chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt little tired) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetic. Concomitant products included CORTISONE for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Felt little tired). At the time of the report, FATIGUE (Felt little tired) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications reported.   This case was linked to MOD-2022-686103 (Patient Link).
Pt developed dizziness , diaphoresis and near syncope shortly after vaccination. BP 100/80, HR 56, SP02 99%.  He state s that he has had issues with similar reactions in the past to injections and blood draws. Symptoms improved and pt was fully recovered after appx 10 minutes.
Received Influenza vaccine on 11/15/02. W/in 2 days developed sore arm. Left from shoulder to elbow - continued to have pain / soreness 3 months later.
After 1st dose got sick and ended up in E.R; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "After 1st dose got sick and ended up in E.R". The event "after 1st dose got sick and ended up in ER" was evaluated at the emergency room visit.  Additional information: Reporter reported that patient not had 2nd dose of vaccine and has been over 3 weeks. Reporter wondered if his mom can get 2nd dose or does she needed to start all over.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient recieved jansen vaccine on march 3 2021 then recieved moderna vaccine on august 4 2021 .patient stated he was informed by a health care provider to take a second shot for more protection
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. Approximately in February 2014 (reported as "30 months ago"), the patient was vaccinated with the first dose of GARDASIL injection (lot number, expiry date, dose, route, frequency and indication were not reported). Approximately in August 2015 (reported as "18 months after the first dose,") the patient received the second dose of GARDASIL injection (lot number, expiry date, dose, route, frequency and indication were not reported). Concomitant therapies were not provided. No adverse effect was reported. No adverse effect was reported. No product quality complain (PQC) was involved. Additional information has been requested.
COVID-19 PNEUMONIA: Ground-glass opacities were found on chest x-ray.  Patient is only requiring 2 L of oxygen at this time, baseline room air, and is not a candidate for dexamethasone at this time. Patient is actually able to breathe on room air while awake, and requires oxygen when sleeping (O2 sat high 70s% when sleeping).  Patient may have superimposed bacterial pneumonia, so we will start doxycycline 100 mg b.i.d. today.  Not reaction to  Vaccine- COVID positive with need for hospitalization.
Spontaneous subconjuntival hemorrhage; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6205), via an unspecified route of administration in left arm, on 08Mar2021 at 03:15 PM (15:15), at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication included omeprazole. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 10Mar2021 at 10:15 AM, the patient experienced spontaneous subconjunctival hemorrhage that resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No treatment was received for the adverse event. The event was considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the event.
Pt had increased myalgia and fever of 103 degrees about 24 hours after dT vaccine. Right shoulder injection site, mild induration, slight erythema, warm to touch, +tender to palpation.
This case was reported by a nurse via call center representative and described the occurrence of  headache in a 17-year-old male patient who received BEXSERO (batch number 156701, expiry date 31st AUGUST 2017). On 7th SEPTEMBER 2016, the patient received the 2nd dose of BEXSERO .5 ml. On 7th SEPTEMBER 2016, less than a day after receiving BEXSERO, the patient experienced headache, driving ability disturbed and general body pain. On an unknown date, the outcome of the headache, driving ability disturbed and general body pain were not recovered/not resolved. The reporter considered the headache, driving ability disturbed and general body pain to be related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. The patient received the vaccine in his left deltoid. Nurse reported that the patient had visited doctor for severe headache and body ache, missed his school and experienced inability to drive after receiving BEXSERO. This case was linked to case US2016132126, reported by the same reporter.
This spontaneous report as received from a patient's mother via Registered Nurse, refers to an 11 year old, female patient with none pertinent medical history and drug reaction/allergy to amoxicillin. On 20-APR-2013 (start date of the therapy also reported as 30-APR-2013) the patient was vaccinated with the first dose of GARDASIL (lot # H021608, expiry date: 13-AUG-2015) (dose, route not reported). The first dose of GARDASIL was concomitantly administered with Tdap (manufacture unknown), IPV (unspecified) and MENACTRA. On 17-JUN-2013 the patient was vaccinated with the second dose of GARDASIL (lot # H021346, expiry date: 01-OCT-2015) (dose, route not reported). It was reported that patient developed hives on the top of the thighs about one week after the first (approximately on 27-APR-2013) and second dose of GARDASIL (approximately on 24-JUN-2013). The outcome of hives on the top of the thighs was reported as recovered/resolved, on unknown date in 2013. Relatedness between the therapy with GARDASIL and hives on the top of the thighs was not assess by the reporter. Additional information has been requested.
