chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Report 2002001243-1 describes fainting in an 11-year-old male who received hepatitis B vaccine recombinant (Engerix-B). This report was received from the mother of the pt and has not been verified by a physician or other healthcare professional. Medical history and concurrent conditions were not specified. The pt did not receive any other vaccinations on 01/22/2002, but he did have the tuberculosis skin test performed. Reportedly, on 01/22/2002, the pt received his 1st injection of Engerix-B. The mother reported that within 5 minutes of getting in the car, her son "was out cold". She said that it was very difficult to wake him and they had to help him out of the car and into the house. She stated that his condition was "like he was going in and out of consciousness". Reportedly, he had no interest in food, felt dizzy and nauseated, and had "some" muscle weakness. Reportedly, he went to go down the hall to his bedroom and fell down in the hall and went to sleep. Mother said he "was just unable to function". The pt was taken to the ER where, reportedly, the physician said that the pt had "fainted" and sent him home. Mother and pt went to the pediatrician's office on 01/23/2002 and, reportedly, the physician stated that the pt "seemed fine". Mother reported that on 01/23/2002, her son was throwing up and was very nauseated. She said that he has not had this type of reaction with any other vaccines he has had in the past. As of 01/24/2002, the pt was "still fatigued".
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot# L016284, expiration date 07-AUG-2016, dose and route were unknown). No adverse effects reported. Additional information has been requested.
Per patient's report, she experiences pain that radiates from injection site toward her armpit and chest, not radiates downward her arm and no sign of chest pain. Possible heart attack was ruled out. Patient was adamant that the pain is resulted from the vaccination since the onset of pain is after the vaccine administration. The pain has not subsided since day one and still occurring on second day. Rph recommended patient to take Tylenol since she is already on diclofenac so another NSAID is not recommended. Rph tried to call to follow up with patient several hours later; however, she did not answer the phone.
Proquad and Varicella given at the same time. Child received 2 does of varicella.
Received Shingrix on 12/10/19. Woke up on 12/11/19 with pain in Rt wrist along with tightness. Also noticed redness and soreness in Rt upper arm - below the injection site. CBC, CRP done. Rocephin 1g given IM, started on Bactrim DS BID x 10 days. Pt went to ER on 12/13/19 with increased pain & redness - given vancomycin 1g IV. Remained on oral Bactrim. Patient follow up in office on 12/16/19 - No redness, pain or swelling. Instructed to finish Bactrim DS
Felt a very strong pain in the heart; felt a very strong pain in the heartand then pain in the middle of my chest as is I had something in my heart.; I'm still not feeling well; My body hurts; I'm very worried.; This is a spontaneous report from a contactable consumer (patient). A 94-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose, via an unspecified route of administration on 21Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination. Medical history included Penicillin allergy, iodine, several antibiotics from an unspecified date. Patient received first dose of BNT162B2 on 15Jan2021 for covid-19 immunisation. The patient's concomitant medications were not reported. Patient got the Pfizer Covid-19 vaccine, the first dose on January 15th and the second dose on February 21st. She was having some really bad symptoms and she was really worried because it has been a while and she was still not feeling well. On 23Feb2021, reported as two days after the vaccine she felt a very strong pain in the heart, and then pain in the middle of her chest (unspecified date in 2021) as if she had something in her heart. She went to the doctor, he did an ECG and told me she didn't had a heart attack; then she went to a cardiologist and he cannot find anything that could cause her symptoms. On an unspecified date in 2021, her body hurts, she was still not feeling well and she was very worried. She would like to know if Pfizer has something to make the symptoms go away, she feels very bad and it's been awhile since she got vaccinated. She was really scared and wanted to report this. Events required physician office visit. Outcome of the events was unknown.  Information on lot/batch number has been requested.
This spontaneous report as received from a Doctor of pharmacy refers to 3 patients of unknown ages. On an unknown date, the patients were vaccinated with doses of ZOSTAVAX (route and lot # not reported) that might have been improperly stored. No adverse effect was reported. Additional information has been requested.
