chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling on the arm; Tenderness; Hot feeling; A 3 inch diameter red area located 1-2 inches below the injection site; Constant pain in left calf; Soreness; Grumpy; Itching; This spontaneous case was received on 28-Oct-2020 from pharmacist via Med Communications (reference number: SEQW20-04406) and concerned a 65-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 26-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular and anatomical location: left arm) for influenza prophylaxis. The batch number reported was 283853, expiration date 30-Jun-2021.   On 27-Oct-2020, one day after vaccination, the patient experienced soreness, tenderness, hot feeling, itching and swelling on the arm. The patient had a 3-inch diameter red area located 1-2 inches below the injection site. She did not have fever. The patient felt grumpy and had constant pain in left calf. The patient did not receive any corrective treatment.  At the time of initial reporting on 28-Oct-2020, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: The patient developed all events one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. The patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed all events one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. The patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
Information has been received from an office manager concerning a 60 year old female patient with a tetanus toxoid vaccine reaction who on 02-OCT-2009 was vaccinated intramuscularly into her left arm with a 0.5ml PNEUMOVAX 23 (lot number 663888/0627Y). Concomitant therapy included TOPROL XL TABLETS, benazepril HCl, CARDIZEM, TEKTURNA, PLAVIX, DETROL, vitamin D (unspecified), ubidecarenone and supplements. On 03-OCT-2009, after the vaccination the patient experienced erythema and swelling at the injection site that had spread to a "large area". She did not have a fever but the area was "really painful". She was treated with anti-inflammatory and cold compresses. The patient had sought medical attention via phone. No laboratory diagnostic studies were performed. At the time of the report, the patient's status was recovering. Follow up information was received from the office manager concerning a 60 year old female patient with no illness at time of vaccination and no drug allergies who in the morning of 02-OCT-2009 was vaccinated intramuscularly into her left deltoid with a first dose of PNEUMOVAX 23 (lot number 663888/0627Y). In the afternoon of 02-OCT-2009 the patient experienced adverse events which were reported previously. On 04-OCT-2009 the patient was recovered. There were no laboratory diagnostic studies performed. This is one of several reports received from the same source. Additional information is not expected.
Redness, rash, warm on where the vaccine was placed, skin firmed/hard.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 81 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "Chronic atherosclerosis" (unspecified if ongoing); "Multiple stents" (not ongoing); "Triple bypass", start date: 2014 (not ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from 13May2023 to 18May2023. Clinical course: The patient did not receive other medication in 2weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300203955 same reporter/patient, different product/AE;
This spontaneous report was received from a pharmacist, via a company representative, concerning a 57 year old female patient. The patient's medical history included hepatitis. On 24-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date and route were not reported), dose and frequency reported as one shot for vaccine. Co-suspect and concomitant therapies were not reported. The pharmacist reported that on 25-JAN-2015, the patient experienced an injection site warmth, injection site swelling and injection site nodule after receiving ZOSTAVAX. At the time of the report the outcome for site warmth, injection site swelling and injection site nodule was unknown. The patient seeks medical attention on the pharmacy. The pharmacist told the patient to "put on it ice" and to take BENADRYL. Additional information has been requested.
Pt 15 years and 8 months at time of vaccination (under 16 years of age). No physical adverse events observed following vaccination. Mother was present with minor at time of vaccination.
LARGE (SIZE OF A TEACUP PER PT'S DAUGHTER WHO REPORTED IT) ROUND RED SPOT WHERE PT WAS INJECTED ON RIGHT ARM
A customer had submitted the following question(s) on MerckVaccines.com on 10-AUG-2013. Direct evidene of vaccine induced food allergies: Most anaphylactic reactions and some urticarial reactions to gelatin-containing measles, mumps, and rubella monovalent vaccines are associated with IgEmediated gelatin alelrgy. DTaP (diphtheria, tetanus, pertussis) immunization histories suggest that the gelatin-containing DTaP (diphtheria, tetanus, pertussis) vaccine may have a causal relationship to the development of this gelatin allergy. Why do you still make vaccines that contain food proteins): Additional information is not expected.
did not feel like getting up and doing thing; tired; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (did not feel like getting up and doing thing) and FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced IMPAIRED WORK ABILITY (did not feel like getting up and doing thing) and FATIGUE (tired). At the time of the report, IMPAIRED WORK ABILITY (did not feel like getting up and doing thing) and FATIGUE (tired) outcome was unknown.            No concomitant and treatment medications were provided by the reporter.   This case was linked to MOD-2022-531856, MOD-2022-531849 (Patient Link).
Lipoatrophy at injection site. Pt reports this has slowly increased. Reporter has not seen this so no other data available.
