chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Nauseous; This is a spontaneous report from a contactable consumer (patient's daughter).  This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899 with Expiration Date 31Mar2021), via intramuscular, on 05Jan2021 at 0.3 mL single dose on the right arm for COVID-19 immunisation. Relevant medical history included ongoing thyroid problems (did not remember but she thought it was about 4 years ago that this was diagnosed), and menopause from  Aug2020. No relevant concomitant medications were provided. On 06Jan2021, the patient developed headache. She had a really bad headache for about 9 days she ended up going to urgent care because of that, she was nauseous and went to the urgent care and they said they were side effects from the vaccine, she said the headache was extreme. She is wondering if it is okay to even take the second dose after having side effects. The patient had recovered from 'nauseous' on 10Jan2021 and from headache on 14Jan2021.
Prevnar 13 (PCV 13)was ordered, the patient was given Pneumovax (PPSV 23). The patient has had no adverse effects.
Swelling and redness with pain same arm as vaccination in < 12 hrs. Treatment - ibuprofen, topical hydrocortisone and oral prednisone.
Within 5 minutes of shot, at injection site - not normal in place of the shot. Like a pain - it was hurting. Around  2 am I feel very hot and very tired; I had a headache. I had muscle pains came and went. On the left leg I had leg cramps - that would came and go,  I slept a lot the whole day  - in the evening I became feverish but not bad. Those symptoms were gone after 24 hours. The rash I had on my back became worse the day of the shot. Rash continued to get worse - I went to the doctor because it was itchy and annoying - dr- 14th of April  - did a biopsy  - I have an appt on Monday to talk about it. My rash is gone now. Treatment: I took Ibuprofen for the symptoms that I had the next day after the vaccine. Cream for the rash: Clobetasol Propionate
PATIENT GIVEN VACCINE AFTER ALL PROCEDURAL ITEMS WERE COMPLETED ANDWAS LEFT SEATED IN A CHAIR ASSIGNED FOR COVID 19 MONITORING . PATIENT STARTED SNORING/GURGLING AND I LOOKED OVER TO SEE IF PATIENT WAS CATUALLY SNORING . PATIENT WIFE CALLED HIM BY NAME HE DID NOT ASWER RIGHT AWAY, I RAN TO TO ATTEND TO HIM AND I NOTICE HE WAS PALE , SWEATLY AND CLAMY ALSO WARM TO TOUCH. I CALLED HIS NAME HE ASWERED I THEN TOOK HIS PULSE WHICH WAS NORMAL AND GAVE HIM SOME WATER TO SIP AND ALSO GAVE PATIENT A CANDY WITH MENTHOL THEN HE STARTED GAINING BACK COLOR . HE FELT WEAK BUT STARTED FELLING BETTER. HE SEEM TO HAVE DIZZY ,LIGHTED HEAD SPELLS RIGHT AFTER VACCINE WAS ADMINISTERED. I MONITORED PATIENT FOR 45 MINS HE WAS ABLE TO GET UP AND WALK AND SAID HE FELT BETTER. ITS SEEM LIKE IT WAS MORE OF A FAINTING SPELL BUT BECAUSE HE WAS SEATED AND BEING MONITORED HIS RECOVERY WAS  GOOD. PATIENT GOT UUP AND WALK AROUND AFTER RECOVERY AND I TOKK HIS NUMBER SO THAT I CAN FOLLOWUP AFTER CLOSING
Menveo administered instead of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 51-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA793A, expiry date 31st January 2024) for prophylaxis.   Concurrent medical conditions included back pain, depression, vitamin d deficiency and blood cholesterol increased. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 17th January 2023, the patient received the 1st dose of Menveo. On 17th January 2023, unknown after receiving Menveo, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt date: 17-Jan-2023. Reporter's Comments: The reporter was a Medical assistant. Reporter stated that the patient came in for second dose of Shingrix vaccine and was inadvertently administered a dose of Menveo instead. The patient had not had any prior doses of Menveo. The patient was not immunocompromised.  At the time of reporting, the second Shingrix dose has not been administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: Patient received Menveo instead of 2nd dose of Shingrix which led to wrong vaccine administered.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 10-JUN-2015 the patient was vaccinated with an improperly stored dose of VAQTA (25U/0.5 ml; lot # K007791, expiration date: 22-AUG-2016; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 6 times. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius), Celsius conversion of the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 1172, -3, -3 and R; 80, 30, -1.111111111 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree/Celsius), Celsius conversion of the highest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 336, 59, 15 and R; 168, 49, 9.444444444 and R; 24, 48, 8.888888889 and R; 416, 47, 8.333333333 and R. This is one of several reports received from the same source. Additional information has been requested.
