chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH, PAIN IN EXTREMITY, PERIPHERAL SWELLING, VACCINATION SITE INDURATION, and VACCINATION SITE ERYTHEMA in a 60-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. Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.     No Medical History information was reported.   On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) at an unspecified dose. In October 2021, the patient experienced VACCINATION SITE WARMTH, PERIPHERAL SWELLING, VACCINATION SITE INDURATION, and VACCINATION SITE ERYTHEMA. On 29-Oct-2021, the patient experienced PAIN IN EXTREMITY and VACCINATION SITE PAIN. At the time of the report, VACCINATION SITE WARMTH, PAIN IN EXTREMITY, PERIPHERAL SWELLING, VACCINATION SITE INDURATION, VACCINATION SITE ERYTHEMA, and VACCINATION SITE PAIN outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  The reaction started a little bit on later on 29 Oct 2021. The patient got the flu shot at the same time at the same arm.
Started feeling sick with a sinus drainage and sore throat and tightness in chest. Took home COVID-19 test, positive. Had telehealth appointment with Dr. and was prescribed PAXLOVID. Started feeling a little better 4 days later. Retested 10 days later and it was negative.
4 hours with warmth, redness, near left deltoid. Had induration yesterday. Somewhat improved.
Grand Mal Seizure lasting about 10 seconds. Recovered without sequela.  No h/o any seizures prior to vaccine.
1024: received injection and came into observation area. I spoke to patient personally and discussed her allergies, she was feeling well at the time.  Sometime since then, patient then began feeling unwell, complained of nausea and sore throat, and vehicle was pulled aside.  1040: upon evaluation of the patient, she appeared in mild-moderate respiratory distress, tachypneic and diaphoretic. She was mildly disoriented and upon inspection of airway, there was oropharyngeal swelling. There was no audible stridor or wheezing. No rash visible on neck or upper chest.  1041: rapid response called for medical team, EMS was called. BP 190/100, P 106, O2 98%  1042: Epinephrine given IM in right thigh. Patient continued to be tachypneic, no wheezing on auscultation.  1044: pulse 102, O2 95%  1045: oropharyngeal swelling worsened upon inspection. second Epinephrine given IM in left thigh. BP 196/110, P 93, O2 98%  1046: pulse 83, O2 97%  1048: pulse 95, O2 98%  1049: BP 170/102, pulse 73, O2 94%  1051: BP 176/100, pulse 77, O2 98%  1053: EMS arrived and evaluated patient, transported to ED.
"I have terrible pain in my upper arm. Not the site but I cannot make certain moves without significant pain. Like my rotater cuff has been injured. I?m attaching a picture because I think the injection was too high. " 12/24/2020 "I went to OC health. Agrees injury from shot but doesn?t think it went into joint just got where deltoid inserts and has inflamed. Rec continue nsaids and voltaren get if not gone in 2 weeks go back.  It is better for sure but some movements are painful still. Thx for checking in. " 12/31/2020
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 at 13:45 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 15Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukaemia" (unspecified if ongoing); "Known allergies: yes" (unspecified if ongoing), notes: Known allergies: Yes. Concomitant medication(s) included: VALACYCLOVIR HCL, start date: 01Feb2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Jun2022 at 12:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 treatment; (07Jun2022) Positive, notes: Still testing positive after completing all doses yesterday. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: The patient received treatment with Paxlovid for COVID-19 from 02Jun2022 to 07Jun2022, Lot number: GA8778.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
fever of 102, severe joint pain, headache, nausea, chills  treated with ibuprofen (500mg);  36 hours
Painful swelling in the back of the neck occurred 20-30 mins after receiving vaccination, lasted about 6 hours, ocular migraine on 08/07,   severe pain in the lower back left side by the hip, was seen by orthopedist, abdominal swelling, weight gain, gastritis, constipation, and elevated resting pulse rate normally close to 60,70 range, after vaccination is elevated to 90's, 100's.
This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion from refrigerated temperature to frozen temperature) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported. On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion from refrigerated temperature to frozen temperature). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion from refrigerated temperature to frozen temperature) outcome was unknown. No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable. The patient would like to know if the patient was vaccinated from a non-viable, or less viable supply. The patient also reported that the side effects from second vaccination were very mild compared to those that from the first dose.
