chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a 74 year old female patient who on an unknown date was inadvertently vaccinated with VARIVAX (Merck) (dose, route and lot number not reported) instead of ZOSTAVAX (Merck). No adverse effect reported. Follow up information has been received from the pharmacist who stated that the patient received the VARIVAX vaccine (lot # 670801/0816AA) on 11-JUN-2012. The patient did not receive any other vaccines that day. The pharmacist stated that the patient had not experienced any adverse event at that time. The pharmacist stated that the wrong vaccine was administered due to the VARIVAX and ZOSTAVAX (Merck) vaccines having similar labels, both with the word "varicella". The pharmacist stated that the VARIVAX (Merck) and ZOSTAVAX (Merck) vaccine were stored in the same refrigerator and assessed through a Pyxis system. The Pyxis system allowed access to the VARIVAX (Merck) and ZOSTAVAX (Merck) vaccines at the same time. The pharmacist stated that the nurse who administered the vaccine saw "varicella" on the box of vaccines. The nurse failed to double check the label of the vaccine. The pharmacist stated that both the nurse and the patient had been notified that the wrong vaccine had been administered. The patient was asked to return 28 days from 11-JUN-2012 to be vaccinated with the ZOSTAVAX (Merck) vaccine. Additional information is not expected.
Patient called to report facial numbness and drooping on left side and trouble speaking.  Was advised to call 911 to go to nearest ER.
Patient is a 35-year-old female presenting to emergency department with complaint of fever, chills, body wide muscle aches, shortness of breath onset 13 hours ago.  The patient received the first dose of her Moderna Covid vaccine 24 hours ago.  She complains of body wide tingling.  She states in route to the hospital both of her hands became clenched and paralyzed.  She also reports a fever the night  prior of 102 °F.  She was tachycardic and febrile . ekg ST @ 108, diffuse NS ST/ T abnl
nausea; This is a spontaneous report from a non-contactable consumer. An female patient (daughter)of unspecified age received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nausea after the second dose (with no vomiting). The outcome of the event was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
pt recv vax; 30-60 days p/ vax, broke out-covered;
positive covid test after receiving 1st dose; lost her sense smell; lost her sense of taste; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive covid test after receiving 1st dose), ANOSMIA (lost her sense smell) and AGEUSIA (lost her sense of taste) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced ANOSMIA (lost her sense smell) and AGEUSIA (lost her sense of taste). On 17-Jan-2021, the patient experienced COVID-19 (positive covid test after receiving 1st dose). At the time of the report, COVID-19 (positive covid test after receiving 1st dose), ANOSMIA (lost her sense smell) and AGEUSIA (lost her sense of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported. Treatment medications included Sudafed and Zyrtec
On December 17, I received my first Pfizer vaccine at the local Hospital. About two hours after the shot, I started with a terrible headache. The headache lasted about three days. On the third day I had a telehealth visit and the Doctor told me that he thought that I had a sinus infection and prescribed antibiotics for 5 days. Later that day I also had a miscarriage. I saw my GYN that week who confirmed my miscarriage. I finished the antibiotics on Dec 25. On December 26 felt like I had just got off plane, my ears felt clogged and I had a hard time hearing. On Dec 27 I called my primary physician told them everything that happened and they prescribed a steroid pack. The feeling did not go away and got worse in my opinion. On Jan 10 went to ENT explained the above and they scheduled a hearing test. I received hearing test on Jan 12, which showed a dramatic loss of hearing in my right ear. That same day I received a steroid shot in my ear. To date the hearing fluctuates. The doctor believes a virus attacked nerve in ear. On Jan 26 I will receive another hearing test and another steroid injection.
pt c/o swelling, erythema & itching since evening of 20JAN97 in rt deltoid area;area is approx 95mm x 70mm;afeb;encouraged warm compresses;denies pain or soreness;referred to FMP;MD prescribed DPH;pt seen by dentist on 20JAN97 given lidocai
Fever Fatigue Narrative:  Employee reported fatigue and fever 101  Other Relevant History:
Severe abdominal pain, all night.  Sleeplessness all night.  All kinds of muscle aches and pain.  Heavy breathing.
