chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left side of her neck above the clavicle is sore; Left side of her neck above the clavicle is swollen; It's like a marble sized lump; Left arm was swollen at injection site; Left arm was sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Left side of her neck above the clavicle is sore), SWELLING (Left side of her neck above the clavicle is swollen), NECK MASS (It's like a marble sized lump), VACCINATION SITE SWELLING (Left arm was swollen at injection site) and VACCINATION SITE PAIN (Left arm was sore at injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0291121B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Dec-2021, the patient experienced NECK PAIN (Left side of her neck above the clavicle is sore), SWELLING (Left side of her neck above the clavicle is swollen), NECK MASS (It's like a marble sized lump), VACCINATION SITE SWELLING (Left arm was swollen at injection site) and VACCINATION SITE PAIN (Left arm was sore at injection site). At the time of the report, NECK PAIN (Left side of her neck above the clavicle is sore), SWELLING (Left side of her neck above the clavicle is swollen), NECK MASS (It's like a marble sized lump), VACCINATION SITE SWELLING (Left arm was swollen at injection site) and VACCINATION SITE PAIN (Left arm was sore at injection site) outcome was unknown.            Patient also reported that the left side of her neck above the clavicle is sore and swollen like a marble sized lump. No concomitant medications were mentioned. No treatment details were reported.
Persistent (L) arm pain s/p vaccine, full ROM, no swelling or bruising. Plan: Ibuprofen BID x 3 days, gentle ROM as tolerated. Will obtain labs if zero better after 72 hours.
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Additional Details: Patient reported her arm was still somewhat swollen and warm to touch at injection site.  She still had mobility of the arm and wasn't restricted in movement.  She was more concerned about efficacy of the vaccine since she doesn't usually get those effects locally.
Patient had a acute occlusive DVT of the left femoral vein from the proximal thigh down to the proximal calf involving the femoral vein, popliteal vein, proximal tibial veins on his left lower extremity. He is now being treated with anticoagulant medication p.o. He is currently being evaluated for possible pulmonary embolism as well.
Headache, Myalgia, Arthralgia, flu like, chills, aches, headache, fatigue Narrative:
Severe hives which have been frequent (every day or two) since getting the Covid 19 vaccine. Also, significant joint pain (particularly of both hips and elbow joints). Multiple episodes of dizziness and vertigo to the point where I thought I was having a TIA or stroke.
Patient reported significant unilateral eye pain behind her left eye ~15 minutes following injection of second dose.  ~20 minutes after vaccine injection, patient developed some facial droop on her left side. Initial patient was given juice and was given  powder acetominophen by her mother.  After facial droop was noted, EMS was contacted for transport to local ED
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant medications was not provided. It was reported that on 30-DEC-2015, the patient was administered VARIVAX (Merck) (lot # K011082, expiration date: 08-AUG-2016, dose and route were not provided), that was improperly stored (temperature: 24.3 F, time frame: 57 hours; there was no previous temperature excursion). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient received the 2nd Moderna vaccine on 4/19/2021. On 4/20/21, patient had typical side effects such as fever, fatigue, headache, and arm soreness.  Patient took Tylenol to treat symptoms. On 4/21/21, patient said he started to develop swelling around base of neck on both sides and had difficulty breathing. He stated that he also had right arm numbness where the injection was given as well as blurry vision. According to patient, his blood pressure was 220/145 and his blood glucose was over 300. Patient went to primary care physician on 4/26/21 about his neck still being swollen after his vaccination. He said his physician gave him diphenhydramine and a steroid shot for the reaction. Patient came to the pharmacy to report his side effects on 4/26/2021.
