chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The injection site was swollen, hard to touch and warm. Pt also complained it hurted when she raised her arm. Recommended: Hydrocortisone 1% cream, Benadryl tab & IBU for pain.
Sever stabbing pains in both legs , feet and back/moderate pain in hands; Sever stabbing pains in both legs , feet and back; Numbness in fingers with the inability to form a tight closed fist; Massive headache; Severe brain fog; Think the words but cannot /will not come out of my mouth properly; Forgetting things , misplace things; Burning eyes; Hot flashes; Severe weakness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Aug2021 (Lot number: Fc3187) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: Other medical history: migraine; "Covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Sever stabbing pains in both legs , feet and back/moderate pain in hands"; BACK PAIN (non-serious), outcome "not recovered", described as "Sever stabbing pains in both legs , feet and back"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "Numbness in fingers with the inability to form a tight closed fist"; HEADACHE (non-serious), outcome "not recovered", described as "Massive headache"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Severe brain fog"; SPEECH DISORDER (non-serious), outcome "not recovered", described as "Think the words but cannot /will not come out of my mouth properly"; MEMORY IMPAIRMENT (non-serious), outcome "not recovered", described as "Forgetting things , misplace things"; EYE IRRITATION (non-serious), outcome "not recovered", described as "Burning eyes"; HOT FLUSH (non-serious), outcome "not recovered", described as "Hot flashes"; ASTHENIA (non-serious), outcome "not recovered", described as "Severe weakness". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of pain in extremity, back pain, hypoaesthesia, headache, feeling abnormal, speech disorder, memory impairment, eye irritation, hot flush, asthenia.  Additional information: Patient didn't received any other vaccine within 4 weeks prior to the COVID vaccine. Patient received other medication within 2 weeks of vaccination. Prior to vaccination patient was diagnosed with COVID-19. Since the vaccination patient has not been tested for COVID-19. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
pt recv vax 18DEC97 & 10FEB98 pt lab test revealed a serotype 19 value of 3 to 12.6 & serotype 51 value of 7.9 to 12.6;serotypes 1,3, 14 & 23 remained the same;
p/vax pt c/o being fired, arm sore & photosensitivity;next day c/o felt tired all day @ school @ awoke that day w/h/a;c/o being tired, h/a. vomiting;
Case number PHEH2014US024947, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 85-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 28 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Initial unsolicited report received from a other health professional via other company (Pfizer, reference number 2016078040) on 18-FEB-2016. This case involves a female (age unknown) patient who was vaccinated with a dose of MENACTRA (batch number, expiry date, route and site of administration were not reported) and also received a dose of TRUMENBA (manufacturer Pfizer, batch number, expiry date, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient developed lot of redness in flowing and discomfort in her arm and swelling. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. Causality was reported as related. List of documents held by sender: none.
Temple on left side of face has gone numb as well as partial numbness in left foot. Both issues started this morning
The day after the third dose of the vaccine I got body aches a sore arm and a low grade fever six hours after the vaccine. I woke up the next morning and I could barely stand up straight because my lower back was very painful. All of my joints and muscles ached. As time progressed after 36 hours my other joints and muscles felt better but the left sided lower back pain persisted. I have never had this problem before. After the first two doses of the vaccine I had the joint and muscle pain but the lingering back pain was new. I am currently in Physical Therapy and it has not improved much. I used a Medrol dose pack about ten weeks out and it seem to be improving slightly.
She reported that she did well initially with vaccination and that 3 days later she noticed localized redness and itching at vaccination site. This cleared in a day or 2. On day 6 noticed itching of her palms, with redness and a few bumps. Initially thought it was her Lupus Flare. The following day had lesions on her hands, soles, arms, back, chest and upper legs. Lesions would come and go and not always in the same place. Did have lower lip swelling on the first day of rash. Denies any respiratory or GI symptoms. Since she initially thought this was her Lupus flare she took steroids, with slight relief. Lesions returned as she was tapering her dose. Did try Benadryl but was not taking consistently. Reports that lesions are itchy.  Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).
Rash around injection site, followed by 4 days of fever, followed by a nervous tic (child began blinking his eyes), followed by him now jerking his arm and twitching.
