chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per, MD note: "Overnight, she developed a high fever (103.2F with temporal scanner), treated with Ibuprofen, but mom is mostly concerned with additional muscle fasciculations of the arms and legs (without voluntary limb movement/contraction). Patient last had this kind of visible fasciculation prior to her dorsal rhizotomy surgery in young childhood.    No additional concerns for seizure or AMS; Patient was alert and her normal self mentally throughout the night and this AM, but was uncomfortable in her muscles and from the fever.    Treatment with Ibuprofen has helped some, but mom needs guidance on whether it is okay to use her PRN muscle relaxers as well. "
Light rash occurred on 07-09-04 progressed to a more generalized rash on 7-12-04 on 7-13-04 she presented with fever of 101.5 papular rash all over her body and scalp.
pt recvd vax on 14AUG92; On 21AUG seen in office w/dx of cellulitis;
vaccine was placed in fridge on 8/19, and therefore expired 9/18. date was not marked appropriately on the box, and was administered to the patient past it's beyond use date. contacted pt, stated she experienced a sore arm. explained what happened and that cdc recommends repeating her dose. pt returned on 10/1 and received replacement dose.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 53-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 20-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Patient administered Pfizer vaccine after receiving the J&J vaccine on 4/11/2021. This incident was first identified when the Pfizer vaccine dose was entered in system. Patient did not inform pharmacy of any adverse events.
Pt was vaccinated for Influenza on 10/31/2022 and presented ill with Influenza A to the office on 12/06/2022
Patient had this vaccine administered on 1/10/22 after its "use-by date" of 1/1/22. 1/1/22 is the 31 days of refrigeration. Expiration date is February 2022. No adverse reactions reported. Per manufacturer, administration not recommended past 31 days + an additional 14 days of temperature excursion. Per manufacturer, patient will not need re-vaccination.
Red itchy rash on abdomen, chest, neck and arms appeared 3 days after shot.  Took 25 mg Diphenhydramine hydrochlo capsule.
He is having uncontrollable shaking of hands and legs, fatigue, body aches, chills. He got his immunization on 09/13/2021 around 1615 and his symptoms started on 09/14/2021 around 0700
The day after vaccine - Fever, body ache, headache  Second and third day after vaccine - throbbing headache only on left side of my head, swollen lymph node, sore throat.  Headache is not going away.
The next morning, I awoke with severe flu-like symptoms which lasted ~24 hours.  Terrible body aches.  Swollen lymph nodes.  Severe headache.  Severe pain in vaccination arm.
Arm swelled up, turned red, patient was itchy all over with nausea and headache
Patient developed a few hives on face and torso. These probable hives resolved with BENADRYL being given.
When I received my booster of the J&J on 10/25 the pharmacist unintentionally gave me 1/2 the required dose in my left arm, then when it was realized it was the wrong dose she gave me the other 1/2 in my right arm. My right arm is covered in tattoos (over 10 years old) and the injection was into a tattoo. My right arm with the tattoo is still sore at the injection site and the ink periodically raises like welts only here there is the ink and not bare skin.
This spontaneous report was received from a registered nurse referring to an unspecified numbers of patients of unknown age and gender. Nurse stated clients may have been vaccinated with improperly stored GARDASIL, (lot number not reported). No adverse effects reported. This is one of two reports from the same reporter source. Additional information is not expected.
Mother called me on 9-17-10 afternoon that her son is sick and feeling very weak. I recommended the mother to take him to nearest ER as the patient was about 50 miles away and mother took him to ER where he was transferred to another hospital.
Pt recvd vax & devel 40 x 52 mm area of erythema & tenderness by 12MAY92; poss hypersensitivity reaction & poss cellulitis;
Not gotten my period for 65 days; Estrogen levels are exceedingly high; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received unknown dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient not gotten period for 65 days and estrogen levels are exceedingly high at 666 on an unspecified date. The patient underwent lab tests and procedures which included blood oestrogen which was exceedingly high at 666. The outcome of events was unknown.  Lo/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Hematoma on tip of tongue; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the right arm on 23Mar2021 at 10:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included mastectomy in 2016, ductal carcinoma in situ (DCIS) on left breast. Concomitant medications included calcium 1000mg (MANUFACTURER UNKNOWN), vit D 2000IU (MANUFACTURER UNKNOWN) and ascorbic acid (vit C) 1000mg (MANUFACTURER UNKNOWN). The patient previously received penicillin (PCN) and erythromycin and experienced an allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021 at 17:00, the patient experienced a hematoma on the tip of the tongue which was 10-12mm in size. The hematoma was still present on 25Mar2021. The patient did not receive any treatment for the event. The event did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event tongue hematoma was not resolved.   No follow-up attempts possible. No further information expected.