This spontaneous report as received from a physician refers to a 38 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 16-APR-2014 the patient was vaccinated with the first 0.5ml dose of VARIVAX (lot# unspecified) (subcutaneous, location unspecified) for "by lab patient was susceptible to varicella". Concomitant therapies included ENPRESSE for birth control. The reporter stated that on an unspecified date in April 2014 after the administration of VARIVAX the patient felt achy (described by physician "as a little bit of a prodrome") and on the next day on an unspecified date in April 2014 she had a lesion on her right wrist. On an unspecified date in April 2014 the patient then developed lesions on her left upper chest, stomach and legs which were itchy since an unspecified date. Patient had sought medical attention with a dermatologist on an unspecified date in April after the administration of VARIVAX. Dermatologist described lesions to physician, as papular and not vesicular which could possible be spider bites. Result of IGG (Blood immunoglobulin G) prior to administration of VARIVAX on 14-MAR-2014 was "less than 0.91". Dermatologist obtained a biopsy of one of the lesions on 30-APR-2014. Result of biopsy was not available. Treatment for lesions since an unspecified date was BENADRYL and ADVIL. Physician described patient as recovering and "back to work" since an unspecified date. Additional information has been requested.
Injection site pain, muscle and bone pain, elevated heart rate to 115, difficulty moving, headache, nausea, fever of 104.1 for 2 days. Tylenol only brought down to 102. Trouble breathing (rescue inhaler used).
Vaccine was given 3:15pm 06/30/2011. 15 minutes after vaccine was administered patient lost consciousness, control of bladder and began having seizure type movement. Patient roused 3 minutes later, incoherent, refused all transport against physicians advice. Was advised to seek seizure work-up.
Phone call from mom 1 hours after shot. He was at school in nurses office. He was shaking and couldn't stop-ears and cheek were red and hot. No trouble breathing, no rash, advised to go to ER now.
I had a fever, joint pains, slight headache, nausea, sore arm.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown date, unspecified number of patients were administered doses of VARIVAX (Merck) injection (dose, route and lot number were not reported) that were improperly stored. Concomitant medications were not specified. No adverse events were reported. This is one of several reports received from the same reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a nurse. The nurse provide the patient's demographics. This case concerning 22 months old female patient. On 09-SEP-2014 at 14:05, the patient was vaccinated with improperly stored VARIVAX (Merck) subcutaneous (lot # J-14407, expiration date: 13-NOV-2015). This is one of several reports received from the same reporter. Additional information is not expected as all information has been obtained.
Pfizer given as second vaccine in primary series, patient had Moderna for first dose in primary series.
Sore arm (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (2nd dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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 PAIN IN EXTREMITY. At the time of the report, PAIN IN EXTREMITY (2nd dose) outcome was unknown.            It was also reported that the patient had a long list of concomitant medication, but details were not provided.  The patient after the second had sore arm.  No treatment information was provided.   This case was linked to MOD-2021-406109 (Patient Link).
Rash started on 10/14 on neck. More papules appeared on trunk, neck and arms on 10/15. Temp 101 on 10/14 eve. Rx Aveeno baths, Benadryl PO, Tylenol PRN.
Had fever of 101.6 for several hours, slept off and on, arm is swollen, red, giving off hear, small rash around injection site on next day after vaccine. Two days after vaccine, no fever but felt very fatigue, slept most of the day. Third day, not sleeping at night, arm is still painful. Fourth day, arm is still swollen and painful to touch, and still giving off heat. Treatment took 2 Ibuprofen to relieve fever and kept cold rags on neck and head.
About 8 minutes post injection, patient became extremely flushed, tachycardic, had pain in left arm and itchiness around the throat. Paramedics were called and transported patient.
arm swollen and hot and red approximately 2 1/2 inch diameter around injection site. Arm also tender to touch
Information has been received from a registered nurse concerning a patient who on an unspecified date during a several week interval in June and July 2010, was vaccinated with a dose of PNEUMOVAX 23 (lot# 666639/0564Z). Subsequently, the patient developed a case of cellulitis centered on the injection site. The patient was treated with antibiotics. At the time of this report, the patient's outcome was not reported. This is one of several reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
8 cm raised, erythematous, warm tender over left deltoid injection site. Treated with antibiotic.
