chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling in arm/Bump after COVID booster vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling in arm/Bump after COVID booster vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, UNK. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling in arm/Bump after COVID booster vaccine). At the time of the report, VACCINATION SITE SWELLING (Swelling in arm/Bump after COVID booster vaccine) was resolving.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event with Humira was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-091154, MOD-2021-624453 (Patient Link).
Vesicular rash on (L) arm, neck and face; rash appeared 3/27/09. No fever. Patient's daughter received live attenuated varicella vaccine 3-4 weeks prior to the appearance of this rash.4/10/09-records received-presented on 3/27/09 with C/O rash and shortness of breath, cough and brown sputum for last couple of days, rash developed today vesicular appearing. Some wheezing.
1/19/22, I went to administer vaccine to patient while sitting on mothers lap. Upon administration of the vaccine the child pulled her arm back and the vaccine went down her arm instead of IM. She was re-administered the vaccine and no further issues.
baseball size swelling @ site for 2wk p/shot;has now been 3 1/2mo & has olive sized bruised areas w/lumpy feel intermittently painful (skin in indented)) resembles mark of a small pox vaccine;
"Pfizer-BioNTech COVID-19 Vaccine EUA"   I awoke on May 11th, '21  with sharp pains in my Right side Armpit area.   The pain was very sharp and intermittent.  When I looked under their I saw 6 red bumps in a V-shape ....   the bumps appear almost like an insect sting,,,  bumps are about 3 to 5 millimeters across,  one of the bumps seems to have much smaller bumps clustered around it.  I assumed that perhaps it was an insect, or spider bite,  and hoped it would heal.   It has now been 9 full days and the bumps still appear the same without fading, and the intermittent pain has intensified like something is pinching very hard in the area.   On May 14th, '21 during my work day I begin to sense painful itching on my On  May 18th, 2021  during my work day I began to feel a sharp painful itching  under my  right-side  Shoulder blade.   This  rash  appears  to be  in a  1.5" diameter circular patch,  with a  cluster of very small  pink bumps.     -----   Again  the pain is intermittent and mostly when I accidentally rub my back on something,  or my shirt stretches across the rash area.    The pain can also be intense.....    so much so that at times  the  pain between the  bumps in my right armpit and the lower area of my right shoulder blade seem to be connected  and the pain stretches across an imaginary set of strings from one rash to the other.      I do work outdoors often,   and  in years past  have been stung or bitten by unknown insects, ants, or spiders,  but usually the pain and the redness subside or disappear within 24 to 48 hours.....   In this case the  armpit  bumps and the rash below my shoulder have NOT  subsided  in  color intensity or in size  ---  AND  the Pain intensity has lingered now  9 days in the Armpit area and  6 days under my Right Shoulder blade.       I have applied  Benydryl at night time to help lessen the itching ---  pain is caused when I move in certain ways to cause rubbing of the affected areas.   For  NOW,  since I do not see an improvement,   I will  seek  medical attention as soon as possible.   Other than the discomfort,  itching,  and  related pain,     I  do not  see this as an  Emergency as this moment,   and  I do not have any associated Fever or change in my blood pressure or  ability care for myself or continue my career responsibilities.  I am mostly more concerned for any long term effects  or additional problems that may occur.
Swelling in arm, Pain in the arm for 2 weeks (Inside the arm), Tingling in the tongue, shallow breathing. - Not 100% recovered.
Arm now feeling normal, had almost every side affect; Arm now has a nice bruise; This case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date and refer case US2022AMR123583).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced arm discomfort and contusion. On an unknown date, the outcome of the arm discomfort and contusion were recovered/resolved.   It was unknown if the reporter considered the arm discomfort and contusion to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR123583   Additional Information: GSK Receipt Date: 23-Aug-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received 2nd shot and had almost every side effect listed for 4 days.  The patient's arm was just now feeling normal but had a nice bruise. The patient was still okay with decision to get the vaccine though because the patient was hoping it would prevent from getting a bad case of shingles. Additional Supportive Information: Follow-up would not possible, as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR123583:Same reporter.
Patient was accidently given 0.2mL of the adult Pfizer vaccine instead of the pediatric Pfizer vaccine.   Happened today.  No issues with the child as of now.
