chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had an achy arm after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient had an achy arm after receiving 2nd dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 016M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included POTASSIUM for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 ml. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Patient had an achy arm after receiving 2nd dose). At the time of the report, PAIN IN EXTREMITY (Patient had an achy arm after receiving 2nd dose) outcome was unknown.            The patient was given Eye drops for dry eyes as concomitant medication. Treatment details was not reported by the reporter.
1st dose, migraine, body aches especially hips, and neck, nauseous, temperature, malaise, Insomnia, agitated , lasted 4 days 2nd dose, migraine, body aches, lower back and neck has seized up, nauseous, malaise., insomnia, agitated.    Continuing to have these side effects.  Headaches are awful go from Migraine, to sinus, to tension like a vise grip is squeezing my temples to pain in the back of my neck.  Brain fog, saying and doing stupid things, vertigo off and on. We are calling  it covid brain.   Its been 2 weeks since the 2nd vaccine.  I have contacted my doctor and we are trying to figure something out.  any of my friends are having long term side effects and they won't contact you.
Information has been received from a physician and a certified medical assistant concerning a 49 year old female patient with no drug reactions or allergies who on 06-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 665925/0932Z) and a dose of FLUARIX in the other arm. Another concomitant therapy included ZOLOFT. The physician report that on 07-OCT-2010, the patient experienced swelling and warmth on the arm the dose of PNEUMOVAX 23 was administered in. The certified medical assistant reported that the patient experienced no injection site reaction on the arm that was vaccinated with FLUARIX. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The physician's office requested a lot check. This is one of two reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 665925/0932Z were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
pt recvd vax;5 days p/ dose 1,exp irritation & sensitivity of lt eye, forehead,scalp & the periorbital area; dx:trigeminal neuralgia;sxs were entirely resolved w/out tx 3 days p/ onset;
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: UNKNOWN) 1 total, dose was not reported administered to right arm on 16-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JAN-2022, the patient experienced sore throat, nasal congestion and felt very tired (confirmed covid-19 infection). On 03-JAN-2022, the patient had diarrhea but feels better on the day of reporting and on the same day given sample for covid test and the polymerase chain reaction (PCR) test results showed covid-19 positive (confirmed clinical vaccination failure). The patient was fully vaccinated and had not taken booster dose yet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000210121.; Sender's Comments: V0-20220104569-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
After getting vaccine patient started feeling dizzy. She was going to faint but one of the employee supported her and set her down on chair. After 5 minutes, patient started feeling better  so lie her down on her back and elevated patient's feet. After 10 minutes patient started feeling better so set on a chair to rest. After 10 minutes patient was ok. Double checked if patient does not have visual disturbances, dizziness or other symptoms. left with father after feeling  completely fine.
Mid May I had chest pain/cramp, sweat and radiation to the left arm, Angina symptoms.  06/02/2021, I saw a cardiac doctor and scheduled me a stress EKG test and that was on 06/08/2021 Results were negative, just showed Pulmonary Hypertension.
Three days post vax the pt had swelling of upper arm, accompanied by redness and itching. Pt was seen by a physician. Pt recovered.
rapid onset of swelling of right side of upper lip sensation of being hit in the back followed by notable difficulty of getting enough air sensation of tightening around the girth followed by additional breathing issues swelling of lip went away shortly after taking zyrtec other symptoms got better over time but resumed to a lesser degree off and on for a couple of days
Narrative: COVID infection following COVID vaccine series 04 16, Pfizer, dose #1 05/07, Pfizer, dose #2 12/24 COVID swab, result: detected 12/23 pt cc: cough, fatigue, fever, loss of taste or smell, sore throat exposure: unknown 12/26 pt admit ED cc: wheezing and chest pain dx: covid pneumonitis LOS: I day 12/26 CXR impression: No acute cardiopulmonary disease. 12/29 clinically resolved
On the third day, my left side of my face became paralyzed, although it happened, but I still have involuntary movements and loss of strength in both arms, I still can't grasp things, I can't push myself, both arms hurt, half a month has passed since I was vaccinated. and I can't force myself to get vaccinated this vaccine garbage was fine a few months before I received blood tests from the whole body and it was fine and this garbage has left me badly they are rubbish And so I have to go to work because nobody gives me anything, they are irresponsible, you do the vaccines and you want me to go to the hospital spending my money, they are rubbish
A couple weeks after the second vaccine I started feeling pain and noticed swelling in my right arm that was similar to the last time I had a blood clot. But this time I also felt pain on the right side of my neck. Went to see Dr . He ordered a panel of blood tests and an xray. I also saw a nurse practicioner who ordered an ultrasound of my arm and shoulder /neck area. They found a spot on the ultrasound that was new but couldn't tell if it was a blood clot or nerve. Waiting to hear back from vascular surgeon.
