chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gave the DTaP-IPV portion and HiB portion of Pentacel separately to patient and diluted HIB in sterile water, no AE; Based on information received on 21-Sep-2020, the report previously considered as non-valid became valid as patient identifier reported.  Initial information was received on 20-Sep-2020 regarding an unsolicited non-valid non-serious case received from the pharmacist.  This case involves 2 months old male patient who was vaccinated with first dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number and expiry date not reported) via an unknown route at an unknown administration site on 19-Sep-2020 (also reported as 19-Jul-2020) for prophylactic vaccination however the DTaP-IPV and HIB portions of Pentacel vaccine were given separately and Hib portion was diluted with sterile water instead of 0.4 % saline solution (product preparation issue).  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.  It was an actual medication error case due to inappropriate reconstitution technique (latency was same day).  The reporter imagine DTaP-IPV component will count as valid dose of DTaP and IPV vaccines, but had questions on the validity of the Hib component with sterile water and asked if the Hib will need to be redone with the 0.4% saline.  No adverse event reported at the time of reporting.  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.  Follow-up information was received on 21-Sep-2020 regarding an unsolicited valid non-serious case received from the pharmacist.  The case validity, event coding updated, patient demographics added.  There will be no information available on the batch number for this case.
vomiting repeatedly; Extra dose administered; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting repeatedly) and EXTRA DOSE ADMINISTERED (Extra dose administered) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 024M20A and 002F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On 17-Aug-2021, the patient experienced VOMITING (vomiting repeatedly). On 15-Aug-2021, EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved. At the time of the report, VOMITING (vomiting repeatedly) outcome was unknown.            No Concomitant Medications were provided. No Treatment Medications were provided.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old male patient who received SHINGRIX for prophylaxis. On 27th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site discomfort. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site discomfort were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site discomfort to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination could be 81 or 82 years. The patient himself reported the case, who received second dose of SHINGRIX and experienced injection site reaction including arm soreness and redness. The reporter stated that his arm was still sore, till the time of reporting and felt uncomfortable at night when sleeping on his side. This case was linked with case US2018136352, reported by the same reporter.
On 07/19/2021 I got my first covid vaccine. That same day started my period, I always have regular menstrual cycles so on the fourth or fifth day I am only spotting then it?s gone, this time around unseats of only spotting began to have huge amounts of blood clots coming out of me, so far it?s been 3 days of these huge blood clots and hemorrhaging. I?ve never experienced this in my life. I went to see my doctor and he doesn?t know what to say or what to do, I call my obgyn she didn?t want to see me until I repetitively called over over finally I can see her tomorrow. I went to the ER they don?t know what to do. No one is helping me so far.
Discovered that vaccine in use in frig had a bud of 4/20/23 on 4/28 after administering vaccine 4/27
Pt started turning head side to side, stiffening, drooling, body taut, making gurgling sounds and shrill, shrieking noises and her skin was sweaty. After 45 mins of attempts to bring her out of what was happening, 911 was called. Paramedic assessed pt as all right at that time.
Pt has redness and swelling on the outer aspect of his left upper arm which is warm to the touch.
Patient received the Fluzone High Dose vaccine today at a clinic hosted by Pharmacy. The patient later called her local pharmacist and complained of pain under arm when she lifted it and the patient believed she received the vaccination too high on her arm.
12/20/22 presents to ED for "cough, headache, generalized fatigue". PMHx of "DM type II, HTN, anxiety/depression, HLD, history of OSA asthma, chronic back pain"
The nurse is reporting that a patient received improperly stored vaccine on 31-AUG-2021; This spontaneous report was received from a nurse, referring to a 6-month-old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 31-AUG-2021, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot# 1691301, expiration date 12-DEC-2021, for prophylaxis (strength, dose and frequency were not reported).  The temperature excursion was of 14.2 Centigrade degrees (°C) for 3 hours 15 minutes. However, a previous temperature excursion of 17.5 °C for 8 hours was also reported. A
Numb lips; A spontaneous report was received from a consumer concerning a female patient who experienced numb lips.  The patient's medical history and concomitant product use were not provided by the reporter.  On 23-Dec-2020, the same day as onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot #011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23-Dec-2020 the patient developed numb lips 30 minutes after receiving the vaccine which lasted for a half an hour.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event was recovered.; Reporter's Comments: Based on the 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. Further information has been requested.
