chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 5-10 minutes after injection, I began to experience soreness at injection site, a sore arm (left side), neck pain/ache (left), and a headache on the back side of my head. About 30 minutes after injection, my upper arm (left) became slightly numb and my hand (left) began to tingle. I also experienced a sharp shooting pain in my lower arm (left), down to my hand and below my thumb (left). The neck pain and sore arm  increased at this time. That night (10/14/2021), at 7:00 pm, I began to experience numbness and tingling in both hands and both feet. When I got up to walk, I experienced numbness predominantly on my left side, my entire leg. I felt significantly weaker on that side. Today, 10/16/2021 @ 7:07 pm, all symptoms remain and numbness in my left knee and left arm are significantly worse.
I developed hives approximately 12 hours after receiving 3 immunizations (Hepatitis B, A, and Polio).  I contacted the doctor the same evening and started a treatment of 40 mg Prednisone once a day for 3 days.  Today is the third day, and I contacted the doctor again because I still had hives.  At 7:15 pm I took 25 mg Hydroxyzine HCL and at 8:05 pm I took an additional 25 mg Hydroxyzine HCL that seem to have brought some relief (as of 11:10 pm).
Inflamed nerves right auditory canal; hearing loss; Zoster Oticus/Ramsey Hunt syndrome.
Hib portion of PENTACEL was reconstituted with sterile water and not the DTaP-IPV portion/ no AE; Initial information was received on 23-Aug-2021 regarding an unsolicited valid non-serious case from other healthcare professional, consumer/non-healthcare professional and physician via call center via Global Medical Information (Reference number- 00632994).  This case involves a 8-month-old male patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which HIB portion was reconstituted with sterile water and not the DTaP-IPV portion (Product preparation error).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) for prophylactic vaccination.  On 20-Aug-2021, the patient received a second dose of 0.5 mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (solution, lot number: UJ389AAA and expiry date: 12-Oct-2021) via an intramuscular route in the left vastus lateralis for prophylactic vaccination.  It was an actual medication error case due to wrong solution used in drug reconstitution (latency: same day).  It was reported "Caller asking if the whole dose is invalid. Caller also asks how soon PENTACEL can be re-administered; caller referred to healthcare provider. Caller also referred to PENTACEL Reconstitution video"  At the time of reporting, no adverse event was reported.  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.
Patient came in 2 days after injection and stated she developed a lump with redness around it a day after the vaccination. They adverse reaction was not at the injection site. It is located approximately 3 to 4 inches below the injection site.  She also stated that at the time of vaccination, it felt like there were metal pieces also being injected. The vaccine was a prefilled syringe (Moderna's Spikevax). I advised the patient to mark the borders of the redness and to follow up with her physician if it continues to get worse.
Systemic: Nausea-Mild, Additional Details: patient vomited 5 minutes after the injection. felt better after the event
Patient received a dose of Rotovirus that was not due. He had never received any vaccinations and was having to catch up. He was not eligible to receive the Rotovirus because he was over 14 weeks old. He did not have any signs and symptoms of any reactions.
Rash, hives localized below injection site. Presented about 1h after immunization. Pt took antihistamine cold compress and improved after
Redness from mid delt to elbow after 4 days. Itching 4 days after.
no adverse event/unknown. administered monovalent instead of bivalent. unable to reach patient via phone.
Pt had altered mental status. Mom stated pt not using lt arm well.Odd behavior @ school pt had dT(or DT) @ Pvt MD 6 days prior to onset of s/s.
Asthma flare began a couple of hours following the injection. Her Asthma is very mild and she has not experienced a flare in several years.
RAISED ITCHY WELTS ON LEFT THIGH AND BUTTOCKS EVENING AFTER INJECTION. TREATED WITH 50 MG PO BENADRYL. WELTS RESOLVED BY AFTERNOON OF 2ND DAY POST APPEARANCE.
Pt stated she noticed one week after being vaccinated an area of redness at injection site. Area has irregular borders and measures 3cm w x 2.5 cm l. Advised to take ADVIL 200 mg 1 tab po Q 4-6 hrs and apply Hydrocortisone 1% cream BID.
At  approximately 15:20, client received 1st COVID vaccine (Janssen, lot #206A21A exp 09/21) at approximately 15:20. Client received vaccine in a zero gravity chair due to reports of history of dizziness during vaccines. Client remained in zero gravity chair for a 30 minute observation. At 15:35, client reported feeling lightheaded and experiencing  left arm pain at injection site. Nurse responded. Client denies SOB, swelling of mouth, tongue, throat; denies itching; client does c/o headache to which she commented "probably because of my anxiety".    Client commented "I think I'm feeling lightheaded"; We reclined patient in chair, offered juice and granola bar (client accepted juice, declined granola bar). Client commented "I'm having pain where I was vaccinated".    Client is 6 months pregnant, reports a history of asthma and pregnancy-induced hypertension. Client takes Concerta 36mg once daily. Client has severe allergic reaction (anaphylaxis) to Benadryl.    Vital assigns were measured:  15:38 - Blood Pressure 148/90; Pulse 70; Respiratory Rate 12 15:55 - Blood Pressure 138/90; Pulse 66, Repiratory Rate 10 Client Alert/Oriented to person, place, time, situation.    Client reports feeling anxious about getting the vaccine, commenting "my family is anti-vaccine but I had to come get the vaccine so I could keep working at my job or I'll be out of compliance" and "I think I'm feeling lightheaded because of my anxiety about it". Nurse observed client appearing tearful 3-4 times throughout observation period.    At 15:55, client reports lightheadedness resolved, continues to deny shortness of breath, swelling or itching; reports headache resolved. Client reported feeling able to stand and walk. Nurse assisted client to standing position and observed client walking. Client reported she felt ready to leave and safe to drive. Nurse observed client with steady gate out of the vaccine area and down the lobby corridor.    Lead nurse provided education to client on when to seek care.
