chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; The patient inadvertently received a dose of PNEUMOVAX 23 Pre-filled Syringe, after the labeled expiration date (Lot: N025656; Exp: 04/19/2019); This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies.  On 09-OCT-2019, the patient inadvertently received a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe for prophylaxis, after the labeled expiration date lot number N025656, expiration date 19-APR-2019 (dosage schedule, anatomical location and route of administration were not reported) (expired product administered).    No adverse effects reported.
Pt received vaccines (6 month vaccines) on 12/8/16 at wellness appointment in clinic. Other than mild runny nose and labial adhesion and rash (candidal) under neck, exam was normal. MGM notes that pt did well that night but was a "little whiny". No respiratory distress. No fever. Woke up Friday (12/9) and was "pale". TYLENOL given, went to Health Department and noted to have "stopped breathing".
103.0 fever that did not respond to Advil, lasted 6+ hours. Lower fever of 100.5, 12+ hours after vaccination.
Vaccine rec'd on 8/10/2021(2nd Pfizer).  Symptoms began the next morning 8/11/2021. Severe arm, shoulder, chest, back and armpit pain.  Sensation of "being on fire" in back and chest.  Hives on face.  Low grade temp (100), severe headache, diarrhea. Inability to move arm where shot was given. Emergency room visit became necessary on 8/12/21 as symptoms were so severe. No relief from Tylenol from start of symptoms. ER discovered acute extremely high blood pressure (207/118), no prior issues. Gave IV fluids, pain meds, ran multiple scans, ultrasounds, chest x-ray.  Pt was discharged the evening of 8/12/21 only because she had a previously scheduled appt with an endocrinologist on 8/13/21 who could do additional testing and follow up exam.
tingling in her face; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in her face) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021 at 6:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PARAESTHESIA (tingling in her face). At the time of the report, PARAESTHESIA (tingling in her face) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported no concomitant medications.   Treatment information was not reported.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 17-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration ate 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Tingling and numbness in left pinky and ring finger, feeling of discomfort in elbow, lower arm like hit funny bone, left hand gets stiff and trembles when trying to extend. Mild symptoms first 2 days, but now significant and unable to type or use left arm without discomfort so have been resting it. Over 3 weeks with no improvement.
The hospital was administering Pfizer vaccine for the day, The patient was checked in at the front desk by the nurse. There are 2 nurses per station, one documents and gives vaccine. Patient identified and was cleared for vaccine administration. Per documentation nurse another screen popped up, which showed patient had moderna before. Incident was reported to charge nurse assessment done on patient, patient didn't have any adverse effect ,family was notified. she didn't have any adverse event
Wasn't certain if it was cellulitis on his left arm; Local reaction where the injection site stung/injection site burning; swollen; Large red things on arm; First dose of Shingrix in his left arm subcutaneous; This case was reported by a physician via call center representative and described the occurrence of injection site cellulitis in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension. Concomitant products included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season).   On 5th October 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 5th October 2019, less than a day after receiving Shingrix and an unknown time after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site cellulitis, injection site stinging, injection site swelling, injection site erythema and intramuscular formulation administered by other route. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim). On an unknown date, the outcome of the injection site cellulitis, injection site stinging, injection site swelling and injection site erythema were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site cellulitis, injection site stinging, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient also received the Fluarix Quad 2019 -2020 in his right arm on the same date. The orthopedic Surgeon reported that he received Shingrix in her left arm subcutaneously rather than intramuscular in error at her pharmacy. The patient experienced a local reaction where the injection site stung and burned after receiving the Shingrix vaccine. He also had large red things on her arm that kept getting larger and were painful, red and swollen and were well defined in the arm area where he received the injection. The physician was not certain if it was cellulitis on his left arm but he was treating it with Bactrim and things were now resolving. The reporter consented to follow up. This case has been linked with US2019183591, same reporter.
