chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was observed for 15 minutes after her COVID injection. Patient left the clinic . She states she was at the grocery store when she started having numbness and tingling in her lips and mouth. She returned to the clinic.  Patient was clearing her throat often. An Epi pen was administered and patient was taken via wheelchair immediately after to Emergency Department for further care.
5.04 114/69 R18 99% 52 5:04 Felt light headed after L arm injection  Pale diaphorelle 5:10 111/72 R18 p45 99% 5:21  119/72  p45 98% 18
fever; Chills; Headache; Swelling on upper arm; Redness of upper arm; Itching of eyes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever), CHILLS (Chills), HEADACHE (Headache), PERIPHERAL SWELLING (Swelling on upper arm) and ERYTHEMA (Redness of upper arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy and Drug allergy (drugs like LAMOTRIGINE , SULFAMETHOXAZOLE.). Concomitant products included ATORVASTATIN, PROPRANOLOL and LISINOPRIL for an unknown indication.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (Chills), HEADACHE (Headache), PERIPHERAL SWELLING (Swelling on upper arm), ERYTHEMA (Redness of upper arm) and PRURITUS (Itching of eyes). At the time of the report, PYREXIA (fever), CHILLS (Chills), HEADACHE (Headache), PERIPHERAL SWELLING (Swelling on upper arm), ERYTHEMA (Redness of upper arm) and PRURITUS (Itching of eyes) was resolving. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Pinkish spot on her arm around the injection site; Arm became sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (Pinkish spot on her arm around the injection site) and PAIN IN EXTREMITY (Arm became sore) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0326204) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced INJECTION SITE DISCOLOURATION (Pinkish spot on her arm around the injection site) and PAIN IN EXTREMITY (Arm became sore). At the time of the report, INJECTION SITE DISCOLOURATION (Pinkish spot on her arm around the injection site) had not resolved and PAIN IN EXTREMITY (Arm became sore) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report was received from a healthcare professional referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On 01-OCT-2015, the patient was vaccinated with PNEUMOVAX 23, (dose, lot # and expiration date were not provided). Concomitant medication was not reported. On 02-OCT-2015, reported as "within 24 hours", the patient experienced terrible pain in the arm after being vaccinated with PNEUMOVAX 23. The outcome of pain in extremity was reported as recovered on an unspecified date in October 2015, reported as "approximately one week after vaccination". The reporter did not assess the relatedness between pain in extremity and PNEUMOVAX 23. This is one of the several reports received from the same source. Additional information has been requested.
WITHIN 30 HOURS OF THE VACCINE I WOKE UP TO RINGING IN BOTH EARS (Tinnitus) AND HAVE BOUTS OF VERTIGO. IT HAS BEEN 6 MONTHS SINCE AND I STILL HAVE IT. :( I WENT FIRST TO DOCTOR, THEN ENT AND IT WAS CONFIRMED BUT NO CURE IS IN SITE. I MAY HAVE IT FOR THE REST OF MY LIFE. BTW MY ENT HAVE HAD SEVERAL OTHER CASES SIMILIAR TO MINE BUT DON'T FEEL THAT THEY NEED TO REPORT SINCE THEY DID NOT GET THE SHOT.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with GARDASIL. Subsequently the patient experienced lupus like reactions. No other information reported. This is one of several reports from the same source. Additional information requested.
Patient reports significant worsening of tinnitus, which he states was previously mild.  He states it is progressively worse and has become much more prominent.
RASH ALL OVER BODY, THAT SOUNDS LIKE PER PATIENT DESCRIPTION, RAISED RED SPOTS, DRAINING SOME FLUID. ITCHY AND PAINFUL WHEN SCRATCHED
12/23/09 TC from patient-received ZOSTAVAX 12/16. On 12/17/09 notified reddened area right arm, bigger than an egg (oval shaped). No raised area or soreness. States itching of the area, area decreasing in size. On 12/23/09 is smaller than a golf ball.
