chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Skin was really red; Itching; Hives like rash; Inflammation; Arm was so swollen; Hot to touch; Vaccination site Warmth to touch; Sore at the site of the injection / arm was sore for a couple of days / soreness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Skin was really red), PRURITUS (Itching), VACCINATION SITE WARMTH (Vaccination site Warmth to touch), INFLAMMATION (Inflammation) and PERIPHERAL SWELLING (Arm was so swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Arthritis. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 11-Jun-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced VACCINATION SITE PAIN (Sore at the site of the injection / arm was sore for a couple of days / soreness). On 15-Jun-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site Warmth to touch). On 18-Jun-2021, the patient experienced PRURITUS (Itching), INFLAMMATION (Inflammation), PERIPHERAL SWELLING (Arm was so swollen), FEELING HOT (Hot to touch) and VACCINATION SITE RASH (Hives like rash). On 20-Jun-2021, the patient experienced ERYTHEMA (Skin was really red). The patient was treated with HYDROCORTISONE at a dose of 1 % and PREDNISONE at a dose of 1 dosage form. On 14-Jun-2021, VACCINATION SITE PAIN (Sore at the site of the injection / arm was sore for a couple of days / soreness) had resolved. At the time of the report, ERYTHEMA (Skin was really red), VACCINATION SITE WARMTH (Vaccination site Warmth to touch), INFLAMMATION (Inflammation), FEELING HOT (Hot to touch) and VACCINATION SITE RASH (Hives like rash) outcome was unknown and PRURITUS (Itching) and PERIPHERAL SWELLING (Arm was so swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication administered included medications for blood pressure and a few herbs.   The patient stated that the second dose of Moderna vaccine was scheduled on 09-Jul-2021.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up document was received on 21-Jun-2021 and contains no new information. On 24-Jun-2021: Follow up document was received on 24-Jun-2021. Concomitant , treatment medication, additional events, onset date of event and outcome were updated. On 06-Jul-2021: Added Medical history Arthritis, Concomitant medication Prednisone . Added New Events Inflammation and peripheral swelling and changed outcome of the event for itching and peripheral swelling from unknown to recovered.
Headache, chills, vomiting, generalized weakness all over. Please note she and her two daughters came by place on December 19, 2009. All three got sick with the same symptoms. These symptoms lasted 2-3 weeks.
Hep B #3 given IM, left deltoid with problems on 08/11/2003. Awoke morning of 08/13/2003 AM with total body rash and small hives and urticaria.  No respiratory problems, rash was not painful.
Weird metal taste; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Weird metal taste) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Weird metal taste). At the time of the report, DYSGEUSIA (Weird metal taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported  No treatment medication was reported
Patient called pharmacy 2 days after receiving PNEUMOVAX vaccine and noticed still redness and swollen area around injection site.
pt recvd vax 7JAN93; pt neck 7 back itching real bad face & back w/fine red spots; started itching 10JAN93; swollen & puffy under eyes, under nose & around jaw; poss allergic rxn;
hurting a lot at the injection site; minor body aches, pain; fatigue; weakness; This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th November 2019, the patient received Shingrix. In November 2019, less than a day after receiving Shingrix, the patient experienced general body pain, fatigue and weakness. On 29th November 2019, the patient experienced injection site pain. The patient was treated with naproxen. On an unknown date, the outcome of the injection site pain, general body pain, fatigue and weakness were recovered/resolved.   It was unknown if the reporter considered the injection site pain, general body pain, fatigue and weakness to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in the afternoon. Around six or seven hours after vaccination, the patient's arm was hurting a lot at the injection site. He took 2 Naproxen which worked really well at alleviating the pain. It took his pain from a seven or eight to maybe a two or three. On 30th November 2019, in the morning, the patient awoke with minor body aches, pain, fatigue, and weakness. He took two more Naproxen which worked really well and he did not have anything after that.
No adverse events, the dose give above was the Pfizer Bivalent dose which is supposed to be the booster dose given after patient has completed the primary series. The dose patient was supposed to receive was the 1st dose in the original series, the monovalent pfizer. RPh on duty gave bivalent dose instead of the monovalent original series dose.
