chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PNEUMONIA; TOO MANY SIDE EFFECTS; This spontaneous report received from a parent via social media a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced pneumonia, and too many side effects and it was reported as "my jabbed daughter. 3 times. 2 very serious causing pneumonia too many side effects". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pneumonia and too many side effects was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000243632. This case, from the same reporter is linked to 20220750036, 20220752074, 20220750167 and 20220750301.; Sender's Comments: V0: 20220752219-covid-19 vaccine ad26.cov2.s- pneumonia. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
This spontaneous report as received from a certified medical assistant refers to a 46 year old female patient. The current condition of the patient reported as hyperlipidemia, anxiety, asthma with chronic bronchitis, dizziness, type 2 diabetes, vitamin deficiency. The patient was allergic to the drugs ADVAIR, glimepiride and sulfa drugs. On 04-NOV-2016, while administering the patient a dose of PNEUMOVAX 23 (lot # M037669 and expiry date 09-MAY-2018), the patient "moved" an unspecified way for an unspecified reason and the patient "ended up not receiving a full dose of PNEUMOVAX 23). It was unknown of how much of the vaccine the patient received. Concomitant therapies included XANAX, XOPENEX, vitamin D (manufacturer unknown), albuterol (manufacturer unknown), sumatriptan (manufacturer unknown), CRESTOR, DIOVAN, FLONASE, metformin (manufacturer unknown), ONGLYZA, budesonide, SYMBICORT and SINGULAIR. No product quality complaint was filed. Additional information has been requested.
Patient checked her BP after the shot and she came back to the pharmacy to let us know.  She said it was elevated.  I offered to recheck and it was slightly elevated for her age.  It was 153/82.. She informed me that she has high bp and didn't eat the proper foods today.  I gave her some water and rechecked the Bp and had her sit for a while.  When she left she said she felt fine
The morning after vaccination, I woke up to intense pain and sensitivity at the injection site. Any movement of or contact with my arm was extremely painful. By that evening, I had pain throughout my body. I took 800 mg of ibuprofen that night and again the next day, but the pain was still quite constant and intense. Even when not moving, it still throbbed, like a headache, but throughout my body. About 48 hours after the vaccination, I ran a mild fever for a few hours. By three days after vaccination, the pain subsided. My arm continued to feel slightly raised and hot to the touch around the vaccination site for several more days.
8/17/21: presents to ED with body aches, cough, congestion COVID POS in hospital started on dexametasone, remdesivir, zinc and baricitinib 8/25/21: discharged home
There was no adverse event reported by the patient, but the pharmacy received a notification, 4 days after administration, that the product, NDC 59267105504, lot FL2757, was possibly short date and had expired 9/30/22. However on 10/25/22, the pharmacy received another notification that the product was in fact stable through Oct 19, 2022. No adverse event was reported by the patient.
Hospitalized 10/31/13 - 11/5/13 for acute transverse myelitis due to flu shot given 10/14/13 at another facility.
Left vaccine center a few minutes after vaccine. Shortly after getting in my car and driving through the parking lot I experienced vision brightness and then tunneled out to almost nothing. I lost my hearing as well. I felt sick and palpitations. I tried to make my way back into the vaccine center but my vision was so diminished I nearly got in a car wreck. I hit a curb and ruined the rim of my car and then left my car parked half way out of a parking stall with my door open to run into the clinic I could barely see before shouting out "something is wrong" I was wobbling and felt like I was going to die. They took me back. No doctor ever came after my episode. I stabilized there with the person who vaccinated me. The vaccine was extremely painful. Later on I started feeling pain shooting down my entire arm. Now my fingers my joints my bones feel in severe pain. I've had the vaccine in both arms but experienced pain in my right almost immediately afterwards. I now am having trouble writing and doing anything. This is difficult because I'm in school. I have to go to a doctor now. Pain is in each one of my phalanges, metacarpals, wrist, and all the way up to almost my shoulder.