1. Acute hypoxic respiratory failure secondary to COVID-19 pneumonia in a vaccinated patient, known exposure through sister- respiratory droplet precautions, 02 to keep sats greater than 92%, dexamethasone. Lovenox daily, remdesivir, vitamin-D, vitamin-C, zinc, albuterol MDI 2. Elevated troponin-serial troponins 3. Hypothyroidism-continue levothyroxine 4. History of prostate disease-continue to tamsulosin 5. Gastroesophageal Reflux Disease-continue pantoprazole CODE: Resuscitate. ER staff discussed code status with a family member. That family member supposed to consult other family members about considering a DNR order.
pt recv vax 13MAY97 & 14MAY97 pt exp a rxn @ the inj site w/erythema & pain, & a fever of 102;19MAY97 pt was dx w/cellulitis;pt exp turning black @ inj site & reported to ER;
C/O chills, fever, sore/scratchy throat, headache, runny nose and/or congestion, myalgia, malaise, diarrhea, nausea and/or vomiting.
Information has been received from a registered nurse for the pregnancy registry for Gardasil concerning an 18 year old white female with seasonal allergies and no medical history, who on 16-NOV-2006 was vaccinated IM with a 0.5 ml dose of Gardasil (lot# 654540/0800F). Concomitant therapy included Depo-Provera and Nasonex. On 16-NOV-2006, the patient's pregnancy test was negative. On 05-DEC-2006, the patient's pregnancy test was positive. It was noted that the patient may have an abortion but that was not related to the vaccine. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information indicated that the patient's LMP was on 28-OCT-2006 (estimated delivery date is 04-AUG-2007). On 03-JAN-2007 (reported as 03-JAN-2006), the patient had an elective termination. Upon internal review, elective termination was considered to be an other important medical event (OMIC). No further information was available.
Jynneos was administered intramuscularly; Case reference number US-BN-2022-001861 is a spontaneous case report initially received from a healthcare professional via Bavarian Nordic on 09-Aug-2022 and concerns a patient of unknown demographics (second out of six).  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: not provided), at an unknown dose (5/8'' needle as reported) or site of administration, intramuscularly, for an unknown indication (explicitly coded as 'inappropriate route of vaccination').  At the time of this report, it was *known that the patient did not experience any negative effects due to Jynneos vaccine.*  This case is linked to cases no. US-BN-2022-001860, US-BN-2022-001862, US-BN-2022-001863, US-BN-2022-001864, and US-BN-2022-001865 concerning the same reporter.  Additional information was received from Bavarian Nordic on 11-Aug-2022, included country of occurrence.  Additional information was received from the reporter on 12-Aug-2022, included confirmation about six patients and information about needle.  Additional information was received from Bavarian Nordic on 15-Aug-2022, included local BN case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information received from a healthcare professional via Bavarian Nordic on 19-Sep-2022 included confirmation that the patient did not experience any negative effects.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, for an unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, the patient did not experience any negative effects due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, for an unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, the patient did not experience any negative effects due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Heart fluttering, pain in chest, pain in left arm, waking up in middle of night due to pain  I went to the doctor three times. I went to primary, urgent care, and the hospital. All of the EKGs were normal but I?m still experiencing adverse effects
side effects worsen and begin to lose mobility; complete loss of mobility; vomiting; fever; tiredness; chills; Initial information received on 02-Nov-2022 regarding an unsolicited valid  courtest serious case received from a consumer/non-hcp via GSK.  This case involves a 76 years old male patient who had side effects worsen and begin to lose mobility; complete loss of mobility, tiredness, chills, vomiting and fever after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s),concomitant medication, vaccination(s) and family history were not provided.   On 29-Sep-2022, the patient received an unknown dose at 10:00am of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On 29-Sep-2022 the patient developed a non-serious event of tiredness (fatigue), chills at 6:30pm (Latency: same day) following the administration of INFLUENZA VACCINE.  On 30-Sep-2022 the patient developed a serious event of side effects worsen and begin to lose mobility; complete loss of mobility (immobile) 1 day following the administration of INFLUENZA VACCINE. respiratory, temperature Regained mobility  at 4:30am and released at 5:00am.  On 30-Sep-2022 at9:00pm the patient developed a non-serious event of vomiting, fever (pyrexia)  1 day following the administration of INFLUENZA VACCINE.  Relevant laboratory test results included: Blood pressure measurement - On an unknown date:  No result provided Chest X-ray - On an unknown date:  no final diagnosis Electrocardiogram - On an unknown date:  No final diagnosis SARS-CoV-2 test - On an unknown date:  Not result provided  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events   Outcome: recovered on 30-Sep-2022 for immobile and Unknown for other events.  Seriousness criteria: Medically significant and was leading to disability for immobile; Sender's Comments: Sanofi company comment dated 15-Nov-2022: This case involves a 76 years old male patient who had side effects worsen and begin to lose mobility; complete loss of mobility, tiredness, chills, vomiting and fever after receiving vaccine INFLUENZA VACCINE. Further patient's individual information regarding medical history, concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the few reported information, the role of the suspect vaccine cannot be assessed.
