chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received PEDVAXHIB, PEDIARIX, and HAVRIX at the same time. / follo-up visit during the past 2 weeks the physician noticed a patch of hair had grown in the spot on the patients thigh where all these products had been administered; This spontaneous report was received from a physician referring to a female patient of unknown age. The patient's concurrent conditions, medical history or concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (lot#, expiry date, dose and route of administration were not provided), diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) (lot#, expiry date, dose and route of administration were not provided) and hepatitis a vaccine inact (HAVRIX) at the same time.  On an unspecified date in August 2023 (reported as "past 2 weeks") during a follow up visit the physician noticed a patch of hair had grown in the spot on the patient's thigh (unknown if left or right thigh) where all three of these products had been administered (hair growth abnormal).  At the time of the reporting the outcome of the vent was unknown. The causal relationship between the event with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) or the suspect therapies was not provided.
Starting 11-11-15 client developed pain, erythema and moderate swelling at the (L) lower deltoid site, client also reports fever of 100.0 F. Recommended 800mg Ibuprofen Q 8 hours x 24-48 hours and ice packs to site TID. Reevaluate on 11-13-15.
Stiffness; Vaccination site reaction; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness), VACCINATION SITE REACTION (Vaccination site reaction) and VACCINATION SITE PAIN (Vaccination site pain) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    There was no reported medical history.    On 12-Apr-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness), VACCINATION SITE REACTION (Vaccination site reaction) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness) was resolving and VACCINATION SITE REACTION (Vaccination site reaction) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.            No Concomitant product use was reported.  The patient reported that they felt stiffness was coming back when over did yard work, with each Covid 19 vaccine site reaction was larger and lasted longer and soreness at Covid 19 vaccine site resolved. The patient reported that, if the patient over did yard work could feel stiffness was coming back. The patient had covid-19 vaccine site reaction with each covid-19 vaccine, it was larger and lasted longer. The patient had soreness at vaccination site except for the second booster and no reaction at all. It was unknown if the patient was enrolled in a COVID-19 Vaccine.  No treatment information was provided.   This case was linked to MOD-2022-580273 (Patient Link).
Caller stated that she noticed a red knot around the injection site the size of a 50 cent piece coin. The area is red and warm.
Fever and irritability for 2-3 days. Gave tylenol and motrin
Reportedly developed urticaria one following immunization with DTaP and Hepatitis B vaccines.  Symptoms lasted approximately one hour.  Later in the evening after taking a hot bath, the rash returned.  She took Benadryl and the rash resolved 30 minutes later.  She had no facial swelling or airway involvement.  She has no known allergies.  She does describe a prior occurrence about one year ago.  No trigger was identified at the time.  She was referred to clinic for recommendations regarding further vaccinations.
Initial unsolicited report received from a consumer (patient) on 08 MAR 2017. This case involves a 72-years-old female patient who was vaccinated with a dose of FLU SHOT and PNEUMOCOCCAL VACCINE (manufacturer: unknown, batch number, dose in series, dose, route and site of administration was not reported) on 28 February 2017. The patient reported having ongoing orthostatic hypotension, low blood sodium and kidney issues (which started before PRALUENT therapy). The patient had a medical history of minor palpitations for a long time prior to PRALUENT, the patient stated that due to the palpitations and chest pain, she had a CT scan towards the end of 2016 which showed that the heart had over 70 percent of blockage in the LAD artery where she had a stent placed in 2014 (exact dates unknown). The patient also stated that shortly after 29 Dec 2016 (exact date unknown) she went to see her electrophysiologist who advised her to "wear a monitor for thirty days.", but lately the heart palpitations have been intense and wake up in the morning (exact time frame of events unknown). The palpitations go on for a period of several hours. The patient reported that the palpitations occur about every two or three days and were not always as intense. The patient reported that the "palpitations go on for a period of several hours." She stated that "the rest of the day she had chest aches and became very fatigued" (exact duration of symptoms unknown). In Jan 2017, started having a lot of different symptoms and was not feeling well (exact time frame of events unknown). Concomitant medications included PRALUENT (batch number- 6F052A, expiration date-30 Jun 2017) 75 mg injections every two weeks on 10 Jan2017 for cholesterol, with the most recent injection on 8Mar2017. The patient stated that she has had a total of five injections at the time of this report, with the first injection given into the stomach and the rest of the injections given into the thigh. The patient reported that while injecting the medication into the thigh per IFU on 8Mar2017. On an unspecified date, since vaccination, the patient was feeling sick and arm with the pneumonia vaccine got so sore and red and was getting to be a round hard spot that were still really sore. The patient was referred to her physician for consultation. Corrective treatment was not reported. The outcome of the event was not recovered. List of documents held by sender: none.
Lymphadenopathy (adenopathy) under the left armpit. Off & on, more painful during the beginning of the side effect (days 3-7 after vaccination). Onsets at random at this point, latest being 10 weeks 2 days after vaccination on July 15th. Unsure if it will continue. Other side effects I had during /after dose 2 from May 4th- (about) May 11 were reported.
