chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of vaccination site swelling (swelling where the needle went in) and vaccination site erythema (red circle where the needle went in) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 026A21A) for COVID-19 immunization. No medical history reported. On Mar 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 25, 2021, patient experienced vaccination site swelling (swelling where the needle went in) and vaccination site erythema (red circle where the needle went in). At the time of the report, vaccination site swelling (swelling where the needle went in) and vaccination site erythema (red circle where the needle went in): unresolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves patient of unknown demography who was supposed receive the doses 8 weeks apart but received the second unknown dose 5 weeks apart of vaccine MENACTRA (lot U5916BA and expiry date 20-Jul-2019) via unknown route in the left deltoid on 06-Nov-2018. The patient's past medical history included Asplenia. The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate schedule of vaccine administration. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Big part of the dose dripped out from injection site; Big part of the dose dripped out from injection site; A spontaneous report was received from a Consumer concerning a 74 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a big part of the dose dripped out from injection site/injection site extravasation and underdose.  The patient's medical history was not provided. No relevant concomitant medications were reported.     On 13 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 32H20A) intramuscularly for prophylaxis of COVID-19 infection.   On 13 Feb 2021 during vaccination, the patient experienced the device connection issue (Big part of the dose droped out from injection site) and underdose.  No Laboratory details were provided. No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the events, a big part of the dose dripped out from injection site/injection site extravasation and underdose was recovered.; Reporter's Comments: This report refers to a case of underdose and injection site extravasation for mRNA-1273 (lot # 32H20A) with no associated AEs reported.
Within minutes of receiving vaccination i had blurred vision, rapid heart rate, extreme nausea, rapid heart rate, shivering but a warm sensation that started in my abdomen that went into my chest. I became blotchy on left arm where injection was per nurse and my eye started to roll back in head per nurse. I was rushed down to Er where i was given water zofran and Benadryl and steroids. BLood pressure was high and pulse was elevated. Was sent home a few hours later w Epi pen and steroids to take over the course of four days. After coming home i developed at headache and fever and severe leg pain and fatigue that last until Saturday the 19th around the evening. I?m feeling better today Sunday the 20th. My main concern at this point is the arrhythmia and sometimes having shortness of breath.
This spontaneous report was received from a back office lead and refers to a 48 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L038499, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in left deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Platelet count decreased; This spontaneous case was reported by a physician and describes the occurrence of PLATELET COUNT DECREASED (Platelet count decreased) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) tablet for Myelofibrosis.    Concomitant products included CANNABIS, SIMETICONE (ALKA SELTZER ANTI GAS), IBUPROFEN, GABAPENTIN, OMEPRAZOLE, BISACODYL (DULCOLAX [BISACODYL]) and HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL AND HYDROCHLOROTHIAZIDE) for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 5 milligram twice a day. On an unknown date, the patient experienced PLATELET COUNT DECREASED (Platelet count decreased). At the time of the report, PLATELET COUNT DECREASED (Platelet count decreased) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: 48,000 (Low) Platelet Count decreased from 60,000 to 48,000.     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.   No Treatment medications was provided by the reporter.
Approx 12 hours after shot was administered I experienced intense nausea, shakiness, and aches.  These symptoms lasted for approx 24 hour, not resulting in any vomiting.  Weakness and some tenderness around injection site still remains 48 hours after shot.
Client returned to the clinic with c/o flushing  and feeling very hot, numb, tingly lips, itching on the face.  Benadryl 50 mg PO given. Patient added some of the previous c/o after the initial communication. Improvement after 15 minutes. Client remained with the Facility HCP.
The patient presented at the pharmacy on 7/2/2021 and reported having continuous arm pain and discomfort since the shot was given on 6/25/2021.  The arm  pain seems to be mostly focused in the joint and she has difficulty raising her arm overhead.  The pain has subsided some but she was concerned because its been over a week. The discomfort is affecting her job and has not completely resolved.
Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not provided. On an unknown date the patient was vaccinated with a dose of improperly stored VARIVAX (lot # M024677, expiration date 18-MAY-2018; dose and route unknown). No adverse symptoms were reported. This is one of two reports received from the same source. Additional information has been requested.
