chrisvoncsefalvay/vaers-outcomes huggingface dataset:
light headache; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (light headache) and FATIGUE (exhausted) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (light headache) and FATIGUE (exhausted). At the time of the report, HEADACHE (light headache) and FATIGUE (exhausted) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.     This case was linked to MOD-2021-085741, MOD-2021-085741.
Received second dose of Pfizer vaccination on 5/10/21.  On 5/11 had severe symptoms all day (cold, achy, chills, fatigue), all expected and manageable.  Went to bed at 8PM  on 5/11, awoke the next morning (5/12) with a distinct, loud ringing in my left ear.  This has not gone away.  My concern is that tinnitus is not curable, and this has been persistent without relief.  I had to purchase a white noise machine to try to drown out the ringing.  It doesn't help much.  I saw my physician on 5/18, but there was nothing they could do.  They are sending me to an Ear, Nose, and Throat specialist.  Hopefully they will have an idea of how to help.  This appt is on 6/3.
Dizziness Narrative: 15 minute after taking moderna vaccine @1050 patient stated she felt light headed and dizzy. Denied chest pain, shortness of breath, difficulty swallowing, numbness/tingling, fever or rash. Patient placed in supine position with head elevated 30 degrees. Patient was given 100mg Diphenhydramine PO once @ 1052. Vitals taken. @1115 b/p 115/78, o298 and hr 84. @1109 b/p 113/76 o2 98 and hr 78. @1115 b/p 115/78, o298 and hr 78. Patient reported improvement and all was resolved at 1115. Patient stated she was not dizzy and had no symptoms. Patient ambulated with no difficulty.
SEVERE nausea days 3-5, severe chills days 3-6, mild headache day 4, moderate fatigue days 3-4, mild soreness injection site days 2-3, extreme brain fog days 3-5 and moderate brain fog (impairs function) days 6-10 and still ongoing.
sore arm/arm is still sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/arm is still sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm/arm is still sore). At the time of the report, PAIN IN EXTREMITY (sore arm/arm is still sore) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Treatment medicines  included Bengay ,Tylenol  and rubbing alcohol at injection site.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up received on 12 April 2021 and updated patient demographics and  event.
Raised red rash whole face and neck, ears and scalp. Upper chest, too. Very itchy. Continues to a lesser degree currently. Worse at night and in the morning.
Patient says left eye is getting puffy. Recommended Benadryl to see if it is relieved with it. Instructed patient to contact health care provider tomorrow if it does not get better, and if symptoms get worse to see medical attention tonight or call emergency services if trouble breathing
Pt developed mild rash over past two days. Has few scattered papules/pustules with surrounding erythema over thighs, trunk, hands, (R) ear. No fever or pruritus. Otherwise well. No treatment given. Discussed self recovery course.
Soreness at injection site, big time fatigue, headache, shivering. I was fine by the evening of 10/3/18.
Case previously recorded as MA2009-5093. We received the following information via the Vaccine info call center from a healthcare professional on the 19 NOV 2009. This 2.5-year-old female patient was vaccinated inadvertently with S-OIV FLUVIRIN (batch number 10127605) intramuscular on 17 NOV 2009. No adverse reaction had occurred at the time of the report. Vaccine info call center reference no. NA09-008583.
This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (I have had a bad stomache for over a week now) and ACCIDENTAL OVERDOSE (I was mistakingly given double booster dose - 0.5ml) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) .5 milliliter. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (I have had a bad stomache for over a week now) and ACCIDENTAL OVERDOSE (I was mistakingly given double booster dose - 0.5ml). At the time of the report, ABDOMINAL PAIN UPPER (I have had a bad stomache for over a week now) outcome was unknown and ACCIDENTAL OVERDOSE (I was mistakingly given double booster dose - 0.5ml) had resolved.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were reported No treatment medications were reported.
It was the patient 1st flu shot so I requested him to wait for 15-20 minutes after the shot so we make sure he is doing fine, 15 minutes stated couldn't feel arm he developed rash & very diaphoretic, was given BENADRYL inj at clinic, taken to hospital -> No further treatment was given.
