chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a other health professional refers to multiple unknown patients of unknown age. On an unknown date the patients were vaccinated with VARIVAX for prophylaxis. On an unknown date the patients experienced incorrect product storage and no adverse event.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: pt takes cetrizin 10mg
Patient is a 41 year old female with 2 prior episodes of neutropenia on clozapine with clozapine being subsequently discontinued on 8/12/03. At the time of discharge the patient was also on Valproic acid 1500mg BID and Abilify 30mg QD. On 9/5/03, Risperdal 2mg was initiated and increased to 6mg. No other medication changes were made until 10/28/03 when the influenza vaccine was administered. On 11/4/03 the ANC = 0.7, 11/5/03 ANC = 0.8 and aripprazole was discontinued and VPA decreased to 1000mg BID. On 11/6/03, ANC = 0.6 abd Resperdal was discontinued and Valproic acid was decreased to 500mg BID. 11/8/03 ANC = 1.2. VPA decreased. 11/10/03 ANC = 1.8 and patient on no meds at this time. Pt developed agranulo cytocis approximately 1 week after being given the flu vaccine. ANC went back up to 1.8 on 11/10/03.
Swelling of L Deltoid/upper arm, warm to touch, tender, and itchy 2 hours post vaccination. Patient came in 2 days later with reduced swelling, treated itching with Zyrtec. Patient assessed by PCM and Immunizations clinic Nurse.
Patient had her shot around 230pm 2/3/22 then about 9pm started with aches then progressed to vomiting, diarrhea, chills, extreme headache, and fever. By morning nothing had subsided her temp was up to 102 and her headache was even worse. Her family called an ambulance. She was treated and released in the ED on 2/4 and started improving over the weekend. The fever, vomiting, and diarrhea subsided Saturday. Her head was still aching into Sunday but improved by Sunday evening.
Tingling/numbness in both arms and hands; Tingling/numbness in both arms and hands; stiff joints in hands and feel like circulation is restricted; This is a spontaneous report from a non-contactable Other HCP (patient).  This 41-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on the left arm, on 22Jan2021 (at 12:00 PM) at single dose for COVID-19 immunisation, administered at Clinic. No other vaccine was received in four weeks. Relevant medical history included hypothyroidism. Relevant concomitant medications included levothyroxine sodium (SYNTHROID), ibuprofen, colecalciferol (VITAMIN D), curcuma longa root (TURMERIC CURCUMIN) and sertraline hydrochloride (ZOLOFT). On 25Jan2021, the patient developed tingling/ numbness in both arms and hands; stiff joints in hands and feel like circulation is restricted. The patient was not treated for the events. The patient had not recovered from the events.  No follow up attempts are possible. No further information is expected. Information about Lot/Batch number cannot be obtained.
Severe insomnia over the past 8 weeks, unrelenting. Start exactly at 24 to 48 hours after vaccine. Had no previous illnesses before that. No history of Covid infection. Has done all sorts of CBT modifications with no improvement. Was previously a super high functioning Interventional Cardiologist with no prior history of anxiety, depression or sleep problems. This was very acute and worsened after second dose. Labs are all normal.  Now unable to work as this insomnia is quite debilitating.
Started with sinus drainage continued for a day or so, fatigue and mild achiness and sensitive skin. Then I started to feel tired. It felt like a cold and mild flu. I coughed because of the drainage, I had some chest congestion, but it was not bad. For the most part it stayed upper respiratory, more so. After 4 or 5 days, I felt fine and then it bounced back the drainage, not the achiness and tiredness. After testing negative, the drainage lingered afterwards, a few days slowly decreasing after 15 days. I tested negative with multiple tests. My son and wife got it a little behind me. None of us were terribly sick. The drainage took a long time to go away. Middle of my back bunch up, knotted up, to stand up straight work with physical therapist. I felt like roaming, stiff neck, stiff shoulders, pain and unstable hips, getting knotted up. It lasted for 4 or 5 days.
Employee received vaccine 10/20. Removed band aid 10/22 to find 1-1.5cm crust over injection site.