Triggered mild/moderate symptoms; This spontaneous case was reported by an other and describes the occurrence of MALAISE (Triggered mild/moderate symptoms) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced MALAISE (Triggered mild/moderate symptoms). At the time of the report, MALAISE (Triggered mild/moderate symptoms) outcome was unknown.            No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.
warmness under the sternum; felt like throat was closing up; blood pressure went lowat time of the vaccine administration; heart racing, heart rate was (93-103); arm soreness; fatigue; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of   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 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with LORAZEPAM (ATIVAN) on 24-Dec-2020 for Adverse event, at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 24-Dec-2020, the patient experienced symptoms like warmness under the sternum, felt like his throat was closing up and blood pressure went low at time of the vaccine administration. He was laid down by the vaccine provider and for about 15-20 mins felt better and he was released to go after. He stated he refused to get blood sugar checked while at the vaccine site and did not eat breakfast or drink anything before getting the vaccine. He experienced fatigue, mild headache, arm soreness, heart racing, heart rate of 93-103 and took half of lorazepam and laid down until about 8pm on same day as first dose vaccination. Concomitant medications were not provided.
This is a spontaneous report from a contactable physician received via a sales representative who reported the same events for 3 different patients. This is the 3rd of 3 reports. A 14-year-old patient of an unspecified ethnicity and gender received TRUMENBA on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chills, fever, headache, malaise, all on an unspecified date with unknown outcome. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016449736 Same reporter/drug/events, different patient; US-PFIZER INC-2016449750 Same reporter/drug/events, different patient.
fever of 105 w/in 24hr p/vax shaking & crying in sleep;devel vomiting PM 27FEB97;
Dose 1: immediate swelling, redness and pain at injection site. Resolved approx 1 week. Pharmacist concerned about allergic reaction. Dose 2: swelling, redness and pain at injection site approx 2 hrs later. Pharmacist recommended watching for allergic reaction, take Benadryl as needed, and report if necessary.
10 minutes after shot  right arm felt itchy just for a moment progressed felt left side chest tightness . No one checked me when it was time to go  and thought maybe it was nerves... so waited in parking lot for a few minutes. 25 minutes later chest tightness stayed and gland in neck , throat felt swollen and stiffness  in my neck.   Drove home felt a little better. Few hours later around 6pm I started using my inhaler for tightness in chest and dry coughing.   NEXT DAY 8;30 -9:00 am while in classroom felt dry coughing more persist and while wearing mask and dizzy. Chest tightness returned and felt tired and sickly. Went home about 10:00 with eyes stinging and felt feverish.  Temperature 100.3 and flushed face, tingly and numbness on left side only when I itched my face (like when novacaine wears off from the detist)   within an hour fever and numbness disappeared. Napped for 3-4 hours. Used inhaler several times for  tighnerss and dry cough , swollen glands in neck.  Next day Thursday  same thing: tight in chest, dry cough, and glands felt swollen. Used inhaler 5-6 times due to terrible chest pain across chest.  Continued for week . 4/22  added sinus infection simptoms: went to dr and have a phone visit instead of walk in while sitting in my truck DR was not available so I talked with nurse practisioner.  She ordered Z pack for 5 days.  Fixed sinus infection temporarily but not my chest. Called Dr on Friday 4/30 and she said it was too late in day that I should have chest xrays. Went to Urgent Care with coughing  attacks  and still tighness in the chest. XRAYS  on lungs and EKG on heart was reported to me as fine.  Sent home with Prednisone and broncitus .  Took prednisone for 5 days and symptoms continued: tightness in the chest and attacks of coughing  with a weez in it and still using my inhaler 3-5 times a day until current status. I feel like I still have bronchitis's and do not know if I should get the second shot today. ???? No one will help me other than saying it is probably an allergic reaction to the shot???  I feel like I have broncial damage???  Doctors just say they understand if I don't want the second dose of the vaccine.
About 10-15 minutes after the vaccine, patient passed out briefly. After she woke up all was fine. Paramedics called as precaution - she refused hospital transfer.
Red rash in 3 areas on upper arm, proximal to injection site. Not raised. Itchy. Hot to touch.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 08-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports form the same reporter. Additional information has been requested.
1st dose of Shingrix on 23Sep2020, 2nd dose on 19Nov2020, and a 3rd dose today (20May2021); This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on 23rd September 2020) and Shingrix with an associated reaction of no adverse event (2nd dose received on 19th November 2020). On 20th May 2021, the patient received the 3rd dose of Shingrix. On 20th May 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional details were provided as follows: The doctor reported that the patient received 3 doses of Shingrix, which led to extra dose administered. No symptoms was reported. No further information was reported. The reporter consented to follow up. The HCP  did not have lot number/expiry date.
