chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Not received the second dose after 36 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Not received the second dose after 36 days) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Not received the second dose after 36 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Not received the second dose after 36 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Follow up information was received and contain no new information
Information has been received from a registered nurse concerning a 33 year old female with on pertinent medical history and no allergies who in approximately 2008 "over 1 year ago" was vaccinated with the first dose of GARDASIL 0.5ml IM. There was no concomitant medication. In March 2009, "last month" the patient had tested positive for HIV. The patient also had a PAP smear at the same time and that was negative. The patient has not received any additional dose of GARDASIL. The patient sought medical attention by phone call. Additional information has been requested.
Cellulitis, needing treatment with antibiotics. Vaccine was administered without putting bandage on post administration.
Case PHEH2016US026052, is an initial spontaneous report received from a consumer on 07 Oct 2016. This report refers to a male patient of unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUCELVAX (batch number: not reported) at a dose of 0.5 ml intramuscularly on 06 Dec 2015. The patient experienced typical injections site reaction, 3 days later had runny nose followed by body aches and muscle aches. The patient was later diagnosed with thyroid crisis. It was reported that, the patient still felt sick on an unknown date. The outcome of the event thyroid crisis was reported as condition unchanged and for other events it was not reported. The seriousness and causality of the events was not reported. The seriousness assessment of thyroid crisis was upgraded based on the Novartis Important Medical Events list.
Pt developed heart pain, tinging in the arms and legs, increased blood pressue. Her blood pressure was taken multiple times ranging from 145/80 to 155/95.  After approximately 40 minutes after the vaccine, the patient stood up and fainted. We kept the patient on the floor as she was light headeed and not very responsive. At that time, 911 was called.  She was taken tp the ER and discardged the same evening.
In early August, perhaps 8/01/2021 I started noticing vision issues. Then on 9/4/2021 My retina separated from viscus in eyes. My retinas are inflamed due to the autoimmune disease birdshot chorioretinopathy. Treatment ongoing. Steroids directly to eyes.
I woke up the following day after the vaccine and was extremely nauseous, worse than sea sickness. I was unable to keep foods or liquids down, so I went to the ER. The doc gave me a general nausea medicine and told me it was a severe case of nausea. I came home and started feeling a little better. I had a headache for the remainder of the day and the nausea resolved the following day.
arm was very sore; tired; her arthritis in hand was painful; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (her arthritis in hand was painful) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Cortisone until November 2020. Past adverse reactions to the above products included No adverse event with Cortisone. Concurrent medical conditions included Arthritis (Hands).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced ARTHRITIS (her arthritis in hand was painful). At the time of the report, ARTHRITIS (her arthritis in hand was painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
just had body aches at first but then became extremely nauseated by Friday and vomiting became very bad by Sunday.
Horizontal diplopia; Pressure headache; Lightheadedness; Headache; This spontaneous case was reported by a physician and describes the occurrence of DIPLOPIA (Horizontal diplopia), HEAD DISCOMFORT (Pressure headache), DIZZINESS (Lightheadedness) and HEADACHE (Headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Diplopia from October 2020 to December 2020. Previously administered products included for an unreported indication: INFLUENZA in October 2019. Concurrent medical conditions included Hypertension since 11-Jan-2011, Anxiety since 11-Jan-2011, Allergic rhinitis since 01-Jan-1980, HSV infection since 11-Jan-1998 and Drug allergy (Bactrim). Concomitant products included MOMETASONE FUROATE (NASONEX) from 12-May-2017 to an unknown date and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) from 12-May-2017 to an unknown date for Allergic rhinitis, SERTRALINE from 11-Jan-2011 to an unknown date for Anxiety, VALACICLOVIR HYDROCHLORIDE (VALTREX) from 11-Jan-1998 to an unknown date for HSV infection, ENALAPRIL from 11-Jan-2011 to an unknown date for Hypertension.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced DIPLOPIA (Horizontal diplopia), HEAD DISCOMFORT (Pressure headache) and DIZZINESS (Lightheadedness). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency. At the time of the report, DIPLOPIA (Horizontal diplopia), HEAD DISCOMFORT (Pressure headache) and HEADACHE (Headache) had not resolved and DIZZINESS (Lightheadedness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) normal. On an unknown date, SARS-CoV-2 test: negative (Negative) Done Three time.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HEADACHE (Headache) to be possibly related. No further causality assessments were provided for DIPLOPIA (Horizontal diplopia), HEAD DISCOMFORT (Pressure headache) and DIZZINESS (Lightheadedness).    Patient underwent complete workup and concluded on NOV-2020, and it was negative for multiple sclerosis, myasthenia gravis, any inflammatory disease and vasculitis. Patient also had sixth cranial nerve weakness. On 05-JAN-2021, patient had experienced recurrence of diplopia.
