chrisvoncsefalvay/vaers-outcomes huggingface dataset:
when lift arm it bothers her a little bit; knot at injection site; warm to touch; arm is itchy; redness; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (when lift arm it bothers her a little bit), VACCINATION SITE NODULE (knot at injection site), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (arm is itchy) and VACCINATION SITE ERYTHEMA (redness) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (when lift arm it bothers her a little bit), VACCINATION SITE NODULE (knot at injection site), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (arm is itchy) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, LIMB DISCOMFORT (when lift arm it bothers her a little bit), VACCINATION SITE NODULE (knot at injection site), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (arm is itchy) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
SHIVERING, FEVERISH, COUGHING, HEADACHE, PAIN  ON LEFT ARM (TIGHTNESS OF MUSCLES ON LEFT ARM)
Patient is a 70-year-old female with history of atrial fibrillation on Eliquis and Plavix, hypertension, hypothyroidism presenting to the emergency department via EMS from home for altered mental status and decreased oxygenation.  Patient has been feeling well for the past 3 days, she went to take a nap today and rolled out of bed, her sister who she lives with heard her and called 911.  Upon EMS arrival to patient's home, they found patient's oxygen to be in the low 80s, they placed her on a nonrebreather with an oxygen saturation in the 90s.  Patient denies any injury or pain from rolling out of bed.  She does states she has had a cough and fatigue over the past 3 days along with decreased appetite.  She denies nausea, vomiting, diarrhea or abdominal pain.  She does not normally wear oxygen at home.  She is somewhat a poor historian as she keeps falling asleep during my exam. Associated Symptoms: bruise easily, cough, fatigue, shortness of breath, weakness
No adverse reaction. Dose is not approved for under 18 and patient is under 18.
5/4/21 woke up with L arm pain and numbness and tingling; unable to lift arm above head
Information has been received from a licensed practical nurse concerning a 11 year old female who for "school and other requirement", on 01-FEB-2011 was vaccinated SC with the second dose of VARIVAX (Merck) (lot # 668473/1187Z). The patient was also given a dose of ADACEL on the same day. The doses were given in different arms. On 01-FEB-2011 the patient experienced an immediate reaction to the VARIVAX (Merck) at the injection site that looked like hives. The patient was given antihistamine and sent home. On 03-FEB-2011, the patient came back with a reaction to both injection sites. The VARIVAX (Merck) injection site was aggravated and the ADACEL injection site was bright red at that time. The patient was given CLARINEX as treatment. The patient was recovering at the time of this report. Follow up information has been received from the licensed practical nurse reporting that the 11 year old female patient with no pre-existing allergies or medical history or illness at the time of vaccination who on 01-FEB-2011 at 10:00 am was vaccinated SC into right arm with the second dose of VARIVAX (Merck) (lot # 668473/1187Z). The patient experienced swelling/edema immediately around the injection site. Redness/edema > 6 cm persisted one week following. On 11-FEB-2011 the patient recovered from the events. No further information is expected.
The Saturday after Thanksgiving, my eyes were doing a crossing thing. When I left Thanksgiving, I was having a hard time seeing. I had vertigo the Saturday morning after Thanksgiving. I lay down and everything started to spin around. I had my annual exam set up so When I saw my PCP, he said it seemed like there was a muscle in my eye (left) that it isn't working properly so I was referred to have an MRI. I'm still waiting to get called to schedule my appointment. He also suggested to have a brain scan.
Janssen vaccine for those 18 years and older.  This patient was only 17 years old.
The morning after receiving the vaccine, patient woke up with with numbness and weakness on right side of body.  The numbness and weakness has persisted to the present day (4-22-21).
Patient described some minor dizziness and remained seated while speaking with me. Less than 2 minutes later patient experienced syncope losing consciousness for less than 1 minute. Patient described feeling faint.