Not sure if this needed in Vaers,  But I ended up getting Covid 5 days after my first dose of the moderna. Symptoms include cough, congestion, sore throat, body aches, headaches, loss of smell and fever. Symptoms started 1/11/2020 around 3pm, got tested around 5pm and got the results 1/12/2020 around 8am.
Injection site swelling, warm to touch erythema to the lower lateral third of upper left arm; Injection site swelling; Injection site tissue being warm to touch; Injection site skin with erythema to the lower lateral third of upper left arm; Injection site skin with induration; vaccine was administered Subcutaneous instated of intramuscular; pregnant woman (week 31 of pregnancy ) received ADACEL vaccine; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 34 years old pregnant female patient who experienced injection site swelling, warm to touch and erythema to the lower lateral third of upper left arm (vaccination site inflammation), (vaccination site swelling), (vaccination site warmth), (vaccination site erythema) and injection site skin with induration (vaccination site induration), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].   Data regarding this pregnancy were received prospectively.   Events occurred at 31 weeks of pregnancy.  The date of last menstrual period was not reported.  Estimated date was reported as 09-Jan-2020.  The medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included Influenza Vaccine for Immunization.  On 08-Nov-2019, the patient received a dose 0.5 mL of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6518AA via subcutaneous route in the left deltoid.  On unknown date, the patient developed a non-serious injection site swelling, warm to touch and erythema to the lower lateral third of upper left arm (vaccination site inflammation), (vaccination site swelling), (vaccination site warmth), (vaccination site erythema) and injection site skin with induration (vaccination site induration) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also the case of vaccine exposure during pregnancy and actual medication error due to inappropriate route of vaccination. The patient was 31 weeks pregnant when she received vaccine via subcutaneous route.  Treatment: the consumer came back to the clinic; that cold compress was applied to the area, and the clinic calling the manufacturer.  Pregnancy outcome was unknown at the time of report.  Outcome of the other events was unknown.  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.
Arm is a bit sore; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (167798). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (COMIRNATY) (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 (First Dose), for Covid-19 Immunization; Bnt162b2 (Second dose), for Covid-19 Immunization, reaction(s): "flu symtoms after my second original Covid vaccination". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm is a bit sore".  Additional information: Reporter reported that he got his Pfizer Covid booster today. Arm was a bit sore, but so far no other side effects (got some mild flu symptoms after his second original Covid vaccination, but rather have those side-effects than the virus).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tingling from below behind my knees and down the legs, it is a bubbly feeling; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Apr-2021 and was forwarded to Moderna on 13-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling from below behind my knees and down the legs, it is a bubbly feeling) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-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 PARAESTHESIA (tingling from below behind my knees and down the legs, it is a bubbly feeling). At the time of the report, PARAESTHESIA (tingling from below behind my knees and down the legs, it is a bubbly feeling) outcome was unknown. Not Provided          No concomitant medications were reported. No Treatments were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-074983 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074983:2nd dose
Patient became dizzy 10 minutes after getting the vaccine, she was instructed to sit down and her blood pressure was taken at 3:10pm and was found to be 130/75, which was normal for her. She stated she wasn't experiencing any itching and no visible signs and symptoms of an allergic reaction were observed. At 3:15 she was still dizzy but wanted to go home as she had another person there to drive her. Instructed her to check her blood pressure at home and to call if anything came up. Did a follow up call around 5:30 pm and left a message but no one answered
During the middle of the night she fell out of bed for no reason and hit the floor causing a blood clot to the brain.  Taken to hospital by ambulance and then transferred to another hospital.  After 18 days was transferred to a Rehabilitation facility. As of this date, she still a patient.
mom c/o t105 2 days p/immun;was seen by MD who advised APAP, cool bath & liquids;dx viral infect; mom states pt better on day 3 - fine rash appeared lasting 24 hrs;mom also states that @ about 10 days another rash appeared due to MMR;
Received VARIVAX 4/4/14. Diagnosed with a secondary herpetic infection of the eye in the area of a previous corneal abrasion 6/18/14.
Patient received a shot at 12:12.  This was his second shot in the series.   By 1530, his heart rate was elevated (120 to 130 beats/minute) .  He was afebrile, with no shortness of breath or chest pain.   He came back and reported the problem without wanting to go to the ED.    He decided to go home.  By later on that evening, his heart rate was normal.  To note:  He stated that with his first shot, he had nausea, fever and fatigue.
after recv vax pt on 10/30/98 devel leg swelling described as ``grapefruit'' size
Shortly after my first vaccination I developed a rash on both arms. On 4/13/2021 I thought I maybe having a heart attack and went to the ER. Doctor ordered an electrocardiogram and determined my heart was okay. He observed the the rash on my right arm and determined I had internal Shingles. ( I had the Shingles vaccine in December , 2019).  He prescribed Valacyclovir and Prednisone. They worked on my condition.
Information has been received from two healthcare workers refers to an unspecified number patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with doses of improperly stored ROTATEQ (lot#, dose not reported, orally). Concomitant medications were not provided. No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.