chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: patient called to report swelling that got worse after administration of her vaccine
Case number PHEH2013US021461 is an initial spontaneous report received from a pharmacist on 11 Oct 2013 with a follow up information received from the pharmacist on 29 Sep 2014. This report refers to a 35-years-old female patient. On 08 Oct 2013, while she was pregnant, she was vaccinated with FLUVIRIN (batch number: 13382P, expiry date: Mar 2014) at a dose of 0.5 ml intramuscularly. No adverse event was reported following vaccination. Upon follow up information received on 29 Sep 2014, the reporter stated that the patient received prepackaged FLUVIRIN vaccine and not a multidose vial and as per their headquarters, it was okay to administer this vaccine to patients who were pregnant. Reporter stated that patient was doing fine and the reporter would like to close this case. No further information was provided. Follow up information received from the pharmacist on 29 Sep 2014: Reporter's comment and lost follow-up updated. Following internal review on 20 Oct 2014 of the data received on 29 Sep 2014: It was identified that the birth type was erroneously updated as outcome pending and the birth type correctly updated as lost to follow-up.
CHILLS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chills, fever, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, headache and nausea was not reported. This report was non-serious.
rash on neck and back; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (rash on neck and back) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash on neck and back). At the time of the report, RASH (rash on neck and back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  Treatment medications was not provided by the reporter   Reporter did not allow further contact
Nurse states that the vaccine was administered after a shorter interval than the 12 week suggested interval between the second and third dose; no adverse effects; This spontaneous report as received from a licensed practiced nurse refers to a 18 year old patient of unknown gender. The medical history, concurrent conditions and concomitant medications were not reported. On 29-APR-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1581027, expiry date 03-JUN-2021, intramuscular for prophylaxis in her three dose series, outside of the prescribing information. The nurse stated that the vaccine was administered after a shorter interval than the 12 week suggested interval between second and third doses. No adverse effects reported. No product quality complaint was filed.
Patient here today with left sided jaw pain starting 2 days ago. He has subsequently had worsening paralysis of the left side of his face. He is not able to fully elevate his left eyebrow, close his left eye, or smile with the left side of his face. He had a COVID 19 vaccine 1 moth ago and was scheduled for his second one today. No word finding difficulty or headache. Diagnosed with Bell's Palsy; treated with prednisone and Valtrex. Instructed to go to ED for loss of vision or evolving symptoms. Wait on second COVID vaccine until prednisone is finished.
Two shots to left arm. 5 hours in: arm became very tight, very sore and weak. Lasted for just over 2 days.  Hard to lift use arm.
2 day h/o mild URI sx, + COVID Abbott test on 10/15/21
37 yo male with multiple 5mm X 5mm crusted lesions on forearms and right thigh that developed 1 wk post/vax. Initial lesion crusted over in 1 wks time. Has had several other lesions develop. Primary vaccination site is crusting over. No fever. No muscle pain.
Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case involves five patients of an unknown demographics who were vaccinated with a dose of FLUZONE HD lot number not reported on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was reported that medical assistant gave high dose to 5 patients under 65 years of age. It was not reported if the patient experienced any administered or not. 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 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. Documents held by sender: none.
Pt came in today and claimed her arm still hurt from the shot (movement limited). She claims the shot was given on the top shoulder blade. The shot was given in the deltoid muscle. She has seen her own doctor who said I should have used a shorter needle, he recommended pain pills for her, but she says she still has limited movement. Added note 2-5-11/Pt says arm still hurts.
CIIS was down on 4/1/21 and the record in EPIC didn't show that patient had already received 2 doses of MRNA vaccine for COVID19  We review CIIS for all people experiencing homelessness due to their mobile lifestyle. That day CIIS was not working and the record in EPIC showed that patient was due for his second dose of Moderna.  Later in the day CIIS was working and we found that patient had a dose of Pfizer also: Moderna 02/04/21, Pfizer 03/20/21, Moderna 04/01/21
Next day had shortness of breath, 8 days later ended up in the hospital with severe shortness of breath and fluid in the lungs, thought to be pneumonia. Was discharged, then 1 week later, which was 3 days after the second COVID shot,  ended up in the hospital again for about 5 days with severe shortness of breath and fluid in the lungs, possible pleural effusion, was discharged after about 5 more days with home oxygen. Approximately 4 days to 1 week later ended up calling 911 with severe shortness of breath and fluid in the lungs still. Patient is still on home oxygen and still recovering as of today.
A red, very itchy, pustule like rash that started in vaccinated arm and spread to opposite arm, then knee area, upper back, then lower back, and breasts. Almost poison ivy like. Very uncomfortable. Pustules left a reddish purple "scar" that has taken several months to disappear.
