chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 62 year old male patient. The patient's pertinent medical history, drug reactions and allergies were unknown. The patient's concurrent condition included chronic obstructive pulmonary disease (COPD). There were no concomitant medications reported. On 26-JAN-2016, when the patient was 60 year old, the patient was vaccinated with first dose of PNEUMOVAX 23 (lot # L035686, expiry date 16-FEB-2017) (dosing regimen and frequency unknown) for prophylaxis. On 28-AUG-2017, at 62 years of age the patient again received the second dose of PNEUMOVAX 23 (lot M018766, expiry date: 15-OCT-2017) (extra dose administered) (inappropriate schedule of drug administration). The patient received a second dose of vaccine since the patient had initially reported that he had never received a dose of PNEUMOVAX 23 before. No adverse events were reported. There was no product quality complaint reported.
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 30-AUG-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Drug ineffective; tested positive; This is a spontaneous report from a contactable consumer. This consumer reporter similar events for 2 patients. This is 1st of 2 reports. A 74-year-old female (Patient) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 10-FEB-2021 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. On an unspecified date, however, they were exposed to COVID-19. Her partner tested positive for COVID-19 and he had very mild symptoms and she states that he had been over it for at least a week. In 2021The caller also tested positive, after her partner, and she states,it will be 10 days ago tomorrow [tested positive 9 days ago]. The caller states that she and her partner have been in quarantine since they were exposed and that their required isolation time will be finished tomorrow. She also states that her partner has an appointment at his doctor's office tomorrow. She was inquiring about receiving the second dose of the COVID-19 vaccine after testing positive for COVID-19. The caller states that they were exposed to COVID-19 along with quite a few people and everyone else was considerably younger than them. The caller and her partner symptoms were very mild and state that it felt like a bad cold and they attribute that to having had the first dose of the COVID-19 vaccine in their system. The caller would like to know if the first dose could have helped their symptoms be milder than their friends symptoms since their friends had not yet received any of the COVID-19 vaccines yet.The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021293934 Same reporter,event, product/ different patient
Headache, chills, low grade fever, and aching all over the body, along with excessive tiredness
Pt felt swelling, stinging pain, redness & warm sensation on (L) arm 9/6/12 at school around 9 AM. "Swelling & redness got bigger 9/7/12" as per pt. Measured firm swelling 2 x 2 inches as of 9/07/12 4:00 PM. Advised to apply warm compress, TYLENOL for fever & to watch for blisters. Advised to go clinic 9/8/12 if worsens.
WiThin   20  min  of  shot ,   pt experienced  Throat  tingling,   followed by lips tingling,  swelling & Throat  swelling. Then trouble breathing, blue lips seve anxiety heart palpitations & SOB. PT took oral Benadryl & Symptoms ...Reduced.  pt went home & continued Benadryl dosing.     Symptoms  resolved over  24 houRs
First 6 hours post injection: localized redness RT. deltoid.  Next 25 hours: febrile 101.2 to 102.6, joint pain knees & hips, muscle pain, extreme fatigued.  On Day 2: same symptoms for next 10 hours. Very similar to full-blown flu symptomatology. This event was followed 18 hours later by a sore throat & signs/symptoms of a head-cold & sinusitis, thought to be viral (clear mucous from nasopharyngeal area.  Weakness & significant fatigue continues; saw my physician?s Nurse-Practitioner: mow on Ampicillin/ clavulanate 825/125 mg.
Seizure lasting approximately 10 minutes. Body jerking 15-20 minutes. ER evaluation and then admitted for 3 days. Testing normal.
This spontaneous report as received from a certified medical assistant refers to a 9 month old female patient. The patient's medical history, concomitant medications were not reported. On 26-MAR-2015 the patient was inadvertently vaccinated with GARDASIL (dose number, dose volume, route of administration, lot number were not reported). No adverse events were reported. Additional information has been requested.
I continue to have severe pain in my right arm where I receive the shot, my shoulders, neck & shoulder blades also have pain.  I just started physical therapy 05/15/17.  The pain is not getting better!
