chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Date the vial was initially stored in the refrigerator on 22Jul2022, Date of administration of vaccine on 22Aug2022, 9:06am; No adverse event; Administered a Moderna Covid-19 vaccine to one patient which has been in the refrigerator for 31 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a Moderna Covid-19 vaccine to one patient which has been in the refrigerator for 31 days), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Jul2022, Date of administration of vaccine on 22Aug2022, 9:06am) and NO ADVERSE EVENT (No adverse event) in a 7-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AR9327B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 22-Aug-2022 at 9:06 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 22-Aug-2022 at 9:06 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a Moderna Covid-19 vaccine to one patient which has been in the refrigerator for 31 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Jul2022, Date of administration of vaccine on 22Aug2022, 9:06am) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a Moderna Covid-19 vaccine to one patient which has been in the refrigerator for 31 days), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Jul2022, Date of administration of vaccine on 22Aug2022, 9:06am) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered a Moderna Covid-19 vaccine to one patient which has been in the refrigerator for 31 days) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Jul2022, Date of administration of vaccine on 22Aug2022, 9:06am).    No concomitant medications were provided. Patients first dose and second dose was given on the left leg. The vial did not undergo any temperature excursions. The vial was initially stored in the refrigerator on 22Jul2022. Patient did not present any adverse event. No treatment medications were reported.
Pt developed a rash & a T of 101.@ wks p/MMR shot. Appears to have a slight case of measles. Take APAP for the T & observe.
On 1/16/03, child had swelling "the size of a baseball", at the distal injection site on her right thigh. The DTAP/HIB was given at that site on 1/14/03. She was seen by her PMD for treatment.
Patient presented to the pharmacy complaining of redness, swelling (very well demarcated) and injection site tenderness (upon touch).  Patient has not seeked medical attention thus far.
CERVICAL LYMPHADENOPATHY; LUPUS; ARTHRALGIA; FEVER; PREGNANCY; This case was reported by a nurse and described the occurrence of lupus in 25-year-old female patient who was vaccinated with hepatitis B vaccine (Engerix-B) for prophylaxis.   The patient's medical history included four previous pregnancies producing four normal, full-term infants.  There was no history of gout, psoriasis, Crohn's disease, or Lyme disease.  Concurrent conditions and medications were not reported.  On 25 March 2003, the patient received her first dose of Engerix-B.  Her last menstrual period began on 02 April 2003, seven days post-immunization.  On 09 April 2003, 15 days post-immunization, the patient presented to the physician with arthralgia and "high" fever.  She also developed cervical lymphadenopathy.  She was seen by a physician, who observed swollen and warm joints (affected joints not specified).  The reporter stated, "It was suspected at one point that the patient had viral meningitis, and she was treated accordingly".  However, treatment was not specified.  The patient was hospitalized twice in April 2003.  It was subsequently determined that the patient was pregnant; date of the positive pregnancy test was not provided.  The events persisted as of 09 June 2003.  The reporting nurse considered the events to be possibly related to Engerix-B administration.  On 03 July 2003, the nurse reported that it was discovered that the patient "is positive for lupus."  The most recent information was received on 11 July 2003.  The pregnancy and lupus were ongoing.  The patient's estimated date of delivery is 11 November 2003.  The reporter stated that the pregnancy is "very high risk" because of lupus.   Upon internal review following correction was performed on 28th September 2020: This case was considered as pregnancy lost to follow up.
Information has been received from a registered nurse concerning a 5 year old white female with no pertinent medical history or drug allergies, who on 06-JUL-2007 at 15:10 was vaccinated at 15:10 with the first 0.5ml SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 653306/0674U) in the left thigh. Concomitant vaccination on that day at 15:10 included a second SC dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (Lot# 656034/0182U) in the right thigh. There was no illness at the time of vaccination. On 20-JUL-2007 at 09:40 (also reported as 23-JUL-2007 at 10:00), the patient developed chicken pox breaking out in 8 to 10 areas characterized as itching, fluid-filled and starting to scab over. No medical attention was sought. No labs were performed. On 26-JUL-2007 the patient recovered. There was no product quality complaint. Follow-up information has been received from a registered nurse who indicated the pox were on the left leg at the injection site around the navel, and on the chest and face. On 01-AUG-2007 the patient recovered. Additional information has been requested.