Information has been received from a nurse concerning a 28 year old female with no allergy who on 22-DEC-2008 was vaccinated with her first dose of VARIVAX (Oka/Merck) (lot# 659723/1659U). On 31-DEC-2008, the patient was seen in the office with swelling and pain at the injection site. The patient was prescribed KEFLEX and ADVIL. In follow-up, the nurse indicated that the patient received the first dose of VARIVAX (Oka/Merck) IM (lot# 659723/1659U) into the deltoid on 22-DEC-2008. She began swelling and "hurting" on 31-DEC-2008 at site of injection. On 02-JAN-2009, the area was tender to touch with 1.5 area of raised, redness, warmth. The patient was prescribed KEFLEX 500mg daily for 7 days on 02-JAN-2009 for inflammatory versus infection. On 09-JAN-2009, the patient recovered. In follow-up, the reporting nurse stated that the patient's adverse events were not serious enough to require medical or surgical intervention to prevent disability or death. None of the experiences should be considered other important medical events, as she misunderstood what this classification meant. Additional information is not expected.
Patient was given MMR instead of MMRV (Proquad). This was realized on 3/21/22 during a vaccine count.  Lot # of vaccine administered was  determined to be MMR and not MMRV.  (The packaging on MMR and MMRV are very similar and the vaccine locations were switched in the fridge on accident.) Patient's mother was called as soon as mistake was realized.
migraines; arm is sore where the injection; she could hear like blood going through her, and if she moved it got faster and faster; Chills; muscle aches; not feeling well; Headache; fever; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (BNT162B2, manufacture: Pfizer), via an unspecified route of administration on 21Dec2020 by injection once to right arm (Lot Number: EJ1685) at SINGLE DOSE, via an unspecified route of administration on 11Jan2021 (Lot Number: EL3302) at SINGLE DOSE for covid-19 immunization (reported as healthcare worker, medical receptionist).  Medical history included Other Conditions No. There were no concomitant medications. The patient experienced fever on 11Jan2021, headache on 12Jan2021, chills on 12Jan2021 23:30 , muscle aches on 12Jan2021 06:00, not feeling well on 12Jan2021 , migraines and arm is sore where the injection on an unspecified date. The caller had her second vaccine (later clarified as COVID vaccine) on 11Jan2021, and had the same symptoms as on the first one. They were not as bad, and she thought the first one was pretty bad. She previously reported her symptoms with the first vaccine. Symptoms with the second were fever, headache, chills, of course, and muscle aches, her arm weighs a ton, and not feeling well. Fever was noted when she was sleeping, it is now 99.6, but it was was 103. Headache was noted in the early morning, it was not a normal headache, it was the worst thing, and she is prone to migraines, but this was not even like that, she could hear like blood going through her, and if she moved it got faster and faster, one time, she stood still and it was like ahhh! Chills started about 11:30 last night, they went away this morning, about 11AM. Muscle aches started at 6AM yesterday, and are finally gone, as of probably about 9AM, they are fine now, just her arm is sore where the injection was. Not feeling well started yesterday and is getting better. First dose was 21Dec2020, she previously provided lot EJ1685, confirms both were Pfizer vaccines. The outcome of the event fever, not feeling well was recovering, headache recovered on 13Jan2021, chills recovered on 13Jan2021 11:00, muscle aches recovered on 13Jan2021 09:00.  No follow-up attempts possible. No further information expected.
Pain at injection site (two days) Joint pain, predominantly in shoulders and knees (three days) Headache (three days) Diarrhea (three days) Extreme fatigue (three days)
This case was reported by a pharmacist via call center representative and described the occurrence of throat tightness in a 67-year-old female patient who received SHINGRIX (batch number 54KZ4, expiry date 25th April 2020) for prophylaxis. On 16th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a day after receiving SHINGRIX, the patient experienced throat tightness. On an unknown date, the outcome of the throat tightness was recovered/resolved. It was unknown if the reporter considered the throat tightness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient developed throat tightness within 2-3 hours after the vaccination.