Pt felt fine post TD shot. Finished augmentin 500 mg antibiotic on 03/13/2002. On 03/14/2002, pt woke up at 5am itching all over, started swelling, especially in face, neck, tongue. Had a hard time swallowing so took ibuprofin and called MD at 9am.
had shots, the two new, still got shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient stated that he/she had 3 shots the old and then the two new and still got shingles. The patient also stated that it erupted in April (unspecified year) and he/she was still dealing with them in September (unspecified year). Not fun. Additional supportive information: This case was considered as suspected vaccination failure as details regarding the time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Rash around injection site; Headache; Hot flashes; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 10:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included cyclic vomiting syndrome and hepatitis c with 0 viral load. Concomitant medications included naloxone hydrochloride, buprenorphine hydrochloride (SUBOXONE) for unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 11:45 the patient experienced rash around injection site, headache and hot flashes. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events rash around injection site, headache and hot flashes were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1st adverse event was on the night of the injection-  typical fever and chills, headache and some numbness to the superficial portion of skin. 2nd adverse - replase of fever and chills and increased headaches on 5/21/2021 3rd adverse - pain in left leg from back of thigh, headaches, and increased superficial numbness on 5/24/2021 As of today the numbness is still prevalent, pain in thigh still prevalent, and headaches are still present but not as strong
9/8/21 pt had a positive COVID test in Hospital; pt asymptomatic for COVID, no treatment required; was transferred to another Hospital for SDH; developed mechanical aortic valve requiring anticoagulation; developed worsening SDH on right side; had an emergent decompression craniotomy; developed seizure activity; intubated; sputum cultures grew Klebsiella pneumoniae; suffered refractory shock; acute renal failure; developed pulseless ventricular arrhythmia; CPR performed without good results; pt expired in the hospital
On 2/6/21 I experienced headache, fatigue, fever, chills, and body aches. along with sore arm on injection site.  This lasted 24 hours.  On  2/19/21 I noticed continued soreness in my arm on the injection site.  I also began noticing itchiness.  I now have a spotty rash all over the same arm along with itching and soreness.  It looks like hives.  It is localized to the arm of the infection.  I did not experience these side effects, other than a sore arm, after the first dose I was given on 1/8/2021.
Case number PHEH2014US0004534 is an initial spontaneous report from the consumer received on 21 FEB 2014. This report refers to a 12-year-old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 006031A, expiry date: JUN 2014) 28 DEC 2013. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indications as "adult product administered to child".
Patient reports fever, chills, nausea. Patient feels weak and just generally unwell. Patient is also vomiting, but it's minimal.
Day 1 - sore injection site; Day 3-10= sore right knee/right knee has arthritis.
erythematous pruritic rash  over lower back and legs. No upper extremity involvement
chills; shaking; body aches; joint pain; mild fever; awful headache; felt nauseous; This is a spontaneous report from a contactable pharmacist. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP-6955) via an unspecified route of administration in the left arm on 02Apr2021 at 13:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disease.  Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unknown indication and from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL 3247) via an unspecified route of administration in the right arm on 11Mar2021 at 13:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 02Apr2021 after receiving the second dose, the patient felt fine initially and went to sleep. On 03Apr2021 at 01:00, the patient woke up with chills, shaking, body aches, joint pain, mild fever, awful headache and felt nauseous. It was lasted all through the day and the patient slept all day. The patient was feeling better at the time of the report. The patient received treatment for the reported events which included tylenol. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events chills, shaking, body aches, joint pain, mild fever, awful headache and felt nauseous were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Headache for 8 days, shooting pains in head and all joints for 2 days,  every muscle in body for 8 days so far. Pain in entire chest area left side from neck to waist on 6 & 7th day. Left arm is painful...big red blotch by injection site getting bigger everyday. On 7th day pain in left arm/chest area increased with numbness, heaviness & tingling.
