chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm did swell considerably and was tender and sore in the swollen area that is not where the injection site itself is; arm did swell considerably and was tender and sore in the swollen area that is not where the injection site itself is; swollen arm; itching; tightness in the chest/tightness in her chest which kind of panicked her for a minute; tickle in her throat on the left side; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6207; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Left arm on 25Mar2021 09:00 (at the age of 64 year old) as dose 1, single for COVID-19 immunization. Medical history included RH negative type O and she has low thyroid; where she is not sure if she has hyperthyroid or low thyroid. Concomitant medication included ongoing levothyroxine taken for thyroid disorder from Dec2020. No prior vaccinations within 4 weeks of vaccination. On 25Mar2021, at 9:00, patient took injection on her left arm, that arm did swell considerably and was tender, sore in the swollen area, where it was not in the injection site itself. It was reported that, about 11:30 or an hour later, in the same arm, that in her left arm, between the pointer finger and index finger there was itching quite a bit, where she thought she cut it on something, and when she looked at her hand, it was swollen up for that area and continued to itch and swell in that hand. Also, she felt like a tickle in her throat on the left side but knows sometimes anyway that could occur, so she did not pay any attention to that. Later, on that same evening, while she was driving, she had feeling in her chest, tightness in her chest which panicked her for a minute and she held out and she was going to go to the emergency room if it got worse, so she was aware what was happening then it got resolved on Saturday 27Mar2021. At the time of report, patient has no longer itching, and the swelling has gone down and looks like a little deflated balloon. She took an allergy medication, Allegra D 800mg to help with the scratching and took one of those for the itching which helped a little but not a bunch. Patient wanted to know if side effects are associated with a specific blood type; that is any interactions with the blood type, where she was RH negative type O. No relevant tests were done for the events. The outcome of the events tenderness and pain in extremity was recovering and of throat irritation was unknown and of other events was recovered.  No follow-up attempts are possible. No further information is expected.
04/18/2012 05:44:42 PM > Patient was happy, doing great after her shots two days ago and then screamed violently, head jerked to the side and she had some irregular breathing.  This episode lasted a few minutes and then she was fine.  She did this after her 2 month shots and had a normal EEG done. I suspect she had a reaction to the pertussis component of the Dtap.  We will plan to defer that at the 6 month WCC and I will discuss with ID at some point our options.
COPD; a rash developed all over her body where the itching is unbearable; Her legs are hot to touch; rash on lower ankle legs it was itchy and resembled bites; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash on lower ankle legs it was itchy and resembled bites), FEELING HOT (Her legs are hot to touch), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) and RASH (a rash developed all over her body where the itching is unbearable) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and #018B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 21-Mar-2021, the patient experienced RASH PRURITIC (rash on lower ankle legs it was itchy and resembled bites). On 17-Apr-2021, the patient experienced FEELING HOT (Her legs are hot to touch) and RASH (a rash developed all over her body where the itching is unbearable). On an unknown date, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). The patient was treated with MUPIROCIN at a dose of 2 % and TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (rash on lower ankle legs it was itchy and resembled bites), FEELING HOT (Her legs are hot to touch), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) and RASH (a rash developed all over her body where the itching is unbearable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided. Treatment with Mucpirocin 2%cream and Triamcinolone cream were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-081605 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Non-Significant follow up appended to AER On 26-May-2021: TCR FORM; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081605:second dose case
Information has been received from a physician concerning a patient who was vaccinated with a dose of Zostavax. Dose/frequency and therapy route were not reported. Subsequently the patient experienced rash. Medical attention was sought. The patient's outcome was unknown. A product quality complaint was not involved. Additional information has been requested.
Had my second shot on Tues 2nd Feb. Had some discomfort during the night and took one Tylenol tablet. The next day around 11am, started to feel very achy, weak nauseous and a headache. Then had severe shakes and felt very cold had to put on a jacket. Lasted about 4 hrs then gradually diminished but not 100% Unable to eat. .Today.(Thurs )feeling much better 90% normal. I feel I could have been given a little more warning about the possible adverse effects. Thanks
Information has been received from a healthcare worker concerning an adult female patient who in November 2004 (date not reported), was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). Approximately two days post vaccination, the patient developed a cellulitis type reaction at injection site, warmth, redness and painful. It was also reported that the patient sought unspecified medical attention. There was no product quality complaint involved. It was also reported that 3 other adult female patients experienced the same adverse event following administration of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P) (WAES0412USA00679, WAES0501USA00532, WAES0501USA00533). Additional information has been requested.