First shot just a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 10:30 (Lot number: EW0151) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing); "beef allergy" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LOESTRIN; BENADRYL. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "First shot just a sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient receive any other medications within 2 weeks of vaccination includes Lo-loestrin and benadryl. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Fadigue, body aches, hypertension to 220/120 level, headaches
PER MEDICAL RECORDS RECEVED FROM THE HOSPITAL- PATIENT PRESENTED TO THE HOSPITAL WITH CHEST PAIN AFTER RECEIVING HIS SECOND COVID VACCINE THREE DAYS PRIOR. COMPLAINED OF NECK PAIN AND HEADACHE IN THE DAYS AFTER HIS SHOT. ON 7/7 THE PATIENT DEVELOPED CHEST PRESSURE IN THE RETROSTERNAL AREA.  MEDICATIONS GIVEN INPATIENT: ASPIRIN, 81 MG = 1 TABS, ORAL, DAILY. LOPRESSOR, 12.5 MG = 0.5 TABS, ORAL, Q12H. SODIUM CHLORIDE 0.9% BOLUS, 1000ML, IV BOLUS, ONCE. SODIUM CHLORIDE 0.9% FLUSH, 5 ML, IV FLUSH, Q8H.   PER MEDICAL RECORD, PATINET WAS DISCHARGED 07/10/21 AND WAS TO FOLLOW UP OUTPATIENT WITH 2 DIFFERENT DOCTORS
Fever, nausea, vomiting, hallucinations and headache for nearly 24 hours.
Received second vaccine shot on 3/05/2021 around 1300.  Around 2200 that same night I began to experience chills which intensified  over the next few hours into the early morning, muscle cramping in hands, feet and overall body aches.  Soreness on right arm at injection site. Overall fatigue. Around 0615 the next morning I had a slight fever of 99.1.  Tried to stay hydrated to bring down slight temperature. Spike again at 0725. Took one 500 mg Tylenol at 0755. Fever reduced and muscle aches began to ease up.  Took another Tylenol at 1400. Felt better as the day progressed yet still felt really tired.  By the evening of 3/6/2021 I was feeling much better. Body aches had disappeared and no fever spikes had occurred again.  By Sunday 3/7/21 I felt much better and very grateful to have received both dosed of this vaccine despite the one day post vaccine that had me "down for the count."
This spontaneous case was initially received on 15-Oct-2015. The case report was received from Health Professional and concerns a 62 year old female patient. The patient received AFLURIA on 14-Oct-2015 - 14-Oct-2015, Batch no: U58107, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Left arm. No additional drugs suspected. On 14-Oct-2015, 2 to 3 hours after starting treatment with AFLURIA the patient experienced headache, chills. Upon walking on the morning of 15-Oct-2015, after starting treatment with AFLURIA the patient experienced arm is very sore/Pain (from the left side of neck) down through the left arm (injected arm), numbness from left shoulder to the fingertips, pain from the left side of neck (down through the left arm (injected arm), Anxiety in chest, feels relatively cool now and not warm, which is unusual, tingling from left shoulder or the fingertips. The patient is not sure if the anxiety is due to the injection or a reaction to the experience. The patient advises that she is waiting to hear back from her doctor's office for an appointment time. Reporter's assessment: Not reported.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 07-MAY-2015, the patient was vaccinated with a dose of PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 46 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Woke up with 100 degree temperature, feeling bad and headache. Took Tylenol then a few hours later Advil. About 18 hours later felt much better.
Patient returned to the clinic 2 hours after administration to report he was experiencing shortness of breath, chest and throat tightness. Vital signs were stable, no signs of respiratory distress or altered mental status. Patient agreeable to transport to local ED for further monitoring and evaluation. EMS activated.
PT DEVELOPED A MODERATE LOCAL REACTION WITH REDNESS, HARDNESS AND TENDERNESS AT THE VARICELLA INJECTION SITE.  AFEBRILE.
Headache, Myalgia, Fever,  fatigue  Narrative:  Employee reports body aches, felt feverish but temp was  normal, headache, and fatigue. She started feeling better late morning on  1/8. She didn't take any medication.