Abdominal pain lower right side; diarrhea; loss of appetite; spasms all unexplained; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported, expiry date: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history and concomitant medication were not reported. On 29Jul2021 01:00 PM, patient experienced abdominal pain lower right side, diarrhea, loss of appetite, spasms all unexplained. The outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101098968 Same reporter/drug/event, different patient.
Approximately 10 minutes after the vaccination, the nursing staff noted the patient looked unwell. We provided water and APAP 650 mg per patient request. A few minutes later, she reported throat tightness and that she needed her albuterol inhaler but did not have this on her. We arranged to have a prescription sent and expedited to OP pharmacy for albuterol , which she received and administered with minimal improvement. The nurse continued to monitor her and she advised she felt itchy and diphenhydramine 25 mg was administered. Ultimately after over thirty minutes, there was no change in the patient's status. The patient refused the ED stating she had additional obligations at home.  A long discussion of risks ensued, patient verbalized understanding and signed AMA form.
Per patient. Patient felt painful, erythema, swelling w/dependent edema. She stated 6 hr. from vaccine. She did warm shower compression to reduce the dependent edema.
No additional AE reported; temperature excusion; This spontaneous report has been received from a medical assistant, concerning a 14-month-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 30-JAN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, right thigh, intramuscular (valid lot number W006412 [expiration date 23-FEB-2024 obtained per internal validation]) (dose, vaccination scheme, anatomical location, and frequency were not provided) for prophylaxis, after a temperature excursion. Total time in the range of -14 degrees Celsius (C) to -10 degrees C: 120 hours. Total time in the range of 9 degrees C to 25 degrees C: 20 minutes. Total combined excursion time: 120 hours, 20 minutes, 0 seconds (product storage error).   No additional adverse events were provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002114:origical case US-009507513-2304USA007931:
About a month later I began experiencing dizziness, disorientation, elevated heart rate, panic attacks, tingling in extremities (mostly left hand) & chest discomfort
swelling underneath armpit on left arm/You can see a little bulge/It's feeling sore; swelling underneath armpit on left arm/You can see a little bulge; swelling underneath his armpit on the left side where he got the booster; This spontaneous case was reported by a patient and describes the occurrence of AXILLARY PAIN (swelling underneath armpit on left arm/You can see a little bulge/It's feeling sore), LYMPHADENOPATHY (swelling underneath armpit on left arm/You can see a little bulge) and VACCINATION SITE SWELLING (swelling underneath his armpit on the left side where he got the booster) in a 44-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 vaccination.     The patient had no allergies. The patient had not receive other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Diabetes, Blood pressure high and High cholesterol. Concomitant products included INFLUENZA VACCINE from 08-Oct-2022 to an unknown date for an unknown indication.    On 22-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Oct-2022, the patient experienced LYMPHADENOPATHY (swelling underneath armpit on left arm/You can see a little bulge) and VACCINATION SITE SWELLING (swelling underneath his armpit on the left side where he got the booster). On an unknown date, the patient experienced AXILLARY PAIN (swelling underneath armpit on left arm/You can see a little bulge/It's feeling sore). At the time of the report, AXILLARY PAIN (swelling underneath armpit on left arm/You can see a little bulge/It's feeling sore), LYMPHADENOPATHY (swelling underneath armpit on left arm/You can see a little bulge) and VACCINATION SITE SWELLING (swelling underneath his armpit on the left side where he got the booster) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient received 1st dose of Moderna COVID-19 vaccine on 06-Jan-2021, Lot number: 037K20A, 2nd dose on 03-Feb-2021, Lot number: 015M20A and received 1st booster on 05-Nov-2021, Lot number: 066F21A. The patient stated that this did not happen with previous Moderna doses.  Patient never had COVID positive test or diagnosis. Patient mentioned the symptoms didn't happen right away either because this is 2 weeks after his dose. On 10Oct2022, patient saw his primary care doctor. His doctor couldn't feel a lump, so he told the patient to monitor it. It hasn't gotten better but hasn't gotten worse either. Patient did not experienced similar event of swelling underneath armpit previously.  No treatment medications were reported.