Slight left arm soreness near injection site, aching in back, slight chills, but no fever, tiredness for 48 hours after injection. Pounding headache.
itchy; red; she experienced a delayed skin reaction; rash 8 days later; large red hives on back; she kind of felt fluy for 24 hours; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchy), ERYTHEMA (red), INFLUENZA LIKE ILLNESS (she kind of felt fluy for 24 hours), SKIN REACTION (she experienced a delayed skin reaction) and RASH (rash 8 days later) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder (when she was younger). Concomitant products included LISINOPRIL for an unknown indication.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2022, the patient experienced PRURITUS (itchy), ERYTHEMA (red), SKIN REACTION (she experienced a delayed skin reaction), RASH (rash 8 days later) and URTICARIA (large red hives on back). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (she kind of felt fluy for 24 hours). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy) had not resolved, ERYTHEMA (red), SKIN REACTION (she experienced a delayed skin reaction) and RASH (rash 8 days later) outcome was unknown, INFLUENZA LIKE ILLNESS (she kind of felt fluy for 24 hours) had resolved and URTICARIA (large red hives on back) was resolving.            On 02-Apr-2022, the patient received a second booster dose (Lot: 001M21A) of Moderna vaccine.  Reported that 8 days later she experienced a delayed skin reaction and got a rash 8 days later, and it started with large red hives on back, they were red and itchy. It was like that for 2 days. Then for 11 to 12 days they were beginning to get smaller and smaller, but it kept itching. She reports she had an autoimmune disease when she was younger, so she thought that is why she had the delayed skin reaction. She reports she was worried what booster dose to get in the Fall. Reported that no reaction to the other doses.  Treatment included cold wet wash cloth.
Patient reported skin red under semi-permeable dressing on 3/19. Patient attributed this to tape sensitivity. On 3/20 redness increased with streaking and induration. Sought medical attention on 3/20 at 7pm. Given oral dicloxicillin. Patient seen again 3/21: erythema and induration decreased.
PULMONARY EMBOLISM AFTER VACCINATION; This spontaneous report received from a pharmacist 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On evening 15-MAR-2021, the patient experienced pulmonary embolism after vaccination, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pulmonary embolism after vaccination was not reported. Vaccination anatomical approach site is unknown. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210331460-pulmonary embolism. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Patient received Covid 19 injection on 1/5/2021. On 1/6/2021 she had frequent urination, was diagnosed with UTI. Later at 6 - 7 pm she was having lighte headed, sweaty. Went to ER / diagnosed with New Onset Afib.
This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a adult female patient who received Shingrix for prophylaxis. Concomitant products included Influenza vaccine Quadrivalent unspecified season. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced feeling unwell, shivering and general body pain. On an unknown date, the outcome of the feeling unwell, shivering and general body pain were recovered/resolved. It was unknown if the reporter considered the feeling unwell, shivering and general body pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported, but it could be either 57 or 58 year old. This case has been linked with US2018102471, reported by the same reporter for 2nd dose.
vasovagal syncope the morning after Moderna  booster. Patient received J&J in April 2021 x 2 and contracted COVID from her children in May 2021.
Information was received from a pharmacist concerning a 60 year old female patient, who on 20-FEB-2017 received a dose of ZOSTAVAX 19400 PFU, lot # M037014, expiration date 22-NOV-2017, 0.65 ml, subcutaneously, which was reconstituted with sterile diluent lot #L008523, expiration date 26-NOV-2017. On 13-MAR-2017, the patient was given a prescription for prednisone. The pharmacist did not know the reason why the patient was given a prescription for prednisone. The pharmacist was not aware of the patient having an adverse reaction to ZOSTAVAX. The outcome of adverse event is unknown. No further details provided. Additional information has been requested.
Information has been received from a nurse concerning a 19 year old female with a "history of seizures when in pain" who on 21-NOV-2007 was vaccinated with a third dose of Gardasil (lot# 655154/1210U) 0.5 mL IM. Therapy with Gardasil started on an unspecified date "6 months ago'. There was no concomitant medication. On 21-NOV-2007 the patient experienced a seizure after receiving her third dose of Gardasil. Medical attention was sought. On an unspecified date a magnetic resonance imaging (MRI), computed axial tomography (CT SCAN) and an electroencephalography (EEG) was performed. The results were unknown. On an unspecified date the patient had recovered. The reporter felt seizure was considered to be immediately life-threatening, other medical event (OME) and disabling. Additional information has been requested.
Defective syringe.  Hub fell off during administration into left arm.  Partial amount administered.  Unable to determine how much was administered.  Per CDC guidelines 2nd full dose administered into the right arm.
