chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Fever up to 103F; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever up to 103F) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051B2IA) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever up to 103F). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, CHILLS (Chills) and PYREXIA (Fever up to 103F) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX (batch number 4LP5Y, expiry date 27th February 2021) for prophylaxis. 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 influenza-like symptoms and chills. On an unknown date, the outcome of the influenza-like symptoms and chills were unknown. It was unknown if the reporter considered the influenza-like symptoms and chills to be related to SHINGRIX. Additional details were provided as follows: The reporter received this information via chat. The age at vaccination was not reported. The healthcare professional (HCP) reported that they had a provider stated that the patient had a reaction of flu like symptoms, chills and shivering.
Chills, aches,  started about 8.5 hrs after vaccination. Fever noticeable about 1 hour after, didn?t measure temp, lasted about 8 hrs. Still slightly achy and tired over next 10 hrs, but all okay about 30 hrs or so after vaccination.
Warm, red minor swelling at injection site - appeared to be subQ infection - recommended MD visit at pharmacy.
Fever - between 99.3 and 101.3.   Severe joint and muscle pain. Stiff, sore arm. Chills.  Severe headache.  At the time of this report, all symptoms continue at day three but are less severe.
Prostate bleeding for 3 hours 6 days post vaccination.  History of  bleeding but always with a known cause.  Last INR before 2.4 and after event with hold of coumadin for 1 day was 1.7
Immediate severe right shoulder pain, concern for vaccine injected into joint space. 1 to 2 days after vaccine develop diarrhea and mild fatigue/aches. Seven days after vaccine started having increased fatigue, severe headache, bodyaches, diarrhea, nausea.
Fever of 99-100 for three days following vaccine, fever dreams and dizziness, shivering chills and then heavy sweating, body aches, weakness, headaches, exhaustion, nausea, diarrhea, and abdominal pain.
injection site swelling; fever; chills; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd August 2019, 1 days after receiving Shingrix, the patient experienced injection site swelling, fever and chills. On 25th August 2019, the outcome of the fever and chills were recovered/resolved. On 5th September 2019, the outcome of the injection site swelling was recovered/resolved.   It was unknown if the reporter considered the injection site swelling, fever and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix on her right arm. The patient developed injection site swelling that lasted 2 weeks then resolved. she also developed fever and chills and those lasted for three days then resolved. The consumer did not have vaccine information for this adverse event. She stated that she received the vaccine at Pharmacy, but wanted the health care professional to follow up to be her physician. The reporter consented to follow up.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: Patient was extremely nervous and sweating prior to the shot.  Patient was already sweating through his shirt and pants.  After the shot patient fainted.  It was likely due to the extreme nervousness and not an adverse reaction to the vaccination.
Arm soreness, chills, fever, myalgia, fatigue for 1-2 days. headache started day 1 and continues, nausea started day 5 with worsening headache, chest heaviness on day 5  Took tylenol on day 4 Started taking Motrin and Aleve day 5
pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included ESCITALOPRAM OXALATE (ESCITALOPRAN) and PRENATAL VITAMINS for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 28-Feb-2021. On 28-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). On 28-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.        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.   No treatment medications provided by the reporter.
A 31 year old male subject presented to the Healthcare Center for evaluation of a progressively disabling fatigue-like syndrome that he believed was due to receipt of the anthrax vaccinations. The symptom complex became increasingly disabling over a 4 year period and ultimately required his removal from Special Forces training and assignment to administrative duties. A detailed investigation uncovered a past medical history of a prolonged diarrheal illness while abroad to a foreign country in 2001 that required almost daily IV fluid replacement for ~6 weeks. Following resolution of the initial illness, the service member developed progressively disabling fatigue and multiple systemic symptoms such as myalgias, arthralgias and headaches that interfered with physical performance. There was no well defined temporal association or exacerbation of symptoms following ANTHRAX vaccine doses. Came to the HC with a diagnosis of Chronic fatigue syndrome.