Patient c/o tongue swelling, throat tingle and chest pain.  Warm tingling around mouth. VS.Benadryl 25 min 7:43,  Epi Pen  Eipi-Pen at 07:45, Rapid response called, Epi Pen working. Transferred to ED.
mcv4 (Menveo or Menactra) vaccine to be administered. However, the medical assistant gave a dose of; Trumenba was inadvertently administered simultaneously with Bexsero/ gave a dose of Bexsero /and / Trumemba; This case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   In July 2021, the patient received Bexsero, Bexsero Pre-Filled Syringe Device and TRUMENBA. In July 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and accidental overdose. On an unknown date, the outcome of the wrong vaccine administered and accidental overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient had ordered a Bexsero vaccine and an mcv4 (Menveo or Menactra) vaccine to be administered.  However, the medical assistant, inadvertently simultaneously administered a dose of Bexsero vaccine and a dose of Trumemba vaccine, which led to wrong vaccine administered and accidental overdose. The reporter consented to follow up.
Patient has not reported adverse events, however was given Moderna vaccine and wasn't 18 years of age.
like a metal taste; rash on my arms; don't feel great after; headaches; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced like a metal taste, rash on my arms, don't feel great after and headaches. It was reported that the patient got vaccination (unspecified vaccine) and has like a metal taste and didn't know if it was a side effect from the vaccination. It was also reported that the patient developed a rash on her arms; one arm cleared up but the other one has just a light rash. She didn't feel real great after the vaccination last week and got headaches at least once a week. The outcome of the event rash on her arms was recovering while the outcome of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache w/ in 5 min, loss of balance after 1 hour, 18 hours later severe pain and inflammation with fatigue in joints, 36 hours sore throat. Since the 18 hours mark steady fatigue and pain
pt recv vax 14JUL96 & learned that was 4wk pregnant @ time of vax (LMP 11JUN96);addtl info from a nurse revealed that the pt had elected to terminate pregnancy;
CHILLS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious. This case, from the same reporter is linked to 20210757030 and 20210756804.
Patient was given the first Moderna vaccine at 11:03 am.  At 11:10 am she began experiencing what she described as a tingling, scratchy sensation on her neck, but said that the inside of her throat seemed fine.  She stated that she has a history of anaphylaxis to peanut butter and asked for some Benadryl, as that usually helps her.  At 11:17 am we gave one oral dose of Benadryl 25mg tablets and she said she believed it was improving.  After about 10 more minutes, she said she began to feel the tingling in the back of her throat and she could start to feel swelling in the throat.  At 11:32 we administered a single dose of the adult EpiPen (0.3 mg per dose).  The patient immediately began to feel relief of her symptoms, and paramedics arrived to take her to the hospital for follow up.
Patient seated while receiving flu shot, upon completion, her head dropped and she slumped in chair.  Her father present and leaned over to "hug" her, stating her name and asking if she was ok.  She did not lose consciousness, her eyes were open.  She quickly became alert and said she was ok.  Pt. stated this has happened in the past during bloodwork.  Pt. also stated she was at a sleep-over last night, got to bed late and had not eaten anything this morning.
Blood pressure over 200; Could not see very clearly; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure over 200) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced HYPERTENSION (Blood pressure over 200) (seriousness criterion hospitalization) and VISUAL IMPAIRMENT (Could not see very clearly). In March 2021, VISUAL IMPAIRMENT (Could not see very clearly) had resolved. At the time of the report, HYPERTENSION (Blood pressure over 200) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender'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.
Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Nausea-Severe
Tdap vaccine given at 9:00 AM.  Patient stated severe occipital headache and increased heart rate of 90 bpm began at 4:00 PM.  Typical heart rate is 60 bpm. Slept late afternoon and was awake at 12 mdinight with increased heart rate of 90 bpm, headache resolved.  No symptoms this AM- has never had Tdap, has had 10-12 Td in life time.
Covid/Pfizer vaccine #2 given approx 12:20 pm. Woke approx 1 am with shaking chills, HA, vertigo,103.4fever.
Breakthrough case of COVID-19 after fully vaccinated with 2 doses of mRNA vaccine.
Severe nausea, not able to drink any fluids, Headache, excessive tiredness, pain and swelling at injection site,  shivering and sweating,  pain in joints and muscle aches,
sore arm; This is a spontaneous report from a contactable consumer (patient's sister). A male patient (reporter's brother) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm. The reporter stated that all that the patient got from the first shot was a sore arm, basically just that and then with the second shot, nothing. The reporter does not know whether the patient got a headache, she would have to ask, but the patient said he got nothing other than sore arm, was perfectly fine, and advised the reporter to take the second shot as there was nothing wrong. The patient received second shot, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation and was fine. It did not affect his appetite, he did not complain of headache, did not complain of taking Aspirins or anything like that. The clinical outcome for the event was unknown.
uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils; top back roof of the mouth, uvula and tonsils felt tingly; migraine; light sensitivity; dry mouth; thirst; racing heart; felt very hot; felt dizzy, like how it felt when standing up too quickly, but she was already standing; sharp pain in her shoulder; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration (left arm), on 31Dec2020 13:30, at single dose, for covid-19 immunization. Medical history included chronic migraines and depression. The patient has no known allergies. Concomitant medication included erenumab aooe (AIMOVIG), clarithromycin (CLARITIN), ibuprofen (IBU), mirtazapine (REMERON), paracetamol (TYLENOL), ascorbic acid (VIT C), and ergocalciferol (VIT D). The patient reported that "about 20 min" after receiving the vaccine, the patient's top back roof of the mouth, uvula and tonsils felt tingly. Then she started having a migraine, with light sensitivity, dry mouth, thirst, racing heart, and felt very hot. For a few seconds she felt dizzy, like how it felt when standing up too quickly, but she was already standing. Simultaneously, she had a sharp pain in her shoulder while she was dizzy. These reactions did not begin to subside until about 4 hours later. All these aforementioned adverse events happened on 31Dec2020 14:00 and the patient recovered from them on an unspecified date with lasting effects (recovered with sequel). After the tingly feeling in her mouth went away, she noticed that her uvula was dropped very low on an unspecified date. It did not look red and it was not sore, but it was so long that it touches her tongue and/or sticks to her tonsils. It has been 3 weeks later and her dropped uvula has not improved or changed. The patient did not recover from the event "uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils". She added that she tried to get her 2nd dose on 22Jan2021, but the clinic and the physician did not feel comfortable with giving her the 2nd dose because they have not heard of any cases of side effects of the tingly mouth/uvula/tonsils and continued dropped uvula. No treatment was received for all the adverse events reported. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the following Covid tests post-vaccination: via nasal swab on 22Jan2021 with result of negative; via nasal swab with Color on 19Jan2021 with result of negative; via nasal swab on 15Jan2021 with result of negative; via nasal swab with Color on 12Jan2021 with result of negative; via nasal swab with Color on 08Jan2021 with result of negative and; via nasal swab with Color on 06Jan2021 with result of negative.
Pt recv vax on 10/6/98; on 10/7/98 pt exp achy & sick feeling; 10/30/98 muscle weakness; 12/2/98 exp swollen glands & ear discomfort
pt woke up-arm was tingling & swelling up;call the ER they told pt to call MD;MD told pt to apply ice & keep it elevated-pt was then seen the next day;pt given med for the rxn;
Fatigue for 3+ days (ongoing), chills, nausea, shortness of breath, anxiety
On Friday 12/25 I felt itchy in the injection site, I checked in the mirror and noticed a red spot. the itchy was tolerated when it happens on and off. On 12/30 all day I had the itchiness increasing in strength, ( I scratched my other arm avoiding to scratch it directly) in the evening  I saw it was red, swollen, raised, hot and hard when touched, I placed ice in the area but did not take any OTC medication at any time
I've had tinnitus (ringing in my ears). I've also felt off balance since Sunday (3/21/21) evening.  I'm very disturbed by this tinnitus and dizziness.
Sudden onset of substernal chest pain radiating to back. Headache radiating to left shoulder and redness of hands
Administered .1cc JYNNEOS vaccine- no wheal appeared. Explained about necessity of wheal to patient, and he consented to another dose. Administered another .1cc of JYNNEOS vaccine- small wheal appeared.
Cellulitis after administration in Left Tricep.  Sx developed with 48 hours of administration.  Patient with edema, soft tissue swelling, fever and chills, tachycardia.
BLOOD CLOTS; This spontaneous report received from a consumer by a other manufacturer company (Pfizer Inc.) received on14-MAY-2021 and concerned multiple (few) patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Reporter stated that Johnson and Johnson vaccine caused blood clots and few people died. It was not reported whether autopsy was performed. On an unspecified date, the patients experienced blood clots. On an unspecified date, the patients died from blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0; 20210545044-covid-19 vaccine ad26.cov2. s Blood clots. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: BLOOD CLOTS
Rash and hives located across entire body to inlcude all extremities.  Red face.  Slight wheezing.  No difficulty breathing
This spontaneous report as received from a pharmacist who received the following information from a nurse, refers to 2 patients (demographics unspecified) who developed swelling, pain and suspected cellulitis after receiving PNEUMOVAX23 (route not reported) in the past. It was unspecified what lot of 23this 2 patients received. It was unspecified what date PNEUMOVAX23 was received in these 2 patients. All other information of this 2 patient was unspecified. This is one of two reports received from the same source. Additional information has been requested.