chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine underdose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Vaccine underdose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Vaccine underdose) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Vaccine underdose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Vaccine underdose).    No concomitant medications were reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. 196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent. Patient received Additional booster dose. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Significant follow up received contains updated age group and narrative.
Really bad muscle pains in hips and legs and left forearm. Chest pain on left side. For 2 days vomiting couldn't hold anything down.
I had a high fever 102.2. I had nausea and diarrhea.
#2 hep B L arm #1 hep A R arm began complaining of headache, tenderness at noon, rc'd shot 8:30, Received 650mg Tylenol orally at noon. Fever spiked 103 deg F ~ 9pm. Took Tylenol.
One hour post vax, the pt reported feeling tired, lightheaded and had a "vinegar taste in her mouth", that self resolved. The pt reportedly recovered from this experience. No additional info was provided from correspondence returned on 07/25/2000. No further info is anticipated, this case is closed.
10-12 weeks after vaccine, I had breast tenderness. You can feel breast lumps in the tissue. It was consistent for about 3 weeks.
Information has been received from a physician for the pregnancy registry for GARDASIL concerning a female baby. The baby's 32 year old mother with 1 previous pregnancy and 1 full term delivery who on 21-APR-2009 was vaccinated with SQ with her first 0.5 ml dose of VARIVAX. Concomitantly therapy included prenatal vitamins. Subsequently, the baby's mother was pregnant. Date of last menstrual period was 23-APR-2009 and her estimated delivery date was 28-JAN-2010. At 20 weeks from LMP, on approximately 10-SEP-2009, the ultrasound was performed and it showed a mild fetal pyelectasia. On unspecified date, the mild fetal pyelectasia was resolved. On 08-JAN-2010, the mother delivered the normal female baby, weighing 5 pounds, 4 ounces. The mother's experience had been captured in WAES #0906USA01405. No further information is available.
Product administered to patient of inappropriate age; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to patient of inappropriate age) in a 17-year-old patient of an unknown 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to patient of inappropriate age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to patient of inappropriate age) outcome was unknown. Not Provided      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 medication details was reported. No treatment medication details was reported.
pt recv vax on lt arm on 23jan95;devel red,raised macules on rt hand,rt ankle & thigh;dermatologist dx granuloma anulare;31mar95,had hives over body;tx w/ medrol;to MD;rash in legs,arms,chest & abd;rash improving;felt adverse rxn to vax;
The facility asked me to stay for monitoring after receiving my first dose for 15 minutes, advising adverse reactions would likely present in that timeframe. During that time, only a slight pain presented at the site where the vaccine was administered. Nearly 24 hours after receiving the first dose, hives covered my left shoulder & arm, chest, neck and face, including random hives all over my body. The hives continued for 48 hours, worsening each evening. I took 1-2 Benedryl every 12 hours to help control the hives. At the 72 hour mark, the lymphnodes under my left arm and into my left breast swelled and became painful. I researched this reaction on the CDC site and learned this was a noted side effect and did not report the hives nor the swollen lymphnodes to my PCP, nor to the facility where I received the vaccine.   The hives continued breaking out all over my body for a solid 9 days  I continue to have random hives breaking out for no apparent reason ever since receiving the shot, although they are only mild in severity now. The swollen lymphnodes went away after 7 days.  I reported the adverse reactions to Dose 1 to the nurse on staff when I went in for my appointment to receive the 2nd and final dose of the vaccine at the same facility noted in this report. They advised me that I need to report my adverse reactions to VAERS and provided me the contact information. They also advised me that my reaction to the 2nd dose could be the same or worse and asked if I wanted to continue. I received Dose #2 on Friday, 11/26/2021, and have only mild pain in the lymphnodes in my left arm pit (no noticeable swelling) to date. No hives have presented with Dose #2 to date.
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------------- ACUTE MI 4/30/2023 ACUTE MI ACUTE MI 4/30/2023 RIGHT ANKLE FX INIT ACUTE MI 4/30/2023 RIGHT ANKLE FX INIT
Information has been received from a medical assistant regarding a case involving PROQUAD (MARRS # 1607USA002225) who refers to multiple unspecified patients of unknown age. On an unknown date the patients were vaccinated with VARIVAX (Lot # L037559, expiration date: 29-SEP-2017). Other suspect therapies included PROQUAD (lot # L030585, expiration date: 10-FEB-2017) and (lot # M007964, expiration date:18-AUG-2017, not valid), subcutaneous. The medical assistant reported that multiple unspecified patients received either VARIVAX or PROQUAD (MARRS # 1607USA002225) that were improperly stored. No adverse effects reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to VARIVAX. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician concerning his "around 18" year old daughter who was vaccinated IM with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included a dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (BOOSTRIX). Subsequently, the patient experienced numbness in her arms and lower extremities. Unspecified medical attention was sought. On an unspecified date, the patient recovered. No product quality complaint was involved. Additional information has been requested. 01/05/2007 Information has been received from a physician and health professional concerning an 18 year old female student with no medical history or allergies, who on 15-AUG-2006 at 09:00 was vaccinated IM into the right arm with a 0.5 ml first dose of GARDASIL (lot# 653650/0641F). Concomitant therapy included a first IM dose into the left arm of ADACEL (batch # C2151AC) and TUBERSOL (batch#C2250AB). On 15-AUG-2006 at 12:00, the patient experienced numbness in her arms and lower extremities. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. On 21-AUG-2006, the patient recovered completely. Additional information is not expected.
