chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Several days following 12 hours of high fever (102-106 degrees) and violent shaking (onset 5 hours from time of administration of Janssen vaccine), I experienced fairly severe pain in the soles of my feet. That pain lasted for several weeks and then became more subdued (pins and needles and tingling). However, the pain and tingling remain persistent more than 7 months later.
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Hypertension-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Medium, Additional Details: Had 2 seizures the night of the vaccine that lasted a few minutes each. A few days later, blood pressure nearly doubled with severe chest pain and was taken to the emergency room. Physician at ER and follow up with PCP both attributed the seizure and hypertension / chest pain with the vaccination.
Narrative:  Inpatient post covid vaccine given 08/02/2021 14:07- Express team event called on this patient. At appx 1727 as this RN was helping patient get dressed, he stated he didn't feel right and couldn't breath. Patient on 2L nc spo2 84. Patient was pale/gray in color around lips and nose. Oxygen level was turned up from 2L NC to 5L. express team called. PAtient has substernal retractions and auditory wheezing. RT placed on NRB, gave two duoneb treatments, drew and ABG. Pt transported to MICU for observation and further treatment if necessary. Pt had hypoxic respiratory failure post COVID vaccine. ADE flagged in pt's chart.
At area of shot itching still persist after 1 week, no rash just itching at injection site, immediately after shot.
Mild pain at injection site; Being sleepy at that time; This is a spontaneous report received from a contactable consumer (patient).   A 60-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration in arm left on 01Mar2021 11:00 AM (Lot Number: EL3247, age at vaccination 60-year-old) as dose 1, single for COVID-19 immunization. Medical history was none. Patient received other medications (unspecified) within 2 weeks of vaccination. On 01Mar2021 23:00, the patient experienced mild pain at injection site approximately 12 hours after vaccination duration (approx 14 hours). It was reported that late at night on 01Mar2021, started to notice very mild soreness that started about 11 PM in the evening (12 hours after vaccination), and being sleepy at that time. She did not report the event until the next day (02Mar2021). No treatment received for the adverse event mild pain at injection site. No information on the treatment received for being sleepy at that time was reported. It was reported that facility where the most recent COVID-19 vaccine was administered was workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination was the patient was not diagnosed with COVID-19. Since the vaccination has the patient has been tested for COVID-19. No allergies to medications food or other products. The patient was not pregnant at the time of the vaccination. The event mild pain at injection site recovered on 02Mar2021 13:00 while the outcome of the event being sleepy at that time was unknown.   No follow-up attempts are needed. No further information is expected.
received a dose of ROTATEQ following temperature excursions; no other adverse effects; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. No concurrent condition, medical history or concomitant therapy was reported.   On an unknown date, the patient was vaccinated with a 2 ml dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R033256 with expiration date of 23-JUN-2020; strength and route were not reported) following temperature excursions (product storage error), for prophylaxis. The vaccines were exposed to the highest temperature of above 47 degrees Fahrenheit (F)/ 9 degrees Celsius (C) (8.5 C) for 30 minutes. Previous temperature excursion included highest temperature above 47 F/9C (12.1 C) for 42 hours, above 47 F/9C (8.5 C) for 1 hour and above 47 F/9C (8.7 C) for 30 minutes. A data logger was involved. No other adverse effects were reported.
Pain around site. Hard to lift right arm that it was administered in. Pain on right side of neck. Tetanus shot.
at 1602 patient became pale and passed out while slouching against the wall post vaccinations. He was carefully laid onto the floor with feet slightly elevated, and provided a cold wash cloth, and glass of water. After drinking his water, his color returned to normal, and he stated he felt better. BP 117/75, hr 71.
The patient received Proquad, and Varivax both at Well Child exam. The child's doctor and staff immediately notified the child's mother. The child did not have any reactions while in the clinic. Provider called the child's mother later in the evening to check on the child, and the child was well. This supervisor called the child's mother the next morning, and confirmed that the child was still doing well. Call placed to the Manugacturer, Merck, to verify next steps, who informed us there was no concerns.  Provider, and the child's mother were informed of this as well. The child's mother was aware to contact us at any time with any questions or concerns.
Patient left vaccine site without waiting in observation with mother.  Came back to site with reported palpitations and anxiety after going to Chik fila nearby.  On arrival patient vitals 125/78 HR 85 regular O2 Sate 98% No signs of distress.  Patient obviously anxious.  Observed for 30 minutes and released with no treatment or transport.  Released with Mother.
Adolescent was leaving the clinic about 5 minutes after receiving her vaccine.  She fell faint, fell onto a chair and into the arms of public health nurse who eased her to the floor.  She rested lying down on the floor with cool compress to forehead, legs elevated, and sucking on lollipop for about 20 minutes.  She was alert.  BP 110/60 P 72.   After 20 minutes of resting lying down and then in sitting position, she was released.
