chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling on neck; All the shoulder area down to her breasts/swelling all around; All muscles feel tight or something; It's not comfortable; Can feel 2 or 3 lymph nodes swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling on neck), SWELLING (All the shoulder area down to her breasts/swelling all around), MUSCLE TIGHTNESS (All muscles feel tight or something), DISCOMFORT (It's not comfortable) and LYMPHADENOPATHY (Can feel 2 or 3 lymph nodes swollen) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020821A and 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included AMITRIPTYLINE and PROPRANOLOL for Migraine, FLUOXETINE HYDROCHLORIDE (PROZAC) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced SWELLING (Swelling on neck), SWELLING (All the shoulder area down to her breasts/swelling all around), MUSCLE TIGHTNESS (All muscles feel tight or something), DISCOMFORT (It's not comfortable) and LYMPHADENOPATHY (Can feel 2 or 3 lymph nodes swollen). At the time of the report, SWELLING (Swelling on neck), SWELLING (All the shoulder area down to her breasts/swelling all around), MUSCLE TIGHTNESS (All muscles feel tight or something), DISCOMFORT (It's not comfortable) and LYMPHADENOPATHY (Can feel 2 or 3 lymph nodes swollen) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-313305 (Patient Link).
TOOK LAST DOSE OF VIVOTIF A DAY LATE; This spontaneous case (PVX2019-1396) report was received from a caregiver on 31-May-2019. It describes a female consumer who "took last dose of Vivotif a day late". She was receiving Vivotif for an unknown indication.  Case report: The consumer took the last dose of Vivotif a day late. The doses were taken on days 1, 3, 5, and 8 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took last dose of Vivotif a day late" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took last dose of Vivotif a day late" was considered as not applicable.
Patient's guardian stated that they were getting Moderna. Moderna was given I then noticed that the patient was a minor, and supposed to receive Pfizer. Guardian and patient was notified and given instructions. No adverse/side effect noted. Pt was alert and oriented.
6 days after injection - pt calls with complaints and is seen at 7 days: L upper arm red, warm, min tender, swollen, and warm lateral upper L arm extending from over the lateral margin deltoid medially over the bicep muscle. AMOXICILLIN 500mg  TID x 10 days. Will use warm compress 10 min TID. Will elev arm.
Narrative: Other Relevant Hx: Symptoms: Myalgia & soreness at injection site Treatment: ACETAMINOPHEN 1000 MG ONCE
Child was vaccinated with Pfeizer before his 12th birthday. Parent stated he had no adverse reactions.  Parent spoke with MD at annual exam. MD stated he wanted child to get the second shot which he got 6/8/21. No problems with shot #2 either.
- gave moderna shot to a 17yo when vaccine is approved for 18+ - observed patient for 15min, no issues and left without complaint - instructed pt and his mother who to call if he feels unwell in next several days - told pt to come to a pharmacy in 2 months when he is 18 and to restart the vaccine series
There is moderate induration, erythema or warmth to left lateral arm with some gravitational dependent swelling to the lateral mid arm. No ascending cellulitis. No crepitance. No other distal rash..  Claritin Tablet, Start Keflex Capsule, 500 MG, 1 capsule, Orally, tid, 07 days, 21 Capsule, Refills 0.
he got tested for COVID 19 and came up with covid; shortness of breath / shortness of breath with zero amount of exertion; tightness in chest; some short jabs occasionally in his chest; fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (he got tested for COVID 19 and came up with covid), DYSPNOEA (shortness of breath / shortness of breath with zero amount of exertion), CHEST DISCOMFORT (tightness in chest), CHEST PAIN (some short jabs occasionally in his chest) and PYREXIA (fever) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Underweight and Stent placement (He had 5 stents put in every 3 months periodically) since 22-Feb-2021. Concurrent medical conditions included Heart disease, unspecified. Concomitant products included PRASUGREL HYDROCHLORIDE (EFFIENT), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), LISINOPRIL, METOPROLOL TARTRATE (METOPROLOL XL), PANTOPRAZOLE, ROSUVASTATIN, COLCHICINE and RANOLAZINE (RANEXA) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced DYSPNOEA (shortness of breath / shortness of breath with zero amount of exertion), CHEST DISCOMFORT (tightness in chest), CHEST PAIN (some short jabs occasionally in his chest) and PYREXIA (fever). On 15-Mar-2021, the patient experienced COVID-19 (he got tested for COVID 19 and came up with covid). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (he got tested for COVID 19 and came up with covid) outcome was unknown and DYSPNOEA (shortness of breath / shortness of breath with zero amount of exertion), CHEST DISCOMFORT (tightness in chest), CHEST PAIN (some short jabs occasionally in his chest) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. On 31-Aug-2021, Electrocardiogram: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-306623 (Patient Link).
