chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. HCP administer expired vaccine to patients, after the manufacture date of expiration and wanted an assessments on the case.  Number of doses/vials:173 doses Date the vial was initially stored in the refrigerator was unknown. Date(s) of administration of vaccine: 08-Apr-2022, 12-Apr-2022 and 13-Apr-2022.  The vial did not undergo any temperature excursions. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information
11/19/15@8A: EXCESSIVE BRUISING. 11/20/15@10A: MORE BRUISING AND PETECHIA. 11/20/15@8PM: AFTER HOUR CLINIC: LABS. 11/20/15@11PM: ER HOSPITAL ADMISSION - PLATELETS AT 1K. 11/21/15@2AM: HOSPITAL TRANSFER, MOUTH BLEEDING, BLOODY NOSE, MORE BRUISES. 11/21/15 PM: IVIG.
VACCINE WAS NOT STORED PROPERLY; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a physician concerned a patient of unspecified age and sex. Initial information was processed along with the additional information received on 12-APR-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: unknown) dose was not reported, administered on 28-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-DEC-2021, the patient experienced poor quality vaccine administered. On an unspecified date, the patient experienced vaccine was not stored properly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was not stored properly and poor quality vaccine administered was not reported. This report was non-serious. This report was associated with product quality complaint: 90000225546. The suspected product quality complaint has been confirmed to be voided. Product was stored frozen until 19-NOV-2021 (when product was received) and then was not properly stored after that. On 07-APR-2022, the shelf life for the vaccine has been extended from 9 months to 11 months refrigerated (stored at 2-8 degree C). It is not clear how the product was stored after it was received. There is no product quality issue described in the information reported as the product was not within Janssen custody during this potential temperature excursion. Based on the evaluation/investigation performed. This case, from the same reporter is linked to 20220421157.
PNEUMOVAX 23 was administered to the patient's right arm. Pt returned to the pharmacy today, complaining of significant inflammation that extended to the forearm.
screamed on & off x 36hrs;was inconsolable for periods of 3 or more hrs per mom
7/1/15 Adult Hep A administered in error. 7/2/15 Present to after hours sick call with rash (mild) to torso; cough also reported. Diphenhydramine ordered. 7/4/15 Seen by pediatrician for F/U on rash. Rash resolved URI symptoms remained. 7/6/15 Seen by pediatrician. URI s/s continue dx conjunctivitis.
Left deltoid nodule s/p vaccination. Ice pack applied. Pt tol well. Decreased discomfort to sit
diarrhea; This is a spontaneous report from a contactable consumer. An adult male patient received COVID vaccine (unspecified trade name), dose 1 via an unspecified route of administration, administered in Arm Right on 08Aug2020 14:30(as reported, pending clarify) (Lot Number: AIN09876R4) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Facility type vaccine was Doctor office/urgent care. Medical history included hypertension, diabetes and food contains nuts allergy. Patient had covid prior vaccination. Concomitant medication included ibuprofen (ADVIL) taken for an unspecified indication. The patient experienced diarrhea from 09Aug2020 08:10(as reported) with outcome of recovered.  The patient was hospitalized for diarrhea for 2 days.
I had the usual symptoms, but one symptom I don't see anywhere.  Usual:  Sore vaccine site, body aches and pains, headache, tiredness. I was unable to sleep due to the symptoms the first night.   I convalesced the entire next day and tired easily for the next two days after that.  Here's the unusual side affect:  I had uncontrollable and very painful leg cramps, that I could not relax. I had to take a muscle relaxer.  That was the night of the second vaccine.  The cramps were abated thereafter. I am reporting them because I saw them as a side effect no where online.
tiredness/exhaustion; chills; muscles feeling funny; exhaustion; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on unspecified date in Jul2021 as single dose for covid-19 immunisation. Medical history included covid-19 from Dec2020 to an unknown date covid virus back in Dec. The patient's concomitant medications were not reported. The patient experienced tiredness/exhaustion, chills, muscles feeling funny on unspecified date in Jul2021. Reporter is a 55-year-old female who received her first dose of the Pfizer BioNTech covid 19 vaccine on Wednesday. Her 58-year-old husband also received his first dose this same day. The reporter reports they both experienced side effects such as tiredness, exhaustion, chills, and muscles feeling funny. Both she and her husband had the covid virus back in December. The clinical outcome of the events was unknown.  Information on batch/ lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100942010 Same reporter/drug/AE, different patient
She got her vaccine, felt a pinch when she gave it to her.  Her arm does not hurt, she came home and felt funny.  Feverish, chills, cold, backache, headache.  Now she still feels like her entire insides are coming out of her, she feels so horrible.  She called her doctor after a week and was told to wait and that some people react to it differently.  She called them this morning and waiting on them to call her back.  She called the pharmacy and did take Tylenol for the fever and chills, and then woke up with the chills again.  The chills have stopped, but sometimes she feels cold sweats but she still feels bad in general.  She feels like her stomach is coming out of her.  She is a very active person and she has not been able to do anything.  She has never felt like this before, feels like she is dying.
