.
Pt received tdap I'm not sure the manufacturer, as it did not occur at my facility. Almost immediately had severe pain and a week later has pain and limited mobility
Pt states she developed red, raised, scaly rash approx. 3" in diameter around injection site. Rash still present on 9/27/07. Also with rash on forearm and abdomen since vaccine.
red marks under skin on right leg; red marks under skin on left knee; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red marks under skin on right leg) and ERYTHEMA (red marks under skin on left knee) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced ERYTHEMA (red marks under skin on right leg) and ERYTHEMA (red marks under skin on left knee). At the time of the report, ERYTHEMA (red marks under skin on right leg) and ERYTHEMA (red marks under skin on left knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment information was provided.
Information has been received from an article on the internet reported by a mother, who's daughter, two years ago, was vaccinated with GARDASIL. Subsequently, the patient experienced an "irregular Pap" 2 years after the vaccine series. Medical attention was unspecified. At the time of the report, the patient's status was unknown. No further information is available.