Patient received the Moderna vaccine on 2/6/2021 at approximately 11:35 a.m. She was observed for thirty minutes post vaccine and no problems were reported. At 13:27 patient reported having an allergic reaction to the vaccine. She was assessed and found to have hives on the posterior aspect of both arms and the posterior left leg. She was not having any breathing difficulty, lungs were clear and her vitals were normal. She was given 25 mg Bendaryl  IM and monitored for 30 minutes more, in which the itching had stopped.   This patient went to Urgent Care approximately 4 hours later stating her symptoms reoccurred. She was given one dose of 50 mg Benadryl IM and one dose of prednisone 60 mg PO, monitored, and discharged.
Information was received on 29-JUN-2017 from a nurse practitioner who was reporting on a 51 year old patient (gender not reported). No medical history or concomitant medications were reported. The nurse practitioner reported that on 28-JUN-2017, the patient was inadvertently administered a dose of PROQUAD (lot, expiration, dose and site not reported) for prophylaxis. No adverse effect reported. No other information was reported. Additional information has been requested.
Information has been received from a physician concerning a 60 year old male with benign prostatic hyperplasia and hypertension who on approximately 02?-AUG-2010 "last week" as vaccinated with ZOSTAVAX (Merck) (therapy dose, route and site unknown). On 09-AUG-2010 the patient was complaining of "burning sensation" on his rib cage. The physician stated that the patient had pain indicated as being a "6/10 on a pain scale". The patient sought medical attention. The patient did not have a rash or any blisters, but the physician believed this was a precursor to shingles. At the time of this report, the patient had not recovered. Additional information has been requested.
3 days p/vax low grade fever (T max 100), noc sweats & cough;this lasted about 1wk;noticed rt eye redness & clogged ears;rt eye redness resolved;seen by family MD dx w/fluid in both ears;some  dizziness also noticed;
pt recvd vax & was screaming; unconsolable X 48 hrs; fever 102.6; seen in ofc; yel fluid behind ear; placed on atb;
Janssen J&J dose given out of age range. Patient is 17 years old.
Information has been received from a consumer concerning her approximately 15 month old son who "at about 15 months of age" in approximately December 1992, was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  After vaccination with the first dose, the child stopped walking for about three weeks.  He was then given booster doses of the monovalent components of "MMR" without incident.  Unspecified medical attention was sought.  Additional information has been requested.
This spontaneous report was received from an unspecified source via published article referring to a 900 unspecified children of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown dates, the patients were vaccinated with a dose of GARDASIL (strength, dose number, route, frequency, lot number and expiration date were not provided)  for prophylaxis, through a free or low-cost vaccine program. It was reported that during a routine compliance visit, problems with refrigeration temperatures were discovered. Also, it was reported that the vaccines were not stored properly at the right temperatures, which possibly reduced their effectiveness and the temperature problems may had occurred as early as November 2014. The children who should be evaluated for revaccination were vaccinated between November 2014 and 28-JUL-2016. Additionally, it was reported that the possible ineffective vaccines did not pose any health dangers to the children who received them but those children may not be fully protected against vaccine-preventable diseases. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA005965: US-009507513-1701USA005969: US-009507513-1701USA004881: US-009507513-1701USA005968: US-009507513-1701USA005964: US-009507513-1701USA005966.
Patient had red, swollen deltoid area of injection site. Area was slightly warm to touch and patient said it hurt to raise arm. Red, swollen area was approximately size of her deltoid muscle.
Male patient recruits at the Clinic, were given expired Pfizer vaccine with the lot number FF2587. The original expiration date was DEC 2021 and was extended 90 days to MAR 2022. The Pfizer was 4 days past the expiration date when given. No adverse signs and symptoms noted, appropriated providers notified. Patients are currently being monitored for any other reactions. Pfizer has data to support stability of the lot number FF2587 through JUNE 2022.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 04-NOV-2014, the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent a temperature excursion (on an unspecified date). This is one of several reports received from the same reporter. Additional information has been requested.
Erythema and swelling at left arm injection. Treated with Zithromax Pridiapred x 3  days.