I was very sick with a temperature going as high as 105 degrees and lost nearly 10 pounds in 3 days.
Information has been received from a physician concerning an approximately 70 year old female with no pertinent medical history who on an unspecified date was vaccinated with ZOSTAVAX. Subsequently the patient experienced a 'weird feeling as if something was crawling on her in her legs". Unspecified medical attention was sought and "blood work" was done. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/26/2008. Information has been received from a physician concerning an 67 year old female with no pertinenet medical history who on 21-NOV-2007 was vaccinated intramuscularly (IM) with ZOSTAVAX vaccine (Merck) (lot # 658084/0888U). Subsequently in November 2007, the patient expereinced a "weird feeling as if something was crawling on her in her legs". Unspecified medical attention was sought and "blood work" was done. It was noted that the patient recovered on an unspecified date. There was no product quality compliant involved. Additional information is not expected.
Pt received vaccines listed below 1/28/02. Grandmother reports pt with non-stop crying, lasting approximately 1 hr and started approximately 2 hr after vaccines given. Reported increase temperature (100 degrees F ax) approx. 1 hr before crying began and was given Tylenol infant strength at that time. Reaction is reported @ 4 mo. immunization visit.
red, warm, swollen arm down to the elbow; swollen arm down to the elbow; warm, swollen arm down to the elbow; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema, swelling arm and feeling of warmth. On an unknown date, the outcome of the erythema, swelling arm and feeling of warmth were recovered/resolved.   It was unknown if the reporter considered the erythema, swelling arm and feeling of warmth to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix experienced a red, warm, swollen arm down to the elbow over several weeks. The reporter consented to follow up. The pharmacist did not have all the information for the report at the time of the call.
1st Dose Administered to a 15-year-old; Initial Report Received on 20-Jul-2021 and 23-Jul-2021   A pharmacist reported that a 15 year-old male patient (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.    No relevant medical history was reported.   No relevant concomitant medications were reported.   On an unspecified date, a 15 year-old male patient received the first dose of HEPLISAV-B (Lot # 934601, expiration date 16-Mar-2022; NDC # and serial number were not reported) injection in the left deltoid from a medical office. No adverse effects were reported. The reporter asked if the second dose of HEPLISAV-B should be given or if another vaccine should be used.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Subsequently post vax, the pt developed swollen glands, muscle aches, became ill, and developed a small bump at the injection site. The pt recovered. This is one of eight pts from this facility who had an adverse experience following receipt of vax.
Pt. had received PREVNAR inadvertently on 11-8-05. Pt. received MENACTRA on 7-24-07 - Pt. was diagnosed with pneumococcal meningitis on 10-6-09. 11/17/09 Medical records received for dates 10/6/09 to 10/26/09 DX: bacterial meningitis. Pt. presented w/ fever. Pt was prev. thought to have vax. But was given wrong vax. Pt. admitted, tx IV abx.  F/u on 10/26 infection resolved.
1.  Extreme soreness in arm for 2 days beginning within 12 hrs. of shots.  2. Body aches, flu like malaise, slight fever & chills within 36 hrs. of shot tested 24 hrs.
Possible generalized vaccinia reaction to smallpox vaccination given 9 days ago.  Tx w/ observation - had 16 pox like pustules erupt across upper trunk and back - not large enough to culture yet.  No systemic s/s.  Expect full recovery.
