chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received 29 April 2008 from a health care professional. A one-year-old male patient developed a black dot at the injection site after receiving a left thigh injection of IPOL and DTaP on 06 March 2007 or after receiving a left thigh ActHIB and Varicella Vaccine on 10 September 2007. On 06 March 2007, the patient received a left thigh injection of IPOL, lot number Z0547-2 (route not reported) and a concomitant left thigh injection of DTaP (manufacturer and lot number not reported). On 10 September 2007, the patient subsequently received a left thigh injection of ActHIB, sanofi pasteur Inc lot number UF207AA, (corresponding sanofi pasteur SA lot number A0175-2) and a concomitant left thigh injection of Varicella Vaccine (manufacturer and lot number not reported). According to the reporter, the physician noticed the black dot on the patient's left thigh on 20 September 2007. At the time of the report, the patient's recovery status was unknown. The reporter received a cluster of reports of black dots at the injection site from multiple satellite locations who were all affiliated with the reporter. The facilities used McKesson alcohol wipes and syringes which included safety glide and vanish point with 25 gauge needles. Some of the black dots were reported to have appeared immediately with some present four months post immunization. This event had been noticed by all health care workers at the facilities and had not been noticed in the past. The reporter indicated follow-up information would be provided as obtained upon future request. The reporter for this case is the same as for case numbers 2008-01334 (IPOL), 2008-01335 (IPOL), 2008-01336 (IPOL and DTaP), 2008-01338 (IPOL) and 2008-01339(Fluzone). These events occurred at multiple satellite locations which are all affiliated with the reporter.
Knot witnedness to Lt deltoid at injection site afternoon of 10-09-15. Rash (sm red bumps) started at injection site 10-10-15. Knot no longer there an 10-10-15 but arm sore. Rash began to spread down the arm to the waist and to Rt arm. Also (rash sm red bumps) on face. C/o itching (rash).
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.
Wednesday 4/28/2021 I was foggy and tired.   Thursday 4/29/2021 I woke up feeling like I had the flu.   At approximately 1pm on Thursday 4/29/2021 I was in the bathroom and started seating and seeing white spots.  I went to my bedroom to lay down in front of the cold air and passed out.  I woke up about an hour later.    I slept the rest of the day and woke up Friday 4/30/2021 feeling fine
Patient experienced syncope, nausea, cold skin, pale, slow response but still conscious less than 5 minutes after receiving 1st dose of Moderna Covid 19 vaccine. EMS was contacted and arrived in about 5 minutes. Patient didn't need first aid response by pharmacy until EMS arrival. EMS personnel checked her vital signs (oxygen, blood pressure). Her blood pressure was 62/39 on first measurement. She was placed on stretcher. Her condition improved in several minutes. She was responsive and able to answer questions by EMS personnel. Her Systolic blood pressure went back up to 90 on 2nd measurement. She was taken out to ambulance to give her some fluid orally. Her husband stated that her condition was stable and she was able to go home with him without any needs to transport to hospital. She has history of anxiety attack, mild anemia, hypothyroidism.
chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-JAN-2023, the patient received the 1st dose of Shingrix. On 18-JAN-2023, less than a day after receiving Shingrix, the patient experienced chills (Verbatim: chills). The outcome of the chills was resolved.   It was unknown if the reporter considered the chills to be related to Shingrix.     It was unknown if the company considered the chills to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR070869   Additional Information: GSK Receipt Date: 12-MAY-2023 The reporter stated that she received her first dose of Shingrix and experienced chills that was resolved. The patient took Ibuprofen to treat these symptoms. The reporter did not consent to follow-up. This case had been linked with US2023AMR070869 due to same reporter and different dose.; Sender's Comments:  US-GSK-US2023AMR070869:Same reporter
After 2 minutes of vaccine I experienced a lose of vision for 4 minutes and numbness of hands for the proceeding 15 minutes.