Initial and follow up information has been received from a 65 year old female with allergic reaction to tetracycline, ampicillin, KEFLEX, REGLAN, NIZORAL, NEURONTIN, oesophageal acid reflux and arthritis who on 29-JAN-2007 was vaccinated with ZOSTER SC on left arm (lot no. not reported). Concomitant therapy included PROTONIX and CELEBREX. On 13-DEC-2007 the patient experienced painful cold sore on upper lip. On 2 occasions she developed painful blisters on her buttocks. First time was 7-FEB-2008. Second time was on 12-JUL-2008. She was prescribed VALTREX for these event's for 5 days and recovered with 1 week after all events. All events occurred after she received the vaccine. Skin tests were negative. In office visit of 21-JUL-08, no lesions noted, but patient had a cold sore present for "a long time" till treated with VALTREX for 5 days. She recovered from cold sore on 28-JUL-2008. Family physician did not feel any of these events are related to therapy with ZOSTER. No further information is available.
In bed sick for two day; Tirdness; nausea; Muscle ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (In bed sick for two day), FATIGUE (Tirdness), NAUSEA (nausea), MYALGIA (Muscle ache) and HEADACHE (headache) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (In bed sick for two day), FATIGUE (Tirdness), NAUSEA (nausea), MYALGIA (Muscle ache) and HEADACHE (headache). At the time of the report, ILLNESS (In bed sick for two day), FATIGUE (Tirdness), NAUSEA (nausea), MYALGIA (Muscle ache) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-087196 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-087196:Same reporter
No additional AEs; PROQUAD administered to a 27 year old; This spontaneous report was received from a Medical Assistant and refers to a 27-year-old patient of unspecified gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 24-AUG-2022, at the age of 27 years, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin) (PROQUAD), subcutaneous injection, 0.5 milliliter (lot #W010525 has been verified to be a valid lot number, expiration date: 25-SEP-2023) administered subcutaneously for prophylaxis (Product administered to patient of inappropriate age). No other information was provided. No additional adverse events (AEs) reported (No adverse event).
It began with my hands feel stiff and painful on both sides.  Within a week I was unable to get out of bed, I couldn't stop sleeping, my whole body was in unbearable pain.  My extremities went from pain, to pins and needles to loss of feeling equally.  The most painful headaches I had ever experienced began that first week.  July 17 every time I would move my neck I would get the feeling I was being electrocuted down my spine.  I began getting internal tremors throughout my whole body.  The feeling down my spine worsened and went around my rib cage and down my legs.  All previous symptoms still were the same.
Developed immediate local reaction to shot. Treated initially with ice and then warm soaks. Returned on 10/19/00, complaining of pain, swelling and redness and on 10/26/00 and 12/5/00. Treated with Keflex X 7 days on final onset with relief. Still with redness, heat and swelling and pain.
Covid-19 vaccine associated myocarditis.; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Covid-19 vaccine associated myocarditis.".; Sender's Comments: Based on the available information in the case, the causal association between the event MYOCARDITIS and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
METALLIC TASTE IN MOUTH AFTER 13 MINUTES STAYED ADDITIONAL 7 MINUTES WITHOUT REACTION.
Flu like symptoms as well as rapid heart beat 12 hours after injection (120 bpm) and significant heart palpitations.  101.6 fever, headache, lymph node shooting pain, and swollen right eye.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or around 04-SEP-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a bad case of the shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries and suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Shingles was considered to be disabling.
Joint aches; Chills; nausea; Muscle aches; Vomiting; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint aches), CHILLS (Chills), NAUSEA (nausea), MYALGIA (Muscle aches) and VOMITING (Vomiting) in a 58-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 13-Nov-2023, the patient experienced ARTHRALGIA (Joint aches), CHILLS (Chills), NAUSEA (nausea), MYALGIA (Muscle aches), VOMITING (Vomiting) and FATIGUE (Fatigue). At the time of the report, ARTHRALGIA (Joint aches), CHILLS (Chills), NAUSEA (nausea), MYALGIA (Muscle aches), VOMITING (Vomiting) and FATIGUE (Fatigue) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No relevant concomitant medications were reported. No treatment medication reported.
