chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Achy; Exhausted; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achy), FATIGUE (Exhausted) and CHILLS (Chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, LISINOPRIL and NABUMETONE for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced MYALGIA (Achy), FATIGUE (Exhausted) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MYALGIA (Achy), FATIGUE (Exhausted) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) he had Covid 6 months ago.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: TCR Received. Significant FU- AE Outcomes updated
Per NP: Patient complained of headache after see another patient transported to the medics. Patient blood pressure was slightly elevated, reassess after 30mins normal limits . After drinking a bottle of water patient reports headache improved. VAERS #
This case was reported by a dentist via call center representative and described the occurrence of back pain in a 78-year-old male patient who received SHINGRIX. Concomitant products included simvastatin, vitamin D and lisinopril. On 1st May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 3rd May 2018, 2 days after receiving SHINGRIX, the patient experienced back pain and pain localized. On an unknown date, the outcome of the back pain and pain localized were not recovered/not resolved. The reporter considered the back pain to be related to SHINGRIX. It was unknown if the reporter considered the pain localized to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The patient is a dentist and received the SHINGRIX vaccine on the right arm. On Thursday, the patient experienced back pain described as along his waistline and around to the front as well. The patient stated, the pain was better when he was prone, and hurts more when he sit up or stood up. The patient would see his physician on the date of reporting. The patient was unable to provide full demographic details of his physician.
Symptoms started on 12/06. Fever 3 hours post injection up to 104. Irritability, crying spells soon after injection. Pt seen on 12/07, still having symptoms.
Woke up, face rad and rashy, eyes watering, especially right eye, scalp was otching and burning, hair loss, bumps on face
Febrile seizure the nite of vaccinations.  Seen for well child exam at 11 am, no apparent illness/fever at that time.  Fever developed in late evening and seized within a few hours.  Seen in ER.  Dx'd with febrile seizure of probable vaccine relation.  Seen the following day by myself fever had subsided, no clinical evidence of infection, and strep screen and WBC count was normal.  Child appeared well.
Background: With Chrohn's and with the Erythromycin - I had some fatigue; stomach upset; and joint pain. I didn't go into it with no symptoms. These that I am reporting would be increased. I could feel injection go into the arm. By the morning of the 15th, I think, increase joint pain and fatigue from my baseline. My knees; feet hands - achy in the joints themselves. Fatigue: wishing I could have a nap throughout the day. These lasted for about a week. I had stomach upset that I believe may have been from the Erythromycin - but that didn't change that stomach upset - still had it... it may have gotten a little worse (the nausea. By morning of the 23rd, I took 2 mg Ondansetron for that nausea. That helped a lot with the nausea. Around 2 am on the 24th, I woke up from a very bad nightmare and I woke up with a pounding heartrate. My chest was really thumping. I got up to the bathroom. My heart kept pounding harder and faster and didn't come down. My watch said tit started going up to:  122 to 144  to 154 and it kept gradually going up. I was petting the dog and sitting in the recliner. I phone my Dr's on-call number and spoke to him on the phone. I called 9-1-1 by his advice. Paramedics came - Heartrate stayed up.  I was still able to walk around the house. I followed up to their truck and they checked me over. By that time as they were taking my vitals my heart rate started to calm down.  (It was elevated about 15 minutes about all together) My blood pressure - 160 over 110 when the paramedics checked me but that was coming down as they had me at the truck and the heart rate went down to 80-90 and was continuing to go down. It hasn't come back.  They listened to my heart. Never had that happen to me before like that. Didn't have to go to ER. I do have the apple records of my heart rate, etc. if needed. The joint pain and fatigue faded back to my baseline.
