chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left Axillary lymph nodes swollen; Left Axillary lymph node tender; A spontaneous report was received from a female consumer of an unknown age who received Moderna's COVID-19 Vaccine, and who developed left axillary lymphs are swollen and tender.   The patient's medical history was not provided.  Concomitant medications were not provided by the reporter.   The patient received her first of two planned doses of mRNA-1273 (Lot number not provided) on an unspecified date intramuscularly  for prophylaxis of COVID-19 infection.   The patient reported a week or so after she received the Moderna vaccine her left axillary lymphs are swollen and tender.  Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events was unknown.   The events of left axillary lymphs are swollen and tender were considered not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
arm is "a little swollen and sore; arm is "a little swollen and sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 15Mar2021, outcome "unknown" and all described as "arm is "a little swollen and sore".  Additional information: The patient wanted to know if they could take naproxen after receiving first dose on 15Mar2021, as their arm is "a little swollen and sore."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no additional AE; improperly stored administered vaccines; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-NOV-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), dose: 0.5 milliliter, lot# S035126, expiry date: 04-NOV-2021 (dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of -10.8 degrees Celsius for 1 hour 30 minutes. There were previous excursions related: -12.3 degrees Celsius for 1 hour and -10.3 degrees Celsius for 10 hours and 30 minutes. Data logger was involved. No adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA003543:
About 1 month after I received the shot, I started to have some breathing and coughing problems.  I still continue to have those effects as of the date of this report
Flu-like systems developing over a few hours into full-body pain and inflamed feeling, followed by labored breathing and wheezing, burning/sharp pain in the chest and ribcage. I spent about an hour struggling to breathe until I was given the rescue inhaler we keep for emergencies. I've still had some trouble breathing and a sore throat but I haven't been able to see a doctor yet.
Patient was administered vaccine that was improperly stored (in freezer for too long and considered expired by manufacturer at date of administration due to lack of study data). Patient acknowledged recommendation and was interested in revaccination, but has not yet sceheduled.
Hands and joints swollen and painful: onset Jun 06; Diagnosed polyarticular inflammatory arthritis; Treated NSAIDS, Palquenil
40 year old female received injectable 10/01/2010. 2 days after vaccine pt. developed hives, which started on the stomach and spread to legs and arms, and were dime sized. Pt. sought care with internal medicine and an allergist 2 weeks post symptom onset. Subject did not tell the allergist or internal medicine doctor about receiving the vaccine 2 days prior to onset of hives. Pt. was diagnosed with idiopathic allergy. Pt. was prescribed 60 mg of fexofenadine 1-2 times per day. Medication has decreased the symptoms of the hives, but the hives still persist 1 month post vaccination. if patient does not take prescription hives will become larger, itchier, and spread to legs/arms.
Extreme Fatigue, Stomachaches, Migraine Headaches, Body Aches, Anxiety and Fear
Patient presents for Pfizer COVID-19 vaccination # 2 and disclosed that with the first dose of the Pfizer vaccination, which she received at  Pharmacy, she had immediate (within 2 minutes of rec'ing injection) difficulty "getting air and taking good breaths" that lasted about 10 minutes and resolved without intervention. This was associated with nausea that persisted throughout the evening. She denies significant anxiety, tachypnea, tachycardia, near-syncope or syncope, rash, swelling of the lips, tongue, throat, or face.   She denies allergic reactions to any other medications or foods and has denies significant past medical hx.   Per updated CDC guidelines, the Pfizer booster is contraindicated and should be listed as an allergy. Additionally, she is eligible for the J & J COVID-19 Vaccination at least 28 days from the time of her first vaccination if okay with her primary care physician
Initial unsolicited report received from a physician via other company (Pfizer) on 02 February 2016. Manufacturer Report Number: 2015310003. This case involves female (age not reported) patient who was vaccinated with a dose of Menactra (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed photosensitivity, unable to walk, psychomotor seizures. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. Upon medical review, the case was considered as serious due to important medical event: unable to walk, psychomotor seizures. List of documents held by sender: none. Sender's Comments: Unable to walk is unlisted but psychomotor seizures is listed with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
"shingles rash" on his "torso side and back".; shingles rash" on his "torso side and back".; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by the son of the patient. He reported that his father received his first dose of shingrix and experienced shingles rash on his torso side and back. He was not sure what side the rash was on.  He could not answer other questions asked. The reporter said he would get more information and call GlaxoSmithKline back. Adverse event filed with limited information
Vaccine leaked out of syringe, patient received deviation from normal dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine leaked out of syringe, patient received deviation from normal dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 25-Feb-2021, the patient experienced UNDERDOSE (Vaccine leaked out of syringe, patient received deviation from normal dose). At the time of the report, UNDERDOSE (Vaccine leaked out of syringe, patient received deviation from normal dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.   Reporter did not allow further contact
Throat, lips and tongue swelling 4 hours after 1st dose followed by 3 months of severe burning and stinging sensations all over my body and face. Put on 6 days of steroids and 3 months of antihistamines. Had blood work done twice. After the three months of constant burning and stinging sensations abated, I was in constant pain in bones, muscles, feet, hands, legs, arms. Referred to rheumatologist who diagnosed me with fibromyalgia and put me on cymbals for pain. On cymbalta for 2 months with no improvement yet. I am in constant pain.
at c/o sob 30 min receiving varicella vaccine.  vis@ 12:30 92/70 pr-100 (thready).  Staff responded  to the incident and on site.  pt c/o swelling on lips and continued sob.  epipin pen was given as ordered: pt remained alerts and oriented : bp 114/68. ambulance was called : b/p 120/70: pr 80 pt was transported to e.r @ 12:44
10 days after received MMR and Varivax, child became less active, increased sleeping, unsteady or wobbly when trying to walk around furniture.
5 hours post injection stiffness to body ,fever started, sore throat , severe headache, dry cough, weakness. So weak it was hard to lift blankets. I took motrin and tylenol. Drank fluids. Very hard to sleep due to achy pain in joints and muscles. Dizzy when upright.
Tachycardia at 155 beats/minute, nausea.  Around 6 pm lasting over an hour. Was able to take Flecainide , it took an hour to  slow rate to normal
Patient presented to  ED on 4/15/21 with fever and cough for 5 days with covid infection after fully vaccinated. Patient was treated for covid and was discharged on 4/17/21.
HIDRADENITIS SUPPURATIVA FLARE UPS; SICK AFTER COVID-19 VACCINE; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: Moderate to severe hidradenitis suppurativa. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe hidradenitis suppurativa. No concomitant medications were reported. On an unspecified date, the patient experienced hidradenitis suppurativa flare ups, and sick after covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient recovered from sick after covid-19 vaccine, and had not recovered from hidradenitis suppurativa flare ups. This report was non-serious.
Headache, Myalgia, Fever, UrticariaPruritus, Injection site pain, Narrative:  Other Relevant History:
Diarrhea lasting for 22 day, RIGHT UPPER QUADRANT pain for 22 days
Fainted off the toilet/again fainted; Felt incredibly ill; Throw up; Diarrhea; This is a spontaneous report from a contactable consumer (patient).   A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Apr2021 13:00 (30 years old at vaccination) (Lot Number: EW0161) as single dose for covid-19 immunisation.  The patient was not pregnant at the time of vaccination. Medical history included Allergy: Bees. Concomitant medication(s) the patient received within 2 weeks of vaccination included drospirenone, ethinylestradiol betadex clathrate (YAZ).  Clinical course as reported: Sunday 18Apr around midnight I felt incredibly ill (roughly 30 hours after vaccine). I went to the bathroom and fainted off the toilet and then proceeded to throw up and have diarrhea at the same time while on the floor. After showering and cleaning up, roughly 30 minutes later I again fainted (this time in the safety and easy cleaning of the bath tub) and repeated the same throw up/diarrhea episode. I slept in the bathtub for the rest of the night. My doctor instructed me to go to the emergency room if I fainted again and to drink plenty of fluids. Events onset date reported as 18Apr2021 12:00 PM. No treatment received for events. Outcome for event was recovered on unspecified date in 2021. Serious reported as No. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   Information on Lot/Batch number was available. Additional information has been requested.
Difficulty breathing, Wheezing, cough, tightness in chest, throat tightening up, tough swelling, eyes during red, and flushing of skin.
