chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was streaky yesterday 08May2022 down her arm, but it's not today 09May2022. It's in the lower part of her upper left arm; It itched and itched and itched; Showed up on her left arm, like a big rectangle of red; It hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (It was streaky yesterday 08May2022 down her arm, but it's not today 09May2022. It's in the lower part of her upper left arm), VACCINATION SITE PRURITUS (It itched and itched and itched), VACCINATION SITE ERYTHEMA (Showed up on her left arm, like a big rectangle of red) and VACCINATION SITE PAIN (It hurts) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 026D21A, 002C21A and 026B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 13-Jan-2021. Concurrent medical conditions included Allergy to animal (Horses), Allergic to dogs (Dogs), Grass allergy and Allergy to animal (Cat).   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2022, the patient experienced VACCINATION SITE DISCOLOURATION (It was streaky yesterday 08May2022 down her arm, but it's not today 09May2022. It's in the lower part of her upper left arm), VACCINATION SITE PRURITUS (It itched and itched and itched), VACCINATION SITE ERYTHEMA (Showed up on her left arm, like a big rectangle of red) and VACCINATION SITE PAIN (It hurts). On 09-May-2022, VACCINATION SITE DISCOLOURATION (It was streaky yesterday 08May2022 down her arm, but it's not today 09May2022. It's in the lower part of her upper left arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (It itched and itched and itched) and VACCINATION SITE PAIN (It hurts) was resolving and VACCINATION SITE ERYTHEMA (Showed up on her left arm, like a big rectangle of red) had not resolved.            No concomitant medication was reported. It was reported that the patient was not given other vaccines within 1 month prior to Moderna COVID-19 vaccine. No treatment medications was reported.   This case was linked to MOD-2022-564453 (Patient Link).
Initial unsolicited report received from a nurse on 23 November 2015. This case involves three patients (age and gender not reported) who was vaccinated with first dose of FLUZONE QIV (batch number: UI431AD, expiry date: 30 June 2016) intramuscularly in deltoid on 27 October 2015. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed pain in the arm muscle and difficulty with ROM for close to a month. The reporter denied actual pain, redness and swelling at the injection site. The patient required ER/doctor visit. Laboratory data was not reported. The patients were prescribed ibuprofen, physical therapy and ROM exercises. The outcome of the event was unknown. List of documents held by sender: none.
Information has been received on 1/31/02 from an RN concerning a pt (demographics unspecified) who "last week" was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt had warmth, tenderness and swelling. The pt sought unspecified medical attention. Two other pts had a similar experience (WAES 0202USA00011 and 0202USA00145). It was reported that 1 of these pts had "swelling down to her elbow, 6" or more" and as of 1/31/02, is still experiencing tenderness and redness. Additional information has been requested.
Pt brought to obs room after getting vaccinated.  Pt vomited, flushing, sweating. BP 103/61, HR 67, RR 14.  12min later, pt reports feeling better w/o symptoms. Able to drink 16oz of water.  Pt reports fear of needles.  Educated pt to let staff know for 2nd dose to be taken to obs room for vaccination.  Pt and family verbalize understanding.  Pt stable and released from vaccination site w/ family.
Employee states she slept for 2 days following vaccine, c/o partial seizures, Temp of 100.7 oral.
vaso vagal reaction   Narrative:  Loss of consciousness X 30 second. Patient was 5 minutes into his minute observation period. Observer noticed patient was tilting in chair and was able to prevent employee from falling out of chair and eased him to the ground in a  supine position. He regained consciousness after about 5 seconds on the ground.  He was orientated to person, place, time. Experienced significant diaphoresis. BP was 130/86 with pulse of 100. Patient remained seated of floor for several minutes. He denied chest pain, change in vision, no headache, with no other symptoms but persistent diaphoresis. He was then moved to a location that he could continue to lay down in a supine position. Patient was advised he should goto Emergency room but choose to be monitored by medical staff in the building outside of the vaccine clinic. The 12 lead ECG was normal sinus rhythm and  choose to go home with his wife who was driving him.