2/27 injection - c/o - swollen, sore about inject site. No fever. Today 2/27 5 cm zone of secondary indurated eg tenderness, no axillary LAN. No fevers.
PATIENT'S LEFT ARM CONTAINS ORANGE-SIZE RED, RAISED, AND WARM TO THE TOUCH AREA.  NO PAIN REPORTED.  AREA IS 'VERY ITCHY.'
2 days after injection. 40 x 42 mm erythematous blanching raised reaction not tender L thigh from the hip/knee/ankle. Normal active movement.
Patient received immunization, reported feeling a little dizzy and became pale. Client then leaned forward, was supported by vaccine administrator, experienced syncope for approximately 1 minute and aroused on own and was alert to time and place. Placed cool towel on neck and observed client for 15 minutes. At that time, client's color returned to normal, lips returned to pink color. Client expressed desire to leave and was ok.
Diarrhea; Had a difficult time sleeping; Really sick; Headache; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea), INSOMNIA (Had a difficult time sleeping), ILLNESS (Really sick) and HEADACHE (Headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), INSOMNIA (Had a difficult time sleeping), ILLNESS (Really sick) and HEADACHE (Headache). At the time of the report, DIARRHOEA (Diarrhea), INSOMNIA (Had a difficult time sleeping), ILLNESS (Really sick) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.  Concomitant medication was not provided.
On 01/31/2001 the patient developed chicken pox with approximately 20 lesions and a headache. Additional information has been requested.
8 months between the first and second dose; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (8 months between the first and second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (8 months between the first and second dose). In August 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (8 months between the first and second dose) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Patient received Hepatitis B vaccine instead of Hepatitis A vaccine. Pt was informed about the error. This Hep B Vaccine was # 4 of the series.  Patient does not show any sign of distress, looks alert and oriented. Patient stayed for observation  for 15 min at the clinic. Pt was educated about an allergic reaction such a difficulty breathing or anaphylaxis reaction  to call 911  or go to the near emergency room.
Tenderness over Left deltoid area. Significant soreness from upper arm to elbow on outer left arm. Treated with Benadryl and Tylenol. Recovering
Pt. commented at time of shot that she may get dizzy. Instructed her to sit and lean against wall during shot. She remained seated for approx 10 mins post. Pt then felt ok shopped and had apparent vagal response. Fainted, hit head upon fall.
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness) and LIP SWELLING (upper lip swelling) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PRURITUS (itchiness) and LIP SWELLING (upper lip swelling). On 18-Mar-2021, PRURITUS (itchiness) and LIP SWELLING (upper lip swelling) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication provided.  No treatment drugs were provided.
No fever, Right thigh red inflammation. Darker in color where shot was given, bruise in area. (W) 7in x (L) 6in. Consulted with doctor. Benadryl 12.5 mg 15ml tsp by mouth every six hours.  Follow-up - vaccine manufacturer provided.
pt recv vax & exp negative titer by latex agglutination;MD reported 9 patients;
First dose, crippling migraines; back aches; joint pain; stiff neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 (Lot number: FF2590) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "If covid tested prior vaccination: Yes" (unspecified if ongoing), notes: If covid tested prior vaccination: Yes. There were no concomitant medications. Past drug history included: Prednisone, reaction(s): "Known allergies: Prednisone", notes: Known allergies: Prednisone.  The following information was reported: MIGRAINE (non-serious) with onset Nov2021, outcome "unknown", described as "First dose, crippling migraines"; BACK PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "back aches"; ARTHRALGIA (non-serious) with onset Nov2021, outcome "unknown", described as "joint pain"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Nov2021, outcome "unknown", described as "stiff neck". Therapeutic measures were not taken as a result of migraine, back pain, arthralgia, musculoskeletal stiffness.  Additional information: Other medical history: No. Other medications in two weeks: No. If other vaccine in four weeks: No. If covid prior vaccination: Yes. If covid tested post vaccination: No.   Follow-up attempts are completed. No further information is expected.
