chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown demographics. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored VARIVAX lot # L048463 with expiration date on 02-DEC-2017 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of -9 to 8 degrees Celsius for 27 hours. Digital data logger was used to record the excursion. There was no previous temperature excursions reported. A properly stored sterile diluent (lot number and expiration date were not reported) was used to reconstitute the doses of VARIVAX. No adverse effects were reported. Additional information has been requested.
weird feeling on head; lightheaded after first shot; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (weird feeling on head) and DIZZINESS (lightheaded after first shot) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    The patient's past medical history included Non-tobacco user and Alcohol use (ALCOHOL USER:BEER, WINE OR HARD LIQUOR BASED ON HIS MOOD). Concurrent medical conditions included Ulcerative colitis and Blood iron decreased. Concomitant products included IRON POLYMALETHER for Blood iron, MESALAMINE for Ulcerative colitis.   In May 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced HEAD DISCOMFORT (weird feeling on head). In 2021, the patient experienced DIZZINESS (lightheaded after first shot). On 27-May-2021, HEAD DISCOMFORT (weird feeling on head) had resolved. In 2021, DIZZINESS (lightheaded after first shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood iron: low.         In 2021 citrate free pen malfunction with Humira 40MG/0.4ML.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment drug was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624152.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Patient age, medical history, laboratory data, concomitant medication and new event were added. Narrative updated.
6 days after receiving my covid19 booster (moderna) my low-mid back started hurting badly.  I got pfizer for my first 2 shots.  I experienced this back pain after my last 2 flu shots as well.  I haven?t done any serious physical exertion since my booster so i know it is unrelated to physical activity.  The type of back pain is exactly like the flu shot reaction.  Like someone went to down punching my kidneys and ribs in my back.  I had to sit on my couch to put my socks on because I can pick and hold my feet high enough to do it.  I have to use my hands to support my thighs to get up and bend over.
Nurse gave patient COVID vaccine without the consent in front of her and did not realize that she was 14 until after the injection was given.
From telephone contact received on 06/14/01 stated that a male patient received Tripedia and a Hibtiter vaccinatioin on 06/13/01. Reportedly that evening, the patient was taken to the emergency room with a fever of 101.5 deg F, stridor and screaming. Hospital administered steroidal Pediapred. The patient was seen at physician's office the next day. His fever was down but was extremely fussy. Continued treatment of Pedipred for three more days.
I was sneezing, had a headache, coughing, tired. I tested myself and was positive. I felt for a couple of days then felt good. Today is my 10th day and I've been feeling bad again. I had trouble breathing yesterday. I did not take any antivirals.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 People were vaccinated with the Moderna Covid 19 vaccine past its best use by date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul-2022 after 30 days) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. In July 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 People were vaccinated with the Moderna Covid 19 vaccine past its best use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul-2022 after 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 People were vaccinated with the Moderna Covid 19 vaccine past its best use by date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul-2022 after 30 days) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. Number of patients involved were 12 patients. Number of doses, vials reported  were 3 vials and 12 doses.The dates of administration and number patients were reported as on16-Jul-2022 to 3 patients, on 23-Jul-2022 to 5 patients, on 24-Jul-2022 to 4 patients. All the vials were moved to fridge on the same day on 13-Jun-2022. The vial did not undergo any temperature excursions. No treatment medication was provided. This case contains information for the 5th of the 12 patients who received the vaccine on Jul-2022 as described by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2022: Follow up received contains updated reporter contact detail and narrative updated.
When entering vaccine into our EMR system I got an alert the vaccine had expired 10/6/2023. No treatment performed for this. Pt mother who brought her to the appointment was informed of the mishap and that the dose would need to be re administered as an expired dose does not count. Pt mother was understanding of having to repeat the Hib vaccine. I also informed one of our office's vaccine leads so they could pull the expired Hib vaccine from our stock to ensure this did not happen again.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: pt states 30 min after her vaccine her face and throat started to swell up and had difficulties breathing. she took 2 benadryl and 2 more 30 min later. she states she has never had a reaction to the flu vaccine in the past and within the hour she felt fine.
Patient reports (12/10/17 1pm) that day after shot (12/08/17) she noticed a hot rash on shoulder of injection site that total and moved down her arm (shoulder is no longer red, starts below that but extends to her elbow and it is hot). Some pain in shoulder. She has had flu vaccine before without any problems. At time she had called, she did not do anything to self-treat. I advised to apply ice to hot swollen areas, oral BENADRYL, and ibuprofen and if doesn't start to improve or gets worse to let me know and should consider being seen in a clinic.
