chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 78 year old male patient with hypertension, artery coronary disease and diabetes and a history of chickenpox and lipids increased who on 05-JAN-2007 (also reported as about a year ago) was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot n 652947/1411F), 0.65 ml. in the left arm. No rash appeared at the site of injection or elsewhere within 42 days of vaccination. On 02-OCT-2008 (also reported as about 4-8 weeks ago), the patient developed shingles which turned into post herpetic neuralgia localized in T3 level, afebrile and pain with the maximum intensity (10). The patient sought unspecified medical attention. The patient did not have any other systemic symptoms. The patient did not have a recent exposure to chickenpox.  At the time of the reporting post herpetic neuralgia persisted. No additional information is expected.
For the  two days prior to presentation the patient had been complaining of chest pain, his breathing seemed to be labored Monday.  He and the family thought the pain was due to shingles as he  carried this diagnosis from a month ago. Patient had also received the COVID vaccine 2 days prior to presentation and assumed he was feeling unwell due to the vaccine.  Family wanted to take him to the hospital yesterday and earlier today but he refused.  She left him in his home earlier this afternoon prior to  presentation and returned to check on him finding him unresponsive and apneic at which time EMS was activated.    #cardiac arrest -- suspect primary cardiac given collateral from family at home, consider hypoxemia which was corrected with advanced airway and 100% FiO2, patient clinically euvolemic and with soft brown stool in diaper not suggestive of GI hemorrhage, attempt to address acidosis with CPR and bicarbonate, not  hypoglycemia, on bedside ultrasound FAST neg and no pericardial effusion suggestive of tamponade and +lung sliding bil not spontaneous pneumothorax  Assessment/Diagnosis:  -cardiac arrest, cause unspecified
Awake 4am, and fell down (down to knees and hands) because I was really dizzy and nauseated.  I couldn't walk (well, I could with great difficulty leaning on furniture) and was very dizzy and felt like I would throw-up.  I moved to a reclining chair and stayed there 20+ hours (it's 20 now)... I got up to go to the bathroom and not much more.  I had a difficult time even making it to the bathroom.  Never had a fever (that I know of... I don't have a thermometer but didn't feel feverish or chilled), but I felt dizzy and nauseated all day and could hardly move from the recliner except for extreme need.
At the end of the Pediatric COVID vaccine clinic on 11/11/2021 at approximately 1715 I, RN Nurse Manager of the Pediatric clinic, realized that additional doses of the COVID clinic would need to be mixed and drawn up for the remaining patients on the schedule. I went into the medication room to mix a vial of the COVID vaccine with normal saline as I had been taught to do earlier in the day with Pharmacist. I opened the red bag of supplies to mix up the vaccine and only found one vial in the bag with a salmon colored top. Remembering that that the vaccine came in a vial with an orange top I believed this to be the vaccine and was looking for the diluent. Unable to locate some I called the Pharmacist and she informed me that I was fine to use normal saline from another source to mix the vaccine. I located another source of normal saline within the clinic and used it to mix 1.3ml of normal saline into the vial. After following the mixing instructions of inverting the initial vial 10x, added the diluent, removed 1.3ml of air, and then inverted the vial 10x to mix, I then drew up multiple syringes of 0.2ml RN adjunct professor for the School of Nursing and MA each took two syringes to vaccinators who were waiting to administer the vaccine to patients. approximately 10-15 minutes later staff member and I called the Pharmacists to ensure I knew how to properly dispose of the unused vaccine. It was during this conversation that I realized I had not used the COVID vaccine vial but had used the diluent vial and had mixed additional NACL into the diluent vial. I immediately asked who had received the last 4 doses, 3 of those patients were still in the building and 1 patient had left. I notified the parents of the 3 children who were still on the premises of the error that was made and apologized. I then asked if they would still like their child(ren) to receive the COVID vaccine tonight and the parents agreed. Those 3 children each received a dose after I went back into the med room and correctly mixed the vaccine. The children remained under observation for 15 minutes and were then discharged.
Symptoms exactly like the COVID Pneumonia I had in hospital Nov.  2020.  Not as severe but felt short of breath like breathing through a wet sponge.  Fever, chills.
Systemic: frozen should that required mri and therapy-Severe, Additional Details: patient claims "frozen shoulder"  from injection too high  needed mri and therapy
Breakthrough COVID infection. Symptoms of cough and shortness of breath. Unsure of onset of symptoms.
Patient had cellulitis in the injection arm. Went to Urgent Care and got Keflex, Medrol Dosepack and clobetasol. Feeling warm and pain. Started the next day of the vaccination and progressed. Went to Urgent Care 2 days after the vaccination.
explosive diarrhea that was liquid and green in color; explosive diarrhea that was liquid and green in color; feeling "queasiness"/queasy abdomen; loose bowel movement; a queasy abdomen right now, kind of gurgling; This is a spontaneous report from a contactable consumer (patient) and nurse. A 75-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140, expiration date 31Mar2021), intramuscularly at site of left arm on 18Jan2021 09:30 AM at single dose for prevent COVID. The patient medical history was not reported. There were no concomitant medications. The patient previously received flu shot in Oct2020 for immunization (she had the flu shot last year but it was not within 4 weeks, it was in the fall time around Oct2020). The patient experienced a loose bowel movement later in the day on 18Jan2021 (after the vaccine dose) and reported that on 19Jan2021 she was having explosive diarrhea that was liquid and green in color. Also reported feeling queasiness. She known about the reported side effects of the clinical trials. She asked if she could get a colonoscopy next day and she was referred to her hcp. She just had a queasy abdomen right now, kind of gurgling in Jan2021. All events were reported as non-serious. The patient did not receive any treatment from events. The outcome of event bowel movement irregularity was recovered in Jan2021, the outcome of events explosive diarrhea and greenish stool was recovered on 19Jan2021, the outcome of rest events was not recovered.
administered an extra dose (Third dose) of Shingrix / patient received the first dose on 10/30/2020 and the second dose on 1/22/21; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 34SD3, expiry date 15th November 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30th October 2020) and Shingrix (received 2nd dose on 22nd January 2021).   On 13th May 2021, the patient received the 3rd dose of Shingrix. On 13th May 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The pharmacist administered an extra dose (Third dose) of Shingrix to the patient. The pharmacist thought they were administering the second dose but patient already received 1st and 2nd dose. The reporter did not consent to follow-up.
Information has been received from a certified medical assistant concerning a 17 year old female with asthma and no known drug allergies who on 06-AUG-2007, 15-OCT-2007 and 28-APR-2008 was vaccinated respectively with the first, second and third dose of GARDASIL, 0.5 mL, intramuscularly (dose 1 lot # 0927U, dose 2 lot # 658558/1061U, and dose 3 lot # 660387/1967U).  Concomitant therapy included LOESTRIN (1.5/30).  The medical assistant stated that the patient's mother called the office on 27-JAN-2009 because her daughter had had a headache for 7 weeks.  It was reported that the patient was evaluated by an unspecified neurologist who could not find anything wrong.  Laboratory tests including "hormones", prolactin, and thyroid were normal.  At the time of reporting, the patient had not recovered.  Additional information has been requested.
c/o cont pain to lt arm area and states unable to raise arm; has used heat/cold compresses;used APAP & @ one time took Ibuprophen PMD prescribed;never had redness or hardness @ site;
1st dose 5 yrs ago, 2nd not yet; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received first dose 5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 5 yrs ago, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 08-MAY-2023 The reporter wanted to know if they can restart the series. The reporter did not had any additional information or patient demographics to provide at time of call.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 16-SEP-2016, the patient was vaccinated with a dose of M-M-R II (strength, dose and frequency were unknown; lot number reported as M007279 with expiration date 09-FEB-2018) via the intramuscular route. M-M-R II was prepared using lidocaine as the diluent. No known adverse effects. Additional information has been requested.
Initial report received from a consumer who is also the patient, on 10 October 2012. A 35-year-old female patient had received a dose of intramuscular Tdap (Manufacturer unknown, Lot number unknown) in deltoid on 08 October 2012. Patient denied any illness at the time of the vaccination. The patient had no past medical history. Patient is allergic to Amoxicillin. The patient had received Tdap in 2004. The concomitant medication included iron supplement and TYLENOL. The patient had menses at the time of vaccination. On 08 October 2012 after 8 hours of vaccination, the patient had headache, body aches, chills, nausea nad sweats. Temperature was not recorded. The patient had received Tdap in 2004 but was informed that Tdap was not licensed until 2005. Corrective treatment was not reported. Laboratory investigations were none as per reporter. The reporter stated that the symptoms were resolving. The patient's outcome was unknown. List of documents held by the sender: None.
