chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling and nodule at the injection site; her chest wall muscle was swollen on the left side; pain (7 out of 10) in her left deltoid that radiates down left arm, which was the injection arm; swelling and nodule at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE NODULE (swelling and nodule at the injection site), CHEST DISCOMFORT (her chest wall muscle was swollen on the left side), VACCINATION SITE PAIN (pain (7 out of 10) in her left deltoid that radiates down left arm, which was the injection arm) and VACCINATION SITE SWELLING (swelling and nodule at the injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 NODULE (swelling and nodule at the injection site), CHEST DISCOMFORT (her chest wall muscle was swollen on the left side), VACCINATION SITE PAIN (pain (7 out of 10) in her left deltoid that radiates down left arm, which was the injection arm) and VACCINATION SITE SWELLING (swelling and nodule at the injection site). At the time of the report, VACCINATION SITE NODULE (swelling and nodule at the injection site), CHEST DISCOMFORT (her chest wall muscle was swollen on the left side), VACCINATION SITE PAIN (pain (7 out of 10) in her left deltoid that radiates down left arm, which was the injection arm) and VACCINATION SITE SWELLING (swelling and nodule at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient was visited emergency room.  No treatment medications were reported.
Dehydration; extremely dizzy; felt violently nauseous; threw up profusely for hours; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION, DIZZINESS, FATIGUE, NAUSEA, and VOMITING in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 029L20A) for an unknown indication.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced FATIGUE. On 07-Feb-2021, the patient experienced DEHYDRATION, DIZZINESS, NAUSEA, and VOMITING. On 08-Feb-2021, DEHYDRATION, DIZZINESS, NAUSEA, and VOMITING had resolved. At the time of the report, FATIGUE had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not provided. At the ER he received treatment for vomiting and dehydration, they put him on a drip and gave him meds for nausea and dizziness
After booster dose pt had trouble breathing, large red area at injection site, body aches, facial flushing- had to take benadryl
Day one there was a metallic taste in my mouth by day 3 after the vaccine it turned to a rotten taste.  I still have the rotten taste at the back side of my tongue( this is where the metallic taste was as well).  It has been 5 days since my vaccination.
Vomiting x1; urticaria all over body; eye edema; positive large wheal eruptions abs, feet, arms, hand; joint pain.
On 2/6/2022, I woke up with body aches, chills, headache, stuffy nose, and sore throat. I immediately knew I had COVID-19, because I had had it previously. Later that same day, I went to an urgent care clinic drive-thru and underwent a PCR test. I got a positive result for the PCR test on the evening of 2/7/2022. Earlier in the day on 2/7/2022, I had also taken a home test, which also yielded a positive result. I had a breakthrough case.
Pt developed edema post vaccine, pt was hypertensive and had proteinuria. DX nephrotic syndrome.
Chest pain, sharp continuous: Lasted from post dose hour 12 to post dose hour 36. No shortness of breath.  Chills: Lasted from post dose hour 12 to post dose hour 24
arm became swollen down to the elbow; induration; erythema; pain down to the side; arm pruritus; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (arm became swollen down to the elbow), INDURATION (induration), ERYTHEMA (erythema), PAIN (pain down to the side) and PRURITUS (arm pruritus) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm became swollen down to the elbow), INDURATION (induration), ERYTHEMA (erythema), PAIN (pain down to the side) and PRURITUS (arm pruritus). At the time of the report, PERIPHERAL SWELLING (arm became swollen down to the elbow), INDURATION (induration), ERYTHEMA (erythema), PAIN (pain down to the side) and PRURITUS (arm pruritus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included None.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Broke out in rash on body, callous like scars on palm of hand and bottom of the feet.
After receiving the vaccine, suddenly, patient became lightheaded. Was sent to ER. 12/30-discharged. 1/3-pt did not feel well had left visual field difficulties that started the night of 12/30, was sent to different ER. CT of the head showed right occipital lobe stroke and stenosis of right vertebral artery.
covid tested post vaccination, tested positive in PCR test, 7 days after receiving second dose; covid tested post vaccination, tested positive in PCR test, 7 days after receiving second dose; This is a spontaneous report from a non-contactable consumer.  A 31-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose, second dose via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient didn't get covid prior vaccination. Covid was tested post vaccination and tested positive in PCR test in Jan2021, 7 days after receiving second dose. There was no treatment received. The patient underwent lab tests and procedures which included PCR test: positive in Jan2021.  The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After 48 hrs after vaccination, pt developed redness and a "knot" at the injection site. A brownish color developed between 48 and 72 hours after injection, similar to bruised appearance. Advised BENADRYL and TYLENOL/ADVIL for possible allergic reaction/inflammation.