NASAL BURNING; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination in left arm. No concomitant medications were reported. On 13-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced nasal burning. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 13-MAR-2021, and had not recovered from nasal burning. This report was non-serious.
approximately 24 hours post dose 2, patient suffered a witnessed syncopal event. He recovered relatively quickly and was brought in to clinic by bystanders. He is suffering no lingering effects 1 hour post event.
Left arm hurt for two days; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6206) via an unspecified route of administration on the left arm on 12Mar2021 at 09:00 (age at vaccination was 35-year-old) for COVID-19 immunisation. She has no medical history and has no known allergies. She did not receive any other vaccines within 4 weeks prior to the vaccination. Prior and post the vaccination she was not diagnosed with COVID-19. Concomitant medications (given within 2 weeks of vaccination) reported included melatonin, ibuprofen (ADVIL), collagen supplement, magnesium. On 12Mar2021 at 10:00, she experienced left arm hurt for two days. No therapeutic measures were taken for this event. The clinical outcome of the event left arm hurt was resolved after two days (on an unknown date in Mar2021).  No follow-up attempts are needed. No further information is expected.
Increase in intensity of my tinnitus of my left ear noticed after receiving the injection.  First noticed it the next morning, but did not think too much of it, but it has been consistently of greater intensity that before the injection.
injection site pain; This is a spontaneous report from a contactable pharmacist. An adult (reported as 39, unit unknown) female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot number and expiry date were unknown), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. The patient received COVID-19 vaccine in a hospital facility. The patient's medical history and concomitant medications were not reported. The patient previously experienced vaccination site pain from flu vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had 1st dose of COVID-19 vaccine and experience injection site pain. She described it as "more painful than any flu vaccine received". The patient did not receive treatment for the adverse event. The outcome of the event was recovered in Dec2020.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.
vaccine had undergone 1 temperature excursion was administered to 2 patients; vaccine had undergone 1 temperature excursion was administered to 2 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (vaccine had undergone 1 temperature excursion was administered to 2 patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine had undergone 1 temperature excursion was administered to 2 patients) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060A22A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccine had undergone 1 temperature excursion was administered to 2 patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine had undergone 1 temperature excursion was administered to 2 patients). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (vaccine had undergone 1 temperature excursion was administered to 2 patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine had undergone 1 temperature excursion was administered to 2 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that two warm temperature excursions occurred with two different batches of the same lot number of the Moderna COVID-19 Vaccine. The two different batches of vaccine were stored in the facilities freezer.   The first set of Moderna Covid-19 vaccine lot number was 060A22A the vaccine reached 7.9 degrees Farenhight in a freezer for 10 minutes. This excursion occurred on 23MAY2022. The second lot number of Moderna Covid-19 vaccine that underwent an excursion was 060A22A. On 8JUL2022 10 vials of vaccine reached 6.24 degrees Farenheigt for 39 minutes.The second lot number of Moderna COVID-19 vaccine that underwent an excursion was 060A22A. On 08-Jul-2022 10 vials of vaccine reached 6.24 degrees Fahrenheit for 39 minutes.  No side effects or Adverse Reactions were known from the Primary Series.  No treatment medications were reported.   This case was linked to MOD-2022-608600 (Patient Link).
81 yr old female with pmh of dementia , parkinsons long term resident of assited living was sent to er for cough fever and hypxia . in er evaluation pt found to have uti , lethargy . pt is admitted for further treatment and close monitoring , including test for covid .
Information has been received from a registered nurse concerning a patient who, on 04-OCT-2013, was vaccinated subcutaneously with an expired dose of M-M-R II lot # 1404AA, expiry date: 06-SEP-2013 (dose not reported). It was unspecified if that was the first or second dose of M-M-R II this patient had been administered. No known adverse effect was reported. Additional information has been requested.
Information has been received from a registered nurse concerning a 6 year old male who on 18-MAY-2005 was vaccinated with Varivax. On 28-JAN-2007, the patient developed chicken pox with a rash less than 50 pox. The rash is located on both arms and was diagnosed by the physician. No treatments were prescribed and the patient is reported to be recovering at home. No diagnostic laboratory tests were performed. There was no product quality complaint. No further information is expected.
