chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm was hurting and hot; Itching; Redness that got bigger and started to spread on her arm; Arm was hurting and hot; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was hurting and hot), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Redness that got bigger and started to spread on her arm), FEELING HOT (Arm was hurting and hot) and VACCINATION SITE REACTION (COVID arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood cholesterol abnormal. Concomitant products included ALIROCUMAB (PRALUENT) for Blood cholesterol abnormal, METOPROLOL, ACETYLSALICYLIC ACID (BABY ASPIRIN), GABAPENTIN and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm was hurting and hot), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Redness that got bigger and started to spread on her arm), FEELING HOT (Arm was hurting and hot) and VACCINATION SITE REACTION (COVID arm). At the time of the report, VACCINATION SITE PAIN (Arm was hurting and hot), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Redness that got bigger and started to spread on her arm), FEELING HOT (Arm was hurting and hot) and VACCINATION SITE REACTION (COVID arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included decongestive pills.   This case was linked to MOD-2021-325448 (Patient Link).
Infant developed bloody stools for three days.  Parents transported infant to Hospital for examination and it was determined that she had intussusception.  She received a successful barium enema reduction and was discharged home in good condition the following morning.
Warmth at the injection site; Swollen injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE WARMTH (Warmth at the injection site) and VACCINATION SITE SWELLING (Swollen injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Blood pressure. Concomitant products included VITAMIN B NOS, VITAMIN D NOS and BIOTIN for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warmth at the injection site) and VACCINATION SITE SWELLING (Swollen injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warmth at the injection site) and VACCINATION SITE SWELLING (Swollen injection site) outcome was unknown.        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.   Concomitant medications also include Blood pressure medicine (2) Treatment information also reported  as applying Alcohol on the injection site
H1N1 vaccine given in (L) deltoid @ 1045 AM. At 11AM rash noted to (L) arm about 6 cm. Rash approx. 3 cm to (L) cheek & across tops of shoulders. 12.5mg BENEDRYL given. DECADRON 2mg & DECADRON la 4mg given IM at 12 noon. Rash resolved by 12 noon.
Menstrual cycle abnormal; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstrual cycle abnormal) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.     On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (Menstrual cycle abnormal). At the time of the report, MENSTRUAL DISORDER (Menstrual cycle abnormal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by the reporter. No  concomitant medical  provided by the reporter. Patient missed her menstrual cycle but had crams as usual but no bleeding.
Initial report was received from a health care professional on 11 January 2012. A 47-year-old male patient had received an injection of DECAVAC, sanofi pasteur Inc. (lot number, route, site and date of administration not reported) on 24 August 2006 for wound management and an unspecified amount of time later developed tetanus. It was unknown if the patient had any illness at the time of vaccination, had any pre-existing medical conditions, took any concomitant medications or received any other vaccinations within four weeks of DECAVAC. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Localized 3cm indurated area on left arm. Itching, swelling, and redness.
On 04-27-10 (PM) developed fever which persisted higher through 4-29-10 and accompanied by a fine papular rash to forearms and lower legs and a few papules on her face, and back.  Fever 103.6 ax. max from 4-27 PM - 5-2-10.  Used TYLENOL - Alt with IBUPROFEN.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: patient called said pain from vaccine hurts badly had to go to doctor and now see physcial therapist; claims was given too high on arm
Shivering (cold), muscle aches, stomach upset, eyes burning, tired, muscle weakness - flu-like symptoms for 2 days.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route not reported) on 28-JUN-2013, lot # H010915 expiration date: 13-FEB-2013. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
3 days after vaccines administered presented to emergency room with fever, vomiting and diarrhea, positive for Rotavirus.
Runny nose one day after vaccine, stuffiness.  Second day, shortness of breath, headache, body aches, diarrhea, cannot taste
From ~12:00pm on 7/3/2021, the patient started the following symptoms: 1. Fever 2. Headache 3. Muscle aches  Around 12:00am on 7/4/2021, the patient sneezed a couple of times and felt a little better.  Around 7:00am on 7/4/2021, the patient wake up and found all symptoms were gone. Only a little bit tiredness.
Diarrhea, nausea, bodyaches, fever, tremors, night sweats, headache, and throwing up
No further adverse effect reported; Patient received a dose of Improperly stored Rotateq; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/ allergies and concomitant medications were not reported. On 19-FEB-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot number S014947 and expiry date 10-DEC-2020 for prophylaxis (strength, route and anatomical location were not reported) (product storage error). It was reported that there were no adverse effects. The administered dose of the vaccine experienced a temperature excursion of below 36 fahrenheit degrees (°F) (34F) for 27 minutes, as recorded by a data logger. The vaccines had no previous temperature excursion. No product quality complaint (PQC) was reported.
