chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; naseau; tiredness; bones aching; This is a spontaneous report from a contactable consumer or other non hcp. A 45-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jan2021 07:45 as 1ST DOSE, SINGLE (at the age of 45-year-old) for covid-19 immunisation. Medical history included High blood pressure from an unknown date and unknown if ongoing. Concomitant medications included losartan potassium (LOSARTIN) once daily, colecalciferol (VITAMIN D [COLECALCIFEROL]) and Men's one a day multivitamin. The patient previously took codeine, neomycin and experienced drug hypersensitivity. The patient experienced headache, naseau, tiredness, bones aching 5 days after vaccine. The outcome of the events was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE UNSTABLE ANGINA ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY ACUTE RESPIRATORY FAILURE
3 hours after administration complained of head stuffiness, dry cough, and nasal congestion and drainage.
(L) arm swollen 2 days after injection reported by mom also states itchy rash. Seen one week later with no swelling around injection site and itchy papular rash on inner aspect of upper arm extending down to forearm. MD unsure if related to vaccine.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: Within 5 min of admin, patient spiked a fever, w/ HR > 90, coughing, trouble breathing, stomach pains (had prev hx of hernia surgery/condition). Had patient lie down, elevated feet, take 3 deep breaths. Brought epipen next to me in case, however, within 2-3 minutes, patients HR was lowering to baseline and fever was going down with a cold compress. Offered water and she was able to drink/swallow water. Told patient to stay as long as she needed - she later was sitting up and drinking water.
Received Moderna Vaccine Dose #2: 2/10/21 at 12:45pm. 2/11-2/14: Chills, fatigue, fever (38.4C), headache, muscle ache, nausea, vomiting Took Tylenol for fever; fever resolved on 2/14/21.  2/15/21: all symptoms resolved.  No additional medical attention needed.
School nurse contacted HD to let HD know that the patient is pregnant, and received confirmation of pregnancy 09/14/2012.
01/25/22 presents to ED for "Abnormal Labs sent by pcp". PMHx of "recurrent metastatic colorectal adenocarcinoma with liver metastases with colostomy and right-sided urostomy"
pt recv vax 27MAY97 & 27MAY97 pt exp t102R, runny nose, congestion;
could not catch her breath if she moved; face swelled, too, it was hard to go down everyday; there is too much fluid in her body; she believes it's swelling; stomach hurt; abdomen hurt; bloating/swell of stomach; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179, Expiration date: 31Aug2021), via an unspecified route of administration on 10May2021 between 07:00-10:00 (at the age of 57-year-old), as 2nd dose, single dose in left arm for COVID-19 immunisation. The patient's medical history included heart dis-functioning, body was slowed and a little overweight. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8731, Expiration date: 31Jul2021), via an unspecified route of administration on 19Apr2021 between 07:00-10:00 (at the age of 57-year-old), as single dose in left upper arm for COVID-19 immunization and experienced stomach hurt and abdomen hurt. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021 morning, after the second shot, the patient experienced stomach hurt, abdomen hurt and bloating/swell of stomach. Patient reported that her stomach was bloated and felt she could not catch her breath if she moved, for which the patient went to the emergency room on 30May2021 and got released on 31May2021. Doctor told her that there was too much fluid in her body. After second shot, patient's face swelled, too, it was hard to go down every day. Her stomach got extended like a balloon. Patient believed it was swelling. When patient was due for her second dose, she really didn't want to get it, because she felt hurt so bad and the doctor advised her to get the shot to be on the safe side. The patient underwent lab tests and procedures which included chest X-ray: normal on 30May2021. The clinical outcome of the events stomach hurt, abdomen hurt, bloating/swell of stomach was not resolved and clinical outcome of all other events was unknown.
HOSPITALIZATION; This spontaneous report received from a consumer via a company representative concerned a male 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 was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, after taking the vaccine, patient was hospitalized. It was reported that, the patient spent 98 days in the hospital after taking the shot and had to learn to walk again. The date of hospitalization and discharge information were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hospitalization was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20230452533-hospitalization. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
PT recieved Hep A immunization on 22 Jan 2010 and received another on 23 Jan 2010.
SINTOMES 3 DAYS , CHILLS,HEADACHE ON RIGHT SITE,PAIN ON RIGHT EAR THIS WAS ON 01/26. ON 01/27/2021 . SHE HAD A DEVATION OF THE MOUTH TURN TO HER LEFT SIDE SHE HAD FACIAL PARALISIS  CONTINUE WITH SINTOMES HAS APPOINMENT WITH PHYSIATRIST 01/28/2021.
