chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Mild reaction after first shot) and FEELING ABNORMAL (She felt like she was coming down with something for 2 hours only) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included Double vision (on & off, before and after her cataract surgery) and Cataract operation (Cataract Surgery Summer 2021) in 2021. Concurrent medical conditions included Diabetes and Hypothyroidism. Concomitant products included METFORMIN for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, INSULIN GLARGINE (LANTUS) for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION COMPLICATION (Mild reaction after first shot). On 29-Jan-2021, the patient experienced FEELING ABNORMAL (She felt like she was coming down with something for 2 hours only). On 29-Jan-2021, VACCINATION COMPLICATION (Mild reaction after first shot) and FEELING ABNORMAL (She felt like she was coming down with something for 2 hours only) had resolved.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication details were reported. This case was linked to MOD-2021-404058, MOD-2021-403866 (Patient Link).
Customer called and reported that a dose of PNEUMOVAX 23 expired on 6/22/2022 and was administered on 8/4/2022. The vaccine had no previous temperature excursion. No additional AE reported. No PQC reported. No additional information provided.; Customer called and reported that a dose of PNEUMOVAX 23 expired on 6/22/2022 and was administered on 8/4/2022. The vaccine had no previous temperature excursion. No additional AE reported. No PQC reported. No additional information provided.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided.   On 04-AUG-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # T034630, expiration date: 22-JUN-2023, 0.5 ml, strength and route of administration were unknown) for prophylaxis (expired product administered). There was no previous temperature excursion reported. No additional adverse event (AE) was reported.
3 hrs after the vaccines (ROTATEQ and HIB vac) baby came back to office, continuous crying, SOB and went into anaphylactic shock. Started scalp IVF, 0.9 NS boluses x2, IV DECADRON 3mg, IV BENADRYL, IV Epi x 1 dose. Obs in PICU x 24 Hrs & in Peds Floor x 24 Hrs.
Awoke 10/30 with a rash on arm around injection site with hot, hard lump. Rash has continued to grow as well as hard lump.
PT RECEIVED COVID VACCINE THAT WAS PAST BEYOND USE DATE. NO ADVERSE REACTION.
Chill, Feverish, headache, vertigo, loss of taste, poor appetite, diarrhea, fatigue, depression.  Treatment includes rest, drink fluid, Advil hospitalization for ten days, currently in half day hospitalization for mental health treatment.
Reported redness and lumpiness in vaccination site that was spreading swelling, warm to touch, and itching.
Systemic: ADMINISTERED AFTER 12 HOURS EXPIRATION BUT BEFORE 31 HOURS FROM PUNCTURE. KEPT STORED IN FRIDGE.-Mild, Error: Improper Storage (temperature)-, Additional Details: ADMINISTERED AFTER 12 HOURS EXPIRATION BUT BEFORE 31 HOURS FROM PUNCTURE. KEPT STORED IN FRIDGE.
The vial was initially stored in the refrigerator on 02-Jun-2023, first punctured on 08-Jun-2023 and was administered with 09-Jun-2023; No adverse event; Patient was administered with vaccine >12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine >12 hours post puncture), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Jun-2023, first punctured on 08-Jun-2023 and was administered with 09-Jun-2023) and NO ADVERSE EVENT (No adverse event) in a 6-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jun-2023 at 3:48 PM, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Jun-2023 at 3:48 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine >12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Jun-2023, first punctured on 08-Jun-2023 and was administered with 09-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine >12 hours post puncture), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Jun-2023, first punctured on 08-Jun-2023 and was administered with 09-Jun-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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine >12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Jun-2023, first punctured on 08-Jun-2023 and was administered with 09-Jun-2023).    No concomitant medications were provided. The vial size was 2.5ml. The vial was initially stored in the refrigerator on 02-Jun-2023 from the freezer and taken out of the fridge on 08-Jun-2023. The vial was first punctured on 08-Jun-2023 at 1:44 PM. The vial was stored post puncture at room temperature. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 26hs and 30 minutes. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728739 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728739:Same reporter
PROFUSE SWEATING WHILE STANDING; NO APPETITE; DRY THROAT; NAUSEA; FATIGUE; HEADACHES; INJECTION SITE FELT HEAVY BUT NOT PAINFUL; ITCHY SPOTS ON BODY; SHARP PAIN ALONG RIBS ON BOTH RIGHT AND LEFT SIDE; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was allergic to one medication but doesn't remember the name of it. The patient was not on previous medications, and had no previous medical conditions at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On DEC-2021, the patient experienced sharp pain along ribs on both right and left side. On 07-DEC-2021, the patient experienced itchy spots on body. On 08-DEC-2021, the patient experienced injection site felt heavy but not painful. On 10-DEC-2021, the patient experienced profuse sweating while standing. On 10-DEC-2021, the patient experienced no appetite. On 10-DEC-2021, the patient experienced dry throat. On 10-DEC-2021, the patient experienced nausea. On 10-DEC-2021, the patient experienced fatigue. On 10-DEC-2021, the patient experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site felt heavy but not painful on 09-DEC-2021, and itchy spots on body on 08-DEC-2021, had not recovered from sharp pain along ribs on both right and left side, and the outcome of nausea, fatigue, headaches, profuse sweating while standing, no appetite and dry throat was not reported. This report was non-serious.
