chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Neck pain after 1st dose; Neck swelling after 1st dose/Armpit swelling after 1st dose; Armpit pain; Mild pain in areas where lymph nodes were swollen; Soreness; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain after 1st dose), SWELLING (Neck swelling after 1st dose/Armpit swelling after 1st dose), AXILLARY PAIN (Armpit pain), PAIN IN EXTREMITY (Mild pain in areas where lymph nodes were swollen) and LYMPHADENOPATHY (Swollen lymph nodes) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00ZB21A and 031X21H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Drug allergy (Allergy to codeine-Sick to Stomach/Vomitting.) since 04-Apr-1992, Drug allergy (Allergy to Artificial sweeteners-Sick to stomach/Vomitting) since 03-Mar-1993, Celiac disease (Autoimmune Reactions) since 16-Mar-2002 and Hypothyroidism since 13-Mar-2021. Concomitant products included PANTOPRAZOLE from 30-Mar-2003 to an unknown date for Acid reflux (esophageal), LEVOTHYROXINE SODIUM (SYNTHROID) from 13-Mar-1997 to an unknown date for Hypothyroidism, MULTIVITAMIN [VITAMINS NOS] from 30-Mar-2003 to an unknown date for Vitamin supplementation.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). On an unknown date, the patient experienced NECK PAIN (Neck pain after 1st dose), SWELLING (Neck swelling after 1st dose/Armpit swelling after 1st dose), AXILLARY PAIN (Armpit pain), PAIN IN EXTREMITY (Mild pain in areas where lymph nodes were swollen) and MYALGIA (Soreness). On 16-Mar-2021, LYMPHADENOPATHY (Swollen lymph nodes) had resolved. At the time of the report, NECK PAIN (Neck pain after 1st dose), SWELLING (Neck swelling after 1st dose/Armpit swelling after 1st dose), AXILLARY PAIN (Armpit pain), PAIN IN EXTREMITY (Mild pain in areas where lymph nodes were swollen) and MYALGIA (Soreness) had resolved.            Treatment information was not provided by the reporter..   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant Follow up-Updated Reporter's address, Updated patient details and Allergies and Other relevant history, Updated suspect product dose1 batch number and dose 2 details. Updated Concomitant medications and start dates, Updated New Events and Outcome of the Events as resolved.
2mins post vaccination pt had a syncopal event and hit her head on the floor Vitals: 19:40 104/47, 69, 18, 100% -- > 19:50 101/49, 78, 18, 100 -- > 100/64, 83, 18, 100% No medications given, cold pack to head.  Pt c/o tenderness to the back of head on palpation.  No Visitble redness or bump on palpation of area. 20:00 pt sitting upright. 20:10 Pt VSS but still c/o pain/tenderness to affected area.  NO dizziness or nausea while standing.  Pt talking smiling, conversational w/ mom. 20:30 Pt stable and released from the vaccination site w/ parents.  Recommended ER check to patient secondary to fall/tenderness on back of head
Chest pain elevated Troponin 112 T EKG Cardio Cath  No sign of damage Diagnosis Cardiovascular Spasms
03/30/2005- started redd. swollen, hard area size of an orange (per mom) Temp normal 98.6, seen on 03/31/2005 in office and examined by DR- documented 6x6cm erythema and induration around injection site. Probable reaction to DTaP.
This spontaneous report has been received from a pharmacist referring to a female patient in her 60's with allergic to morphine. On 18-JAN-2016 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (route and lot# not reported) in the left upper arm. Concomitant therapy was not reported. It was reported that on 20-JAN-2016 (reported as "now") the patient had raised, itchy b umps at the injection site. No other symptoms reported. The patient sought medical attention by calling pharmacist. The outcome of the events was reported as not recovered/not resolved. The causality was not reported. Additional information has been requested.
FELT FEVERISH IN NIGHT AWAKE WITH NAUSEA AND FEVER 102 BODY ACHES AND INJECTION ARM SLIGHT RED AND SWOLLEN.