Pt recvd 3 doses of Engerix-B vax & was determined to be a non-responder on 23AUG91 & 28AUG91 pt chose to wait & be retested in 8 to 10 wks; 3DEC91 HBSAB was neg; 8DEC91 pt chose to wait on booster (4th) dose;
Patient said she went to her doctor 9/18/15 with facial tingling left side of her face which she claims started after receiving varivax vaccine in Feb/March of 2015.
During my first period post-full vaccination, occurring May 5-10, I had nausea which I had never experienced as a period symptom prior to vaccination. The nausea started on the 10th and lingered through the 12th. My second period post-full vaccination, started May 30, has also included nausea, with it starting on the first day. Being that it?s the first day as I?m typing, I don?t know how long it will last. I have not yet actually thrown up during either period if time, but have felt queasy.  For full disclosure of all symptoms, I did also have some fatigue the day following the final dose (4/20/21).
Muscle aches; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches), HEADACHE (headache) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-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 an unknown date, the patient experienced MYALGIA (Muscle aches), HEADACHE (headache) and PYREXIA (fever). At the time of the report, MYALGIA (Muscle aches), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.            Concomitant medications details were not reported by the reporter. No treatment information provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Had DTaP, Hib, Polio, & Hep A vaccine at about 930am on 9-18-12. Mom noticed hives about 530pm.
I received my first CoVid vaccine March 4th, - exactly 2 weeks out. Last night, March 17,  my arm was itching.... so I scratched... (due to the cataract removal/eye surgery, not the best vision last night everything still blurred), When I looked this morning, March 18 and it felt, warm to the touch, no lumps/bumps, itchy and red... I do not have a fever, temps for cataract eye surgery were fine yesterday and at this morning's post op F/U. Did not notice anything yesterday morning.  Nor did anyone in the pre op area say anything (I had on short sleeves) and had to change in to a lovely patient gown. Today March 20, still red, no itching, smaller in size.
Experienced hypothermia (temp 95 F), wretching, nausea, myalgias, and joint pain beginning on 3/31/2003. Had left subscapular pain on 4/3/2003 and saw a doctor on 4/4/2003.
Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L201A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus (since 10 years old). Concomitant products included INSULIN for Type 1 diabetes mellitus.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, RHINORRHOEA (Runny nose) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment drug information was provided after dose 1 . Patient reported lot number 025L201A - Said it was either an A or 4. Patient stated that her nose has ran since the day of the 1st dose but said it could be allergies.That runny nose has been going on and on.   This case was linked to MOD-2022-513603, MOD-2021-214960 (Patient Link).
Pfizer Monovalent given to 10 patients instead of Pfizer Bi-Valent Booster.  All 10 patients had no Adverse reaction to Mono-valent vaccine.
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 19-Apr-2022; Vaccine was expired on 01-Apr-2022 administered on 19-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 19-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 19-Apr-2022) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 19-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 19-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 19-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 19-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that pharmacist thought that the vaccine was expired in Jun-2022, however it was expired on 01-Apr-2022.  No treatment information was reported
Arm pain and swelling. Patient presented to urgent care and was given a 5 day course of a steroid for inflammation and tylenol for pain.
Mom reports shaking of head and arms. Occurred about 3 hours after vaccines administered and occurred several other times in the next 18 hours. Pt not responsive during episodes. Temp 101F. Persistent crying lasted 5 hours.
Following Covid vaccine on 6/30, Patient has significant fatigue.  This has continued for the last month and continues today.  Pt has some days that are better with less fatigue, however notable fatigue with falling asleep for extended periods of time is noted.  Pt at one point slept 21/24 hours in the day.  Pt is pale with no other symptoms or findings.
Clients mother called about 45 minutes after vaccine was administered stating she had developed "hives"on both arms and her face. Benadryl 50mg was given. Client denied any resp. distress. Clients mom advised to call physician for follow up.
