chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB, lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9, lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a timeframe of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-year-old patient of unknown gender. On 26-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot number N023828 (expiration date 25-JUN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Inbound call from HCP stating that ROTATEQ and VAQTA may have been administered during and after a supported temp excursion.; No additional AE details; This spontaneous report was received from a medical assistant regarding an unknown number of patients of unknown age and gender. Their medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, improperly stored vaccine doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and hepatitis a vaccine, inactivated (VAQTA) underwent a temperature excursion of 50.2 degrees Fahrenheit (F) for about 8 hours and 30 minutes without previous excursions.  On a unknown date, the patients were vaccinated with improper storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #W011278, expiration date: 01-NOV-2023, lot #U037815, expiration date 28-MAY-2023, taken orally (dosage regimen, and route of administration were not provided) administered as prophylaxis; and hepatitis a vaccine, inactivated (VAQTA) lot #W002894, expiration date: 06-MAR-2023, lot #W006214, expiration date: 04-MAR-2023 (dosage regimen, anatomical location, and route of administration were not provided) administered as prophylaxis (Product storage error).   This is a non-valid report due to lack of patient's identifiers.
I really got sick; Had to go to bed because I was weak; Had the worst headache of my life; My back hurt something terrible; Was very sick to my stomach; Ached in every bone in my body; I felt like I had the worst case of flu; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced twice). Previously administered products included Shingrix with an associated reaction of malaise (1st dose received years before the date of reporting and was quite sick, for tolerance of 1st dose refer case US2019AMR170739).   On 16th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced sickness, weakness, headache, back pain, upset stomach, bone pain and influenza like illness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sickness, weakness, headache, back pain, upset stomach and bone pain were unknown and the outcome of the influenza like illness was recovered/resolved.   It was unknown if the reporter considered the sickness, weakness, headache, back pain, upset stomach, bone pain and influenza like illness to be related to Shingrix.  Additional details were provided as follows: The patient got sick after receiving the 2nd dose of Shingrix.  The patient was also weak, had the worst headache of life, back hurted terriblly. The patientI was very sick to the stomach and ached in every bone in the body. The patient's friends did not get sick and so the patient wondered. The patient thaught it could it be because had shingles twice and the friends never had, or it could be an allergy to the drugs in the vaccine. The patient was just curious about experiencing sick from the vaccine, and felt like had the worst case of flu that lasted 24 hrs. At the time of reporting, the patient was still  little weak yet.
After walking outside in the cold temp, my ears began to burn and itch. The next day my hand itched after cutting up Cauliflower. A couple days after that when leaving work my ears started to itch and burn again when it was really cold, the ear lobes swelled and became pitted where my earring holes are. My hand also itched at the same time. The symptoms never lasted more than 20 minutes and I did not take anything to help them resolve.
Within 30 seconds after getting the shot, I felt nauseous, dizzy, blurred vision and fainted. I was given water and told to lay down for 10 minutes. After 10 minutes.... no improvement. My vitals were monitored. After 20 minutes, no improvement --- still nauseous, lightheaded, dizzy. My arms and legs began to stiffen and within 40 minutes after the shot, I couldn't move my arms or legs. I was transported to two hospitals. After 10 hours not being able to move and physical exams, it was determined that I had Conversion Disorder as a result of "trauma" of the shot. The question is what's in the shot that caused me to faint and become so ill, that my brain shut my arms and legs down for 10 hours!
Initial symptoms was exhaustion and nausea around 12:00 pm. .  Headache, chills and trouble breathing followed.  Symptoms worsened as the day progressed.  I triggered a high heart rate alarm on my watch while sitting and dozing about 6:00 pm.   I ended up in bed at 6:30 that night and slept off and on with fever, chills, headache and throbbing arm pain until 7:00 am 4/9/2021.  I had to use my inhaler during the night to help breathe but do not remember the time.  The next day I was much better with the exception of tiredness, nausea and headache throughout most the day.  I have pretty much fully recovered on Saturday 4/10/2021 with only tiredness continuing to bother me as of the this report.  I am sleeping more than usual.        I did not notify the clinic of my reaction as they were closed over the weekend.
