chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US017606 is an initial spontaneous report received from the nurse on the 29 Aug 2014. This report refers to a patient of unknown identifiers. The patient's medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: not reported) intramuscularly without being reconstituted with Men A lyophilized component of vaccine on 29 Aug 2014. No adverse events reported after the maladministration. The patient was also vaccinated with another dose of only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: not reported) intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 29 Aug 2014 (see related case number: PHEH2014US017718).
Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild
- WITHN TWO DAYS OF INJECTION I HAD VERY STRONG INJECTION SITE PAIN - WITHIN FOUR DAYS, I HAD MEDIUM TO MODERATE PAIN IN UPPER BODY JOINTS (SHOULDERS, ELBOWS, WRISTS AND FINGERS) - OVER THE FOLLOWING WEEK (NO IDEA OF ACTUAL DAYS POST-INJECTION) I EXPERIENCED DIFFICULTY SWALLOWING, ALMOST "ICE CREAM LIKE" HEADACHE/PAIN BEHIND MY EYES, STOMACH UPSET, ONE NIGHT OF EXTREME SHORTNESS OF BREATH (WORSE THAN MY NORMAL COPD SHORTNESS) AND ONE EPISODE OF "SEEING" A FLASHING/SPARKLY MULTI-COLOR LIGHT PATTEN IN THE UPPER LEFT CORNER F MY LEFT EYE (THIS LASTER ABOUT AN HOUR AND HAS NOT RETURNED).  - AS OF THIS MORNING (12/16/2021) ALL SYPTOMS SEEM TO BE GONE.
About 1 hour after the FLUARIX injection I began to have itchiness and tightness in my throat. I also had a burning sensation in my mouth and throat. I took 25mg BENADRYL and wasn't feeling relief so I took another 25mg tablet about 30minutes after 1st dose. I began to feel some relief after about 30 minutes. I did continue to take BENADRYL 25mg-50mg every 6 hours for the next 48 hours. I also had the usual symptoms that I usually have after my yearly flu vaccination----extreme muscle and body aches, headache, fatigue, and low grade temperature for which I took Acetaminophen.
10 hrs after receiving the vaccine, the patient developed a rash which then spread to the entire body with diffuse itching.  There were no fever or shortness or breath , only rash and there were no symptoms of hives but patient has already a history of dermatographia and when she scratched, there were hives over the area she scratched.   The Rash is improving with Zyrtec and Benadryl but still there now 11 days after the vaccine.
intermittent hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The patient got intermittent hives for a week after the first shot of Shingrix.
Patient felt dizzy after shot.  Patient had sweat and nausea.  patient vomited 15 minutes after immunization and felt better after vomiting.  EMS was called and arrived checked him out and released him.   Mother came and drove him home.  xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 19-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ lot # L037921 expiration date: 31-MAY-2017 (dose, strength, and route unknown) (incorrect product storage). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
N/A. NO ADVERSE EVENT. PATIENT WAS GIVEN VACCINATION THAT WAS STORED OUTSIDE OF REQUIRED TEMPERATURE FOR STORAGE. REVACCINATION REQUIRED.
Patient reported temporary loss of taste about 8-10 hours after vaccination. It resolved spontaneously overnight
Severe body pain. Started with swollen lymphnodes and severe headache. Now the pain is transient and moves all over her body. Swollen feet and hands. Dizzy, excruciating pain. Can't walk more than 15 steps. Veins swell up and become blue when it is about to start hurting or is hurting. Treated with Gabapentin and Amitriptyline.
Patient reports raised, warm rash, consistent with CDC's description of "COVID arm." She sought medical attention and was prescribed cephalexin.
I had a painful nodule on the left side of my neck, I applied pressure to it and I had complete loss of sensation and paralysis in my right arm that lasts 5-7 hours. MRI confirmed I had a small stroke. 85% recovered. fatigue and loss of energy.
Patient stated that she experienced pain in her elbow after administration. The pain still persists as of today.
