chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 24 hrs. after shots, patient's outer ears swelled and turned red with severe pain. Within 48hrs, both outer ears (sparing the lobes) turned black. She'd had massive blood clots in both ears. She was hospitalized for 13 days receiving treatment / dealing with add % compilations.  10/15/09:  Medical Records and Discharge Summary received for Dates of Service 8/6/09-8/19/09.  Discharge Diagnoses:  Antiphospholipid antibody syndrome, Juvenile rheumatoid arthritis, Multiple thrombotic events, Iatrogenic right neck hematoma with extension into the superior mediastinum following attempt at right internal jugular venous catheterization, Adrenal hematoma. Presenting sx:  Pt. admitted for microvascular necrosis of the ears probably secondary to lupus anticoagulant syndrome two days after meningococcal and Tdap vaccines. She was started on unfractionated heparin IV infusion, while coumadin was continued.  She suffered a right Para tracheal hematoma extending into the superior mediastinum after an attempt at internal jugular venous catheterization.  Coumadin was discontinued on 8/18 in favor of low molecular weight heparin and Lovenox.   IVIg was ordered.  Nitroglycerine paste was used on the ears for vasodilation.   A 1/6 systolic murmur is noted throughout the precordium.   Lymphopenia and anemia noted.  The patient was discharged on Lovenox, Amicar, Imuran and prednisone to be tapered as an outpatient.  Follow up consults with Hematology and Rheumatology.
pt recvd vax; PAR relate pt get wheezy like bronchitis  p/ shot;,lasted about 2wks;chest congestion; no SOB;T for a day or 2;this rxn happen p/ vax;
The injection site was sore for about 2 days right after injection.  Then several red bumps appeared 7 days after the injection on the arm at the injection site.  The area is swollen and hard to the touch and warm.  The size is about 5 x 7 cm, a little itchy but not sore.
WAS VACCINATED ON THURSDAY, 09/02/21, FRIDAY MORNING 09/03/21 STARTED ITCHING. 1 HOUR POST ITCHING NOTICED WELPS ALL OVER BODY. BECAME SUPER ITCHY AND NOTICED WELPS WERE ALSO GETTING WORSE. STARTED BENADRYL ON 09/04/21. STILL HAVING THE ITCHINESS AS OF 09/08/21 AND WELPS STILL PRESENT IN CERTAIN AREAS.
needle hit bone;pt c/o nausea & dizziness;BP 68/40;BP 70/40, diaphoretic, pale skin;pt instructed to lay down, drink fluids, cold compresses to wrists & head;p/30 min pt felt better;pt given ride so would not need to drive;
serious neurological symptoms/insignificant ones; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (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 (DOSE 1, MANUFACTUERER UNKNOWN), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Batch/Lot number: unknown), for COVID-19 immunization, reaction: "serious neurological symptoms". The following information was reported: NEUROLOGICAL SYMPTOM (medically significant), outcome "unknown", described as "serious neurological symptoms/insignificant ones". Clinical course: After being extremely thankful for the amazingly quick development of the Pfizer COVID-19 vaccine, patient had ever single one, including the omicron booster. After the second shot, patient had some significant side effects, insignificant ones for two boosters, then the worst symptoms from the Omicron booster. Patient told the doctor shortly after and to patient's surprise, she said they were serious neurological symptoms and getting another would be dangerous. Patient was very concerned about COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd vax & 3 days later c/o swollen upper lip & lt foot; took DPH & dx disappeared; on 9SEP94 itching in palms of hands bilaterally & feet & wrists; c/o pain in lt wrist & rt ankle; to er on 8sep94, tx w/ DPH, pred;
Received nasal flu vaccine on 11/15/06. Later that day developed headache, achiness, lethargy. Next day nasal congestion. Over next few days developed chest congestion, cough. Felt feverish but did not take temp. Coughing produced greenish sputum. Did not see doctor talked to doctor. Symptoms continued on and off for 2 weeks. Recovered when talked to him 12/28/06.
pain in chest, shortness of breath, inability to move right arm (location of vaccination)from elbow to fingers
Patient developed COVID and was positive on 9/6/21, patient hospitalized for low 02 levels
Patient states that she felt a sharp pain in left arm on deltoid that radiated down to left wrist at time of injection.  Around 5:00pm her left deltoid felt ok but left wrist was feeling  tingling. Advised patient to ice arm for a couple of minutes if necessary and follow up with primary care doctor if wrist discomfort does not go away by 1/7/2023.
