chrisvoncsefalvay/vaers-outcomes huggingface dataset:
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case contains information for the 36th of 190 adult patients described by the reporter.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE
Tachycardia; A report was received from a physician concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and developed/experienced tachycardia.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 03 Jan 2021, approximately 2 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 05 Jan 2020, the patient experienced tachycardia. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
1100hr swelling of rt thigh started; thigh was swollen for 24 hrs doubling in size; 48 hrs later was normal in size again; 1230 crying started pt inconsolable for 3.5 hrs; cry was described as different; t100 x 48 hrs;
Patient was given undiluted pediatric pfizer vaccine- so too high of a dose. They were informed that day but have not reported any symptoms to us so far.
PT CAME IN WITH PARENT, IMMUNIZATION RECORD CHECKED AND SHOWED PT WAS DUE FOR 12 YEAR VACCINATIONS (TDAP AND MCV4), PT'S MOM NOW HAS CHILDREN BACK AND REPORTS PT HAD GOTTEN THE SAME IMMUNIZATIONS PREVIOUSLY AT ANOTHER CLINIC AND THEY HAD NOT UPDATED
1 - 1 1/2 hours after receiving the vaccine I felt like I was going to black out. This happened 2x and lasted 15 seconds.
No adverse reactions during 15 minute monitoring time period.  The patient's 2nd Moderna dose was administered 5/21/21 so his booster  could have been given no sooner than 11/21/21.  His Moderna "booster" dose was administered 11/16/21.
Initial report received on 21 April 2009 from the patient's spouse. A male patient (demographics not provided), who has autoimmune reactions to milk, had received a dose of ADACEL on an unspecified date. The lot number, route and site of administration were not reported. Per the reporter, the patient, who had a pre-existing autoimmune reaction to casein, suffered severe permanent damage after receiving the vaccine. A description of the adverse event and permanent damage were not provided. Treatments received and diagnostic tests performed were not reported. The patient has not recovered.
From Church felt dizzy standing in line, near syncopal per daughter. Complaining of L arm and back pain from falling. Hypotension 18 G LAC 200ml NS 2 days ago got her Covid booster and that's when her symptoms started
Redness, warmth and swelling of left thigh where Quadracel was given on 10/20/22, began on 10/21/22 and worsened over 2 days then started to resolve.   Large 6x6 cm  oval  slightly indurated fading erythema regressing according to marker outlines.  At its worst, erythema nearly covered entire anterolateral left thigh.  Reassured Mom that reaction appears to be resolving.  May continue cool compress, Benadryl and Cortaid as needed
Mild nausea,  diffuse myalgia, chills, fever to 101.5.
Patient is 61 years old and received a Fluzone Quad High Dose vaccine. According to CDC: Fluzone High-Dose Quadrivalent vaccine is approved only for people 65 years and older. Fluzone High-Dose Quadrivalent is not approved for people younger than 65 years or for people of any age with a history of severe allergic reaction to any influenza vaccine or to vaccine components other than eggs. Information about vaccine ingredients is located in the manufacturer?s package insert.
5/24/2012: Sore stiff arm and shoulder on side where shot given, lasting 2 days.  Sore throat and ear ache developed in PM, lasting 4 days.  5/25/2012: Exhaustion and weakness, headache, joint aches all over body, chills, slight fever, lasting all day.  5/26/2012: Very slight nasal congestion; heavy, aching lungs and very large amounts of mucous in throat (to the point it felt like it might obstruct breathing several times); lasting 3 days.  5/27/2012: Sinus congestion and productive cough with yellow or dark mucous; lasting about 10 days. 6/8/2012: Nasal congestion reduced but still present; cough becoming drier and less productive, although still somewhat productive; lasting about 2 weeks.  6/22/2012: Nasal congestion mostly gone; cough dry and tickling in throat and lungs with occasional production of large blobs of mucous; lasting one week so far, with no sign of lessened severity at this time.
Terrible spasms, fast heart rate, troubled breathing. Fell on floor - pain in skull down back and couldn't move myself. Husband couldn't get me up as would stiffen. Finally got me in bed sick.
