chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician and described the occurrence of fever in a 77-year-old female patient who received SHINGRIX (batch LT533, expiry date 11th October 2020). Concurrent medical conditions included hypertension (controlled), hyperlipidemia (stable) and gastroesophageal reflux disease (sable). On 8th May 2018, the patient received the 1st dose of gastroesophageal (intramuscular) .5 ml. On 10th May 2018, 2 days after receiving gastroesophageal, the patient experienced fever, malaise, diarrhea, rash, fatigue and hives. The patient was treated with steroids NOS. SHINGRIX was discontinued. On an unknown date, the outcome of the fever, malaise, diarrhea, rash, fatigue and hives were recovering/resolving. It was unknown if the reporter considered the fever, malaise, diarrhea, rash, fatigue and hives to be related to gastroesophageal. Additional details were provided as follows: The patient was a nonsmoker. The adverse events were not related to medical history or concurrent condition, erroneous administration, suspected transmission of an infectious agent via medicinal product and lack of effect. The patient was symptomatic after receiving SHINGRIX injection. The patient was treated with topical steroid lotion or shampoo. No diagnostic details were provided.
12:50pm- Patient with complaints of red blotchy areas that suddenly appeared on neck and bilateral upper arm region.  Denies itching to areas, and denies nausea, vomiting, or dizziness. B/P 137/101, HR 90, R 20 O2 sat 99%.  Offered rest break and water, and patient stated felt better after those measures. 1:10pm Patient states feels better, and advised Benadryl, and patient stated will self-administer at the house on return home since she is driving.  1:15pm- Patient released.
Very itchy, muscle soreness, redness and swelling around the arm, tender to the touch. Dr. gave her Doxycycline and MEDROL 4 mg dose pack.
Continued weakness, limited range of motion, area injection site gets inflamed and rise in temperature when stressed
Right arm erythema - no constitutional symptoms, no induration or lymphadenopathy lymphademitis, Temp 96.6
Has received influenza inj 13 other times at medical center without any noted problems. Headache and sore ribs, sharp pain from left flank to left axillary and left breast, dull achy pains still ogoing 2 months after inj.
Swelling of bilateral upper and lower eyelids, right eye watering and red  Treated with Benadryl which was effective   Symptoms lasted at least 24 hours
Information has been received form a physician concerning a child who was vaccinated with a dose of MMR II/Varicella vaccine on an unspecified date. Subsequently the pt developed chicken pox. Unspecified medical attention was sought. No other information has been provided. There was no product quality complaint involved. Additional information has been requested.
Breakthrough case: Tested positive in ICU, breathing difficulties, on B-Pap,
This case was reported by a nurse and described a 14-month-old male subject who inadvertently received separate injections of diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) and diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) on the same day. On 09 May 2005 the subject received the third dose of Pediarix. The subject then inadvertently received an injection of Infanrix (lot number and injection site not specified). On 09 May 2005, the patient also received injections of Haemophilus influenzae type b conjugate vaccine (PedvaxHIB, Merck), measles, mumps, rubella virus vaccine (MMRII, Merck), varicella virus vaccine (Varivax, Merck), and 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs). The nurse reported that "the next day," on 10 May 2005,the subject experienced vomiting and a small amount of redness and soreness at the injection site of Infanrix. The outcomes of the vomiting and injection site redness and soreness were not reported. The nurse considered the events to be related to the vaccination with Infanrix.