feels that "her body is not her body anymore; no/lack of energy (cannot do much of anything without resting for 15-20 minutes, cannot go to the store); injection site was kind of sore; body fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels that "her body is not her body anymore), ASTHENIA (no/lack of energy (cannot do much of anything without resting for 15-20 minutes, cannot go to the store)), VACCINATION SITE PAIN (injection site was kind of sore) and FATIGUE (body fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A710) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced FEELING ABNORMAL (feels that "her body is not her body anymore), ASTHENIA (no/lack of energy (cannot do much of anything without resting for 15-20 minutes, cannot go to the store)), VACCINATION SITE PAIN (injection site was kind of sore) and FATIGUE (body fatigue). At the time of the report, FEELING ABNORMAL (feels that "her body is not her body anymore), ASTHENIA (no/lack of energy (cannot do much of anything without resting for 15-20 minutes, cannot go to the store)), VACCINATION SITE PAIN (injection site was kind of sore) and FATIGUE (body fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Started getting a headache first and then about 15 minutes in, they started having me sitting on the side as a higher risk - I have had reactions to vaccines in the past. I noticed my throat itching really bad. I wasn't having trouble breathing but itching was getting really bad and there was redness on my neck and heat and then I got cold sweats. Someone came and checked my vitals and they gave me Benadryl. It helped with itching but it did not help with the cold sweats or anything like that. They advised me to go home and rest and get something to eat. I got a fever after that - it was about 102. I felt kind of tired and lethargic. I felt a little bit dizzy. Around 5 pm, I woke up and had chest pain really bad on my left upper chest. I tried to sleep through the night but work up a lot. The next day, I tried to sleep and around 09:00 pm the pain got really bad and around midnight, I tried to find someone to watch my daughter so I could go to ER but couldn't find anyone. The next day, I made an appt I went to my doctor and they did an EKG to check heart function. They did a physical exam - they said it was major inflammation in my body that was causing the pain and they put me on Prednisone (40 mg a day) for the next 5 days and then asked me to come back. Later that night, strange dull achy pains, under my last bottom rib, on the left side on middle of my abdomen, I didn't call the dr's office - that lasted through the night but in the morning that pain was gone but the chest pain I still have. I have had a headache since that day - it's off and on but it is pretty severe when it comes on. I have taken a couple of Benadryl since then due to asthmatic symptoms with allergy type stuff.
NO ADVERSE RXN. PT. WAS 1 OF 2 PATIENTS WHO RECEIVED MENVEO THAT DAY. 1 OF THE 2 PATIENTS WAS GIVEN CORRECT DOSE AND THE OTHER DIDN'T. MA'S BOTH DENY GIVING WRONG DOSE BUT THERE WAS 1 VIAL OF THE SOULUTION (GREY TOP) IN BOX AND THE ORANGE TOP (POWDER WAS MISSING) AND MY COUNT IS CORRECT.
contracted covid post-vaccination; contracted covid post-vaccination; This is a spontaneous report received from contactable reporter (Pharmacist).  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose 1, single (batch/lot number: unknown) and in Oct2021 as dose 2, single (batch/lot number: unknown) at the age of 15 years for covid-19 immunisation. The patient had no relevant medical history, notes: no known allergies, no other medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracted covid post-vaccination". The patient underwent the following laboratory tests and procedures: Covid-19 test: positive, notes: post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events drug ineffective, COVID-19 and the use of suspect product cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202201300297 same reporter, different dose/event;
ON 12/5/2018 PATIENT CAME TO THE PHARMACY SHARING WITH ME THAT ON OR AROUND 11/30/2018 HE NOTICED HIS ARM WOULD HURT AS HE RAISED IT UP. HE DID MENTION THAT A WEEK OR SO AFTER IMMUNIZATION HE HAD CUT DOWN A TREE. LOOKED AT PATIENT'S ARM SAW NO REDNESS OR SWELLING. PATIENT HAS NOT TAKEN ANY OVER THE COUNTER PAIN RELIEF TO HELP OR APPLIED ANY FORM OF THERAPY TO THE ARM. HE HAS NO FEVER. PATIENT HAS HAD INFLUENZA SHOTS IN THE PAST WITH NO ISSUES.
