chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient came in for their COVID vaccine. The adult and pediatric dose boxes were in the same drawer in the refrigerator and the pediatric box was opened. The pediatric dose was administered and the error was discovered when processing another vaccine. Pfizer was contacted and the recommendation was to re-administer the age appropriate vaccine as soon as possible. The patient was contacted and will return tomorrow for the correct vaccine (Comirnaty). He was encouraged to call with any future questions or concerns.
redness, swelling, hot to touch;localized rxn size of quarter;verbal report per pt 2wk p/incident;
No adverse event; Moderna Lot number 021H22A was accidentally administered yesterday June 7/23 to 3 patients after the expiry date of June 1 2023; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday June 7/23 to 3 patients after the expiry date of June 1 2023) 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)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 07-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday June 7/23 to 3 patients after the expiry date of June 1 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday June 7/23 to 3 patients after the expiry date of June 1 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday June 7/23 to 3 patients after the expiry date of June 1 2023).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was also reported that one of the patient had COVID-19 No concomitant medication was reported.  No treatment information was reported   This case was linked to US-MODERNATX, INC.-MOD-2023-728521, US-MODERNATX, INC.-MOD-2023-728530 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728530:Patient 3 US-MODERNATX, INC.-MOD-2023-728521:Patient 2
After approximately 12 hours extreme body aches and chills.  Extreme Fatigue and body aches continued for approximately 36 hours.  Swollen lymph node in arm pit started after approximately 28 hours.
Breakthrough covid case. Patient received Pfizer vaccine x 4. Presented to ED on 6/18/22 with c/o of persistent cough, body aches. Exposure by family. Patient states she tested positive in May at another facility and was told she has long covid. DC home.
Severe pain in the immunization arm on exertion. Per the patient, pain is a 9.5/10 when he lifts things with the immunization arm
A report received from a health care professional on 11/06/02, concerning approximately 100 vaccinees less than 4 years of age who were inadvertently administered Fluvirin on unknown dates. The reporter is in the process of indentifying the vaccinees. It is not known if any of the vaccinee's subsequently experienced adverse events. There was insufficient information to determine the reporter's causality assessment.
Right shoulder with approx 8 cm area of induration, swelling superficial area of swelling and redness, heat, tenderness. Ultram 50 mg 1 tablet PRN for severe pain. L injection site-no abnormality.
Within 4 hours of vaccine and lasting 12-24 hours: Injection site pain, then severe chills followed by fever (99.9 degrees F), nausea, vomiting, joint aches/pain, shivering, loss of appetite, difficulty sleeping, GI pain, headache, severe light and sound sensitivity, fatigue;  At 24-48 hours, headache, joint aches, fatigue, light sensitivity, decreased appetite, increased pulse; 48-72 hours - 2 pound weight loss, joint aches in major joints, fatigue, unable to perform physical work >72 hours - feeling better, but tired
Leg muscle pain and stiffness the day after treatment. The condition has persisted for two weeks.; Leg muscle pain and stiffness the day after treatment. The condition has persisted for two weeks.; This is a spontaneous report received from contactable consumer, the patient. A 78-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in right arm on 11Mar2021 at 09:00 (at the age of 78-year-old), as single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient was not allergic to medications, food and other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 15:00, the patient experienced leg muscle pain and stiffness the day after treatment. The condition had persisted for two weeks. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the adverse events. The clinical outcome of leg muscle pain and muscle stiffness was not resolved at the time of report.                  No follow-up attempts possible. No further information expected.
I received Fluzone HD Quadrivalent influenza vaccine on 9/14/2020. I had extreme cases of the expected side effects, and had the same thing happen when I received high dose Fluzone ~5 years ago.
Metal taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0169) via an unspecified route of administration in the left arm on 16Apr2021 at 14:30 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. concomitant medications were not reported. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8732) via an unspecified route of administration in the left  arm on 25Mar2021 at 13:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 12:00, the patient experienced metal taste in mouth. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event metal taste in mouth was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
'Patient mistakenly given 0.5 ml dose of Moderna Covid vaccine approx 1 year after rcv'ng J&J Covid vaccine, as a second dose instead of 0.25 ml dose  as a booster (as variously mandated by CDC  and FDA per  current guidelines).
pt recvd vax & next day devel rxn at site of tetanus & diphtheria inj.Pt also recvd Pneumovax (MSD)other arm same day as tetanus vax & devel inj site rxn at that site. This is 1 of 2 pt from this site to devel inj site rxn p/vax. SEE commen
While getting my Moderna booster, the technician jabbed the needle very hard into my arm. There was blood at the injection site. Is this OK Should it bleed at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE HAEMORRHAGE (While getting my Moderna booster, the technician jabbed the needle very hard into my arm. There was blood at the injection site. Is this OK Should it bleed at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (While getting my Moderna booster, the technician jabbed the needle very hard into my arm. There was blood at the injection site. Is this OK Should it bleed at the injection site). At the time of the report, VACCINATION SITE HAEMORRHAGE (While getting my Moderna booster, the technician jabbed the needle very hard into my arm. There was blood at the injection site. Is this OK Should it bleed at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided.  Patient reported that while getting the Moderna booster, the technician jabbed the needle very hard into the arm and there was blood at the injection site.
