chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen Injection Site; Red at site of injection; Hot to the touch at site of injection; This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a 4-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 425T2, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than 2 months after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site warmth to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The reporter stated that the 4 years old patient experienced red, hot to touch, swollen at site of injection after vaccination. The batch number reported for Fluarix Quadrivalent 2019-2020 season(42512) did not exist and was updated to 425T2, as per sales database. The reporter did not agree to the follow up. This case has been linked with case US2019AMR185042, reported by the same reporter.
Started with right ear pain on 01/08/2021. Moved to left ear pain as well on evening of 01/08/2021. Went to ER on 1/10/2021. Dx of ear pain and given oral and drop abx. Have been taking all abx for 39 hours with no relief. Left and right ear are both at same severity of pain.
This spontaneous report was received from a pharmacist via company representative concerning a male patient of unknown age. The patient's concurrent condition included diabetes. The patient's medical history was not reported. Concomitant medications and drug reactions/allergies were reported as none. In approximately October 2018 (reported as "within the last month"), the patient was vaccinated with PNEUMOVAX 23 (strength, dose, unit, dose number, lot# and expiration date was not reported) via subcutaneous route for prophylaxis. On the same day, a couple of hours after the injection, the patient experienced redness (vaccination site erythema) and swelling (vaccination site swelling) at the injection site. The patient sought medical attention and was recommended by the reporter for treatment with an unspecified dose of anti-inflammatory drug and to apply ice to the local area of swelling. No lab diagnostics/studies were performed. Outcome of the events were unknown. Causality assessment of the events was not provided. Product quality complaint (PQC) was not involved.
the patient was again tested COVID positive; the patient was again tested COVID positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 69-year-old female patient received BNT162b2 (BNT162B2), on 01Jul2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Influenza B virus infection", start date: 03Mar2021 (unspecified if ongoing); "COVID-19", start date: 03Mar2021 (unspecified if ongoing). Concomitant medication(s) included: ENBREL unknown, start date: Mar2021, stop date: Dec2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Dec2021, outcome "unknown" and all described as "the patient was again tested COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Mar2021) positive; (21Dec2021) positive.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID breakthrough. Patient has been in the hospital since 11/19/21. On 12/2/21, she developed a low grade fever. On 12/3/21 there were changes in her chest xray which prompted COVID testing on 12/4/21 which was positive. She is mildly symptomatic on room air.
pt noticed sx on Monday 19AUG96 PM redness, warmth, minimal swelling;DPH prescribed by ER MD;
Patient received COVID Jassen vaccine on 05/13/21, at different facility, then received one dose of Pfizer COVID vaccine on 08/21/21 at our facility. No symptoms within 15 minutes post Pfizer vaccination.
Behind ears hurts/tense; Blood pressure; blood sugar was 54mg/dl; blood pressure was high 140/80, 149/96 mmHg; Dizziness; severe headache; Lightheaded; This spontaneous case was reported by a medical assistant (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Lightheaded), HYPOGLYCAEMIA (blood sugar was 54mg/dl), HYPERTENSION (blood pressure was high 140/80, 149/96 mmHg), DIZZINESS (Dizziness) and EAR PAIN (Behind ears hurts/tense) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history not reported.), Blood pressure low and SARS-CoV-2 test.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced DIZZINESS (Lightheaded) and HEADACHE (severe headache). On 08-Jan-2021, the patient experienced HYPOGLYCAEMIA (blood sugar was 54mg/dl), HYPERTENSION (blood pressure was high 140/80, 149/96 mmHg) and DIZZINESS (Dizziness). On 14-Jan-2021, the patient experienced EAR PAIN (Behind ears hurts/tense) and BLOOD PRESSURE MEASUREMENT (Blood pressure). At the time of the report, DIZZINESS (Lightheaded), HYPOGLYCAEMIA (blood sugar was 54mg/dl), HYPERTENSION (blood pressure was high 140/80, 149/96 mmHg), DIZZINESS (Dizziness), EAR PAIN (Behind ears hurts/tense), BLOOD PRESSURE MEASUREMENT (Blood pressure) and HEADACHE (severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood glucose: 54 mg/dl (Low) low. On 08-Jan-2021, Blood pressure measurement: 140/80 mmHg (High) high. On 14-Jan-2021, Blood pressure measurement: 149/96 mmHg (High) high. On 14-Jan-2021, Heart rate: 67 (normal) breathes per minute.     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 con meds reported.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
01/25/21- 103.9 temp,  aches, malaise  01/26/21- no symptoms  01/29/21- rash ( thought to be bug bites) appear on left abdomen  02/07/21- rash painful, teledoc diagnosed with shingles  02/10/21- annual physical- confirm shingles
Several hours after vaccine had chills and then insomnia that night. The following day developed severe arm pain and redness, swelling at site of vaccine. Also had feeling of "shakiness and anxiety".  Nausea and diarrhea 3 days later.
Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient who was administered the unstable vaccine FLUZONE QUADRIVALENT (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (patient had been administered the unstable vaccine). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Patient felt light headed 5 minutes after receiving the vaccine. Patient had an episode of syncope, which was attended by EMS. Patient regained consciousness within 30 seconds of episode. Patient has had previous episodes of syncope, but not with vaccinations.  All vitals were normal when checked by EMS.  Her BG was 121 mg/dl. Patient recommended to go to the hospital to get checked out but patient refused. Waited for husband to come pick her up - 5:45pm.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 6-months old male patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 13-JAN-2014 in the afternoon. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Parents were going to consult the physician and declined to revaccinate. No adverse event was reported for the patient. The reporter reported the outcome as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
pt says he has body aches, 103 fever, chills, loss of taste, sore left arm, and headaches.  he called his PCP but has not been able to reach them so may go to the ER or UC.
I started having numbness in both arms, became REALLY fatiqued and dizzy for two plus months, became unable to work.
Information has been received from the published literature article referring to a 12 year old male patient with asthma and allergy to eggs. His medical history included atopic dermatitis and allergic rhinitis. On an unknown date, the patient was vaccinated with a dose of MMRV (manufacturer unknown), a dose of meningococcal conj vaccine (unspecified) and a dose of Tdap (dose, route and lot# were unknown). Less than 3 hours after vaccination, the patient experienced generalized urticaria, pruritus, rash and cough. The initial evaluation was performed in a clinic and the pediatrician provided the diagnosis as vaccine-triggered anaphylaxis with Brighton level was 2. The patient was treated with oral antihistamine and cool compress. Then on an unknown date, the patient recovered. Upon internal review, the event "vaccine-triggered anaphylaxis" was considered to be medically significant. This is one of several reports from the same source (1211USA007452, 0911USA01970, 1207USA012332, 1606USA012239, 1002USA01291, 1606USA012686, 1606USA012687, 1606USA012689, 1606USA012690, 1606USA012691, 1606USA012692, 1606USA012693). Additional information has been requested.
This spontaneous report as received from a Registered Nurse refers to a 69 year old patient. On 17-OCT-2013 the patient was inadvertently received single dose of VARIVAX, 0.5 ml, subcutaneously for shingles prevention instead of ZOSTAVAX. No other effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4509038.  A 55-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "arthritis" (unspecified if ongoing); "multiple sclerosis" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN; PHENAZOPYRIDINE; BIOTIN; VITAMIN D3; FLUCONAZOLE; FLUOXETINE; SULFAMETHOXAZOLE; CEFUROXIME. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "weakness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My stress level went through the roof in November. I went to sleep in a hotel room in contact with one of their dusty pillows. I also had eaten chocolate that night that also triggers allergies. I woke up with contact dermatitis from the hotel pillow's dust mites. I got home and called my nurse at telehealth. My dermatitis had gone systemic by the time I had called the advice nurse. She prescribed Atarax to take three times a day. She also prescribed me a .01% Cortisone cream to apply topically. Once the Atarax was wearing off my anxiety got worse, and I started having heart palpitations and ended up in the ER the next morning. When I got to the emergency room, I received an EKG, and they took blood. We waited until the Atarax left my system then they sent me home and put me on Zyrtec. The doctor concurred that I had contact dermatitis and had me taking Zyrtec two twice a day. I'm afraid the vaccine has affected my liver's ability to process toxins and my allergies have been heavily triggered.  I am working with an acupuncturist and herbalist.
My son turned 11 years old so I took him for his initial HPV vaccine on 8/21/17. As soon as it was given to him (approximately 11:00 am), we were told to go wait in the waiting room for 15 minutes so he could be checked again before we left. On our way to the waiting room, I was stopped by the front desk staff to make the co-payment. My son was standing next to me and said that he wanted water. I asked a staff member if he could get water from the water fountain that was located behind the front desk area. They said yes and on his way to the fountain, he blacked out and fell onto a table and hit his head on the wall. This was within a few minutes of receiving the vaccine. There were several other children and parents in the waiting room that witnessed the event. One parent said that it looked like my son had a seizure. Since I was trying to make the co-payment, I had my back to my son and did not see him fall. I heard a crash and rushed to him and helped him get up and he asked what happened. He then started complaining about his head and knee hurting. The doctor had him come back into the exam room and lay down for a while and said he would check him again before we left. I asked why this happened and was told that it happens to about 1 in 4 kids. I was never informed that fainting was a possibility and we were not told that he needed to remain lying down for 15 minutes. My son had an injured knee and a knot on his head. He complained of pain for about a week following the accident. My son is extremely terrified to get another vaccine now and was upset when I pulled into the parking lot today at the clinic for my daughter's appointment. He did not want to go inside and asked to wait in the vehicle. I made him come inside and told him that it was for his sister, not him. Parents need to be informed ahead of time and children should not be told to get up and go to another room immediately after the vaccine is given. This could have been much worse. Thankfully, he did not break anything or get more seriously injured but I am sure that he will be scarred by this event for the rest of his life.