Breakthrough case admission after three vaccines Pfizer 3/18/21 Lot# ER2613;  Pfizer 4/8/21 Lot# Ew0158;  Pfizer 10/10/21 LOt# FF8841
How long can the delay be on the side effects; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (How long can the delay be on the side effects) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (How long can the delay be on the side effects). At the time of the report, VACCINATION COMPLICATION (How long can the delay be on the side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No treatment information was provided
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was infection control manager.  Concomitant medication of the patient was not reported.  Date the vial was placed in the refrigerator was 18-Sep-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
There is a pain in the knee; This is a spontaneous report from a contactable consumer reporting for herself. A 66-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  The patient medical history was not reported. The patient received the first dose of BNT162B2 on an unknown date.  The patient's concomitant medications were not reported.  The patient stated  there is a pain in the knee  on an unspecified date with outcome of unknown.   It was reported that the orthopedic doctor wants to give a cortisone shot in the patient's knee.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a 6 year old female, with no pertinent medical history, drug reactions or allergies, who on 20-MAR-2002 was vaccinated subcutaneously with Varivax (lot number 641268/1295L). On 19-February-2007 the patient presented with a rash which began 13-February-2007. The rash, which was papular, extended from the right elbow to her fingers. The rash was not vesicular in nature, but had three areas of distinct indurated nodules, with three to five nodules in each area. The rash was reportedly painful. The patient was treated with prednisone and hydroxyzine hydrochloride. There was no concomitant therapy. The patient was recovering at the time of this report. Lab diagnostics were not performed. There was no product quality complaint. Additional information has been requested.
9DEC95 fever 102 father stated very sick;fever did not go down w/APAP;10DEC95 macropapular rash;began @ hairline, spread to face & trunk;splotches ran into each other;seen by MD;mom states cough, conjunctivitis, rhinitis;
Gardasil given 6/25/07. Patient reports flu-like symptoms, nausea temperature 102 during night of 6/25/07- 6/26/07 flu-like symptom. Nausea continued, loss of consciousness "few minutes" at work. Has bad headaches, abdominal pain "feels like some one has hit me". C/O fatigue.
This spontaneous report received from a consumer via a company representative concerned a non Hispanic or Latino male of an unspecified age and race. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, right after the vaccination, the patient experienced a stroke and was partially paralyzed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220349302-Covid-19 vaccine ad26.cov2.s-Stroke. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
I received healthcare from Pharmacy in the early evening on October 9, 2020 in the form of the following two vaccines:  DRUG: FLUBLOK QUAD 2020-2021 PFS NDC: 49281-0720-10; QTY: 0.5  DRUG: SHINGRIX VIAL KIT NDC: 58160-0823-11; QTY: 1  Firstly, the flu shot was administered in the left shoulder. I've had many a flu shot, and none were this painful. I think the young man pharmacist didn't use the proper length needle, because I had the sensation that the needle went right through the muscle and into the bone. It hurt a lot, so much so that I let out an un-ladylike expletive.  Second was the Shingles shot in the right shoulder. I once again had the sensation that the needle went all the way through my muscle and into the bone. It hurt a lot. Later that same evening, I felt nauseous like I wanted to throw up, and I had such excruciating pain in my right shoulder that I was screaming & writhing in pain and the neighbor's dog could hear me [by barking in acknowledgement]. I applied ice and I was finally able to fall asleep. It was better the next morning. However, to this day (today is 12/14/2020 as I write this), my shoulder is not the same. I am not able to reach for things or use my shoulder in certain ways without experiencing pain and discomfort. I don't think the young man pharmacist followed proper technique in administering the vaccine(s) to me. And I feel sorry for all his prior and subsequent patients, both young and old.  Upon reading articles on the internet about the proper technique for administering shots (in order to help explain the extraordinary pain I've been having in my right shoulder weeks after my shot at Pharmacy on 10/9/2020), I've come to the conclusion that the needle was too long. Also, I don't remember the pharmacist bunching up my muscle first before giving me the shot. I'm not saying that it didn't happen; it's just that I don't remember whether he did or not. In my mind, I'm thinking that he didn't.
