chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Side effects seem to have cleared up by the 17th; Weird burst of pain on the left side of my head; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects seem to have cleared up by the 17th) and HEADACHE (Weird burst of pain on the left side of my head) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-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 VACCINATION COMPLICATION (Side effects seem to have cleared up by the 17th) and HEADACHE (Weird burst of pain on the left side of my head). On 17-May-2021, VACCINATION COMPLICATION (Side effects seem to have cleared up by the 17th) had resolved. At the time of the report, HEADACHE (Weird burst of pain on the left side of my head) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 81-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received 6 month from the date of reporting). On 2nd September 2018, the patient received the 2nd dose of SHINGRIX. On 2nd September 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue. On 5th September 2018, the patient experienced injection site rash, injection site itching, injection site erythema and trouble falling asleep. The patient was treated with BENADRYL and Hydrocortisone Cream. On an unknown date, the outcome of the injection site rash, injection site itching and injection site erythema were not recovered/not resolved and the outcome of the fatigue was recovered/resolved and the outcome of the trouble falling asleep was unknown. It was unknown if the reporter considered the injection site rash, injection site itching, fatigue, injection site erythema and trouble falling asleep to be related to SHINGRIX. Additional details were reported as follows: The doses were administered in her upper left arm. The day of vaccination, in the evening she started feeling fatigue, and she felt very fatigued on 3rd September 2018. On 4th September 2018, she felt better. On 5th September 2018, 3 days after vaccination, she woke up and noticed a red, itchy rash around the injection site. She saw her pharmacist, who suggested taking some BENADRYL. Overnight the itching bothered her enough that it was hard to sleep. She had also applied hydrocortisone cream to the rash.
I had a sore arm within moments of receiving the shot. Later in the night I got chills and fever. Now I have a cough, nausea and feel like I have COVID again.
Pruritis to scalp and upper arms. Temp. 97.9, BP 135/97. Sent to ER for treatment. Chest tightness and pharynx red.
Vomited <1hr post immunization and had syncopal episode - No seizure activity. 3/11/09-records received for DOS 2/17/09-presented with vomiting profusely then became limp, lethargic, admitted for observation. Subsequently developed a fever to 101.3, Assessment reaction to vaccine.
One week after injection discovered large elevated hive about 1-1/2 inches in diameter on front lower part of left upper arm.  It was pink.  The upper arm muscle got hard as it initially did after the injection and ached for 3 to 4 days.  Then all symptoms disappeared & I was fine.
Information has been received from a physician assistant via a company representative referring to a female patient of unknown age. No concurrent or historical conditions were reported. The physician assistant stated that on an unknown date the patient might been vaccinated with a dose of MMR (manufacturer unknown) (dose, frequency, route, lot# and expiration date were not reported) when she was a child. Concomitant therapies were not reported. On an unspecified date the patient had titers drawn and the result showed that the patient had no titers for measles. It was also reported that the patient had her spleen removed on an unspecified date. The patient was seen by the physician assistant on an unspecified date and no treatment was given for the events. The outcome of the events and the causality were not provided. Upon internal review, the event "spleen removed" was considered to be medically significant. Additional information has been requested.
Patient received shot at 10:18 AM, started experiencing nausea at 11:09 AM, was administered epi-pen at 11:30 AM followed by 50mg of benadryl. Noted that patient had headache, nausea, high blood pressure, trouble breathing and went by ambulance to ER
I became fatigued that day. Hi progressively became more ill feeling over the weekend. On Sunday morning I awoke with massive diarrhea. I developed a 3° above normal temperature throughout the day. I had chills, nausea, dry heaves, headache, loss of appetite, fatigued. This lasted about 24 hours. I was a little bit better on Monday. I tried to go to work on Tuesday. I left early from work on Tuesday because of nausea, extreme headache, vomiting. It is now Wednesday and I have diarrhea again, no fever. I haven?t had the fever since Monday around noon. I still have a headache, nausea, fatigued.