p/vax pt exp chills, fever, felt lousy;sx resolved by morning;later pt exp achiness, fatigue,neck stiffness & a daily fever of approx 100;tx given;sx ongoing;pt has not recovered;
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOVOLEMIC SHOCK 8/12/2022,  9/1/2022,  9/17/2022 -- RECURRENCE OF SAME SYMPTOMS
Patient awoke with severe headache.  Progressed to abdominal pain which was band like across entire abdomen.  Patient presented to labor and delivery with severe hypertension and tachycardia---168/110 and hr 138. Fetal heart rate also tachycardic on presentation in the 180's.  Temp 99.4. Pain was treated with nubain and IV fluids.  Full work up for Cholecystitis, appendicitis, preterm labor, preeclampsia were all performed and were all normal.  After 12 hours of treatment with pain meds and IV fluids patient is at this time feeling better. Blood pressure and heart rate (both maternal and fetal) have returned to normal.  Pain was rated at 8/10 but is now 2/10. Patient remains with localized erythema and swelling at injection site on right arm.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 13-NOV-2015 at time1 12:32, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.6 and 2.8 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Developed symptoms of Unilateral facial paralysis within 2 weeks of vaccination. Was evaluated in the ED, treated with anti-virals and steroids and the symptoms have resolved as of 8/28/21
breakout of hives on arms and abdomen area with some on the right side of face; This is a spontaneous report from a contactable consumer (patient). A 17-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in left arm on 03Jun2021 at 18:45 (at the age of 17-years-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number was not reported) via an unspecified route of administration in left arm on 13May2021 at 18:45 (at the age of 17-years-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 04Jun2021, the day after receiving the second dose, the patient noticed a breakout of hives on arms and abdomen area with some on the right side of face. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Patient had not received any treatment for the event. The clinical outcome of the event breakout of hives on arms and abdomen area, with some on the right side of face was not recovered at the time of the report.  This 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.
No adverse event known to date. 15 year old patient received 0.3 mL (30 mcg) booster dose of the Pfizer COVID vaccine that was prepared from a Pfizer COVID vaccine 5 year to 11 year old vial. Patient should have received this dose prepared from the Pfizer COVID vaccine 12 year and up vial.
Pt started with numbness and paralysis to the right side of his face on the morning of 11/5/15.
10/12/2022 at 1:00 AM, when I came off the plane, I woke up the next morning with a sore throat and significant congestion.  I am prone to sinus infections and that is what is was. On 10/12/2022 I started testing till 10/16/2022. I was testing every day. I was negative every day. On the 10/15/2022 I tested positive. On 10/16/2022 I went to urgent care for the medication. They did not test me at the urgent. They did prescribe me the Paxlovid because I have a non-essential tremor.  They wanted to put me on Lagevrio. It was not used. They said they did not get much efficacy from it. I was on the 5 day cut off point, I chose not to take it because my symptoms were mild as far as the congestion. My congestion has stayed, and I have a little bit of a headache off and on. Yesterday was a little bit of muscle ache, mostly in the shoulder and neck area. It feels achier than it does tight. I have no cough; my oxygen has stayed 98 consistently. On Sunday and Monday, I had 97.7 temperature. I have not had fatigue. I started sneezing a few days into it. I have been using saline rinse. My sore throat is much better today. I was exposed by my two travel friends. Today, 10/18/2022, is my 7th day with symptoms. I have not tested since Sunday.
mom called to reports pt rt leg was red,warm & the size of a baseball;pt had visited MD earliest in day for BOM;
My parents had come into town 6/11/2021-6/13/2021 and I visited with them. Found out she was exposed while visiting with them and she did not have any symptoms. 6/14/2021 I began to have a really bad sore throat, it didn't go away so I thought it would turn into a sinus infection. When it didn't go away I called a HCF and they told me to get tested 6/15/2021 It came back negative. On 6/16/2021 I found out my dad positive, so I retested on 6/17/2021 and it was positive. 6/18/2021 I lost taste and smell, fever 100-101, body aches, headache that wouldn't quit. The symptoms last for about 2 weeks. 6/18 or 6/19 I had a telehealth visit with my primary doctor and she prescribed me albuterol  and told me to get a pulse ox and to watch my o2 and if it ever went into the 80's to go to the ER. It never went into the 80's. Keep hydrated, rest, and take Tylenol or ibuprofen if fever spiked. Tested negative 07/03/2021 and could return to work.
02/17/22 presents to ED for "Abdominal Pain, Vomiting". PMHx of "GERD, heavy alcohol use (half to full pint per day)"
21NOV93 weakness, prostration, vomiting, cold hands, muscle aches & pains; husband gave VICODIN to relieve aches;
COVID Breakthrough case Symptoms began: 10/21/2021 Lab confirmed: 10/23/2021
Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Wants booster, no revax