Information has been received from a physician concerning a patient (age and gender unknown) who was vaccinated (route unknown) into the hip area with a dose of GARDASIL (Lot # unknown).  Subsequently, on an unknown date the patient experienced numbness in the leg.  It was reported that the patient is fine, numbness has resolved, no other issues.  Additional information is not expected.
On March 8, I began coughing whenever I breathed deeply, shallow I had no problem. I also started whizzing and gasping for air, it was short live, and the cough was nonproductive. Whenever I breathe deeply or talk, I could start coughing. I treated it with Mucinex DM and it didn't help completely but it did decrease some of the coughing. It didn't affect I didn't reduce anything else. I went to the clinic on Monday, 03/13, I was prescribed Benzonatate. For the coughing and also given Albuterol haler.  Alka-seltzer  cold and flu. The clinic did advise me to stop that because I'm on a calcium channel blocker and for high blood pressure. This was totally separate in November I was put on Amlodipine Besylate. I went to the clinic on Monday and today I am doing much better, but I still have shortness of breath and some coughing. During the examination my lung were clear, and they found zero pneumonia.
Dizziness, Fever, NauseaVomiting, Tachycardia, sore arm, night sweats Narrative:  Fever 105.7, HR 150, Dizzy, nausea, arm soreness, night sweats; took ibuprofen and tylenol. had Covid 2 weeks prior to second dose.
I experienced a high fever, chills, aches and pains everywhere, terrible cough, sore throat and difficulty breathing.
CHILLS; INJECTION SITE ITCHING; SHORTNESS OF BREATH; FEVER; HEADACHE; FATIGUE; MUSCLES ACHES; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and shellfish allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180522, expiry: 25-DEC-2021) dose was not reported, administered on 14-MAR-2021 10:00 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced injection site itching. On 14-MAR-2021, the subject experienced shortness of breath. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced fatigue. On an unspecified date, the subject experienced muscles aches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, injection site itching, shortness of breath, fever, headache, and fatigue on 16-MAR-2021, and muscles aches. This report was non-serious.
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 18-FEB-2016, the patient was vaccinated with an improperly stored PEDVAXHIB Single Dose Vaccine, 10-pack, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and, the highest temperature of excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
headaches that won't go away; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (headaches that won't go away) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches that won't go away). At the time of the report, HEADACHE (headaches that won't go away) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Patient reported to a technition that she was having some swelling of the tonge. I was administering vaccines to other patients and attended to her as soon as possible. When I got to her she said she had taken a drink of water and the swelling was coming down. She wasn't having any difficulty breathing. Since the swelling was coming down, i gave her some benadryll and checked back with her in 5-10 min. at that point she had not taken the benadryll and the swelling had subsided completely.
Information has been received from an advanced practice nurse also reported as a physician concerning a 21 year old female patient who on an unspecified date, was vaccinated with the first dose of GARDASIL injection (Lot# not reported). Subsequently, the patient experienced a rash on her upper chest. On an unspecified date the patient had recovered. It was unknown if the patient sought medical attention. No further information is available.
Initially sore arm and chills around 8pm. Around 2 am notes Fever, chills, body aches all over, a killer headache, nausea and I could not stay asleep. I took 2 extra strength Tylenol at that time, put an ice pack on my forehead, and drank a Pedialyte.   In addition to those, at about 4 I had ringing in my left ear and then lost the hearing in it. I just went to bed. When I woke up, around 10am on Friday, I could hear, but super dizzy. I couldn?t really walk without  feeling like I?m going to fall over, especially with turns. All symptoms continued throughout all of Friday.  I continued to take the Tylenol per the instructions on the bottle with my last dose around 5pm, I also drank 3 more pedialytes throughout the day in addition to plenty of other fluids. Took a warm shower around 7PM which seemed to help some with body aches and chills, however, dizziness/vertigo remained.  Saturday I woke up several times drenched in sweat. Around 9am my fever was gone. Still feeling a little ?off? in terms of balance/vertigo but nothing compared to Friday.  Slight body aches remain. Other symptoms gone.
