chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After several hours after getting Prevnar and Menveo on 9/23/2020 at our primary care office, pt reported getting fever 103, redness, swelling and pain on right arm. He went to an urgent care and dc'd to home without interventions, supportive care only. Symptoms resolved over the course of several days on his own. Pt reports got both vaccinations in right arm, although our records indicated he got Prevnar in left arm and Menveo in right arm.
redness and swollen arm in the area of the shot 6 days post vaccination. No treatment.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Severe, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Vomiting-Mild, Systemic: Weakness-Mild, Additional Details: Patient fainted. I was able to wake her up, then she vomited. Looked gray and complained her hands and feet were numb. She felt great as we were giving her the shot. Within seconds she fainted.
Onset of pretty severe neck and upper back pain that made it difficult to sleep because I was unable to find a position that didn't cause any pain about 12 hours after injection (inj: 12:45 pm on 4/16/21; onset: 12:30 am on 4/17/21). Saturday, 4/17/21, the pain lessened and I just felt a bit of fatigue and injection site pain. Sunday night (4/18/21) going into Monday morning (4/19/21) I was woken up from my sleep with very severe upper neck pain that radiated down the R-side of my back, on the muscle. I could not fall back asleep for 2 hours because any position I was in I experienced intense pain. Today, 4/19/21, during the day, the pain is definitely less severe. I took my meloxicam this morning as I usually do but it was still pretty bad pain so I rubbed CBD cream on it. Pain still feels dull but tense, with occasional flare-ups of sharp pain. Today it is more widespread, across my shoulders and in the bilateral upper back area. When I rubbed the CBD cream on it, it hurt to touch. I also take gabapentin at night, which is my standard for my fibromyalgia, and I'm not sure if that is what is exacerbating this pain, seeing as it is so much worse at night. I have never woken up from pain before like I did last night, and I deal with pain daily with fibromyalgia. It was very intense.
Pt had tetanus Diphtheria administered in right upper outer arm on 3/31/06. The next day she noticed /// pain, redness and swelling in area which progressively increased in severity for 48 hours, gradually improved. Symptoms improving.
Pt presented to the ER complaining of swelling and a warm red area around the injection site. ER did not seem to think was infected but was an adverse reaction to vaccine. In case of cellulitis prescribed Doxycycline twice daily for 10 days. Patient did not show reaction to pharmacist so that we could determine if typical reaction.
Pt developed chest pain 30 mins after vaccination, associated with feeling of shortness of breath and persistent cough that has lasted for 7 days.  She developed fever/chills/muscle aches 14 hours after vaccination that lasted for 1-2 days and then resolved.  Pt referred from our health center to local ED  for more thorough evaluation to r/o PE.
Patient with Positive flu symptoms, beginning approximately 1-1 1/2 after receiving shot.  A order: runny nose, sneezing, chills, bad headache, fever of 101 degrees, body aches.  Call her PCP.  No antiviral.  Bed rest no MD visit. Out of work x 4 days.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided. In or around September 2014, the pt was inoculated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In 2014 (reported as "shortly after receiving zoster vaccine live(ZOSTAVAX)"), the pt suffered shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), the pt experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. As a result of the zoster vaccine live(ZOSTAVAX), the pt  sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Shingles was considered to be disability by the reporter.
This is a spontaneous report from a contactable nurse calling from physician's office who reported similar events for 15 patients. This is the 6th of 15 reports. A patient of an unspecified age, gender and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017) via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter/drug/AE, different patient.
Lung infection - that was persistant for months - scarred lungs from coughing. Addisons Disease. (auto- immune) Trisonomy 18 was detected at 17 weeks pregnant. Abortion was advised. Post DE, i am now infertile and do not get menses.