REPORT 11/5/2021 (after 3 weeks); 1st J & J COVID-19 Vaccine Shot; Allergic reactions: Day 1, 10/14/2021, Noon I have a history of Hashimoto?s + Glaucoma, but -0- else; Arnica gel on the injection site = had -0- inflammation, swelling or bad pain day/night at site. Bloat was bad 5 hrs later & gall bladder acupuncture points tender; Day 2: Felt ?bad? & low energy. Not strong enough to go to gym. Bad Insomnia. I  slept 12:30-1:30. Reduced bloat using antacid with meals. Injection site sore, little inflammation, top of ears mild pain. A 3/8? dark brown liver spot appeared on web of thumb back of left hand (gut reflexology point) & aching sore there on both hands. Pink-brown mole left breast turned black. Ringing in ears -loudest at highest pitch. Headache. Top of head, right front sore spot. Later in day, sore spot moved mid-head on right side; Day 3: Insomnia > slept 4:30 - 5:30 >woke with outside fingers on right hand numb. Energy better> 1/2 usual time at gym. Right foot numbness  in first 3 toes in afternoon.; Day 4:  3AM: whole right hand going numb? stopped on waking. 5:30 outer edge left hand numb. Lower energy> 5 min. at gym. Injection site remains sore with pressure only. 9 hrs. sleep; Day 5: low energy: 5 min in gym; Day 6: similar pattern; Day 7: On waking sat up & took a sip of water and laid down again, as I often do. But I had severe dizziness, like being drunk. Took 30 min. to reduce enough to get up to walk to the toilet. No position was better, so stayed horizontal for 2 hours more. Dizziness slowly reduced over the morning so I could fix food and eat. I stayed sitting and watched TV the rest of the day. Numbness in hands and feet only occasionally at this point; Day 14: Dark spots now very faint. Mole on breast looks normal. Dizziness continues. Shot site still sore to touch; Day 22: Mild dizziness  & occasional dull pain right mid head left side comes & goes. Numbness in feet occasional (right foot most common) but never both feet at the same time. No numbness in hands remains.
Symptoms started about 5pm day of vaccines with redness, swelling at site. Hives started on arm in am 12/30/16 pain in arm, neck, and head that continues. It continues to be hot to touch. No respiratory distress but felt like her throat was thickening all night. She did not rest well. She had abdominal pain with diarrhea all the next day, but better now.
Nurse administered two unsuccessful administration attempts intradermally. Wheel was not achieved with either attempt. A second nurse came and successfully administered intradermal vaccine on right arm with wheel. No adverse outcomes or problems; simply lack of wheel with first two attempts.
Local erythematous lesion a about 4-5 cm in diameter enlarge after the shots.  Child is otherwise well appearing without other acute distress.
Swollen tongue started a few minutes after the two vaccinations and is still swollen about 4 hours later.  I have not sought medical assistance and hope that was not a foolish decision.  Hospitals and healthcare workers are so overwhelmed right now that I'm not going to use those resources unless it becomes an absolute emergency.  I have had this happen before and it has never gone to full anaphylaxis (knock wood).  I will take Benadryl before going to sleep.  I will message my doctor through My Chart to ask if I should be more cautious when getting the second Shingrix vaccine in a couple of months.