Injection site, L/arm, swollen, rash from L/shoulder to L/neck, fever up to 103.1F, sore throat & vomiting x1, 15 hrs post/vax.
Nurse medication error.  Gave covid vaccine to child whose guardian did not want him to receive.  He received the vaccine with Tdap, menveo.  Was given in left arm.  No events occurred at time of vaccine.
After first shot on 1/28/21: Very slight headache next two mornings and very slight arm at site of shot.  After second shot on 2/20/21: Almost imperceptible arm soreness day after (when driving and arm touched driver door), slight nausea (extremely unusual for me) on afternoons of 2/21, 2/22 & 2/23 along with moderate afternoon fatigue those days (I napped which is extremely unusual for me).  Alka Seltzer didn't help but CupOSoup eliminated the nausea completely.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date; No adverse event; Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date).    No concomitant medications were reported.  The patient received half dose of Moderna vaccine.  The vial had not undergone any temperature excursions.  The vial was initially stored in the refrigerator on 04-Jun-2022 and 35 vials were affected.  No treatment medications were reported.
Pt with brief moment where head dropped down and began shaking uncontrollably. Symptoms recognized and lasted for 5 seconds after administration of HPV. Once patient lifted her head she reported voices being muffled and feeling dizzy. FNP-C called in room and patient was taken to exam room 17 via wheelchair to rest. Pt was given cool cloth and reported feeling better after a few minutes. Pt's step mother was called after verifying that it was ok with patient and came to pick patient up. Pt instructed to go to Emergency Room if symptoms were to return and she verbalized understanding. Pt was able to walk out to vehicle with assistance.
Diagnosed with shingles/Shingles under the left breast and left leg; Swollen nipple & left Breast; Breast swelling; Scratchy under her left breast.; Bumps under her left breast; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Diagnosed with shingles/Shingles under the left breast and left leg), PRURITUS (Scratchy under her left breast.), SKIN MASS (Bumps under her left breast), NIPPLE SWELLING (Swollen nipple & left Breast) and BREAST SWELLING (Breast swelling) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Back pain since 27-Sep-2021, Leg pain since 27-Sep-2021 and UTI since 27-Sep-2021.    On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced PRURITUS (Scratchy under her left breast.) and SKIN MASS (Bumps under her left breast). On 30-Sep-2021, the patient experienced HERPES ZOSTER (Diagnosed with shingles/Shingles under the left breast and left leg), NIPPLE SWELLING (Swollen nipple & left Breast) and BREAST SWELLING (Breast swelling). At the time of the report, HERPES ZOSTER (Diagnosed with shingles/Shingles under the left breast and left leg) had not resolved and PRURITUS (Scratchy under her left breast.), SKIN MASS (Bumps under her left breast), NIPPLE SWELLING (Swollen nipple & left Breast) and BREAST SWELLING (Breast swelling) outcome was unknown.        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 medication was reported.  Patient said that she had shingles under the left breast and on the left leg, which was spreading.  No treatment medication was reported.  No lab data was provided.
Fever, chills, body aches, fatigue, lightheaded, rash on arm
Patient claimed throat was closing and could not breath. Rapid response called. Dr. ordered 50 mg Benadryl IM and 0.5 mg Epi SubQ, both given on Right arm. Sent to ED.
SORENESS AND PAIN IN LEFT SHOULDER, LIMITED LEFT ARM-SHOULDER USE, MOVEMENT ASSOCIATED WITH PAIN. INITIALLY RECEIVED A STEROID INJECTION FROM PRIMARY DOCTOR, FOLLOW UP WITH ORTHOPEDIC DR, PRESCRIBED METHYLPREDNISOLONE AND PHYSICAL THERAPY.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. No medical history or concomitant medications were reported. On 02-MAR-2016, the patient was vaccinated via subcutaneous route with an expired dose of VARIVAX (Merck) (lot # K002915 and expiry: 26-FEB-2016). The patient experienced no adverse effects. Additional information has been requested.
He first described discomfort in his left foot on Monday evening. By Tuesday evening 8/2, he said he was very irritated in his left foot. By Wednesday afternoon, his first and second toes and ball of his foot were visibly swollen with some mild redness around the area (nothing warm and no fever at any point). He woke up in the middle of Wednesday night distressed by the sensation of a "rock in his toe" and could not comfortably walk. The swelling had worsened. Based on a call with his pediatrician's office, we gave him ibuprofen and Benadryl in the night and checked on his foot throughout the night.   By morning, the swelling was somewhat worse and he visited his provider's office.  She found no abrasions, cuts, or bites, and no other visible sign of infection. He had played barefoot in a field the day after the vaccination (Sunday). She prescribed cephalexin out of caution for possible infection/cellulitis, and he began a 9-day course on Thursday morning, but the examination was not conclusive. By Thursday afternoon,  clear fluid blisters developed on the top of the first toe and bottom of the second toe. The larger blister on the bottom of the second toe ruptured. There was no pus or cloudy fluid.  The swelling started to reduce about 18 hours after starting antibiotics and was resolved by Friday night.
