chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain to injection site from 8-hrs and resolved 48 hrs after the injection. Slight itching to puncture site for 3 days  yesterday 1/11/21 onset of Swollen Lymph node to the L axilla and under the L clavicle bone , same side as the injection site. They are both visibly swollen and tender. Ongoing today.
pt reported to the pharmacy on 11/14 that after the shot he was feeling feverish and had severe arm pain that radiated from the site of the shot up to his neck and didn't seem to be getting better
cold sweats; chills; Pretty intense reaction; achy; arm tingling; headache; nauseous; fatigued, tired; muscles ache; site of injection was pretty sore; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Pretty intense reaction), COLD SWEAT (cold sweats), PAIN (achy), PARAESTHESIA (arm tingling) and HEADACHE (headache) in a 61-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 Allergy to molds (Allergy to molds and overreact to it). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ADVERSE REACTION (Pretty intense reaction), PAIN (achy), PARAESTHESIA (arm tingling), HEADACHE (headache), NAUSEA (nauseous), FATIGUE (fatigued, tired), MYALGIA (muscles ache) and VACCINATION SITE PAIN (site of injection was pretty sore). On an unknown date, the patient experienced COLD SWEAT (cold sweats) and CHILLS (chills). At the time of the report, ADVERSE REACTION (Pretty intense reaction), PAIN (achy), PARAESTHESIA (arm tingling), HEADACHE (headache), NAUSEA (nauseous), FATIGUE (fatigued, tired), MYALGIA (muscles ache) and VACCINATION SITE PAIN (site of injection was pretty sore) outcome was unknown and COLD SWEAT (cold sweats) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.9 101.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took extra dose of Aspirin to help her with the symptoms occurred after 1st dose.   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: Follow-up contain new AE's
pain Narrative: pain, weakness right arm, soreness. wakes  up at night and unable to grasp w/hand
Fever, chills, muscle aches, fatigue, headache. Symptoms started sometime during the night after vaccination, woke up feeling horrible the next day. Fever peaked at 101.3 F, broke in the afternoon. Intense muscle aches, fatigue, and headache persisted for nearly a week. Very disruptive to my daily life.
other zoster related injuries; shingles; Initial information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was 65 years old. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or about an unknown date in January 2011, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a healthcare provider at a medical center for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by a physician at the medical center, and other healthcare providers, for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
10/11/03 4PM (verbal report from pt): Right arm felt uncomfortable. An area from the injection site to a few inches above elbow was red, swollen and warm to touch. Pt thinks it was more than a mild local reaction. 10/13/03 late afternoon: Right arm almost back to normal.
Arm became red hot and itchy 30 minutes after vaccine, Redness extended down entire arm. Vaccine given 10/19/18, symptoms resolved completely on 10/21/19. BENADRYL was used every 6-8 hours for symptoms.
Vaccine exposure during Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy) outcome was unknown. Not Provided          No Concomitant medications provided No treatment information provided
Woke up in the middle of the night with a fever around 101 Fahrenheit. Also had chills, severe headache, lack of energy, and no appetite. Condition significantly improved over the next 24 hours without seeing a doctor or taking any medication.
he developed diarrhea 10 days ago and has since complained of >10 watery stools a day. He reports frequent incontinence. Diarrhea seems to be worst at night when he lays down. Weakness - Generalized, Vomiting, and Diarrhea
2 month vaccines (PEDIARIX Hib, PCV-13, ROTATEQ) given 1-23-17. On 1-25-17 mom reports infant had a "meconium looking dark stool: x1. Fussy and low grade fever. Seen in office on 1-26-17. Normal stool Guaiac negative.
Very dry mouth and felt uneasy , lightheaded, dizzy, tingling/numbness  arms, mouth, tongue, heart racing, chest tightness.   Then on Tuesday the 26th at work was eating my lunch and my mouth went numb/tingling, mouth got very dry and heart started racing, heart was 140-150s and I was sent down to the ED and they did an EKG and labs right away. My potassium was 2.9 then I received potassium IV and Po while in the ED and a liter bolus of fluids then had to follow up with my NP and redraw labs.