3 cm erythema rash with sore associated pinpoint vesicle at the injection site.
STIFFNESS; BODY ACHES RESOLVED IN 36 HOURS; Narrative:
"Pfizer-BioNTech COVID-19 Vaccine EUA." Patient received first dose of vaccine on 12/21/2020. Patient called on 1/3/2021 to notify that she developed symptoms on 12/27/2020 and had an appendectomy on 12/28/2020 at another facility. Patient also reports that CDC V-Safe Application was used to report event as well. Patient reports that she is recovering well.
This spontaneous report as received from a registered nurse, refers to an unspecified patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reaction were reported> On 13-JAN-2015, the patient was vaccinated with ZOSTAVAX injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. On 28-OCT-2015, the same unspecified patient received another dose of ZOSTAVAX injection (strength, dose, route and lot number or batch number unspecified). No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Received 2nd dose of vaccine on Wednesday. About 5 hours after 2nd dose, chills and fever. Part-way through night (about 12 hours after) started with violent diarrhea and intense abdominal pain. Fever continued for about 65 hours. 2 X 3 inch rash appeared on thigh on Friday, 2 days after receiving vaccine. Liquid diarrhea continued despite fever breaking, as did intense abdominal and back pain. Pain medication helped temporarily with pain. Immodium tried on Saturday but only made things worse. Became dehydrated. Visited emergency department on Sunday morning, 4 days after receiving vaccine. Was diagnosed with infectious colitis and possibly Lyme disease. Treated with doxycycline and metronidazole. Received 2 liters of IV fluid for dehydration.
10/4/07 Hepatitis and Pneumococcal vaccines given. Evening time at same day I started development like a high fever, difficulty breathing, hoarseness, weakness symptoms like flu 10/5/07 getting worse. 10/6/07 I lost my voice, a lot green mucus. Heavy headache, etc.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 5 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The pharmacist stated that in 2018, the patient got SHINGRIX a few months before reporting date, and she developed shingles. The healthcare professional stated that this was the patient's first episode of shingles. The reporter gave consent to follow up.
mom reports pt broke out in rash w/in 2hr of vax;pt was taken to ER but no tx given; rash began to clear up;no inc temp;MD prolonged crying reported;
redness that started at injection site the day after Vaccine. itchy and has moved down arm almost to elbow. The area now is about 3inches by 6 inches in size. now it looks bruised still itchy. I had the booster on 11/8/2021. today is 11/13. I had the pharmacist look at it today she told me to have a physician look at it. Today is Saturday so my Dr is not in. I may go to Urgent Care to have it looked at.
massive headache and body aches starting around 7 am the following day that woke me up from the pain and for me that's significant. it felt like a hangover but from 5 people after a holiday. couldn't move any part of my body without making things worse. finally got up to get pain meds and it felt like I had the coordination and strength of a toddler. so very weak body. 500 mg of ibuprofen and 4 hours later it was as if nothing happened and my body was fine. also occurred at the same time: large welt (similar characteristics to a cyst) at the site of injection roughly 3 1/2 inches in diameter and raised about 1/2 inch. no associated pain just very uncomfortable and sore. couldn't raise arm past 45 degrees in any direction. welt lasted several days, the soreness was slightly less.
Chills with uncontrollable shaking (took 3 blankets and a heating pad to stop), nausea, vomiting (blood sugar was in normal range throughout reaction), body aches, significant fatigue, headache
After each annual flu shot I normally end up having upper arm & the effected side ache in the neck which is mild & lasts about 2 days. However, this time the upper arm pain & especially the neck & between shoulder blade is severe & very uncomfortable & it is still bothering me.
This spontaneous report as received from a male physician of unknown age via company representatives refers to himself. In 2008 the patient was vaccinated with a dose of ZOSTAVAX injection, subcutaneously (lot# and strength not reported). On an unknown date the patient experienced a "spot" on the back of his unspecified leg during an unspecified time while on therapy with ZOSTAVAX. The patient had stated that the "spot" was a shingles "spot". he stated that this "spot" appears sporadically on his unspecified leg in the same vicinity. The patient did not seek medical attention. The outcome of the patient's event was not reported. The relatedness between therapy with ZOSTAVAX and the patient's event was not reported. This is one of 2 reports from the same reporter. Additional information has been requested.
