chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 18-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). On 18-May-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Pharmacy Technician found a box of Moderna Covid-19 vaccine that had a letter with the vaccine dated 16MAR2021 which stated that these batches of vaccine expired on 28 Apr 2021. The pharmacist reported that the patients received expired Moderna Covid-19 vaccine since 28 Apr 2021.  No relevant concomitant medications were reported. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.
Day 10-12-17 was immunized on my left arm with the Influenza Injection just right after not even 1 minute had a rash, hives and itching on site. Took some allergy medication next day still had redness, itchiness and still some hives and started with diarrhea. Days 13th, 14, 15, 16, 17 was still having stomach pain and diarrhea. Tuesday night started feeling sick cold, body aches, Wed still having body aches, headaches.
This spontaneous report as received from an office manager refers to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies, if any, were not provided. The office manager reported that, on 05-JUN-2018, the patient was inadvertently vaccinated with an expired dose of VARIVAX for prophylaxis (dose number, route and anatomical site of administration were not reported; lot number M024680, expiration date 18-MAY-2018). No adverse effects were reported, or product quality complaints involved. No additional information was provided.
Both injections initially left a large, red, and swollen bump near the injection site that persisted for less than a week before swelling stopped. Redness faded but remains persistent, with both injections leaving a visible darkened mark more than six moths later.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing), notes: type 1 diabetes; "Contrast dye allergy" (unspecified if ongoing), notes: known allergies: Contrast dye. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine was received. Other medications in 2 weeks was noted as no. Treatment noted as COVID 19 Treatment of Pfizer. Treatment start date was noted as 30Nov2022 and treatment stop date was noted as 05Dec2022. Indication noted as treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Symptoms I experienced were head and body aches, alternating chills and overheating, sinus congestion and pressure, postnasal drip, and coughing. I did not have a fever at any point. I was prescribed by the doctor Paxlovid antiviral medication. That was a 5 day course and I started it on Thursday, May 19 through May 24. Unsure of the effects with or without the medication. I did experience a side effect from the medication, strong chalk or metallic taste in my mouth while taking the medication. I had symptoms for about two weeks. I still have some lingering symptoms today. Really at this point, lingering cough and congestion. The other symptoms have improved. I did retest using a home test this morning and it came back negative. Symptoms have improved, in recovery, but not 100% fully recovered.
Pt recvd 4 doses of Engerix-B 19AUG92; on the same day as 3rd dose was given 19JUL92 pt exp feeling poorly, head pounding, profuse sweating, temp, stomach sickness, joint aching, felt drained; all sx abated next day;
Pt developed cellulitis @ inject site & rash following immun; Tx Erythromycin;
Pt received Pfizer dose on 1/30/21, 2/21/21, 10/6/21 and 7/00/22. He came in for his COVID Bivalent booster dose on 10/18/22. Due to mix up of the Pfizer monovalent and bivalent vaccine- he may have gotten either the monovalent or bivalent Pfizer vaccine.
pt recv vax 6AUG96 & 7AUG96 pt exp unrelenting h/a;pt eyes bother her but there is no photosensitivity;ER or MD visit required;tx w/pred & augmentin & tried APAP w/codeine;pt went to neuro for migraine eval;
About 24 hours after the vaccine, my son developed a hard and round circle the size of 3 quarters around the injection site. It was warm to touch. We were told it was a normal reaction but to draw a circle around it to ensure no spreading over next 12-24 hours or high fever. About 12 hours later the redness and warmth had gone done although it did spread about an inch or two. We teated with lavendar oil diluted in coconut oil 2x daily. It is slowly turning less red 48 hours later.
I had some stiffness in my left leg couple of weeks after receiving my booster shot; I kind of ignored it and noticed the leg started turning black from discoloration after a couple of days from noticing the stiffness. My husband took me to local Hospital on 12/13/2021 where they performed ultrasound and blood work testing on me; I was there for 5 hours and wasn't discharged until 2am. The doctor informed me I had a severe blood clot in my left leg that damaged the veins and disrupted blood circulation. They prescribed me Eliquis and pain medicine to tolerate sore pain. Since then, I currently attend physical therapy twice a week to try to regain mobility in walking in my left leg.
Sharp burning pain, (felt like a cigarette burn); redness covering the back side of her arm, swelling the size of a half-dollar area, and , excessive itching. This occurred within about 4 hours of the injection. The next day, clear fluid was draining at the injection site when pressure was applied. The patient had an appointment scheduled with her physician on 12/20/16. Her physician did not see a need for steroid treatment as it was a live vaccine. Patient reported the swelling reduced to a quarter sized area and the fluid under the skin burst. The fluid was clear at the time it burst on 12/25/16. The patient started benedryl on 12/19/16 and the itching has stopped since starting benadryl.
