chrisvoncsefalvay/vaers-outcomes huggingface dataset:
20 hours after administration of PENTACEL, PREVNAR, and Flu shot.  Pt had tonic clonic seizure activity for 30 seconds followed by vomiting.  He was seen in ER and had 3 episodes of apnea, cyanosis and desaturations.  He was admitted, monitored in ICU without further sequelae.  Discharged after 24 hours. 12/2109 ER and Hospital records received for DOS 10/22-10/23/09. Pt. woke up fussy one day after immunizations.  Eyes rolled back in head and rhythmic jerking of arms and legs, vomited x1.  Upon arrival in ER, unresponsive to voice, 02 sats decreased to 65%. LP done, no CSF obtained. Admitted for overnight observation to ICU. Discharged home, stable, with apnea monitor, to F/U with pediatrician.  To have sleep study and  EEG as outpatient. DX: seizure, apnea
Lymph nodes under armpit are swollen; Lymph nodes under armpit are painful; Fever/fever hasn't gone down/around 101 F; Chills; Throwing up/can't hold any food; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes under armpit are swollen), LYMPHADENOPATHY (Lymph nodes under armpit are painful), PYREXIA (Fever/fever hasn't gone down/around 101 F), CHILLS (Chills) and VOMITING (Throwing up/can't hold any food) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 939906) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021 at 6:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced PYREXIA (Fever/fever hasn't gone down/around 101 F), CHILLS (Chills) and VOMITING (Throwing up/can't hold any food). On 14-Oct-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes under armpit are swollen) and LYMPHADENOPATHY (Lymph nodes under armpit are painful). The patient was treated with FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Lymph nodes under armpit are swollen), LYMPHADENOPATHY (Lymph nodes under armpit are painful) and PYREXIA (Fever/fever hasn't gone down/around 101 F) had not resolved and CHILLS (Chills) and VOMITING (Throwing up/can't hold any food) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: 101 (High) around 101 F.         Concomitant medication reported included hormone birth control. Treatment medication included Pepcid, and some other medication.  The patient reported that after getting the second shot, that night, the patient began to experience fever, chills and throwing up. The patient said that fever had not gone down, and it was around 101 F. The patient said that they were not able to hold any food at the moment and on 14-Oct-2021, morning, they woke up with their lymph nodes under the armpit of second shot being swollen and painful.
This spontaneous report received from a registered nurse referred to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-MAR-2017, the patient was vaccinated with PROQUAD (dose, frequency not reported, lot:M034692, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Up at midnight, over 104 fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles Vaccine (On an unknown date 1st dose received.).   On 26th August 2022, the patient received the 2nd dose of Shingles vaccine. On 26th August 2022, less than a day after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     Additional Information: GSK receipt date :27-AUG-2022 Reporters comment: This case was reported by a patient via interactive digital media. The patient received shingle vaccine and was up at midnight with over 104 degree F fever it was horrible. The patient stated that he heard that shingles was very painful, so he/she got his/her shingles vaccine. Additional Supportive information: Follow-up would not possible as no contact details were available.
Time of vaccination not precisely known (mom stated the child received an oral vaccine along with other vaccines within 1 week of admission), patient also received other 2 month shots at that time but again we were not able to obtain the immunization record; Presented with fevers from 10/1/07 with subsequent diffuse maculopapular rash, nonpurulent conjunctivitis, L cervical lymphadenopathy (by history it was visible but had resolved by admission), red cracked lips, foot swelling.  Fevers lasted until patient treated for Kawasaki disease on 10/9. Patient was treated with IVIG 2grams/kg and high dose aspirin until day #14, then 40.5mg Aspirin qd.   Patient subsequently had peeling of his hands and feet in classic KD fashion.  01/22/2008 MR received for DOS 10/7-10/2007 with DX:  Kawasaki Disease.  Infant presented to ER with 1 week hx of fever, 3 day hx of rash on hands, legs, feet, and back, vomiting, cough, congestion, diarrhea, increased urination, decreased appetitie and red eyes.   PE (+) for erythematous sclera bilaterally, crusted nares, enlarged subauricular lymph nodes, 2/6 systolic murmur, and erythematous rash.  Dry lips and red tongue noted by ID consultant as well as swelling of hands and feet.  TX with IVIG and high dose ASA. Peeling skin noted at f/u appt 12/5/07.  Also episodes of "zoning out".  No seizure activity noted.  otherwise doing well
It started with a powerful headache, near migraine level, nausea and a low grade fever. It faded the next day and I only had a general headache and the nausea. All seemed fine and under control and I went about my business taking aspirin but that night, around 11pm I got intense chills and was up all night shaking. It was so extreme I nearly called the ER except I saw on the site that this might be a side effect. Diarrhea started that evening and kept up all through the next day. The chills were nearly gone by about 10 am but the stomach and diarrhea continued and as of today 5 days after having the vaccine, the stomach is still unsettled and the diarrhea, while under control, is still continuing. The stomach is making a lot of noises but other than that I'm back to normal. I haven't felt the need to have a doctor's visit because it seems to be slowly fading but if it continues tomorrow I will go in to see what to do about the stomach.