Received phone call from doctor's office. Client saw her PCP 6/18/08 due to increased pain and swelling to right arm after receiving vaccines at our health department. Per doctor, client's injection site was swollen size of tennis ball with a dime size hard, red center. Client instructed to apply hydrocortisone cream as needed for itching. No other treatment required.
15 minutes after administration of Pfizer vaccine her Initial complaint was light headedness and nausea, shortly followed by shortness of breath and anxiety. Taken to ED
There was no adverse event. An expired Pfizer booster dose was given to client.  Client was contacted about the event and was revaccinated on Nov 3 with Pfizer
This spontaneous report has been received from a pharmacist referring to a 60 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 02-MAY-2017 the patient was vaccinated with improperly stored doses of ZOSTAVAX 19400 plaque-forming units (PFU) (dose and route of administration were not provided; lot # M037014, expiration date 22-NOV-2017) reconstituted with properly stored sterile diluent (DILUENT MRK) (lot# and expiration date were not provided). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 30 degrees Fahrenheit for 4 hours. The doses of vaccine experienced also previous temperature excursion: from 15 to 46 degrees Fahrenheit for 15 minutes. Digital data logger was involved. The pharmacist stated that the vaccine was cleared, so they had vaccinated patients since the excursion. This is one of several reports from the same reporter. Additional information is not expected as all the information has been received.; Sender's Comments: US-009507513-1704USA006516: US-009507513-1705USA013606: US-009507513-1705USA013607: US-009507513-1705USA013609: US-009507513-1705USA013610:
pt recvd vax 18JUL95 &1/2 hr later devel a one inch diameter induration @ the inj site on legs; tx DPH & recovered; No further details were provided;
Local injection site reaction w/ erythema, induration and pruritus approximately 25 cm in (L) thigh.
pt recv vax & became pregnant (WAES 96060994);it was noted that the mom exp cystitis during pregnancy & was treated w/Macrobid;mom delivered a male infant (8lbs;15oz) following compound presentation on 15FEB97;pt had mild lt arm weakness;
Six hours post vaccination- chills, fever, headache. Twelve hours post vaccination- chills, fever, headache, nausea. Feb 4, 2021 - Swollen lymph node at right clavicle; Swollen right eye; swollen, warm, hard knot in right arm below injection site; headache.
7MAR 10Pm t105.3 R given Motrin 230AM t104 R given APAP 10AM t102 R; pt awake all noc-gen lying still but would occasionally jerk; 8MAR appt w/MD adm to hosp given anti-fever med; fever persisted @ 104-105; 9MAR95 PM t103; 10MAR95 pt disch
got the flu and have been dealing with it for over a week now; tested positive for Influenza A twice; Initial information received on 18-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age and unknown gender patient who got the flu and have been dealing with it for over a week now and tested positive for influenza a twice after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, the patient developed non-serious events of got the flu and have been dealing with it for over a week now (influenza) and tested positive for influenza a twice (influenza a virus test positive) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, we get our flu shot yearly, this year included. I know every year is a different strain but this year, WHEW what a huge miss!!  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor.   Relevant laboratory test results included: Influenza A virus test - On an unknown date: Positive  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was unknown.  The patient was treated with PREDNISONE (PREDNISONE) for Influenza and Influenza A virus test positive, just to get a little relief.  At time of reporting, the outcome was Unknown for the event got the flu and have been dealing with it for over a week now and was Unknown for the event tested positive for influenza a twice.
Fatigue, headache, myalgia, generalized weakness, chills, felt hot. Symptoms began 02/23/13, had swelling to injection site. Seen in ER on 02/25/13 d/c any meds, take TYLENOL, & MOTRIN for pain. Occ Health saw her on 02/26/13 still weak & headache. Seen in Occ Health 03/01/13 symptoms resolved.
Facial swelling, headache, and one episode of vomiting 24 hours after vaccination. Treatment with medrol dosepak, Benadryl, and Claritin. Unsure of treatment outcome.
I took a nap when I got home and woke up with some red bumps in my face. They looked like hives. But they were itchy and they lasted for weeks. Disappeared then came back again today
Rash fever 102.6, and fussy, pain in injection site, redness increased on one side.