Narrative:  Hospitalized in March for a migraine after the first COVID Pfizer Shot. Hospitalized in March again SOB and wheezing. She attributes this to the Covid vaccines. Booster shot caused generalized hives which she sough medical treatment for and was treated with steroids at an urgent care. Per patient: "Yesterday I went to the Medical Center for the Phizer first dose COVID vaccine. I had a severe adverse reaction. I had a migraine with sensitive to light, and vomiting due to vertigo. I called 911 and went to Hospital. They treated me with Fioricet, Ibuprofen, and Zofran."
Seen in our office on 11/5/08 for a 1 year well check.  Recieved Varivax #1 and Prevnar #4. Woke up on 11/6/08 with right thigh red, warm, and swollen.  Seen in our office on 11/7/08 with cellulitis after vaccine.  Treated with Augmentn.
Information has been received from a physician concerning a 3 year old male who at the age of 7 months (in approximately 2005) was vaccinated with VARIVAX (Merck). Subsequently the patient experienced generalized rash about 10 days after his pregnant mother had developed a generalized rash. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. Follow up information was received through the Varicella Zoster Virus (VZV) identification program which reported that there was odd looking "scabs" on the patient. The sample was inadequate. This is one of two reports from the same source. Additional information has been requested.
pt devel knot rt arm p/vax sl sore x 1wk;no tx states entire lt arm area was big & hard & gradually going down;palpable 1cm firm nodule inc lt arm deltoid area;
I started getting dizzy and slightly nauseated after about ten or fifteen minutes. The dizziness worsened after about 30 minutes but the nausea went away. About 30-40 minutes after the shot, my head got very foggy feeling, my limbs felt heavy and weak, and I suddenly became very tired. I don't have any trouble breathing and my heart rate is fine. I'm just going to sleep it off and drink lots of water.
Patient presenting on 3/18/2019 with severely enlarged left axillary lymph node that was excruciatingly painful to touch. Node smaller but still present today, 4/4/19. On 4/1/19, Samuel presented with left elbow redness, swelling and pain as well as what he described as "neck pain" only when turning his head to the left.
Additional information received on 03-FEB-2003 from a healthcare professional provided additional adverse event information, concomitant vaccine therapy, and recovery status.  Information was received from a nurse concerning a male patient who received FluShield (influenza virus vaccine, trivalent, types A & B (2002-2003 formula) on 19-NOV-2002.  On 18-NOV-2002, he received a booster dose of tetanus toxoid (Aventis).  On 20-NOV-2002, he developed a red, itchy rash beginning on both arms, that progressed to all areas of the body below the neck.  the patient was treated with Claritin (loratadine) which "provided fair results."  the patient was subsequently examined by a dermatologist.  Skin testing and a lesion biopsy were performed.  The physician's evaluation "failed to identify the cause of the dermal eruption."  The patient recovered.
burning /pain in hand the arm then feet . pain moved up shooting pain and stabbing in arms and feet. later numb feeling in hip.. later numb  up to abdomen too and then neck face and jaw pain.
Patient received vaccine on 10/29. Experience soreness for few days but then it started hurting on 11/01. It got progressively worse over the next week. she reports that it is in constant pain and she cannot lift her arm as of 11/08
Information has been received from a certified medical assistant concerning a patient (age and gender unknown), who on 28-AUG-2007 was vaccinated with a 0.5mL dose of PNEUMOVAX 23 (Lot# 658074/0961U).  Subsequently, the patient experienced arm pain, swelling, and redness.  At the time of the report, the patient's outcome was unknown.  This report is one of three reports received by the same source.  Additional information has been requested.
After the first dose the caller got sick and really mean and irritable and out of character; After the first dose the caller got sick and really mean and irritable and out of character; This is a spontaneous report from a contactable other hcp (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included regular aging stuff like sore shoulders and sore hips from an unknown date and unknown if ongoing, arthralgia from an unknown date and unknown if ongoing. The patients concomitant medications were not reported. The patient experienced after the first dose got sick and really mean and irritable and out of character on an unspecified date in Apr2021. This happened 2 or 3 days after the first dose which was on 01Apr2021. Patient could not be around people because she was so sick. It went away within a couple of days. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a nurse via company representative and refers to a female patient (a registered nurse) of unknown age. There was no patient's concurrent conditions, concomitant medications and drug reactions or allergies reported. On an unknown date, the patient was vaccinated with ZOSTAVAX injection (lot#, expiration date, dose, anatomical location and route of administration were not reported). On an unknown date, the patient experienced shingles. No treatment was given and no lab diagnostics studies were performed. The patient did not seek medical attention. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
About 10:00pm on the night of vaccination I started to feel like I had the flu. I was feverish, dizzy and coughing. It continued for over 24 hours. Two days after vaccination I woke up feeling better. I had a mild headache. Where I received the injection it was red and swollen. Everything got better but my arm. By five or six days after the shot the sore arm was gone.
