chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills after 2nd shot; Pain in joints after 2nd shot; Slight fever after 2nd shot; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills after 2nd shot), ARTHRALGIA (Pain in joints after 2nd shot) and PYREXIA (Slight fever after 2nd shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced CHILLS (Chills after 2nd shot), ARTHRALGIA (Pain in joints after 2nd shot) and PYREXIA (Slight fever after 2nd shot). At the time of the report, CHILLS (Chills after 2nd shot), ARTHRALGIA (Pain in joints after 2nd shot) and PYREXIA (Slight fever after 2nd shot) outcome was unknown.            No concomitant medicines reported. No treatment information reported.
Couldn't lift arm; Dermatitis on the right side; Felt like radioactive dye injection; Extreme heat/Heat sensation all over body; Extreme arm pain; Swelling; Injection site felt tender; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Couldn't lift arm), DERMATITIS (Dermatitis on the right side), FEELING ABNORMAL (Felt like radioactive dye injection), FEELING HOT (Extreme heat/Heat sensation all over body) and PAIN IN EXTREMITY (Extreme arm pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Tylenol) and drug allergy (codeine).    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MOBILITY DECREASED (Couldn't lift arm), DERMATITIS (Dermatitis on the right side), FEELING ABNORMAL (Felt like radioactive dye injection), FEELING HOT (Extreme heat/Heat sensation all over body), PAIN IN EXTREMITY (Extreme arm pain), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Injection site felt tender). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (Couldn't lift arm), DERMATITIS (Dermatitis on the right side), FEELING ABNORMAL (Felt like radioactive dye injection), FEELING HOT (Extreme heat/Heat sensation all over body), PAIN IN EXTREMITY (Extreme arm pain), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Injection site felt tender) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. no concomitant medications are provided.  nurse advised him to take Tylenol but he took naproxen instead. Patient also stated that several days after the injection he had dermatitis on the right side which lasted a few days.   This case was linked to US-MODERNATX, INC.-MOD-2021-054713 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054713:case for dose 1
Patient called pharmacy 6/15/22 to state that she received an immunization on 6/12/22 and is experiencing side effects. She states the site where she received the injection hurts to touch, swollen, red, hot and is about 2 inches big.
I have hives all over my back, chest stomach, neck, behind ears, lower abdomen, underarms, shoulder, and itchy ears
Approximately 65 hours post-vaccination patient felt profound fatigue, no appetite, and had increase in baseline chronic cough, and anosmia. Patient was admitted to the hospital on 12/21 due to worsening respiratory symptoms that required supplemental oxygen-initially 2L via nasal cannula. Patient was upgraded to ICU-level of care at 6:30PM 12/21 to receive high-flow nasal cannula, and has had one episode of fever (100.6) 12/22 at 7:00 AM.
1st shot-Had convulsions, hallucination 4/5 taken by Ambulance and sedated released 4/7 a couple days later got a throat infection  Cleared by 4/20 and received 2nd vaccination on 4/22.  Following day breaststroke were engorged and pelvis and buttock area hard for 4days; dehydrated h
Pt received vaccines at 1420. At 1425 pt c/o feeling dizzy and nauseated. No vomiting. After laying pt down, giving fluids and taking frequent vital signs, pt was brought down to ER at 1520.
On November 5, 2021, my daughter went to the pharmacy to receive her first dose.  The vaccine was taken due to College mandating the vaccine, in order for her to continue her studies. Patient was healthy with no issues prior to taking the vaccine.  The next day, November 6, 2021, Patient became extremely tired, which we dismissed, as that side effect was expected.   However, on November 6, 2021, nighttime, she started throwing up.  She vomited numerous throughout the night, and that lasted until November 10, 2021.  On November 20, 2021, she called me as I was driving home from work, extremely anxious, and crying, as she stated that she was vomiting blood.  I told that it might be from having throw up so  much during the past week.  She then send me a picture of the toilet bowl FULL of blood, and like blood clots stuck on the side on the toilet.  Her father then called me, and we agreed to take her to the emergency room.  At the emergency room she was informed that it was highly possible that the effects were from the vaccine, due to the current circumstances, including that she was not ill prior to the taking the vaccine.  There were numerous tests run, and everything came out normal.  She was then given an IV due to dehydration.   I then took her to her PCP to inform the Doctor of the occurrence.  She was observed by all of us, lethargic and dehydrated.  She was  prescribed by the ER and her PCP Zofran, as she had also been experiencing nausea.   During the course of her experiencing negative side effects due to the vaccine, she also missed work and school between the dates of November 9, 2021 and November 12, 2021.
