chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial case was received on 10 September 2010 from a consumer/patient. A 35 year old female patient received at 11:00 a.m. on 08 September 2010 an injection of either "ADACEL" or a "DTaP" (manufacturer "sanofi pasteur", lot number unknown). The patient was not sure which vaccine was given to her. On 08 September 2010, the patient also received a tuberculin (TB) test (manufacturer and lot number unknown). Five hours after the injections (also reported as 5 p.m.), she experienced body aches, headache and a fever. The patient had no illness at the time of the vaccination. She received TdaP in May 2009. Her medical history included seasonal allergies and migraine headache. As of this report, the headache had resolved but, the patient had not recovered from the fever and body aches. Follow-up information was received from a health care professional on 09 October 2010. The patient received on 08 September 2010 a left deltoid injection of ADACEL, lot number C3491AA and a left forearm placement of TUBERSOL 5 TU, lot number C3371AA. The patient did not inform that she already had a "Tdap" in May 2009. The outcome was reported as recovered. Follow-up information was received from a healthcare professional on 06 December 2010. The patient did not require treatment, and was not seen by a physician. ADACEL was administered intramuscularly, and TUBERSOL was administered intradermally. The reporter had no additional information to provide. Follow-up information was received from a healthcare professional on 04 February 2011. The patient was evaluated by a physician (previously reported as not being seen by a physician). The credentials for the vaccine administrator were also reported. No further information was provided at the time of the report. Documents held by sender: None.
At 1300 on 1/23 she began to experience dizziness, body aches, and head ache. Head ache has continued through today 1/25 without stopping. Dizziness on 1/25 as well.
*Friday 9/3/21, ~2:30pm: Moderna vaccine at Pharmacy and waited the full 15min to monitor for immediate reaction. *Friday 9/3/21, ~4:30pm: Itching similar to a heat rash to bilat hands, forearms, inner elbows, feet, ankles, and lower legs. Became flushed from chest up to face, drenching sweat, heart palpitations, with generalized weakness and malaise. I took Tylenol and Benadryl. *Saturday 9/4/21, ~7am: Woke up hot, backache (similar to a kidney infection), urine was tea-colored despite drinking clear fluids, generalized fatigue and malaise *Saturday 9/4/21, ~12N: Laid down with generalized HA (4/10), fatigue and malaise. Slept for ~2hrs, moaning and crying in my sleep, soaked the bed and myself with sweat, but woke up with horrible chills ?to the bone?, couldn?t get warm, generalized pain (>8/10), urine still tea-colored. Took some Tylenol, ate a little something, drank some lemonade, and laid back down. Now burning up with ?low-grade? fever, couldn?t get cooled off. *Saturday 9/4/21, ~6pm: Still burning up from the inside-out, urine still tea-colored. Still trying to get cooled down, staying hydrated, taking Tylenol. Moaned, groaned, and had fever/chills all night. Soaked the bed and myself with sweat. *Sunday 9/5/21 ? present: Still burning up from the inside-out, having drenching sweats day/night, trying to get cooled down, staying hydrated and taking Tylenol. Have had increased frequency of ?migraine? type headaches and heart palpitations/chest tightness, dizziness, generalized weakness/malaise/lethargy and excessive somnolence.
a 19 month old patient inadvertently received MENACTRA instead of HIB vaccinewith no adverse event; a 19 month old patient inadvertently received MENACTRA instead of HIB vaccine with no adverse event; Initial information received on 16-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 19 months old female patient who experienced a 19 month old patient inadvertently received menactra instead of hib vaccine with no adverse event while receiving vaccines HIB (PRP/T) vaccine [ACT-HIB] and Meningococcal a-c-y-w135 (D CONJ) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine (pneumocin [pneumococcal vaccine]), diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (dtap), measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (proquad), hepatitis a vaccine (hepatitis a) and influenza vaccine (flu) all for immunisation.  On 15-Mar-2022, the patient received a dose of suspect Meningococcal a-c-y-w135 (D CONJ) vaccine and HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  On 15-MAR-2022 (latency: same day) the patient developed a non-serious event a 19 month old patient inadvertently received menactra instead of hib vaccine with no adverse event  (accidental exposure to product) (wrong product administered) following the administration of Meningococcal a-c-y-w135 (D CONJ) vaccine and HIB (prp/t) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events (accidental exposure to product) (wrong product administered).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
itchy; Arm is red; swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (Arm is red) and VACCINATION SITE SWELLING (swollen arm) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 05-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (Arm is red) and VACCINATION SITE SWELLING (swollen arm). At the time of the report, VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (Arm is red) and VACCINATION SITE SWELLING (swollen arm) outcome was unknown.            No concomitant medication was mentioned. No treatment medication was mentioned.
