chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash and itching at vaccine site (left upper arm) beginning 1/29/2021, last two days. Repeated same on 2/5/2021 and lasted 2 days.
Information has been received from a Licensed Practical Nurse (L.P.N.) referring to a 67 year old female patient with asthma, hypothyroidism, hypertension, sleep apnea, insomnia and drug allergies to morphine and pravastatin. It was reported that the patient had a history of an unspecified reaction to morphine and pravastatin (manufacturers unspecified). On 22-JUL-2015 the patient was vaccinated with PNEUMOVAX 23 (0.5 ml/once, intramuscular, lot# reported as K018183, expiration date 04-MAY-2016) for vaccination. Concomitant therapies included trazodone (manufacturer unknown), methylphenidate, PROAIR (trade name reported as "PROAIR INHALER", levothyroxine (manufacturer unknown), estrogens, PREMARIN, FLEXERIL, promethazine, aspirin, oxycodone and tretinoin. On 22-JUL-2015, the patient experienced swelling at the injection site and bilateral lower leg cramps. The patient sought medical attention by calling the nurse. Ice was applied to the injection site as treatment. No lab diagnostics studies were performed. Outcome of the events was not recovered. Causality assessment was not reported. Additional information has been requested.
Mom reports 104 fever given APAP; ER visit t103.2 dx febrile illness, poss rt otitis media; Rx Amoxicillin; Seen by family MD dx early BOM; Ceclor, Advil rx'd;
Pt had a seizure following administration of 2nd pediatric pfizer dose. 10-15 minutes later she vomitted
Fever low grade 99.5-100.5 2 weeks and ongoing till current. Severe body pain evening after injection. Swollen/painful right finger joints.  Constant pain in right hip-Motrin 800 does not help. Lethargy. Swollen Lymph glands.
Left arm-there are two erythematous area at the deltoid muscle-each approximately 2cm diameter. There is clearing in the middle area between the two erythematous areas.
Patient received vaccine on 8/26/21. On 8/27/21 started c/o headache, fever, numbness in left arm, SOB, dizziness, lightheaded and nauseated. Seen at local ER who dx: localized shot reaction.
had high fever of 103; headaches; body aches; fatigue; This is a spontaneous report from a contactable physician (Pfizer colleague). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 2 via an unspecified route of administration on 07Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historically took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on as dose 1, single for covid-19 immunisation. On an unspecified date in Jun2021, the patient experienced had high fever of 103, headaches, body aches, fatigue. Reportedly, after 2nd dose of COVID vaccine on 07Jun (24 days ago) patient had high fever of 103, headaches, body aches, and fatigue. As of today, 24 days later, patient still has a high fever of 101 and headaches, body aches, and fatigue. The patient underwent lab tests and procedures which included high fever: 103 on Jun2021 (24 days ago, had high fever of 103) and high fever: 101 on 01Jul2021 (As of today, 24 days later, still has a high fever of 101). The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a 22 years old male patient concerning himself. The patient was allergic to sulfur, penicillin and bee sting. There was no pertinent medical history. No information was provided about the concomitant medication. On an unknown date in October 2018 (reported as beginning of October of this year), the patient received his first dose of GARDASIL 9 (0.5 ML, intramuscularly, lot # N020139 and expiration date 14-FEB-2020) for HPV prevention. On 10-DEC-2018, the patient got his second dose of GARDASIL 9 (0.5 ML, lot # N020139 and expiration date 14-FEB-2020) intradermally into his right arm instead of intramuscular as indicated in the official Prescribing Information (incorrect route of product administration) for HPV prevention. On the same day, the patient received a TRUMENBA (dose, route and lot # were not provided) in his left arm. On an unknown date in December 2018 (reported as after he got the TRUMENBA vaccination), his left arm felt sore. On 11-DEC-2018, the patient's right arm became very sore and he also developed a giant red spot on his right arm. The patient reported that his right arm felt very inflamed and was very tender and it hurt to the touch. The patient also reported when he went to work the next day (on 11-DEC-2018), he felt weak and dizzy while at work and when he got home from work, he felt so fatigued that he slept for hours. The patient contacted his doctor's office on 12-DEC-2018 regarding his adverse experience symptoms. The patient was not prescribed any specific treatment for his adverse reaction, but he had been applying some ice on his right arm to help with the soreness and inflammation. At the time of the report, the patient felt normal and had recovered from most of his side effects, but his right arm still felt a little inflamed. The outcome of sore, a giant red spot, dizziness, weak, fatigue was reported as recovered/resolved. The outcome of left arm felt sore was unknown. The outcome of inflamed was reported as not recovered/not resolved. The causality assessment between the events and therapy with GARDASIL 9 was not provided.