Left arm injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported but it could be 62 or 63 years. The patient received Shingrix on left arm. After receiving Shingrix, the patient experienced left arm injection site pain which resolved in 1.5 days. The patient did not provide address, phone number or date of birth.  The reporter did not consent to follow up. This case was linked with case US2019209767, reported by the same reporter.
Case number PHHY2011US48972 is an initial spontaneous report received from a nurse on 02 Jun 2011. This report refers to 12 year old girl. She was vaccinated with MENVEO (batch number: 024011) 0.5 ml, intramuscularly on 01 Jun 2011. However, the Men A component was reconstituted with sterile water instead of Men CYW-135 liquid conjugate. No adverse event was reported following this drug administration error.
This spontaneous report as received from a non-health care professional via social media regarding a 14-year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (lot, expiry date, dose, strength and indication were not reported) for prophylaxis. On an unknown date, the patient experienced Lyme disease, post viral fatigue syndrome (myalgic encephalomyelitis) narcolepsy and chronic fatigue syndrome (CFS). The outcome of narcolepsy, post viral fatigue syndrome, chronic fatigue syndrome and Lyme disease was unknown. Causality for the events was not reported. Upon internal review the events Lyme disease and narcolepsy were determined to be medically significant. This is one of the three reports from the same reporter.
Patient administered expired dose from vial puncture more than 12 hours before administration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired dose from vial puncture more than 12 hours before administration) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021 at 9:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired dose from vial puncture more than 12 hours before administration). On 24-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered expired dose from vial puncture more than 12 hours before administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The vial was initially stored in the refrigerator on 23DEC2021. The  vial was first punctured on 23DEC2021 at  11:00AM and after post puncture vial was stored in refrigerator.
Information has been received from a 65 year old female registered nurse reported herself with no pertinent medical history and drug reactions/allergies who on 04-FEB-2011 was vaccinated with ZOSTAVAX, subcutaneous in upper right arm. On the same day she was also vaccinated PNEUMOVAX in the same arm. Other concomitant therapy included SYNTHROID and simvastatin (MSD). On an unspecified date, the nurse experienced a lot of pain and swelling around injection site of ZOSTAVAX in upper right arm, and she also reported her entire arm was very painful and she believe it is from the ZOSTAVAX injection site. No lab diagnostics studies were performed. It was unknown if she sought medical attention. Ibuprofen was given to treat AEs. At the time of report, the nurse present status was unknown. No further information is available.
Injection site reaction.  The reaction is an ~4-inch diameter, red, slightly swollen area that is warm to the touch.
p/vax pt c/o severe h/a; axillary T101.3; no non-aspirin product given; 9/9 spoke to mom pt ok; seen by MD; stated probably had a cold
The second dose caused headache, low grade fever, chills began 8 hours after vaccination and lasted 12 hours; took Tylenol and side effect dissipated  The fourth dose 5/23/22 caused soreness and minor swelling at injection site began 8 hours later; swelling continued to enlarge over the course of the next day (5/24/22); swelling on 5/25/22 became the size of a large egg, became itchy, red and sore and rash appeared (flat, red dots) at injection site confined in a circular pattern the size of a small round teacup; 5/26/22 the site is warm to the touch, decreased in swelling slightly, reddened and rash remains. Cortisone cream applied to the injection site once with no relief
Had swollen lymph nodes underneath the left arm of the injection. Swelling still exists, just not as much originally.
