chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection arm was warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection arm was warm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN, FOLIC ACID, CALCIUM and MELOXICAM for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection arm was warm). At the time of the report, VACCINATION SITE WARMTH (Injection arm was warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was unknown This case pertains to patient 1. Patient 1 calling to report their spouse (patient 2, reported in another crosslinked case) and themselves got three doses of the Moderna vaccine already. First dose was on 07Jan2021 (lot#039K20A, expiration date 20Jun2021), second dose was on 04Feb2021 (lot#029K20A, expiration date 31Dec2026) and the third dose was on 04Sep2021 (lot#037F21A) for both. Neither patient is immunocompromised, although patient 1 has diabetes and had their thyroid removed, and patient 2 has high blood pressure. Patient 1 reports that the next days, after their first and second dose, their injection arm was warm. After the second dose patient 1 also experienced a little discomfort and body ache. After the third dose, administered on the left arm, the next day patient 1 had to much swelling on their left arm, it was very hot, lasting 2-3 days, and they experienced body aches and discomfort for a whole day, more severe than after the second dose, and they had to lay down. Patient 1 provides consent for Safety to follow up with them or their HCP. Patient 1 state that patient 2 had no reactions after getting the third dose. Patent mentions 3 other people got the third dose of the Moderna vaccine without any reactions. This will be reported in 3 different crosslinked cases   This case was linked to MOD-2021-318654, MOD-2021-318659 (Patient Link).
fever; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were provided.
This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX. Concomitant products included atorvastatin. On 22nd February 2018, the patient received the 1st dose of SHINGRIX 50 mcg/mg. On 22nd February 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. Rechallenge with SHINGRIX was positive. In February 2018, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: The reporter was a GlaxoSmithKline employee. The reporter was at a meeting a night before the date of reporting, where the patient at the meeting mentioned that she had the experienced sore arm at the injection site that lasted for 5 days. The patient also stated that this event was more severe as compared to the 2nd time when she experienced the events. This case was linked with case US2018GSK087986 (dose 2), reported by the same reporter for the same patient.
This spontaneous report as received from a office manager via company representative refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with the dose of ZOSTAVAX via 19400 plaque-forming units (PFU), injection (dose, route of administration, lot# and expiration date were not reported). On an unspecified date, the patient experienced unspecified reaction to ZOSTAVAX. The outcome of the adverse event was not provided. The causality between the adverse event and ZOSTAVAX was assessed as related. This is one of the two reports from the same source. Additional information has been requested.
she got achy; Her joints were hurting; She had a headache; Chills; Lymph nodes stayed swollen for a few months; She also had a fever with her 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Feb2021 11:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EK9231, Anatomical Location: Right arm, Time: 9:00), administration date: 14Jan2021, for Covid-19 Immunization, reaction(s): "Lymph nodes stayed swollen for a few months", "Achy", "Joints were hurting", "Had a headache", "Chills". The following information was reported: PAIN (non-serious) with onset 04Feb2021, outcome "recovered" (2021), described as "she got achy"; ARTHRALGIA (non-serious) with onset 04Feb2021, outcome "recovered" (2021), described as "Her joints were hurting"; HEADACHE (non-serious) with onset 04Feb2021, outcome "recovered" (2021), described as "She had a headache"; CHILLS (non-serious) with onset 04Feb2021, outcome "recovered" (2021), described as "Chills"; LYMPHADENOPATHY (non-serious) with onset 04Feb2021, outcome "recovered" (2021), described as "Lymph nodes stayed swollen for a few months"; PYREXIA (non-serious) with onset 04Feb2021, outcome "recovered" (2021), described as "She also had a fever with her 2nd dose". Therapeutic measures were not taken as a result of pain, arthralgia, headache, chills, lymphadenopathy, pyrexia.  The lot number for bnt162b2 was not provided and will be requested during follow up.
5 cm - swelling and heat at vaccine site. Rt thigh on site of PENTACEL.
Post vax, the patients arm was red, warm and black and blue above and below the injection site. On 08/15/2001 the patient was treated with Tylenol, Duricef and ice packs. On 08/16/2001 the patient's mother advised the patient is much improved.