This spontaneous report was received from a healthcare worker and refers to a 9 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-AUG-2015 and 15-OCT-2015, the patient was vaccinated with two separate doses of improperly stored oral, ROTATEQ (doses were not provided) lot # K023534, expiration date: 22-MAY-2016 and lot # K016261, expiration date: 23-JUN-2016, orally. No adverse effects were reported. Additional information has been requested.
Pain, swelling, redness. Pt being started on Kelfex and Bactroban. Will follow up with PCP on Monday.  Mark made around site and instructed mom to take pt to ER if swelling extends beyond mark.
Hospitalization: 2/16/2023 - 2/20/2023 (4 days) Presentation to the ED: generalized weakness and hip pain. COVID + date: 2/16/2023 Treatment: redemsivir  Discharge to: SNF  010M20A 2/18/2021 047A21A 3/22/2021
Severe diarrhea for over 2 weeks starting on the night of the second day after shot
Site: Itching at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: He appeared to have an allergic reaction.  He had itchiness on multiple parts of his body with a rash on multiple extremities.  He had shortness of breath, but throat did not start to close.  He was observed for around an hour and 2 diphenhydramine 25 mg tablets were given to him.  His vitals were monitored and they were okay.  A nurse from the minute clinic came to observe him as well as a pharmacist.  He was sent home later and told to go to the ER if his symptoms did not lessen.
pt recvd vax & exp a tightness in the chest which subsided shortly  p/; 1/2 hr later pt devel urticaria & pruritus; pt seen by MD & was treated w/Vistaril;
Severe rash/eczema.  The rash is not controlled with any medications or creams.  Bruising all over the left side of body.  Severe vertigo.
Left arm swollen, red with a few small pale areas, with some induration (resembling what happens with an infiltrated IV).  These symptoms were observed by RN on 12/14/16 when PPD test on right forearm was read.
3 cm.X6 cm. raised, red, pruritic rash at site of vaccination
Appox. 1:15 developed whelps and redness to bilat. arms from shoulder to elbow, with itching. Dad took child to a doctor and pharmacist who said it may be a reaction to the tetanus vaccine. Rask went away after one dose of BENADRYL.
Pfizer-BioNTech COVID-10 Vaccine EUA. After receiving the 1st dose of Pfizer vaccine, patient experienced itchiness of her upper lip. Vital signs included BP 117/77, P 80, O2 99%. Cetirizine 10mg PO administered at 12:54. Patient denied SOB, trouble breathing, swallowing or symptoms of anaphylaxis. Patient had no additional or worsening symptoms before leaving the clinic.
Received T.C. from patient stating her left arm had a hard raised lump that was hot to touch about 3 hr after injection pain is improved. T.C. to directory assistance for phone number-no listing (11/20/09).
Soreness and tenderness, swollen lymph nodes, pain from armpit across breast to the sternum. Trouble breathing. Patient did see her personal physician and the symptoms are improving.
Injection caused pain and limited ROM.  Unable to lift arm past 90 degrees without significant pain.
From physician notes: Went to the hospital then transferred/admitted to secondary hospital on April 10, 2021 for numbness/weakness on left side of face, left arm, and left leg that started on the same day after receiving COVID-19 vaccine the day before, suddenly woke up with a headache on the right side of her head that was 10/10 in intensity and left sided weakness. Attributed it to migraine and COVID-19 vaccine, but her symptoms persisted and she could not move, so she called her mother and had symptoms consistent with stroke so she called 911 and went to the hospital, where she was admitted, and discharged on April 12, 2021. While she was in the hospital she was admitted to the stroke unit, received serial CT and MRI which did not show ischemia or brain bleed, Neurology gave her IV tPA and had her admitted for observation. Several hours after receiving tPA she steadily started improving (left-sided weakness and headaches resolved before discharge), with instructions to follow up with Neurology.
Patient had episode of vertigo/syncope/emesis, patient was examined by onsite MD, patient was advised to rest and given fluids, patient recovered well and was sent home with responsible party.