Headache, upset stomach, abdominal pain/stomach ache daily post vaccine.  Some days more than others.  5/17/22 11:00 AM Flushing, feeling hot, tachycardia.  1215 had bowel movement dark purple/ black in color, liquid. Light headed, pulse 125-135.  Taken to ER via ambulance at 1:30.  Had 4 more liquid bm.  Admitted  to hospital 5/17 11pm.
Intermittent rapid heart rate at rest that made me seek medical attention. Also, dizziness and gastrointestinal discomfort.
kidney infection; fever as high as 103 F; This is a spontaneous report based on the information received by Pfizer   (Reference ID: NVSC2021US100597). A contactable consumer (patient) reported that a 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported she experienced fever as high as 103 F and was admitted to the hospital on 30Apr2021. Patient stated she was discharged on 03May2021. Patient noted that while admitted to the hospital she was found to have a kidney infection, and also stated that she received the COVID-19 vaccine 1 week prior to start of fever. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
From about 6PM to 10PM (on the day vaccinated), I visited neighbors to watch college football on TV. I drank 3 or 4 beers and consumed a BBQ dinner. I went to bed about 10:30PM and was awoken about mid-night by the worst splitting headache I have ever had. It was so bad that I could not lie down. I sat on the edge of the bed for some slight relief, but it was still extremely painful. I tried to sleep sitting up, but wasn't very successful. My spouse woke up about 7AM and I tried to tell her about my condition, but all my words were a jumbled jiberish that was totally uncomprehensible. We realized the symptons were that of a potential stroke, so my spouse drove me to the Hospital emergency room. The staff immediately began tests and scans and blood work for a potential stroke. They concluded my diagnosis was TIA (transient ischemic attack) Primary, (code G45.9), Cerebrovascular accident (CVA), unspecified mechanism (HCC) (code I63.9), and Dysphasia (code R47.02). As time went by my symptoms decreased and I gradually was able to gain my speech and increase my vocabulary such that I was again understandable. They gave me one aspirin (325mg) each day I was in the hospital and a B-1 injection on my last day in the hospital. I did not take my daily medications on Saturday night, Sunday morning and night, and Monday morning. The hospital doctor changed my daily prescriptions for 30 days to add an 81mg aspirin 1/day, add 80mg atorvastatin 1/day, and stop taking simvastatin 40mg. They recommended follow-up appointments with my primary care physician (PCP) and a neurologist. My headache dissapated daily while in the hospital and has nearly ceased today.
oxygen levels went down; fever; chills; This is a spontaneous report from a contactable consumer or other non hcp. A 35-years-old male patient received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 03Feb2021 (35-years-old at the time of vaccination) (Batch/Lot Number: EL9264) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included gout, Sjogren's syndrome from an unknown date and unknown if ongoing, covid-19 from Mar2020 to an unknown date (when I had COVID in Mar2020), coma (This is what initially sent me to the hospital for COVID which ended up with 22 days in a coma and on a ventilator) from an unknown date and unknown if ongoing. The patient previously took quinolones and experienced drug hypersensitivity. Patient was allergic to Barley. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on13Jan2021 09:45 AM (Batch/Lot Number: EL8982) as DOSE 1, SINGLE for covid-19 immunisation. Concomitant medication included allopurinol, apixaban (ELIQUIS), fluoxetine hydrochloride (FLUOXET), clonazepam (KLONOPIN), gabapentin (NEURONTIN) taken for an unspecified indication, start and stop date were not reported. Patient stated that on 03Feb2021 06:00 PM, A few hours after his second injection, he started to have the same symptoms as when he had COVID in Mar2020. His oxygen levels went down (to 91) and he had fever and chills. This was what initially sent him to the hospital for COVID which ended up with 22 days in a coma and on a ventilator (2020). The patient underwent lab tests and procedures which included oxygen saturation: 91 on 03Feb2021 oxygen levels went down (to 91). Patient did not receive any treatment. The seriousness of the reported event oxygen levels went down was assessed as serious medically significant. The clinical outcome of the events was recovered in 2021.  No follow-up attempts are needed. No further information is expected.