I had a 104 degree fever from Saturday through Tuesday afternoon  Very tired, nauseous Bad headache
Fever fever and chills Narrative:  OTC Tylenol alternating with Motrin as  needed  Other Relevant History:
Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 4 years old patient who received vaccine FLUZONE QUADRIVALENT injection lot no 3E5SX, expiry date: 30-Jun-2019 via intramuscular route on 15-Nov-2018. The patient received FLUZONE QUADRIVALENT also on 11-DEC-2015, 21-OCT-2016 and 13-OCT-2017. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included QUADRACEL for Immunisation. It was a case of actual medication error due to Inappropriate schedule of vaccine administered. It was reported that the patient who is currently 4 years old has never received the second FLUZONE QUADRIVALENT injection. No AE was reported. 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. Documents held by sender: none.
Swelling and redness at site, nightmares several nights,  fatigues,  had   labs done today and has appointment with MD 2/11.
24 hours after receiving shot: soreness at injection site, swelling about the size of a quarter, itchiness. Feels like and looks like a large mosquito bite.
edema extremity; allergic reaction; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of edema extremities in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-JUN-2023, the patient received the 1st dose of Shingrix. On 30-AUG-2023, 77 days after receiving Shingrix, the patient experienced edema extremities (Verbatim: edema extremity) and allergic reaction (Verbatim: allergic reaction). The outcome of the edema extremities was unknown and the outcome of the allergic reaction was not reported.   The reporter considered the edema extremities to be related to Shingrix. It was unknown if the reporter considered the allergic reaction to be related to Shingrix.     The company considered the edema extremities to be related to Shingrix. It was unknown if the company considered the allergic reaction to be related to Shingrix.   Additional Information: GSK receipt date: 23-OCT-2023 The patient received 1st dosage and reported allergic reaction, edema extremity to provider The reporter consented to follow up.
1245: Moderna COVID-19 vaccination to left deltoid 1249: episode of coolness sensation/loss of blood flow to bilat forearms and hands, lightheaded and increase in heart rate to 120, then nervous response and and increase in contractility-informed RN, heart rate quickly decreased to 100, then to 80/90s, followed by metal taste and feeling it move through mouth, throat, neck, chest; little twinges of pain various locations (left elbow, left TMJ, quickly dissipating).  Mild chest tightness/very mild sob upon exiting 30+min later with increase in mucus? (Clearing my throat, raspy voice for approx 2 hrs after vaccination).  Left tongue tingly. Very tired!  14:30: very tired, slight chest tightness 16:30: mild L.arm soreness 19:30: mild arm soreness, L.tongue tingly, increase in tinnitus (slightly more than normal), feel fine otherwise 1/9/2021: moderately sore left deltoid, mild intermittent nausea, otherwise fine
Hospitalized 01/26/2022; COVID-19 positive 01/29/2022; fully vaccinated  Hematologist/Oncologist: No care team member to display Primary Care Physician at Discharge: (Privacy), NP Admission Date: 1/29/2022 Discharge Date: 1/30/22 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Intractable nausea and vomiting [R11.2] Hematemesis with nausea [K92.0]   HOSPITAL COURSE: No notes on file   This is 35 y.o female who has hx of nasopharyngeal ca, who was admitted to hospital with intractable nausea and vomiting. Patient had 5-6 shots of Hennessey on Friday and post that developed nausea and vomiting, also had hematemesis. She had CT C/A/P in ED, results show concentric wall thickening involving the mid-distal esophagus. This is consistent with esophagitis. Consider further evaluation with upper endoscopy. GI consulted,  they recommend PPI and no scope currently. (she had recent EGD - esophageal stricture - bx neg for malignancy). Avoid NSAIDs, tobacco, etoh. Patient given IVF, replaced electrolytes and supportive care. Her sx have resolved, but still has some chest discomfort from vomiting. Patient also had positive covid test, and imaging also shows subtle groundglas opacities. Patient has no sx of PNA. Her case discussed with ID, no role for steroids or remdesevir. Patient stable to DC today, will have our cc make a follow up after her isolation ends.
Sxs onset 7/26. -Death Disease Report says that the patient was admitted to ICU. Admitted to hospital on 8/6 and died on 8/10. *Death DIsease Report said he was NOT admitted to hospital due to COVID.  *Death Disease Report said his death was NOT related to COVID.