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a female neonate who was exposed through her 26 year old mother with a history of 2 previous pregnancies and 1 full term delivery and no other significant past medical history or concurrent medical conditions who was vaccinated with a 0.5 ml dose of GARDASIL on 06-APR-2011 (lot # 666987/1016Z) and a 0.5 ml dose on 22-JUN-2011 (lot # 668260/1570Z) respectively. Concomitant therapy included folic acid, vitamins D and multivitamin. The mother's date of last menstrual period was approximately 27-MAY-2011, the estimated conception date was 08-JUN-2011 and the estimated delivery date was 02-MAR-2012. The physician stated that she did not have access to the patient's medical records any longer, but did recall the outcome of the pregnancy. She reported the mother delivered her baby girl at 32 weeks gestation (in approximately January 2012) via vaginal delivery. The physician did not recall the date of birth or weight of the baby. She could not recall why she went into early labor. However, she stated she saw the mother earlier this summer with her baby. She stated the baby was healthy with no congenital anomalies and that the baby did quite remarkably post delivery with no residual heart, lung or brain or other organ dysfunctions with the early delivery. That was all the information she could recall. Upon internal review early labor was considered an other important medical event. The mother's case was reported in case # 1110USA04004. Additional information is not expected.
The patient received her 1st dose Moderna on 2/6/21.  On 2/7/21, the patient reports that she began "shaking, chills, numbness all over, headache, and felt as though she may pass out.'  She sought care via a visit on 2/11 where she described heart palpitations.  She was referred to the Emergency Department on 2/11/21.  On arrival, her chief complaints were "shaky, dizzy, intermittent heart palpitations, some shortness of breath at times, headache, and body aches."  Labs and vitals normal.  EKG showed a right bundle branch block with nonspecific ST changes (Twave inversion V1V2).  No prior EKG for comparison.  Normal troponin, d-dimer = 0.29.  Overall clinical impression per ED: (1) heart palpitations, (2) fatigue following covid-19 vaccine, (3) shortness of breath, (4) Right bundle branch block.'  She was discharged to home with instructions to follow-up with her PCP.  A post-discharge phone call on 2/12 confirmed patient was feeling well and only reported 'dizzy' as an ongoing symptom.  The only medication intervention in the ED was one dose of ketorolac for body aches.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2014, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. In 2015, the patient was treated by a health care provider at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
No adverse effects at all until 3:00 AM the next day when I woke up unable to breathe.  The heaving and gasping for breath lasted for about 5 minutes.  I thought I was going to die.
2 days after receiving flu shot, hot, red, swollen, tender, no fever or chill, loss of use of arm.  Full range of motion of shoulder.
approximately 30 min after vaccination, patient reported burning sensation down their throat with possible redness, swelling, and numbness around their mouth, benadryl was administered and patient was seen at urgent care
Temperature of 100.7 throughout the day after receiving the shot. Also felt tired and unable to move limbs easily. I felt exactly the same way I felt when I had Covid-19 in October of 2020. This lasted approximately 7-8 hours. I also had severe soreness in my right arm where I received the shot. The next day I woke up and my right arm was still sore and the injection site had developed a knot and a large red patch that got increasingly bigger over the next 24 hours. After that, it started to dissipate and turned into a bruise that took about 2 weeks to go away.
Vaccine given 7-12-16. At 5pm 7-13-16, redness and swelling noted to injection site, left deltoid. Measured 3 1/2 x 6 cm. Presents to office 7-14-16 with increased redness and swelling measuring 10 x 11 cm. Mild itching, full ROM, denies pain.
Covid 19 Pfizer Gray Top was diluted with 1.8 ml of diluent in error. Patient received diluted dose.
07/30/10 Awoke @ 3am extreme (L) arm pain. At 10am fever & feeling miserable; and bilat. arms extremely sensitive and tingling.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 30-DEC-3014, the patient was vaccinated with a dose of ZOSTAVAX lot # K018172, expiration date 02-DEC-2015 (route was not provided). On 30-DEC-2014, an improperly stored dose of ZOSTAVAX was administered to a patient. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Tested positive for Covid-19 on 7/2/2021.  SOB and coughing since 6/30/2021