Seizure, Generalized Tonic-Clonic. First episode of seizure, about 24 hours after receiving vaccine. No fever at that time of seizure.
tired; This is a spontaneous report from a contactable nurse. A male patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient went to work afterwards, and was only tired after the administration on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
About 2 to 3 minutes after receiving my injection, I began to feel a burning sensation in my nostrils. It felt like a 4/10 pain. The burning sensation worsened when breathing through my nose. When trying breathing techniques to calm down (breathing deeply through the nose, exhaling out the mouth), the burning sensation deepened towards the back of my throat - but I never felt it in my lower throat and chest - only the top of my throat and nose.  The nurse on staff took me to a corner for closer evaluation. She had me remove my mask and checked my body for hives. I had no hives and the burning sensation occurred even after my mask was removed. She asked if I had trouble breathing or itchiness, I had neither of those symptoms. My heart rate was high and I began to hyperventilate because I was having a panic attack. I had no other symptoms besides the panic attack symptoms (tight chest, tingly face and hands, rapid heart rate, and dizziness) and the burning nostrils.  The sensation lasted about 5-10 minutes, then dissipated. I then put my mask back on after it was requested. I continued to be monitored by the nurse for another 20 minutes until I gained back my normal breathing and my heart rate lowered. I was scheduled for a 2nd dose and was dismissed with no other treatment or issues. I drove myself back home and rested for the remainder of the day.  I had no other symptoms that day, other than the typical sore arm, fatigue, and mild chills, which resolved themselves in a couple days. I had no other complications.
Baby stop growing 3 days later (7 weeks 3 days per sono); Baby stop growing 3 days later (7 weeks 3 days per sono); This is a spontaneous report from a contactable Other HCP. This Other HCP reported events for herself and fetus. This is a fetus report.   A 40-year-old mother received bnt162b2 (BNT162B2), dose 2 administered in Arm Left on 20Feb2021 (Batch/Lot Number: El9266) as SINGLE DOSE, dose 1 administered in Arm Left on 27Jan2021 (Batch/Lot Number: El3248) as SINGLE DOSE for covid-19 immunisation. The mother medical history included allergies: Shellfish. No other vaccine in four weeks. No COVID prior vaccination. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The mother was  pregnant. Last menstrual date: 04Jan2021. Due Date: 11Oct2021. The mother was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono) on 24Feb2021 08:00 AM. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient died on 24Feb2021 08:00 AM. It was not reported if an autopsy was performed.; Sender's Comments: Based on provided information and temporal association the reported events causal relationship with the suspect drug cannot be excluded. However there is very limited information provided in this report. Additional information is needed to better assess the case, including complete medical history and diagnostics workup. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021277400 Same reporter/drug, different patient /event (mother case); Reported Cause(s) of Death: Baby stop growing 3 days later (7 weeks 3 days per sono); Baby stop growing 3 days later (7 weeks 3 days per sono)
This spontaneous report as received from a healthcare worker who reported that approximately 71 individuals had been administered expired ZOSTAVAX vaccine, Lot # H011430, Expiration 12-SEP-2013 (dose and route were unknown), between the dates of 13-OCT-2013 and 15-OCT-2013. There were no reported adverse effects to any patient. The patients did not sought medical attention. Additional information has been requested.
Dizziness, Headache, Bilat LE edema, runny nose, periods of disorientation w/in 24 hours Narrative:
INJECTION SITE PAIN; SLIGHT FEVER; This spontaneous report received from a consumer concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe adult crohn's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced injection site pain. On 2021, the subject experienced slight fever. The action taken with covid-19 vaccine ad26.cov2.s, and adalimumab was not applicable. The outcome of the injection site pain and slight fever was not reported. This report was non-serious.
