chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchiness and weals all over body; little weal; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (little weal) and PRURITUS (itchiness and weals all over body) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced URTICARIA (little weal). On 15-May-2021, the patient experienced PRURITUS (itchiness and weals all over body). The patient was treated with CORTISONE (topical) on 14-May-2021 for Urticaria, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 15-May-2021 for Itching all over, at an unspecified dose and frequency. At the time of the report, URTICARIA (little weal) and PRURITUS (itchiness and weals all over body) outcome was unknown.            No concomitant medication information was reported. Patient received her first dose of Moderna Covid-19 vaccine either on 27-Mar-2021 or 27-Apr-2021 (patient got confused and did not make clear which month). Second dose was administered on 14-May-2021. Patient observed a little weal 3 hours after getting the second dose and applied topical cortisone At 3AM of 15-May-2021 patient woke up with itchiness and weal all over her body (arms, legs, stomach). Patient has taken Benadryl to treat symptoms.
Fever to 102.3. Fussiness, emesis, diarrhea & no URI signs. 4 wks later pt & brother had febrile illness with URI signs- resolved spontaneously.
This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a 72-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site warmth (hardness and soreness after receiving 1st dose in April 2018, refer case US2018132476). On 20th July 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site burning, injection site swelling and injection site itching. On 20th July 2018, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site burning, injection site swelling, injection site itching and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site burning, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: Four days before the reporting date, the patient received SHINGRIX subcutaneously on the backside of her left arm about 3 inches below her shoulder, which led to incorrect route of vaccination. The patient stated that the area at the injection and around it was swollen, itching and burning along the outer side of her arm and it was lasting longer than her previous site reactions. The patient stated that she knew it should have been given into the deltoid muscle, as was her first dose. The patient received injections at different pharmacies. The patient had not reported these events to her physician or this last concern of subcutaneous injection back to the pharmacy. The patient was concerned if she would need another injection. The patient had a concern if the subcutaneous injection of 2nd dose would be as effective as intramuscular injection of 1st dose. The patient was asking if she should receive another dose properly administered. The patient had been referred to her physician. She had provided contact details of the physician as well.
I developed mild h/a, nausea, & sore arm day of injection- h/a & sore arm resolved in 48 hrs. Mild, intermittent nausea has cont x13 days now, no vomiting. Also noted (day after jab) difficulty starting urine & mild pain in bladder area on urination for several days afterward. Increased anxiety, possibly b/c Moderna has refused to advise me on this reaction x3 calls now. I am not likely to take vax2, b/c now I am concerned this may be permanent and I refuse to make it any worse that it already is. I need to know if I can try the J&J vax, and if so, when should I get it?
p/recv vax pt dizziness, light headedness, nausea, headache, chills, sweats, & temp 102f. generalized joint & body aches/pains some severe. pt told had UTI & ? S.E. fr vax
This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Enability to eat), PYREXIA (High Fever), MYALGIA (Extreme muscle pain) and ARTHRALGIA (Extreme joint pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 041L20A) for COVID-19 vaccination. The patient's past medical history included Parvovirus B19 infection, Back surgery and Immunoglobulin therapy (IG treatment) since an unknown date. Concurrent medical conditions included Allergy, Sinusitis NOS, Mastocytosis (Mast cell disease), Hives, Back pain, Nerve pain, Allergy to antibiotic (Levaquin and Ceclor) and Drug allergy (Paxil). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Allergy, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Back pain, DOXEPIN for Hives, GABAPENTIN for Nerve pain. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced FEEDING DISORDER (Enability to eat), PYREXIA (High Fever), MYALGIA (Extreme muscle pain) and ARTHRALGIA (Extreme joint pain). On 10-Mar-2021, FEEDING DISORDER (Enability to eat), PYREXIA (High Fever), MYALGIA (Extreme muscle pain) and ARTHRALGIA (Extreme joint pain) had resolved.No treatment medication details were provided. This case was linked to MOD-2021-029464 (Patient Link).
