chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sneezing; clogged nose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 08:45 (Lot number: FC3180) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Diagnosed about 8 years ago. The patient's concomitant medications were not reported. The following information was reported: SNEEZING (non-serious) with onset 13Aug2021, outcome "not recovered", described as "sneezing"; NASAL CONGESTION (non-serious) with onset 13Aug2021, outcome "not recovered", described as "clogged nose".  Additional information: The caller was calling about the Pfizer covid vaccine. On Friday the caller had her first vaccination. Since then, the caller has been with her nose completely clogged and sneezing a lot. The caller event when she was waiting that's when she started sneezing and sneezing and sneezing and then her nose became clogged. Patient did not have Prior Vaccinations (within 4 weeks).  Follow-Up (25Aug2021): Follow-up attempts are completed. No further information is expected.
After giving the booster shot, the patient felt his arm tingle.  He sat down for the 15 min observation period and then got up within the first 5 minutes to come get us to say he wasn't feeling well.  He then passed out as he was telling us this and got pale/white.  We caught his head so it did not hit the floor.  His eyes rolled back and I was tapping his chest and saying can you hear us.  He came back within about 5 seconds or so and we were able to get him to sit up and talk.  At first he couldn't hear us but then he quickly got his hearing back.  He said he had not ate enough today.  We provided snacks and water once safe and was able to get him back into a chair where he sat there for about 20-30 minutes until someone came to get him.  He said his arm/hand still felt weird and was cool to the touch when he left but did not feel light headed or dizzy.  I suggested he follow up with his primary care dr as we had called 911 but he refused care said he didn't need an ambulance.
Myalgia, Tachycardia, fatigue, soreness at the injection site. Narrative:  12/21 employee received vaccine at 0930 - later in the afternoon he noted tachycardia to about 100. He was watching the rate on his Apple watch. The highest rate was 130. His only other symptom was fatigue which was bad enough on 12/22 that he had to go home. He saw his PCP on 12/22 for the tachycardia who ordered labs which were all normal. He is a resident so he asked anesthesia to do an EKG which showed sinus tachycardia. On 12/23 his heart rate average went down to 100. Today (12-28) his resting heart rate is 70-80 which is his baseline. He has not had recurrence of the tachycardia since 12/23. He also reports he had soreness at the injection site and myalgias both of which have since resolved.
Fatigue, nausea, vomiting, headache, swelling and redness and injection site
Feeling miserable; Sick; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling miserable) and ILLNESS (Sick) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling miserable) and ILLNESS (Sick). At the time of the report, FEELING ABNORMAL (Feeling miserable) and ILLNESS (Sick) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not Applicable.
Case number PHEH2015US026548, is an initial spontaneous report from a consumer (patient) via Claim Management Services (claim number: 30154848910-0001) received on 14 Dec 2015. This report refers to a female patient of an unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514601, expiry date: 01 May 2016) on an unknown date. On 14 Oct 2015 the patient was diagnosed with Guillain Barre Syndrome. The outcome, seriousness and causality of the event were not reported. Seriousness assessment of "Guillain Barre Syndrome" was upgraded based on the NVS-IMS list.
Received Menactra 09/06/2005, arm became red, hard, swollen 12 hours after shot.  Area swelling 6 inches from deltoid to elbow - area painful - no fever.  Child given Tylenol initially 09/07/2005 - seen by doctor, 09/08/2005 started on Benadryl.  On 09/10/2005 area no longer red and hard but still swollen.  Advised to continue Benadryl and Tylenol as needed.  Call if not better in 2 days. 09/12/05 per telephone f/u with reporter, additional symptoms included pruritus and warmth at injection site.
Ear pain that started in one ear and moved to both ears began around 6 days after. Still going after 5 days- got wax removed, started antibiotics, still can't hear well.
Information has been received from a consumer concerning her 16 year old daughter with a sulfonamide allergy and other unspecified allergies who in December 2007, was vaccinated IM into the deltoid muscle with a first dose of Gardasil.  Other concomitant therapy included CLARITIN.  Within two weeks, the patient experienced heart palpitations and severe abdominal cramping with diarrhea.  Due to the abdominal cramping her daughter could not eat for a period of time.  Therefore she lost 18 pounds in a 3 week period.  It was reported that her daughter has seen various specialists and gastrointestinal specialists.  Her daughter was diagnosed with gastroparesis.  It was reported that blood work and stool samples were all negative.  The consumer reported that her daughter's pediatrician felt that the events were not related to the vaccine.  The consumer stated that her daughter will not receive the additional doses of Gardasil.  At the time of this report, she was recovering.  No product quality complaint was involved.  Additional information has been requested.