It caused me to experience a lot of joint pain in all areas of my body. I was already seeing pain management so they doubled the medication and added additional medications to my regimen. This provided temporary relief so I began to take the medication 3 times more. I was put in physical therapy which made it worse so I stopped going. The pain remained bad for 9 months. A steroid injection in my back and knee and prednisone were administered. I still have the pain but it is not as severe. I still have it in my elbows, wrist and knees. I was unable to sleep at night. The provider did blood work but did not look further into to see if there were any abnormalities in my system. My primary provider indicated that I had developed additional arthritis in the joint. I got a fracture on my right ankle as I was trying to balance myself in the shower. I am currently in the process of getting a boot placed when I am able to afford to get it.
About 30 hours after COVID19 vaccination, I experienced severe neck pain, fever, chills and weakness. The fever, chills and weakness has subsided but the neck pain continues in the are of my cervical spine.
Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patients developed mild cases of chicken pox. Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that have experienced a chicken pox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chicken pox have recovered. One of the previously vaccinated patients was a 6 year old patient who on 5/15/97 was vaccinated with a dose of varicella virus vaccine live. In April 2003, the patient developed chicken pox. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chicken pox. The other patients that developed chicken pox post vaccination with varicella virus vaccine live were also identified. Additional information is not expected.
Patient called today at 2:45 pm, about 24 hours after receiving the vaccine. She stated her arm is somewhat swollen "about halfway down to her elbow". I am unsure of exact time of onset.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (In 2016). Concurrent medical conditions included drug allergy (to sulfa and codeine with upset stomach, and weakness) and pollen allergy. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site stinging, nerve pain and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site stinging and injection site warmth were recovered/resolved and the outcome of the nerve pain was unknown. It was unknown if the reporter considered the injection site erythema, injection site stinging, nerve pain and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: The caller reported she received SHINGRIX the first week in April. The same day she states she experienced stinging with administration and redness and hotness at the site. She noted it was the size of an orange on her arm, this patch of angry redness and warmth. She states the second week it wasn't hot and still red. She noted it took 3 weeks to disappear then she states she felt pings of nerve pain like she did when she had shingles about a year and a half ago. She noted it was pain in the nerve endings. She was determining if she would get the 2nd dose or not.
31 year old patient with no significant past medical history received the influenza vaccine on 9/28. On 10/1 she had URI type symptoms and a rash around her eyes for which she started Durezol and tobramycin eye drops. She also began noticing a rash on her face. On 10/2 she went to an urgent care where she was diagnosed with a UTI and started oral Augmentin and received a Decadron shot. On 10/5 she was admitted to the hospital with a rash concerning Stevens-Johnson Syndrome (SJS)/toxic epidermal necrolysis (TEN). The patient complained of eye pain due to swelling and blisters, oral ulcers, dysphagia/odynophagia and had difficulty swallowing. The patient also had anal and genital blisters/sloughing. A biopsy was positive for TEN and it was noted the influenza vaccine was the possible inciting event. Patient had 30% skin involvement with a skin biopsy showing full epidermis necrosis consistant with TEN. Patient was treated supportively as well as received IVIG. Patient was given aggressive fluid resuscitation w/ continued monitoring. Patient managed in MICU initially requiring vasopressors and intubation. Patient progressed well, was extubated and transferred to general medicine unit. The patient continued to progress with continued supportive care and was discharged on 11/7/16.
Neck pain, headache, vomiting, body aches, chills, fever of 101.6
Patient received first Pfizer Covid-19 immunization on 4/12/2021. The shot was administered at 11:01 am into the left upper deltoid. Approximately 3 minutes later patient complained of faintness and experienced syncope. Patient was able to lie on the ground without assistance and her legs were elevated. Emergency services were placed on standby, and a first responder from the fire department was on hand.  Patient was responsive and alert, citing tingling in her left arm and an irritated, scratchy throat. Diaphoresis, but no signs of dyspnea or acute anaphylaxis. Blood pressure elevated. Supine position with elevated legs maintained for about 30 minutes. Patient declined EMT evaluation and was able to leave without assistance.