Redness & swelling @ site of inject 24 hrs p/vax; t104; 12JUL91 temp 101 redness spreading down leg;
Got dizzy; Pain in right arm and shoulder; Pain in right arm and shoulder; Low grade fever; Chills; Migraine; Aches; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 05Apr2021 at 12:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to tree nuts and COVID-19 from unknown dates. Concomitant medications included buspirone (MANUFACTURER UNKNOWN) and multivitamins (unspecified) for unknown indications from unknown dates and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 12:45, immediately after the vaccination, the patient got dizzy and had pain in her right arm and shoulder. That night and continuing into the following day, the patient had a low-grade fever, chills, aches and migraine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events got dizzy, pain in right arm and shoulder, low grade fever, chills, aches, migraine were resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
LOSS OF VISION THE DAY OF VACCINATION-DID NOT NOTIFY PHARMACY, BUT WENT TO DOCTOR AFTER 2 WEEKS. NOT CLEAR IF VISION GOT BETTER THEN WORSE DURING THAT TIME. THE DOCTOR CONCLUDED THAT THE PROBLEM WAS DUE TO THE VACCINE AND IS TREATING WITH STEROID DROPS. OUTCOME UNKNOWN AT THIS TIME.
my right thumb and index finger from the point where i bend it to the top of the thumb and index finger it is completely numb like its dead since three weeks after having vaccine.
Redness and swelling for the 3 days after vaccination, which then resolved. On the 8th day after vaccination, she developed redness, itch and tingling over the proximal right upper arm. Resolving with time, but still present 2 weeks after the vaccination (one week after reaction started).
This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the right arm on 13Mar2021 at 13:15 (at the age of 41-years) as a single dose for COVID-19 immunisation. Medical history included pancreatitis, high blood pressure and dizziness. Concomitant medications included prednisone (MANUFACTURER UNKNOWN) 1 dose the day after and losartan (MANUFACTURER UNKNOWN) for unknown indication. The patient previously received tobramycin (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021 at 18:00, the patient experienced face, neck, lips, and hands swollen, trouble swallowing and increased dizziness. The adverse events resulted in emergency room or urgent care visit. On 22Mar2021, post vaccination, the patient had nasal swab test and was tested negative. The patient did not receive any treatment for the adverse events swollen face, swollen neck, swollen lips, swollen hands, trouble swallowing and increased dizziness. The clinical outcomes of the events swollen face, swollen neck, swollen lips, swollen hands, trouble swallowing and increased dizziness were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Initial case was received from a health care professional on 14 October 2013. A 06 months female patient had no medical history reported, received a dose PENTACEL vaccine on an unspecified date (route, dose, site and batch number not reported). Patient had no reported concomitant medication. It was reported that on an unspecified date patients had hives after the vaccine. No corrective treatment was reported. At the time of report the outcome of event was unknown.
Patient stated they were becoming dizzy and lightheaded. Immediately had patient come into vaccine room to see what else was happening. Patient stated they were also having breathing difficulties. Immediately tested patients bloods pressure. Tested twice and came to 220/120 with heart rate 80. Was an emergent situation. Informed patient I was contacting 911 to have them take him to the hospital as this is an emergency situation. Went and made phone call. Had staff bring patient into waiting area so that we could monitor him if something worsened. 911 advised to just monitor the patient. If he began vomiting or passed out to have him on his side, so he doesn't choke from vomit. We monitored patient until ambulance arrived. They asked for current medications we knew of (listed in report) and that he had received Pfizer Covid vaccine 0.3ml resulting in emergency BP readings of 220/120 after receiving.  Ambulance took patient to Hospital. Current condition unknown or if anything even occurred after that point. Whole event lasted about 1 hour before patient left with medical personnel.
Erythema and induration 30x 25 over () arm (PCV 7). No treatment except for warm compress.
A report was received from a health care professional on 10OCT2003 concerning an unspecified number of children of unspecified age who received Fluvirin from an unspecified date to 10OCT2003. From an unspecified date to 10OCT2003 an unspecified number of vaccinees of unspecified age received Fluvirin. To the reporter's knowledge no adverse reactions had occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
After I got the two shots, I felt woozy and lightheaded. I had to take a seat and I started to have cold sweats. It took me like 5 minutes to finally be able to stand up. I went home and soon after, I start to get the absolute worst uterine cramps I have ever gotten on my entire life. It was on the level of a contraction pain, the absolute most horrendous pain I've ever had. I am diagnosed with endometriosis but even then, not even the worst cramp compared to the pain I was going through. I was almost crying because of the agonizing pain and I put warm compresses on my lower abdomen and took 1000 MG of acetaminophen. I wanted to go to the emergency room, but I was in too much pain to even get out od bed. It took a full 30 minutes for the pain to die down. It was traumatizing.
