chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an obstetrician-gynecologist, for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast), a Pregnancy Registry product, concerning an approximately 21-year-old Caucasian female patient. The patient had no significant past medical history, no concurrent medical conditions and no obstetric history. The patient's last menstrual period was reported to be on 19-MAY-2018. On 01-JUN-2018, the patient was vaccinated with the second dose of GARDASIL 9 (lot # R000301) for prophylaxis. On approximately 02-JUN-2018, the patient conceived (exposure during pregnancy). The estimated date of delivery (EDD) was reported to be 23-FEB-2019. On 03-AUG-2018, the patient underwent an ultrasound test as she was dating and received a result confirming a single live intrauterine pregnancy (IUP). The patient's other medication included prenatal vitamins taken daily.
Patient developed swelling, redness, hot to the touch, painful reaction after receiving first dose of Shingles vaccine. The redness and swelling occurred below where the injection site was. Patient waited 4 days and with worsening symptoms went to the doctor. The doctor stated that it is an infection and prescribed the patient medication.
p/vax pt fainted in hallway;pt limp, pale w/in a few min a/ox4;BP nl, resp nl, pulse nl;
This patient has seizure, paleness, weakness, dizziness, fast heart beat, fainting. Had Benadryl injection (IM) Ammonia inhalant, and Benadryl tab, a lot of fluids, water, rest recovered after thirty (30) minutes.
3 minutes after receiving 1st dose Covid vaccine experienced paresthesias of lips and oropharynx that self-resolved within 5-10 minutes. Also developed paresthesias of bilateral hands and feet with stomach discomfort.
Hospitalization for non-STEMI (incidental COVID-19) on dates 10/10/22- 10/14/22. Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Itching; Swelling; Top of shoulder is pink/Pain from Shoulder to Elbow/Pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), SWELLING (Swelling) and ARTHRALGIA (Top of shoulder is pink/Pain from Shoulder to Elbow/Pain in shoulder) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PRURITUS (Itching), SWELLING (Swelling) and ARTHRALGIA (Top of shoulder is pink/Pain from Shoulder to Elbow/Pain in shoulder). At the time of the report, PRURITUS (Itching), SWELLING (Swelling) and ARTHRALGIA (Top of shoulder is pink/Pain from Shoulder to Elbow/Pain in shoulder) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Concomitant and treatment information were not provided.
Began vomiting and continued doing so until 5:45PM that day (16 hrs). Incidents were every 15 minutes, then tapered off to every half hour, then 45 minutes until stopping. Had very real concerns about becoming dehydrated, but was unable to get myself to the ED or Urgent Care Center for treatment.
Persistent ringing in the ears since 2nd shot; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Persistent ringing in the ears since 2nd shot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008c21a) for COVID-19 prophylaxis.     Concurrent medical conditions included Migraine headache.    On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced TINNITUS (Persistent ringing in the ears since 2nd shot). At the time of the report, TINNITUS (Persistent ringing in the ears since 2nd shot) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.
Patient experienced febrile seizure following DTaP and Prevnar.  Patient evaluated in ER and sent home.  Seizures less than 24 hours after vaccinations.
Left arm 4 1/2 x 6 area red, warm and swollen. Mom says that one of the shots was given almost horizontal not vertical to the skin surface because of all the fighting the child did.
There was some bleeding in his mouth; he tasted the blood on his tongue; blood is coming from the mouth continuously and I can taste the blood; Had a nose bleed but that happened one time; This is a spontaneous report from a contactable consumer (patient). This 37- year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EW0171), via an unspecified route of administration, on 20Apr2021 (at the age of 37-years-old) as a single dose for COVID-19 vaccination. Patient has no relevant medical history or concomitant medications. He got the 1st dose of Pfizer COVID vaccine yesterday around 12, and had "normal swelling and stuff like that, nothing major but today from the morning, blood is coming from the mouth continuously and I can taste the blood like as if the sensation that you get in your mouth when you have a blood in your mouth and usually when I spit I found it a bit more and sometimes a bit less but it is there, every time I spit, it was once I got from the nose but from the mouth I am not sure what is the source of that bleeding, is it gums or coming out from where I do not know."  No treatment was received. The clinical outcome of the events was unknown.   Information about the Lot/batch number has been requested.
