chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via a representative and described the occurrence of an adult female subject not responding to therapy following vaccination with Engerix B (GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject received 3rd dose of Engerix B (unknown) to complete the series.  The subject completed the Engerix B series approximately six months prior to reporting.  At an unknown time during that six month time period, a titer was drawn and was found to be low.  The subject had not responded to therapy.  At the time of reporting the outcome of the event was unspecified.
No additional adverse effects reported.; patients have been administered improperly stored vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 10-JUN-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot # S016870, expiration date 26-FEB-2022 (exact dose and injection site were not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally, lot # 1660958, expiration date 23-FEB-2021 (exact dose and injection site were not reported), both for prophylaxis.  Administered doses of vaccines experienced the temperature excursion of below 36 degrees Fahrenheit (29.5 degrees Fahrenheit) for 10 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No additional adverse effects were reported.; Sender's Comments:  US-009507513-2007USA001137: US-009507513-2007USA001780: US-009507513-2007USA001782: US-009507513-2007USA001783: US-009507513-2007USA001777: US-009507513-2007USA001778: US-009507513-2007USA001779:
RIGHT THIGH IS DIFFUSELY ERYTHAMTOUS FROM PANTY LINE TO KNEE, AND MUCH MORE TENDER TO TOUCH THAN THE LEFT THIGH. RX WITH IBUPROFEN AND BENADRYL FOR 4 DAYS. PATIENT WAS SEEN ~2 DAYS AFTER VACCINE GIVEN. 3-25-08 Mom states leg looks normal and child walks normaly.
Chills,  constant aches and pains since the Moderna booster.  Joint pain, back pain, body aches.  Constant pain.
Two days later I was VERY very sore throughout my body. It lasted about two days. And that didn't happen with any of my other vaccinations. I felt like I was going to fall out my body hurt so bad. It last for about two days. I didn't go see a doctor because I figured it was from the vaccine and knew it would go away.
Second dose of vaccine was given 21 days after first dose rather than 28 days after first dose. First dose given 3/4/22, and second dose was given 03/25/2022.
30 min after vaccine: numb lips and tongue 45 min after vaccine: above symptoms + numb palate and lump in throat 60 minutes after: above symptoms + Numb bilateral 4th and 5th fingers, hives on chest
Nerves would start to tingle; This case was reported by a consumer via interactive digital media and described the occurrence of tingling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included lysine (L-Lysine) for product used for unknown indication.   On an unknown date, the patient received Shingrix and L-Lysine at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced tingling. The action taken with L-Lysine was unknown. On an unknown date, the outcome of the tingling was unknown.   It was unknown if the reporter considered the tingling to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and stated even while taking the L-Lysine 1 to 2 times a day and the patient noticed that if he/she consumed nuts, bread and beer, the nerves would start to tingle. The patient finally agreed to the Shingrix proven effective vaccine. The reporter stated that L-Lysine was a supplement that was easily found at most drug Stores. It really helped. It was unknown if the reporter considered the tingling to be related to L-Lysine. The follow-up would not possible as no contact details were available.
5 hours after vaccination, became overwhelmed with unexplained exhaustion. Had to go to sleep and slept for 12 hours straight. Also next morning had very swollen lymph node under arm that received the vaccination.
[Moderna COVID19 Vaccine] treatment under Emergency Use Authorization(EUA): Post-injection, patient felt scratchy throat, had inability to speak, and was tachycardic. Rapid response team was called.
Numbness / in her arm; Pain in her arm / Pain is so intense; Consumer cannot lift her arm to a horizontal level; This case was reported by a pharmacist via call center representative and described the occurrence of numbness of upper extremities in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 04th October 2020).   On 14th January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced numbness of upper extremities, pain in arm and mobility decreased. On an unknown date, the outcome of the numbness of upper extremities, pain in arm and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the numbness of upper extremities, pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in left arm. After receiving Shingrix, the patient had numbness and pain in arm. The pain was so intense that the patient could not lift her arm to a horizontal level. The reporter did not consent to follow up. AIl information was not available.
Dizziness, Headache, chills, arm pain and fatigie Narrative:
This case was reported by a healthcare professional and described the occurrence of bleeding from colostomy in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). The subject has a history of Downs Syndrome, pulmonary stenosis, imperforated anus with malrotation of intestine (subject has surgery scheduled for 26 August 2008 to correct this issue) and a colostomy placed at birth. The subject has no history of adverse events following previous vaccinations. Concurrent vaccination included ACTHIB (Sanofi Pasteur) given in the left thigh and PREVNAR (Wyeth) given in the left thigh both on 31 July 2008. Concurrent medications included an unknown medication (Progetameal for feeding with a colostomy). On 31 July 2008 at 13:30 the subject received 2nd dose of PEDIARIX at 0.5 ml in the right thigh. On 31 July 2008, immediately after vaccination with PEDIARIX, the subject experienced injection site bleeding, which resolved the same day. The following day, on 01 August 2008, the subject developed a high fever and rash. A systemic reaction. It was also reported that the subject was bleeding from his colostomy. The subject was hospitalised because he is suppose to undergo surgery on 26 August 2008 and they wanted to monitor the subject prior to the surgery. At the time of reporting the outcomes of fever, rash and bleeding from the colostomy were unspecified.