Information has been received from a nurse practitioner concerning her 13 year old niece with seasonal allergy and no medical history who on approximately 17-OCT-2011 ("three weeks ago") was vaccinated intramuscularly with her 2nd dose of 0.5ml GARDASIL (Lot number not reported). There was no concomitant medication. Since the administration of the dose, the patient had a persistent fever of 104F. The patient was seen in physician's office to seek medical attention. Her physician prescribed her a Z pack and AUGMENTIN which had not helped her. Also a CT of her sinuses showed that her mucous membranes were severely swollen. Patient was "on her way to the hospital" at the time of the call. The patient was not recovered at the time of the report. The patient's fever of 104F and mucous membranes severely swollen were considered to be life threatening. Follow up information has been received from a nurse. She did say, however, that the 2nd GARDASIL was given concomitantly with a flu shot (no details known), and that her niece had gone to two different emergency rooms. She said she would call her niece's pediatrician to get the lot #. Later the nurse called back to provide her niece's name and birth date. She provided the pediatrician's name, address and telephone number. On 09-NOV-2011, a call was then place to the pediatrician. Her medical assistant pulled the chart and provided the following: The 1st dose of GARDASIL given on 03-AUG-2011, lot # 0626AA. The 2nd dose of GARDASIL administered on 14-OCT-2011, (lot number on validation exp date 28-JUN-2012); concomitantly the patient received FLUARIX (lot number AFLUA634AA). On 19-OCT-2011, the patient presented at the office with a fever, sore throat, cough, and eczema; a rapid strep test was negative, Z pack was prescribed. On 25-OCT-2011, the patient was seen in the office again with persistent fever; sent for a chest x-ray which was normal; prescribed albuterol. On 02-NOV-2011, the patient went to emergency room for unknown origin. On 04-NOV-2011, the CT of the sinuses was performed. Additional information has been requested.
Information has been received from a mother concerning her 12 month old son with no past medical history or allergies who on 1/5/01 was vaccinated with 1 dose of varicella virus vaccine live in the left leg and 1 dose of Hep-B in the right leg. He also had poliovirus and DPT in the left leg. Approx. 1 week, post vax, the pt developed vomiting, severe diarrhea, fever of 104F, dehydration and itching and swelling at the injection site, "left leg was swollen with a black dot in it, like a bruise." The child would often "stiffen up and scream with a high-pitch sound". On 1/15/01, the pt was hospitalized. The pt was tested negative for Rotavirus and was released on 1/16/01. The pt was hospitalized again on 1/17/01 with the same symptoms. The pt was released from the hospital on 1/21/01 and the mother reported that the child still had diarrhea for several days later. The reporter stated that the child was dx'd with a "virus". It was noted that the pt's symptoms have now resolved. Additional information has been requested.
Fever 102 degrees Fahrenheit; nausea; heartburn; red at injection shot; swollen; itchy; Chills; This is a spontaneous report from a non-contactable consumer. A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 (at the age of 41 year) as dose number unknown, single for COVID-19 immunisation. The patient medical history was not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. On 12Mar2021, patient experienced fever 102 degrees Fahrenheit, chills, nausea, heartburn, red at injection shot, swollen, and itchy. It was reported that no therapeutic measures were taken for the events experienced. The patient underwent lab tests and procedures on 12Mar2021 which included body temperature: 102 Fahrenheit. The outcome of events was recovering.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Initial report received from a vaccine provider on 07 January 2013. This case is not medically confirmed as the reporter was not identified as a healthcare professional or not. The report involves a cluster of 6 children from the same reporter and same lot number UH753AB. This case captures one of the children and the other children are captured in cases 2012-11111, 2013-00526, 2013-00527, 2013-00529 and 2013-00530. A four year-old female patient whose illness at the time of vaccination was reported as "N/A" and past medical history was unknown had received a dose of FLUZONE (lot number UH753AB, IM) on 06 November 2012 and tested positive for Influenza A and influenza B via the Binaxnow quick test on 10 November 2012. The patient's outcome was not recovered. Documents held by sender: none.
A report has been received from a Health Professional concerning a 6 year old, Female subject, who had been receiving FLUMIST QUARDIVALENT (intranasal). FLUMIST QUARDIVALENT started on 14-Jan-2014. The patient received expired FLUMIST QUARDIVALENT on 14-Jan-2014. The outcome of the event of received expired FLUMIST QUARDIVALENT is unknown. The report was considered to be non-serious.