Pt became dizzy after injection.  VS were stable and as follow: BP 118/80, 116/80, 120/80, & 118/80; HR 80, 78, 73, &72; OxSat 98%, 98%, 98%, & 97%.  Ice pack applied to neck, lying supine on a cot.  Reported feeling better.  Started feeling dizzy again.  EMS called.  Also became nauseated over the course.  It was reported that patient only had egg w/coffee for breakfast.  Took a few sips of V8 fruit and drink prior to EMS arrival.  Vitals obtained by EMS also stable but pt continued to gag/vomiting sounds.  Was able to sit and stand.  Reported she felt better after EMS suggested transport for further evaluation.  Pt continued to gag (but no actual vomit)  The moment she does any movement pt gets dizzy.  Did reporte early on some numbness left hand.  Transported to the ER by EMS @2:10PM
Stroke like symptoms like Loss of balance, loss of words, mixing up words, headache, nausea, distance in vision off, muscle aches
April 22, 2021 Body aches and sore arm around 4pm Shallower breathing than normal and chest pains around 6pm Subjective fever around 9pm Fever of 102 and nauseated from 11pm-8am next day (04/23/2021) Headaches all day long April 23, 2021 Fever all day long 99.5-102 with symptoms included above April 24, 2021 Bump around injection sight  Fever gone Still shallow breathing and chest pains Headaches still Body aches still, back worse
Systemic: Anaphylaxis-Severe, Systemic: Seizure-Medium, Systemic: Tingling, tremors, convulsions, numbness and difficulty breathing -Medium
After flu injection on 10/16/2010 noticed severe fatigue starting that evening and continued the next four days.  Contacted neurologist to check blood levels for epilepsy drug currently taking - KeppraXR.  Had grand mal seizure on 10/20/10.  Blood levels were at a good level (61.8) and had not had a seizure since 12/27/2009 when break through seizure occurred probably due to low blood levels of seizure drug (12.7). Both of my son's neurologists seem to think that the severe fatigue and seizure was brought on by flu shot. Did not get H1N1 shot last year due to neurologist not recommending it due to neurological side effects, but did recommend him getting one this year even though the H1N1 was in the combination.
Severe shoulder pain where injection was given. Severe muscle weakness of Left shoulder joint. Difficulty moving arm due to severe pain and limitation of range of motion.  Severe pain and muscle weakness occurred again on Tuesday morning 10/4/16 and again, to a slightly lesser extent on Friday 10/7/16. Currently still have pain (non-severe) during movement of shoulder joint.  Tried to communicate with prescribing physician the day after vaccinatin administration (9/29/16) as well as the day following, asking to be seen (9/30/16).  Did not receive any return call.  On day of second "flare up" (10/4/16) needed to visit Urgent Care due to severe pain, weakness, and decreased range of motion.  Treated with 3 day supply of prescription pain medication and pending referral for orthopedics.
Starting feeling pain/discomfort on 01/16/2021 when waking up. When woke up on 01/17/2021, upper arm was red
Pain in Ribcage; Pain (Injection Site); This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Pain in Ribcage) and VACCINATION SITE PAIN (Pain (Injection Site)) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension in December 2015, Flutter atrial in August 2017 and Subdural hematoma removal in September 2015. Concurrent medical conditions included Drug allergy (Norco (Tetracycline, Hydrocodone, Bitartrate, Acetaminophen)) and Drug allergy (Achromycin (Tetracycline HCL)). Concomitant products included CEFALEXIN MONOHYDRATE (LEXIPRON) for Depression, LOSARTAN for Hypertension, LATANOPROST for Prevent Glaucoma, APIXABAN (ELIQUIS) for blood thinner, ATORVASTATIN CALCIUM (LIPITOR) for stroke prevention.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (Pain in Ribcage) and VACCINATION SITE PAIN (Pain (Injection Site)). At the time of the report, MUSCULOSKELETAL CHEST PAIN (Pain in Ribcage) and VACCINATION SITE PAIN (Pain (Injection Site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.    Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: No specific follow-up information recorded. On 20-Apr-2021: No specific follow-up information recorded.
Elevated BP of 166/110 from norm of 128/78.  Also ringing in ears.
