chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been downloaded from Regulatory Authority (US-SEQIRUS-201802125). Information has been received from a health professional reporter referring to a 1 year old male patient. The patient's historical drug included polio (22-JUN-2016), hepatitis A virus vaccine (unspecified) (31-AUG-2016), pneumococcal conj vaccine (unspecified) (on 22-JUN-2016 and 31-AUG-2016), DTAP (on 30-OCT-2015, 06-JAN-2016 and 22-JUN-2016) and hepatitis B virus vaccine (unspecified) (22-JUN-2016). The patient's concurrent condition and concomitant therapy were unknown. On 11-JAN-2017 the patient was vaccinated with VARIVAX (dose, route, batch/lot number and expiration date were not provided), M-M-R II (dose, route, batch/lot number and expiration date were not provided) and FLUVIRIN (0.5ml; route, batch/lot number and expiration date were not provided), all for unknown indication. On 12-JAN-2017, the patient experienced shaking, could not move, constant sleeping, randomly collapsing, jolting, screaming in the middle of the night ever since (always wakes screaming), crying for first week and screaming in the middle of the night ever since (he had been walking in to walls). It was reported that the child was constantly crying and sleeping for the first week after vaccination with FLUVIRIN. It was also reported that the child also experienced dyskinesia more than 2 months and syncope and abnormal behaviour, more than 3 months. The outcome of all the events was reported as not recovered. The causality assessments between all events and suspect vaccines were not reported by the reporter. All of these events were considered to be medically significant.
Vesicular rash along C6 dermatome from thumb to shoulder; began 1 day after vaccine.
ACUTE NON ST ELEVATION MI SINGLE SUBSEGMENTAL PULMONARY EMBOLISM WITHOUT ACUTE COR PULMONALE
This is a spontaneous report from a contactable other-HCP (patient himself). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9263, Age at Vaccination: 67 years), via an unspecified route of administration, administered in Arm Left on 01Feb2021 12:00 as dose 1, single for COVID-19 immunisation at Hospital. The patient medical history was not reported. Other medications were taken in two weeks. No other vaccine in four weeks. It was reported that, he was not tested with COVID post vaccination and if diagnosed with COVID prior vaccination was unknown. He had no known allergies. On 11Feb2021 08:00, the patient experienced he had a runny nose. It wasn't heavy, but still a runny nose. Friday, he woke up and the runny nose was gone, but he had chest congestion. It was like 3/10. Sunday it seemed weird the chest congestion and it lasted till Monday. The first symptoms popped up 10 days after first shot. He was calling to ask if he is ok to get the shot as planned next Friday given his symptoms? The seriousness of the events was non-serious. No therapeutic measures were taken for the events. The outcome of the events runny nose and chest congestion was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
After receiving Hep B#2 mom reported child's skin got very cold and needed to do a skin to skin to warm child.
Patient felt dizzy and vomited after she got the flu vaccines. Parent declined to get emergency help from urgent care or hospital or report to pediatrician.
Moderate flu-like symptoms for four days, including headache, fever, chills, sore joints and muscles, stomach upset, farting.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown demographics. Since 05-MAY-2014 the patients were vaccinated with GARDASIL. The reporter stated that on 05-MAY-2014 onwards her refrigerator and freezer units began to have temperature excursions and GARDASIL was improperly exposed to 29F for multiple unspecified excursions (many more than 2 cycles into the freezing range), and also to 49F for 12 hours. No known adverse effects. Lot # and expiration date of GARDASIL was unspecified. All of the data listed here was reconfirmed with the reporter. No further information was available at the time of this report. No product quality compliant was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, muscle pain and aches, feverish, shivering, clammy and cold, sleeplessness, nausea.
Patient developed hives within a few hours of receiving the vaccine and they have continued  almost daily since then.
