chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016561769) on 23-Dec-2016. This case involves a 69 years old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot/high dose) (batch number, expiry date, dose, route and site of administration- were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date and unspecified time frame, following the vaccination patient developed allergies to suspect drug. Laboratory investigations and corrective treatments were not reported. The events outcome were not reported. List of documents held by sender: none.
Following the second shot, I've experienced lethargy, headaches, and weakness and pain in my legs.  It's still on-going
This spontaneous report was received from a non-pregnant female patient of unknown age, concerning herself. The patient had no medical history, concurrent conditions, concomitant medications, historical drugs, drug reactions nor allergies reported. The patient reported that she received 3 doses of an unspecified hepatitis b vaccine (manufacturer unknown) injection in arm (not specify), 0, 1, 6 month schedule (route, lot # and expiration date were unknown) first dose was administered on 09-NOV-2016 and second dose on 13-DEC-2016 for Prevention of Hepatitis B. On an unknown date approximately mid December 2016, after receiving the first two doses, she felt a heaviness in her chest, fatigue and joint pain in her wrists, knees and hips. Subsequently, on 06-JUN-2017, the patient was vaccinated with her third dose, and after it on an unknown date in July 2017, she felt like she was hit by a truck, with brain fog and vision difficulties along with a rash and hives. On and unknown date, the patient also reported that she had been diagnosed with chronic urticaria and angiodemia. The patient sought for medical attention and received treatment for the adverse events, and also unspecified blood tests were performed without results provided. At the time of the report, the patient was recovering from the angioedema, arthralgia, fatigue, feeling abnormal, chest discomfort, visual impairment and urticaria chronic. The patient did not mention the causality assessment between the events and unspecified hepatitis b vaccine (manufacturer unknown). Upon internal review, angioedema was determined to be a medically significant event.
Moderna COVID-19 Vaccine EUA Headache 8/10, chest tightness 6/10, body aches 8/10, sore throat 4/10, congestion 3/10.
Received MMR and Varivax on 10/27/04. November 4th had temperature of 103.7 - also rash developed on November 6th on chest only. Rash was gone the next day. Mother reported on 11/8/04
Felt fine at first then got extremely nauseous and dizzy. Vomiting, chills,
She is here for follow-up on a pneumovax reaction from three days ago. The area on her right upper extremity that was outlined is somewhat smaller. The area directly over her elbow is still quite erythematous. She has no complaints of pain. The range of motion in the elbow is much improved today over yesterday. She has no known drug allergies. She is an alert and oriented elderly female in a wheelchair in no acute distress. Physical exam shows a somewhat indurated, bright red area over the lateral aspect of the right upper forearm, most markedly over the lateral aspects of the elbow and medial aspects. The demarked area is shrinking. The elbow has no crepitus. No effusions are noted. There is no axillary lymphadenopathy. Her lungs are clear and she seems to be improving. Assessment: 1) Improving pneumovax reaction, right upper extremity. 2) Early cellulitis. Plan: 1) She is to continue with the cool packs and the Keflex as directed yesterday. 2) If anything worsens of any new symptoms develop she should return for a follow-up either to the clinic or ER at that time. Keflex was ordered for Cellulitis secondary to Pneumococcal vax.
Patient was administered the first Pfizer vaccine as a medication error; he was not yet 16, the approved age.   The patient is doing well and reported no local or systemic side effects after the first dose.
trouble breathing; rash; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble breathing) and RASH (rash) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product CODEINE for an unknown indication.    Concurrent medical conditions included Blood pressure high, Nose bleeds, Venous insufficiency (in both legs), Disorder ear (an ears disease that cause her to feel vertigo) and Allergy to chemicals (13 allergies to medicines (no further details provided)).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and CODEINE (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (trouble breathing) and RASH (rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of 1 dosage form and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Rash, at a dose of 1 dosage form. At the time of the report, DYSPNOEA (trouble breathing) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter mentioned during call that patient was in the hospital (when she received the first dose of the vaccine) that her trouble breathing was from Codeine not that she had an anaphylactic shock.
Woke up on 11/25 with hives on arms and legs, they were mirror on both sides of my body... they have continued off and on for 6 days now.  I have no other symptoms, but the reaction has continued no matter the environment that I'm in or what I eat or omit from my diet.
I gave pt her flu shot and immediately she developed a large lump at inj site. The lump was about the size of a quarter. Pt reported some pain and lightheadedness. Ice pack was applied and she layed down for 5min. Site was evaluated by NP who had just seen pt and likely local reaction. Pt left without further incident.
itchiness and redness all over the arm where the product was injected; itchiness and redness all over the arm where the product was injected; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), administered in arm (Batch/Lot number: unknown) as DOSE NUMBER UNKNOWN, SINGLE for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 26Jul2021, outcome "unknown" and all described as "itchiness and redness all over the arm where the product was injected".  Additional information: it was reported that the reporter was not 100% sure if the events were related to the Prevnar 13 but at the 6 month mark, the patient experienced more itchiness and redness all over the arm where the product was injected.  No follow-up attempts are possible. No further information is expected.