Swollen raised warm area at injection site. Measured about 1 1/2 inch diameter.
I started noticing excessive fatigue, shortness of breath, increased heart rate. When this did not settle down I went to see my PCP. She referred me to a Cardiologist who did an echocardiogram and a two week Holter study. The cardiologist said the my tachycardia was no longer responding to the metoprolol. He referred me to see a more specialized cardiologist. This cardiologist determined I have in conjunction with the inappropriate sinus tachycardia I also have postural orthostatic tachycardia syndrome. He prescribed me another medication to take with the metoprolol tartrate.  I am still more tired than normal, the shortness of breath is gone and my heart rate is improving.
Patient had ED visit 40 days after receiving first COVID vaccine, and was admitted to hospital 41 days after this dose.
Patient began to have fevers/chills night after vaccine. Continued with fevers and night sweats. Exhausted during the day for a week. On day 6, patient reports feeling very thirsty, vertigo, fell, lost balance and use of extremities, loss control of bowels, and speech for period of about 20m. Taken to the ER where she was told she might have had a mild UTI that worsened after the vaccine. Was started on antibiotics.
unknown number of patients had been given doses of an expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (unknown number of patients had been given doses of an expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    In September 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (unknown number of patients had been given doses of an expired vaccine). In September 2021, EXPIRED PRODUCT ADMINISTERED (unknown number of patients had been given doses of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow up document received contain Email updated
Information has been received from physician concerning a "probably 1 1/2 -year-old" who was vaccinated on an unspecified date with a dose of PROQUAD. Subsequently, 3 or 4 weeks later, the patient developed a purplish, painless, elongated scar which was 2 inches long and 3 quarter inches wide at the injection site. From the side view there was a dent on the scar that looked like burned skin. Unspecified medical attention was sought. No laboratory or diagnostic tests were ordered. No product quality complaint was involved. The outcome is reported as not recovered. Additional information has been requested.
had both shots and still got it / suspected vaccination failure; still got it; it is very painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 26-JAN-2023 Reporter's comment: This case was reported by the patient via  interactive digital media. The reporter stated that he/she had both shots and still had got it and it was very painful. Additional supportive information: This case was considered as suspected vaccination failure as details regarding, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible, as no contact, details were available.
Headache, Myalgia, Arthralgia,  Fever,Chills, left axillary lymph node enlargement Narrative:
feeling sick; lethargic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220508866.  An 80-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "feeling sick"; LETHARGY (non-serious), outcome "unknown", described as "lethargic". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: A patient reported that their blood sugars were high and the reading were in the 200s mg/dL. Patient reported that blood sugar readings were in the 300s mg/dL before medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started with pain, itching, redness and swelling.  Low grade temp.  Treatment was just ice.
received the vaccine on 8/24/21.   "Sweet Syndrome" symptoms began on 8/28/21, painful blisters/lesions still present today, 9/27/21.   currently taking prednisone taper (40mg daily x 1 week then 20mg daily x 1 week and then 10mg daily x 1 week and zyrtec.
Sudden onset of vitreous detachment and black spots and spider webs in left eye. Went to eye doctor immediately for exam, confirmed vitreous detachment, black spots and spider webs. Vision is extremely impaired in the left eye.
This case was reported by a consumer via other manufacturer and described the occurrence of lip swelling in a female patient who received SHINGRIX. In May 2018, the patient received SHINGRIX. In May 2018, several days after receiving SHINGRIX, the patient experienced lip swelling. On an unknown date, the outcome of the lip swelling was not recovered/not resolved. It was unknown if the reporter considered the lip swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in the last week before date of reporting. The patient experienced swelling of the lip about a few days after getting SHINGRIX. The patient's lip was slightly swollen. The demographic details were not provided for the patient and physician. This case was not reported to FDA. No additional information was available.