This case was reported by a healthcare professional and described the occurrence of numbness in finger in a 42-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Relevant medical history, medical conditions and concurrent medications, if any, were unspecified. Subject's previous vaccinations went uncomplicated. On 4 June 2014 at 3:50 pm, the subject received 2nd dose of ENGERIX B (1 ml, unknown, left arm). On 4 June 2014 at 5:00 pm, 70 minutes after vaccination with ENGERIX B, the subject experienced numbness in her fingers, side of face, and tongue. At the time of reporting the events were improved.
Pfizer booster for the Covid vaccine; itchy bump appeared at the injection site; red spot appeared at the injection site.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (COMIRNATY), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, she had no reaction with the first 2 doses), for Covid-19 Immunization, reaction(s): "No reaction on previous exposure to vaccine"; Bnt162b2 (Second Dose, she had no reaction with the first 2 doses), for Covid-19 Immunization, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "Pfizer booster for the Covid vaccine"; VACCINATION SITE PRURITUS (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "itchy bump appeared at the injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset Nov2021, outcome "not recovered", described as "red spot appeared at the injection site."  Additional information: Per caller after receiving the Pfizer Covid 19 booster vaccine, she developed an itchy bump. The bump has now went away and she has a red spot that appeared. The bump and red spot appeared at the injection site. Caller asking if it is normal. If it would go away. Calling about the Pfizer booster for the Covid vaccine. She stated that she got the booster a couple weeks ago and she still had a red spot. Is that normal and will the red spot go away or will she be left with a spot there. She stated that she had no reaction with the first 2 doses, but after the booster she did a have little itchy bump, but the itchy bump had gone away and now she just had this red spot. She stated she only had a few minutes before she had to leave, and requests to be transferred to address her questions.   The lot number for bnt162b2 was not provided and will be requested during follow up.
ITP post MMR seen at ER for bruising x 2 days. Heavy duty bruises to lower extremities. Bruise over anterior lateral rib cage. Left forearm several, right forearm very small x 2.
This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a 20 month old female patient with allergy to ZITHROMAX and no pertinent medical history. On 20-JUN-2012 the patient was vaccinated subcutaneously with a 0.5 mL dose of VARIVAX (Merck) (lot # 671083/0826AA, exp. date: 02-JUN-2013). Concomitant therapies included copper (unspecified), ferrous fumarate, folic acid, vitamins (unspecified), POLY-VI-SOL with Iron tablets. On 12-FEB-2013 the patient developed upper respiratory infection and shingles after receiving VARIVAX (Merck). The patient developed congestion, fever, and drainage so AUGMENTIN was prescribed. The patient also presented with rash on top of both buttocks and some spread down the left leg. Rash consisted of "maculopapular papules with unilateral dermatomal distribution". Treatment with ZOVIRAX ointment, AUGMENTIN and oral acyclovir were given for the events. Viral culture was performed but no result provided. The patient was seen by physician. The outcome of the events was reported as not recovered. The relatedness for the events with the therapy was unknown. Additional information has been requested.
A spontaneous report has been received from a Physician concerning a two years old male patient. Patient relevant history, concurrent diseases and concomitant drugs were not provided. The patient had been receiving nasal FLUENZ, started on an unknown date. The patient had been administered with FLUENZ TETRA 36 hours beyond the expiry date. The physician unintentionally administered the vaccine to patient which was expired on 31-DEC-2014. He removed it from fridge and was not used to the new year. Action taken with FLUENZA TETRA, intranasal was unknown. The reporter considered the event to be non serious. Follow-up of insignificant information received by AstraZeneca/MedImmune 12-Jan-2015 received from physician via spontaneous report:No new information added.Narrative updated.
Patient called the pharmacy and said she had a bad reaction to the Moderna bivalent booster. She received the vaccine around 2:00 pm 12/6/2022, and started feeling bad around 8:00 pm that evening. She was shaking uncontrollably, full body aches, pain in muscles and joints, severe headache, and was very light-headed. She said she took Ibuprofen and it resolved after 3 hours. The only symptom she has today is feeling light-headed and "woozy." She said she doesn't have any other health issues and has never had this kind of reaction before. She wanted this to be reported and noted in her profile so we don't give her this vaccine in the future.
