chrisvoncsefalvay/vaers-outcomes huggingface dataset:
solid part was mixed with one of Merck's diluents for varicella; incorrectly giving Menveo; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: solid part was mixed with one of Merck's diluents for varicella) and inappropriate dose of vaccine administered (Verbatim: incorrectly giving Menveo). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-JUN-2023 The physician reported that one of the staff members told that she recalls incorrectly giving Menveo where the solid part was mixed with one of Merck's diluents for varicella.  So the Menveo diluent was not used. Menveo reconstituted with one of Merck's diluents for varicella instead of the supplied CYW-135 liquid conjugate, which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. The reporter consented to follow up.
got sick from the 1st shot; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got so sick from the 1st shot. The pharmacy said most people did not get any side affects but the paperwork she gave me after he/she got it said 1 in 6 would people. The follow-up would not be possible as no contact details were available.
Extensive swelling of right arm with associated warmth, mild erythema; minimal pain at injection site.  Swelling noted about 48 hours after vaccination.  Temperature = 100.0F at time of presentation.  Well-appearing child;reassurance provided to family.
Hives formed near injection site on right arm. Larger area of hives formed on left arm. Hives formed on left lower abdomen. Hives formed on upper right thigh. Called 24 hour nurse line for advice at around 11:00 PM. Nurse recommended diphenhydramine. Patient instead treated hives with H1 antihistamine fexofenadine.
G62.9 PERIPHERAL NEUROPATHY 10/18/2022 ACUTE PULMONARY EMBOLISM I26.99 ACUTE PULMONARY EMBOLISM 10/18/2022 ACUTE PULMONARY EMBOLISM I95.9 HYPOTENSION 8/24/2022 ACUTE PULMONARY EMBOLISM J96.00 ACUTE RESPIRATORY FAILURE 11/22/2022 ACUTE PULMONARY EMBOLISM
This spontaneous report as received from a pharmacist refers to a 71 year old female patient. On 13-SEP-2014 the patient was vaccinated with ZOSTAVAX lot # K003601, subcutaneous. It was reported that in September 2014, the patient experienced that the injection site was swelling and there was a 1 to 1.5 inch long red streak over the injection site. There was no additional symptoms. The outcome of the event was reported as not recovered. Additional information has been requested.
interchange of vaccines; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 71-year-old male patient who received HAB (Twinrix) (batch number 2PG39, expiry date 19-SEP-2025) for prophylaxis.   Previously administered products included Havrix (on 2nd February 2023, received a dose.).   On 03-AUG-2023, the patient received Twinrix. On 03-AUG-2023, an unknown time after receiving Twinrix, the patient experienced wrong vaccine administered (Verbatim: interchange of vaccines).  The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 11-SEP-2023 The pharmacist reported a patient got a dose of Havrix on 02nd February 2023, then Twinrix was given 03rd August 2023. The vaccine administration facility was the same as primary reporter. The patient received Twinrix after Havrix, which led to wrong vaccine administration. The reporter did not consent to follow-up.
tongue numb on the end/her tongue is still numb, on the tip not even halfway up; tired; little chill; cold; couldn't swallow/she has always had a swallow problem but last night she could tell it was intense; achy, and neck feels achy; achy, and neck feels achy; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 2 via an unspecified route of administration on 19Jul2021 (Lot Number: EW0127) as a single for COVID-19 immunisation. Medical history included cardiac disorder from an unknown date and unknown if ongoing Caller stated that she is a heart patient, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine dose 1, (Lot number EW0186 expiry date was not reported) via unspecified route of administration at left arm on 28Jun2021 for COVID-19 immunisation. The patient did not received vaccination within 4 weeks. The patient took second dose of vaccine and at four in the morning she woke up. She was tired, a little chill and on the second shot she could not swallow, and her tongue was numb on the end. She took omeprazole for swallowing and she had always had a swallow problem but last night she could tell it was intense. She was suggested to take a Benadryl (diphenhydramine) 25 mg and it helped to get the swallowing down and her tongue was still numb, on the tip not even halfway up. It scared her. She called her doctor, and she was going in for an Epi (epinephrine) pen today just in case her tongue gest swollen. It was reported that for achy and neck pain the patient did not receive any treatment. Outcome of the events was Hypoesthesia oral, Chills, Dysphagia, Nasopharyngitis Unknown Fatigue, Neck pain and Pain was Not recovered.