Bell's palsy; A spontaneous report was received from a physician concerning an unknown years old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event bell's palsy/ facial paralysis.  The patient's medical history was not provided. The concomitant medications on use were also not provided.  On unknown date on Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Batch number: unknown) through unknown route of administration for prophylaxis of COVID-19 infection.  On 22 Mar 2021, patient experienced bell's palsy and was sent to emergency department. It was medically significant event.  No laboratory data was not provided. The patient is being treated with prednisone for bell's palsy.  Action taken with mRNA-1273 in response to the events was not reported.   The event bell's palsy was not recovered.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
This case was reported by a healthcare professional and described the occurrence of hepatitis B antigen positive in a 72-year-old male subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  Concurrent medical conditions included hemodialysis and type 2 diabetes.  On 1 August 2008 and 25 June 2008 the subject received 2nd dose and 1st dose of ENGERIX B (unknown).  On 4 August 2008, 3 days after receiving the 2nd vaccination with ENGERIX B, the subject tested positive for hepatitis B antigen.  At the time of reporting the outcome of the event was unspecified.  Follow-up information was received on 03 September 2008 via a nurse, who reported that the subject received 40 mcg doses of ENGERIX B on 25 June and 01 August 2008.  The healthcare professional considered the hepatitis B antigen positive result to be related to vaccination with ENGERIX B.  On 18 August 2008, the subject tested negative for hepatitis B antigen and the reporting healthcare professional indicated that the event was resolved.  The healthcare professional indicated that the hepatitis B vaccination series was neither discontinued nor delayed, but the subject had not received the 3rd and 4th doses of the series at the time of this report.
Headache, Fever, Diarrhea, Increased Heart Rate (98 usually 67 ), increased nasal congestion, productive cough, increased fatigue, headache, diarrhea Narrative:  Increased Heart Rate (98 usually 67 ), increased nasal congestion, productive cough, increased fatigue, headache, diarrhea
Faint; Skin turned grey; Blood pressure was below 40; Vomited; Light headed; This spontaneous report has been received from a registered nurse, concerning an 11-year-old male patient.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml, administered intramuscularly (IM) as prophylaxis against anal, oropharyngeal and other head and neck cancers caused by Human Papilloma Virus (HPV) (lot number, expiration date, and anatomical location were not provided).  On the same day, the observation for 15 minutes after administration was not complete because the patient started running and moving around. He felt light-headed (Dizziness), faint (Syncope), and his skin turned grey (Skin discolouration). The patient's blood pressure was below 40 (units not provided) (Blood pressure abnormal) and he also vomited (Vomiting). For these events it was sought medical attention.  At the reporting time, the patient had recovered from the events.  The causal relationship between all the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event faint was determined to be medically significant.
DEMYELINATING NEUROPATHY; This spontaneous report was received from literature. This report concerned a male of unspecified age, race and ethnicity. The objective of this study was to report on demyelinating neuropathies following COVID-19 Vaccination.  The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not had other co-morbidities or histories suggesting an alternate diagnosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose not reported, 1 total, administered on an unspecified date 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.  It was reported that four cases of acute and chronic demyelinating neuropathies following COVID-19 vaccination were seen. All were males, ages 2683 years old. Two received the Pfizer-BioNTech vaccine, one received Moderna and one received Johnson and Johnson. Post vaccination ranged from 221 days after the final dose of vaccination, the time from symptom onset to neurological evaluation ranged from 3 weeks to 4 months, during which symptoms progressed. Patient presented with progressive numbness, weakness, areflexia in all limbs and had difficulty walking. Severe facial diplegia was seen and other bulbar symptoms one other case. Three patient had electrophysiologic studies confirming demyelination while one case had subacute polyradiculopathies. Cerebrospinal fluid protein was elevated and also normal. The diagnosis was acute inflammatory demyelinating polyneuropathy (AIDP) in one case, chronic demyelinating polyradiculoneuropathy (CIDP) in two, and subacute polyradiculopathies in one. The cases with AIDP and CIDP received treatment with intravenous immunoglobulin due to significant motor disability, while the case with subacute polyradiculopathies had spontaneous recovery within 8 weeks. Of the treated cases, two had significant improvement by outpatient follow-up at 24 weeks post-treatment and one has yet to follow up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of demyelinating neuropathy was not reported. The authors emphasized that continued identification and reporting of demyelinating neuropathies following COVID-19 vaccination was essential to determining whether a causal association was present. Prompt evaluation for alternative etiologies was vital, and early treatment was recommended. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221216773-demyelinating neuropathy. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Initial report was received from a consumer through another manufacturer on 13 November 2012 under service request number 1-5724965661. A female patient (age not reported) received an injection of Diphtheria, Tetanus and Pertussis Vaccine (lot number, route, site, and date of vaccination not reported) and an unspecified amount of time later experienced a seizure. The patient said she was allergic to the pertussis portion of the vaccine. The patient's outcome was not reported. Documents held by sender: None.
