chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 days after the first injection a red rash appeared, covering both feet and extending up the body to the armpits. Nothing on the neck, face or head; very little on the back but heavy on the front torso.  (I have pictures). Not painful or itching. Took Benedryl for 2 days, no change. Dr. prescribed Fluocinonide Cream .05% on Feb 4. Have applied one dose and will continue doing that. Urgent care suggested that the site location personnel need to be contacted.  He is scheduled for Feb 11 to get injection #2.  Should he or not?
Filler swelling (face); This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El9265, expiry date: unknown), via an unspecified route of administration on the left arm, on 29Jan2021 17:00, at single dose, for covid-19 immunization, at a public health department. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date: unknown) received at 41 years of age, via an unspecified route of administration on the right arm, on 08Jan2021 17:00, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 31Jan2021, the patient experienced filler swelling (face) (pending clarification). It was unknown if treatment was received for the event. The outcome of the event was not recovered. The reporter assessed the event as non-serious.
Four days after booster I had redness in fingers ? red, hardened skin ? and I still have this on my fingers.   I also had an itchy scalp with no redness from October 2021 to July 2022.   I started having night sweats that drenched the sheets every night and they lasted from October 2021 until August of 2022.  COVID-19 and Mononucleosis in January 2022.  COVID-19 symptoms were very mild.  I was not having my periods since my second dose of Moderna in February of 2021.  In January of 2022 we learned of hormonal deficiencies.  I had an MRI of my brain to learn more and was diagnosed with Pituitary Micro Adenoma.  I saw a rheumatologist and was diagnosed with Anti-Nuclear Antibodies (ANA).  This was in April 2022.  I was having gastrointestinal issues with regurgitations and was diagnosed with Gastro Perisis in September of 2022. In addition, my heart rate would go very high up to 140 just from standing and 170 when I would go upstairs.  I was diagnosed with POTTS by a cardiologist.  I saw a pulmonologist for reason of shortness of breath.  I began taking Corlanor to reduce tachycardia and responding well.  They also found perforation in my nasal septum possibly from COVID-19.  There was a 5mm hole that required 7-hour surgery to repair and reconstruct my nose.  Acupuncture has resolved night sweats.  Electric stimulation and Motegrity for Gastro Paresis.  Diagnosis: Long COVID-19; POTTS (Postural Orthostatic Tachycardia Syndrome) ; Gastro Paresis; Hypo Cortosolism; Pituitary Micro Adenoma;  Hypogonad Atropric Hypogonadism; Anti-Nuclear Antibodies (ANA)
Scattered chicken pox lesions- head, trunk, and scalp extremities. Friend broke out 5 days ago.
Allergic reaction; This is a spontaneous report from a contactable consumer or other non hcp (consumer). A female patient of an unspecified age received BNT162b2 (CONMINTARY, Solution for injection, Lot No, NDC number, Expiry Date: was not reported), via an unspecified route of administration on 11Apr2021 as 1stdose, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced allergic reaction on Apr2021.  Patient had to visit emergency room from unspecified to unspecified. Dates for patient are telling her to get the second dose from unspecified to unspecified. Reason for no lot number of Covid vaccine was patient was unwilling to complete the report. Patient had her second dose, but if she has already had an allergic reaction does she need the second dose because she does not know what to do. Investigation assessment was not provided. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Initial case received from a consumer on 26 October 2012. A female patient, was administered IMOVAX Rabies, lot # G-1377 on an unspecified date. The indication, route, site and number of previous doses were not reported. The reporter questioned the possibility of vaccine failure, but the patient history and vaccination details were not reported. Concomitant drugs and laboratory results were not reported. No further details were available at the time of this report. The patient outcome was not reported. Documents held by sender: None.
Chest pain, chest tightness, stomach upset, diarrhea , headache, arm soreness, brain fog
approx 3yrs p/vax pt exp chickenpox w/approx 2 dozen lesions.
Patient called 1/19 letting me know she had soreness at site of injection. I told her that is a normal reaction and that it should clear up in 2-3 days. On January 22 at approx. 9 AM she called to state she had a large leaking bump. She went to see her physician this afternoon on January 22 he stated that it may be an infection but unsure and that he was not "concerned" as the area was not surrounding red. She came and saw me after her appointment. I saw the large lump that looked much like a blood blister. I also submitted a report to Merck. Thank you.