They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medications details were reported.  Patient received vaccine at Pharmacy.  Beyond use date of the vaccine was 01-Jul-2021.  No treatment medications details were reported.  NDC number was reported as 80777-273-10.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up received wherein patient and vaccination details added. Case narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Chills; shaking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm right (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; TREMOR (non-serious), outcome "unknown", described as "shaking".  Additional information: Reporter mentioned some of her coworkers had side effects within 3 days   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HIP SWELLING; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease, lupus, ex smoker, non alcoholic, penicillin allergy, and coal tar product allergy, and other pre-existing medical conditions included patient had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 14:55 at right arm for prophylactic vaccination. Concomitant medications included meloxicam for right hip replacement surgery. On 13-MAR-2021, the subject experienced hip swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hip swelling. This report was non-serious.
Localized pain at injection on left arm site as expected. After a few hours the pain started to radiate from injection site down to my lower arm & fingers. I could not lift my arm due to severe pain, worse at injection site that seemed like into the shoulder socket. Fever resulted that reached 100.9 Used ALEVE for pain and fever, used ice for pain without much effect. Pain so severe that it limited the ability to sleep. During the next day, today, the pain has lessened an localized to the left shoulder joint and am able to use the arm sparingly. Contacted the Dr. office with information and was told "OK let us know if you need anything. I feel that the injection into the shoulder joint contributed to the adverse reaction, I have had plenty of injections but never on so high on my arm.
Initial non-serious report received from a health care professional on 06 November 2008. A four-year-old female patient received a left deltoid intramuscular injection of FLUZONE SV 2008-2009 on 30 September 2008 and since that time had been experiencing and "urticarial" appearance rash specifically known around the injection site only. In addition, the symptoms "itchy" was reported, however, it was not specified if this symptom was limited to the injection site. Specific onset date of symptoms was not reported. It was indicated that the rash had been coming and going since the patient was vaccinated. The patient had no further symptoms. The even required a visit to the doctors office. At the time of the report, the patient had not recovered. The patient had received the following vaccines on 29 August 2008: right deltoid injection of MMR (manufacturer no reported, lot number 0842X); right deltoid injection of VARICELLA (manufacturer not reported, lot number 0103X); left deltoid intramuscular injection of DAPTACEL (lot number C2957AA); left deltoid subcutaneous injection of IPOL (lot number A0491); and TB test to the left arm. Follow-up information was received 04 December 2008 from a health care professional. According to the reporter, the patient had no known illnesses at the time of vaccination and they had no prior reactions with the flu vaccine. Documents held by sender: None
she has mild COPD; Hidradenitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "cyst under armpit" (unspecified if ongoing), notes: Treated with erythromycin and injected with cortisone. The patient's concomitant medications were not reported. The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "she has mild COPD"; HIDRADENITIS (non-serious), outcome "unknown", described as "Hidradenitis". Therapeutic measures were taken as a result of chronic obstructive pulmonary disease, hidradenitis.  Additional Information: She had Hidradenitis 2 weeks ago and needed to be injected with Cortisone and a supply of Erythromycin. She is due to have her 2nd dose on 26Mar2021. If it persists again, she wants to know if the medications will have interference with the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient took first shot of Shingrix and was fatigued to the point of returning to bed.; This non-serious case was reported by a physician via sales rep and described the occurrence of fatigue in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fatigue (Verbatim: patient took first shot of Shingrix and was fatigued to the point of returning to bed.). The outcome of the fatigue was not reported.   It was unknown if the reporter considered the fatigue to be related to Shingrix.     It was unknown if the company considered the fatigue to be related to Shingrix.   Additional Information: GSK receipt date: 25-JUL-2023 The patient (physician) self-reported this case. The patient took first shot of Shingrix and was fatigued to the point of returning to bed.
"Covid arm"-redness,itchy-started 1 week after injection, last 5 days
Itching, swelling, redness at injection site.  Patient noted symptoms within a day or two.  Staff noted redness and swelling on 1/23/21 (10 days after injection). Evaluated in clinic on 1/28/21.  Felt to be either allergic response to vaccine or possibly resolving hematoma.  Treatment: Benadryl cream.
Headache for 3 days following shot on 1/23/17. MENACTRA given. (Had previously in 1984). Employee notified us of H/A on 1/30/17 when came to office for Tdap shot.
Product temperature excursion issue; Poor quality product administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported. No Adverse event was reported. The Suspect product was exposed at 34 degree Fahrenheit. Expiry date of suspect drug was 02-Jan-2022.
Severe headache, pain in face, increased heart rate, increase blood pressure, nausea vomiting, major bodyaches, stomach pain, tingling feeling throughout my body,  Outcome: Going to the emergency room
Patient stated Menstrual bleeding started 7 days after the vaccine and continued for 18 days. It stopped for 4 days then continued 7 more days.