Approximately 10 minutes after being administered with Pfizer COVID vaccine patient became lightheaded and almost fainted. Patient did not fall out of chair, but did slouch over in chair. The patient's father alerted pharmacy staff and the nurse administering vaccines today, and I went out to check on him. Patient was sitting up in chair at this time, but was very sweaty, pale and cloudy. Nurse instructed him to place his head down by his knees and provided him with water, Gatorade, and cold compresses. Once patient was feeling a little bit better we moved him into a private room with father and let him lay down at rest. When patient felt okay to leave he was advised to lay flat when he got home and eat. Father was also advised to stay with him until he was feeling 100%. Event lasted approximately 30 minutes.  A call was placed to parents around 3pm to check on him and he was doing well. (moving around and playing video games)
Reports sore, enlarged nodule in right arm pit 3 days after receiving vaccine. Three days later, she reports that the nodule is smaller and not as sore, but now her deltoid feels firm and warm to touch but not red.
One week after 1st shot I noticed an itch on my right arm as well as an itch on my palm of my hands.  The itch on my arma I was able to ignore but the itch on my palms started to spread to my fingers like small blisters and between my fingers.  Very itchy.  It did not spread to any other parts of my body except one toe, which had one blister.  Only thing used at the time was Benedryl.  After a week in a half the blisters dried up and peeled off.        After my second shot, I noticed itchy palms once again, after 2 weeks, of the shot..  This time it spread on the palms of my hands, between my fingers and on my feet.  My doctor gave me a steroid cream, which only seemed to make it worse. Spreading like a rash around my fingernail and under my  nails.   I was also given a scabies lotion even though the doctor didn't think it was scabies. That lotion did calm the itch but it didn't go away.  I continue to use Benedryl now that half of the blisters are dring up.   It was 2 weeks of itch and on the third week it is now beginning to dry up.
Adv eff bact vac NEC/NOS on 2013-11-14. Clinician comment: The patient developed redness, warmth and swelling distally from the site of her immunization for PNEUMOVAX. She had apparently gone straight from our office to 2 different exercise classes, one involving weights, the other involving aerobic exercise.
On 09/21/2021- I had abdominal pain on my right side, that was getting more intense. I made an appointment with Doctor 09/25/2021.   09/29/2021-   I had an abdominal sonogram. Due to my scan results I had large gall stones, one which was too large to pass and would need removal. One of the gall stones was large the rest were small.  I am still in the process of following through. I have an appointment with a gastroenterologist  for 11/02/2021.
Patient  received the first dose of COVID vaccination at approximately 12:36pm on 5/9/2021 at approximately 1:00pm on 5/9/2021 the patient's caregiver informed the Rph that patient was having tightness in chest and her arm was warm.  The pharmacist called EMS.  EMS took patients blood sugar, an ekg, and blood pressure.  Patient was  blood sugar was elevated but she refused to be taken to hospital.
pt recvd vax 4FEB94 & the following day devel weakness, malaise, dizziness, easy fatigue; this has persisted from 4FEB94 to this day 16FEB94; until the devel of this illness pt had worked regularly w/o any difficulty;
Swollen Lips, Cracked/Bleeding, Top lip touching nose. Treated with Benadryl, ER visit followed by steroids for allergic reaction. Onset approximately 1-2 hrs. after administration. Next day blue/purplish discoloration of face & forehead again for approximately 2 weeks.  Discoloration first began with child one day after first set of immunizations and continued until after 6 month immunizations.  During the break between her 6 and 9 month vaccines, the discoloration had ceased.  It was not until after her 9 month Hep B vaccine did I realize the discoloration was from vaccines.
no problems at the time of the injections- just noticed months later - I bruise more easily than before the shots- - also had an episode of shingles in May- had to have telemed visit- work up with  painful rash down leg and across buttocks- I have a large bruise across my upper pubic area I have an appointment for  doctor take a look at a quarter size lump surrounded by bruising. May not be related to shot but  wanted it checked out anyway.
Mild soreness at the injection site started within within 3 hours of the injection. However, on 12/29/20 at 3:00 AM, I woke up with moderate pain  (5 out of 10 pain level).  I got up  and  within 1-2 minutes I felt nauseous, a hot flush raised up my neck, my vision went black and I collapsed. I did not fully lost consciousness. I was on the bathroom and fell onto the bathtub hitting  my right tight and right forehead strongly against the edges of the bathtub.  As of today, 30 hours after the fall, my right leg and forehead continue to be moderately soreness, with limiting my ability to walk up and down stairs.
No adverse reactions were reported by the patient. The Tdap dose given was found to be expired after the patient received it. Expired 12/4/20. Attempts to contact patient were ineffective, mom did not answer calls and voicemail could not be left on phone due to voicemail box not being set up.
Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadedness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe.
Complaint of red, swollen left deltoid, itching at site, head ache, flu-like symptoms.  Evaluated by medical provider and was told it was an "allergic reaction."  Benedryl and Advil administered (10/20) and client felt better by the next day (10/21), with still some head ache, no complaint of itching.
