chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen fingers; Mild headache; Site of injection started itching; Feeling lethargic; Joint pain in hips; Joint pain in her neck; Joint pain in finger; Feeling run down; Coughing; Tonsil area was hard like a rock; Restlessness; sore arm; Hot episodes; Flush episodes; Wakes up in the pool of sweat; Internally she is on fire; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESSNESS (Restlessness), TONSILLAR DISORDER (Tonsil area was hard like a rock), LETHARGY (Feeling lethargic), ARTHRALGIA (Joint pain in hips) and ARTHRALGIA (Joint pain in her neck) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced RESTLESSNESS (Restlessness), FEELING HOT (Hot episodes), FLUSHING (Flush episodes), HYPERHIDROSIS (Wakes up in the pool of sweat), FEELING HOT (Internally she is on fire) and VACCINATION SITE PAIN (sore arm). On 27-Mar-2021, the patient experienced TONSILLAR DISORDER (Tonsil area was hard like a rock). On 28-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling run down) and COUGH (Coughing). On 01-Apr-2021, the patient experienced LETHARGY (Feeling lethargic), ARTHRALGIA (Joint pain in hips), ARTHRALGIA (Joint pain in her neck), ARTHRALGIA (Joint pain in finger) and INJECTION SITE PRURITUS (Site of injection started itching). On 03-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen fingers) and HEADACHE (Mild headache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, RESTLESSNESS (Restlessness) and VACCINATION SITE PAIN (sore arm) had resolved and TONSILLAR DISORDER (Tonsil area was hard like a rock), LETHARGY (Feeling lethargic), ARTHRALGIA (Joint pain in hips), ARTHRALGIA (Joint pain in her neck), ARTHRALGIA (Joint pain in finger), PERIPHERAL SWELLING (Swollen fingers), FEELING HOT (Hot episodes), FLUSHING (Flush episodes), HYPERHIDROSIS (Wakes up in the pool of sweat), FEELING HOT (Internally she is on fire), FEELING ABNORMAL (Feeling run down), COUGH (Coughing), INJECTION SITE PRURITUS (Site of injection started itching) and HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included paracetamol and unspecified cough medicine.  Concomitant medications details were not reported by the reporter. The patient reported taking an antihistamine for her seasonal allergies as well.
Initial misuse report received from healthcare professional on 18 October 2013. A 03-year-7-month old patient received 0.25 ml dose of FLUZONE instead of 0.5 ml (no other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Wheeze, cough, SOB. Pt has egg white allergy but parent didn't note on FLUVAX form.
Immediately following shot, experienced itchiness and burning at injection site. Then numbness and tingling all down left arm and into hand experienced for 24 hours following injection, onset about 2 minutes after shot. Two days later, started to experience numbness, tingling, and weakness in left leg and foot from mid-thigh down on and off. Randomly experienced same sensation in all four limbs at different times and at the same time for a few minutes over the course of the next few days. For the following 2 weeks, continued to experience on and off numbness, tingling, and weakness in left leg and foot and occasionally in left arm. Left leg and arm (primarily foot and hand) numbness, tingling, and weakness increased and has not gone away since 1 week + 5 days post shot. Circulation in arm and leg affected by sleeping on right side (completely limp and numb). Somewhat restored to regular tingling sensation by sleeping on left side.
vaccine administered past published expiry date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered past published expiry date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered past published expiry date). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered past published expiry date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.
Pt reported "pins and needles" in chest and veins, itching, nausea, and feeling hot. Administered 20 mL of 12.5mg diphenhydramine 15-20 minutes post-admin. Pt reported he continued to feel worse, then vomited 5-10 minutes after administration of diphenhydramine. Checked BP after pt vomited, 160/100. He reports that his BP is usually not high. Advised for HR representative to call EMS. Update from HR representative states that pt reported swelling of throat upon arrival to hospital, but appears to be "settling down".
Prolonged high pitched crying spell x 25min. Marked swelling and erythema, tenderness of right upper thigh in 24 hrs of vaccination. No associated fever. Given Tylenol and cool compresses. Swelling was in the right thigh.