Information was received from a lawyer 08-AUG-2017 regarding a case in litigation concerning a female plaintiff of unspecified age. It was claimed the plaintiff was inoculated with ZOSTAVAX in 2013 at the office of a physician, as recommended for routine adult health maintenance and for the prevention of shingles. It was claimed the vaccine did not prevent shingles as intended, but rather caused her to contract a persistent strain of herpes zoster. On or about 24-FEB-2015, the plaintiff was treated by a Nurse Practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. She had been prescribed mupirocin topical ointment and valacyclovir (VALTREX) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
On March 27th, I started having chest pain and an elevated HR and Pulse that sent me to the hospital because I thought I was having a heart attack. Difficulty swallowing, severe left shoulder blade pain
Had mild swelling and pain in deltoid muscle. No evidence of color or ecchymosis.
She felt some swelling and tenderness on the side of her neck to the side of the shoulder; She felt some swelling and tenderness on the side of her neck to the side of the shoulder; This is a spontaneous report from a contactable consumer (patient) via information team. A 56-year-old female patient received BNT162b2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 (Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that when she woke up, she felt some swelling and tenderness on the side of her neck to the side of the shoulder. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Delayed hypersensitivity Rxn with large erythematous, well demarcated patch 12x6cm very tender, plus fever.
2 hours after shot site swollen large grapfruit size, redness swelling went to side of left neck by ear. Tongue fuzzy swollen edema went to elbow left arm and forearm.  911 to ER.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 23-NOV-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot #L043702 with expiration date 03-NOV-2017, status albumin: RHA) . Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
Positive event. 1st injection initiated same headache as the one associated with the Bells Palsey headaches.  A frequent symptom when palsey virus is escalating. Intensity requires me to sleep with ice packs on head. After first covid shot and palsey headache, I have been completly palsey headache free. My body feels as if that palsey virus is gone.
violently sick; Initial information received on 01-Feb-2021 regarding an unsolicited valid non-serious social media case received from a consumer via campaign.    This case involves a patient of an unknown age and gender who experienced violently sick (illness), while he/she received INFLUENZA VACCINE.  The patient's medical treatments, vaccinations, concomitant medications and family history were not provided.  The patient had no medical history, concomitant disease or risk factor.   On an unknown date about 20 years ago, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious violently sick for a week (illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  The patient reported he/she won't take the vaccine again.  It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Not Provided.   There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  The patient was recovered from the reported event.  There will be no information on the batch number for this case.
didn't receive the second dose in the appropriate timeframe; if they did receive an additional dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (didn't receive the second dose in the appropriate timeframe) and EXTRA DOSE ADMINISTERED (if they did receive an additional dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (didn't receive the second dose in the appropriate timeframe) and EXTRA DOSE ADMINISTERED (if they did receive an additional dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (didn't receive the second dose in the appropriate timeframe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 02mar2021, post vaccination, the patient reported that she didn't receive her second dosage of the vaccine in the proper timeframe. No other reactions reported. Patient declined to provide any other information   No treatment information was provided No concomitant information was provided
Swelling and hard knot @ injection site. Lasted about 7 days. This was an injection for
21OCT pt stated noc of inj felt so bad had to go to bed;pt feb;next AM felt fine;17-21OCt devel rash w/vesicle around site;pt itchy, painful had some drug;area around site remained warm & hard;seen by MD 21OCT;
became very sick; Initial information was received on 12-Jul-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 70 years old female patient who experienced became very sick after being vaccinated influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (dose, strength, formulation, lot number, route, administration site, expiration date: Unknown) for prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date the patient developed with became very sick (illness) (unknown latency) following the administration of influenza vaccine.  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (became very sick).  At time of reporting, the outcome was Unknown for the event became very sick.
she has covid-19; she has covid-19; Pt reports having shingles; This is a spontaneous report received from contactable reporter (Other HCP and Consumer).  A 52 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19, outcome not recovered ; HERPES ZOSTER (non-serious) with onset 2021, outcome unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, lack of efficacy  of the suspected vaccine BNT162B2 cannot be completely excluded. Similarly the reported event of HERPES ZOSTER cannot be excluded, very limited information is provided for proper medical review, Case will be reassessed should the additional information be available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Evening of vaccination had fever 101.7 for 24 hrs. Painful at injection site, reddened, swelling.
Hot to touch at injection site; Swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch at injection site) and VACCINATION SITE SWELLING (Swollen injection site) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot to touch at injection site) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, VACCINATION SITE WARMTH (Hot to touch at injection site) and VACCINATION SITE SWELLING (Swollen injection site) outcome was unknown.            No concomitant product use was provided by the reporter.  No treatment medication was provided.