PATIENT RECEIVED THE 12+ VERSION OF THE PFIZER VACCINE. PATIENT WAS CONTACTED AND DID NOT REPORT ANY ADVERSE EFFECTS
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 14-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Lot # K007822, expiration date 15-AUG-2015) dose, route and anatomical location were not provided. There was no concomitant medication provided. On unknown dates, the PNEUMOVAX had temperature excursions for 72 hours with lowest recorded temperature of 28F (-2.2 Celsius) and 8 hours with the highest recorded temperature 47 F (8.3 Celsius). The vaccine status was reported as "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved and no adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
About ten days after the vaccine, I got Iritis in my left eye. I noticed some blurriness and my eye was painful  and got worse over the course of three days. I went to the eye doctor and they diagnosed Iritis in my left eye. Sensitive to light and darkness and it was very painful. I was prescribed Steroids and it took two weeks before my vision improved and the pain was lessened. It took six weeks of Steroids before the condition was resolved. No symptoms after the second dose.
Woke up next morning with a sore arm right at the injection site, but thought nothing more of that as that is expected. This morning (10/29/2021) was at work talking with co-workers and client rolled up her sleeve and her co-workers saw a red area and asked what that was from. It was the site from her flu shot two days prior. Area is red and warm to the touch. Client did have a left breast mastectomy due to breast cancer and was told never to have a blood pressure taken or any shots from this arm. She wanted to test this so she got her flu vaccine shot in her left arm and now has this adverse reaction, she was also wearing a shirt that she had to roll up the sleeves which was then tight on her arm at the time of injection. She was advised to watch the area closely and just give her PCP a message on mychart so they are aware as it is a Friday.
A fever, chills, and body aches began about 11 hours after the shot. The next day body aches, headache, and tiredness continued. By the following day, all side affects had subsided.
Pt felt sick; sat down and had an absence seizure (in my personal opinion). 911 was called; pt refused to emergency room and seen by ER physician. Mom states pt has never had any experience like this prior. This was the pt's 1st flu vaccination.
5/15 vaccination  5/25 He got up and go dressed, ate breakfast, was ready to do work out in yard. Went to walk across the room to his brother, turned to look out the window, and all of a sudden fell straight back. Came to 10 seconds later, didn't know where he was, felt like he had had a bunch of dreams, 'everything turned white', doesn't remember much, didn't know where he was (thought he was in bed). He had hit his head on the wood floor, back of head (standing to smacking head). We live on an island, had to take ferry to town. Possible concussion. We went to Hospital in town. We worked with Dr.   They gave us the verbal instructions if HA gets worse, anti nausea meds, rest, ibuprofen; concussion.
Upon arrival to health department, the Pfizer Monovalent 5-11 Covid Vaccine Packet label was completed with 10 week Refrigeration expiration date which was 01/02/2023 being recorded for the Manufacturer Expiration date which was 11/30/2022.Pfizer.  The vaccine was marked to expire 01/02/2023 but should have been 11/30/2022.  1 Dose of the expired vaccine was given 12/05/2022.
Patient came into pharmacy to receive 2nd COVID-19 Vaccine dose. I screened patient and there was no contraindications. Patient mentioned she was dizzy after the first dose and it resolved quickly and gets dizzy with most vaccines and lab-work. Patient stated she ate food and drank a lot of water prior to coming as she had not eaten last time. I recommended patient just stay still in chair for few minutes after administration to avoid dizziness. I administered vaccine at 9:36 am and patient was fine, and verbally speaking for couple minutes and then stated she wanted water and was feeling dizzy and hot. I called the patients husband from the waiting area and at that moment the patients eyes went inwards and it seemed like she was passing out. Patient was conscious, and kept talking but looked very pale and clammy. I dialed 911 and EMT responded after few minutes. Patients blood pressure was 93/67 and pulse was 75 bpm according to EMTs. Patient declined to go to hospital and patient and husband sat in the waiting area for a bit and left pharmacy at 10:30 am.
This spontaneous report was received from a medical assistant and refers to a 12 year old female patient with no pertinent medical history or drug reactions or allergies. The patient was not pregnant. On 22-JUL-2014, the patient was vaccinated with the first dose of GARDASIL intramuscularly (lot #, expiration date and dose were not reported). On 20-OCT-2014, the patient was vaccinated with the second dose of GARDASIL intramuscularly (lot #, expiration date and dose were not reported). The patient did not experience any symptoms after these doses were administered. On 11-JUN-2015, the patient was vaccinated with the third dose of GARDASIL lot # L007531, expiration date 04-NOV-2016, intramuscularly (dose was not reported). Concomitant therapy included VENTOLIN. On 11-JUN-2015, within 1 hour of receiving the third dose of GARDASIL, the patient experienced sudden onset of symptoms including headache, stomach pain, diarrhoea and vomiting. The patient's mother was advised by the physician assistant via phone call to offer rehydration and ensure rest for her daughter. No lab tests were performed. The outcome of the events was reported as not recovered. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Per Mother:  Leg started to look red and swollen on Saturday. Pt also started to develop a cough today. Mild fever on Friday and given Tylenol with improvement. Pt is stating that when she walks it hurts.  Per Dr.  "Leg swelling on the left thigh near insertion of the immunization needle with erythematous, warm and swollen thigh. Nonperulent in nature and causing some purities and pain with movement. Mother edu that this is likely a bacterial infection therefore will treat empirically with Keflex 4ml Q6hrs for 10 days (due to non purulence) and will have close follow up."