I noticed a rash on my face on 9/15 it got progressively got worse and on 9/16 I saw my doctor and he dx Shingles I was prescribed valacyclovir and topical hydrocortisone and steroids I also noticed a rash on my leg for which I went to see a Dermatologist on 9/22 and he prescribed another round of steroids. I am immunosuppressed prescribed steroids on the 9/22/2022. It is slowly improving but the rash on my leg continues to bother me. I again saw a Dermatologist to confirm that it was Shingles and not another skin condition. Saw a dermatologist on 10/03 again and he currently paused valacyclovir.
Period started within 24 hours of getting vaccine.  Initially very heavy.   My period was due for another 12 days.
After 2 weeks of receiving my 5th Pfizer Bivalent COVID-19 vaccine. I noticed at noon time that I got sun burnt on my lower left leg at the cast. It was a large 1 and half inch big blister in diameter appeared in the center. It was very red,  painful, big and a round water blister in the middle. I went to my doctor after 1 week because it was getting bigger and bigger. My doctor prescribed me with antibiotics for 10 days then my doctor recommended that I should go to a wound clinic. I went there for 2 months since it was healing I didn't continue going there anymore. Now I noticed on the same spot, there is a big red scar about 2 inch in diameter. I am using VASELINE every day to keep it moisturized. I could actually take sun but after getting the last vaccine, my skin burned. I am not sure if the vaccine triggered it but just curious since it happened right after my last dose.
One week after receiving the vaccine the location of the injection swelled up and became hard, hot and itchy covering the whole biceps area.  It is warm, sore but does not have any rash or any outward sign of skin rashes.  I took some Benadryl and I am watching the area for additional reactions
Fever, emesis, arm pain at site (L) deltoid, rash decreased, decreased energy.
Pfizer-BioNTech COVID-19 Vaccine EUA Rec'd Pfizer-BioNTech COVID Vaccine on 3/3/21 and 3/28/21. Admitted 8/12/22 @ 37wk gestation for tx of sickle cell pain crisis w/IVF and pain relief. ED labs - Tbili 3.2, Alk phos 172, AST 80, Hgb 11.2, Hematocrit 31.1, SARS-CoV-2 detected, CXR revealing Increased interstitial markings bilaterally. 8/13/22 clinical course c/b nonreassuring FHR strip, acute mental status changese and hypoxia. Underwent Cesarean 2/2 IUFD, DIC/abruption noted. Rec'd 4u pRBC, u1 FFP, 1u Plts. Transferred to ICU intubated. POD #1 c/b resp failure & liver shock. Postop course c/b worsening resp status w/sickle cell crisis, acute hypox resp fail. severe Covid PNA, asp PNA, AKI, leukocytosis, transaminitis, reactive hyperglycemia and thrombocytopenia. Pulmonary status cont to decline; VV ecmo started w/improvement in sats. Severe ARDS w/refractory hypoxia present; trach place 8/23/22. 8/25/22 PEA arrest c/b multiorgan failure. On 8/25/22 overall condition determined to be terminal and irreversible. Status changed to DNAR and transitioned to comfort care. Tx'd w/decadron, , zosyn,cefepime, clindamycin, azithroycin, flagyl and remdesivir. Expired 8/26/22.
I had a sore arm and was tired for about a day after receiving the vaccine. In 03/2023, I had an endoscopy, and I was diagnosed with GERD. I am now taking medication to help with my symptoms.
The initial case was missing the following minimum criteria: no adverse event, only reported product complaint. Upon receipt of follow-up information on 22Jan2019 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 2-month-old patient of an unspecified gender received PREVNAR 13, (lot number: X39675, expiry date: Oct2020), intramuscularly on an unspecified date at 0.5 ml, single for immunization. The patient's medical history and concomitant medications were not reported. The reporting nurse reported on 18Jan2019 that PREVNAR 13 syringe broke upon administration. She said that the same thing happened on 22Jan2019 again. The patient got scratched by the needle. This incident happened was from the same lot as the one she reported on 18Jan2019. The reporter said that they are freaking out and want to know if this has been reported before or is it just this lot number.
Left arm had bumps on wrist and left hand, these bumps were small in size and itched, would not go away with topical ointments, lasted until July, these bumps also persisted onto the left foot and were all over the foot again small bumps and very itchy also caused dry skin on the foot the bumps have since gone away but dry skin on the foot is still an issue
First dose covid vaccine given 1/28/21, second dose given 2/18/21.  Admitted for bilateral pulmonary emboli to hospital on 4/25/21. From H&P "He reports that he woke up this morning and then subsequently started developing left-sided chest discomfort, it was pleuritic in nature.  It is sometimes worse with position.  He traveled to the Emergency Room where he was found to be mildly hypoxemic.  He underwent workup to include a CT angiogram, which revealed multiple predominantly small peripheral bilateral pulmonary emboli with borderline dilation of the main pulmonary artery and slightly greater than 1:1 right to left ratio.  He subsequently was felt to be appropriate for admission because of his underlying hypoxemia.  He denies any unilateral weakness or stroke symptoms.  He does have a patent foramen ovale.  He also reports no history of calf discomfort.  With the exception of being sedentary because of the pandemic, he has not traveled anywhere in a car or in a plane in the last 6-12 weeks." treatment: enoxaparin 1mg/kg SQ Q12h starting 4/25 @1659, changed to apixaban 10 mg PO Q12h 4/26 at 1756.