Pt did not want to suck & had trouble swallowing for 4 days p/shots; Fever 101-102 intermittently x 4 days; APAP given to control fever;
Chills started around 10pm. Vomiting around 2am. Fever up to 100 degrees by morning. Chills continued until the following evening. No additional problems after that.
Severe pain in joints of shoulders & elbows; chest pain (muscular); sleepiness, weakness started during the evening the vaccines were given, then worsened over the next two days.  Saw personal physician on the 3rd day - tests done, including EKG.  All tests wnl. Symptomatic treatment with ibuprofen, increased liquids.
I was called for help pt was gripping chair tense and not responding properly. I could not see her face so I moved hair she was conscious and breathing and able to respond. Slight nausea and pale. Responses abnormal and slow recovery called 911 for further assessment. Possible seizure according to friend who was with her.
Presents to virtual urgent care with a complaint of she received her 1st COVID 19 vaccine on Friday, she states since then, she has felt dizziness, nausea, and feeling a bit disoriented. She had an episode of seeing bright lights, she feels she can't see correctly.  She states it feels like she felt when she had west nile virus.  She denies any fever or chills, no pain.  Advised pt she will need an in person exam and possible some lab work. Patient opted to go to PCP instead of in person urgent care. Referred to eye center and MRI and diagnosed with vaccine related symptom triggered migraine.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to an 8-months old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the third dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 22-JAN-2014 at 10:00 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event was also reported as 27-FEB-2014 at 10:00 AM). The parents of the patient were going to consult with physician and declined to repeat the dose. No adverse event was reported for the patient. Outcome was reported by the reporter as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Pt. had vertigo for 3 days, had to stay in bed. Extremely inflamed at injection site, area size of her hand.
soreness at injection site; redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that she had soreness and redness at the injection site with her 1st dose of Shingrix, but no reaction with the 2nd dose. The reporter gave consent to follow up.
Vertigo symptoms on Saturday morning - off and on for a few days. It's gotten better. It was worse over that weekend - it's gotten better after the last several day. I had a little bit today - very mild. Started having chest pain on Wednesday, the 6th - and left arm pain.  ER, no treatment - and then I saw my doctor the next morning and she ordered a stress test that I'll have at the end of this week. Chest pain is gone but have just have had some heart palpitations which actually I had after the second shot as well.
Woke up 10/26/21 -- fussy, lethargic, not eating well, and blood in stool. Seen in ER and diagnosed with intussusception. KUB c/f pneumotosis. US w/ intuss. IR attempted x 2- partially reduced. received NS bolus x 2, and then mivf as well as 1 dose of zosyn at 1200. Intussusception resolved and monitored x 5 hrs.
Pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0125L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 18-Jul-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        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.   No Concomitant medications were provided by the reporter. No treatment information provided.. Company Comment  This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Injection site swelling) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced INJECTION SITE SWELLING (Injection site swelling). At the time of the report, INJECTION SITE SWELLING (Injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Shooting pain down after vaccine and once home. Patient reported to us 2 days later and patient is still having issues with tremors, arm pain, and numbness/tinging throughout the vaccinated arm. Patient has stated that the symptoms are improving, but still significant.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 03-FEB-2015, the patient was vaccinated with MMR II (lot number: K02816 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with MMR II, live was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Pain, stiffness in left arm (unable to lift arm for one day); fever (102 and decreased to normal after 36 hrs); hot flashes/flushing after fever broke; muscle and joint aches; feet felt swollen and tingled; pain in lower back; headache.
Patient reported to the pharmacy on 10/1/2016 that she had developed an allergic reaction to the immunization. She showed her vaccination site and it was red and swollen. She states that she was feverish starting the night of the immunization.
Chills, fever, pounding headache, myalgia, severe pain at site of injection. Racing heart. Could not sleep
Heart felt like it was pounding out of my chest on Monday evening on April 26, 2012.  On Wednesday morning, around 8:30, April 28, I collapsed at at kickboxing class and was sent by ambulance to Hospital Emergency Room as my heart rate was very high and my oxygen was low.  In the ER I was diagnosed with blood clots in my lungs, pulmonary embolism, and was sent by ambulance to another facility where I had a procedure to try to break up the clots (catheter directed thrombolysis).  I spent 24 hours in the ICU, and another 24 hours in Cardiac Care.  I was released on Friday, April 30 at around 2:30 pm.  I am now prescribed Eliquis, have a follow up with my PCP on Monday, , May 10, a follow up with cardiology on May 24, and a follow up on June 14 with the Pulmonary Embolism group.
