chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 12 month old female with no know medical history or allergies who on 09-Aug-2004 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 647707/1245N). There was no illness at the time of vaccination. Subsequently the patient broke out with blisters and a few lesions and developed a fever of 103. No tests were done. Unspecified medical attention was sought.  There was no produce quality complaint involved.  follow-up information indicated that on 17-Aug-2004 the patient came in with a 102 fever, rash and red lesions all over her body. Her rash was consistent with atypical varicella. On approximately 20-Aug-2004 the patient recovered. There was no laboratory or diagnostic tests performed.  The reporter also indicated that another patient (WAES # 0408USA01717) has similar experiences following exposure to varicella virus vaccine live (Oka/Merck).  No further information is expected.
Complaint of feeling hot, difficulty breathing and feeling anxious. 1614 vitals: BP 160/72, T 98.3, P 106, R 20 O2 98%. Bilateral lung sounds clear. 1644 vitals: BP 124/60, T 98.4, P 80, R 16, O2 98%. Patient feeling better and discharged from clinic.
Waves of extreme fatigue, fever, body aches, upset stomach, diarrhea, slight sore throat and a wave of nausea.  Nausea started about 2 hours after shot.  Fatigue started at 5:30 pm along with body aches.  Fever, upset stomach and diarrhea started at 11 pm .  Fever lasted until 6pm next day (Tuesday) along with fatigue, body aches and sore throat.  Upset stomach and diarrhea ended about 10 pm next day (Tuesday).  As of Wednesday morning all symptoms are gone.  Took ibuprofen 2 times for fever and aches.
24 hours post injection, high fever (mom did not check temp) lethargy, abd pain, achy, looked sick for 3 days.  sibling with same symptoms but only for 24 hours
pt recvd vax & 6 days prior to vax had virus; 5 mins p/vax exp shaking, rapid pulse, rapid resp, was pale, had cool & clammy skin looked like a sugar react treatment:juice WBC was elevated & blood sugar was low 1 1/2 hrs later sx recurred;
This case was reported by a pharmacist via call center representative and described the occurrence of migraine in a 54-year-old female patient who received TWINRIX (batch number 2BA47, expiry date 27th September  2018). On 8th December 2017, the patient received TWINRIX. On an unknown date, less than a year after receiving TWINRIX, the patient experienced migraine and dizziness. On an unknown date, the outcome of the migraine and dizziness were unknown. It was unknown if the reporter considered the migraine and dizziness to be related to TWINRIX. Additional details were provided as follows: The patient was not hospitalized. It started about a week ago from the date of reporting, after the vaccine being administered. The reporter recommended the patient to see her provider to check if it was caused by other conditions. The patient had not seen a physician till the time of reporting and it has been a month ago from the same. The caller has been informed that they have reported an experience with GlaxoSmithKline product that needs to be shared with GlaxoSmithKline. The reporter has agreed to have GlaxoSmithKline's Safety team follow-up with them via postal mail.
Left arm was red, swollen, warm to touch, itching and had a lump in the left upper arm where these 2 injections were given. Called on 4/24/00 and child's mother told her that the child is doing better after DR advised to give Tylenol.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider (unspecified healthcare professional), recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, the patient's healthcare provider (an unspecified healthcare professional), administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by the healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
pt recvd vax 6SEP95 11AM; APAP given about 1/2hr later;fever started about 1/2 hr p/APAP given; fever no higher than 101 ax; rash began 4AM over head, arms, trunk & legs; red macule, that caused itching-welt hive;
started as sinus infection, drainage was extremely thick / tenacious. Coloration was tan/ brown / green. Swollen lymph nodes submaxillary. sore throat. laryngitis for several weeks. SOB in evenings.  Antibiotics were started on telemed conference with my internist using Annamox 875.   Thrush / yeast developed due to all the penicillin. Diflucan and nystatin swish and swallow given.  SSX continued so second round of Annamox given. Drainage became heavier and thicker.  Contacted ENT and started on Leaveqid 500 mg and cultures were run; culture came back Staph and candida yeast. Meds switched to Bactrium DS BID for 10 days; SSX continued so switch over to tetracycline 500 mg TID for 10 days. Second round of tetracycline was prescribed which finally stopped the SSX. Drainage had become thick  tan/yellow near the last week before it stopped coming out in globs. I have never been DX with a staph infection prior this or have had an infection last from mid Oct to almost second week in Feb.  This may not be related to the vaccine, but with being in the study, I wanted to provide the information since it was an atypical drainage and was unusual  for me to be down with an infection for this length of time
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 26-JUN-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot#  N024562 and expiration date 06-MAR-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
Heavy menstrual bleeding twenty days per month for six months after the vaccine,  and I had previously been almost in menopause. Previous to vaccine I bled for one day every two months only.
