chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (On the injection arm he experienced itchiness), VACCINATION SITE RASH (injection arm rash), VACCINATION SITE ERYTHEMA (injection arm red spot), PRURITUS (Itchiness) and RASH (RASH) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Z01A21A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (On the injection arm he experienced itchiness), VACCINATION SITE RASH (injection arm rash), VACCINATION SITE ERYTHEMA (injection arm red spot), PRURITUS (Itchiness), RASH (RASH) and ERYTHEMA (Red spot). At the time of the report, VACCINATION SITE PRURITUS (On the injection arm he experienced itchiness), VACCINATION SITE RASH (injection arm rash), VACCINATION SITE ERYTHEMA (injection arm red spot), PRURITUS (Itchiness), RASH (RASH) and ERYTHEMA (Red spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported no side effects with first dose of Moderna vaccine. Patient reported that he experienced similar reactions on his opposite arm under elbow on which he had injection  No concomitant medications were reported.  No treatment information was reported.
THE MORNING AFTER THE INJECTION, EMPLOYEE STATES THAT HER LEFT LATERAL ASPECT OF THE ARM CLOSEST TO THE ELBOW WAS SWOLLEN AND EXTREMELY SORE, TO THE POINT OF WEAKNESS WHEN ATTEMPTING TO LIFT ANYTHING, EVEN A LIGHT ITEM LIKE A PATIENT CHART. LEFT UNDERARM WAS ALSO PAINFUL. INJECTION SITE WAS NOT ABNORMAL, ONLY SLIGHTLY SORE.
Per patient she had pain and swelling in the left upper extremity. Patient was informed to apply ice and take Motrin from ER visit on 5/12/13.
About 06:00 PM, I got really cold and couldn't get warm. At 09:00 pm, I started diarrhea and had nausea. That lasted about 72 hours. I ran about 100.5 fever the whole time. My lips were even blue I was so cold. A week and a half after all of that, I was getting out of breath with everything I did. I couldn't breathe. I called my doctor. My lungs didn't look bad. Pulmonologist and heart doctor. Heart doctor told me to do a stress test - which I barely passed. It's Lower Ventral Branch block - I had mild to moderate of this before but now it's considered acute, and another valve thickened too and that I had hadn't before. Echo cardiogram - my valves had thickened, and it was causing some possible leakage. He adjusted my medication some and I'll need to monitor this every year. The Pulmonologist did test - he put me on Trilogy inhaler to help me breathe and open up airways. I do go through phases of when I'm feeling really good for several weeks and then I'll have a week or two where I'm really down again and not feeling well. The heart doctor is saying I'm a COVID-19 a long hauler. I still haven't gotten my full smell sense back. I had some enlargement in my left side heart, too, that I have not had before. That's a concern. Before this, I could walk around and keep physical but now I try physical things and get to huffing and puffing really bad. I have not felt energetic at all. I was always before I was going, going going. I was keeping up with people before but now I can't keep up with my husband when we take a walk because I get out of breath.
Information has been received from a registered nurse concerning a 16 year old male with down's syndrome and an atrial ventricular septal defect who was vaccinated with hep b vaccine recombinant. The pt was on concomitant therapy with Depakote. On 10/25/2001, a divalproex sodium drug level was drawn, and the pt's dose of divalproex sodium had been doubled to 750 mg twice daily. On 10/26/2001, the pt was vaccinated with a first dose of hep b vaccine recombinant IM in the left arm. On 10/27/2001, the pt became highly agitated, irritable, combative/physically aggressive, and did not respond to redirection. The pt had been responding well to medication and was pretty calm prior to the weekend of 10/27/2001. The pt received medical attention for his experience. On 10/30/2001, the pt was still agitated. Additional info received indicated that the outcome of the pt's experience was unknown. No additional info is expected.
