chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered only the liquid component; Administered only the liquid component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA748A, expiry date 13th September 2024) for prophylaxis.   On 28th November 2022, the patient received Menveo. On 28th November 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 9-Jan-2023 Reporter's comment: A pharmacy manager called to ask for information about the administration of only the liquid component of Menveo.  The pharmacy manager asked for safety information and if patients had to be revaccinated. The reporter consented to follow-up. This is 1 of 2 linked cases reported by same reporter. Additional supportive information: The patient only received the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023002251:Same reporter
Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe
Information was received on 09-JUL-2018 from a lawyer regarding a case in litigation. A male patient, age unspecified, was inoculated with ZOSTAVAX on 21-OCT-2015 at a pharmacy as recommended for routine adult health maintenance for prevention of shingles. It did not prevent shingles as intended and subsequently the patient contracted a persistent strain of herpes zoster. In 2016 the patient was treated at a hospital for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for 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, pain, suffering and other damages. Additional information has been requested.
Patient left waiting area while waiting 15 minutes post-administration to go get a drink of water. On the way, patient reported getting dizzy and lightheaded and passed out for a few seconds. She fell over, hitting a vitamin display, and then landed on the ground. She was responded to and was conscious, sitting upright, and talking. She reported not being injured and stated that she was feeling okay, that she was just nervous from receiving the vaccine. EMS was still called to make sure she was okay. The patient was checked out by paramedics and was able to go home with her husband.
This case was reported by a nurse via call center representative and described the occurrence of vaccine exposure via breast milk in a adult female patient who received FLUARIX. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced vaccine exposure via breast milk. On an unknown date, the outcome of the vaccine exposure via breast milk was unknown. Additional information: Nurse reports that she administered a FLUARIX injection to a woman who is breastfeeding.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2014, PROQUAD (Merck) 0.5 ml, subcutaneous. No adverse effect reported. This is one of several reports report from the same source. Additional information has been requested.
Varicella Vaccine administered 04/22/04.  Pt developed generalized vesicular rash starting 8 days post vaccine. Also intermitt fever to 102.  Please note 2nd episode same lot # varicella.
MAJOR NEUROLOGICAL DAMAGE IN ONE ARM; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination (dose number in series 1).  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced major neurological damage in one arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of major neurological damage in one arm was not reported. This report was non-serious.
Severe gas, abdominal pain, cramping, bloating, nausea, fatigue and dizziness
pt recvd vax 29DEC92 & testing revealed that pt was pregnant; LMP 18DEC92; had a hx of abortion & smoked 2-3 cigarettes a day; a 6lb 13oz child was delivered @ 40 wks by C-section due to fetal distress;
semptember 8/2021 woke up with numbness lack of feeling and blisters on left hand.had son take me to emergency room..symptoms continued to get worse,numbness from top of head to waste on left side,burning and tingling of arm.tightness under arm to waste.have not been able to get a diagnosis to this date of 07/13/2022
20 minutes after receiving the vaccine, patient felt her lips swelling. She then noticed facial swelling and chest tightness. She then developed erythema to her chest area. She immediately was evaluated. Denies any SOB or difficulty breathing. Denies any itching or hives.
Patient has described arm soreness for 10 + days. Warm sensation, no loss of feeling or movement. No swelling. Patient currently using MOTRIN 600 mg q6H prn.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions and allergies provided. On 18-AUG-2015, the patient was vaccinated with improperly stored ZOSTAVAX (lot# K020186, expiration date 27-JAN-2016, dose, site and route of administration were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a 65 year old female with no illness at the time of being vaccinated and a history of penicillin allergy who on 06-MAR-2007 was vaccinated with Pneumovax 23 (lot # 655291/0985F) 0.5 ml IM into left deltoid in the morning. Concomitant medication included hormones (unspecified), BENADRYL, aspirin, and PREVACID. On 06-MAR-2007, later that day, the lower part of the patient's left arm became swollen and red. The area was warm to touch and the patient was in some discomfort. Medical attention was sought. At the time of reporting, the patient was recovering. The office requested a lot check be performed. No further information was available at the time of reporting. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government agency and was released. Additional information was received the registered nurse. On 06-MAR-2007, the patient also experienced muscle aches and fatigue. The patient was treated with cetirizine HCl 10 mg and BIAXIN XL. On an unspecified date the patient recovered. No additional information is expected.
This case was reported by a nurse via call center representative and described the occurrence of nausea in a 64-year-old female patient who received SHINGRIX (batch number AS9CM, expiry date unknown) for prophylaxis. On 14th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 14th May 2018, less than a day after receiving SHINGRIX, the patient experienced nausea, pain, headache and mobility decreased. On an unknown date, the outcome of the nausea and headache were unknown and the outcome of the pain and mobility decreased were recovered/resolved. It was unknown if the reporter considered the nausea, pain, headache and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that the patient developed nausea, headache, and severe soreness (where she could not lift anything) within 4 hours after receiving a dose of the SHINGRIX. The HCP did not have expiration date of vaccine. The soreness lasted for 5 weeks and resolved.
Mom reports not short severe screaming and crying for 3 1/2 hours. Stopped only after 2nd dose of Tylenol.
