chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via other manufacturer and described the occurrence of injection site pain in a 68-year-old male patient who received Flu Seasonal QIV Dresden (Quadrivalent). Co-suspect products included 10PN-PD-Dit (Pneumococcal vaccine). Previously administered products included XTANDI with an associated reaction of adverse event (bruising, depressed, loss of appetite, joint aches, hot flashes, headache, fatigue (in July 2016), fatigue (in October 2016), fatigue (1st episode), soreness in the arm and achiness at the injection site). Concurrent medical conditions included pain. On 7th November 2016, the patient received Influenza vaccine Quadrivalent 2016-2017 season and Pneumococcal vaccine. in November 2016, less than a week after receiving Influenza vaccine Quadrivalent 2016-2017 season and Pneumococcal vaccine, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were unknown. It was unknown if the reporter considered the injection site pain and pain in arm to be related to Influenza vaccine Quadrivalent 2016-2017 season and Pneumococcal vaccine. Additional details were provided as follows: This case was reported by the patient's wife to other manufacturer on 8th November 2016. No concomitant medication information was provided. The patient experienced various adverse events after receiving a dose of XTANDI (batch number: 1539683PC, 1543982PC, 1553886PC). The patient experienced soreness in arm and achiness at injection site after vaccination with flu and pneumococcal vaccine. No lab test information was provided. The soreness in arm and achiness at injection site were considered to be non-serious and the causal relationship to XTANDI was not related as it can be attributed to flu and pneumonia vaccine. No further information was available.
Fever (low-grade), nausea, dizziness, malaise x 24 hrs.
Severe pain, swelling (L) upper arm. Erythema & swelling at site of injection. Ibuprofen 800mg PO TID x 5 days.
Mis administered Zostavax for varicella on 11/15/06 11/22/06 alerted parent, He stated child had no fever, no problems to date 11/23/06 sleeping trouble, fever, headache, wanted to be carried wasn't eating like normal. 6/17/10 This is in follow-up to report(s) previously submitted on 12/14/2006. Information has been received from a registered nurse concerning a 12 month old female who on 15-NOV-2006 was vaccinated SC with a 0.5 mL first dose of varicella-zoster virus vaccine live (Merck) (lot # 652946/1012P) instead of a dose of MMR II (Merck upgrade process). Concomitant vaccination on the same day included an IM first dose on the right thich of FLUZONE (lot # U2175HA) and an IM fourth dose in the right thigh of PREVNAR (lot # B08682E). There was no illness at the time of vaccination. It was noted that there was no product confusion. No medical attention was sought. Additional information was received from the administering nurse who reported that there was no confusion with the packaging. They kept MMR II and varicella-zoster virus vaccine live (Merck) in the freezer together with an intranasal flu vaccine. Occasionally, the flu vaccine would fall onto the other small vaccine boxes. They took the top lid off the boxes so they could easily get to the vials of vaccine. At some point, the boxes got tipped over and someone put the vaccine into the wrong box. The reporter looke for MMR II  in the purple box and grabbed the vial, not realizing that the lid was the wrong color. Essentially, someone put the vaccine in the wrong box and he did not catch it. He realized a week later that the wrong vaccine was given. Additional information has been received from the administering nurse wh on reported that according to the parent, from 23-NOV-2006 to 30-NOV-2006, the patient had a low grade fever, difficulty sleeping, wanted to be held and was not eating normally. After seven days she was back to normal, recovered and doing well. Additional information is not expected.
Bad cold turned into sinus infection. Did home rapid tests and they were negative for COVID 19.
3/20/21: All over body rash, toes on right foot turned blue, itching, swelling went to urgent a care. Rash became worse over following days. Went to emergency room 3/23/21 when throat felt strange when swallowing
Narrative:  Patient experienced a breakthrough infection approximately 7 months after completing the Moderna vaccine. The patient required hospitalization for treatment of secondary pneumonia.
maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved.            No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.  This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
I noticed two weeks prior to the 9th of December I had sinus dip.  On December 9th I came home from work and wasn't feeling right and I accessed telehealth service and they put me on zpac.  Later that night I had the chills and was achy.  I was freezing under the covers.  I went to sleep and when I woke up on the 10th I couldn't stand.  I took my temperature and it was 100 degrees.  I went back to bed about 11:45am.  I took two COVID-19 home tests and they both came back positive.  I went to urgent care about 5pm on December 10th and they ran a dual COVID/FLU test.  Dr. put me on steroids.  Today is last dose Decadron and put me on Pepcid.
Complete loss of smell & taste.   No treatment sought.   To this date, still no smell or taste.
Pain began immediately upon injection. Did not report to Clinic. Sought medical  care on her own from three providers. Did not report until 01/06/2020. Questionable diagnosis of brachial plexus?. Pain continues and limited arm motion continues.
