chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received the first dose on 12Nov2020 and has not received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th November 2020,batch number 2XG53, expiry date 12th February 2022).   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Pt called indicating large, itchy, red welt with heat size of her hand. RPh referred to MD to rule out infection or other. Pt says no time to see MD. Wanted RPh to suggest OTC. RPh suggested cold compress and MD follow-up.
Left arm swollen and itchy at injection site. She is diabetic. Now blood sugars are out of control. Has red area 3-4 inch diameter on arm. Used ice and ibuprofen.
problem with her breathing; wheezing; itching in her mouth and all over; itching in her mouth and all over; fine rash on her upper body; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing lupus erythematosus and ongoing sjogren's syndrome. Concomitant medications were not reported. The patient received her first dose of the Pfizer COVID-19 vaccine. She first had a problem with her breathing. Within a few minutes, she had itching in her mouth and all over. She had a fine rash on her upper body. She was itching and wheezing. She called to take her to the hospital. She was taken to the emergency room and administered 2 different intravenous medications. The doctor administered epinephrine injection. She was also given 50 mg oral diphenhydramine (BENADRYL). She was given an intravenous (IV) push of salmeterol, it's like famotidine (PEPCID). She clarified further it's like a form of prednisone. She also mentioned something else IV but did not know the name of it. The patient was also taking levosalbutamol hydrochloride (XOPENEX) as treatment. She was still having problems with itching. She was still really itchy. She asked when this stuff would clear out of her system. She had been taking diphenhydramine to calm down. She was constantly scratching. She took diphenhydramine and used her rescue inhaler. She had her inhaler, but she keeps itching. She carried an epinephrine (EPIPEN) and now she was having trouble with her breathing and she was trying to rest. Outcome of the rash and wheezing was unknown while of the remaining events was not recovered.  The following information on the batch number has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 6th October 2018, the patient received SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. In October 2018, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's spouse.  The arm where the patient got the injection was sore.
This spontaneous report was received from a medical assistant referring to multiple patients of unknown age. On an unknown date, multiple patients were vaccinated with M-M-R II lot # L011528, expiration date 03-APR-2017, that were improperly stored. No adverse effect was reported. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received bnt162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EW0162), on 29Apr2021 as dose 2, single (Lot number: EW0167) and on 13May2022 as dose 3 (booster), single (Lot number: FM9992) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "TBI" (unspecified if ongoing); "spinal cord injury" (unspecified if ongoing); "mild asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
First Jynneos dose on 30-Nov-2022, missed the second dose; Case reference number US-BN-2023-000132 is a spontaneous case report initially received from other health care professional via Communications (reference number: USBAV23-0138) on 24-Jan-2023 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 30-Nov-2022, the patient was vaccinated with the first dose of Jynneos vaccine (batch number: unknown), at an unknown dose, route or site of administration, for indication reported as monkeypox.  As reported, the patient missed the second dose (explicitly coded as 'incomplete course of vaccination').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccine.  Additional information received from Bavarian Nordic on 24-Jan-2023 included the local BN case ID.; Reporter's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos vaccine, at an unknown dose, route or site of administration, for indication reported as monkeypox. Reportedly, the patient missed the second dose, which is considered as incomplete course of vaccination. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos vaccine, at an unknown dose, route or site of administration, for indication reported as monkeypox. Reportedly, the patient missed the second dose, which is considered as incomplete course of vaccination. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Oct 27 2021  i got Bells Palsy  in my face right side that affected my right eye  I can't close I got medication : Prednisone 20 mg  Valacyclovit Hcl   Methylprednisolone 4mg for my eye  Retaine ointment  and drops  and  Thera tears  I visited cardiologist and Acupunture office too.
After many laboratory tests I was diagnosed with Gillian Barre with extreme weakness in both legs and slight weakness in the right hand.
erythematous patch over the vaccine site left upper arm - lateral posterior aspect no warmth; no tenderness; full range of motion
14 patients administered expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant were reported.  No treatment were reported.