LEFT EYE BEGAN TO SWELL, DEVELOPED COUGH WAS GIVEN epinephrine AND BENADRYL IN OFFICE.
Systemic: swollen lymph nodes on left side; painful to swallow-Severe, Systemic: Lymph Node Swelling-Severe, Additional Details: pt was fine with 1st dose.  received 2nd dose on 5/16/21 and developed pain, trouble swallowing on friday 5/21/21 and got progressively worse where pt had to go to er on sunday 5/23/21.  Er nurse gave pt an antibiotic and norco for the pain and advised pt to call pharmacy to report.  According to pt, er did not advise pt to follow up with primary care md.  Rph advised pt to follow up with primary care md
Information has been received from a 66 year old white female with an allergy to ampicillin, who on 06/11/01 was vaccinated with the second dose of pneumococcal vaccine 23 polyvalent (lot # 637261/1067K) in the left deltoid. Concomitant therapy included Timolol Maleate, levothyroxine na, famotidine, omeprazole and azithomycin. On 06/11/01, "later that day", the patient developed swelling of the left arm, particularly at the injection site, and  reported that the injection site became red and hot. She also developed a fever. She sought unspecified medical attention. FOLLOW- UP information, from the physician, indicated that the  patient had developed "intense pain and swelling at the pneumococcal vaccine 23 polyvalent site, left deltoid" on approximately 06/12/01 (also reported as 06/11/01) and was started on diphenhydramine HCL (Benadryl), loratidine (Claritin), and ice. The physician reported  that the patient recovered from the pain and swelling on 06/16/01. However, the consumer stated in her original report, on 06/19/01, that her arm is much better now, except it is still slightly swollen. It was also reported that on 11/15/96, the patient had previously received one dose of pneumococcal vaccine 23 polyvalent. No further information is available.
2nd dose was an incorrect pediatric (0.5ml) dose; 2nd dose was an incorrect pediatric (0.5ml) dose; 1st dose of Engerix on 04Jun2021 / late 2nd dose on 03Dec2021; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 58-year-old female patient who received HBV (Engerix B pediatric) (batch number 722KC, expiry date 6th April 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (1st dose received on 4th June 2021).   On 3rd December 2021, the patient received the 2nd dose of Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 3rd December 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced accidental underdose, adult use of a child product and drug dose administration interval too long. On an unknown date, the outcome of the accidental underdose, adult use of a child product and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. but it could be 57 or 58 years. The patient received the 2nd dose of Engerix later than the recommended interval, which led to lengthening of vaccination schedule. Also the 2nd dose was an incorrect pediatric (0.5ml) dose, which led to accidental underdose and adult use of child product. No symptoms reported. The reporter consented to follow up.
extreme tiredness; headaches; muscular pains; body itch; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received bnt162b2 (Lot Number: EN6205), dose 2 via an unspecified route of administration, administered in right arm on 04Mar2021 (at the age of 46 years old) as single dose for covid-19 immunization. The patient previously received bnt162b2 (Lot Number: EL9264), dose 1 via an unspecified route of administration, administered in left arm on 11Feb2021 at 09:30 AM as single dose for covid-19 immunization. The patient's medical history reported as no. The patient had no other vaccine in four weeks and no other concomitant medications in two weeks. The patient experienced extreme tiredness, headaches, muscular pains, body itch on 06Mar2021. No treatment for the events. The patient had not COVID prior vaccination and did not have COVID tested post vaccination. The outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected.
Fever, Nausea, vomiting, diarrhea, headaches, and shortness of breath.
Pt. called and reported he had a reaction to the flu vaccine that he received on 11/24/08. Stated he had a bad headache and was disoriented. He had to leave work and went home to bed, and did not wake until next AM. Stated he felt fine the day he called on 11/25/08.
10-11-10 vaccinated 10-21, 10-22 fever 100 degrees, 101 degrees 10-23 - started getting itchy rash - spaced like chicken pox, but did not pus/crust  - about 80-100 spots 10 -28 bottom lip swelled, white patches appeared - cracked and bled - couldn't eat or drink.
