chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5/21/09 Swollen, reddened, tender and hot to touch R upper arm.  Afebrile. Received vaccines 5/18/09 - Cellulitis R upper arm - 2 hours to injection - AUGMENTIN 400 mg Bid. Strict precautions re: temp increase, streaks to ER immediately
Reconstituted with sterile water and administered; Reconstituted with sterile water and administered; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 99E53, expiry date 9th April 2023) for prophylaxis.   On 9th November 2021, the patient received Shingrix. On 9th November 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that, Shingrix was reconstituted with sterile water and administered to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
This case was reported by a consumer via call center representative and described the occurrence of axillary lymph nodes enlarged in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 15th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, less than a month after receiving SHINGRIX, the patient experienced axillary lymph nodes enlarged, fatigue, headache, injection site erythema, injection site pain, swelling, breast swelling and sleep excessive. On an unknown date, the outcome of the axillary lymph nodes enlarged, fatigue, headache, injection site erythema, injection site pain, swelling, breast swelling and sleep excessive were recovered/resolved. It was unknown if the reporter considered the axillary lymph nodes enlarged, fatigue, headache, injection site erythema, injection site pain, swelling, breast swelling and sleep excessive to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The patient experienced injection site reaction consisting of redness of 4 inch circle around site and pain also experienced headache, swollen lymph node in left armpit and swelling that went from there across left chest to breast and was fatigued and slept for 3 days. The patient had denied permission to contact their physician.
Chest pain; Headache; Body ache; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and FATIGUE (Fatigue) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    No Medical History information was reported.   On 20-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced CHEST PAIN (Chest pain), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and FATIGUE (Fatigue). On 22-Sep-2021, CHILLS (Chills) had resolved. At the time of the report, CHEST PAIN (Chest pain), HEADACHE (Headache), MYALGIA (Body ache) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Sep-2021, Blood pressure measurement: 130/90 (High) 130/90.   No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-328763 (Patient Link).
Pt. walked out after vaccinations - notified shortly after pt. had severe back pain/headache - pt. seen by his doctor, TYLENOL 2 tabs - BP stable - several minutes after back pain decreased/ headache decreased.
Swelling; This is a spontaneous report received from a contactable consumer. This consumer (Patient's wife) reported for a patient (Reporter's husband) that:  The male patient of unspecified age received bnt162b2 ( solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced swelling due to the vaccination. At the time of reporting, the outcome of event was  unknown.  Follow-up attempts are needed; information about lot/batch number can be obtained
Initial consumer report received on 12 Jan 2010: This patient who was 3.5 year old received H1N1 (batch number 1013285P) 0.5 mL intramuscular dose on 07 Jan 2010. Outcome was not provided at the time of this report.
Complaint of itching beginning on face and all over body within 25 minutes of receiving vaccine. Hive-like rash to back present. Patient was given Benadryl 50 mg IM per Nurse Practitioner order and symptoms began to resolve within 10 minute with complete resolution within 30 minutes. Patient left clinic with family member and was advised to contact emergency care or physician if symptoms return.
MMR-Varicella given 7/18/06. Rash developed 7/31/06 on arms, leg, trunk. Decreased appetite 7/28/06. Spike Temp 103 deg on 7/30/06, fever lasted 3 days. Treated with Motrin
Patient presented to hospital on 3/11 with shortness of breath. History of chronic oxygen dependency at night. Became more sob over last several days and was not able to make it to md appointment. Had a recent abnormal stress test. Family states she was febrile at home. Was low on oxygen level on 2LNC, placed on non-rebreather and then BIPAP. Positive for Rhinovirus. Chest xray showed bilateral lower infiltrates. Patient detiorated through the night and was intubated and placed on vasopressors for septic shock. Patient was made DNR and family refused hemodialysis. Family then made decision to withdraw care.
have COVID-19 / currently still have symptoms; route was reported intercostal; This case was reported by a pharmacist via call center representative and described the occurrence of covid-19 in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intercostal). On an unknown date, unknown after receiving Shingrix, the patient experienced covid-19 and intramuscular formulation administered by other route. On an unknown date, the outcome of the covid-19 and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The reporter called on behalf of a patient.  The reporter did not have any patient demographic information. The age at vaccination was not reported. The route of administration was reported intercostal, which led to intramuscular formulation administered by other route. The reporter called to inquire if a patient could have the 2nd dose of Shingrix as they were due, but had Covid-19 and currently still had symptoms.  The reporter also reported that the patient received monoclonal antibodies and inquired if the patient could still had the 2nd dose of Shingrix or if they had to wait a period of time.  Monoclonal antibodies was suspect in this case.  The reporter did not have any further details apart from the patient was tested positive for covid-19 a few days ago and they received antibodies.  The reporter reported that the patient was due for her 2nd dose on 2nd February 2022 (6 months from 1st dose). It was unknown if the reporter considered the covid-19 to be related to monoclonal antibodies. The consent to follow up was granted.