Pt came in and got shot earlier on in the day. Later that night it started to really hurt she started to have flu like symtoms (fever, fatigue) so she went to bed. When the patient woke up the next morning her arm was swollen and red and warm to touch. She came into the Dr office on 3-11-13 and was seen by Dr the area was red and swollen and warm to touch. The redness was 7 inches in length by 6.5 wide. She has a knot where the injection was given.
swelling in the whole arm that received the dose of GARDASIL 9; This spontaneous report as received from a medical assistant via company representative refers to a 36 year-old-female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.       On 03-JUL-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 # 1614897, expiration date 20-SEP-2021) (dose and route of administration were not provided) to prevent human papillomavirus (HPV).        Then, on an unspecified date in July 2019, the patient developed swelling in the whole arm that she received the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient sought medical attention and went to see a physician assistant. On an unknown date, she started treatment with unspecified steroid therapy for the swelling. On an unspecified date in July 2019, the patient recovered from the event.  The relatedness between the event and the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
she cut her finger because the vial was broken; 1 vial of MenCYW liquid conjugate that was broken; This case was reported by a other health professional via call center representative and described the occurrence of laceration of finger in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA390A, expiry date 31st August 2021) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Menveo. On an unknown date, immediately after receiving Menveo, the patient experienced laceration of finger and pharmaceutical product complaint. On an unknown date, the outcome of the laceration of finger and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the laceration of finger to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The reporter reported that in a physician's office receive 1 vial of MenCYW liquid conjugate that was broken and was discovered after only 1 dose had been used out of the box. The reporter attempted to remove the vial from the box prior to preparation she cut her finger because the vial was broken. The box did not appear to be damaged from shipping, the product was not administered to a patient, and the HCP attempting to prepare the vaccine was an experienced user. The reporter statet that there was no evidence of leakage in the box, there were pieces of glass still in the carton, and there was no product still present in the vial and the whole circle on the bottom of the vial was broken off and missing. No additional information obtained about the event due to the adverse event  being filed after call. The reporter did not consent to follow up.
3 1/2 hrs after immunizations, infant was breast feeding but fussy. He then appeared sleepy and his eyes rolled back. Mom began changing his diaper but he developed difficulty breathing, then stopped breathing and became cyanotic/pale. She attempted to rouse him. He had a small mild and perocic breathing persisted. He was difficult to arouse for 20-30 mins. In ER, difficulty breathing, cyanotic, retracting improved: oxygen, albuterol. No fever.
Little bit of a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little bit of a sore arm) 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 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Little bit of a sore arm). At the time of the report, PAIN IN EXTREMITY (Little bit of a sore arm) had resolved.            No concomitant medication was reported.  Treatment medication was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
PT received Flucelvax instead of Fluvirin. Flucelvax is indicated to pts 18 yo and over only. Pt had no adverse reactions.
Incidentally discovered thrombocytopenia on CBC performed 5/10/2021 for workup of other symptoms (ongoing fatigue), with platelet count 108. Workup reveals like ITP, with otherwise normal peripheral smear and elevated immature platelet fraction.   Platelet counts remained stable on follow up labs  in May and again in July 2021.   Most recent recheck showed platelet count of 115 on 7/12/2021.  Therefore, diagnosis appears to be ITP, that is asymptomatic.   Previous platelet count on 1/11/2018 was notably slightly low, at 148.   This suggests possible pre-existing ITP.  Timing of this lower platelet count does not prove, but suggests possibility that vaccination may have worsened ITP to a new, lower platelet level.