38 hours after injection the patient experienced severe dizziness, vomiting. Couldn't walk. Moving slowly. Went to ER on Monday, and was diagnosed with Left Subclavian Thrombosis causing cerebellar infarction and requiring a subclavian thrombectomy.
pt recv vax 13JUN95 & & 24DEC96 pt devel varicella which consisted of 65070 lesions, pruritus, & a low grade fever for 1 day; tx w/DPH & Caladryl;
Patient has one episode of Palpitation for about an hour, got better on its own. Patient had palpitation, long time ago and got better with ablation.
Shooting arm pain in right shoulder began 1/23/21 around 11AM and continued for most of the afternoon. 1/24/21 around noon it came back. Monday 1/25 it was getting worse and just began to feel like I tried to lift entirely too much weight for a long time but I hadn't done anything. Tuesday 1/26 the pain was all but gone but returned and was worse on 1/27 and 1/28. On 1/29 it subsided again and I felt fine but on 1/30 and 1/31 it came back with a vengeance and hurt all day on both of those days.  On Monday 2/1 it was back to just being sore again and has been the same soreness on 2/2 and 2/3. No more shooting pain just lingering soreness.
Patient tested positive for COVID on 4/3 or 4/4. Despite this, patient decided to take a road trip since he only had mild symptoms (headache, cough). While he was out of town, his symptoms worsened and he decided to return to home. Patient presented the the ER on 4/13 and was admitted to the hospital for COVID treatment (remdesivir and dexamethasone). He was also found to have a PE and was started on therapeutic Lovenox.
RUNNING NOSE; DISCOMFORT IN THROAT; SORE THROAT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAY-2021, the subject experienced sore throat. On 12-MAY-2021, the subject experienced discomfort in throat. On 13-MAY-2021, the subject experienced running nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore throat, running nose and discomfort in throat was not reported. This report was non-serious.
Fever  up to 101 degrees 4 hr after the injection followed by chills and a headache, followed the next day by a sore throat and then by 3rd day by swelling  and pain of left side of the face
Flushed face and chest pressure at 09:34. Patient brought her own childrens oral Benadryl and took 40 mL as instructed by her doctor . At )9:53, patient stated her throat was getting tight and her tongue swelling so she received a epipen.
Pt c/o numbness in (L) legafter GARDASIL #3 shot given in (L) arm.
Information has been received from a physician concerning his partner's patient (age and gender not reported) who on an unspecified date was vaccinated with Pneumovax 23 (unspecified). Subsequently, the patient developed a "reaction" after receiving a combination of Pneumovax 23 and influenza virus vaccine (unspecified). At the time of this report, the outcome of the event was unknown. Additional information has been requested.
She got her vaccine, she just thought she had a normal reaction to the vaccine.  She started putting alcohol on it and subsided some.  Then noticed as she was using the arm, it was still tender, hard to move a little and brushed it off.  She is still having this issue, going into her shoulder blade and annoying to her.  She has put Ben-Gay on it and nothing seems to alleviate the symptoms and does not do anything to aggravate it.  She looked in the mirror as it was given on the back of her arm, can feel it but can't see it.  She then had it checked out, went to the ER because her shoulder blade was hurting, one of her friends suggested it might be her heart.  She went and had that checked out, had x-rays done and that was cleared.  She had never had this sensation on the left side of her body until she got the shot.  If she puts her elbow down on her chair she knows there is an issue, constant reminder of this.  She now has to put a heating pad on it.  She doesn't do any type of work to aggravate it and doesn't lift anything.  She cannot shake it off and is reporting it as it does not seem to go away.  Her previous doctor Dr. just brushed her off regarding her symptoms.   The pain goes from her shoulder blade area between the neck and the end of her scapula hurts.  It's a dull pain, knows it's there but if she presses on it then that's when she has the after effect.  She has been treating this herself at this point and is not improving.  The injection site is still  tender, nagging type feeling that did travel to her shoulder blade.    She did see on TV where they squeezed the muscle and give the injection feels she did not get it in that muscle, got it below that on the back side of her arm.
