chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching on skin after 2nd vaccine; Existing mass in ovaries grew after 2nd vaccine; Can feel lump under right arm pit after 2nd vaccine; Swelling of the lymph nodes under the right arm after 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on skin after 2nd vaccine), OVARIAN MASS (Existing mass in ovaries grew after 2nd vaccine), AXILLARY MASS (Can feel lump under right arm pit after 2nd vaccine) and LYMPHADENOPATHY (Swelling of the lymph nodes under the right arm after 2nd vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Ovarian mass (She states that prior to vaccination she had a mass in her ovaries and after vaccination it grew.So they had to remove he ovaries.).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PRURITUS (Itching on skin after 2nd vaccine). In 2021, the patient experienced OVARIAN MASS (Existing mass in ovaries grew after 2nd vaccine), AXILLARY MASS (Can feel lump under right arm pit after 2nd vaccine) and LYMPHADENOPATHY (Swelling of the lymph nodes under the right arm after 2nd vaccine). The patient was treated with Surgery (ovary removed) for Ovarian mass. At the time of the report, PRURITUS (Itching on skin after 2nd vaccine), OVARIAN MASS (Existing mass in ovaries grew after 2nd vaccine), AXILLARY MASS (Can feel lump under right arm pit after 2nd vaccine) and LYMPHADENOPATHY (Swelling of the lymph nodes under the right arm after 2nd vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: dense breast tissue (normal) dense breast tissue.         No concomitant medication was given by reporter. No treatment medication was given by reporter According to case narrative the patient had breast Sonogram and result not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Significant Follow up-PQC provided On 08-Nov-2021: Non significant follow up appended
Patient is a 80 years old male patient of DO with history of COPD, CHF, Hypertension, CAD S/P 3 Stent, CVA, DM presented to Hospital with Weakness .   Covid-19 infection. Acute Hypoxic Respiratory failure. H/O COPD. Vaccinated against COVID X 2 ,No booster. Tested positive 1/3/22,chronically cough,short of breath. CXR;Chronic obstructive pulmonary disease with clear lungs currently. Has remained stable on 1L NC, continue to titrate for SpO2 > 89% with exertion  Documented on decadron however never initiated.   Will start now given continued oxygen requirement for 10d burst.    AKI;resolved Admission creatinine 1.50 ,currently 1.24. Etiology unknown, likely poor oral intake Resolved with hydration on admission   Recommend repeat labs in 1-2 weeks.    Weakness,Deconditioning. Likely due to COVID-19. PT/OT   Essential hypertension Uncontrolled on admission. Resume home medications.   CAD S/P 3 Stent. Hyperlipidemia No chest pain. Stable on aspirin, Imdur, atorvastatin   CVA Stable, will continue aspirin.   DM,Hyperglycemia. Controlled on admission. Hemoglobin A1c; 6.5 . On glipizide at baseline Will continue sliding scale, carb controlled diet.   Depression Self-harm comments. Evaluated by psychiatry, increase his dose of Wellbutrin. Scheduled melatonin and trazodone for sleep
Pt states she started feeling chest pressure about 5 minutes after the vaccine was administered. Says she has had this feeling other times but never after a vaccines. BP checked WNL. States sometimes she has high BP. after talking with pt for about 5 mins she said it had decreased to a "little discomfort" and after another 5 mins she said she was feeling better. Advised check with PMD if pain or discomfort return.
High grade fever 106+; ear drum appeared to have ruptured but not red, checked by APN also a/vax administered MD next day; stated pt had blister on eardrum;
Patient said he noticed swelling at injection site the night he received it. He woke up the next day with pain & more swelling and felt very sick to his stomach. Took BENADRYL & ADVIL with no relief. We advised him to see a doctor - who told him an abscess had developed.
He developed fevers >102 degrees, swelling and redness of the injection area up to 3 inches x 3 inches. Swelling of axillary and inguinal lymph notes. Myalgias.