PATIENT STATED THAT SHE HAS HAD SEIZURES WITH THE FLU VACCINE AND WAS ADMITTED TO THE HOSPITAL FOLLOWING A HEP B BOOSTER AND HER BLOOD PRESSURE DROPPED AFTER FISRT DOSE OF PFIZER COVID 19 VACCINE BUT WAS ADVISED BY NEUROLOGIST TO GET THE SECOND DOSE . ABOUT 30 SECONDS AFTER ADMINISTRATION OF THE VACCINE WHICH  WAS THE PFIZER COVID 19 VACCINE PATINENT PASSED OUT AT WHICH TIME A CODE WAS CALLED IN THE HOSPITAL AND WHILE AWAINTING MEDICAL HELP THE PATIENT APPEARED TO HAVE A SMALL SEIZURE AFTER WHICH SHE CAME  TO AND PRESENTED WITH NAUSEA BUT NO VOMITING AT WHICH POINT THE ER STAFF FROM THE HOSPITAL SHOWED UP TO TRANSPORT HER TO ER. SHE WAS RELEASED AFTER EVALUATION WHICH SHOWED HER BLOOD PRESSURE HAD DROPPED BUT SHE WAS NOT ADMITTED TO THE HOSPITAL.PATIENT STATES SHE IS FEELING FINE.
Same day, 6pm, started having severe loud ringing in ear/tintis. Then I became nauseated. Ringing began in the left ear, then it moved to right ear. Was more severe in left ear. Still having ringing, but not as bad as day of vaccine. Ringing has not subsided. I have history of tinitus, but it's worse now. Unsure of which flu or Pneum shots were given one month prior to getting the shingrix vax (were given 3 weeks prior to getting the shingrix, one in right, one in left, unsure of which shot in which arm).
Pt. states that after receiving the 2nd dose of Moderna 02/17/2021, started experiencing symptoms 03/10/2021 of lower back, arms, skeletal pain. Primary visit with recommendations to see Specialist. Specialist seen mid-May recommendation to see a Rheumatologist. Still under investigation by Physicians. Still continuing to experience symptoms.
Patient started having large bruises throughout body about 10 days after receiving the vaccine. Platelet count 3K/uL. Patient currently being observed without treatment.
Lymph nodes in neck swollen after Covid 19 vaccine #1( Jan 7, 21)  Nodule noted on thyroid (Left side) 1 week after Covid 19 dose #2(Jan 30,21).Ultrasound noted nodule  on thyroid. FNA on 3-15-21 revealed Cyst and I was diagnosed with Hashimoto's disease.
Within 24 hours of injection started to feel tired and weak with onset of headache by evening of that same day, low grade fever with head and chest congestion lasting 4-5 days.
Pfizer vaccine administered to patient who received Janssen vaccine at clinic on 3/8/2021 per Representative. Patient aware that this was out of protocol and that they can not get the second Pfizer vaccine at a pharmacy at this time. Patient reported that PCP recommended and referred them to our pharmacy to get the vaccine. PCP office was notified that they can not refer patients to get another COVID-19 vaccine at any pharmacy at this time.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 01-JUL-2013 at 07:40, ZOSTAVAX lot # J001005 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 44.5 hours. On 01-AUG-2013 at 07:40, ZOSTAVAX lot # J001005 was exposed to -12C for an estimated total time out of range of 14 hours. On 15-AUG-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J001005, Exp. Date: 24-APR-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
arms, legs and chest were spastic; chills; heart was racing; soaking wet; cold; A spontaneous report was received from a consumer concerning a 75-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced spasticity in arms, legs and chest , chills, heart racing, soaking wet,  and cold.  The patient's medical history was not provided. Concomitant medications reported were Tylenol, albuterol (Rescue inhaler), albuterol tablets, Proventil, baby aspirin, Lipitor, Symbicort, budesonide formoterol, Trulicity, iron, finasteride, Flonase, gabapentin, Lispro U-200, Humalog quick pen, lamotrigine, Toprol XL, Flomax, Effexor XR ( for unknown indication).  On 14 Feb 2021, prior to the onset of the events the patient received their unknown dose of two planned doses of mRNA-1273 (lot/batch: 006M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the events-  spasticity in arms, legs and chest , chills, heart racing, soaking wet,  and cold.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events- spasticity in arms, legs and chest , chills, heart racing, soaking wet,  and cold-  was considered resolved on 15 Feb 2021.