Patient had history of fainting with injection received Hep B injection patient nauseated/emisis 1 time faint feeling. Satin chair, v/s assessed cool cloth to face.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: Patient's mother reports the patient developed swelling and hives a few hours after administration. The mother administered an Epi-Pen when the rash spread across the patient's face, neck, trunk, and extremities. The patient was not hospitalized. Residual rash can be seen on his face. Patient received Varivax and M-M-R II vaccines on the same visit.
Varivax given 09/26/1997. Left leg Beginning 4/18/2002 began (?) left hip and thigh area and diagnosed 4/25/2002 as Herpes(?) on entire left leg beginning on buttocks
Patient was given a vaccine on 10/11/2022 with a lot number FL2757 that had a manufacturer expiration date of 9/30/22, however additional manufacturer safety and efficacy data show that the vaccine can be used through 10/19/22
Vaccine abruptly stopped menstruation. Have not had another cycle since I received the vaccine last year.; This is a spontaneous report from a non-contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administered in right arm (Lot number: unknown) at the age of 22 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient did not receive any concomitant medications. Vaccination history included: Covid-19 vaccine (manufacturer unknown) (DOSE 1; MANUFACTURER UNKNOWN; Anatomical location: Right arm), for COVID-19 immunisation.  The following information was reported: AMENORRHOEA (non-serious) with onset 13Sep2021, outcome "not recovered", described as "Vaccine abruptly stopped menstruation. Have not had another cycle since I received the vaccine last year". The event "Vaccine abruptly stopped menstruation. Have not had another cycle since I received the vaccine last year." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of amenorrhoea.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Called Dr (on call MD) on 9/14/13. C/O temp 102, L arm swollen, warm and sore - referred to another med center was started on Keflex and prednisone.
pt recv vax 2JUN95 & devel chickenpox described as small fluid filled pimples there was one on forehead, 2 on buttocks, one on chest & 2 on legs & 1 on arm;
First shot 2/22/21 chills, body aches occurring 8 hours after shot. 2nd shot 3/30/21 chills, body aches after  6 hours.  I recovered after day and half. I had COVID 19 December 14 and quarantined for 16 days. Both shots were Moderna. First shot left arm, Second right arm.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No pertinent medical history, drug reaction or allergies were reported. On 15-AUG-2014 the patient was inadvertently vaccinated with PNEUMOVAX 23 expiration date July 2014, (strength, dose, dose number, route, anatomical location, lot number and exact date were unspecified). No concomitant therapies were reported. No adverse effects reported. The outcome of the event was unknown. Additional information is not expected because the reporter refused additional contact.
pt in Pavilion  for major neurocognitive disorder with behavioral disturbance; pt transferred to Medical Center for a positive COVID test; asymptomatic; spent one night in the Medical Center then sent back to the Pavilion to restart medications and ECT for psychiatric stabilization; DNR/DNI; palliative care and hospice; pt transferred to Hospice in which is where he passed away
Delayed injection site reaction. I woke up this morning with five 1-2 cm erythematous indurated spots on my left upper arm. One spot at the injection site and four spots far below the injection site closer to my elbow. The areas are extremely painful and I have pain from my trapezial neck to my shoulder all the way down to my finger on the left side. Also this morning I woke up with hip and knee pain on my left side not sure if that has anything to do with the injection but it's not normal for me and I didn't have any of this yesterday.
Fever, HA and body aches x 2 days after receiving J&J vaccine on 13 Apr 21.  Pt report taking tylenol and ibuprofen with minimal relief; last dose meds yesterday at 1800.
Pt. above was given second dose of influenza too early. Mother was notified and was told to return on 12/21/18 for second dose of influenza.
Patient received 1st dose of Pfizer Covid19 vaccine today at approx 10:45 AM; pfizer lot number EN5318. Patient has history of severe head to toe rash within minutes of receiving Vancomycin/Gent IV. Order obtained from APRN to give dose and monitor for 30 min.  Patient alerted monitoring nurse at 10:59AM that she was experiencing a "scratchy" throat and difficulty swallowing. BP 130/88 O2 99% room air, P84. Epi 0.5mg 0.5ml (Lot 339384) administered LD IM at 11:02 AM. Patient hesitant with receiving Benadryl, does not respond well, has to take allegra instead; Benadryl not given. EMS arrived at 11:08AM and assumed care of patient. Patient transported to Hospital.  Attempted phone call on 2/11/2021 with no answer.
Rash, erythema & swollen right upper arm, associated with fever of 102 degrees F during two days.