Narrative:  75 year old female who tested positive for COVID on 1/8/22 and was admitted for non-productive cough and worsening dyspnea. She had received Pfizer vaccine on 1/21/2021 and 2/11/2021. Notes reported that patient had also received a booster dose, however there are no records of patient receiving that booster dose at any facility. Do not know the date of the booster or if booster dose was Pfizer or moderna. Patient was treated with 5 days of remdesivir and 5 days of dexamethasone prior to discharge on 1/14/22.
felt like he had been hit by a truck  / general malaise; This case was reported by a consumer via call center representative and described the occurrence of general malaise in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced general malaise. On an unknown date, the outcome of the general malaise was recovered/resolved.   It was unknown if the reporter considered the general malaise to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingrix vaccine and he felt like he had been hit by a truck for a couple days and then was fine. she described it as general malaise. The reporter did not consented to follow up. This case is linked with US2021179662 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021179662:same report
Cold, a nose congestion; Cold, a nose congestion; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported that a female patient of an unspecified age received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection), via an unspecified route of administration on 24Jul2021 (Batch/Lot number and Expiration date were unknown) as dose 1, single for COVID-19 immunization. Relevant medical history indicated that the patient already had the Covid prior (previous of) getting vaccinated on an unknown date. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced cold, a nose congestion. The patient wanted to know if she could get the second dose. It was further reported that the patient was supposed to get the second dose (unclear) on next week, but just wanted to make sure that, because she had to go and she didn't have fever or anything; she felt good. She was pretty good and didn't have like nausea or anything like that, but just wanted to make sure that she could still go even if she had it long before. The outcome of the events "cold, a nose congestion" was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
acute hypoxic respiratory failure; septic shock; This literature-study case was reported in a literature article and describes the occurrence of ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) and SEPTIC SHOCK (septic shock) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Concurrent medical conditions included Hypertension, Chronic obstructive lung disease, Graves' disease and Lung cancer.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) (seriousness criteria death, hospitalization and medically significant) and SEPTIC SHOCK (septic shock) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was Acute hypoxic respiratory failure and Septic shock. It is unknown if an autopsy was performed. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) and SEPTIC SHOCK (septic shock) to be possibly related.    Concomitant product and treatment medication use was not provided by the reporter.  Company Comment: This case concerns a 76-year-old female patient, with medical history of hypertension, chronic obstructive pulmonary disease and lung cancer, who experienced the fatal events of ACUTE RESPIRATORY FAILURE and SEPTIC SHOCK. The events occurred on an unknown date after receiving an unknown dose number of the Moderna COVID 19 vaccine. The rechallenge is not applicable considering the outcome of the events. Patient's medical history of hypertension, chronic obstructive pulmonary disease and lung cancer remains as a confounder. The benefit-risk relation of the Moderna COVID 19 vaccine is not affected by this report.   This case was linked to MOD-2021-371501, MOD-2021-371537, MOD-2021-371538, MOD-2021-371539, MOD-2021-371541, MOD-2021-371542, MOD-2021-371543 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up received by safety 03-Nov-2021 included an Email with FTA received from SARA team and  contains significant information. Added correspondence contact in general tab; medical relevant history in patient tab.; Sender's Comments: This case concerns a 76-year-old female patient, with medical history of hypertension, chronic obstructive pulmonary disease and lung cancer, who experienced the fatal events of ACUTE RESPIRATORY FAILURE and SEPTIC SHOCK. The events occurred on an unknown date after receiving an unknown dose number of the Moderna COVID 19 vaccine. The rechallenge is not applicable considering the outcome of the events. Patient's medical history of hypertension, chronic obstructive pulmonary disease and lung cancer remains as a confounder. The benefit-risk relation of the Moderna COVID 19 vaccine is not affected by this report.; Reported Cause(s) of Death: acute hypoxic respiratory failure; Septic shock
CLIENT HAD EPISODE OF SYNCOPE 5 MINUTES AFTER RECEIVING SHOTS.
Fluzone vaccine administered 1-25-06 a.m. 2:00 p.m. child started to itch from her head, chest, back and ears, Mother described it as a "slightly raised pink rash." Child is playing eating and sleeping but continues to scratch next day.
