chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tongue was itching; tongue was tingling; couldn't swallow; throat was swelling; allergic reaction to the ingredients of Fluzone HD vaccine; slight fever; throat felt like she had a plum pit stuck in it and this feeling travelled up her throat and to the sides of her throat and by her tongue; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 68 years old female patient who experienced tongue was itching (tongue pruritus), tongue was tingling (paraesthesia oral), couldn't swallow (dysphagia), throat was swelling (pharyngeal swelling), allergic reaction to the ingredients of Fluzone HD vaccine (allergy to vaccine), slight fever (pyrexia) and throat felt like she had a plum pit stuck in it and this feeling travelled up her throat and to the sides of her throat and by her tongue (oropharyngeal discomfort), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for Immunisation received a couple weeks ago, patient got sick from that shot but that is typical with the second shot. She had fever and chills.  On 02-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ253AA via unknown route in the right arm.  On an unknown date, the patient developed a non-serious tongue was itching (tongue pruritus), tongue was tingling (paraesthesia oral), couldn't swallow (dysphagia), throat was swelling (pharyngeal swelling), allergic reaction to the ingredients of Fluzone HD vaccine (allergy to vaccine), slight fever (pyrexia) and throat felt like she had a plum pit stuck in it and this feeling travelled up her throat and to the sides of her throat and by her tongue (oropharyngeal discomfort) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was throat felt like she had a plum pit stuck in it and this feeling travelled up her throat and to the sides of her throat and by her tongue, slight fever, allergic reaction to the ingredients of Fluzone HD vaccine, throat was swelling, couldn't swallow, tongue was tingling and tongue was itching.   The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and DEXAMETHASONE (DECADRON [DEXAMETHASONE]) 3, 4mg tablets.  On an unknown date, the patient was Recovered from throat felt like she had a plum pit stuck in it and this feeling travelled up her throat and to the sides of her throat and by her tongue, allergic reaction to the ingredients of Fluzone HD vaccine, throat was swelling, couldn't swallow, tongue was tingling and tongue was itching and not recovered from slight fever.  Information on the batch number was requested.  Documents held by sender: none.
Symptoms 6/29/2006 AM. Cellulitis to left deltoid. Treatment with Keflex 250 mg one tsp BID for 5 days.
Patient developed raised red morbiliform rash. Reportedly started on face. By the time of the visit has spread to upper extremities and shoulders. Otherwise well, afebrile.
Fully vaccinated, not boosted.  Admit for labor, asymptomatic COVID.   Delivered a full term baby girl (baby girl, name not mentioned)  1/22/22  40 week gestation.  Discharged 1/24/22.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was intramuscularly vaccinated with first dose of GARDASIL (lot number not reported) on 09-SEP-2011 and would be administered the second dose on 14-SEP-2012. No other co-suspects or concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Patient received original pfizer vaccine instead of the bivalent pfizer booster.  No adverse events reported.
PT IS A COVID-19 BREAKTHROUGH CASE THAT EXPIRED ON 8/10/2021.   NEARLY 5 MONTHS AFTER COMPLETING SERIES. HEALTH DEPARTMENT WAS NOT THE VACCINATING FACILITY BUT WE ARE THE REPORTING FACILITY.
Mother called Hlth. Dept. this AM (10-2-08) stating her son experienced fever of 102, Nausea, Vomiting, & Dizziness beginning evening of 10-1-08 post vaccine administration and was still experiencing N,V,& Dizziness with fever reduced as a result of Tylenol admnistration. Advised mother if child was still experiencing same problems he should see a physician to determine if symptoms were resultant of vaccine or another cause. Requested mother to advise me of the outcome.
Patient was administered a pfizer purple cap dose that was past the beyond use date.  Patient was observed for the 15 minute period without any incident.