I wasn't having a fever when I got the flu vaccine. But later that night, the fever came back, and I developed Guillain Barre syndrome (mild but progressive, I was almost paralyzed). Now I'm still recovering from this syndrome.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies from the patients were not provided. From 29-AUG-2017 to 07-SEP-2017 (specific dates unknown), the patients were vaccinated with improperly stored doses of PROQUAD lot # N016113, expiration date: 21-NOV-2018, and lot N013270, expiration date: 25-OCT-2018, for prophylaxis. Concomitant therapies included sterile diluent. The temperature excursion was reported as: -14°C to 10°C for 8 minutes. Data logger was reported as "Yes". Sender's Comments: US-009507513-1709USA005074.
Woke up with extremely swollen and inflamed knuckle on hand.  Saw pediatrician who put splint on finger could find no injury, sent for xrays no injury.
Patient called today 9/12/22 stating he had 4 expanded vaccines plus covid 19 pfizer vaccine (5 total) on 8/12/22 and he has been having  (per patient) side effects. Patient stated he also start some new medications (Imipram, Solifenacin, nitrofurantoin) as well and not sure if from vaccines or medication. Patient stated had redness on both arms for about 1 month, now started to get better after 1 month. He also have dry mouth, vision changes, deep sleep, difficulty chewing. These symptoms, he has for a month and still experiencing them.
This spontaneous report was received from a health professional referring to a 16 year old female patient. On 28-NOV-2018, the patient was vaccinated with VAQTA, intramuscular for prophylaxis. On an unknown date, the patient experienced inappropriate schedule of product administration and no adverse event.
I developed genital ulcerations after the vaccine. I developed this this once in my life before in January 2020. I was ten tested for flu and got extremely sick. I did not have any other issues until receiving the vaccine in April. I got the vaccine on Friday and woke up the next day with typical side effects. This lasted most of the day and in the evening I felt better. By Monday morning I had developed pretty severe genital ulcerations. It was worse than January. I asked how many were visible and they told me 6. I had only back when it happened in January. I did a swab and were tested for herpes which came back negative. They thought it might be Bechets syndrome. I do not meet the other criteria for Bechet's though. Back in January some tests were done to test for Bechet's but all came back normal.  This leads me to believe the vaccine could've triggered this. I was not prescribed anything, but I was referred to a rheumatologist. They were not super helpful though. I believe I had COVID in Jan 2020 and the genital ulcerations accompanied it along with the vaccine.
Pt described nausea, exhaustion, headache, fever, and dizziness starting at 5pm after receiving the vaccinations at 12 pm. She was unable to eat or drink anything for 18 hours. She was able to keep solid food down 2 days after vaccinations at which time she noticed a very large red area that was hot to the touch and painful. She started taking antihistamines and the redness and heat went away.
Initial information was received on 18 November 2008 from a consumer (corrected on 17 August 2009). A four year old female with a history of sinus infection received an injection of Fluzone SV (lot number not reported) in the end of October or the first week in November. The patient's mother stated that one to two days post vaccination the patient began to have ticks which included jerking movements in her arm, moving her arm back and forth as well as sounds coming out of her mouth. Both symptoms were uncontrollable per the patient's mother. She was seen by her physician, who suggested sending the child to a neurologist if the symptoms persisted. The patient had not recovered at the time of the report. List Documents held by Sender: None.
6/7/22-Shortness of breath, low oxygen saturations, cold chills, fever of 101, body aches, headache,  6/8/22-Thursday morning nose bleeding x2, stood up walked to bathroom started bleeding. Got it to stop and 5 minutes later began bleeding again. Continued symptoms as previous day with fatigue. Arm local reaction: soreness, raised redness of the upper part of the left arm at injection site. "Felt like it had a ball in there", in reference to her arm.
Starting the evening after receiving the vaccine, I developed swelling in my arm and it went numb from the shoulder to the end of my fingers. I had my annual physical scheduled for the next day, so I let the doctor know my symptoms. They let me know my lymph nodes were swollen underneath my arm into the left breast. They advised ice packs, and alternating ibuprofen and tylenol for the fever and the swelling of the lymph nodes. My temperature was elevated up to 102 for about 2 days after the vaccine. After about 3 days, the swelling of the lymph nodes went away.