RED, SWOLLEN, WARM ARM EXTENDING FROM ABOUT 4 INCHES AND AROUND TOP OF ARM. APPLIED CREAM. TOOK A FEW DAYS TO SUBSIDE.
Left thigh swelling, erythema, induration, improved in 12 hrs with residual symptoms. Thigh circ. 11".
Vaccine had been punctured for 26 hours; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jun-2021 and was forwarded to Moderna on 18-Jun-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours). On 17-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
10/17/2020  after the injection on Thursday I had a sore body, sore throat ringing ears joint pain, my self esteem was very low, my boss sent me home because my voice sounded so rough, I checked my temp around 100 and 101 and I took Panolol and it went down to 99. Fri I woke up with sore throat every time I take a breath I have chest pain sore body ringing in ears, chills and I went to the  ER Friday 12/18/2020 they gave me some anti inflammatory injection and I went back home that day, they gave me a medical order to take a covid test today 12/19/2020. ER Dr gave me good results on tests.I have a headache and sore my body feels heavy but other than that I'm trying to avoid contact and staying at home until the results come through
The  next day on the 10th March 2021 I started having a very bad headache and nothing OTC would help. The next day (11th) we went to the clinic and saw the doctor they diagnosed me with cluster headaches. I was given a 1 dose drug and it didn't help. Not sure what it was. Then on the 12th (3rd day after vaccine) I went to ER I had some itchy rash on my forehead. I didn't connect it to the headache but the ER doctor immediately diagnosed Shingles. I then erupt over the left quadrant of face/eye. I was given Acyclovir High Dose 1000mg 2x daily for ten days.
Pt. became lightheaded, diaphoretic and sick feeling in stomach 5 min after flu vaccine. BP 82/58 HR = 60. Administered water, banana and head down between legs. Resolved after 5-10 mins with BP increased 94/60 HR = 68.
I became ill with cold symptoms on the evening of October 4. The morning of October 6 I tested myself at home and had a positive test. I then went to an urgent care facility and they confirmed I had Covid. I was prescribed an antiviral medication which I started taking that day. I was also given instructions on quarantine and follow up. My experience with Covid was that it was extremely mild. It felt like a bad cold. I was really only feeling quite bad for two days started improving by four. Had I not had Covid I probably would have been going out and continuing with my every day activities by day five. However I did continue to quarantine and follow CDC guidelines on masking after Covid.
Pt developed loose, green, mucousy and eventually mildly bloody stools 1 day following rotavirus vaccination. Pt also received other 2 mo vaccines at the time.  Loose stools persisted for approximately 6 weeks.  No associated abdominal pain as perceived by parents. Abnormal stools have now resolved, but pt was not vaccinated with rotavirus again.  Tolerated all other 4 mo vaccines well.
my cancer has spread very quickly; This is a spontaneous report from Pfizer sponsored program   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient's medical history included cancer from that diagnosed last year (2020). The patient's concomitant medications were not reported. It was reported that, the patient diagnosed with cancer last year (in 2020) and it was slowest growing kind by oncologist. The patient just got covid shots, both yours and as of Friday the patient's cancer has spread very quickly. The patient had to hear from you as soon as possible. The patient doesn't know where else to turn. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Began experiencing gripping stomach pain radiating to upper back 30 minutes to 1 hour after eating and at other times. Pain lasted from a few minutes to an hour or more. Also experienced hives on my legs and arms at the same time. On 11/9/21 went to ER for pain in stomach without having eaten in several hours. Given Protonix with no relief, sent home with Omeprazole. 11/9/21 to PCP for same symptoms and given Famotidine. Ultrasound on 11/12/21 - normal. 11/22/21 to PCP for continued abdominal pain - referred to Gastroenterologist. 12/20/21 - new symptoms of early am bowel movements along with heart palpitations, nausea, and shakiness which lasted through mid morning, at times all day. Weight loss ongoing since start of event, now at 10 plus pounds. 12/23/21 - barium swallow - normal. 12/24/21 - to local hospital ER for continued early am symptoms, continued weight loss. CT and Ultrasound done - all normal. MiraLAX, Bentyl, Zofran and omeprazole given. 12/28/2021 - to PCP who sent urgent referral for endocrinology and cardiology at local Hospital. Placed ZIO Patch on for 7 days. 1/5/2022-1/6/2022 - admitted to local Clinical Unit for same symptoms - Endoscopy, Colonoscopy and MRCP completed - all normal. Throughout all PCP, ER visits blood and urine tests continued to be normal. 1/8/2021 to local Hospital ER for am symptoms, heart rate at 133 BPMs, nausea, and shakiness. Consult with cardiology. Put on Metoprolol 1/2 of 25 mg tablet in am for tachycardia. 1/10/2021 Metoprolol stopped because blood pressure bottomed out. 1/14/2021 Cardiologist - EKG normal, Echocardiogram normal. 24 hour urine and 72 hour fecal test completed and both are normal. On Famotidine and Omeprazole now but told by GI to decrease as there is no sign of anything wrong showing in the numerous tests.
