chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a patient of unknown age. No concomitants were reported. On 15-MAY-2014, the patient was vaccinated with VAQTA inj, lot K000943, expiration date 26-SEP-2016 (dose, frequency, route of administration and indication were not provided) that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. On 02-JUN-2014 a phone call was placed to reporter. The receptionist stated they do not have any one by that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013915 and 1405USA013916 1406USA004906, 1406USA004908, 1406USA004909, 1406USA004913, 1406USA004914, 1406USA004915, 1406USA004863, 1406USA004874, 1406USA004881, 1406USA004891, 1406USA004896, 1406USA004897, 1406USA004900, 1406USA004901, 1406USA004814, 1406USA004830, 1406USA004831, 1406USA004832, 1406USA004833, 1406USA004835, 1406USA004837 by the same reporter link. Additional information is not expected.
Swollen red itchy painful toes on left foot  less than 1 week after receiving dose. Intense pruritus. Heard of ?Covid toes? so thought I should report here just Incase.  Taking Benadryl to help with itching.
Since receiving DPT a month ago has had nightly tingling in both feet and all toes. Has had a febrile viral illness over last 3 days and last night had increased paresthesia associated with involuntary knee flexion-lasted 3 hours and finally stopped when fell asleep. Fine now during days.
expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 8 patients. This report is for 3rd of 8 patients.  A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed.  Information about Lot/Batch number is requested.; Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported death and the administration of COVID 19 vaccine, bnt162b2.  However, more information on the patient's underlying medical condition, concomitant medications, patient's age group, clinical course and relevant lab tests would be helpful for the Company to make a more meaningful causality assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.; Reported Cause(s) of Death: expired before receiving the second dose
Chills, body aches, severe bone and joint pain and stiffness.  Chills and body aches 12 to 16 hours. Bone and joint pain and joint stiffness 24+ (still present). Pain reduced with homeopathic anti-inflammatory supplement. Stiffness still present especially in hands and shoulders, with mild pain since using the supplement. Bone pain in arms and back also reduced with supplement.
Raised red bumps about 50 lesions, blister like within 24 hrs of HPV vaccine, then 48 hrs later became nauseated, weak, c/o headache.
Signs of pink eye; Bruising around eye; Loss of taste; Loss sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVITIS (Signs of pink eye), EYE INJURY (Bruising around eye), AGEUSIA (Loss of taste) and ANOSMIA (Loss sense of smell) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. t041L20A and 037K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 03-Dec-2020 and Stroke (Stroke from COVID.) on 23-Dec-2020.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss sense of smell). On an unknown date, the patient experienced CONJUNCTIVITIS (Signs of pink eye) and EYE INJURY (Bruising around eye). At the time of the report, CONJUNCTIVITIS (Signs of pink eye), EYE INJURY (Bruising around eye), AGEUSIA (Loss of taste) and ANOSMIA (Loss sense of smell) outcome was unknown.            concomitant medication and treatment taken was not reported. The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
About 10 hours after vaccine, began to feel tired and fatigued and nauseous.  Then I developed a fever and sore muscles.  It progressed to the point where I needed assistance walking.  I had extreme chills with uncontrollable shivering and muscle spasms.  I felt very cold though I was burning up and sweating profusely.  I went to sleep and woke up a few hours later with no fever but very sore muscles.  When I woke up in the morning, I felt like nothing had happened, I was just a bit groggy.
First seven - 14 days: swollen lymph nodes under arm pits, shortness of breath, heart palpitations, swollen lymph nodes in neck, ear and head swelling, ear pressure, ear ringing, internal hot/cold rush, tingling and numbness in arms, legs and hands.    Still ongoing/present: heart palpitations, ear, head ressure, ear ringing, internal hot/cold rush, tingling and numbness in arms, legs and hands.
This spontaneous report was received from a physician via Pfizer (2016467917) and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinate with a dose of PNEUMOVAX 23, (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient experienced rash. The reporter consulted if the patient gets a bad rash with PNEUMOVAX 23, is there a possibility that the patient will experience the same when he/she gets the dose of PREVNAR 13 a year after. The outcome of the event was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. The reporter consulted if the patient gets a bad rash with PNEUMOVAX 23, is there a possibility that the patient will experience the same when he/she gets the dose of PREVNAR a year after. Additional information has been requested.
Dizziness, Headache, Myalgia, chills,right arm injection site pain Narrative:
This spontaneous report as received from a healthcare worker via a physician's office refers to an infant of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB via an unknown route of administration for an unknown indication. Past medical history and concomitant medications were not reported. The reporter stated that an infant received a 1.0 mL dose of hepatitis B vaccine and another 1.0 mL dose of hepatitis B vaccine two days later (dates of vaccination were not reported). She stated that she was unsure whether the vaccine was RECOMBIVAX or other hepatitis B vaccine. She stated that the patient did not have any adverse effects. The outcome of an infant received a 1.0 mL dose of hepatitis B vaccine and another 1.0 mL dose of hepatitis B vaccine two days later and no adverse event is unknown. The reporter considered an infant received a 1.0 mL dose of hepatitis B  vaccine and another 1.0 mL dose of hepatitis B vaccine two days later to be not related to RECOMBIVAX HB. Additional information has been requested.
inconsolable high pitch crying 5-8hr p/vax lasting 5hr & then still cranky;
Patient admitted with 2-3 days of left vision loss and confusion. CT Head showed right PCA infarct with CTA H/N showing complete occlusion of the P1 segment of the right posterior cerebral artery; patient opted for ASA, with reassessment after outpatient MCOT. ED visit and hospital admission within 6 weeks of receiving the COVID-19 vaccine.