Headache- severe for the first 2 days then recurring in the evenings several nights a week since then. Also severe menstrual cramps for 1 day- about 1 month after vaccine but it was the first cycle since the vaccine.
A non-serious spontaneous report of FLUMIST administration to child under 1 year old was received from a health professional concerning a ten-month-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 03-Oct-2011, a child below two years of age received FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Maternal exposure during pregnancy; Laryngomalacia/omega epiglottis; Tracheomalacia; Arterial compression on his epiglottis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A neonate male patient was exposed to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), transplacental, administration details for the mother: as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The mother's relevant medical history and concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (life threatening), outcome "unknown"; LARYNGOMALACIA (life threatening), outcome "unknown", described as "Laryngomalacia/omega epiglottis"; CONGENITAL TRACHEOMALACIA (life threatening), outcome "unknown", described as "Tracheomalacia"; VASCULAR COMPRESSION (life threatening), outcome "unknown", described as "Arterial compression on his epiglottis". Therapeutic measures were taken as a result of vascular compression.   Additional information: Reporter on the line calling with a question asking if Pfizer has done any research into possible birth defects with the covid vaccine. The reporter explained he had to watch them run a code on his 2.5 week old son and do CPR. He was born with several airway defects. Reporter clarified that before his son was born, both his son's mother and he (the reporter) received the covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300275193 Maternal case;
Pt recvd vax w/Hep B (recombinant) on 29JAN92; same day pt exp neurologic sx including muscle weakness, ataxia, & facial paralysis; On 30JAN92 sx worsen; Pt taken to ER; 05JAN92 pt not completely recovered;
The day after the vaccine, 08/12/2021 at 04:30 PM, I was out of town, I was totally fine the whole morning, I had an overwhelming feeling  dizziness and nausea. I was hot, and thirsty. I was drinking lot of water. I couldn't get rid of the thirst.  I had an extremely dry mouth. I was only feeling well if I was laying down, I couldn't be sitting or standing. A few days after I had extreme pain on my right ear. I was taking ibuprofen and it wasn't helping. I went to the clinic , on 08/16/2021 for my ear. and I ended up having a double infection in my inner and outer ear. With my ear infection I was prescribed Amoxicillin antibiotic, she prescribed 7 days worth , at the 7 day mark it still didn't feel completely right. I called my doctor yesterday to see if it was ok to get the 2nd dose, She said its probably something in my inner ear that's causing the nausea and to go ahead and get the 2nd dose tomorrow, 09/09/2021.  This Tues. 08/31/2021 around 1:00 pm I had another spell of dizziness and nausea and had to leave early  from work because I felt like I was going to pass out. I still have the dry mouth and excessive thirst. The last time I felt bad was last Thursday ,09/02/2021, At work at school, the motion of the kids walking in different directions made me nausea. Same for Friday, picking up something up from the floor makes me feel dizzy. I still have dizziness a little but I am extremely thirsty, more than usual. I have a telehealth appointment with my doctor on Monday.
02:30  reported feeling flushed and hot--B/P 160/80 P-120 feeling tingling in mouth, tongue felt thick, no SOB, no tightness in chest-- Dr in to see and orders per protocol 0.3mg Epi given at 2:40pm   2:50pm  reported feeing better P now 84  no resp issues, tong feeling better, still with tingling in mouth 3:20pm  sent to ER for observation--B/P 145/70 P-102 report from ER---symptoms did return later and she received Benadryl/steroids/another epi and no further symptoms after that discharged from ER approx 10pm
No additional AE reported; patient was administered improper stored dose of MMRII and VARIVAX; This spontaneous report has been received from a registered nurse concerning 12-months-old male patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions and allergies were not provided.   On 15-SEP-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R-II), albumin status of rHA (recombinant human albumin), for prophylaxis, subcutaneously, in the left thigh, (lot number T012419 is an invalid lot number for measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R-II)) (dosage and frequency were not provided). Additionally on an unknown date (conflicting information reported as 15-SEP-2022), the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX), for prophylaxis, subcutaneously, in the right thigh,(lot number T003706 had been verified to be a valid number; expiration date 30-JAN-2022, and upon internal validation established as the same date) (dosage and frequency were not provided). However the administered doses of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II), and varicella virus vaccine live (Oka/Merck) (VARIVAX) were stored at an unspecified temperature, during an unspecified time frame (product storage error). There was a previous temperature excursion on 25-OCT-2020. No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA002212:
RT ARM SWELLING WITH CELLULITIS TREATMENT BACTRIM,  MOTRIN
Covid-19 vaccine breakthrough case. Dose 1- 2/18/21 Moderna 013M20A, Dose 2- 3/16/21 Moderna 045A21A.
