chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccine 12-15-09 - 2 wks later, had severe pain and stiffness in neck, shoulders, arms and down into hands. Swelling in hands - now in care of 2 doctors and on prednisone and other meds.
WATERY EYES; RUNNY NOSE; CONGESTION IN THROAT; SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 18OSO18), dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021,the patient had a sore arm, but was not too painful.  On 06-MAR-2021, the morning after receiving the vaccine, the patient woke up with watery eye, runny nose, and congestion in throat.  The patient was inquiring if she should take Benadryl (dIphenhydramine) to help with those symptoms.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 06-MAR-2021, and had not recovered from watery eyes, runny nose, and congestion in throat. The patient assessed all of the events as as related to covid-19 vaccine ad26.cov2.s. This report was non-serious.
Pt developed redness just inferior to injection site that was streaky in nature and spreading. She also had fever and chills and body aches.  She was started on oral Augmentin and the streaking progressed. She was diagnosed with cellulitis and possible lymphangitis and admitted to inpatient hospital for IV clindamycin. She had a 2 day stay and the infection was resolving. She was discharged on oral clindamycin to finish the course. She had complete resolution of the infection.
About 10-15 minutes after receiving the shot, my  arm swelled and turned red and hot around the injection site and through my shoulder area.  I was in tremendous pain and felt nauseous.  I made it home, but had to stop to throw up on the way.  When I arrived home, I laid down to rest but the vomiting continued.  Within 3 hours, I had severe diarrhea and a terrible headache.  Those symptoms lasted for approximately 10 hours, at which point they began to subside.  I was very tired and weak for the next 48 hours, at which time I began to feel pretty normal.
Patient had pain shooting from back to leg. He was unable to walk or work for two days. He had high fever of 102. Pain was said to be an 9/10.
expired Menactra was administered today to a patient, no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 17 years old female patient who received 0.5 ml dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U5989AA via intramuscular route in the left arm on 30-Oct-2019, that was expired on 27-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. The pt's concurrent conditions, medical history and concomitant medications were not reported. On or about 30-AUG-2018, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the pt's inoculation, he was treated by a healthcare provider at a hospital, for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), he had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was not provided, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).
Prolonged pain, tenderness and weakness in left shoulder to elbow. Numbness in left arm.
Patient needed first dose Covid vaccine and instead was given Bivalent Covid Booster. No known side effects.
Had third COVID booster on 10/08 5 pm. Next morning 10/9 began to feel ill with chills, headache, nausea and vomiting which lasted the entire day. 10/10 still felt nauseous and had headache. 2nd booster I also felt ill but 3rd booster I felt worse. Had flu shot administered at the same time
I had a lot of fatigue and numbness in the leg, I couldn't hardly walk, my nose and arms. I couldn't even sleep, from my neck into my back. I had a really bad headache. I have a lot of cramping in my gut. I felt swollen, bloating and I had Tinnitus in both ears along with dizziness. I had brain fog, high blood pressure an high heart rate for about 3 weeks. I had diarrhea, vomiting, I had double vision with the left eye and slow vision in both eyes. I had tingling all over my body, it not as worse now. My muscles is very loose. Even in my throat was hurting, my feet got swollen and turned blue. I even had a rash on my arms, chest and abdomen. I am still having these issue. I am even experiencing hair lost.
I woke up with severe chills and body aches that lasted for 3 hours. In the morning I had some aches and a headache. It felt like I had the flu.