Administered Moderna vaccination at 1746 and patient stated that he has experienced vagal responses to injections in the past.  Patient remained in the vaccination chair for 5 minutes after injection and he reported feeling well and moved to the observation chair without any problems [~10ft].  After being the observation chair patient stood up and took 4-5 steps toward the wall and sat down on the floor.  The patient stated he felt dizzy and then became limp & slumped to the right side, eyes remained open with dilation of pupil fixed at 2mm with no blinking noted.  Patient's breathing pattern became shallow & snoring sounds noted.  Patient did not respond when spoken to nor did he respond to soft shaking of shoulders.  Patient began to demonstrate large jerky body movements similar to seizure activity.  The seizure like activity continued for 3-4 minutes before the patient was able to become aware of surroundings and answer orientation questions.  BP 120/72, HR 64, O2 sats 99%, RR 20.  Patient was diaphoretic, pale, shaking of hands and arms, restlessness of lower limbs with frequent repositioning/twitching of legs.  EMS arrived to find the patient regaining stability.  Patient reported to EMS that his is familiar with this type of response and declined to be taken to
Patient developed headache, fever and extreme sweating the evening after vaccination. Also, she developed gum swelling, purple spots on the gums, sores in the mouth, and fever blisters on the lips. Symptoms worsened and patient went to the facility to get a COVID test, which was negative. Over the weekend, patient developed swollen lymph nodes/neck and also noticed a lump in the left breast (same side as vaccination). Patient was nursing 11 month old and supply diminished (never returned). Went to stat care and was diagnosed with strep throat over the weekend. About 2 weeks post-vaccinations symptoms resolved and lump in breast no longer present.
During a review at a local Department of Health?s internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
Pt complained of numbness and pain to right arm and across right chest area for approximately one hour then symptoms subsided. No further issues reported after f/u call the next day 9/13/2018.
Symptoms started 1-2 weeks after vaccine given; include episcleritis, H/A, severe muscle & joint pains, numbness & tingling of hands & feet, weakness, dizziness, fatigue, nausea, rash, nosebleeds 3 weeks of steroids taken for treatment did not help, seeking ongoing medical treatment
Shooting pains; Arm is still tingling; Left arm was numb tips of fingers numb and toes numb on the left side; Llft arm was numb tips of fingers numb and toes numb on the left side; This is a spontaneous report from a contactable consumer or other non hcp. A 51-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8735), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 at 22:45 (at the age of 51-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Apr2021, the patient experienced left arm was numb tips of fingers numb and toes numb on the left side, left arm was numb tips of fingers numb and toes numb on the left side, shooting pains, arm is still tingling and It was April 27 and her arm was still tingling and she continued to get shooting pains between her elbow and shoulder. The adverse event resulted  in Emergency room/department or urgent care. Facility where the most recent COVID-19 vaccine was administered was a pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received no other medications within 2 weeks of vaccination. 8 days later left arm was numb tips of fingers numb and toes numb on the left side where the shot was administered.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events were not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Face, chest and arm around the injection site became very red for a sold half hour. Also my chest felt tight like when my asthma is acting up and my throat was slightly itchy.
34 year old female patient received 1st dose in 2019 and is now requesting to complete series; No additional AEs; This spontaneous report was received from a medical assistant and refers to a 34-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions or medical history provided.  On an unknown date in 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, once (route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. It was reported that the vaccination series have been interrupted, and the patient wanted to complete the series "now" (inappropriate schedule of product administration). No additional adverse events have been reported (no adverse event).
Moderna Covid 19 EUA  I have swelling a hard knot, redness, itching at vaccination site but it didn't start until eight days after shot. I am wondering if that is unusual. Today is the third day symptoms.