Patient was inadvertently given Shingrix. Patient does not have immunocompromising condition to qualify him within his age range.  Patient did not have an adverse reaction to these vaccinations.
swollen arm, severe achy body, extremely painful swollen lymp node in left armpit, headache, chills
Losing weight, confusion, physical pain but no known cause, shaking, trembling, difficulty swallowing, high anxiety , headache, neck pain
Muscle and joint pain; Muscle and joint pain; Moderate fatigue; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the second dose of BNT162B2 (Covid 19 Vaccine, lot number: EL9263), via an unspecified route of administration in right arm on 04Feb2021 at single dose for COVID-19 immunisation. Medical history included osteopenia. Concomitant medications included meloxicam from 2016, vitamin D nos (VITAMIN D) for osteopenia from 2019, and vitamin nos (MULTIVITAMIN) at 2 multivites daily from 01Jan2016. The patient previously received the first dose of BNT162B2 (lot: EL3246) in right arm on 14Jan2021 for COVID-19 immunization and side effects began 24 hours later. The patient experienced moderate fatigue on 05Feb2021. Patient also experienced muscle and joint pain 3 weeks later and lasting 4 days. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
The first Shingrix shot hit me hard for about three days with achiness, stomach issues, tiredness, injection site reaction. The second was milder with injection site reaction - red and sore - from the first, along with tiredness, lethargy, and general malaise. Today, the third day after the injection, the site is very read to a diameter of 3 or so inches, I am achy, tired, lethargic and having stomach issues including diarrhea.
Patient had a high fever 103.8 about 2 hours after the vaccines and even with tylenol it hoovered around 101-103 for one day. She reports he was not excessively fussy. Denies any such reaction with first set of vaccines. No other symptoms per MOM.
I received my first two vaccinations through Pfizer and my booster was Moderna.  Only Moderna caused my body blister rash
Numbness and tingling in right hand after administration of GARDASIL 9; Numbness and tingling in right hand after administration of GARDASIL 9; Information has been received from a pharmacist via a company representative referring to a 32 year old female patient. The patient's concurrent condition, historical drugs, medical history and concomitant therapies were not reported.   On an unknown date, the patient received a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose detail, strength, lot#, and expiration date were not reported) via unknown route for prevention of human papillomavirus (HPV).  An unspecified amount of time later, the patient developed numbness and tingling in right hand for about a week. The patient had sought medical attention. The outcome of the events was not reported.   Causality assessment was not reported.
No adverse event Received expired Moderna Dose expired 10/13/2021 date administered 10/14/21
Patient reported tingling, warmth and swelling to lips, face and ears, 15 minutes after 2nd Pfizer Vaccination
Complications of dementia; OSC: COVID-19 (September 2021 and January 2022)
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Patient had no pertinent medical history. On 03-DEC-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml. Concomitant therapies included generic simvastatin (manufacturer unknown) and PREMARIN. On 03-DEC-2013, the patient experienced injection site reaction. The patient stated that the dose was administered on the front of the arm "just above the bend of my elbow". She stated that she was unsure whether it was given in the muscle, or if it was given in the subcutaneous tissue. She stated that 10 minutes after the injection, she began to have itchiness and redness and swelling at injection site. She stated that after 24 hours the itching stopped. She stated that the site was "about the size of a half dollar", and it was red, slightly raised and hard. The patient said that the swelling "felt like there were lumps in it". The injection site reaction had not improved since the injection. The patient stated that she went to the clinic and saw a physician's assistant, who recommended over the counter cortisone cream, did not do any lab work and diagnosed the event as "an allergic reaction". The patient stated that when she received ZOSTAVAX, she was taking generic simvastatin (manufacturer unknown) but that at an unspecified date after the injection she "had to stop taking the generic simvastatin (manufacturer unknown) because it gave me cramps in my legs". The outcome of cramps in legs was not provided. Causality assessment was not provided. Additional information has been requested.
ACUTE DVT OF RIGHT FEMORAL VEIN 4/4/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
No adverse effects reported; improperly stored doses of VARIVAX and PROQUAD; This spontaneous report was received from an administrator referring to patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 28-MAR-2019 or 31-MAR-2019 or 02-APR-2019 or 03-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot# R023736 with expiration date on 20-AUG-2020 or measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot numbers R008697 and R000551, for prophylaxis (dose and routes of administration). The administered doses of the vaccines experienced temperature excursion -12.85 degrees Celsius for 15 minutes. There was no adverse effect reported.  This call was because of a data logger and there was not previous temperature excursion.   No product quality complaint was involved.   Lot number R008697 and R000551 are invalid lot numbers for  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) .  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1904USA004741:Original Case : 1904USA003556 US-009507513-1904USA004742:Original Case : 1904USA003556 US-009507513-1904USA004743:Original Case : 1904USA003556 US-009507513-1904USA004744:Original Case : 1904USA003556 US-009507513-1904USA003556:Original Case : 1904USA003556 US-009507513-1904USA004740:Original Case : 1904USA003556
Fever 100.9. The time the shot was given after 08:00 AM. I made a couple of stops before I went home. Around 15:00 PM I started shaking uncontrollable. I shook so hard that my head hurt. Then I develop a fever all night. Was hospitalized 10/2/17.
