chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 3 (booster), single (Lot number: GJ2524) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: There were no known allergies reported. The patient did not receive other medication in 2 weeks. High cholesterol but patient did not take statin while on Paxlovid and had not taken any since stopping Paxlovid. Paxlovid, from 09Dec2022 to 14Dec2022, Paxlovid was given as antiviral treatment for COVID-19.
Patient was seen on 11/30/17 had a flu shot and PNEUMOVAX, on 11/30/17 patient started running a fever of 101 x 3 days. Also developed severe muscle aches mostly on left, joint pain in left hip, fatigue, tightness in chest toward left side, cough, hoarseness in voice, ear pain, headaches, nausea, and anorexia, but no diarrhea, and no difficulty swallowing, some lightheadedness but no syncope. Also some light and sound sensitivity. The cough, hoarseness persist. Muscle ache, joint pain improved but still has some in neck and head. Developed welts and rash at injection site, the rash spread to armpit about the size of a melon, but is decreasing today. No fever today. She noted swollen lymph nodes left axilla but not the right for about 2 days only, and some left breast pain and tenderness and swelling that has resolved.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 13-MAY-2014, the patient was inadvertently vaccinated with an expired dose of ROTATEQ, oral, (lot # not provided) expiry date: 01-APR-2014. Concomitant therapy was not reported. No adverse effects reported. It was reported that the expired vaccine was supported. Additional information has been requested.
a vial of powder was left on its own / patient had been given the partial dose; a vial of powder was left on its own / patient had been given the partial dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA396A, expiry date 31st August 2021) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided are as follows: The age at vaccination was not applicable for this report. The patient received partial dose of Menevo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. After administering 5 doses of Menveo, the reporter observed that a vial of powder was left on its own. At time of the call, the reporter did not know which patient had been given the partial dose, consequently no patient or vaccine information was specified. The reporter would investigate which patient was given the partial dose. The reporter consented to follow up.
Woke up with URQ pain would come and go, but pain was like a contraction. Ran low grade temperature during this course. Proceeded with ultra sound and Pipida scan to rule out gallbladder. Diagnosis serum sickness.
pt recvd vax; lt upper arm started swelling; applied hot compresses p/ taking to er;inc edema, pain; seen in er; skin was hot, swollen (size of a grapefruit)
Paresthesia in R/upper arm on 11/4/99, then 1 wk later, paresthesia & tingling in R/lower ext (thigh) down to toes, continuous.
1/11 vaccination 1/15 COVID - 1/18 I had a scheduled colonoscopy at 10AM. Close to 11AM, started IV sedation, put me on my side. I remember gagging and then i woke up. My chest was burning and they were talking to them, OZ mask because SPO2 had dropped to 48. They needed to monitor me longer, took to recovery, and put on bronchodilator (?) thru the O2 mask. They started and IV antibiotic for 90 minutes. SPO2 went back to 98. I went home, felt weak. The Dr said to take it easy next couple of days. Work stated to only come back when feeling normal. My husband tested for COVID 20th.  1/26 I tested COVID +.  I felt like it would be negative due to having both vaccines but it wasn't.
sore and swollen arm; sore and swollen arm; This is a spontaneous report from a non-contactable consumer (patient). A 41-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number EL9261; expiration date not reported), via an unspecified route (administered on right arm) at the age of 41-years-old on 22Jan2021 06:15 AM as single dose for COVID-19 immunization. Medical history included seasonal allergy and penicillin allergy both from unknown date and unknown if ongoing. Concomitant medication included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19 and didn't receive any other vaccines. The patient is not pregnant at the time of vaccination. The patient experienced sore and swollen arm on 23Jan2021. The events were reported as non-serious.  Since the vaccination the patient has not been tested positive for COVID-19. No treatment was received for the events. The outcome of the events was not recovered/resolved.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse practitioner and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M035693, expiration date 07-NOV-2017 (dose and route of administration were not reported). The ZOSTAVAX was reconstituted with properly stored diluent (lot number and expiration date were unknown). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 40 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA006889:
A report was received from a health care professional on 27 October 2003 concerning 3 vaccinees of unknown demography who experienced red, swollen arms an unspecified length of time after receiving Fluvirin vaccine on an unknown date. On an unknown date, the vaccinee's arms became red and swollen. The swelling ranged from the size of a golf ball to the size of a tennis ball. The outcome of the events was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200300897.