Patient reported that she believes her vaccine was given too high in the arm. This was reported weeks after receiving her second dose of the vaccine. She has experienced a lot more pain than the first dose, and was unable to do daily activities such as raising her arms above her head and sleeping on her side. She has been in contact with her doctor regarding the incident. The pain has gotten better in the last week, but some pain is still present.
Fatigue, fever, chills starting ~12 hours after vaccination to ~36hours after vaccination  But more importantly (which is my motivation to fill out this form): Debilitating worsening of chest pain (associated with my chronic conditions mentioned before), starting with the onset of the other symptoms but gradual worsening for at least 4 days.
Within a short period of time my neck became stiff.   I developed a headache  and  became unsteady on my feet.  After sitting longer while being observed by our nurse I was allowed to leave.  That night I woke up  nauseous and vomited.  The next day  I develped muscle and joint  pain.  Similar to flu symptoms.  Everytime I ate I felt nauseous again.  All the symtoms disappeared about 42 hour later.  I have had an annaphilatic shock to penicillin as a child.
Angina Upper lip swelling/tickling and tongue tingling Narrative: 61 year old female with HTN and asthma with multiple allergies to meds and prior angioedema in past. Presented for her first dose of COVID19 vaccine; after the injection she felt her upper lip tingling and tongue. NO SOB, no throat symptoms, no change in voice, no rash, no hives. NO N/V. She did have some chest tightness. Diphenhydramine IV, famotidine IV, and methylprednisolone IV one-time doses given in ED with surveillance. Patient recovered, denied previous sxs, and was discharged from ED with a family member. ED physician note documents patient  "will take" following medications at home (however no outpatient prescriptions found): Benadryl 50 mg po Q8H x 5 days, prednisone 40 mg po daily x 4 days, and famotidine 20 mg po BID x 5 days
COVID-19 diagnose after first shot; Body aches; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19 diagnose after first shot), MYALGIA (Body aches) and HEADACHE (Headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) 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) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced MYALGIA (Body aches) and HEADACHE (Headache). On 24-Jan-2021, the patient experienced COVID-19 (COVID-19 diagnose after first shot). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia and Headache, at a dose of 1 dosage form and VITAMINS NOS for Myalgia and Headache, at a dose of 1 dosage form. At the time of the report, COVID-19 (COVID-19 diagnose after first shot), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative. On 24-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   When asked about concomitant medications patient mentioned she only consumes vitamins
Fever x 3days. (temp up to 104 deg F). Febrile seizure on 05/21 seen at hospital.
approx 15 mins p/vax c/o tightness in throat, dizziness, feeling faint; no resp distress; no hives/itching; seen LMH placed on monitor & observed; dx allergic reaction;
Bike accident; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left rm on 20Mar2021 14:30 (Batch/Lot Number: ER2613), at the age of 45 years old, as dose 1, single for covid-19 immunisation in a public health clinic/veterans administration facility. The patient's medical history was not reported. No known allergies. No covid prior to vaccination and was not covid tested post vaccination. Concomitant medication included cefalexin (CEPHALEXINE) taken for an unspecified indication, start and stop date were not reported. On 08Apr2021 13:00, the patient experienced bike accident. The event resulted in emergency room/department or urgent care. Treatment included stitches. The patient received tetanus shot on 08Apr2021 in left arm. The patient was recovering from the event. The patient received dose 2 of Pfizer COVID 19 vaccine on 10Apr2021 15:15 in right arm.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Road traffic accident and the suspect drug bnt162b2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Ptnt administered Adacel 09/19/2007 post partum. Admitted 9/23/07 with severe cellulitis, temp 104.7; IV Vancomycin therapy, recovered. 2/27/08-records received for DOS 9/23-9/26/07-DC DX: Right arm cellulitis status post DPT shot. Admitted with temperature of 103.4. Erythema at injection site, injection site warmth and tenderness and crusted lesions.