No additional AE reported; administration of an expired PROQUAD (Lot: T034828; Exp: 11APR2022) to a patient on 21APR2022.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, concomitant medications, pertinent medical history or drug reactions/allergies was not provided.  On 21-APR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin, rHA) (PROQUAD) lot number: T034828, expiration date: 11-APR-2022 (dose, strength, route of administration and anatomical location was not reported) for prophylaxis (expired product administered). The reporter confirmed measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) had no temperature excursions and had been stored per the recommended storage range until administration. No additional adverse event (AE) was reported (no adverse event). No product quality complaint (PQC) reported.
It started with a fever and so I took him back to the doctor on 10/29/2014 at 8:20 AM they said he had a throat infection and sent him home with a prescription. His fever then got worse by that night at 6:00 PM I took him to the emergency room and they couldn't find any reason his fever was so high. his fever had gotten to 103.8 and he was lethargic. His fever lasted another 2 days. And now he is not very active and gets very tired easily and he is normally a very active baby.
sinisistus; low grade fever; cough; body aches; chills; This is a spontaneous report received from a non-contactable consumer or other non-health care professional (patient) via a Regulatory Authority.  A female patient with unspecified age received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; batch no/Lot number: not reported) via an unspecified route of administration on 06Apr2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient and her husband had 1st dose of Covid Vaccine on 06Apr2021. On an unspecified date in Apr2021, after 1st dose of Pfizer vaccine patient experienced with Sinusitus and low-grade fever, cough, body aches and chills. Patient was asking the reason for the time lapse in reactions and whether they get the second dose. Outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
PATIENT STATES DEVELOPED SEVERE ABDOMINAL PAIN 3-4 DAYS AFTER VACCINATION IN RIGHT LOWER QUADRANT.  SHE STATES SHE THOUGHT IT WAS A PROBLEM WITH HER OVARIES BECAUSE OF THE SEVERITY AND LOCATION.  THIS PROMPTED HER TO HAVE A TRANSVAGINAL ULTRASOUND DONE TO INVESTIGATE THROUGH HER PCP.  PT STATES PAIN LASTED ABOUT 2 WEEKS AND RESOLVED.
mom reports that pt cried a high pitch cry cont for more than 3 hrs; had a temp of 100;
Weakness, no longer able to walk, needed wheelchair, COPD became more severe after receiving injections, overall condition rapidly deteriorated.  Had been stable on 4 lpm of Oxygen prior to vaccines.     Always had negative COVid tests and no Covid symptoms.
Bexsero meningococcal B, OMV  was given as an initial dose instead of initial dose of Menveo A-C-Y-W-135-Dip
pt recvd vax;on 15dec at 2pm was found by daycare to be cyanotic,rigid & difficulty of breathing;to hosp & found to be in severe metabolic acidosis;
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received from another manufacturer (no case reference number provided) on 20 May 2008.  The other manufacturer received the report from a health care professional.  A patient (age and gender not reported) with no reported medical history, had received an injection of "flu vaccine" (unknown manufacturer) on an unspecified date.  The trade name and lot number for the product were not reported.  An unspecified amount of time later, the patient "had a severe reaction".  Symptoms included "closing of throat".  It was not reported whether the patient recovered from the event and no other information was provided.
Allergic reaction to the flu shot. Two days after the shot he noticed itchiness in bilateral antecubital fossae. Rash appeared on neck, bacck, chest, groin.