I got vaccine on Friday3/19/21. Everything was good on Saturday but when I wake up on Sunday morning I realized that my neck is very stiff and I was not able  move my neck. The pain was very severe and was predominantly in the area of upper back and  right shoulder area.  I was on bed whole Sunday. On Monday i had the same issue. On Tuesday I got little improved. On Tuesday I can move my neck left and right with some pain but still I can?t move my neck downward. I call my doctor?s office and they told me to use over the counter pain medication and if I still have pain until Thursday then schedule office visit.
head to toe rash, massive itching, began about 11 pm 2 days aver I was vaccinated
Drop of blood pressure at 9am of the morning after vaccination leading to convulsion like activity. Extremely strong headache on the back of the head, which later traveled to frontal lobe and down the jaw. Discharged from ER around 3pm. Persistent headache, low fever, and weakness for one more day. Blood pressure and heart rate fluctuates abnormally when changing from laying down, to sitting down to standing up
Immediate joint pain in elbow following injection.  Joint pain as persisted and worsened over the past 8 days.
Palpitations; This case was reported by a other health professional via interactive digital media and described the occurrence of palpitation in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced palpitation. On an unknown date, the outcome of the palpitation was unknown.   It was unknown if the reporter considered the palpitation to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-APR-2022 Reporter's comment: This case was reported by other health care professional via interactive digital media. The reporter read different information about not giving and giving 2nd dose of Shingrix vaccine. The reporter asked recommendation for the same. Additional Supportive Information: The follow-up would not possible as no contact details were available.
subsequently received a booster dose of the Moderna Covid-19 vaccine.One patient is a cancer patient; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (subsequently received a booster dose of the Moderna Covid-19 vaccine.One patient is a cancer patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (subsequently received a booster dose of the Moderna Covid-19 vaccine.One patient is a cancer patient). At the time of the report, ACCIDENTAL UNDERDOSE (subsequently received a booster dose of the Moderna Covid-19 vaccine.One patient is a cancer patient) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided. Patients had been administered the two full primary series Moderna Covid-19 vaccines. The patient was cancer patient. No treatment medication details were provided.   This case was linked to MOD-2022-494052, MOD-2022-494052 (Patient Link).
Patient was administered Adacel that was exposed to temperature excursions and not acceptable for use/no AE; Initial information received on 06-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA157616, 2019SA157599, 2019SA157614 and 2019SA157615 (same reporter).  This case involves a 48 years old female patient who received a second 0.5 ml dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot C5585AA and Exp. Date 06-Mar-2021 via intramuscular route in the left deltoid on 31-May-2019, which was exposed to temperature excursions and not acceptable for use.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  It was reported that Adacel was ordered on 22-May-2019 and did not arrive until 28-May-2019. Patient was administered Adacel that were exposed to temperature excursions and not acceptable for use.  No reactions reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.  List of documents held by sender: none.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 22-MAR-2016, the patient was inoculated with the ZOSTAVAX, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 25-MAR-2016, the patient was treated for the onset of a vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed valacyclovir hydrochloride (VALTREX) for management of her painful symptoms and chronic pain. As a direct and proximate result of the 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Patient presented to hospital with 1-day history of bleeding, bruising and low platelets. History included epistaxis, left elbow bruise and a platelet count of 2,000 in her primary care physicians office on 5/12/2009. Patient was admitted to hospital on 5/12/09 and received 10g IVIG that evening. On the morning of 5/14/09, Pt had responded with a platelet count of 49,000, and was subsequently discharged.  8/3/09 Hospital records received DOS 5/12/09 to 5/14/09. Assessment: Idiopathic Thrombocytopenic Purpura. Parents noted dried blood in child's nostrils, started to bleed when cleaned. Bruise on left elbow. Presented with bleeding, bruising, and low platelets. Fussy. Petechiae of lips, oral mucosa, pharyngeal mucosa, extremities, and trunk. IVIG given.  9/14/09 ICD-9 Codes Received: 287.31 Immune thrombocytopenia purpura, 287.5 Thrombocytopenia unspecified.
Patient received vaccines 2/22/08 about 8:30 am.  Patient spiked a temperature of 105.8 at 10:30 pm 2-23-08; went to the ER where his blood count was NNL and tested negative for Influenza.  RSV is now being R/O by pediatrician.
Systemic: Fainting / Unresponsive-Mild, Additional Details: After He got a shot, he collapsed while he was looking at his cell phone according to his mom. when I went out he was unresponsive a few minutes later. He was responsive a few minutes later, but, we called 911 to check him. Paramedics came and checked him. He was okay according to paramedics.