swollen lymph nodes in the armpit; arm pit pain; This is a spontaneous report from the Medical Information Team.  A contactable other health professional reported that a 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 27Dec2020 at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was having arm pit pain, it felt like a swollen lymph node. She saw that this was a side effect. Outcome of events was unknown.  Information about lot/batch number requested
pt states on the evening of 31JUL97 could not sleep well d/t achy joints, especially hips;also c/o itchy skin; pt stated both are starting to diminish 6AUG97;pt later added thought had a temp that noc;
still or its still coming back for her facial paralysis, like part of her neck is still getting numb; facial paralysis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FACIAL PARALYSIS (medically significant) with onset 2021, outcome "not recovered"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "still or its still coming back for her facial paralysis, like part of her neck is still getting numb". The event "facial paralysis" required physician office visit. Therapeutic measures were taken as a result of facial paralysis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had severe chill, fever, body ache and pain, also rash. Pt. took one dose of ADVIL 500 g and symptoms went away. Pt. has same symptoms after 1st dose, but only mild.
approximately 30 minutes after Tdap immunization employee reported by phone that both hands were swelling by base of thumbs. No airway involvement or rash or other locations of swelling. Advised to report back to ER by husband or by EMS.Employee did not report to ER because symptoms resolved.
Initial report received from a health care professional on 17 October 2007. A 59-year-old female with a history of bilateral moderate mastectomy with reconstruction developed muscle aches and pain in the left shoulder on an unknown date after receiving a left deltoid intramuscular injection of Adacel (lot number C2825AA) on 01 October 2007. On 09 October 2007, the patient called her physician complaining of muscle aches and pain in the left shoulder and she was advised to take aspirin and Aleve and to use warm compresses. On 15 October 2007, the patient called her physician complaining of continued pain and soreness in her left shoulder joint; there was no redness or swelling to the arm. The patient could hardly lift her arm. It was reported that the pain shoots down from the shoulder to the arm at times. It was indicated that the patient was using a Lidocaine patch. On 17 October 2007, the patient called the physician and reported that the symptoms persisted and that the over-the-counter medications were not helping. The physician ordered Vicodin and scheduled an MRI for 18 October 2007. The patient was advised to continue using warm compresses. At the time of the report, the patient had not recovered.
Swelling and redness approx. golf ball sized at site of injection. Itching, pain, and hot to the touch.
I was in the shower and I felt a lump on my body that I never noticed before. When I looked in the mirror it looked like I had a burn on my backside. When I rubbed it with ointments and stuff it was slightly sore. I couldn't set exactly on my rear so I had to adjust how I sit. It was on my right glute. I went to Urgent Care(09/17/2021) a day later and I felt like I was having numbness in my leg on the opposite site. The doctor said I did not have a blood clot. They gave me a anti viral medication acyclovir and they gave me some sort of non anti inflammatory medication.
EMPLOYEE STARTED FEELING A HEADACHE SHORTLY FOLLOWED BY NAUSEA. EMPLOYEE VOMITED TWICE AT 3:30 PM.
After I received my second dose of SHINGRIX I had a fever of 101, the night of the injection along with leg cramps, upset stomach and shivers, belly pain, feeling tired and weak and pain on the injection site. On 9/3/2018, I still had a low grade fever along with all the side effects.
pt got the TDAP vax (manufacturer unknown) at hospital after falling on 3/13/2021.  Pts had a headache and her arm became red, swollen, itching, sore, black and blue.  These symptoms lasted 2 weeks.
Day after vaccination she had overall itching. 2 days after she had flat measle-like itching rash all over and eyelids and chest were bright red and itching. Over next 2 weeks-the rash remained but different areas became very red and itchy and then it would move somewhere else. Last area was 1 armpit. Injection site was fine. She was going to see her primary care dr next week and minor emerg clinic possibly.
The day (4/25) I received the 2nd vaccine, I was more tired than the first one. On the next day, Monday I felt really tired and little feverish, but no fever. I rested all day. I had vertigo that night I don't remember which side. The next day, Tuesday I was still tired.  On Wednesday I felt ok. On Thursday, I felt tired again and when I rested I had vertigo on my right side.  Then on Saturday, I was cold before I slept, I wore a sweatshirt to sleep. During the night I started sweating, felt like night sweats. I don't remember when tinnitus got worst. I only remember the vertigo. Currently tinnitus in my right ear is noticeably louder and has been getting me up. I just had vertigo yesterday 5/17 while resting in the afternoon as the night before I did not have enough sleep.
Patient states a large welt occurred around the injection site. She states the welt was itchy. The welt lasted for 1 week after the vaccine and resolved on its own.
pt recv vax 6NOV98 & felt strange;severe chills, unable to warm up;T101-took aleve x 1tab;7NOV98 woke up sweating;took APAP & woke up feeling very tired;