Had a lost of taste and smell; Had a lost of taste and smell; Tingling in his hands and legs; Trembling inside his muscles/electricity through his muscles; Trembling inside his muscles/electricity through his muscles; COVID toes and fingers; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 46-year-old male patient received bnt162b2 (COMIRNATY), administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single and administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Contracted COVID", start date: Oct2020 (unspecified if ongoing), notes: Mild and not hospitalized. The patient's concomitant medications were not reported. The following information was reported: AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 2021, outcome "not recovered" and all described as "Had a lost of taste and smell"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "Tingling in his hands and legs"; MUSCLE DISCOMFORT (non-serious), TREMOR (non-serious) all with onset 2021, outcome "not recovered" and all described as "Trembling inside his muscles/electricity through his muscles"; RASH (non-serious) with onset 2021, outcome "not recovered", described as "COVID toes and fingers". The events "had a lost of taste and smell", "had a lost of taste and smell", "tingling in his hands and legs", "trembling inside his muscles/electricity through his muscles", "trembling inside his muscles/electricity through his muscles" and "covid toes and fingers" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient contracted covid in Oct2020 and received Pfizer vaccines in Jan2021. He was also "boosted". The case of covid was mild and he was not hospitalized. He has had continuing problems since having covid and the vaccines" and that he was scheduled to see a neurologist in a long covid clinic. He has had a lost of taste and smell, "covid toes and fingers", tingling in his hands and legs, "trembling inside his muscles", "electricity through his muscles", he spent a night in the ER, had a "CAT scan" and a "MRI of his neck", and blood work. He began to recover his sense of smell and taste when he lost it again after the booster dose. The reporter said they "don't know" if his symptoms were from "this vaccine or COVID". Caller asked if there was a way to access reports filed about tingling and numbness. Caller commented that she "couldn't glean anything" from the material she read online, including the prescribing information, which is why called. Caller said she is wondering if there is any information on accessing risks post study.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd flu vax 4NOV93 & exp local bruise @ inject site; sx abated the following day; No known allergies;
This case was reported by a other health professional via call center representative and described the occurrence of fever in a 4-year-old male patient who received DPTa (batch number Z9Z4Y, expiry date 2nd July 2018). On 6the May 2016, the patient received BOOSTRIX .5 ml. On 6th May 2016, several hours after receiving BOOSTRIX, the patient experienced fever, accidental underdose, wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the fever, accidental underdose, wrong vaccine administered and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the fever to be related to BOOSTRIX. Additional details were provided as follows: The reporter stated that the 4 years old patient was accidentally vaccinated with BOOSTRIX vaccine instead of an INFANRIX. This led to wrong vaccine administered, inappropriate age at vaccine administration and accidental underdose. Later in the evening of the day of the vaccination, the patient was feverish. The batch number reported for BOOSTRIX did not exist and was updated to be Z9Z4Y, as per sales database.
5 DAYS OUT I STILL HAVE SWELLING & PAIN AT THE INJECTION SITE, IT IS ALSO WARM/HOT TO TOUCH AND STARTED TO ITCH ON 5/3/21
redness at site of injection; c/o left sided facial numbness approximately 20 minutes after injection, still with some numbness left upper lip and left side of face today (client also with history of polio as child and states has had similar episodes of facial numbness such as this in the past)No visual facial weakness on exam
Initial unsolicited report received from office person medical assistant on 24-May-2018. This case involves a 15-month-old patient (gender was not reported) who was vaccinated with a dose of ADACEL (batch number, expiry date, dose, route and site of administration were not reported) instead of DAPTACEL (batch number and expiry date were not reported) on an unknown date. It was a case of actual medication error due to wrong vaccine administered. No adverse event 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.
No other information avaialable.; VARlVAX administered after temperature excursion; This spontaneous report was received from a consumer, referring to a patient of unknown age and gender. The patient 's pertinent medical history, drug reactions/ allergies and concomitant medication were not provided.      On 09-SEP-2021, the varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T032316, expiration date 22-SEP-2022; strength, dose and route were unknown) administered for prophylaxis after temperature excursion (product storage error).         Temperature excursion of this vaccine was 21 Fahrenheit degrees for 2 hours and 5 minutes. The previous temperature excursion was reported as 7.5 Fahrenheit degrees for 1 hour and 55 minutes and 7.5 Fahrenheit degrees for 30 minutes, respectively. No other information was available.
Patient states that she developed a rash and inflammation in her mouth. She also states she developed "cysts / a lump" within her breasts.
Intermittent, stabbing pain on right side of scalp and cheek began approximately 36 hours after receiving the Shingrix vaccination.  A quarter-size raised red spot just below the right earlobe approximately 60 hours after receiving the Shingrix vaccination.  Between 60 to 96 hours after receiving the Shingrix vaccination, more raised red patches have appeared on  the right side of  the face along the jawline and hairline.