Red streaks, hot to touch, headache, neck ache (RD) Tx with KEFLEX.
Swelling and pain at injection site and down left arm. Body aches in legs. Right cheek, directly under the right eye swollen, down to mouth. Swelling continued for 3 days.
12/21/2017 PNEUMOVAX given-pt went to ER twice over holiday W/E for pain and swelling. Tx'd with ATB and pain med.
6 hours following vaccine, severe chills, fever, nausea, body aches, tiredness but unable rest and headache - all lasting 30 hours. Starting the morning after vaccine, redness, swelling and heat from injection site and spreading across upper arm for 8 inches in diameter and worsening for 3 days. Improvement notes to begin after 75 hours following vaccine.
Staff was not aware that the EUA for monovalent vaccines was discontinued immediately the evening prior to administration, 4/18/23
After the first shot, my legs weakened and I had to use a walker to move.  The intensity of the weakness increased until I collapsed on August 6 and was admitted to Hospital on August 9 where I received six infusions of a steroid, and a follow-on reducing does of prednisone from 60 to 10 mg.  I am receiving intensive physical therapy now and will have to continue as an out patient.  I believe the vaccine exacerbated the MS and increased several weaknesses in my right hip that was removed over five years ago as before the shots I had not had an exacerbation in 30 years and my hip increased n pain.
Arm has been very sore since administration. She is still having pain and difficulty moving her arm in certain positions. She is seeing her PCP for follow up.
Chest pain starts midline and moves up toward left side, shortness of breath, high blood pressure. High heart rate. All the time
Left lymph node swollen next to breast. Warm to touch and painful to touch.  Slightly red area noted as well.   Currently taking motrin, did ice first day
SWELLING IN ARM/NECK; SWELLING IN ARM/NECK; SHE HAD PAIN IN THE ENTIRE RIGHT SIDE OF HER BODY; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): EC-2022-106395 (Agency).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; lenvatinib mesilate (LENVIMA), from 12Jul2021 (Lot number: 1844114, Expiration Date: 31Aug2024) to 26May2022 at 8 mg daily, oral for endometrial cancer. The patient's relevant medical history included: "Allergies to penicillin" (unspecified if ongoing), notes: Allergies to penicillin; "eating difficulty" (unspecified if ongoing), notes: Esophagus mets. Concomitant medication(s) included: KEYTRUDA; LEVOTHYROXINE; MULTIVITAMINS [VITAMINS NOS]. The following information was reported: PERIPHERAL SWELLING (non-serious), SWELLING (non-serious), outcome "unknown" and all described as "SWELLING IN ARM/NECK"; PAIN (non-serious), outcome "unknown", described as "SHE HAD PAIN IN THE ENTIRE RIGHT SIDE OF HER BODY". The action taken for lenvatinib mesilate was temporarily withdrawn on 26May2022. Therapeutic measures were taken as a result of peripheral swelling, swelling, pain.  Additional information: Patient reports, she recently had COVID vaccine and several days after. Patient started to experience swelling in arm/neck. She had pain in the entire right side of her body. Patient was sent to infusion center to replenish fluids/potassium. MD held Lenvima on 26May2022. Prescriber aware  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1 day post inject pt devel hoarsness, non-productive cough; Seen an allergist who referred to ENT MD; This MD told pt vax shocked vocal records & froze them; w/voic exercise pt voice has returned;
Right arm slightly swollen, hot to touch, slightly red at injection site; complained of pain, decreased range of motion. None today.
Numbness and tingling that started in both feet then moved into both legs, ribcage, and eventually both hands/fingers.
Dose 1 was administered in the biceps region of the right arm. Patient had a scar from skin sloughing  at the site of band-aid removal. Granulation tissue formed and healed well. He did not experience any adverse effects otherwise and have advised vaccine team to administer in the deltoid region since it appears from photos that there was sufficient muscle mass to administer there.