Patient felt lightheaded, dizzy, popping and ringing in ears, blurred vision, and fainted for a few seconds. This occurred about 5-10 min following vaccination. Most likely a vasovagal syncope reaction. No history of allergic reactions nor syncope. After laying  patient down and elevating his legs, he felt much better. Patient remained in this position for about 15 minutes. He then sat up, ate a snack, and drank water and was observed for an additional 15 minutes. Vitals were within normal range. Patient stated feeling"normal" and "fine" after this and he was able to go home without additional issues.
1 of 2 pts who exp an inject site react following immun which required ER visit; No further clinical info available @ time of this report;
received REMDESIVIR for COVID-19 treatment; This case was reported by a pharmacist via call center representative and described the occurrence of covid-19 in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced covid-19. The patient was treated with remdesivir. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient had received first dose of Shingrix and developed COVID-19. The patient received Remdesivir for COVID-19 infection on 27th March 2021 as a treatment. The patient had not received second dose of Shingrix yet. No other information was reported.
Pt recvd Engerix-B & exp malaise, vomiting, & a slight fever;
6 hours after receiving the vaccination I experienced severely burning hands and feet. Within 15 minutes I observed hives forming on my torso and arms. I went to the clinic, and by that time hives were all over: arms, chest, torso, abdomen, thighs, hips. They gave me BENADRYL and Methylprednisolone. They prescribed a 6-day MEDROL pack, and advised me to take ranitidine and antihistamines for a month. I still have the sense of anxiety that began the day of the reaction.
8/20-Current: inj site redness/swelling 1.5" diameter. dull burn 8/20-21: unable to raise left arm 8/20-22: terrible inj site pain 8/23: terrible chest pain between L breast/L shoulder blade. made difficult to breathe in 8/23-Curent: uterine cramping and spotting.  has not stopped.  never have periods or cramping.   8/20-Current: multiple migraines
He was hallucinating; Temperature was 103 to 104 Fahrenheit; This case was reported by a other health professional via interactive digital media and described the occurrence of hallucination in a 17-year-old male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, less than a day after receiving Meningococcal B vaccine, the patient experienced hallucination (serious criteria GSK medically significant) and fever. On an unknown date, the outcome of the hallucination and fever were recovered/resolved.   The reporter considered the hallucination and fever to be related to Meningococcal B vaccine.  Additional details were provided as follows: The reporter was a health care worker and parent of patient. The age at vaccination was not reported. The reporter stated that the patient had reaction to the vaccine. On the first night, it was worse as patient was hallucinating. The patient experienced temperature between 103 to 104 Fahrenheit for 3 days.  The reporter got scared and mentioned that they wont given the vaccine to their other two children. The follow-up was not possible.
Started feeling bad two=three days after shot, became fatigued, lost 15 pounds and could not go to work. On morning of 4/21 was found unresponsive and rushed to hospital where he died 2 hours later
Like the reaction to the first dose, pain and swelling at injection site, swollen lymph node under armpit, fever of 101 F, headache , severe joint pain, fatigue and unusual and heavy menstrual bleeding starting two days after the injection. Bleeding so heavily medical care was sought after first injection. Thought it might be my IUD, which was removed after the first episode. Full gynecological exam indicated everything was normal. Menstrual bleeding happened again 2 days after second vaccine,  characterized by early arrival, heavy flow and clotting.
I started my period two days after receiving the shot, which was two weeks earlier than expected. Flow was unusually heavy and very clotted - all abnormal for me. While I may have felt some fatigue from the shot, I never felt ill in any way.  I also never felt any of the points of pain I might feel with my normal period, such as sore breasts prior to my period and cramps in my upper legs when it arrived.  I only had a sore arm for a day where I received the shot.
Initial case was received from a healthcare professional on 29 October 2013. The 74-year-old female patient whose medical history and concomitant medication was not reported had received an intramuscular FLUZONE HD (batch number: U4781AA, dose unknown) on her left deltoid (LD) on 07 October 2013. The patient had previously received FLUZONE HD last year on an unknown date. The patient did not have any previous illness, allergies or other history at the time of vaccination. On 29 October 2013, the patient called up reporter and stated that she had been experiencing backache, headache and fatigue since the time of vaccination. The symptoms continued till 29 October 2013. No laboratory details were reported. No corrective treatment was reported. The outcome of the event was not recovered. List of documents held by sender: None. Follow-up information received from healthcare professional on 5 September 2014. No new information was updated.