Redness (5 in circle), raised, hot, itchy around injection site of left  arm
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 13-month-old male patient received the fourth dose of PREVNAR 13 in the thigh on an unknown date in 2012. Relevant medical history, family history, drug allergy history and concomitant medication were none. Past vaccine history includes: the first dose of PREVNAR 13 administered on 31Jan2011 at the age of 2 months (Lot #914514, expiration date: 29Feb2012), the second dose of PREVNAR 13 administered on 31Mar2011 at the age of 4 months (Lot #914972, expiration date: 31Mar2012) and the third dose of PREVNAR 13 administered on 01Jun2011 at the age of 6 months (Lot #915371, expiration date: 31May2012). On 17Jan2012 the patient experienced pneumococcal meningitis and pneumococcal sepsis and was hospitalized. Relevant laboratory data on (17Jan2012) was as follows: Blood culture positive for Streptococcus pneumoniae (Pneumococcal serotype: 29, 35, 42); CSF culture positive for Streptococcus pneumonia (Pneumococcal serotype: 29, 35, 42) and chest x-ray: normal. Laboratory data on (18Jan2012) was as follows: Pneumococcal IgG serotypes 1: 0.5; Pneumococcal IgG serotypes 3: less than 0.3; Pneumococcal IgG serotypes 4: less than 0.3; Pneumococcal IgG serotypes 5: 0.7; Pneumococcal IgG serotypes 8: less than 0.3; Pneumococcal IgG serotypes 9: (N) less than 0.3; Pneumococcal IgG serotypes 12: (f) less than 0.3; Pneumococcal IgG serotypes 14: 2.5; Pneumococcal IgG serotypes 19: (f) 0.7; Pneumococcal IgG serotypes 23: (f) 0.7; Pneumococcal IgG serotypes 26: (6B) 0.5; Pneumococcal IgG serotypes 51: (7F) 1.7; Pneumococcal IgG serotypes 56: (18C) 0.4 and Pneumococcal IgG serotypes 68: (av) 0.5. The patient recovered from the event on an unknown date in 2012. Follow-up (12Mar2012): New information reported from the contactable physician includes: patient demographics, product details, past vaccine history and lab data. Follow-up attempts completed. No further information expected.
Side effects: Headache, fatigue, aches in joints through out body, fever (100). Taking 1200 mg of Advil ever 6-8 hours and once an additional Tylenol, and caffeine.
I took 2 Aleve's for injection redness & red discomfort - left arm. Redness went away after 5 - 6 days. I had big red blotch at site of injection. It was still red on my whole left arm for 5 or more days. It was tender. It bothered me. I took 2 Aleves. I was told to inquire if I should take a second shot 2-6 months later. My mother had a severe reaction to the Shingles shot, that I remember. She had to lie down. I was not dizzy, but I did have pain at the site - about 8 on a scale of 1 to 10. 5/29/2020 Pharmacy advised to take 2nd injection I had the second Shingrix (Shingles injection at. Pharmacy again on Oct 23, 2020. The site felt hot - but no other reaction.
Developed high heart rate >150bpm with irregular rhythm on 5/16 around 12:00pm,  Sought care at Emergency Department, diagnosed with paroxysmal atrial fibrillation, first known occurrence. Treated with metoprolol and metoprolol tartrate, and returned to normal rate and sinus rhythm by 3:00pm.
Swelling, itching from upper arm to elbow for a week. Then tenderness, now a dark spot about 3 inches long.
Awoke 5/6/21  FatigueD, achey, tired and 2 bumps over lips  Early   morning 5/7 through 5/8 Enlarged, painful  lips  later 5/7 bumps on finger lasted 2 days  I have had enlarged lips reaction with unknown origin 5/19/2020;  also 12/8-12/9/21 at beginning of viral sinus infection. I thought I should report it because I am afraid to get the booster shot. I am going to see my allergist and possibly an epidemiologist because I am having other immune issues.
Fatigue, myalgia, joint pain, chills, headache during first 72 hours. Rash at injection site starting on day 6 and still present on day 8.
Headache and neck pain and stiffness (moderate), lethargy, joint pain & muscle soreness (mild). No fever. Treated with Tylenol,  Motrin, fluids, and rest. Symptoms resolved after 24 hours.
Vaccine was received on Monday. On Wednesday redness and inflammation around site of injection that spread throughout entire arm from shoulder to elbow. On Saturday patient felt weak and could not get out of bed.