1/26/2021 Swollen hand/redness/painful . 1/27 Urgent care possible infection. Doxycycline HYC 100mg 1 capsule x2 for 10 days. Naproxen DR/EC 375 mg 1 tablet x2 for 7 days. On 2/5/21 hives all over and hitching ( see pictures). Allergist prescribed  Prednisone 5 mg 8 day for 3 days ( 2 Benadryl twice a day for 1 day) as of today 2/12/21 down to 2 prednisone a day until 2/14 21 and Zyrtec 10 mg at night. Going for testing 2/16/21 for test. Allergies, Lisinopril, shellfish containing products shrimp. Amlodipine Polyethylene Glycol, Analogues, Prevnar 13-Val,Xonj-Dip Cr (pf), Sulfa (Sulfonamide Antibiotics) Augmentin ( amoxicillin-pot-clavulanate) Azithrolycin, Bactrim (Sulfamethoxazole -Trimethoprim) Brimonidine- **not able to attach pictures
5 minutes after the injection, I began to feel a sense of panic. My eyes started to ?white out.? I felt extremely hot,  nauseous, and light headed.  I vomited after a few minutes. Paramedics took my vitals and stated that my blood pressure was very low,  in the 70s. I felt dizzy and nauseous for at least 30 minutes. Once I felt better, they gave me some Gatorade and I was able to go home. The next morning, I woke up with a sore neck, sore arm, headache, and slight chills.
Patient admitted to Hospital on 1/26/22 with COVID pneumoia and acute respiratory failure after 3 doses of Pfizer COVID vaccine on 10/1/21, 2/22/21, and 2/1/21
Arm was sore 9/28/12, on the evening. Noticed on 10/1/12, after he woke up, that his arm was swollen. Had itching on top of head & below ears on 10/1/12. Right hand swollen. He used iced pack & that reduced swelling.
Pt complained of numb feeling like NOVOCAIN on left side of face approximately 40 minutes after vaccination. Feeling went away by 6:40pm (2 hrs later).
Patient experienced chest pain, shortness of breath and diffuse body pain for 2 weeks following vaccination with Pfizer vaccine on 9/10/21. Seen in outside hospital ED on 9/21/21. No evidence of pulmonary embolism, deep vein thrombosis nor myocardial infarction.
The morning following COVID-19 vaccination, patient's right shoulder had swelling, generalized weakness and myalgia. Hospitalized for 2 days, received intravenous fluids and bedrest, and acetaminophen.  He was prostrate for 2 days.
Flu-like symptoms: body aches, shivering and shaking (unable to stop the shaking), headache, general malaise, tired, weak x 2 days, then improved symptoms on day 3, then felt better, although still a bit weak and tired from being so ill for 2-3 days.
This spontaneous report was received from a Licensed Practical Nurse refers to a 2 month old patient (gender unknown). On 24-OCT-2013, a 2 month old child was vaccinated with a dose of PROQUAD (merck) (lot#, expiry not reported) in error today (no product confusion discovered, just medication error). No adverse event reported. Additional information has been requested.
Dizziness, Headache, Fever, Fall, Difficult to open eyes, and Body-pain (allover).
3/22/2021   Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  rapid heart rate, tachycardic   Assessment : Time of assessment 1700. Alert and oriented.   Actions taken:  VS taken at 1700, BP- 132/79, P- 66, Gave water and crackers       Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for . minutes. Discharged home.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/22/2021  4:52 PM
any reports of vertigo after shingrix; This case was reported by a consumer via interactive digital media (Shingrix GSK Chatbot) and described the occurrence of vertigo in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was unknown.   It was unknown if the reporter considered the vertigo to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient asked, if GSK (GlaxoSmithKline) have any reports of vertigo after 1st Shingrix dose. GSK Note- since follow up is not possible, there is not way to know if patient had vertigo or was just enquiring. Case considered valid by considering worst case approach.
Case previously recorded as MA2009-3780. Initial case report received from a physician via MedCom, on 04 NOV 2009. A patient 3-year-old female was inadvertently vaccinated with 0.5 mL S-OIV FLUVIRIN (batch no. 1008136P) once i.m. on 04 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-007589.
Experienced nerve problems in lower back and left leg, extreme pain and burning, trouble walking for approx. 2 weeks. Had a routine physical performed November 28, 2021 and my PSA had elevated from 1.9 to 4.9. Had Eye exam in December and was sent to a specialist for signs of Glaucoma. Recently visited my urologist and tested PSA again and it returned to my normal range of 1.9. My eye doctor is currently having me use eye drops to treat possible normal -tension glaucoma. Will re examine in 4 months. I can not say for sure if these problems are side effects from the vaccine but it appears very suspicious to have this many issues within a short period after the shot. Several months after my second shot I also experienced Shingles. I am reporting these incidents because I recorded this information. I then received a call from them asking me about the issues and was asked to fill out this form.