Pain in the lymph nodes; swelling like bumps under her armpit in the same side of the injection, in the lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling like bumps under her armpit in the same side of the injection, in the lymph nodes) and LYMPH NODE PAIN (Pain in the lymph nodes) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced SWELLING (swelling like bumps under her armpit in the same side of the injection, in the lymph nodes). On an unknown date, the patient experienced LYMPH NODE PAIN (Pain in the lymph nodes). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, SWELLING (swelling like bumps under her armpit in the same side of the injection, in the lymph nodes) and LYMPH NODE PAIN (Pain in the lymph nodes) outcome was unknown.            No concomitant drug details were reported.   Reporter did not allow further contact
no reported adverse event,  parents told us patient was 12, however patient was 11 yr and 8 months upon first vaccination on 6/5/21 and subsequent second dose of 6/26/21
Within 10 minutes of vaccine administration patient became anxious with noted wheezing. Vitals signs at the time of the event were stable. Patient with continued hyperventilation and wheezing. Patient transferred to ER via EMS for further evaluation and treatment. Significant symptoms included anxiety, wheezing. NO symptoms of anaphylaxis (rash hives, throat swelling) noted during event.
Per patient's oral history, he experienced some typical muscle soreness characteristic of previous vaccinations on days 1-2 postvaccination. Vaccines were given 1 inch apart in the same deltoid. After initial day or 2, patient experienced some redness and swelling (more itchy than painful per his report) starting a few inches below the injection site and spreading downward and medially toward his bicep/inner elbow. He said thinking it may have been an insect bite he did apply OTC hydrocortisone to the initially reddened area (starting approx. 3-4 inches below the injection site). This area has cleared up but there is still some minor redness/puffiness on the patient's bicep proximal to the inner elbow. Patient also complains of some tingling in right fingertips, and depending on arm position occasionally escalates to "pins and needles" sensation. Upon assessment of initial injection site IM injections appear placed appropriately about 3 inches down from acromion process. Redness appeared distal to injection site according to patient's report. Visible erythema seems to have almost cleared up, but due to paresthesia side effect advised patient that if this symptom is unremitting after the weekend (4 days' time) to seek further care and follow up.
Red, swollen, skin hot, headache, fatigue. Onset was a week later and has gotten worse over the past 2 days.
Information has been received from a physician concerning a 14 year old female patient who was vaccinated with a first 0.5ml dose of Gardasil (Lot# 658490/0802U).  Concomitant therapy included MENACTRA.  After receiving the vaccine, the patient experienced dizziness and passed out for a couple of minutes.  Upon awakening, the patient experienced shaking.  Unspecified medical attention was sought.  Subsequently, the patient had recovered.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. Information has been received from a physician concerning a 14 year old white female patient with no medical history who was vaccinated into the left deltoid with a first 0.5ml dose of GARDASIL (Lot# 658090/0802U). Concomitant therapy included MENACTRA. After receiving the vaccine, the patient experienced dizziness and fell forward. She was caught by the medical assistant. It was reported that she "came to" within seconds and has no memory of the incident. Laboratory diagnostic studies included blood pressure measurements. The patient's initial blood pressure was 90/60, after having apple juice it was 110/60. On 06-AUG-2007, the patient recovered. No product quality complaint was involved. Additional information is not expected.
was administrated with an expired dose of Menveo; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva519a, expiry date 30th April 2022) for prophylaxis.   On 27th May 2022, the patient received Menveo. On 27th May 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 01-JUN-2022 Reporters comment: The patient was administrated with an expired dose of Menveo. The vaccine was expired on 30th April 2022.  No adverse event was reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up by fax.  Additional supportive information: The patient received expired dose of Menveo, which led to expired vaccine used.
the common warts on my hands disappeared; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "warts on my hands" (unspecified if ongoing), notes: disappeared, after 25 years and many different , attempts to get rid of them. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "the common warts on my hands disappeared".  Additional information: Clinical course: It was reported that two weeks after patient first covid vaccine, the common warts on patient hands disappeared, after 25 years and many different attempts to get rid of them.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Body ache/fever 4:00pm Friday- 2:00am Sunday. Left eye swelling  5:00pm Sunday- present.
Information has been received from a literature article title as stated above concerning a 27 year old female patient developed uveitis following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476 days); time to onset was unknown in 1 case; the time to onset in this case was 3 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested. A copy of the published article is attached as further documentation of the patients experience.