Chills and fever all of the following day. Uncontrollable shaking for most of the day. Three following days had the same symptom to a lesser degree. No energy for about a week.  shortness  of breath
Front desk gave pediatric dose of Pfizer and subsequently, nurse administered pediatric dose vaccine to a 12 year old pediatric patient. Patient's family was ok with patient getting an adult dose of Pfizer. Patient was immediately given adult dose of Pfizer vaccine per CDC/manufacturer guidelines. Patient's family had minimal concerns regarding side effects. To assist with language and translation, speaking nurse was included in the conversations and all patient's family's questions were answered.
Headache, fever, chills, nausea, drenching sweat, extreme body aches,  fatigue. Swollen clavicle and axillary lymph nodes bilateral.
This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), DIARRHOEA (Diarrhea), MYALGIA (Body ache), PYREXIA (Fever) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced DIARRHEA (Diarrhea) and PYREXIA (Fever). On 17-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), MYALGIA (Body ache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swollen arm), DIARRHEA (Diarrhea), MYALGIA (Body ache), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   This case was linked to MOD-2021-091059 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Information regarding the Email Address was updated.
17 years of age, were inadvertently administered the Moderna COVID-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age, were inadvertently administered the Moderna COVID-19 Vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age, were inadvertently administered the Moderna COVID-19 Vaccine). On 03-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age, were inadvertently administered the Moderna COVID-19 Vaccine) had resolved. Not Provided      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.   Concomitant product use was not provided by the reporter.  The patient did not experience any adverse event symptoms and no treatment was administered. This report refers to a case of product administered to patient of inappropriate age,  for mRNA-1273, lot: 016B21A,  with no associated adverse events.   This case was linked to US-MODERNATX, INC.-MOD-2021-067217, US-MODERNATX, INC.-MOD-2021-067645, US-MODERNATX, INC.-MOD-2021-067250, US-MODERNATX, INC.-MOD-2021-067547 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Patient was not Pregnant during vaccination, No adverse event deleted as relevant history.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age,  for mRNA-1273, lot: 016B21A,  with no associated adverse events.
This spontaneous report as received from a physician refers to an 11 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 29-JUL-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # N000326, expiry date 14-DEC-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
Pt recvd 1st dose of Hep B vax on 17APR91 & the following day exp nausea, muscle aches & pain, & an elevated temp; no further details were provided;
Information has been received from a RN concerning a over 60 year old female who on approximately 03/15/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647654/0865N).  On approximately 03/15/04, several hours after vaccination, the pt developed injection site pain, redness, warmth and swelling.  Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. A pt from the same source had a similar experience WAES# 0403USA01639.
Pt felt light headed, had Elevated BP 177/1106, HR 86, Pulse Ox 98% on room air, very anxious, placed on cot, feet up, with OS symptoms improved as did blood pressure
Sx onset approximately 30-45 min after giving injection, then returned 5-6 hrs after taking Benadryl - see original note.
Around 24 hours after vaccine a red area about an inch in diameter from vaccine inj. Site became itchy and slightly raised. Has been itching for 2 days and redness has not spread nor gone away. I also am experiencing different taste/smell like how I had when I was previously covid positive in December 2020.
We had a patient get their second dose of Pfizer today but due to issues with the syringe, I believe the patient did not get the full dose.  The syringe used was one provided in the ancillary supply kit. I added the 23G x 1 needle provided in the ancillary supply kit. I ensured the needle was twisted tightly so that it was secure. I drew up the dose of 0.3ml. However, the plunger in the syringe slid easily inside the syringe and the rubber stopper did not hold the dose in place very tightly. When I went to administer the dose, liquid fell down her arm as I injected the dose into her arm.  I do not believe she received the full dose.   I have administered another dose for the patient as recommended by Pfizer in the CDC guidance, which said to give in the opposite arm immediately with no interval.