Information has been received from a nurse concerning a 20 year old female patient who on 27-JUN-2008, was vaccinated with the first dose of GARDASIL vaccine (yeast) IM into left deltoid, on 19-AUG-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast) into left deltoid muscle. On 26-AUG-2008, the patient complained of swelling, itching and redness at the injection site. Nurse stated as far as she knew client recovered. Additional information has been requested.
Patient experienced redness and swelling at the injection site. He was seen in the ED, where he reported that there was no pain, but he was feeling some numbness and was having difficuly moving his arm. He did not have a fever. After being discharged, the swelling continued to spread outsde of previous borders and the patient was seen in clinic he next day. He had swelling from shoulder to ebow and was unable to lift his arm. He was treated with diphenhydramine, cetirizine, and cold compresses.
Patient experienced a sore arm at the injection site, flu like symptoms (chills and fever) 08-18-2018, and resting heart rate over 120. Patient has not received treatment to date, he feels better today than yesterday, but not nearly as good as Friday prior to the immunization. I instructed to seek medical care if necessary.
Constant leg pain/cramps in night or early morning.  Mostly calf pain in both legs.
GUILLAIN BARRE SYNDROME; VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; This spontaneous report was received from literature: concerned a multiple patients (around 143 with guillain barre syndrome and about 3.2 with vaccine induced immune thrombotic thrombocytopenia) of unspecified race and ethnicity. The objective of this study was to describe COVID-19 Variants and Vaccine Benefits-Risks Balance. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced guillain barre syndrome and vaccine induced immune thrombotic thrombocytopenia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the guillain barre syndrome and vaccine induced immune thrombotic thrombocytopenia was not reported. In summary, currently, vaccination is considered as the best strategy to protect people from COVID-19 and prevent severe illness and death. There are few proved vaccine mild side effects and the possibility of very rare serious events of coagulopathy. However, vaccines have proved efficacious and safe and hopefully, be able to eradicate the devastating COVID19 pandemic. Nevertheless, rapidly progressing updates of the era of COVID-19 pandemic are being continuously monitored. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220336932-Covid-19 vaccine ad26.CoV-2.s- Guillain barre syndrome, vaccine induced immune thrombotic thrombocytopenia. This event(s) is labeled per RSI and is therefore considered potentially related.
Information has been received from a nurse practitioner, concerning a 10 year old male patient with sickle cell anaemia and a seizure disorder, who on 18-JUN-2007 was vaccinated SQ in the right arm, with a dose, 0.5ml, of Pneumovax 23 (Lot # not provided). Concomitant therapy included folic acid and TRILEPTAL. At the time of injection, the patient experienced pain, redness and swelling at the injection site, and later in the evening of the same day, 18-JUN-2007, he experienced pain, redness, and swelling of his right arm. The child's mother treated him with TYLENOL. On 20-JUN-2007, the child's mother took him to the hospital for evaluation. The child did not have a fever, but was admitted to the hospital to rule out "sepsis, sickle cell crisis, or allergy to (pneumococcal 23v polysaccharide vaccine)." Diagnostic testing was performed, though no results were provided. Treatment included ceftriaxone (manufacturer not specified). On 24-JUN-2007, the child was considered to be "fully recovered," and was released from the hospital. Additional information has been requested. 18-Jun-2007 complete blood cell count, 18-Jun-2007 blood culture, 18-Jun-2007 whole blood hemoglobin electrophoresis test, 18-Jun-2007 upper extremity X-ray, 18-Jun-2007 blood reticulocyte count.
