chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diagnosed with COVID after 3rd dose; diagnosed with COVID after 3rd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), on 11Feb2021 at 10:00 as dose 1, single (Lot number: EN6201), in arm, on 04Mar2021 at 10:00 as dose 2, single (Lot number: EN6206), in arm and on 05Nov2021 at 11:00 as dose 3 (booster), single (Lot number: FA8020), in arm for covid-19 immunisation. The patient's relevant medical history included: "moderate to severe eczema", start date: 2019 (ongoing), notes: DOSE 4 seemed to help eczema. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Feb2022, outcome "unknown", COVID-19 (medically significant) with onset Feb2022, outcome "recovered" (Feb2022) and all described as "diagnosed with COVID after 3rd dose". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) Positive.  Clinical course: The patient was diagnosed with Covid after dose 3 but friend, who I was on vaccination with and who was not vaccinated, has never tested positive. The only medication that Withheld has provided is topical. Prior Vaccinations were unknown.  No follow up attempts are possible. No further information is expected.
generalized weakness; headache; right sides numbness/bilateral hand numbness/bilateral face numbness; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date unknown) via an unspecified route of administration at the right arm on 18Dec2020 10:00 at single dose for COVID-19 immunization. The patient medical history was none. The patient was not diagnosed with COVID-19 prior vaccination. Concomitant medication included influenza vaccine inact split 3v (FLULAVAL, lot number 542MY, expiry date unknown) on 20Nov2020 for immunization. On 18Dec2020 at 16:00 (day 1), the patient experienced headache and right sides numbness. On day 2 (19Dec2020), patient has headache. On day 3 (20Dec2020), the patient has overall improvement. On day 4 (21Dec2020), the patient experienced generalized weakness, at 1300 bilateral hand numbness, at 1540 bilateral face numbness that has persisted into the afternoon (pm). The outcome of the events headache, right sides numbness/bilateral hand numbness/bilateral face numbness and generalized weakness was not recovered.
MODERATE TO SEVERE PAIN, SWELLING, FEVER (100.5), NAUSEA.
4 year old boy was given shots. Went out of the room to front desk to pick out stickers and went to waiting room where his father noted that child is pale, pick him up and he went limp in his fathers arm. Father returned to the exam room given 02 by mask examined and monitored until fully recovered about 30 minutes.
Tingling and numbness in left arm hand and left side of face injection was in left upper arm.
On 7/27 began sneezing and horrible runny nose this happened for two days and I decided to test and tested positive for COVID-19. On day 3 I began heavy coughing and decided to go to walk in clinic. The dr prescribed Paxolovid. After 36 hours I saw an improvement in symptoms, and they completely resolved in 5 days.
PAIN; This spontaneous report received from a consumer concerned a 5 decade old female. The patient's height, and weight were not reported. The patient's past medical history included: stress relapse, could not see, and fall, and concurrent conditions included: sinus infections, multiple sclerosis is getting worse, seasonal allergies, depression, short term memory loss, difficulty walking, imbalance, anxiety, difficulty sleeping, difficulty swallowing, tired, and secondary progressive multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. Concomitant medications included buspirone, escitalopram, fampridine, fluticasone, montelukast, and trazodone. On JUN-2021, the patient experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain. This report was non-serious.
2 weeks after 2nd injection of the Pfizer mRNA vaccine, the patient developed bloody diarrhea and frequent bowel movements, which persist to this day (12-15 bowel movements on average). She denies any travel, or other contributing factors that may have caused this aside happening after the vaccination. After months of pain and intestinal spasms she ultimately got 2 colonoscopies to unveil the medical issue at hand. She was diagnosed with ulcerative proctitis a form of IBD (irritable bowel disease) and has been placed on Mesalamine and occasional steroids for flares ever since. Her former physician mentioned having seen this once before after this vaccination she states although uncertain of which manufacturer.
Profound lethargy lasting 24 hours. Slept most of day following administration of the vaccine. Also had pain at injection site which I understand to be common. Had pain with the first dose, as well, but did not have the lethargy.
Desaturation, bradycardia within 8-9 hours after vaccines. Irritability began at approximately 3 hours after vaccines. No interventions required. Temperature slightly elevated. Infant placed on pulse oximetry. Continued monitoring.