Father called us at 11:00 AM on 12/29/10 to notify us that patient has swelling, redness, and warmer skin at injection site. We had pt come into office for evaluation. Dr. recommended Benadryl and use of a cold compress to be placed on injection site to reduce swelling.
status epilepticus requiring parenteral diazepam & phenobarbital; endotracheal intubation;
pt recvd vax & the day p/2nd dose exp flu-like sx which subsided; 8 days later exp rash which was like prickly heat;
Received an expired third dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired third dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 031A21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired third dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The patient was given the Moderna COVID19 vaccine dose past the 30 days in the refrigerator.   This case was linked to US-MODERNATX, INC.-MOD-2021-362998 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-362998:MOD21-156364(crosslink) (Master Case)
Started with joint pain, achy, fever. Right arm red from injection site to elbow. Warm to touch. Seen by dr on 11/29/19 diagnosed with cellulitis. Started on Bactria DS twice a day for 10 days.
This is a spontaneous report from a contactable pharmacist and physician via a Pfizer sales representative. A female patient (66; Unit: Unknown) of unspecified ethnicity received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) via unspecified route of administration on unspecified date at single dose for immunization. Patient medical history and concomitant medications were not reported. Pharmacist stated that the patient experienced extreme redness and discoloration at the injection site in the days after her injections. She said there was bruising and blue/red/yellow coloration on her skin. The events took place on 11Oct2017, and were confirmed to experience after the vaccination. Outcome of the events was unknown. The information about batch/lot number has been requested through follow-up activities.
everything started back up again with my hip pain and I had, it hurts me to like sit down/ Joint pain/ they got worse again; It hurts me to like sit down; It hurts me to sit or lay down like, it depends on the height of the seat. Like when I get up it''s really painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received BNT162b2 (BNT162B2), administered in arm, administration date 16Aug2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "I did have covid previously like last March", start date: Mar2021 (unspecified if ongoing); "hip pain and joint pain" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), administration date: Aug2021, when the patient was 43 years,  for COVID-19 immunization, reaction(s): "I had bunch of hip pain from that and joint pain". The following information was reported: ARTHRALGIA (non-serious) with onset 23Aug2021, outcome "unknown", described as "everything started back up again with my hip pain and I had, it hurts me to like sit down/ Joint pain/ they got worse again"; PAIN (non-serious) with onset 23Aug2021, outcome "not recovered", described as "It hurts me to like sit down; It hurts me to sit or lay down like, it depends on the height of the seat. Like when I get up it''s really painful". Therapeutic measures were not taken as a result of arthralgia, pain.  Additional Information: The patient did not have prior vaccinations within 4 weeks.  The patient stated that she didn't have the events before she had covid and then the events got better and then she got the vaccine and then the event got worse again. The first dose was two weeks before second dose. The side effects started right after a week the patient got the vaccine. The outcome for "hip pain" and "It hurts me to like sit down; It hurts me to sit or lay down like, it depends on the height of the seat. Like when I get up it's really painful" was not recovered and the outcome for "joint pain" was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
her immune system is jeopardized; When she has a cough she doesn't breathe right; When she has a cough she doesn't breathe right; as she was having a cold.; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored program. A female patient of an unspecified age received of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. Patient medical history and concomitant medication were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: was not provided), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunisation. It was stated that she always gets the same cold around Christmas and in summer on an unknown date. She has this now and hasn't had it in a few years. stated it could be good for her immune system. States it was not any different than it always was. States it's no better or no worse; it was the same garbage. States it goes away when she takes Zithromycin, states she needs 500mg not the 250mg because the 250mg did not help. On an unknown date, the patient stated it was the same cough, something that she gets. Said of course when she has a cough she doesn't breathe right. The patient said she cannot take generic because that was not good. The patient wants to know how she can get the 3rd dose of covid-19 vaccine. She had both doses before. She said her immune system was jeopardized as she was having a cold on an unknown date. She took a cough medicine Zithromycin. Therapeutic measures were taken as a result of all events and treatment included Zithromycin. The outcome of the event was unknown.   The follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
I had finished the my 2nd Pfizer shot in March  and I got Covid this week; I had finished the my 2nd Pfizer shot in March  and I got Covid this week; This is a spontaneous report from a contactable consumer (patient). A 74-year-old patient of unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EP7584, expiry date: Jul2021), via an unspecified route of administration in Arm Left on 25Mar2021 (patient was 73-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. Medical history included heart disease, osteoporosis; both was diagnosed probably 2 years ago. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6205, expiry date: Jun2021), on 04Mar2021 as dose 1, single for covid-19 immunisation. The concomitants medication included Vitamins and also something for Osteoporosis. On 03May2021 patient had Covid-19. Reported that patient did not know if anyone ever find out that I had finished my 2nd Pfizer shot in March and I got Covid this week and I have been really careful but I, I guess that was not very common. The patient underwent lab tests and procedures which included echocardiogram unknown results on 04May2021, COVID test unknown results on 03May2021. Reported that patient had an Echo cardiogram but that was not a (incomplete sentence), tested on Monday 03May2021, Tuesday 04May2021, results were back in night. Patient received treatment for events with Tylenol. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.  Follow-up attempts are completed. No further information is expected.
The following day I experienced a headache and soreness in the arm/shoulder. I couldn?t sleep on that side for the next 2 nights due to extreme tenderness. I do have some concerns that the shot was given too high on my arm.  Fast forward 11/12/2021, I now have muscle and joint paint but more painful in area of  L shoulder, neck and clavicle. Small movable lump on left clavicle.