toothache; This case has been considered invalid as there is no indication that the consumer experienced an event under BNT162B2.  The initial case was missing the following minimum criteria: Other-Info not qualifying for AE reporting. Upon receipt of follow-up information on (01Jun2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "low platelet count" (unspecified if ongoing), notes: She has a medical condition and low platelet count and is getting medication for it. The patient took concomitant medications. The following information was reported: TOOTHACHE (non-serious), outcome "unknown".  Additional information: Caller mentioned that she received both doses of the vaccine including the booster, she has a medical condition and low platelet count and is getting medication for it. She mentioned that she has a scheduled dentist appointment tomorrow because of toothache and wants to get the 2nd booster dose before getting to her dentist. Caller wants to confirm about what she heard from the news that there(s) an issue with the vaccine about blood clot and she wants to check if it is correct before she gets the 2nd booster dose of the vaccine. Medical questions were addressed by this program forwarded/referred to Medical Information. Customer and/or medical inquiry forwarded or referred to MI.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient Name: "PRIVATE", Patient MRN: Unknown, Date of Birth: 12/23/1955. Facility: Local Hospital, Attending Physician: "PRIVATE" MD. Date of Admission: 11/30/2021- Date of Discharge: 12/2/2021. Admission Diagnosis: Abdominal pain, right upper quadrant [R10.11], RUQ pain [R10.11], Herpes zoster without complication [B02.9]. Discharge Diagnosis: Shingles- Discharge Disposition: Home. My date of service is 12/2/21. History (with Chief Complaint) From attending Dr.: "Patient is a 65 y.o. female with UC s/p total colectomy with J pouch c/b multiple SBOs in the past presenting with RUQ pain x3 days. She initially presented to ED 11/30. She has been afebrile with stable VSS. Her labs were normal with normal LFTs, no leukocytosis, Hgb 14.9 -> 10.4 after IVFs. RUQ with no gallstones or cholecystitis. CTAP with dilated loop of terminal ileum/J pouch which may be obstruction at anastomosis, possibly chronic. Surgery consulted and felt patient not clinically obstructed and no indication for surgical intervention. She was admitted for pain control. After >24h, patient still with significant pain getting IV morphine so requested admission to medicine. Of note, patient has had a small painful rash on R abdomen starting on Tuesday so she was also started on Valtrex given c/f shingles. On my evaluation, patient had a small vesicular rash over R abdomen. She notes this started Tuesday. Describes pain in RUQ/R abdomen as sharp, stabbing and intermittent. It is NOT pain similar to her prior episodes of SBO. Pain (prior to morphine was 7-8/10), now 4/10. When she has SBO, she has no PO tolerance and her pain is 10/10. She currently has no n/v. No recent BMs as she has been kept NPO/on clears since 11/30. She states she has been vaccinated against Shingles in 2019. No recent exposures. No new stressors but she works in cancer research so experiences stress day to day. She states on Tuesday there were 3 small areas of redness, now appears to be slightly expanded with vesicles". Brief Hospital Course by Problem: # Zoster: Presented with abdominal pain, with development of classic zoster rash 2-3 days after onset. Vesicular rash associated with electrical pain over single dermatomal distribution. Given abdominal pain and h/o prior surgeries with multiple SBOs, extensive imaging was performed prior to diagnosis of zoster (abdominal ultrasound; CT A/P with contrast), which was unrevealing for alternative etiology of pain. CT A/P was notable for dilated loop of terminal ileum/J-pouch with fecalization of contents. She was evaluated by General Surgery and determined to have no clinical obstruction. She was able to tolerate a regular diet without difficulty. Pain was controlled with oxycodone, Tylenol, and gabapentin. She was started on valacyclovir treatment and discharged to complete a 7 day course. Continue valacyclovir 1000mg Q8h x 7 days total, Take gabapentin 200mg TID while on valacyclovir; may up titrate to 300mg TID as tolerated, short supply oxycodone prescribed. Database was reviewed and consistent with expected prescribing. Discussed keeping lesions covered until crusted over, and provided a note to excuse from work for 7 days.
