chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SORENESS IN RIGHT ARM; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (SORENESS IN RIGHT ARM) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In April 2021, the patient experienced PAIN IN EXTREMITY (SORENESS IN RIGHT ARM). In 2021, PAIN IN EXTREMITY (SORENESS IN RIGHT ARM) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  The patient reported in Apr 2021, she had first covid vaccine and her right arm was really sore for about 12 days. But it was okay as of 18 Nov 2021.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-642680.
sore arm after first dose; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (sore arm after first dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart transplant (heart transplant patient   ).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm after first dose). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at a dose of 1 dosage form. At the time of the report, MYALGIA (sore arm after first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitantly, the patient was taking steroid shots every 6 months. Patient reported she was on a lot of medication given this and did not list them.   This case was linked to MOD-2021-230116 (Patient Link).
Information has been received from a registered nurse concerning a 26 year old female who on 25-JUN-2009 was vaccinated with the first dose of GARDASIL (lot# 662518/0087Y, 0.5ml, route and site of administration not reported). Concomitant therapy included (ZOLOFT), amphetamine (ADDERALL TABLETS), (XANAX), (AMBIEN), (CLEOCIN) and (NUVARING). The patient's relevant medical history and past drug history were unknown. On 25-JUN-2009 the patient reported feeling weak, tired and mentally slow. As of 25-JUN-2009 the patient was still feeling weak, tired and mentally slow. It was unknown if the patient would continue to take the GARDASIL vaccine. Additional information has been requested.
It was around May 3rd 2021 that I got Bronchitis out of the blue it was weird, I went into the ER for that and was put on antibiotics and an inhaler. Well I started having a sinus infection sometime in May and around June the 17th 2021 is when I had a telehealth appointment with my DR. That was happening and let me see, then I went back in to the DR on July 2nd 2021 and they had to do a check up and they put me on a lot of medications for allergies basically. I still feel the same though. I was put on doxycycline and feel no difference. I had an allergic reaction to Ellipta medication, I had a bad reaction to that one. I also got Claritin, Flonase, albuterol inhaler along with the doxycycline.
thrombocytopenia; neutropenia; facial paralysis; Body felt flushed; body felt warm; reaction to her myasthenia gravis symptoms; tremors; not been able to swallow the water; esophagus spazzing; acute exacerbation to her myasthenia gravis; couldn't eat for 7 days in hospital, needed feeding tube; symptoms of rheumatoid arthritis; A spontaneous report was received from consumer who is a 72-year-old, female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Flushing (Body felt flushed), Feeling hot (body felt warm) , Myasthenic syndrome (reaction to her myasthenia gravis symptoms), Oesophageal spasm (esophagus spazzing), feeding tube user (couldn't eat for 7 days in hospital, needed feeding tube), Condition aggravated (acute exacerbation to her myasthenia gravis) , Neutropenia (neutropenia) , Thrombocytopenia (thrombocytopenia), Rheumatoid arthritis (symptoms of rheumatoid arthritis), Facial paralysis (facial paralysis), Tremor (tremors), and Dysphagia (not been able to swallow the water)   The patient's medical history included Myasthenia Gravis and breast cancer. No relevant laboratory tests were reported. Concomitant medications included: mestinon, pantoprazole, tamoxifene, methylprednisolone, clopidogrel, rosuvastatin, leflunomide, oxybutynin, actemra, vitamin B12, vitamin D3.  On 04-MAR-2021, the patient received her  first of two planned doses on her left non dominant deltoidof mRNA-1273 (lot/batch: 025A21A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 04-MAR-2021, patient had reaction to her Myasthenia Gravis symptoms as she started having facial paralysis and tremors and  not been able to swallow the water due to her esophagus spazzing. She  admitted to the hospital for 11 days and finally discharged on 15-MAR-2021. While in the hospital she could not eat for 7 days so she was placed on a feeding tube.  Patient provided with the treatment: IV plasmapheresis, feeding tube put in, endoscopy, platelets and blood infusion, and medications to keep unspecified blood levels.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, flushing, feeling hot, Myasthenic Syndrome,  esophageal spasm , feeding tube user, condition aggravated, neutropenia, thrombocytopenia, rheumatoid arthritis, facial paralysis, tremor, dysphagia was resolved on 15-MAR-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's advanced age along with underlying conditions may have been contributory for the occurrence of the events.