fever x 8 days to 104.8;macular rash, conjunctivitis, gingivitis father + strep cult no CNS problems;did not meet full criteria for Kawasaki's but echo done anyway & was nl;rx ATB & antipyretics;no residual problem;skin tested for MMR neg;
Patient tolerated both vaccines at first. She was standing, walking and chatting. About 10 minutes after the vaccines she had a syncopal episode. I was not witness to this but another nurse reports seeing it. Patient did not hit her head. The patient was assessed by a Provider
Vaccine expired. Vaccine expiration mislabeled due to confusion over Pfizer BUD extension. Labeled 01/21/2022 31 days from movement. Per health department and Pfizer, expiration is 12/31/2021.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 02-FEB-2015, the patient was vaccinated with GARDASIL (lot number: KK007828 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion (incorrect product storage). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with GARDASIL. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Pt recvd vax & exp t105 orally, taken to ER t103.7; Mom states child vomited x 2, h/a, WBC 12,000 on 9JUL91; MD states poss inc temp & illness due to URI;
Elevated temp of 102.5, highest elevated temp. On 08/28/01, received immunizations x 7. Tuesday at 3:30 PM elevated temp and seizure at 1:30 PM on 08/29/01 to ER.
Swelling and erythema of face approx. 2 hrs post administration. Resolved within 2 hrs post administration of Allegra 180. No further symptoms
ACUTE NON ST ELEVATION MI 3/2/2023 OTHER GRAM-NEGATIVE SEPSIS
Seven hours post third vaccine; acute onset of all symptoms such as headache, high blood pressure, neck & ear ache, sensitivity to cold, pain in all joints, body aches, dizziness, weakness & chest pain. All persisted for two days. Not relieved by any OTC medications. Random chest pain still appears on occasion.  First vaccine - sore on site Second vaccine - No S/E
- bleeding at injection site when given the vaccine - arm soreness & swelling from the elbow to shoulder, major bruise on arm covering 1/2 of the area of the elbow to shoulder - slight headache & fatigued - upset stomach, stomach churning, diarrhea - confusion & forgetfullness *** *** these 2 items are why I am reporting on this form.  I worked the day after the shot & things I have done for years, I either forgot how to do or was confused on how to do it.  These side effects scared me & lasted for 2 days.  It has taken 4 days to resolve all side effects
lt side to top lip swelled up & pt got hives on face;pt c/o lip hurting;lip stayed swollen for approx 1hr;hives lasted 24hr;DPH prescribed;
Patient is a staff member at the clinic. Patient is immunocompromised and came to mobile clinic yesterday to receive her booster shot. Her 3rd dose was 10/04/2022. She reported that her 2nd and 3rd doses had quickly affected her and that she had felt increased heart rate and sweating afterwards. Patient would still like to continue with booster shot for complete protection. She was given 0.25mL of Moderna (lot #033K21-2A) IM in her left deltoid at 1511.  About 15 minutes after injection, she reported increased tiredness and fatigue. RN goes over to assess patient and palpates heart rate. Heart rate is within normal limits and there is not increased sweating observed. RN sees a mild rash on patient's chest. Patient denies any increased difficulty breathing, swelling/tightness in throat, or any increased itchiness. RN observes patient is speaking in full sentences, normal rhythm, and normal breathing positioning. RN suggests that provider come out to see patient due to rash. Provider FNP comes outside 20 minutes after injection. Suggests patient come lay down on exam table and have 1 Benadryl. Patient given 25 mg of Diphenhydramine about 25 min after injection. RN continue to observe patient and confirm not increased difficulty breathing or worsening symptoms. Patient does report increased fatigue. She says it is similar to how she felt after 2nd and 3rd dose. Patient heads home at 1641 after reviewing ER precautions with RN and home care for the next few days. Patient also, has epi-pen at home and know how to use it should anything change.
