chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cold; Sneezing; weakness; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), SNEEZING (Sneezing), ASTHENIA (weakness) and FATIGUE (Felt tired) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced NASOPHARYNGITIS (cold), SNEEZING (Sneezing), ASTHENIA (weakness) and FATIGUE (Felt tired). At the time of the report, NASOPHARYNGITIS (cold), SNEEZING (Sneezing), ASTHENIA (weakness) and FATIGUE (Felt tired) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was provided.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Event associated with Dose-1 is recovered.
Today around 5:00 pm, my arm at the injection site started itching. It is a red rash, circular, about the size of a silver dollar, and quite round. The skin is swollen and tender to the touch.
By the time I got home, I was very tired and I felt achy mostly on my upper body. I did experience a general headache. I was struggling to do my chores. I decided to take Tylenol and that helped the headache and aching. I went to bed. When I woke up I felt tired still and I was not aching anymore. I just had a sore arm. After about two day I was back to normal.
Chilling day of vaccination, took Tylenol and did sponge bath. T about 103-104.
Pt reported her left arm felt heavy since first vaccine.  Shortly after receiving the 2nd vaccine she reported radiation of pain in left arm to fingers, and neck with some nausea.  I was asked to see pt.  She was given ice to place on left arm.  Pt lungs remained clear and she was able to answer all questions with no confusion and no shortness of breath.   Vitals: 170/70 p99 10:14am- 161/89 P76 10:25 am 160/98 P76 10:27- 178/97 P 78 10:30- 167/90 P78  During the time together she relayed her twin sister died of COVID in December and asked several questions if the vaccine can lead her to get COVID.  After 30 min of observation patient felt well and said she could drive home.
Noticed a thyroid nodule in my neck in early June. 2 cm in diameter. Nothing present 6 months prior at my annual physical. Tests have come out benign. Had ultrasound, biopsy, and DNA sequencing due to uncertain nature of previous results.
Client presented his vaccination card with two stickers of vaccination dates of 02/23/2021 and 03/23/2021 and stated he was there for his booster shot. He was administered Moderna 0.25 ml IM  by nursing staff  Vaccine provided by the local County Health Dept  Later when info was being entered into database  It was noted that he had received at Moderna booster 12/16/2021  not through HD  Client was called on 01/20/2022  and client verified he had received that dose. He thought he needed another booster. He was informed that was not the recommendation. Client stated he was feeling  fine. He was instructed to contact if having any issues or questions. He was instructed not to obtain another booster at this time. A new card with all the Moderna vaccines given was then mailed to the patient.
intermediate allergic reaction. Localized redness, swelling, and itch at injection site for 2 days. After 2-3 days: small itchy red bumps around the injection site. Days 4-6, small red bumps spread up arm, across torso, and onto other (right) arm. Ongoing.  No blisters, pain, swelling, or anaphylactic response.
Infant with history of allergic proctocolitis but had increase blood in stool after 2 month shots. Infant was free of blood for 2 months and then immediately after 6 month shots had blood in stool. Infant otherwise well.
Information has been received from a nurse referring to a patient of unknown  age and gender. No pertinent or historical conditions were reported. On 10-SEP-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # L009203, expiration date 17-MAR-2017, strength, dose and route unknown) and a dose of (Oka/Merck) PROQUAD (lot # L014401, expiration date 23-OCT-2016, strength, dose and route unknown) (overdose). No adverse effect was reported. Additional information has been requested.
This spontaneous report was received from a nurse practitioner via a company representative and refers to a female patient who is currently 19 years old. The patient's concurrent conditions and medical history were not reported. Approximately in 2009 (reported as "8 years ago,") the patient was vaccinated with GARDASIL intramuscularly (lot number, expiry date, dose and frequency were not reported) for prophylaxis. Information regarding concomitant therapies was not reported. The reporter stated that the patient completed the GARDASIL series. Then, since an unspecified date, the patient experienced unspecified neurological issues. No product quality complaint (PQC) was involved. At the reporting time, the outcome of nervous system disorder was reported as not recovered. The reporter did not provide a causality assessment between the event and GARDASIL. Additional information has been requested.