2 days after the vaccine, 11/03/2021, In the morning while I was getting dressed, I noticed a green bruise on my right arm. I called the pharmacist. She said she was not concerned and keep an eye out on it. Then I found a 2nd bruise on the top, front, left side of my left leg. Then I called my doctor. He said to keep an eye on it. He did not think it would be serious he offered to do blood work but did not think it was anything serious. I did not go for the blood work. 11/08/2021 the bruises are there very faintly.
began getting hives which got worse and worse till today..     Hives are intense and mostly form at night.  Seem to be exacerbated by pressure/contact.  Usually start out raised and later change to a red splotch.  Start out itchy and later are painful.   Some leave a dark red splotch looks like broken capillaries.   Sleep is extremely adversely affected
Patient received 2nd Covid vaccine on 04/23/2021. About a month later she woke with Dupuytren's Contracture  w/ 3 cysts on palm of her right hand.  The cysts have since increased in number. The patient also is experiencing an intermittent burning sensation and soreness at the injection site.
Next day chills, muscle and body ache, headache and vomiting, and fatigue.
About 9 days after smallpox administration patient experienced loss of appetite, muscle aches, sore throat, neck pain, and headache that lasted for a total of 3-4 days. The site had redness and swelling around the site.
Patient was administrated with an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 38-year-old female patient who received HAB (Twinrix) (batch number x239d, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 12th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments: The medical assistance reported female patient was administrated with an expired dose of Twinrix on 12th August 2022 which was expired on 7th August 2022, which led to expired vaccine used.  The patient had no adverse event reported. The reporter did not consented to follow-up. Additional supportive information: The patient received expired dose of Twinrix which led expired vaccine used.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. On an unknown date in 2016, the patient was treated by the physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Fever up to 103.6 oral, weakness, body aches, passed out x 1. Advised to increase oral fluids and begin wtih Tylenol 500mg; take 2 tabs initially and then 1 tab every 6 hours thereafter x 48 hours per recommendation of Dr. To be seen in Occ. Health in am if no improvement.
Patient received vaccine around 4:30pm. After 10 minutes patient reported that she was having a headache, felt like her breathing was a little bit heavy. Patient was brought to exam room with mother present. BP was 150s/100, O2: 99%, HR: 65, RR 20. No distress noted. Patient was slightly anxious, continued to complain about headache. Denied any blurred vision, changes in vision, nausea, vomiting. Around 4:45, patient was asked to lay down for a while to be observed further and to give her time to relax.  Patient was given cold wash cloths for forehead. Patient suddenly became more increasing anxious at 4:49, complained of excruciating headache and bilateral arm pain. Oxygen remained at 100%. 911 called at 4:50pm. Paramedics arrived at 4:55pm. Paramedics checked patient's blood sugar: approximately 345. Patient reported last meal around 12:30pm. Patient was crying and continually stating that her head hurt. She was alert throughout the entire process and able to answer questions. Mother elected to have patient sent to ER for further evaluation.  Followed up with family on 04/14/2021. Mother reported that patient was held at hospital for 5 hours, was given norco for headache. Diagnosed with panic attack. Mother reports that patient is doing better today.
Patient medical history and concomitant medications were not reported. Patient stated, on 07Apr2021, he received his first dose of the COVID vaccine and approximately four days after that, he showed symptoms of having COVID, had cold and tested positive for COVID. He was dealing with that for a couple of weeks and on 28Apr, he was supposed to get the second dose but never did because I was dealing with COVID and its his understanding that once you have COVID, you are basically free from getting it for 90 days. So, somebody recommended not to get the second shot and so, he is not sure when he should be getting that. When questioned whether still experiencing the side effects, patient stated that he did not experience any side effects, he just got COVID and he was just having fever and headache. Patient asked if someone was going to tell him if he needs to get the second shot or when he should. The lab tests included SARS-CoV-2 test on an unspecified date in Apr2021 with result as positive. There is a product complaint component. Patient did not receive any treatment for the events headache and fever. Reporter seriousness for the events was unspecified.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
As I reported with first dose, a 4" diameter red raised bump on arm below injection about 2-3" (entire site red, puffy, hard) This one happened a little sooner. It would grow and migrate down and cleared up in about a week. Firm, hot, red. I did not go to ER this time. I did ice it and use ibuprofen.
Minor pain in injection site when pressed on; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 09:30 (Lot number: EW0185) at the age of 22 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anemia" (unspecified if ongoing). Concomitant medication(s) included: ALEVE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0170, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 19Apr2021, when the patient was 22 years old, for Covid-19 immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21Oct2021 23:45, outcome "not recovered", described as "Minor pain in injection site when pressed on". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks Aleve. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No Known allergies.  No follow-up attempts are possible. No further information is expected.