This spontaneous report was received from a physician assistant and refers to a 26 year old patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 08-DEC-2017, the patient was vaccinated with PROQUAD, therapy type rHA, lot # M044575, expiration date 04-MAY-2018, for prophylaxis (dose and route of administration were not provided). Concomitant therapies included sterile diluent. The administered dose of PROQUAD was stored in the refrigerator from 18-OCT-2017, in temperature of 38 degrees Fahrenheit for 1224 hours (51 days). The call was because of digital data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1712USA009167.
LIGHTHEADED, HEADACHE 5/10 FRONTAL/TEMPORAL, WEAK
Patient is 16 years old female here with stepmother for sports participation clearance. Patient was also due for 3 vaccines including Menveo. HPV. and Bexsero. Mother requested to give all three vaccines today. After patient received the vaccines, she fainted. Patient was standing when she received the vaccines After the third Shot. She slowly fell to the ground.
Had vaccine on December 31, 2020.  Itchiness and rash began on January 2, 2021 and lasted the entire month.  Tried using Benadryl, but it didn't stop the itchiness.  Had Virtual Urgent Care visit on January 19, 2021.  Was prescribed famotidine, hydroxyzine, and triamcinolone.  This stopped the itchiness.  The rash disappeared.  I stopped taking the meds after two weeks, but the rash/itchiness returned after two days.  So I resumed the medication until the end of January when the pills ran out.  The rash/itchiness did not reappear.
At the injection site: swelling, red rash, heat, pain (3 days) Left forearm: rash, tingling, numbness (3 days) Left hand: tingling, numbness in fingers (3 days) Face: tingling, numbness (bell's palsy like symptoms) (2 days)
This is a spontaneous report obtained from a contactable consumer (Pfizer employee) for his 15 years son. A 15-year-old male patient received, on 06Aug2015 at 04:00 pm, second dose of TRUMENBA (Lot. J29203, Expiration date: Jun2016), via an unspecified route of administration in the right upper arm, at 0.5 ml single. Relevant medical history included allergies (he took medication for seasonal allergies). Concomitant medications included SINGULAIR (tablet) 10 mg once daily (every day at night) for allergies, NASONEX once at night for allergies, Ibuprofen as needed (occasionally) for soccer accidents and XYZAL 5 mg as needed (occasionally) for antihistamines. Previously the patient received first dose of TRUMENBA, on an unspecified date. On 06Aug2015, the patient experienced sore at injection site, the patient had little bit of soreness but nothing really bad. On 07Aug2015, the patient experienced chills, fever, joints achy, body ache and he was not feeling well. Relevant laboratory data included body temperature at 102.2 Fahrenheit on 07Aug2015 and at 103 Fahrenheit on an unspecified date, in Aug2015. Patient's clinical course was the following: the patient received TRUMENBA, 06Aug2015, at 2:00 pm. The patient came home and was doing fine except his arm was sore. Reporter does not know which arm the vaccine was given in. He went to soccer, he came back from soccer and took a shower. He was not feeling well, feeling chilled and his joints were achy. At 6:00 pm, reporter took the patient's temperature which was 102.2 Fahrenheit (orally). He gave the patient ibuprofen 200 mg two tablets at 6:00 pm. Reporter then called the pediatrician who said the temperature may be elevated for 72 hours and maybe due to the vaccine. The Paediatrician recommended to give him TYLENOL/MOTRIN and if the fever was high be sure that he was hydrated; if fever continues and get worse to go to emergency room. On 08Aug2015, the patient recovered from the events (patient had no chills, no feeling achy and no fever. He did not complain anymore). The reporting health professional assessed that TRUMENBA did not have a causal effect to the adverse events. The patient received again, on 17Oct2015, TRUMENBA (Lot. J29203, Expiration date: Jun2016), via an unspecified route of administration, at 0.5 ml single. Follow-up (10Aug2015): New information reported from the same contactable consumer includes: reaction data (body ache added as additional adverse event). Follow-up (09Sep2015): New information received from a contactable health professional includes: reporter's causality assessment, treatment for fever updated, TRUMENBA details, past vaccination. Follow up (21Oct2015): New information received includes: patient's clinical course. Follow up attempts completed. No further information expected.
The following morning,, back pain/sciatica began after waking.  As the day went on, it got worse.  Night-time ... difficult to sleep.  Next morning (today) very painful ... difficult to stand (at times) and sit.    All similar to my back condition in December that I thought was under control.  Taking over the counter medications haven't helped yet.  Alternating heat / ice / bacx-brace.