This literature marketed report refers to a case of a novel mutation associated with an immunodeficiency. A 20 years old female patient with trisomy 10p and monosomy 4q, developmental delay, type 1 diabetes, hypothyroidism and deafness. She had no history of pneumonia, bacteremia, or skin infections. She did have an episode of mucocutaneous candidiasis requiring two months of antifungal medications to treat. The patient was vaccinated with PNEUMOVAX 23. She had a poor antibody response to Streptococcal pneumoniae after PNEUMOVAX 23. Her antibody titer was protective to tetanus. Her IgG (666 mg/dL), IgG2 (97 mg/dL), and IgG4 (2.8 mg/dL) were low with normal IgG1 and IgG3. IgA was low (41 mg/dL) and IgM was normal. Lymphocyte subpopulations were normal. Her lymphocyte mitogen proliferation was diminished to pokeweed, Candida albicans, and tetanus. Repeat lymphocyte antigen and mitogen proliferation were normal. Despite prophylactic antibiotics, she continued to have infections and was placed on intravenous immunoglobulin replacement. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 20 year old female patient (student) with allergy to amoxicillin. The patient's pre-existing medical condition included dysmenorrhea and tension headache. Patient came into the physician's office on 11-OCT-2013 for her third dose of GARDASIL (lot#, dose and route not reported). Patient declined receiving the medications and stated that on 11-JUN-2013 at 11:00 AM, the patient was vaccinated with second dose of GARDASIL (lot# H020002, expire date as 08-AUG-2015, intramuscular in the right deltoid, dose unspecified), she had nausea and vomiting the following day, on 12-JUN-2013. The outcome of nausea and vomiting was reported as recovered (unspecified date in 2013). Additional information is not expected.
Patient got all three vaccines on 5/7/22. His symptoms started on 5/12/22. The symptoms are are limited to the left arm and are asa follows ; soreness at the injection site, numbness of the fingers, and Shooting pain radiating to his shoulder and back
lt arm red, swollen, itching on SUnday had flu shot on Friday (swelling from shoulder to elbow);ER on Sunday-DPH & Motrin advised;redness gone, swelling inc on Monday p/DPH;
Patient came to ER for dizziness and unsteady gait. Patient was found to be COVID-19 positive.
Rash on top of foot featuring small blisters that have begun popping after administering topical hydrocortisone for one day
Patient was given a second dose of J7J vaccine.  First dose was given on 7/27/21 with Lot 204A21A and a second dose was administered on 8/18 with lot 207A21A.  No adverse reactions noted.  Patient was monitored and had no complaints.
Patient  received 1st dose of Pfizer Vaccine Lot#ER8730 and was sitting in chair at administering station when he lost consciousness. Patient regained consciousness, A/Ox4, skin pale, cold and clammy, pupils dilated. FNP assessed pupils were non reactive to light. Per FNP, patient then had a seizure for approx. 18 sec at 2:55 pm; seizure precautions maintained at all times. Upon regaining consciousness, pt. began  projectile emesis. 911 called/patient brought to sick bay. BP 104/51, HR 120, O2 97%, Temp 97.1 Patient remained A/Ox4 and stated he felt "very tired."  Patient transferred to paramedics and transported to Hospital.  EMS Incident.
DEVELOPED PAIN LEFT DELTOID AREA IMMEDIATELY AFTER VACCINATION. PAIN PROGRESSED SAME AREA AND NOW CAN'T LIFT HER LEFT ARM AND HAS WEAKNESS IN LEFT HAND. NO SENSORY DEFICIT. NO PAIN RADIATION. TOOK IBUPROFEN, NOT HELPING.
Experienced flu like symptoms the next day after second dose; very sick; slight fever; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events experienced flu like symptoms the next day after second dose, very sick, slight fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route for prophylaxis of COVID-19 infection. On unknown date, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, experienced flu like symptoms the next day after second dose, very sick, slight fever.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, experienced flu like symptoms the next day after second dose, very sick, slight fever was unknown.
Vertigo; Was super tired; Arm hurts; This case was reported by a consumer and described the occurrence of vertigo in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2019, the patient received the 2nd dose of Shingrix. On 15th October 2019, 1 days after receiving Shingrix, the patient experienced tiredness and pain in arm. On 16th October 2019, the patient experienced vertigo. On an unknown date, the outcome of the vertigo, tiredness and pain in arm were unknown.   It was unknown if the reporter considered the vertigo, tiredness and pain in arm to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. On monday, the patient received second shot of Shingrix. On the reporting date, 2 days after receiving Shingrix, the patient experienced vertigo. The patient asked whether that was a normal side effect. The day before reporting date, the patient was super tired and arm was hurt and went to bed at night. This was new on the reporting date.