I received a J&J vaccine on 4/2/21, a Moderna booster on 10/31/21 and this Pfizer shot on 5/6/22.   On 5/20/22 I felt a ball of phlegm in the back of my throat that made it difficult to swallow and difficult to sleep. At-home antigen tests were negative on 5/21 and 5/22, congestion increased. Aches and low-grade fever started on 5/22. Positive rapid PCR test on 5/24. Cough started 5/24. Started rinsing and gargling with Listerine Zero 4x a day on 5/25, coughing practically stopped. Fever and chills gone by 5/26 a.m. Aches stopped 5/27. Coughing returned 5/30. Needed albuterol inhaler on 5/31. Bronchi are clear, sinuses still congested 6/1.
Moderna second booster shot was administered on April 6, 2022 to patient. She never had any problem with the other Moderna vaccines. She said her arm began to itch the day after (4/7/22) by Saturday (4/9/22) her arm was very red and pink from her scratching where the itching was located. She is fine otherwise no other symptoms or adverse effects.
Fever of 102, severe chills,  severe body aches, chest pain, rapid heart rate, joint pain, nauseau and vomitting, fatigue, red painful rash on left arm which was hot and painful to touch, swollen lymph nodes in arm pit and above collar bone on left side,  most symptoms lasted about 6 days.
This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 10Feb2021 at 07:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included multi-vitamin (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL); both for an unknown indication, from an unknown date and unknown of ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the left arm on an unknown date in Jan2021 at 10:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. On 10Feb2021 at 15:00, the patient experienced headache that started about 8 hours after receiving the second shot and continued through the next day. On 12Feb2021, 2 days after receiving the second shot, the patient experienced swelling in the lymph node in left arm pit. It was reported that the swelling gradually went down over the course of 2 weeks. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache and swelling in the lymph node in left arm pit was resolved on an unknown date in Feb2021.   No follow-up attempts are possible. No further information is expected.
aguesia; anosmia; fatigue; body aches; cough; shortness of breath; This is a spontaneous report from a contactable other-health care professional.  A 25-year-old male patient BNT162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number EK5730) in left arm, intramuscularly as dose 2, single on 23Mar2021 for covid-19 immunization. The patient age at vaccination was 24 years old. The patient medical history and concomitant medications were not reported. Vaccination history included BNT162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number EJ1685) in left arm, intramuscularly as dose 1, single on 01Mar2021 for covid-19 immunization. On 14Jul2021, the patient experienced aguesia, anosmia, fatigue, body aches, cough and shortness of breath. The outcome of events was Not recovered.  Follow-up attempts are completed. No further information is expected
Patient received the 2nd dose of Moderna COVID Vaccine on Wednesday 4/7/2021. He called the office today 4/12/2021 at approximately 9:00AM. He stated that his left arm was swollen from the shoulder, down to the his fingers. He said that the swelling started on Thursday 4/8/2021, and has not improved. I scheduled him to come into the office for an appointment with PA, at 10:20AM today, 4/12/2021. Patient was sent him to have an ultrasound, which showed DVT  in the left subclavian vein and internal jugular vein.
24 hours after third dose of Engerix-B pt presented with numbness & tingling of left arm and facial drop. Pt denies any reaction with first 2 doses
Skin rash, bruises, petechia, decreased platelet counts. Later diagnosed with Idiopathic thrombocytopenia purpura. Received one platelet transfusion when platelet counts were down to 3,000. Have had 6 intravenous immunoglobulin infusions (IVIg). So far, when platelet counts are low, will receive the IVIg. Discharge summary states fever. msv
Swatting a lot almost her bedsheet was wait; upset stomach; Joint pain,; tempera100.2C; extreme headache; 7 days she got hives; redness at upper arm dawn to elbow; burning; swelling for 5 days and after that symptoms subside; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (7 days she got hives), ERYTHEMA (redness at upper arm dawn to elbow), PAIN IN EXTREMITY (burning), SWELLING (swelling for 5 days and after that symptoms subside) and HYPERHIDROSIS (Swatting a lot almost her bedsheet was wait) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced URTICARIA (7 days she got hives), ERYTHEMA (redness at upper arm dawn to elbow), PAIN IN EXTREMITY (burning) and SWELLING (swelling for 5 days and after that symptoms subside). On 02-Feb-2021, the patient experienced HYPERHIDROSIS (Swatting a lot almost her bedsheet was wait), ABDOMINAL DISCOMFORT (upset stomach), ARTHRALGIA (Joint pain,), PYREXIA (tempera100.2C) and HEADACHE (extreme headache). At the time of the report, URTICARIA (7 days she got hives), ERYTHEMA (redness at upper arm dawn to elbow), PAIN IN EXTREMITY (burning), SWELLING (swelling for 5 days and after that symptoms subside), HYPERHIDROSIS (Swatting a lot almost her bedsheet was wait), ABDOMINAL DISCOMFORT (upset stomach), ARTHRALGIA (Joint pain,), PYREXIA (tempera100.2C) and HEADACHE (extreme headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.