Pfizer-BioNTech COVID-19 Vaccine EUA: four days after vaccination patient presented to emergency department with neck and facial rash and some shortness of breath. Patient reports taking loratadine, diphenhydramine (oral), hydrocortisone (topical), and famotidine at home. Patient denies nausea, vomiting, chest pain, fevers, chills, and abdominal pain. Initial vital signs within normal ranges except blood pressure 134/83 mmHg. Physical exam shows a raised erythematous rash on face and neck and erythematous rash on left forearm and elbow consistent with irritant dermatitis. No eye or mucous membrane involvement. No stridor, wheezing, rhonchi, rales, or resiratory distress noted. Patient observed and prescribed topical and oral steroids and discharged to home. On telephone follow-up two days after emergency department visit patient reports symptom improvement.
This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 11-MAR-2019, the patient was inadvertently vaccinated with an expired dose of VARIVAX, subcutaneously, lot # N001527, expiration date 13-JAN-2017 (dose was not reported) for prophylaxis. No adverse effects were reported.
About 1 week after vaccination, I noted sensations of fullness or bloatedness.  It felt like gas trapped in my upper abdomen that could not be relieved by burping.  Within 2 days, I began to have pain in lower, left rib cage akin to side cramps/stitch after strenuous running, but persisted the entire day.  About 2-3 days later,  the pain intensified and spread throughout my diaphragm region (left and right sides).   Breathing was somewhat affected, after semi-strenuous activities, such as walking up/down stairs.  So, I avoided physical exercise, and took Advil for a couple days to minimize the pain.  After another 3-4 days, the pain in the diaphragm region subsided.  I have not experienced further discomfort for the past week (today is 4/21/2021).  No treatments were sought during this period.  I self-researched the symptoms and hypothesize the pain stemmed from a swollen spleen, which might have been caused by an overactive immune system due to the vaccine.
Patient received Daptacel 2/15/06. 2/18/06 Mom called arm significantly red with slight swelling. Examined by Dr. 2/18/06 advised to use Benadryl 1 1/2 tsp q 6 hrs for next couple of days. Pt does c/o itchiness also.
On 2/21/2021, I had minor muscle pain following the injection at the injection site.  On 2/23/2021, I developed a warm rash that somewhat resembled pityriasis rosea (I had that illness October 2017 - June 2018) which covered the skin of the muscle of the injection site. Both the rash and the muscle pain were completely gone by 2/26/2021.  I did not have this reaction with the first injection.
PATIEINT REC'D PFIZER ON 2-5-2021 FOR 1ST COVID VACCINATION. CAME TO CLINIC ON  2-20-2021 & WAS GIVEN THE MODERNA FOR DOSE # 2 BEFORE IT WAS REALIZED. SPOKE WITH WIFE  THIS MORNING & SHE STATED THAT HER HUSBAND IS DOING FINE, JUST A LITTLE SORE FROM THE  INJECTION BUT NOTHING ELSE. SHE STATED THAT SHE "KNEW HE WOULD BE FINE". SHE WANTED HER'S  THAT DAY BUT STAFF REFUSED & SHE IS SCHEDULED TO GET HER # 2 PFIZER THIS COMING WEEKEND.