Cold; This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8734, Expiration Date: Jul2021), dose 1 via intramuscular, administered in upper arm on 29Mar2021 15:45 (at the age of 19-year-old) as single dose for COVID-19 immunisation in pharmacy. The patient had no medical history and no family medical history to AE. The patient had concomitant medication taken as birth control. The patient did not receive any other vaccines within four weeks prior to the vaccination. After the first vaccination on an unknown date of 2021, the patient experienced just small cold. At the time of reporting, the outcome of event cold was unknown.
For 4 hours post vaccine administration, I experienced the following: Acid reflux flare Fatigue Mild headache General feeling of being unwell
This spontaneous report as received from a healthcare worker refers to a 13 year old male patient. The patient was vaccinated with his first dose of GARDASIL (lot#, expiration date, strength, dose and route not reported) on 10-MAY-2013, second dose on 11-JUL-2013, and the third dose on 30-AUG-2013. This occurred at another facility. No adverse events was reported. It was unspecified if the patient sought medical attention. Additional information is not expected since the reporter didn't want to be contacted.
This spontaneous report was received from a physician assistant, via company representative, and refers to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, 1 dosage form (reported as: vaccine dose) for prophylaxis (route of administration, lot number and expiration date were not reported). On an unspecified date, after receiving the vaccine, the patient was diagnosed with necrotic tissue. The patient received treatment for the event, and recovered on an unspecified date. It was reported that the patient seek medical attention contacting the primary reporter. Upon internal review the event of soft tissue necrosis was considered to be medically significant.
received Infanrix instead of Boostrix; Infanrix administered to an adult; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 20-year-old patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th January 2023, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 10th January 2023, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and adult use of a child product. On an unknown date, the outcome of the wrong vaccine administered and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's Comment: The healthcare professional reported that earlier that day an adult patient accidentally received a dose of Infanrix instead of Boostrix. The reporter did not have enough information regarding the patient or the vaccine but gave consent for the safety team to follow-up. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: An adult patient accidentally received a dose of Infanrix instead of Boostrix, which led to wrong vaccine administered and adult use of a child product.
I never had this issue before receiving my second dose. On 03-01-2021, I started to notice swelling on my feet. I also developed an UTI. I went to see my PCP who performed complete lab work and my lab work numbers came back high. I also saw a cardiologist due to my numbers being high and my PCP though it was related to my heart. My exams to my heart were normal. I then started to experience severe swelling in both lower legs and feet, severe inflammation on my right leg. My PCP treated me with several antibiotics and steroids and it would go away, but once I stop taking the steroid the swelling would reoccur. I have also seen a cardiologist and vascular surgeon and no one knows what causes my swelling. I've had MRI, CT scans and everything has been ruled out, and the doctors I have seen can not find anything wrong. I also have a screw on my right foot which is where I have the severe inflammation. To this day I still continue with severe inflammation to my right leg and foot. To this day no one has been able to tell me why I have the severe inflammation to my legs.
Severe pain at site in left arm extending to whole arm, unable to lift arm or do things.; Severe pain at site in left arm extending to whole arm, unable to lift arm or do things.; Severe pain at site in left arm extending to whole arm, unable to lift arm or do things.; This is a spontaneous report from a contactable nurse (patient herself). A 39-year-old female patient (no pregnancy) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at site of right arm at 16:00 on 19Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe pain at site in left arm extending to whole arm, unable to lift arm or do things on 20Dec2020. No treatment received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.   Information on Lot/Batch number has been requested.
Hives muscle weakness fever took Benadryl Tylenol fever weakness lasted 2days hives came and went on and off for 2 weeks
Nausea, vomiting, dizziness, injection site pain, redness and swelling. Treating arm with KEFLEX and BENADRYL.
Patient received booster dose without receiving initial primary series.  Patient did not disclose that they had not received the primary series, but had requested the bivalent booster.
Generalized itching, bumps on inside of lips occurred in less than 1 hour after vaccination. Given BENADRYL 50mg IM. EMS transported to hospital.