Information has been received from a consumer concerning her approximately 18 year old daughter with penicillin allergy and no other pertinent medical history who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, dose and route not reported). There was no concomitant medication. The mother reported that while on GARDASIL in 2010, her daughter experienced uncontrolled twitches and jerking of the body, excessive headaches, passing out and seizure like activity. The patient was admitted to the emergency room of an unspecified hospital on an unspecified date for an unspecified length of time (also reported as did not seek medical attention). At the time of the report the patient's uncontrolled twitches and jerking of the body, excessive headaches, passing out and seizure like activity persisted. Upon internal review seizure like activity was considered to be an other important medical event. Additional information has been requested.
"41 y/o F pmhx Asthma presents with concern for reaction to Moderna COVID-19 Vaccine x 1 day. Received first dose of vaccine x 8 days ago (2/4). Last night states she started to notice redness and swelling near her injections site of Right arm. Associated intermittent tingling sensation down her arm and generalized fatigue. States she also received her flu vaccine x 4 days ago in the opposite arm and her Dupixent injection (for asthma) on 2/5 (abdominal injection site). She has no hx of previous vaccine reactions or allergies.
I initially felt dizzy about 20 mins after my first dose. My arm is sore which is to be expected, however last night before bed I felt shortness of breath and my heart felt like it was fluttering. I tried to sleep last night after a day of work and light exercise and had trouble sleeping throughout the night.  My respirations throughout the night are usually between 14-15 breaths per minute. Last night my respirations were between 17-18 breaths per min.  My heart rate is normally around 50 bpm, last night it was 63 bpm. My HRV was also negatively affected from a normal of 65 to 53. The device I use to track this is called the WHOOP. It's an athletic training device used by sport professionals and enthusiasts to track day strain and recoveries for an optimal training regime. The data is saved on the WHOOP app and is available if necessary.
Patient came to office for 3 month exam. Received all of her 3 month. Per provider mom requested flu vaccine as well. Flu vaccine administered into left thigh and tolerated it well. Pt remained in the office for 10 or so minutes following vaccination and showed no s/s of reaction. Mom notified that vaccine was given at 3 months instead of 6.
Exactly 1 week after the first dose, I experienced continuous pain in my buttocks and hips which made walking or standing difficult.  However, after 4 days, the pain disappeared.   Exactly 1 week after the second dose, the pain recurred and continued to increase until I could no longer stand it; I went to the ER on 9 August 2021.  The doctor diagnosed me with acute arthralgia in the lower back and pelvis from "uncertain" cause.  I was given  medications for inflammation and pain, and directed to get additional tests (MRIs).   I continued the prescribed medicines, and had two MRIs during the next six weeks.  The MRIs revealed that I had spinal stenosis of the L4 & L5 vertebrae, but that had been without ANY  symptoms before the vaccine.
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medications, pertinent medical histories and drug reactions or allergies were not provided. On unknown dates, the patients were administered multiple doses of improperly stored GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). Administered doses of vaccines underwent an unknown temperature excursion, which lasted for an unknown time frame. There was no previous temperature excursion. A digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007015: US-009507513-1709USA007016: US-009507513-1709USA007017: US-009507513-1709USA007019: US-009507513-1709USA002966:
Patient received her first MODERNA COVID vaccine shot on 08/12/21 and was due for her second shot after 28 days on 09/09/21. But mistakenly worker administered her the second shot on 09/02/21. She called complaining about being sick and with a rash. The other symptoms seem to have subsided but her rash remains. Though she said she is feeling better than before. I asked her to call her doctor and check with the pharmacy again in a day or two.
Baseball size area of red, hot, swollen responsive within hours of administration. Increased area of inflammation affecting entire upper arm, football size prompting trip to ER. PT DX with cellulitis 2 deg inj . ATB'S RX'd.
1st vaccine 2/12/21; developed diarrhea and abdominal pain 2/19/21; seen in ED for ongoing symptoms 2/20/21 and d/c'd home; seen again in ED for same ongoing symptoms 2/25/21 and d/c'd home.
