chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Practically fainted; short of breath; Feels weak; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Practically fainted), DYSPNOEA (short of breath) and ASTHENIA (Feels weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included TRETINOIN (RETIN-A) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRESYNCOPE (Practically fainted), DYSPNOEA (short of breath) and ASTHENIA (Feels weak). At the time of the report, PRESYNCOPE (Practically fainted) outcome was unknown and DYSPNOEA (short of breath) and ASTHENIA (Feels weak) had not resolved.            Concomitant medications also include d unspecified thyroid medication and lots of vitamins.   Treatment to the events not reported.   This case was linked to MOD-2021-034392 (Patient Link).
trouble getting up out of chair, aches and pains my joints, hurts my shoulder to sit down on the toilet; had excruciating pain all over my body, and I it hurt me to get up out of the chair; My ankles and hands were swollen; Chills; My right fingers sometimes go numb; I'm weak when I do get up and walk I walk in slow motion because it hurts then I cry all the time; My arm was extremely sore; I couldn't lay on my side like I normally do; arm is still swollen; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 24Mar2021 (at the age of 82-year-old), as dose 1, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Mar2021, the day the patient got COVID vaccine, the patient arm was extremely sore, and it was swollen and went to bed. The patient couldn't lay on side like she normally does. On 25Mar2021, when the patient got up the next morning, arm was still sore but felt better but then it went away now (as reported). On 26Mar2021 afternoon, the patient had trouble getting up out of chair and had excruciating pain all over body, aches and joints pains and it hurt the patient to get up out of the chair. Same way when patient went to the bathroom it hurts shoulder to sit down on the toilet and to get back up. The patient had toilet rails to help but that it was excruciating underline that pain made the patient cry to get up and down upon the toilet. The ankles and hands were swollen and had chills and right fingers sometimes go numb and patient was weak when patient get up and walk. It was reported that, the patient walks in slow motion because it hurts then she cries all the time. The patient did some lab work on 11Mar2021 and the results were good. The outcome of sore and swollen arm was not recovered while for other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had previously received the HEPLISAV-B for first Hep B dose on 2/21/2019. At this visit RN gave the ENGERIX-B not realizing the HEPLISAV-B was given previously. RN called Regulatory Authority for advice and was told Patient could either receive the HEPLISAV-B today, which would finish that series or continue to receive the two subsequent doses of ENGERIX-B at regular intervals. Patient decided to receive the HEPLISAV-B at this visit to finish the series.
Approximately 8 hrs after the second shot, the injection site became extremely sore. I also started experiencing chills. The next day approximately 19 hrs ,after the shot, I had a low grade fever 99.8, extreme chills, extreme muscle fatigue, gas, extreme heartburn that would not go away with medicine. Heartburn was steady for approximately 6 hours and then intermittent over the next 7 hours. Other symptoms were constant through 24 hours. Fever broke after approximately 24 hours resulting in sweating.
Muscle pain which was presumed normal for about a week but pain 8/10 persists to this day 11/29/2012. I cannot lift my arm from the shoulder to elbow without help, the deltoid muscle in the left arm is still extremely painful, I cannot lift anything with my arm or even get dressed, the intensity of the symptoms has been consistent and unchanged since the time of the vaccination, no doctor or PA can tell me anything and do not see anything as there has never been a black and blue mark over the muscle. I have tried Aleve, ibuprofen, Excedrin, Valium, robaxin, and oxycotin have only decreased the pain to a 5/10. As of right now I am still unable to use my arm which I need in order to work.
couple of patients who are past the 2-6 month window for the 2nd dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   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: couple of patients who are past the 2-6 month window for the 2nd dose of Shingrix).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 2-Oct-2023 The pharmacist stated that there were a couple of patients who were past the 2 to 6 month window for the 2nd dose of Shingrix. The vaccine administration facility was the same as primary reporter. The reporter did not have any patient or additional details at this time.  The reporter consented to follow-up via postal. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Hellish headache--nothing makes it stop. My body hurts, my face is puffy, I'm nauseous, I almost passed out at work today--everything went grey, and I grabbed onto my desk to stop fall then sat down again. The room was spinning.  I had to leave work to come home and lie down.  This is horrible.  After researching for HOURS on my lap top from the comfort of my couch, I found that these symptoms are pretty common...so I will ride it out for a few days.  Wish someone would've warned me in advance, as I have a very important meeting to attend this Thursday--a budget meeting with the BOD--and I don't want to vomit or faint.  I absolutely must be present. THERE SHOULD BE A LAW REQUIRING HONEST COMMUNICATION/WARNINGS IN ADVANCE TO PATIENTS REGARDING VACCINES AND POSSIBLE REACTIONS. If I had known about the side effects, I would've scheduled the injection when I had time available to take off of work. I never had a reaction like this to a vaccine before--ever.  This is horrid. Seriously...all this misery from a TETANUS BOOSTER SHOT?? I sure hope it doesn't get worse??