She has a redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (She has a redness at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. L012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (She has a redness at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (She has a redness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Developed diffuse pruritic rash about 4 hours after receiving vaccine. Patient reports that rash looked like measles. No other new symptoms (such as shortness of breath, dizziness, facial swelling, difficulty swallowing). Resolved after 1 week. Did not seek medical care. Symptoms reported when she returned for the 2nd dose. Because it could possibly be classified as an immediate reaction, she was not given the 2nd dose of the vaccine.
Shingles diagnosed on 05/04/2021; symptoms started 05/01/2021
lymph nodes along the left neck swollen.; lymph nodes along the left side of back swollen/lymph nodes along the left ear swollen; lymph nodes along the left collarbone swollen; Covid arm; pinkish spot at the injection site; Mild itching at the injection site; mild swelling at the injection site; soreness at the injection site; muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Covid arm), INJECTION SITE DISCOLOURATION (pinkish spot at the injection site), PRURITUS (Mild itching at the injection site), SWELLING (lymph nodes along the left neck swollen.) and SWELLING (lymph nodes along the left side of back swollen/lymph nodes along the left ear swollen) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced INJECTION SITE DISCOLOURATION (pinkish spot at the injection site), PRURITUS (Mild itching at the injection site), INJECTION SITE SWELLING (mild swelling at the injection site), INJECTION SITE PAIN (soreness at the injection site), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). On 27-Feb-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Covid arm), SWELLING (lymph nodes along the left neck swollen.), SWELLING (lymph nodes along the left side of back swollen/lymph nodes along the left ear swollen) and LYMPHADENOPATHY (lymph nodes along the left collarbone swollen). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Covid arm), INJECTION SITE DISCOLOURATION (pinkish spot at the injection site), PRURITUS (Mild itching at the injection site), SWELLING (lymph nodes along the left neck swollen.), SWELLING (lymph nodes along the left side of back swollen/lymph nodes along the left ear swollen), LYMPHADENOPATHY (lymph nodes along the left collarbone swollen), INJECTION SITE SWELLING (mild swelling at the injection site), INJECTION SITE PAIN (soreness at the injection site), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment included Benadryl cream, oral Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Non-significant follow-up received on 20-jul-2021- Email details were updated.
Felt like she was floating.  Patient refused transport.  Patient stated that she is feeling better.  Patient advised if not feeling well to call 911 or primary doctor.  Verbalized understanding. B/S 189, BP 146/90, HR 80, O2Sat 100.
she wakes up with her back muscles exhausted; Pain on the injection arm/Her muscles continue to be bad; Pain on shoulder and scapula; Little tiredness; Little pain in muscle; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (she wakes up with her back muscles exhausted), VACCINATION SITE PAIN (Pain on the injection arm/Her muscles continue to be bad), ARTHRALGIA (Pain on shoulder and scapula), FATIGUE (Little tiredness) and MYALGIA (Little pain in muscle) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE FATIGUE (she wakes up with her back muscles exhausted), VACCINATION SITE PAIN (Pain on the injection arm/Her muscles continue to be bad), ARTHRALGIA (Pain on shoulder and scapula), FATIGUE (Little tiredness) and MYALGIA (Little pain in muscle). The patient was treated with IBUPROFEN at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MUSCLE FATIGUE (she wakes up with her back muscles exhausted), VACCINATION SITE PAIN (Pain on the injection arm/Her muscles continue to be bad), ARTHRALGIA (Pain on shoulder and scapula), FATIGUE (Little tiredness) and MYALGIA (Little pain in muscle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown ), the reporter did not provide any causality assessment   This case was linked to MOD-2021-264250 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up contains non-significant information with NNI On 16-Sep-2021: New event Fatigue and Myalgia added
MG CAME TO PHARMACY WITH MOM TO RECEIVE THEIR COVID VACCINES. MOM'S SECOND MODERNA SHOT WAS PROCESSED AND MG'S FIRST PFIZER  SHOT WAS PROCESSED. MG ACCOMPANIED MOM TO ROOM AND SAT IN THE CHAIR TO RECEIVE THE SHOT. MG SPOKE UP FOR MOM AND VERIFIED MOM'S DOB WHEN PHARMACY TECHNICIAN ASKED FOR VERIFICATION AND THE TECHNICIAN DID NOT CATCH THAT IT WAS THE MOM'S DOB SO SHE ADMINISTERED THE MODERNA VACCINE TO 14YO MG. ERROR WAS IMMEDIATELY REALIZED AND BOTH MOM AND MG WERE COUNSELED ABOUT THE ERROR. VAERS FORM IS BEING SUBMITTED AS WELL AS WALGREENS INTERNAL STARS REPORT FOR INCORRECT VACCINE ADMINISTRATION.