Narrative:  Patient was seen after administration of the 2nd dose of Moderna COVID-19 vaccination. He and his wife alerted staff to their concerns about 2-3 minutes after the vaccination. Patient notes having developed the feeling of full body flushing a/w diaphoresis and palpitations that lasted 1 minute. This provider happened to be nearby while this was being reported. HR was in 70's and regular at that time. No associated pruritus, urticaria, flushing, swelling, confusion/ disorientation, dizziness/light headiness, confusion, LOC, shortness of breath, nausea, vomiting, abdominal cramping or feeling like the need to have diarrhea, His wife did not visualize any changes in skin color during the episode and also confirmed that she did not see any facial swelling. Patient likened the experience to the beginning of a panic attack. T98.1 BP 125/89 HR72-81 RR initially 18. 10-12 upon resolution SPO2 98% on RA Gen: initial distress resolved 1 minute, nontoxic, answering questions appropriately, pleasant/joking, speaking in full sentences w/o increased respiratory effort, diaphoretic HEENT; atraumatic/normocephalic, PERRL, nares, throat non erythematous/ no swelling Neck; no swelling CV: regular rate and rhythm, normal S1/S2/, no murmurs plum: clear to auscultation bilaterally with no wheezes/rales EXT: moves all 4 spontaneously, no edema skin: no lesions or rashes were visible Neuro: Grossly intact 5/5 strength UE and LE Psycho: appropriate, thoughts linear A/P: 52 y/o Patient here at vaccination clinic, who experienced likely vasovagal reaction s/p 2nd vaccination. Normalized response and reassurance provided to patient and accompanying wife. Completed additional 5 minutes of post-observation period past the 15 with continued completed resolution of six. ER Precautions Provided bottle of water, no further needs at conclusion of encounter. The patient visualized ambulating w/o difficulty from observation area.
Initial report received from a healthcare professional on 14 OCTOBER 2013. A female patient whose, date of birth, age at the time of vaccination was not reported and medical history and concomitant medications was unknown, had received an intramuscular dose of FLUZONE, batch number, dose, site of administration were not reported) on 30 SEPTEMBER 2013. On 01 OCTOBER 2013, one day after vaccination, the patient noticed a discoloration of her skin at the injection site. IT was about the size of a pencil eraser. The skin in this area. Lightened up in color. NO other symptoms reported.  Corrective treatments were not reported and laboratory investigations were not performed.  At the time of this report the patient was not recovered from the event.  Documents held by sender: None.  Follow-up received on 14-OCTOBER 2013: Lot # 134224 and vaccination site, arm. Updated
Metal taste; Metallic smell; swollen lymph nodes in armpit; Chills; Fever; This is a spontaneous report from a contactable consumer (patient). A 73-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 09Feb2021 at 13:30 (at the age of 73-years-old) in left arm as a single dose for covid-19 immunization. Medical history included peripheral arterial occlusive disease and prior to vaccination, the patient was not diagnosed with covid-19 from an unknown date and unknown if ongoing. The patient previously took codeine and experienced allergy. No other vaccine in four weeks. Post vaccination, the patient had not been tested for covid-19. Concomitant medications received in two weeks included rivaroxaban (XARELTO); atorvastatin (ATORVASTATIN); estradiol (ESTRADIOL) and aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) all taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for covid-19 immunization. It was reported that within 24 hours of vaccination the patient experienced chills and fever lasting 24 hours, swollen lymph nodes in armpit which dissipated after 10 days, metal taste and smell which lingered on 10Feb2021 at 13:00. The patient did not receive any treatment. The outcome of all the events was resolved in Feb2021 with sequelae (lasting effects).  Follow-up attempts are completed. No further information is expected.
Client received 1st dose of  Pfizer on 04/28/2021. Client went through J&J vaccine line and verified with staff that they were receiving J&J vaccine. Client then received J&J vaccine, was observed for 30 minutes. No adverse reaction.
No adverse event; Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced UNDERDOSE (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose).    No concomitant medications information was reported. Patient received a 0.25 ml dose as booster from booster dose only presentation vial, with a volume of 0.25 ml instead of 0.5 ml. Vaccination date: between 22-Jul-2022 and 28-Jul-2022. It was unknown if patient experienced any symptoms after getting the vaccine. No treatment medications were provided.
Upon arriving at home after vaccine, pt face and neck swelled, picture shows right side of face and eye swelling. Used Benedryl to calm it down for two days, then developed 101 fever and persistent headache. Patient was feeling better on visit 11/08/2017.