945PM recv vax pt got very pale & vomited, very sleepy, weak, pale;chewing motion w/mouth jerking motions all over body;apical pulse 120+ & BP 98/84 recheck BP 100/72;dx acute tonsillitis
( days after injection, soreness heat and redness with swelling appeared with pain and itching.  Laster aprox. 5 to 6 days, then bicep tendon tore at site of inflammation.  Will need to have repaired as is painful.
Trouble breathing, itching on my face- went away after a couple of days. Upcoming appointment with a pulmonologist.
pt recvd flu vax 7NOV92 & exp resp distress a few days later (approx 10NOV91) pt devel pneumonia & was hospitalized (dat unk); following hospitalization pt suffered a stroke;
Pt vax w/ expired hepta B.  Lot number was unavailable.  No adverse reaction
Information has been received from a physician concerning a 65 year old black male with no known drug allergies who on 10-MAY-2007 (previously reported as 15-MAY-2007) was vaccinated in the left arm with a dose of Zostavax (lot #656859/0357U). Concomitant therapy included LIPITOR, NEXIUM, ZYRTEC, aspirin and lisinopril. Subsequently the patient the patient developed a headache and arm stiffness in his vaccinated arm. Unspecified medical attention was sought. No laboratory tests were performed. There was no product quality complaint involved. Additional information indicated that on 16-NOV-2007 at 09:30 the patient complained of stiffness in his left arm which proceeds to get worse and that his head hurt. The physician advised the patient to take ibuprofen 400 mg prn and if not better in 24 hours to call the office. Additional information has been requested.
Information has been received from a physician concerning a 19 month old female who on 01/17/2006 was vaccinated with a dose of MMR and Varicella.  Concomitant vaccinations on that same day included a dose of pneumococcal vaccine.  The physician reported that on 01/17/2006, the patient broke out in hives after vaccination.  Unspecified medical attention was sought.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Got a Tdap vaccine on 1/26/10. Area of injection swelled and bruised. A knot formed lasting 3 weeks then resolved. Reports arm is still sore and dose not have full ROM - encouraged to see Dr.
This spontaneous report was received from a licensed practical nurse in her early 60's reporting on herself, who "approximately one week ago" on 25-JUN-2012, was vaccinated with a dose of ZOSTAVAX (Lot # not reported) subcutaneously. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that on 25-JUN-2012, "one week ago", she experienced redness and swelling at the injection site. The patient used CORTIZONE cream. The patient did not seek medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
When I got the vaccine, I had no real adverse symptoms - just a little pain in my arm (at (left arm).  Got sick in September starting on the 14th - on the first day, I thought I was getting a cold, went to work the next day; Thursday, the 16th, I called in - got a pretty severe sore throat during the night. I didn't know if I had the variant or not. Thursday, Friday I stayed home from work. I had various sort of not feeling well symptoms. Friday night, I threw up and had  really bad headache. I went to Urgent Care. They gave me shots of medicine - for nausea and for headache. Felt better the next day, headache did come back though. I developed a cough. The work place said to stay home on Monday. After Monday, I went back to work. I didn't have trouble breathing or chest pains at that point and so it felt more like a flu or cold. Just took at-home remedies - cough drops and Acetaminophen. I didn't have chest pain increases during this time. At Urgent Care, the doctor also prescribed me a new kind of medicine for my headaches - very similar to Excedrin - caffeine, Tylenol and a different type of medicine to help with headaches - preventative measure.   Note: Chest pain - I had been experiencing that off and on since before I had COVID and the COVID vaccines - had xrays done. It hasn't been too bad - it hasn't been real severe. I would say it a little bit continuing after the x-rays were done in June.
