chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ANXIETY (Anxiety rate went up), ASTHENIA (Weakness), MYALGIA (Body aches) and NAUSEA (Serious nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. No medical history information was reported. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced DIZZINESS (Dizziness), ANXIETY (Anxiety rate went up), ASTHENIA (Weakness), MYALGIA (Body aches) and NAUSEA (Serious nausea). At the time of the report, DIZZINESS (Dizziness), ANXIETY (Anxiety rate went up), ASTHENIA (Weakness), MYALGIA (Body aches) and NAUSEA (Serious nausea) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication were reported.
This is the second time this has occurred, so I wanted someone to be aware. Within one week of recieving my vaccine I was hospitalized with multiple bilateral pulmonary Embolisms.  My first vaccine I also was hospitalized shortly after for the same condition. I was put on blood thinner Xarelto. I received doses 2 and 3 while on Xarelto without any issues. I discontinued Xarelto and 4 months later recieved my 2nd Embolism after the 4th dose. This vaccine may not be good for people with sickle cell anemia due to added clotting risk factors. I was never informed nor when I reported it to the administrator was I deterred from getting the vaccine.
Initial information received on 18-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 12 months old male patient who received vaccines ADACEL instead of DAPTACEL which was ordered (lot number, expiry date, dose, dose in series, route and site of administration was not reported). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PROQUAD. On 18-Mar-2019, the patient received a dose of suspect DAPTACEL (lot number: U5979AA and expiry date: 13-Jun-2020) via intramuscular route in right vastus lateralis. It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. It was not reported if any adverse event occurred or not. 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 and Module VI of the 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.
Pt requested covid vaccine in the left gluteus. I did ask approval before administering vaccine. Second vaccine was given right deltoid due to painful site.
RETURN OF CLEAR TRANSPARENT QUARTER SIZE GEL LIKE SPUTUM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: viral infection, fever, and dry persistent cough, and concurrent conditions included: clear transparent quarter size gel like sputum, and other pre-existing medical conditions included: The patient have several controlled comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced return of clear transparent quarter size gel like sputum. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of return of clear transparent quarter size gel like sputum was not reported. This report was non-serious.
Patient states "Three hours after receiving vaccination he began to have abdominal pain, bloating, loss of appetite, weakness in arms and legs.  Reports going to ED on 11/4/21 for evaluation and was discharged to home the same day.  Reports provider who evaluated him did not think symptoms were from vaccine, but patient wanted to make our facility aware. Reports symptoms are improving.
Facial numbness and increased sensitivity on the left side of her face. There is no facial droop or lid lag. Other cranial nerves are stable. She did notice some numbness on the right side of face after receiving the first dose of vaccine.  Concern for early Bell's Palsy will be treated with valganciclovir and prednisone.
Pain, stiffness when you get up in the morning from the lower back all way down to the knee; Pain, stiffness when you get up in the morning from the lower back all way down to the knee; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 29Mar2021 (Lot number: EN6205) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: 06Mar2021, for COVID-19 immunization. The following information was re  ported: MUSCULOSKELETAL STIFFNESS (non-serious), PAIN (non-serious), outcome "unknown" and all described as "Pain, stiffness when you get up in the morning from the lower back all way down to the knee". Therapeutic measures were taken as a result of musculoskeletal stiffness, pain.  Additional information:Consumer stated, Am I going to report side effects to you or you are going to transfer me to someone for this Pfizer vaccine the COVID-19 vaccine.Consumer stated, I got both shot in March, one on March 6th and one on March 29th and I am still having the pain, stiffness when you get up in the morning from the lower back all way down to the knee and that was the result of vaccine when I got it. I did not see it so much at the first shot but at the second shot. I am hoping it with, I know that the other people experience the same thing some says its gone away and some says they are still having that problem. Have that been reported to you at all. Do you know?Age: Consumer stated, It is from lower back and all the way down to the back of the leg all way down to the knee and when you get up in the morning you can hardly, you know, I have to take some pain medicine. I am very (Incomprehensible voice) should be able to move about like I need to.Consumer stated, That would be fine you know do I need to go to the doctor to therapy or anything if it still going on. I take pain medicine.Treatment: Consumer stated, Over the counter pain medicine. I just take it whenever I need it.No, I am hoping this would eventually go away so I will not have to take the pain medicine everyday but my sister in research told me to report it.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021751197 Same reporter/ drug/ AE, different patient
Headache, Nausea, Diarrhea, Vomiting, body weakness.  Treatment - rest, water, bland foods, Pepto Bismol. Symptoms also occurred with the first HPV vaccine, however three vaccines were given at that time and the adverse effect was not reported due to not knowing the source of the symptoms.  Vomiting was worse the first time. Symptoms resolved within 24 hrs.  Not yet recovered from the symptoms of the second dose (now 15 hrs post-vaccine).