11/1 1800h onset shaking chills, anorexia, tachycardia, weakness.  Bedridden requiring 2 extra blankets for 14 hours.  11/2 no longer chilling after arising but felt too weak to go to work (making it a Gr 3 adverse event ) 11/3 normal Maximum temperature 99.8.  No injection site reaction Janssen protocol VAC18193RSV3001, Synexus is site U01-US10041
started bleeding and has not stopped bleeding; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (started bleeding and has not stopped bleeding) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced VAGINAL HAEMORRHAGE (started bleeding and has not stopped bleeding). At the time of the report, VAGINAL HAEMORRHAGE (started bleeding and has not stopped bleeding) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported.
flushing reaction; feeling hot; her tongue felt weird; little dizzy; This spontaneous report was received from a pharmacist referring to a female patient of unknown age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, administered intramuscularly for immunization (lot #W034714, expiration date: 18-OCT-2023; strength was not provided) with sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion, 0.5 milliliter, administered intramuscularly (lot #W011298, expiration date: 27-NOV-2024; strength was not provided).  On 24-MAY-2023, the patient began having a flushing reaction (flushing), feeling hot, her tongue felt weird (paraesthesia oral), and she was a little dizzy after receiving vaccination. She had sought medical attention. Treatment with diphenhydramine hydrochloride (BENADRYL) and rest was given for the events. At the time of reporting, the patient was recovering from the events.  The causal relationship between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and sterile diluent (MERCK STERILE DILUENT) was not reported.
Headache, fever, chills, Body aches , injection arm hurts, feels weak.  Overall after Tylenol, arm still hurts and feels weak.
On 5/27/2009 24 hours after immunizations were given L upper arm started to swell & redden.  They were advised to use Tylenol + cold packs by clinical in our office.  Today 5/28/09 the redness + swelling progressed from shoulder to elbow.  She came in to be assessed in our office.
Patient lost conciousness 5 minutes after vaccine was administered. She came around after 1 minute. She may have had a seizure. She rested, recovered and went home.
On May 16th my son started with pain on the throat and with swelling that was painful to touch. Next day, at 3 AM started with more pain, more swelling and high fever. I took him to the emergency room.
Local itching/redness/swelling. She was examined at 18:30 on 3/8/17 and had a 16 cm long area of redness, swelling and warmth along her left upper outer arm to width of 5 mm. I am reporting it because it was so large.
high fever 102.7; pinpoint rash 9 days p/vax;nonspecific abd & back pain;no apparent source of fever otherwise;
Per pt upper arm is swollen, armpit is swollen and front of pec muscle is swollen.  Patient also has some tenderness in neck and tingling down pinky finger.  Pt will monitor and contact MD.
Guillain-Barre Syndrome (like symptoms).  Headaches (Anterior and Posterior).  Systemic muscle pain and weakness, joint and nerve pain.  Severe Pain - Achy, shooting, cramping and worse at night.  Extreme Fatigue.  Toes, Fingers and Wrists Burning.  Chills and Rash after 1st Dose.  Weakness in Legs,  Difficulty Walking/Unsteady.  Difficulty pronouncing Words at times and Jaw Pain.  Brain Fog.  Symptoms have somewhat subsided in the legs and right arm.  Symptoms have continued in left arm and range from mild to severe (acute).
received Shingrix adjuvant alone without the lyophilized antigen component; received Shingrix adjuvant alone without the lyophilized antigen component; pain; chills; This case was reported by a nurse and described the occurrence of pain in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 753RM, expiry date 18th December 2022) for prophylaxis.   Concurrent medical conditions included hypothyroidism.   On 21st April 2021, the patient received the 1st dose of Shingrix. In April 2021, less than a week after receiving Shingrix, the patient experienced pain and chills. On 21st April 2021, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the pain and chills were not recovered/not resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the pain and chills to be related to Shingrix.  Additional details was reported as follows: The patient received a dose of Shingrix and was administered adjuvant alone without the lyophilized antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient also experienced pain and chills. Leader licensed vocational nurse called to report this situation as well as for guidance on timing for a new dose and side effects expected. The reporter consented to follow up via email or a phone call. The batch number reported in the source document was 753NP, however, it was updated to 753RM as per the sales data sheet.
Swelling and red at the injection site with itching and minor pain. Ninth day after injection. Putting ice and antihistamine itch cream. Don?t know the outcome at this moment.
vertigo, anorexia-resolving on day 6; onset 24 hrs administration;