chrisvoncsefalvay/vaers-outcomes huggingface dataset:
drug ineffective; SARS-CoV-2 infection; Alopecia areata; This is a literature report.   A 29 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Aug2021, outcome "unknown", described as "drug ineffective"; COVID-19 (medically significant) with onset Aug2021, outcome "unknown", described as "SARS-CoV-2 infection"; ALOPECIA AREATA (non-serious) with onset Apr2021, outcome "unknown", described as "Alopecia areata". The patient underwent the following laboratory tests and procedures: anti-thyroid antibody: (2021) elevated; (2021) elevated. Therapeutic measures were taken as a result of alopecia areata with ILTAC.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2  to the reported drug ineffective/COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202200081166 same article, drug, different patient, event;US-PFIZER INC-202200081167 same article, drug, different patient, event;US-PFIZER INC-202200081168 same article, drug, different patient, event;US-PFIZER INC-202200081169 same article, drug, different patient, event;US-PFIZER INC-202200081170 same article, drug, different patient, event;US-PFIZER INC-202200081171 same article, different patient, drug, event;US-PFIZER INC-202200081172 same article, different patient, drug, event;US-PFIZER INC-202200081173 same article, different patient, drug, event;US-PFIZER INC-202200081174 same article, different patient, drug, event;US-PFIZER INC-202200081175 same article, different patient, drug, event;US-PFIZER INC-202200081176 same article, different patient, drug, event;US-PFIZER INC-202200081177 same article, different patient, drug, event
Patient received dose 1 of the Moderna COVID vaccine on 02/12/21. Patient received a dose of the Pfizer vaccine on 03/03/21. No adverse event occurred at the time of administration; this was an error where the patient received a different brand for their second dose 19 days after the first dose. Patient was observed for 15 minutes after administration and no adverse effects were noted.
For patients dosing series on moderna, she is immunocompromised and qualifies for 3 full doses and 1 booster. She was given 2 full doses and 2 boosters. Dose 3 she was eligible for a full dose and requested a half dose (booster), so for dose 4 she also received a booster/half dose which was discovered when we had trouble billing the claim.
15min p/vax pt exp a syncopal episode;@ that time pulse was 40 beats/min, thready, & irregular;pt was ashen, diaphoretic, & only sl responsive;20min later pulse was 80 beats/min & BP was 120/80;
On 17 Jan 2018 he received PNEUMOVAX 23 and several hours later noted onset of headache, dizziness, and blurred vision. He then developed fever to 102 F overnight; his symptoms (fever, blurred vision) persisted for the next 24 hours. He was seen in the ER on 18 Jan where he was treated with BENADRYL and Acetaminophen with resolution of his symptoms over the next several hours. He denies generalized cutaneous symptoms but notes pain/swelling at the injection site associated with localized redness and streaking which persisted for three days prior to resolving. No rhinoconjunctival, laryngeal, pulmonary, or GI symptoms.
Within a few hours of vaccintion, he experience low grade fever and myalgias. Next day, a pruritic maculopapular rash appeared over the trunk and extremities.
Pt was given shingrix 09/02/2022 and then today given shingrix #2 10/05/2022. This is too soon as it is reccommended to get it 2-6 months from your first dose.
Subsequent to receiving the second dose of varicella virus vaccine live the pt experienced a lack of response.
Was fine the day of the IZ, but became extremely active "could not sit still". He was running from room to room, unable to calm himself from the next afternoon at about 13:30 until about 20:00. He fell asleep at that time and woke up fine. Mother had felt that she had to almost restrain him, so he would not hurt himself.