Fever 101.7 F to 101.4 with malaise for 24 hours then resolved. No erythema, no induration at injection site.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild
Recv'd Hibtitter vax on 12/3/99. 12/8 or 12/9 parents noted urticarial whelt approx 2-3cm from inject site & smaller welt (2 cm) next to that. Larger measured 5 cm. 12/11 whelt disappeared. Tiny vesicle at inject site also.
Muscle swelling, shoulder to elbow of arm of injection site, began within a few hours of immunization.
Patient became diaphoretic, pale & fainted after injection. She layed supine for approx. 15 minutes and recovered without incident.
I woke up with hills, body aches 12 hrs after 2nd dose. My arm was hurting I expected that was one of the symptom as 1st dose. The following day chills, body ache fever 99.6 took Ibuprofen slept most of the day. On 1/17 started exp stomach cramps (described as the muscles in stomach).
Pt recvd vax 30OCT92 & since that time pt exp nausea, malaise, generalized body aches, sweating, chills, warmth, muscular twitching in arms & a soreness in the inject arm; No further details were provided;
After receiving my second dose of Pfizer vaccine, I caught a cold at a restaurant and since that I was violently coughing and felt nauseated. It turns out I was having symptoms of having Lymphoma cancer. On August 13, I got a diagnosis of it from a chest x-ray scan. I have gone through at least 6 sessions of chemotherapy. I will have chemo sessions until February. I got both the first COVID-19 Pfizer vaccine and second COVID-19 vaccine on the left arm, and I now have a tumor on the left side of my chest.
Advised by the DOH that Pfizer Covid Vaccine adminstered to 3 patients that needed to be revaccinated which a phone call and letter provided was sent to them all, which were deemed non viable.  and 93 patients were deemed not consistent with manufacturer approved guidelines.  no revaccination required for these patients.
Persisting hip joint pains even after 24 hours post vaccination.  Hip pains are felt when getting up and walking.  Not severe pain but achy and felt throughout the day.
This case was reported by a healthcare professional and described the occurrence of burning in a female subject of unspecified age who was vaccinated with HEPATITIS A. On an unspecified date the subject received unspecified dose of HEPATITIS A vaccine. At an unspecified amount of time following injection with HEPATITIS A vaccine, the subject experienced burning and tingling. The burning and tingling worked it's way down the arm. The reporter stated that the events only last 2 to 5 minutes and then seem to be fine. Resolution was not specifically stated. The reporter felt that this was not occurring say 6 months ago. These events occurred in a number of different subjects from the same source, but with different contacts. Linked cases included A0732483A, A0732491A, A0732492A, A0732501A, A0732515A, A0732528A, A0732533A, A0732539A, A0732540A, A0732936A and A0732944A.
1/30/16 presented to ER for swelling to the proximal posterior (L)UE approximately 24-48 hours after receiving vaccination at that site. Approximately 40 hours after receiving vaccination developed diffuse myalgias, chills, fatigue, and diaphoresis. (2-1-15) -> (L) arm tenderness remains tender w/palpable hard swelling on (L) posterior upper arm dense erythema extends along triceps through medial upper arm down just past elbow. Full ROM of elbow no appreciable swelling of forearm or hand. Continue w/BENADRYL, ice and elevation.
aching in the stomach; achy neck; stomach problems; sore arm; headache; achy shoulders; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (aching in the stomach), NECK PAIN (achy neck), ABDOMINAL DISCOMFORT (stomach problems), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (aching in the stomach), NECK PAIN (achy neck), ABDOMINAL DISCOMFORT (stomach problems), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and ARTHRALGIA (achy shoulders). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 08-Apr-2021, ABDOMINAL PAIN UPPER (aching in the stomach), NECK PAIN (achy neck), ABDOMINAL DISCOMFORT (stomach problems), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and ARTHRALGIA (achy shoulders) had resolved.            No concomitant medication information was provided. Action taken with mRNA-1273 in response to the drug was not applicable.
I did not have an adverse reaction to the vaccine. My husband and son tested positive for the flu and negative for COVID-19. I got sick within a few days after them. I was never tested but my doctor treated me for the flu. I had a cough that lasted three months.