This spontaneous report was received from a nurse via a company representative and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On unspecified dates, the patient was vaccinated with the first and the second dose of GARDASIL (dose, route, lot # and expiration date were not reported) for prevention of human papillomavirus (HPV) infection. Approximately in 2012 (reported as 5 years ago), the patient was vaccinated with the third dose of GARDASIL (dose, route, lot # and expiration date were not reported) for prevention of human papillomavirus (HPV) infection. On an unknown date, the patient had an abnormal Papanicolaou (PAP) smear which showed that she was positive for high-risk HPV, one of the strains covered by GARDASIL. The previous information was reported approximately in 2017 (stated as several months ago, late summer or early fall). No additional information was provided. The outcome of the patient was unknown. The causality between the event Papanicolaou smear positive and GARDASIL was not reported.
Patient was given the vaccine at approximately 11:40 am by technician. The patient was advised to wait for 15 minutes in the waiting area after the vaccination was given. During the 15 minute waiting period the patient fainted in the waiting area of the pharmacy. The patient was immediately assisted. The technicians were told to call 911 and management. Upon encountering the patient, the patient was gently rubbed and asked if he could hear me. The patient was immediately responsive and told me his name and date of birth. The patient was asked if he had any health conditions or prior incidents of fainting after a vaccination and the patient stated "no". The patient was provided water and asked if he could sit up. The patient stated that he could. The patient sat on the floor in an upright position for approximately ten minutes. The patient was then asked if he felt that he could stand to get back into the chair. The patient sat back in the chair and continued to drink water and take deep breaths. The patient stated that he still felt dizzy and nauseous. The patient's emergency contact was contacted to inform of the situation. EMT arrived at approximately 12:15 pm. Patient was asked by EMT's if he wanted to go to the hospital. The patient responded "no". The patient was then asked if they could "check him out" and he agreed. After assessing the patient the patient was taken to the hospital by ambulance.
Patient experienced nausea, vomiting, diarrhea and headache approximately 40 hours after receiving the flu shot. Patient was also having chills, whether it was a fever was not confirmed. Symptoms persist at the time of AE reporting.
Headache, vomiting 4 x approximately 30 min after receiving the vaccines.
After 2 days of receiving my first COVID vaccine, I started my menstrual cycle. My cycle was very heavy with large clots. It lasted four weeks. Very unusual, I never had a menstrual cycle like this before.
My first shot on April 21, i woke up  on the 22 with a terrible headache, nauseus, my shoulder hurt to my neck, and I  ached like i had hte flu, shaking, and did  not eat until the afternoon of the 23rd when all the symptoms subsided.  On the24th i  started coughing for a few days.. i thought at the time mabye i have allergies this year,  i coughed a day here and there until the night of Friday May14th- i coughed noon stop all day until  Tuesday night, the 18th. I was fine Wedn day and got my second shot ( i let them know about the coughing) i woke up Thursday with a 100 temp and all the same exact symptoms as above..thursday night i called dr because my fever got to 102 and i was really nauseus, headache, eyes hurt, i couldnt break the fever and i was so miserable and a little scared. Friday the 21st my fevor broke in the afternoon. I woke up on the 22 coughing really bad again with headache and its still lingering. I am exhusted, my head hurts, but am feeling better. i called dr  last night and he said to try  allergy medicine to see if that can help he symptoms.  and to follow up in a few days.
Post vax, pt fainted with jerking motions to head and arms, lips blue, cold sweats on upper lip, ammonia used. Jerking episode lasted for several seconds. BP monitored for 1 hour running from 110/80 to 90/60. Pt status did not improve. She was complaining about epigastric pain. Report will follow when received from hospital.
low fever at 7 hour mark = 100.4 fever at 20 hour mark for 7 hours = 102.5 severe body aches and headache fever subsided at 30 hour mark of course my arm hurt really badly, but it always hurts badly from an intramuscular shot
About 30 min after the vaccine, I started to feel symptoms. I had a fever, chills, vomiting, diarrhea. The next day, my arm swelled up at the injection site and was extremely tender, hot, and my whole arm was swollen as well.