Chest palpitations. Swollen lymph node in left armpit. My lymph node was so swollen that it was clearly visible when compared bilaterally. It swelled especially at night so badly that my left arm would become numb. I would wake up and massage it until feeling returned. If it wasn't numb my arm was painful. Since I had left arm pain, numbness accompanying new palpitations I visited the ER after consulting with a nurses hotline. The lymph nodes swelling has reduced but I now have chest palpitations daily which I have never had before. I also have left arm pain on the ulnar side of my fore arm and left arm weakness. The pain is worse when I use my left hand and I can't lift more than 5 pounds  without pain being present.
Itching to right forearm and bilateral upper thighs, provided Benadryl 25mg po, and recovered
Stated that 45 min after vaccine when walking to car, began having SOB, felt like she was breathing through cotton and then sand. Increased her prednisone to 20 mg per day. Day 3-4 became dizzy, weak, developed a rash with itching.  SOB continued Day 8 SOB is getting better and weaning down to 8 mg prednisone
Chills; Tiredness; Pain stomach; This is a spontaneous report from a contactable consumer. A 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN9581) via an unspecified route of administration, in right arm on 02Feb2021 11:30 (at the age of 81-years-old) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL3249) via an unspecified route of administration on 12Jan2021 at 9:30am as 1st dose, single for covid-19 immunisation. No additional vaccines administered on same date of the pfizer suspect. Patient explained that it had been a week since getting her second shot and she went through the chills (on 03Feb2021) and muscle aches, but the acute tiredness is still on going. Caller clarified that there were no muscle aches. She explained she did have pains in the stomach (on 02Feb2021). This started 6 hours after the second dose and lasted about 8 hours. Acute tiredness this started Wednesday (on 03Feb2021) and had gotten worse. It is now a little better but still ongoing and exhausted. Adverse event did not require a visit to emergency room or physician office. Outcome of the event fatigue was recovering, pain stomach recovered on 03Feb2021 and chills recovered on 04Feb2021.  Follow-up attempts completed. No further information expected.
Patient had a reaction to the first dose (previously reported), but mainly involved itching and some throat swelling/tightness. Due to the previous reaction, we had him pre-medicated with 50mg diphenhydramine about 1 hour prior to vaccine (per patient took dose around 4PM). He received vaccine at 501PM in the left deltoid. About 10 minutes later his left foot started itching. At about 20 minutes post-dose had several other itchy spots around his body (left ankle, below injection site, left wrist, top of head, left knee and right chin/jawline). He had no swelling/itching or other throat symptoms and no noticeable rash/hives. At 540PM patient was still feeling fine other than mild itching, so he left. He was advised to take another dose of 25-50mg diphenhydramine at bedtime (or sooner if symptoms worsened). If difficulty breathing or any swelling of the face, patient advised to go to hospital immediately.
This spontaneous report was received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of ROTATEQ oral liquid (dose, dose number, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. Thi sis one of several reports received from the same reporter. Additional information has been requested.