After 3rd HPV - within 2 months, developed darkening of skin of posterior neck and arm pit, had primary amenorrhea, hirsutism, Acanthosis nigricans.
pain at injection site (beginning 4 hours after injection)  sickness beginning at 3am (15 hours after injection and continues as this is being completed 9.5 hours later) fatigue, headache, muscle pain, pain in legs, chills, nausea and periodic vomiting, fever (100.6)
arm was red for about 4 days; arm was swollen for 4 days; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included neuropathy and celiac disease.   In August 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities and swelling arm were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022121477   Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's Comments: The caller was the patient stating that she had the first Shingrix vaccine at the end of August 2021 and her arm was red and swollen for about 4 days. The patient received vaccine in left arm. The patient did not have any further information about the vaccine itself. The reporter consented to follow up. Health care professional for follow up. Additional Supportive Information: In 2021, the patient experienced erythema of extremities and swelling arm. In 2021, events erythema of extremities and swelling arm were recovered. For tolerance of 2nd dose refer linked case US2022121477.; Sender's Comments:  US-GSK-US2022121477:Same patient
She received 0.25ml dose of bivalent Moderna vaccine, instead of 0.5ml dose.
The client received the COVID vaccine Pfizer booster (Lot# FL3197 exp: ) at 2:23PM. They did not verify the dates the client received the primary series of Pfizer COVID vaccine. After administration of the booster COVID vaccine Pfizer,  noted the client received the first dose of COVID vaccine Pfizer (Lot #EW0178) on 06/16/2021 and the second dose of COVID vaccine Pfizer (Lot#FA6780) on 07/12/2021. The client did not report any symptoms during the 15 minute observation period.  RN educated client on possible adverse reactions and when to seek medical care. The client left the vaccination site at unassisted with a steady gait.
Patient reports Right arm pain radiating to right leg, 1 hour post injection. States symptoms subsided within 24 hours. Reports "lump" at right neck area starting 4/14 and currently still present, lympadenopathy has not subsided. No other complaints, no signs/symptoms of allergic reaction. Did not require treatment/medical intervention.  Patient was provided PCP & FQHC contact list to follow-up with a PCP.
after receiving the bivalent pfizer vaccine patient's arm started to itch and he had some redness up and down arm. it was then warm. i advised him to take benadryl and watch it closely. if it gets worse to go to urgent care/ER.
Body aches, stiff/sore neck, pain in joints, swollen lymph nodes in chest, arm, neck, that are worse on the left side, fatigue, sore throat, chills
On Saturday, her arm was sore, having chills, fatigued as well.  The symptoms kind of went away.  On Thursday night, 1/28/21 had burning sensation on her feet, like fire on her feet.  Went to bed, the feeling went over her entire body.  The sensation continued on her hands and her feet.  She went to the ER on Saturday morning, early in the AM on 1/30/21, informed her hemoglobin was a little low.  Said that it could be neuro, saw her doctor and informed that she had received the vaccination and he prescribed Gabapentin for the neuropathy.  He did blood work and going to check what would trigger the neuropathy pain.
not feeling well after receiving COVID vaccine; The initial case was missing the following minimum criteria: ICH-Reporter with No First-hand knowledge. Upon an updated that Pfizer colleague reported for a patients AE even the information did not come from the individual who experienced effects and has First-hand knowledge , this case now contains all required information to be considered valid.   This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) via Pfizer colleague.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling well after receiving COVID vaccine". It was unknown if therapeutic measures were taken as a result of malaise.        Additional information: None  Follow-up attempts are not possible, information about lot number cannot be obtained. No further information is expected.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Pt has PMH significant for CAD, t2dm, CKD, hyperlipidemia, HTN, Carcinoma of Bladder, Anemia. Patient deceased on 4/12/2021 of unknown cause, no note listed.
started with fever and hives per mom night of shot, blistered 5/31 and fever, 6/1 no fever just blisters and crusting, redness and pain around site, well appearring otherwise seen in office given benadryl, bactroban and triamcinalone with f/u scheduled for next AM by photograph
Immediate redness in face (similar to Rosacea). Approximately 30 minutes later, swelling in face, hands and feet, dizziness, and fatigue. Swelling in face, hands and feet, fatigue, fever x 3 days. Dizziness x1 day. Rosacea x1 day.  Since vaccine, I have had bouts of shortness of breath, and occasional pain in my left breast area near the heart.