Fatigue; Headache; Shivering; Fever; Gastrointestinal symptoms; Burning during the injection; Stiffness in her right arm /  Arm was stiff in the muscle; This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2019-2020 season. In September 2019, immediately after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced injection site burning and limbs stiffness. On an unknown date, the patient experienced fatigue, headache, shivering, fever and gastrointestinal symptom nos. On an unknown date, the outcome of the injection site burning, fatigue, headache, shivering, fever and gastrointestinal symptom nos were unknown and the outcome of the limbs stiffness was not recovered/not resolved.   It was unknown if the reporter considered the injection site burning, limbs stiffness, fatigue, headache, shivering, fever and gastrointestinal symptom nos to be related to Shingrix. It was unknown if the reporter considered the fatigue, headache, shivering, fever and gastrointestinal symptom nos to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received the first dose of Shingrix five weeks ago in left arm and she experienced stiffness in her right arm and burning during the injection.  The day after the shot, her arm was stiff in the muscle.  The patient also reported that she received the flu shot in her left arm which was the senior flu shot on the same date.  The patient had concerned that she was still experiencing stiffness after 5 weeks and she wonders if it was because this was the first time she had received a shot in her right arm. The reporter consent to follow up.
Child had swelling at the vaccine site and also had some warmth to the skin.   Treated with Prednisolone and Benadryl
Period was two weeks later having both doses of Pfizer; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 21Apr2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. 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 Apr2021, the patient was expecting her period within a week after the second dose but she had her period which was two weeks later on 13May2021 (delayed period), after having both doses of Pfizer. The patient's cycle was of 28-33 days long and this one was 55 days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event delayed period was resolved on 13May2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a 43 years old female patient. On an unspecified date, the patient started therapy with M-M-R II (dose, route, lot not reported). On 17-MAR-2014 the patient was vaccinated with the expired, unspecified dose (dose number unknown) of M-M-R II (route not reported, lot # 671685/1873AA and expiration date: 30-NOV-2013). No adverse effect was reported. Additional information has been requested.
Redness around the vaccinated site aprox 2 cm erythematous patch visible. Skin intact localized inflamation. No tenderness, no fever, no systemic symptoms, no right arm pain, no SOB, no throat tightness, no palpitations. Member advised to go to ER if symptoms worsen.
Patient complained of extreme soreness that had a quick onset. She felt nothing during the injection, nor any soreness for the hours in between. She was not able to lift her arm above the waistline. She took naproxen and used a heating pad. The following day, she kept the arm moving and took more naproxen. She reported soreness, but not near as bad.
May 7 after shot arm sore and some swelling.  May 7 arm swollen and Erythema 4 inchs aprox.  May 8 arm swollen and " 4 inches aprox.  May 11 arm swollen from shoulder to elbow.  Pt took one day of steroids 50mg told to hold steroids and started on KEFLEX 500mg trd for ten days.
This spontaneous case, initially received on 29-Sep-2016, was reported by a health professional and concerns a 28-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 29-SEP-2016 to 29-SEP-2016. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT52005. No additional suspect drugs. Adverse event description: On 29-Sep-2016, the patient received a partial dose of AFLURIA because the plunger got stuck during the administration (special circumstances: medication error, underdose without adverse event).
Right after I received flu shot my are began to hurt.  Upper left shoulder VERY sore and painful.
thrombocytopenia; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of THROMBOCYTOPENIA (thrombocytopenia) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOCYTOPENIA (thrombocytopenia). At the time of the report, THROMBOCYTOPENIA (thrombocytopenia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Patient stated it has shortened the patient life in 20 years now.  Company comment- This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected non-serious AESI of Thrombocytopenia. The event occurred an unknown amount of time after an unspecified dose of mRNA-1273 vaccine. Manual override done to remove seriousness criteria of Medically significant from the event based on review of source document that did not include information supporting seriousness criteria. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected non-serious  of Thrombocytopenia. The event occurred an unknown amount of time after an unspecified dose of mRNA-1273 vaccine. Manual override done to remove seriousness criteria of Medically significant from the event based on review of source document that did not include information supporting seriousness criteria. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report was received from a nurse refers to an unspecified number of unspecified patients. On unspecified dates in 2014 the patients were vaccinated with doses of GARDASIL (lot #, expiration date, dose and route unspecified) which were exposed to a previous temperature excursion on 20-MAY-2014. The nurse was not aware of any adverse effects. This is one of several reports received from same source. Additional information has been requested.
Fever and muscle aches lasting until noon on Sunday 24Jan2021. Diarrhea beginning on 25Jan2021 at 1:00am and lasting until noon on 25Jan2021.
I experienced an immediate (within 1 minute) one sided facial numbness after the shot that lasted for about an hour after the injection. This occurred after my first Covid vaccine as well, but I did not recognize it as related to the shot at the time. I thought it was psychosomatic and thought nothing of it until it happened again. My first dose was in my left arm and affected my left face. My second dose was in my right arm and affected my right face.
Upper left arm red, hot and swollen.  Given prescription for Cephalexin and also given oral Benadryl.