This literature marketed report as obtained from a published literature article, refers to the clinical and serological response of 72 children and adolescents with recurrent upper respiratory tract infections and low antipneumococcal immunity. In this retrospective, descriptive study, the authors report the clinical and serological response to PPV23 (PNEUMOVAX) 23 in 72 patients older than 2 years, 62 percent of which (45 of 72) had received  PCV7 (PREVNAR 7). These patients were seen in the clinic with recurrent upper respiratory tract infections, mainly otitis media and rhinosinusitis, and had evidence of deficiency of pneumococcal antibodies with data over a follow-up period of at least 6 months. Institutional review board approval was obtained before the review of the patient data. Patients with 4 or more upper respiratory tract infections treated with antibiotics per year, 4 or more acute otitis media episodes treated with antibiotics per year or 2 or more episodes of sinusitis per year fulfilled the criteria for recurrent upper respiratory infections and were included in the study. All patients had a 12-14 serotype pneumococcal antibody panel drawn to assess their pneumococcal antibody status as part of the initial evaluation. The pneumococcal antibody titers for each of the serotypes were analyzed by the reference laboratory using the Multi-Analyte Immunodetection panel based on the Luminex flow cytometric system. The procedure included absorption of sera with cross-reactive polysaccharide C and serotype polysaccharide 22F. The antibody levels were considered protective if the specific IgG titer was > or equal to 1.3 microg/mL in at least 50% of the serotypes in children aged 2-5 years and in >70% of children aged 6 years and older. On the basis of these criteria, patients with non protective pneumococcal antibodies levels were given a dose of PNEUMOVAX 23. The vaccine (0.5mL) was applied intramuscularly in the anterolateral thigh for toddlers aged 24-35 months and in the deltoid muscle of the arm for children aged 3 years and older. Written parental consent for treatment was obtained before PPV23 administration. Clinical and serological responses to PPV23 were recorded in the 1- to 6-month interval after immunization. Overall, 69 patients (96%) had a positive clinical response to PPV23 with resolution of the upper respiratory infections in most cases, whereas only 3 patients (4%) had no clinical response. Four (5%) patients were given a booster of PPV23: 3 (4%) because of recurrence of the upper respiratory infections and loss of antibodies over time and 1 (1%) because of lack of clinical response with partial serology. Two patients (3%) were given intravenous IgG for 6 months because of lack of clinical and serological response to the PPV23 booster. Three (4%) other patients were given intravenous IgG after no clinical or serological responses to the first dose of PPV23 were observed. Outcome of 'no therapeutic response' was not reported. The authors considered 'no therapeutic response' to be related to therapy with PNEUMOVAX 23. Additional information has been requested.
On 03/20/21 a day after receiving 1st dose of Moderna, I woke up at around 8am with a dark bruise on the right outside corner of my bottom lip.  I checked it in the mirror and noticed a dark bruise inside the same area.  I also noticed some small boil like bumps on the same corner of my right bottom lip.  Also some sort of lesions inside of my mouth on the right cheek and inside the right side of the bottom lip and inside the bottom of the skin between my gums and bottom of bottom lip.  The next day 03/21/21 the bruises were gone, but the small bumps and lesions were still there and have been until the present.  I did not call my doctor or go to urgent care, because I got very sick to my stomach like stomach flu, and it takes forever to get through to make an appointment with the clinic and urgent care.  I was going to call for an appointment today,  but have had diahrrea  for the last week.  I also don't know what type of doctor to call for oral  type problems.  I was going to call my insurance company to ask them.  I have a great doctor, but I don't feel  like waiting on the phone to get through to my doctor or urgent care.  So haven't been seen by a doctor.
Wed 6/21 and Thurs, 6/22/06, our son wasn't himself. Friday 6/23, he woke up with a fever. his highest fever temp was 101.7. At 4:30 PM, he began convulsing, his eyes went back of his head and lips turned blue. Had been giving liquid and baths to reduce fever with Advil and Tylenol.
Woke up with headache, but it was manageable. While at work, I got chilled and couldn't get warm. About 12:00pm, I felt feverish and ended up leaving work early at 1:45pm. I checked my temperature when got home and was running a temp 102. By 5:00pm, my temp was up to 104, and it stayed there until 10:00am on 02/11/2011. By 5:00pm on 02/11/2011, my temp was down to 100.
Local reaction at site; redness, warmth, large wheal; Fever 101F; URI sx; Rx was 1000 ml NS, CXR; 650 mg Tylenol and 25 mg IV Benadryl.