She received H1N1 shot in her left arm and did not have pain or swelling at the injection site. The next morning, she noticed multiple, raised rashes on both her upper arms. When she consulted a doctor, it was diagnosed as hives. She was prescribed anti-histamines which did not relieve her symptoms. Then she was prescribed steroids which worked. It took 4-5 days from the onset of hives to relief of symptoms. She does not have any chronic condition and she has not experienced any adverse reactions associated with vaccines earlier.
Chest pain constantly (due to high heat in room); Malaise; Weakness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain constantly (due to high heat in room)), MALAISE (Malaise), ASTHENIA (Weakness) and FATIGUE (Fatigue) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced CHEST PAIN (Chest pain constantly (due to high heat in room)), MALAISE (Malaise), ASTHENIA (Weakness) and FATIGUE (Fatigue). On 03-Feb-2021, CHEST PAIN (Chest pain constantly (due to high heat in room)) had resolved. At the time of the report, MALAISE (Malaise), ASTHENIA (Weakness) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Aug2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Aug2023) Positive; (26Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient used Paxlovid from 17Aug2023 to 21Aug2023 as treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
The pt experienced a hard reddened warm area that was grapefruit sized. On 3/2/00 when came into the clinic, the area was the size of a grapefruit with bruising and a knot the size of a quarter in the center. Mother using cool compresses.
Redness, heat, itchiness and swelling from shoulder to elbow surrounding injection site.
Broke out in hives almost a week after second injection.  Have taken benadryl and a steroid taper with no change. Hives have only gotten worse.
This spontaneous report as received from a health care worker refers to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (dose strength, dose number, route unspecified). No adverse events were reported. The outcome of events reported was unknown. No product quality complaint was involved. This case is linked to the cases 1506USA004940, 1506USA004986, 1506USA004987 via same reporter link. Additional information has been requested.
Eye swelling,  under eye swelling,  headaches,  fatigue, weakness,  itching around eyes, red  rash on both sides of my face,  eyelids  both swollen
My son awoke at 2:00 am on 8/22/17, approximately 10 hours after receiving vaccine, with abdominal pain, nausea and vomiting. This lasted with same intensity pain with nausea and repeated episodes of vomiting (pain scale 7 out of 10) throughout the course. He was seen at pediatrician's office due to concern of adverse reaction at 2:00 pm on 8/22/17 and exam was concerning for appendicitis. He was then brought to hospital emergency room. Ultrasound was performed around 3:30 pm and confirmed he had appendicitis. Surgery was scheduled the same day and done around 8:00 pm on 8/22/17. He had laparoscopic appendectomy with an overnight stay in the hospital, discharged home on 8/23/17 around 11:00 am. Pain from appendicitis resolved and recovering from surgical pain.
5 minutes after receipt of second COVID vaccine developed  rapid onset of nausea, vomiting, body aches.  Did seek care in the Emergency department where was given IV fluids and Zofran.  18 hours later, feeling improved.  Still showing some s/s. First vaccine was on 12-28-20 with Pfizer Lot # EL 1284.  3-4 hours after that vaccine developed headache, Body aches and exhaustion that lasted about 24 hours.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug allergies or reactions were no provided. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX, lot # N031003, expiration date on 03-NOV-2019, for prophylaxis (strength, dosage, route and frequency were no provided). It was stated that the sterile diluent was properly stored. Also it was explained that the VARIVAX, was during 8 hours in a temperature of 8F, and that there were previously excursions: 41F for 62 hours, 6F to 14F for 72 hours. Data logger was positive. No adverse events were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1809USA000594: US-009507513-1809USA000587: US-009507513-1809USA000596: US-009507513-1809USA000592: US-009507513-1809USA000593:
Started ~10:00 PM - Current: Fever (101 F), Chills, Severe night sweats, Nausea and vomiting all night, Abdominal pain
wheezing and tightness in chest, coughing (asthma-like symptoms) ~4 hours post-vax lasting 6 hours before sleep- no symptoms next AM; sore throat ~10hrs post-vax - no symptoms next AM; redness and irritation in both eyes ~6 hours post-vax lasting ~24hrs.  No treatment sought.