C/O swelling - redness after injection. Increased BP. Pain (L) deltoid. Went to ER - dx with BENADRYL 11/19/15. 11/20 - more inflammation to site - very hot to touch 4.5 x 4.5. T = 99.8. Seen in ER - ? cellulitis Sent home.
Shortly after administration I started to lose ability to move my arm. When moving arm in certain directions, I get shooting excruciating nerve pain through the entirety of my arm. The pain is so sporadic it will randomly wake me up in the middle of the night. I cannot put any amount of weight on my shoulder. I cannot lift my arm past a 45 degree angle.  I am a registered dental assistant and it effects my ability to perform my duties on a daily bases. I have had to miss work and have not been preforming to my utmost capability, thereby negatively influencing  my work place. The pain is progressing and only getting worse as time goes on.
Pt immediately (1-4 min) developed hives, followed by abdominal cramps, nausea and vomit and diarrhea. She was agitated but had no terpuatory compromise. She received Epipen Jr and symptoms resolved. Rescue came and cleared her.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/02/21 , Moderna,Lot#039K20-2A 2nd dose: 01/30/21 Moderna Lot# : 013L20A Diagnosed covid positive:08/10/21 Symptom onset:08/09/21 Exposure:Travel Symptoms:Fever, cough,fatigue,muscle ache,runny nose, headache, chills, sore throat
pt inadvertently recv tetramune;the next day devel extreme soreness @ the inj site which resolved p/6 days;
Had a mild allergic reaction: itching throat and mouth, hot mouth, frontal headache, and almost immediate itching at injection site (I did not mention this to the healthcare professional, as I did not want to scare or alarm those waiting to get their vaccination). Took two Benadryl, and the symptoms subsided within thirty minutes. The itching throat and mouth, frontal headache, and hot mouth reaction happened within 20-30 minutes of receiving the shot. Told a pharmacy technician/pharmacist at the counter about the incident.
?Pfizer-BioNTech COVID-19 Vaccine    My upper lip began to swell  about 5 hours after the injection and after a while turned into a terrible cold sore. I haven't had a cold sore in many, many years and have only gotten one if I have been in the sun too long or have a high fever.  I called the doctor on call the following morning  and asked for a prescription of acyclovir. Starting it that late resulted in not stopping the progression of the cold sore. Also had runny nose (haven't had a cold since masking started last year), and a red swollen arm..still red and swollen two days later and a terrible headache (started the day after injection and still bad today which is two days after).
Tmj; the area on his chin was still bruised up; there was an area on the chin that was hard and scabby; there was an area on the chin that was hard and scabby; This is a spontaneous report from a contactable other HCP (Nurse). A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient injected with 1cc of Restylane Lyft in the chin on 12Jun2021. Patient also received a neuromodulator, Jeuveau, into the jaw line to treat TMJ at the same visit. Patient called the healthcare professional on 14Jun2021 at 05:06pm and reported that the area on his chin was still bruised up and there was an area on the chin that was hard and scabby. Patient denied any pain, numbness or tinging. Patient denied any signs and symptoms of infection. HCP advised patient to call back if he had any worsening signs and symptoms and to see her in office on 15Jun2021. HCP saw the patient in office on 15Jun2021. The HCP believed that the bruising and hard scab may have been due to abrasive scrubbing with alcohol during the injection. At this time, HCP was advised to grab 3 vials of Hylenex and take the patient down the street to office, where she was more equipped to handle a possible vascular occlusion. HCP injected the patient with 2 vials of Hylenex (300 units) at 11:41 am. HCP massaged the area and there were no changes, there was still bruising and a small scab. Events are ongoing. Patient had NKDA and no medical history. It was unknown if patient had received fillers in the past. Patient received the COVID-19 vaccination a while ago (exact dates unknown) and the HCP believes it was Pfizer. Patient did not report any illness leading up to the injection and has had no dental work in the past 6-12 months. It was unknown if patient had any other vaccinations in the past 6-12 months. The clinical outcome of the events were unknown whereas bruising and small scab was not recovered. Follow-up activities closed: Batch/lot number not available for BNT162B2.
SHINGLES OUTBREAK 2-3 DAYS AFTER THE VACCINE HAD NUMBNESS ON MY CHEST AND ON DAY 5-6 OF THE VACCINE DEVELOPED PAPULAR RASH WHICH AHS TURNED INTO VESICLES. TINGLING AND ITCHINESS ALONG THE LINE OF T5 DERMATOME.
I started with a high fever of 104.0 and I went to the emergency room. I was shaking by this time.  was admitted with a fever of 103.8. I was giving Remdesivir drip as well as IV antibiotics. I was released from the hospital on the 5th. The antibiotics worked and the doctor released me advising me that my immune system was pretty low and to remain isolated for 10 days.  I'm still tired, my brain is scrambled and I am still coughing. I was also diagnosed with pneumonia after having a chest x-ray completed.