Painful/sore arm first 3 days less painful but still sore next 4 weeks. Consulted Dr and was put on Prednisone. After 3 days of Prednisone pain is much better.
swollen lymph nodes after both shots in vaccinated (left) arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes after both shots in vaccinated (left) arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 025L20A) for COVID-19 vaccination.     Medical history was not provided.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes after both shots in vaccinated (left) arm). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes after both shots in vaccinated (left) arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On an unknown date, Patient had a biopsy with unknown results.  Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-132300 (Patient Link).
1.5 hours after receiving shot Patient had a swollen puffy face. She became weak and "absent". By 6pm he had a big headache and vomiting. Following dinner (which she barely ate - normally has a very healthy appetite) she had vomiting and a low grade fever. She took ibuprophen. At this point we checked her sugar and it had spiked to 241 which for her only happens when she gets sick. She had uncontrollable shakes and chills for several hours into the night. Between the shakes, high sugar and fever it was very scary for several hours. Fever remained elevated, spiked a couple times above 101 - 102 degrees. I slept in her room with her to monitor her all night long. Following morning her sugar started to come back down and fever lifted. By 24 hours later she was back to her normal self.
Patient received both vaccinations on 5/16/2019,  On Saturday 5/18/19 patient called to state she had experienced an adverse reaction.  She complained of extreme tiredness and some soreness at site of injection.  She stated she was unable to continue at her place of employment because of the tiredness.  She stated she thought she would have to call her doctor for guidance.  She called again on 5/20/2019, apparently feeling better, but still not 100%
diarrhea has disappeared and has stayed gone for 1 1/2 or 2 years.; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (diarrhea has disappeared and has stayed gone for 1 1/2 or 2 years.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Chronic diarrhea and HIV infection.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (diarrhea has disappeared and has stayed gone for 1 1/2 or 2 years.) and NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (diarrhea has disappeared and has stayed gone for 1 1/2 or 2 years.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for THERAPEUTIC RESPONSE UNEXPECTED (diarrhea has disappeared and has stayed gone for 1 1/2 or 2 years.).    It was reported that patient was fully vaccinated with 2 original, 2 boosters and one variant booster.  Patient was taking medication for chronic diarrhea for a couple of years. When patient received the first shot, diarrhea had disappeared and had stayed gone for 1 1/2 or 2 years. No treatment information was provided.   This case was linked to MOD-2023-705061 (Patient Link).   Reporter did not allow further contact
vaccine liquid running down the patient's skin while injecting/no AE; Syringe Broken During Use/no AE; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a female patient of unknown age who was exposed to vaccine, INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] while a nurse was administering to her on 07-Nov-2019 (lot UJ294AA via unknown route in unknown administration site).  The patient medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On 07-Nov-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ294AA via unknown route in unknown administration site.  It was of actual medication error due to exposure via skin contact. It was also a syringe issue case. Nurse saw the vaccine liquid running down the patient's skin. She stopped and removed the needle from the patient's arm, at which point the syringe fell apart (broken during use). Syringe broke at the point where the barrel and luer lock meet. Patient was re-vaccinated immediately. There was no obvious damage to the packaging or carton and had no crack or other defect in this syringe prior to use  Local PTC number was issued: CO2019-00399.  It was unknown whether adverse event was noticed or not.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
pt recv vax 05DEC94 & 21DEC94 pt devel parotitis; No further details were provided;
Left arm became warm, swollen, painful (cellulitis). Treatment with ice, Tylenol and cephalexin 500mg 1 capsule by mouth four times a day for 7 days
No symptoms. Pt given adult dose 1mL instead of ped dose - 0.5mL.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ALOPURINOL and MAGNESIUM for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On 28-Jan-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) had not resolved.            Concomitant medications also included statins (not specified). Treatment included Ibuprofen.     Action taken with mRNA-1273 in response to the event was not applicable.