Starting within four hours of injection, I began to feel fatigued and a bit groggy, which is persisting two days later.  I am also experiencing soreness in most of the arm that received the injection, which has been the most bothersome at night.  I have felt chilled at times and feel as though I may be running a slight fever.
Right upper thigh - no raised, no induration, round - 2 cm diameter, red/purple in color - noticed at 2:30pm (was pink at that time) - PENTACEL.
Patient came in to receive his 2nd dose of Pfizer primary series. Patient received the bivalent booster instead
No additional AE reported; Expired GARDASIL 9 was administered to patient; This spontaneous report has been received from an medical assistant and consumer referring to a patient of unknown age and unknown gender. Information about concomitant medication, pertinent medical history, drug reactions or allergies was unknown.  On 09-DEC-2020, the patient was vaccinated with expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter (formulation: vial, intramuscular (IM), lot # R009614, expiration date 30-NOV-2020) for prophylaxis (Expired product administered) and was inquiring of vaccine was still viable. There was no additional adverse event reported.  This is a non-valid case due to no patient's identifier.
Patient showed unusual behavior (laughing /crying) his wife took him to the ER 10:30P that night. Discharged same night wife said that all tests are normal.
Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient received 3rd dose and 3 hours after patients right arm, right side of face, and right arm became numb and it has continued. Patient called today (48 hours later) and I advised patient to go to emergency room/urgent care. Patient does not have PCP.
In April 2021 I reported  my adverse reaction to my J&J vaccination.  My employers health unit offered a Pfizer booster this week, and they advised me to take antihistamine prior to receiving the booster to avoid adverse reactions.  I had the exact same reaction to this Pfizer booster as I did with the J&J initial vaccine.  Last night I became very cold and could not get warm, which was followed by uncontrollable shaking for approximately 4 hours.  I woke up throughout the night still shaking and trying to get warm (with lots of blankets and a heater on high).  This morning I have muscle aches all over and my head and neck hurt.  I have zero energy.
shot hurt; feel sick for days; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced injection site pain and sickness. On an unknown date, the outcome of the injection site pain and sickness were recovered/resolved.   It was unknown if the reporter considered the injection site pain and sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received the shingles shot that hurt and felt sick for days.
Information has been received from a physician concerning a 33 month old healthy Caucasian female with no illness at the time of the vaccination, no pre-existing allergies, no significant medical history, including no immunosuppression, no recent varicella or zoster exposure and no concomitant medications who on 9/7/99 was vaccinated with a 1st dose in the leg of varicella virus vaccine live (2nd generation) (0.5ml). On 5/18/01, the child presented with an extensive area of varicella zoster vesicles from her mid left buttocks down to her left lateral thigh along the L2 dermatome distribution. It was reported that the zoster was quite extensive. There was no rash at the injection site or elsewhere within 42 days of the vaccination. The maximum temperature that the child had was 101.5F. The physician reported that it was unknown if the child's lesions or scabs resolved. No additional information is available.
Fever, chills, muscle aches, fatigue, headache, chest congestion, cough. All symptoms lasted 4 days, chest congestion and cough still present today
Patient c/o dizziness and HTN 15 minutes after receiving Covid vaccine booster. Patient states she felt dizzy when she stood up from exam table "too fast" . Patient's BP 148/86, HR 75. Patient declined to come to UC for observation but agreed to wait another 15 minutes to have BP rechecked. Recheck BP142/82. Patient unsteady on feet and still c/o dizziness, denies HA or CP. Patient agreed to come to UC for observation. Patient transported to UC in WC. Pt dc'd home after 1 hour of observation. Patient ambulatory with steady gait and dizziness resolved
Severe weakness, unable to eat, prolonged high temp 103 for almost 2 days.  Had to take days off from work.  Returned after 6 days still very weak.  Better today (day 8).
Patient refers abdominal pain, sweating, cold to the touch. Legs were elevated. head goes back and the paramedic is notified. We take his vitals BP 78/48 45 BP 122/73 53.
Breakthrough COVID infection. Tested positive 07/27/2022. Symptoms of fatigue and body aches. Unsure of onset of symptoms.
Pt's arm became stiff; felt hot behind her ears, then muscles of arms/legs and neck became stiff. Had cramps of calves. Neck felt quite stiff and led to limited ROM of neck and headache.