This case was reported by a nurse via sales rep and described the occurrence of intramuscular formulation administered by other route in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient  experienced intramuscular formulation administered by other route and injection site erythema. On an unknown date, the outcome of the intramuscular formulation administered by other route and injection site erythema were unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the registered nurse. The age at vaccination was not reported. The nurse at the practice administered SHINGRIX subcutaneously instead of intramuscular, which led to inappropriate route of vaccine administration. The patient developed erythema surrounding the spot of administration. No other reactions were noted. The reporting nurse agreed to follow up from GlaxoSmithKline.
I received my vaccine in my right arm. I never felt the injection as it was being administered, nor was my arm initially sore. I remained in observation for 15 minutes with no problems noted. I got in my car, and 20 minutes later, I noticed my hand feeling very cold. I touched both hands to my cheeks to measure temperature variation. It was very cold. The cold sensation traveled up my arm to my deltoid muscle. I got home at 07:45 PM. My husband used his infrared thermometer to measure the temperature difference. My right hand/fingers were several degrees colder. The cold sensation is constant. No real alleviating or exacerbating factors. It feels internally like my hand is in ICE. Hard to use hand at times.
Interruption in menstrual cycle. I have not had a period since first or second dose of Pfizer vaccine and pregnancy is not a possibility. Vaccine appears to stop effects of sertraline for about a week. I experienced manic depression for about a week both after first and second dose of vaccine, despite not having any issues while on sertraline prior to being vaccinated. It was like my sertraline medication completely stopped working.
At 2:45pm on 11/11/21, patient received the Pfizer-BioNTech Covid-19 vaccine 12-17 years formulation (purple cap) INSTEAD OF the Pfizer-BioNTech Covid-19 vaccine 5-11 years formulation (orange cap). Patient was observed in the office for 15 minutes without adverse reactions and was taken home by her mother. The on call pediatric Infectious Disease physician was paged by Dr. Dr called the family to inform them of the event and for reassurance and education on  symptoms. Facility will monitor patient closely.
severely dehydrated; sweaty; dizzy; This is a spontaneous report from a non-contactable consumer (patient).  A 30-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration from 03Jan2021 14:30 to 03Jan2021 14:30 as single dose for COVID-19 immunization.  Medical history included allergies to latex, psoriatic arthritis, asthma, migraines and COVID19 prior vaccination.  The patient's concomitant medications were not reported.  The patient previously took Vicodin, Codeine, Imitrex and experienced allergies.  On 03Jan2021 15:00, the patient got severely dehydrated, sweaty, dizzy. The outcome of the events was recovered.  The patient does not received treatment for the events.  No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
Received vaccine at 1745 on 1/27. On 1/28 had fever chills, body aches, headache. Fever lasted one day. Fatigue headache continued. Now day 5 post vaccine and still have fatigue, headache. Feeling of light headedness, has continued. Near syncope event on 1/31. I have been unable to work.
Pt verbalized he felt dizzy. Pt was sitting down at this time. The patient verbalized that the dizziness resolved after a duration of 30 seconds. No epinephrine or diphenhydramine was required for recovery. Pt denied distress or SOA.
pt recvd vax & w/in 24hrs p/vax pt exp an arthritic flare in both hips & knees;sx cont
I got ringing in my right ear after getting the 2nd vaccine. # or 4 weeks after getting the vaccine, it started and has not stopped. I went to an emergency clinic and my PCP. The ER clinic prescribed me 10 days of Augmentin to treat an ear infection but that did not work. I was then given levothyroxine antibiotic which also did not work. They were unable to determine what was causing the ringing, The ringing varies in intensity. I am still in the process of finding a resolution. I am getting a blood test to determine is there is a vitamin deficiency.
Developed fever - 100.2F - 2 days following vaccine.  Seemed to recover.  6 days following vaccine, developed maculo-papular rash over arms, sides and inside of his legs.  No itching or fever with rash.  Patient is recovering.
The patient received first dose Moderna vaccine February 17, toward the end of February noted swelling behind right knee and pain, Patient reports pain continued to increase and became  'alarming'  on March 9 - he was sent for stat venous duplex which revealed a right lower extremity DVT involving entire right femoral vein, popliteal vein, calf veins. At that point the patient was started on Xarelto.
She reported feeling lightheaded and foggy. Patient reports being a cancer survior and having a similar reaction to a past flu vaccination. She was able to ambulate to the recliner and denies other symptoms such as shortness of breath, rash, or diaphoresis. BP 96/70 mmHg, HR 64 bpm, SPO2 99% After 30 minutes in the recliner she states she is feeling much better and denies any current symptoms.  BP 100/70mmHg, HR 71bpm, SPO2 99%.
Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a three years and four months old female patient and reported that 0.25 ml, in a prefilled-syringe, IM, was administered in the left arm of a patient that was 3years and 4 months old, she should have received the 0.5 ml dose, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 16-Oct-2018, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT626ma and expiry date: 30-Jun-2019) via intramuscular route in the left arm. It was a case of actual medication error due to under dose. 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. List of documents held by sender: none.