Chills (followed by heavy sweating), Aches, Head aches, sore throat, indigestion, fitful sleep/ dreams, increased heart rate. The big change from dose 1 to 2 is muscle twitching.  The twitches coincide with the more extreme joint aches.  Sore arm  All started about 9 hours after vaccine. Sore arm was mitigated with movement and stretching (as compared to the first dose). Other symptoms have lessened since 7am (19 hours after shot), but linger.  Ibuprofen seems to lessen, but not end eymptoms.
Patient states that her arm still feels sore from the shot, sometimes shooting pain. She said she  feels it moreso when she lifts weights or sometimes when she lifts her arm to drive.
administration of an expired Shingrix dose to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a male patient who received Herpes zoster (Shingrix) (batch number PY3VD, expiry date 25-SEP-2023) for prophylaxis.   On 13-NOV-2023, the patient received the 2nd dose of Shingrix. On 13-NOV-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: administration of an expired Shingrix dose to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 13-NOV-2023 The nurse called and reported regarding the administration of an expired Shingrix dose to the patient, which led to expired vaccine used. She reported that it was the second dose of the series.  The health care professional had asked what was the recommended interval between the expired dose and the repeated dose.  The reporter had consented to follow up.
Patient was given both Shingrex and Prevnar on 08/08/19. Patient is on Keppra due to stroke. Pharmacist on duty contacted patient's doctor to receive approval for immunizations to be given and approval was received. In the evening of 08/08/19, the patient had what appeared to be a mini seizure per the patient's wife. He shook once and turned his head to the right and appeared out of it for a few minutes then returned to baseline. Patient's wife then called 911 and had him transported to Hospital. At the hospital all values were normal and patient was release to go home. Patient's wife says he appears fine today. They have informed his doctor of the incident.
Nausea 3 weeks after injection; This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was unknown.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient asked can Shingrix give nausea 3 weeks after injection.
This case was reported by the father of a consumer and described the occurrence of leg giving out (weakness) in a 5-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included vitiligo. There were no concurrent medications. On 16 August 2011 at 15:30 the subject received 3rd dose of HAVRIX in the left arm. On 17 August 2011 (at 17:00), 1 day after vaccination with HAVRIX, the subject experienced leg giving out (weakness) (legs collapsing), screaming, loss of awareness (did not know what was going on) and vertigo. At the time of reporting the events were unresolved. The father commented that they were driving 30 miles per hour in the car and the subject thought the car was going very fast and that they were going 100 miles per hour.
w/in 5min of vax pt reported burning in chest area above breast;pt went back to work 30-40min p/vax c/o burning & heaviness in chest area;no SOB;BP 170/100, P88 R 20BP 150/99;chest pain;
Have not sought treatment. The bumps appeared 2 days after the vaccine and do not itch. They aren't getting worse but they also aren't getting better.
Modern a COVID-19 Vaccine EAU: Arm pain 4 hours after injection. Around 14 hours after injection, temperature of 99.9 degrees, and painful, almost tickling sensation all over body. Chills with chattering teeth, couldn?t relax, completely restless. Felt as though I wanted to jump out of my skin. Aches and pains moved throughout various locations of my body. As of the next morning (3/18/21 today), l have an elevated temperature and extreme fatigue. Used 600 mg of ibuprofen to sleep and for comfort. Still experiencing weakness/fatigue.
lump underneath the arm pit; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173; Expiration Date: 30Nov2021), via an unspecified route of administration in right arm on 17Sep2021 at 19:44 (at the age of 52 years old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive any additional vaccines on same date of the Pfizer suspect. She noticed early last week on 26Sep2021 a lump underneath the arm pit. She was aware from her doctors office it might be a side effect, she had a virtual visits on 14Sep2021 before getting the shot and was told that one of side effects that has been reported. She explained that prior to this, she remembered she had a small bump under her arm from her deodorant that comes and goes, it was a little lump in a certain location. It was noticed that he little lump she had before the shot disappeared or moved locations, to center of her arm pit. The lump from her deodorant was the size of a dime but the new one was the size of nickel. She was calling because she was supposed to take the second shot today and was wondering should she hold off on this second dose. The one, the lump, that was there previously, it went away about 3 days after the shot. Both lumps were in the opposite side the shot was given, in the left arm. She stated that her doctor told her that the lump was normal and was experienced by that person but went away. On 21Oct2021 she is to go to the doctor related to this. No family medical history relevant to adverse events was provided and no relevant tests were performed. The adverse event resulted in a visit to the physician office. The outcome of event was unknown.  Follow-Up (12Oct2021): Follow-up attempts are completed. No further information is expected.
Used the vial outside the recommended 12 hour vial puncture range; Vaccine opened and was left in refrigerator overnight; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Used the vial outside the recommended 12 hour vial puncture range) and PRODUCT STORAGE ERROR (Vaccine opened and was left in refrigerator overnight) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (Vaccine opened and was left in refrigerator overnight). On 19-Nov-2021 at 11:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Used the vial outside the recommended 12 hour vial puncture range). On 19-Nov-2021, PRODUCT STORAGE ERROR (Vaccine opened and was left in refrigerator overnight) had resolved. On 19-Nov-2021 at 11:00 AM, EXPIRED PRODUCT ADMINISTERED (Used the vial outside the recommended 12 hour vial puncture range) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information were not provided. The patient was given covid vaccine booster from vial that was expired by a couple of hours vial was refrigerated the whole time.
