chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bacterial infection; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 29Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A 76-year-old female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACTERIAL INFECTION (non-serious), outcome "unknown", described as "Bacterial infection". Therapeutic measures were taken as a result of bacterial infection.  Additional Information: The patient was calling about the COVID-19 vaccine. The patient was scheduled to receive the second dose of the Pfizer-BioNTech COVID-19 vaccine tomorrow, 30Mar2021. The patient was currently taking 1000 mg of cefalexin (KEFLEX) for a bacterial infection after the first dose of her vaccine. The patient was concerned if this would have a possible interaction with the vaccine and if this would make her sick if she gets the second vaccine. The patient asked when is the latest she can get the second dose if she doesn't get the second dose tomorrow.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 14 year old female patient who was vaccinated with 0.5ml first and second dose of Gardasil. Subsequently, the patient experienced pelvic pain to the point where she couldn't get out of bed in the morning the day after receiving the vaccine. This happened with both the first and second shots. Unspecified medical attention was sought. Laboratory diagnostic studies included a sonogram. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a licensed visiting nurse concerning a 14 year old female student with no medical history or allergies, who on 01-MAY-2007, was vaccinated IM with a second 0.5ml dose of GARDASIL (Lot# 657617/0384U). On 01-MAY-2007, the patient experienced pelvic pain to the point where she couldn't get out of bed in the morning the day after receiving the vaccine. The patient was seen at her primary physicians office. Laboratory diagnostic studies included a pelvic ultrasound which was normal. On 03-MAY-2007, the patient recovered. It was also reported that the patient experienced pelvic pain after the first dose of GARDASIL. No product quality complaint was involved. Additional information is not expected.
temp x 2hr, swelling @ inj site measuring 2 1/2 x 1 1/2 diameter;tender to touch;rx warm packs & Atarax;no sign of cellulitis;
Patient received 2nd dose of HPV. 2 hrs after receiving 2nd dose pt. broke out with blotchy rash on trunk, arms, and upper thighs. Had chills. Fever started and was highest at 102.5. Mother gave TYLENOL and fever resolved by 10 pm. Pt. woke the am of 05/17 and felt better.
11:05 injection-burning sensation at site, assumed to be normal, sat down, within 17 min. top  of hand began to prickle.  Drawing cramping pain followed in forearm, prickling turned to numbness. Mentioned this to one attendant, who recommended sitting longer. Sensations continued, another nurse/attendant checked on me, also mentioned I sit at least 30 min. All other sensations normal-no nausea, no headache, etc.  Small finger, finger next to it,-and their part of the hand to the wrist -were first numb, with occasional tingles, now still numb.[7:30 pm.]  Slight cramp from top of arm to neck, is off -and- on from injection wait-time til now.  I left at 11:55, took temperature at 12:20, =99.4 (my usual basal is 97.6).
Whole body aches, clammy, headache, nausea, entire right arm feeling as though burning, moderate fatigue starting overnight. All sypmtoms still current except for burning pain in right arm. That lasted until approx 12pm, then moderate pain at injection site only.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. In November 2018, unknown after receiving SHINGRIX, the patient experienced inflammation localized. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and inflammation localized were unknown. It was unknown if the reporter considered the pain in arm and inflammation localized to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of SHINGRIX, the patient experienced pain in arm and it was still inflamed since November of last year. On 4th April 2019, the patient received the 2nd dose of SHINGRIX.
Initial report received from pharmacist on 23 Feb 2010: This patient received vaccination with FLUVIRIN batch no. 102125P1, unspecified dose intramuscular on an unknown date. On 21 Feb 2010 and 22 Feb 2010, the patient experienced nosebleed in the morning and red, itchy and watery eyes. The patient was also taking COUMADIN. The outcome of the events was not reported.
Pt has Rheumatoid Arthritis and Lupus and is on several meds, including Avara, Methotrexate, Leucororan, Placueril, Prednisone. Pt given Pneumovax on right deltoid. Had some soreness and nodules develop, in right deltoid area only, about 24 hours later. Seen in office 2 days after injection. Right deltoid region had <7 tender papules, suggestive of erythema nodosum. Pt given darvocet prn pain.
injection site swelled; injection site swelled, got really hot; I felt sick for 3 week; Information has been received from a lawyer, which was split from a legal case regarding to a currently 67 years old female patient. The patient's current conditions, medical history and concomitant medications were not reported.  On an unknown date in August 2019, the patient was vaccinated with pneumococcal Vaccine, Polyvalent (23-valent) (manufacture unknown) (strength, dose, route, lot number and expiration date were unknown) for prophylaxis. On an unknown date, the patient experienced injection site pain and got really hot. The patient felt sick for 3 weeks. The outcome of all events was not provided. The causality between events and pneumococcal Vaccine, Polyvalent (23-valent) (manufacture unknown) was related.; Sender's Comments:  US-009507513-2003USA003895:
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 6-month-old female patient who experienced extreme redness and bruising at the injection site with a small not raised bump underneath the skin. It was noted that the healthcare professional did not shake the syringe before administering it. The patient received a dose on 23-Jul-2010. The patient experienced extreme redness and bruising at the injection site with a small not raised bump underneath the skin at the injection site in Jul-2010. It was reported that the healthcare professional did not shake the syringe before administering it on 23-Jul-2010. No additional information was available at the time of this report.
2nd dose was administered after 15 days of 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered after 15 days of 1st dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered after 15 days of 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered after 15 days of 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient states she is doing fine and has no complaints  No Treatment and concomitant medicines were reported  Action taken with mRNA-1273 in response to the event was not applicable
pt was hot and lightheaded while sitting  then fainted in his chair  pt reawoke after maybe 2 minutes and then was helped to floor 911 was called and ambulance crew checked pt over he refused to go to hospital after they checked him out and said that he looked fine he sat for maybe 5 more minutes then walked out of pharmacy
Pt became nauseaous 10 minutes after receiving second dose vaccine. Pt layed on cod allowed to rest for a bit, Paramedics at Pt's side to offer assistance. Pt's own nebulizer treatment was used per her request;which did not help. After 10 minutes Pt reported feeling more ill and nauseated. Medics called, Pt transported to ED
pt lethargic, not playful, crying excessively. not eating well has had a 1lb 8 oz weight loss since vaccine was administered.  pt is also holding his head as if he was in pain.
Tested positive after 1st dose.; Tested positive after 1st dose.; This is a spontaneous report from a contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (BNT162B2) dose 1, via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported, tested positive after 1st dose. The outcome of the events was unknown.  Information about lot/ batch number has been requested.
Employee C/O red, swollen, and pain right arm 9/14/2006.
SkinRash itchiness at injection site, hard/slight elevation at injection site Narrative:
Information has been received from a physician concerning a female who on unspecified date was vaccinated with the 3rd dose of Gardasil and passed out. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
24 hours after immunization the patient developed redness and swelling at the injection site and a fever of 101F. Purulent drainage from the injection site was observed by the parents, but was not seen by the MD. The patient was treated with antibiotics for possible cellulitis.
Blisters on the left side of my mouth and the left side of the roof of my mouth; Arm was little sore; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL BLISTERING (Blisters on the left side of my mouth and the left side of the roof of my mouth) and MYALGIA (Arm was little sore) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 0024C21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis, Asthma and Allergy. Concomitant products included CETIRIZINE for Allergy, PROCATEROL HYDROCHLORIDE (PRO-AIR) for Asthma, LISINOPRIL (LISINOPRIL +PHARMA) for Blood pressure management, CHLORTHALIDONE for Fluid retention, PREDNISONE (PREDNISONE WESTFIELD) for Rheumatoid arthritis, LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]) for Thyroid disorder NOS, CYANOCOBALAMIN (VITAMIN B12 AAA) for Vitamin supplementation, ATORVASTATIN CALCIUM (ATORVASTATIN [ATORVASTATIN CALCIUM]), DILTIAZEM HYDROCHLORIDE (DILTIAZEM 1 A PHARM), POTASSIUM, HYDROXYCHLOROQUINE, CLOPIDOGREL (CLOPIDOGREL VIR), PANTOPRAZOLE, URSODIOL, METHOTREXATE (METHOTREXATE CIPLA), GABAPENTIN, DULOXETINE, CYCLOBENZAPRINE HCL and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced MYALGIA (Arm was little sore). On 26-Apr-2021, the patient experienced ORAL MUCOSAL BLISTERING (Blisters on the left side of my mouth and the left side of the roof of my mouth). On 22-May-2021, MYALGIA (Arm was little sore) had resolved. At the time of the report, ORAL MUCOSAL BLISTERING (Blisters on the left side of my mouth and the left side of the roof of my mouth) had resolved.            The concomitant medication reported included atorvastatin for cholesterol and diltiazem for heart Treatment information included the use of salt water that eased the pain, but it went away.   The patient reported that post first dose of vaccination she got blisters in her mouth that got better but never away. On 23 Apr 2021 at night she had sore arm, but the soreness went away quickly. Three days after the vaccination there were blisters on left side of mouth and on left side of the roof mouth. On 18 May 2021 she noticed that blisters started going away but not completely. The patient reported that she likes to eat spicy food but haven't had any spicy food since vaccine administration and she was planning to call the physician on 24 May 2021.   This case was linked to MOD-2021-162323 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up document was received on 09 Jul 2021. The dosage regimen of concomitant medications, Pro-air inhaler, outcome of event and narrative were updated.