End of May i had some vision issues seeing double but did not think much about it .  Went to my PCP for annual physical exam where he did the bloodwork and everything came back normal except Cholesterol which was marginally higher.  The issue was not causing much discomfort for me and it sort of went away the best i recall or dont recall.  Around June 14th 2021 I started having trouble focusing with my eyes again. It was causing me more discomfort than before so i visited my PCP Dr  June 15th. Dr mentioned there was slight difference in ear pressures and maybe it was that.  Not totally satisfied with that i visited my Optometrist Dr the next day and he suspected 4th nerve Palsy and asked me to
Some weeks later i awoke in the middle of the night with extreme bilateral weakness and pain in my extremities. After about two months I have now been  tentatively diagnosed as having polymyalgia rheumatica.
This spontaneous report was received from a physician via company representative refers to a 6 month old patient. On 31-OCT-2016, the patient was vaccinated with improperly stored ROTATEQ. The physician reported two patients were vaccinated with VAQTA. No adverse effects. Additional information was received from the physician who phoned to provide lot numbers. The physician stated that the Hepatitis A vaccines in question are not MSD products. The physician reported that the administered dose of ROTATEQ came from either lot # M005733 expiration 01-OCT-2017 or lot number M018957 expiration 22-NOV-2017. The temperature was reported a 1 degree centigrade and time frame of 60 hours. No further information was provided. Additional information has been requested.
The next morning, pt developed tingling around right eye. Rash started next day 5/14 diagnosed by ophthalmologist with herpes zoster.
15 to 20  minutes after the shot I got very hot/clammy, weak and confused the employee health nurse came to check on me and told me to come to her office and I passed out.  I was taken to the ER and kept there approx. 5 hours.  I was extremely weak, could not lift my head and had trouble forming thoughts and words.  They gave me medication via IV's and observed me.  I started to feel better after about 4 hours after the vaccine, but have had more headaches than usual after receiving it.  I still have some issues with being upset and anxious about the reaction and if it will have long term adverse effects on me.  I will never get another vaccine of any type again.
Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: Patient described the following symptoms--  paralysis, numbness, tremors, and shooting pains.  She could not walk and had to be carried/dragged.  She said she was awake, but could not respond to questions.  It was hard for her to think.  This lasted about 2-3 hours.  She went to the ER, but her insurance would not pay for her care, so she waited the next day to go to her regular prescriber for a check up.  The symptoms began on Septmeber 2, and for the next 2 days she was exhausted/tired.
NO ADVERSE REACTION. PATIENT RECEIVED BOOSTER DOSE WITHOUT PREVIOUSLY RECEIVING PRIMARY SERIES DUE TO MISUNDERSTANDING / MISREPRESENTATION OF VACCINE HISTORY.
My right side temple and right eye haven began twitching. My right side of the mouth also chatters sometimes at the same time the twitching is happening. Sometimes it?s two of the three issues at once or sometimes it?s individually reacting.
04/18/202 I received my booster 4. I started to experience adverse event from 04/21/2022 I felt tired, My heart would not stay in a regular rhythm. I tried to rest but it wont not help. I felt poorly and I had my friend to take me to ER they did EKG, blood work and they hooked me up to a heart monitor. I happened yesterday morning. It was happening for couple of days. I was admitted in the ER for 7 hours. The doctor said they had seen other patients with the same issue after the 4th booster. They suggested I should take magnesium.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2017 (from 24-AUG-2017 to 07-SEP-2017), the patients were vaccinated with improperly stored doses of ROTATEQ (lot # N005617, expiry date 03-OCT-2018) orally (route of administration was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Fahrenheit to 25 degrees Fahrenheit for 12 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA012574.
This is a literature report for the following literature source(s): "Graded Administration of Second Dose of Moderna and Pfizer-BioNTech COVID-19 mRNA Vaccines in Patients with Hypersensitivity to First Dose", 2021; Vol:8 (12), DOI:10.1093/OFID/ofab507. The authors reported a case series of outpatients referred from the community from January to May 2021 for evaluation of symptoms consistent with immediate hypersensitivity reactions to the first dose of the Moderna or Pfizer-BioNTech COVID-19 vaccine, who subsequently received their second dose through a graded administration protocol. A 44 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TYPE I HYPERSENSITIVITY (medically significant), outcome "unknown", described as "immediate hypersensitivity reactions"; RASH (medically significant), outcome "unknown", described as "Non-urticarial rash", time of symptom onset 30 mins. The event "non-urticarial rash" was evaluated at the emergency room visit. The events "immediate hypersensitivity reactions" and "non-urticarial rash" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood immunoglobulin g: 17.85, notes: Log2 dilution. Therapeutic measures were taken as a result of type 1 hypersensitivity, rash which included diphenhydramine. Skin test was not performed. There was no reaction to second dose via graded administration. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on a drug event temporal association and on the compatibility with the known adverse event profile of the suspect product, the company cannot completely exclude a reasonable possibility that the suspect BNT162B2  may have contributed to the onset of reported events. Linked Report(s): US-PFIZER INC-202200151789 Same article/ drug/event and different patient.
