chrisvoncsefalvay/vaers-outcomes huggingface dataset:
staff mixed the ACTHIB with NACL 0.7% VS NACL 0.4% and administered with no AE; staff mixed the ACTHIB with NACL 0.7% VS NACL 0.4% and administered with no AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves unknown demographics patient who received a dose of vaccine HAEMOPHILUS TYPE B (HIB) VACCINE[ACT-HIB] (lot: not reported, expiry date: not reported), via unknown route, on 13-Oct-2020 for prophylactic vaccination (product preparation error) and (incorrect product formulation administered).  The patient's past medical history, medical treatments, vaccinations, family history and concomitant medication were not provided.  It was an actual medication error due to wrong solution used in drug reconstitution and Inappropriate formulation of vaccine administered. It was reported that the acthib was mixed with nacl 0.7% vs nacl 0.4% and administered.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Flush face immediately after. Rash on left side of body after 14 hours. Mostly disappeared after 24 hours 48 hours rash over whole body; Flush face immediately after. Rash on left side of body after 14 hours. Mostly disappeared after 24 hours 48 hours rash over whole body; This is a spontaneous report from a contactable other hcp. A 29-years-old non-pregnant female patient received first dose of BNT162B2(Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 03Mar2021 12:00 PM at the age of 29 years as 1ST DOSE SINGLE for covid-19 immunisation. Medical history included Low blood pressure, Recurrent UTI (Urinary tract infection), Recurrent BV (Bacterial vaginosis), vitamin d deficiency, history of abnormal Pap, sensitivity to pork products. The patient had covid before vaccination. The concomitant medications included Birth control, antibiotics and topical antibiotics. Patient did not receive any other vaccines within 4 weeks. On 03Mar2021 patient experienced flush face immediately after. Rash on left side of body after 14 hours. Mostly disappeared after 24 hours 48 hours rash over whole body. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Chills, muscle aches throughout body, headache and pain in left arm that made it too painful to move or use it.  All symptoms except arm pain resolved within 24 hours.  Pain in arm lessened to tenderness on touch and slight pain on movement within 48 hours.  All arm pain symptoms were gone by 6th day after injection.
2 mos after small pox vaccine administration, pt comes to clinic with c/o pus oozing from site and skin breaking when changing bandaide.  Pt was seen again on 16 November with continual sx of injection site not healing, pus, and numbness down the arm.  Pt was sent to Derm where he underwent a skin punch biopsy and wound culture with coagulase negative Staphlococcus organism growth.  He has been treated with TMP 800-160 tabs PO bid for 7 days.  Wound was healing.  Another f/u on 12 December shows formation of new pustule.
Day after the vaccination, patient woke up with hives at the site of injection. It lasted 1 day and resolved on its own without treatment.
Within 2 hours of the shot, I got a headache and started feeling deathly ill.  I felt as if I was going to vomit and nothing I did helped.  My arm got a little red and sore a few hours after the injection.  Over the next few days my arm continued to get even more red & irritated as well as swelling some.  I have photographs of each phase of the irritation; if this is needed, I will gladly send them in to you all.  I had to stay out of work that whole weekend (2/26, 2/27, & 2/28) due to not being able to get out of bed.  I stayed in bed for the majority of the weekend sleeping and was not up moving around more than 8 hours the whole weekend.  Since I was still sick and having issues after so many days, the Medical Control Unit at my job (run by our Fire & Rescue Department) made me get tested on 3/1/21 to make sure it was not COVID.   Later that afternoon, the test came back as negative.  I still was feeling nauseated and fatigued even weeks after the shot.  I have stayed nauseated since then and have also been very tired still.
Swollen arm around vaccination site. Per patient, MD stated it was an infection and treated with KEFLEX.
This 11 year old patient was inadvertently given 12yr+ Covid (30 mcg). There were no adverse symptoms within the 15 minutes after given and no treatment needed. Physician discussed this error with family and patient.