4/14/2021- Easy bruising started appearing. 4/19/2021- At 1750 patient presented to ER (Post Fall). Lab showed platelet count of   less than 3,000.  4/19/2021- Patient Admitted to Hospital, 2 packets of platelets.  4/22/2021- Patient discharged from hospital
Pt vaccinated with Recombivax HB experienced generalized maculopapular pruritic rash mainly involving face, chest & both upper extremities
After 10 days soreness reappeared in left arm.  Red rash appeared about the size of a saucer.   Mild soreness remains.  Size of rash has diminished as has color intensity
Dizziness, Headache & NauseaVomiting Narrative: dose 1:Headache, Nausea, Vomiting, ITCHY THROAT dose 2: Arm sore ; Monstrous headache, eye pain, nauseated, weak, dizzy
Patient received the Moderna mRNA COVID vaccine on 3/5/21. On 3/19/21, patient presented to the emergency department with chest pain starting the night prior to presentation. Patient admitted from 3/19/21-3/20/21 for possible pericarditis.
Left arm tender; Lump at injection site; Diarrhea; Pain in left arm; The injection hurt a lot; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Left arm tender), VACCINATION SITE MASS (Lump at injection site), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Pain in left arm) and VACCINATION SITE PAIN (The injection hurt a lot) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced TENDERNESS (Left arm tender), VACCINATION SITE MASS (Lump at injection site), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Pain in left arm) and VACCINATION SITE PAIN (The injection hurt a lot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, TENDERNESS (Left arm tender), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Pain in left arm) and VACCINATION SITE PAIN (The injection hurt a lot) outcome was unknown and VACCINATION SITE MASS (Lump at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The consumer that about 1 hour later of receiving first dose, her left arm became tender, painful, and developed a lump the size of a quarter.   The consumer stated that the injection hurt a lot and the lump still has not gone away. He has taken Tylenol, Advil, and put ice on her left arm  as treatment.  No concomitant product use was provided by the reporter.
Arm felt warm; Redness; Arm felt hard; Headache; Tender; Felt lymph nodes under her armpit, swollen and tender; Hardness; Swollen arm at injection site; Felt feverish; Chills; Joint pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm felt warm), PAIN IN EXTREMITY (Tender), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE INDURATION (Arm felt hard) and LYMPHADENOPATHY (Felt lymph nodes under her armpit, swollen and tender) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Hardness), VACCINATION SITE SWELLING (Swollen arm at injection site), PYREXIA (Felt feverish), CHILLS (Chills), ARTHRALGIA (Joint pain) and the first episode of HEADACHE (Headache). On 16-Mar-2021, the patient experienced LYMPHADENOPATHY (Felt lymph nodes under her armpit, swollen and tender). On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Tender). On 18-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Arm felt warm), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE INDURATION (Arm felt hard) and the second episode of HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Mar-2021, VACCINATION SITE INDURATION (Hardness), VACCINATION SITE SWELLING (Swollen arm at injection site), PYREXIA (Felt feverish), CHILLS (Chills) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (Arm felt warm), PAIN IN EXTREMITY (Tender), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE INDURATION (Arm felt hard), LYMPHADENOPATHY (Felt lymph nodes under her armpit, swollen and tender) and the last episode of HEADACHE (Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
experiencing itching, extreme itching, around where the shot was given; the area is really red; very hard like a hard nut; is very swollen; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PRURITUS (experiencing itching, extreme itching, around where the shot was given), VACCINATION SITE ERYTHEMA (the area is really red), VACCINATION SITE INDURATION (very hard like a hard nut) and VACCINATION SITE SWELLING (is very swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included blood pressure pill for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (experiencing itching, extreme itching, around where the shot was given), VACCINATION SITE ERYTHEMA (the area is really red), VACCINATION SITE INDURATION (very hard like a hard nut) and VACCINATION SITE SWELLING (is very swollen). At the time of the report, VACCINATION SITE PRURITUS (experiencing itching, extreme itching, around where the shot was given), VACCINATION SITE ERYTHEMA (the area is really red), VACCINATION SITE INDURATION (very hard like a hard nut) and VACCINATION SITE SWELLING (is very swollen) outcome was unknown. 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.