Initial report was received from a health care professional on 12 December 2011. An 11-year-old female patient received an intramuscular injection in the left deltoid of FLUZONE, lot number UH463AB on 05 October 2011 and developed symptoms on the same day. On 07 October 2011, the patient was seen for complaints of a swollen left hand, fingers were numb and tingling and hand was red and itchy. The patient was treated with BENADRYL. On 14 October 2011, the patient was seen again with hives all over her body and a swollen left knee and foot. The patient was treated with ZYRTEC and BENADRYL. The patient was seen again on 10 December 2011 and tested positive for an allergy to FLUZONE. Illness at time of vaccination was reported as none. The patient took no concomitant medications and has no known allergies (NKA). No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Fever, face flushing, painful arm motion, loss of breath/energy when just walking (unable to move much), headaches, injection site soreness
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. On unknown dates, multiple unspecified patients were vaccinated with GARDASIL lot # H020901, expiration date: 05-JUL-2015 or lot # J012212, expiration date: 18-FEB-2016, (dose, administration route and site were not reported) after it was exposed to a supported temperature excursion of 32.9F for 2 hours and 45 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 26 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Lot number: FF2590) at the age of 26 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "oral allergy syndrome" (unspecified if ongoing); "allergy to birch trees" (unspecified if ongoing); "certain foods make her throat itch" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Lot No: EN6205), administration date: Mar2021, for Covid-19 immunization, reaction(s): "stomach swelling"; Bnt162b2 (DOSE 2, Lot No: EN6205), administration date: Apr2021, for Covid-19 immunization, reaction(s): "arm and stomach swelling"; Bnt162b2 (DOSE 2, Lot No: EN6205), administration date: Apr2021, for COVID-19 Immunization, reaction(s): "arm and stomach swelling". The following information was reported: LYMPHADENOPATHY (non-serious), PAIN (non-serious), outcome "unknown" and all described as "Terrible pain and swollen lymph nodes under her arm"; ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "belly was swollen"; RASH (non-serious), outcome "unknown", described as "Rash"; URTICARIA (non-serious), outcome "unknown", described as "small hives". The events "terrible pain and swollen lymph nodes under her arm", "belly was swollen", "rash", "terrible pain and swollen lymph nodes under her arm" and "small hives" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, abdominal distension, rash, pain, and urticaria. Additional Information: The rash disappears and comes back somewhere else. She was on antihistamines for 6 weeks and has gone to dermatologist and allergist. She said that her daughter had a extreme reaction after the vaccine. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202200463199 similar report from same reporter; US-PFIZER INC-202200463200 similar report from same reporter.
2/25/2021 a rash surrounding a brighter red spot appeared on left arm.  It itches and is still visible today.  I also have a sore throat, dry cough, and a stuffy head which all started this morning 2/2/2021.  No fever.
Headache; possibly no/not enough Humira was on patient system; This spontaneous case was reported by a physician and describes the occurrence of DRUG LEVEL DECREASED (possibly no/not enough Humira was on patient system) and HEADACHE (Headache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    The patient's past medical history included Alcohol use (one or two drinks, variety, occasionally) from 1974 to 2019. Concurrent medical conditions included Crohn's disease. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Acid reflux (esophageal).   In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DRUG LEVEL DECREASED (possibly no/not enough Humira was on patient system). On 17-Mar-2021, the patient experienced HEADACHE (Headache). On 18-Mar-2021, HEADACHE (Headache) had resolved. At the time of the report, DRUG LEVEL DECREASED (possibly no/not enough Humira was on patient system) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 15 Mar 2021, blood work was performed to determine if adalimumab was in the patient's system (results not provided).  Treatment information was not provided. On 16 Apr 2021, the patient received his second dose of mRNA-1273 (Moderna COVID-19 Vaccine) intramuscularly (lot number 027B21A, expiration date 18 Sep 2021).  Therefore, the action taken in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Temperature of 103.5Degress Farenheit; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature of 103.5Degress Farenheit) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced PYREXIA (Temperature of 103.5Degress Farenheit). At the time of the report, PYREXIA (Temperature of 103.5Degress Farenheit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-May-2021, no new information was recorded
Sinus infection with cough, dizzy spells, loss of balance, weakness, anxiety, ear pain, abdominal pain, and nausea,legs give out, brain fog, sea legs, rapid heart beat, high blood pressure, nasal polyps.
8/9/17-8/11/17 diarrhea and extreme fussiness. 8/12/17- lack of energy and little appetite. Fever of 104.9.