A nurse reported that a pt was inadvertently administered w/an expired lot of pneumococcal vax, polyvalent; No further details were provided;
pt recv vax 16OCT98 & awakened day following vax 17OCT98 w/hives on lt thigh size 1"-1 1/2" spreading to buttock (lt on 18OCT);painful;T99-99.3;buttock still red raised areas, painful;
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer contains multiple patients (6 patients) of unspecified age, sex, race and ethnic origin. No past medical history or concurrent conditions were reported. All of them were vaccinated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patients were hospitalized. They were tested and diagnosed positive for covid-19 (test and dates unspecified) [suspected covid-19 infection and suspected clinical vaccination failure]. All 6 patients were given Regeneron Infusion (not otherwise specified). Number of days hospitalized and discharge status were not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210807871 and 20210807550.; Sender's Comments: V0:20210808196-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure, Suspected covid-19 infection. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
This spontaneous report as received from a physician refers to a 53 year old female patient with irritable bowel syndrome, skeletal back problems and no known allergies. On 28-JUN-2014, the patient was vaccinated at an unspecified pharmacy with a dose of ZOSTAVAX injection in the left arm (dose, route of administration, lot#, expiry date unspecified). Concomitant therapies included diazepam (manufacturer unknown), gabapentin, cyclobenzaprine hydrochloride, AMITIZA, pantoprazole and montelukast sodium (manufacturer unknown). On an unspecified date in 2014, the patient experienced erythema, itching, and mild acute swelling, 3 centimeters in diameter, at the injection site and also localized myalgia. There was no compartment syndrome. The patient sought medical attention - she was in the emergency room at the time of report (on 02-JUL-2014) and received the treatment: DECADRON, 4mg (route of administration unspecified). The physician stated that the patient would not be hospitalized. The outcome of events was reported as not recovered. The relatedness between events and ZOSTAVAX was not reported. Additional information is not expected as the physician did not wish any contact.
Developed generalized macular rash. No reaction at site of injection. Prednisone and tapering dose. Zantac 150 bid, Zyrtec 10mg 1 qid.
Swelling, redness & heat; lasted about 2 days; no prior vax;
Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves female patient of unknown age (reported as newborn grandchild) who received TENIVAC in the unspecified of deltoid instead of ADACEL (batch number, expiry date, dose, dose in series, route was not reported for both the vaccine). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was case of actual medication error due to Wrong vaccine administered and inappropriate age at vaccine administration. It was not reported that if any adverse event was occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Pain at injection site. Then increased heart rate, dizziness, nausea, slight upper back/chest pain. Patient vomited, had nausea. Arm started swelling within 30 min of injection and continued to swell for 24 hours. (Her right arm had swelling/none in left).
From vaccine or coincidental?  After both Moderna vaccinations  thru a pharmacy that came to our workplace both my lower legs swelled edema and turned red and hurt. Both times it subsided within 14 days.  No other incidences of this.
Very sore arm - Right after shot; lasted 3-4 days Fatigue - Day after shot; lasted 3-4 days Headache - 5 days post-shot; lasted 1 day
Diminished capacity to draw a full breath; Mild discomfort with deep breathing; Productive cough; This is a spontaneous report from a contactable other healthcare professional, the patient. This 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose 1, single dose via intramuscular route of administration in the right arm on 06Jan2021 at 09:45 AM (at the age of 24 years-old) for COVID-19 vaccination. Relevant medical history included attention deficit disorder and allergy to non steroidal anti-inflammatory drugs .  Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included lisdexamfetamine mesilate (VYNASE). The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 18Jan2021 at 06:00 AM, the patient had diminished capacity to drawa full breath that started 12 days after vaccine date and has persisted. mild discomfort with deep breathing, productive cough. Laboratory tests included negative COVID polymerase chain reaction (PCR) tests (nasal swab) on 19Jan2021 and on an unknown date. The clinical outcome of diminished capacity to draw a full breath, mild discomfort with deep breathing and productive cough was not recovered. There was no treatment received for the events.  It was also reported that since the vaccination, the patient had been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Left deltoid swollen, red, warm to touch. Fever, chills, night sweats, body aches from Friday night until Mon morning.
anaphylaxis shock; swelling in her lip; swelling in her tongue; swelling in her glands; headache; fluid build up in her body; all her systems started to breakdown; Initial information received on 28-Oct-2019 regarding an unsolicited valid serious case received from a physician.   This case involves a 68 years old female patient who experienced headache (headache), anaphylaxis shock (anaphylactic shock), swelling in her lip (lip swelling), swelling in her tongue (swollen tongue), swelling in her glands (lymphadenopathy), fluid build up in her body (fluid retention) and and all her systems started to breakdown (multi-organ disorder), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ0288AA via unknown route in the arm.  On 26-Oct-2019, the patient developed a serious headache, anaphylaxis shock (anaphylactic shock), swelling in her lip (lip swelling), swelling in her tongue (swollen tongue), swelling in her glands (lymphadenopathy), fluid build up in her body (fluid retention) and all her systems started to breakdown (multi-organ disorder) two hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. These events were assessed as medically significant. The patient was hospitalized for these events.  Relevant laboratory test results included: Blood pressure measurement - On an unknown date: 80/50.   Final diagnosis was anaphylactic shock.  The patient was treated with Epinephrine (Epi pen) and was put on oxygen.  On an unknown date, the patient recovered from all the events.; Sender's Comments: This case concerns a 68 years old female patient who developed anaphylactic shock, headache, lip swelling, swollen tongue, lymphadenopathy, fluid retention and multi-organ disorder two hours after vaccination with FLUZONE QUADRIVALENT. The time to onset was compatible. However, patient's past history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Since receiving the vaccine, I have had heavy bleeding each month beginning 2 days post vaccine.  I had menstrual bleeding for approximately one month  immediately following and for every menstrual cycle following. I have had tests/ ultrasounds etc. and all natural causes for heavy menstrual bleeding have been ruled out. I have also had heavy cramping and gastrointestinal issues.