On 27-Jul-2022 1:47 pm vial was first punctured and administered on 28-Jul-2022 8:52 am; Second dose taken as 0.5 ml; On 27-Jul-2022 1:47 pm vial was first punctured and administered on 28-Jul-2022 8:52 am; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (On 27-Jul-2022 1:47 pm vial was first punctured and administered on 28-Jul-2022 8:52 am), PRODUCT STORAGE ERROR (On 27-Jul-2022 1:47 pm vial was first punctured and administered on 28-Jul-2022 8:52 am) and ACCIDENTAL OVERDOSE (Second dose taken as 0.5 ml) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1414B and AS1414B) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Jul-2022 at 8:52 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 28-Jul-2022 at 8:52 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (On 27-Jul-2022 1:47 pm vial was first punctured and administered on 28-Jul-2022 8:52 am). 28-Jul-2022 at 8:52 AM, the patient experienced ACCIDENTAL OVERDOSE (Second dose taken as 0.5 ml). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 27-Jul-2022 1:47 pm vial was first punctured and administered on 28-Jul-2022 8:52 am). At the time of the report, EXPIRED PRODUCT ADMINISTERED (On 27-Jul-2022 1:47 pm vial was first punctured and administered on 28-Jul-2022 8:52 am), PRODUCT STORAGE ERROR (On 27-Jul-2022 1:47 pm vial was first punctured and administered on 28-Jul-2022 8:52 am) and ACCIDENTAL OVERDOSE (Second dose taken as 0.5 ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient height was reported as 38' 3 1/4''.  The patient had no known allergies. It was unknown whether the patient had been diagnosed or tested positive for COVID 19.  No acute illness at the time of vaccination and up to one month before.  No chronic or long standing health conditions were reported.  No concomitant medication was taken by the patient.  No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  On 27-Jul-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. It was unknown if the vial was exposed to room temperature for more than 24 hours.  No treatment medication was reported.
red, circular, hardened area of skin about the size of an orange around the injection site. It is also itchy and warm to the touch.
Patient stated that the day after her injection she had a very small "pin-point" spot like you would with any vaccination. Then over days, she developed a Red Rash like area not at the inj site but further down the arm. She went to the ER, where they treated her for possible Cellulitis (Clindamycin 150 mg every 6 hours for 7 days). However, the area did not improve and a "soft lump" developed in the same area. Not at the injection site, but further down the arm. Patient states that her arm is still sore to touch 21 days later.
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to a female patient vaccinated with improperly stored ROTATEQ (oral; lot# N005618 with expiration date 04-OCT-2018) on 02-OCT-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter(link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618,1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
Patient has fever 101.7 - broke 3/25/10 at 4:30 PM.  Aching.  Sore at site & weakness in arm.
This case was reported by a healthcare professional via a sales representative and described the occurrence of crying uncontrollably in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included PREVNAR (Pfizer) and ROTATEQ (Merck) both given on 12 April 2011. There were no concurrent medications. On 12 April 2011 at 16:30, the 5 month old subject received 2nd dose of PEDIARIX at 0.5 ml in an unknown leg. On 12 April 2011, less than one day after vaccination with PEDIARIX, the subject experienced crying uncontrollably. A day later, on 13 April 2011, at 01:00, the subject developed a fever (101.5 degrees F). Loss of appetite was also reported with onset 13 April 2011. Fever remained unresolved at the time of reporting. Outcome for uncontrollable crying and loss of appetite was unknown. It was additionally reported that the subject experienced the same events of uncontrollable crying, fever and loss of appetite following the 1st administration of PEDIARIX at the subjects two month old check up. Dates of administrations, onset of events and outcome was not indicated. Follow-up information was received on 13 April 2011. Concurrent vaccination included pediatric Hib vaccine given on 12 April 2011.
After having the vacine I felt a rushing burning sensation up my left arm and across to my chest, I couldn't breath or talk I fell to the floor and everything was out of focus my heart was racing I felt very cold and was shaking. The Doctor came running and administered adrenaline I was put in a lying down position and sent to hospital via ambulance were I was put on a heart monitor for around 6 hours and kept in under observation overnight.
This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unkonwn demographics. No relevant medical hisotry of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with VARIVAX (Merck) (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with VARIVAX (Merck) that was stored improperly on unknown dates. There were no adverse effects reported. It was unspecified whether the patient had sought any medical attetion. There was no product quality complaint involved. Follow up information has been received from office manager, who stated she may call back or fax information as it become available. Also, reported that M-M-R II was not mentioned inthe original call, but did experience a temperature excursion. No further information was available at that time. Follow-up information as received from office manager refers to a 15 months old patient. On 02-JUN-2014 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # reported as J012818, expiration date 10-OCT-2015) (strength, dose, route and site of administration were not reported). Thisis one of the several reports from the same source. Additional information has been requested.
This spontaneous report received from a consumer concerned a female of unspecified age. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for the batch number. No concomitant medications were reported. On an unspecified date, the subject experienced nose bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nose bleed was not reported. This report was non-serious.
Heart Palpitation. I experience irregular heartbeats.  Faster heartbeats. No treatments yet. But seeing a doctor about it. Everything started this year. I have never experienced this before. I cannot say exactly when it started this year. I am not sure if it started before I received my early vaccine doses or after. I did not report it because I was not sure of the start date and did not know heart palpitations were linked to Pfizer vaccines. I learned later that it was a side effect. But I had my booster shot on 12/16/2021 and I experienced heartbeat pacing faster and irregular this evening (12/18/2021).
This pt was found in cardiac arrest by the Fire Dept. at 10:43 am pt was warm. ALS preformed CPR, but the pt was not resusitated. The pt had received a vaccination for Covid 2 days prior and began having fever and flu like symptoms in the past 24 hrs. Adverse event was death.