Redness, swelling, itching appeared at injection site "size of coffee cup", low grade fever, "red spots" inside of swollen area. Seen by Dr. recommended ADVIL, cold compresses. Sx subsiding 4 days after shot given.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 18 years old male patient received the third dose of TRUMENBA (NDC number: 0005-0100-01, Lot#R45100, Exp date Jul2018) in the deltoid at 0.5 ml, single on 25Apr2017 for protect against MenB. Medical history and concomitant medications were none. No investigations were performed. The caller stated that the patient received the first dose of meningococcal group b rlp2086 about 6 months before and the second 2 months after the first one. After his second dose of meningococcal group b rlp2086, he experienced pain and fever with outcome of recovered. Approximately 6 to 8 hours after vaccination, that same evening on 25Apr2017, the patient began to experience numbness in his limbs and tingling in his spine. His mother was the prescribing pediatrician so she just kept an eye on him and no treatment was initiated. By the next morning the numbness and tingling were better and then they completely resolved on 26Apr2017.
dizzy and woozy; This spontaneous report as received from a registered nurse via a field representative referring to a 14 years old female patient. Information about pertinent medical history, drug reactions/allergies and concomitant medication was unknown.  On 19-AUG-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose detail, lot # and expiration date were not reported) via intramuscular route for prophylaxis.  On the same date, the patient felt dizzy and woozy. No treatment was given for the event. The patient rested for a couple minutes and recovered in the office on the same date. The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
104.3 AX fever x 24 hr. Used Motrin 1tsp. was instructed to increase to 1 1/2 Motrin every 6 hours. prm, tub bath.
Local pain, swelling, redness. Patient reported only local rxn. to MD. Additional symptoms reported to pharmacist nausea, coughing, difficulty breathing, fever x 4 days. Pt. did not seek medical attention at time of reaction. Reported symptoms to RPh on 2/23/15 and Dr. on 2/25/14.
Patient stated she woke up next day (10/31/2020) at 6:00am and was sweating, had chest pain on right side, had right shoulder pain, and pain up her neck.
Urticaria- Erythematous Wheals all over body + itchiness TX: Benadryl 25mg to tabs PO 4-6 Hrs for itchiness.
I woke up on October 15 in the early hours of the morning with pain on the left side of the neck , fever and pain on my whole body.  Have marks on the neck and painful inflammation.
First Covid vaccine on 8/16/21. Menstrual period started 3 weeks later (which came 1 week early) Heavy bleeding and cramping for 11 days. On Oral contraceptives without missing any pills.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jul2022, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. He had no other medication in 2 weeks. Symptoms of COVID-19 began on 19Jul2022. He received COVID 19 treatment as Paxlovid, started from 21Jul2022 to 25Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from an officer manager referring to a currently 1 year old male patient. No information was provided regarding the patient's medical history and concurrent conditions. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 30-JAN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and anatomical location and route of administration were not reported)  lot # M046004, expiration date: 18-NOV-2018 indicated for prophylaxis. The vaccine had not had any previous temperature excursions as recorded by a data logger. On an unknown date, VARIVAX had temperature excursions of   -14C to -10C  for a time frame of 7 minutes which was called by a data logger. There were no adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1805USA000841: US-009507513-1805USA000922: US-009507513-1805USA000923: US-009507513-1805USA000928: US-009507513-1805USA000925: US-009507513-1805USA000926: US-009507513-1805USA000927: US-009507513-1805USA000924:
0.5ml H1N1 was administrated to patient less than 36 mos instead of 0.25ml.