Woke up realizing that I had started my period and was experiencing horrible menstrual cramps (pain scale of 9 out of 10) and nausea. Took ibuprofen but vomited from pain. After applying a heated pad I managed to fall asleep. Continued to take ibuprofen regularly over the next 3 days as my cramps continued. Normally my cramps are between 4-6 on a pain scale out of 10 and only last the first day. I have never vomited from menstrual pain before, so this was very unusual.
I staretd getting everishf chills around 6pm and I went to bed around 9.30pm. Just beore ofr fafroundf midnigfht my right leg started getting seizure.  It came in set of 3. Each one lasted 8 to 10 seconds and happens 3 time in a row. Once I start to fall asleep. It will happen again. When I walk around nothing happens. But once I start fall asleep it will happen again. this occurred throughout the night. The next day I took a small nap and I had reoccurring cramps at the bottom of my foot and it also happens 3 times in a row. this occurred for a short while and stopped. I called the healthcare provider as it was the weekend to confirm that it was north life threatening. I went to walk-in clinic on 7th September and report the event to a doctor. He performed some balance and reflex exercise. I was discharged.
9/8/17-pt called office complaining of tingling in arms and body, feeling achy and not well. 9/10/17-to ER-stroke workup negative-had (L) facial droop->dx=Bell's Palsy. 9/12/17-return to ER for chest pain and slurred speech-cardiac and pulmonary embolus workup negative so sent home. 9/14/17-presented to PCP office-balance off/fell, slurred speech, facial droop so sent back to hospital who admitted-dx eventually was Guillain-Barre syndrome.
01/05/22 presents to ED for "rapid heart rate""poor appetite, weakness and chills, but progressed to SOB and rapid heart rates". PMHx of "HTN, atrial fibrillation"
Child started fever on 7/27/2011 at 5:00a of 102.5 & kept running temps to 104.5 till Sat AM 7/27/2011 with MOTRIN & TYLENOL take. Child very cranky & not sleeping with high temp & chills.
March 11 took Janssen Covid vaccine April 1 took my second Shingrix vaccine April 6, started having what I thought might be an ear infection left ear, started out as like a constant itching way down deep April 7, went to clinic, was given a z pack and steroids April 13, went back to clinic, was given Augentin 10 days and prednisone During this time, pain getting worse and radiating May 19, Feels like my neck is boiling? On fire, pain radiating and it almost felt like chest pain Went to hospital, CT scan, they say normal. Told me to take sudafed around the clock and gave me singular?  During this time, I would feel pretty good in the mornings but it was anyones guess how long I would last through the day. Once Istarted having the swelling in my neck, I would be done for the day and nothing except sleeping on a heating pad would even come close to helping May 25-Nurse practioner gave me 5 more days of augmentin and tylenol with codine June 1st- The same neck boiling up happens, this time it felt like my throat was closing up. I called emergency services as I was alone and husband did not answer phone. Went to ER. They coded it as neck pain. Told me nothing was wrong. They did do 113 lab tests and did not discuss with me.  After this, I made appointment with primary care and ENT as advised I call original endondist and they said to call a neurologist as he thinks is is nerve pain.  Made appointment wiht neurologist and that appoitment is on 8/9 June 10-Went to urgent care, they put me on ivermectin told me I was having lingering issues from vaccine June 17-Getting worse, NP put me on Cipro 5 days All during this time, I am in pain at least half of the day. I go to sleep right after work and lay on a heating pad. I have slept no longer than 3 hours at a time since this started June 21 I have the appointment wiht ENT. I take my CT scan. She says she see some thing that do not look right to her and she want to have a radiologist look at it and will call me the next day. I do not hear anything. I send messages to clinig on 6/29. 7/2 and 7/8 After the 7/8 message I was called to go do an MRI. 7-16 MRI done 7-19 Radiology faxes me copy of MRI results 7-20 clled ENT clinic and no call back  7/21 Requested an appointment in online portal, I am lethargic and know something is not right. Still have the pain in neck, ears. Wherever it is. 7/23 Call clinic and said I need to be seen, see PA. Husband was with me. I did not know what was wrong.  7/24 Feel so much worse, because of all money spent, could not go to ER gain. Went to urgent care and had a UTI. Was given MACROBID 7 days 7/27 tooth that had original root canal is now painful and ear on left side radiating pain 7/28 neck pain in right side is much better, been alternating heat and ice. It is the left side that is still so painful  Dr called to talk to me about MRI and plan, he advised me to call  endodontist. His office says they will prescribe me a medrol dose pack and the first available appointment is 8/18 The PA tells me "We think you were injured by the vaccine, we do not know what to do about it. She told me to report it and to call the NP who had given me ivermectin to get that again.
