chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11 days after I got the first dose of the Covid19 vaccine, from the manufacturer Modena; I started getting a rash,hives and swelling in my entire body (including my scalp, lips and tongue), these hives got red and swollen, the ones on my face got extremely swollen, I didn't even recognized my self when looking in the mirror because I looked like a different person.  16 days after I got the first dose of the Covid19 vaccine, from the manufacturer Modena; I started getting a red rash/hive on the arm and area where I got the vaccine, I also got this hive/rash on the back of my neck and my upper inner thigh.   I first went to see two different doctors on the 11th day) and by looking at me they told me that this was not something related to the Covid19 vaccine and that it was a mere allergy even though I have never been allergic to anything, one of the Doctors prescribed an anti allergic pills (Fexofenadine 60mg) and the other Doctor did some blood tests to see what I was allergic to ?I?m still awaiting for the results?.  I had to go to an urgent care and saw a third Doctor because even though I was taking the prescribed anti allergic pills, my lips and tongue became very swollen and with a rash/hive on them, and I continued getting the rash on my body. This last and third Doctor I saw, told me by looking at me that this was a reaction to the Covid19 vaccine and that he has seen this same reaction on other patients a day after/several days after getting the Covid19 vaccine. This Doctor prescribed to me Steroids (MethylPREDNISolone tablets, USP 4mg) and asked me to take these for 6 days along with the anti allergic pills I was taking. These helped a lot to reduce the swelling and rash, even though 2 days after the arm got a rash but nothing compare to the days before.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Conciousness regained immediately upon lower extremity elevation. Fell from seated, left temporal contusion. Applied ice, notified EMT/firefighter father. No PCP, directed to nearby Urgent Care, notified urgent care of his arrival. Will follow up further
Severe lymphadenopathy (in armpits, very painful/tender), rash on left side of body (buttocks, side),  nausea, extreme fatigue
While administering vaccine, needle went loose, vaccine sprayed out, went to her eye; while administering vaccine, needle went loose, vaccine sprayed out, went to her eye; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (While administering vaccine, needle went loose, vaccine sprayed out, went to her eye) and DEVICE CONNECTION ISSUE (while administering vaccine, needle went loose, vaccine sprayed out, went to her eye) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced UNDERDOSE (While administering vaccine, needle went loose, vaccine sprayed out, went to her eye) and DEVICE CONNECTION ISSUE (while administering vaccine, needle went loose, vaccine sprayed out, went to her eye). On 27-Apr-2021, UNDERDOSE (While administering vaccine, needle went loose, vaccine sprayed out, went to her eye) and DEVICE CONNECTION ISSUE (while administering vaccine, needle went loose, vaccine sprayed out, went to her eye) had resolved.        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 medication list was not provided. Treatment information was not provided.
Patient reported 9/29/21 having  multiple "extreme" reactions to 1st dose. ie: Brain fog,shaking,arm pain,"not able to function/stand",decreased quality of life,"hormonal",nausea,fatigue,bowel problems.I explained I did not feel comfortable giving her the 2nd dose based on her complaints and referred her to the PCP for her health and safety.She said she didn't want the first dose,but was "forced" to get it by her employer.
Pt complained of shortness of breath 15 minutes after influenza vaccination. This was relieved with oxygen 2L. Pt also developed large indurated bump, bigger than golf ball, tender to touch 15 minutes after vaccination. 20 minutes after vaccination the indurated bump was 4 cm in diameter. Pt sent to ER.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 15th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, sickness and fever. On 15th July 2018, the outcome of the injection site pain, sickness and fever were recovered/resolved. It was unknown if the reporter considered the injection site pain, sickness and fever to be related to SHINGRIX. Additional details reported as follows: After vaccination, the patient experienced pain at the injection site that lasted for weeks and a slight bit of fever that day that went away fairly quickly. For tolerance after 2nd dose, refer case US2018180180.
