chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a nurse regarding multiple unspecified patients of unknown demographics. No medical history was reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PROQUAD (Merck) lot # L030586, expiry date: 10-FEB-2017 (dose, route and frequency: unknown). No adverse effects were reported. There was no product quality complaints (PQC). This is one of the several reports from the same reporter. Follow up information was received on 30-DEC-2015. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 4 year old male patient. On 23-DEC-2015, the patient was vaccinated with PROQUAD (Merck). This is one of the several reports from the same source. Additional information has been requested. Patient, product, event and narrative were updated.
Woke up arm aching red swollen.  Lungs burning.  Continued to feel bad freezing with every blanket. I was shaking forhours then I got a fever. Had bloody infection in lungs later that night. Sick for about a week felt bad for about 6 weeks lost 11 lbs.
Patient began reporting a feeling of light-headedness 5-10 minutes after injection.  Also reported nausea and feeling clammy, as well as numbness and tingling of both her arms.  She laid on the ground in reverse trendelenberg position with some improvement in symptoms, but upon sitting upright, symptoms returned.  Patient was transported to the ED for 1 L NS IV bolus with improvement of symptoms and discharge.
Patient reported on 2/16/21 he had begun to experience weakness in his lower extremities. On 2/26/21 he sought treatment with his primary care physician.  On 3/3/21 was admitted to the hospital and was diagnosed with Gullian-Barre Syndrome.  No other information is available due to uncooperative nature of individual.
Severe back  approximately  2 hrs after vaccine  Symptoms still here the day after, was advised at time of vaccine  if  symptoms  occur and last up to 72 hrs  in form primary care provider.
Head and body aches, low grade fever of 100.5 degrees F., felt faint when woke the next morning and checked blood pressure which was reported to be 75/47 mmHg, Patent stated she took ibuprofen, benadryl, and drank extra fluids.
felt bad; EXTREME chills; extreme aching; nausea; vomiting; balance was off; blood pressure went up; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of CHILLS (EXTREME chills), PAIN (extreme aching), NAUSEA (nausea), VOMITING (vomiting) and BALANCE DISORDER (balance was off) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL, MONTELUKAST SODIUM (SINGULAIR) and PAROXETINE HYDROCHLORIDE (PAXIL CR) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced CHILLS (EXTREME chills), PAIN (extreme aching), NAUSEA (nausea), VOMITING (vomiting), BALANCE DISORDER (balance was off) and BLOOD PRESSURE INCREASED (blood pressure went up). On 08-Jan-2021, the patient experienced MOOD ALTERED (felt bad). On 08-Jan-2021, CHILLS (EXTREME chills), PAIN (extreme aching), NAUSEA (nausea), VOMITING (vomiting), BALANCE DISORDER (balance was off) and BLOOD PRESSURE INCREASED (blood pressure went up) outcome was unknown. On 11-Jan-2021, MOOD ALTERED (felt bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Reporter did not allow further contact
Redness, swelling,  erythema, and warmth surrounding the injection sight approximately 2 inches in diameter on patient's left deltoid. Redness warmth and swelling is localized to injection sight. Treatment will include over the counter Zyrtec, over the counter Motrin, and over the counter hydrocortisone cream twice daily. Advised to ice injection sight.  Will follow up 08/09/2019 for evaluation. No signs or symptoms of systemic allergic reaction.
Mother brought child in today for assessment of oval shaped 3 inch by 6 inch reddened area on left posterior lateral upper arm, site of VZV sc injection on 04/06/09..Assessed by RN and MD; skin warm, dry, tender to touch. Rx. given for Atarax and instructed to use warm compresses over site.  Mother states that site became reddened on evening of 4/6/09 and gradually grew in size and she "applied ice" to the site last night. Afebrile, NAD otherwise.
Patient presented to the ED on 5/10/2021 for weakness. Patient presented to the ED on 5/17/2021 and was subsequently hospitalized for atrial fibrillation with RVR. These visits are within  weeks of receiving COVID vaccination.
Information has been received from a registered nurse concerning a 67 year old male with asthma, (better after prednisone), heart/aortic valve disease, iodine allergy, AICD device implant in 2004, subacute bacterial endocarditis prophylaxis, erectile dysfunction, benign prostatic hyperplasia without obstruction, idiopathic hypertrophic subaortic stenosis and a history of presbycusis asthma which was reversed in November 2006 and catheterisation cardiac which was within normal limits, who on 06-AUG-2007 (previously reported as 24-AUG-2007) at 10:45 was vaccinated IM with a dose of Zostavax (Lot # 658082/0744U). Concomitant therapy included AVELOX, prednisone, saw palmetto, CARTIA XT, aspirin, BETAPACE, ADVAIR, and albuterol. On 10-SEP-2007 the patient presented with a full body rash (including the hands and feet), lip swelling, and mild sores in his nares. Medical attention was sought. The physician noted that the rash was urticaria, and appears "like a CARTIA rash". The patient was advised to stop CARTIA XT and consult his cardiologist for alternative therapies. The physician also noted that the rash is "less likely from AVELOX, saw palmetto, and Zostavax. No further information was provided. There was no product quality complaint involved. Additional information has been received from the registered nurse who stated that on 10-SEP-2007 the patient developed body rash, itching, lip swelling and had mild sore in his nares. At the time of report the patient had recovered.