Got the double dose vaccine, had symptoms twice, dealing with it now/Suspected vaccination failure; Had symptoms twice, dealing with it now (shingles); It might be post herpetic neuralgia; No rash, just pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the double dose vaccine, had symptoms twice, dealing with it now/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Had symptoms twice, dealing with it now (shingles)), post herpetic neuralgia (Verbatim: It might be post herpetic neuralgia) and pain (Verbatim: No rash, just pain). The outcome of the vaccination failure was unknown and the outcome of the shingles, post herpetic neuralgia and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and pain to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, post herpetic neuralgia and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the double dose of shingles vaccine.  The patient had symptoms twice since and the patient was dealing with it now. The reporter further stated that it might be post-herpetic neuralgia.  The reporter further stated that there was no rash, just pain. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
A spontaneous report (United States) was received from a consumer concerning a 39-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced metallic taste, eyes burning, dizzy spells, heart rate dropped, sharp stabbing pain abdomen, sharp stabbing pain chest, vaccination site swelling, and vaccination site tenderness. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27-JAN-2021, the patient received first of two planned dose of Moderna vaccine and after one minute of dose he experienced the event(s) metallic taste, eyes burning, he waited in the nursing area for one hour. While he was driving home, he experienced a dizzy spell for a couple of minutes and then his heart rate dropped to 40 beats per minute coming back to normal after. On 28-JAN-2021, for a period of three to four hours, the patient experienced localized sharp stabbing pain at upper left abdominal and lower chest areas and then it stopped. All side effects have stopped except for swelling and tenderness at vaccine location. No treatment information was provided. No laboratory tests were reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the events, metallic taste, eyes burning, dizzy spells, heart rate dropped, sharp stabbing pain abdomen, and sharp stabbing pain chest, was resolved on 28-JAN-2021. The outcome of events, vaccination site swelling and vaccination site tenderness, was unknown.; 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.
tongue and throat feels puffy; extreme vertigo; Depleted energy; blurred vision; confusion; disoriented; sinuses feel inflamed; tongue and throat feels puffy; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 44-year-old-female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: ep7533, expiry date: unknown, Age at vaccination: 44-year-old) via an unspecified route of administration in arm left on 09Apr2021 05:00 PM as dose 2, single for COVID-19 immunisation. Medical history was not reported. Concomitant medications included MECLIZINE HCL, PREDNISONE. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: en6206, expiry date: unknown) via an unspecified route of administration in arm left on 12Mar2021 08:45 AM as dose 1, single for COVID-19 immunisation. On 10Apr2021 23:00, patient experienced tongue and throat feels puffy (throat swelling and swelling of tongue), extreme vertigo, Depleted energy, blurred vision, confusion, disoriented sinuses feel inflamed. Patient has been to the ER three times with in one week. Facility where the most recent COVID-19 vaccine was administered was pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event result in doctor or other healthcare professional office/clinic visit. Adverse event result in emergency room/department or urgent care. Treatment received for the adverse event as Meclizine and prednisone. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Allergies to medications, food, or other products none. The outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
initially had 2cm induration & pain @ inj site;devel abscess @site 4wk later;had spontaneous drainage of purulent material;devel sinus tract;seen in clinic;dx sterile abscess;
This spontaneous report as received from a pharmacist refers to a 67 year old female patient. Medical history and concurrent conditions were not reported. On 05-AUG-2014 the patient was vaccinated with VARIVAX. Dose, route, lot number and expiration date were not reported. The pharmacist reported that the patient received VARIVAX instead of (Oka/Merck) ZOSTAVAX (on 05-AUG-2014). No adverse effects were reported. This is one of two reports from the same source (other case # 1408USA003125). Additional information has been requested.
urinary tract infection; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received the first dose of the Covid-19 vaccine and her second dose is scheduled on 26Jan2021. She has currently a urinary tract infection and she may receive an antibiotic (Nitrofurantoin) she would like to know if this would affect the vaccine. Patient also asked if it is okay if she does not take the second dose of the vaccine 21 days after the first dose, but a couple of weeks later. The outcome of the event was unknown. The event was assessed as non-serious.  Information about lot/batch number has been requested.