Pt returned to her work area. At 1314 - Team member was taken to the ED. She reported feeling like her tongue was swelling, she attempted to each chips and felt like her throat was sore and needed to be cleared. Pt had a syncopal episode and c/o chest pressure, and difficulty swallowing (able to control secretions). Hives were noted to her face, neck & chest upon arrival to teh ED. At that time - pt reported feeling like her tongue started swelling 15 minutes after the vacciation. Pt was confused and "extremely" anxious. VS: 209/102, HR 125, RR 30 SaO2 96% r/a 1321 -diphenhydramine 25mg IV, pepcid 40mg IV and IV NS started VS: 159/105, HR 118, RR 31, SaO2 100% r/a 1322 -  epinephrine 0.3mg SQ, Solumedrol 125mg IV 1332 - Zofran 4mg IV  1351 - Ativan 1mg IV 1359 - 128/91, HR 100, RR 22, SaO2 99% 1411 - pt calm- redness improved. still c/o of feeling something in her throat. 1441 - Calm, asking for a drink - tolerated well.  BP 110/72, HR 82, RR 18, SaO2 98% 1635 - d/c orders written.
Patient received Pfizer COVID vaccine at clinic. About 15 minutes afterward developed swelling of right eye and whole body itchiness. Was given benadryl about 30-45 min after vaccine dose for these symptoms. She was then observed at the clinic. Epi given at about 1753 and patient was subsequently brought to Emergency department for further management. No breathing issues. No swelling of lips, tongue, mouth. No rash noted on body. No vomiting. Patient is otherwise healthy. Takes no medications. No food allergies or other known allergies. No recent fevers, rhinorrhea, cough, abdominal pain, dysuria, diarrhea. Patient received lidocaine under arm prior to vaccine injection. Family wondering if she could have touched the lidocaine and then touched her thigh. Had eye redness and itchiness with swelling initially.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0108214) for COVID-19 vaccination.     The patient's past medical history included Vertigo. Concomitant products included VENLAFAXINE, SIMVASTATIN and OMEPRAZOLE for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications included.
Extremely sore and swollen glands; Itchy throat; This is a spontaneous report received from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 12Mar2021 at 04:30 PM (at the age of 50-years-old) as a single dose for COVID-19 immunisation. No relevant medical history given. The patient reported of no known allergies. Concomitant medications include Magnesium (MANUFACTURER UNKNOWN), Levoxyl (MANUFACTURER UNKNOWN), Advil (MANUFACTURER UNKNOWN), Tylenol (MANUFACTURER UNKNOWN), Benedryl (MANUFACTURER UNKNOWN) for an unknown indication and unknown date. Patient had no symptoms associated with COVID-19 and not had a COVID-19 test. On 12Mar2021, the patient experienced itchy throat approximately 30-35 minutes after receiving the vaccination. On 14Mar2021, the patient experienced extremely sore and swollen glands on the back of neck. No treatment was received for the itchy throat and extremely sore and swollen glands. The clinical outcome of the event itchy throat & extremely sore and swollen glands was not recovered. Information about lot/batch number cannot be obtained. No further information is expected.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Near fainting episode. Pt did not lose consciousness but blacked out (visual disturbances, tinnitus/temporary hearing loss, nausea) occurred within 2-3 minutes of administration. First attempt to read BP was low (~80/60). Pt is an athlete, so I waited until after water was consumed to take BP again. 2nd reading was ~106/65. Pt felt better after drinking water and after sitting for 15 minutes under observation.
9 days after the vaccine, the injection site swelling; Injection site redness; injection site warmth; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN6207/EN6206, Expiry Date: Unknown) via an unspecified route of administration in left arm on 18Mar2021 at 19:30 (at the age of 30-year-old) as dose 1, single for COVID-19 vaccination. Medical history included asthma, COVID-19 and ADHD. Concomitant medications received within 2 weeks of vaccination included dexamfetamine saccharate, amfetamine sulfate, amfetamine aspartate (ADDERALL) for unknown indication on an unknown date, levocetirizine dihydrochloride (XYZAL) for unknown indication on an unknown date. Allergic to medications included CECLOR (MANUFACTURER UNKNOWN), BACTRIM (MANUFACTURER UNKNOWN) and AUGMENTIN (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 00:00, 9 days after the vaccination, the injection site swelling surface area had increased from the size of a golf ball. It was still red and still warm to the touch. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of vaccination site swelling, vaccination site erythema, vaccination site warmth was not recovered.   No follow up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's address added and Past drug event Augmentin was coded.