Initial unsolicited case received from a consumer, who is also the patient's mother, on 10 February 2015. An 18-month-old-male patient, with a history of febrile seizures, received a third left thigh injection of PENTACEL (lot number not reported) on 11 January 2015. Information for the first two doses was not provided. The patient was not ill at the time of vaccination. One day post-vaccination, on 12 January 2015, the patient had a febrile seizure. The patient's family called for emergency services, and upon arrival the medics applied oxygen; however the patient had already recovered. The reporter stated that she refused treatment for the patient, since he had a history of febrile seizure. She also noted that the patient had not received TYLENOL post-vaccination. Documents held by sender: None.
After having received a Pneumovax injection in her right upper deltoid, she developed a severe local reaction to the Pneumovax vaccine. Within hours after receiving the Pneumovax, the patient developed an exuberant, erythematous reaction of right upper arm with marked localized tenderness and induration.
Crippling body aches, fever of 100.2, severe headache, chills, chest congestion, impaired cognition - lasted for 36 hours after injection
Headache, Myalgia, Fever, NauseaVomiting,   FATIGUE, CHILLS, NUMBNESS IN FINGERS BOTH HANDS, TEARY EYED, SWELLING/SORENESS INJECTION SITE   Narrative:
Received flu shot vaccine 3 days prior to vaccine on 9/23@ 2:05PM.  After I got the vaccine on the 28th, around 4:45 AM I got real dizzy, weak, and nausea, and a weird sensation in my upper body made me feel like I was going to faint. Later that day I sort of felt like this slight stinging sensation in 3 spots in my heart. That lasted about a week to 10 days.  Then I started having issues with my blood pressure going high, and then when it gets above 180 I started getting a stinging in my right side. Then about two days ago I started feeling a stinging in my left side when it gets too high. The highest my blood pressure got was 201/127 with a pulse of 81 and I could feel the pressure in my head. I called my doctor and they advised I go to the ER, but I wanted to wait. Then when I checked with my other meter was 180/120. I took a shower to try to help and it was 151/93 with a pulse of 73, so I didn't go to the ER for this specific instance. I've been in and out of the ER the last month or so for blood pressure issues. 10/9 I went and was released after 53 hours, diagnosed with high blood pressure and dehydration. Went to another ER 10/10, diagnosed with Lactase Sepsis because of dehydration and my metformin. ER on 10/15 chest pain and hypertension, and high blood pressure. When i first got there it was 166/117 but when I left the house it was at 189. On 10/16 at 8:45 pm my blood pressure was 192/124, and my pulse was 84 and my left side of my chest hurt. I took some aspirin and about 28 mins later and my blood pressure was 178/108 with a pulse of 74. Then I ate before I went to bed before midnight 155/104 with a pulse of 76. I've been trying to control my diet so anytime I've been having issues I try to sit down and eat. I've been separating my blood pressure medication from the rest of my medications.
fever; flu symptoms; achy; lethargic; She had an adverse reaction to Hep B vaccine; This spontaneous report was received from a other health professional regarding to herself;  a female patient of unknown age with egg allergy and crohn's disease. The patient's medical history included allergy to bee sting, pneumonia and anaesthetic complication pulmonary. Information regarding the patient's  concomitant therapies and historical drugs was not provided.   On an unknown date the patient was vaccinated with On an unknown date the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).         On an unknown date the patient experienced adverse reaction to  hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (vaccination complication), fever (pyrexia) influenza like illness, was achy (pain) and lethargy.  The outcome of pyrexia, vaccination complication, lethargy, pain and influenza like illness was unknown.      The reporter considered vaccination complication to be related Hepatitis B Vaccine (Recombinant)(RECOMBIVAX HB) while the causality between fever, influenza like  illness, pain and lethargy  with the suspect vaccine was not provided.   This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2101USA009976:
Patient mentioned that she felt "itchy." Patient also mentioned that she had a history of "itchiness" with vaccines.