Caller reports that she is now experiencing some numbness at front of her tongue and lips.; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 09Feb2021 as DOSE 1, SINGLE covid-19 immunisation. Medical history included anaphylactics from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient had first dose of vaccine a few hours ago. Patient reports that patient was now experiencing some numbness at front of her tongue and lips on 09Feb2021. Patient states she was just calling to report her symptoms. Patient was not seeking medical advice. Patient states that she will follow up with HCP on if she should get second dose. The outcome of the event was unknown.  Informatio0n about lot/batch has been requested.
Woke up next morning with my arm so sore I could barely move it.  I had a fever of 100.0 and body aches.  I took a fever reducer drank fluids, put an ice pack on my arm and went to sleep for 4 hours.  Fever broke when I woke up.  Symptom free the next morning, but arm still sore.
Narrative:  Patient states he had muscle pain for a day, but symptoms resolved on own. Other Relevant Hx: Symptoms:  Myalgia Treatment:
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse on 27-OCT-2104, who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse on 13-NOV-2014, concerning a patient (age range reported as 11, units not reported) of unknown gender. On 29-OCT-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
After receiving vaccine on 1/15/21 next day I started to experience chills, headache, fatigue, and soreness in the right arm. On Sunday I had the same symptoms but I noticed a sharp pain in my back. By Sunday evening I started to feel pain on right side of back in the middle of my back felt like it was my ribs at first. The pain elevated as the evening went on to the point where I couldn't stand for too long or sit.
Site: Pain at Injection Site-Severe, Systemic: PAIN FROM INJECTION SITE TO FINGERTIPS-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: PATIENT HAD PAIN FROM INJECTION SITE TO FINGERTIPS THAT HAS LASTED FOR UP TO 3 DAYS
She has had problems with a rash since/ a rash on her shoulder/ rash on her breasts/ She has a rash on her upper body/ a rash on her arm and head/a rash on her chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (She has had problems with a rash since/ a rash on her shoulder/ rash on her breasts/ She has a rash on her upper body/ a rash on her arm and head/a rash on her chest) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 02FL20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) and METOPROLOL for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 10-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (She has had problems with a rash since/ a rash on her shoulder/ rash on her breasts/ She has a rash on her upper body/ a rash on her arm and head/a rash on her chest) (seriousness criterion medically significant). At the time of the report, RASH (She has had problems with a rash since/ a rash on her shoulder/ rash on her breasts/ She has a rash on her upper body/ a rash on her arm and head/a rash on her chest) outcome was unknown.            Concomitant medication included Zedia.  After the second shot of vaccination, patient visited dermatologist, a family practice, and the emergency room. She had problems with a rash since. The doctor prescribed with something to put on the head for the rash so she could sleep at night. Patient had salves, lotions but nothing had helped her.  No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of this event, 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 this event, a causal relationship cannot be excluded.
A non-serious spontaneous report of tested positive for Influenza A has been received from a health professional concerning a 14-year-old female child, subsequent to receiving FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 20-Nov-2010, the patient received FLUMIST. On 01-Dec-2010, the patient tested positive for Influenza A. The outcome of the event was unknown.
Headache, slight fever, lethargy, loss of appetite Around 7am when I woke up, took an advil for the headache
On 4/2/21, arm pain, body aches, bad headache, chills, fatigue, redness at injection site. At about 7:30 pm, I started feeling bruising under my right eye. At about 9:30 pm, I had a small bump under my left eye. On 4/3/21, I woke up with facial swelling. I was swollen underneath my eyes, cheeks were swollen, and lip was swollen. Headache, slight back ache, redness at injection site and sore injection area continue. Took 2 Benadryl at 9:00 am to reduce swelling.
PATIENT RECEIVED 0.5 MLS INSTEAD OF 0.25 MLS. WE CALLED PATIENTA AND EXPLAINED THE SITUTATION AND PATIENT SEEMS TO BE SATISFIED WITH THE OUT COME
expired dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04721A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported No treatment Drug was reported
Lingering fatigue ad sense of fogginess starting 2 weeks after first shot. I feel like I could go back to bed for half of the day every day, usually less so in the evenings.
Sore arm; Briefly "sick; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm and sickness. On an unknown date, the outcome of the pain in arm and sickness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and sickness to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in August 2020 and had a sore arm and was briefly sick  The reporter did not consent to follow-up. For the tolerance of 2nd dose refer case US2020226580.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020226580:same reporter
fever; chills; fatigue; pain; This is a spontaneous report received from a contactable consumer. A 57-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), from an unspecified route and location on 16Apr2021 as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant products were not reported. The patient experienced fever, chills, fatigue, and pain on Apr2021. The patient wanted to know how symptoms may be with the second Pfizer Covid 19 Vaccine?. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Narrative:  Patient tested positive for Covid-19 and was hospitalized despite full vaccination including booster (Pfizer 1,2,and booster). Vaccines received on 1/11/21, 2/4/21 and 12/2/21.