Patient told me prior to administration that she has alpha-gal syndrome and I looked over ingredient list and nothing stuck out to me as something she should react to. She said she had no issues with previous doses. I administered the vaccine and the patient came back 10-20 minutes later saying her hands were starting to itch and it was one of her first reactions that she usually has with her alpha gal. She stated she had already taken 50mg diphenhydramine (what she usually does when this occurs) and asked to see the ingredient list herself. She agreed there didn't seem to be anything that would affect her alpha-gal. She said she felt okay and also had prednisone at home and would talk to her allergist. I called her around 5pm this evening to check in and she said she was feeling totally fine now.
I received my Moderna Bivalent booster on 12/1/2022. On 12/24/2022 or 12/25/2022, I developed a sore throat. I then developed a cough, so I took a home antigen test on 12/26/2022, and the result was positive. I then called my doctor, who prescribed me PAXLOVID. I took it for 5 days. On 1/4/2023, I took another test, and the result was negative. My doctor had advised me that if the test result was negative after taking the PAXLOVID for 5 days, I could come see him for my prescheduled physical on 1/5/2022, which I did. At the time of this writing, I still have a bit of a runny nose and feel like I have a cold, but otherwise, I feel fine.
Mouth sores; Headaches; Joint pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWC178) via an unspecified route of administration in the right arm on 19Aug2021 at 08:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included unspecified multi vitamin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 20Aug2021 at 11:15, the patient experienced mouth sores, headaches and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mouth sores, headaches and joint pain was not resolved at the time of this report.
Pfizer COVID vaccine incorrectly diluted with 0.9% normal saline in multi-dose vial with preservative. Correct diluent should be 0.9% normal saline in single-dose vial without preservative. When Pfizer was called at store level, they were not able to give any information on anything other than the single-use vials that were studied. Called the morning of 8/3/21 and spoke to the medical team at Pfizer who gave the same information. Was able to say that the reason Pfizer wants medical providers to use the single-use vials is so that there is no cross contamination from puncturing the vial multiple times to dilute multiple vaccine vials. The multi-dose vials that were used were only punctured once so no risk of contamination. Considering this a valid dose still since the vaccine was still diluted and administered with normal saline.
Patient received vaccine at 17:00. At 17:04, she complained of nausea, of feeling 'hot" and had noticeable diaphoresis. At 17:06, patient started having emesis X 4. We placed cold packs on her neck, directed several floor fans toward her chair, offered her cold water and reassured her. At 17:20, patient was no longer diaphoretic and she said her stomach "felt better.' At 17:28, patient denied having any more symptoms. She felt better and wanted to go home with her mother who was with her. She had no dizziness upon standing and walked out of vaccination clinic on her own.
Within 8hrs he developed left thigh redness warmth and swelling. I did remove 2 latex bandages in the office and over the course of 20 mins felt there was some improvement, but this remained at the knee.
Left inner thigh with 7cm area of warmth and redness. Rx Keflex 250/5 5cc PO Tid x 10 days, Benadryl 12.5cc/5cc 1/2 tsp PO every 6
Patient developed acute dyspnea with exertion 04/27.  Went to hospital ED, found to have acute hypoxic respiratory failure.  CT-PE showing submassive saddle pulmonary embolism with several large emboli in bilateral upper and lower pulmonary arteries.  Transferred from outside hospital to another Hospital.  Started on IV Heparin  infusion with transition to Enoxaparin.  Had significant drop in platelet count and developed peripheral thrombi in all extremities.  Concerned for HIT at that time, and review of CDC recommendations for COVID vaccine-associated thrombi, patient transitioned to Fondaparinux and remains on at present.
Probable human papilloma virus vaccine unmasking of Relapsing-remitting multiple sclerosis (RRMS); human papilloma virus vaccine; Literature Report:   This literature marketed report has been received from the authors of the published literature article entitled as above regarding an early 20's patient of unknown gender, who was part of a study that evaluate the prevalence and clinical characteristics iatrogenic central nervous system (CNS) inflammatory events of a total of 27 patients in a tertiary neuroimmunology clinic over five years from January 2017 and December 2021. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided. The patient did not have any other autoimmune disease, nor cancer history.  On an unknown date, the patient was vaccinated with a human papilloma virus vaccine (manufacturer unknown) (product of unknown orugen (dose, vaccine scheme, route, lot number and expiration date were not provided).   After 14 days of the last dose of the vaccine, the patient experienced probable of human papilloma virus vaccine of relapsing-remitting multiple sclerosis (RRMS) with spinal motor attack. The Adverse Drug Reaction Probability Scale result was 7 and was used to score the probability of iatrogenicity.  Treatment with intravenous methylprednisolone (IVMP) with full response. The final disease course was reported as RR (initial relapse). The outcome was not provided.  The causality assessment between the event and the suspect vaccine was considered to be related.  Upon internal review, the event probable of human papilloma virus vaccine of relapsing-remitting multiple sclerosis (RRMS) was determined to be medically significant.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports derived from the same literature article.; Sender's Comments:  US-009507513-2303USA007194:MSD
1st dose March 2019 , 2nd not yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose in March 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose March 2019 , 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 08-MAR-2023 The reporter called and reported that a patient received the first dose of Shingrix in March 2019 and wished to know if the patient could receive the second dose.  The information about the site or vaccine was not provided as it was unknown. The patient gave consent to follow up. Till the time of reporting, the patient did not receive the second dose of Shingrix which led to incomplete course of vaccination.