Redness in arm around injection; Lymph nodes in arm pit sore; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site erythema and lymph node pain. On an unknown date, the outcome of the injection site erythema and lymph node pain were unknown.   It was unknown if the reporter considered the injection site erythema and lymph node pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and had redness in arm around injection and asked could this vaccination cause lymph nodes in armpit to be sore, same arm as injection. Additional Supportive Information: Unknown arm was conservatively captured as anatomical location and lymph node pain was conservatively captured as event although in narrative it was stated as question. Follow-up would not possible as no contact details were available.
Redness Under the Site of Injection; Warm; Very Itchy; Initial Report Received on 23-Feb-2023.  A registered pharmacist reported to a sales representative that she, the patient (age, race, and ethnicity unknown), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced redness, warmth, and itching.  Medical history, concomitant medications, and allergies at the time of vaccination were not reported.   On an unknown date, the patient received a dose of HEPLISAV-B vaccine (details not reported). The patient experienced redness slightly below the injection site (not the actual injection site), warmth, and increased itching. The patient stated that it was "not a large area."  No further information was provided. Additional information was requested.  Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Swollen under left arm  Swollen tender arm around injection site  Red  swollen area around injection site
I had the normal chills but this time starting Friday; I have chest pain I went to my primary doctor and she checked all my vitals she said everything was good she did mention that it has turned it into extreme chest pain and acid reflux.
1/29/08 - sore inj. site.  1/29-1/30 - fever 99.8 - body aches.  1/31 - fever gone & body aches gone.  2/1 - better, recovered.
PULMONARY EMBOLISM/RIGHT SIDED MID BACK PAIN; This spontaneous report received from a health care professional concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Crohn's disease. The patient was previously treated with infliximab for Crohn's disease. The patient experienced drug allergy when treated with infliximab (Remicade). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: unknown) dose was not reported, 1 total administered on 31-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included vitamins nos, azathioprine, dicycloverine, and mesalazine for drug used for unknown indication.  On 22-APR-2021 by evening, the patient experienced right-sided mid-back pain and shortness of breath and was presented to ED (emergency department) on 23-APR-2021. The patient's pain was sharp and worsened with coughing and deep inspiration; she felt that she was taking shallow breaths. Upon ED (emergency department) presentation, there was no shortness of breath, chest pain, dizziness, fevers, dysuria, or abdominal pain. The patient had reproducible pain on her right mid-back area. There was some mild diffuse tenderness in her abdomen, but it was reported that she always had a tender abdomen due to Crohn's disease. The patient had no peritoneal signs and had no recent travel history. On 23-APR-2021, the CTA (Computed tomography angiography) of chest was done with and without contrast and found out central and peripheral pulmonary emboli in the right lower lobe. The patient had no CT (computerized tomography) evidence of right heart strain. The patient's ground glass opacities within the right lower lobe was somewhat band like in appearance and concerned for early pulmonary infarcts. It was reported that this might also relate to sub segmental atelectasis or less likely an inflammatory/infectious process. The patient had also small right pleural effusion; no acute inflammatory process in the abdomen or pelvis. On 23-APR-2021, the patient's platelet count was 252 k/mcL and was tested negative for covid test. The patient was diagnosed with pulmonary embolism; she consulted hematology/oncology specialist and recommended with initiation of argatroban for treatment of pulmonary embolism. The patient was admitted to inpatient on 23-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pulmonary embolism/right sided mid back pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0;-covid-19 vaccine ad26.cov2.s-Pulmonary Embolism. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Information has been received from a health professional concerning a 7 year old female pt who was vaccinated on 02/03/1997 with a dose of varicella virus vaccine, live. Subsequently, on approximately 03/02/04, the pt developed breakthrough chickenpox with 50-500 lesions. Follow up information indicated that "there was not a single report of adverse reaction following varicella vaccination. The reporter indicated that 49 other pt's developed breakthrough cases of chicken pox (WAERS # 0405USA02615, 0405USA00572, 0405USA00573,0405USA00574,0405USA00575,0405USA00576,0405USA00577,0405USA00578,0405USA00579,0405USA00580,0405USA00581,0405USA00582,0405USA00583,0405USA00584,0405USA00585,0405USA00586,0405USA00587,0405USA00588,0405USA00589,0405USA00590,0405USA00591, 0405USA00592, 0405USA00593, 0405USA00594, 0405USA00595, 0405USA00596, 0405USA00597, 0405USA00598, 0405USA00599,0405USA00600,0405USA00601,0405USA00602, 0405USA00603,0405USA00604,0405USA00605,0405USA00606,0405USA00607,0405USA00608,0405USA00609, 0405USA00610, 0405USA00610,0405USA00611,0405USA00612,0405USA00613,0405USA00614,0405USA00615,0405USA00616,0405USA00617,0405USA00618,0405USA00619). No additional information is expected.