Flu like symptoms including chills, fever, night sweats, body aches; Flu like symptoms including chills, fever, night sweats, body aches; Flu like symptoms including chills, fever, night sweats, body aches; Flu like symptoms including chills, fever, night sweats, body aches; Flu like symptoms including chills, fever, night sweats, body aches; This is a spontaneous report from a contactable consumer via Sales Representative. A patient of unspecified age and gender received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient previously took the first dose BNT162B2 and experienced lot of arm pain. The patient experienced flu like symptoms including chills, fever, night sweats, body aches after 8 hours received vaccine. The outcome of events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Information has been received from an investigator regarding a 6 month old male who received his third dose of study vaccine along with DTaP (manuf unk), IPV, and influenza virus (manuf unk) vaccines on 10/29/02 as part of the study, "A Phase III Randomized Study to Evaluate the Safety of the 9-Valent Pneumococcal, Meningococcal Group C Saccharide-CRM197 Conjugate Combination Vaccine Comparred to Licensed 7-Valent Pneumococcal Conjugate Vaccine (Prevnar) Administered to Healthy Infants." The reporter noted that at the time of immunization, the infant had viral gastroenteritis with "excessive" weight loss. Approximately 15 to 20 minutes post-vaccination, the infant developed  limb shaking and his eyes rolled back. He also developed hives on his face and was crying intermittently. Emergency services were called and the infant was seen in an ER. Urinalysis and serum electrolyte test results were normal. A CBC showed a "slightly high" white blood cell count of 18.7. A CT scan was "normal." A physician exam revealed no abnormalities and a diagnosis of seizure was made. The family physician suspected an allergic reaction to egg protein in the influenza vaccine. On 10/30/02, the infant was seen by an allergist who indicated the possibility that the "infant had aspirated and developed laryngospasm mimicking like seizure activity." Results of egg allergy skin tests performed that day were negative. The investigator considered the events to be medically important (OMIC). Both the medical monitor and the investigator agreed that seizure and hives (both expected per the investigator brochure) were "possibly related" to study vaccine and concomitant vaccine administration.
Seven weeks after I got the vaccine, I had a pain in my left side next to my navel but further left. As the day went on it went to my side and my back. I had trouble rising from sitting also occurred when I drove. Also felt like a sharp object in my back. Then it happened again 4 to 5 weeks later. Then it happened a third time again, two weeks ago. That's when I called my doctor. I have an appointment tomorrow, on December 1st.
09/11/02 -phone call from pt , ? temp training room, took temp 102,slight swollen @ injection site@ (right deltoid), Fatigue and tried, Pt came to student health services, temp 98.2 "feels  tired", History of tonsilitis, Rest, increase fluids, Tylenol or Ibuprofen, Call or see, 09/12/02 incoming phone call from pt, Fatigue, slept in, c/o " tired and  achy all over", appt made 9/13/02 due to schedule with student 09/13/02, Dx; adverse reaction to shots
first dose in November of 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided are as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. Pharmacist inquired that when the patient should receive the 2nd dose or if they should restart the series. The caller provided 2nd dose response from Shingrix frequently asked questions content. The caller was not at work, therefore he did not had information regarding the patient. No additional details were provided by the caller. The reporter did not consented to follow-up.