My initial symptoms were light swelling a region around the shoulder of my injection arm and excessive sweating in the armpit on my injection arm side.  Following this, symptoms similar to being on a hallucinogenic gradually manifested over the next several hours, including euphoria, a persistent urge to grind teeth, and some mild-to-moderate visual and physical effects.  Following the date of the injection, the primary symptom has been a bruise/cramp hybrid pain in the upper arm of the injection site that is gradually receding (but still ongoing), along with random light bouts of nausea and headaches, random light pains throughout my injection arm, and occurrences of coldness in my injection arm (lasts about an hour)
This spontaneous report was received from a pharmacist refers to a 76-year-old male patient. The patient's concurrent conditions included high blood pressure, high cholesterol and diabetes. Concomitant therapies included PLAVIX, atenolol, isosorbide mononitrate, gabapentin, TOUJEO, tramadol hydrochloride, HUMULIN R, nitroglycerin, cyclobenzaprine hydrochloride, lovastatin (manufacturer unknown), glimepiride and furosemide (manufacturer unknown). On 23-JUL-2009, the patient was vaccinated with a dose of ZOSTAVAX (reported lot # 1413X, expiration date: April 2010) (dose regiment and route of administration were not reported) dissolved in sterile diluent (MERCK). On 23-SEP-2017, the patient experienced painful rash that started at his naval and went around his back. The outcome of the event was not reported. The relatedness between vaccination with ZOSTAVAX and the event was not reported.
Arm swollen below elbow up to top of shoulder, hot to the touch, knot and rash at injection site, arm very sore. Relieved with ice, ibuprofen, hydrocortisone cream.
4mm across, 3mm down 1/2 dollar size reaction to varicella vaccine, red and itchy, bubbled and sticks out about 1.2 inch from arm.
Injection site pain, intermittent, radiating, severe - Lt arm. No associated trauma to site, shoulder to other areas.
She cannot sleep; Stomach ache; Stomach upset; Headache is off and on; She is sick of the headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 92 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 (Lot number: EN6206) at the age of 92 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 05Mar2021, outcome "not recovered", described as "Headache is off and on; She is sick of the headache"; INSOMNIA (non-serious), outcome "not recovered", described as "She cannot sleep"; ABDOMINAL PAIN UPPER (non-serious), outcome "not recovered", described as "Stomach ache"; ABDOMINAL DISCOMFORT (non-serious) with onset 05Mar2021, outcome "not recovered", described as "Stomach upset". Therapeutic measures were taken as a result of headache, insomnia, abdominal pain upper.  Follow-Up (30Mar2021): This a follow-up spontaneous report from a Pfizer Sponsored Program. A contactable consumer (husband) reported for a patient that: additional information regarding adverse events were updated  No follow-up attempts are possible; No further information is expected.
He has sore arm; shoulder pain; headache; A spontaneous report was received from a consumer concerning himself an 86 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shoulder pain, headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown  date, the  patient received first of two planned doses of mRNA-1273 (lot/batch number: Unknown) via unknown route for prophylaxis of COVID-19 infection. On 10-feb-2021, prior to the onset of events which was experienced on unknown date, the patient received the second of the two planned doses of mRNA-1273 (lot/batch number : Unknown) through unknown route.  On an unknown date, the patient experienced the event(s) shoulder pain, headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), shoulder pain, headache was unknown.
Information has been received from a health professional concerning a female patient who on 01 Nov 2006 was vaccinated with a 0.65ml dose of varicella zoster virus vaccine live (lot #652936/0981F). On approximately 01 Nov 2006, the patient developed an injection site reaction that was described as red, swollen, hot, and itchy. Unspecified medical attention was sought. The patient was told to take antihistamines and to use a cold compress. As of 06 Nov 2006, the reaction was less severe, but had not resolved. A product quality complaint was not involved. Additional information has been requested.
suspected vaccination failure; shingles/shingles are painful; low grade fever; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient had a Family History of shingles (mother suffered with shingles).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and low grade fever. On an unknown date, the outcome of the vaccination failure and low grade fever were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and low grade fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix 3 years before the date of reporting. The patient experienced shingles every year since the time of receiving Shingrix. The patient was happy with the Shingrix vaccine when it was released newly in the market. At the time of reporting, the patient again suffered shingles for the third time and stated that it always broke out shortly on back the right leg after a bout of low grade fever.  The patient felt to be compensated and reported that the GSK's research department should pay to study why Shingrix could not protect the patient from shingles, but the patient experienced shingles inspite of receiving Shingrix. The reporter could be contacted by phone. This case was considered as suspected vaccination failure as the details regarding vaccination schedule was unknown.