Red blood clot in left eye; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, on 12May2021 (lot number: EW0182; expiration date: 31Aug2021), as 1st dose, single dose, at age 25 years old, for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine taken for an unspecified indication, start and stop dates were not reported. On 12May2021, the patient had sore arm. On 13May2021, when the patient woke up, she had a red blood clot in her left eye. Treatment for sore arm included Tylenol. The outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
I give Kinrix at 4 months of age; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: As per reporter, the age at vaccination for all patients was 4 months. The reporter stated that in order to avoid giving 4 doses of Hepatitis B to patients, reporter gave Kinrix at 4 months of age, which led to inappropriate age at vaccine administration. The reporter stated that this happened about 12 times a year, once a month. The reporter consented to follow up. No further information available regarding product or patients. This case has been linked with case US2021090084, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021090084:same reporter
Swollen on the Injection Site; Itching on the Injection Site; Lump came back on the Injection Site; Soreness on the Injection Site; Redness on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness on the Injection Site), INJECTION SITE ERYTHEMA (Redness on the Injection Site), INJECTION SITE SWELLING (Swollen on the Injection Site), INJECTION SITE PRURITUS (Itching on the Injection Site) and VACCINATION SITE MASS (Lump came back on the Injection Site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced INJECTION SITE PAIN (Soreness on the Injection Site) and INJECTION SITE ERYTHEMA (Redness on the Injection Site). On 03-Mar-2021, the patient experienced INJECTION SITE SWELLING (Swollen on the Injection Site), INJECTION SITE PRURITUS (Itching on the Injection Site) and VACCINATION SITE MASS (Lump came back on the Injection Site). On 26-Feb-2021, INJECTION SITE PAIN (Soreness on the Injection Site) and INJECTION SITE ERYTHEMA (Redness on the Injection Site) had resolved. At the time of the report, INJECTION SITE SWELLING (Swollen on the Injection Site), INJECTION SITE PRURITUS (Itching on the Injection Site) and VACCINATION SITE MASS (Lump came back on the Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Client c/o dizziness and states "I'm going to pass out". Head lowered between legs, but client began to slump to side. FOC lowered client to the ground with RN assistance. Legs placed up on chair. Client's eyes remained open during episode and responded to his name after 3-5 seconds and client asked "what happened". Color beginning to return to face. Moved client from ground back up to chair at 10:15 and ice back applied to back of neck as cold compress. Water provided. Client c/o nausea. Continued to keep client's head between legs in chair. Client begins to shiver at 10:18. Granola bar offered and client takes 1 bite and vomits. 10:25 client continues to feel nauseous and states his legs feel weak. Moved to ground with legs elevated on chair. Pulse = 70. Client states he continues to go through periods where he "feels better" and then "feels nauseous". 10:40 911 called. RN comes into room. At 10:43, client c/o tightness in throat. 10:45- 0.4 cc epinephrine administered in left thigh by RN. Within 30 seconds of epinephrine, client states he "feels much better" and denies tightness in throat. Client continues to remain on ground with legs elevated and is conversing with FOC. 10:50 EMS arrives and evaluates. FOC declines transport to hospital. EMS instructs FOC to take client to PCP ASAP. FOC agrees. Client walked out of clinic on his own at 11:30am.
The vial was initially stored in the refrigerator on 25-Oct-2022 and administered on 01-Dec-2022; No adverse event; Moderna Bivalent dose was administered to patient after the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent dose was administered to patient after the 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Oct-2022 and administered on 01-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a 46-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent dose was administered to patient after the 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Oct-2022 and administered on 01-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent dose was administered to patient after the 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Oct-2022 and administered on 01-Dec-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent dose was administered to patient after the 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Oct-2022 and administered on 01-Dec-2022).    No concomitant information was reported. The injection site was deltoid. The size of the individual vial in carton was 2.5ml. The vial did not underwent any temperature excursions. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-681957, US-MODERNATX, INC.-MOD-2022-681956 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681957:patient 03 US-MODERNATX, INC.-MOD-2022-681956:patient 02
Information has been received from a registered nurse concerning a female who in 1996 was vaccinated with the first and second doses of varicella vaccine. Subsequently on an unspecified date, the pt failed to seroconvert. Unspecified medical attention was sought. Follow-up info stated that the reporter was unable to locate the file to complete the info and that the "employee has been terminated." No further info is expected.
Patient was a resident of a HCF.  Patient had a history of Covid-19; tested positive on 01/20/2022.  Family felt she had recovered from illness.  On 02/20/2022 patient was being seen and in significant distress.  The patient became increasingly dyspneic.  Family was at the bedside and requested that nothing aggressive be done, including xrays.  Patient expired on 02/20/2022.
devel inconsol "pain scream" lasting 1 1/2 hrs @ 2AM on 23MAR95-APAP given better next day;
19 hours after vaccine I woke up with  a headache, then some chills and went to bed. In bed all day and night with Fever, 101, body aches, crushing headache . Day 2 up for 3 hours in morning then back to bed and  slept all day, and night with crushing headache. Fever down to 99 on day 2. Moderate headache for next few days., but no more bed rest. 6? rash at vaccine site and swollen area at shot site.
patient received 0.25ml of dose; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (patient received 0.25ml of dose) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 dosage form. On 25-Mar-2021, the patient experienced UNDERDOSE (patient received 0.25ml of dose). On 25-Mar-2021, UNDERDOSE (patient received 0.25ml of dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Left arm pain that began after flu injection. Continues (1 month post vaccination) to still have pain in left arm (muscle and joint) and complains of pain in both arms with greater pain in left arm. Pain aggrevated with certain positions and throbbing at night.
Patient called the pharmacy on 03/15/2021 to report adverse effects experienced post-vaccination. Patient reported feeling a burning sensation in front of / underneath knee cap area of right leg with symptom onset of about 3-5 days post-vaccination. Patient noted that symptoms escalated to severe swelling of both knees about a week post-vaccination.