Patient diagnosed with varicella 01/17/2005. Received varivax 03/27/1997
Arm injection site was red, swollen, sore. Symptoms improved after 24hrs.
CONFUSION, DIZZINESS, BODY ACHES, FEVER, AND HEADACHE STARTED ABOUT 7-8 HOURS AFTER VACCINE. HEADACHE, AND HTN, UP TO 250/113, SINCE VACCINE AND STILL ONGOING.  PT HAS BEEN TO DOCTOR NUMEROUS TIMES. TRIED GABAPENTIN 400MG AND AMLODIPINE, AND THEY DIDN'T HELP.  HE STARTED ON LOSARTAN 50MG 6/29.2021 AND REPORTS HIS BP IS BACK TO NORMAL, BUT HEADACHE, DIZZINESS, AND PROBLEMS WITH BALANCE IS STILL PRESENT.
Right eye pain; Redness of right eye; Pain at injection site; Headache; rash on her chest became worse; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rash. Concomitant products included COVID-19 VACCINE MRNA (MRNA 1273) (MODERNA COVID-19 BOOSTER).   On 19th November 2021, the patient received the 1st dose of Shingrix (intramuscular). On 19th November 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, headache and rash aggravated. On 22nd November 2021, the patient experienced eye pain and eye red. On an unknown date, the outcome of the injection site pain, rash aggravated, eye pain and eye red were not recovered/not resolved and the outcome of the headache was unknown.   It was unknown if the reporter considered the injection site pain, headache, rash aggravated, eye pain and eye red to be related to Shingrix.  Additional details were provided as follows: The patient self-reported the case. The patient received Moderna Covid-19 Booster vaccine on 20th September 2021. The patient states that she had a rash on her chest that had started prior to receiving the vaccine.  The health care professional administering Shingrix told her that since it was not painful it could not be shingles.  After the administration she had pain at the injection site, headache and the rash on her chest became worse.  The patient started experiencing pain and redness of her right eye. The patient consented to follow up.
Muscle aches; Dizziness; Nausea; This is a spontaneous report from a non-contactable healthcare professional (patient). A 25-year-old female patient (non-pregnant) received the first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a military base. On 02Jan2021, the patient experienced muscle aches, dizziness, and nausea. No treatment was received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient was recovering from the events.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Patient reported that about 3 hour after her first dose she experienced extreme abdominal cramping, described as menstrual cramps. She stated that she took both Acetaminophen and Ibuprofen with no relief at all. Within 2 days, she reported starting her monthly cycle 1 week earlier than anticipated.
This is a 44y.o. male with a medical history of hypertension and prior pancreatitis as well as alcohol abuse and tobacco abuse who presented to the emergency department secondary to epigastric pain. The patient states that he has had 3 days of Bastrop pain radiating to his back after drinking alcohol during a football game. He states that the symptoms are similar to his previous bout of pancreatitis. He states that he has had multiple episodes of pancreatitis and this is his seventh or eighth episode. He states that his last episode was about 3 months ago.   On presentation, CT of the abdomen and pelvis did reveal findings consistent with interstitial pancreatitis as well as a fluid collection within the pancreatic head. There was no evidence of necrosis at this time.
Blood in stool; stomach pains; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot#: EN6206, expiration date unknown) via an unspecified route of administration at left arm on 06Mar2021 at 10:00 AM at age of 21-year-old at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination and not pregnant at event onset. Patient had no COVID prior vaccination. COVID wasn't tested post vaccination. There was no known allergy and no other medical history. There was no other vaccine in four weeks. There was no other medications in two weeks. Patient experienced blood in stool and stomach pains, both on 07Mar2021 at 15:30. No treatment was received for both events. Outcome of both events was recovering.
Patient reported mild redness and itching to both inner aspect of both arms. Hives. No SOB, A&Ox3 Vitals: 16:05 140/75, 76, 18; O2Sat 100%. Patient given Benadryl 25mg PO @16:10. No progression of hives or development of other unusual symptoms. At 16:17 stable; thereby released from the vaccination site accompanied by husband and daughter.
soreness and stiffness in shoulder slowly increasing to point of going to orthopedic surgeon for rotator cuff treatment. Turns out not rotator cuff but a knot in bicep putting pressure on tendons causing pain. Physical therapy broke knot down and arm is fine now. There is no way of knowing for sure if this is related to the vaccine or is just a coincidence of timing seeing as I have received two shingles shots, a pneumonia shot, two flu shots and two Covid shots in the same arm in less than two years. Have started switching them up now.