I received the vaccine at 0615 am on 1/8/21.  Had no symptoms (not even injection site pain). At 2100 on 1/8, began to develop a lot of pain at the injection site.  Within 2 hrs of that time, I developed other symptoms, which include total body (bone and joint) pain (especially in my knees), and what I would describe as a "bad sunburn type" rash across my cheek bones, bridge of my nose, and orbital area.  Small raised bumps to this area, with swelling, and a feeling of pins and needles stabbing me all across my face.  My airway was fine, and at no time did I feel shortness of breath.  I was unable to sleep due to the bone and joint pain, and felt the need to walk continually (it was more painful to stay in one position). These symptoms persisted throughout the day (Saturday 1/9/21), noting at 5pm I described myself "miserable" to my friends and family.  All symptoms described above,  were at their most elevated intensity between the hours of 1700 - 0400. At 0400 Sunday (1/10/21) I felt a gradual release of the body aches, enough so that I could sleep until 0800.  At this time, 1300 (Sunday 1/10)  I note that I still feel "flu type" body aches, but constant pain has diminished in intensity by estimated 50%.  The sunburn type redness and swelling across my face/orbital area has also less by 50% (there is still redness, mild swelling, warmth, and some raised bumps across this area;  pins and needles feeling is gone).
This case was reported by a healthcare professional and described the occurrence of vaccination error in a 51-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  Previous and/or concurrent vaccination included Twinrix; GlaxoSmithKline; unknown; unknown given in January 2008.  On 15 February 2008, the subject received unspecified dose of Engerix B (20 mcg, intramuscular, left arm).  On 15 February 2008, the subject experienced vaccination error and wrong vaccine administered.  The nurse reported that the subject started the Twinrix series one month prior to this report.  The nurse reported, "on 15 February 2008, they made a mistake and gave Engerix-B instead of Twinrix, for the second dose."  No clinical events were reported.  The healthcare professional considered the events were clinically significant (or requiring intervention).
This is a spontaneous report from a contactable physician through a Pfizer Sales Representative who reported on behalf of a patient. A male patient with HIV infection, received PREVNAR 13, single dose on unknown date. The next day he experienced pneumonia. No further information received.
Patient was administered a third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient was administered a third dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 011A20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Patient was administered a third dose). On 29-Jun-2021, EXTRA DOSE ADMINISTERED (Patient was administered a third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.  The patient received third dose on 29-Jun-2021 with lot number 007B21A.
Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported. Treatment details included Ice Pack.    Reporter did not allow further contact
My knees started aching. My muscles and my head and my shoulders was sore that night after the vaccine. The next week, on Monday I had some swelling in my eyelids, they both were puffy. I started itching all over my body and get these random welds like mosquito bites. It was random on my leg hips and side. I was prescribed prednisone. It has stop since on the medication. I now just have a headache more often than usual. I am still puffy around my eyes as well.
4pm (4.5 hours after vaccination) my arm became sore and stiff, fatigue set in. 6pm (6.5 hours after vaccination), the fatigue was more severe, severe muscle, joint and bone pain, chills, headache. About 6:30pm (7 hours after vaccination) I developed severe vertigo and nausea with dry heaving. 7pm my lips and face felt strange, tingling and dry mouth. I don't know when my lips became swollen, but a friend saw and pointed it out to me at about 11pm. They remained slightly swollen and tingling at least 3:30am when I fell asleep. When I woke the tingling and swollen lips were completely back to normal, but the vertigo and other symptoms lasted until about 10pm on 4/17/2021. I am still fatigued and experiencing joint and muscle pain and injection site soreness, but I'm aware those are normal, expected side effects from this vaccine.
pt recv vax & 3wk post vax pt exp a febrile sz & was hosp;had a full work up & no other etiology was found;febrile sz was considered to ban important medical event;20MAY98 exp sz & hosp;EEG revealed spikes, positive;
Regional lymphadenopathy with diffuse erythema extending from left deltoid to ant shoulder. Pt treated with ATB for poss cellulitis very robust take with daily f/u with provider.