Mom states that teacher says the area is slightly raised, warm to touch, no fever, no pain.  Pt's mom reports that area is slightly red and pt is itching, but does not c/o other sx.
pt felt her throat was closing and was observed for 30 minutes, this was followed by lightheadedness. symptoms went away after 1 hour and patient left the hospital symptom free
"Shaky from the inside out" after 7 min.  Lip tingling 22 min. after vaccination - Benadryl 50mg IM given Feeling lip swelling (not on physical exam) and feeling flushed at 27 min after vaccination 0.3mL of Epi. given 5 min. after Epi. felt better, lips not feeling swollen, felt sleepy - from Benadryl, felt chills 20 min. later felt a little shaky, better than initially, felt tired, no body aches, no headache.
3 days after receiving the 2nd pfizer dose I had terrible menstrual cramps.  I had an ablation 10 years ago and no longer have periods.  Cramping has intensified over the last month and I finally went in to get an ultrasound.  the vaccine caused endometrial lining to re-grow back in "pockets".  I now have 2 large blood filled areas in my uterus that is encapsulated by scar tissue so they will not drain.  I am now going to have to have a hysterectomy because of this tissue regrowth.
Client stated that at approximately 9:00 PM he began to salivate so uncontrollably that he was unable to control the amount of saliva by simply swallowing.  Under his tongue was tingling.  Mosquito bite size hives covered his neck, his wrists, thighs and ankles and a "V" shaped pattern of hives extended from his shoulders to his sternum.  The client, who happens to be a nurse, took Benedryl and the symptoms subsided.  The client fully recovered.
Pt received flu shot in the left deltoid on 10/17/16. Came to office 10/31/16 c/o persistent pain. Pt stated at that time she believed she had SIRVA (shoulder injury related to vaccine administration). Exam seemed c/w rotator cuff strain and possible deltoid tendonitis (ttp over entire deltoid, anterior rotator cuff/shoulder and lateral shoulder joint. Pt noted she had previously had similar sx on the right side. Rec'd conservative management. Pt called 11/7/16 reporting no improvement so PT was ordered. Pt stopped attending PT after ~2 weeks (5 sessions) and requested ortho referral. MRI was done 12/29/16 (see below). Pt came to the office 1/2/17 reporting persistent significant pain limiting function/ROM- this was the first and only time she requested any pain medication. Rec'd pt return to PT (also rec'd over the phone 12/30/16), but to our knowledge pt has not returned. Pt saw ortho 2/22/17. Ortho notes her MRI finding is quite common. The note specifically states they feel it unlikely that the vaccine caused her MRI findings. They note her symptoms and exam are not fully explained by the MRI and are suggestive of adhesive capsulitis. They again recommended further PT, suggesting 6-8 weeks.
Pt received PROQUAD injection and additional varicella injection. 6-1-18 manufacturer called. Parent notified.
Patient came to clinic complaining of swelling of neck and face on same side as Tdap injection. Denies respiratory involvement and is breathing and swallowing without difficulty. Sent to Emergency room for further evaluation.
The day after pt. received vaccines, she developed redness, pain, induration, from left axilla to elbow. She also had fever of 102 degrees, chills and joint pain for approx 48 hours, then low grade fever for a couple days. Physician friend of hers gave her a prescription for Amoxicillin. 13 days after injection all symptoms resolved except dime sized knot @ injection site. Pt missed 5 days of work.
memory kind of brain fog type of thing; "so out of character"; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (memory kind of brain fog type of thing) and PERSONALITY CHANGE ("so out of character") in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (memory kind of brain fog type of thing) and PERSONALITY CHANGE ("so out of character"). At the time of the report, FEELING ABNORMAL (memory kind of brain fog type of thing) had not resolved and PERSONALITY CHANGE ("so out of character") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatments were reported.
Approximately a week after first vaccine, began to experience SOB, cough which persisted through 2nd vaccine. She finally presented to the ED on 5/11/21 and was found to have bilateral PEs. No recent travel, surgery, trauma or immobility. Not on hormones. Normal BMI. Non-smoker.  No prior hx venous thromboembolism.