Client displayed hives near the injection site shortly after injection.  The client was not scratching the area nor did he state that it was itchy, but wanted to see the band-aid.  Mother pulled up his sleeve and noticed the small, red, raised wheals on the right arm, shoulder and axillary area.  I gave him an ice pack and a chewable 12.5 mg Benedryl tablet.  Symptoms did not worsen and the client was breathing regularly and talking well after the 15 minute recommended wait period.  Mother stated that he has never had hives after a vaccine before.
Seriousness criteria: other-medically significant.  Initial report received on 08 January 2008 from a health care professional.  A 37-year-old male patient, with no known past medical history, had received a first dose, "right deltoid", subcutaneous injection of YF-VAX, lot number UF081AA, and a first dose, left deltoid, intramuscular injection of Typhim VI, lot number Z0922-2, on 04 January 2008.  Three hours post-vaccination, the patient experienced shortness of breath, chest tightness, facial flushing, and lip swelling.  He was transported to an emergency room and kept for several hours of observation.  Treatment included Benadryl.  The symptoms resolved, and the patient recovered.
my 17 year old patient was given vaccine 2 weeks ago; Blisters on arm; Rash on arm; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (my 17 year old patient was given vaccine 2 weeks ago), BLISTER (Blisters on arm) and RASH (Rash on arm) in a 17-year-old male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (my 17 year old patient was given vaccine 2 weeks ago), BLISTER (Blisters on arm) and RASH (Rash on arm). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (my 17 year old patient was given vaccine 2 weeks ago), BLISTER (Blisters on arm) and RASH (Rash on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
This spontaneous report was received from a female patient of unknown age and refers to herself. There was no information about patient's concomitant medications, pertinent medical history, drug reactions or allergies provided. In June or July 2014, the patient was vaccinated with a dose of ZOSTAVAX injection (lot#, expiration date, dose, site and route of administration were not reported) one time vaccine. The patient reported that it did not help her because on unknown date, she got mild case of shingles, which lasted about a month. It was also stated that at the time of this report, she still got pangs. The outcome of the pangs and vaccination failure was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected, as no contact details were provided.
Arm swollen, numbness, rt arm, red-hot, fever, swollen chest wall, shoulder-seemed did not get hospitalized, got iv antibiotic, pain med and oral antibiotic.
Information has been received from a physician concerning a patient who was vaccinated with a dose of GARDASIL (Lot # not reported).  After patient received the vaccine experienced an unspecified side effect.  The physician who reported the adverse experience did not administer the vaccine.   Additional information has been requested.
Information has been received from a Licensed Practical Nurse (L.P.N.) concerning an 18 week old male patient with no pertinent medical history and drug reactions/allergy who on 19-AUG-2011 was orally vaccinated with a first dose of 2ml ROTATEQ and on 19-Oct-2011 was orally vaccinated with a second dose of 2ml ROTATEQ (lot# 669757/0884AA, exp: 14-OCT-2012). There was no concomitant medication. During administration of ROTATEQ on 19-OCT-2011, the patient "made a gaggy face" and started to gag, scream, and cry throughout the administration. Nurse reported that the patient did not vomit. Nurse suspected a quality issue with this dose of ROTATEQ. Nurse requested a lot check. No lab diagnostics study was performed and no treatment was given for the adverse events. At the time of report, the outcomes of the adverse events were unknown. Follow up information was received from the Licensed Practical Nurse (L.P.N.) concerning an 18 week old male patient with no pertinent medical history and drug reactions/allergy who at AM on 19-Oct-2011 was orally vaccinated with a second dose of ROTATEQ (lot# 669757/0884AA). Upon administration of ROTATEQ, the patient began to gag, scream and cry. The patient made a face like vaccine did not taste well. The patient had been recovered already on 19-OCT-2011. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Case number PHEH2012US019182 is an initial spontaneous report received from a pharmacist on 28 Sep 2012. This report refers to a 49-years-old male patient whose medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1204901, expiry date: May 2013) intramuscularly on 25 Sep 2012. On 26 Sep 2012, he felt sick and nauseous. It was reported that he suffered a heart attack at his work site and expired before the ambulance arrived on 27 Sep 2012. No further information was available.