On /3/26/21 the resident developed redness, warmth and small pustules in left upper arm about 2-3 inches below the injection site.  The APRN assessed the area while in the facility on 3/26/21 and placed the resident on Doxycycline 100mg po BID x 5 days and Hydrocortisone cream to area QID x 3 days.  She dx the area as a COVID vaccine reaction.
mom states pt cried for 10hr & refused to eat;did not check temp, but pt felt warm to touch;pt given 3 doses of APAP;pt was irritable for 2 wk;
I get the first dose on March 1st 2021. Within a day later I started experiencing muscle pains, being extremely weak, being light headed and chest pains. It?s been about a month and a half and I am still experiencing these symptoms
pt recv vax 15JAN96 & 1wk later pt presented to MD w/mild case of chickenpox, which consisted of 25 to 30 lesions;
Parents report intermittent illness since vaccination: fever(101) every other day x7 days, nausea, vomiting, diarrhea, headache, fatigue, somnolence, dizziness, cough, Left leg pain.
Patient was seen in my office on 1/15/21 due to a reaction from the  covid. Reports that "3 of the reserve doctors were running a covid vaccine clinic and were giving the injections themselves." He reports that he "received the first dose/shot in his left arm then about an hour later received the second dose/shot in his right arm." This happened on Saturday 1/9/21 in the evening and he reports his symptoms started late Sunday night/early Monday morning and were significant by later in the day Monday 1/11/21; he reports he had severe headaches, dizziness, nausea/vomiting, numbness and tingling in both arms from injections sites to forearms, "felt like he was going to die." He is unsure if he had a fever because he did not check it. He reports his symptoms improved on Wednesday and "were pretty much gone by Thursday." At his appointment on with me on Friday 1/15/21 he had no symptoms and his physical exam was normal. No injection site irritation and normal neuro exam. He reports he "notified the reserve doctors about his reaction and symptoms and was told at that time that he was given the vaccine incorrectly because both doses were given at once instead of a few weeks apart." He reports his comrades that also had the vaccine given incorrectly on Saturday "were also really sick" but states that "by Sunday the doctors realized their mistake and were giving the doses correctly just one at a time."
Moderna 7/23/21, 8/20/21, 2/2/22; Positive on 6/26/22
1 1/4" lump, hard with red area 3/4" around injection site.
Itchy; Patchy rash with pin point spot and hives with blisters all over my right lower flank and bilateral posterior proximal leg. Rash started 2 days after the initial vaccine.; Patchy rash with pin point spot and hives with blisters all over my right lower flank and bilateral posterior proximal leg. Rash started 2 days after the initial vaccine.; Patchy rash with pin point spot and hives with blisters all over my right lower flank and bilateral posterior proximal leg. Rash started 2 days after the initial vaccine.; This is a spontaneous report from a contactable other hcp. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 11Jan2021 09:00 at a SINGLE DOSE for covid-19 immunisation.  Medical history was reported as none. Concomitant medication included magnesium citrate (MAGNESIUM CITRATE), turmeric [curcuma longa rhizome] (TURMERIC [CURCUMA LONGA RHIZOME]) and Organic multi vitamin. On 13Jan2021 16:30, the patient experienced itchy, patchy rash with pin point spot and hives with blisters all over my right lower flank and bilateral posterior proximal leg. It was noted that the rash started 2 days after the initial vaccine. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
severely fatigued; chills; aches; fever; arm was also sore; This is a spontaneous report from a contactable consumer (patient) via  Pfizer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6203, Expiration Date: Jun2021), via an unspecified route of administration on 10Mar2021, at 13:20 as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 11Mar2021, the patient woke up severely fatigued. The patient took a sick day and stayed in bed all day, but she was starting to feel better. The patient had chills, aches, and a fever - all mild. The patient's arm was also sore. The fatigue was the most prominent adverse effect.  No follow-up attempts are needed. No further information is expected.