Left upper arm - just inferior to what appears to be the puncture wounds from vaccinations, with 3cm x 4cm area of erythema and swelling. With warmth to touch. There is no circumferential swelling noted. FROM of arm. Distal pulses and sensation intact. , seen on 09/29/17 was prescribed Doxycycline for cellulitis. Returned to clinic on 10/01/2017,  he continues to have spreading redness. The redness is almost circumferential. He denies fever, systemic symptoms, no n/v. Not responding to doxy, added rantidine for H2 blockade and benadryl qHS. Patient will return to clinic on 10/03/2017 for further eval.
chest pain and elevated troponin  hospitalization for 2 days  Ibuprofen 600mg q6hr and pepcid  Troponin downtrended
Vaccine was given past "before use date." No adverse events reported. Moderna was called and vaccine was still stable and okay to use.
Information has been received from a nurse concerning a female who was vaccinated intramuscularly with a 0.5 ml dose of Gardasil. Subsequently the patient experienced a lump underneath the injection site. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information has been requested.
After receiving my third dose, I felt sick and experienced flu like symptoms for 2 days. It wasn't quite as severe as my second dose, but it was difficult. I recently noticed that my leg looked swollen which was not normal. I called the doctor that I had seen when I had to have hip surgery. Since I could not reach my doctor, I went to the E.R. Where they discovered blood clots in my lungs and legs. My blood pressure was also abnormally high which is something I have never experienced.
I had 5 little bumps starting at least 12 days after. And I was like gosh what's wrong with my arm. I went to store and I am walking out and my neck start itching bad by my hair line. And I kept feeling back there and I could feel little bumps. I called my doctor and told him what was going on and he told me to come on it. And I went in and someone looked at it and they didn't know what it was. They look at my arm and neck and stated that maybe it was eczema. And I never had that in my life and I get shots all the time. I went to the dermatologist and they didn't know either but they gave me some cream for it to go away But it did not happen until after I got my shot.
During the first day after taking vaccine, started having a fever, headache, and sore throat. By the evening, fever was severe and 102+, with severe headache and sore throat. After sleeping on that nigh (had disruption of sleep from 2 - 4 in the morning), it was looking normal., just had usual fatigue after a fever. But on Thursday (Took vaccine on Tuesday morning, March 02, 2021), I suddenly started having a seizure, my whole body was shaking, legs were cramping. I thought it was going to go away, but after 10 minutes it was getting worse and I had to call the emergency services. The fire service members first came, they measured my blood oxygen level, it was 98%, but my blood pressure was high (140). I was still shaking and having the seizure. They tried to calm me down by talking, after some time, my blood pressure came to normal and I started getting normal (no seizure at that point). I declined the ambulance service as it is expensive and I was getting normal. I had a 101 fever just after that and went to visit the health care facilities .
Patient came to clinic status post ER cellulitis of the left arm. Received PCV23 and flu shot on left arm. Patient stated it was very swollen and painful.
Patient came to observation after receiving first dose of the COVID-19 pfizer vaccine.   Patient passed out from his chair to floor after about 5 minutes in  observation.  Patient placed on mat with 6 liters oxygen.  Vital signs of 116/68, HR 78, and oxygen saturation of 98%.  Patient remained lying down for about 10 minutes on oxygen to recover.  Patient moved to sitting up and then standing with stable vital signs.  Oxygen removed.  Patient had no other concerns and left in stable condition.
minor was accompanied to his appointment by his grandmother, not his mother. grandmother signed off on consent form and was present during vaccine.
Fever over 102 for three days, wheezing,coughing, difficulty breathing, weak, no appeitte, very sleepy, irriatable
Fever 105.2, diaphoretic, nausea, diarrhea, head pain, stomach pain  Treated with fluids and acetaminophen and ibuprofen brought fever down gradually by next morning only slightly elevated temp of 101 that was at baseline by midday. All other symptoms were relieved by morning.
Elevated liver enzymes approximately 1 year following 2nd dose. Performed follow up blood work and performed ultra sound. Doctor plans on monitoring liver enzymes.