bivalent dose, was documented by HCP to expire on 3-17-23; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent dose, was documented by HCP to expire on 3-17-23) and NO ADVERSE EVENT (No adverse event) in a 67-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (bivalent dose, was documented by HCP to expire on 3-17-23) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent dose, was documented by HCP to expire on 3-17-23) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (bivalent dose, was documented by HCP to expire on 3-17-23).    No concomitant medications were reported. It was reported that 2 vials from the lot number was used to administered vaccines to 3 Patients. No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716687, US-MODERNATX, INC.-MOD-2023-716749 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716687:Master case US-MODERNATX, INC.-MOD-2023-716749:
Extreme fatigue fever- 100.3 highest chills headaches rash on site of  injection
Information didn't upload into patient chart to identify that 2 previous doses  of Pediatric Moderna had been given at another location. Staff inadvertently gave additional dose of Moderna 6mo-5y under the impression it was a second dose to complete series.
Pt stated approx. 12 hours after receiving the Hep A vac, she experienced dizziness.  Also, approx. 2 hours after injection, pt had a lack of appetite. Nov 12, Pt stated she only has a mild headache.  Denied any localized reaction at site.
About 5 to 10 minutes after receiving the vaccine, the patient reported feeling unwell, saying she felt like she was about to faint. She reported no chest tightness, shortness of breath, or trouble breathing upon being asked.   She drank some water. I (the pharmacist who administered the vaccine) then asked her to lay flat on the floor, which she did. The pharmacy technician called 911, but the patient said she was going to be ok and refused an ambulance. I took her pulse manually, and it was about 59 BPM. After about 5 minutes of lying down, she said she was feeling well enough to get up and sat back up on a chair. She did not lose consciousness at any time. She drank some Gatorade. I took her blood pressure and pulse twice about three minutes apart with an automatic monitor and the readings were 127/78 mmHG, pulse 68BPM and 108/67, pulse 67 BPM, respectively. She remained sitting and drinking Gatorade for about 20 more minutes and then left.
On 10/20/09, patient reported that she had noted petechiae on her abdomen & upper chest while showering (before coming to work). She contacted facility & was advised to seek medical care from her physician. Saw patient on 10/21 & again told to pursue care through her physician. She works as RN on pediatric unit, received H1N1 vaccine as part of campaign for health care workers.  Pt was admitted to ICU at health center on 10/22/09 with a platelet count of ZERO. She had two hemorrhages in her right eye per her local optometrist when she was having persistent visual chanes. She sought care from her optometrist on 10/22/09. She was referred by the opometrist toa local ophthalmologist, but before seeing the ophthalmologist, she sought care from her family physician who ordered a CBC and oagulation studies, and admitted her immediately to the ICU. Hematologist was immediately consulted. MD was told Pt and her family that she most likely had adult idiopathic thrombocytopenia purpura. MD explained this is that most likely caused by a virus and that it may never be known if it was the nasal spray H1N1 that caused it or it it was caaused  by something else. She had a low grade fever and body aches and 'felt rough' on 10/23/2009, but other than those symptoms, had felt ill. She was started on large doses of steroids and received IV gamma globulin on 10/22/09.  Her platelet count on 10/23/09 is 8,00 according to her mother ( who also happens to be a nurse). She is to receive more gamma globulin today and mostly likely will be released from the hospital when her platelet count reaches 20,000-25,000. Pt wanted her mother to "Call reporter and let her know what's going on. If it can help the CDC to know this, I don't want anyone else going through the trauma of what we've been through. Reporter has my permission to review my chart, send infomatioin to the CDC or whatever would be helpful. I could hear Pt speaking in the background and Pt's mother called me from her room in the ICU. I told them that I'd alreay filed the VAERS report, ut would send an update to VAERS today. I have not reviewed her meical records of laboratory reports at this time and explained that I would seek a written release in order to do so. The local health department has verbally been informed  of this case also.
This spontaneous report as received from a nurse refers to an unknown patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ (lot# M007125 and expiry date 06-OCT-2017) (lot# M016919 and expiry date 17-FEB-2018) (lot#L046320 and expiry date 29-SEP-2017) (lot# M004726 and expiry date 19-OCT-2017) and (lot# M029252 and expiry date 14-MAR-2018) orally (also reported as depends on the vaccine). The vaccine was exposed to temperature excursion of 1.4C for 21 minutes. No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was filed. Additional information has been requested.