she had numbness and tingling on the left side of the face, then her left arm; she was tired and sleepy; she was tired and sleepy; she felt a bit tingling in her right ankle; tingling on the left side of the face; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 subcutaneous, administered in left arm on 27Mar2021 09:15 (Lot Number: EP6955) as single dose for covid-19 immunisation at age 46 years old. Medical history was not reported. No allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included unspecified medications received within 2 weeks of vaccination. No other vaccines received within 4 weeks prior to COVID vaccine. The patient got the vaccine Saturday 27Mar2021, she felt a bit tingling in her right ankle in the evening. On Sunday, 28Mar2021, she was tired and sleepy. On Monday, 29Mar2021, around 10:00 she had numbness and tingling on the left side of the face, then her left arm. She called her primary care doctor and she was directed to go to urgent care.  She went to urgent care and the doctor sent her to the emergency room then she was admitted to the hospital. Multiple tests were done, CT-Scan, MRI, echo results came back negative and everything looked fine. She was discharged from the hospital Tuesday 30Mar2021. The patient was tested for COVID (nasal swab) post vaccination on 29Mar2021 with negative result. The patient recovered from the events.  Information on the batch number has been requested.
This is a spontaneous report from a contactable physician. A 18 year old male patient (reporter's son) received TRUMENBA on 19MAR2015, single dose in upper arm. The patient was in good health. The patient complained that  his upper arm was sore for about 1 day afterwards. It did not limit his normal activity. Follow-up (30APR015): Follow-up attempts completed. No further information expected.
Dr. orderd a Pentacel on 10/23/2019 for this patient but medical assistant administered a Kinrix instead of the Pentacel.
2mos pt recvd DTP/OPV/Hibtiter on 28Jan91. Found in crib on 30Jan91-unable to resuscitate.No intervening illness.Preliminary autopsy report, no pathology, probable SIDS
Has red rash over body. Follow up 01/18/05: Lot number for vaccine not known.
pt recv vax 14JUN94 & 28JUN94 devel an abscess @ the Tetramune inj site; no cultures; ofc visit x 2; abscess drained spontaneously-purulent matter; rx w/Augmentin; pt also had concurrent OM @ 1st ofc visit;
Feverish, itchy, first few days. 9/17/04 and 9/18/04, swelling and itching in right wrist and hand. 9/20, swelling in knees and ankles-- worsen in 2 days. Right knee and ankle more swollen than left, some pain with squating.
Information has been received from a health professional concerning a 15 month old female who on 13-MAR-2009 was vaccinated SC in the left leg with a dose of VARIVAX (Merck) (dose not reported, lot number 661988/1190X).  Concomitant therapy included MMR II (dose and route not reported, lot number 660203/0452X) (rHA) (patient was given the vaccine in the right leg).  On 13-MAR-2009, the patient had hives at injection sites.  The patient recovered from the events on an unspecified date.  The patient sought unspecified medical attention.  Additional information has been requested.
Initial unsolicited report received from a consumer via other company (Pfizer) on 6 November 2015. Manufacturer reference number: 2015378577 This case is linked with case number 2015SA180851 (same reporter, different patients). This case involves a female (age not reported) patient who was vaccinated with a dose of flu shot (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient had medical history of very severe form of strep that was treated with penicillin for a greatly extended period of time in order to rid body of the infection. The patient concomitantly received TRAVATAN eye drops to treat eye pressure. The patient did not mention an AE specific to TRAVATAN. On an unspecified date, four days following the vaccination, the patient developed flu. On an unspecified date, following the vaccination the patient also developed bacterial pneumonia. On 19 December 2014, the patient was hospitalized. Laboratory investigation and corrective treatment were not reported. List of documents held by sender: none.
pt reports difficulty getting a full breath of air, her oxygen saturation is 95% today in clinic. she has diminished breath sounds. no hx of asthma/allergic rhinitis. she reports that her tongue 'feels fat'.
painful  joints an aching muscel,  hair loss, not steady on my feet, some itching.
Swelling shoulder to elbow of lt arm, resolved /win 48-72 hrs.