This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received ROTA (batch number A41CB504A, expiry date 5th February 2017). On 11th April 2016, the patient received ROTARIX lyophilized formulation .5 ml. On 11th April 2016, an unknown time after receiving ROTARIX lyophilized formulation, the patient experienced inappropriate age at vaccine administration and inappropriate dilution of medication. On an unknown date, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate route of vaccination and inappropriate dilution of medication were unknown. Additional details were received as follows: This case was reported by a Medical Assistant. The patient inadvertently received a dose of ROTARIX lyophilized formulation at an age of 11 years which was administered intramuscularly in the left deltoid muscle that was reconstituted with Normal Saline. This led to an inappropriate age at vaccine administration, inappropriate route of vaccination and an inappropriate dilution of medication.
Swelling both cheeks; Swelling around ear; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling both cheeks), EAR SWELLING (Swelling around ear) and VACCINATION SITE PAIN (Pain at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (esophageal) (Stomach reflux). Concurrent medical conditions included Penicillin allergy.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced SWELLING FACE (Swelling both cheeks), EAR SWELLING (Swelling around ear) and VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, SWELLING FACE (Swelling both cheeks), EAR SWELLING (Swelling around ear) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.
Sore throat,  achy, cough, chills, slight headache, not much of an appetite
Chills, fever, vomiting began 12 hours after dose. Followed by full body rash, swelling in face, headache, body aches. Still present almost 48hrs later.
didnt receive the second dose/ a second dose has not been administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received HAV (Havrix) for prophylaxis.  Previously administered products included Havrix (she received the 1st dose of Havrix on 17 June 2017 with lot number 5D952).  On an unknown date, the patient did not receive the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incomplete course of vaccination (Verbatim: didnt receive the second dose/ a second dose has not been administered). The outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK receipt date: 01-MAY-2023 Pharmacist was the reporter, as well as the patient. She reported that, she had received a dose of Havrix and did not receive the second dose. At the time of reporting, a second dose has not been administered. The reporter had consented to follow up. The reported corresponded to the 1st dose. Until the time of reporting, the patient did not receive the second dose of vaccine, which had led to incomplete course of vaccination.
pervious visit had a "funny feeling" in his face and throat, currently has same "funny feeling" in throat only
Information has been received from a licensed practical nurse (L.P.N.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 25-MAR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K008927 with expiration date 17-MAR-2016, dose and route unspecified), which had been expired. No adverse effects were reported. Additional information has been requested.
Pt recvd all 3 doses of ? Hep B vax (brand unspecified) in 1990; titers were done in 1992 pt did not seroconvert;
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Shakiness-Mild, Additional Details: Pt came back 30 min after vaccination given at 7pm. Was shopping in store, but felt very faint. Had patient lay down with legs propped up. Took blood pressure was low 106/68 and pulse rate was 158. Decided at that point to call Emergency medical due to time of day and wait time at urgent care. Both Fire and EMS came. Patient was stable blood pressure had rebounded all other vitals were good, EMS transported to facility of choice for evaluation.
I got my shot at 8:30 in the morning and started to feel symptoms at 8:30pm. It began with chills and being very shaky. I went to bed and did not sleep well.  At 4:00am, I woke up sweating, and went to the bathroom. I was so dizzy that I could not return to bed. I sat on the bathroom floor for 45 minutes until I could get up. I was drenched in sweat and had sharp stomach pains. I have never experienced such bad night sweats and dizziness in my life. The rest of the morning/day I had a headache, was very tired, and weak.  I had a slight headache for the following 3 days.
Red, itching, swollen and hot injection site from day after injection to current date Headache  for 4 days Muscle aches for 3 days
Headache, UrticariaPruritus, Arm pain with urticarial rash Narrative:  Given antibiotic with what appears localized infection area