Rash on both forearms; Itching; Bumps; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 05Apr2021 at 16:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, hypertension, COPD (chronic obstructive pulmonary disease), asthma, fibromyalgia, anxiety, depression, arthritis and fatty liver. The patient had no known allergies to medications, food, or other products. Concomitant medications included  many prescribed medications (MANUFACTURER UNKNOWN) taken on unknown date for unknown 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 06Apr2021 at 00:00, the patient experienced rash on both forearms and bumps (swelling) and itching. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures taken were unknown. The clinical outcome of the events rash on both forearms and bumps and itching were unknown at the time of this report.    No follow-up attempts are needed. No further information is expected.
Information has been received from a hospital staff member concerning a patient who was vaccinated with the second dose of ROTATEQ vaccine(Lot number was not provided) at four months of age.  Subsequently the patient was vaccinated with the third dose four days later by mistake.  No adverse event was reported.  It was unknown whether medical attention was sought.  There was no product quality complaint.  Additional information is expected. This is in follow-up to report (s) previously submitted on 9/17/2007.  Additional information is not expected.
This RPH was called to assist patient at 11:27a. Patient stated he felt dizzy and I assisted patient to the floor. Once laying on floor I elevated patient's feet above his head. By stander reported that patient appeared to have blacked out right before I arrived on scene. Patient stayed upright in chair during blackout which only lasted a few seconds.  Patient stated he did eat breakfast but had not slept due to working overnight. Patient was assisted to sitting position on floor at 11:33a at which time he drank a bottle of water. After finishing bottle of water he stated he felt dizzy again and I assisted him back to a laying position on floor.  After 10 minutes I assisted patient back to a sitting position. After sitting for a few seconds patient stated he felt like he would get sick. Before I could return, patient vomitted on himself and over the floor. Patient continued to vomit/dry heave into trashcan for a few minutes. After patient was done getting sick, he drank another bottle of water. He sat for a few minutes prior to standing. At this time patient's mother-in-law had arrived at store to take patient home. Patient wanted to leave store immediately as he felt it was making him more uncomfortable due to current condition. Patient left store approximately 12p.
PAIN IN LEGS; CHILLS; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced pain in legs, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in legs, fever and chills was not reported. This report was non-serious.
This spontaneous report was received from a physician referring to a 11-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 21-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
She experienced severe pain (muscle spasm) in left leg & hip about 1 & 1/2 hour after vaccine. She wasn't able to walk. Pain resolved in 4 days. She had to take pain med (VICODIN). Pain only occur on side of vaccination.
Right arm swelled, warm to touch 11/3, red patches around injection site. Benadryl 50 mg and Tylenol 1000 mg. No fever. Arm sore to touch.  Local reaction right deltoid
10-5-2015 woke at 2:30AM throbbing left shoulder, left knee, left baby toe-iced, elevated-arm in sling. Could not walk. 10-13-2015 Saw Dr (internist) labs ordered, Rx: prednisone, Nabumetone and omeprazole. 10-15-2015 Knee worsened-no improvement in shoulder or toe. 10-16-2015 Saw Dr (orthopedist) removed fluid from knee-ran labs for gout or infection (Negative) gave me a cortisone shot which made it possible to barely walk-PT recommended (at home). 10-26-2015 Saw Dr-shoulder worsening-told to sleep upright. 12-3-2015 Saw Dr (finally) orthopedist for shoulders. Sent to PT. 12-26-2015 Saw Dr for cortisone shot in shoulder. 12-29-15 to 4-3-2016 Went away for winter-very debilitated. 4-2016 MRI of left knee showed meniscus tear-PT prescribed by Dr. 9-2016 Dr. did left knee meniscus surgery and Rx PT. 5-2016 Saw Dr (foot ortho)-he referred me to Rheumatology and had Rheum. labs ran. 7-2016 Saw Dr (Rheumatology)-he thought NEGATIVE. Drugs: from 10/16/2015 to 6-2017 Naproxen 500mg 3/day and Omeprazole for all 3 areas of pain. 6-2017 Labs showed I had diminished kidney function so I stopped Naproxen and Omeprazole. Permanent Damage: Swelling in knee caused medial meniscus tear, so needed surgery and soon full replacement. Now I have bone on bone and limited in my movements. My left shoulder required I sleep elevated, and support that arm when sitting or laying down or pain intensifies. Shoe adjustments to accommodate toe pain. Kidney function. Fear of flu shot. Conclusion reached by doctors involved: High dosage shot had 4 times the heavy metals in it and they were attracted to my chronic arthritic sites-causing the FLARES-which in turn caused damage in these joints.