approximately 3-4 hours after injection severe pain developed in right deltoid muscle site of injection, Pain severity about 9 on scale 1-10.Unable to move arm due to pain. Swelling developed measuring about  3x5 inches extending from 1 inch below top of the shoulder tpo about 3 inches above elbow, The swelling was hot to touch, but minimal redness was observed. Sensation of flushing (all over but mostly face) started increasing at 5-7 hours (temp was rising at that time and was 100.2) and reached peak at 12 hours after injection, accompanied by chills and severe shivering.   Max temperature measured was 101.9 (oral) at 12 hours after injection. Profuse sweating during the night. Treatment started at 5 hours after injection: cold compresses to the arm Tylenol 1 gram every 6 hours x 2 days (4 doses total) Cetirize HCL 20 mg  every 24 hrs x 2 doses total Ibuprofen 800 mg q 12 hrs   Dexamethazone p.o. 6 mg at once and then  6 mg 12 hours later.  Symptoms started to improve  24-36 hrs after the injection and almost all  symptoms resolved  at 48 hrs, mild residual pain in right deltoid area remaining. without impact on the range of motion.
on April 3, 2021 woke up with  SHINGLES on the right ninth subcostal nerve.
Info has been received from a health professional concerning a pt who on 11/15/2002 was vaccinated with pneumococcal vaccine 23 polyvalent (lot #644105/0820M) subcutaneously into the left deltoid. Subsequently the pt developed local injection site reactions involving swelling, redness and soreness. According to the pt's physician the reaction was severe and the pt developed cellulitis. The pt went to the ER and was treated with cephalexin (Keflex). The pt was not hospitalized. The reporter also described the experiences of two other pts who were also vaccinated with pneumococcal vaccine 23 polyvalent (WAES #0212USA00646 and 0212USA00647). Additional info has been received from a physician concerning this 64-year-old male pt who is HIV positive "with a good T cell count and a low viral load." It was reported that the pt was not ill at the time of vaccination. Within 24 hours, on 11/16/2002, it was reported that the pt developed marked swelling, erythema, tenderness of the entire left arm extending from the site of the injection to the elbow. The pt was seen in the ER and was diagnosed with a reaction and a question of cellulitis. The pt recovered from his experiences on 11/19/2002. It was reported that the pt has never had an adverse event following prior vaccinations. Additional info is not expected.
4 days later on tues the 13th, and wed the 14th the patient experienced hives on thighs, upper arms, chest, and back. No SOB occurred. Pt reported this on 2/16/18 to me (PharmD).  I informed Dr. and in that conversation we both agreed to not give second dose due in 2 to 6 months.
Information has been received from a consumer concerning her a 36 month old son who, "probable when he was 18 months to 2 1/2 years old", was vaccinated with one dose of MMR II. There was no concomitant medication. Within a couple of hours after vaccination, the patient experienced fever and redness on the injection site. The patient's mother noticed that the patient couldn't eat normally for 3 to 4 days. Subsequently, the patient recovered. No further information is available.
mom relates that p/vax pt had a fever overnoc of 102 & leg @ site of DTP/HIB was red & swollen & had a piercing persistent cry for several hr;pt not seen by MD @ that time
torage temperature reached a high of 70.42 degrees F for 7 hours/no AE; No human error involved and stability data not reported in source document and vaccine administered hence non-case
This spontaneous report as received from a registered nurse via a company representative refers to a currently 66 year old female patient. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with PNEUMOVAX23 (injection, lot # K001504, expiry date 28-MAR-2015, dose and route were not provided). On an unknown date the patient experienced cellulitis after receiving PNEUMOVAX23. The patient sought medical attention by office visit on an unspecified date. The outcome of the event was not provided. Additional information has been requested.
Patient is a 56 y.o. year old male with PMH of COPD, CAD, DM, HTN, HLD presenting to the ED for cough and shortness of breath. Symptoms started one week prior to arrival. Patient states cough more frequently and productive of clear-yellow sputum. Dyspnea worse with exertion. Symptoms noticeable shortly after receiving first dose of pfizer COVID19 immunization today. Chest tightness though denies chest pain. No leg pain/swelling. Patient has been compliant with previously prescribed trilogy.
Left arm is warm to touch, swollen with erythema. Temp 101 degrees itchy at injection site only. Observed on 11/19/2010 at 1:15PM cool compresses, hydrocortisone cream, BENADRYL if needed. 11/24/10 redness gone, not itchy anymore. Seen in office 12/2/2010 resolved.