8/31/22 I went to pharmacy for the Prevnar 20 and the pharmacist cleaned the site and then injected particularly high on my arm. As soon as he injected it I had pain in my arm and shoulder. The pharmacist said it was normal. The pain persisted for weeks. When I saw my PCP in October with pain and low mobility in that left arm. I was prescribed physical therapy which I did in November and it slightly improved it. Pain still persisted, limited range of motion, it wakes me at night. I did see an orthopedic surgeon at the end of the year and he said it may have been injected into the Bursa. I was given a Cortisol Shot. I was fine for 5 months and then it came back with a vengeance. I went to my Rheumatologist who did X-rays. Nothing was significant besides mild arthritis. She did a cortisol injection but I had no relief with that cortisol shot. I got prescribed a new physical therapist regimen and I did that upon June this year. I am scheduled for an MRI next week (First week of July).
Narrative: Per PCP note in system: "He had second moderna [vaccine] on Monday and when he had the first shot he was asked to stay due to allergy from wasp bite. First shot he was lightheaded. {with the second dose of vaccine,] They did not keep him more than 15 min and he felt same as last time. He thought he had to be there for 30 min and they let him go and he got stuck in traffic and he started to have allergic reaction. He was not far from his house and he made it home and was having trouble breathing, his fiance is a nurse and was at work so he took pics and sent to her so she told him to call 911. His face was red and patch and his throat was closing down, he gave himself epi and called 911. He had trouble breathing and he used a second epi pen and he does not remember anything after that and he was taken to the ER and he had an allergic reaction to it." No notes found in system pertaining to hospitalization. Patient has since fully recovered.
Information has been received from a certified nurse midwife, for the Pregnancy Registry for GARDASIL, concerning a 17 year old female with asthma, hypersensitivity and no known drug allergies who on 03-JUN-2008 was vaccinated a 0.5 ml dose GARDASIL intramuscularly (lot number and injection route not reported). There was no concomitant medication. Subsequently the patient was found to be pregnant. Unspecified medical attention was sought. The patient's LMP was 30-MAR-2008, and the estimated delivery date is 04-JAN-2009. Follow-up information was received from a registered nurse concerning the 17 year old black female with asthma and obesity who on 03-JUN-2008 was vaccinated with the first dose of GARDASIL (lot number 659005/1522U). Concomitant medications included albuterol and Nasalcrom. On 11-SEP-2008, an ultrasound was performed (result unspecified). On an unspecified date, the patient had a CT culture which was positive. The patient was given Zithromax 1 g xl. On 10-JAN-2009, the patient delivered a female baby, weight 6 lb, 8.5 oz. The nurse reported that the baby was normal with no congenital anomalies and not other complications or abnormalities. No further information is available.
After about 6 hours had chills, shaking, fatigue, joint and muscle pain.
lost her sense of taste/nothing tastes the same/can't taste it/can't taste food; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost her sense of taste/nothing tastes the same/can't taste it/can't taste food) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hypertension, Anemia (due to esophagus bleeding), Incontinence and Reflux gastritis. Concomitant products included FERROUS SULFATE for Anemia, GATIFLOXACIN, LOTEPREDNOL ETABONATE (LOTREL G) for Blood pressure high, MIRABEGRON (MYRBETRIQ) for Incontinence, PANTOPRAZOLE for Reflux gastritis, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), PROBIOTIC 10 and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (lost her sense of taste/nothing tastes the same/can't taste it/can't taste food). At the time of the report, AGEUSIA (lost her sense of taste/nothing tastes the same/can't taste it/can't taste food) outcome was unknown.            Treatment details not provided.
She stated it was almost 24 hours "to the minute" from when she got the flu shot.  She had swelling in her arm, joint pain, night sweat, she is now coughing and feels phlegm in her lungs.  She has not seen her primary care physician.