Shoulder that she got the vaccine in is a little hot; Shoulder that she got the vaccine in is hard; Shoulder that she got the vaccine in is swollen a little bit; Shoulder started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Shoulder that she got the vaccine in is a little hot), VACCINATION SITE INDURATION (Shoulder that she got the vaccine in is hard), VACCINATION SITE SWELLING (Shoulder that she got the vaccine in is swollen a little bit) and ARTHRALGIA (Shoulder started to hurt) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 VACCINATION SITE WARMTH (Shoulder that she got the vaccine in is a little hot), VACCINATION SITE INDURATION (Shoulder that she got the vaccine in is hard), VACCINATION SITE SWELLING (Shoulder that she got the vaccine in is swollen a little bit) and ARTHRALGIA (Shoulder started to hurt). At the time of the report, VACCINATION SITE WARMTH (Shoulder that she got the vaccine in is a little hot), VACCINATION SITE INDURATION (Shoulder that she got the vaccine in is hard), VACCINATION SITE SWELLING (Shoulder that she got the vaccine in is swollen a little bit) and ARTHRALGIA (Shoulder started to hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. No concomitant medication information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up information received on 22-06-2021 contains no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Swelling around injection location.  Severe hives.  His entire back, buttocks, and legs were bright red and painful. It looked like his skin was burnt in a fire. His stomach had blotches of hives and he could not stop scratching. Swollen eyelids He cried for over 2 hours until I nursed him.  Even still he wimpered tossed and turned and was in discomfort.  This occurred within 7 hours of the vaccination.
PAIN FEELS LIKE BURN-LIKE A CHEMICAL BURN OR SUN BURN; RED ITCHY RASH ALL OVER THE BODY; This spontaneous report received from a patient concerned a 36 year old female. The patient's weight was 125 pounds, and height was 66 inches. The patient's concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: 19-SEP-2021) dose was not reported, administered on 11-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-AUG-2021, the patient experienced pain feels like burn-like a chemical burn or sun burn. On 11-AUG-2021, the patient experienced red itchy rash all over the body. On 11-AUG-2021 13:00, treatment medications included: diphenhydramine hydrochloride. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red itchy rash all over the body, and pain feels like burn-like a chemical burn or sun burn. This report was non-serious.
A report was received from a health care professional on 2/3/04 concerning a 15 month old female vaccinee who inadvertently received Fluvirin on 2/3/04. On 2/3/04 the vaccinee inadvertently received Fluvirin. No adverse effects were reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 5/4/04: A follow up report received from a health care professional indicated that the vaccinee was 16 months old and experienced a slightly sore leg but no fever on the same day as receiving Fluvirin on 2/3/04. The vaccinee had also received Fluzone on a different side on 1/2/04. The vaccinee recovered on an unspecified date. No follow up pending. All information received.
It was reported the patient had ME/CFS and had sever fatigue reactions to Pfizer BioNTech Covid-19 Vaccine and Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of POST VIRAL FATIGUE SYNDROME (It was reported the patient had ME/CFS and had sever fatigue reactions to Pfizer BioNTech Covid-19 Vaccine and Moderna COVID-19 Vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    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 and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced POST VIRAL FATIGUE SYNDROME (It was reported the patient had ME/CFS and had sever fatigue reactions to Pfizer BioNTech Covid-19 Vaccine and Moderna COVID-19 Vaccine). At the time of the report, POST VIRAL FATIGUE SYNDROME (It was reported the patient had ME/CFS and had sever fatigue reactions to Pfizer BioNTech Covid-19 Vaccine and Moderna COVID-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medications were not reported.  It was reported the patient had ME/CFS and had sever fatigue reactions to Pfizer BioNTech Covid-19 Vaccine and Moderna COVID-19 Vaccine, lasting several months.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a female patient of unknown age, with no medical history reported, who experienced the unexpected and non-serious AESI of Post viral fatigue syndrome, which occurred after an unspecified dose of mRNA-1273 vaccine. Since no vaccination nor event dates were provided, temporal association and latency cannot be properly assessed. Co-suspect product includes Pfizer vaccine for COVID-19. As reported, patient experienced ME/CFS (Myalgic encephalomyelitis/chronic fatigue syndrome) and had severe fatigue reactions, lasting several months. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact
Patient said she has pain at the injected site since she got the shot on 1/13/10. It's hard for her to sleep on the side now. And when she raises her arm up, she feel the pain. Patient says she got the pain in the evening of the date she got the shot.
NauseaVomiting A l"ittle SOB" left upper arm sore Narratie:
I had a headache that felt like a sinus headache that would not go away, it progressed to a sore throat. I used a home COVID-19 test on Saturday that came back negative. On Sunday the sore throat got worse and by Monday I could not, I also had a runny nose and a cough. I used a home COVID-19 test that came back negative. By Tuesday my symptoms progressed to body aches and chills. I tested myself with a home COVID-19 test on Wednesday and it came back positive. I called into work and had a PCR test ordered and that also showed positive. I was advised to take TYLENOL and get bed rest. I still have a lingering headache that is uncomfortable but is going away. It is at the base of my head, at the head neck area.