can''t breathe very well; looks like there''s a clog in his throat; can''t swallow its painful; around his waist is painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administration date 04Dec2021 (Batch/Lot number: unknown) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DYSPNOEA (non-serious), outcome "not recovered", described as "can't breathe very well"; OROPHARYNGEAL DISCOMFORT (non-serious), outcome "not recovered", described as "looks like there's a clog in his throat"; ODYNOPHAGIA (non-serious), outcome "not recovered", described as "can't swallow its painful"; PAIN (non-serious), outcome "not recovered", described as "around his waist is painful".  Additional Information: NDC number, Expiry date of Pfizer Covid vaccine was unknown. The caller does not have the patient's vaccination card with him and hence information on lot number and product details were not provided. No information provided on other products, patient history and investigation assessment. Caller calling behalf of patient declines about height and weight. The patient taking Pfizer Covid vaccine to be safe.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe pain- swelling- redness at site of injection and upper arm. Decreased movement of left arm. Treatment- Ice to area as needed & Atarax 25 mg three times daily.
Immunizations administered Friday 9/11/08 and Pt reports a rash on her legs developed Saturday morning. Pt states rash only developed on legs, no other Sx, and rash disappeared within 48 hours (just reported to Us on 10/9)
pt recv vax 28APR97 & 1mo post vax pt devel a delayed hypersensitivity rash;
10/1/21 Pain at injection site within an hour after administration R Deltoid going into  back of neck and shoulders.  10/1/21 About 4 hrs post injection -  fatigue, body feeling heavy and feeling like need to lie in bed,  headache.   10/2/21  Next day the symptoms continued with some pain in eyes and burning in eyes, eyes feeling heavy, felt fuzzy in head.    10/3/21 They following day, all symptoms gone.    I had no reaction after 1st and 2nd Pfizer vaccine other than arm pain at injection site.
Pt was given a moderna bivalent dose at 33 days refrigerated. Moderna is to fridge expire at 30 days of refrigeration.  Moderna was contacted, internal studies indicate that dose remains just as effective at 33 days as it would have been at 30 days or less. Provider informed. No additional doses needed/advised. Pt did not have any side effects from dose received.
Fever; Dry throat; Weakness; First 2 days he slept 12-14 hours; Pain; soreness in left shoulder and arm to wrist in the injection arm; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age (79 unit not reported) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as DOSE 1, SINGLE, for covid-19 immunisation and he had similar symptoms after the first shot but mild. Patient stated that, he had his second dose last Friday and had side effects they were gone now. Last Friday (05Feb2021) after second dose, first 2 days he slept 12-14 hours, pain, soreness in left shoulder and arm to wrist in the injection arm. After the 4th day (09Feb2021) had fever, dry throat, weakness did not feel himself. He said Today he is good. Patient wanted to know when does this vaccine start protecting after the second dose, 7 days 14 days. At the time of this report event outcome was recovered on an unknown date in Feb2021.   Follow-up attempts are completed. No further information is expected.
pt recv vax 14JUL98 & had local redness, warmth & tenderness;had flu like synd w/malaise, h/a;
09/11/2019 swelling and redness 09/12/2019 swelling and redness expanded 09/13/2019 swelling and redness expanded 09/13/2019 took him to urgent care. I  was told it was a skin reaction, not vaccine reaction.  He was prescribed Hydrocortisone Cream, 2.5% and Cetirizine Hydrochloride Oral Solution 1 mg/ml. Neither one seemed to reduce the swelling.  09/15/2019 took him again to urgent care. This time the Dr agreed that it may be a reaction to the vaccine, not skin allergy. 09/19/19 He broke into 101.9 fever 09/20/19 voice became hoarse and developed croup cough. Fever came back 101.3. 09/21/19 cough worsened. Tylenol reduced fever.  09/22/19 cough sounded more like whooping 09/23/19 took him back to facility. He was diagnosed with croup.
Headache, Arm swollen with heat and redness, chills, sleeping, diarrhea.  Not feeling well for 3 days. Arm still painful  with redness on day 4.
Patient was not due for a bivalent booster because she already had one on 10/25/22.
Pt experienced syncope with flushing and sweating, BP 98/59, HR52, RR18. Outcome not reported.