Patient WAS INAVERTENTLY GIVEN FIRST DOSE MODERNA VACCINE ON 04/08/2021 AT DRIVE THROUGH COVID-19 VACCINE  VISIT AT HEALTH DEPT.   ( SHE IS ONLY 17 YEARS OLD).  STATED SHE HAD SCHEDULED HER APPOINTMENT ON LINE. PHONE CALL WAS MADE TO PATIEN T AND HER PARENT ON 04/29/2021 , ADVISING OF INCIDENT AND RECOMMENDATIONS FROM DR, TO RECEIVE SECOND DOSE OF MODERNA AS SCHEDULED (WILL BE CONSIDERED AS OFF LABEL)
Pulmonary embolism/ two large blood clots, one in each lung; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on an unspecified date (Lot Number: EP6955) as single dose for COVID-19 immunisation.  Medical history included high blood pressure and cholesterol abnormal, both from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19.  The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 28Feb2021 at 08:00 (Lot Number: EN6202) as single dose for COVID-19 immunization. On 29Apr2021 at 07:00, roughly one month after second dose of vaccine, the patient couldn't breathe, sweating profusely, accelerated heart rate and chest tightness. He was diagnosed with a pulmonary embolism. He had two large blood clots, one in each lung. The events were serious, it required emergency surgery to save his life. The patient spent 2 days in ICU (Intensive Care Unit) and 3 additional days in the hospital. The doctors told to the patient that they had never seen blood clots like those and that large. The patient reported that he is now on blood thinners. The patient outcome of the event was recovering.
This spontaneous report as received from a nurse practitioner 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, the patients were vaccinated with improperly stored doses of M-M-R II lot # L024268, expiration date reported as 01-JUL-2017, lot # L030162, expiration date reported as 11-AUG-2017 (therapy type, dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 55 degrees Fahrenheit for 187 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Within minutes of vaccination patient stated urticaria to the site with a "mosquito bite-sized" bump.  Persisted for four days and resolved.  States no other side effects or problems until 04/14/2011 when 4" flat, red ring appeared near site of immunization, no edema, no warmth, no c/o of constitutional symptoms.  Will to to PMD if persists or other problems develop.
Throat pain; Hard to swallow; having a hard time talking; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unspecified route of administration, on 14Jan2021 11:00, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called because she received the COVID vaccine at about 11:00 this morning of 14Jan2021 and then around 16:00 this afternoon of 14Jan2021 she started getting throat pain, she found it hard to swallow and with having a hard time talking. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
Symptoms presented as debilitating chest pain daily for approximately one week. Blood pressure and pulse were normal. Took aspirin for pain. Follow up visit with Primary Care Provider after several days of pain provided probable Myocarditis diagnosis.
itching all over and breaking out into hives. Arms, legs, back, neck, face; itching all over and breaking out into hives. Arms, legs, back, neck, face; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 03Apr2021 11:00 (at the age of 20-year-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient had no medical history and no concomitant medications. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive other medications within 2 weeks of vaccination. On 03Apr2021, 23:00, about 12 hours after the shot, the patient started itching all over and breaking out into hives in her arms, legs, back, neck, and face. She applied diphenhydramine (BENADRYL) cream which helped somewhat. By the morning, it was gone. When she went to get the 2nd vaccine, they wouldn't give it to her because of the reaction she had and said that the 2nd could give a worse reaction. She stated that she will play soccer in college and was required to get a full vaccine prior to returning to school in August, so she needs to know what she can/should do. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was recovered in Apr2021.  Information about batch/Lot number has been requested.
pt recvd vax & devel hives & fever p/2nd dose of Hep B vax; No further details were provided;
Tingly at fingertips; feels numb; all fingerips and similar sensation in toes.
Shingles-like rash on torso and back with burning sensation and nerve pains.  This began approximately 30 hours post vaccine administration.  Patient has not yet received treatment for this rash however intends to go for treatment in the next day.
pt states began having facial swelling approx 1130AM; took DPH slept most of the afternoon & the facial swelling was nearly all gone by 4PM;
Extreme hand eczema (never had this before in my life). Hands were covered in eczema and topical steroid treatment of 2 different kinds did not help. Eucrisa and finally a steroid injection in June started to help with this new condition.