This spontaneous report as received from a pharmacist refers to a 70 year old female patient. The patient had none drug allergies. On 30-JAN-2013, the patient was vaccinated subcutaneous with 0.65 ml ZOSTAVAX (lot # reported as H019092, expiry date reported as 09-FEB-2014). "Two days later", on 01-FEB-2013, the patient developed a reddened area around the injection site, "about the size of a baseball" that was hot and itchy. The patient sought for medical attention by coming to the pharmacist and had not been to see healthcare provider. No treatment was given. Lab diagnostics studies performed were reported as none. The outcome was unknown. Additional information is not expected.
immediately after Hep B vax #2 given, area in R lat thigh swelled and bled.  Direct pressure and protected ice pack applied with essentially immediate cessation of bleeding.  After initial crying, baby fed normally, did not seem shockey and area felt essentially normal without hardness, swelling or bruising.  Child observed for at least one hour.  parents instructed to report continued bleeding, taut thigh or any other concerns.  Told to perhaps suspect some bruising in area.
patient reported pain in the shoulder of left arm that began the evening of receiving flu vaccine, raditating shoulder pain prevented her from sitting in her recliner comfortably or applying deodorant. movement is restricted in the arm.
rashes spreading all over her body; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on 03Mar2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) on 10Feb2021 as first dose for covid-19 immunisation. On an unspecified date, the patient experienced rashes spreading all over her body. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Around 1:00 pm on 10-13-2022 I noticed both upper eyelids were red and itching. The evening of 10-13-2022 I noticed mild swelling in addition to the redness and itching, to both upper eyelids and under both eyes.  On 10-14-2022 when I woke up both eye -lids and under both eyes  were severely swollen, with itching, and redness. I immediately started taking over the counter po benadryl. There has been gradual improvement in both eyes with less swelling, redness and itching. No other adverse reaction symptoms noted other than bilateral eye areas.
Left upper arm with 5 cm area of redness and induration, warm to touch. Treatment: hydrocortisone cream topically, ibuprofen, ice packs, if worsening may start steroid on 7/23/17.
I tested positive yesterday for Covid 19; I tested positive yesterday for Covid 19; This is a spontaneous report from a contactable Other-HCP (patient). A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) , via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation.  Medical history reported as none.  There were no concomitant medications.  The patient tested positive for covid 19 on 09Jan2021. No treatment for the events.  The outcome of events was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported "tested positive for Covid 19".
Patient received full dose instead of half of a dose for booster.  Pt reported no adverse effects so far.
This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age who on an unknown date, was administered intravesicularly with one dose of BCG USP instead of TICE. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
headache; Nausea; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El 3248), via an unspecified route of administration in left arm on 09Jan2021 12:45 at single dose for COVID-19 immunization. Medical history included high blood pressure, asthma and shellfish, turmeric and antibiotics allergies; all from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (ADVIL), fexofenadine hydrochloride (ALLEGRA), hctz, montelukast sodium (SINGULAIR) and budesonide, formoterol fumarate (SYMBICORT). The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 11Jan2021 05:00 AM, 2 days later from the vaccination, the patient experienced nausea and headache. No treatment was given to the patient for the events. The outcome of the events was not recovered.
Bad fatigue, body aches, chills, fever topped out at 102.3. Fever has lessened over 35 hours but rest of symptoms remain.
arm was itchy. redness developed 2" wide 5 in band. hot arm was very achey Nov22nd & the redness was at it's worse. Took advil & warm compress 2-3 times Bruised area distal to injection site
Swelling of arm that spread down to left leg causing leg swelling,  pain and unable to bend leg. Occurred next day following flu shot
Four hours after receiving the flu vaccine (injection) I had a severe reaction. My ears suddenly started ringing - then my entire body became shakey with an overwhelming feeling of nervousness and I vomited most of the night. My ears have been ringing ever since - and I have experienced some hearing loss. I visited my practitioner the next day to report the problem but she just dismissed it and said the flu vaccine could not have given me this reaction. I have been struggling ever since. I am unable to get a normal nights sleep, and if I do not get the ringing diagnosed properly and remedied I may lose my hearing. I have had ENT's examine my ears and they do not see any reason for the ringing based on a visual examination - though they tested my ears and did show evidence of some hearing loss. I am continuing to seek answers. I have an appointment with an allergist to determine if this may be an allergic reaction. I need a full list of ingredients in this vaccine to help me figure out why after 10 months my ears are still ringing.
Pain in arm, swelling, redness, fever in a few hours up to 102 degrees.  Patient took Tylenol.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart Disease" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: 03Jul2015, stop date: 25Aug2022; LEVOTHYROXINE, start date: 03Jul2015, stop date: 25Aug2022; ALLOPURINOL, start date: 03Jul2015, stop date: 25Aug2022; FERROUS SULFATE, start date: 03Jul2015, stop date: 25Aug2022; SPIRONOLACTON, start date: 03Jul2015, stop date: 25Aug2022. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Initial soreness and swelling at injection site, next day fatigue, nausea, headache, muscle pain.