CHILLS, FEVER, HEADACHE, BODY ACHES FROM 1AM ON 1/15/20 UNTIL 9PM 1/15/20  REST, TYLENOL AND MOTRIN
patients received a Flu shot from an extended shipment of Fluzone Quadrivalent/no AE; patients received a Flu shot from an extended shipment of Fluzone Quadrivalent/no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2019SA278134, 2019SA278136, 2019SA278137, 2019SA278138, 2019SA278139, 2019SA278140, 2019SA278141, 2019SA271944 and 2019SA271944 (same reporter).  This case involves a patient of unknown demographics who received Deteriorated dose of vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED from an extended shipment.  Patients past history and concomitant therapy was not reported.  On Oct-2019, patient received a multi-dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot: UJ254AC) (no dosing details were reported.  It was of actual medication error case due to Deteriorated drug administered (Poor quality product administered) and Product shipment delay (Product distribution issue).  It was unknown whether adverse event was noticed or not.  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.
tinnitus, electric static-type sound in my right ear. Same sounds appeared after booster #3.
left arm is swollen and painful then it started hurting in my armpit and my  lymph node underneath my arm pit is swollen. Also had body aches and head ache through the night. That is better but the swollen arm and lymph node is not
Information has been received from a physician's office concerning a 11 year old male who on 07/02/1996 was vaccinated with the first dose of varicella vaccine SC in the arm. On 07/02/1996, the pt was also vaccinated with the third dose hep B vaccine recombinant IM in the arm. There was no illness at the time of vaccination. On 04/21/2001, the pt was diagnosed by his physician with chicken pox. In follow-up, the physician reported the pt had chicken pox on 04/25/2001. The physician reported that the pt had recovered without sequelae. No further info is available.
Mother states daughter began c/o nausea and dizziness 1-2 days after receiving vaccine. To physician on 10/ /07. Prescribed Antivert p.o. - Mother notified health dept, 11/8/07. Symptoms continue of N/V and dizziness to date.
Nurse depressed the vaccine plunger, and when this happened some fluid trickled down the patient's arm.  The needle was in the arm the entire time of administration.  The nurse feels that about half of the immunization was administered.  There was some leakage out of the needle hub down the patient arm.
Approximately 5 min after receiving vaccines child presented with dyspnea.  coughing.
having a reaction like an allergy and she had itching; having a reaction like an allergy and she had itching; This is a spontaneous report from a contactable consumer (patient's husband). A 45-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date (received at the age of 45-years-old) as 1ST DOSE, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced having a reaction like an allergy and she had itching on an unspecified date. The reporter called for his wife who had "itching and all" after getting the first dose of the Pfizer COVID-19 vaccine. He wanted to be advised on what to do with that adverse reaction. Reporter stated, "I am calling for my wife, she took the first Pfizer vaccine (unspecified vaccine) on 3rd day she started having a reaction like an allergy and she had itching, first she had it on her abdomen, on her back and then she had it on her legs. When I spoke to her Doctor, he told me to give Benadryl, then Medrol nothing happened and then later on he gave a steroid called Prednisone for 9 days, slowly after 2nd day the itching went away, again she is having an itching on her back, so what should we do in this case now." Therapeutic measures were taken as a result of the adverse events. Outcome of the events was not recovered.  Information about lot/batch number has been requested.
Chest pain and SOA for 2 weeks prior to 2/2/21. Went to ER on 2/2/21. Diagnosed with Chest pain, and Shortness of breath at rest.
Severe arm pain night after shot arm was unable to move/ moderate/mild pain in the upperarm; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173 8/21) via an unspecified route of administration in the arm left on 12May2021 at 16:00(at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease from unknown date and unknown if ongoing. Concomitant medications included only vitamins/supplements (MANUFACTURER UNKNOWN) from unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021 the patient experienced severe arm pain night after shot, all night long her whole arm was unable to move. This strong pain subsided in about 2 days. Now 2 weeks later, she still have moderate/mild pain in the upper arm. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe arm pain night after shot arm was unable to move was recovering.  No follow-up attempts are needed. No further information is expected.