Information has been received from a registered pharmacist concerning a 72 year old female with no known drug reaction or allergies who on 30-MAY-2012 was vaccinated subcutaneously in the left arm with a dose of (Lot# 670754/0621AA, expired date 26-JUL-2012, dose not reported). On 31-MAY-2012 the patient developed "hives/rash that looked like big, round, red welts. These hives appeared on the back, chest and abdomen. There was no swelling or itching. It looked like a ringwarm infection in the middle of the hives". The patient also had headache and also "nerve pain in the right arm". The patient came to the pharmacy for medical attention. The pharmacist told the patient to start BENADRYL and cortisone as treatment. There was no any lab and diagnostic test performed. At the time of this report, the status of the patient was unknown. Follow up information has been received from a pharmacist who reported that the female patient on 31-MAY-2012, experienced red welts all over the body, It was described by the pharmacist that the patient said that red welts all over the body disappeared after about 5 days about 05-JUN-2012, the patient was doing fine. The outcome of the other events was unknown. No further information is available.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 18-OCT-2012 the patient received an expired dose of ZOSTAVAX (lot # not reported). No symptoms reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Menveo was reconstituted with sterile water and administered to a patient; Menveo was reconstituted with sterile water and administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA927A, expiry date 31-MAY-2024) for prophylaxis.   On 04-AUG-2023, the patient received Menveo. On 04-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo was reconstituted with sterile water and administered to a patient) and inappropriate dose of vaccine administered (Verbatim: Menveo was reconstituted with sterile water and administered to a patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 08-AUG-2023 The nurse reported Menveo was reconstituted with sterile water and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter The reporter consented to follow up.
Temperature 100-101F, upper left arm where vaccine given swollen, not red nor indurated. Was dizzy this morning. Better after breakfast. Developed 2 hives, on in left axilla, one in hand. Improved with benedryl and mortin. On 11/9/02, developed HA, point pain. Lasted 24 hours, completely improved by 11/1//02, back to school, per mom.
Using Pentacel off Label with Pediarix on both VFC and Private; Initial information was received on 21-Jun-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (under reference number: US-SA-SAC20210628000362).  It was reported that DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was used off Label with DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [PEDIADRIX] on both VFC and Private on an unknown date for prophylactic vaccination (off label use).  It was a case of actual medication error due to off label use.  At the time of report, 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 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.  There will be no information available on batch number for this case.
much more dizzy than first vaccine. Completely weak. 2/11 Next day: same symptoms plus chilled all day. No appetite. 2/12 third day: weakness subsiding, slightly dizzy, very little appetite. 2/13 fourth day: Legs weak but much improvement
High pitched tone in head; 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 HYPERTONIA (High pitched tone in head) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 HYPERTONIA (High pitched tone in head). At the time of the report, HYPERTONIA (High pitched tone in head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Redness, itching, swelling, increase in size since immunization given. Pt reports no other reactions otherwise. Was only giving ice therapy, and was counseled today (1/31/15) to begin Benadryl as directed.
Received both vaccines on 1/14/21 and 2/4/21. On 2/4/21 went to ICC with complaints of fatigue, loss of appetite, body aches, chills, nausea, headache, sore throat, and nasal drainage x3 days. Diagnosed with Acute viral syndrome
Pt felt itchy 10 to 20 min after shot and noticed rash and redness 2 to 3 hours later rash on upper arms, chest, back and neck. Benadryl 50mg IM, Prednisone 10mg po 60/60-40/40-20/20-10/10, Hydroxyzine 25mg 1 tab every 6 hours.