This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (The booster made me incredibly ill within a day of receiving, Been sick since Jan 2022), FEELING OF BODY TEMPERATURE CHANGE (Severe temp changes/Temp off), DISTURBANCE IN ATTENTION (Concentration), PRODUCTIVE COUGH (Coughing up chunks of white stuff) and JOINT SWELLING (Swollen ankles, knees) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced ILLNESS (The booster made me incredibly ill within a day of receiving, Been sick since Jan 2022). January 2022, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Severe temp changes/Temp off), DISTURBANCE IN ATTENTION (Concentration), PRODUCTIVE COUGH (Coughing up chunks of white stuff), JOINT SWELLING (Swollen ankles, knees), EYE PAIN (Sore eyes), SLEEP DISORDER (Disrupted sleep), EAR DISCOMFORT (Ear issues), HYPERHIDROSIS (Sweats), MUSCULAR WEAKNESS (Weakness in arms and legs), PAIN (Pain), HYPOAESTHESIA (Loss of feeling in hands and feet), DIZZINESS (Dizzy), VACCINATION SITE PAIN (Pain in arm at sight), HEADACHE (Headaches) and FATIGUE (Fatigue). At the time of the report, ILLNESS (The booster made me incredibly ill within a day of receiving, Been sick since Jan 2022), FEELING OF BODY TEMPERATURE CHANGE (Severe temp changes/Temp off), DISTURBANCE IN ATTENTION (Concentration), PRODUCTIVE COUGH (Coughing up chunks of white stuff), JOINT SWELLING (Swollen ankles, knees), EYE PAIN (Sore eyes), SLEEP DISORDER (Disrupted sleep), EAR DISCOMFORT (Ear issues), HYPERHIDROSIS (Sweats), MUSCULAR WEAKNESS (Weakness in arms and legs), PAIN (Pain), HYPOAESTHESIA (Loss of feeling in hands and feet), DIZZINESS (Dizzy), VACCINATION SITE PAIN (Pain in arm at sight), HEADACHE (Headaches) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Weight: increased Excessive weight gain despite barely eating.         Concomitant medications were not reported. Patient had reported not been the same since third dose of Moderna vaccination.Patient had to leave her job for months and she was due to go back. The booster dose made patient incredibly ill within a day of receiving it. The symptoms that occurred had lasted for days, weeks , months. She was  a single mother with two children and had to work The events has started back in Jan-2022 and patient was still experiencing those changes/ events. Treatment information was not reported.
On 5/2/21 patient presented to Emergency Room with Rt upper chest pain that is worse after meals and associated with vague nausea and some sob. Reported that pain was constant and burning in nature. Pt was admitted to hospital with mildly elevated troponin. D-dimer was greater than 20. Pt had a VQ lung scan which confirmed the diagnosis of pulmonary emobolus. Pt was given Enoxaparin 100 mg subcutaneously every 12 hours from 5/2-5/7. Then patient was started on Apixaban 10 mg po bid x 7 days which will transition to 5 mg po bid. Pt improved and will be discharged today 5/7/21.
Patient reported having light headedness and then developed chest heaviness. 911 was activated to respond to the facility.
pt experienced hearing loss in left ear the morning following their flu shot. has had MRI since and patient has permanent hearing damage in left ear and brain damage. neurolgist said the flu shot likely may have triggered her autoimmune system to overreact
Symptoms; Right arm swollen, red, tender, and warm. Pain to right arm and described by patient as burning. Treatment: Pt prescribed 5 days of KEFLEX antibiotics.
Intense freezing feeling in the lower half of my body up into my lower back / felt more like an internal coldness; This is a spontaneous report received from a contactable reporter (Other Healthcare Professional). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Mar2021 10:30 (Lot number: EN8207) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "Concerta Allergy" (unspecified if ongoing). Concomitant medications included: TOPAMAX; ZOVIA; IMITREX; DITROPAN; ALBUTEROL [SALBUTAMOL]. Vaccination history included: Bnt162b2 (Dose 1, single (Lot number: EL9265) via intramuscular route of administration in the left arm at 13:00), administration date: 04Feb2021, when the patient was 43 years old, for COVID-19 immunisation. The following information was reported: FEELING COLD (non-serious) with onset 18Mar2021 20:00, outcome "unknown", described as "Intense freezing feeling in the lower half of my body up into my lower back / felt more like an internal coldness". Therapeutic measures were not taken as a result of feeling cold.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 08:00 PM, the patient experienced an intense freezing feeling in the lower half of her body up into her lower back. The patient reported that this had not felt like chills when one gets sick. This felt more like an internal coldness and not like the pins and needles feeling associated with topiramate (TOPAMAX). The patient reported that she had not felt this until after she received the second dose of the vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Constant clearing of throat and continuous coughing; at 8:30 pm used rescue inhaler, didn't help, breathing and coughing became much worse, increase in blood pressure, went to Hospital, Emergency Room.