A non-serious spontaneous report of administration of expired product was received from a health professional concerning a 49-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 04-Dec-2011. On 06-Dec-2011, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
First night - fever, extreme chills, achy body, arm had large knot and was hot to touch.  Second night feverish, throwing up multiple times, dry heaves multiple times - face got extremely hot and woke up with large red splotches on my face that looked like sunburn spots (but they were dried and swollen)
Rapid Heart Beat; Heart rate pounding for hours; Full Body aches; Nausea; Headache; Fever; Chills; A spontaneous report was received from other concerning 77-year-old female patient who developed Rapid Heart Beat, Heart rate pounding for hours, Full Body aches, Chills, Nausea, Headache and Fever.   The patient's medical history included Cardiac issues in 2016 and 2018. Concomitant medication included Motoporal for heart issues.   The patient received their first of two planned doses of mRNA-1273 (Batch number:001AZ10 ) on 26/2/2021 Intramuscularly and suppose to have second dose on 26/3/2021, for prophylaxis of COVID-19 infection.    On 26 Feb 2021, the patient took the shot and experienced fever, chills, full body aches, nausea and headaches. The patient also had very fast heart rate that was pounding for hours, she had the fast heart rate for 24 to 30 hours. The patient also said that she had Covid in Dec 2020 and Jan 2021 for 6 weeks with the same symptoms. The patient was supposed to have her second dose on 26 Mar 2021.  Treatment information was not provided/unknown.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events Rapid Heart Beat, Heart rate pounding for hours, Full Body aches, Chills, Nausea, Headache and Fever were resolved on 28 Feb 2021.; Reporter's Comments: This case concerns a 77 Y/O F with a serious unexpected event of tachycardia, and nonserious unexpected palpitations, and expected pyrexia, chills, headache, pain, and nausea.  Event onset the same days as first dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site swelling) in an adult male 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 Panuveitis. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, VACCINATION SITE SWELLING (Vaccination site swelling) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received 1st dose COVID-19 Vaccine manufactured by Moderna. The reporter's causality for the event of vaccination site swelling  with HUMIRA was a reasonable possibility. No treatment medications were reported. 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.
Initial unsolicited report received from a consumer on 12-Dec-2014. A 36 year old female patient, who was allergic to PCN, BENADRYL, Robitussin and concomitant medications were not reported had accidentally received a dose of IPOL (batch number, route of administration and site of administration were not reported) in here right eye on an unspecified date. It was reported that the female patient was holding her son when he was being vaccinated with IPOL. The needle was not on the syringe properly and it squirted out, splashing her in the right eye and the eye was rinsed. The patient consulting to physician and no injury were found on exam. On 12-Dec-2014, patient stated that since this occurred she developed tightness in her jaw on the right side, no pain or discomfort while taking or eating. The right shoulder was a little sore and the right side of her nose was more stuffy than usual. The patient felt this may be just due to all the stress and she has been under today. The patient was 17 weeks pregnant. Laboratory investigations and corrective treatments were not provided. At the time of this report, the patient had not recovered from the events. Documents held by sender: none.
This spontaneous report was received from a physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 10-JUN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 840 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Improperly stored temperature excursion; Information has been received from a nurse assistant regarding to a patient (age and gender not reported). No medical history, concurrent conditions nor concomitant medications were reported. On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Strength and route of administration not reported) (Lot # S038698, exp. date 01-DEC-2021).  Temperature: -10.2C Time frame: 1 hour and 53 minutes Previous temperature excursion: No Call because of data logger: Yes  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA014950: US-009507513-2008USA014951:
The patient was to receive the flu vaccine simultaneously with the covid vaccine. Instead she received two doses of the flu vaccine, one in each deltoid. The Covid vaccine was subsequently administered in a separate location in the right arm. She experienced no immediate adverse reactions other than pain at the injection sites. Follow-up 48 hours later confirmed that all arm pain was gone and she had no identifiable adverse reactions.
Received TD on 03/05, on 03/06 he developed body aches, subjective fevers and chills without an obvious source. Area of immunization with 2cm induration and tenderness.