The adverse event was heart palpitations whereby heartbeat stopped for 2-4 seconds then resumed as evidenced by strong thump in the chest, the event repeated approximately 12 times over the course of 1/2 hour during which time 102 deg. F fever was measured.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, drug reactions or allergies and concomitant medication were not reported. From 17-APR-2017 to 11-MAY-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M037770, expiry date 01-JUN-2019 and lot # M043731, expiry date 22-JUN-2019; dose and route were not reported). The doses were stored under temperature of 47F to 77F for 84 hours. There was no previous temperature excursion and data logger was not involved. No adverse reactions were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007430.
Information has been received from a medical assistant concerning another female medical assistant, at the age of 37 year old, with diabetes and high triglycerides and a history of heart attack in 2005 who on 06-MAY-2010 was administered VARIVAX (Merck) (lot# 665909/1648Y) and MMR II (Lot# 665874/1335Y) to a patient and some of the vaccines got in her right eye and nose. Concomitant therapy included metoprolol, enalapril maleate, aspirin, insulin, metformin and niacin. On 06-MAY-2010 the patient was experiencing burning in the right eye and burning in the nose. She flushed her eye out with water. The medical assistant stated that the nose was better, eyes were still irritated and itchy but now she felt like her throat was burning. She sought medical attention in the office. There were no laboratory diagnostics studies performed. At the time of this report, the patient had not recovered. The patient's conditions were considered to be other important medical events by the reporter. Additional information has been requested.
Approximately 12 pm the patient fainted in bathroom and hit her head. Patient received a flu vaccine at approximately 10:30 AM.
burning a little bit but nothing out of the ordinary; itching; little sore; it was a pretty big round red spot. it was itchy and hard, and red; it was a pretty big round red spot. it was itchy and hard, and red; it was a pretty big round red spot. it was itchy and hard, and red; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (burning a little bit but nothing out of the ordinary), PRURITUS (itching), PAIN IN EXTREMITY (little sore), VACCINATION SITE INDURATION (it was a pretty big round red spot. it was itchy and hard, and red) and VACCINATION SITE PRURITUS (it was a pretty big round red spot. it was itchy and hard, and red) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Asthma. Concomitant products included ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced BURNING SENSATION (burning a little bit but nothing out of the ordinary), PRURITUS (itching), PAIN IN EXTREMITY (little sore), VACCINATION SITE INDURATION (it was a pretty big round red spot. it was itchy and hard, and red), VACCINATION SITE PRURITUS (it was a pretty big round red spot. it was itchy and hard, and red) and VACCINATION SITE ERYTHEMA (it was a pretty big round red spot. it was itchy and hard, and red). At the time of the report, BURNING SENSATION (burning a little bit but nothing out of the ordinary), PRURITUS (itching), PAIN IN EXTREMITY (little sore), VACCINATION SITE INDURATION (it was a pretty big round red spot. it was itchy and hard, and red), VACCINATION SITE PRURITUS (it was a pretty big round red spot. it was itchy and hard, and red) and VACCINATION SITE ERYTHEMA (it was a pretty big round red spot. it was itchy and hard, and red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Developed petechial lesions on bilateral lower legs Tuesday 10/3.  Seen in clinic Thursday 10/5.  Most lesions beginning to fade.  No new lesions developing.  No known trauma.  Patient otherwise eating and playful.
First Vaccine received on Feb. 28, 2021 in right arm with mild fever and lethargy beginning around six hours after injection and lasting for several days-manageable with Tylenol. Second Vaccine received on March 22, 2021: very small amount of soreness in left arm for first day.  Begun to feel ill after about 15 hours.  Fever of 100 with major body aches and chills for about 24 hours after this, not managed by Tylenol this time.  Forty-eight hours after the injection the soreness at the injection site was minimal but there was major swelling and pain in the lymph nodes underneath the left arm as well as general fluid retention all over ( five pound weight gain overnight).  This swelling and pain was also present in the left chest area and continued for about four days with extreme discomfort. At this point, one week after the injection, the pain and swelling in the left armpit is reduced to mild discomfort and fluid retention has also reduced.