On 2/15 I begin to have chill, body aches, headache, fatigue and breast pains which continued into the next day.  I was again prescribed the same 7 day antibiotic and disagnosed again with Mastitis but this time the symptoms lasted a little longer and after about day 5 I began to feel myself again.  A mammogram and an ultrasound has been ordered to see why I developed the Mastitis so frequently but is not scheduled for another few weeks out from today.
Patient noticed her left deltoid area getting red and swollen sometime in the evening on 7/12/18. She called the pharmacy and spoke with the pharmacist at the time, who advised her to ice the area and monitor it closely. The patient did so and noticed the skin reaction getting worse over the following day (7/13/18). She then came into the pharmacy around 7:30 PM on 7/13/18 and spoke with the pharmacist. The area was noticeably swollen, hot to the touch, and very painful. The patient was given 2 BENADRYL tablets for home, was advised to trace the reaction area with a marker to monitor its progression, and was told to monitor it closely. She was also counseled on the signs of anaphylaxis and told to call 911/seek medical attention should the reaction get any worse. The pharmacy will follow up with the patient tomorrow to see how she is doing.
On the evening of the same day I received dose 4, Thursday morning, I began to feel a little bit warm and achy.  The next morning it was the same and I had a headache and no appetite.  I had flu like symptoms.  The following Saturday I thought I was better but was much worse.  Sunday I was aching and the headache lasted the whole time.  I took my blood pressure in my left arm and I got whelps on my arm.  I called the my nurse line and nurse said she thought they would go away.  My arm was real hot and itchy.  She thought I may have cellulitis.  She prescribed an doxycycline.  The whelps were about 3 inches long.  The next morning one whelp was still visible.  I was still fatigued but went to my doctor.  On Monday I took my doxycycline and after my nap I realized my face itched.  I had lumps and splotches all on the top of my head and face.  I went to Urgent Care and they determined it was not cellulitis and it was an allergic reaction to doxycycline.  I was given prednisone and had side effects to this drug as well.  I called Urgent Care again and was told my side effects were normal.
Face was very flushed; Face red and hot; Had rosacea but it was never inflamed.; Headache; Chills; Fever; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 23Mar2021 at 08:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included rosacea which was ongoing. The patient was allergic to swordfish. Concomitant medications included famotidine (PEPCID), levocetirizine dihydrochloride (XYZAL), alprazolam (XANAX), ascorbic acid (VITAMIN C), calcium (MANUFACTURER UNKNOWN) and K2-D2; all from an unknown date, for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 02Mar2021 at 16:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021, the patient experienced face was very flushed-red and hot for 48 hours almost immediately after received the shot. The patient had rosacea but it was never this inflamed (Condition aggravated). On 23Mar2021, the patient had a headache, chills and fever on the first night after the shot; felt fine the next day but that night again experienced chills and fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of these events. The clinical outcome of the events of rosacea condition aggravated, face flushed red and hot, headache, chills and fever were recovered on 25Mar2021, after the duration of 2 days.  No follow-up attempts are needed. No further information is expected.
41yo woman, concerned about adverse event(s) following immunization (AEFI), specifically related to influenza vaccine. Most recently dxd with GBS by Neurology and received IVIG as an inpatient 10-14 Oct 2014. GBS dx was temporally associated with receipt of LAIV (quadrivalent) on 30 Sep 2014; approximately 3 days later she developed tingling in hands and feet and increased (above baseline) paresthesia and pain in face, as well as progressively heavy feeling of weakness in back and legs. Dx was primarily based on symptoms, with 4/5 to 5/5 strength on all testing, and cytoalbuminic disassociation changes on CSF; no EMG was performed. She had partial clinical improvement with IVIG during hospitalization. Since return to work in late Oct 2014, she reports improvement in "perceived weakness", but she has continued burning pain and paresthesia in face and feet, dull pain in back and thighs, and extreme fatigue. She has been followed closely by Pain Clinic, and received >12 sphenopalatine ganglion blocks (via intranasal spray of bupivacaine and naloxone) with some relief.
Loss of breath to the point it became almost like an asthma attack; oxygen & epinepherin required;
Patient reported at 1235 tingling in her throat and small swelling of the tongue. Administered Benadryl IM to right deltoid. 1237 Vital signs: b/p: 126/82, p:54, R: 18, O2: 99%. Monitored for 30 minutes and patient did not report any other symptoms and stated her symptoms have lessened. Patient was driven home by her mother.
6 days after the first dose i've noticed swelling of lymph nodes. Supraclavicular lymph nodes are swollen and sore to touch as well as swollen lymph nodes under my left arm pit. The Calvicular lymph nodes is also located on the left side. The same as the injection point.
pt recvd vax; pt devel low grade fever; t 100.4 24 hrs after injection; pt exp headache; 4cm area of redness & tenderness w/ above systemic symptoms of headache & fever;
Thick skin peeling from left palm. Woke day 8 with joint pain, body aches, fatigue. Bruise pain still present at injection site.
inadvertently administered a Flulaval instead of Flaud; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 74-year-old female patient who received Flu Seasonal TIV (Flulaval) for prophylaxis.   On 27-SEP-2023, the patient received Flulaval. On 27-SEP-2023, an unknown time after receiving Flulaval, the patient experienced wrong vaccine administered (Verbatim: inadvertently administered a Flulaval instead of Flaud).  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: 29-SEP-2023 A practice manager called and inquired regarding any information on Flulaval and Fluad or on administering a high dose flu vaccine after Flulaval. The manager mentioned that the Physician ordered the patient to receive Fluad but the patient was inadvertently administered a Flulaval  instead which led to wrong vaccine administered. The reporter did not consent to follow up.
I got itchy rashes on my arms, hands, chest, face, feet, legs, then abdomen. Not at the injection site! Started on my opposite arm (right). I treated with benadryl every 6 hours and hydrocortisone cream as needed. Went to urgent care after no change on 5/6/21. concluded I had a allergic reaction. Prescribed Prednisone 10 mg, starting with 4 pills for 4 days, 3 pills for 4 days, 2 pills for 4 days, then 1 pill for 4 days. Also suggested to take antihistamines (I chose Loratadine 10mg once/day), benadryl to sleep, and calamine lotion for the rashes.  Rashes cleared about 2 days after, itching stopped after 1 day. Got my second shot while still on Prednisone.
Fever, 103°F controlled by fever-reducing medicines.  Fever continued for ~48 hours.
Minor hair loss; dose1, dose 2, dose 3: Moderna Dose 4: Comirnaty; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 29-year-old female patient received BNT162b2 (BNT162B2), on 15Jul2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 28 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure", start date: 15Oct2012 (ongoing), notes: Pertinent details: None; "Acute Psychosis" (unspecified if ongoing); "Altered mental status" (unspecified if ongoing); "Hallucinations" (unspecified if ongoing), notes: X 3 days. There were no concomitant medications. Vaccination history included: moderna (Dose: 1, Lot 046A21A), administration date: 24Mar2021, when the patient was 27-year-old, for COVID-19 immunization; moderna (Dose: 2, Lot 046A21A), administration date: 28Apr2021, when the patient was 27-year-old, for COVID-19 immunization; moderna (Dose: 3, Lot# 033F21A, Expiry date: 02Feb2022), administration date: 17Nov2021, when the patient was 28-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 15Jul2022, outcome "unknown", described as "dose1, dose 2, dose 3: Moderna Dose 4: Comirnaty"; ALOPECIA (non-serious), outcome "unknown", described as "Minor hair loss". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that patient did not received prior Vaccinations. Booster dose due to a weakened immune system. No specific relevant test for thromboembolic events with thrombocytopenia. Patient had first 3 Moderna vaccines without incident. Patient had minor hair loss after Pfizer vaccine on 15Jul2022. Technique was CT images acquired through the Head without contrast. Multiplanar reconstructions were performed. All CT scans are performed using dose optimization techniques as appropriate to the exam being performed. These techniques include automatic exposure control and/or standardized protocols utilizing dose matching according to exam type and patient size.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300098133 same reporter/patient/vaccine, different dose/AE.;
arm was red & swollen;in 2 days it extended from the armpit to the elbow;MD prescribed ceftin for 10 days & use of a heating pad;child back in school p/4 days as arm was fully recovered;
Pain in right arm, swollen lymph nodes by 6:30pm on 2/5/2021.  By the morning of 2/7/2021, rash on right and left arms, all over chest abdomen and back.
This is a spontaneous report from a contactable consumer (reporter's wife). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265), via an unspecified route of administration on 26Feb2021 (Friday) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On 28Feb2021 (on the following Sunday), the patient had a reaction to the shot and started hurting and she was still hurting 2 weeks later, she hurts in her shoulders, arms, and she just hurts all over. The patient can't touch her wrist, all pain down her shoulder and her arms. On 11Mar2021 (yesterday), the patient had a burning in her chest and said it was hard to get air. The patient had to fight to get a good deep breath. She was having trouble breathing and got the deep breath. It was reported that the patient needed to go someplace to get something done. Outcome of the events were unknown. No follow-up attempts are possible. No further information is expected.
She was not feeling well at first; felt sick day after injection; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number: not reported), dose 2 via an unspecified route of administration on an unspecified date as single and dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as single for covid-19 immunization. Medical history included endocarditis from an unknown date and unknown if ongoing endocarditis 8 years ago, diagnosed of Endocarditis specifically mitral valve prolapse, miscarriage from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was allergic to these antibiotic medications (Gentamycin and Vancomycin). She added that Amoxicillin did not help with her condition and diagnosed of Endocarditis specifically mitral valve prolapse. On an unspecified date, the patient was not feeling well at first and felt sick day after injection. The patient was not feeling well at first but was able to do normal activities and she was not feeling well at first. She mentioned that it's not that debilitating. She received the first and second dose of the vaccine and will be scheduled on 04Oct2021 to receive the third dose .Patient asking if the third dose (booster) is the same as the first and second dose of the Pfizer BioNTech (Comirnaty) vaccine. Clinical outcome of the event was reported as unknown.  The lot number for the vaccine was not provided and will be requested during follow up.
This spontaneous report as received from a nurse practitioner refers to 10 unspecified patients of unknown age and gender. The patient's pertinent medical history and drug reactions allergies were not reported. The nurse practitioner nurse reported that on unspecified dates, the patients received doses of improperly stored PROQUAD (Merck) (lot # K018142, exp. date 10-APR-2016). No concomitant therapies or adverse experiences were reported. No product quality complaint was involved. Additional information has been requested.
I am an EMT, working in an emergency department. Approximately 45 minutes after receiving the COVID-19 vaccine, the left side of my face turned numb with a tingling sensation. There was a heaviness when attempting to raise my left eyebrow and my left arm felt heavy. After consulting with a physician at work, they informed me they have not heard of this and it seems like a bells palsy reaction. This lasted for 4 days and on the 5th day, I am experiencing a severe migraine. This is not the kind of reaction I expected, and as a healthcare personnel, I am displeased and frightened to receive my second dose.
Approximately 36 hours subsequent to the vaccine, patient developed pain and swelling at the base of the neck/occipital region ipsilateral to where vaccination was given.
Pt developed itching to ears, face and throat a few minutes after injection. 50mg of benedryl injection given immediately at 1248. Reports no difficulty breathing. Improvement noted after benedryl given.
body aches, injection site pain, headache, "head congestion" & "flu-like" symptoms. Denies fever, chills. Taking ibuprofen as needed. Advised to continue to take ibuprofen or tylenol as needed and increase fluids. Follow up with PCP if symptoms do not resolve in next few days.
Information has been received from a physician concerning a 13-month old female with Marfan's syndrome, arthrogryposis and respiratory distress who on 28-Feb-2003, was vaccinated in the thigh with a dose of varicella virus vaccine live. Concomitant therapy included prednisolone (Prelone). The physician reported that on 04-Apr-2003, the patient develped a vesiculo-pustular chickenpox rash characterized by approximately 12-15 lesions on her trunk and back. It was noted that the patient had no recent exposure to shingles. On 07-Apr-2003, a scab specimen was obtained and was sent for laboratory testing on 08-Apr-2003. At the time of this report, the patient was being treated with acyclovir for the chickenpox rash and the outcome was unknown. Results of the PCR analysis revealed that the scab specimen contained the manufacturer vaccine-strain virus. No further information is available.
Received varivax on 3/30/98 through a previous MD. Dx'd with Herpes Zoster on 2/8/02.
hair loss continual (over a period of years)- a few weeks p/vax;final dx hepatitis;
48 hours after the shot began experiencing Vertigo and a dryness headache. 8 Days after the shot had a TIA and Stroke.