the patient had an allergic reaction; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 17-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "the patient had an allergic reaction".  Additional information:: On 06Oct2022, it was reported that a patient started treatment on an unspecified date in Apr2021 with Pfizer BioNTech COVID-19 Vaccine for COVID-19 immunization. It was reported after the 1st dose, the patient had an allergic reaction, and after the 2nd dose, the reaction he experienced was close to anaphylaxis. No further follow-up is anticipated  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Chills; Shakes (bad); Loss of Balance; Constipation; Extremely dark orange urine; very smelly urine; uncontrollable urination (had to wear incontinence  pads)
Sore arm/Leg pain; Legs felt heavy in a painful way; little nausea will be better; Massive headache; Sleepy in a restless way; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Lot number: EN6208) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01, Lot number: EN6201, Reaction: felt very tired), administration date: 25Feb2021, when the patient was 40 years old, for COVID-19 immunization, reaction(s): "felt very tired", "couldn't keep eyes open from when I got home mid afternoon yesterday till midmorning today", "Injection arm is sore at injection spot", "pain in my left shoulder blade", "mouth, throat, eyes and chest felt slightly dryer than usual", "light headache", "a little nausea", "feet sore (tingly, dry, burning- feeling not looking) as well yesterday- not from walking but from that achy bone muscle feeling", "feet sore (tingly, dry, burning- feeling not looking) as well yesterday- not from walking but from that achy bone muscle feeling", "mouth, throat, eyes and chest felt slightly dryer than usual/the skin on my hands and feet felt like they had the moisture sucked out of them", "mouth, throat, eyes and chest felt slightly dryer than usual", "mouth, throat, eyes and chest felt slightly dryer than usual"; Bnt162b2 (Reaction: Had trouble walking, Dose:01, Lot number: EN6201), for COVID-19 Immunization, reaction(s): "Had trouble walking"; Bnt162b2 (Reaction: feet sore (tingly, dry, burning- feeling not looking) as well yesterday- not from walking but from that achy bone muscle feeling, Dose:01, Lot number: EN6201), for Covid-19 Immunization, reaction(s): "feet sore (tingly, dry, burning- feeling not looking) as well yesterday- not from walking but from that achy bone muscle feeling", "feet sore (tingly, dry, burning- feeling not looking) as well yesterday- not from walking but from that achy bone muscle feeling". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Sore arm/Leg pain"; LIMB DISCOMFORT (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Legs felt heavy in a painful way"; NAUSEA (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "little nausea will be better"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Massive headache"; SOMNOLENCE (non-serious) with onset Mar2021, outcome "unknown", described as "Sleepy in a restless way".  Additional information: Dose 2 thoughts: first day really sore arm, legs felt heavy in a painful way, yesterday (day 2) a little nausea, massive headache, day 3 fine so far...first two days, sleepy in a restless way   Follow-up attempts are completed. No further information is expected.