Shot given 4/23/2021 at 1pm. 4/25/2021 around 1pm started losing vision in both eyes while at work, also passed out & fell down multiple times. By evening of 4/25/2021 had extreme nausea when trying to consume any food or drink any liquid. Went to urgent care 11am-ish on 4/26/2021 for continued nausea symptoms and overall body pain. Was told symptoms likely an adverse reaction to the COVID vaccine received days prior. If anything else worsened to go to ER.  Felt better during day of 4/27/2021 until a migraine came on at 7pm. Went to ER. Was given a COVID test (awaiting results at this time) as well as some muscular shots of Toradol, Benadryl & Reglan. Felt better within 30 mins and was discharged to go home.
Erythema and pain which radiated across upper arm and shoulder lasting 1-2 weeks.
After 15 minutes, lightheaded as ready to leave. Is DM, BS 126 before came; ate lunch; takes 75U. BP 100/60--bit low for her; pulse 80, pulse ox 98. No hives, itching, trouble breathing. Monitoring, gave water, juice, cracker. BP 118/60. Still lightheaded plus nausea. Rapid response; agreed to be monitored in ED; went by cart.
Moderna vaccine inadvertently given and client wanted Janssen vaccine.  Client notified via voicemail and notified of when to come back for a second vaccine.
bladder infection; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CYSTITIS (non-serious), outcome "not recovered", described as "bladder infection". Therapeutic measures were taken as a result of cystitis. Additional information: Clinical course: The patient currently has a bladder infection and has taken Cephalexine for 8 days as treatment. She started taking this medication on 27Jan2021 and has already completed it. But she felt like still having trouble with her bladder, so she went to Urgent care and was confirmed that there was still a bladder infection. The patient wanted to know if she can take her second COVID vaccine today with the bladder infection. She said that she was feeling fine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
JE vax 1st dose-no rx; 2nd dose feeling dizzy, nauseous;
This spontaneous report was received from a medical assistant, via company representative, concerning a 17 year old female patient. The patient's medical history, concurrent conditions, drug reactions and allergies and it was stated that she had not any concomitant medication. On 07-NOV-2018, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis, on her right arm, lot #1586749 and expiration date 13-FEB-2021 (strength, dose, frequency and route of administration were not reported). On the same date, while still in the office, the patient fell over and hit her head on the ground (head injury) and was unconscious for about 30 seconds. It was reported that the patient was transported by ambulance to the hospital. The reporter advised that the event was not life threatening but it was unknown what happened at the hospital. It was reported that the patient recovered from the loss of consciousness the same day after 30 seconds and from falling and hitting her head and  on an unspecified date in November 2018. The casual relationship between the vaccination with GARDASIL 9 and the events was not provided by the reporter. Upon internal review, loss of consciousness was determined to be a medically significant event.
Per patient, she started vomiting and spiked a fever the night of the vaccination,. She said her vomit included blood. Her fever was about 100 degrees Celsius. She used acetaminophen every 6 hours to keep her fever down. Both of these symptoms lasted 2 days.
Arm was warm; Big sized circle reaction around the injection site; Arm was itchy; Redness; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (Arm was warm), VACCINATION SITE REACTION (Big sized circle reaction around the injection site), VACCINATION SITE PRURITUS (Arm was itchy) and VACCINATION SITE ERYTHEMA (Redness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 002A21A) for COVID-19 vaccination.     The patient's past medical history included Knee pain (Left and right) on 24-Nov-2020. Concomitant products included HYDROCORTISONE (CORTIZONE 10) and HYALURONATE SODIUM (EUFLEXXA) for Knee pain, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ), ROSUVASTATIN CALCIUM (CRESTOR), DULOXETINE HYDROCHLORIDE (CYMBALTA), LORAZEPAM (ATIVAN), MELOXICAM (MOBIC), CENTRUM SILVER +50 and HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Arm was warm), VACCINATION SITE REACTION (Big sized circle reaction around the injection site), VACCINATION SITE PRURITUS (Arm was itchy) and VACCINATION SITE ERYTHEMA (Redness). On 08-Feb-2021, VACCINATION SITE WARMTH (Arm was warm), VACCINATION SITE REACTION (Big sized circle reaction around the injection site), VACCINATION SITE PRURITUS (Arm was itchy) and VACCINATION SITE ERYTHEMA (Redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication include Benadryl, non drowsy antihistamine   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Added HCP details, vaccine facility information,patient demographic details, other relevant history , concomitant medication, second dose information,event stop date, event outcome.