She develped pain on her left shoulder and it affects her daily life. It is hard for her to lift shoulder.  When she presses affected area she can feel pain also. Activity like changing clothes is a hard task for her because of shoulder pain. She has been taking OTC Ibuprofen but it didn't help much.
No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 14-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    Concomitant product use was not provided by the reporter.  On 10-Jun-2023, the vial was initially thawed.  On 14-Jun-2023, the vial was administered.  Treatment information was not provided.  This case contains information for the 12th patient out of 30 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live follow-up information received included Suspect details and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (patient 1)
Burning down (L) arm after receiving flu vaccine continues to have pain, especially in the morning after sleeping on arm. Declined treatment. Given high in arm.
stomach cramps x last couple of days 27JAN97 130AM vomiting several times until 430Am;4430AM-12noon vomit x 1, T100;
This child was adversely given two covid vaccinations. The incorrect vaccine was Pfizer Bivalent GK0928.
The following was reported to this writer: Guest reports compounded of heaviness of head and generalized tingling. Denies shortness of breath, chest pain. Guest reports history of anxiety, asthma, and allergic to CIPRO.
Rash on the injection site; Developed soreness [and a rash] on the injection site/had soreness; Some of the vaccine came out afterwards/a couple of drops came out; Some of the vaccine came out afterwards/couple of drops came out; This spontaneous case, initially received from a pharmacist on 03-Oct-2018, concerns a 66-year-old, elderly female patient.  The patient's current conditions included abnormal blood pressure and breathing problems (reported as medical history). The patient's concomitant medications included Norvasc (amlodipine besilate), lisinopril, metoprolol, simvastatin, isosorbide, Symbicort (budesonide, formoterol fumarate) and Ventolin (salbutamol) for unknown indications.  On 02-Oct-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: reported as 0.5 ml but few drops came out (explicitly coded as injection site leaking), route of administration: intramuscular, anatomical location: deltoid, batch number: 01944611A and expiry date: 24-May-2019] (explicitly coded as incomplete dose administered) for active immunization against influenza.  On the same day (reported as the end of the day), the patient developed soreness and rash on the injection site. The patient used Tylenol (paracetamol) and applied ice packs as treatment.  On an unspecified date in Oct-2018 (reported as after 3 or 4 days), the patient had recovered from the events.  The reporter assessed this case as non-serious.  Follow-up received from the pharmacist on 30-Oct-2018: Expiry date of the product was changed from 14-May-2019 to 24-May-2019 in the product tab. Treatment drug Tylenol was added in the product tab. Stop date (unspecified date in Oct-2018) was added and outcome of the events injection site rash and injection site pain was updated from not recovered to recovered in the event tab. Narrative was amended accordingly.; Reporter's Comments: A 66-year-old, female patient developed soreness and a rash on the injection site, on the same day after administration of an incomplete dose of the suspect vaccine Afluria Quadrivalent (incomplete dose administered) since a couple of drops of vaccine came out (injection site leaking). The company assessed the causality of the events injection site soreness and injection site rash as related due to plausible temporal relationship between the events and suspect vaccine. The company assessed the causality of the events incomplete dose administered and injection site leaking as not related, considering the events as accidental nature of the events.
Presented to ED w c/o body aches, fever & chills; chest xray showed not acute findings but pt tested COVID-19+; tx w/O2, abx, steroids & zinc; dc'd home on RA
My whole right side is numb. My lips, gums, everything I?ve lost feeling. I also have cold chills and fever (unknown temp) and headache.
This is a spontaneous report from a contactable nurse via a Pfizer Vaccines Sales Representative. A 65 years old female patient received PREVNAR 13 at single dose on unknown date. Medical history and concomitant medications were not provided. On an unspecified date the patient's arm swelled up really bad, like real bad cellulitis and it was bright red, really red, and it was all the way around the arm. The events occurred after the patient got the vaccine shot and they did not get better after she received antibiotics. The events were not resolved at the time of the report.
Severe Headache Random Severe Muscle Pain Fatigue Joint Pain Chills/Feverish Minor Disorientation
Heavy menstrual cycle after second dose in April & again in May 2021.  June 2021 was normal. July cycle was very short. Have not menstruated since July.
Pain, swelling, induration 4x2 cm after receiving DTaP, Prevnar IM and MMR S.Q. in Right Thigh.
My daughter had bad reaction after Covid vaccination 2 and Miralax which both contain PEG. She has severe insomnia, rage, confusion, OCD and severe constipation. She has had multiple ER visits, admission to Hospital and countless doctor visits. Our daughter is suffering and we don't know how to fix her.