3 days after receiving 2nd dose many side effects presented causing several trips for medical care Fever, abdominal cramps much like a consistent runner's cramp, high BP, head ache,  dry mouth feeling of burnung skin, heaviness/ tiredness in arms and legs, extreme tiredness ER dr confirmed adverse reaction to vaccine,  Adverse symptoms are still present after 10 days Dr informed that symptoms may be present for weeks. I have been incapacitated by symptoms
Information has been received from a registered nurse concerning a patient who was vaccinated with Zostavax (Oka/Merck). It was reported that the patient developed shingles after receiving Zostavax (Oka/Merck). It is unknown if medical attention was sought. There was no product quality complaint. This is one of several reports received from the same source. The nurse mentioned that some of the cases were reported to VAERS. Additional information is not expected.
Husband was in to pick up a Rx for her. Said she had localized site inflammation and infection at injection site. Hospital physician said was due to needle not retracting properly into lumen of the self-retracting syringe.
Narrative:  COVID infection following COVID vaccine series 01/23, Pfizer, dose #1 06/01 COVID swab, result: not detected 02/12, Pfizer, dose #2 08/27 COVID swab, result: detected 08/27 SARS-COV-2 Variant Sequencing result:  pending 08/29 pt cc: NO SYMPTOMS exposure: unknown 09/28 COVID swab, result: not detected
Pt. received vaccines on 7/31/08 and was then brought to the local emergency room unresponsive, without vital signs. They attempted resuscitation but he did not survive.   2/20/09 Autopsy report states COD as SIDS; perimembranous atrial septal defect.  Manner of death undetermined.  Report also states patient had seen PCP & slight heart murmur detected.  referred to peds cardiologist but expired prior to appt.
Vasovagal response. Pt decreased BP, decreased pulse - drowsy - lasted about 5 minutes.
Erythematous and tender with mild edema - to (R) upper arm. This is arm that vaccine was administered in.
mom stated that pt had got high fever 104, uncontrolled vomiting & diarrhea & lethargic w/in 1-2 days p/vax;went to ER twice, eventually recovered, mom also stated that had rxn to prior vax;
Information has been received from a physician concerning a patient who was vaccinated with Zostavax (Oka/Merck) instead of Varivax (Oka/Merck) (MSD).  Concomitant therapy included DTaP, IPV, Vaqta (manufacturer unknown) and MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (MSD).  No adverse experiences were reported.  Additional information has been requested.  The patient's sibling had the same experience (WAES # 0708USA04598).
tinnitus - constant high pitched whistling sound in my ears, intensity varies, wakes me up at night
Patient reported to local Health Department on 14OCT with concerns about mixed series. Patient mistakenly received Pfizer vaccination at vaccination clinic on 03 September as she believed her first dose mRNA vaccination was with Pfizer. Patient did not have vaccination card on person. Patient called home following the vaccination and verified with parents that her 1st vaccination was with Moderna.  outpatient pharmacy was called on 14OCT and Moderna vaccination was verified and entered into patients record. Patient  was instructed to not receive further vaccinations of mRNA COVID vaccines.
woke up 21DEC95-w/nausea, mild abd pain x 1 1/2days, low grade temp, soreness in joint (all) on 24DEC95 started w/upper resp congestion (nasal) w/yellow discharge from nose going down into chest;
Inadvertently given expired vaccine. No reaction for patient. Dose repeated per CDC and Sanofi recommendations
Runny nose; "Sore throat it seems like it's kind of coming and going, I don't really feel it right now"; Congestion; Breathing is kind of off and on; "I am not feeling well, have not feeling well for the last couple of days"; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER- BIONTECH COVID- 19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced runny nose, sore throat it seems like it's kind of coming and going, don't really feel it right now, not feeling well, have not feeling well for the last couple of days, congestion and breathing is kind of off and on. It was reported, the patient was called to report some side effects that is not consistent with, anyway the patient will tell what was experienced. It was reported, the patient took that Pfizer Vaccine. When paraphrased, patient stated, yeah, the breathing was kind of off and on. It was reported, patient can ask a question? patient probably need to talk to somebody really quick about what patient need to do because patient not feeling well, have not feeling well for the last couple of days, patient have been out of work. Patient was provided the number of Pfizer Medical Information Department. When asked for the permission to probe the questions, patient stated, No, just not feel like to talk, not right now not at the time of report. Patient stated, where will get the LOT# and expiration date from? yeah, patient don't have it. Patient was unwilling to answer questions to complete the report, hence limited information available over the call. The outcome of the events was unknown.   Follow up letter has been generated for further information.