It was reported that a pt after receiving vaccination developed pain and swelling at injection site within 48 hrs of vaccine being administered.
All joints hurt really really hurt, Temp ranged between 100.5 and 100.7 for appox 24 hours. I couldn't hold my urine. Food tastes bad, metallic. Took home COVID test, it was negative. Took Tylenol for fever. I felt like I did when I had Swine flu 30 years ago. Teeth hurt.
Vaccinated: 11:18 Reaction: 11:20 2 minutes after vaccination, patient had a tonic-clonic seizure lasting 30-45 seconds. Patient's head was turned to side and supportive care was given. 911 was called and patient left by EMS at 11:50. Per patient's mother at ED, patient was in the backseat after having gotten her COVID-19 vaccination when she immediately started to scream for her mom and left hand began shaking. Then, the patient lost consciousness and mother called for help. She notes that the patient urinated on herself and was back to being alert 30 seconds to a minute later. Patient reported to be very anxious about getting the vaccine. Patient noted to hvae rhinorrhea and sneezing prior to getting COVID-19 vaccine. Vitals: @9:44: 150/110, 10 -> @1142: 125/84, 101, O2 93% -> @13:36: 116/66, 87, 18, O2 99% Patient reports she is back to baseline in ED taking PO and ambulating normally. Patient also appeared nontoxic in appearance with normal vital signs and normal neurologic exam.  and provider recommended patient be discharged with Keppra. During follow-up call, mother expressed concern over using Keppra on daily basis and was reassured that because it was a singular event triggered by getting a vaccine, routine use of Keppra will not be necessary at this time. Mother also plans on getting next COVID vaccine in controlled environment with proper observation and provider advised that if she has any involvement of left side that is concerning for seizure, patient will need daily anticonvulsant.
I started getting a sore throat. I was at a major conference when I began having problems swallowing and my throat hurt. It just hit me like a brick. I was going to spend another night, but I decided to head home that day. I started feeling extremely run down and had a cough. I pulled off the highway at around 09:00PM to a rest stop. I happened to have some COVID-19 tests with me so I took two and they were both positive. I called my workplace to inform them of my positive results so that they could tell others who had been with me. I then continued driving home and returned home at around 11PM. I had a fever, chest pain, cough. I felt like I had the flu. I called my doctor in the morning. I am on Stelara which lowers your immune system, so my doctor arraigned for me to receive a monoclonal antibody infusion on 06/18/2022. They told me it would take around 48 hours for me to feel the effects. It took less than 24 hours for me to feel significantly better. For the next 2 days, I felt exhausted but better. I continued to feel fatigued and slept a lot for the following 5-6 weeks. I could work, but not a whole day. I would fall asleep in the middle of the day for about a month.
Upper arm (above the elbow) was red, swollen, and slightly warm to the touch.
Report of local reaction, left leg plus edema, redness, pain on knee .Extremity warm by touch. Seen by physician.
The pt complained of aching in joints, reddened rash on elbows and knees.
Interrupted vaccine schedule / The patient received her first dose of GARDASIL 9 on 20-FEB-2017 at the age of 17 years old and did not receive the second or third dose; No additional AE reported; This spontaneous report was received from a registered pharmacist and refers to a female patient, who was 21 years old at the time of the report. There was no information regarding her medical history, concurrent conditions nor concomitant therapies provided.  On 20-FEB-2017, when she was 17 years old, the patient was vaccinated with her first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL (route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. At the reporting time, she did not receive the second or third dose of the vaccine yet and the pharmacist was requesting information regarding interrupted vaccine schedules for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). No adverse event (AE) was reported.
At 2 a.m., Patient began getting very sick. She has a fever. She reports her whole body feels it is on fire. She can not sleep.