Patient did not feel well after injection, MD states that he either had a reaction to the vaccine or a localized cellulitis. Skin rash and chills. Ibuprofen 600 mg PRN.
soreness at the injection site; tender lump on her L armpit; tender lump on her L armpit; tightness around L arm (as if there was a rubber band around it); bruising on her L arm which extended to her L breast; This spontaneous case was reported by a consumer and describes the occurrence of SKIN TIGHTNESS (tightness around L arm (as if there was a rubber band around it)), CONTUSION (bruising on her L arm which extended to her L breast), VACCINATION SITE PAIN (soreness at the injection site), TENDERNESS (tender lump on her L armpit) and AXILLARY MASS (tender lump on her L armpit) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced SKIN TIGHTNESS (tightness around L arm (as if there was a rubber band around it)), CONTUSION (bruising on her L arm which extended to her L breast), TENDERNESS (tender lump on her L armpit) and AXILLARY MASS (tender lump on her L armpit). On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, SKIN TIGHTNESS (tightness around L arm (as if there was a rubber band around it)) had not resolved, CONTUSION (bruising on her L arm which extended to her L breast), VACCINATION SITE PAIN (soreness at the injection site) and TENDERNESS (tender lump on her L armpit) had resolved and AXILLARY MASS (tender lump on her L armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment for the event included paracetamol, diphenhydramine and ibuprofen.   Company Comment: This case concerns a 31 Y/O F with nonserious events of unexpected contusion and skin tightness, and expected vaccination site pain, tenderness and axillary mass.  Event onset Day 3 after first dose mRNA-1273. Events resolved, but skin tightness ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a 31 Y/O F with nonserious events of unexpected contusion and skin tightness, and expected vaccination site pain, tenderness and axillary mass.  Event onset Day 3 after first dose mRNA-1273. Events resolved, but skin tightness ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
On 08/28/2021, I went on a 45 minute by ride and I was feeling off. By Sunday, I had on and off fever, flu like symptoms-body aches , Sunday night -cough.  Monday, 08/30/2021,  I called the doctor by telehealth,  and they prescribed steroid and z-pack . I started taking it Monday, 08/30/2021 in the afternoon. I was  miserable Mon, Tues,  & Wed. I started feeling better by Friday.  I stopped taking the steroids  on Friday.  I was a bit puny a week after that. I quarantined 10 day after my 1st symptoms. By Tuesday I was released and I went back to work on Wednesday, 09/08/2021. Back to pretty much normal.
arm was super hot and burns; arm was itchy; arm was swollen; arm was red; feels very tired; arm was super hot and burns; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (arm was super hot and burns), VACCINATION SITE PRURITUS (arm was itchy), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE ERYTHEMA (arm was red) and FATIGUE (feels very tired) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (arm was super hot and burns), VACCINATION SITE PRURITUS (arm was itchy), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE ERYTHEMA (arm was red), FATIGUE (feels very tired) and VACCINATION SITE PAIN (arm was super hot and burns). At the time of the report, VACCINATION SITE WARMTH (arm was super hot and burns), VACCINATION SITE PRURITUS (arm was itchy), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE ERYTHEMA (arm was red), FATIGUE (feels very tired) and VACCINATION SITE PAIN (arm was super hot and burns) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Patient took Tylenol and Benadryl for treatment.
3 1/2 hrs after vax, pt developed congestion, difficulty breathing, purulent mucous membranes, face swollen, coughing - took antihistamine - sx began to subside approximately 3am - groggy following day.
PAIN IN SHOULDER AND DOWN THE ARM THAT INCREASED AS DAYS WENT BY WITH NUMBNESS IN FINGER TIPS--STILL CONTINUES ON DEC 10 BUT HAS LESSENED A BIT RECENTLY--PROBABLY ADMINISTERED TOO LOW IN ARM RESULTING IN NERVE INFLAMMATION.  IT STILL PERSISTS.