Red, swollen, hot area at elbow and slightly above. Pt advised to use ice, ibuprofen and seek medical attention if not improved. Pt. saw MD next day (9/6/15).
Covid vaccine monitoring documentation.  PT admitted 12/1/21.  POC SARS COV2 ANTIGEN POS 12/5/21. Moderna dose 1 2/3/21 Lot 031L20A, Moderna dose 2 3/3/21 Lot 031M20A.
The pt received PNEUMOVAX on 10/28/11 at at 1100 in her right arm (pt is right hand dominate). The pt felt fine at the time of the vaccination and immediately after. Around 1300 the pt noted that she was nauseated. At 1500 the pt ate hamburger helper which she prepared fresh (no milk products used). Soon after eating the pt experienced increased nausea and she vomited undigested food X 3. The pt denied fever, diarrhea or abdominal pain. Around 2300 that night the pt noted a dry, hacky, unproductive cough which was worse with lying down (the pt denied a flair of the GERD, asthma or seasonal allergies). On 10/29/11 the pt experienced mild nausea which did not interfere with daily activity or eating. The pt did note that her cough was worse (more frequent). On 10/30/11 at 2130 after the pt showered she noted 6-8 quarter-sized red, raised, non-pruritic lesions on her right upper arm. The pt denied previous similar rash; no new medications, clothes, detergents, foods, hygiene products. No recent outdoor activities or travel. These lesions were flat when the pt woke on 10/31/11. The pt was seen by her primary care provider on 10/31/11 and was told that her lungs "were clear" and that she should return to immunizations regarding the skin lesions. The pt was seen on 10/31/11. The pt was concerned about the rash on her right upper arm and if it was caused by her recent vaccination. On PE the pt's lungs were CTA, no adventitious sounds were present, no cough noted. Approximately six 2cm oval, pale red, flat macules were noted on the pt's right upper arm. As the rash was improving and was not causing any discomfort for the pt, treatment was not initiated. The rash had resolved when the pt was seen on follow-up on 11/3/11.
incredible headaches the entire day; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (incredible headaches the entire day) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HEADACHE (incredible headaches the entire day). The patient was treated with PARACETAMOL (TYLENOL) on 17-Feb-2021 for Headache, at a dose of 1 dosage form. At the time of the report, HEADACHE (incredible headaches the entire day) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
This case was reported by a consumer and described the occurrence of rash in a 32 year old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) and later her spouse was vaccinated with influenza virus vaccine for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medical conditions included drug allergy to gentamician. In November 2006, the subject received unspecified dose of Fluarux (unknown) and experienced rash and itching. Treated with Benadryl. events resolved within two weeks. On 09, December 2006 the subject's husband received unspecified dose of Influenza virus vaccine (manufacturer unknown). The reporter stated that the following day she had intercourse with her husband and she began to experience rash and itching on her back. legs and chest like she did following her vaccination with Fluarix. The reporter stated that she believed "that she may have had a reaction from her husband's bodily fluids which may have carried gentaician into her system form the flu vaccine. She received treatment with diphenhydramine hydrochloride (Benadryl). At the time of reporting the outcome of the events were unresolved. she considered that the events jeopardized/required intervention.
12 hours after administration, woken up from sleep by tingling, throbbing in lower legs. Described as a nerve and muscle ache/throb, or "growing pains"/RLS symptoms. Put on compression socks which helped, but still too uncomfortable to sleep. Was able to sleep after taking ibuprofen 800mg and drinking water. 6 hours after the ibuprofen was administered, pain returned in lower legs as well as neck/ears  with body temperature swings (cold, teeth chattering to sweating uncontrollably in a few minutes). After 1 hour of trying to sleep but failing, put compression socks back on. Temperature rose to 100-100.2 F, chills causing whole body to shake under multiple blankets. Tingling/muscle pains extremely uncomfortable and unable to rest, took another ibuprofen 800mg and water and was able to sleep. Tingling and muscle pains have continued as soon as ibuprofen wears off and come back more intense each time, most notably in the lower legs and near ears/neck and elbow of arm administered in (similar to "tennis elbow," assumed to be provoked by inflammation, happened with first dose).
Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were provided. No temperature excursion were reported. No adverse event reported. Date place in refrigerator was 03 Nov 2021. No treatment information were given.
On 3/1/2006 patient reports having "seizures" (fixed stares, tremors and "foaming at the mouth").  Pt. reports symptoms began 1/27/06 with symptoms occuring again on the following dates: 1/28/06, 1/29/2006, 2/22/2006, 2/24/2006 and 2/27/2006.  Pt. seen by a neurologist, on 2/28/2006 for the seizure activity.  Pt. has a follow-up appointment on 3/6/2006.
PATIENT STATES THAT 2 DAYS LATER SHE BROKE OUT IN HIVES ON HER NECK, BREAST, AND CHEST. ALSO STATES HAD A SORE(FEVER BLISTER) ON HER LIP. CALLED PHARMACY 7/5/18 TO LET US KNOW AND THAT HER MD ADVISED HER TO NOT REPEAT SECOND DOSE.
The patient was present at the school base center for his 11-year-old well exam.  MCV4 and TDaP given. Patient did not feel well. Positioned patient supine with HOB slightly elevated and legs up. Patient able to respond verbally. Patient feeling well and states normal within few minutes. Able to drink water and snack. Patient and mother reviewed risks and occurrence. Consented to continue vaccines. Positioned in supine, HOB up, talking throughout vaccines, HPV and Flu given. Felt tired. Legs up again. Symptoms resolved after few minutes. Maintained position HOB slightly elevated and supine for 15 minutes. No orthostatic hypotension with BP checks positionally. Pulse and pulse ox remained stable.
PNEUMOVAX given too high on left arm per visual inspection of site next day. Patient reports severe pain, tingling and swelling of arm during the evening after receiving immunization. Reports not being able to move arm at all on 2/8 after immunization. Swelling had subsided by when patient was seen by me on 2/9.  He reported that he could move lower arm, but could not lift upper arm still. I referred him to his regular physician as soon as he can be seen.
hospitalization for SOB, weakness and non-productive cough.  Chest X-ray:  normal
This spontaneous report was received from the patient's mother concerning a 12 month old female patient. The patient's historical conditions, concurrent conditions, concomitant therapies and historical drugs were not reported. With an allergy to egg products. On 21-SEP-2018, the patient was vaccinated with M-M-R II (laterality, strength, dose, route, frequency, lot number and expiration date were not reported) for vaccination against measles, mumps, and rubella. On the same date, the patient's mother reported that the patient had a "reaction" (unspecified) to M-M-R II. Also that she was on the way to get her daughter to a doctor or a hospital (unspecified). The outcome of adverse reaction was reported as not recovered. The causality assessment between M-M-R II and the aforementioned event was not provided.
Mom phoned day after immunizations reporting patient woke up with pain, swelling, heat, and redness at injection sites.  He was brought to the office that day.  He had no fever.  Left deltoid area had redness measuring 7.5 by 6cm, warm and tender.  He was dx with vaccine reaction/cellulitis and placed on cephalexin for 10 days.  Reaction completely resolved 11/2/19, 2 days later.
ARM PAIN, NUMBNESS, SWELLING , SORENESS TWO WEEKS AFTER SHOT
A report has been received from a Health Professional concerning a patient, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that the nurse didn't remove the clip so only half dose was administered. The outcome of the event of 1/2 dose FLUMIST administered for dose is unknown. The report was considered to be non-serious.
Patient woke up with 101 degree fever and severe headache, did not take anything for it  and at the office visit at 11 am, temp was 98.6 but still had the headache.
over 42 days, 1st dose 04/27/21, 2nd dose 08/5/21
Pt describes having flu, aches (about 3 days), fever of 101.0 ( about 4 days) and sore throat continuing starting on 10/22 - patient is still feeling lethargic.
1st dose of Shingrix on March 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The registered pharmacist reported that, till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter also reported that this patient was vaccinated at another pharmacy so she did not have any demographic details from patient neither details from 1st dose. The reporter did not consent to follow up.