Three hours after administration. Tremors, Body Shakes, Sweating, Vomiting, back pain
I had facial tingly, numbness ad swelling.  I went to ER, they did lab work and honestly that was all and thought it was a side effect. This lasted about a month or so .
Pt. received the Pneumovax on 9-20-22 (Tuesday) in the left deltoid. Pt. came by the pharmacy the next evening and presented with redness and pain in the left arm around the elbow. Pt. stated that other then the pain in her elbow, she was fine. She was counseled to follow up with a doctor the next day. Pt. at the present time does not have a PCP.
Day after vaccination (vaccination given on 8/28/17) Patient developed swelling rash diameter about 4 inches on inside of elbow (around 6 inches from injection site (L) deltoid) - Patient went to urgent care on 8/31/17, was given triamcinolone 0.1% Inj.
began feeling ill w/heart pounding, feels shaky, nauseous, h/a;site of inj w/o redness or swelling;CBC drawn;WBC 12.3 (4.6-10.2);
(2008) Received flu shot Nov 3 & ok until Nov. 22nd.  Woke up and had #6 pain left arm (upper only) with pain to left LUE distal to that.  Still has some pain (#2 at rest), increased #8 with movement.  Pain described as "weakness" & "achy".  No new routine or activity noted post flu shot given to cause pain.  Exercises but not since flu shot.
PATIENT REPORTED RASH/VOMITING, WENT TO DOCTOR FOR APPT LATER THAT DAY, WAITING TO HEAR BACK FROM DOCTOR.
This is a spontaneous report was received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported ), via an unspecified route of administration on 03Feb2021 as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medication were not reported. It was reported that the patient received first dose of the Pfizer covid vaccine yesterday on 03Feb2021 and was having a bit of a headache. She called her HCP and said it was okay to take Tylenol (paracetamol) and decided to call us to see what information we have on our side. The patient took treatment with Tylenol. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
pt recvd vax;noted a burning sensation at inject site;next day,flu-like sxs,fever,n;these sxs cont 3-4 days & started to resolve'1 wk p/ 2nd dose,sudden tiredness,sore throat,malaise,low fever;delirious;seen by MD;to hosp;liver failure
Indurated inflamed injection site in left upper deltoid; crusty granulation tissue, no vomiting, no fluctunancy Temp of 100.6 deg taken.
Two hours post vax, developed angioedema of the upper lip. Progressed despite treatment with Benadryl. ER treated with epinephrine, IV Benadryl, and prednisone.
Information has been received from a medical assistant concerning a female (age not reported) who on 12/8/05 was vaccinated with Pneumococcal 23v polysaccharide vaccine (lot 650329/0747P). That same day the pt experienced a sore arm. At the time of this report it was unknown if the pt had recovered from the sore arm. Additional information has been requested.
Mild to moderate tinnitus in both ears. Started approx the day after receiving first dose. More noticeable when less background noise. Hear it every day. Not really any changes in symptoms. Within the first two weeks however, I heard occasional and much louder and noticeable bursts of ear ringing that lasted 15-30 seconds. Have not heard that since the first couple of weeks. Now just chronic mild tinnitus, which is currently manageable. I would very much like to get fully vaccinated, but I'm very concerned about receiving the second dose since others I've spoken to who have experienced similar side effects from the first dose have reported worsening on second dose and some indicating their tinnitus becoming unmanageable. I'm very concerned that this condition could become disabling after second dose. I've tried very hard to research this and see if there are any mitigation measures that I could do to prevent worsening of tinnitus on second dose. Only thing I have heard is that I should receive second dose as far as possible from area of side effect, and that my second shot should be in the thigh. I also considered getting one of the other vaccines as the second dose, but they have all had reports of tinnitus, so I don't think that would make a difference. The general medical community has no knowledge of how to help people with this issue and is not accepting that my condition was caused by the vaccine. However, I have NEVER had long term tinnitus. Only rarely in my life, which was short lived, such as after hearing a loud noise. But not like this. While the medical community can debate the cause and effect, I'm fairly confident my reaction was due to the vaccine. People who have Covid also have reported tinnitus, so I imagine this is something to do with the body's immune response. There are MANY more people experiencing this side effect than have reported I am sure. These people would all like to be fully vaccinated (if they have not received the second dose) and this needs to be addressed if we are going to help relieve their hesitancy. The Director for a large regional hospital system in the area told me that my choice is: receiving the second dose and possibly becoming disabled with severe Tinnitus (as side effects experienced on first dose are normally, but not always, worse after second dose of a vaccine) OR getting Covid!!Neither one is a good outcome!!