Two weeks later (9/9/03) while at a chiropractors office, patient had apparent convulsion with loss of consciousness, eyes rolling back and quick twitching of limbs. some tiredness afterward. She was seen by neurologist that day with a normal exam. sunsequent work-up revealed normal EEG and MRI
I was covered in sweat when I got up and shaking; I was covered in sweat when I got up and shaking; Cold all over; Terrible headache; I have got 'chill bumps'; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 22Oct2021 03:00 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERHIDROSIS (non-serious), TREMOR (non-serious) all with onset Oct2021, outcome "unknown" and all described as "I was covered in sweat when I got up and shaking"; FEELING COLD (non-serious) with onset Oct2021, outcome "unknown", described as "Cold all over"; HEADACHE (non-serious) with onset Oct2021, outcome "unknown", described as "Terrible headache"; CHILLS (non-serious) with onset Oct2021, outcome "unknown", described as "I have got 'chill bumps'".  Additional information: event onset dates was unspecified, Consumer stated, patient have a couple questions and got the Pfizer vaccine today probably about 03:00 O' Clock and I have done just fine no problems at all and I went in and lay down and took a nap at 06:00 O'clock and just got up. I am covered in sweat and while I was covered in sweat when I got up and shaking and now I have got 'chill bumps'(word not clear) and cold all over, terrible headache and I got my paperwork out and read it and it says something about like you should not have it if you are on blood thinners (Intent: Medical query). Is that true?" Consumer was informed about role of Pfizer drug safety and informed that Pfizer Medical Information is the concerned department to answer the question. Consumer was informed that Medical Information department is closed on Saturday and Sunday. Consumer was again informed about role of Pfizer Drug Safety Department and also informed that Pfizer Medical Information can answer the Medical query. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My 6-year-old son developed COVID arm more than 24 hours after the second dose of the Pfizer vaccine.  More than 24 hours after administration of the second shot, his left arm swelled up in a perfect circle. The swollen area feels hard to the touch and appears red.  It is not itchy. It is about the size of a half-dollar. Thus far, the swollen area has lasted 2 days (12/5/21 & 12/6/21). It does not yet appear to be decreasing in size.  He has no other signs of allergic reaction.  He has never had an allergic reaction to a vaccine before and he has received all recommended childhood vaccinations appropriate to his age.  We have not attempted to treat it with any ice pack or antihistamine.
Pt. called next AM after immunizations c/o ( R ) arm pain with redness/swelling/soreness. Pain radiating upper ( R ) shoulder. Reported pain caused difficulty sleeping last pm, but reported swelling/pain decreased from prev. night, with warm skin & soreness from elbow to shoulder. Rx - TYLENOL/Ibuprofen.
joint pain /shoulders hurt; muscle pain; Achiness/moderate amount of pain; sore left arm/upper arms both really hurt; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in left arm on 11Mar2021 at 10:00 A.M (at the age of 53-year-old) at single dose for COVID-19 immunisation. The patient medical history included high blood pressure and anxiety and known allergies included Peridium and Diflucan. Concomitant medications included amitriptyline and losartan (LOSARTAN). Patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID since vaccination. The patient just had a bit of a sore left arm as with any other vaccine on 11Mar2021 when received the COVID vaccine. On 16Mar2021 at 09:00AM (day of report) both shoulders and upper arms both really hurt. It was like sore left arm, both of shoulders and upper arms both really hurt as well. The patient has not done any new exercise or heavy lifting recently. It felt like the joint pain and achiness that you have when you were sick with a virus. The patient does not have any other symptoms, except moderate amount of pain. The patient received ibuprofen, but it had not helped a lot. The clinical outcome of events was reported as not recovered.  No follow-up attempts are Possible. No further information is expected.
Pt. got Pfizer at 3;25 PM. At 4?10 complained of heart palpitations. At that time her BP was 197/113, 02 sat was100 percent and pulse was 79. No chest pain, shortness of breath or dizziness. Pt. did not feel comfortable ambulating to ER.  EMS was called. BP at 4:256 was 184/129, O2 was 97 and pulse was 66.EMS vehicle arrived with responders  at 4:25 and took individual to  ER>
past due for second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION IN ERROR (past due for second vaccine) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Type II diabetes mellitus.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, the patient experienced PRODUCT DOSE OMISSION IN ERROR (past due for second vaccine). At the time of the report, PRODUCT DOSE OMISSION IN ERROR (past due for second vaccine) had resolved.            No Concomitant medications were reported.  No Treatment medication was provided   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up  received and second dose information was added On 20-Jul-2021: Follow up received and Contain No new information.