No additional adverse events; 16 year old female patient who weighs 154 pounds was administered an adult dose of VAQTA; This spontaneous report was received from a medical assistant and refers to a 16-year-old female patient. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided. On 27-JUL-2020, the adolescent patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) reported as vial but established as syringe upon lot validation (lot # S021729, expiration date: 20-AUG-2020) (exact dose, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S021729; expirationdate: 20-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Approx 30 min following administration of both FLULAVAL 0.5 ml IM and TUBERSOL pt developed a papular rash on his back. It has not spread in 24 hrs. It does get worse with heat and painful at times. So far managed adequately with Ibupofen and BENADRYL.
3 chronic illnesses: Interstitial Cystitis: showed symptoms immediately after vaccinations. Ehlers Danlos Syndrome: showed symptoms 5 months after vaccinations. Postural Orthostatic Tachycardia Syndrome: showed symptoms 5 months after vaccinations.
When cycle count was done it was determined the patient received a concentrated dose. The patient did not have any adverse side effects at the time or in the days after.
Approx 4 hrs p/immun w/Typhoid vax, pt exp dizziness, nausea, vomiting, & chills; Pt was treated in ER w/DPH & APAP; p/ 4 hrs of monitoring, was released;
Information has been received from a nurse concerning a 23 year old female patient who on unspecified dates was vaccinated with the first and the second of GARDASIL. On 22-JAN-2009 the patient was vaccinated with 0.5 ml of the third dose of GARDASIL (Lot not reported). There was no concomitant medication. On 23-JAN-2009 the patient experienced achiness and shaky. As of 23-JAN-2009 the patient outcome was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/13/2009. Follow up information was received from the licensed practical nurse who requested the report be disregarded since it was called in by mistake by the company representative. Additional information was received from the registered nurse who stated that she thought the patient received the vaccine at the original reporting doctor's office. The nurse stated she did not remember the patient's name or date of birth but she would be working in the other office on 11-Mar-2009 and would provide additional information if available. Further information is expected.
8 hours post-vaccination left arm (injection site) became sore and painful.  Over the course of the next 48 hours experienced fatigue, body muscle aches, intermittent low grade fever and chills, headache.  All side effects resolved within 3 days of vaccination with the exception of left arm symptoms.  At Day 5 following vaccination experienced increased swelling in upper arm, a light red rash along the entirety of the left arm, tenderness and soreness.  Rash and swelling resolved by Day 9 but pain and soreness in upper left arm persists.
Since my second shot April 10, 2021 my left arm at the site of the shot has ached so badly it keeps me up at night.  It is very painful.
lower HTN (160/98); This is a spontaneous report from a contactable other healthcare professional. A contactable other healthcare professional reported in response to HCP Letter sent in cross-referenced case.  A 65-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), via an intramuscular route of administration, in deltoid right on 28Jan2021 (at the age of 65-year-old) as single dose for COVID-19 immunization. The patient medical history included, first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, frequency (0.3cc) solution for injection, Batch/Lot Number: EH-9899), via an intramuscular route of administration in Lt Deltoid (Arm Left) on 23Dec2020; 15:48 as single dose for COVID-19 immunization. Patient's Medical History (including any illness at time of vaccination): None. Family Medical History Relevant to AE (s) includes, Father, HTN died ago 80 Lung cancer (Fire fighter), Sister: HTN. Concomitant medications included Losartan (MANUFACTURER UNKNOWN) taken for indication, suspected underlying HTN from 07Jan2021 and Continues. Most recent dose (daily dose and regimen including Formulation, Route, Frequency): 50mg PO (per oral) Daily; clonidine (MANUFACTURER UNKNOWN) taken for an unspecified indication from 28Jan2021 to an unspecified stop date.   On 28Jan2021 at 12:48 (15 min after admin), patient had low HTN (160/98) resolved with Clonidine at site. Adverse event required visit to the physician office, visit to Emergency Room was not required. Relevant Tests were None. The outcome of event was recovered.   Causal Relationship, a reasonable possibility that the event is related to suspect product/s was reported as Yes.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Hypertension cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