Patient reported feeling hot and having chest pain and tightness. I called 911 and she was moved via ambulance to medical center.
mom noticed a sudden change to her behavior after last visit for vaccine  had DPaT on 8/11/23   prior to vaccines seem to be   immediately fell asleep after crying for a few minutes  seems very fast to fall asleep // but was responsive  was fussy after vaccine after seems to be a little restless  twin sibling seemed fine in the morning but patient seem to not to engage as her usually self  seemed to "internalized" // parents were concerned along with nanny is being different  more frustrated, seemed more shaking,   lasted for over two weeks
Severe pain in (L) arm (entire arm) (same as injection arm) no redness, warmth. Paresthesia in hand lasting several days.
Developed Shingles. Was prescribed valacyclovir by my doctor, Shingles resolved in 8 days.
This afternoon, mom received call from school that pt arm was red, itchy and lump at site. This is his left upper arm. Last evening only complained arm hurt a bit. Suggested ice to area and referred mom to call physician for further direction.
little fatigue; pain in arm of vaccination; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 12Aug2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The historical vaccine includes bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient reported sore arm and fatigue after the first dose. After second dose, the patient experienced little fatigue and pain in arm of vaccination on an unspecified date. Reporter asked a question about the second dose and reported sore arm and fatigue for the first dose, she asked about the reported adverse events, but she said she never talked about chills or headache, just sore arm and fatigue, and she never called for the second dose. But in the second dose, received on 12Aug2 021, she had a little fatigue, pain in arm of vaccination and no other adverse events. The events outcome was reported as unknown.  information about lot/batch number has been requested  Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Tinnitus constant ringing in the ears.  Ongoing went to DR unable to determine actual cause.  Vertigo  dizzy  sweaty went to hospital  no significant findings to cause incident.  Daily headaches
Facial numbness since the day vaccine is taken. Onset of migraine occurring started soon after Feeling fatigue most of the time Facial numbness worsened and got Ocular Migraine since July
A few minutes after vaccination patient felt faint, placed on floor with legs elevated, ice placed on back of neck, No LOC.  Vitals taken 11:35am BP 126/70 P 68, 11:40am BP 130/88 P 72, 11:50am BP 112/68 P 68. After resting for a few minutes, she was given water and a protein bar, she had not eaten.  She was feeling better and called friends to walk with her back to her dorm room.  Follow up call to patient - she has recovered fully and no further adverse effects. She claims she gets squeamish most times around needles and faints most times she goes to the doctors office, so this is common for her.
Neck pain left side of neck; ongoing tic upper left lip without pain.  History of trigeminal neuralgia but rarely symptomatic for  past 11 years.
SWELLING OF THE FACE RIGHT AFTER I GOT THE VACINATION.  LATER THAT NIGHT; I WAS HAVING TROUBLE BREATHING.  I END UP GOING TO THE EMERGENCY ROOM WHERE THEY CONFIRMED THAT IT WAS A REACTION TO THE VACCINE,  BUT WROTE ON THE REPORT AS SINUSITIS.
No additional AE details provided.; Medical assistant calling reports 2 doses of expired PROQUAD were administered to 2 patients. Products did not experience any temperature excursions through the date of administration. See AE case 02225333 for additional patient. No additional AE det; This spontaneous report was received from a medical assistant and refers to a 3-year-old male patient.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent manufacturer unknown).   On 13-JUN-2022, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), rHA (recombinant Human albumin) subcutaneous injection, lot #T029102, expiration date: 23-FEB-2022 (both confirmed to be valid), administered for prophylaxis (strength, dose, route and site of administration were not provided).  The suspected measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) did not experience any temperature excursions through the date of administration. There were no additional adverse event details provided (no adverse event).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA006220:
11SEP90 PT vax hepta b. pt ex h/a, dizziness, dry mouth, anorexia, dysgeusia.  sx resolved.
Patient did not have any adverse reactions or symptoms. Pt was 17 and pregnant and given a vaccine for 18 and older. Pt is pregnant with 1st baby with a due date of 06/14/2021.
(R) deltoid with 6-7 cm erythematous, splotchy, pruritic area and one 1mm erythematous papule centrally.