Monday evening through Friday temperature ranged from 102.3 to 96.1, extreme body aches, terrible headaches, nausea and equilibrium was way off. An entirely miserable experience.
The day of my first shot I felt sick for a few days normal symptoms then when I got the second shot I had severe symptoms and was in bed for four days with fever chills high temperature dehydration horrible flu like symptoms. Since I have had the second vaccination I have been sick Pretty continuous and have had some weird issues such as ringworm that has spread all over my body
4/16/03-Patient complained of headache, back and hip pain. 4/17/03-Hospitalized with fever of 103, became incoherent, developed multiple organ system failure. 4/18/03-Died
Pain on right deltoid muscle.  Could not move arm due to pain.  On 10/10/2011 had to go to Urgent Care for treatment.  Doc prescibed Ibuprofen and a muscle relaxant.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concomitant conditions were reported. On 04-MAY-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (which had a lot # of L042265 and an expiration date of 26-OCT-2017; however, dose, dosage number, route of administration and anatomical locations were not reported). Information regarding concomitant therapies was not provided. The vaccines experienced a temperature excursion of 10 F for a time frame of 3 hours and 16 minutes. Reportedly, no previous temperature excursions had occurred and the aforementioned one was called out due to a data logger. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
In the beginning of Feb 2022, my daughter and husband got sick. I hadn't been feeling well but my symptoms were mild and I wasn't concerned as I get sick often. I had tested negative for COVID-19 so was still going to work. After my family tested positive, I went to get a PCR test which was also negative. But I ended up having to stay home with all of the same symptoms as the rest of my family. After a week or so, I thought I was feeling better and returned to work since there weren't many other employees there, but I got to the point where I couldn't anymore. I spoke with my doctor about how I was feeling pressure on my chest to the point that I had trouble breathing. I went for an appointment where my doctor diagnosed me with COVID-19 despite was the tests had said due to my symptoms. She prescribed steroid inhalers and was monitoring my oxygen levels which remained ok but I was still having breathing issues so my doctor switched my steroid inhaler and I continued to monitor my blood oxygen but for weeks I still had trouble breathing and was unable to work or even very effectively work from home. It ended up taking a month for me to return to work properly but even then, I was still having issues. After more than a month and returning to work, I still couldn't go back to my normal activities like exercising and dog walking, etc. Gradually, I have been able to return to my normal life. I believe that my chronic inflammation has made me more susceptible to the long COVID-19 that I have been suffering from. Still now, 3 months later, I tire significantly more easy than I did before and have to be careful to not exert myself too much, too quickly.
1st  Covid shot (Pfizer) on 5-5-21  experienced tiredness and headache, pain in the right calf. 2nd Covid shot (Pfizer) on 6-2-21 experienced a fever of 100.8, chills and hot flashes, upset stomach, body aches, headache, pain in right calf, and tiredness.
No COVID-19 symptoms reported. Case was admitted to hospital 10/03/2022 due to history of falling at home.
Felt a little knot; Painful to move arm, couldn't move it; Hot to touch at arm; Itches sporadically; Red next to the injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Felt a little knot), PAIN IN EXTREMITY (Painful to move arm, couldn't move it), VACCINATION SITE WARMTH (Hot to touch at arm), PRURITUS (Itches sporadically) and ERYTHEMA (Red next to the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE MASS (Felt a little knot), PAIN IN EXTREMITY (Painful to move arm, couldn't move it), VACCINATION SITE WARMTH (Hot to touch at arm), PRURITUS (Itches sporadically), ERYTHEMA (Red next to the injection site) and MYALGIA (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Felt a little knot) was resolving, PAIN IN EXTREMITY (Painful to move arm, couldn't move it) outcome was unknown and VACCINATION SITE WARMTH (Hot to touch at arm), PRURITUS (Itches sporadically), ERYTHEMA (Red next to the injection site) and MYALGIA (Sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Immediate pain at site of injection x 36+ hours. Shivers beginning 12 hours post injection followed by severe myalgias, sweats, possible fever (I did not check). SX improved 36 hours post injection and resolved 60 hours post injection.
21MAR23 I woke with a sore throat which lasted a day and turned into light coughing, very tired and a bit of sneezing. The toughest part of being tried like I had a mild cold. I felt like I had a heavy weight my chest and it was hard to take a deep breath. I let it go for a while and called my doctor 31MAR23 and he prescribed antibiotics for 5 days and steroid pills for 6 days. I took everything and felt better after that but I still have a lingering cough and not tired any more.