didn't go back for the 2nd shot.; topical reaction and arm was red; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse reaction (received 1st dose on unknown date as had a reaction).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: topical reaction and arm was red) and incomplete course of vaccination (Verbatim: didn't go back for the 2nd shot.). The outcome of the erythema was recovered/resolved (duration 1 week) and the outcome of the incomplete course of vaccination was unknown.   It was not reported if the reporter considered the erythema to be related to Shingrix.     It was not reported if the company considered the erythema to be related to Shingrix.   Additional Information: Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received the first shot and had a reaction to it and did not go back for the 2nd shot, which led to incomplete course of vaccination. The patient insurance covered it and had the original shot once was eligible to get it.  The patient mother had shingles so bad she could not put any clothing on back.  So the patient wanted the vaccine and couple of years ago they came out with a new shingle vaccine that was 2 part and 2 shots at different intervals.  Upon internal review the case was updated on 27-Feb-2023 The patient had a reaction from the first shot.  The patient did not go back for the second one.  The patient had the original shot years earlier. It was so long ago at the time of reporting that his/her mother had them. 40 to 45 plus years before, that he/she did not recall what the treatment was.  But when they came out with the for it.  The patient did not have any reaction to that one.  When they came out with the Shingrix vaccine he/she was told he/she should that even though he/she had had the original shot.  The patient got it and had a topical reaction.  The patient did not go back for the second one.  The patient got a pneumonia shot in November and he/she had the same topical reaction. The patient's upper arm was bright red for well over a week. Summary of Changes: New event was added. Narrative updated.
Developed rash, on lower back, upper  thighs, lower legs, in between some of the fingers. Dr perscribed Benedryl. He also was given dospak of Methylprednisolone 4mg. After dospak medication, the rash dimished considerably. He had minimal itching. Rasg is almost most completely disappeared . It Lasted for about two weeks.
Pain, cannot lift arm over shoulder, weakness, and insomnia. Patient tried Advil which did not help.  Symptoms began within 2 hours after administration.
I  received the Pfizer vaccine (2nd booster) on 10/11/2022 @1500, and developed sudden onset of  darkening of visual field , reduction of visual acuity with accompanied visual distortion, I could not see the computer screen at work and became quite blurry.  The incident occured same day at 2115 . I did sit down for 20 minutes and it gradually cleared.
Tinnitus in the left ear that started shortly after the second dose.   Note I have never had this issue prior to taking the covid vaccine
Dad had been feeling dizzy and tired much of the time when he first knew something was not right and went to his primary doctor and his heart doctor.  From the date of 02/13/2021,the first COVID-19 vaccine shot,  Dad?s condition worsened but once he was administered the second dose of the COVID-19 vaccine it quickly accelerated. One month and one day after the second vaccination shot he was dead from internal bleeding, an excellerated decrease in hemoglobin, red blood cells, platelets, and the complications this caused after surgery which removed a portion of his colon to stop the bleeding. Following is a chronological list of occurrences to the best of my recollection:  1) 2/25/2021 NP, received lab results which she had ordered earlier.  Red blood cells 2.21 MIL/uL, hemoglobin 6.7 GM/DL, platelets 92 THOUS/uL. 2) 2/28/2021 admitted to the hospital to receive 3 units of blood and a bone marrow biopsy. Discharged 3/2/2021. 3) 3/3/2021 diagnosis: anemia, unspecified Melena, and ocult blood in stools. 4) 3/5/2021 Dr. with lab results: red blood cells 2.7 MIL/uL, hemoglobin 8.6 GM/DL, platelets 56 THOUS/uL. 5) 3/10/2021 Video Capsule Endoscopy. 6) 3/12/2021 Outpatient blood transfusion. 7) 3/15/2021 Dr. with bone marrow report.  Diagnosed with Myelodysplastic Syndromes. Received first shot of ARANESP with orders to receive the  ARANESP shot every two weeks and see a specialist at Hospital. 8) 3/16/21 transported to ER by ambulance with GI bleed. Received blood transfusions and admitted. Received several more tests and blood transfusions.  Diagnosis: Arteriouvenous Malformation in descending colon. Treatment:  4 clamps in bleeding veins. Discharged: 3/19/2021. 9) 3/29/2021 Dr. office visit, labs, and second ARANESP shot. Ordered transfusion, no blood match.   10) 3/29/2021 Taken from Dr. office to ER and admitted to Hospital. Transfusions and additional tests performed. Test showed additional bleeding in colon. A colonoscopy was performed and several areas in the colon were sealed. 11) 4/2/2021 Discharged 12) 4/4/2021 Hemorrhaging from colon.  Transported by ambulance to Hsopital. More transfusions and tests. 13) 4/5/2021 Performed surgery to remove part of colon. My dad continued to worsen over the next 9 days.   14) 4/14/2021 My dad died.