Warm red rash on left upper arm and left thigh. This resolved, then had red warm to touch rash on (R+) forearm..
Fever, tiredness, feel like I got run over my a truck, nauseated, stomach upset, body pains, chills, hot and cold flashes, weak
Sudden onset of dizziness (nearly to the point of passing out), weakness, extreme fatigue, joint aches (started with hands and quickly moved throughout body), atypical behavior (crying, snapping), fever, nausea, injection site bruised, swollen, and bleeding more than the usual shot. By the next morning, everything but the weakness and fatigue had dissipated. The next day, those symptoms had resolved, as well.
No adverse event; Patient received first dose in primary series one day beyond manufacturer's expiration date of 11/28/2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received first dose in primary series one day beyond manufacturer's expiration date of 11/28/2022) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 29-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received first dose in primary series one day beyond manufacturer's expiration date of 11/28/2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received first dose in primary series one day beyond manufacturer's expiration date of 11/28/2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received first dose in primary series one day beyond manufacturer's expiration date of 11/28/2022).    Concomitant medication was not reported.  Patient received first dose in primary series one day beyond manufacturer's expiration date of 28-Nov-2022. Physician and patient was notified on 30-Nov-2022. Patient was not experiencing any adverse symptoms at that time. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.  Vaers report submitted 01-Dec-2022.
Warm to touch left upper arm, aching in left elbow. Chilled (clammy feeling, feverish) no fever, no headaches, no sharp pains (started 7-19-07 PM). He is left handed.
Systemic: Headache-Severe, Additional Details: Patient started having headaches 1-2 weeks after administration date. Patient gets them 2-3 times per week and the pain level varies from mild to severe as well.
shortness of breath and chest tightness within 1 hour of the second vaccines only, resolved with use of her albuteorl inhaler
Patient reported for simple vaccine update - she'd had one GARDASIL (unsure if 4 or GARDASIL 9) on 10/27/17 without any prior reaction - and due to prior lab work showing lack of immunity to measles or hepatitis B. After administration of 4th vaccine (3 IM and 1 SC) nurse reported that patient felt light-headed and warm and then lost consciousness - this was almost immediately after injection of 4th vaccine. She yelled to me and I came in to room to find patient unconscious and seated, going quickly into tonic stiffening with mild extension of trunk and total extension of BUE/LE. She became incontinent of urine as well. No tongue trauma. We laid patient supine and within 30 - 45 seconds patient's tonicity had relaxed and she had regained consciousness. She was able to bend knees up while laying supine at this time. She had a NL pulse (HR 70's) and had a normal respiration rate, roughly 14 - 16. Within minutes she was AO x 3 with VS stable/normal (97/67, HR 87, Px 100% RA). After 10 - 15 minutes she was seated and felt slightly tired and nauseated but eager to go home. She was messaging with her boss and friend and said friend would drive her home or she would consider ordering Uber ride home. We discouraged driving until she felt well enough for this. She was able to walk out of wellness center without incident. This reaction will be reported to the VAERS by myself.
Immunization administered at top of shoulder joint (not in arm muscle) into shoulder area w/ little tissue, significant joint discomfort & immobility now. Diagnosis ongoing.