Vaccine stored outside of recommended storage temperatures for greater than 2 weeks and administered to patient. Manufacturer contacted. Patient did not experience signs or symptoms of adverse outcome.
Nausea Feeling sick Low blood pressure Clammy skin Signs and symptoms started 5 minutes after the administering the vaccine. Vaccine administered at 12:22. At 12:27, the consumer complaints of nausea and feeling sick. Consumer remained awake, alert, and oriented. The consumer denies shortness of breath, chest pain, or difficulty breathing. Vital signs checked: BP 80/50 (manually), 86/50 (electronically), heart rate 65, oxygen saturation 94-97%.  Consumer admitted taking her cardiac medications 10 to 15 minutes before we arrived for the in-home vaccine administration.  The EMS arrived around 1:00 pm, assessed the consumer, BP remains low. At 01:40 pm, the consumer was transported to the hospital by the EMS.  NOTE: Consumer states, she took cardiac medication 10-15 minutes before the vaccine was administered. She verbalized, the medication has not been take for a while (about 6 weeks), just resumed medication on 5/14/2021.  BP reading 12:28 80/50 manually, 86/50 electronically 12:48 - 60/45 Called 911, fluid offered 12:55 - 161/87 1:00 - 104/54 EMS Arrived 1:05 - 106/54 1:06 - 108/70 1:15 - 77/45 1:40 - Consumer transported to the hospital by the EMS. Consumer remains awake, alert and oriented. Denies shortness of breath, chest pain, or difficulty breathing.
Approx. 4 hours, post vax, pt had 45 second interval of petit mal seizure.
I got the shot and still got COVID; I got the shot and still got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I got the shot and still got COVID".  Clinical course: It was reported that, the patient lost interest because she was tired of companies and the government telling her to get boosters. She got the shot and still got COVID. Also now they were hearing about so many bad side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client closed eyes, looked like she was going to faint and then she had two jerky movements. She then opened her eyes and asked what happened. Jerky movements lasted three seconds. Involved head and upper body.
This spontaneous case reported by a consumer, describes the occurrence of chest pain, dyspnea (shortness of breath), palpitations, urticaria (hives all over the body) and pain in extremity (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031A21A) for COVID-19 immunization. No medical history reported. On Mar 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 22, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 24, 2021, patient experienced chest pain, dyspnea (shortness of breath), palpitations), urticaria (hives all over the body) and pain in extremity (sore arm). The patient treated with paracetamol; 1 dosage form. At the time of the report, chest pain, dyspnea (shortness of breath), palpitations, urticaria (hives all over the body) and pain in extremity (sore arm): not resolved. Concomitant product use not provided by the reporter. Action taken with mRNA-1273 in response to the event: not applicable.
Patient complained of "achiness" around 2:30 to 3:00 pm. His symptoms progressed to stiffness and soreness by bedtime and needed help with his clothing before bed. Around Midnight, there was a loss of bowel control and he passed away.
Extremely fatigued on Thursday   During the night swelling of lips tongue  Inflamed mucosa of cheeks   Hurts to swallow.  Fever  Went to Emergeny care Center  Friday morning.  Throat swab   Prescription for Z pak   and over the counter Benadryl.    Today fever down with Z pak  but swelling of lips and throat  same   Hurts with each swallow  No desire for food.    Obtained a medrol pack today which has helped with the swallowing  and since i have just started it will continue with the rest of the swelling.....My symptoms and lip swelling are exactly like the internet pictures of vaccine reaction except that mine is 2 months out   No change in routine or diet and i have no allergies
This spontaneous report was received from a Licensed Practical Nurse refers to a 4 year old male patient. The patient previously received one dose of M-M-R, one dose of varicella virus vaccine live (unspecified), 4 doses of diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid and 3 doses of poliovirus vaccine inactivated (unspecified). On 01-AUG-2018, the patient was vaccinated with PROQUAD from lot R002935 dose 1, subcutaneous in the right thigh for prophylaxis. On the same day, the patient was also vaccinated with KINRIX from lot 95FR9 dose 1, intramuscular in the left thigh for prophylaxis. The sterile diluent (manufacturer unknown) (lot# M012716 with expiration date 20-AUG-2018, lot # N030577 with expiration date 19-APR-2019, lot# N027783 with expiration date 17-NOV-2019, lot# M013220 with expiration date 24-SEP-2018, lot# M035268 with expiration date 19-APR-2019; lot # N006322 with expiration date 11-JUL-2019, lot # M012718 with expiration date 10-NOV-2018, lot # N004190 with expiration date 04-JUL-2019, lot # N022038 with expiration date 27-NOV-2019, lot# N030574 with expiration date 05-JUN-2020, lot# N030178 with expiration date 15-JUL-2020) used to reconstitute the vaccines was properly stored. The medical assistant was not sure which sterile diluent (manufacturer unknown) lot numbers were used. The vaccines were exposed to temperature excursion of -14 degree Celsius up to -10 degree Celsius for 5 hours total (including the previous exposure to temperature excursion). Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved in this case. No symptoms were reported. This is one of the two reports linked via same reporter link. Sender's Comments: US-009507513-1807USA007589.