I developed a case of the shingles till now 04/17/21  my doctor prescribed a acyclovir and gabapentin.  He also added diclofenac
Headache; fatigue; muscles aches; Fever/ 103.6/100.8/"102 something"; Dizziness; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, expiry date: Mar2021, via an unspecified route of administration from 20Dec2020 at a single dose (dose unknown, by injection once) for covid-19 immunization. Medical history included multiple sclerosis (MS) from 2015 and ongoing. The patient's concomitant medications were not reported. The patient previously took ocrevus for multiple sclerosis. She had COVID in August, and got antibody testing, as the medication she was on (ocrevus) for MS knocked out antibodies, so she received the vaccine. The patient spiked a fever of 103.6. She couldn't get out of bed all day and she started having dizziness and headache yesterday, which got progressively worse, and last night she had fever of like 100.8, muscles aches and fatigue, and she woke up this morning and her temperature was "102 something", and she took ibuprofen. She stated that she then got out of bed, as she could hardly get out of bed before or she would pass out, and now her temperature is 103.6, and she has never had it that high before. The dizziness started soon after vaccine. It is all over the place, when she stands, she is incredibly dizzy, but is ok now that she is sitting. She added that she has MS, so dizziness was not abnormal for her. The headache started soon after vaccine; it comes and goes, it goes away and comes back. For the muscle aches and fatigue, they got a lot worse, but was ok now, the Ibuprofen is kicking in. She had stayed in bed all day, then her temperature was 103.6, she had finally got out of bed and took her temperature and ibuprofen. Outcome of events fever, fatigue, myalgia was not recovered whereas the outcome of other events was unknown.  No follow-up attempts are possible. No further information is expected. The information on the batch/lot number was obtained.
A large red area appeared at the injection site on the evening of 7/17/07. The area was the size of a playing card. The area felt hot and painful. The area felt knotty. The patient the area and took Diphenhydramine 5 7/27/07 (PM).
Red, swollen, tender right deltoid area worsening after 24 hours. No fever, nausea or vomiting. Treated for cellulitis and allergic response.
temperature excursion which lasted for a total duration of 44 minutes opened ipol refrigerator door was left open temperature reached: sep 22: 1.3c for 19 min sep 30 1.7c for 14 min oct 9: 1.8c for 11 minutes with no ae; after temperature excursion opened ipol.if was the product administered with no reported adverse event; Initial information received on 11-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3-years-old female patient who was administered vaccine IPV (vero) [IPOL] after temperature excursion which lasted for a total duration of 44 minutes as refrigerator door was left open temperature reached: sep 22: 1.3c for 19 min sep 30 1.7c for 14 min oct 9: 1.8c for 11 minutes with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP); Influenza Vaccine; and pneumococcal vaccine conj (Pneumococcal Conjugate Vaccine) for Prophylactic vaccination.  On 03-Oct-2023, the patient received 0.5 mL dose 1 of suspect IPV (VERO), Suspension for injection (batch number: W1A191M; expiry date: 16-Feb-2025) via intramuscular route in left thigh for immunization after temperature excursion which lasted for a total duration of 44 minutes as refrigerator door was left open temperature reached: sep 22: 1.3c for 19 min sep 30 1.7c for 14 min oct 9: 1.8c for 11 minutes with no adverse event (poor quality product administered) (same day latency) (product storage error) (unknown latency).  Human error: Yes  Action taken: not applicable.  Treatment: None  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
It started 2-2 1/2 hrs. after I had vaccination. Rapid heartbeat. Irregular heartbeat. It lasts a couple-3 days (non-stop).