Nickel sized bruise left deltoid, no pain. Patient advised to take O.T.C. (Benadryl) and return to doctor. Symptoms don't subside or worsens.
I95.9 HYPOTENSION 4/16/2022 FEVER J96.00 ACUTE RESPIRATORY FAILURE 4/23/2022 FEVER R09.02 HYPOXIA 4/23/2022 FEVER I95.9 HYPOTENSION 4/16/2022 ABNL GENITOURINARY SYSTEM IMAGING R09.02 HYPOXIA 4/23/2022 ABNL GENITOURINARY SYSTEM IMAGING I95.9 HYPOTENSION 4/16/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION J96.00 ACUTE RESPIRATORY FAILURE 4/23/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION R09.02 HYPOXIA 4/23/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION
12 hours after 2nd dose, fever (99 - 102 degrees) for about 48 hours and body aches, headaches as a result of the fever. Took 2 full doses of tylenol.
Post vax, the pt's mother stated that the pt had a fever of 99-101 during the day and 102-104 during the night. She states she is giving Motrin and Tylenol alternately. Mother also states that pt has a poor appetite. Pt was seen by his doctor and said nothing was wrong, to just continue with Tylenol.
Pt recvd vax & devel nausea, & a red raised rash 24 hrs p/each inject unk whether pt's sx have resolved p/eight dose;
Following the 2nd dose of the Moderna Vaccine, I experienced a severe inflammatory reaction that included muscle weakness, fatigue, and joint pain particularly in both knees. The knee pain and feeling of instability has lingered for months following. I did not have knee pain/issues prior to the vaccine.
Death  Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 95 and admitted to ED on 2/26/21 with leg edema and diarrhea. Had periods of bradycardia in the 40s during admission. Diagnosis was heart failure exacerbation which caused a significant decline in his condition resulting in eventual palliative care before his death. Notable comorbidities include CAD s/p cabg, T2DM, HFrEF, CKD, HTN, recurrent UTIs.
I was sick for 2-3 mo this; Initial information received on 18-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via Social Media.  This case is linked to case 2020SA296074.  This case involves an unknown age patient who was sick for 2-3 month this (illness), while he/she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose  dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot number not reported via unknown route in unknown administration site, for prophylactic vaccination.  On an unknown date (latency unknown), it was reported that Every time patient got a flu shot, patient was sick for 2-3 month this (illness), patient have not had a shot in seven or more years and have not been sick was reported following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown at the time of reporting.  There will be no information available on the batch number for this case.
Information has been received from a healthcare worker referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. Since 01-MAY-2015, these patients were vaccinated with VARIVAX (Merck) (lot# K026386, expiration date 15-DEC-2016; lot# K020757, expiration date 31-Oct-2016; lot# K016132, expiration date 24-SEP-2016; dose and route not reported) which underwent supported temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Experienced bilateral lower extremity weakness, mid-thigh down to feet, with numbness. No chills, no fever, no other bodyache. Restless and could not sleep that night.Symptoms resolved in 1 day. No injection site reaction
scar inflammation, joint pain/stiffness, nerve pain in upper extremities, and numbness/tingling in upper and lower extremities
Increased saliva production that occurred shortly after receiving Moderna vaccine; This spontaneous case was reported by a physician and describes the occurrence of SALIVARY HYPERSECRETION (Increased saliva production that occurred shortly after receiving Moderna vaccine) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Obstructive sleep apnea.  Concurrent medical conditions included Obstructive sleep apnoea syndrome.    On 15-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. In October 2022, the patient experienced SALIVARY HYPERSECRETION (Increased saliva production that occurred shortly after receiving Moderna vaccine). At the time of the report, SALIVARY HYPERSECRETION (Increased saliva production that occurred shortly after receiving Moderna vaccine) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The patient had increased saliva production that occurred shortly after receiving Moderna vaccine (as I understand things, Bivalent). This was occurred about 3 weeks after vaccine receipt and continues now. The patient underwent biopsy of salivary glands. The result was not reported. The patient did not experience any additional symptoms/events.