Reaction to site includes redness, tenderness, warmth and swelling. The patient developed a fever with chills that evening.
Pre-Operative Diagnosis:EARLY ARRIVAL FOR COVID TESTING               Primary Cesarean Section  Dichorionic DiamnioticTwins   Breech Pre-eclampsia Post-Operative Diagnosis:EARLY ARRIVAL FOR COVID TESTING               Primary Cesarean Section  Dichorionic DiamnioticTwins   Breech Pre-eclampsia
Operating at about 50%  on good days. Trying to string a few good ones together but haven?t yet had back to back good days since we shot.    Lower level persistent brain fog and vertigo, plus intermittent higher intensity acute spells.  The lower level stuff is concerning because I can?t focus .. clumsy, dropping things.. have to move a lot slower concentration and reading is hard. Generally feel impaired.    The more autonomic stuff seems to be more of an acute attack. It accompanies the vertigo and brain fog, as those increase, the chills sweating hot cold trembling and pressure in my head and eyes, strange sensations in different parts of my body. This happened when I was hospitalized a few days after the shot and again, the night before I spoke with doctor after acute episode  again the following 3 nights to gradual lesser degrees . It hasn?t happened since friday 1/7  but have had some increase in the intensity of the vertigo. Some difficulty swallowing.   Blotchy skin on knees after walk and on head after showering. Some ringing in the ear. Not persistent.. but have noticed? Tightness in chest consistent with previous diagnosis of spine issues,  has ben steady. Lower back pain has also been steady and that is new this week.  Intermittent pain in my bicep.  Very noisy stomach.. draining sounds in upper abdomen w unusual frequency. Not hunger noises.. more like circulation noises.. Some stiffness in neck. visual issues w reading on screen. Hallow effects around words. Some GI issue.. constipation and mild belly discomfort/ pain. Frequent urination has subsided. Fatigue is waning but, depending on the activity level, im not anywhere near capacity.  Still experiencing low level headaches here and there. Thinking is off.  Doing weird stuff.. like emptying th dishwasher half way? not finishing tasks.. looking for an item that is right in front of me, but forgetting what im looking for? so like I wanted an eye glass wipe for my glasses and instead ill pick up something else.. and find myself wondering .. waht am I doing w this? // confusion. Remembering stuff. .. coordination,  little things that seem to be improving w time and might seem insignificant, but I do think that they speak to the specific level of impairment I feel.  Im typically very active and haven't been able to do much other than walk outside.
This is a spontaneous report from a contactable consumer reporting for herself. This 69-year-old female patient received PREVNAR 13, via an unspecified route of administration on 30Oct2015 at 0.5 ml, single. Medical history and concomitant medications were not reported. The patient experienced lymphocytic colitis on an unspecified date in 2015 and diarrhoea on 04Nov2015, both with outcome of not recovered. The patient mentioned that a week after she received the shot, she started experiencing diarrhea. She thought it was because of a supplement that she was taking too much of them, so she did not relate it to the shot at all and then she stopped taking the supplement completely and she continued with the diarrhea and it was not going away. With the another couple of weeks the patient ended up going to see a Gastroenterologist, she had a colonoscopy on 22Dec2015 and she has been diagnosed with lymphocytic colitis. When she had the colonoscopy, her doctor took biopsy and when she got the result, her doctor said it was basically an inflammation, so she was just trying the medication that doctor gave to her. She was trying samples of LIALDA 4 a day, and it was the initial stage treatment but she did not know what her doctor will do after this. Before she started taking mesalamine, her doctor recommended her to take IMODIUM for diarrhea.