He got the vaccination on 5/12/21 and he got his second vaccination on 6/15/21 and we completed his vaccination record with the second sticker.  When we billed the vaccine we noticed he got another vaccination on 6/10/21 at another pharmacy. So he received 3 vaccinations total.
Pt had red, painful, warm-to-touch injection site. She went to a doctor's office to have it examined on 12/19/2022, two days after vaccination. Per the patient, doctor diagnosed her with cellulitis. Physician prescribed patient Medrol dose pack and amoxicillin 500mg  three times daily for 10 days.
Received flu vaccine at approx 2 pm on 10/10/14. Vaccine was injected very high almost on shoulder of my left arm. Injection itself was very painful. Within 30 minutes of the injection I had pain going down the arm up the arm into my neck and across my left upper chest from the shoulder. Was unable to lift my arm Friday night (10/10/14). Two and a half weeks later. Still having severe shoulder and arm pain.
little swelling in the arm; ached and pains; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (little swelling in the arm) and PAIN (ached and pains) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 017170A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PERIPHERAL SWELLING (little swelling in the arm) and PAIN (ached and pains). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, PERIPHERAL SWELLING (little swelling in the arm) and PAIN (ached and pains) had resolved.            Concomitant information not provided.   This case was linked to MOD-2021-036179 (Patient Link).
Day of injection - sore injection site Day 1 post injection - headache, nausea Day 2 post injection - nausea  Day 3 post injection -  increasing nausea, gas Day 4 post injection -  Loose stool x 7, gas, nausea
Right scrotal pain; This spontaneous case was reported by a consumer and describes the occurrence of SCROTAL PAIN (Right scrotal pain) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Scoliosis.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Dec-2020, the patient experienced SCROTAL PAIN (Right scrotal pain). At the time of the report, SCROTAL PAIN (Right scrotal pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Urine analysis: normal (normal) result did not indicate any infection.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The treatment information included antibiotics for ten days.   This case was linked to US-MODERNATX, INC.-MOD-2021-066407 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-066407:2nd dose case
There were no adverse reactions to the first dose, EL9261.  In the hours immediately after the second shot, EN6200, there also were no reactions.  However at approximately 1915 of the date of administration, several worrying effects presented, including; * strong headache * reaction site pain, though not redness * generalised weakness, but especially noticeable in legs * mild fever at 99.9 consistently for over 12 hours
Discovered a rash like markings in my stomach from almost hip to hip and spread out to groin then went to my breast.  Eventually went to my left underarm.  Not itchy.
c/o pain at site (left upper arm). Pain radiated down whole left side of body including left leg and left jaw for next 2 weeks - including today (10/31/14) - difficulty sleeping and moving left arm.  Has an appointment with PCP this Monday (11/3/14)- asked her to report these findings back to nurse.  Gave patient this web site also - may also report on own.
This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number H4H34, expiry date 27th November 2021) and (batch number J3M5J, expiry date 2022) for prophylaxis. On 2nd December 2021, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. On 2nd December 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details were provided as follows: The patient was accidentally administered expired Shingrix vaccine on the date of reporting, which led to expired vaccine used. The reporter noted that, antigen had a lot number of H4H34 and expired 27th November 2021, and the adjuvant lot number was J3M5J and does not expired until 2022. The reporter consented to follow up.
Sore arm  Nausea  Diarrhea  Headaches  Migraines  Myalgia Body aches  Ear ache Fatigue  Chest pain  My ears pound
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 07Feb2021 as dose 1, single (Lot number: EN6201), in right arm, on 28Feb2021 as dose 2, single (Lot number: EN6201), on 27Sep2021 as dose 3 (booster), single (Lot number: EW0185) and on 06Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, stop date: 24Apr2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: soon after completing the Paxlovid, I testing positive again; (03May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received other medication in 2 weeks. Patient had no known allergies. Several days after completing Paxlovid therapy, very minor sore throat, cough, and scalp sensitivity reoccurred. Even though I got a negative (home) test soon after completing the Paxlovid, I testing positive again.