Shingles; Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about the patient's (pt) concurrent conditions, medical history or concomitant medication.  In 2018, the pt was inoculated with zoster vaccine live (ZOSTAVAX) prescribed and/or administered by a pharmacist for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, lot number and expiration date were not reported).  Subsequently, the pt was treated for shingles. As a direct and proximate result of pt use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was not provided. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
01NOV89 pt devel acute torticollis, h/a, fever & weakness & pain in lt arm; DEC89 pt also devel rash & migratory polyarthralgia; ANA was pos @ 1:160; EMG & nerve conduction studies were pos for bracheal plexus neuropathy; see WORM...
There was a hard lump in my supraclavicular lymph node on the left side after my 2nd dose of the vaccine. I also had a great deal of pain and swelling on the underside of my upper left arm and axilla for a week after the injection of the 2nd dose. The lump in lymph node was painless and the size of a marble.
got mind and it almost kill me; Initial information received on 07-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who got mind and it almost kill him/her while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (formulation, strength: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a serious event "got mind and it almost kill me" (near death experience) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got mind and it almost kill me).  At time of reporting, the outcome was Unknown for the event got mind and it almost kill me.; Sender's Comments: Sanofi Company Comment dated 13-Jan-2022. This case involves a patient of unknown demographics who got mind and it almost kill him/her while receiving vaccine INFLUENZA VACCINE. Based upon the reported information, the role of a vaccine cannot be assessed Further information regarding time to onset, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case.
Patient had 2nd Pfizer COVID-19 vaccine on 1/11/2021.    On 1/12/2021 developed loss of taste/smell, rhinorrhea.   Positive COVID test.
Pt. received SHINGRIX Vaccine 6/15/18. Has experienced fever (highest 100.0F yesterday), slight redness, pain and warm approx. 3" in diameter surrounding injection site. Has not taken any otc meds. RN recommended acetaminophen/ibuprofen per instructions on label as well as to apply ice and monitor s/s.
symptomatic covid positive breakthrough case. cough, shortness of breath, subjective fever/chills, fatigue, weakness, hypoxia onset date 8/15/21. Pt did have hx of respiratory symptoms in July but was not tested at that time
Severe muscle spasms in feet, calves, and thighs starting last night and continuing today.
Patient broke out into vesicular lesions on arms, abdomen and the neck.  The areas were red, raised, not preceded by cold symptoms.
Patient reported on 8-26-10 that she had shortness of breath, low grade fever (100 F) and felt like she was going to die on evening of 8-25-10. Stated MD told her not to get ZOSTAVAX. Pt. had redness silver dollar size at injection site.
up to date with covid vax- booster dose listed above, tested positive for covid on rapid antigen test 2/13/2022
Pt fell asleep after vax woke up and had stiffness of limbs followed by twitching motions deemed to be seizure activity. Pt monitored afterwards.
Chronic urticaria; started out with hives; the vaccine may kick your immune system in to a hyperactive state; This is a spontaneous report from a contactable other hcp. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported, Expiry Date: Not Provided) via an unspecified route of administration on Mar2021 as dose 1, single and dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. on an unspecified date, the patient experienced chronic urticaria, started out with hives, the vaccine may kick your immune system in to a hyperactive state. The patient underwent lab tests and procedures which included laboratory test: unknown. The caller has done lots of test and they can't figure it out. NDC number of Pfizer covid vaccine was not provided. Investigation assessment was not provided. It was reported that the caller asked about possibility of chronic urticaria after the vaccine. She explained she was fine initially. Consumer is now reporting developing urticaria that began three months post vaccination series and is aware that the vaccine may kick immune system into a hyperactive state. The patient wanted to know if there has been any reporting of urticaria post vaccination. The caller did not provide age or demographic information. The patient gave appreciation to the team for helping with the information. The outcome of the events was unknown.