allergic reaction; itchy; Dizziness; Chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ALLERGY TO VACCINE (allergic reaction), PRURITUS (itchy), FATIGUE (Tired) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029LZ0A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concurrent medical conditions included Food allergy (Unspecified).   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 30-Jan-2021, the patient experienced FATIGUE (Tired).   On 02-Feb-2021, the patient experienced DIZZINESS (Dizziness) and CHILLS (Chills). On an unknown date, the patient experienced ALLERGY TO VACCINE (allergic reaction) and PRURITUS (itchy).   At the time of the report, DIZZINESS (Dizziness), ALLERGY TO VACCINE (allergic reaction), PRURITUS (itchy), FATIGUE (Tired) and CHILLS (Chills) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
I was in the shower.  I got a dizzy, my arm started tingling, and my whole back started hurting.  I went to ER.  They did a EKG and a CT scan of my heart, and found out that one of my artery's was blocked.  So they put a stent in right then and there.  I had a heart attack.  I was hospitalized for 2 days.
In Dec I developed a rash/bumps on my leg that became red and painful. I went to urgent care and was dx'd w/ shingles.  I was given medication and it went away and it just came back in 4/2022. The medication is working.
Rash - Information has been received from a pharmacist concerning a patient who was vaccinated with one with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Two to three weeks post vaccination the patient developed a rash (not described).  Unspecified medical attention was sought. Additional information has been requested.
Got COVID-19 vaccine 11:30 pm at hospital. hx + COVID-19 in in 6/20. Immediately felt headache, joint pain and weakness. dizzy. sat down. Pt is psychiatrc nurse assistant. 4 hrs later left face numb. decreased sensation. left face feels weaker. has baseline tinnitus. 3:30 am , 5 hrs ago. no fever nor chills.
25apr90 pt vax 2nd hepta B. 02may90 pt devel nonpruritic hive like rash over neck trunk and arm.  pt reported rash sensitive to heat. 17may90 tuberc test neg. following day rash became pruritic. pt treated w/ diphenhydramine HCL.
Baby slept for 7 hours post vaccinations and woke up extremely angry. He screamed all night long into the next day. He became a very unhappy baby from that point on. He stopped sleeping 5-6 hours at night and would only sleep 1-2 hours combined. He was never content after that.
Patient has a ring like rash near the elbow on the same arm she received the injection. Her arm is also hot to the touch but she did not notice it until a nurse came to her house and mentioned it.
still unable to wear her contacts; felt like something was in her left eye; bumps under her eyelid like an allergic reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMPAIRED ABILITY TO USE MACHINERY (still unable to wear her contacts), OCULAR DISCOMFORT (felt like something was in her left eye) and EYELID THICKENING (bumps under her eyelid like an allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Contact lens wearer.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced IMPAIRED ABILITY TO USE MACHINERY (still unable to wear her contacts), OCULAR DISCOMFORT (felt like something was in her left eye) and EYELID THICKENING (bumps under her eyelid like an allergic reaction). At the time of the report, IMPAIRED ABILITY TO USE MACHINERY (still unable to wear her contacts) had not resolved and OCULAR DISCOMFORT (felt like something was in her left eye) and EYELID THICKENING (bumps under her eyelid like an allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 01-Sep-2021, Patient stated that she got her first Moderna vaccine about 4 weeks ago and was due for the second shot on 02-Sep-2021.  After 5-6 hours of vaccine she felt something in her eye and removed her contacts and wore her glasses. Her eye doctor after assessing gave her a lubricant.   No relevant concomitant medications were reported.
This is the fifth of eight spontaneous reports as received from a physician refers a female patient between 14-15 years old who throughout this year "in 2012", was vaccinated IM with a dose of GARDASIL (route and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician stated that the patient suffered from syncope after having GARDASIL vaccination. The syncope was also more prevalent with the first dose given than with subsequent doses. Orange juice was given as treatment. The patient did not seek medical attention. The patient improved before leaving the office. The relatedness for syncope was unknown for GARDASIL. This is one of several reports from the same source. Additional information has been requested.
4 days after Vaccine #2, Pt with difficulty Breathing, SOB, and Hypoxia. Went to ED on 09/09/21 as SaO2 at home dropped to 88%. D/C'd with PO Omnicef, Steroids, and O2
temperature up to 101.5, on and off up and down over 3 days, Large swollen lymph nodes under right arm (half a tennis ball size or bigger) and those in the neck were also very tender.  Lymph nodes back to normal by 5 days. Felt pretty lousy.  Diahrreah on the first day about 6 hours after injection but temperature and other symptoms started about 9 the night of the injection.