Information has been received from a licensed practitioner nurse concerning a 60 year old female who on 28-DEC-2010 was vaccinated with VARIVAX (Merck) (lot # 668256/0903Z, expiration date 09-JUL-2012) rather than ZOSTAVAX (Merck) for the prevention of Herpes Zoster. No problems reported with the VARIVAX (Merck) vaccination. The nurse stated that the medical assistant that made the medication error was confused. The VARIVAX (Merck) and ZOSTAVAX (Merck) were contained in the same freezer and the medical assistant became confused when she could not find the ZOSTAVAX (Merck) (ZOSTAVAX (Merck) was reported to be out of stock at the office). The nurse could not explain what exactly confused the medical assistant, but stated that the VARIVAX (Merck) and the ZOSTAVAX (Merck) packing were very similar. The patient sought unspecified medical attention. Follow up information has been received from the nurse indicating that on 28-DEC-2010 the 60 year old female with no illness at time of vaccination was vaccinated SC with the first dose of VARIVAX (Merck) (lot # 668256/0903Z). No adverse events. No lab diagnostic tests were performed. It was unknown if the patient sought medical attention. On follow-up information received via telephone call from a receptionist indicated that VARIVAX (Merck) was pulled off the shelf by mistake and it was not product confusion. Additional information is not expected.
Pt had the immunization on 08/06/2014 next day pt woke up with (L) leg swollen. Symptoms was swollen, painful, and feeling hot on the area that I gave the DTaP and Polio vaccine.
Bradycardia, dizziness; fainting; Immediately after shot was given; Laid down; water given; PEDIALYTE given; better after 15mins of rest/laying down.
This spontaneous report was received from a medical assistant regarding unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown day in 2016, the patients were vaccinated with an improperly stored dose of ZOSTAVAX (lot # L044528, expiry date 02-SEP-2017) dosage regimen and route unknown. Concomitant medications were not reported. No adverse events were reported. The vaccine was subjected to temperature excursion of 45.9 degrees Fahrenheit for 4.5 hours on 11-JUL-2016. It was reported there were no previous temperature excursions. Product quality complaint (PQC) was not filed. This report is one of several reports received from the same reporter. Additional information has been requested.
Breakthrough case admission after 2 vaccines Moderna 2/6/21 Lot# 011M20A;  Moderna 3/6/21 Lot# 030A21A;
Within 1-2 minutes following injection patient began to feel lightheaded (Syncope) and complain of stomach ache. Patient had just had lunch prior to coming to receive vaccine. Mother and I laid him on the floor and asked him to turn on the side. He was communicative at all times and did not display any signs of  anaphylaxis. 911 was called for precaution due to his age. He slowly began to feel better and after about 15 minutes was on his feet again. No treatment was administered. 911 arrived and checked his vitals. He was okay. He was not taken to hospital.  Mother said she would follow up with Doctor.
Pt recvd vaccine that expired on 9/19 on AM of 9/20. No adverse reaction noted. This was a third dose in an immunocompromised pt.
3/30/2022 at 1631 reporter called the Vaccine Support line to report symptoms post COVID-19 booster vaccine. Vaccine Name - Pfizer Vaccine Date - 3/29/2022 Booster Dose - Yes Location - Right Deltoid Date of Symptom Onset - 3/30/2022 (Morning of) Symptoms - Body Aches, Headache, Tiredness  Home Remedies - N/A (Per reporter "Just been Trying to Sleep It Off"). Any Improvement - N/A
Hives occured 15 mins after vaccination Patient took diphenhydramine 25 mg