02/27/21 urgent care visit for Bells Palsy . moderate to severe . Onset of L facial weakness 02/26/2021. Negative Covid test 02/23/2021 because of loss of sense of taste on L side of tongue.  No known covid exposure. Treatment with Prednisone 60m/d x7d & Valacyclonl  1000m, TID x 7d
within 24 hours began to experience severe abdominal pain and diarrhea.  within 72 hours had bloody diarrhea and full crohns flare up.  Nausea. Extreme fatigue .  has lasted over 6 weeks now. at two week mark noticed numbness in hands and feet that continued to spread over the next month. was dropping items cause lost hand strength,  Cold all the time and realized when I accidentally burned myself I could not feel pain on my skin anywhere. 2nd degree burn on arm legs and torso 2 weeks after vaccine which is what really made me aware of the neurological issues after the vaccine.  These neurological symtoms have increased to involve both hands and both feet and part of palms and arch of feet.  Numbness and pins and needles feeling all the time now. do not know if nerve stuff will be permanent or not.  had to go on fmla due to disability related to this.
On 2/27/2021, nine (9) days after receiving first dose of Moderna vaccine, injection site is red circle and warm and hard to the touch.
Symptoms started approx 9PM 9/27/05. Symptoms included sweating progressively, nausea, headache, slight cough. No change during today (9/28/05) except nausea worse. Had trouble sleeping last night. Temp on 9/28/05 normal.
expired dose ofRECOMBIV AX HB was administered to a patient; administered vaccine had a previous temperature excursion; This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 12-NOV-2020, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (route and dosage information were not reported; lot # R021370 expiration date 07-NOV-2020) for prophylaxis.  It was also mentioned that, the administered vaccine had a temperature excursion of 46.1 °F for11 minutes, on 06-OCT-2020.    The reporting nurse wanted to know if the patient needed to be re-vaccinated.
Severe brain fog and pulsing headaches, unsteadiness, increasing inability to drive or even walk any normal distance. Increasing inability to use screens or read. Became completely unable to drive. Became unable to read books or read things printed on white paper (could read for white period of time if printed on light blue paper). Could use only a mobile phone for short periods of time and only if covered with a blue sheet of acetate. Could not do zoom. Sought care from a neurologist, eventually also from an interventional pain specialist for severe chronic migraines that continue 6 months later despite treatments with topomax, muscle relaxants, Tylenol, ibuprofen, ice, physical therapy, and now we are trying trigger point injections and other targeted interventional migraine treatment. To prepare for the booster dose of Pfizer received on 12/22/21 the neurologist recommended I  take antihistimine and Tylenol in advance to try to head off another reaction. It's hard to tell if I am or am not having another reaction because I am continuing to manage the earlier one.
Patient reports that he has been fatigued, low back pain, weakness, and tremors since he had his second vaccine.  His workups have been negative for his neurologic symptoms and newly diagnosed neuropathy and he was concerned it may be the vaccine since his health has worsened since the second vaccine
Fever of 102.3 since 1.20 AM on 04/30/2022. Severe headache; Nausea and diarrhea since 2:15 AM on 04/30/2022; Chills; Inability to concentrate; Cough; Muscle and joint pain; Swelling in left knee; Auxiliary pain; Arm tenderness.
Provider gave this patient two vaccines, Fluzone Quad and Spikevax.  After getting the vaccines the patient reported feeling not well. Provider came to get me to tell me he patient wasn't feeling well.  I spoke to the patient and tried to calm her by taking deep breaths while sitting in the vaccine chair.  She said she couldn't hear me, I put both hands on her shoulder to keep her in the chair.  She fainted in the chair and provider and I carefully moved her to the floor.  As we were moving her to the floor she woke and quickly oriented herself.  I had her still lay down ground and raised her legs.
Left lower jaw inflamed and swollen.  SAME THING happened while I had covid in November.  t was a rare and specific event.  Started with pain near lower left molars, sensitivity biting which went away.  Cheek pad remains inflamed but painless.   Boy, do I look good.
Developed skin rash on inner thighs, hips, torso, back, neck about 5 hours after injection
Vaccine administered expired on 7/31/2022.  Pt experienced no adverse reactions.