pt recvd vax; noticed a dec sense of taste; was found to have Bell Palsy; as of 9aug94 states still has minor drooping in lt corner of mouth;
Patient came today for her second vaccine. After receiving first vaccine, patient had some throat swelling at home. Was advised by MD to take Benadryl. Patient did, symtpoms resolved. Patient received vaccine around 0830. Within about 10 mins patient reported feeling of throat closing. No shortness of breath, no audile wheezing, able to speak with clear speech. O2 at 100%. Heart rate 50-60. Mom administered Benadryl PO at 0840. About 15 minutes after, patient began to complain of worsening throat swelling, lip swelling, and eyelid swelling. Patient unable to swallow water. Vital signs remain stable. 0.3mg EpiPen was administered at 0845. Security was called to initiate 911 procedure. After Epi, patient reported feeling better right away. Eye are little less swollen and O2 remained 100% entire time. Patient was alert and oriented, stable. Regular respiratory rate, regular heart rate, mild shortness of breath with speaking. EMS arrived and escorted patient to emergency room. In The ED, patient was observed and no medical intervention is needed. patient symptoms resolved and was discharged home
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2015, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 69-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 18-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: right deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805447 was crossed linked to original cases 201804863 due to same reporter.
Information has been received through the Merck pregnancy registry from the mother of a 17 year old female who on 22-MAR-2007 was vaccinated with GARDASIL. The mother reported that her daughter was pregnant at the time of vaccination. She experienced no adverse experiences. at the time of this report, the patient was 18 weeks pregnant. Date of LMP was 30-DEC-2006, estimated delivery date is 06-OCT-2007. Follow-up phone call information from a registered nurse reported that the patient had spontaneous rupture of membranes and arrest of first stage of labor which led to a primary cesarean section at 37 weeks gestation (full term) on 01-OCT-2007. The patient delivered a healthy, normal, baby. Upon internal review arrest of first stage of labour leading to a cesarean section was considered an other important medical event. No additional information is expected.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, an unspecified number of patients may have been vaccinated with an unknown number of doses of PROQUAD (dose, route, lot number and expiration date were not reported) that were exposed to temperatures outside of those specified in the prescribing information. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
aunt states p/shots pt cried inconsolably x 9 hrs; didn't take temp, called MD said given APAP; MD wrote on pink card DT only from now on;
Patient states the day of the injection her arm started to feel funny within one to two hours. She finally went to the MD on 01/08/10 with complaints of nerve and muscle pain of the neck, arm and shoulder. MD did a shoulder X-ray. Pt. was prescribed MEDROL dose pk, DILAUDID 2 mg and nerflex 100 mg to deal with side effect of the injection from over a week ago.
1:50pm Pt walked from parking lot to vaccine tent to report she felt strange.  Complaining of a sensation that started in her vaccination arm site and seem to spread over her upper body and described it as swimmy eyes and chest tightness.  Patient placed in a chair, VS obtained: BP 150/90 in RUE, HR 60/normal, RR 20/normal.  Otherwise the patient was calm in appearance in A&O x3.  Patient states  she hadn't eaten much that day.  Provided a bottle of water and a Chewy snack bar.   2:05pm Patient reports symptoms are no worse or better; Nursing Supervisor notified. 2:07pm Medical Director, Doctor notified of patient and subjective/objective data.  Order for Benadryl 50mg IM obtained.  Along with instructions not to drive post administration of the Benadryl and to call EMS or report to the nearest ED if reported symptoms related to chest tightness did not improve.   2:08pm Benadryl 50mg IM given in right upper extremity.  Patients husband has arrived and is standing next to her.  Patient remains calm and in no apparent distress other than the symptoms previously reported.  2:18pm Patient states she feels woozy from the Benadryl, but no worse or better than previous.  Offered to call EMS, patient and husband declined. 2:30pm Nursing Supervisor onsite.  Patient re-evaluated by asking questions related to current symptoms.  Patient states chest tightness had resolved.   2:40p Patient reports feeling better.  Patient instructed not to drive due to the potential for drowsiness related to the Benadryl administration.   2:45p Patient and husband left the vaccination area together.