At around 3:30 pm, patient's left upper arm began to swell at the injection site and she became very anxious. 911 was called and she was treated at the scene with steroids and sub-q epinephrine then transported to the emergency department.
Pt recv vax on 8/6/97; 4 - 5 hr later pt exp warmth, swelling &hard core at site of injection.  Pt f/u visit(11/17/97) revealed Rt leg very red &angry appearance, fever (103F); tx=ice packs &Motrin. On 11/18/98 pt imp. It was reported that a 16-month-old patient was vaccinated with ACTHIB/DTP on 6-Aug-1997. Four to five hours after vaccination the patient experienced warmth, swelling and a hard core at the site of injection. From follow-up of 17-Nov-1997 it was reported, "Right leg became very red, angry in appearance. Patient ran fever, highest reading 103 F. Advised applying ice packs to leg, MOTRIN for fever. Mother reported following day that child had improved." Reportedly the patient recovered form this experience. From correspondence received on 16-May-2000,  additional patient information was provided. No further information expected. This case is closed.
Pt presents to clinic with right leg swelling and redness. No fever noted, warm to touch. Pt received vaccines yesterday. Diagnosis: local reaction to DTaP, right leg. Tx: Augmentin x 10d. When awakened c/o right leg pain.
As expected soreness in left arm, not unexpected stiffness in left shoulder and left side of neck + back extending down to left shoulderblade.  The unexpected effect is tingling and coldness in both hands/fingertips.   I could logically assume it is from the swelling in the neck pressing on the nerves, as I have experienced a similar feeling occasionally in the past due to compressed discs in my spine and neck.  At this point I am not particularly alarmed but I wanted to make you aware of this side effect.
This spontaneous report was received from a registered nurse concerning on multiple unspecified patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the multiple unspecified patients received improperly stored doses of ROTATEQ orally (lot # M007307; expiration date: 30-NOV-2017), (strength and dose were not reported) for prophylaxis. The temperature excursion with ROTATEQ was at 58 Fahrenheit degrees for 28 hours. The temperature excursion was detected by a data logger. There were no prior excursions. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1612USA010295: US-009507513-1612USA010293: US-009507513-1612USA010294: US-009507513-1612USA010291: US-009507513-1612USA010292.
Redish ring around the injection site.  Not painful or itchy at this point in time.  About a 2" x 3-4" oval
seizure; fell out of bed; bruises; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient who received the vaccine experienced and similar seizure same day she feel out of bed/ bruises/spent night on an unspecified date. The outcome of the events was unknown.   Additional information on lot/batch number has been requested.
raised rock hard size of a golf ball; raised bright red the size of a golf ball; a 27 weeks and 6 days pregnant female patient received a dose of Adacel vaccine; Initial information received on 06-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA036161, 2020SA036199 and 2020SA036190 (same reporter).  This case involves a 25 years old female patient who experienced raised rock hard bright red the size of a golf ball (induration) and (erythema), when she received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] while she was pregnant.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The patient was 27 weeks and 6 days pregnant. The date of last menstrual period was not reported. The estimated due date was not reported. Medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Jan-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6518AA, expiry date: 05-NOV-2021 via unknown route in the left deltoid.  On an unknown date, the patient developed a non-serious raised rock hard bright red the size of a golf ball (induration) and (erythema) two weeks following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was case of vaccine exposure during pregnancy. A 27 weeks and 6 days pregnant female patient received a dose of Adacel vaccine.  No lab data reported.  Final diagnosis was induration and erythema.   It was not reported if the patient received a corrective treatment.  The patient was recovering from the events.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Onset of fever, malaise, muscle aches 1 hour after vaccinated. Symptoms lasted until 5-15 or 5-16-04. Was given Tylenol and ibuprofen for symptoms. States fever was 102 and below.