This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age and gender. On 23-APR-2015, the patient was vaccinated with one dose of PROQUAD (Merck) that had been improperly stored (subcutaneous, lot # K025760, expiry: 08-JUN-2016, dose not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
can not walk yet without walker; Initial information was received on 21-Jun-2021 regarding an unsolicited valid serious case from a consumer or non-healthcare professional. This case involves an elderly male patient who can not walk yet without walker (gait inability) after he received FLUVIRIN [INFLUENZA VACCINE INACT SAG 3V], ZOSTAVAX and INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect ZOSTAVAX not produced by Sanofi Pasteur [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect FLUVIRIN [INFLUENZA VACCINE INACT SAG 3V] not produced by Sanofi Pasteur [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious cannot walk yet without walker (gait inability) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, ZOSTAVAX and FLUVIRIN [INFLUENZA VACCINE INACT SAG 3V]. This event was assessed as medically significant and was leading to disability.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the event outcome was unknown.  Information on batch number is requested.; Sender's Comments: This case involves an elderly male patient who experienced gait inability (unknown latency) after vaccination with FLUZONE HIGH DOSE, ZOSTAVAX (not produced by Sanofi Pasteur) and FLUVIRIN (not produced by Sanofi Pasteur). The time to onset was unknown. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccines cannot be assessed.
Pt. had a whelp & redness around injection site within 5 mins. after vaccine was given. Was given BENADRYL.
High pulse rate at rest - over a 100; I feel it in my right ear-Swishing sound; Couldn't sleep; Afraid to go to sleep, and afraid to not wake up; Felt delirious; High fever 100.5° - 101.1°; Chills; A spontaneous report was received from a 58-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) felt delirious and experienced high fever 100.5 - 101.1, chills, high pulse rate at rest - over a 100, I feel it in my right ear - swishing sound, couldn't sleep until 3 am, afraid to go to sleep, and afraid to not wake up.  The patient's medical history, as provided by the reporter, included menopause and high blood pressure. Concomitant product use included valsartan and bumetanide.   On 15 Jan 2021 between 7:15  7:30 AM, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 15 Jan 202 between 4:30 - 5 PM, the patient experienced symptoms of high fever 100.5 - 101.1 degrees Fahrenheit, chills, and felt delirious.  On 18 Jan 2021, the patient reported a high pulse rate at rest, in her right ear she felt a swishing sound. Additionally, the patient, could not sleep, she was afraid to go to sleep and afraid to not wake up. Treatment for the events included a cold compress and paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, high fever 100.5  101.1, was considered resolved. The outcome for the events, high pulse rate at rest - over a 100, in her right ear she felt  swishing sound, couldn't sleep, afraid to go to sleep, and afraid to not wake up was considered not resolved. The outcome for the events, chills and felt delirious, was unknown.; Reporter's Comments: This spontaneous report refers to a case of a male patient with medical history of high blood pressure, who experienced a serious event of felt delirious and non-serious events of high fever 100.5 - 101.1, chills, high pulse rate at rest - over a 100. "I feel it in my right ear"  swishing sound, couldn't sleep until 3 am, afraid to go to sleep, and afraid to not wake up. The events of fever, chills and delirium developed on the same day after the administration of the mRNA-1273 vaccine (lot # unknown, expiration date-unknown).  The other couldn't sleep, felt swishing sound in ear, afraid to go to sleep and afraid to not wake up and high pulse rate occurred 3 days after the vaccine administration. Treatment administered include cold compress and paracetamol. The events of fever and chills are listed in safety profile of the vaccine and based on the information provided which includes a temporal association, a causal association between the reported events and the administration of the vaccine cannot be excluded.
The vaccination given was expired by 2 days. Given on 12/2/2022 and expired on 11/30/2022. No adverse reaction occurred. Reported to Pfizer and waiting to hear back if vaccination needs to be repeated.
This spontaneous report as received from a health care worker via company representative refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, several years ago, the patient was vaccinated with GARDASIL, (dosing details not provided). On an unknown date, the patient experienced unspecified neurological symptoms after receiving the unspecified doses on unspecified dates. Outcome of the event and the causality were not reported. No product quality complaint (PQC) was involved. Additional information is not expected as the reporter did not give consent for follow up.