Patient had a fever around 101 degrees that night, after waking up around 130am. He also reports moderate pain at the injection site during this time. The following morning, the fever had subsided, and the soreness decreased over time.
vaccine was expired, no temperature excursions occurred and moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration".   Patient reported no adverse reactions.
Immediately after vaccine, there was redness, swelling and soreness to the site.  This resolved within 3 days.  Then, 6 days after vaccination, area became hot, red, swollen, indurated and extremely pruritic, interfering with sleep, mobility and usual routine.  Affected area was approximately 15cm x 10 cm.  These symptoms remained until January 2, 2021.  On January 2, 2021, the redness and swelling dissipated except for the edges, where there remained a red, irregular ring marking the edge of the affected area.  Area continues to be pruritic. All visual abnormalities have resolved.
Soreness at injection site started developing after few hours. The following two days of soreness on injection site and developed large medium-hardness knot on injection site, which gradually got better. On Day 7, started developing a small clutter of rash-like presence on injection site--a lot of the swelling and "knot" had gone down at this point. The following day after the rash presented itself (Day 8), the injection site became very inflamed, itchy, and firm to touch. 10cm x 6cm in size. Developed sore throat starting around Day 5, which may or may not have been an AE related to vaccination. COVID-19 test administered Day 7 and awaiting results.
pt recvd vax;9nov95 devel 5-6 gen chicken pox like lesions w/ no fever; dx w/ chicken pox;
Hospitalized mid-November 2021 for acute left lower extremity weakness. Brain MRI found acute ischemia in the R MCA-PCA watershed territory as well as ischemia in the right thalamus and occipital head regions. Old lacunar infarcts in the bilateral cerebellum. Is on chronic anticoagulation for a-fib. Was in NSR during his hospitalization.
Patient called at 12pm to inform us that about 3 hours after her 1st Covid vaccine she was moving her arms around to prevent soreness and then both arms began to feel itchy, tingling, & burning & this moved up into her neck. She was encouraged to come in and be seen, but she does not feel that is necessary at this time. She reported her symptoms have since improved and that she had a similar reaction when she received the shingles vaccine.  I encouraged patient to monitor her symptoms and to come be seem if she gets worse. She reported that she is feeling much better at the end of our phone call.
make me sick; Initial information received on 30-Jan-2022 regarding an unsolicited valid Social Media non-serious case received via consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced make me sick while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine (strength, formulation, dose and route: unknown) produced by unknown manufacturer lot number not reported in unknown administration site for prophylactic vaccination (Flu vaccination).  On an unknown date the patient developed a non-serious "make me sick (illness)" (unknown latency) following the administration of Influenza Vaccine.  It was reported that "They make me sick I'll have to pass thx".  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (make me sick).  At time of reporting, the outcome was Unknown for the event make me sick.
kind of shingles; This spontaneous case was reported by a consumer and describes the occurrence of   in a 59-year-old female adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the parent received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. The Adult was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
There is no adverse event reported. immunization registry noticed patient had received first dose of Moderna on 04/23/2021 at a different facility and then came and got Pfizer on 06/19/21 and 07/09/2021. was not aware of Moderna vaccination when first dose of Pfizer was given.  It was asked that we report event, but no adverse reaction to either shot.
itchy; swollen 3 inches in size; redness; arm soreness; arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), PERIPHERAL SWELLING (arm swollen), PRURITUS (itchy), PERIPHERAL SWELLING (swollen 3 inches in size) and ERYTHEMA (redness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041620A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for Cholesterol, ESTRADIOL for Hormone level abnormal, IBUPROFEN for Pain, CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID), ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), CALCIUM, COLECALCIFEROL (CITRACAL CALCIUM PEARLS + D3) and POLYCARBOPHIL CALCIUM (FIBER) for Supplementation therapy, PREGABALIN for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and PERIPHERAL SWELLING (arm swollen). On 22-Jan-2021, the patient experienced PRURITUS (itchy), PERIPHERAL SWELLING (swollen 3 inches in size) and ERYTHEMA (redness). On 17-Jan-2021, PAIN IN EXTREMITY (arm soreness) and PERIPHERAL SWELLING (arm swollen) had resolved. At the time of the report, PRURITUS (itchy), PERIPHERAL SWELLING (swollen 3 inches in size) and ERYTHEMA (redness) outcome was unknown. Not provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient felt dizzy immediately after the shot. Had an episode of non responsiveness but still breathing. Called EMS. Had two more non responsive episodes once when paramedics were here. Was reposonsive but taken to hospital for precaution.
Patient came to ED with complaints of shortness of breath, upper respiratory symptoms, and nausea/vomiting.  Patient was admitted to the hospital with Covid and treated with remdesivir.
Facial swelling started few minutes after vaccine and lasted 1 1/4 hr. With my 3rd vaccine this lasted only 10 mins
Mother noticed that patient had a rectal temp of 102.4 on the evening of 03/16/2017. On 03/17/2017 a phone call was made to our practice requesting an appointment for 03/17/2017 with the covering physician due to rash and fever. Upon examination by Dr.it was determined that both the rash and fever were possibly related to the MMR or varicella vaccination given 11 days ago. Patient is expected to recover fully.