increased heart rate (86-92); Headache; extreme face flush; This is a spontaneous report from a contactable consumer (patient herself). A 70-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6202; Expiration date: was not reported) via an unspecified route of administration, administered in Arm Left on 23Feb2021 12:00 (at the age of 70-years-old) as dose number unknown, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included hypertension and atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication included hydrocortisone (HYDROCORTISONE) taken for an unspecified indication from 22Feb2021 to an unspecified stop date. Patient had not known allergies. Patient did not receive any other vaccine in four weeks of vaccination. Patient had not COVID prior to vaccination. On 23Feb2021 13:00 the patient experienced increased heart rate (86-92), headache and extreme face flush. Patient did not receive any treatment for adverse events. The patient underwent lab tests and procedures which included heart rate which was increased on 23Feb2021, on same day heart rate was 86-92. Patient did COVID test post the vaccination (SARS-COV-2 test: nasal swab) which was negative on 19Feb2021. The outcome of all events was recovering.  Follow-up attempts are completed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 55-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received and experienced pain in Apr 2018, refer linked case US2018GSK151852). On 4th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 6th August 2018, 2 days after receiving SHINGRIX, the patient experienced pruritus and rash. On 10th August 2018, the patient experienced erythromacular rash. On 11th August 2018, the patient experienced shooting pain. In August 2018, the patient experienced pain in arm. The patient was treated with hydrocortisone and benadryl (nos) (Benadryl). On an unknown date, the outcome of the pain in arm and pruritus were recovered/resolved and the outcome of the shooting pain was recovering/resolving and the outcome of the erythromacular rash and rash were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, shooting pain, erythromacular rash, pruritus and rash to be related to SHINGRIX. Additional details were provided as follows: On 10:05 AM, the patient received 2nd dose of SHINGRIX on right arm. Less than a day after receiving SHINGRIX, the patient experienced pain in her injection arm, which less than the first dose and resolved after a couple of nights for both injections. On Monday, after the injection, the patient experienced itchy spots which turned into a rash. On Friday of next week from the date of reporting, 6 days after receiving receiving SHINGRIX, the patient looked in the mirror and noticed a rash and red spots on her torso. The patient bought hydrocortisone cream and took Benadryl. On Saturday, 7 days after receiving, SHINGRIX the patient experienced periodic shooting pain on her torso which she described as feeling like shingles. The shooting pain was less on the day of reporting and the itchiness had resolved but the rash was still unresolved. The patient was going to meet her health care professional for an evaluation.
6NOV97 pt devel acute severe varicella & nl recovery;1wk later a less severe crop appeared & underwent nl course;21NOV97 new papules appeared;22JAN98 new papules devel;poss zoster & new lesions cont to grow;hosp w/lesion of conjunctivae;
Pt was admitted on 2/5 for right lower extremity cellulitis.   She was tested for COVID on 2/10 for SNF placement and found to be positive.
Pt got vaccines on 9-9. On 9-11 she called pharmacy stating started feeling sick (flu like) the evening of sots and progressively developed a fever that peaked at 103. Also patient had red lumpy swelling at pneumonia site.
Baby had an approximately one minute seizure with all over shaking/jerking and extra oral secretions.  Episode resolved and baby was sleepy but appeared otherwise fine.  No cyanosis noted or fever at time of event.  Parents presented to my office on Monday after the event on Saturday evening.  At time of office visit, no further episodes and normal exam.  Her immunizations were given at the local health dept.  I have no record of vaccine manufacturer or administration information as not provided via my office.
Pain; Flu like symptoms; Further described as malaise; A really sore arm at the injection site; A general feeling of fatigue; Also achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), MALAISE (Further described as malaise), VACCINATION SITE PAIN (A really sore arm at the injection site) and FATIGUE (A general feeling of fatigue) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis relapse (Relapsing Remitting Multiple Sclerosis).    On 23-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), MALAISE (Further described as malaise), VACCINATION SITE PAIN (A really sore arm at the injection site), FATIGUE (A general feeling of fatigue) and MYALGIA (Also achiness). At the time of the report, PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), MALAISE (Further described as malaise), VACCINATION SITE PAIN (A really sore arm at the injection site), FATIGUE (A general feeling of fatigue) and MYALGIA (Also achiness) had resolved. Probable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.