Information has been received from a medical assistant concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or other concomitant medication. On 07-JUL-2017, the patient received an improperly stored dose of VARIVAX, lot # M046005, expiration date 18-NOV-2018 (route not reported). The sterile diluent used to reconstitute the VARIVAX was properly stored. No adverse effect reported. Temperature was reported as: 15°F to 46°F. Time frame: 1 hour 17 minutes. Previous temperature excursion: No. Data logger involved: Yes. No further information was provided.  Additional information has been requested.
Pain in heart 15 after vaccine. Difficulty breathing that same night after vaccine. Blood work and CT of chest showed enlarged heart. Was told to wait and see if symptoms subside. Still having trouble breathing.
Two days after my 2nd dose of the Pfizer vaccine, I felt painful burning in my chest and back area. I went to my PCP, and was given an EKG. The EKG came back normal. The pain hadn't subsided so I went back and saw my PCP again and I was given another EKG test, and it came back normal again.   My Dr. referred me to a Cardiologist. I was given an Echocardiogram, a Stress test, and had inflammation markers looked at. Everything came back normal. My heart still doesn't feel as strong as it did before the vaccine.
COVID + on 10/12. Received monoclonal antibody infusion on 10/13. Admitted to hospital on 10/15 with shortness of breath with  O2 saturation at 78%. Placed on nonrebreather and Vapotherm. Transitioned to ICU on 10/19 with intubation for ARF with hypoxemia. Treated with remedesivir and dexamethasone. Dependent on mechanical ventilation. Multiple discussion with team and family for trach and dialysis.  Family requested comfort care and extubated.
Patient has redness that continues to worsen at injection site - given steroid pack at walk in clinic.
Pt. called the pharmacy on 3/26/21 to report a reaction to the boostrix vaccine given on 3/21/21. Patient reported a one-dollar coin size redness reaction around injection site and tenderness and warm-to-touch feeling of about a one-quarter coin size around injection site. Patient started taking ibuprofen when it occurred 24 hours after administration. RPh counseled about other therapies and recommended to seek medical attention for evaluation.
This was a booster shot so my third dose of Pfiezer.  After this dose and each earlier dose my period skipped a month.  For example, I received this dose on 4/1 and my period was due on 4/15.  I did not commence menstruation until 5/15.  I otherwise have a very regular cycle, and continued to have a regular cycle between doses except for the first cycle after each dose.
Past lot that had also been expired that was administered to patients; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 065F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients).    No concomitant medication information was reported.  Patient age was reported as 69 Year 8 Month.  No treatment medication information was reported.
Sodium Imbalance/LowSodium; Eye problem; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD SODIUM DECREASED (Sodium Imbalance/LowSodium), OCULAR DISCOMFORT (Eye problem) and HEADACHE (Headaches) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack (Two mild heart attacks), Stent insertion NOS (3 times) and Bypass surgery.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD SODIUM DECREASED (Sodium Imbalance/LowSodium), OCULAR DISCOMFORT (Eye problem) and HEADACHE (Headaches). At the time of the report, BLOOD SODIUM DECREASED (Sodium Imbalance/LowSodium), OCULAR DISCOMFORT (Eye problem) and HEADACHE (Headaches) had resolved.            It was reported that patient had a number of heart conditions and patient received her first two Moderna shots in a very nice clinic half mile away from her home.  Patient felt fine now and doctor recommended her to take the booster.  No concomitant medications were reported.  No treatment medications were reported.
Cellulitis left upper arm (inject site) following DTaP immunization 4 cm by 6 cm area - erythema, induration. Warmth and tenderness. Tx - Rocephin 500 mg IM in office - Keflex 250 mg / 5 ml. 3 ml PO TID x 1
Discoloration of lower legs (red and purple spotting); cramping in both legs randomly; numbness in right leg occasionally; lower legs slightly swollen; feeling like mild sunburn; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 (Lot number: ER8732) at the age of 33 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left), administration date: 25Mar2021, for COVID-19 immunization. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 18Apr2021, outcome "not recovered", described as "Discoloration of lower legs (red and purple spotting)"; MUSCLE SPASMS (non-serious) with onset 18Apr2021, outcome "not recovered", described as "cramping in both legs randomly"; HYPOAESTHESIA (non-serious) with onset 18Apr2021, outcome "not recovered", described as "numbness in right leg occasionally"; PERIPHERAL SWELLING (non-serious) with onset 18Apr2021, outcome "not recovered", described as "lower legs slightly swollen"; SUNBURN (non-serious) with onset 18Apr2021, outcome "not recovered", described as "feeling like mild sunburn". The events "discoloration of lower legs (red and purple spotting)", "cramping in both legs randomly", "numbness in right leg occasionally", "lower legs slightly swollen" and "feeling like mild sunburn" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of skin discolouration, muscle spasms, hypoaesthesia, peripheral swelling, sunburn.  Additional information: Patient had discoloration of lower legs (red and purple spotting), cramping in both legs randomly, numbness in right leg occasionally, lower legs slightly swollen and feeling like mild sunburn. Seeing a physician tomorrow in hopes that they will refer me to a cardiovascular specialist. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. No other vaccinations within four weeks. No other medications in two weeks. Patient not had Covid prior vaccination; Patient was tested Covid post vaccination. Patient had no known allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.