Patient complains of redness, heat and swollen are about 2 in x2 in at the area surrounding the site of injection. She also complains of body aches and fever that lasted for a day.
My wife has shooting pain from the neck down to the elbow that does not stop; it was shooting is muscle pain; She also have the other things like chills and fatigue; She also have the other things like chills and fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Lot number: EN6199) as dose number unknown, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "My wife has shooting pain from the neck down to the elbow that does not stop"; MYALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "it was shooting is muscle pain"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", CHILLS (non-serious) with onset Mar2021, outcome "recovered" (2021) and all described as "She also have the other things like chills and fatigue".  No follow-up attempts are possible. No further information is expected.
The patient developed acute migraine headache and vestibulitis. Associated blurry vision due to nystagmus and body aches.
This spontaneous report as received from a healthcare worker and clinical coordinator refers to an approximately 8 week old patient of unknown age. On 08-SEP-2014, the patient was inadvertently vaccinated with expired initial dose of ROTATEQ, lot # H015682, expiry 18-MAR-2014, 2.0 milliliter (ml) once, oral. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. No further information provided. Additional information has been requested.
Severe Headache, body aches, nausea, slight fever, chills Duration was five days. Shingles vaccine Zoster RZV Recombinant
73 YO received Pediatric dose; 73 YO received Pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 73-year-old male patient who received HAV (Havrix) (batch number F7X23, expiry date 25th May 2023) for prophylaxis.   On 2nd March 2023, the patient received Havrix. On 2nd March 2023, unknown after receiving Havrix, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 03-MAR-2023 Reporter's Comments: The patient was back in clinic on the day of reporting and medical assistant intends to re-administer the age-appropriate dose on the day of reporting.  The medical assistant granted permission for safety follow up. Additional Supportive Information:  One day before reporting, the patient was inadvertently given a pediatric dose of Havrix, which led to underdose and adult use of a child product.
a few days after receiving the second dose my period (which I had started about 2 days prior to the injection) which was coming to an end all of sudden became extremely heavy.  This very heavy bleeding lasted for over 30 days until I saw doctor who gave me medication to stop the bleeding.  My period has since resumed it's normal cycle albeit slightly heavier than before.
Patient was given the adult dose of the pfizer COVID-19 vaccine and she is only 11 years old. No adverse outcome noted after vaccine or days following according to patients parent.
The first 2 days after my shot I had a very sore arm, but no redness or swelling. After 2 days, the pain went away. One week later my arm started to hurt again and became red and swollen.
pt recv vax 5JAN96 & 1wk p/vax pt exp a vesicular lesion on chin;2FEB96 pt was seen in MD office @ which time the lesion appeared impetiginous & was about 1 to 1 1/2 cm in size;MD felt lesions was herpetic;
Initial report received from a healthcare professional on 02 October 2013. A 35 years old pregnant female patient received FLUZONE ID (Lot # UT472013A, expiration date unknown) intradermal at left deltoid on 01-Oct-2013. It was reported that the pregnant patient was administered with FLUZONE ID. The estimated date of delivery was 03-Feb-2014. As of 02-Oct-2013, the patient did not have any adverse events. Documents held by sender: none.
Case number PHEH2014US024319 is an initial spontaneous report from a nurse received on 02 Dec 2014, and with a follow up report received from nurse on 19 Jan 2015. This report refers to a 64 years old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN, (batch number: 14511P, expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml on 05 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up report received from nurse on 19 Jan 2015. No adverse event reported to vaccine.
Tiredness, Body aches, Headache, Chills started 1/14 at 1500 . I am still having symptoms today.
pt recvd vax & one day post inject exp burning pain, numbness below deltoid & paresthesias;