Ran 103 to 104 fever; This is a spontaneous report from a contactable consumer (patient). An 18-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0171; Expiration date was not reported) on the right arm on 04Jun2021 (13:30) as a 2nd dose, single, with route of administration unspecified, for COVID-19 immunization at the public health clinic. Medical history included attention deficit hyperactivity disorder (ADHD) and asthma. Concomitant medication included lisdexamfetamine mesilate (VYVANSE). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0171; Expiration date was not reported) on 14May2021 (13:30) (when the patient was 18 years old) for COVID-19 immunization. On 05Jun2021 (12:00 AM), the patient had run a 103 to 104 fever. The event had resulted into an emergency room/department or urgent care visit. High dose of Motrin and intravenous (IV) fluids were administered to the patient as treatment for the event. The outcome of the event was recovering. The patient was not diagnosed with COVID-19 prior to vaccination; and had been tested for COVID-19 since the vaccination. The patient had a negative COVID-19 nasal swab (post-vaccination) on 05Jun2021.
Smelling constant chemical smell; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Smelling constant chemical smell) and HEADACHE (Headache) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced HEADACHE (Headache). On 14-Apr-2021, the patient experienced PAROSMIA (Smelling constant chemical smell). At the time of the report, PAROSMIA (Smelling constant chemical smell) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
4 yr old male with vaccination to right shoulder site IM RD is red, warm to touch, c/o mild pain, soreness.
Patient given vaccine, was okay, talking and walking normal about 12 minutes after shot patient complained to mom very dizzy. Patient went unconscious. Patient was layed on floor. approx. 1 min began to rouse, legs were elevated prior to this. She was "in and out" for few minutes. Patient was given sips of coke. 40 minutes after all this, till too dizzy to stand. Sent to ER.
REACTIVATION OF EPSTEIN-BARR, ONSET OF CHRONIC FATIGUE SYNDROME/ME; ONSET OF SEVERAL AUTOIMMUNE. DID NOT MOUNT ANTIBODIES.
5 hours after the vaccine was administered, she noticed arm redness and swelling on left arm. The next day, she had nasal congestion, sore throat, body aches, fever (101.0). Currently has body aches and a headache on 5/15/2023.
On 02/17/2022 I started having pain in my calve muscle in both legs. It felt like a pulled muscle and very difficult to walk. I went to a HCF on 02/24/2022 who referred me to get an Ultrasound with Cardiologist/Vascular specialist. I saw the Cardiologist/Vascular specialist for an ultrasound on 02/25/2022 and they found no clots. They repeated the Ultrasound on 03/08/2022 and the doctor did confirm my veins were enlarged/larger than normal and my legs were swelling at that point. In the process of talking to doctor or nurse. At the time I did I asked them if they seen more and more patients with this. They suggested I wear compression socks and if it didn't go down, they suggested surgery. I am not longer am experiencing pain at this time. I was also prescribed a furosemide 40mg I took for 12 days or PRN for swelling. I also did have 2 surgeries for infection on my chest for previous heart surgery one being in November so I am not sure if that caused this. He suggest to keep to keep moving. In the last two weeks I have not had the pain and I did not have to wear compression socks. I  only wear them if I am going to be on my feet for a long time.
Pt states she had throat irritation and breathing problems but took BENADRYL and okay. Pt states had flu shot before this time was fine until after eating Mexican so not sure what from.
3.5 days after vaccine started with fever.  Patient had syncopal episode with complete LOC that lasted 10-15 sec. Mom RN and felt pulse and barely palpable. Ready to start CPR and patient woke, very diaphoretic and pale. Took time to recover. At that time temp 100.6. No other signs of illness. Brought to the Emergency Room as not typical vasovagal syncope. Patient was well hydrated, walking when it occurred.
This spontaneous report was received from a doctor of pharmacy refers to unknown number of patients with unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (lot # not reported) dose and route not reported. No concomitant medications were reported. Reporter stated than an unspecified number of unspecified patients have experienced unspecified injection site reactions and soreness after receiving PNEUMOVAX 23 on unspecified dates. No further information is available. The outcome of the reported events were unknown. This is one of the several reports from the same reporter. Additional information is not expected.