Dizziness, weakness,  digestive system issues, loose stools, active bowels actively with gas. 5 minutes after injection I noted pain below both of my ears and visual disturbances. Nausea with the taste of bile in my mouth
Patient started to get a chicken-pox like rash up her left arm and back on the Thursday following her vaccination.  It was itchy and she took Benadryl to help with it.  The rash was more prominant on her back.
C/o dizziness, light headedness, anxiety. BP134/87, PR97, T98.4, RR20. Offered patient ice, cool dam rag and talked with patient until calm. Patient ambulated from station 9 to observation area. Patient reported feeling "fine" after ambulation. Pt. advised to wait 30 minutes total for observation. Patient declined. Assessed V/S BP110/78, HR64, SPO2 99% T97.5 Patient appears to have no s/s of distress. Patient left facility with spouse.
Had shingles in Oct, I also had the one shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details reported were as follows: The age at vaccination was not reported. The patient received one Shingles shot and had shingles in October. The patient still had lot of problems. The follow-up would not possible as no contact details were available.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Joint Pain-Medium
Patient with Mast Cell Activation Syndrome. Patient began feeling tightness in her throat, difficulty breathing, extreme dizziness, flushing, feeling hot. Patient pre-dosed with 50 mgs of Benadryl before her shot per instructions with her PCP. Patient brought a protocol with suggested adverse reaction medications in case of need. Patient was given another 25 mg of benadryl liquid per Dr. at the clinic. Patient did not make any improvement and continued to have difficulty breathing and began having difficulty swallowing. EMS called.  Patient was evaluated and continued to decline and have problems with dizziness and breathing. Patient given 25 mgs more of Benadryl via IV that was placed by medic in the R arm. Patient transferred to the ambulance and taken to the hospital to continue treatment.
This spontaneous report as received from a medical assistant concerning unspecified patients of unknown age and gender. No concurrent conditions, medical history and allergy/drug reactions were reported. Approximately in 2017 (reported as between 01-JUL-2017 to 16-AUG-2017) the patients were vaccinated with improperly stored PROQUAD lot # N002917 with expiry date: 24-JUL-2019 (dosing details, anatomical location and route were unknown) for prophylaxis. Concomitant therapy included sterile diluent (MERCK) (no details provided). It was reported that the vaccines were exposed to a temperature range of 6F to 14 F for a duration of 1 hour 59 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1708USA008268.
After patient received the vaccine in the back seat of his car he then fell towards the other seats. Upon arrival of onsite ems, which included myself, we found the patient slumped toward the side seats while shaking. Upon interacting with patient he began to slowly sit upright while continue to shake. Vitals were unable to be received except for pulse because the patient was uncooperative with the blood pressure cuff. After the observation period patient stated he was fine and wife stated this had happened before on the first dose as well. Patient denied any further treatment
Breakthrough case admission after 2 vaccines Moderna 4/15/21 Lot# 010M20A;  MOderna 5/29/21 Lot# 022B21A
Fever 101.5°, headache, chills, nausea, muscle soreness, joint pain, fatigue
Cataract in right eye. Had an eye doctor appointment previous year and there was no sign of any cataract in either eye. Cataract is getting worse every month. Also, floaters in both eyes have increased in numbers and size making my vision worse in both eyes.
19 year old student dies 6 weeks after her second moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (19 year old student dies 6 weeks after her second moderna COVID-19 vaccine) in a 19-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date It is unknown if an autopsy was performed.            Reporter reported that 19-Year-Old student died 6 weeks after her second Moderna COVID-19 vaccine.  No concomitant medication details were provided by reporter.  No treatment medication details were provided by reporter.
CLAIMS SHE WAS HOSPITALIZED; This spontaneous report received from a patient via a company representative 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 was not reported, administered on 11-APR-2021, 1 total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  The contact reporter mentioned that they were working on story of woman who was the patient, received the vaccine on 11-APR-2021 and was hospitalized on 13-APR-2021 with no given release date yet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of claims she was hospitalized was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: covid-19 vaccine ad26.cov2.s-Hospitalization. This event(s) is considered unassessable. The event(s) 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(s).
Began with symptoms for and was diagnosed with Bell's Palsy on 2/3/2021. Right eye will not close. Lips and bottom of face droop.
No adverse event, this was administered IM instead of SQ. Sanofi states unlikely to affect efficacy in administering im instead of sq. Do not repeat dose. prescribing physician states no problem.