STOMACH SPASM; NAUSEA; FEVER; TIREDNESS; MUSCLE ACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 10-SEP-2021, the patient experienced fever. On 10-SEP-2021, the patient experienced tiredness. On 10-SEP-2021, the patient experienced muscle ache. On 12-SEP-2021, the patient experienced stomach spasm. On 12-SEP-2021, the patient experienced nausea. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from nausea, and stomach spasm, and the outcome of fever, tiredness and muscle ache was not reported. This report was non-serious.
Patient reports abnormal menstrual/vaginal bleeding the day following vaccination of first COVID-19 vaccine dose.  Patient reports being 12 days early in cycle and keeps track of menstrual cycles on calendar.  Patient reports to have regular menstrual cycles.  Patient feeling general side effects of vomiting, headache, dizziness, pallor, fast heart beat and fatigue.
Allergic hives; Elevation on the site of injection; Redness on the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Allergic hives), VACCINATION SITE SWELLING (Elevation on the site of injection) and VACCINATION SITE ERYTHEMA (Redness on the site of injection) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-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 URTICARIA (Allergic hives), VACCINATION SITE SWELLING (Elevation on the site of injection) and VACCINATION SITE ERYTHEMA (Redness on the site of injection). At the time of the report, URTICARIA (Allergic hives), VACCINATION SITE SWELLING (Elevation on the site of injection) and VACCINATION SITE ERYTHEMA (Redness on the site of injection) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant product use was reported.  Treatment details included diphenhydramine.
Stomach discomfort and constant watery diarrhea that has not stop since Pfizer second dose
Health Care worker had break through COVID after exposure from significant other who had not received the COVID vaccine. Was asymptomatic but tested positive on 5/17/21 after being fully vaccinated.
Received Hepatitis B#3 on 8/23 and he reports later that night he noted that his hands and feet had an orange discoloration.  Pt. denies having any sore throat, fever, rash or open lesions develop.
1045 Patient c/o nausea; he was encouraged to lay down on a cot, he however declined. Agreed to sit with RN in the Vaccine Administration room. He stated that he was nauseated prior to the vaccine because he had had coffee without  eating breakfast. He was  alert and actively interacting with this RN, while he waited to feel better. 1104 Patient stated he no longer felt nauseated. He walk out clinic stable.
Redness; Heart palpitations; Chills; Fever; heart issue; Fatigue; This is a spontaneous report from a contactable consumer (patient) via COVAES. This 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8736) via an unspecified route of administration in the left arm on 18May2021 at 12:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included non-ST elevated myocardial infarction (NSTEMI), aortic valve replacement, dye contrast allergy, and 4 stents placed, all from unknown dates and unknown if ongoing. Concomitant medications included acetylsalicylic acid (ASPIRIN), apixaban (ELIQUIS), lisinopril, and metoprolol, all from unknown dates for unknown indications. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccine in four weeks. The patient previously received ciprofloxacin, metformin, and simvastatin, all from unknown dates for unknown indications and experienced drug allergy. On 21May2021 at 12:00 the patient experienced redness, and heart palpitations. The patient stated he was having heart issues before vaccination which he stated could be verified by records. He also had chills, fever, and fatigue, but not severe, "only heart issue" stating he had been having heart issues but reaction to vaccine had not been severe. The events resulted in an emergency department visit; no treatment was received for the events. The clinical outcomes of redness, heart palpitations, chills, fever, fatigue, and heart issues were recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.
Arm  was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm  was sore) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included Congestive heart failure. Concurrent medical conditions included Diabetic, Kidney disorder and Hypothyroidism. Concomitant products included TICAGRELOR (BRILINTA) for Congestive heart failure, INSULIN GLARGINE (LANTUS) and INSULIN LISPRO (HUMALOG) for Diabetic, LEVOTHYROXINE SODIUM (TIROSINT) for Hypothyroidism, FUROSEMIDE (LASIX [FUROSEMIDE]) for Kidney disorder, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm  was sore). On 13-Mar-2021, PAIN IN EXTREMITY (Arm  was sore) had resolved.        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 treatment medications were reported   This case was linked to MOD-2021-073227, MOD-2021-073227 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received on 18-MAY-2021 contains no new information with respect to dose 1 of vaccination.