severe fatigue in bed x 2 days, body aches, headache, nausea. Persistent but improving tiredness x 5 days
pt recvd vax 14DEC90 & 9MAR94 lab testing was neg for rubella antibody, IgM 0.268 w/an index of 0.003; No further details were provided;
Pt reports after receiving shot 1/27/14 had fever, took TYLENOL, 1/28, 129-RD very hot to touch, swollen, red, applied icy hot ointment on 1/31 and sx worsened. Came into H. D 2/3 - no redness noted but swelling noted 60 mm areas. Advised cold compress. TYLENOL 2/7/14 arm much better after TYLENOL and ice.
No side effects on day of vaccination.  Next a.m. (Feb. 5):  sneezing, stuffy nose, chills, aches; these symptoms lasted until evening of Feb. 6.  I take a natural antihistamine during pollen seasons (Natural D-Hist)--started that 3X a day a.m. Feb. 6, and also echinacea and astragalus tinctures 3X a day through Feb. 7.   These remedies helped, and I was feeling ok by evening of Feb. 6.
WAITED IN THE STORE FOR 15 MINUTES. THEN GOT READY TO LEAVE. WHILE LEAVING HE FELL DOWN
This case was reported by a consumer via call center representative and described the occurrence of death wishes in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 13th December 2018, the patient received SHINGRIX. On 13th December 2018, less than a day after receiving SHINGRIX, the patient experienced death wishes (serious criteria GSK medically significant), tiredness, depression, abnormal dreams, feeling sad and sleepiness. On 14th December 2018, the patient experienced concentration impaired. On an unknown date, the outcome of the death wishes, tiredness, depression, abnormal dreams, feeling sad, concentration impaired and sleepiness were unknown. It was unknown if the reporter considered the death wishes, tiredness, depression, abnormal dreams, feeling sad, concentration impaired and sleepiness to be related to SHINGRIX. Additional details were provided as follows: The patient was in good shape. The patient received SHINGRIX shot in the afternoon, a day before the date of reporting and was tired so she went to bed at 8.00 pm until 5.00 am and had difficult dreams and woke up very depressed. The patient wanted to die. The patient was up on but felt very sad and unable to concentrate on anything and was going back to bed. The patient usually goes to bed at 10.00 or 11.00 pm and gets up at 6.00 am. At the time of reporting, the patient had not called her internal doctor of medicine (MD). The patient had provided contact details of her physician.
Irritability progressing to coughing, then wheezing, then having difficulty getting enough air in.  By Monday morning 10/07/2013 called health center and went to walk in as soon as it opened.  First thing they did was put me on oxygen to bring my saturation level up.  Said I should go to Hospital if I don't improve.
The patient was accidentally stuck with a used needle from a previous patient. As of 1 week, the patient has not shown any injection site reactions or ailments. The patient that originally had the used needle is known and it appears they do not have any blood-borne pathogens.
patient thinks they may have received Shingrix via subcutaneous route; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: patient thinks they may have received Shingrix via subcutaneous route). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 18-Oct-2023 No further details regarding patient or product available. The reporter consented to follow-up. The patient thought he or she might had received Shingrix via subcutaneous route which led to intramuscular formulation administered by other route.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt fainted a couple minutes after vaccine administration, pt woke up seconds later, said had no injury.