mouth and tongue was swollen; mouth and tongue was swollen/swelling of tongue; Tongue has lost of taste; tongue is slimy; tongue when touched by a utensil, it is very painful; has a breakdown on the skin of the tongue/lips are tapping; Swelling of both lips; Entire underside of the tongue is inflamed; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (mouth and tongue was swollen), SWOLLEN TONGUE (mouth and tongue was swollen/swelling of tongue), AGEUSIA (Tongue has lost of taste), TONGUE COATED (tongue is slimy) and GLOSSODYNIA (tongue when touched by a utensil, it is very painful) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy (12 years agao). Concomitant products included FLECAINIDE ACETATE (TAMBOCOR), METOPROLOL, RIVAROXABAN (XARELTO), Probatozole, ACICLOVIR (CYCLOVIR) and VITAMINS NOS for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced AGEUSIA (Tongue has lost of taste), TONGUE COATED (tongue is slimy), GLOSSODYNIA (tongue when touched by a utensil, it is very painful), TONGUE DISORDER (has a breakdown on the skin of the tongue/lips are tapping), LIP SWELLING (Swelling of both lips) and GLOSSITIS (Entire underside of the tongue is inflamed). On 12-Feb-2021, the patient experienced MOUTH SWELLING (mouth and tongue was swollen) and SWOLLEN TONGUE (mouth and tongue was swollen/swelling of tongue). At the time of the report, MOUTH SWELLING (mouth and tongue was swollen), SWOLLEN TONGUE (mouth and tongue was swollen/swelling of tongue), AGEUSIA (Tongue has lost of taste), TONGUE COATED (tongue is slimy), GLOSSODYNIA (tongue when touched by a utensil, it is very painful), TONGUE DISORDER (has a breakdown on the skin of the tongue/lips are tapping), LIP SWELLING (Swelling of both lips) and GLOSSITIS (Entire underside of the tongue is inflamed) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient was Prescribed with  Dexofemidine 50 mg in the morning and Adorax 10mg after dinner that she is currently taking. Suggested was Dupsone, to be added with the other drugs she is currently on. patient also taking  Estradiol 1mg daily.   This case was linked to US-MODERNATX, INC.-MOD-2021-099506 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follo up case triaged on 30-APR-2021; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-099506:wife case
Received shingles vaccine and experienced agonizing breakouts; Agoonizing breakouts of shingles; Agonizing breakouts; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Received shingles vaccine and experienced agonizing breakouts) (serious criteria GSK medically significant), shingles (Verbatim: Agoonizing breakouts of shingles) and pain (Verbatim: Agonizing breakouts). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-MAR-2023 This case was reported by a patient friend via interactive digital media. The reporter reported that the patient never had shingles before received shingles vaccine. The reporter stated that the patient now have agonizing breakouts of shingles. The reporter stated that probably there was nothing to pay attention to here. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case had been linked with US2023AMR059715 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR059715:Same reporter
Pfizer Dose 1 2/12/21 (EN6201) Pfizer Dose 2 3/7/21 (EN6199) COVID Positive 1/7/22  1/7/22: 83-year-old lady presented hospital with history of increasing shortness of breath overnight.  Staff at nursing home noted that the patient was struggling with breathing, oxygen saturation dropped to 78.  She was put on 2 L and that improved and placed on CPAP.  The patient was transferred to the emergency department for further management. Apparently, patient tested positive for COVID last week and has not had any symptom until last evening.  In the emergency room, patient was noted to be desaturating.  Currently has been put on BiPAP, saturating 92% on BiPAP. Patient is a poor historian.  Her daughter reports that she is DNR, DNI, but has agreed that the patient is set up for BiPAP use.  The patient has a history of multiple myeloma, chronic anemia, and CKD.  1/13/22: An 83-year-old lady presented to the emergency room with history of increasing shortness of breath.  She had a history of multiple myeloma with severe __________ and severe malnutrition.  The patient's exam was suggestive of pneumonia, malnutrition, COVID-19 infection. Further lab workup revealed that the patient had bacteremia due to Enterococcus faecalis.  The patient's antibiotic therapy was adjusted.  She was on and off BiPAP.  Her oxygen saturation improved with BiPAP up to 2 L; however, she remained very deconditioned.  She required nutrition via TPN and p.r.n. by mouth.  The patient, unfortunately, overnight, suddenly aspirated, and respiratory status worsened.  She remained obtunded and unconscious following that episode.  After discussion with the family about the prognosis, family opted for comfort measures, that were initiated. The patient eventually passed away on January 13, 2022, at 1:10 p.m. the family members were at the bedside at time of passing.
Two red raised lump around both injection sites. Treatment was cold compresses. No chenge when left clinic.
12/01/2021 I had my vaccination 03/23/2022 I started to have cold like symptoms, burning in the sinuses. Developed into cough and fatigue.  04/06/2022 I tested COVID-19 NEGATIVE. I was sick for about 10 days.  04/07/2022 I went to see family.  04/09/2022 We traveled out of town to attend family function w/ about 20 people.  04/11/2022 COVID-19 POSITIVE  I had the lingering cough for 6-8 weeks.  Lots of fatigue and was unsure if it was related to COVID-19.