Extreme pain in right thigh-swelling-redness in 6 hrs-"injection was given in right thigh" next day-swelling extreme-extreme pain for 5 days-fever broke in 6 days-this date still very sore.
Patient fainted 3 times  - Called EMS and they checked him out before he left - tried to call patient to follow-up 3/19/21 5:30pm - no voicemail set up
Information has been received from a physician concerning an 80-year-old male who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck) (lot# "05840").  Subsequently the patient experienced a chickenpox, varicella like rash.  The patient did require one doctor's visit for follow-up.  The outcome is reported as recovering.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/24/2007. Follow-up information received indicates that y=the patient is a 74 year old (previously reported as 80-year-old), with bladder cancer, chronic renal failure, hypothyroidism and allergies to sulfa, penicillin, FLAGYL and MACROBID who on 10-JUL-2007 at 1100 was vaccinated subcutaneously in the abdomen with a first dose of ZOSTAVAX ( lot # 657764/0584U) . There were no illnesses at the time of the vaccination. On 28-JUL-2007, the patient developed an acute diffuse vesicular rash diagnosed as acute chickenpox. On an unspecified date the patient recovered. It was reported that the patient and his siblings have had no adverse events following prior vaccinations. Additional information is not expected.
Flu shots do kill; Initial information received on 11-Feb-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp via media.  This case involves Adult female patient (reporter's mother in-law) (age unspecified) who died (death), after she received INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient died from flu shot (death) (unknown latency) following the administration of INFLUENZA VACCINE.   It was unknown if the patient experienced any additional symptoms/events before death.   It was unknown if there were laboratory data/results available.   It was not reported if the patient received any corrective treatment before death.  It was unknown if an autopsy was done.   There will be no information available on the batch number for this case.; Sender's Comments: This was a poorly documented media case which involves an adult female patient who died, after she received vaccines INFLUENZA VACCINE. The time to onset was unknown. Further information regarding medical history, concomitant disease or risk factor, concurrent condition during vaccination, previous vaccination and tolerance, laboratory tests ruling out other alternate etiologies and autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Flu shots do kill
Child became flushed which resolved quickly. EMS was called as a precaution no medical intervention (no meds etc) administered.
This child had cellulitis approximately 3 - 3 1/2 inches at the injection site, redness clearly marked, hot, and tender. No induration. Antibiotics - Keflex prescribed. Left arm injection site - either the DTaP or IPV. Cellulitis now gone.
Shaking uncontrollably; body and head aches; chills; Fever; body and headaches; A spontaneous report was received from a consumer concerning a 67-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shaking uncontrollably, body and head aches, chills, 100.7â°f fever,  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 028L20A) via unknown route for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the event(s) shaking uncontrollably, body and head aches, chills, 100.7â°f fever.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), shaking uncontrollably, body and head aches, chills, 100, 7â°f fever was unknown.
24 hours after vaccination, right arm site red, swollen, onset of fever and chills which lasted three days.  Injection site developed cellulitis 3inch in diameter.  Tylenol and ice packs used.
within 10 minutes of vaccination very rapid heart rate; shortness of breath; restlessness; incredible nervousness; This is a spontaneous report from a contactable consumer or other non HCP (patient, self-reporting).  A 73-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: PfuzerEN6203 and expiration date was not reported), via an unspecified route of administration in arm right on 23Feb2021 at 09:30 as 1st dose, single for COVID-19 immunization, (age at the time of vaccination was 73-year-old). Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient previously took epinephrine, some antibiotics, sofa and experienced drug hypersensitivity. Concomitant medications included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported and immunitone Plus mushroom extracts bo. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 23Feb2021 at 09:45, within 10 minutes of vaccination the patient experienced very rapid heart rate, incredible nervousness, shortness of breath, restlessness. The patient received treatment for all the events and nurse remained with me until 10:45. Outcome of the events are reported as recovered.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
PATIENT WAS GIVEN VACCINATION IN LEFT DELTOID AND THEN ASKED TO WAIT 15 MINUTES AFTER RECEIVING INJECTION. I WAS NOTIFIED ABOUT 5 MINUTES LATER THAT PATIENT FELT FAINT. PATIENT WAS PALE IN COLOR AND FELT DIZZY. PATIENT WAS LIED DOWN ON FLOOR WITH FEET ELEVATED UNTIL SYMPTOMS SUBSIDED ABOUT 5 MINUTES LATER. PATIENTS BP WAS CHECKED AND DR WAS NOTIFIED. PATIENT WAS THEN ALLOWED TO LEAVE WITH FATHER.