2/24/23 I had an itchy right eye and it gradually got worse over the next few days. It became so bad, I made a doctor?s appointment with the eye doctor on March 1,2023 and was prescribed eye drops, unsure of name.  On March 3, 2023, I had a skin flare up on my chin, eczema. I went to the Urgent Care because it was so intense. I was given Clotrimazole ? Bethamasone. The eczema is still in the healing process.  My eye got better pretty quickly. I finished the eye drops after 10 days and have not had another event.
I take sertraline daily and the side effect is rolling nausea. Usually it occurs in the hour or two after taking my daily dose. After the vaccination, the nausea would roll over me in waves at various times all day for the first week.  Nausea is a side effect I was warned about with the vaccine and wanted to report the perceived connection here between the sertraline, worsening nausea and the vaccine dose. Thank you. It didn't require special treatment or anything but I think people should be aware.
Information has been received from a physician concerning a patient who was vaccinated the first dose of ProQuad. Subsequently, the patient experienced breakthrough chicken pox (number of lesions unspecified). Patient outcome was unknown. Additional information has been requested.
Systemic: pain in opposite arm of injection-Severe, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: pain/tingling in opposite side arm
The day after the patient recieved the vaccine she developed hives and itching all over her body.  The patient went to her MD and was given benadryl and has recovered from her hives.
LPN states an expired dose of Infanrix was administered to a patient yesterday; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-month-old female patient who received DTPa (Infanrix) (expiry date 16-SEP-2023) for prophylaxis.   On 26-SEP-2023, the patient received the 4th dose of Infanrix. On 26-SEP-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: LPN states an expired dose of Infanrix was administered to a patient yesterday).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-SEP-2023 The reporter was a licensed practical nurse. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal. The patient received expired dose of Infanrix, which led to expired vaccine used.
Client was mistakenly given BOTH  Kinrix  IM vaccine and IPV vaccine SQ. Error was realized while charting. I phoned my supervisor, RN and reported the error to her. Incident report was filed. Mother was phoned several times that day and a message was left for her to contact us. VAERS report filed.
SYMPTOMS 09/05/08 A.M. NAUSEA, VOMITING, ACHINESS AND PETIT MAL SEIZURES, SOME BETTER IN EVENING.  09/06/08 AGAIN BECAME ILL AND HAD GRAND MAL SEIZURE. TO E.R. ABOUT 12 NOON. RELEASED BACK HOME. HAD TO RETURN TO THE E.R. ON 09/07/08 BECAUSE STILL ILL.  WAS GIVEN I.V. FUIDS, PHENERGAN, AND TORADOL. T-99 P-86 B/P 138/74. ADVISE REST, EAT, AND DRINK. LEFT ARM ALSO HAD SWELLING, REDNESS, SL PAIN TO AREA.
Aches, pains, fever, muscle aches, headache, some shivering, freezing, knot on arm.
Information has been received from a physician concerning a 15 year old female who on 30-Nov-2007 was vaccinated IM in the right arm with the first dose (lot# 658490/0802U) and on 30-Jan- 2008, vaccinated IM in the left arm with the second dose of GARDASIL (lot# 658490/0802U). Concomitant therapy included MENACTRA (lot# 42375BA) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (lot# AC52B019AA). After the first dose the patient did not get her period for four months. She was on no medication at that time. Negative labs and negative pregnancy test. On 14-Apr-2008 she had her period. The patient recovered. Additional information has been requested.
Blurry vision for 15 minutes. Unsteady on my feet for the rest of the evening. Crying involuntarily for 15 minutes at 11pm.    On 7/10/21 itching in vulva area. Fatigue.
Chills, weakness, feeling faint, progressed to more chills, fever, sweats, headache, back pain, hip joint pain throughout the night. Fever & chills broke the neck morning but headache continued next day; overall fatigue/weakness for 5 days; onset of minor cough on 5th day for a week.