After the 2nd shot, four days later, I woke up and tried to go to the bathroom, but I couldn?t because I was dizzy. When tried to get up from bed I felt back, I couldn?t sit or stand.  I was dizzy all day and till now I feel dizzy.
Advised to go to ER: symptoms included hive to face, itching to face an d body and itchy throat  aproximatley 30 minutes after getting Pfizer Vaccine Was prescribed benadryl and prednisone.
Patient developed cellulitis of his shoulder upper arm and chest 10 days after vaccination. Patient given antibiotics due to severity of cellulitis.
The vaccinee received her 3rd dose of haemophilus influenza B vaccine on 10/30/00. On 6/27/00, 8/28/00 and 10/30/00, the vaccinee received her 1st, 2nd and 3rd left thigh doses of Infanrix. Three days, post vax, of the 3rd Infanrix, on 11/2/00, the pt was seen in physician's office with redness and swelling below the injection site. There was no fever noted, nor complaint of pain or fussiness. No treatment was given. As of 11/2/00, the outcome of the events is unknown.
On 3/8 after returning from skiing with severe headache, fever, photophobia. No neurologic deficits and mental status intact. CBC, LFTs, Cr all normal. CSF 3/12- with normal protein and glucose, 700 WBC- all lymphs/monos. CSF cultures neg to date.
This is a spontaneous report from a contactable physician. A 83-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at the age of 83, intramuscularly, on Feb 19, 2021, single dose, for COVID-19 immunization. Medical history included diabetes and use of a pacemaker from an unknown date and unknown if ongoing. The patient's concomitant medications not reported. Historical vaccine included the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. On Feb 19, 2021, patient felt a heaviness and tingling of both arms after the injection. Treatment received for the events: water and apple juice; had normal vitals. The outcome of the events: resolving. Follow-up attempts completed. No further information expected.
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 25-FEB-2016, the patient was vaccinated with an improperly stored PEDVAXHIB Single Dose Vaccine, 10-pack, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and, the highest temperature of excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
Arrhythmia; A spontaneous report was received from a consumer who was an 81-year-old, male patient who was administered Moderna Covid-19 vaccine.  The patient's medical history was not provided. No concomitant medications were reported. No information on allergies.  On 21-Jan-2021, approximately four hours prior to the onset of events, patient received first of two planned doses of Moderna Covid-19 vaccine for the prophylaxis of Covid-19 infection. (Lot number unknown).   On the same day, four hours after administration, patient experienced Arrhythmia and continued on and off for 4 days and stopped. It is not known that patient seek the treatment for the condition and details were not provided.  Action taken with 2nd dose of vaccine is not reported.  The outcome of the event Arrhythmia is resolved.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
I had my vaccination on 09/02/2022. On 01/17/2023 I started to experience cough low grade fever and fatigue. I tested COVID-19 Positive on 01/18/2023. I contacted my physician but I didn't qualify for the Paxlovid. I currently feel better on 03/30/2023.
Information has been received from a woman in a physician's office concerning a female who was vaccinated with the second dose of pneumococcal vaccine 23 polyvalent (Lot# 644106/0819M). The woman reported that the patient had an injection site reaction as her elbow became red and hot to the touch. A diagnosis of cellulitis was subsequently made. Unspecified medical attention was sought and the patient was treated with cephalexin (Keflex). At the time of this report, the outcome was unknown. The woman also reported that another patient had also developed cellulitus after being vaccinated with pneumococcal vaccine 23 polyvalent (WAES0301USA03064). Additional information has been requested.
08/20/10 TDAP received. Experienced left deltoid pain. Pain continued daily. 8/22/10 Pain at left deltoid, redness and swelling area warm to touch. 8/24/10 Pain, redness, swelling in left deltoid. Chest pain in midsternum area. 8/25/10 Pain, swelling, redness in left deltoid, chest pain in midsternum area. Itching all over. No rash.
Patient has had pain and swelling since the evening of vaccination.  Swelling is in her armpit, front and back of arm and up to neck/collarbone area.  Patient says it continues to get worse.  She is trying to reach her primary care provider to have it looked at.