Narrative: Patient received first dose of Moderna COVID vaccine on 3/25/21. On 4/14/21, patient reported to PCP that he was treated by outside facility 2 weeks after dose and diagnosed with Bell's Palsy. He was given a course of prednisone at outside facility. Bell's palsy was still present at time of reporting and patient was referred to ophthalmology due to complaint of dry eyes.
Fine for 4.5 hours after shot (was not doing any physical activity, only reading) then sudden anaphylaxis aura (sense of impending doom) and realized heartrate (measured with pulse ox) had gone up to 160bpm with mild cheek, tongue and throat swelling. Took a Pepcid then my Epi-pen around 1500, called 911 for ambulance. EMTs gave me 50mg of Benadryl through IV at 1530. Heartrate persisted above 140. At ER was given another Epi injection and Decadron at 1630. Heartrate very slowly decreased each hour following the second Epi; at 1730 it was consistently reading under 130bpm, at 1830 under 120bpm, at 1930 under 110bpm. Discharged around 2030, heartrate around 100bpm. Heart rate has been consistently under 100 at rest since I've been home and then today (May 1) it's been consistently under 80 at rest.
We had all 4 of the shots and the immunoglobulin for post exposure; This case was reported by a consumer via other manufacturer and described the occurrence of incomplete course of vaccination in a female patient who received Rabies NVS (RabAvert) for prophylaxis.   Previously administered products included Rabavert (received 1st dose on unknown date.), Rabavert (received 2nd  dose on 25th November 2016, batch number 595011A, expiry date May 2019.), Rabavert (received 3rd dose on 29th November 2016, batch number 595011A, expiry date May 2019.) and Rabavert (received 4th dose on 6th December 2016, batch number 626011A, expiry date March 2019.).   On an unknown date, the patient received the 5th dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by the patient for herself. The age at vaccination was not reported. The patient had all 4 of the shots and the immunoglobulin for post exposure prophylaxis for a bat in the house and doctor proposed we get that done.  The reporter did this was November 2016 and had another bat in the house and were instructed by the doctor and hospital to call Agency. The patient informed that the series contains 5 shots not 4. The reporter might not go any further with this and had the rabies shots and called daughter and asked her what she remembered the hospital told her about how long it would last and had the shots and they said 5 years.  The patient saw the bat, caught the bat and got rid of it and are having this problem with bats.  The reporter caller that she needs to speak with her doctor on how to proceed as she did not have a full series with her first series. The patient did not received 5th dose, which led to incomplete course of vaccination. This case linked with US2020AMR163481 and US2020AMR163493, reported by same reporter.   Following internal review it was determined that initial receipt date was 12th August 2020, which is earlier than initially reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR163493: US-GLAXOSMITHKLINE-US2020AMR163481:
Patient called today to report a red itchy painful bump. Patient states that bump and swelling went away after the injection, but came back and is worse today
Urticaria to bilateral upper & lower extremities with an onset about 2 hours after receipt of anthrax #5 (lot # not documented), typhoid #5 ( G1124) & IPV #1 ( as adult, E02041) in JAN 2015. She had no symptoms suggestive of anaphylaxis and was seen by DHA-IHD the day of event 06 JAN 2015.  She was treated with Zyrtec, topical Lidex & prn hydroxyzine and had fully resolved at f/u two days later. POC was anthrax exemption, and prick testing for IPV & typhoid vaccine after deployment.
Constant pain at injection site persists. Arm losing muscular strength and pain when arm is engaged in any physical activity. Losing grip strength in hand.
I started having shortness of breath, my chest got congested, really bad nose congestion, extremely tired with body ache, I had trouble tasting and smelling, and started running a fever. I called the DR and was prescribed the antiviral drug and other medication. I took the antiviral and probably within 48 hours I started feeling much better. And by Thursday of that week I started feeling like I was over that hill and much better.
Site of injection swelled and became red.  It was warm to the touch and burned but didn't hurt.
PT DEVELOPED A RED, HARD, WARM SPOT ON BACK OF ARM WHERE VACCINE WAS ADMINISTERED.  I TOLD PT TO TRY TAKING BENADRYL AND IF IT DOESN'T RESOLVE, GO GET IT CHECKED OUT AT WALK-IN CLINIC.