Information has been received from a healthcare worker concerning unspecified patients of unknown demographics. Pertinent medical history and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored COMVAX (dose, route, lot number and expiration date unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Swollen joints; Depression; Headache; General body pain; Joint pain; This is a spontaneous report based on the Information received by Pfizer from Pharmacovigilance (MFR. Control No: 20K-163-3461869-00) from a contactable physician.  Spontaneous report from a physician of a 64-year-old female with events of non-serious Swollen joints, Depression, Headache, General body pain and Joint pain with Humira (ADALIMUMAB) via subcutaneous at 40 mg for Rheumatoid arthritis from 06Jul2019. There was no reported medical history. The patient did not receive any concomitant medication. On unknown dates, the patient experienced Swollen joints, Depression, Headache, General body pain and Joint pain. On unknown dates, Swollen joints, Depression, General body pain and Joint pain resolved. The outcome of the event headache was unknown. Prevnar (PNEUMOCOCCAL VACCINE CONJ 7V (CRM197)) and Shingrix (VARICELLA ZOSTER VACCINE RGE (CHO)) were also considered suspect. The patient was treated with Prednisone. Causality for Humira (ADALIMUMAB) The reporter's causality for the event(s) of swollen joints, Depression, Headache, General body pain and Joint pain was not provided. The action taken in response to the events for adalimumab was unknown.   No follow-up attempts are possible. No further information is expected.
Patient presented to the ED with blood in his sputum, nasal congestion lasting for a week, he had low grade fever. He initial came in for a suspected Urinary tract infection. Patient tested positive for COVID status post monoclonal antibody therapy.  Urine culture shows Pseudomonas and E coli growth and tracheostomy culture shows Pseudomonas Staph aureus growth.  He was on vancomycin and cefepime.
pain; swelling; This case was reported by a other health professional via sales rep and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on an unknown date and experienced swelling and pain, refer case US2019AMR219517).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and swelling. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain and swelling were recovered/resolved.   It was unknown if the reporter considered the pain and swelling to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and had local reactions of pain and swelling. The reporter consented to follow up.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  It was mentioned that the vial was initially refrigerated on 03-Nov-2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events.   No treatment medication was provided by the reporter.
Left arm swollen and itchy at injection site, very fatigued, horrible headache, sick to stomach
immediate sinus with no previous problems, redness on arm where shot was given, bump on arm where shot was given, overly tired, achey body, cold like symptoms, severe dizziness began evening of 3/28/2012 until morning of 3/29/2012, and pain in arm where shot was given until 3/26/2012.
no adverse event; Vaccine was administer 12 hours after it had been opened for 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administer 12 hours after it had been opened for 12 hours) and NO ADVERSE EVENT (no adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 09-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administer 12 hours after it had been opened for 12 hours). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administer 12 hours after it had been opened for 12 hours) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administer 12 hours after it had been opened for 12 hours).    No concomitant product reported by the reporter. No treatment medication reported by the reporter.
Client called 05/18/05 to report that she has redness, swelling, pain, and a bruise @ LD right after receiving Hep A #1 1.0ml IM. Also reports fever for that day- unknown what the reading was.
I had a headache, worst I've had for about 3 weeks; fatigue, sore throat, runny nose; congestion in my head and chest. With activity I would get really winded and find it hard to catch my breath, even with minor activity like walking around. Bloody sinus and I'm still coughing up stuff and have the runny nose. I didn't have a fever. I tested negative but still have symptoms.
nausea; vomiting 3 times; chills/rigors; sore arm; This is a spontaneous report from a contactable physician (patient).  A 30-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL0142, via an unspecified route of administration on left arm from 08Jan2021 09:30 to 08Jan2021 09:30 as single dose for COVID-19 immunisation.  Historical vaccine includes first dose of BNT162B2, lot number: EJ1685, on 18Dec2020 at 09:00 AM on left arm. There were no medical history and no concomitant medications. On 08Jan2021 21:30 (12 hours after vaccine), the patient experienced sore arm; on 09Jan2021 at 00:30 (15 hours after vaccine), the patient experienced chills/rigors; on 09Jan2021 at 01:30 (16 hours after vaccine), the patient experienced nausea and vomiting 3 times. The outcome of the events was recovering. No treatment was given to the patient.  No follow up attempts are possible. No further information is expected.
p/vax pt red macule @ inj site followed by blotchy rash both thighs w/facial swelling; hives for 4days on face, back; burned sensation & painful; tx w/ice packs; cool baths;