Old sacroiliac hip injury and sciatica flared up immediately after each injection; Old sacroiliac hip injury and sciatica flared up immediately after each injection; Old sacroiliac hip injury and sciatica flared up immediately after each injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Lot number: EN6205) as dose 1, single and administered in arm left, administration date 01Apr2021 (Lot number: ER8734) as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypothyroid" (unspecified if ongoing); "sciatica for 11 yrs" (unspecified if ongoing); "sacroiliacitis for 3 yrs" (unspecified if ongoing); "old sacroiliac hip injury" (unspecified if ongoing); "known allergies: statins" (unspecified if ongoing). No Covid prior vaccination. There were no concomitant medications. No other vaccine in four weeks. No other mediation in two weeks. The following information was reported: JOINT INJURY (disability), SCIATICA (disability), CONDITION AGGRAVATED (disability) all with onset 2021, outcome "not recovered" and all described as "Old sacroiliac hip injury and sciatica flared up immediately after each injection". Therapeutic measures were not taken as a result of joint injury, sciatica, condition aggravated. Clinical course: The patient's old sacroiliac hip injury and sciatica flared up immediately after each injection-inflammation. This faded after first vaccine after a couple of days, after second vaccination in a week. Pain started day of each injection. Serious side effects. Exercises and diet that helped in the past do not work. Patient was not tested for Covid post vaccination. Patient took the third dose of BNT162B2 on 05Oct2021 (Lot number: FE3590) administered to left arm.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The nurse reported that she felt that there was a potential for product confusion or medication error with PNEUMOVAX23 because of the label. She also stated that part of the label was in dark wine color and the 23 was in a ghost type print. Additional information has been requested.
flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00063418 and 015L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown.            No concomitants or treatment medications were reported.
PATIENT GOT HIS 2 SHOTS,- PFZIER COVID 19 BIVALENT AND ABRYSVO (RSV) AFTER A COUPLE OF MINUTES AS HE WAS WALKING OUT HE FAINTED.
Patient said they had soreness in the right arm which radiated to their head which felt numb.
Today 7/8/2021 patient walked into the Pharmacy and reported that he had adverse reaction as result of his Janssens covid-19 vaccination from 4/8/2021. he reported that he had headache for three weeks which went away, then on June 4th 2021 he was coming down a stairway and passed out. He was take to urgent Care and was treated for Hypertension and re-aggravation of concursion according to patient.
Patient has had a belly ache And mild fever for the past 5 days.  He has been lethargic and not eating well and has been constipated.
11/17/09 awakened in sleep by irretractable pain right arm. 11/18/09 middle of night irretractable pain across shoulders. 11/19/09 middle of night pain whole posterior lower extremities. 11/20/09 middle of night pain across scapular and flanks - went to ER. 11/21/09 paresthesia both hands and feet unsteady. 11/22/09 - gait weakness. 11/25/09 deep tendon reflux absent but increasing both legs. 11/27/09 diagnosis, GUILLAIN-BARRE Syndrome.  12/7/09 Discharge summary, hospital records received. Service date 11/27/09. Assessment: Acute inflammatory demyelinating polyneuropathy / Guillain-Barre syndrome.  Patient presents with progressive weakness and paresthesias, primarily involving legs, but also hands and arms. Sense of imbalance. Diminished deep tendon reflexes, absent achilles reflex. Hypertension. Recent weight loss.  12/18/09 Additional hospital, neurology records, service dates 7/14/09 to 11/27/09. Assessment: Acute inflammatory demyelinating polyneuropathy / Guillain-Barre syndrome.  1/4/2010 Neurology consult records recieved. Service date 12/8/09. Assessment: Acute inflammatory demyelinating polyneuropathy or Guillaine-Barre syndrome.  IVIG administered during hospitalization. Post discharge follow-up. Improved muscle strength and ambulation. 2 more days of IVIG planned. Full recovery anticipated.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 100.9,) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included IBUPROFEN.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PYREXIA (fever of 100.9,). At the time of the report, PYREXIA (fever of 100.9,) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 101.0 (High) temperature now reads 101.0 on one thermometer and 100.0 on a different thermometer.. On 17-Mar-2021, Pyrexia: 100.9 (High) fever of 100.9.         Reporter did not provide any other AE information.    Action taken with mRNA-1273 in response to the events were not applicable.