A 55-year-old male patient, with no known allergies, had received a dose of Fluzone SV 2006-2007 on 03/Oct/2006.  The route and site of administration were not reported.  Approximately 15 to 20 minutes post-immunization, the patient developed "throat discomfort" and tingling in his hands and face.  The patient denied any shortness of breath or difficulty in breathing.  Treatment received was not reported.  The recovery status of the patient was reported as unknown.
No adverse event; Inadvertently administered 3 doses of the bivalent vaccine which was beyond the 30 day use by date today; the vial was initially stored in the refrigerator on 22Sep2022 administered on 26Oct2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 3 doses of the bivalent vaccine which was beyond the 30 day use by date today), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 22Sep2022 administered on 26Oct2022) and NO ADVERSE EVENT (No adverse event) in a 26-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Abilify, Haldol, Risperdol).   On 26-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 22-Oct-2022, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 22Sep2022 administered on 26Oct2022). On 26-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 3 doses of the bivalent vaccine which was beyond the 30 day use by date today). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 3 doses of the bivalent vaccine which was beyond the 30 day use by date today), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 22Sep2022 administered on 26Oct2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 3 doses of the bivalent vaccine which was beyond the 30 day use by date today) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 22Sep2022 administered on 26Oct2022).    No concomitant medication information was reported.  The patient took previously first dose on 18-May-2021, route of administration as unknown, second dose on 07-June-2021, route of administration as unknown.  No treatment medication information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-673501 (Linked Report). This case was linked to MOD-2022-673510 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673501:Same reporter
Pt recv #1 dose vax on 8/12/97;on 8/19/97 pt exp raised rash w/ welts on face,neck,back&chest/pt recv #2 dose vax on 9/15/97;on 10/10/97 pt exp abd pains&diarrhea/pt recv #3 2/23/98;abd pain, fatigue,fever;tx=Hydrocortisone cream w/no help
Patient arm was swollen; Patient felt very tired; Patient had mild fever; Patient had pain in the injection site; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Patient arm was swollen), FATIGUE (Patient felt very tired), PYREXIA (Patient had mild fever) and INJECTION SITE PAIN (Patient had pain in the injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 031B21A) for COVID-19 vaccination.     No medical history reported relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.  Concurrent medical conditions included Drug allergy (Bentyl).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PERIPHERAL SWELLING (Patient arm was swollen), FATIGUE (Patient felt very tired), PYREXIA (Patient had mild fever) and INJECTION SITE PAIN (Patient had pain in the injection site). On 14-Mar-2021, PERIPHERAL SWELLING (Patient arm was swollen), FATIGUE (Patient felt very tired), PYREXIA (Patient had mild fever) and INJECTION SITE PAIN (Patient had pain in the injection site) had resolved.            Patient was not under any concomitant or regular medication.  Patient also experienced same events on 9-Apr-2021 after 2nd dose. Adverse event did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). The patient did not experienced a similar event in the past. symptoms were improving.  No treatment medication was provided.   This case was linked to MOD-2022-658151, MOD-2022-658153 (Patient Link).
patient was 13 years old at time of vaccine administration.  moderna covid19 vaccine was only approved for patients 18 years old and older at time of visit
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose unknown, lot # L026602 with expiration date: 19-OCT-2017, lot # M007764 with expiration date: 30-JAN-2018. No adverse effect was reported. Lot verification has been received on 17-AUG-2016, lot number M007764 is not valid for GARDASIL 9. Additional information has been requested.
The patient received a dose of Pfizer vaccine that was out of the 6 hour window since it was reconstituted. The dose was kept refrigerated the entire time, but was out of the 6 hour window. When realized by the pharmacy, patient was notified immediately and per guidelines from supervisors was offered an additional vaccine to ensure full efficacy. Patient declined an additional dose at the time and said he would decide if he wanted to going forward. As of this reporting, patient has not yet received an additional dose. No negative reaction occurred to our knowledge in response to this incident.
Nausea, fever, lethargy, headache, weakness for 12 hours.  Then first oral herpes outbreak in 5+ years followed 2 days later.