This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Herpes Simplex was cured after the 2nd primary dose / His 60 year Herpes virus was cured after 2nd vaccine. / His Herpes is not back so far, after 6 shots) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Herpes simplex (for 60 years).   On 11-Sep-2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2020, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Herpes Simplex was cured after the 2nd primary dose / His 60 year Herpes virus was cured after 2nd vaccine. / His Herpes is not back so far, after 6 shots). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Herpes Simplex was cured after the 2nd primary dose / His 60 year Herpes virus was cured after 2nd vaccine. / His Herpes is not back so far, after 6 shots) outcome was unknown.            No concomitant medications were reported.  The start date for dose one was reported as 17-Aug-2022.  Patient was a clinical trial participant and received the first 3 primary doses in while participating in the Moderna   Patient stated that after the first 2 primary dose, His Herpes Simplex was cured. He states that Covid vaccine not only works for COVID-19 but it also cured his Herpes Virus. He had Herpes for 60 years, and after vaccination it is gone. The Herpes symptoms have not come back so far.  It was reported that patient received third primary Full dose on 17-May-2021.  Patient also received the 2 Monovalent boosters on an unknown date.    No treatment medications were reported.
Several months later, I had multiple blood clots in superficial veins. They were there for 6 months before I went to the doctor. I had an ultrasound to ensure there was no deep vein clots. The pain was horrible in my leg. My left leg hurt worse. There were lumps all up and down the veins in my leg. I alternated heat and ice to get rid of the pain and I eventually went to urgent care. I also went to the emergency room to ensure it was not deep vein thrombosis which was ruled out. I went to my arthritis doctor who advised that the pain was from bursitis not the superficial veins. He gave me 2 injections one in the hip and one in the bursa area. I was able to lay on my side for the first time after that. I am still experiencing pain in my calf and legs but not as intense. I also have the clots in the superficial veins.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. The patient was 72-year-old gentleman with a past medical history significant for non-small cell lung cancer with metastases to the brain and spine who is status post XRT, COPD (oxygen dependent)currently at 3 L nasal cannula, hypertension, insomnia, anxiety, CHF, chronic pain who was transferred from the Hospice to ED for evaluation and possible placement in a facility. The patient reports that he was no longer interested in treatment and was looking for comfort care. He states that he experiences dyspnea on minimal exertion and at times with no exertion at all. He also reports a diminished appetite with increasing weakness. The Patient Was Transferred to the facility on January 5, 2021. From there the patient's condition was noted to slowly decline. He became weaker and is speech became slurred and garbled. His appetite remained intact until just recently. The patient became unresponsive and passed quietly at 2044 on 5/12/21.
I had an episode of rapid heart rate for about 10 minutes.  I am not sure if it had anything to do with the vaccine or not.
This case was reported by a consumer and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and local reaction. On an unknown date, the outcome of the influenza-like symptoms and local reaction were unknown. It was unknown if the reporter considered the influenza-like symptoms and local reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu like symptoms and also had a local reaction. For tolerance after 2nd dose of SHINGRIX, refer case US2018GSK162977.
Client received Pediatric Monovalent 5-11 year old dose instead of bivalent dose
I received my first dose of the vaccine on 8 August 2021 at the medical clinic. After 24 hours i experienced very tenderness and a throbing pain in my lower back. I had done nothing that would be considered a risk of possible injury. This continued for 5 days and then began to diminish.  I received my second dose at the same location a month later September 3 2021. 24 hours after i received he second dose i felt the onset of the covid19 symptoms. (I know these symptoms because i had a confirmed case of covid that started almost 2 weeks prior to the first dose).  The next day I felt better as i anticipated however, after waking up i showed and then walked into my living room and sat on the couch. My wife then asked, "what is that on your legs?" When i looked down at my legs i saw red dots where my pores are and  bruising from my calves down to my ankles and to the bottom of my foot. I called my  aunt that is a nurse to help and she told me to get to the ER immediately because it was ptechiae. I had every characteristic of petechiae on my legs and they corresponded to the medical information i read.  apparently this issue is report ed in a very small portion of people vaccinated
On1/24/2023 the patient in the office for office visit. Alerted nurse on  previous day 1/23/2023 that the patient needed a 4th  COVID booster vaccine upon doing chart prep. On 1/24/2023  PCP this nurse aware that the patient needed a COVID-Bivalent booster shot. Orders placed in chart by PCP. New vaccine card made for patient for 2nd bivalent booster injection.  Vaccine given in left deltoid without difficulty.
floaters on the eye; headache; swelling of the lymph node; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 19 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 19 years as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VITREOUS FLOATERS (non-serious), outcome "unknown", described as "floaters on the eye"; HEADACHE (non-serious), outcome "unknown", described as "headache"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swelling of the lymph node".  Additional information: Reporter mentioned that PFIZER should develop an antidote to the poison (referring to the PFIZER-BIONTECH COVID-19 VACCINE) that we are administering to many people. She would not recommend getting the vaccine from Pfizer. Also, she was asking why Pfizer is keeping on pumping this poison to everybody and that the Emergency Use Authorization (EUA). Reporter had a daughter who finished the 2 doses of the PFIZER-BIONTECH COVID-19 VACCINE and had experienced side effects such as that of floaters on the eye, headache and swelling of the lymph node. She would like to know if there is any available information in regards the side effect experienced specifically that of the development of floaters in the eye amongst her daughters age group (for teenagers). She mentioned that she know that both headaches and swelling of lymph nodes are commonly reported. Also, gave contact information by CDC as stated on the FAQ-COVID-19 Vaccine - CDC vaccination registry V-safe (adverse effects, pregnancy, lactation, other comorbidities).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine was given below deltoid and patient's arm is red and swollen and has a knot where the vaccine was administered
On 10/31 started not feeling good. Had nausea, tiredness, achy. Went to many Drs. & hospital. Had dry heaves bad. Went to hospital emergency 4 times. Finally in April found out I had strep through my body. Put on medicine for 8 weeks.
"COVID Arm"--Twelve days after receiving the vaccine, a large circular pink rash developed at the injection site.  It is warm to the touch and it is itchy. It is my understanding that this reaction is uncommon but harmless and nothing to worry about.  It should go away in a few days.
Pt complains of pain at time of vaccination that progressed by evening. Pt unable to sleep at night due to fever and pain at injection site. Injection site is red, swollen, and hot 24h later, even with use of cold packs and ibuprofen. Pt plans to go to ER for evaluation since pain has not subsided.
Swelling, warm, red, x 1 day per pt on 12-15-11. Pt doing better redness going down, able to move elbow.
Hot Flashes through the day, and on 10/03/16 started vaginal bleeding as if having a Mens period. Have not had a Mens period in 15 years.
Subsequent to receiving first and second doses of varicella virus vaccine live, a serum VZV antibody test revealed negative titers.
My husband is dying right now from your vaccine.; This is a spontaneous report from Pfizer-sponsored program - via a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported, expiration date not provide) as a single dose for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient's (reporter's husband) was dying right now from the vaccine  (life threatening) on an unspecified date with outcome of unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Blood in the Urine; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Blood in the Urine) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No medical history reported.  The patient's past medical history included No adverse event. Concomitant products included RIVAROXABAN (XARELTO), LOSARTAN, CHLORTHALIDONE, CARVEDILOL (COREG), MEMANTINE and ATORVASTATIN for an unknown indication.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD URINE PRESENT (Blood in the Urine). At the time of the report, BLOOD URINE PRESENT (Blood in the Urine) outcome was unknown.              The treatment information was unknown. Action taken with mRNA-1273 in response to the event was not applicable.
I got the PNEUMOVAX 23 shot and by the evening about 2 or 3 inches below where the injection site is it began to swell and turn very red. It was hard to move my arm and I was unable to move my arm. By Sunday morning 10/30/16 I had to go to the emergency room for further evaluation as my arm was seriously red and swollen. I am presently still in the emergency room and being evaluated, they have given me steroids and BENADRYL. With no changes so far.
Dizzy, head felt really heavy - the rest of the night my arm where I got the shot started throbbing; Next day felt better but my arm was still throbbing