mom says that noc pt has t102, very cranky;next day noticed diff swollowing;choked on food lasted 2-3days;also has approx fifty cents piece redness @ inj site;saw MD on day 3-felt it was from the pertussis;tx w/Pedioprophen for temp;
I received 1st injection on 02/26/21. on 02/27/21 i had some soreness in and around injection site. ( which will be normal) then 2 weeks later i continue with the soreness, so i received my second injection in my left arm  on 03/20/21. i experienced increase soreness and pain in left shoulder, with  difficult to raise my left shoulder and arm, with pain and stiffness. I still didn't thing  much  about about it. But now it is 06/08/21 and  i am  still  having  the same symptoms.  no other problem except what i mention above. I did notified the Health Dept where i got  my  vaccine, and they  instructed me to notify VAERS
Pt presented with left thigh warm, swollen, and indurated. No other distress noted shots given 48 hours ago.
Td done 9/7/02. Sore on 9/8/02. 9/11/02 had several little red spots. 9/12/02 had several small whelps and itching. 9/13/02 5" x 7" red whelp, hot to touch. Pt to use Benadryl, Tylenol, and ice to area. To f/u with MD as needed.
covid 19; injection site became itchy, and then it started to swell up, and it eventually swelled up larger than a baseball, and was sore and painful; injection site became itchy, and then it started to swell up, and it eventually swelled up larger than a baseball, and was sore and painful; injection site became itchy; body aches for a day or two; low grade fever; Initial information received from on 11-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who had experienced injection site became itchy, and then it started to swell up, and it eventually swelled up larger than a baseball, and was sore and painful,  body aches for a day or two, low grade fever after receiving Influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent]   The patient's past medical history included Skin peeling.  The patient's past medical treatment(s) and family history were not provided.  At the time of the event, the patient had ongoing Drug allergy.  The patient had allergy with Benadryl, which includes topical formulation found in Caladryl lotion, which makes her skin peel off, diclofenac sodium and Ceclor.  The concomitant vaccine administered was the Pfizer pneumonia vaccine in the left arm and medication included Asfotase alfa (Strensiq).   On an unknown date in 2021, the patient had body aches for a day or two (pain) and low grade fever (pyrexia) after a dose of suspect Influenza quadrival A-B high dose HV vaccine (lot number- not reported) in the arm nos. for Immunization with unknown form, strength, dose, frequency, route, expiry date.  On an unknown date the patient had developed covid 19 (covid-19) (unknown latency).  On 08-Nov-2022 at around 4:00 or 5:00 pm, the patient had injection site became itchy, and then it started to swell up, and it eventually swelled up larger than a baseball, and was sore and painful (injection site pain), (injection site swelling) and (injection site pruritus) after she received a 0.7 ml dose of the Influenza quadrival A-B high dose HV vaccine (lot- UJ924AD) via intramuscular route in the right arm for Immunization with unknown form, strength, frequency, expiry date.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all the events except for for COVID-19 with Nirmatrelvir, Ritonavir (Paxlovid).  Outcome: Recovering / Resolving on 11-Nov-2022 for the events- injection site pain, injection site swelling and injection site pruritus and Recovered / Resolved in 2021 for pain and pyrexia and recovered/resolved for Covid-19 in 2 months.  Additional information was received on 11-Nov-2022: patient past history of drug allergy is updated (Benadryl, diclofenac sodium and Ceclor), concomitant medication is updated (Strensiq), event of Covid-19 is added. Text amended accordingly.
Vomiting was so severe that he burst a blood vessel in his eye; severe emesis; This spontaneous report was received from a health professional (also reported as administrator) and refers to a 16-year-old male patient. The patient's medical history was not reported. His concurrent conditions included allergic rhinitis and unspecified tic disorder; he had no know allergies. Concomitant medications included unspecified over the counter (OTC) antihistamine medicine. On an unknown date in July 2020, the patient was vaccinated with unspecified hepatitis A vaccine (manufacturer unknown) and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) with no issues.  On 14-AUG-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly into right arm, once for 3 doses (lot# S022598, expiration date was reported as 25-FEB-2022; exact dose and frequency were not reported) for prophylaxis (reported as vaccination). Within the first 12 hours after receiving the vaccination, he developed severe emesis. The vomiting lasted for about 24 hours after the dose and no other members of the household were ill, which led the patient's mother to believe the vomiting was a reaction to the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient's mother was nervous, because the he had 2 additional doses to go to complete the vaccination schedule. Vomiting was so severe that the patient burst a blood vessel in his eye, but he did not seek additional treatment. No lab diagnostic tests were performed.  On 15-AUG-2020, the patient recovered from the events, per mother, he seemed fine. The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event of broken blood vessel in eye was determined to be medically significant. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022598; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
High fever to 102(Ax), headache (top of head); fatigue; Lasting 2 days occuring 3 days p/vax; HA & temp decreased slowly over course of 2 days.