Patient started feeling dizzy with blurred vision 4 minutes after vaccine.  Vitals were taken; BP 142/72, Pulse 68, O2 99%, temp 97.2, respiration 16.  Patient observed for 15 minutes.  Patient stated he felt better and his vision improving.  Advised to eat, drink, and get rest.  Advised to see his PCP or go to ER if symptoms persist.
redness and swelling in her left arm; redness and swelling in her left arm; left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm soreness), ERYTHEMA (redness and swelling in her left arm) and PERIPHERAL SWELLING (redness and swelling in her left arm) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and High cholesterol. Concomitant products included VITAMIN D3, CALCIUM, VITAMIN C [ASCORBIC ACID], LISINOPRIL, HCTZ and ATORVASTATIN for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (left arm soreness). On 24-Mar-2021, the patient experienced ERYTHEMA (redness and swelling in her left arm) and PERIPHERAL SWELLING (redness and swelling in her left arm). At the time of the report, PAIN IN EXTREMITY (left arm soreness) outcome was unknown and ERYTHEMA (redness and swelling in her left arm) and PERIPHERAL SWELLING (redness and swelling in her left arm) had not resolved. Not Provided          Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Information has been received from a medical assistant concerning a 12 month old white female child with no past medical history and no known allergies who on 06 JUL 2001 (also reported as 16 JUL 2001) was vaccinated with a first dose of varicella virus vaccine live in the right thigh ((lot #636580/0098L). Concomitant therapy that day included a first dose of measles vaccine (+) mumps vaccine (+) rubella vaccine live (second generation) (MSD) (lot #637837/0373L) in the left thigh. There were no illnesses at the time of vaccination. The medical assistant reported that immediately following the varicella virus vaccine injection, the patient developed a significant local injection site reaction of swelling and tenderness about the size of a half-dollar. On 27 JUL 2001, the child was again seen in the office and still had a bump at the injection site that was tender to the touch. Follow up information received from a medical assistant on 24 SEP 2001 indicated that on 06 JUL 2001 the child had an immediate (+) local hive)" at the varicella injection site. It was reported that the child was administered diflorasone diacetate (PSORCON) cream and diphenhydramine hydrochloride (BENADRYL) and was sent home. The child's mother was told to call the office if the symptoms got worse. Itw as reported that the child recovered from the hive on 07 JUL 2001 and that she recovered from her experience. No further information is available.
Second dose of Pfizer vaccine given on 5/4/2021 to left Upper arm. I immediately felt burning inside my left shoulder joint as the medication was being pushed in. Approx 20 min after injection as I was waiting/being monitored I felt very dizzy and felt like I was going to pass out, I was seeing stars. Nursing staff had me lay on a stretcher and drink fluids. I have had burning pain inside my left shoulder joint since. It is exacerbated when lifting left arm above my head and across my chest. I have trouble lifting heavy objects and holding doors open. I was seen by orthopedic Dr.  6/7/2021 and he said that if pain persisted into July I should be seen again for a steroid injection  to the left shoulder to decrease inflammation and pain secondary to the injection, likely causing subacromial bursitis. I have a follow appointment scheduled 7/19/2021.
I got 2 doses for Pfizer vaccine, then 6 months later, got Moderna as booster.  I had reactions to all the doses. With the second dose, I already was experiencing more severe cramps during my period. Then on  day 1 of my first  period after the booster shot,  (around 11pm) I got urticaria all over my body, focused on palms, neck, inner legs and abdominal. I took antihistamine pill I had, and got better. I thought it was related to what I ate. Then, today, on day 1 of my second period cycle, I am getting the exact reaction. Around 11:30 PM, My palms started itching, then my face, ears, head, neck and body. Rashes showed up. No one told me about this type of side effect, but the Booster shot is the only thing that changed between December. I have never had these hives during my period before. This should be studied.
8/29/14  VCZ 2 administered SQ left upper arm - 5-10 mins after receiving, student reported left arm didn't feel right. Dr into examine: injection site reddened, warm, tender to touch. Redness resolved as swelling, warmth approximately 30 mms. Plan ice to area, Ibuprofen, BENADRYL 25 mg every 6 hrs to 14 as needed. 9/1/14 1240 p reports was improving til yest increased pain increased heat ? Immunization ran with ? early cellulitis - started on KEFLEX 500 mg TID x 10 days. 9/3/14 F/U visit, sxs much improved.
had the flu; Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who had the flu (influenza), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported that the patient stopped taking them 9 years ago and have not had the flu since.  On an unknown date, the patient developed non-serious had the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
chills; Left Arm ache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 09:45 (Lot number: EL3248) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypertension controlled with lisinopril" (ongoing); "Allergy to penicillin" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Mar2021, outcome "recovered" (11Mar2021), described as "Left Arm ache"; CHILLS (non-serious) with onset 10Mar2021, outcome "recovered" (12Mar2021), described as "chills". Therapeutic measures were not taken as a result of pain in extremity, chills.  No follow-up attempts are possible. No further information is expected.
Patient stated her left arm red with rash and itch, and has a pimple like on her underarm.