LIP AND INJECTION SITE EDEMA BENADRYL 25MG Q6HRS
high blood pressure, hives, light headedness and slight fever. patient didn't take anything till 1/31 at about 9 am patient took Tylenol fever was as 100.8
she "passed out for 9 hours"; My legs felt paralyzed and it was very hard to move; had a headache; felt sick; My legs felt paralyzed and it was very hard to move; was weak; tired; Body aches, after booster; felt like I had Covid-19/not sure if she had Covid; sore arm/Arm a little sore; my coccyx is very sore; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in arm left on 29Sep2021 (lot number: (reported as '1308A'); expiry date: unknown) at the age of 75-years-old, as dose 3 (booster), single, for Covid-19 immunisation. Medical history included ongoing polymyalgia. There were no concomitant medications. The patient previously received bnt162b2 (COMIRNATY), on 15Jan2021 (lot number: EL1284) at the age of 74-years-old as dose 1, single, and on 05Feb2021 (lot number: EL9262) at the age of 74-years-old as dose 2, single, for Covid-19 immunisation. Patient reported side effects after receiving her Pfizer BT Covid vaccine booster on 29Sep2021. She felt fine right after the shot. On the same day of vaccination her arm was a little sore. On 30Sep2021, patient got up from lying down, and then passed out in her bathroom, she thinks she was unconscious for 9 hours and was evaluated by primary care physician (PCP). She also had headache, sore arm and body aches after booster. She got the vaccine in her arm and then the next day, she was getting ready to go out, she had a terrible headache, felt sick/ ill, weak, felt like she had Covid-19 but she was not sure if she had Covid. Patient got in to bed at 12:00pm and must have gotten up to bedroom while it was still daylight, because there were no lights on and she woke up on the bathroom floor and it was dark outside and it was 5am. Her legs felt paralyzed, and it was very hard to move. She dragged herself to bed and went to sleep. Her daughter took her to the doctor the next day. She was better but her coccyx was very sore on unspecified date in 2021. She called CVS to ask if these could be side effects. The healthcare provider recommended that she does not take another shot. She will call her healthcare provider before she gets her Flu shot. Patient stated that she believes in Science, and she has a history of taking vaccines and they have worked. Outcome of the events passed out and paralyzed was recovered on 01Oct2021, for events headache, pain in arm, sickness and weakness was recovered in Oct2021, for event tired was not recovered, for event body aches after booster was recovering, while for the other events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
pain, HA, cough, loss of taste, COVID-19 pneumonia  remdesivir and dexamethasone
Severe gastrointestinal purging (projectile vomiting and diarrhea) for about 8 hours. Unable to keep even saltines down until 8pm (18.5 hours). Others in family had eaten exact same meals all day - only difference was vaccines.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 81-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date February 2019) for prophylaxis. On 28th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, 30 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient developed full blown shingles, 1 month following the injection. The caller stated that the patient's doctor advised her not to get the 2nd dose. The caller stated that the doctor prescribed the patient a few medications to treat the symptoms. No additional information was provided. This case has been linked with US2018167901 and US2018167902, reported by same reporter.
Red, itchy rash on the left arm, a few inches around the vaccination site, ten days after receiving the vaccine
Could not move left arm at all started at 3 am on 05/5/21. Proceeded to have hot and cold flashes all day. On 5/6/21 around 5 am I got up to drink water and couldn?t see was super dizzy and fainted. My blood pressure was in the 90s as per my blood pressure machine. By time I got up at 8 am my blood pressure was 112/72.
Patient visiting from Sacramento area. Seven days after receiving MMR(11/15/02) Had 2.5 hours of high pitched screaming inconsolable. Next day fine. Normal
Woke-up at 0600 hrs. on 4/7/22 with uncontrolled shivering over entire body. Oral temp of 96.6. Severe upper right arm pain and swelling. Placed in 3 cotton blankets x 19 minutes to control shivering. Oral temp increased to 97.8.  .
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
This spontaneous report was received from a Registered Nurse referring to an 18 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 10-OCT-2017, the patient was vaccinated with her first dose of GARDASIL 9, then she received her second and third dose on 11-DEC-2017 and 09-JAN-2018 respectively, Intramuscular route with lot # N02157 and expiration date 01-MAY-2020 (dose and anatomical location were unknown) for prophylaxis. This doses were administered outside of prescribing information. No adverse effect were reported.
010522 VIRTUAL VISIT WITH PROVIDER: PARENT REPORTED PATIENT WITH A LOW GRADE FEVER, NAUSEA AND VOMITING. 010722 PCP IN-PERSON VISIT: PARENT REPORTED PATIENT CONTINUES TO COMPLAIN OF NAUSEA, NO FEVER OR VOMITING. 011222 VIRTUAL VISIT WITH PROVIDER: PREVIOUS SYMPTOMS NOTED TO BE RESOLVED
Developed fever evening after receiving vaccination to 103 deg. Seen at ER sent home.
pt recvd vax; approx 8 hrs later, mom states t up to 100-102; pt began v & was very lethargic; v for next 16 hrs about 2x hr;