No treatment yet. Enlarged testicles for days after the vaccine. Then after about 10 days a playful bump against my wife's buttocks lead to the enlarged testicles having pain for days. Never experienced such before the Vaccine.  Also, a shooting nerve down the inner right thigh and leg, right down to my foot. It lasted for about 1-2 hours in the morning and started about the second after the vaccine. It seemed to try to reappear about 14 days later but didn't. My wife has has pains at the bottom of her stomach, inner thigh (near her private) and head along with all over her body. We both have has continued drowsiness which remained 14 after vaccination but was worse the first 4 days. Slight chest pain near my heart has appeared within the first 7 to 10 days along with some coughs and stuffy nose, which appeared about 7 days after the vaccination. My wife also slightly had sneezing symptoms after vaccination.
ADR to Moderna Vaccine History of allergic reactions.  Took diphenhydramine 25 mg prior to injection.  Facial and finger swelling along with redness noted 40 minutes later.  Took second dose of diphenhydramine.    Was decreasing when patient returned to clinic.  Has allergy treatment plan form allergist and felt comfortable going home.  Developed metal taste soon after vaccine.  Several hours later developed heahache and chills a couple hours later.
Patient seen at ER for significant left upper extremity swelling after DTaP/IPV.
Patient called on 12/6/21 to inform us of an adverse reaction she is experiencing after receiving a vaccine from us on 12/2/2021.  Patient states she has been experiencing the following adverse effects: extreme headache, lightheadedness, nausea, fatigue and achy.  Patient states headache is most bothersome.  Symptoms started on Friday 12/3/2021 and have been progressively getting worse since then.  I instructed the patient to call her primary care to discuss, due to her statement that symptoms have been getting worse.  Patient was very angry and aggressive, stating she knew she shouldn't have received this vaccine.  She also sounded as though she was not going to contact her primary care, stating she doesn't have time for all this, she needs to get back to work.  I urged her to contact them anyways, informing her that we typically would not expect side effects to continue to worsen.  Unsure if she will be taking my advice.
At approximately 1300 client  (DOB: 03/12/1974) received 1st dose COVID Janssen vaccine (lot #1821286) in the R arm. Immediately after receiving the vaccine, the client asked vaccinator if he could sit with her for his observation. He advised the client to sit in the observation area and educated client that he would be directly observed by an RN. he walked client across the room to observation, advised him to sit in the zero gravity chair, provided water, and notified observer, RN that the client was feeling anxious about receiving the vaccine. Client layed back in zero-gravity chair and drank water. At 1306 client reported  to RN that he was feeling slight tingling in his arms and began to get teary eyed. RN took client's vitals at 1307 with BP of 124/80 in L arm laying down, HR 88, O2 99, and RR 18. RN auscultated lung sounds which were clear bilaterally and heart rate which was normal. Lead RN assessed client who presented A&O x4, skin warm and dry, grip strong and equal, and cap refill under two seconds. Lead RN provided ice pack for client's R arm and held ice pack at the site of injection. At 1311 the client reported that he has "severe anxiety" and was contemplating outside the building if he was going to move forward with getting vaccinated for 20 minutes. Client is taking Zoloft 25mg twice daily for anxiety and reported that he took 25mg this morning and ate a bowl of cereal at 0900. Client has NKDA and no chronic health conditions. At 1315 client reported that he has a "fear of needles" and gets" faint with needles". Client also reported a history of vasovagal reactions. At 1316 client reported feeling "chest achiness" on the L side but reported that he experiences this feeling of chest aching on a daily basis as a result of his anxiety. Client denied chest pain, SOB, swelling, and trouble swallowing. At 1316 client vitals were taken by RN with BP of 124/80 laying down on the L arm, HR 84, O2 98, and RR 18. At 1319 client stated that he has "impending doom syndrome". Lead RN educated that client's vitals were all within normal range. Client denied dizziness, chest pain, numbness, trouble swallowing, changes in vision, slurred speech, and shortness of breathe. At 1324 client reported he was "feeling better" and the tingling in his arms was improving. Client denied chest achiness. At 1332 vitals were taken by RN with BP of 110/72 laying down in the L arm, HR 73, O2 98, and RR 16. Client reported that he drove himself to the vaccination site. At 1343 RN educated on covid program, when to follow up with his PCP, and ER Precautions. At 1345 vitals were taken by RN with BP of 110/80 in the L arm laying down, HR 72, O2 98, and RR 16. At 1403 the client stood up and RN assessed an even, symmetrical, and steady gait. Client left the vaccine site at 1404 and drove himself.