This spontaneous report as received from a registered nurse refers to a 79 year old male patient. The patient's medical history and current conditions are not reported. On 15-09-2014 the patient was vaccinated with PNEUMOVAX 23 of dose 0.5 ml, intramuscular in the right arm (lot # J009827 and expiry date 10-AUG-2014). Concomitant therapies included INFLUENZA VIRUS VACCINE (Unspecified) in the left arm. It was reported that the patient was vaccinated with expired PNEUMOVAX 23. Product quality complaint was not reported. The outcome of the expired vaccine administered is unknown.
gland in armpit got very swollen.; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 12Apr2021 at 12:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes from unknown and unknown if ongoing. Concomitant medications included metformin (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and daily multivitamin (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via unspecified route of administration in the right arm on 22Mar2021 at 12:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Apr2021 at 15:00, the patient experienced gland in her armpit got very swollen. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event gland in armpit got very swollen was unknown.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient came back to clinic 2 days after receiving vaccine complaining of "reaction" no resolving. There was a red circle approximately 1-2 inches in diameter around the injection site. The injection site was swollen, warm, and painful.
Left deltoid swollen, red, painful, warm to touch approximately 24hrs. after Varicella vaccine administered. ER administered prednisolone 15mg/5ml (42.99mg) and went patient home with Rx for prednisolone and famotidine.
knot in neck; Rash on legs, arms, Knees and waist; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (knot in neck), RASH (Rash on legs, arms, Knees and waist) and INJECTION SITE PAIN (pain at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (knot in neck), RASH (Rash on legs, arms, Knees and waist) and INJECTION SITE PAIN (pain at injection site). At the time of the report, SWELLING (knot in neck), RASH (Rash on legs, arms, Knees and waist) and INJECTION SITE PAIN (pain at injection site) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.     This case was linked to MOD-2021-030910 (Patient Link).
severe contraction of chest muscles and neck lasting about 20 minutes; This is a spontaneous report from a contactable consumer (patient).  A 65-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283, expiry date unknown), via an unspecified route of administration on 25Jan2021 at 10:30 on the left arm at a single dose for COVID-19 immunization.  Medical history included allergies to bee stings from an unknown date and unknown if ongoing.  Concomitant medication included salbutamol sulfate (ALBUTEROL).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on 25Jan2021 at 11:30, one hour after injection the had severe contraction of chest muscles and neck lasting about 20 minutes. The patient did not receive treatment for the event. The outcome of the event was recovered.  The event was reported as non-serious.
For 6 hours-Nausea, vomiting,  Fir 36 hours- fever, chills, sweating, headache, joint ache.
Day after PNEUMOVAX injection pt developed large area of induration on (R) deltoid inferior to inj. site.
CHILLS, NAUSEA, VOMITING, ACHES, SWEATING, EXTREME FATIGUE
Shoulders hurt, joints hurt, knees ache all over. Took IBUPROFEN didn't help with pain also took Tylenol and didn't help either
patient was given covid vaccine at 1028 in right arm. at 1040, patient complained of right arm and right leg tingling. vss. denies chest pain, sob, n/v, hives. injection site wnl. at 1050, vss. offered to take patient to ER and patient refuses. at 1053, patient complaining of cramping in right arm radiating to right shoulder and neck tingling. vss. once again offered patient to go to ER and patient refused.
5 PATIENTS GIVEN 0.3ML OF JANSSEN VACCINE (VERSUS THE STANDARD 0.5ML); PARTIAL/ SPLIT DOSING; This spontaneous report received from a health care professional concerned multiple patients of unspecified age and sex. 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: 1808609, expiry: UNKNOWN) 0.3 ml, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the 5 patients given 0.3ml of janssen vaccine (versus the standard 0.5ml) at three different facilities. On 29-MAR-2021, the patients administered partial/ split dosing. The health care professional stated that they thought that the vaccine was like the another company vaccine and should be given at 0.3ml. The reporter was unable to obtain the information for the five patients. The five patients were in different facilities. The health care professional was unable to give the names but however they recalled the cities with one of the facilities being an institution for homebound patients. The health care professional further mentioned that she was unsure if a sample would still be available as the remaining vials had been turned in at the end of the day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 5 patients given 0.3ml of janssen vaccine (versus the standard 0.5ml) and partial/ split dosing was not reported. This report was non-serious.