At 4:30pm 9/11/10, pt called pharmacy to report experiencing tingling on tip of tongue, no swelling, SOB, or hives.  Advised to monitor and report to physician care if progression of symptoms occurred. At 4:42 pm, pt called back to report tingling in tongue continuing as well as now tingling on lips. Left side of face and inside edge of eyelids also tingling/numb. Felt tongue was swelling. Pt took 50mg diphenhydramine on recommendation of pharmacist and reported to emergent care promptly. Pharmacist called pt at 12:05pm 9/12/10. Pt reports receiving more diphenhydramine, prednisone, and ranitidine from emergent care providers to treat reaction.  Pt reports feeling back to normal today.
Breakthrough case admission after three vaccines Pfizer 3/7/21 Lot# EL9265;  Pfizer 3/28/21 Lot# EN6200;  Pfizer 9/23/21 Lot# FE3592
Within 4 hours of the vaccination, patient suffered a complete collapse, going limp, turning blue, eyes crossed, and drooling fever of 101. Thereafter patient was on frequent occasion unable to control his eyes. His eyes would roll and his hands would shake. He has been diagnosed as having an infrequent, upbeat nystagmus, which affects his vision and his balance. A few weeks after the vaccination, patient began to have episodes where he would become stiff, arms extended with his fists clenched as his eyes rolled back. From july 20, 1999 to september 14, 1999 patient's head circumference increased from 14.5" tpo 17". When patient learned to walk, he would lose his balance frequently and had problems navigating around objects in his path. He also has general neurological deficits affecting muscle tone. Patient has weakness or dysfunction of his right side. He toe walks on his right side but walks flat footed on his left. He is left handed due to a greater lack of fine motor control on his right side. He is significantly developmentally delayed and visually impaired. He apparently also has a seizure disorder. *F/UP report on 3/14/03: Seizure and difficulty with motor central and speech.*
had gotten Covid over holiday 2021 even though she was vaxxed and boosted (don't know what vaccine); had gotten Covid over holiday 2021 even though she was vaxxed and boosted (don't know what vaccine); had gotten Covid over holiday 2021 even though she was vaxxed and boosted (don't know what vaccine); This is a spontaneous report received from a contactable reporter (consumer) via COVID-19 Vaccine Adverse Event Self-Reporting Solution (COVAES) portal. Other Case identifiers: US-PFIZER INC-202200015890 (Pfizer), US-PFIZER INC-202200015904 (Pfizer).  A female patient received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Solution for injection), (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown," DRUG INEFFECTIVE (medically significant) and SUSPECTED COVID-19 (medically significant) both with onset Dec2021, outcome "unknown" and all described as "had gotten Covid over holiday 2021 even though she was vaxxed and boosted (don't know what vaccine)."  The batch/lot number for BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown) was not provided and will be requested during follow up.
29DEC96 pt was sitting w/father got up walked away in daze & then went into sz;another occurred 28FEB97 then a worse on AUG97;mom believes vax is responsible for pt misery & depression;
Muscle and joint pain moderate to severe whole body, chills with no fever, headache, nausea. This ran from approximately midnight Friday thru Sunday morning.  The longest lingering was the headache.