Uncomfortable, a nuisance or irritation, but able to carry on with everyday activities, Had short-term effect that was bad enough to affect everyday activities, Significant enough to lead you to seek advice from a healthcare professional. After being administered a flu shot, my left arm was immediately limp. The pain was so horrible, I cried out. It felt like a nerve was punctured and my shoulder was hot and swollen two times bigger. Dr. recognized the discomfort and made me stay in the room for several minutes. My arm remained inflamed so I went to the ER that evening. After no luck, I went to my physician and explained my discomfort was prescribed pain medication. Not feeling better, my physician request an MRI and it was that I had arthritis. No onset arthritis was apart of my medical record. I am still in pain. I am suffering and I truly feel it was because of the flu shot. A second optioned was a request by another physician next week.
I received my first Moderna vaccination on 1/19/21.  I did not have any reaction for the first week. On 1/26 I noticed that the area where I received my vaccine started to feel warm and itchy with a little red rash. I took 25mg of Benadryl. The next morning it was fine, still a little warm and not too itchy. On 1/27 around 5pm the area started getting heated and red again and I took another Benadryl. Morning of 1/28, it was still warm, itchy, and the red area is slightly larger.  I contacted my primary Dr. and sent her photos for each date/time noted above.  DOes not feel it's related to the vaccine itself, possibly an infection from the needle puncture and prescribed cephalexin.  Dr. suggested I go ahead and report  just in case.
Mild nausea the beginning the following evening (approximately 10PM on 01/27/21) that subsided upon waking up the following morning. Mild to moderate full body aches, particularly around the shoulder and hip joints, beginning the following evening (approximately 10PM on 01/27/21) that persisted through the following day. General fatigue coincided with the full body aches and  followed a similar time course. Migraine beginning the following morning (approximately 9am) that still persists through till 01/30/21. No medication were taken for any of the symptoms at any time.
Sore throat, followed over next day with achey joints, headache, coughing -- basically felt like the flu.
Patient received Td on 03/28/05. Returned to clinic on 03/30/05 c/o pain x 2 days left axillary area. Exam- no fevers, rates pain 7/10. no numbness or tingling. Red throat sub mandibular LAD. Redness left upper arm. pain to palpitation left axilla freely mobile axillary LAD bilateral.negative for strep. Flu 04/08/2005 much better , after strep 48 hour culture for strep. Negatvie axillay node.
PATIENT STATES THAT ON 1/23 HIS INJECTION SITE WAS RED AND ITCHY.THE NEXT DAY HE BROKE OUT IN A RASH/HIVES ON HIS HEAD.SOME OF THEM ON THE LEFT SIDE OF HIS FACE.HE HAS BEEN TAKING BENADRYL AND USED A TOPICAL ITCH CREAM. I TOLD HIM TO MAKE AN APPOINTMENT WITH HIS DOCTOR . PATIENT SAID THERE WAS NO CHANGE IN MEDICATION,DETERGENT OR ANYTHING THAT HE REMEMBERS AROUND THE TIME OF THE VACCINATION.
The dosage for a 12 year old is 0.5ml and the patient received a dose of 0.25ml instead. The parents and the patient are reluctant to come back to get the second half of the dose.
Reddened area approx 6" x 5", slightly warm. Sinus congestion, drainage approx 32 hours after injection Tylenol/Advil as needed Augmentin 250mg (Tid x 10D)
Patient complained of soreness at injection site, as well as he said he felt weak and experienced vertigo for a couple days after receiving the injections.
This spontaneous report as received from a female consumer of unknown age regarding herself. Concurrent conditions and medical history was not reported. On 20-JAN-2015, patient was vaccinated with ZOSTAVAX vial, through injection  (dose was not reported). Concomitant medications were not reported. On an unknown date approximately in January 2015 the patient did not feel like she actually received the vaccine when she was given the ZOSTAVAX from her physician's office. The outcome of the event was unknown. The causality of the reported event was not reported. No adverse experience were reported. No further adverse event (AE) information was reported. Additional information has been requested.