1 hour after receiving the vaccine, I had a hard spot on the injection site. The area was swollen and red and hot, also itchy. This disappeared after 2 days. I experienced vertigo and fatigue for 3 days. This morning, 1 week after vaccination, my arm became itchy. It is now very swollen at vaccine site. It?s also very itchy and hot. The swollen, hard area is about a 3 inch circle. I also have pain in my arm.
Pt recvd 1st dose of Hep B vax in AUG91 & later that day devel h/a & felt bad; next day devel flu-type illness including vomiting, dizziness & fullness in ears; 1mo later pt recovered;
just like getting a flu shot; sore arm; Pain underneath the pectoral muscle; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA IMMUNISATION (just like getting a flu shot), PAIN IN EXTREMITY (sore arm), MYALGIA (Pain underneath the pectoral muscle) and VACCINATION SITE PAIN (Injection site pain) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced MYALGIA (Pain underneath the pectoral muscle) and VACCINATION SITE PAIN (Injection site pain). On an unknown date, the patient experienced INFLUENZA IMMUNISATION (just like getting a flu shot) and PAIN IN EXTREMITY (sore arm). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, INFLUENZA IMMUNISATION (just like getting a flu shot), PAIN IN EXTREMITY (sore arm), MYALGIA (Pain underneath the pectoral muscle) and VACCINATION SITE PAIN (Injection site pain) had resolved.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: TCR received on 29-06-2021.Dose 2 information was added.Events were added
Fever, chills, sweats and severe debilitating deep joint pain starting around 13hrs after vaccination and lasting for 36hrs, although moderate to severe joint pain has persisted
Oct. 31 CoVid test (positive) Note: She ate 3 premade pumpkin pie slices(lactose intolerant) Nov. 25 Complained of heartburn and nausea, later vomited repeatedly and was in much pain(8 of 10). Stabilized and decided instead of going to ER or Urgent Treatment Clinic,  got advise from an on phone physician. Suggested to  stay home and take fluids and regular "as needed" medicines. 11/27 new occurrence of a little diarrhea and still had nausea.  11/29 Nausea still going on but went to school. Seemed to recover at or after 11/30. Complained that throat started tickling again 12/30 CoVid test(positive) Was called by care to follow up and that was after sending a message through medical site.
Left Leg Heaviness on 11/7/2021 Left Leg Heaviness, Left Arm Numbness, and Left Face Numbness on 11/16/2021
BRIGHT RED, WARM, HOT, SIZE OF AN EGG, ITCHING, RASHY,
Patient's mother came in later in the day to pick up epi-pen and steroid.  I inquired about what happened.  She states that about an hour after her son received the vaccine, he was at school and started to experience an anaphylactic reaction. He developed welps, profuse sweating, swelling of the throat and face, trouble breathing.  The ambulance was called and arrived. Epinephrine was administered and he was rushed to ER where his symptoms began to subside.  He was prescribed an epi-pen and medrol dose pack.  He was referred to an allergist.
Became lightheaded and sweaty about 20 minutes after the vaccine was given. Recovered in 5- 10 minutes. Normal  vital signs. BP 128/83, pulse 78, O2 sat 92%.  Normal exam except was diaphoretic.  No  difficulty breathing, urticaria. No swelling of lips or tongue.
Information has been received from a physician concerning a 12 month old female who on 13Sep04 was vaccinated with a dose of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC). Concomitant vaccines included varicella virus vaccine live (MSD). The physician reported that on the night of 13Sep04, the pt developed a fever of 103F and was described as irritable, crying and inconsolable. The pt's fever continued into 14Sep04. The pt was seen at the physician's office and was treated with ibuprofen. On 15Sep04, the pt's fever resolved. At the time of this report, the outcome of the pt's other events was unk. The reporting physician considered fever, irritable, crying and inconsolable to be other important medical events (OMIC). Additional information has been requested. Follow up 03/03/05: Patient date of birth, lot number for vaccine's 1 and 2 not provided.
rash left deltoid from Prevnar administered on 05/13/2009. left deltoid 5x4 erythemetous lesion, not indurated, nontender. ice and 12.5mg benadryl twice a day as needed.
33 weeks pregnant 6 hours after injection patient reported: fever myalgia uterine contractions abd pain diarrhea