I would like to report that I had a reaction to my flu vaccination that I received on January 12, 2010. I tried to report this on the internet and found the website to be most awkward and unusable. So I am contacting you the old fashion way and hope that it works. I had this same reaction last year when I received a flu shot...told my physician and told the administrator at the place that I got the flu shot. Both looked at me as if I were speaking a foreign language. But when I got the same reaction this year I made a point of noticing the exact timing of the reaction. In exactly 2.5 to 3 hours after the shots (Regular and H1N1) I began to have a tiny grain of sand feel in the back of my throat. Within the hour my throat felt large and it was hard to swallow. Not sore, just very hard to swallow. I looked into my throat and the uvula was swollen and elongated to about an inch long 3/8 inch wide. It lay across and along the tongue making it hard to swallow. At the same time I began to have chills and aches feeling generally lousy all over my body. I took my temperature, but I had no temperature, just chills. The tongue swelling lasted about 6 to 7 hours and the chills about the same amount of time. I could feel a very rapid heart beat in my ears as well as my chest. I did not take my pulse as I was cold and miserable. Feared knowing what it was. I am now sorry that I did not get up and take a reading! Before the shots were administrated I was asked if I was allergic to egg, chicken, formaldehyde and a list of others that were unfamiliar to me. I did ask if they were associated to molds, yeast, or sulfa or sulfites of any kind as I have very bad allergic reactions to them. The person did not think so...so I took the shots. I would very much like to know for sure what preservatives are put into the vaccine formula. I am certain that there is something I am allergic to in those formulas. Can a vaccine be administrated without preservatives?? I noted that on the patient receipt flu vaccine with preservative is listed! Please, if you would...give a response to my letter. Thank You!
Initial case was received on 03 November 2010 from a healthcare professional. An 82 year old female patient received on 08 October 2010 an intramuscular right arm injection of FLUZONE HIGH DOSE (lot number U3618AA). Two days after vaccination on 10 October 2010, she experienced confusion and didn't know who she was and had a "bad" fever of 103 F for three days with general weakness. The patient had no illness at the time of the vaccination. Pre-existing medical conditions included a positive PPD test (date not reported), hyperlipidemia and blood pressure ("BP") NOS. Concomitant medications included "several" (unspecified). She was allergic to BIAXIN, PNEUMOVAX, ZETIA and statins. The patient recovered on an unspecified date. Follow-up information was received on 10 December 2010 from a health care professional. The patient was vaccinated at a private doctor's office/hospital and the vaccine was purchased with "other/unknown". No further information was provided at the time of the report. Documents held by sender: None.
Left arm redness, heat, swelling, pain onset 4 hours after flu and  Pneumovax injections yesterday, tired, body aches-head chest back   fever 101.6 this am. Left upper arm with 4 cm area of blotchy erythema, and induration extending about 8 cm diameter, very tender to palpation, warm to touch.
Sore and Swollen lymph nodes under right arm. Started less than 24 hours after shot. Started as a feeling of a pulled muscle and got worse throughout the day. By evening, I noticed significant swelling.
Severe Headache; Dizziness; sore left arm; This is a spontaneous report from a contactable consumer or other non hcp. A 41-years-old female (non pregnant) patient received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200 and expiry date was not reported),via an unspecified route administered in Arm Left on 20Feb2021 09:00 ( age at vaccination 41 years old) as dose 1,single for COVID-19 immunisation.Medical history and concomitant medications were not reported.On 20Feb2021 12:00 patient experienced severe headache, dizziness, sore left arm.The outcome of the events was not recovered.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Fever to 104 within 12 hours of immunizations. No other symptoms. WBC 20.5 on 9/13. Blood cultures drawn. Rocephin 350mg given IM. On 9/15/03 WBC 9.5, afebrile, BC negative. No further treatment.
Large, swollen knot around the injection site on right arm, beginning the day after vaccine.  The knot grew in size, bright red, and is warm to the touch on day 10 after the vaccine.  The swollen area is about the size of a softball on day 10 and is painful.  Entire right arm feels weak and aches, similar to growing pains.