week later deep depression suicidal for 2 hours. Nausea , dizzy , body camps
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). On 28th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 28th April 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovering/resolving. The reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The pharmacist stated that the patient called on the reporting day to talk about the side effects listed on a more severe level. The patient did mention that the pain and the redness moved up her arm and over to the right bicep. The patient said the injection site was better at the time of reporting. The patient did not receive any other vaccines at that time. This was all the information the pharmacist had.
pt recv vax 3SEP96 & 6SEP96 pt exp swelling of the upper rt arm, severe arm pain, weakness in the thumb & index finger, & numbness & tingling in the fingertips by 19SEP96 pt sx were markedly improved;pain upper arm;
I got my vaccine on Sunday - 4/17 and i have still not recovered from post effect of the vaccine. First two days I had fatigue, fever, pain and swelling in the arm which got little better by Wednesday. On Wednesday evening  i got extremely itchy on my left arm where I had got the shot - Redness spread to almost 60% of my upper arm and I got bad headache. The same evening I got bad sprain in my back just by bending a little and it got so bad that i needed help to sit & stand. I had never experienced this before. I used heating pad to relieve my back pain but it did not work. Thursday evening I partially recovered from the pain and I started experiencing a constant pressure on a spot on my back bone. Today is Friday - 4/23 , I am still experiencing the same pressure along with itching all over my face & body and dryness in my throat & bad headache.
Pt vaccinated with Flu shot developed redness, swelling,rash. Injection was given 22OCT90. Pt did not report rx until it was gone on 25OCT90.
could not get dose two within six months from dose one; This case was reported by a other health professional via call center representative and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.   Additional Information: GSK Receipt Date: 15-June-2022 Reporter's Comments: Pharmacy Operations Manager reported that a couple years ago (as reported) the patient could not get dose two of Shingrix within six months from dose one.  The patient could not get the vaccine because it was not available. The reporter consented to follow-up. Additional Supportive Information: The patient could not get the 2nd dose of Shingrix vaccine because it was not available, which led to product supply issue. This case has been linked with cases US2022093601 and US2022AMR094050, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093601:Same reporter. US-GLAXOSMITHKLINE-US2022AMR094050:Same reporter.
Patient developed dizziness, pallor, and had a mini-seizure about 15 mins after vaccine. No LOC.  911 called due to hx of epilepsy.  Patient recovered on his own after sitting and drinking some water. Escorted out by paramedics but did not go to hospital.
Information has been received from a physician about her daughter who on 21-OCT-2007 was intramuscularly vaccinated with her second dose of GARDASIL vaccine (yeast) (Lot # 658558/1061U). Subsequently the patient experienced a "knot" at the injection site. Additional information has been requested.
This spontaneous report as received from a registered pharmacist refers to a 70 year old male patient. On 16-JUL-2014 (also reported as 17-JUL-2014 by the patient's wife) the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # K005261, expiration date 20-MAR-2015) subcutaneously. The pharmacist reported that on 18-JUL-2014, a hard lump and swelling at the ZOSTAVAX injection site, pain and swelling at the injection site and could see where the needle from the ZOSTAVAX injection went in. The patient did not seek medical attention. The patient was treated with TYLENOL. At the time of the report, the patient had not recovered. Additional information has been requested.
Dizziness; upset stomach; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 23Mar2021 at 07:30 (at the age of 40-years-old) at a single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medications included losartan, metoprolol, omeprazole (PROTONIX) and citalopram. The patient previously received Keflex and experienced allergies. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced dizziness and upset stomach on 24Mar2021 at 06:00. No treatment was given for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
pt recvd vax & 4-6 hrs p/1st dose exp jaundiced eyes & elevated indirect bilirubin; no further detials are available;
Large round rash around injection site. Left arm. Looks like "Covid arm" as seen online search.
Redness and swelling around injection site.  The patient did say she had fever and chills after the vaccine.  The redness and swelling almost doubled in size from 11/1/16 to 11/2/16.   Patient did see her physician 11/2/16 and was advised to take an antihistamine and was prescribed a Medrol dose pack (steroid).