When he got his second shot his arm didn't even hurt. It hurt for maybe 4 or 5 hours; feels he was not given the vaccine because he felt a discharge on his arm at the injection site; feels he was not given the vaccine because he felt a discharge on his arm at the injection site; feels he was not given the vaccine because he felt a discharge on his arm at the injection site; potential counterfeit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 17Feb2021 (Lot number: EL3428) at the age of 62 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 (First dose lot number EL1283- customer service confirmed it is a Pfizer vaccine/ Expiration date confirmed with customer service- 30April2021.), administration date: 27Jan2021, when the patient was 62 years old, for COVID-19 immunisation, reaction(s): "He reports his arm was not sore like it was from the first vaccine". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 17Feb2021, outcome "recovered" (Feb2021), described as "When he got his second shot his arm didn't even hurt. It hurt for maybe 4 or 5 hours"; ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious), UNDERDOSE (non-serious) all with onset 17Feb2021, outcome "unknown" and all described as "feels he was not given the vaccine because he felt a discharge on his arm at the injection site"; SUSPECTED COUNTERFEIT PRODUCT (non-serious) with onset 17Feb2021, outcome "unknown", described as "potential counterfeit".  Additional information: It was reported that patient was not too sure about the validity of the second shot because of the way people were behaving. He was not accusing anyone of anything and just wants to make sure we have a record of the lot number for his own peace of mind. He asked if there was a way to track where that lot number was used and what the ingredients are in the lot number. He stated he has given shots to people for 30 years and this [his experience] was a little bit different. He stated they told him when he got his first shot to watch out for the second shot because that one will have the doozy side effects. When he got his second shot his arm didn't even hurt. It hurt for maybe 4 or 5 hours but he had no side effects at all. Patient also reported that he felt he was not given the vaccine because the he felt a discharge on his arm at the injection site. The patient wanted to report this as a potential counterfeit. He also reported that his arm was not sore like it was from the first vaccine, he further stated like he expect from an IM injection. The patient also asked if symptoms are more severe after the second dose.  No follow-up attempts are possible. No further information is expected.
Tachycardia; Tremors; Pressure in the head; Distress; This is spontaneous report from a contactable consumer and a response to the mail trail regarding confirmation of the query. A 52-years-old non-pregnant female consumer (Patient) reported for herself that she received first dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Not provided, Reason why batch/lot is Unknown: Not available/provided to reporter at the time of report completion) via an unspecified route of administration on 04May2021 at 02:00 pm in left arm as dose 1, single for covid-19 immunisation at the age of 52 years old. Vaccine was administered at other facility. Patient's medical history included hypertension (dates unspecified). Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Patient experienced tachycardia, tremor, pressure in the head and distress on 04May2021 at 02:00 pm. AE did not result in emergency room visit or physician's office. No treatment was given for the adverse events. The outcome of events was recovered on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
within 24 hours, developed 3 small nodules around left clavicle (left arm was injection site); nodules around 0.5 cm, easily moveable, not painful; no change in size over last 4 weeks
COVID Vaccine Breakthrough Case  Moderna Dose 1 3/20/21 (038A21A) Moderna Dose 2 4/17/21 (040B21A) COVID Positive 11/9/21  11/9/21: Patient is 70-year-old male with past medical history of hypertension, dyslipidemia, hypothyroidism and unspecified leukemia status post chemotherapy P in remission.  He is being transferred from Medical Center ED for further evaluation of acute hypoxic respiratory failure secondary to COVID-19 pneumonia.  He presented to the emergency room with a complaint of cough productive of sputum and shortness of breath X 2 weeks. Patient was in relatively good state of health until 2 weeks ago when he started to have cough productive of brown sputum.  He also reported associated shortness of breath. He reported generalized body ache, generalized weakness and fatigue.  Reported decreased appetite but no nausea vomiting abdominal pain or diarrhea.  Patient denied fever chills or rigors.  Since a week ago, he was not able to do his regular work.  He is a truck driver by trade.  Patient is fully vaccinated for COVID-19.  He denied use of tobacco products or alcohol.  Upon evaluation at referring facility ED, he was hypoxic with saturation as low as 78% on room air requiring 7 L of oxygen to maintain saturation.  He was hemodynamically stable and afebrile.  Significant lab findings were hyponatremia of 132, lactic acidosis at 2.5. Nasopharyngeal swab was positive for COVID-19.  Chest x-ray was suggestive of vascular congestion.  CT chest with IV contrast was suggestive of viral pneumonitis with no acute pulmonary embolus. At the referring facility ED, patient received ceftriaxone 1 g IV, azithromycin 500 mg IV and remdesivir to 100 mg stat.  He also received Lasix 40 mg IV.  11/23/21: As noted patient presented to the hospital with shortness of breath cough fatigue weakness for 3 weeks. Patient COVID-19 positive with COVID-19 pneumonitis.  Was placed on high-flow oxygen in ICU, patient received remdesivir, Decadron, Actemra, Rocephin/azithromycin, along with supportive measures and pulmonary toileting.. Gradually clinically improved, his oxygen requirements continued to decrease and eventually was weaned down to room air.  Finish course of antibiotics, discharged on Decadron taper.  Patient will be discharged to skilled nursing facility.  Patient's losartan was held on discharge is pressures were normotensive, can restart as clinically appropriate.  All ED and RTC precautions were provided to patient, clearly endorsed understanding and was in agreement with plan as outlined.  Will follow up with PCP within 7 days of discharge.
Seizure activity 4 hours following vaccinations.  Child recently diagnosed with epilepsy.
Immediate redness, itchiness. After an hour arm became swollen at site. The next morning it continued to be red, with > 7cm induration. On the 2nd day post vaccination arm had "bullseye" look as well. Symptoms were gone by day 6 post vaccination.
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 22-JUN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 10 single DS, 0.5 mLVls 10SDV, (lot number L035882, with an expiration date of 19-APR-2017) (route and anatomical location were not reported) that was improperly stored. On an unspecified date, the PNEUMOVAX 23 vaccine had a temperature excursion. The lowest temperature excursion was of 34 degrees Fahrenheit (F), (1.111111111 Celsius degrees) for a total of 176 hours. No adverse effects were reported. The vaccine storage criteria and the type of excursion were refrigerator (R), and the vaccine status was reported as  "in excursion". Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Had a fever, so tested for COVID-19 and it was positive. Contacted doctor and was prescribed Paxlovid. Taking doses right now and starting to feel better.
Expired vaccine given to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-365967, MOD-2021-365701 (Patient Link).
The pt experienced 12 hours post vax. the pt developed a fever of 103.2. No other symptoms. The fever resolved later that day and then experienced a diffuse erythematous tiny papular lesions appeared all over the body.
Right arm was red and sore at injection site after dose given. This lasted for a few days just as it happens with other immunizations in the past. The area improved significantly. On day 8 the site got red, warm to touch, shiny, and skin tight, and very sore. It was very itchy.
Patient called 2 days after receiving vaccine on 10/2/19 stating area has become red and is growing larger - referred patient to seek medical attention, patient will see NP at dr's office today at 12pm
pt presented with cough and sore throat 1 day after discharge from hospital . Was discharged then presented again 2 weeks later with intracranial bleed, pt is not expected to survive, brain death being confirmed.
Headache injection site pain Narrative: Pt got COVID vaccine 1/8 and on 1/9 reported headache and inject4ion site pain - took aleve tylenol and applied ice to the area
I experienced symptoms of fever of 101/9 at highest point, clammy, nausea, abdominal pain, fatigue, slight cough, runny nose, shortness of breathe, and wheezing in my lungs. I was prescribed Azithromycin, Doxycycline for 10 days, Zofran for nausea, Fluticasone, Loratadine, Benzonatate, and I was diagnosed with an Upper Respiratory Infection and Bacterial Infection of Lung. I have improved, but I am still experiencing fatigue, clamminess, and shortness of breathe.
I received my first COVID vaccination and woke up the next morning and I could not move my neck, my shoulder hurt and my arm was numb all the way down it.  The symptoms have persisted since 1/27/21
Headache, Fever, NauseaVomiting, chills, extreme fatigue,  Narrative: