chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHHY2015US058460 is an initial literature report received on 09 May 2015. The author discussed about a retrospective, multicenter, observational study which was conducted to evaluate the spectrum of retinal diseases that could demonstrate paracentral acute middle maculopathy and isolated ischemia of the intermediate and deep capillary plexus. This report refers to a 53 year old female patient. Her medical history included pseudophakia of eye. Her current conditions included hypothyroidism, hypertension and anxiety. She was vaccinated with H1N1 pandemic influenza vaccine (manufacturer and batch number: not reported) on an unknown date. Two to three days after vaccination, she had an acute onset of paracentral scotomas in the right eye (OD). At the time of baseline presentation, paracentral acute middle maculopathy lesions (isolated band like hyperreflective lesions in the middle retinal layers) were observed in the patient. Her baseline best corrected visual acuity (BCVA) was 20/50. Baseline fundus showed scattered parafoveal whitening (localized with paracentral acute middle maculopathy (PAMM)) and peripapillary cotton wool spot (CWS). Follow up spectral-domain optical coherence tomography (SD OCT) analysis of paracentral acute middle maculopathy lesions demonstrated subsequent thinning of the inner nuclear layer (retinal layer). The patient presented with a form of retinal vascular disease. Follow up BCVA was 20/50. The events outcome was not reported. The seriousness of the events was not reported, but the event was upgraded as medically significant based on the information available in the source documents. The causality of the event was not reported. The author stated that H1N1 vaccine was one of the novel retinal vascular associations leading to retinal vasculopathy and paracentral acute middle maculopathy. The author concluded the article stating that paracentral acute middle maculopathy lesions might develop in a wide spectrum of retinal vascular diseases. These were best identified with SD OCT analysis and might represent ischemia of the intermediate and deep capillary plexus. These lesions typically result in permanent thinning of the inner nuclear layer and were critical to identify in order to determine the cause of unexplained vision loss.
the headache is in the same place; her temperature has backed off; she was in the bed for a couple of days; little bit of nausea; 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 female patient received bnt162b2 (BNT162B2), administration date 23Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no:1), administration date: 26Mar2021, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "the headache is in the same place"; BODY TEMPERATURE ABNORMAL (non-serious), outcome "recovered", described as "her temperature has backed off"; BED REST (non-serious), outcome "unknown", described as "she was in the bed for a couple of days"; NAUSEA (non-serious), outcome "unknown", described as "little bit of nausea". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated about the COVID shot and he reports AE on himself and mentions during his call that his daughter had the same reaction but she does not have a temperature anymore. He says she had the same dates as both of his. In his report he said his first dose was on 26Mar2021 and his second dose was on 23Apr2021. He says she had the second one, the first one made her sick, the second one gave her a headache and temperature but she has no more temperature today. He says they both have sinus problems but this is not a sinus issue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult male patient who received 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 adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient just had his 2nd dose of SHINGRIX and forgot that he had a bad reaction to his 1st dose. The patient inquired about taking Ibuprofen to treat his current symptoms, but he did not elaborate. He did not want to share any additional details regarding his experience. The reporter did not consent to follow-up.
Sore Arm, Uncontrollable diarrhea within 15 hours of getting vaccine, lung issues. Persistent cough for over one month. Placed on Steroids, antibiotics, inhaler, Flonase in April, then again in June, now again in August. Had covid back in December and doctor stated that it may have been ill-advised to have vaccine so soon after having covid. Continue with weakness and allergy like symptoms in lungs. Can't be around dust, sand, highly pollinated areas. Start coughing and can't stop.
Suspected vaccination failure; Got the shingles; Severe pain because they could not break out of the skin; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient had the vaccine and got the shingles. The patient stated that, the vaccine made shingles worst and the patient was in severe pain 24 by 7 for over 6 weeks. As per the patient, because the vaccine made it to where shingles could not break out of the skin therefore made it so pain than the times before the vaccine and due to this, the patient had to go to ER (emergency room) twice and doctors. This case was considered as suspected vaccination failure, since the details regarding the completion of vaccination schedule, the time to onset for event and laboratory confirmation for herpes zoster were not provided.
This spontaneous report was received from the pharmacist referring to an unknown female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. Pharmacist reports that a physician inquired about an unspecified patient who received an unspecified dose of ZOSTAVAX (lot and expiry date not reported) sometime during October 2017. Co-suspect medication included sterile diluent (manufacturer unknown). Pharmacist reported that the physician reported that the patient told him a few days after receiving the vaccine, the patient began to see some bumps in the area, then they became lesions clustered on her back and then her groin too. When the patient stated this had been going on for four months, the physician performed a biopsy of the lesions which came back with a diagnosis of fat necrosis. Outcome of fat necrosis was not recovered and its causality assessment was not reported.
Case number PHEH2016US032407, is an initial spontaneous report received from a consumer on 08 Dec 2016. This report refers to a female patient of an unknown age. Medical history was not reported. Vaccination history included administration of flu shot (manufacturer unknown, batch number: not reported) from which the patient never had reaction. Concomitant medication was not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1620201, expiry date: May 2017) at a dose of 0.5 ml intramuscularly on 08 Nov 2016. Two days after vaccination on 10 Nov 2016, the patient experienced flu like symptoms (sore throat, fatigue). On 25 Nov 2016, the patient broke out into bite like rash on neck, shoulder then moved to back, side of face and ear. On 28 Nov 2016, the patient developed ear swelling. On 30 Nov 2016, the patient went to physician and was misdiagnosed and given VALTREX 2 gm daily for Herpes which made rash worse. The patient went back to physician on 07 Dec 2016 and was given ZYRTEC and ZANTAC for rash. The outcome of the events was reported as complete recovery on 12 Nov 2016 for flu symptoms (sore throat, fatigue) and on 07 Dec 2016 for rash and ear swelling. The seriousness of the events was reported as non serious and causality not reported.
J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/27/2023 SECONDARY HYPERCOAGULABLE STATE DUE TO UNSPECIFIED ATRIAL FIBRILLATION R09.02 HYPOXIA 3/27/2023 SECONDARY HYPERCOAGULABLE STATE DUE TO UNSPECIFIED ATRIAL FIBRILLATION
non stop diarrhea; nausea; chills; joint pain; sore at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 02Jan2021 07:30 at single dose for covid-19 immunization. The patient's medical history was none, and there were no concomitant medications. The first dose patient received on 02Jan2021 morning, and she just had symptoms she expected, she was sore at the injection site and she had some joint pain on 03Jan2021, but those disappeared on 04Jan2021. On 05Jan2021, she woke up and had non stop diarrhea with a little bit of nausea. Patient had not had a fever, but did feel chilled. Patient didn't think she ate anything bad. She was suspecting this may be a side effect of the vaccine. Patient didn't have a prescribing doctor. She got it at the hospital she worked at. She received it the 02Jan2021 7:30 am. Patient started the diarrhea on 05Jan2021 morning at 8:30. The nausea was on and off, but started this morning as well. Patient didn't take any ongoing medication. Outcome of events sore at the injection site and joint pain was recovered on 04Jan2021, outcome of event diarrhea was not recovered, and outcome of events nausea, and chills was recovering.
First 3 days only some arm soreness. Symptom free after day 3 until day 9. Then on 17 January right arm near injection site because sore and hot to touch with swelling and itching.  These have not resolved as of today, 18 January.
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter. No treatment information was provided.
LIGHTHEADEDNESS, NAUSEA, FEELING OF WARMTH FEELING OF NAUSEA CONTINUED WHILE FEELINGS OF LIGHTHEADEDNESS AND WARMTH SUBSIDED AFTER 10 MINUTES.
Prior to administration of Janssen Covid-19 vaccine the patient was anxious but was completely fine once the procedure commenced and concluded. After finishing explaining the possible side effects of the vaccine and handing the patient the V-Safe handout, she got up slowly and proceeded to our designated post vaccination monitoring seating arrangement. Upon concluding the vaccination process with the patient?s partner, she alerted the pharmacist that she does not feel well. To which he asked her to further elaborate on what she is experiencing. She began to say she thinks she?s going to faint as she is attempting to drink water. As she was having a drink of water she fainted. To which he responded by running over and catching her before she hit the ground, cradling her upper torso, specifically the head and laid her down on the floor with the assistance of pharmacist and her partner. In the midst of everything he instructed another pharmacy technician to call 911 for the paramedics. As she was in the process of drinking water I saw her other hand go to the region of the neck, thinking it was also an allergic reaction and administered a dose of Epi-Pen. He administered the Epi-Pen on the upper side of her thigh, directly to the skin not through clothing. There was a very brief moment where the patient began to convulse but gradually regain consciousness. The patient became lucid and was conversing with him, apologizing for the incident. He assured her there was nothing to apologize for and to which she told me she had similar incidents from vaccinations as a child. She did not mention this prior to administration of the vaccine and through conversation we believe the incident may be caused from high anxiety of needles / vaccinations. When the paramedics arrived, they assisted the patient from the floor and gave a warning that she believed she was going to faint again, and fainted in the arms of the paramedics.
Starting Feb. 14th 2021 I began feeling weak, shaky, abdominal pain. The pain persisted and ai went to the ER 5 times (4 times for extreme pain/abdominal distention). The fifth time CT found a twisting of my small intestines. Surgeon let me sit for a few days, and I worsened. He did laparoscopic surgery on me (3 holes in abdomen to look around) and he found that i did not have a twisting of the small intestine, but my large intestine presented completely flat. He stated that he had never seen this before. Within this time (5 ER visits/6 days as inpatient) my eyes completely went blurry and very painful. I was referred (after multiple eye doctors, they had never seen the things wrong with my eyes (he can share with you). I have been treated by him for 1 year.  Other specialist I have seen over the past year due to adverse reaction, Endoscopy, Immunology/Rheumatology.
revised temperature excursion data; This spontaneous report was received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical histories, current conditions, previous drugs reactions or allergies, and concomitant medications were not reported.  On an unknown date, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 1 injection (dose, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number S033539, expiration date reported and validated as 22-OCT-2021), measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 1 injection (dose, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T007397, expiration date reported and validated as 29-AUG-2021) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 2 injection (dose, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number S005251, expiration date reported and validated as 20-FEB-2021, lot number S018595, expiration date reported and validated as 17-JUN-2021) for prophylaxis (Improper storage of product in use). The vaccines were exposed to the following temperature excursions: 14 degrees Fahrenheit to 46 degrees Fahrenheit, with an average of 21.8 degrees Fahrenheit for 14 hours as recorded. The temperature excursions were detected by a data logger. There were no previous temperature excursions. The excursion was identified as a result of a digital data logger, however it was the facilities mistake. The refrigerator door had been secured closed, however the door was still slightly ajar and was not noticed until the next morning. The temperature excursion was safe to administer the vaccines. The vaccines were administered post approval from a Merck associate.  This case has been considered non-valid due to the lack of patients' identifiers.
Large rash on back of arm. Could see injection site. Unusual blister about 2 inches below injection site. Rash occurred night of injection, but had gotten bigger 2 days later.
This spontaneous report was received from a pharmacist (the patient's father) and refers to a currently 19 year old female patient with none pertinent medical history, drug reactions or allergies. The patient's concurrent conditions were not reported. On 03-DEC-1996, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX and then, on 24-SEP-2007 (which was considered an inappropriate schedule of drug administration) the patient received a second dose of (Oka/Merck) VARIVAX, (dose, route, lot numbers and expiration dates were not reported for both vaccines). The patient's concomitant therapies included minocycline. On 08-AUG-2015, the result of a titer for immunity to varicella (IgG) was reported as negative 0.8 (units not provided), (antibody test negative). No treatment was given to the patient. At the time of the report, the outcome of the resantibody test negative was unknown. The relatedness between the event and therapy with (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of injection site erythema in an elderly female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site rash and injection site swelling. The patient was treated with BENADRYL and Ice Pack (Nos). On an unknown date, the outcome of the injection site erythema, injection site rash and injection site swelling were unknown. The reporter considered the injection site erythema., injection site rash and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient developed a reddish rash and local swelling around the injection site after receiving SHINGRIX. The patient called to physician about the reaction and the physician recommended ice and BENADRYL. The patient received SHINGRIX from different the health care professional and did not have any vaccine information. The physician reported only limited details about the adverse event.
Initial unsolicited report received from a Physician via other company (Pfizer) on 07 November 2016. (Manufacturer report number: 2016493474) This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (dose, batch number, expiration date site and route of administration was not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following vaccination patient had a reaction. Lab data and corrective treatment were not reported. Outcome of event was not reported. List of documents held by sender: none.
This spontaneous report as received from a physician (also reported as healthcare worker) refers to 2 patients of unknown age and gender (all reported as not pregnant). On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX (lot#, strength, dose, frequency and route unspecified). Eighteen days later (exactly date unknown) they developed mild varicella like rashes. He stated that samples of the rashes were sent to the Centers for Disease Control and Prevention (CDC) and it was determined the strain of varicella "was not wild type". He stated that the patients were treated with ACYCLOVIR and "topicals". The outcome of the event was reported as recovering. He stated that at the time of the call he did not have any patient specific information available. Additional information is not expected as the physician did not want to be contacted.
Information has been received from a Registered Nurse referring to a 6 month old female patient. On 28-MAR-2016 at 11:18, the patient was orally vaccinated with her third improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of ROTATEQ (lot # L013202, dose was unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
5 days post-vaccination (1st dose of Moderna), patient started developing lethargy, and difficulty swallowing.  7 days post-vaccination patient looked "ashen".  12 days after vaccination patient was improving, but 14 days after vaccination patient was found to have (on lab work) critical hypernatremia (sodium level of 180 mmol/L), patient was re-referred back to hospice, and 17 days post-vaccination patient died.
A physician reported that a 4 month old male received his second dose of Prevnar on 16-JAN-2001. He received his first dose on 10-OCT-2000. On 08-SEP-2001 at the age of 1 year, he developed pneumonia with bacteremia and was hospitalized. The organism was identified as Streptococcus pneumoniae, serotype 14. No further information was available as of the date of this report. Additional info received on 12/19/2001 provided past medical history. The child recovered.
I've been experiencing on-going inflammation primarily in the site of the injection in my left shoulder.  Sometimes the pain spreads to my neck/shoulder areas as well but not too often.  The soreness started a week or so after the 2nd injection and has not gone away.  I can get temporary relief from taking ibuprofen but I don't want to keep doing that.   This is more of a nuisance than anything else right now but I don't want this to be lingering/ongoing like it has been.
Information was received on 10-JAN-2017 from a medical assistant regarding unspecified patients. Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date 3 doses of improperly stored PNEUMOVAX 23 (lot # L014458, expiration 11-FEB-2017, and lot # M013156, expiration 15-OCT-2017) were administered to unspecified patients (dose not specified). The temperature was 46.8 degrees F for 48 hours. No adverse effects were reported. The call was made because of a "data logger." No additional information was available. Additional information is not expected.
About 36 hours after receiving the vaccine, started having heart palpitations/flutters. Happened after both the first dose and the second dose. Learned that they are actually PVC's. Have never had pvc's in the past, so I assume that they are linked to the vaccine. Pvc's were very frequent at first and then slowed a bit to only a few  a day, after the second dose, they resumed again.
Head aches, chills, joint pain in neck and hip, blurred vision, change in taste and smell