The same day of the vaccine I had some tingling on the left side of my face. That passed and the next day I experienced extreme eye dryness that lasted for around 2 weeks. I would wake up at night needing to put eye drops in. I constantly needed eye drops because my eyes felt like sand paper. This eventually mostly subsided, although my eyes are still occasionally dry. 2 weeks after vaccine I developed alopecia areata on my head. Hair did not start growing back until months later. It's still very short compared to the rest of my hair but it is growing. I had never had alopecia or eye dryness prior to vaccine.
Awakened past midnight / sweating / continued every night / and is unresolved; This case was reported by a consumer via call center representative and described the occurrence of night sweat in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 1st February 2021, the patient received the 2nd dose of Shingrix. In February 2021, less than a day after receiving Shingrix, the patient experienced night sweat. On an unknown date, the outcome of the night sweat was not recovered/not resolved.   It was unknown if the reporter considered the night sweat to be related to Shingrix.  Additional information was provided as follows: The patient received 1st dose of Shingrix vaccine about 2 months before reporting and there were no reports of any events associated with it. Later the evening of receiving 2nd Shingrix vaccine, while the patient was sleeping, she was awakened past midnight and was sweating. The sweating continued every night since the 2nd injection and was unresolved at time of report. Formulation of Shignrix was not known for both injections. The reporter did not consent to follow up. Discrepancy: As per narrative time to onset was considered as less than a day and not 1 day as per provided onset date.
Patient c/o occasional vertigo since 1/9/21, day after she received the first dose of Moderna vaccine. It happens several times a day and seemed to be triggered by laying on a flat surface. Tried meclizine, no effect. No improvement since symptom started.
Pt. received 4 immunizations on 6/10/04 at 4 month check up. Next day mother called because the right was red, tender and swollen. Child came to after hour clinic & was seen by doctor for swelling, redness and tenderness to right.
Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 11-SEP-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes Oka/Merck VARIVAX (lot # R008393, expiration date 20-MAR-2020; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# M040792, expiration date 29-MAY-2019). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758.
No adverse event; 11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap).    It was unknown if the patient receives any other vaccine in the 4 weeks prior to Moderna Pink Cap COVID-19 vaccine.  These patients were never vaccinated with any other COVID-19 vaccine in the past. Patient age was between 6 months to 5 years. Concomitant product use was not provided by the reporter. It was reported that the incidents started in May-2023 and they just noticed it (Lot number 215K22A & Exp. Date: unknown), (Lot number 216K22A & Exp. Date: unknown). Treatment information was not provided.  This case contains information about patient 2nd out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-740029 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740029:Patient 02 out of 11
Moderna Covid-19 vaccine drawn up into individual syringes at about 745pm - 8pm on 3/24/2021, vaccine was administered to patient at 1:45 pm 3/25/21, outside the recommended 6 hours after vial puncture. Vaccine remained in the refrigerator from the time drawn up to administration. Vaccine was inspected there was no particulate matter or discoloration prior to administration.
I?ve never had an allergic reaction to anything before.  Received the vaccine at around 9:55am on 03/08/21.  Pain while the vaccine was being administered but it healed within a few minutes. I started getting a mild headache at around 3:30pm while at work. When I got home at around 6pm I started having severe chills, the headache became intense, my mouth and eyelids felt hot, my hands and feet felt very cold and when I checked temperature it was 102.4.  By 9:00 pm the headache became excruciating like I?ve never had it before, as if my head was being squeezed or pressed. Eyes and the back of my jaw hurt too.  Had light and sound sensitivity. Took 200mg of Advil but pain was still almost intolerable until I was finally able to fall asleep at around 4:00 am.  Was still in pain the day after but not as bad as the night before. Only mild pain today but started feeling itchy tonight and noticed some rashes on my body.