Day 1 (day of vaccine): arm pain and redness at the site;  Day 2(Thursday, day after vaccine): cellulitis at site, burning pain at site, generalized pain/back pain; Day 3(Friday, 2 days after vaccine): bilateral eye swelling, nasal congestion with drainage,  headache with photophobia
No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 05-MAY-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Pt had vaccine in left upper arm, had immediate pain and now has reduced ROM and pain in that shoulder
June 4th pain in arm initially, pain in legs like arthritis by June 11 could not walk, 3 days later went to the Hospital and found her to have blood clots
Narrative:  Patient who was admitted for respiratory failure due to COVID 9/18, previously in CLC left AMA to non compliance. HE was being treated for acute hypoxic respiratory failure , multiple causes SARS COV 19 PNA, Volume overload due to worsening CKD, not fluid responsive, then subsequently anuric not lasix responsive. Renal was consulted for Severe metabolic acidosis and ANURIa, poor candidate for renal replacement. He went into respiratory failure on my 1st day on service 9/20, was placed on HFNC 100 % FIO2 with abg showing severe hypoxemia, was placed in the ICU because he wasn't making urine and most likely will need HD and Intubation. Patient and family made a decision after failed BIPAP in ICU, that he is HOSPICE. Patient was downgraded later in the day, with HOSPICE certification 9/21 AM and patient passing 9/22/2021.
Extreme flu symptoms with high fever 104 to 102 degrees for over 14 hours that started on the second day after receiving the injection.  Flu symptoms lasted 3 days.
Systemic: CYCLE CAME 2 WEEKS EARLY 2ND DAY OF VACCINE-Medium, Additional Details: PT CALLED  THE PHARMACY TODAY 04/19/21 AROUND 3PM REPORTING THAT HER CYCLE STARTED 2 WEEKS EARLY. THIS STARTED NEXT DAY AFTER VACCINE AND STILL HAS BLEEDING. SHE DID TALK WITH A MD BUT DID NOT REMEMBER MD NAME AS WAS VISUAL. PER PT MD TOLD HER THAT SOME WOMEN REPORTED SAME SIDE EEFECT AFTER VACCINE. SHE IS GOING TO HAVE ANOTHER VISIT WITH HER GYNECOLOGISTS FOR FURTHER EVAULATION. INFORMED PT THAT WE WILL REPORT THE INCIDENT.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient was revaccinated on 03/19/21 and has since received dose 2 on 04/09/21
Patient used a scheduling tool to book vaccine for Moderna injection. He was under 18 years of age. The mother signed the authorization and consent form for the vaccine administration for Moderna Vaccine. The scheduling system for Moderna allowed a patient under 18 years of age to be scheduled. Registration failed to recognize he was under 18 years age. The RN who administered the vaccine also failed to recongnized the patient was under 18 years of age. Moderna was contacted after administration, Moderna recommended the second dose be given to patient and may be scheduled iin 4 weeks.
I had cold chills, high fever, body aches, cramps, nauseated/vomiting, and really tired.
Patient said felt dizzy after administration, woke up next day very tired and slept days. Arm has red, swollen baseball sized area around injection site and smaller dark red quarter size area where needle went in.
I started feeling muscle pain that afternoon. I struggle with pain the next day, I cam hm from work I had chills. High temp, I went strait to be. Lost a day of wor today.feel like I?m getting over the flu.taking it easy.
Patient received her first dose of the Pfizer pediatric COVID shot. Approximately 1 minute after getting her shot, while still in the immunization room, she passed out, hitting her head on the wall on the way down. 911 was called and EMTs responded. The patient regained consciousness quickly and her vital signs (as monitored by the EMTs) were normal. Out of an abundance of caution, the parents chose to be transported to the ER for follow up.
This consumer spontaneous report (25-Mar-2015) concerns a 59 year old male patient who had a medical history of a small non-malignant tumour which was removed in Dec-2014. About one year ago, he was prescribed sulfamethoxazole/trimethoprim for a suspected bladder/prostate infection and after taking it for 6-7 days, he felt fatigued and the sulfamethoxazole/trimethoprim was ceased and went to the Emergency Room where they could not find the source of the fatigue. It was discovered that he had a kidney stone and not a bladder/prostate infection. The fatigue lasted 9-10 months and had almost gone. His neurologist explained that the sulfamethoxazole/trimethoprim was most likely the cause of the fatigue. The patient was not on any concomitant medications. On the 10-Oct-2014, the patient received AFLURIA (batch number not reported). In late Dec-2014 or early Jan-2-15, the patient started to feel shoulder pain. He had not been self treating the pain because it did not bother him most of the time, only when he reached for something behind him. He sought medical advice from his neurologist who stated that the patient may have had a delayed response to the vaccine given his past medical history and was advised to take naproxen or ibuprofen. The pain had lasted for a couple of months and was subsiding. Outcome was reported as not yet recovered. Reporter comments: The consumer stated that the shoulder pain was probably not related to vaccination.
Chemical taste in mouth was the first sign, then inability to swallow for approximately 1-2 minutes.  Resolved by itself and no further problems.
Period/ hormones. Had an extra long cycle (over 55 days to bleed) have now been bleeding heavily for over 3 weeks.  Only thing that has changed was I got my booster.