chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling bad; COVID-19; This spontaneous case was retrieved on 26-Jan-2023 from Reporting System (reference number: 2554876-1), reported by other healthcare professional and concerned a 73-year-old, female patient.  The patient's medical history was not reported. The patient's concomitant medications included Lipitor (atorvastatin calcium), used for an unreported indication.  On 08-Oct-2022, the patient was vaccinated with Afluria Quadrivalent vaccine (influenza vaccine inact split 4v; dose: as reported 'one,' route of administration: injection (SYR), anatomical location: left arm and indication: not reported). The batch number was 346336. The reported batch number was identified by Seqirus to be linked to the suspect product Fluad Quadrivalent (influenza vaccine inact sag 4v) instead of the reported suspect product Afluria Quadrivalent vaccine. Based on the reported batch number, the suspect product was changed to Fluad Quadrivalent.  On the same day, the patient was vaccinated with non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, Bivalent (tozinameran, riltozinameran; dose reported as 'five'; route of administration: injection (SYR); anatomical location: right arm; indication: not reported). The batch number reported was GH9703.  On 17-Dec-2022, two months and ten days after receiving Fluad Quadrivalent vaccine and non-company co-suspect Pfizer BioNTech COVID-19 vaccine, Bivalent, the patient contracted COVID-19 infection. The patient's home COVID-19 test came back positive.  On an unspecified date in Dec-2022, the patient called primary doctor, who prescribed Paxlovid (nirmatrelvir, ritonavir).  On 25-Dec-2022, reported as eight days after, the patient took another home COVID-19 test, which returned negative.  On an unspecified date, reported as a few days after the negative COVID-19 test, the patient started feeling bad again.  On an unspecified date, the patient's home COVID-19 test returned positive. Patient rested and was isolated.  On an unspecified date, the patient recovered from the events.   The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A 73-year-old female patient was vaccinated with Afluria Quadrivalent and with non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, on the same day. Two months and 10 days following vaccination, patient was tested positive for Covid-19. A few days after that, patient was feeling abnormal. Considering unsuggestive temporal relationship for the event feeling abnormal and biological implausibility for the event Covid-19, causality of the suspect vaccine is assessed as not related.; Sender's Comments: A 73-year-old female patient was vaccinated with Afluria Quadrivalent and with non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, on the same day. Two months and 10 days following vaccination, patient was tested positive for Covid-19. A few days after that, patient was feeling abnormal. Considering unsuggestive temporal relationship for the event feeling abnormal and biological implausibility for the event Covid-19, causality of the suspect vaccine is assessed as not related.
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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 05Mar2021 as dose 2, single (Lot number: EN6202), in left arm and on 05Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Colorectal cancer", start date: 2017 (unspecified if ongoing), notes: Other medical history: Colorectal cancer (surgery required but no chemo) 2017. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: I still have reoccurring symptoms in between days of no symptoms butI have not tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had been experiencing various Covid symptoms on and off since completing the paxlovid treatment (10 days). Patient completed the medication on 30Jun2022 and patient still had reoccurring symptoms in between days of no symptoms but had not tested positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Developed loose stools and fussiness next day after vaccines administered persisted for more than week.
The morning after (6/28) my 6/27 injection, I felt fine until about 10 a.m., when I started feeling extremely fatigued. My left upper arm was also sore, but I expected that. By noon I was having trouble sitting up because of fatigue. By 1 p.m., I ended my work day early because I was no longer able to sit up from fatigue. I was having stomach pains (not quite the same pains as from Gastroparesis or IBS) and nausea. I went to bed with cold chills. I slept a few hours. By 6 p.m. I was still freezing (it was 78 in the house) so I stayed in bed, but I was feeling better. I did not eat anything but a piece of toast, and went back to bed. I remained cold until about 1 a.m. (1 a.m. on 6/29) when I woke drenched in sweat, horribly nauseated, with a horrible headache. My body was bright red. My temperature was 101. I showered to cool off, took Ibuprofen, dressed in dry clothes, and returned to bed with an ice pack for my head. I fell back asleep. When I woke again at 7 a.m., the fever had broke and though I still felt tired, I felt "over it" and I was hungry. My left upper arm is still (mildly) sore today - 7/1 - and I expected that.
Anaphylaxis shock reaction w/biphasic allergic reaction 5 days reoccurring. Patient is a 13-year-old female with a history of tree nut and shrimp allergy and esophagitis, GERD, presented to Emergency Department with worsening of her hives. She started about 2 days ago having some itching. She then had appearance of her hives at 2:00 p.m. on June 4th where she was seen at an urgent care, where she was given 10 mg IM dexamethasone and BENADRYL, epinephrine IM at 0.1 mg. She was then transported to ER where she received a bolus of normal saline and famotidine and discharged to home at 7:00 p.m. the night prior to coming in here with anaphylaxis. She woke up just prior to coming in with a lot of hives and itching and sensation of her sore throat coming back. Mom brought her here. She is also having chills, but otherwise no other symptoms. She denies any new foods. No new exposures. Mom states that she thinks it may be from a mosquito bite, but they are really not sure.
One month after finishing the COVID vaccine my cycle changed.  My periods have been 23-25 days long for over 10 years.  Since the covid vaccine my cycles have been 40 days, 24 days, 30 days, 17 days, 26 days, 16 days.  My cramps have been very heavy.   Additionally, around April I started have painful heart palpitations, dizziness, and chest pain  most days of the week.  At least once a week I feel like I am going to pass out from the palpitations.  They come on suddenly and then they are gone.
I began running a fever daily for over a month, my doctor ordered lab work. Elevated WBC along with elevated clotting factors causing my blood to be too thick. Put on antibiotics for 5 days. Symptoms seemed to clear and then came back a week later. Repeat labs done but when the doctor did not get the results fast enough she sent me to the ER and I was admitted with Sepsis, C-Diff, Colitis and Enteritis on 3/25/2022
severe body aches, fatigue, nausia, temperature 102.7, brain fog, virtigo
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administered in a 12-month-old male patient who received FLUARIX (batch number DH937, expiry date June 2015). On an unknown date, the patient received FLUARIX. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the appropriate age at vaccine administration was unknown. Additional information received: 12 months old given FLUARIX QIV.
Severe headache, nausea, vomiting (x2), hives on the Right inner upper arm/axilla, malaise.
Fever of 102.5 degrees F, muscle ache, soreness, swelling of left arm, flu-like symptoms.
Felt like I had the flu, sleepiness body aches ,fever 101.3-101.5,  Started on 2-10-2021 lasted through till 2-12-2021
Pt experienced prolonged pain, swelling, redness, hot to touch, in her left arm at injection site. Pt states pain radiates up to her shoulder and neck and under her axilla. Pt went to ER 4 day after the shot. Pain still persists today. Treated with Keflex and Motrin.
Appt. with orthopedic physician on 9/28/11 for c/o (L) knee pain. Referred by primary physician at well child exam 9/26/11. While at orthopedics a small bruise (smaller than penny) was noted. Within an hour in the office the bruise expanded to 5cm. in size, indurated & painful. Ortho sent pt. to ER to r/o coagulopathy.
Racing mind; accelerated heart rate; outbursts of uncontrollable screaming and anger; trouble staying in one place as if I couldn't control my own body movements; severe anxiety with desire to escape. None of these symptoms had been experienced in my past. The events looped in cycles for approximately 5-6 hours. Thought I might be losing my mind. No treatment or medical attention given other than having friends watch over me, and forcing myself to drink plenty of fluids. Outcome: back to normal the next day.
pt recv vax JAN99 & 2 days post vax pt devel a fever & diarrhea;pt recovered;
Ten minutes after injection patient developed hives on bilateral arms, chest, and upper back. Patient complained of tingling on her lips and in her mouth. Nurse performed assessment and observed hives. MD informed and MD performed assessment. Benadryl 25mg IM ordered x1. Pt stated she was still itchy and takes extra strength Claratin when she normally breaks on in hives. MD referred patient to allergist for further testing.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The pharmacist reported about the administration of expired moderna vaccine that was given as booster shot to patient. The vaccines was stored in freezer, which was taken out one to two vials and place in fridge each day as needed.  No treatment was given on the patient.
3/22 When administered shot body felt a little warm 3/24  Burning pain like a yeast infection or bladder infection. Treated at urgent care for a yeast infection 3/25 Woke up with a fever and a rash on my back and chest 3/27 Right side of face was droopy 3/28 Right side of face felt numb, more swollen, droopy, and tingly went to the doctor immediately as worried about Bell's Palsy or worse case a stroke
metallic taste in my mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Feb2021 13:00 (Lot number: EN6202) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: Diagnosed 20-25 years ago; "smoker" (unspecified if ongoing), notes: He states he is not smoking, it has been about 5 months now. Has history of smoking 40 to 45 years. Concomitant medication(s) included: HUMALOG taken for diabetes mellitus; METFORMIN taken for diabetes mellitus; NIFEDIPINE; EDARBYCLOR; ACEBUTOLOL; ATORVASTATIN taken for blood cholesterol increased. The following information was reported: DYSGEUSIA (non-serious) with onset 27Feb2021, outcome "not recovered", described as "metallic taste in my mouth". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The day patient took the first dose he had a metallic taste in his mouth. He had a nasty taste in his mouth. It was still there. None of the serious stuff started happening until after 2nd dose. He had been able to walk and jog 2 -3 miles a day. The patient was Diabetic and had high blood pressure and was taking medication for that. He was also overweight. He stated they bounce his dose of high blood pressure medication around depending on his readings. The patient was taking metformin in the last 12 years. Humalog use was depended on his work if he can eat small meals working 12-16 hours. He may check 7 time a day and sometimes 3 days. Started 12 years. Nifedipine started over 10 years for High blood pressure. Patient was taking Edarbyclor for at least 12 years for high blood pressure Acebutolol was started 10-12 years ago. Atorvastatin was taking for 12 years. His Cholesterol has been like 114 for 3 years, so he dis not know why they still have him on it. No other Vaccines were administered on same date of the Pfizer Suspect. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
The next day, he developed a fever on 6/26/2022 that continued until 6/27/2022. His fever got up to 101.8 at the highest. On 6/27/2022, he developed a rash that was in a couple of spots on his body. The rash progressed and spread all over. The rash was red with small botchy circles but not raised. On 6/29/2022 we took him to the doctor. The rash was worse on his stomach that looked like Rosacea but it looked different than on his face that looked more like hives. Today his rash looks better and it is resolving. He has also had Diarrhea since 6/26/2022 that has resolved today. The doctor did do a COVID-19 test that was negative.
Awoke about 3 AM with nausea.  No retching or vomiting.  Mild nausea/queasiness persists now (11 AM).   Fatigue, but not sure if primary reaction to Shingrix or due to being awake intermittently with nausea.  Also arm swelling and soreness at injection site but these aren't severe.
Admin May 16, 2011. Pt. called pharmacy on 5/25/2011 complaining that injection site still has a rash, redness & sore at the site. Told to call her physician.
Pain and bruising in the back between shoulder blades and across the ribs reported by patient.  Advised them to contact their doctor since this is not a reaction in the VIS. No reaction to first dose in series.
First symptom was feeling of globus in her throat along with fatigue. Then she started having sensation of heat and dryness in the eyes, which later became bloodshot, and then headache and fever, which alternated between feeling hot and having chills, and excessive fatigue and hypersomnolence. She had blurriness of vision which has not completely resolved. The sublingual frenulum was swollen and tender. She is still having headaches, blurry vision, and swelling of the sublingual frenulum, nasal congestion, and cough today (day 3) but fever/chills/excessive sleepiness, and heat sensation in the eyes (but not the dryness) have resolved.
PROQUAD being administered after an excursion that occurred on 4/25/2022; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 27-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) subcutaneous injection, 0.5 ml, lot #U029319, expiration date: 19-MAR-2023 (anatomical location and route of administration were not provided) for prophylaxis, after the vaccine undergone temperature excursion in -2 Celsius degrees (C) for 1 hour and 12 minutes on 25-APR-2022 (Product storage error). Previous temperature excursions were as follows: -10 C up to 8 C (7.3C) for 2 hours 37 minutes 0 seconds, and -10 C up to 8 C (0.7C) for 2 hours 56 minutes 0 seconds.
Redness, swelling and  warmth to Rt deltoid down to Rt elbow. Pt afebrile.
Initial misuse report received from a health care professional on 18 October 2013. The cases were received on 21 March 2014 at GPV. A female patient, received FLUZONE ID. (No other information was provided regarding the patient). IT was reported that the patient used the forearm because the product is intradermal. No adverse event was reported. List of documents held by sender: none
I have very served chills.  I had a headache.  I had served fatigue.  My vision was blurry.  At first, I had some abdomen pain, and I could not eat food.  These symptom for about 3 days.  I went to see my doctor on the Oct 15th.   They did Covid-19, negative.  They did blood test.  They said I had acute kidney injury.  That I should got to the ER.   There they did confirm that I had an acute kidney injury.   They did test for inflammation.  They did blood work as well.  I was hospitalized for a week. I had a CT scan of my head.  I also had an ultra sound of my head as well as a templar biopsy.
Vaccine ordered was Hep B - Hep A was given. Not discovered until entering into WIR that wrong vaccine given and mom called that night to state patient had a fever; then vomiting and diarrhea and "drowsy" for next 3 days.
This spontaneous report was received from a healthcare worker refers to a 47 or 48 year old male patient. The patient current conditions included HIV positive. The reporter stated that on an unknown date, the patient who was 47 or 48 years old was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). No adverse events were reported. No further information was provided. Additional information has been requested.
chest congestion; bother in the throat, at the bottom, me raspa; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported she was feeling chest congestion and "bother in the throat, at the bottom, me raspa". The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Moderna 2/10/21, 3/17/21, 11/32/21, 7/27/22. Positive on 7/29/22; deisolated 8-8, over 10 days
Bruising and swelling at the injection site, soreness in lymph nodes under left arm. Along with Fever/chills, headache, muscle aches, dizziness, and coughing phlegm.
Information has been received from a 72-year-old female retired nurse with high cholesterol, hypothyroidism, glaucoma, osteopenia and a dust allergy who "one year ago" in approximately November 2006, was vaccinated with a first dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included LIPITOR, SYNTHROID, XALATAN and ACTONEL.  In approximately November 2006, "one year ago", the patient experienced a red, hot, hard swollen area at the injection site.  No treatment was required.  No medical attention was sought.  No laboratory test were performed.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested. 03/26/2008 Follow-up information has been received from the physician's office indicating that the patient is a 71-year-old (previously reported as a 72-year-old) with an allergy to indomethacin sodium (manufacturer unknown) (WAES# 0712USA02496) who was vaccinated on 25-AUG-2006 at 10:30 AM in the right deltoid with ZOSTAVAX (Oka/Merck) (lot# 652966/0722F). There was no illness at the time of  vaccination. On 25-AUG-2006 the patient's arm became swollen, hot, hard and red which locally lasted about 1 week. Additional information has been requested.
SOB, THROAT TIGHTENING, HX OF PANIC ATTACK, TOOK XANAX PRIOR RECEIVING INJECTION, VSS, SX IMPROVED, REFUSED TRANSPORT
Information has been received from a registered nurse (R.N.) concerning an approximately 75 to 80 years old male patient who on an unspecified date was vaccinated with a single dose of ZOSTAVAX (Merck) (Lot number unknown). The nurse stated that on unspecified date the patient received ZOSTAVAX (Merck) and after receiving it he experienced shingles. On unspecified date, the patient recovered from shingles. The patient sought unspecified medical attention. No further information is available.
vaccine was mixed with bacteriostatic saline and administered to the patient, directed by CDC and pfizer to readminister.
Back pain, muscle aches, headache, abd. discomfort, upset stomach, chills, edema at site with redness, warmth, anorexia and insomnia. Had surgery scheduled for 4/25/2006 and was cancelled. Was started on Cephalexen 500 mg. twice daily for 10 days.
Reported to pharmacy several days after immunization with a large area of her arm swollen, red and painful. Her concern was that it was continuing to intensify over time.
I did not have an immediate reaction on the same. The next day I noticed red hives disperse on my torso: stomach, upper back, lower back, upper buttocks, legs, and penis. On Sunday, I got a burning red rash on my anterior arm, but it went away in a hour. By Wednesday, when I visited my doctor, the hives were not red, only a small dot was left.
Grape-sized deep nodule formed at injection site 5 days after HPV-9.
Contracted Covid 19. Symptoms began on 31Jul2022: painful headache, body aches, neck pain, congestion, cough.  Provided Paxlovid on 01Aug2022. Symptoms reduced over few days.
Patient experienced adverse  event after leaving clinic and arriving at home (mother estimated 30 minutes after vaccine. He had an itchy rash (widespread) that  appeared when they arrived  at home. Mother gave pt Benadryl which she  had  a home. Mother  did not  feel  that it was necessary to have rash checked.  No facial swelling, no difficulty breathing.  Mother described a patchy rash, did not have photo. Mother informed PCP of reaction when pt was seen again in clinic  for an unrelated concern 03/26/2021
16 Aug, 180 heart rate, my heart rate went up and shortness of breath, I was not go up and down the stairs. 17Aug2021 ER, showing sign of A-fib.
The patient with a past medical history of Hypertension presented 3 days after receiving the 2nd dose of Pfizer vaccine with chest pain. The patient initially received pain medication for symptom relief.  An echocardiogram showed a low normal ejection fraction. Cardiac MRI showed evidence of myocarditis. COVID antibodies were positive. RVP and Lyme panel for myocarditis negative. The patient received a total of 2g/Kg of IVIG over 2 days then was discharged on colchicine, ibuprofen, Aldactone, and lisinopril. In follow up appointment patient endorsed having gotten back to baseline activity and function