experiencing symptoms of COVID-19, tested positive for COVID; experiencing symptoms of COVID-19, tested positive for COVID; pulmonary embolism on lower left lung; shortness of breath; severe chest pains; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Sep2021 14:00 (Lot number: ff2588) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart Murmur" (unspecified if ongoing); "gastrointestinal issues" (unspecified if ongoing), notes: Unresolved. Concomitant medication(s) included: METHYLPHENIDATE. Vaccination history included: Tdap, reaction(s): "severe reaction"; Pertussis, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Oct2021 08:00, outcome "recovering" and all described as "experiencing symptoms of COVID-19, tested positive for COVID"; PULMONARY EMBOLISM (medically significant) with onset 09Oct2021 08:00, outcome "recovering", described as "pulmonary embolism on lower left lung"; DYSPNOEA (medically significant) with onset 09Oct2021 08:00, outcome "recovering", described as "shortness of breath"; CHEST PAIN (medically significant) with onset 09Oct2021 08:00, outcome "recovering", described as "severe chest pains". The events "experiencing symptoms of covid-19, tested positive for covid", "experiencing symptoms of covid-19, tested positive for covid", "pulmonary embolism on lower left lung", "shortness of breath" and "severe chest pains" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (09Oct2021) diagnosed with a pulmonary embolism on lower left, notes: lung; sars-cov-2 test: (12Oct2021) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, pulmonary embolism, dyspnoea, chest pain and treatment included blood thinner. No other vaccine in four weeks. No covid prior vaccination.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
At my first pap smear when I was around age 21, it came back abnormal. One year later at my next pap smear, it was abnormal again and we tested for HPV. The HPV test came back positive. I decided to come back after 6 months to monitor the situation as I was close to cervical cancer. After 6 months, my pap smear came back normal. I came back again after 6 months and this time, my pap smear was so abnormal that my OBGYN wanted to do a cervical biopsy that day. The results came back and I was extremely close to having cervical cancer. I had to have a  LEEP surgery to remove the abnormal cells. I will have difficulty getting pregnant now and may go into early labor. When we tested the strain of HPV I had, it was a strain that Gardasil is supposed to protect against.
Patient inadvertently received an expired Quadracel dose,  no adverse event; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from the other health care professional via phone.  This case involves a four year and ten month old male patient who was vaccinated with a 0.5 ml final dose (in series) of an expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (single-dose vial , lot C5532AA  and expiration date 09-Oct-2020) via an intramuscular route in the right thigh on 13-Oct-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient had concomitantly vaccinated with a dose of HEPATITIS A VACCINE on 13-Oct-2020 for prophylactic vaccination.  This was an actual medication error case due to expired vaccine used (latency was same day).  At the time of reporting, no adverse event was reported to the patient.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Patient noticed muscle soreness that seemed to be worse than previous vaccines and had some redness and swelling around the injection site.
Sore; 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 Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The reporter stated that, 2 weeks after vaccination her arm became sore. The reporter was unwilling to provide any additional details.
15 hours -ringing in ears began after first dose. Headache, chills, bodyaches- very bad in back, hips and stomach, fever of 101. Body rash. Ringing in ears became worse  Drank lots of water prior to 2nd vaccine and following  yet very dry mouth probably due to fever. Ate plenty of meals and fluids herbal teas and water.  Fever broke at 48 hours. Headache stopped at 60 hours. Currently 78  hrs  following second vaccine and still have  body rash on back, chest, neck, stomach and ringing in ears.
Child very anxious. Mom, RN held child's L Arm. Vaccinator RN admin. vax using a vanish point syringe. When needle retracted, a large amount of vaccine pooled on surface of skin. Given that most if not all of dose did not go into muscle, it was decided with mom to administer a second shot on the child's thigh. Dose administered. Though this vaccinator has seen some instances of contracted muscles causing minimal seepage of vaccine after needle retraction, I have not seen this issue occur with so much vaccine seepage. I am not sure if it was the child's contracted muscle, a defective vanishpoint syringe, or a combination of the two. Per mom on 3/23/23, child is doing well.
Localized pain/inflammation at site of admin. Felt hot. Red rash about 3" by 3" - painful when touched. Ice, ADVIL and BENADRYL were used.
This spontaneous report was received from a physician referring to 7-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 03-JUN-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012768:
Severe vomiting began on 11/17 approximately every six hours and continued on 11/18 and less severe on 11/19.  Initially vomit was food, digested food, then bile then the last day clear liquid.  Headache from 11/17 - 11/20.   Weak and bedridden.  Of course no appetite.  Felt awful.  Some diarrhea starting 11/18-11/21  as well.  Pain in the left flank.   Tried to make myself sip water every now and then.   Tried to go out for a walk on 11/19 and I could barely get around.  Finally improved the evening of 11/21 began to get better.
Patient received H1N1 vaccine 12/16/09 at school and rash noted 12/17/09 (+) itching.
A cold feeling, all over. It started late in the evening after I received the vaccine. Its still ongoing.
Patient was given Pfizer 5-11 Bivalent instead of Pfizer 5-11 Primary series.
soreness under both arms and breasts; soreness under both arms and breasts; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (soreness under both arms and breasts) and PAIN IN EXTREMITY (soreness under both arms and breasts) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced BREAST PAIN (soreness under both arms and breasts) and PAIN IN EXTREMITY (soreness under both arms and breasts). At the time of the report, BREAST PAIN (soreness under both arms and breasts) and PAIN IN EXTREMITY (soreness under both arms and breasts) had not resolved.        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.
2 hours after immunizations, had 1 minute episode of shaking and unresponsiveness.
Patient fainted then as she came out of the faint her arms bent and were all tense for a minute she looked straight ahead unseeing, she was very pale. She stated everyone sounded really far away. After a minute she came back around drank some water and waited around for about 20 minutes stated she was fine and left.
Longer-term headaches, tired feelings, abdominal cramping in the mornings, tiring pain in legs. Specially left leg feeling Sharp shooting pains.
Within 60 seconds after MMR vaccine, pt dropped paper on floor and pt head leaned backwards against leaver of chair. No response to verbal stimuli. Ammonium was administered below nose and pt responded in 60 seconds, becoming alert and able to speak. Urine noted on seat. On 9/12/01, TC to client, states "OK"! had not eaten, before shot, was nervous.
2 episodes of cont shaking of entire body followed by acting tired afterwards; ea episode lasted about 2 mins; 1 episode was the evening of the vax;
The day following the booster injection in my left arm, the muscles in my in my left ribcage became inflamed; acutely painful to turn, cough, hiccup, inhale, lie down, get back up, lift with my left arm, etc.; prev dose brand=Moderna/ brand=Pfizer, dose number=3; dose received = 3/ The day following the booster injection; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received third dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Nov2021 at 13:00 (at the age of 68-year-old), as a single dose for COVID-19 immunisation. Medical history included left anterior descending artery (LAD) stent. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received influenza vaccine (MANUFACTURER UNKNOWN) via unspecified route of administration in the right arm on 08Nov2021 for immunisation, within 4 weeks prior to COVID vaccine. The patient received unspecified concomitant medications. The patient previously received first dose of COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 67-year-old) and received second dose of COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 67-year-old); both for COVID-19 immunisation. The patient previously received codeine (MANUFACTURER UNKNOWN) for unspecified indication from unknown date and experienced drug allergy. On 11Nov2021 at 10:00, the day following the booster injection in the left arm, patient's muscles in the left ribcage became inflamed so that it was acutely painful for the patient to turn, cough, hiccup, inhale, lie down, get back up, lift with the left arm. This continued for two days before resolving. The patient experienced no side effects from the two Moderna vaccine shots in the same arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment ibuprofen (MANUFACTURER UNKNOWN), paracetamol (TYLENOL EXTRA STRENGTH ) and rest. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events the muscles in left ribcage became inflamed so that it was acutely painful to turn, cough, hiccup, inhale, lie down, get back up, lift arm was resolved on 13Nov2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Severe itchy rash/hives all over body. Particulary on both forearms, stomach, chest (nipple area), thighs. Also tenderness and slight swelling in under armpit area/gland with discoloration.
RA; pain presented in the hips,glutes, buttocks, hamstrings, thighs and groin areas. YOo It then spread to the left shoulder and neck.; she was in a wheelchair; 1st dose in October 2019 / second dose was administered on 8/17/2020; This case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number NZ4ZJ, expiry date 31st May 2022) for prophylaxis.   The patient's past medical history included rotator cuff repair. Previously administered products included Shingrix (1st dose received on 1st October 2019, No adverse reactions reported for this dose).   On 17th August 2020, the patient received the 2nd dose of Shingrix. On 17th August 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In September 2020, the patient experienced neck pain (serious criteria hospitalization), pain in hip (serious criteria hospitalization), buttock pain (serious criteria hospitalization), pain in thigh (serious criteria hospitalization), groin pain (serious criteria hospitalization) and wheelchair user. On 23rd September 2020, the patient experienced rheumatoid arthritis (serious criteria hospitalization and GSK medically significant). The patient was treated with analgesic, nos (Pain Killer) and steroids nos (Steroids). On an unknown date, the outcome of the rheumatoid arthritis was not recovered/not resolved and the outcome of the neck pain, pain in hip, buttock pain, pain in thigh and groin pain were recovering/resolving and the outcome of the wheelchair user was recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the rheumatoid arthritis, neck pain, pain in hip, buttock pain, pain in thigh, groin pain and wheelchair user to be related to Shingrix.  Additional information was provided as follows: The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. In the beginning of September 2020, severe pain presented in the hips,glutes, buttocks, hamstrings, thighs and groin areas.  It then spread to the left shoulder and neck. The patient was treated in the ER several times.  The dates provided were 12th,13th 18th and 19th September 2020.  She received IV fluids, pain killers and steroids during those visits. She was admitted to the hospital for one overnight stay on 23rd September 2020 and was diagnosed with rheumatoid arthritis at that time. The pain was so extreme that she was in a wheelchair for a few weeks.  She said on a scale from 1 to 10, the pain was a 15.  The pain had improved.  She was currently on day 7 of 20mg of a steroid. The reporter consented to follow up. The batch number was updated from NZ4ZJ to NZ4ZJ as per sales data sheet.