Muscle pain, redness, hardness on day 1-3 after dose 1 Swelling of lymph node on the same side of arm on day 6 after dose 1
Full respiratory arrest on 3-27-09.  Seizure prior to arrest.  Discharged 4-11-09 with DNR & hospice.  10/23/09:  Medical Records and Discharge Summary received for dates of service 3/27/09 to 4/11/09.  Discharge Diagnoses:  Full cardiopulmonary arrest requiring 30 minutes of cardiopulmonary resuscitation.  Likely seizure activity.  Markedly abnormal EEG findings.  Post resuscitation respiratory failure requiring intubation.  Hyponatremia.  Elevated transaminases, likely related to shock liver.  Chronic tracheal colonization with Pseudomonas.  Anemia requiring transfusion of packed red blood cells.  Nutritional deficiency addressed by nasogastric feeds.  Medical stress on the family. Assessment:  Developed some upper respiratory tract sx. on 3/25, seen for 6 month well child check and immunizations on 3/26.  Found the morning of 3/27 with his eyes rolled back, arms flexed, legs extended with labored breathing and generalized unresponsiveness, he was afebrile but sweating.  The baby became apneic and unresponsive in the car on the way to the hospital, no rescue breathing was done.  He arrived at the ED pulse less and CPR was initiated immediately.  CPR continued for 30 minutes with the subsequent resumption of spontaneous circulation.  On clinical exam there was always evidence of severe anoxic encephalopathy.  The child was intubated due to poor gag reflex and cough as well as pooling of oral secretions.  The baby was eventually extubated and a Do Not Resuscitate order put in place.  MRI consistent with diffuse anoxic injury in both hemispheres.  Initial EEG was quite abnormal, a second was more abnormal.  There was no overt seizure activity, the patient was maintained on Dilantin and an EEG on 4/06 noted no seizure activity.  The prognosis is that the child will likely make no developmental progress and will require a lifetime of complete custodial care. The baby was discharged to home hospice care with an out of hospital Do Not Resuscitate order.   10/28/2009 records from Neuro Consult 10/1/2009. PE: + for vision and hearing abnormalities, neuro exam noted abnormal tone, hypertonicity, poor suck, and encephalopathycic, patient with a flat demeanor. EEG done 10/1 still consistent with severe encephalopathy, no seizure activity noted. Etiology still unclear for encephalopathy, have recommended mitochondrial dysfunction studies. Prognosis for any meaningful neurological recovery is poor. Tx: Dilantin x 1 yr and if still no seizure activity can be weaned off medication. DC
07/08/2010 mild other.  Patient received TDAP, MENACTRA, HEP A, and HPV vaccine today.  Had nausea/vomiting within 5 minutes of injections.
Developed Guillain-Barre 31 days after the vaccine. Discharge summary states tachycardia, pharyngitis, headache, hypertension. msv
After IM administration of Gardasil into patient left deltoid muscle patient stood up after sitting on exam table and proceeded to become near syncopal and extremely diaphoretic. Patient eased to floor with assistance. Patient did not loose loc. MD notified and b/p checked q15min x 1hour.
vasovagal syncope, sweaty, eyes dilated and rolled back, was unresponsive. He became responsive and said he couldn't see. Lasted 10 or 15 minutes, was seated at the time. Gave him gatorade and called 911. Hadn't consumed much food or drink. EMS walked him out and presumably checked his vitals.
Unexpected therapeutic benefit; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included post herpetic neuralgia.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that she had a friend who described that her mother experienced a reduction in post herpetic neuralgia from a shingles outbreak after receiving the Shingrix vaccine, which led to unexpected therapeutic effect. The reporter was unable to provide any additional information. This was one of the 4 cases, reported by the same reporter. This case has been linked with cases US2019125910, US2019125912, US2019125907, reported by the same reporter.
Patient called 1/8/11 reporting raspy voice, laryngitis & all over malaise which she attributes to ZOSTAVAX 17 days ago, as well as a knot @ injection site & localized rash which have resolved. She has not seen MD for this.
Fatigue, which worsened as the day went on; headache; nausea; chills; temp 99.7; ringing in her ears, skin hypersensitive; leg pain; body aches; dizziness; crying uncontrollably; lightheadedness.
Patient stated on consent form, and confirmed verbally, that they had never received a COVID vaccine in the past and were given a dose of the pfizer vaccine at the location on 6/11/21.  Upon charting the vaccination information into the system, it was discovered that the patient had previously received the J&J vaccine, on 3/30/21.    Patient monitored.  No symptoms reported.
Migraine; This spontaneous case was reported by a health care professional and describes the occurrence of MIGRAINE (Migraine) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced MIGRAINE (Migraine). The patient was treated with PARACETAMOL (TYLENOL) (oral) at a dose of 1000 milligram. At the time of the report, MIGRAINE (Migraine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: NNI On 26-Mar-2021: NNI On 29-Mar-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 onset date of the event, a causal relationship cannot be excluded.