Pt awoke approximately 13 hours after administration with difficulty beathing.  Felt as if something was blocking her airway. After taking po Benedryl, patient drove herself to the ER, . O2 SAT =90.  Pt was given "steroid" injection and steroid nebulizer.  Pt states that the diagnosis was Pharangitis and edema of the uvula.  Pt was d/c'd home and recovered within 3 days. The ER summary received on 1/12/04 states difficulty swallowing, sore throat, edema of uvula and anxiety.
While on my PC I started to see "sunspots" in my vision when looked away. Also, my vision in general went blurry and had a blind spot in the center of my vision. This lasted a couple hours and corrected afterward. When I saw the doctor, I had a physical and suggested to see an optometrist just to be sure.  Saw doctor for a Retinal scan and Glaucoma screening. Both were normal. No treatment given or needed.
I got my second Pfizer covid shot on 2/17/21. Since then I have ahad 2 large blood clots form in my lower right leg. I had one in the same place 24 years ago.
Pt walked into facility and requested to be seen per having pain, redness and swelling of her left upper arm. Per patient she received the Pneumovax 23 vaccine on Monday, 2/28/22 during a visit with her provider. Patient states that upon returning home that day her arm was very red and painful. Patient c/o pain and stiffness in her neck. Observed large red area on skin of upper left arm approximately 5.5 x 5 inches of which patient identified was around and below the injection site of the vaccine. Area was hot to touch with some puffiness, and painful to touch. Per patient the redness was improved from Monday evening and yesterday. Patient denied and history of alllergies/difficulties after receiving any other vaccines.
I had some dull pain immediately following the vaccination that lasted three days.  One the fourth day, I woke up with serious arm pain.  By day five, I could barely move my arm.   Raising my left arm above my waist would cause excruciating pain and I had to walk around with my arm at my side for over a week.  Putting on or taking off a shirt was nearly impossible.  I am not the type of person to complain about a little pain.  I have undergone foot surgery with no anesthesia and don't need any local anesthetic when I get a cavity filled at the dentist, but this was really bad.  I had some pain relievers left over from nose surgery years before and I had to take those just to get to sleep.  It is now almost a month later, and my arm still hurts around the crease of my shoulder during physical activity.  If I had a job that involved the muscle in my left shoulder, I would not have been able to do my work.
Two weeks after my second dose of Pfizer vaccine I developed PVCs which I had only rarely had before.  NO SOB or CP.
Extreme full arm pain and pinched nerve, alternating going numb and tingling, extending along the left side, neck, arm, wrist, and hand.  Pain started one hour after the shot and has been consistent for one month now.  Also nausea, vertigo, weakness, headaches, insomnia.
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 12-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Starting 6/3/08, employee started progressive multi-joint pain and swelling.  Also complained of "burning" along left side of throat.  Symptoms slowly resolving.  Advil taken on 6/7 and 6/8.  Employee reported symptoms on 6/9/08.
Zero arm pain until around 8PM. Then came on and intensified for next two hours. Became very tired. Went to bed at 10PM. Woke up at 12;30AM with a 101 degree fever and intense pain in lower back/upper buttocks. Fever/pain persisted and worsened throughout the night. Aches spread to other areas of my body but still centralized to back/buttocks. Headache introduced in the AM. Fever bounced all day between 102 and 104.2 degrees all day until about 8:30PM on Sunday. Tried ibuprofen to manage pain and temperature but had minimal effect. General tingly and buzzy feel after 8:30PM and into Monday. Headeache reappeared on Monday evening with cold sweats. Strange calf ache in right leg Monday night into Tuesday AM that consistently woke me up. Tried massage, stretching, to no avail. Tuesday AM most everything dissipated with just a bit of fogginess throughout Tuesday (though less than Monday).
Approx 1 week after administration cause of death reported to be cardio/pulmonary failure.