High pitch scream different cry than usual, very restless, unable to be consoled, regressed from progress made, lack of head control, throwing back head abruptly while screaming, extreme side to side movement, very lethargic, does not engage in eyes contact or engage verbally when spoken to, was cooing, and babbling with parents but seems like a different baby, has not slept more than 3 hours since 02/13/2012. Does not seem to be satisfied after feeding, wakes up in the middle of the night with a shrill scream about every hour and half, sometimes 45 minutes. Baby has changed since vaccinations.
her arm was sore for 3 days then on 8/26 developed 2 different red spots one the size of palm, the other the size of a quarter (No itching or pain) pt. took benadryl
Body aches; Low fever; chills; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via unspecified route of administration in right arm on 25Mar2021 at 12:30 (at the age of 64-year-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and high cholesterol. The patient was allergic to contrast IV dye and erythromycin. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), and cod liver oil (MANUFACTURER UNKNOWN) for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via unspecified route of administration in right arm on 03Mar2021 at 17:00 (at the age of 64-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 (also reported as at 02:00), the patient experienced low fever, body aches and chills. Therapeutic measure was taken as result of events included treatment with TYLENOL (self-administered). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events low fever, body aches and chills were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Day one after the shot, my left arm was sore all the way up my neck. Lots of pain and swollen under the armpits in the lymph nodes. Both sides but worse on the left-side where the shot was. Painful to use. Shot was on Sunday afternoon and the pain seems to be getting worse. It is now Thursday.
This initial spontaneous report was received on 11-SEP-2018 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 25-JUL-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Took shot on the 8th ended up with shingles on the 9th. Shot was in the left arm right arm started hurting that afternoon. Rash showed up later on and spread within a few days.
Rapid heart rate, high blood pressure. 3-4 days following first dose I experienced a rapid heart rate (100-120) consistently. Blood pressure was in the 150/100 range as well for 3-4 days.
On day 9 after shot, a bump on the arm in the area of the injection site and a red, slightly itchy, hive-like area about 2" in diameter.  By end of day 10 after shot, the area had increased to about 5" in diameter.  This is day 11, and it has reduced in size to about 4" in diameter
Mom states pt had high pitched cry lasting 12 hrs; Mom also states could not calm pt down; MD called & APAP given; hx of this happening w/1st DTP but not as bad as this time states mom;
RN administered Pfizer Bivalent dose of 0.3ml for patient's second primary dose on 1/6/2023 at 1210. Patient reports to this RN, after receiving vaccine that she began feeling burning and itching of chest and neck at 1238. Patient denied respiratory distressed, though stated her heart rate was elevated and she felt "out of it." Patient then developed rash which spread from chest to right shoulder, around right breast, and right side of torso. Vital signs taken at 1340 as follows: temperature- 98.1F; Blood Pressure- 113/79; Pulse- 70; Respirations- 16; O2 Sat- 93% on room air.  Patient sent to urgent care for further assessment/treatment at 1350. Patient refused EMS call.
Injection site erythema within 24 hours of injection with increased swelling of arm that developed to 6x8 cm on 2/22/21.
pt had no sx until this morning.  Today pt woke up at 6am with tongue swollen and redness on one side of his tongue. no progression, no worsening, breathing ok and able to swallow.  Unable to confirm this is related to the vaccine, but possible. Since no progression and red area is only on one side of the tongue, I mentioned to also consider the possibility of sxs being due to him accidentally biting his tongue while sleeping. May take a dose of Benadryl-if indeed this is an allergy reaction, monitor yourself at home, f/u with pcp. Call 911 if any difficulty swallowing and/or difficulty breathing. Call back if any q. Will f/u.