Headache, fever,  body aches, right sided pain, neck stiffness, lower lung pain that seems to be worsening after 24 mark rather than improving
Pt reported swelling 3/16/10 to pharmacy that occurred in his home 2/4/10.
she thought she was getting Bell's Palsy; Lymph nodes swelled; This a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 17:30 (at the age of 60years) as single dose for Covid-19 immunization. There was no medical history; no known allergies. The patient is not pregnant at the time of vaccination. Concomitant medications included colecalciferol (VITA D); ascorbic acid (VITAMIN C); fish oil; ubidecarenone (COQ10); magnesium; and zinc; all taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her lymph nodes swelled on the same side where she received the shot. Also, the left side of her checks down to neck and shoulders felt weird, she can't quite explain the feeling; she thought she was getting Bell's Palsy which is one of the adverse reactions. She was alarmed as she was unaware of the swelling of the lymph nodes. The adverse events occurred on 19Mar2021 (16:30). There was no treatment received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovering.  Information about lot/batch number has been requested.
bilateral pneumonia; acute on chronic respiratory failure; left lower extremity deep vein thrombosis; This spontaneous case was reported by a physician and describes the occurrence of ACUTE RESPIRATORY FAILURE (acute on chronic respiratory failure), PNEUMONIA (bilateral pneumonia) and DEEP VEIN THROMBOSIS (left lower extremity deep vein thrombosis) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012LZ0A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (corn, dairy aid, peanuts,tomato), Drug allergy (codeine, aspirin, chlorine, tartrazine, lanolin, Prevnar, Pulmicort, penicillin.), Iodine contrast media allergy, Allergy (cat dander, yellow dye, purple dye), Latex allergy, Hypertension, COPD and Lung cancer. Concomitant products included ALPRAZOLAM, BENZONATATE, ENOXAPARIN, GABAPENTIN, HCTZ, HYDROCODONE, ACETAMINOPHEN, OMEPRAZOLE, PREDNISONE, PROCHLORPERAZINE EDISYLATE (COMPAZINE [PROCHLORPERAZINE EDISYLATE]), BECLOMETASONE DIPROPIONATE (QVAR), MONTELUKAST and CETIRIZINE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (left lower extremity deep vein thrombosis) (seriousness criterion medically significant). On 05-May-2021, the patient experienced ACUTE RESPIRATORY FAILURE (acute on chronic respiratory failure) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PNEUMONIA (bilateral pneumonia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 05-May-2021 due to ACUTE RESPIRATORY FAILURE and PNEUMONIA. The patient was treated with Hospice care (increased supplemental oxygen) for Pneumonia. At the time of the report, ACUTE RESPIRATORY FAILURE (acute on chronic respiratory failure), PNEUMONIA (bilateral pneumonia) and DEEP VEIN THROMBOSIS (left lower extremity deep vein thrombosis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Ultrasound Doppler: unknown (Inconclusive) unknown. On 05-May-2021, Chest X-ray: unknown (Inconclusive) unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   treatment includes IV antibiotics. concomitant medication includes duo-nebs.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt presented to pharmacy on 9/18/16 complaining of feeling exhaused, drained, excessively tired, nauseous, and like she was getting the flu. She also reported having significant swelling and redness at the injection site shortly after receiving vaccine, which has slowly subsided over the next few days. She was concerned that at 5 days post-vaccination, she was left with a large blackish bruise at the injection site with tenderness still in her arm. She stated that even her t-shirt rubbing against her arm still hurt. When asked about treatments she has tried, she reported icing the injection site and surrounding areas and also using a heating pad on other sore/painful areas of her body.
Headache for over a week; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), 1st dose on 19Dec2020 14:45 and 2nd dose on 11Jan2021 08:45; both via unspecified route of administration via the left arm at a single dose for COVID-19 immunization. Medical history included asthma, allergies and COVID-19 (prior to vaccination). The patient is not pregnant at the time of vaccination. Concomitant medication included azelastine hydrochloride (ASTELIN), fluticasone propionate, salmeterol xinafoate (ADVAIR), zafirlukast (ACCOLATE) and omeprazole (PRILOSEC). The patient previously took motelukast (SINGULAIR), dimeticone, glycerol (CETAPHIL) and budesonide, formoterol (SYMBICORT); all for allergy. The patient experienced headache for over a week on 11Jan2021 08:45. No treatment was received for the evet. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.