Narrative: 83 y.o. patient who received dose #1 of Moderna COVID vaccine (Lot #07B21A, exp 9/8/21) on 3/29/21 and dose #2 of Moderna COVID vaccine (Lot # 037B21A, exp 10/1/21) on 4/26/21. PMH including head and neck cancer, ESRD, DM, HTN, HLD, afib, OSA, COPD, asthma, OA, low back pain, and obesity. He was admitted to hospital on 1/20/21 for shortness of breath and acute hypoxia. He was found to be Covid positive. His acute hypoxic respiratory failure was management with oxygen and home inhalers. On admission, he had acute kidney injury which progressed to ESRD, etiology thought to be from Covid infection vs chemotherapy. He was started on dialysis on acute floor. Patient had a chronic thrombotic occlusion on left side vessels so a left femoral perm cath placed on 3/20/21. Patient was initially transferred to nursing home on 3/29/21 for rehab due to multiple comorbidities and debility from chemoradiation. On 3/31/21, he returned ASIH to step down unit due to atrial flutter with RVR during dialysis with rate in 140-160s with low pressure systolic in 70-80s. During ASIH, it was determined the atrial flutter with RVR during dialysis sessions was related to volume depletion, responsive to fluids and beta blockade. He was seen by palliative care during acute hospital stay and ASIH. Patient returned to nursing home on 4/13/21 as a long stay continuing care. Transitioned to hospice/palliative 4/23 as was not tolerating dialysis. Patient passed away in the nursing home on 5/2/21 @ 1345. Reaction classified as severe as death occurred following vaccination.
Patient waited her 15 minute time of observation. She said she felt her throat closing . Moved her into the observation area. Dr.  was present and ordered for 25mg of Benadryl to be administered po. This was given at 16:00. Dr. observed patient for approximately 45 minutes until all symptoms resolved. Patient was allowed to leave at 16:45. Patient was provided with the instructions to please go to the ED if she should have any new symptoms tonight.
sick; Soreness in his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in his arm) and ILLNESS (sick) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness in his arm). On 04-May-2021, the patient experienced ILLNESS (sick). On 15-Apr-2021, PAIN IN EXTREMITY (Soreness in his arm) had resolved. At the time of the report, ILLNESS (sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment drugs are not provided by reporter. ADHD medications and HIV medications includes in concomitant medications.   This case was linked to MOD-2021-106811 (Patient Link).
Received Td on 8/5/03. Mother reports she had fever of 101 the next day. Left arm reddened and swollen around injection site only. On 8/7/03, fever subsided; site tender to touch with slight swelling and very little redness.
Patient called on 8/30/21 to let us know that after his shot on 8/25/21, his calf started hurting. Then today, the patient could not walk because of the pain in his lower leg. According to the patient the pain had just continued to increase until he couldn't walk. When the patient called Pharmacy he was instructed to go to an Urgent Care, ER, or Primary Care Physician. He went to the Urgent Care where he was seen by a Doctor C. and they found a blood clot in his calf. He was prescribed Eliquis for the blood clot on 8/30/21. I reached out to the Urgent Care and was left on hold for 10+ minutes.
Morning following flu shot pt reported itching between fingers that progressed to full body "rash" and itching (over 3-4 hours). Started BENADRYL on 10/7/16-Symptoms subsided.
swelling, reddness of leg @ site of inj mom reported swelling made pant leg tight;
I have had all my Pizer vaccinations and boosters except the one for the Omicron booster which was Moderna. I have never had a reaction to any of them except a sore shoulder for a day or two; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "I have had all my Pizer vaccinations and boosters except the one for the Omicron booster which was Moderna. I have never had a reaction to any of them except a sore shoulder for a day or two"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "I have had all my Pizer vaccinations and boosters except the one for the Omicron booster which was Moderna. I have never had a reaction to any of them except a sore shoulder for a day or two". The following information was reported: ARTHRALGIA (non-serious), outcome "recovered", described as "I have had all my Pizer vaccinations and boosters except the one for the Omicron booster which was Moderna. I have never had a reaction to any of them except a sore shoulder for a day or two".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200129597 same patient/vaccine/event, different dose;