father stated that pt had a sz "(shaking & trembling) @ 10PM; denies any fever but temp was not taken; pt was asleep during this time; MD felt probably did have seizures about 12 hrs later; pt to have only DT in future;
Patient was seen by Surgery clinic and also by study Physician (writer) and labs were obtained.  The patient was found to have a hemaglobin level of 5.3.  She required brief observation and transfusion of 2 units of Packed Red Blood Cells. AE not related to vaccine. 11/2 and 11/3/2009 records from ED visits on 10/6 and 10/11/2009 and DC summary for dates 10/12-10/15/2009. Patient was seen for a critically low hgb of 5.3 done at MD office and was tranfused with 2 units PRBC's and DC'd with hgb 13.6. 10/11/2009 patient was seen with c/o's fever and erythema around broviac cath site, (patient is S/P jejunostomy with closure of and broviac catheter placement on 9/1/2009 and is TPN dependent) was dc'd home after neg labs and normal cxr. On 10/12/2009 patient was called back and admitted to hospital for + blood culture  with dx of ? line sepsis. Tx'd with IV ABX. Repeat blood cultures came back neg. Ongoing: Patient has had trend of elevated bilirubin (total and direct) levels associated with short bowel syndrome and TPN cholestasis. Unlikely to be related to vaccination. 12/7/09 DC summary and medical records received for dates 10/12/09 to 10/15/09. DX: pyrexia of unknown duration. Presented to ER initially w/ fever. Pt was eval and dc after blood tests WNL. The following day blood cults returned that were (+)gram pos. cocci in clusters. Pt was then admitted. Pt is TPN dependent w/ h/o short gut syndrome. Repeat cultures were negative, and it was determined first blood culture bacteria was of skin source and pt did not have (+)blood culture. Pt. dc home w/ unknown reason for fevers.12/29/2009 MR and DC summary for 10/6-10/7/2009 admitted for critically low hgb of 5.3, transfused, hgb at 13.6 at discharge.
IM injection given SC route.  patient was observed for 45 minutes;  no adverse event occurred;
Rapid onset chills, shakes (severe). Progressed to inability to stand or walk. Became incontinent of urine. Pt has Parkinson's; this caused transient severe symptoms. Much improved 12 hrs later.
17-year-old male showed up to the Mobile Vaccination Unit for dose number 2 of the Moderna COVID-19 Vaccine. He had received the first dose 28 days prior (also from the Mobile Vaccination Unit), at which time this dose was given inappropriately due to the patient being less than 18 years of age. When he showed up for dose number 2, the Agency was consulted by telephone and a decision was made to go ahead and complete the two-dose series even though he was still about 6 weeks shy of his 18th birthday. This report is being made due to the inappropriate vaccine administration to an underage recipient, but he otherwise suffered no adverse effects.
swollen below the injection site (in the same arm; red below the injection site; hurts a lot below the injection site; pain; quite a fever (yesterday she still had); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (quite a fever (yesterday she still had)), INJECTION SITE SWELLING (swollen below the injection site (in the same arm), INJECTION SITE ERYTHEMA (red below the injection site), INJECTION SITE PAIN (hurts a lot below the injection site) and PAIN (pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, High cholesterol, Blood pressure high and Asthma. Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA) for Diabetic.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced PYREXIA (quite a fever (yesterday she still had)). On 06-May-2021, the patient experienced INJECTION SITE SWELLING (swollen below the injection site (in the same arm), INJECTION SITE ERYTHEMA (red below the injection site), INJECTION SITE PAIN (hurts a lot below the injection site) and PAIN (pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PYREXIA (quite a fever (yesterday she still had)), INJECTION SITE SWELLING (swollen below the injection site (in the same arm), INJECTION SITE ERYTHEMA (red below the injection site), INJECTION SITE PAIN (hurts a lot below the injection site) and PAIN (pain) outcome was unknown. Not Provided          Patient also takes medicine for her high cholesterol, high blood pressure, and asthma.   This case was linked to MOD21-088035, US-MODERNATX, INC.-MOD-2021-114643 (Linked Report).; Sender's Comments:  MOD21-088035:Daughter's case US-MODERNATX, INC.-MOD-2021-114643:Mother case
Subjective fever, chills, body aches beginning around 0100 AM on 3/28. Took ALEVE in AM - symptoms resolved around 5 PM 3/28 with the exception of a rash at the vaccine site. Rash is tender, improving since initial injection. Rash is not painful or hard. Size of a Soup Can Lid.