Throat closing up; Hives; terrible allergic reaction; This spontaneous case was reported by a non-health professional and describes the occurrence of THROAT TIGHTNESS (Throat closing up), URTICARIA (Hives) and ALLERGY TO VACCINE (terrible allergic reaction) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced THROAT TIGHTNESS (Throat closing up), URTICARIA (Hives) and ALLERGY TO VACCINE (terrible allergic reaction). The patient was treated with EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, THROAT TIGHTNESS (Throat closing up), URTICARIA (Hives) and ALLERGY TO VACCINE (terrible allergic reaction) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used Benadryl as a Treatment Medication Patient used Another medication she has to take as a taper.
Pt. states she was freezing cold, reported a Fever.. did not take with a thermometer. Aching all over.Treatment: went to the After Hours clinic 11AM on saturday 4/2/2011. Given Benadryl and Tylenol and advised that her condition was a reaction to the pertussus inthe Tdap she had received 4/1/2011.
Initial side effects: Severe flu symptoms (body pain and stiffness, upset stomach, restless legs, fever, lack of appetite, extreme tiredness, upset stomach and loose bowels). Approximately 2 weeks after vaccine: Extremely heavy periods with clots. Periods lasting more than 14 days with clots, stopping and then 14 days later beginning again.
COVID-19 symptoms started 07/09/2022; tested positive 07/10/2022. It started out with severe sore throat and then I proceeded to have fever and chills. It moved into my sinuses and bronchioles and lasted 4-5 days. I could at least drink and other symptoms are in the process of clearing. The Doctor gave me steroids and cough medicine that had antihistamines and also a zpak. I had extreme fatigue for 4 days and it has progressively gotten better. I never sleep good and when I was sick I slept good, and last night I didn't sleep good so I know I'm getting better.
Her mother states that she developed a rash around the injection site. The rash continued to spread over the following days to the rest of her body. On 31 March she developed swelling in both arms at her elbows. Her mother states that it was at that time that she called the ambulance and was admitted to the hospital. Her mother states that she was given IV cortisone which made the rash and swelling go away.
Severe Lethargy, Muscle aches and pains constantly, Color Blindness to certain colors.  Failed the color dot test
Site: Itching at Injection Site-Medium, Additional Details: pt described itching of the left arm. given benadryl and stayed for 30 minutes.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 23-JUN-2015 the patient was vaccinated with ROTATEQ (dose was not reported, route of vaccination defaulted to oral, lot # K013661 with expiration date 26-MAY-2016) which was improperly stored. No adverse symptoms reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns a 38-year-old male patient. On 16-Oct-2018, the FLUCELVAX QIVc had underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805011) was cross-linked to the case: 201805002 due to the same reporter. Follow-up report received on 13-Nov-2018: The reporter refused to provide the patient's initials. The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The narrative and case comment was amended accordingly.
He is seeing his urine color as red after the vaccine. He is having the problem still today. Every time when he passes urine he sees the color red.; Dose 1: headache; This is a spontaneous report from a contactable consumer (patient, self-reported). A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0186 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 28May2021 at 6:45 pm -7 pm (age at vaccination: 35 years), as a single dose for COVID-19 immunization. The patient took covid 19 vaccine because everybody was getting the vaccine and he might go back to the office. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date in Jun2021, he was seeing his urine color as red after the vaccine. He was having the problem still today. Every time when he passes urine he sees the color red. The patient was not sure if what he was experiencing was a normal side effect of the vaccine. He hasn't seen his experience listed on the list, so he just wanted to check. The patient also stated that he has seen this before when he has had a beet root, but for the past two days he has never had a beet root. He had a headache 3 or 4 days before he received the second vaccine (Dose 1: headache). He took Tylenol for the headache. Headache occurred in the evening on Monday or Tuesday before the vaccine, he was not really sure. He stated maybe 6:14-6:15 pm for onset. Complete recovery the same day. Outcome of the events was recovered on an unspecified date in Jun2021.  Information on the lot/batch number has been requested.
Seen 4 days after vaccine with fever 101.4. Slight rash under chin for less then 24 hours that was gone by time of visit. Saw child for 18 month WCC and dad stated he saw staring spells and what he though could be seizure activity which has since resolved.
Patient received HPV vaccination and immediately felt faint, lost all color in his face, was clammy and began vomiting. This episode lasted nearly 25 minutes before he felt ok to leave the clinic. Patient was given apple juice.