Patient received vaccine at 3:53 PM and while waiting in the lobby said she started having headache and dry throat at 4:10 PM and immediately see by a MD. Patient monitored for 30 min and discharged t 5:10 PM with daughter and advised on ER precautions if symptoms persists or gets worst.
Patient presented with enlarged infrarenal and iliac artery aneurysm.  He underwent enndovascular repair via bilateral femoral percutaneous access. Hospital admission within 6 weeks of receiving the COVID vaccine.
This spontaneous report as received from a registered nurse refers to a 63 year old patient of an unknown gender. Patient's concurrent conditions, medical history and concomitant therapies were not provided. On 21-JUN-2017, the patient was vaccinated with an expired first dose of PNEUMOVAX 23 lot # L048265 exp. 10-JUN-2017 for prophylaxis. No adverse effects were reported. Additional information has been requested.
3 hours, post vax, pt developed trembling, abdominal pain which progressed to nausea, retching and vomiting which lasted 3-4 hours, then resolved. Not examined; this reported by the mother.
I developed generalized pruritus, sore throat, lip and tongue tingling and numbness. Symptoms started 30 min after the injection and progressively got worse. Took Zyrtec without much relief. Took Benadryl 25mg when lip tingling and Buke ness started and went to bed. Symptoms resolved by morning.
Pt had fist sited swelling in LA on evening of 5/18/05. By the afternoon of 5/19/05. Swelling wrapped around arm and extended distally past elbow. Hot to touch.
pain 3/10 right deltoid affected site 98.6, 84, 20, 97 % on room air, 117/79, 5 ft., 134.2 lbs. Right deltoid area  with erythematous  patch  appears oval size shape approximately  1.5-inch x 3/4 inch in diameter, afebrile, no ulceration
Headache, Myalgia, NauseaVomiting, headaches, body aches and mild chills with mild nausea feeling after vaccine.; resolving with ADvil and Tylenol Narrative:
Bones ache, fatigue, arm soreness along with whole body aches, sweating, depression, can't think clearly, chest pain been feeling like this since I got vaccine on November 19th but I haven't been to a doctor yet. I don't know if this is long term yet but I still feel sick. It's been 2 days and am still in pain. I can't sleep or eat. There's a big red lump on my arm where they injected me.
This case was reported by a physician and described the occurrence in hives in a 48-year-old female subject who received Wellbutrin and vaccination with FluLaval vaccine for prophlaxis. Concurrent medications included unknown concurrent medications. Medical history was not provided. On an unspecified date in 2006 before 03 November 2006, the subject initiated therapy with Wellbutrin for an unspecified drug indication. On 03 November 2006 the subject received a dose of FluLaval. On 03 November 2006, the  subject had been receiving Wellbutrin for "weeks". About 4 hours following immunization with FluLaval and "weeks" after initiation of Wellbutrin, on 03 November 2006, the subject developed a rash/hives and went to the emergency room. The subject also experienced a urinary tract infection that developed on an unspecified date on or after 03 November 2006 and before 21 November 2006. The physician considered that the events were probably related to vaccination with FluLaval or therapy with Wellbutrin. At the time of initial reporting, 21 November 2006, the events were improved.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date approximately in May 2013 (also reported as approximately 7 months ago) the patient was vaccinated with GARDASIL dose 1. On an unknown date approximately in 2013 (also reported as approximately 5 and one half month later than the first dose) the patient was vaccinated with GARDASIL dose 2 and on an unknown date approximately in 2013 (also reported as approximately 5 weeks after the second dose). No adverse events were reported. No product quality issue was reported. Additional information has been requested.