pt noticed edema;redness, warmth w/in 24hr of vax;edema cont;pt  given meds & ice to site;
I had swelling in arm; had swelling in arm; it was hard and hurting; runny nose; I am about to have a cold; My throat also became heavy; This is a spontaneous case received from a contactable consumer, the patient. A 64year old female patient received the first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, lot number: EN6198) on 02Mar2021 as a single dose for COVID-19 immunization. It was unknown if any other products taken together with vaccine. On 22Mar2021 at 18:30:53 UTC, patient had sinus allergy and postnasal drip. It was reported that the second dose was scheduled on 23Mar2021. After the vaccine, patient's allergy symptoms came back even worse 3 days later. The allergies were mainly postnasal drip, and it was continuing. It was a runny nose with mucous that was like salty water that went behind throat, so patient had to spit out. It was dripping in the back of the throat (not out of the nose), her nose was wet but not stuffy patient could still breathe, her throat also became heavy, she was about to have a cold. The patient got some garlic with lemon tea, soup with cayenne pepper and ginger tea and throat heaviness went away. The patient had sinus allergies before the vaccine, but it was going on a little bit less due to the pandemic since she was working from home, while patient was at home, patient was outside less, so less symptoms also, on the third day after the vaccination, patient had swelling in arm; it was hard and hurting but after massaging the area, it went away after 1 day. Patient delayed ENT doctor visit due to COVID but did not have an appointment with ENT doctor on this coming friday, 26Mar2021. The flu vaccine did not go with patient; patient was so sick after her last one so had not gotten a flu vaccine for last 5 years. Patient was transferred from Safety (cold transfer) since patient was calling for adverse reaction to vaccine. It was reported if patient could get the second dose tomorrow if patient developed sinus allergy symptoms after the Pfizer-BioNTech COVID-19 vaccine. If patient did not take the second dose, any side effects. Were the symptoms worse with second dose. Response: Discussed per Pfizer-BioNTech COVID-19 Vaccine EUA PI (LAB-1457-6.0, Revised: 25 February 2021) contraindications (those allergic to product or ingredients) and Adverse Reactions sections, including Tables sharing incidence of dose 1 versus dose 2 for select events; individual results vary. Also discussed per attached CONS documents (risks; use with medical conditions) and attached VR noting risks/benefits assessment and referred to HCP for further discussion/guidance, based on medical history. Outcome of the events "I had swelling in arm, it was hard and hurting and My throat also became heavy" recovered, patient also received treatment for them. Outcome of the events runny nose and I am about to have a cold was unknown. It was also reported that it was unknown if patient received treatment for them. No PQC was present.  Follow-up attempts are needed. Further Information has been requested.
Narrative: Myalgia, Arthralgia, Localized pain, chills, fatigue
facial reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (facial reactions) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (facial reactions). At the time of the report, VACCINATION COMPLICATION (facial reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: follow-up received and contains no new information.
Narrative:  46 yo female with facial flushing, tachycardia, and hypertension after second dose of Pfizer COVID vaccine. Patient was seen in the emergency department where she received diphenhydramine, methylprednisolone, and famotidine for a possible hypersensitivity to the vaccine. Patient was then discharged home in stable condition.
blocky spots; terrible itch; hives; This spontaneous case was reported by a non-health professional and describes the occurrence of SKIN DISCOLOURATION (blocky spots), PRURITUS (terrible itch) and URTICARIA (hives) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 61620A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced SKIN DISCOLOURATION (blocky spots), PRURITUS (terrible itch) and URTICARIA (hives). At the time of the report, SKIN DISCOLOURATION (blocky spots), PRURITUS (terrible itch) and URTICARIA (hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       There is no concomitant details provided.
On 1/8, extreme fatigue.  Slept most of the day On 1/9, uncontrolled shaking, chills, temp 100.3, loss of appetite, headache
Welt and rash on the left arm, 3 inches below the injection site. Itching and redness. Welt appeared days after vaccine.
Tingling of fingertips both hands which lasted for 30 minutes. At the same time experienced lip numbness which lasted for most of the day approximately 8 hours.  This was like I had went to the dentist and was numbed for dental work.
no adverse event reported, but after completion of the vaccine, patient reported she never received primary doses yet on the consent form she said she completed the primary doses.
Rash as blisters on joint areas of the wrist, fingers, elbows, knees, ankles, toes. Extremely itchy with burning. Triamcinolone Acetonide cream, Zyrtek, Benadryl,  Helps some but still breaking out
Rash on arm. Appeared on day 8. Itchy on day of presentation, then warm on second day.
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 26-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot# L016429, expiration date 09-AUG-2017, dose and frequency unknown), intramuscularly. It was reported that the patient received an incomplete dose as he/she suddenly moved during the injection. No adverse events were reported. No product quality complaint (PQC) issue was involved. Additional information has been requested.
A day after the vaccines, I had chills, nauseous, rapid heartbeat (pounding hard), dizzy, and slept all day.  On the 2nd day after, still had rapid heartbeat, light headed, and loss of appetite for several days. Most of these symptoms lasted up to 5 days, and it's been a week and I still don't feel back to normal.
No adverse event; Received Bivalent instead of  Monovalent 2nd primary dose; Wrongful 2nd primary dose was administered more that 6 months from the first primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Bivalent instead of  Monovalent 2nd primary dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Wrongful 2nd primary dose was administered more that 6 months from the first primary dose) and NO ADVERSE EVENT (No adverse event) in a 25-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Bivalent instead of  Monovalent 2nd primary dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Wrongful 2nd primary dose was administered more that 6 months from the first primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Bivalent instead of  Monovalent 2nd primary dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Wrongful 2nd primary dose was administered more that 6 months from the first primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Received Bivalent instead of  Monovalent 2nd primary dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Wrongful 2nd primary dose was administered more that 6 months from the first primary dose).    No concomitant medications were reported. In 2021, Patient received first dose of Monovalent Moderna COVID-19 vaccine. Lot number and expiry date of vaccine was unknown. No treatment information was reported.