This spontaneous report was received from a licensed nurse practitioner refers to an unspecified number of unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored VAQTA (lot #, expiry date was not reported). No adverse event was reported. The outcome of the events were not reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Enlarged lymph nodes; pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28May2021 (Lot number: EW0185) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: if Covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot number=EW0182, dose number=1, vaccine location=Left arm), administration date: 07May2021, when the patient was 39 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 31May2021, outcome "recovered with sequelae", described as "Enlarged lymph nodes"; INJECTION SITE PAIN (non-serious) with onset 31May2021, outcome "recovered with sequelae", described as "pain at injection site". It was unknown if therapeutic measures were taken as a result of lymphadenopathy, injection site pain.  Additional information: No other vaccine in four weeks, No Other medications in two weeks  No follow-up attempts are possible. No further information is expected.
Patient received the vaccine with no problems and sat in the pharmacy waiting area for 15minutes. When I told her the 15 minute wait was done, she said she wasn't feeling right and was a little light headed. I got her a bottle of water and told her I had a cot for her to lay down on but she didn't want to lay down and continued sitting in the chair. She said her face felt tingly but denied having cough, wheeze, flushing, nausea, dizziness or difficulty breathing. She did not want rescue squad called. She did say her tongue and roof of mouth hurt and tingling face. I gave her a bag to breathe in because she was hyperventilating. She said she has had panic attacks/ hyperventilated in her past but wasn't currently being treated. She was in the pharmacy until around 2:30 when her brother came to get her since I did not want her driving. I followed up today and she said she had a mild HA, fatigue, and joint aches that she didn't get with previous Pfizer doses. She did contact her doctor, but can't be seen for a few weeks. I recommended she get further Covid boosters at the clinic.
HOUR 0-6: Ache in arm was immediate. Felt alright, with very light nausea. Drank lots of water under advisement.  HOURS 6-12: there were some chills. HOURS 12-24: By 4 am I was shivering, fevered, and aching enough to officially call out of work, though there was no coughing (and honestly that made me wonder if i was being a wuss, but the next day, the difference was real). The rest of the day was mostly aching and chills, with rest when possible. I felt distinct sluggishness. Bright light or changing orientation too quickly resulted in headaches and squints. My lips were dry even though i had been downing water constantly, thank you fever. Very light eating the whole day, dry toast, pretzels, etc..  HOURS 24-36: Felt vaguely crummy throughout the rest of the evening. After sleeping the next night through i felt great, and even exercised before work.
Fever to 102.9 degrees axillary x 5 days. Malaise, Headache, Rash, "Stiff neck". No nuchal rigidity, no neuro changes.
Patient received 4 injections 1/2/2007 and had reaction associated with DTap and IPC. Staff wrote that themother called 1/8/2007 and stated patient had (L) Thigh swelling the size of a quarter 1/7/2007 (hard knot) but it was less 1/8/07. Staff instructed her to apply warm soaks to L thigh and report if not better on Friday 1/12/2007.   1/12/2007 Denied pain,redness or fever.
Injection on 03-30-08 - Donor called in to center on 03-31-08 to report stomach cramps after receiving Rabies vaccination.  No pain at injection site.  Denies rash, swelling or SOB.
Vaccine administered in left deltoid 11am 12/22/05.  Patient states arm swelled, red, painful to touch by 8pm on 12/22/05.  Reported to Dr. on 12/23/05.  States arm is improving and will use Benadryl for reaction.
Migraine, muscle aches, weak, exhausted, a lump and red rash on left arm near injection. On the 16th, diarrhea and continued exhaustion (lasted 5 days)
Infant started to have desaturations and tachypnea, followed within a hour by apnea and bradycardia. Required Oxygen via Nasal Cannula and a sepsis work up.
Patient called me on 03/18/2018 (4 days post vaccination) in morning hours after 10 am complaining of swelling, redness, pain and itching at site of injection. Upon questioning for more details, she said the swelling and redness on her arm at one point was 4 inches in radius. The site was painful and uncomfortable to the touch. Recommended treatment with BENDRYL and pain relievers. Followed up with patient on 03/19/2018 and the symptoms have significantly improved, including reduced swelling.
After receiving the vaccine in the morning, I had no problems until the evening, when I began feeling feverish, with headache and muscular aches & pains. During the night, I experienced shaking chills that were so severe that I was unable to walk to the bathroom without assistance. I slept very fitfully because of the chills. The next day, I got up briefly, but almost immediately went back to bed, and slept all day without eating or drinking much at all. My left arm was very sore, painful, and hot to the touch. Even now, my arm has the rash.