Mar 8, 2022:   Ate a cookie that had walnuts in it around 12PM Tuesday. By 2PM, I started getting hives on my forearms. I thought it was a normal reaction I would have to eating a walnut, and didn't think it was serious. I took one Claritin when I got home around 6PM since I still had hives. By 10PM, the hives continued to spread and I took one dose of Benadryl before bed.   March 9, 2022:  Woke up with hives all over my body. I took another Benadryl, called off of work, and went to urgent care around 10AM. At urgent care, I was prescribed 50mg of Prednisone and to continue taking Benadryl every 6 hours. By 10PM at night, the hives continued to spread and was not getting better. My skin started to swell as the hives would last for the entirety of the day. At 10PM, I spoke with a doctor through Teladoc since my condition continued to worsen. I was prescribed Xyzal, an Epipen, and more Prednisone. Since it was late, I couldn't pick up any new medication.   March 10, 2022:  I scheduled an appointment with Dr. from ENT and Allergy. He recommend to continue the predinsone, and take a Zyrtec (Cetirizine 10 mg) once every 4-6 hours. My hives and swelling continued to persist through the day.  March 11, 2022:  I continue the medication and the hives still don't go away. By 6:30PM, my head begins to see some swelling. At 12:30AM, I start to feel my throat start to swell and close up. My throat would hurt while I drink water and try to swallow. At that point, I administered the Epipen into my thigh and called emergency. I was picked up by an ambulance and brought to Medical Center. At 2PM I was given Benadryl, Solumedrol, and fomatadine through an IV. Within 10 minutes, my hives began to go away. At 9AM, before checking out of the ER my hives started to reappear. I was administered another dose of Benadryl prior to being discharged.   March 12, 2022:   After being discharged, I called ENT and Allergy at 10AM to speak with my allergist. I was connected to the off-hours doctor and spoke with Dr. She stated she's been seeing multiple cases like mine due to the Moderna booster, and advised my current medication doses were not enough. I was advised to take: - 2 doses of zyrtec (20 mg cetirizine) every 4-6 hours -50 mg of prednisone once a day, morning - 50 mg of Hydroxyzine once a day before bed  With this medication dose, my hives were contained throughout the day and next  March 16, 2022:  I continued to take off work since the amount of medication would keep me drowsy throughout the day. I had a followup with Dr. this day, and she switched my medication routine to the following:  - 50 mg of Prednisone once a day - 1 Allegra & 1 Zyrtec - every 4-6 hours - Fomatadine 20mg - twice a day - 10 mg Montelukast - once before bed - 50 mg Doxepin - once before bed  This medication was able to contain my hives throughout the day. I would get hives or red marks on my body every 4-6 hours and would trigger me to take a dose of zyryec & allegra.   March 27, 2022:  Im continuing to take medication daily, but my doses are continuing to taper down. I still get red marks on my body, but taking an allegra will help minimize them through the day.
RASH RESEMBLING A SUN BURN; DIARRHEA; BODY ACHE; CHILLS; FEVER; ASTHMA; RESTLESS LEG SYNDROME; MIGRANE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with cortisone for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced asthma. On 08-MAR-2021, the subject experienced restless leg syndrome. On 08-MAR-2021, the subject experienced migrane. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced rash resembling a sun burn. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from asthma, and migrane on 08-MAR-2021, and restless leg syndrome, body ache, and fever on 09-MAR-2021, had not recovered from rash resembling a sun burn, and diarrhea, and the outcome of chills was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
The patient walked out of the vaccination room and around to sit in clinic just outside the pharmacy.  The patient then passed out.  d emergency staff was called by other staff members as we attended to him.  His wife stated after that he has a tendency to do this.  We gave him juice as he was coming to.  The staff took him to the emergency room at Medical Center.
Narrative: On 2/16, pt states he lost 60 % in left eye and 30% in right eye. Describes as mostly blurring of vision. Problem started on 2/11 after receiving the 2nd COVID vaccine dose. Vision loss worsened on 2/12 and has not improved since. He denies hx of vision problems, no HA, n/v or sinus or ear pain. Advised ptt hat he should be seen in the ER asap, esp, since the sx's started on Thursday  2/11.