My daughter has become severely allergic to many foods, very suddenly. It all started about two weeks after her first shot. My daughter does have allergies, but never to these new items, (nuts, she was a big peanut butter fan), (and new strange items, like sweet tarts, just gave her a horrible reaction) and never with such a severe reaction as now. She gets terrible hives, and difficulty breathing. I just connected the Gardasil shot and the onset of her severe allergies, because she is due to receive her next shot tommorow and I started thinking about when all this started! * Another daughter age 16 received her first shot the same day and has had no side effects*
Racing hate every night since 10/24/21 around 10:00pm. Then woke up by racing are in the morning at between 5:30am-7:00am.
Redness, swelling, induration (7 cm x 6 cm), warmth, tenderness.
4/18/06 Tetanus injection given left arm. 4/20/06 exam Dx cellulitis left arm injection site. Temp 99.9. Keflex and Motrin prescribed. 4/24/06 Re exam; continue medication. 5/4/06 Re exam condition resolved. No further treatment.
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 28-JAN-2016 and 04-APR-2017, the patient was vaccinated with Oka/Merck VARIVAX (lot # L035124, expiry date: 14-SEP-2017) for prophylaxis (dose and route was not reported), which was stored improperly(reported as vaccine temperature excursion) (Product storage error).
Itchiness starting with both hands front and back on day 7 progressing to itchiness to top of both feet and both elbows. Noticeable raised red lesions on day 9. Cortisone cream and lidocaine cream minimally effective. Will try one Benadryl cap before bed. Will consider pcp office visit if sx do not resolve by Monday (day 14).
NUMB TONGUE WITHIN 5 MINTUES OF VACCINE.  GOT THE VACCINE ON WEDNESDAY AND THREW UP ONCE ON SUNDAY.  SHE SAID LATER SHE HAD METALLIC TASTE IN HER MOUTH.
2 raised, red spots each measuring approximately 2x3 cm per patient report located immediate adjacent to the injection site at the 2 o'clock and 6 o'clock position in relationship to the vaccination site on the upper left arm. Patient reports significant pain in his deltoid and describes it as if he 'were punched really hard on the shoulder.' Symptoms lasted for approximately two weeks but did not seek care.
He could barely breathe; he felt like his heart it was something involved with his heart, he couldn't even take the normal breath; He could barely breathe; he felt like his heart it was something involved with his heart, he couldn't even take the normal breath; He had a swelling around the calves; This is a spontaneous report from a contactable consumer. The consumer (patient's mother) reported for her son. A 21-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 12May2021 in arm as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccines were administered. The reporter stated that her husband got the first dose (lot number: ER8732) on 03Apr2021 at 11:30 and all of a sudden, his ears started ringing, but in one ear it was like unbearable siren going on and it calm down. He received the second dose on 24Apr2021 at 11:30 (lot number: EW0170; expiry date 31Aug2021) and the events came back with full force again but were gone. She was sure that the events were because of the vaccine. Her husband went for an MRI because he got something going on with his brain and went to a neurologist but later it was gone. She reported that her girlfriend's husband lost hearing in one ear after he got the vaccine. She also reported that her son received the vaccine on 12May2021 and had lot of side effects which were very normal for 21 years old, but the third day he woke up and said he could barely breathe, he felt like something was involved with his heart and he couldn't even take the normal breath. She reported that they almost took him to the hospital, and he started to calm down by the end of the day, the events were gone but he had swelling around calves. The outcome of the events was recovered in 2021.  Information about lot/batch number is requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021694827 Same reporter, different drug/patient/ AE
Information regarding PREVNAR 13 was received from a nurse regarding an unknown patient who experienced injection site redness and swelling at the injection site. The patient received a dose in 2010. An unknown patient experience injection site redness and swelling at injection site in 2010. Both events were not resolved. No additional information was available at the time of this report. See related case(s): US-WYE-H15507310 (adverse event, non-expedited).
Pt had pneumococcal vaccine on 5/4 and states it's heating up, how long is this supposed to last? Pt states area on left upper arm is red, 2 1/2 in diameter, itchy and hot to touch. Denies fever. Pt has been applying ice to area since yesterday and it is not getting any better and localized skin rash (some swelling, itching, itching and redness). Cephalexin 500 mg QID, Cetirizine 5 mg everyday.