5/21/2022 I began with a slight cough that progressed throughout the day.  on 5-22-2022 I woke with  Shortness of breath.  It got progressive worse  Went to ER and was diagnosed with multi blood clots in both lungs and pneumonia in my left lung.  Was admitted to ICU for 1 day and released from the hospital after 3 days.
After both the first and second shots I suffered from: Headaches Nausea Fever Lethargic Body aches / overall pain  After only the second shot I also suffered from: Chills  The day of my second shot I also got my period a week later than normal. It lasted the normal amount of time, but then 4 days after it ended I got it for another week. After that the cycle length and timing went back to normal, but the intensity of my period increased. (All while having an IUD in.)
local reaction at injection site.  Red, indurated, pruritic area left arm 4cm diameter in size. Developed a very small pruritic area the day after injection, which worsened in size by the following morning.
Splotchy red rash on large part of upper arm of injection site, 11 days after injection
1st injection: headache, tired 2nd inection: fever, severe chills, headache, upset stomach, dizziness, diarrhea, lasting 48 hours. Took advil, plenty of water and rested
11/01/2023 -   0600-woke with symptoms of bumps on neck 0900- rash began to itch. Rash was located on face, neck and hands. Raised red rash irregular shaped clustered areas. 1200- took claritin 10mg 1300- rash spread to arms/forearms and 3-4 spots on lower back 1400-benadryl 50mg  11/02/2023 rash became worse. Same areas darker red at this time. Just deeper red color. Arm area more profound rash. Now have a burning sensation in ears. 1100- Patient went to PCP. He prescribed Solumedrol 40mg IM, and prescribed Medrol dose pack.
Swelling of injection site, upper arm pain, head ache, Tiredness, Muscle pain
Patient had pain in the arm for 1 week. Day after vaccination he got a big red rash below injection site that did not itch. It has since resolved.
VASOVAGAL EVENT HR INCREASED TO 170 MAX 174 CLAMMY,SWEATY,PALE,SHAKEY. PT VERY SCARED.PT WITH HX OF ANXIETY
SHOT WAS GIVIN ON 3/13/07, FEVER SPIKED ON 3/30/07 WAS SEEN BY PHYSICAN AND RESULTED IN A DIAGNOSIS OF A POSS VIRAL,FEVER CONT. UNTILL 4/01/07,ALSO COMPLAINED OF SOME DISCOMFORT IN HIS LEGS TOOK A NAP AND WHEN HE WOKE UP WAS UNABLE TO WALK. HE WAS ABLE TO MOVE ALL EXTREMITIES BUT IT WAS VERY TRAMATIC TO BARE WEIGHT ON HIS LEGS. SEEN BY DR. ON 4/02/03, SHE SAID TO WAIT 48HRS TO SEE IF HE WOULD WALK ON EVE 4/3/07 HE BEGAN TO WALK. ALL OF HIS ABILITIES WERE GAINED BACK.MY CHILD HAS HAD AN MMR IN THE PAST, AT THE AGE OF 1 BUT NEVER THIS PROQUAD.
Patient presented to clinic for Hep B #2. Stated the first dose of Hep B gave her a rash at injection site lasting 2 weeks. Instructed patient to see private physician for evaluation and future doses.
Pain in lower abdomen closest to penis. Extreme urgency and frequency (every 15 minutes) in urination. No actual pain during the act of urination. It's almost like there was a blockage. Flow was very weak with lots of dripping. Only lasted for 24 hours (thankfully). Not that this is germane probably but I am Type O+.  I did have Covid with 11 days of symptoms March 17-28 2020. Lastly, in this episode I did also experience fever, chills, fatigue, and body aches, and I know those are known AE's
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 24 months old who received 0.5 ml dose of vaccine FLUZONE QIV (lot number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
After I took I vaccine I only had the sore arm at injection site for 2 days. One 01/17/2021 at lunch while drinking water, I noticed water dripping out the right side of my face (mouth). The next day morning my doctor I work from found that right side weakness. The referred me to my primary care doctor, and she did a video visit with me and was diagnosed with Bell's Palsy, I seen her at 01/18/2021 at 1:50 PM. She prescribed prednisone 60 mg and once a day and  Acyclovir 800 mg taking 5 times a day q4hr for 7-10 days.  As of today I have  not recovered, it is not getting worse but not getting better.