Feeling sick; Fever; Really bad headache; Arm hurts a lot; Aching all over; Woke up with up with sweat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts a lot), MALAISE (Feeling sick), PAIN (Aching all over), NIGHT SWEATS (Woke up with up with sweat) and HEADACHE (Really bad headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts a lot), PAIN (Aching all over) and NIGHT SWEATS (Woke up with up with sweat). On 26-Feb-2021, the patient experienced HEADACHE (Really bad headache). On an unknown date, the patient experienced MALAISE (Feeling sick) and PYREXIA (Fever). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurts a lot), MALAISE (Feeling sick), PAIN (Aching all over), NIGHT SWEATS (Woke up with up with sweat), HEADACHE (Really bad headache) and PYREXIA (Fever) outcome was unknown.            Concomitant medication information was not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a 18-year-old female patient who received BEXSERO (batch number 165601A, expiry date 31st October 2018). On 31st July 2017 09:30, the patient received the 1st dose of BEXSERO .5 ml. On 31st July 2017 14:00, 4 hrs 30 min after receiving BEXSERO, the patient experienced fatigue, loss of energy, difficulty breathing and eating disorder. On an unknown date, the outcome of the fatigue, loss of energy, difficulty breathing and eating disorder were unknown. It was unknown if the reporter considered the fatigue, loss of energy, difficulty breathing and eating disorder to be related to BEXSERO. Additional details were provided as follows: The patient experienced, extreme fatigue, having to force herself to eat, lack of energy, and had to force air out to breathe. No emergency interventions were required. The healthcare professional would continue to monitor the patient.
Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a six months old patient (gender not reported) who was vaccinated with 0.5 ml dose of PENTACEL (Batch number: C5591AA, expiration date: 15 Nov 2019) in left thigh on 23 Oct 2018. The patient's medical history was not reported. Concomitant medications includes PREVNAR for Immunisation; FLUZONE for Immunisation; and ROTATEQ for Immunisation. It was an actual medication error due to underdose as needle was loose and the vaccine came out from around where the needle attaches to the syringe. It was also a case of exposure via skin contact as some of the vaccine ran down onto the infant's leg. It was reported that, the patient had no adverse event. 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.
Nausea, stomach pain, joint  pain, lower back and left upper back pain. Went to urgent care 4/10/2021 and followed up on 4/11/2021 with provider. Had blood work and cat scan of abdominal area. No adverse findings however today 4/14/ 2021 still nauseous and upper back pain. Currently taking onde seton ODT 4mg tab as needed, Famotidine 2x a day.
Cold like symptoms; Small welts show up; Very itching; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8737) via an unspecified route of administration in the right arm on 16Apr2021 at 10:30 (at the age of 43-years-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 07May2021 at 10:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021, the next day, after the first shot, the patient had cold like symptoms showed up, lasted 2 days and after that on an unknown date in 2021, small welts showed up and felt very itching. The same thing happened after the second shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of reported events. The clinical outcome of the events cold like symptoms, small welts show up and very itching were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pain/swelling in L hand.  Warm compress, MOTRIN 400 mg 1 6 hours; if swelling or sensation increase go to ER.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided.  No treatment medication provided.   This case was linked to MOD-2021-395985 (Patient Link).
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 26-OCT-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5 ml; lot # K026247, expiration date: 29-JAN-2017; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 5 times. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius), Celsius conversion of the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 152, 30, -1.111111111 and R; 184, 29, -1.666666667 and R; 24, 33, 0.555555556 and R; 320, 31, -0.555555556 and R; 224, 32, 0, and R. This is one of several reports received from the same source. Additional information has been requested.
1-2 weeks after receiving my second dose of Pfizer, I started having heart palpitations, and dyspnea on exertion. I didnt think much of it at first, but it continues for over a month and it became difficult to climb stairs. I got the first available doctors appointment at the end of March, and the doctor noted that my saturations were dropping as we walked around the clinic. The symptoms continued for another month, but resolved around May. I was in good health previously. I was referred to pulmonology and cardiology, but wasnt able to get an appointment with cardiology given scheduling issues. At the time, the association between vaccine side effects like myocarditis weren't well known, so my PCP was more concerned with asthma, though as a doctor myself, I keep articulating that I think its heart related and having been so close to when I received the vaccine, there was a causation.
Patient and family leaving exam/PE. I was called to the hallway and saw patient lying prone on the floor making twitching body motion, mildly  non responsive to her mother calling. I went to patient, held her arm firmly to feel her pulses and check breathing. At that time pt. suddenly regained consciousness and became responsive. Bruise noted under (L) eye-P.T.O. 911 called.  Assisted pt to exam bed in a colder room. O2 by nasal cannula started approximately 10L/min. As patient increased responsiveness and shared she hadn't eaten since morning offered to provide 8 oz apple juice and granola bar which pt ate on site. VSS. Numbness and tingling pt reported on the (L) side of face extending into her (L) hand resolved. Recheck of neuro and ROM and MM strength. Full return to baseline as previously documented in her well child exam. Pt. released to home under watch of her mother. S/sx of concern and where to call reviewed. Pt and mother state understanding. PV scheduled at 24, 48, 72 hrs follow up. Bruise was noted under the (L) eye and ice pack was provided to apply to minimize swelling.
He completed COVID vaccines in April 2021. He has a history of COVID positive in Feb, 2021. He came to the emergency department at Hospital due to several days of altered mental status, poor appetite, and weakness, and he was admitted for worsening lethargy and hypoxia on 9/13/21.
Pt recvd vax 28OCT92 & 29OCT92 awoke 2AM w/chest pain & SOB; seen by MD;