I received my COVID booster and my regular flu shot at the same time but in different arms. My first two doses of the vaccine were Moderna as was my booster. 8 days after receiving the shot I was out and started getting super itchy mostly on my back, shoulders, head, and neck. I was itching like crazy and getting hives all over. I?ve never had a reaction like this before to anything. The hives and itchiness has persisted for a number of weeks  but gradually become less intense overtime. However at the beginning for the first two weeks I was getting very itchy and hives everyday and always flaring up in the evening. I haven?t found anything else in my apartment or workplace that could?ve caused such a reaction.
severe diarrhea; diffuse abdominal pain; swollen lump in face; face redness; migratory arthralgia in right foot; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (diffuse abdominal pain), SWELLING FACE (swollen lump in face), ERYTHEMA (face redness), ARTHRALGIA (migratory arthralgia in right foot) and DIARRHOEA (severe diarrhea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Ammoniacal dermatitis (Allergic to ammonia (hair dye).), Myasthenia gravis and Lymphoma.   On 01-Mar-2021 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021 at 1:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 01-Mar-2021, the patient experienced ABDOMINAL PAIN (diffuse abdominal pain), SWELLING FACE (swollen lump in face), ERYTHEMA (face redness) and ARTHRALGIA (migratory arthralgia in right foot). On an unknown date, the patient experienced DIARRHOEA (severe diarrhea). At the time of the report, ABDOMINAL PAIN (diffuse abdominal pain), SWELLING FACE (swollen lump in face), ERYTHEMA (face redness) and ARTHRALGIA (migratory arthralgia in right foot) outcome was unknown and DIARRHOEA (severe diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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.   Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: No specific follow-up information recorded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
June 15, 2022 I had a bad headache and was coughing, a low grade fever , chills and felt fatigue. I felt a lot of mucus congestion in my throat, like making it hard to talk without having to cough.  I took a home test and it was positive. I went to ER. I was prescribed Paxlovid and took it for a week. I felt better on that third day. On June 27th, 2022 I started to feel the symptoms again and tested on a home test again. After consulting with my doctor I decided not to take another Paxlovid, I just waited it out at home. I currently have a tingling in my throat with a slight cough lingering.
Patient came to receive her follow-up COVID vaccine indicating that she had previously received the Pfizer vaccine. Accordingly we gave her the Pfizer vaccine and she went on her way after waiting 15 minutes and having no ill effects. Upon entering her information later in the day we discovered she had actually previously received the Moderna vaccine. We notified the patient, our clinical team and district manager. Upon further research we found that because they are both mRNA vaccines the patient does not require further vaccination for COVID. We informed the patient who seemed pleased with this outcome.
Pt expressed nervousness prior to shot being administered. She had a small amount of blood at injection site. When she looked at blood she became rigid, her eyes rolled back and fluttered, and her head fell back. She was not responsive for about 1 minute.  I helped her to the floor and made sure her airway was clear. I called her mother into the room and continued to monitor the patient. She regained consciousness. Mother stated this had not happened previously and that pt had not hx of seizures or fainting. I had the patient remain lying on floor for another couple of minutes and had her raise her knees.  Mother and pt declined further medical assistance.
Started with mild itching Wednesday evening into Thursday.  Intensified Friday evening (11/5/21).   Hands, torso, feet.  Patient noticed some  slight swelling in hands/feet.  No hives/no rash. Symptoms come and go.  Still occurring, but at the present time of report.
a pediatric dose of Pfizer to a 12 year old. This child should have received the 12+ dose of Pfizer
About 35-40 minutes after the vaccine I started to experience altered sensory perception and fatigue. It became significant enough I went to bed early. I woke up in the middle of the night with a migraine type headache, full body fatigue, myalgias, neuralgias, and arthralgias. I called out of work and spent the rest of the day shivering and in full body aches. I took 600mg ibuprofen in the morning and again in the evening.