I was expecting to get the common side effects after my second dose, getting sick for a day about 12 hours after the 2nd dose. I did not get sick the next day, I just had the regular big red sore bump at the injection site. However, slightly more than a week after my 2nd dose, I started to experience double vision. Not blurry vision, but double vision, with one image on top of the other, both clear. At first it didn't bother me much, it was mostly happening in the mornings and in the evenings. Then suddenly, between the dates of 2/25 and 3/1, I started experiencing the double vision much more intensely and earlier in the day. It was not safe for me to drive, and it bothered me a lot, causing headaches and extreme nausea, I found myself going to bed at 6pm because I didn't want to be awake and deal with the side effects. I saw an Ophthalmologist (Dr.)  about the problem (not realizing it was a COVID-19 vaccine side effect) who diagnosed me with cranial nerve 4 palsy in the left eye.  I had to notify my job that I was unable to drive and that effected my work. Furthermore it was extremely stressful not knowing the cause or prognosis, and the worry over the medical costs for test and lab work. Since 3/2, the condition has been improving. There have been no other changes to my lifestyle or health that could account for this, other than receiving the COVID-19 vaccine. People need to know about the possibility of horrible side effects like this, it's worse when you don't know what's causing it or the prognosis.
Punctured Janssen COVID 19 vaccine vial was left at room temperature for 2 hours longer the manufacture recommended time. First punctured was at 11:45a, and vaccine was given at 3:40pm on 5/16/21. Patient said that he is fine with no issue or side effects.
This case was reported by a consumer and described the occurrence of swelling arm in a 4-year-old male patient who received Influenza vaccine. In 2015, the patient received Influenza vaccine. In 2015, an unknown time after receiving Influenza vaccine, the patient experienced swelling arm. In 2015, the outcome of the swelling arm was recovered/resolved. It was unknown if the reporter considered the swelling arm to be related to Influenza vaccine. Additional details provided were as follows: The patient was reporter's nephew. The patient recently received the unspecified Flu vaccine and had experienced a quite significant swelling on his arm. The event lasted for at least a day. The reporter did not have any further details to provide.
Sickness; Hot flashes; Nausea; Dizziness; Diarrhea; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), ILLNESS (Sickness), HOT FLUSH (Hot flashes), NAUSEA (Nausea) and DIZZINESS (Dizziness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.     On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (chills). On 10-Feb-2021, the patient experienced ILLNESS (Sickness), HOT FLUSH (Hot flashes), NAUSEA (Nausea), DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHILLS (chills), ILLNESS (Sickness), HOT FLUSH (Hot flashes), NAUSEA (Nausea), DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), ILLNESS (Sickness), HOT FLUSH (Hot flashes), NAUSEA (Nausea) and DIZZINESS (Dizziness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.     On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (chills). On 10-Feb-2021, the patient experienced ILLNESS (Sickness), HOT FLUSH (Hot flashes), NAUSEA (Nausea), DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHILLS (chills), ILLNESS (Sickness), HOT FLUSH (Hot flashes), NAUSEA (Nausea), DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.
Pt. states that after the 1st dose of Moderna of 07/22/2021, started experiencing symptoms 07/22/2021 10mins after of warm sensation through blood vessels, anxious, brief heart palpations, (underpart) tingling in the tongue (on/off), jittery, dizziness, and occasionally waking up through the night paralyzing sensation. 07/23/2021 felt fatigued, arm soreness, and feeling of heat throughout the chest area. Continuing to experience on/off symptoms. Primary communications 09/07/2021. Cardiologist visit (Stress Test) 09/02/2021 Abnormal, continue to self-monitor.
I am not sure if this is typical, but it's been really scary and I'm not sure if I should get the 2nd dose now...  about 7p on 3/11/21 I started noticing my Right hand was feeling cold/tingly/numb.  By the time I went to bed it was feeling strange up to my  right elbow.  I woke up (3/12/21 about 6a) with both hands (mostly all my fingers) looking very white (like Raynaud phenomenon).  My right hand to elbow still feels strange and seems most affected (shot was administered on Left deltoid).  My right hand almost feels like I have a glove on (wetsuit material).. I've been trying to keep circulation to them by taking hot showers and rubbing them.  They now seem more reddish and almost like chilblains might occur.   They feel tingling.   I have previously had chilblains in my feet when they were cold, but I've been good at managing and don't get that anymore.  Never had it in my hands previously..