On 1/11/21  noted with headache, nausea/vomiting, severe melaise.  On 1/12/21 resident expired.
hand soreness disappeared; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (hand soreness disappeared) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A310 and 00321A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), LIOTHYRONINE SODIUM (CYTOMEL), TESTOSTERONE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (hand soreness disappeared). At the time of the report, PAIN IN EXTREMITY (hand soreness disappeared) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Pt vax w/ hepta B on 22May90, 13Jul90, 30Nov90.  06Feb91 tested neg for HBSAB.
During clinic visit on 3/18/19 mom stated patient had discoloration of (R) lateral arm (upper) that she noticed at an unspecified time after receiving vaccines. Denies pain or mobility issues.
Patient did not feel well.  He was sweating and felt his heart was racing and blood pressure was a little higher than normal.
Patient ambulated to exit after receiving COVID-19 vaccination. Patient had syncopal episode witnessed by staff. Patient assessed by staff and EMS. Patient's vital signs reassesed after 5 minutes. Blood pressure low. Patient transported to local ER for further evaluation. 1344 BP=83/62, HR 44, O2 sat 95% on room air. 1350 BP= 84/39, HR 49, o2 sat 95% on room air.
Flush (cheeks, neck), tightness in neck and throat, upper lip and nose tip tingly and itched.
The patient began with feelings in her throat as well as fever, and nausea beginning the next day after receiving the vaccine.
Generalized vaccinia dx'd. On 2/25/03, soreness, swelling under arm and knot on anterior shoulder with traditional flu-like symptoms (congestion, malaise, fever, aches and muscles). Follow-up with army medic on the following day and they referred him to ER. He was treated with Dicloxcline and Entex and Afrin. F/u 48 hours for changes on 2/27/03. Follow-up with doctor if symptoms don't improve. Dx'd with generalized vaccinia cellulitis/lymph dermatitis. Addendum: Bumps across chest "sore, fire-ant bites" radiated from left arm to chest.
It was reported that a 52 year old female received a Fluzone SV 99-00 vaccination on 10/26/1999 at 6:00 pm. Reportedly immediately after the vaccination, the patient experienced a warm flush all over the body, she felt "weird". Her blood pressure rose to 168/112 and pulse to 106. The patient went to the ER where the doctor prescribed Enderal. The patient then experienced pain in her chest. The patient was then taken to another hospital where a doctor prescribed Prednisone. The patient also developed large blisters on her hands and had spotted vision in her right eye. The patient had not yet fully recovered, she is still experiencing pain at the injection site. From follow up correspondence received at Aventis Pasteur Inc. On 03/10/00, it was reported, "No additional information". From follow up correspondence received at Aventis Pastreur,Inc. on 05/15/00, it was reported that the patient did fully recover from the adverse event, and there was no result of permanenet disability. It was also reported that the patient had a pre-existing condition of Stephens Johnson syndrome. The patient was being treated for this condition at the time of vaccination. Follow-up 06/14/02: during internal review of all files, it was deemed necessary to amend the report by updating Adverse Event coding (added depersonalization, chest pain and tachycardia). Also re-ranked Adverse Events which did not change the onset date.
Headache, tiredness, brain fog and joint pain that still persist over 1 week later.  Fever for the first 3 days, highest 100 degrees on day 2 all day.  Injection site pain, site was hot & swollen for 5 days, also had intense shooting pain down injection site arm on day 2 from shoulder to fingertips for most of the day.  Swollen, burning and painful lymph nodes initially in injection site armpit the first 3 days then both until day 6, unable to put injection site arm down by my side on days 2-5 due to the pain it caused.  Diarrhea on day 4.   Tightness in chest on day that 4 that felt like a 10 pound weight on my sternum making it hard to take deep breaths so I went to Urgent Care.  I occasionally still feel chest tightness over 1 week later.  Have been taking 800 mg Ibuprofen at 8 hour intervals to help alleviate symptoms ever since I received the vaccine.  Tried a warm compress on injection site armpit for painful lymph nodes on days 2 & 3 but it did not seem to help so discontinued.
Patient states a half an hour to one hour after getting shot that she was feeling a rapid heartbeat. Patient states around 7:00pm on 2-4-2021 she developed fever 103.0 to 104.0 with severe body shivering that lasted all night. Shivering was so bad that the bed was shaking. Shivering lasted through the night. She woke up in the morning and was wet with sweat. Patient had body aches and a bad headache that lasted for 2-3 days. OTC medicine, Tylenol and Advil did not help the headache. Patient states she had no energy and was weak. She had nausea and vomited a couple of times She was feeling hot and cold all night. She states she had a rash on her chest that she put Benadryl cream on. She states left arm where she got