Injection site pain, Headache, Fatigue, Mild Sore Throat, Swelling of injection site
Hives all over body.  Oral antihistamines have been taken, along with 1% hydrocortisone applied topically to affected areas as needed; medication helps lessen but not eliminate symptom
Hepatitis B vaccine administered at 1855 to (R) thigh on 5/29/18. Within short period of time (within 30 minute) developed diffuse erythematous urticarial like rash. No cardiorespiratory compromise. Rash dissipated significantly within 1 hour of PO BENADRYL administration.
1 of 3 pts who experienced swelling & redness fr the inject site to the elbow; Tx APAP, DPH, & cold compresses;
Significant pain at injection site soon after. 2/12/21 Fatigue 2/13/21 Muscle  aches 2/13/21
My symptoms started on November 05, 2022. I had a dry scratchy throat for about three days. A few days later, I got a stuffy nose that progressively got worse. The stuffy nose lasted for about three days. Then, I developed a mild cough. I did an at home COVID-19 test on November 08, 2022, and it was positive. I went to the doctor for a COVID-19 PCR test the same day. That was also positive. I went into isolation. When I contacted my doctor, I asked for a prescription of Paxlovid. I started Paxlovid the evening of November 09, 2022. I finished the prescription on November 14, 2022. On the afternoon of November 17, I started having symptoms again. The stuffy nose came back. It progressively got worse, and I still had a mild cough. Late morning of the 18th, I took another COVID-19 home test, and it came back positive. On the 18th, I went back into isolation. On the night of the 18th, I started a second round of Paxlovid. I finished the Paxlovid on November 23rd, 2022. I left isolation on November 27, 2022. I still have a very mild cough, but that is my only lingering symptom.
pain is also experienced if I try to raise my right arm; pain and burning sensation in right shoulder joint.; Soreness near the injection site; Light pain in the  lower right forearm.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Light pain in the  lower right forearm.), INJECTED LIMB MOBILITY DECREASED (pain is also experienced if I try to raise my right arm), ARTHRALGIA (pain and burning sensation in right shoulder joint.) and INJECTION SITE PAIN (Soreness near the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Ankylosing spondylitis on 01-Jan-1975. Concomitant products included NAPROXEN from 02-Feb-2020 to an unknown date and MELOXICAM from 02-Jan-1985 to 25-Feb-2020 for Antiinflammatory therapy, ATORVASTATIN from 02-Jan-1990 to an unknown date for Cholesterol, ASCORBIC ACID (VITAMIN C ACID) from 02-Jan-2000 to an unknown date for Vitamin C supplementation, VITAMIN D3 from 02-Jan-2000 to an unknown date for Vitamin D supplementation.   On 11-Jan-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Light pain in the  lower right forearm.) and INJECTION SITE PAIN (Soreness near the injection site). On an unknown date, the patient experienced INJECTED LIMB MOBILITY DECREASED (pain is also experienced if I try to raise my right arm) and ARTHRALGIA (pain and burning sensation in right shoulder joint.). At the time of the report, PAIN IN EXTREMITY (Light pain in the  lower right forearm.), INJECTED LIMB MOBILITY DECREASED (pain is also experienced if I try to raise my right arm), ARTHRALGIA (pain and burning sensation in right shoulder joint.) and INJECTION SITE PAIN (Soreness near the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable. No treatment was provided.    Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: follow-up received on 24-APR-2021 included second dose information,concomitant medications,addition of two new event arthralgia and Injected limb mobility decreased.
Rash on arm - noticed 3 days later.  7 days later the rash 2 1/2" x 2" was uncomfortable, hot to touch, with a small raised portion about the size of a dime at the injection site.  Now 9 days later the rash is now 3 1/2" x 3", still hot to touch.  Local doctor said to take benadryl and use warm compresses.  This has not helped and the site is getting larger.