Arm was sore right before bedtime; Checked temperature at 1pm and it was 99.5; Woke up really cold and achey.; Woke up really cold and achey.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 21Apr2021 at 11:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included scalp psoriasis and COVID-19. The patient had known allergies to penicillin. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included topical treatment for scalp psoriasis from an unknown date and unknown if ongoing and vitamins (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 20:30, the patient experienced arm was sore right before bedtime. On an unknown date in Apr2021, the patient woke up and was really cold and achy and checked temperature at 13:00 and it was 99.5. On an unknown date in Apr2021, the patient underwent Body temperature and the result was 99.5 (Units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm was sore right before bedtime, was really cold and achy and checked temperature at 13:00 and it was 99.5 was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
has not been sleeping well; experiences drowsiness; fatigue; This is a spontaneous report from a contactable consumer reported for herself that. A 31-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 10Sep2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. After the administration of 1st dose of vaccine, the patient reported not been sleeping well, experiences drowsiness and fatigue on an unspecified date Sep2021. Her main question is, she's not being able to sleep very well and how does sleep affects the ability of the immune system to develop the antibody response required to be immune to Covid. The event outcome was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Information has been received from a physician concerning a 16 year old female who on approximately 27-Nov-2006 was vaccinated with the first dose of Gardasil vaccine (yeast) (0.5 ml) (lot#653650/0641F). Concomitant vaccination the same day included Fluvirin vaccine. It was reported that " a few days after receiving the vaccination", on approximately 01-Dec-2006, the patient experienced dizziness when standing and walking and experienced a headache. Unspecified medical attention was sought. Subsequently, the patient recovered from the dizziness and headache on an unspecified date. Additional information has been requested.
Swollen red, itching and pain at injection site, Slight Shortness of Breath, within 3 hrs mild skin redness in abdominal area and arms. Raised red lesions (hives) within 6 hrs.
Headache, Myalgia, inj site pain and swelling; fatigue, headache, myalgia Narrative:  symptoms lasted for x3 days
Possible incorrect administration of second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Possible incorrect administration of second dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020 and COVID-19 in July 2020.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Possible incorrect administration of second dose). On 07-Apr-2021, PRODUCT ADMINISTRATION ERROR (Possible incorrect administration of second dose) had resolved.            The reporter was calling on behalf of their husband who received their second dose on 07-Apr-2021. The reporter informed that during the administration of the second dose of the vaccine, it was believed that there was an administration error. The reporter believes that the patient did not receive the dose correctly.  Reportedly, instead of the injection being done straight into the deltoid muscle, the administrator pinched the skin on the deltoid and then administered the vaccine. No other side effects have been reported by the reporter with the second administration. The reporter also informed that the patient had previous COVID-19 infections in July and December of 2020.  No Concomitant product use was reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to INC.-MOD-2021-069658 (E2B Linked Report). This case was linked to MOD-2021-069658 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: TCR was received on 19-May-2021 and contains non-significant information.; Sender's Comments: INC.-MOD-2021-069658:First Dose of husband
At first, it was a dry cough. Then, on Saturday (10/31/09) I developed a fever, chills, sore throat, wheezing, difficulty breathing, bad violent cough, bad headache, some nasal congestion.
Within a couple hours my throat started feeling tight and I couldn't breathe right. I woke up in the morning and felt like I was being choked. I took my inhaler and it only helped enough for me to wait to go to the hospital until my partner came home. I went to the hospital and they gave me a breathing treatment. I haven't been hospitalized for a breathing treatment in 5 years. I do not smoke and am not around toxins, I am a stay at home mother. And it rained all this weekend and there are no allergens in the air. Saturday night my throat was still tight but didn't notice anything more. Sunday morning and night my thinking was off and I couldn't move my body without joint pain and pain in my arm. It's now Monday and I have a headache that is unbearable, pain in my abdomen, and dizziness along with being pale in color. I have made sure to stay up on water to make sure it's not dehydration, that is not the case.
Incorrect dose given: administered COVID 6 month-4 year dose to this patient. Patient was due  12+yr Booster dose. Informed family of what occurred. Patient tolerated vaccine well, no reaction. Mom agreed to have patient revaccinated with correct dosage on 10/17/2022.
A report has been received from a health professional via medical representative concerning a 10 year-old female patient. The patient's medical history, concomitant medications and concurrent diseases were not reported. On 20-Aug-2012 the patient received nasal FLUMIST. On 19-Nov-2012 the patient was tested positive for Influenza B. At the time of reporting the outcome of the event was unknown. The report was considered to be non-serious by the reporter.
Information has been received from a nurse practitioner concerning an approximately 13 year old female patient who was vaccinated with a dose of GARDASIL.  Following vaccination the patient experienced numbness and tingling in the throat.  The patient received other vaccinations at the same visit.  The nurse practitioner administered epinephrine and the patient recovered.  It was unknown if the patient sought medical attention.  Upon internal review numbness and tingling in the throat treated with epinephrine was determined to be an other important medical event.  No further information is available.
Eyes burning first, then tongue felt swollen, left arm red and sore.  Woke up the next morning and was fine.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 03-AUG-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # L038132 with expiration date 01-OCT-2017, dose unknown, subcutaneous). The vaccine was improperly stored at 6 degree Fahrenheit for 11 minutes. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.