Initial report received from a patient's parent on 08 October 2007. An 7-year-old male with history of Pervasive Development Disorder and unspecified environmental allergies received a left deltoid intramuscular injection of Daptacel (Lot number C2657AA) on 07 August 2007. By that evening, the patient began showing signs of eye blinking, facial tics and uncontrolled movement which was more pronounced by the next day. The parent reported that the patient was suffering from possible tardive dyskinesia. The patient was seen by a physician and was referred to a neurologist whom he has seen three to four times. The patient was treated with Cogentin. Outcome was reported as 'not recovered'. No additional information had been provided at the time of this report.
Patient felt like throat was closing. No stridor or increase work of breathing.  Given 50 mg Benadryl with good response and improvement of symptoms.  911 called and EMS arrived and as patient was back to normal and did not want to go to ER the patient was discharged home. 99% O2 BP 102/59 HR 96
5/7 shots=2:30 (Taking Ibuprofen/rest), 5/8 3:00=Headache, under arm pit pain and across back of shoulder pain, 5/9 muscle pain upper arms and lower leg muscles, 5/10-To prevent=aching muscles-move around during day.
This case was reported by a healthcare professional and described the occurrence of facial rash in a 22 month old male subject who was vaccinated with Havrix, for prophylaxis. On an unspecified date before 07 September 2006, the subject received Havrix at 0.5 ml, intramuscularly in the right thigh. "A couple of hours later," following vaccination with Havrix, the subject experienced facial rash and arm swollen. The subject developed hives. At the time of initial reporting, 07 September 2006, the outcome of the events was not reported. Report received. Follow-up information received on 22 September 2006 indicated that the onset of the earliest sign or symptom was 04 August 2006. The events completely resolved (date not provided). In the reporter's opinion, the events were related to treatment with Havrix.
two-doses of Fluzone High-Dose 10-days apart; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 78 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and reported that two-doses of Fluzone High-Dose 10-days apart (extra dose administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for Immunisation.  On 28-Oct-2019, the patient received a dose of suspect 0.5 ml INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ287AA and expiry date: 28-May-2020 via intramuscular route in unknown administration site.  It was a case of actual medication error due to extra dose administered.  It was unknown if the patient had any adverse event.  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.
Noticed a mild headache and fatigue before going to bed for the night, about 8 pm on 1/4/21.  My jaw on the left felt sore. I took 2 Aleve.   Upon waking the next day(1/5/21) , I felt like I had a migraine on the left side of my face.  Head, ear, and jaw on the left side was painful.  Used  Aleve . The pain was still present, although a little less intense the following day (1/6/21). Arm is also sore but much more manageable than the head pain.
Info has been received from a physician concerning a 5 year old male with attention deficit/hyperactivity disorder and mild asthma who on 9/5/03 was vaccinated, SC in the left arm with a 1st dose of varicella virus vaccine live (lot 644558/1156M). Concomitant therapy included a 2nd dose in the left arm of MMRII (lot 644577/1037M), a 5th dose in the right arm of Tripedia (lot C1387AA) and a 4th dose in the right arm of IPOL (lot W0750). On 6/6/05, the pt experienced an erythematous vesicular rash that was itchy. It was noted that it was in clusters. Subsequently, the pt recovered with supportive care. There were no labs done. The pt's sister had a similar reaction after vaccination with varicella virus vaccine live. Additional info is not expected.
Patient unclear if this is related to vaccine.  A few weeks following vaccine she began to get left abdominal wall/skin sensitivity and pain.  No rash.  Did not report until 7/20/2010 so unfortunately could not treat until then.  Treated with acyclovir 800 one tablet 5 times a day.
Patient's arm swelled the morning following immunization.  She visited her PCP who told her the injection was given "too fast" and ended up in the "fat".
Pt c/o only a "slightly sore" arm for 1-2 days after receiving vaccine. however, he c/o being " very tired and blisters" and having "no energy" since receiving the vaccine. Pt was advised to consult his MD for advise. Pt states he is due for lab work and a check up.
A report was received from a health professional on 11/18/02, concerning an 81 year old female who experienced a rash under both breast after receiving Fluvirin on 11/15/02. The event occurred on 11/16/02 or 11/17/02. At the time of reporting the vaccinee had not yet recovered. There was insufficient information to determine the reporter's causality assesement.
fever 100.6F, nasal congestion, headache starting 11/20/21
Extreme nausea to the point of not being able to eat or drink much without getting super nauseous. When upright and walking, experienced periods of lightheadedness and dizziness. First day temp 99 treated and gone with advil.
patient stated that they have previously fainted at their md office in the past but that he did not on the first two doses of Moderna. I administered vaccine and he went to sit on bench with his wife. I had technician watch him while I went to fridge to grab a water for a him just in case. It had only been a few minutes and my technician said he was going down. She went out, I grabbed the cold paks followed. He was extremely hot and pale. It was about 40 minutes before he was comfortable enough to sit up. He stated he didn't want emergency vehicle. He stayed for another 15 minutes and felt comfortable enough to leave.