Shortness of Breath; Urticaria; Bronchospasms; Flushing; redness; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot EN5318) via an unspecified route of administration in left arm on 09Mar2021 at 10:00 AM (at the age of 60-years-old) at single dose for COVID -19 immunisation. Medical history included systemic lupus, asthma, rheumatoid arthritis, thyroid cancer. She had allergies for antibiotics, pneumovax and morphine. She had taken other medications in two weeks. No other vaccine in four weeks was received. She experienced urticaria, bronchospasms, itchiness, shortness of breath, flushing/redness on 09Mar2021 at 10:15 AM. The adverse event was resulted in emergency room/department or urgent care. She was treated with IV fluids, benadryl, decadron and solumedrol. She did not have COVID prior vaccination and COVID tested post vaccination. Outcome of events was ecovering.  No follow-up attempts are possible. No further information was expected.
Fell off exam table and was shaking x 15-30 seconds. Then in elevator-passed out for 5 seconds.
I started having abdominal pain and bloating around 9 pm. Pain continued to worsen to the point I was throwing up. Took some gas x to see if that helped. It did not. Pain got so bad that I went to er.  They thought it was my appendix,  how ever CT showed my appendix was good.  I had and still have inflammation in my intestines and still have right side pain not sure if it is related to the vaccine or not
Initial information received on 12-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a two months old patient (gender not reported) who did not receive ACTHIB, while patient received a 0.5 mL 1 dose of PENTACEL in left leg on 03 July 2018. The patient's past medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included Pneumococcal Conjugate Vaccine for Immunisation; and Rotavirus Vaccine for Immunisation (on 03 July 2018). It was a case of actual medication error due to Inappropriate reconstitution technique. It was reported that Vial 1 had DTAP/TPA and Vial 2 had the ACTHIB. The nurse only gave the Diluent and did not constitute the medicine. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by sender: none.
Fatigue, night sweats. Symptoms have resolved. Took Ibuprofen at time of symptoms.
given using sterile diluent instead of the adjuvant included for use; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA946A, expiry date 31-JUL-2024) 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: given using sterile diluent instead of the adjuvant included for use) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-OCT-2023 The nurse reported that a Menveo vaccination was given using sterile diluent instead of the adjuvant included for use, which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered The reporter consented to follow up.
pt states she woke up w/ dry heaving, dehydration,  fast heart rate , sweating and headache.  Pt went to ER and called her PCP today.  Her symptoms have subsided with the exception of fast hear rate.
I had my 2nd COVID vaccine shot early May 2021! On 7Jun2021: I started having breakthrough bleeding, severe stomach upset/diarrhea. My last menstrual period started 25May2021, and have regular monthly period, every 4 weeks. Therefore, this is an unusual episode of bleeding.
Started having pain in my right cheek around bottom of my eye. Then pain that felt like lightening strikes in my cheek. The pain has traveled down to my lip and mouth. The pain is more intense as time goes by. It is now very hard to eat, brush my teeth, and talk without horrific pain. I saw my PCP and she sent me to the dentist. He did x-rays and told me my teeth and gums were not the problem. Went back to health center they thought it is trigeminal neuralgia. Waiting to see a neurologist on August 10th.
Redness at injection site; Swelling at injection site; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12th July 2022 Reporter's Comments: This case was reported via interactive digital media. The patient had redness and swelling at injection site the next day after the Shingles shot. The reporter stated that it matches with the common side effects of the vaccine. However, if someone was allergic to this vaccine, what symptoms would show. Additional Supportive Information: Follow up would not possible as no contact details were available.
Previously I had been able to remit my ataxia and essential tremor with a ketogenic diet. After the PNEUMOVAX 23 shot, my tremor and ataxia came back despite my adherence to the diet. I also suffered cognition lapses. I have terrible preexisting cognitive problems but after the vaccine I went to wash clothes and forgot to put the clothes in the washer. This was a worsening of my cognitive state. I could not think straight.
12/30/21 presents to Cardiology for "staged intervention to the OM and/or RCA". PMHx of "HTN, HLD, tobacco dependence and CAD"
Initial unsolicited report received from a pharmacist on 16-Nov-2017. This case involves a 72-year-old male patient who was vaccinated with 0.5 ml dose of ADACEL via intramuscularly (batch number, expiry date, dose series were not reported) in the left deltoid on an unknown day of Oct-2016. The patient medical history were not reported. Concomitant medication included vaccination with a dose of FLU VACCINE via intramuscularly in the right deltoid on an unknown day of Oct-2016  On an unknown day, following the vaccination, the patient experienced severe pain, which felt like an electric shock going through the left shoulder area through neck to the right shoulder, the pain lasted almost one year and then started to subside. It was a case of actual medication error due to inappropriate age at vaccine administration Lab test and corrective treatment were not reported. The outcome radiating pain was not 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.
Pink or red below inj site 11-9->11-13-15 hot/swollen. Less in color 11-14-15.
Constant headache. Onset within hours of receiving vaccine on 1/9/2021- intensity varies day to day however it has never resolved. OTC analgesics are little to no help.
Actually, since the 2nd Pfizer shot on April 14, 2022, same pharmacy location listed, I have had the longest and most painful gout attack ever. Until then I rarely had an attack, I also never needed to take Allopurinol regularly since it is not good for kidneys.  I had a severe gout attack from end of June to August 2022 in my right foot.  I thought the gout was progressing on its own.  Shortly after the most recent Oct. 2022 shot, November 3, 2022 for the very first time, I had the beginning of a wrist/hand gout attack. this is when I had to begin using Colchicine to stop the attack. This mostly worked and I only started taking Colchicine after the wrist/hand attack not prior to receiving the last vaccine. Since then, I now have lost almost all my strength in both wrists, hands. Simply Putting my hands together in prayer hands pose is extremely difficult.  My entire body feels compromised with arthritic pain throughout. I have never had such arthritic pains everywhere such as I do now.   Very rarely and occasionally I took OTC Tylenol and other OTC meds throughout the years. I don't care to take medication unless necessary.  Today, both wrists and hands have constant arthritic pain, my feet, not just my ankles have the same arthritic pain. I have not been taking any OTC. I have had to take and have been taking Colchicine doses almost weekly. I have read other online forums of people also claiming their gout was activated far more after getting the Pfizer vaccine. My mother also received the Pfizer most recent vaccine and she actually mentioned heightened arthritic pain in hands, feet and knees and shoulder.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site discolouration (injection site black and blue) and vaccination site rash (big red ring, rash like, below injection site, raised area but now is just red) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 007B21A) for COVID-19 immunization. Concomitant products included Prozac (fluoxetine hydrochloride) for an unknown indication. On Mar 22, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 23, 2021, patient experienced vaccination site discolouration (injection site black and blue) and vaccination site rash (big red ring, rash like, below injection site, raised area but now is just red). At the time of the report, vaccination site discolouration (injection site black and blue) and vaccination site rash (big red ring, rash like, below injection site, raised area but now is just red): unresolved. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. Other concomitant medicine: Vitamins.
Case number PHEH2015US024870 is an initial spontaneous report received from a consumer on 23 Nov 2015. This report refers to a patient whose identifiers were not reported. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515601) multi dose vial intramuscularly on an unknown date. It was reported that on an unknown date the patient was hospitalized and he was diagnosed with Guillain Barre syndrome. The patient was in the intensive care unit (ICU) at the time of reporting. The outcome of the event was unknown. The doctors believed that the event might have been caused by the flu shot. No further information was provided.
Woke up drenched in sweat (gown, hair, bed were all wet; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Woke up drenched in sweat (gown, hair, bed were all wet) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L209) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NIGHT SWEATS (Woke up drenched in sweat (gown, hair, bed were all wet). At the time of the report, NIGHT SWEATS (Woke up drenched in sweat (gown, hair, bed were all wet) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-062216 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: non significant follow up was received
Eyes started to film over after 4 hours, glands under my tongue started to swell, felt like I was hurting all over.  Showered, tyenol, went to bed.  During the night I woke and eyes crusted still, ached, headache, this morning somewhat better but hurt all over with a headache