received the first dose of Shingrix on 16-Oct-2019. This patient experienced shingles starting on 10-Apr-2020; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number PF454, expiry date 26th January 2022) for prophylaxis.   On 16th October 2019, the patient received the 1st dose of Shingrix. On 10th April 2020, 177 days after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: A pharmacist reported that a patient experienced shingles starting on 10th April 2020. As a treatment, the patient was given valacyclovir. The symptoms were reported as ongoing. This patient has also not received dose two of Shingrix as of 13th April 2020. Consented to follow up.
FLU-LIKE SYMPTOMS (EXTREME BODY ACHES, EXTREME FATIGUE, LOT OF MUSCLE PAIN, BODY FEELS SO WEAK); UNUSUAL JOINT POPPING ESPECIALLY IN ELBOWS; BED RIDDEN; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight was 180 pounds, and height was 71 inches. The patient's concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies, no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 13-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2021, the patient experienced unusual joint popping especially in elbows. On OCT-2021, the patient experienced bed ridden. On 13-OCT-2021, the patient experienced flu-like symptoms (extreme body aches, extreme fatigue, lot of muscle pain, body feels so weak). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms (nagging, extreme body aches, extreme fatigue, lot of muscle pain, body feels so weak), and unusual joint popping especially in elbows, and the outcome of bed ridden was not reported. This report was non-serious.
This spontaneous report was received from a 61 year old female patient with allergy to penicillin (manufacturer unknown). The patient's pertinent medical history was none. On an unspecified date in January 2013, the patient was vaccinated with ZOSTAVAX (Dose/Frequency: "1 single shot") subcutaneous for prevention of shingles. Concomitant medications were unspecified. On an unknown date in February 2014, the patient was diagnosed with shingles. Lab Diagnostics Studies Performed were none. The outcome of shingles was reported as not recovered. The causality was not reported. The patient did not sought medical attention. Additional information has been requested.
About 10 minutes after vaccine administration, patient stated her mouth was starting to tingle.  She states she was not having trouble breathing but it was starting to tingle some.  Because she was not having any trouble breathing did not think an epipen was appropriate at the time.  50 mg liquid Benadryl was given in case there was an issue swallowing.  After dose of Benadryl patient was monitored for another 40 minutes.  Patient stated she was getting a little better and most importantly it was not getting worse nor was she having trouble breathing.  Counseled patient if she felt ok to go she was free to go.  Counseled to have Benadryl on hand if her symptoms get worse and/or to call 911 if she was starting to have trouble breathing.
I broke out in hives 15 mins after my flu shot and started itching all over, I had to take BENADRYL.
Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff). This case involves 200 patients of an unknown demographics who received a 0.5 mL dose of FLUZONE lot UI998AC via intramuscular route on an unknown date, which was stored incorrectly. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that FLUZONE delivery came three days later than expected. Delivered on 20-Aug-2018 instead of 17-Aug-2018. Approximately 200 doses had been administered. The vaccines were cool to the touch but unknown temperature. The patients did not experience any adverse effects following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by the sender: none.
Soreness/pain at the injection site, headache, drowsiness, slight sore throat (persisted over approximately 48 hour period, seem to be dissipating)
Tenderness to left upper arm. Sore, blister like, with bleeding and drainage. Left arm warm, stiffness to the neck. Appointment 4/27/23: Pt advised to apply warm compress 3-4x a day, use Tylenol PRN. Medrol  dose pak Pt reported on 5/1/23 sxs improving
redness and swelling to the arm; redness and swelling to the arm; large sinus pressure; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE ERYTHEMA (redness and swelling to the arm), the second episode of VACCINATION SITE ERYTHEMA (redness and swelling to the arm) and PARANASAL SINUS DISCOMFORT (large sinus pressure) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced the first episode of VACCINATION SITE ERYTHEMA (redness and swelling to the arm), the second episode of VACCINATION SITE ERYTHEMA (redness and swelling to the arm) and PARANASAL SINUS DISCOMFORT (large sinus pressure). At the time of the report, last episode of VACCINATION SITE ERYTHEMA (redness and swelling to the arm) and PARANASAL SINUS DISCOMFORT (large sinus pressure) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient received a 3rd dose of Moderna. 1st dose on 1/4/21, 2nd dose on 2/1/21, and a 3rd dose on 8/3/21.