Pt states he had itching at injection site beginning soon after vaccine given (given 12/19). Around midnight 12/21, pt awoke to get out of bed and had syncopal episode. Wife noted skin was red. EMS was called. BP 67/47 and patient became syncopal every time they tried to sit him upright. Pt was given BENADRYL 50mg IV and NS fluids bolus and transported to ER. In ER pt was experiencing rigors and chills and temp was found to be 95.3 and BP = 215/165. Pt was noted to have a diffuse blanching erythematous rash. Pt received SOLUMEDROL 125mg IV, PEPCID 20mg IV, and ZYRTEC 10mg PO. Pt stated he remembered feeling like his throat would close. Vital signs in ER: Temp: 95.5, 97.4, 97.8, 97.9; Pulse: 90, 79, 64, 63, 73, 76, 81, 87, 83; Resp: 17, 79, 18, 18, 18, 18, 18, 18, 18; Syst: 215, 158, 142, 128, 140, 158, 159, 133, 119; Diast: 165, 64, 79, 87 89, 84 94 85, 78; O2 Sat: 96, 93, 100, 100, 100, 100, 100, 100, 98. Pt was admitted on PREDNISONE 15mg PO BIX and ZYRTEC 10mg daily. Pt discharged home on 12/24 with ZYRTEC 10mg PO daily x 5 days, PREDNISONE 10mg daily x 2 days followed by 5mg daily x 2 days.  01/06/2009 MR receoved for DOS12/22-24/2008 with D/C DX:  Transient shock probably related to anaphylaxis.  No evidence of sepsis.  Organic heart disease with inferior wall ischemia on stress testing.  Type 2 DM, non-insulin requiring.  Dyslipidemia. Pt presented with injection site itching, chills, rigors, diffuse erythema and weakness. EMS noted BP to be low with subnormal temp. Diffuse erythema of skin noted, otherwise normal PE and VS. Tx with steroids and IVF with K+ with no further problems.
severe, intractable outbreak of cold sores. Ongoing since around 10/25. I have cold sores in every branch of the trigeminal nerve on both sides and this has been ongoing since 10/25. I even have one on my rib. I started taking 3grams per day of valtrex on 12/8 when there was one by my eye and I am still getting so many cold sores everywhere. I called my clinical trial site and they are not impressed.
15 mo patient received Boostrix instead of Infanrix; 15 mo patient received Boostrix instead of Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2B723, expiry date 17-OCT-2025) for prophylaxis.   Previously administered products included Pediarix (received 3 doses of Pediarix prior to Boostrix).   On 01-SEP-2023, the patient received Boostrix. On 01-SEP-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: 15 mo patient received Boostrix instead of Infanrix) and inappropriate age at vaccine administration (Verbatim: 15 mo patient received Boostrix instead of Infanrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 8-Sept-2023 The case was reported by registered nurse. The reporter consented to follow up. The patient received a dose of Boostrix instead of Infanrix at an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Fever and chills for 26 hours started 12 hours after the shot  Muscle spasms for 4 hours started 12 hours after the shot  Heartburn for 8 hours started 30 minutes after the shot - I got this with the first shot too  Headache 2 days
I gave her the shot and she said it went fine. I right away gave her a bandaid.  When I was disposing the syringe with needle, the needle was not there anymore. I am scared the needle is in her arm.  She said she does not feel anything. I am not sure if needle fell on the floor.
Information has been received from a registered nurse (R.N.) concerning a patient who on 12-JUN-2012, was vaccinated with an expired dose of ZOSTAVAX (Merck) 0.65ml, SC (lot number 670383/0170AA, expiration date 07-MAY-2012). Follow-up information has been received from the registered nurse (R.N.) concerning the 73 year old patient, who had "sulfa-allergy" and has had none illness at time of vaccination, "it was a immunization update", administered the first dose of ZOSTAVAX (Merck) 0.65ml, SC (lot number 670383/0170AA, expiration date 07-MAY-2012) in left arm on 12-JUN-2012 at 11:37AM. Additional information has not expected.
Patient presented to the pharmacy on 12/26/20 to have us add Shingrix as an allergy. She developed a rash all over her body, including vaginally, resulting in pustules on her body that eventually popped forming crusty sores. She did not connect the reaction after her first vaccination (saw her dermatologist after first vaccination) but connected the 2 after her second. Rash did not appear immediately but days later.
Loud ringing sound inside my right ear; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PAA165969), via an unspecified route of administration in the right arm on 16Mar2021 at 14:30 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included breast cancer treatments completed recently including chemo and radiation. Concomitant medication included minocycline 100mg capsule and (sulfonamide) SULFACETAMID lotion 10% for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Allergies to medications, food, or other products was reported as None. On 16Mar2021 at 20:45, the patient experienced loud ringing sound inside right ear, that started about 6 hours after first dose. The patient did not receive treatment for the reported event. The clinical outcome of the ringing in ears was not recovered.   No follow-up attempts are needed. No further information is expected.