got a little scared; This spontaneous case was reported by a consumer and describes the occurrence of PANIC ATTACK (got a little scared) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergic to sulfa).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PANIC ATTACK (got a little scared). At the time of the report, PANIC ATTACK (got a little scared) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Approximately 9 days after receiveing Covid19 shot I start having issues with my legs where they felt very heavy. Over the course of the next approx 17 days my legs got weaker, walking became more difficult, my balance started to be affected.  My legs would randomly collapse and I would fall.  By the 17th day I was barely able to walk and what little I could was only for very short distances, less than 50'!  On June 15th I went to the Emergency room located at where multiple tests were run on me.  I was admitted into the hospital with Guillan-Barre Syndrome and I was given four doses of Immune Globulin (IVIG) and sent over to rehabilitation.  After four days I went back to ER with recurring symptoms was returned to Rehab facility and five days later I  returned to hospital a 3rd time and was five more rounds of Immune Globulin, I have again been returned to rehabilitation facility.  As of this writing of this I have been hospitalized 23 days and I have at least 14 days more of rehabi before I can go home in a wheel chair.  My full revcovery outlook is 6-12 months.
Pt had shortness of breath/wheezing post vaccination. Pt had a steroid inhaler on hand and give one Epi Pen. Transferred to ED.
syncopal episode, unresponsive for one minute then AAOx3 yet groggy. EKG i s NSR with possible old MI? IV started, patient transported to hosptial. Pt states this, syncopal episodes, occurs on occasion.
Pt was given vaccines and approximately 5 minutes later he began feeling nauseous, and turned pale in color. Cold water and a cold towel was given, and Dr came in to check on pt. Pt. drank 2 glasses of water in 20 mins. Complexion returned and left w/ father.
Patient had received Janssen 4/8/21 as first dose.  Received first booster of Moderna Monovalent on 2/24/22.  Patient should have received a booster dose of Moderna Bivalent on 12/1/22 but instead another monovalent dose was given.  When patient was called to discuss error she was experiencing body aches as expected.
Itching; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EY0584, expiry date: not reported), via an unspecified route of administration on 24Jul2021 as dose 2, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EY0587), via an unspecified route of administration on 05Jul2021, as single dose for COVID-19 immunization. On 24Jul2021, after second dose,the patient experienced itching and had a doctor visit, took some unspecified medications in response to the event. It was reported that the medication gave some relief temporarily, but keep on coming back again. At the time of report, still it did not go away. The outcome of the event was not recovered.
1100: Client requesting BV booster 1120: Client inadvertently received Pfizer BV booster  1135: Client waited in lobby for adverse reactions 1155: client notified of early immunization.
approximately 3 hours prior to expiring the patient was experiencing forceful emesis.  later was found to have expired, patient was comfort care only.
Initial report received from pharmacist on 15 Jan 2010: The patient was vaccinated with FLUVIRIN (batch no.: 104045P1) on an unknown date. One dose of influenza vaccine that had been stored at temperatures as low as 34F and 35 F was given to an adult. No adverse effect was reported.
Flu shot given 10:30.  Ate lunch and took 500mg zithromycin at 11:30.  Within 20 minutes now lightheadness, nausea, shortness of breath, tachycardia.
Fever 101 to 102.5 5/7 -5/8 fussiness cellulitis to left upper thigh.
I started suffering from heart attack like sensations a few years ago with deltoid muscle pain and weakness. After the most recent 23/24 COVID booster the same symptoms returned suddenly.  Going back to the history this event has started and worsened approximately 1 weeks after a COVID vaccine. It has lead me to seek hospital care with check pains and was treated for about a year with severe muscle pain in the left side.
pt recv vax;exp muscle spasms in shoulders and arms;fever 103-106;to er and dx of ear infect;devel swollen testicles;brown discharge from penis;jerk & twist movements;poor appetite & irritability;gastroenteritis,rt hydrocele,diaper dermatit
Mild rash to neck and upper back- not itchy, just red starting at 9:30 pm on the night of the injection. The following morning- Body aches, headache, sore throat- moderate in severity.
RN was the vaccinator at the time and immediately after administration  patient complained of feeling light headed. Patient reported not having eaten prior to vaccination. Patient given Gatorade and crackers. At 11:40am patient  complained of feeling tingling in her tongue, difficulty breathing, and difficulty swallowing.  RN administered epi- pen at 11:41 am. 02 sat 99, BP 140/90, HR 80. Patient given therapeutic 02. Patient reported feeling improved.  Patient transported via EMS to ED.
Rash, shortness of breath occurred several hours after vaccine administered. Patient taken to ER by ambulance for treatment.