Headache, fever, swollen arm at injection site burning, rash, muscle ache, overall discomfort. Rash appeared  day after injection as well as burning.  Day of injection tired, arm very sore, didn't sleep well followed by feeling really sick nausea, just a little, then fever started terrible headache continued until next evening. Now arm  sore also realized I have neck pain yesterday and now, still have rash the burning has subsided
I blacked out completely; Felt very dizzy; fallen on the dresser; hit myself on my stomach and leg; hit myself on my stomach and leg; Was completed disoriented; Headache; Sore arm; Body ache; wound on my stomach; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 30Mar2021 19:45 as single dose for covid-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant. Concomitant medications were unspecified received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After taking the vaccine at 19:45, the patient drove back home and had minor symptoms when she went to bed (headache, sore arm, body ache) on 30Mar2021. She woke up around 3:45 am on 31Mar2021 to use the restroom and felt very dizzy. While walking back to bed, she blacked out completely, fallen on the dresser and hit herself on her stomach and leg. She was feeling extremely dizzy at this point, was completed disoriented and couldn't process what was happening around me. Her husband walked her back to bed and put her to sleep. Treatment was reported as First aid for the wound on her stomach. Since the vaccination, the patient had not been tested for COVID-19. The report was non-serious. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Patient stated received 2nd Shingrix dose and day after the 2nd dose was administered, patient had "tightness" in knee that he had replaced this summer. The tightness then moved to his achilles tendon and is still there. Patient also stated that he received vaccination in left arm (verified) and this occurred in left knee (same knee that was replaced) and left achilles tendon only. Patient stated received first shingrix while in a recovery home after knee replacement. Patient stated he asked his physician about this "reaction" and Dr said he had not heard of it and would have to look it up and patient hadn't heard anything from physician.
Vaccine received on 1/25/21, on the evening of 1/26/21 I began having systems of being itchy and having redness.  Took Benedryl.  On Wednesday, 2/27/21, increased redness, swelling in my face, lips, neck.  Rashes spreading over body and face.  Took Benedryl and applied caladryl.  Began steroid treatment on evening of 2/27/21.  Symptoms continue to increase.  On the afternoon of Friday, 1/29/21, having a feeling of a lump in my throat.  I sought care at the Emergency Department.  Received epinephrine, benedryl and pepcid.  When that did not clear up the rash, had additional does and they had me stay throughout the night to monitor me.  Symptoms are slowly improving but I continue to be on multiple medications to decrease swelling, itchiness, redness.  I have a follow up appointment with an allergist on 2/2/21
Information has been received from a Licensed Practical nurse concerning a 60 day (reported as 2 months) old patient who on 30-NOV-2010 was vaccinated with ROTATEQ (lot number not provided, expiration date 25-NOV-2010) that expired. No adverse effect was reported. The patient did not sought medical attention. Follow-up information received from the Licensed Practical nurse stated that the patient was a 70 day old male with no illness at time of vaccination and no pre-existing allergies, birth defects and medical conditions and no adverse event following prior vaccination who on 30-NOV-2010 was vaccinated with the first dose of ROTATEQ (lot number 663848/0147Y, expiration date 25-NOV-2010) which expired 5 days. On 03-DEC-2010, the patient was re-administered with the second dose of ROTATEQ (lot number 668268/0947Z). Concomitant therapy included PEDIARIX, PREVNAR and Hib (unspecified carrier) (manufacturer unknown). It was reported that the patient did not require emergency room/doctor visit. No further information is available.
Vaccine on 06/10/13. Patient seen in office 06/13/13 with swelling at Rt thigh 5 1/2" x 3". No regional lymphadenopathy. H/O allergy to egg white.
10/03/3016 Moderate other. Pt. states went to ER and Dr. Complaints of both arms, wrist and hands with burning and shooting pain. Has numbness and tingling both hands and left leg. Started after took vaccines. States Dr ordered amoxicillin and gabapentin 10-17-16.
Patient states within 30 minutes of vaccine, she began itching around her neck. She then noticed a red "bumpy" rash on her waist, chest, neck and face. She did not go to the dr or ER. She used ALLEGRA and cortisone cream. No fever. States the rash is fading 2/6/14.
Patient was given undiluted pediatric dose .2 ml Patient was contacted.  No side effects noted. Patient scheduled for full booster in 8 weeks, per CDC guidelines.
C/O fine rash inside (L) upper arm, chest over sternum, legs, and chin started 6-12 hours after flu shot. Very itchy.
Patient called on 10/27/12 and said her left arm was swollen, red, and itching. She said the area was 3 inches big and there was a lump under the skin. It starting bothering her on 10/26/12 but only when she was sitting around doing nothing (not busy). She started putting AVEENO lotion on the rash and she said it did help the itching.
Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and NAUSEA (Nausea) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided. Treatment medication were not reported. Patient has no known allergies. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.