None.  Pt received vaccine that had been stored in conventional freezer for more than 2 weeks.  Pt was offered another dose.
patient received a dose of Infanrix that had expired on September 16th 2023; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received DTPa (Infanrix) (batch number AK443, expiry date 16-SEP-2023) for prophylaxis.   On 18-SEP-2023, the patient received Infanrix. On 18-SEP-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: patient received a dose of Infanrix that had expired on September 16th 2023).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-SEP-2023 The vaccine administration facility was the same as primary reporter The physician reported that a patient received a dose of Infanrix on 18th September 2023 that had expired on September 16th 2023, which led to expired vaccine used. The reporter consented to follow up.
Patient complained of feeling funny, "prickly" feeling in lower lip and having to force to swallow
severe pain in her left arm area; could not move the shoulder area with out experiencing a "horrific pain"(AE no arm movement); incapacitated by pain for 48 hours; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2023, the patient received the 1st dose of Shingrix. In January 2023, less than a week after receiving Shingrix, the patient experienced injected limb mobility decreased, debility and pain in arm. The patient was treated with paracetamol (Tylenol Arthritis) and ibuprofen. In January 2023, the outcome of the debility and pain in arm were recovered/resolved. On an unknown date, the outcome of the injected limb mobility decreased was recovered/resolved.   It was unknown if the reporter considered the injected limb mobility decreased, debility and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-JAN-2023 Reporter's comment: The reporter was a patient who had reported that after getting her first dose of Shingrix vaccine on her left arm at a pharmacy location.  She had an extremely intense side effect with the first Shingrix injection and she was incapacitated by pain for 48 hours.  She also had reported of having severe pain in her left arm area and could not move her shoulder area, without experiencing a horrific pain.  She took a maximum of three tablets of a 200 mg Ibuprofen (600 mg) 3 times a day every 8 hours.  She was around the 2nd or 3rd day. The patient had reported that in addition to that, she had taken two tablets of Tylenol Arthritis 650mg (1300 mg) after the ibuprofen.  The patient had reported that on 09 January 2023 she had a full range of motion in her left arm and had pain in a scale of 1 to 10 as 0.5. Not all information was available. Lot and expiry date unknown. Patient said she had considered going to the Emergency Room (ER) because of how severe it was.  However, no visit to ER was documented. The reporter had consented to follow-up.
Child c/o pain, distal and proximal on right arm. He stated it did not feel right. Started to cry and sob due to pain, holding arm. Mom gave Motrin for pain. Fever started at 4 am at 103. There was twitching of his arm at this time. Fever lasted until 11/10/2010 at 7:45 pm. On 11/11/2010 he was fully recovered and using arm. There was no redness only slightly pink and no swelling.
High fever, freezing, skin hurt to touch, headache, dizzy. Started within 1 hour of getting flu shot and lasted around 24 hours.
Started 10-12-13 1030-12 and into afternoon. Child's nose started running nose and cough, then he got sick and vomited, stomach hurt, had 99 degree temp. Sat afternoon around 3-4 pm called on-call nurse and reported gave BENDARYL 1 tsp Q 4-6 hours and this decreased running nose and vomiting stopped.
Moderna vax - symptoms are paresthesias and pain in the extremities and muscle spasms and weakness
5/15 tell call from mom she reports son has febrile seizure last night. 5/14 with temp of 105 brought child to ER given Advil temp decreased to 103.7. Child is feeling better now. MD wants mom to report to health worker. Hx of febrile seizures.
Case number PHEH2013US014618, is an initial spontaneous report received from a nurse on 03 Jul 2013 with a follow-up received on 24 Jul 2013: This case refers to a 14-year-old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: A12095), intramuscularly in to the right deltoid without being reconstituted with Men A component on 03 Jul 2013. No adverse reaction was reported following this administration error. Follow-up received from the nurses on 24 Jul 2013: Updated patient demographics and site of administration of MENVEO.