Began at 1130 w/ right side of lip losing mobility/muscle movement and progressed through the evening to entire right side of face including his eye, brows, lips, cheeks.  His right eye will not blink but he can get it to close to sleep.  He notified me at 9pm and I instructed him to call his Dr.  He called Dr. who saw him the next day and confirmed Bell's palsy. He is being referred to a neurologist.
Pt called into clinic c/o hives on face and body with same itching. Denies any other symptoms/problems. Pt declined clinic appt for evaluation at this time. Instructed to contact clinic for f/u if needed. Pt states she received pneumonia shot on Thursday 10/24/02 and broke out in hives on Friday 10/25/02.
This spontaneous report was received from a medical assistant and refers to a 15-year-old female patient. The patient's pertinent medical history included scoliosis. It was also reported that she had no drug reactions or allergies. On 01-MAR-2017, the patient received GARDASIL 9, in right arm (lot# M043731, expiration date: 22-JUN-2019) (dose and route of administration were not reported) for prophylaxis (reported as "routine vaccine"). Concomitant medications included etonogestrel implant (NEXPLANON) inserted subdermally in her left arm on an unspecified date, by an unspecified provider at an unspecified location (lot# and expiration date were unknown). The patient's mother informed the medical assistant via voice mail message (dated 04-APR-2017) that the patient experienced a "knot-like swelling" at the injection site since receiving GARDASIL 9, on unspecified date in approximately March 2017 (reported as since receiving GARDASIL 9 and also reported as beginning on an unspecified date). It was reported that the adverse event had not resolved. No treatment was provided for the adverse event. No lab diagnostic studies were performed. The patient did not seek medical attention. No Product Quality Complaint (PQC) was involved. The relatedness between the adverse event and the suspect therapy was not reported. Additional information has been requested.
10/6/04: general weakness for three days. 10-6-04: suddenlylost hearing in the evening. Audiologist diagnosed nerve damage. Put on prednisone.
Heart Palpitations... Treated in Emergency room with 2 liters IV fluid. Also had nausea and vomiting, treated with IV Zofran.  Symptoms started approx 18 hours after receiving vaccine. Heart palpitations started at 5:30pm the day after receiving the vaccine.
Chest pain, headache, fever, fainted, extreme fatigue, nose bleed,and nausea. I got the first does on 08/10/2021 and my second dose on 8/31/2021.
This case was reported by a consumer via call center representative and described the occurrence of pain localized in a adult female patient who received SHINGRIX. On 8th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 8th March 2018, less than a day after receiving SHINGRIX, the patient experienced pain localized, insomnia and chills. On an unknown date, the outcome of the pain localized, insomnia and chills were unknown. The reporter considered the pain localized, insomnia and chills to be related to SHINGRIX. Additional details were reported as follows: An internal employee reported this case on behalf of another employee (patient). The age at vaccination was not reported. The patient received SHINGRIX on the left arm. The patient experienced significant local pain, and she could not sleep. The patient did not expect to experienced chills after receiving SHINGRIX.
I waited 15 minutes after getting the shot and my arm was sore but I assumed that was to be expected. I left the store at 1137 because everything seemed okay. I headed to the grocery store. I left the grocery store  at 1152 and  I was concerned because the left side of my face felt like I'd taken a light hit of Novocaine (no droopy eyelids or mouth though) and the left side of the back of my neck felt like it was trying to spasm. My left arm felt strange and I began having sharp pain in my left outer thigh, which also felt strange. It is now 1300 and I feel a little better although the left side of my face still doesn't feel right and left back of my neck is feeling sore.
First Dose Heplisav-B Second Dose Engerix; Initial Report Received on 10-Nov-2021  A registered nurse reported that a patient (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization for the first dose and a second hepatitis B vaccine was given, which was Engerix.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported), route and site not reported.   Just over a month later, a second hepatitis B vaccine was given, which was Engerix. No adverse reactions were reported.  No additional information was reported. The reporter refused to provide any further details.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
45 minutes after administration pt became nauseated, tachycardic, numbness and tingling hands and feet, progressing to the knees.  Injection site warm, BP 132/96.  On exam, oropharynx mild erythema - no edema and no stridor.  Lungs CTA.  Cor - S1 S2 slightly rapid. Abd soft, non-tender, positive BS.  No rashes.  Gave Benadryl 50 mg and prednisone 20 mg.  BP 110/72. HR 72. O2 Sat 98%.  Temp 98.3F.