2AUG3 arm swollen & red w/whelps; called MD 2AUG93 & told to take DPH; 11AUG93 temp up & down; sick to stomach; went to ER 11AUG(3; took blood test, gave ATB; 15AUG93 face red, feels bad; itching, nauseated;
Headache, Myalgia, also chills/warm, arm pain (injection site), fatigue Pt self reported N/A myalgia, chills/warm, headache, arm pain (injection site), fatigue and self medicated with 650mg tylenol oral. Event happened on same day of injection, first dose.
Headache, Body Aches, Swollen Glands (arm pits), sore throat, light headed/dizziness, nausea. tired.  Trainer made him see Dr to test for Myocarditis  SYMPTOMS LASTED 2 WEEKS
Vomiting, fever, chills, trouble swallowing, started at 3:00 pm 3 1/2 - 4 hour after vaccine administration vaccine administered at 11:30 AM.
Patient developed episodes of  palpitation, nausea, high Blood pressure and chills that lasted <5minutes each.   BP 140/82, HR 138, SPO 100  BP122/83, HR 95, SPO2 98 BP 119/87, HR 87, SPO2 98  Patient monitored for 1 hour and she is back to baseline without symptoms.
high fever, uncontrollable chills, loss of strength in arms;in bed for four days (15 through 18) excessive evil smelling urine-uncontrollable;tea & drying toast & advil-still wobbly;
Pharmacist reports that patient received first dose of VARIVAX as a child but did not complete series as recommended. Pharmacist reports that patient received the second dose as an adult. No additional details available. Call was disconnected before; No additional adverse events.; This spontaneous report was received from pharmacist and refers to a adult patient (exact age not reported) of unknown gender. The patient's medical, concurrent conditions and concomitant therapies were not reported.  On an unknown date, as child, the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (exact dose, lot #, expiry date, route of administration, and anatomic location were not provided) for prophylaxis. The patient did not complete series as recommended and on an unknown date, second dose was administered to adult patient (inappropriate schedule of product administration). No additional adverse events was reported.
Patient came back to the Pharmacy after one hour of receiving the flu shot. He has a bruise (swelling) on his upper side of left hand. The inject site was normal, no swelling, no sign of any bruising. Patient was able to move his arm normally but he was feeling soreness on his left hand. Patient did not experience any anaphylactic reaction. We gave him ice to put on it. Patient went to his doctor, but they could not figure out and advised him to come back after couple days. I called the patient after few hours to follow up and he told me that its still there but better than before.
I started getting a headache which eventually led to fever of 101, fatigue, chills, diarrhea, nauseated, vomiting, left arm where I received was beginning to turn red (redness in entire arm) and I was in a lot of pain, and I could not even walk had lots of pain in my legs and whole body. I could not move my left arm due to swelling and redness (turned to cellulitis). I felt paralyzed on the left side where I got my flu and pneuomonia shots. Dehydration. No appetite. Extreme pain.
Information was received on 19-APR-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine on or about 16-FEB-2011 at a health clinic, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-JAL-2014, the patient was treated at a hospital emergency department for a painful rash that was diagnosed by a physician as a severe case shingles. Although herpes zoster is an incurable viral condition, the patient was prescribed ZOFRAN and NORCO to manage the painful symptoms of shingles. As a direct and proximate result of these malfunctions, 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.
13 days after vaccine still feeling fatigue, chills at times, Headache at times. diarrhea this am.  Day 6 same symptoms plus brain fog at times didn't feel like thinking clearly,  Day 7 8/24 experienced unusually multiple  nightmares,  8/27 injection site became tender and warm when it had not been since 8/20, 8/28 injection site itching, 8/30 injection site no tenderness, warmth or itching,
Cold like symptoms including chest cough began Monday Feb 1, 1 week after vaccination. Tested positive for Civid 19 3 days later on Thursday Feb4.
Patient inadvertently received vaccine after published expiration date. Moderna company analyzed vaccine and advised lot 031L20A maintained activity necessary to protect against covid 19 on date of administration. Also patient did not call in to complain of adverse event.  This is administration error without adverse event.
I had numbness and tingling in left arm, face and neck about 5 minutes after receiving the shot in the same arm.   The numbness started in my arm and them radiated to my lower arm, up my neck and across my jaw, lips and up to my left eye.  From the start of the numbness to the time when the numbness started to go away was about 1 hour 30 minutes.  In the days, weeks, and months since receiving the shot, I still have occasional numbness in my left arm and face.  The numbness did not affect my eating, drinking or function.