The patient first exhibited diaphoresis, then was thirsty. He was then unresponsive and started seizing, and lost control of his bladder. The seizure lasted approximately 1 minute. Emergency services were contacted, and they assessed the patient after the event. He was released from their care back into the community.
no adverse event; VARIVAX was administered during a T/E; This spontaneous report was received from a certified nurse midwife referring to a 5-year-old female patient.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 13-OCT-2023, the varicella virus vaccine live (oka/merck) (VARIVAX) lot# X010525 underwent a temperature excursion of 12.5 Fahrenheit degree for 25 minutes.  On 16-OCT-2023, the patient was vaccinated with the varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot #X010525, expiration date: 11-APR-2025, administered subcutaneously in the left arm for prophylaxis (strength was not provided) that underwent temperature excursion before viability determination. No additional adverse event was reported.  Subsequently, varicella virus vaccine live (oka/merck) (VARIVAX) was determined viable.
This spontaneous report as received from a pharmacist refers to his currently 6 year old daughter. The patient's past medical history and past drug history was not reported. On an unknown date in 2009, the patient was vaccinated with VARIVAX (Merck) dose 1, once, when she was about 1 year old. No concomitant medication reported. This pharmacist reported that, his currently 6 year old daughter got a VARIVAX injection once in 2009 when she was about 1 year old. The pharmacist reported that about 9 weeks later in 2009 she got the second VARIVAX (Merck) vaccine. On 24-FEB-2014, the nurse accidentally read her chart wrong and she was given a third VARIVAX (Merck) injection in her arm. The reporter reported that she is acting fine tonight. It was unknown if there was any relevant laboratory data. The reporting pharmacist does not have lot number or expiration date for the VARIVAX (Merck). Additional information has been requested.
Moderate sore arm on first day and night, slight fatigue on second day,  On third day (Wednesday) depression, sadness, lack of interet in normal activities, difficulty concentrating as normal.   Better on Thrusday.
This spontaneous case, initially received on 11-Oct-2016, was reported by a health professional and concerns a 33-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 07-OCT-2016 to 07-OCT-2016. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On 07-Oct-2016 a couple of hours after vaccination, the patient started to feel very tired. That night the patient felt like she had a fever, with sweating and chills and achiness to her joints. She could not sleep very well. The next day the patient had no energy and felt lightheaded with a mental 'fogginess' (start date: 08-Oct-2016). Her muscles were very weak and she felt achy all over (start date: Oct-2016). Today, day number 2, the patient still feels tired with muscle fatigue in particular (outcome: not recovered/not resolved, start date: Oct-2016). Though the patient states this may not be a severe adverse reaction, she is concerned about this sudden drop in energy (start date: Oct-2016). Outcome for all other events: unknown. Reporter comments: The reporter states that set-backs like this are not acceptable and she will never have another vaccination again. The reporter thinks that the symptoms that she just described go underreported and wishes she could take it back and let her immune system deal with the flu the way it should.
45 mins after administration child became limp, lifeless, pale. Took 15 mins or so to arouse him back to normal. Subsequently he acted "off" to parents - not as social. Approximately 2 wks later was back to normal.
Pfizer Covid-19 Booster shot; Swollen and tender lymph nodes in left armpit; Swollen and tender lymph nodes in left armpit; Nausea; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: 33130819) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Pfizer Covid-19 Booster shot"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious), outcome "unknown" and all described as "Swollen and tender lymph nodes in left armpit"; NAUSEA (non-serious), outcome "not recovered", described as "Nausea"; HEADACHE (non-serious), outcome "recovered", described as "Headache".  Follow-up attempts are completed. No further information is expected