She looked in the mirror and it is really red; Throat is hurting a little; Headache; Knot on her neck; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 23Mar2021 13:40 (at the age of 71-year-old) (Lot Number: EP7534) as dose 1, single for COVID-19 immunization. Medical history included none. There were no concomitant medications. The patient did not have any vaccine within 4 weeks prior to COVID vaccine. The patient experienced knot on her neck, she has been squeezing it; it was really hurt, really bad on 24Mar2021 and had throat is hurting a little, headache on 26Mar2021. The patient looked in the mirror and it was really red on an unspecified date. The outcome of knot on her neck was not resolved and the outcome of other events was unknown. The patient is scheduled to get second dose of vaccine on 13Apr2021.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from the father of a 3 year old female patient. Concurrent conditions or pertinent medical history were not reported. On an unknown date, the patient was vaccinated with a second dose of VARIVAX (Merck) (dose, route of administration and frequency were not reported), 6 weeks after the first dose (dates were not specified). At the time of the report, no adverse effects were reported and it was stated that the patient did not die. Concomitant therapies were unknown. Additional information has been requested.
Information has been received from a certified medical assistant concerning a 6-month-old male with no medical history or allergies who on 06-AUG-2007 and 05-OCT-2007 (Lot #656845/0409U) was vaccinated PO with the first and second doses, respectively, of RotaTeq. There was no concomitant therapy. The CMA reported that on 05-OCT-2007, five minutes after receiving the second dose, the patient vomited. The patient was seen while still at the physician's office, recovered and was sent home. No laboratory/diagnostic tests were performed. Additional information has been requested.
Started as rash/itching on thighs, spread to legs and ankles.  By next day was developing on arms and hands and lumbar area. Patient took Benadryl and Claritin and used diphenhydramine cream. By 2 pm the next day the rash kept spreading and the itch was intolerable. What had appeared to be petechiae/purpura now looked more like hives on ankles and lower legs. Patient went to an urgent care and was given a steroid shot and prescribed hydrocortisone 1% ointment.
Fluzone high dose vaccine that was given to a 60 years old patient, no AE; Fluzone high dose vaccine that was given to a 60 years old patient, no AE; Initial information received on 21-Oct -2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 60 years old female  patient who received a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number: uj288aa, expiry date: 02-Jun-2020) via intramuscular route in the left  arm on 21-Oct-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the inappropriate age at vaccine administration and overdose.   At the time of reporting, the patient had no adverse event.  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.
Case completed covid vaccine series in APril 2021, then was hospitalized for treatment of Covid in October 2021
Within a minute of receiving shot I had numbness on the left side of my face near my cheek and mouth. A short time later less than 3 minutes I had difficulty swallowing. I also experienced a POUNDING heart. It felt as though it would pound out of my chest. It was VERY strong not like rapid but pounding so hard. The heart pounding and difficulty swallowing lasted less than 5 minutes. The facial numbness lasted a few hours.
She completed COVID vaccine on 03/16/2021.  8/4/21: She originally presented at an outside hospital on 8/1/21 and was transferred to another facility on 8/4/21. Her symptoms are nausea, diarrhea, weakness, and SOB. She noticed no improvement, and was hospitalized at the Hospital on 8/4/21. CTA chest shows diffuse bilateral infiltrates.  8/9/21: on BiPAP with 100% FiO2, completed 5 days of remdesivir, continuing steroids and baricitinib 8/17/21: on  HHFO 30L, desats on exertion, hypotensive episode upon sitting up 8/23/21: on heated high-flow, SOB persists, still admitted
RECEIVED THE VACCINE ON 07/21/2020 STARTED RUNNING A FEVER ON 07/24/2020 WAS SEEN IN OFFICE ON 07/31/2020 WITH FEVER AND RASH ON FACE, TORSO, AND BACK.  THE RASH WAS SMALL RED BUMPS