I had a break-through Covid-19 case I had a cough and was prescribed Paxlovid.
A little of soar throat, symptom of a flu (running nose, feeling tiered, headaches) soar arm, soft stool(not too much), feeling of fever but not having actually fever and lack of appetite
little sore throat; muscle pain at the site of the injection; if it's fine to take a shot of steroid for her back; This is a spontaneous report from a Pfizer-sponsored program from a contactable female consumer. A female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced little sore throat and muscle pain at the site of the injection on an unspecified date. The reporter was asking if it was fine to take a shot of steroid for her back this Wednesday morning 27Jan2021. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot and batch number could not be obtained. No further information is expected.
On September 18, I woke up at 7am and found my left arm was extremely cold (like ice cold), my left arm was numb, I realized I had been sweating while asleep and I felt "off" - the most strangest "off" feeling I've ever felt.  I called 911 and at my request, I was transported to the emergency room.  Initial blood work showed my troponin levels were 1.2.  I was admitted and the following three blood tests showed my troponin levels as follows:  3.2 at 2pm on Sept. 18, 1.8 at 8pm on Sept. 18 and 1.0 at 2am on Sept. 19.  I remained in the hospital until the afternoon of Sept. 20.  Please see item 19 for additional information.
Erythema, swelling (R) 2 hours after vaccines. MEDROL Dose Pack on 10/18. 15 mg of IM TORADOL for pain. She also received 25 mg and 60 mg of IV BENADRYL and SOLU-MEDROL respectively. 10/20 KEFLEX 500 mg TID for 10 days and she is to use warm compresses to right arm.
very ill; Fever; no energy; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route administration in the right arm on 16Mar2021 at 00:00, (at the age of 53-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have allergies to medications, food, or other products. On 16Mar2021 at 20:00, the patient experienced fever, no energy, nauseous and very ill. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events illness, fever, loss of energy and nauseous was not recovered at the time of this report.   Information about lot number cannot be obtained. No further information is expected.
This spontaneous report as received from the physician assistant via the company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route unknown). On an unknown date after vaccination the patient developed a rash and shingles. The outcome of the event was unknown. Additional information has been requested.
Redness, warmth to arm. Levaquin 500mg IV for 3 doses.
Loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of Loss of taste in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced Loss of taste. At the time of the report, Loss of taste outcome was unknown.            This case was linked to US MODERNATX, INC MOD-2021-067136. Sender's Comments:  US MODERNATX, INC MOD-2021-067136 reporter's case
Was given the vaccine in the right arm and about 5-10 mins after being vaccinated as the patient was walking out of the consultation room the patient became lightheaded     Patient sat down for about 15 mins and given 2 small cups of water to sip
Pt presented for FLU vaccine.  Screening form reviewed  screening question- pt denied any food/med allergies, except mil.  Has had previous FLU shots.  After vaccine administered, pt slumped in chair- unresponsive to verbal commands.  Ready to call 911- pt awake, responsive, unaware he fainted. Pt stayed additional 10 min-alert and oriented.  Called pt at home at 2:30- pt states he feels fine, no complaints.
Change in pms symptoms December, early menstrual cycle in January, delayed menstrual cycle in February.
BLOODY LEFT EYE CHILLS/FEVER BODY ACHE HEADACHE  INDUCED MENSURATION WITH HEAVY BLEEDING  AND PASSING LARGE BLOOD CLOTS . I TOOK ONLY TYLENOL  1,000 MG TWO 3 TIMES AND FELT BETTER BUT STILL BLEEDING AND HAS RED EYE
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-DEC-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 48, 34 and R.; 144, 31 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
12/3/09 resented to ER from vvcc this AM as he was noted to have swelling of  left arm. Pt said that he noted that swelling yesetrdy morning as small swelling  on back of left hand and today progressed to involve whole arm. Pt stated that  there is pain 3/10 at the site of swelling but denied redness or increased local  temperature. Daughter reports upper extremity swelling was present `1 month  prior but was resolved with upper extremity elevation and warm packs. Pt stated  that he had bilateral LE swelling since 2 months now.