Information has been received from a pharmacist concerning a 67 year old male patient with hypertension, hyperlipidemia, drug reactions or allergies to penicillin and codeine and a history of gastrointestinal esophageal reflux disease, hepatitis unknown type, gout, neuropathy and prostatitis who in 1993 was vaccinated with the first dose of PNEUMOVAX 23. The pharmacist reported that the patient has an injection site reaction after received the second intramuscular dose in the left deltoid of PNEUMOVAX 23 (Lot # 665707/1407Y) on 18-AUG-2010. Concomitant therapy included tetanus in right arm. The reaction was a swollen left deltoid with generalized redness, warmth and pain. Patient sought medical attention by a visit to the office. He was prescribed TYLENOL for pain. The outcome of the patient was not reported. No lab diagnostics studies were performed. This is one of several reports received from the same source. Follow up information has been received from the pharmacist indicating that on 23-AUG-2010, the patient was contacted by phone. The patient stated that he had recovered with no residual side effects. The pharmacist also stated there were other patients that had received PNEUMOVAX 23 with lot number 665707/1407Y and those other patients did not have any adverse experience. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 20-AUG-2015, the patient was vaccinated with the improperly stored dose of PROQUAD (Merck) (lot number L005297 and expiration date 23-SEP-2016; dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 76 years old male patient. On 22-OCT-2012, the patient was vaccinated subcutaneously, back of left arm with, 0.65 ml ZOSTAVAX (lot H012521 Exp: 09-OCT-2013). No concomitant medications were reported. The pharmacist stated that on 22-OCT-2012, the patient was vaccinated with improperly stored ZOSTAVAX vaccine. No adverse effects reported. Additional information is not expected.
Patient states that she had itchy hives that began the day after vaccination. No throat swelling or trouble breathing.
This spontaneous report as received from a consumer refers to her father a 64 years old male patient. The patient's medical history included lyme disease, cataract surgery and no drug reactions or allergies. The patient was vaccinated with a dose of PNEUMOVAX 23 on 21-MAY-2012 (Lot #, dose and route not reported). No other co-suspects were reported. Concomitant medications included metformin, lisinopril (manufacturer unknown) and prednisone (manufacturer unknown). The patient's daughter reported that the next day on 22-MAY-2012 her father began to have a fever that fluctuated and he was in bed all week. The doctor had been called on 23-MAY-2012. On 14-JUN-2012 the patient had an appointment with the eye doctor. On 15-JUN-2012 the patient was admitted to the hospital. While in the hospital he was given insulin and 3 blood transfusions. The patient had experienced shortness of breath, but his electrocardiogram (EKG) was normal. The patient was advised that his low blood count caused the shortness of breath. His red blood count was 19. A bone marrow biopsy was done that proved inconclusive. He was discharged on 18-JUN-2012. On 28-JUN-2012 he had bloodwork done and it was found that his hematocrit and platelets were bad. He was admitted back to the same hospital where 3 more blood transfusions were performed as well as blood cultures and body scans (results not provided). At the time of the report the events persisted and the patient was in the hospital. Additional information has been requested.
shingles; postherpetic neuralgia; vision issues; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently might be 67 years old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 08-AUG-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by providers for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: herpes zoster, postherpetic neuralgia and vision issues. The outcome of the events were not reported. The events were considered related to zoster vaccine live (ZOSTAVAX).
pt recv vax OCT97 & OCT97 pt exp inj site rxn that included inj site soreness, swelling & edema;
Upon awaking next morning, lethargy and fever (102.5), shaking. Fever higher than 102 persisted for two days. Still nauseated and weak on 3rd post vaccination.
9/12/05 Client received hepatitis B vaccine and MMR in her left arm and Td in her right arm. 9/13/05 Client's right deltoid was sore, she had joint pain, tired, and general malaise. 9/14/05 Right arm was red and swollen. 9/17/05 She was seen by doctor. Diagnosis questionable cellulitis/allergic reaction. Placed on Benadryl and Keflex 500mg QID for 7 days. 9/19/05 She felt better.