Moderna Covid-19 Vaccine EUA  First 3 days only had minor discomfort, 4,5,6 days itching started, next  3 days were great, no pain or itching. Tenth day woke up to large red itchy mark on arm. Went to urgent care and got antibiotics. Next morning the circle was bigger and redder. Went to the doctor who sent me to ER where I received an antibiotic drip. This morning the area looked much better however tonight it is pink and itchy again. Going back to ER tomorrow. Second shot due on 1/18/21
Arm red down to about the elbow. Also a little swollen. Had a fever over night.
Child presented to urgent care for suturing of forehead laceration after falling from monkey bars. DTaP administered at that facility. Mom noted increased, swelling and redness at injection site and distally. Anterior erythema and swelling of thigh and knee. No limitation to function.
infraclavicular lymphadenopathy on the left - same side as vaccination 2 days prior
Cellulitis left thigh, treated through ED on 02/24/18, with Prednisone and oral antibiotic.
Right deltoid area became red, hot and swollen with a 7cm diameter area of erythematous induration. Child also developed red cheeks, vomiting and diarrhea. Pt was given Benadryl.
swelling on back of hand/lumps on back; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th May 2019, 1 days after receiving Shingrix, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovering/resolving.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.  Additional case details were provided as follows: The patient received 1st dose of Shingrix in left arm.   The next day, she experienced a lump on the back of her left hand about half the size of a golf ball.  It was the same arm as she received the injection.   The swelling had improved somewhat but was not completely resolved yet. The patient consented to follow up and provided her physician's details.
Fevers to 39 degrees, rigors, severe local reaction with redness, warmth, pain.  No ulceration.
Joints have begun feeling more sore than usual over the last 6 - 7 months. Any movement under stress (weight lifting, etc) causing acute pain.
Chills, body aches, severe headache, tiredness temp 100.4 - 102.  Lasted 36 hours.  Tiredness, headache lasted 48.
Abnormal blood counts, CBC, anemia followed by diagnosis of Lupus SLE. Several months after receiving HP4 #3 dose my daughter developed abnormal blood counts and anemia which later led to a diagnosis of Lupus SLE.
I feel a little stuffy today/I feel like crap.; tested positive for Covid-19; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (I feel a little stuffy today/I feel like crap.) and COVID-19 (tested positive for Covid-19) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57144B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Patient had unknown allergies to (medications, food and other products). Medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination was unknown.    On 09-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 18-Sep-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (tested positive for Covid-19). On 22-Sep-2022, the patient experienced FEELING ABNORMAL (I feel a little stuffy today/I feel like crap.). At the time of the report, FEELING ABNORMAL (I feel a little stuffy today/I feel like crap.) and COVID-19 (tested positive for Covid-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2022, SARS-CoV-2 test: (Positive) tested positive for Covid-19.         No concomitant medications were provided by the reporter.  On 25-Jan-2021, the patient received first dose of Moderna vaccine (unknown route) 1 dosage form (batch no. 011L20A), on 28-Feb-2021, the patient received second dose of Moderna vaccine (unknown route) 1 dosage form (batch no. 002A21A), on 27-Oct-2021, the patient received 1st booster dose of Moderna vaccine (unknown route) 1 dosage form (batch no. 045C21A), on 20-Apr-2022, the patient received 2nd booster dose of Moderna vaccine (unknown route) 1 dosage form (batch no. 045L21A) for COVID-19 prophylaxis.  Event Covid-19 cause patient to seek medical care to (office visit, Urgent care, ER, hospitalized). The patient did not experienced a similar event in the past. Event Feeling abnormal did not cause patient to seek medical care to (office visit, Urgent care, ER, hospitalized).  No treatment medications were provided by the reporter.
This is a spontaneous report from a Pfizer-sponsored program Corporate (Pfizer), from a contactable Consumer (patient's mother). A male patient of an unspecified age and ethnicity received pneumococcal 13-val conj vac (dipht crm197 protein) and meningococcal group b rlp2086 via an unspecified route of administration on an unspecified date to an unspecified date at single dose for immunisation.  The patient's had two siblings, one older and one younger. Family medical history included maternal history of pertussis vaccination, psoriasis, varicella, influenza, ear infection from an unknown date, and paternal history of influenza immunisation, and sikness on an unknown date.  The patient's concomitant medications were not reported. The patient experienced asthma on an unspecified date and was hospitalized. The outcome was unknown. Pfizer is the marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) and meningococcal group b rlp2086  in the reporter s country. This may be a duplicate report in situations where another Marketing Authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) or meningococcal group b rlp2086  has submitted the same report to the regulatory authorities. No follow up attempts are possible. No further information is expected.