Systemic: Allergic: Rash Generalized-Mild, Additional Details: patient asked about rash on top of back after being given second dose of pfizer and answering negative to all screening questions.  After questioning it may be injection related.  rash is mostly healed.
Injection site redness, warmth, pain Puffy eye lids bilaterally Fatigue Malaise
Fever developed only hours after receiving vaccination. Spiked at 103.5 at 10pm on 4/1. Down to 101 the morning of 4/2. Aches are also present
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient passed out after getting vaccination and hit head on chair. She was checked out by EMS
Generalized macular rash. Looks like a viral exanthem. Happened 1 week after the vaccine administration. Also, mild diarrhea.
Just got 1st shot is my nose suppose to run; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Just got 1st shot is my nose suppose to run) 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 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 RHINORRHOEA (Just got 1st shot is my nose suppose to run). At the time of the report, RHINORRHOEA (Just got 1st shot is my nose suppose to run) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
patient was given the Pentacel diluent component alone without it being mixed with the Hib component/No AE; separate ActHIB vaccine was improperly mixed with a Merck sterile water diluent and then administered/NO AE; Initial information was received on 20-Mar-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 7 month old female patient who received diluent component alone without it being mixed with the Hib component of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (0.5 mL dose, lot U6613AA expiry 22Feb2021) and then, when that error was realized, another error was made when a separate HIB (PRP/T) VACCINE [ACT-HIB] (lot UI965AA expiry 29Jun2020) was improperly mixed with a Merck sterile water diluent and then administered, both via unknown route in the left thigh for prophylactic vaccination on 19-Mar-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunization.  It was a case of an actual medication error due to Inappropriate reconstitution technique and Wrong solution used in drug reconstitution.  At the time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This is a spontaneous report from a non-contactable consumer. A 44-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 12Apr2021 at 11:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 09:00 as a single dose for COVID-19 immunisation.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 03.00, the patient experienced low grade fever ~99.6 Fahrenheit, muscle aches, fatigue and sore arm for approximately 36hours; Injection site redness and itching starting about 2-3 days post injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 13Apr2021 patient checked his body temperature and it was 99.6 Fahrenheit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade fever ~99.6 Fahrenheit, muscle aches, fatigue and sore arm were recovered on unknown date in Apr2021. The clinical outcome of the event injection site redness and itching were recovered on 18Apr2021 (lasted until18Apr2021). No follow-up attempts are possible. No further information is expected.
Child was severely constipated, bloody stool, told by ER physician and later by our pediatrician to use suppositories and Q-tip in rectum to relieve bowel movement we continued this for months. Condition worsened.
Hospitalization: 1/30/2023 - 2/4/2023 (5 days) Presentation to the ED: Presented to the ED due to anemia with hemoglobin 5.2 noted at outpatient/rehab facility where she was recovering from a stroke. COVID + date: 1/30/2023. Treatment: NO TREATMENT REQUIRED. PATIENT WAS NOT SYMPTOMATIC. Discharged: PATIENT LATER EXPIRED ON 2/17/2023. 002A21A 2/24/2021 017B21A 3/29/2021 035C21A 10/26/2021 AS7146B 10/22/2022
Next day, I began to itch all over and had bumps all over. Thought maybe was flea bites but when I saw the doctor, said was hives. Gave Zyrtec and cleared up.
I spoke with the nurse for the provider that saw the patient. The patient was seen in person by the provider on 3/30/21.  She reported discomfort in the arm that began several hours after administration that originated in the area of the AC joint (patient pointed to that area during the physical exam).  Patient reported discomfort across the shoulder that extended the length of her right arm into the tumb.  Patient said the pain resulted in loss of mobility in the right arm and subsequent exhaustion due to inability to sleep comfortably overnight.    Provider recommended Ibuprofen 200mg 2 tablets by mouth every 8 hours for 2 days and asked the patient to follow up with her in 24 hours.  The patient spoke with the provider on 03/31/21 and reported an improvement in symptoms, increased range of motion and less pain overall.