pt recv vax 23OCT95 & 13FEB97 presented w/several small lesions on trunk & one on scalp which was suspicious for typical chickenpox;pt recovered;
Began with an itchy top left hand (same side as injection site).  Raised bumps began appearing on both hands and up to the right wrist.  Looks similar to heat rash. Extremely itchy.  Irritation and itch continues on both hands and wrist and continue on to the lower back and abdomen three days later.  Topical anti-itch creams have been applied- very little relief.
Information has been received from a physician concerning an 18 year old male who on 14-OCT-1994 and 21-FEB-2001 was vaccinated with the first and the second doses of MMR II respectively. On 09-NOV-2009 the patient experienced mumps. On 26-NOV-2009, the patient was diagnosed and the patient was afebrile. The patient had left parotitis. The parotitis count was 83. At the time of the report, the outcome of the patient was unknown. Follow up information has been received from a physician reported that on 09-JAN-2010 (also reported as 09-NOV-2009) the 18 year old (also reported as 12 year old) patient experienced mumps. On 10-JAN-2010 (also reported as 26-NOV-2009) the patient was diagnosed and the patient's body temperature was 102.8 degree Fahrenheit (also reported as afebrile). It was reported that the patient was exposed to others with mumps 2 weeks ago. This is one of several reports from the same source. Additional information has been requested.
mononucleosis; This spontaneous report was received from a nurse practitioner and refers to a 12-year-old male patient. He had no pertinent medical history, no drug reactions or allergies and no concomitant therapy. On 27-NOV-2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (lot number, expiration date and dose were not reported) for the prevention of human papilloma virus (HPV). On 26-MAR-2018, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (lot number, expiration date and dose were not reported) for the prevention of HPV. On an unknown date in October 2019, the patient was diagnosed with mononucleosis. The patient sought medical attention and had an office visit, however, no treatment was given to the patient for the event. Also no lab diagnostics or studies were performed. The outcome of the event was reported as recovered on an unknown date. The relatedness between the event and suspect therapy was not provided.
I took the vaccine at Pharmacy on November 20, 2014. Within a couple of hours I began to ache, particularly in my lower back and down my legs. I developed a rash on one side of my body, stuffiness in my sinuses, felt generally very unwell and had a hard time sleeping and getting up and out of the bed the next morning. The following day I had diarrhea and felt generally unwell. I took one Aleve the second day and no longer has leg and back pain. The attendant gave the shot in what appeared to be my shoulder socket. It was quite painful. I believe that my body worked so hard to overcome the vaccination that it might have been at risk for other viruses. I have had some sort of a reaction with every flu shot taken since the vaccinations have not been live. In the old days, our doctor would give half the live dose then the other half in two weeks. No one became ill. Can the current vaccines also be given in two dosages? It seems the dosage is the same whether you are 100 pounds or 250. Having taken allergy shots for years with no reactions, I find these flu vaccines wrought with problems.
Pt started to develop itching within 5 min of injections. Small welts developed on LT arm. Large welts developed on Rt arm. one welt developed on side of neck. Vital signs taken at 9:30, BP 102/88, pulse 62, resp 24. Benadryl 25mg given IM RA deltoid. Vital signs re-checked 5-10 min times 30 min. Dr notified. Follow-up Q 4-6 hrs at home if welts re-occur, ER if breathing difficulty. Pt to be at home with Mom. Left at 10:00am BP 100/60, pulse 114.
Atfer a week into my second dose i started having heaviness around the chest. I initially thought it will last for couple days but i am continuing to have this symptom prolonging for 2 months now. I am also getting headache and jaw pain often
Pulsatile tinnitus in right ear every night since Dec 1 when laying down for sleep.
Erythema, warmth, swelling at injection site after injection. Treated with clindamycin. Area of erythema 8.5 x 6.5 cm left arm.