The vaccinee received his 1st injection of Lymerix on 07/27/00. On 07/30/00, three days post-immunization, he experienced soreness and stiffness of his back, buttocks, and hip joints. He also experienced muscle weakness and was listless. No diagnostic evaluation was performed. The events resolved after approximately two weeks without treatment. The reporter considered these events to be mild in intensity and possibly related to Lymerix administration. The vaccinee received his 2nd injection of Lymerix on 09/07/00. On 09/09/00, two days post-immunization, he again experienced soreness and stiffness of his back, buttocks, and hip joints. He also experienced muscle weakness and was listless. He did not seek medical attention. The events resolved after approximately two months, without treatment. The reporter considered the events to be severe in intensity and possibly related to Lymerix administration. The vaccinee received his 3rd injection of Lymerix on 07/26/01. On 07/28/01, two days post-immunization, the vaccinee again experienced soreness and stiffness of his back, buttocks, and hip joints. He also experienced muscle weakness and was listless. No diagnostic evaluations were performed. The events resolved after approximately one week, without treatment. The reporter considered the events to be mild in intensity and possibly related to Lymerix administration.
Patient presented to the ED on 7/17 with a chief complaint of nausea and vomiting since receiving COVID vaccine on 7/16/22.  Patient was also found to have some faint wheezing on exam.  Patient was given IV fluid, ondansetron and albuterol/ipratropium nebs with improvement of symptoms and so she was dischanged.  Approximately 24 hours later on 7/18  she returned to the ED with similar symptoms except she was experiencing more wheezing, cough and shortness of breath.  She was again treated with IV fluids and a nebulizer treatment and discharged.  On 7/19 the patient again presented to the ED with similar symptoms.  She stated that the wheezing and shortness of breath were getting progressively worse.  She denied any chest pain but states she just felt bad and had worsening fatigue.  A 12 lead EKG showed A Fib with rapid ventricular response.  The patient was then admitted for management of her new A Fib.  She was started on a diltiazem infusion and converted back to NSR.  Patient was discharged from the hospital on 7/21 on diltiazem and apixaban with plans for an outpatient event monitor.  Event monitor was completed and showed occasional PAC and PVC with borderline sinus tachycardia.
made it hard to talk.; all around the ears hurt; all around the the throat hurt; swollen under the arm too but those didn't hurt; swelling on the lymph nodes around the jaw and the neck, and the side of the throat; This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA (made it hard to talk.), EAR PAIN (all around the ears hurt), OROPHARYNGEAL PAIN (all around the the throat hurt), PERIPHERAL SWELLING (swollen under the arm too but those didn't hurt) and LYMPHADENOPATHY (swelling on the lymph nodes around the jaw and the neck, and the side of the throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.    On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced DYSARTHRIA (made it hard to talk.), EAR PAIN (all around the ears hurt), OROPHARYNGEAL PAIN (all around the the throat hurt), PERIPHERAL SWELLING (swollen under the arm too but those didn't hurt) and LYMPHADENOPATHY (swelling on the lymph nodes around the jaw and the neck, and the side of the throat). At the time of the report, DYSARTHRIA (made it hard to talk.), EAR PAIN (all around the ears hurt), OROPHARYNGEAL PAIN (all around the the throat hurt), PERIPHERAL SWELLING (swollen under the arm too but those didn't hurt) and LYMPHADENOPATHY (swelling on the lymph nodes around the jaw and the neck, and the side of the throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided.  No treatment medication information provided.
Pt reports swelling and soreness of arm. Pt states injection site was blue and turned yellow 3 days later.
pt recv vax 15MAR97 & 7MAY97 pt devel 32 lesions that were blistering itching bumps;
dizziness, nausea, flushed skin, mild urticaria to arms and back. headache as well sx onset less than 5 min post vax EMS called and trasnported to ED no meds given on site no resp distres
I was perfectly healthy when I got my vaccine on Saturday.  The following Monday my skin on my right upper back and under my armpit was tender to touch and felt fiery, this continued to intensify Tuesday and Tuesday night I broke out with blisters, right side only upper torso on back and  below my armpit.  Went to urgent care on Wednesday morning and call my doctor.  Started Famciclovir 500 mg TID
Arm swollen approx 3-4 inches in diameter, painful and warm to touch.
Daughter stated that patient got very weak about a week after the 2nd dose of pfizer vaccine.  Daughter also stated that patient was taken to ER bc she was unresponsive and her blood pressure was dropping, patient passed at ER on 05/19/2021
No adverse effects reported; product storage error; This spontaneous report was received from a medical assistant, regarding a 4 year old female patient. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (DTAP-IPV) and "FW".   On 21-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # S012472, expiration date 20-OCT-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The vaccine was exposed to a temperature of 25.61 degree Celsius from 19-AUG-2019 to 02-OCT-2019 as recorded by a digital data logger. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA007637: US-009507513-1910USA012349: US-009507513-1910USA012240: US-009507513-1910USA012350: US-009507513-1910USA012352: US-009507513-1910USA012353: US-009507513-1910USA012354: US-009507513-1910USA012355: US-009507513-1910USA012356: US-009507513-1910USA012357: US-009507513-1910USA012358: US-009507513-1910USA012359: US-009507513-1910USA012360: US-009507513-1910USA012981: