chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 16 year old female who on 09-JUL-2008 was vaccinated with a second dose of GARDASIL (lot# 657872/0515U) (route and administrating site not reported). There was no concomitant medication. After receiving the GARDASIL the patient was going to receive a tuberculin purified protein derivative. Right before the patient was going to receive the tuberculin purified protein derivative she passed out and twitched/convulsed for about thirty seconds, when the patient came to she was very dizzy and pale/white. The physician reported that when the patient came to they gave her water and the patient stayed for 15 minutes. She got color back in her face, she was fine and left the office. The physician reported that they did not end up giving the tuberculin purified protein derivative to the patient at all. When the patient received the first dose of GARDASIL she was fine. Upon internal review the twitching/convulsing was considered to be an other important medical event. Additional information has been requested.
Pt didn't know that she has already completed the 2 doses in 12/19/2019 and 02/20/2020. On 02/09/2023, she came to the pharmacy and received a additional dose (3rd dose for her). I realized it when she asked for 2nd dose on 04/19/2023 that she has already completed the series. She has not reported any adverse reaction.
This spontaneous report as received from a physician refers to an unspecified number of patients. On an unknown date the patients might have been vaccinated with RECOMBIVAX HB (lot 3, expiration date, route and route unspecified) that was exposed to temperature conditions that Merck cannot support. NO PQC. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
mild pain injection site; severe pain in her left knee when walking / right knee; severe pain in her left knee when walking / right knee/ severe pain/felt it was a reaction to the vaccine; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in October 2019, for tolerance refer case US2020034267).   On 2nd December 2019, the patient received the 2nd dose of Shingrix. In December 2019, 2 days after receiving Shingrix, the patient experienced injection site pain, knee pain and pain upon movement. The patient was treated with ibuprofen (Advil), naproxen (Aleve), paracetamol (Tylenol) and non-drug therapy (Ice Pack (No Medication)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the knee pain and pain upon movement were recovered/resolved.   It was unknown if the reporter considered the injection site pain, knee pain and pain upon movement to be related to Shingrix.  Additional details were received as follows: The patient reported for herself. The patient reported that, she was very active, plays tennis and does aerobics, she walks and jogs every day and was very healthy. She was not on any medications. The patient received Shingrix injection in left arm and experienced mild pain at the injection site.  Ten days later, she experienced a sudden onset of severe pain in her left knee when walking but had no pain when she stood still. She reported, there was no swelling or pain to touch to the knee. After this, 24 hours later she experienced the same sudden onset of severe pain in her right knee. She stated that, icing the sites or taking Advil, Aleve or Tylenol did not help with the pain.  Three days later, the pain in her left knee resolved and five days later the pain in her right knee resolved.  In the last week of reporting, she saw her primary doctor and orthopedic doctor and nothing was found but they felt it was a reaction to the vaccine.  A few days ago of the reporting date, her both knees simultaneously developed the severe pain which lasted three days and then it resolved, no swelling was noted. The patient consented to follow up and also provided her physician's contact details.
This spontaneous report has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX with lot number M038351 and expiration date on 06-DEC-2017 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis, reconstituted using a properly stored sterile diluent (lot number and expiration date were not provided). It was reported that on an unspecified date, the vaccine was exposed to a temperature between 15 Fahrenheit degrees and 46 Fahrenheit degrees (20 F) for 9 hours. No adverse effects were reported.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. In November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities, headache, feeling hot, nausea, activities of daily living impaired and influenza-like symptoms. On an unknown date, the outcome of the pain in arm, erythema of extremities, headache, feeling hot, nausea, activities of daily living impaired and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the pain in arm, erythema of extremities, headache, feeling hot, nausea, activities of daily living impaired and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The symptoms were milder post vaccination and did not come on so fast. For tolerability of the second dose of SHINGRIX, refer case US2019021233. The reporter did not provide the consent to follow up. The reporter was tried to be contacted but they got answering machine and therefore were unable to obtain any additional details.
Right arm swelling 2 days after (PROQUAD) MMR, Varicella and KINRIX. 3rd day rash spread to up arm.
Information has been received from a licensed practical nurse concerning a female (age not reported) who on 16-OCT-2006 was vaccinated in the upper arm with a 0.5 mL dose of Pneumovax 23 (lot 651374/0485F).  Subsequently, the patient developed localized swelling, redness and tenderness.  The patient sought medical attention and was told to take an antihistamine and apply warm compresses to the affected area.  At the time of this report, the outcome was unknown.  Additional information has been requested.
arm hurt p/shot;small red area day p/shot;on day 6 devel a large reaction ( 3 1/2 x 2 1/2) w/tender, swollen area;exam: 3 1/2 x 2 1/2 swollen, erythematous, warm area on rt upper arm, tender to touch;IMP: vax rxn vs cellulitis
Low hemoglobin. Low iron and potassium. Unable to walk due to losing balance. Infection in right leg. Stool spilled into body which caused leg infection and dark spots in face. Unable to control bowels which resulted in now having to wear diapers and bed ridden.
Received immunizations on 9/21/06 during the afternoon. She began to develop itching and flushing of the skin in the evening hours. She reported feeling very hot, and noted some welts on her arm and neck. No swelling of the tongue or extremities was noted. Erythema noted at base of neck along the right side, and patchy redness present on the R arm. Injections were given on the R upper arm. Additionally had a PPD placed and blood drawn on the same day. Patient was given 50mg Benadryl, 1,000mg Tylenol orally. Improvement noted within 1/2 hour. Discharged with Benadryl orders and instructions to pretreat with Benadryl and Tylenol prior to receiving any immunizations. Diagnosed as histamine reaction by ER MD. Follow up visit on 9/23/06 notes diagnoses of Anaphylactic reaction probable to Immunizations still with mild symptoms, reports still feeling "thick tongue", hives present to back of neck. Orders given for Epi Pen, Benadryl 50mg and Medrol Pack. Profile written, allergy list updated by provider as follows: Typhoid Vaccine Live, Attenuated.
Within 12 hours after admin of vaccines began vomiting Q 30 min- was taken to ED- called night clinic X2.
COVID 19 Treatment; COVID 19 Treatment/Rebound COVID 2 days after testing negative; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2022, outcome "not recovered", described as "COVID 19 Treatment"; COVID-19 (medically significant) with onset Dec2022, outcome "not recovered", described as "COVID 19 Treatment/Rebound COVID 2 days after testing negative". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Dec2022) Negative, notes: Rebound COVID 2 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
REDNESS, SWELLING, MUSCLE ACHES, DIZZINESS, WARM FEELING AT INJECTION SITE, FATIGUE.
TINITUS in both ears started on or about 1-1-2022.  Tinitus runs 24/7 and has never stopped.
This spontaneous report was received from Registered Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 13-APR-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with Lot # M034780 and  expiration date of 15-APR-2019 (route, dose, dose number and frequency were unknown) for prophylaxis. This information was obtained with a digital data logger which reported that the vaccine was exposed to a temperature of 47 to 77 degrees Fahrenheit for 1 hour and 20 minutes. There was no adverse effect reported. No previous excursions reported. Additional information has been requested.
12 year old male patient administered expired dose of Menactra, no AE; Initial information received on 02-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 year old male patient who was vaccinated with expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation.  On 01-Feb-2021, the patient received a 0.5 ml first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6521AA and expiry date: 26-Jan-2021) (frequency once) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired product administered (latency on same day).  It was also reported that patient was administered Menactra that was expired for 3 days.  Reporter relationship: Self Product used: Used, first time product used: yes Still using product: no  At the time of reporting, patient had no adverse event.  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 guidelines. 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.
Bruising. Raised bump at injection site and soreness. Fever up to 103.6 degrees during 30 hour period after shot. Body aches, chills, headache and fever not able to be relieved by Extra Strength Tylenol. Day 2 after shot, fever was gone. Body chills and aches subsided.
The infants mother reported that at a later unspecified date, the infant developed diarrhea. The infant recovered after nine days. The vaccine provider stated "we have no record of a problem". The infants mother reported that the infant subsequently developed a fever and a rash following her second dose of Rota Shield.
1) 3 hours post-injection sore aching arm; 2) 18 hrs post-injection: Excruriaring pain, headache, muscle pain entire body, hand stiffness, fatigue, lack of apetite.
pt became very cranky w/temp of 101.3 on Friday AM;also congested;temp inc to 103, but did come down;saw MD 28FEB97;MD stated that temp may be from congestion, teething, or the MMR;pt had rash over trunk;MD told to give pt DPH;
1 hour after receiving flu vaccine patient developed L facial numbness/nerve pain radiating to bridge of nose with extreme sensitivity.  Following morning, patient stated numbness/pain radiating to L arm/L leg.
Patient first noticed swollen lymph node on left side of neck on 4-14-2021.
Signficant headache, difficulty breathing, pain in ribs and body aches elsewhere, fever, chills.  Continued through early morning hours.  By 7:00 AM had abated to dull headache, body aches, cough, nausea.
Pt received 5 vaccines (DTaP, Polio, MMR, Varicella & Hep A). During the 15 min wait after vaccines pt vomited about 10 minutes after receiving vaccines. Dr. was notified. The following symptoms began to occur as pt was being monitored. (Itching, cough, decreased BP). Pt was administered Jr EPI-PEN, ZYRTEC & BENADRYL. AMR was called & pt was taken to hospital.
I am having bad allergic reaction to this Pfizer Vaccine, I broken out, I am sitting here broken out in blisters and everything; I don't want to my skin being inside out, they test the rash that I am breaking out; This is a spontaneous report received from a contactable consumer (Patient reported for herself). A 33-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8733), via an unspecified route of administration, administered in Arm Right on 05Apr2021 (at the age of 33-years-old) as dose 1, single for COVID-19 immunisation. Medical history included asthma, migraine and seasonal allergy all from an unknown date and ongoing. Concomitant medications included salbutamol (ALBUTEROL HFA) taken for asthma, start and stop date were not reported, sumatriptan succinate (IMITREX DF) taken for migraine, start and stop date were not reported, caffeine, paracetamol (EXCEDRIN ASPIRIN FREE) taken for migraine, start and stop date were not reported, diphenhydramine hydrochloride (BENADRYL) taken for seasonal allergy, start and stop date were not reported. The reporter reported as I am having bad allergic reaction to this Pfizer Vaccine, I broken out, I am sitting here broken out in blisters and everything, went to emergency room and I don't want to my skin being inside out, they test the rash that I am breaking out on an unknown date. Consumer stated, she had both shots of Pfizer vaccines. After both shots she experienced a breakout. This second break out she experience was way worsened first, her skin has evaluated into a blisters. She went to the emergency room both times and the first time it did breakout then. This time they had to do biopsy of my skin to test the skin. She have been prescribed medications for allergic reactions and they gave me some ointment to put on my skin because my skin was hurting. Patient got the first vaccine on 05Apr and on 08Apr I experienced my first breakout. It lasted from 08Apr until 13Apr. On the Second shot I have got 25Apr and my breakout started yesterday, today and my breakout started on 11May and it's still on off. The patient underwent lab tests and procedures which included skin biopsy with unknown result on an unknown date. The outcome of the events was reported as recovered on 13Apr2021.  No follow-up attempts are needed. No further information is expected.  Follow-up (28Jun2021): Follow-up attempts completed. No further information expected.
One week after receiving first vaccine, right arm at injection sight began swelling itching. A rash began to show and the swelling spread on the arm. Rash and swelling are still present and a low grade fever of 100.8 is now present.
5 minutes after injection, itchy, hot and noticed rash and hives on arms, face. Hands started to swell.  Went to pharmacy and took 25mg of Benadryl.
I was given the 2nd Shingrix shot on 6/22/2021 at 2pm.  Within a few hours the same day as the shot I had tinnitus where I did not have tinnitus before.  It is horrible, as I can't sleep at night as the high frequency won't go away.  My life is ruined.
Patient received the Pfizer vaccine on 1/26/21 and 2/16/21, so was fully vaccinated when they tested positive for COVID-19 on 8/25/21.
Appendicitis resulting in appendectomy.   Pain grew steadily from May 7th in the evening, resulting in severe abdominal pain the following morning (May 8th). Went to the ER on May 8th, CT Scan confirmed appendicitis several hours after arrival. Appendectomy same night. Admitted for that week.
PPD test placed intradermally in clients left lower foremarm 8/16/2010 at 9:05 am. At approximately 1:00 pm, the client noticed her left arm and hand, below the elbow only, were slighly swollen and tender to the touch. There was no fever or redness noted. Her throat was also slightly swollen, no difficulty breathing. She also had extreme tiredness. Client took Tylenol at approximately 1:30 pm. Late in the afternoon, her throat was back to normal on 8/16/10. On 8/17/10, by early afternoon, she noticed that her arm and hand were also back to their normal state. PPD was read on 8/18/10 with 0mm, negative results.   Tubersol--Manufacturer: Aventis Pasteur--Lot: C3584AC  Under vaccines admin. PPD was not an option, so I have placed the pertinent intormation here.
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 22-SEP-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L018499; expiry: 25-FEB-2017, (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
exacerbation of cough, arm pain, vasovagal syncope (suspected to be from cough)
11/11/21 - 5:40p - vaccine dose 1 received 11/12/21 - 10:00a - fever, chills, fatigue, headache, muscle aches, joint aches 11/12/21 - side effects continued throughout the day 11/12/21- 5:00p - fever, chills, fatigue, headache, muscle aches, joint aches, nausea
This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6198), via an unspecified route of administration, administered in Left arm on 19Feb2021 10:00 (at the age of 70 year) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included COVID-19 prior vaccination. The patient had no known allergies and other medical history. The patients concomitant medications were not reported. The patient did not receive other vaccine in four weeks of vaccination. The patient did not receive other medications in two weeks of vaccination. The patient was diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 19Feb2021 at 10:00, the patient experienced extreme tiredness, constant headache, extreme muscle pain in left arm, extreme joint pain, these lasting 2 full days lite and off balance for first 10 hours. No treatment was received for adverse events. The outcome of the events, lightheadedness and off balance was recovered on 19Feb2021 at 20:00 and for other events was recovered on 21feb2021. Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.
he can't even lift his arms up due to the pain; severe fatigue; achy shoulder; neck not sleeping well; neck not sleeping well; body pain; The patient got sick from the virus.; This is a spontaneous report from a contactable consumer. This consumer reported similar events for five patients. This is the fourth of three reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were 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 unknown date the patient experienced severe fatigue, achy shoulder, neck not sleeping well and body pain. Patient cannot even lift his arms up due to the pain. The patient got sick from the virus. The outcome of the events reported was unknown.   Information on the batch/lot has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541547 Same reporter/drug/event, different patients.
Noticed a big red rash (about the size of a golf ball) on left arm an inch below the scabbed injection site; warm to the touch and itchy. No other symptoms at this time, but not sure how long it has been there.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot number, strength, dose and route were not reported). No adverse effects were reported. The outcome of the patients events were not reported. This is one of several reports from the same source. Additional information has been requested.