5-10 minutes after vaccine developed 5 hives on her head and face.  She returned to clinic, no distress or respiratory compromise, given Benadryl PO.  By 12:20 pm hives almost resolved and no respiratory distress or compromise.
Chills, rapid heart rate in the 130. Low Oxygen saturation level was 91. Drank lots of fluids and rested.
I am filing this on behalf of my sister, who feels it needs to be reported but she is too grief-stricken to do this herself.   The morning after the second shot, my sister texted that her husband was up at least 10 times during the night, and five times the next night. He was agitated and hallucinating (swatting at bugs that weren't there.) For the next four weeks he had progressively more difficult breathing, and on 4/28 a liter of fluid was drained from his chest. He continued to have difficulty breathing and was taken by ambulance to Hospital on May 2 where they again drained his chest and diagnosed him with pneumonia. A nurse told him they were seeing a number of cases of fluid around the lungs (his fluid was around the lungs, not in them) after COVID vaccines. He was sent home May 4 and commented that it was strange his cardiologist hadn't visited.   Almost immediately he was experiencing liver and gall bladder pain, even though tests for those showed the two organs were healthy. On May 8 my sister said patient woke up hyperventilating, which also became more frequent. On the 9th his daughter told me the labs were not trending well, and on May 10 he saw his cardiologist. He diagnosed him with congestive heart failure and got him an appointment at the Heart Hospital on May 17 - he explained congestive heart failure is scary but can be managed through programs at the heart hospital. He began sleeping outside because it made it easier to breathe.   On May 15 he was advised to go to the ER/Hospital for tests the heart hospital would need and, once there, they discovered his kidneys weren't functioning and he was admitted immediately. He spent 17 days at Hospital- if the kidneys improved, the heart got worse. If the heart improved, the kidneys failed. He was released on June 2.   On June 7  my brother took him to get blood work done - Patient was too weak to get in and out of the car by himself. The blood work came back bad, and on June 8 he was admitted to the Heart Hospital. On June 10 he was transferred to the Regional Community Hospital to be closer to his cardiologist. From there he continued to decline, and the doctors wanted to do surgery for a LVAD but couldn't. To help him get stronger, he had an impeller put in by catheter on June 19 and died that night.   His own cardiologist said congestive heart failure is manageable. The symptoms started the night of the second vaccine and his illness wasn't gradual - he went off a cliff. With all the heart problems appearing in males, we don't think this was coincidence.
Adult > 12 years old was reconstituted with 1.3 sterile saline and 0.2 mL was administered IM Patient observed for 30 minutes post vaccination, no adverse reaction noted
Chest pain developed 3 days following vaccine administration. Presented to ED the morning of 4/11/2021, and was found to have diffuse ST elevation on ECG, and troponin level of 0.52. Received dose of aspirin, and then was transferred to Hospital for treatment and monitoring of pericarditis the afternoon of 4/11. Echo at Hospital with good LV function. Repeat EKG demonstrated ST elevation again, and he was started on ibuprofen 600 mg every 6 hours. Chest pain recurred in the evening of 4/11, but resolved some time after administration of ibuprofen. Troponin level upon arrival to Hospital were 3.92 at 17:11 on 4/11, then rose 8.68 at 23:42 on 4/11 at the time of his worsening chest pain. Chest pain still resolved by morning of 4/12, and troponin level downtrended to 5.87 at 6:22 on 4/12. Diagnosis consistent with myopericarditis.
A little after 24 hours from vaccine developed swelling and erythema in both feet. Woke up next morning with swelling/erythema of left lower lip corner and right thenar eminence. Felt like needed to itch inside her skin. Ibuprofen helped pain but could not walk due to swelling/pain. No pitting edema.