Shortly after the vaccine was administered, pt endorsed feeling as if a "lump" was in her throat. Felt some tightness with swallowing. No SOB, wheezing, nausea/vomiting, urticaria. Normal vitals and exam, post oropharynx clear, no angioedema and no wheezing on exam. Pt given oral Benadryl, a nd observed in car for 30 minutes prior to discharge
Onset of painful subcutaneous nodule, patient reports this began the day after vaccination and persists.
Left face numb/ paralyzed starting 7am on 7/15/2021 7/16/2021 Lost of muscle control on left face, can?t close left eye, half smile, can?t raise left eyebrow 1pm went to hospital  Bells Palsy
Sore arm; fatigue; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (Sore arm) and FATIGUE (fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 29-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced ARTHRALGIA (Sore arm) and FATIGUE (fatigue). At the time of the report, ARTHRALGIA (Sore arm) and FATIGUE (fatigue) had resolved.            No treatment information and concomitant medication was provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was not applicable.   Reporter did not allow further contact
Patient felt tingling and vibrating in all extremities right after the vaccine.  She was hyperventilating.  Had o2 sats between 98-100. HR ranged from 100-117.  She was clammy with no chills.  Rapid COVID test performed and it was negative.  Because the patient complained of trouble breathing and was about  to use her AuviQ, paramedics were called. The patient did go with the paramedics.
facility administered an expired Menactra vaccine; Initial information received on 06-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves unknown demographic  patient who received an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5916AA (Expiry date 27-Jun-2019) via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At a time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
The top right side of my lip is extremely swollen like I got a lip implant or something - its extremely swollen. I never had a side effect from the other three Moderna shots so it may be the flu shot (that I didn't want but was convinced to get).
Pt recvd vax w/in mins following vax pt devel feelings of faintness, nausea, diaphoresis, tachycardia;  approx 45 mins later sx resolved; No further details were provided;
I have missed one menstrual cycle completely and think I am going to miss a second after receiving the Moderna vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (I have missed one menstrual cycle completely and think I am going to miss a second after receiving the Moderna vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (I have missed one menstrual cycle completely and think I am going to miss a second after receiving the Moderna vaccine.). At the time of the report, MENSTRUAL DISORDER (I have missed one menstrual cycle completely and think I am going to miss a second after receiving the Moderna vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided. No concomitant medication information was provided.   Reporter did not allow further contact
The first several days after the 1-7-21 vaccination there was only a very sore arm then no symptoms. 0n 1-16-21, I woke up with a very swollen arm with a red rash and very warm to the touch around the injection site about the width of my palm. There was a little pain.  The redness & swelling increased during the day.  Beginning the next day the symptoms began decreasing but as of today (1-19-21) there is a circular pattern of slight redness around the injection site & no pain.
1st dose 3 years ago, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received over 3 years ago prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's Comment:  The reporter reported that the patient received first dose of Shingrix vaccine over 3 years ago and 2nd dose not received yet. The vaccine administration facility was the same as the primary reporter. The reporter did consent to follow up via mail. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. VAERS details provided corresponded to the 1st dose as the 2nd dose had not been administered yet.
Fever, chills, severe headache, myalgias, arthralgias, malaise, nausea, weakness, injection site swelling and rash, leukocytosis.
Numerous papules on trunk and itchy. To do Benadryl, Tylenol and Aveeno baths.
Numbness and tingling in arms, legs and back beginning April 8. Tingling and pain in face April 22 with emergency room visit, low red blood cell count and low folate level. April 23, Stabbing pain in back and jaw, nauseous and vomiting. First vaccination on 3/17 and second vaccination on 4/14.
This spontaneous report was received from a company employee, who referred to her mother, a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions and allergies was provided. On an unknown date (reported as years ago), the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) as prophylaxis. On an unknown date, the patient experienced shingles. The outcome of the event was unknown. The relatedness between the event and suspect therapy was not reported. No product quality complaint was involved. Additional information has been requested.
9 cm area erythema; hot to the touch at the injection site; itching at the injection site; red at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (9 cm area erythema), VACCINATION SITE WARMTH (hot to the touch at the injection site), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ERYTHEMA (9 cm area erythema), VACCINATION SITE WARMTH (hot to the touch at the injection site), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) (oral) at an unspecified dose and frequency and TRIAMCINOLONE ACETONIDE (topical) at a dose of 0.1 percent. At the time of the report, ERYTHEMA (9 cm area erythema), VACCINATION SITE WARMTH (hot to the touch at the injection site), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided.  Treatment medication included Bactrom and triamcinolone acetonide 0.1 % topical cream.
Extreme swelling and pain in left arm, followed by nausea, vomiting and diarrhea after about 18 hours