A physician reported that a 12 month old child received his second dose of Prevnar on an unspecified date. Subsequently, the child developed a blood culture positive to Streptococcus pneumoniae, serotype 19F. The child received the remaining doses and following the fifth dose, an IgG titer for Streptococcus pneumoniae, serotype 19F, returned a "particularly" low level. See HQ8996429NOV2001. FOLLOW-UP received on 01/25/02 indicates the vaccine was administered on 08/28/00. Concomitant vaccination included Hepatitis B (manufacturer unknown. The positive blood culture was obtained on 10/22/00 and a diagnosis of pneumococcal bactermia was made. the patient has since recovered. Upon receipt of follow - up information, this report has been upgraded to a serious report.
Left deltoid with swollen, erythematous area on immunization injection site with hard pain, indurated area.
pt recv vax;mom was holding pt when she apparently had s brief episode of cyanosis, hypotonia & apnea,lasting less than a min;then v & color returned to nl;fever up to 103 Ax;irritability lasted 1 wk;apap every 4 hr;
Patient complained of mild to moderate pain at injection site x2 days after vaccine administration. No other complications noted.  Patient perceived injection was given higher in the deltoid muscle and wanted to rule out SIRVA
Caller replied he knows it is causing strokes; Collapsed and is on a respirator; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant, life threatening), outcome "unknown", described as "Caller replied he knows it is causing strokes"; SYNCOPE (medically significant, life threatening), outcome "unknown", described as "Collapsed and is on a respirator". Therapeutic measures were taken as a result of cerebrovascular accident, syncope. Clinical course: Caller (Son) reported an adverse event with the Comirnaty. He talked about the vaccine having a direct link to strokes. He said he knew the vaccine caused strokes. He asked why it was causing strokes? Caller said that his father randomly collapsed in the morning and now was on a respirator. Caller stated that his father received Comirnaty vaccine (unclear timeline). Caller stated he was angry, asking how long does his father have left? He stated that his grandpa also received Comirnaty vaccine, he also stated that Comirnaty does not care too much about customer satisfaction. Patient was currently on a respirator at the moment. Caller was just calling to ask and wanted to speak to someone who made the vaccine or who worked on helping create the vaccine. The CDC was investigating Pfizer currently about how the COVID-19 vaccine has a direct correlation to strokes. He mentioned the documentary that speak about how thousands of people are dropping and it was a direct correlation to Pfizer's vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
hand issues like swelling and pain; hand issues like swelling and pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: covid-19 three times and had long cold symptoms . The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "hand issues like swelling and pain."  Additional information: The reporter had queried on behalf of someone that he tried to help with some of their medical stuff. He said he was not a doctor. He mentioned that someone had covid-19 three times and had long cold symptoms and the bivalent helped them to get rid of the symptoms. He said he suggested that to that person but after they took the bivalent six months or five months later, they got covid again and that person has hand issues like swelling and pain. He wanted to know if they could take the bivalent booster for the second time. Also, the reporter had a query about Paxlovid. He wanted to know if you could take that after you have covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148557 Same patient, samedrug, different event (split);
Patient admitted to hospital 5/15/2021 with acute toxic encephalopathy due to disseminated varicella zoster virus and acute hypercapneic respiratory failure.  Patient remains hospitalized as of date of this report.  Encephalopathy is resolving and patient has been extubated but remains on 4 liters of oxygen via nasal canula.
pt recv vax & that noc or the following day devel raised pimples @ the inj site;rash lasted 3-4 days;
Fifteen minutes after vaccination, I had stomach pain and gas. Felt faint  and sweat profusely. Then, that evening extreme pain in upper left shoulder, injection site. Low grade fever and chills.  Just felt bad and had fatigue. Feeling fine, other than left shoulder pain today, three days after vaccination.  No treatment required.
Had generalized redness, tenderness, pain at injection site. Next day, experienced fever, chills, nausea and diarrhea. Following day, lips and mouth broke out with approx. 15 large cold sores (fever blisters) many bleeding and painful. Took L-Lysine tabs and applied ABREVA as directed on pkg. Cold sores were painful and unsightly. Was unable to attend pre-planned events due to concerns. Took approx. 7-10 days for sores to heal. Have residual scarring on lips/mouth area. Contacted Pharm D who did vaccination with concerns. No info re: cold sores showed up. Looked at monograph as well as CDC website which provided no insight. Contacted my daughter, a Pharm D, and former drug information specialist who contacted her colleagues. No one was aware of any such reported reactions.
7hrs p/shot recd pt had sz, t100R; @ Hosp took 20 min to stop; Phenobarb given; @ that time EEG normal but not now;