Significant erythema and swelling to injection site with (1) blister and darker red area next to injection site. Pt. denies any distress 2 days after injection. F/U with PCP.
Woke up the next night  with chills, fever of 100.5, fatigue,  sore arm at injection site.  Took 1 ibuprofen every 6 hours.   Syptoms disappeared after 24 hours.
Pt recvd 2 doses of Engerix-B 2OCT91, 6NOV91, & 20NOV91 reporting MD indicated that pt was admitted to hosp due to acute Hep-B; HBSAG positive;
hives on left shoulder extending from neck down my back a bit, happened 5 hours after, was itchy for hours leading up to it; took allergy medicine and it went down
Vaccine remained in the freezer past the recommended guidelines (14 days). Once discovered, Pfizer was contacted but did not have stability data to support acceptability of the product greater than 31 days in the freezer. All patients that were administered vaccine past 31 days were contacted and given an option to be re-vaccinated based on their doctor'S recommendation or guidance.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed chickenpox with approximately 30 lesions. Within 24 hours the chickenpox consisted of 300-400 lesions with some scaling. The pt was exposed to the chickenpox approximately two weeks before onset.
This spontaneous report was received from a physician refers to a 9 year old patient of unknown gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 2 for prevent varicella (dosage schedule, route, anatomical location, lot number and expiration date were not reported). On an unknown date, the patient experienced shingles after having previously received 2 doses of VARIVAX. The outcome of herpes zoster was unknown.
Numbness throughout both arms. Painful lump at injections site. Flu-like symptoms, lymph node swelling, ringing in ears, nauseous.
Perhaps unrelated, but began brief episodes of AFib (atrial fibrillation) shortly after this 2nd dose.  Saw cardiologist, but went undiagnosed with episodes never happening while being monitored.  Symptoms stopped throughout summer and fall, until after the BOOSTER in October. Finally got diagnosed on 02/10/2022.
bad shake's, nauseated, vomiting after 4 hr sweating along w/chills, headache and feeling of faintness. Slight tenderness at site of injection.
Information has been received from a physician's office concerning a 46 yr old white male with a sulfonamide allergy, drug hypersensitivity to naproxen (Naprosyn) and doxycycline, gastrooesophageal reflux disease, chronic obstructive pulmonary disease and depression. On 23Oct05, in the AM, the pt was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine. At the time of vaccination, the pt was noted to have abdominal pain, nausea, vomiting and a small bowel obstruction. On 23Oct05, at 1:20PM, the pt experienced shortness of breath and back pain. The pt was given methylprednisolone sodium succinate (Solumedrol) 125mg and hydromorphone hydrochloride (Dilaudid) for back pain. The shortness of breath resolved with disipation of back pain. On 24Oct05 the pt recovered from the events. Additional information is not expected.
pt recd vax 215PM 21JAN93; mom states woke up @ 7Am next morning t-zone of face & cheeks were swollen; no fever or other sx;
This spontaneous report as received from a patient's parent refers to a 13 year old female patient. On 30-OCT-2014 the patient was vaccinated with GARDASIL, dose 4, injection. On 30-OCT-2014 the patient received fourth shot of GARDASIL in error. The patient had completed all the three doses in the previous year approximately in 2013 on an unspecified date. The patient experienced no adverse event. The reporter called to ask a question about the possible effects of receiving a fourth shot. Additional information has been requested.
No adverse effect, PT was vaccinated 02/23/22, Vaccine expired 02/17/22.
Fever; Chills; He is like sick; This is a spontaneous report from a contactable consumer or other non hcp. A 13-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Aug2021(age at vaccination:13 Years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced fever with outcome of unknown, chills, he is like sick. Therapeutic measures were taken as a result of fever was Tylenol and multivitamins. The outcome of the events pyrexia, chills, illness was unknown.  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a patient who on 19-JUN-2009 was vaccinated with VARIVAX (Merck) (lot # not reported) 0.5ml, subcutaneously instead of ZOSTAVAX (Merck). No adverse effect was reported. This one of two reports from the same source. Additional information has been requested.
About 16 hours after the injection, I had muscle pain and swelling at the injection site - I had a headache and upset stomach and my entire body was tired. About 20 hours after the injection, I felt disorientated. I looked at my watch 4 different times before it actually registered in my brain what time it was. I could walk and talk but my thinking was not registering correctly - it was very slow. The next morning I was still tired, but the other side effects were gone.
Swelling, erythema, edema, warmth of left deltoid at injection site - spreading - consistent with cellulitis.