Person administering vaccination grabbed syringe she thought was ready to administer and instead grabbed a syringe that was about to be drawn, only containing air. A dose of less than 0.5ml of air was administered into the patients left arm and the administrator quickly realized what had happened, alerted the patient, and got a new syringe (verifying it was drawn up) and administered the correct 0.5ml of the moderna vaccine.
Couldn't drive, so she called off work; Felt nauseated; Heart was pounding so hard in my chest; she could hear it in her left ear; Body jolted; Terrible nightmare/ nightmare all over again, this happened all night long; Woke up at least 20 times or more / insomnia; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart was pounding so hard in my chest; she could hear it in her left ear), TREMOR (Body jolted), NIGHTMARE (Terrible nightmare/ nightmare all over again, this happened all night long), INSOMNIA (Woke up at least 20 times or more / insomnia) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't drive, so she called off work) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21 and 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 26-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced PALPITATIONS (Heart was pounding so hard in my chest; she could hear it in her left ear), TREMOR (Body jolted), NIGHTMARE (Terrible nightmare/ nightmare all over again, this happened all night long), INSOMNIA (Woke up at least 20 times or more / insomnia) and NAUSEA (Felt nauseated). On 25-Oct-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't drive, so she called off work). At the time of the report, PALPITATIONS (Heart was pounding so hard in my chest; she could hear it in her left ear), TREMOR (Body jolted), NIGHTMARE (Terrible nightmare/ nightmare all over again, this happened all night long), INSOMNIA (Woke up at least 20 times or more / insomnia), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't drive, so she called off work) and NAUSEA (Felt nauseated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2021, Heart rate: 130 (High) Increased.         No treatment medications were reported.
Patient came to pharmacy on 10/27/2022 to get her 2nd shingles vaccine (shingrix). Rph followed the correct procedure by using hand sanitizer and wearing gloves. Then, used alcohol swab to clean the skin then used the proper needle to mix shingrix vaccine and used proper needle into the muscle at 90 degree with a quick thrust. Patient suddenly moved her arm after finishing administering the vaccine while the needle was still in her arm. RPh took the needle out and make sure no bleeding or swelling as result of the sudden movement. Patient came next day to the store and mentioned she has pain in her arm and she doesn't know if it's because of the vaccine or it's a local site reaction
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 7 year old female pt who experienced nasal congestion, feeling lethargic and cough.  At 7 years of age, the pt received a dose on 10/16/03.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 10/16/03.  Dose regimen was 1 dose intranasal.  Pt was not taking concomitant therapy.  The pt experienced nasal congestion (nasal congestion), feeling lethargic (lethargy), and cough (cough) on 10/16/03.  The pt's mother stated that she doesn't know if these events are related to Flumist or seasonal allergy or cold. As of 10/29/03, the pt's symptoms persisted.  No additional information was available at the date of this report.
Had 2nd Covid vaccination with Pfiezer on 1/6/2021.    She reports that night around 8pm she developed terrible leg pain in which OTC meds did not help.  On 1/7/2020 she had a temp of 101, dry heaving, weak and chills.  On 1/8/2021 she felt better but still no appetite and was nauseated even with fluids, body aches and temp of 99.7.  She reported a sore arm and mild nausea after the 1st vaccine.
Sunday(10/28/2018) about 3 days later after the vaccine I developed numbness on the right side of my lips,. On Monday (10/29/2018) I went to Medical Center were I underwent a series of tests and the medical staff concluded I developed Bell's Palsy.
pt recv vax; devel blisters; 5-10 days later,exp joint pain & n;f/u stated recv 3 doses in 94 & a booster shot;following vax,pt devel a "sick & upset stomach",sore joints & muscles & clear blisters on the skin around inject site;
Significant brain fog following the 2nd dose of Pfizer vaccine, started approximately 1 week after 2nd injection. "Feels like a zombie walking around" ever since vaccination