chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired Menactra was given to patient, no AE; Initial information received on 19-Jun-2020 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 17 year old male patient who received 0.5 ml dose of expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6207AA, Exp. Date 25-May-2020) via an intramuscular route in the deltoid on 19-Jun-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.  It was an actual medication error case due to expired vaccine used.  At the time of report, no adverse event was reported.  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.
11AUG pt called to report arm still sore 1wk p/vax; no redness or swelling @ site of inj; muscle sore in AM & evening;
1435 received vaccine. 1445 warmness to arm and dry mouth, anxiety. 124/80, hr-114, 02 sat 94%ra. Warmness to arm resolved 1500. anxiouness resolved 1505. throat cont to be dry able to drink water w/o difficulty. drank one full bottle of water. Report sensitive and has many allergies. Pt husband is in car and informed of pt condition. 1520 pt condition dryness in  needs to take mask off.. went outside totake off and get fresh air. 1540 128/89-hr-122-02 sat 96%ra r-18. Pt instructed to f/u with MD has appointment on tuesday. upon discharge reports tired and dry throat.
Patient presented with finger lesions (raised white blisters on a red base) (6-7 blisters) on 3rd finger left hand. Culture sent to Laboratory-results pending. Patient treated with Famciclovir 500mg 1 PO TID #15. There was a very faint pink stripe noted up arm.
Screamed x 3 hrs w/o being able to console; some jerking type movement noted by mom; not seen by hlth care provider; mom called ER;
Breakthrough case admission after 3 vaccines  Pfizer 1/18/21 lot# EL3249;  Pfizer 2/8/21 lot# EL9265;  Pfizer 10/14/21 lot# FF8841
Approximately 11 hours after the vaccination my arm became very sore, to the point that it was difficult to lift it.  I then developed body aches and chills.  I did not develop a fever that I know of but the body aches and chills continues throughout the night.  During the night a severe headache developed as well as generalized weakness.  I was unable to sleep and had to miss work the next day.  Because the weakness and body aches continue, I plan to miss a second day of work tomorrow.  I treated the symptoms with Tylenol.
left arm was painful; left arm was red/ red down past her elbow; left arm was swollen/ swollen past her ebow; This spontaneous report was received from a pharmacist, referring to a 75 -year-old female patient. The patient had no concomitant medication, no pertinent medical history and no drug reactions/ allergies. Information about concurrent conditions was not reported.      On 18-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 mL, lot # T024669 has been verified to be valid, expiration date 21-MAR-2022) intramuscularly in the left arm for prophylaxis.    On 20-NOV-2020, the patient's left arm was red, swollen and painful. The patient's arm was swollen and red down past her elbow. The pharmacist told the patient to put an ice pack on the site. The patient was taking acetaminophen (TYLENOL) for the pain. No lab disgnostics/studies was performed. The patient did not seek medical attention. The outcome of all events was reported as not recovered. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and all events was not reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T024669; expirationdate: 21-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent.
Syncope vasovagal; difficulty speaking for minutes. Treatment was given by medical doctor at the office and then went home after full recovery.
Sore arm, off and on severe menstrual bleeding even during times when I have never had a period. I do not have menstrual cycles and after receiving my first, second, and booster shots I have now been having severe menorrhagia, bleeding to the point of faintness and having to use adult diapers, etc. I've spend well over 1000$ on feminine products and to replace ruined clothing. Birth control has done nothing to keep the bleeding at bay either.
12/07/2006 pt received MMR, Varivax, Prevnar in our office. No noted adverse reaction to Imm while at office. Pt presented in ER that PM with prolonged febrile seizure. After exam and labs, he was DX viral syndrome, febrile seizure.  MR received for an ER admit for new onset of seizure activity on the day of MMR, Varivax, and Prevnar.  Father noticed child was having difficulty getting off the ground and then began having seizure activity.  He was transported via EMS to the ER.  PE: WNL.  Temp=103. Pulse 179. RR 46.  Not currently having seizure activity. Admitted for observation.  Fever continued however no seizure activity was noted. Discharged home the next day. Discharge DX:  Febrile Seizure. Viral Syndrome.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from a practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 12-APR-2018 and 14-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020352 and expiration date 10-APR-2020; lot# N023828 and expiration date 25-JUN-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
deltoid muscle pain in left arm where she got the shot; Left arm feeling heavy in within 2 hours of vaccination, hard to lift up; she was feeling very tired and in day-2 she felt fatigue; This is a spontaneous report from a contactable consumer reporting for a patient.  A 48-year-old female patient received first dose of BNT162B2, (Pfizer-BioNTech Covid-19 Vaccine, lot number EH9899) , via an unspecified route of administration on 28Dec2020 10:00 at single dose on left arm for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medications were none.  The patient experienced deltoid muscle pain in left arm where she got the shot (28Dec2020 12:00). Left arm feeling heavy in within 2 hours of vaccination, hard to lift up (28Dec2020 12:00). In the afternoon she was feeling very tired and in day-2 she felt fatigue, took Tylenol multiple times a day. On day-3 she felt perfectly fine and no pain was left. Functioning properly. No known allergies. The patient did not receive other vaccine in four weeks. No covid prior vaccination; no covid tested post vaccination. The patient was not pregnant at the time of vaccination. Therapeutic measures were taken as a result of deltoid muscle pain in left arm where she got the shot. The outcome of the events was resolved on an unspecified date.
I received Moderna  #037K20A COVID 19 vaccine yesterday and 3 hrs after that I developed tingling and numbness in my arm. I then developed a swelling and intense pain. There is area of induration and erythema around the vaccine injection site.  I have been using Ibuprofen every 6 hrs for pain and applying ice pack which is helping some with pain.
Pt. states received Phizer 07/07/2021, at 7:00pm experienced extreme dizziness lasting until 11:00pm while entering bed. No other symptoms reported.
Patient stated he started to feel weak that night. Over the past couple days has felt a headache, weakness and body aches. No reaction at injection site.
On 4/15/2021 I saw on my leg blisters, went to my local urgent care and was diagnosed with Shingles at the age of 43 and 2 weeks to the date after my 2nd dose of Pfizer Covid 19.  I was put on a anti viral famiciclovir and antibiotic doxycycline, as well as tramadol for pain.  Over the past week since my diagnosis, the lesions are large and in a straight line down my leg and then turn to the right.  I have a patch that covers a varicous vein that looks like it might be infected.  I am on a immuno suppressant medication for my Multiple Sclerosis.  I am still being treated and recovering from shingles to this date.
hoarseness, soreness in lt deltoid, body aches, sore throat & blood shot eyes are reported in a pt who recvd 1 dose of fluogen on 15OCT93 & 3 hrs later exp the above sx; pt tx DPH & recovered;
Robust take with large vaccine reaction >12cm. No evidence of superimposed bacterial infection. Occurred 10 days postvaccination, worsened over the next few days. He does have some mildly inflamed lymph nodes, but not the fluctuant enlargement that would warrant further evaluation of a secondary bacterial infection. Since upon questioning he did admit to some mild chest pain that is sometimes positional, which he attributed to his GERD, I obtained an EKG which was normal to rule out myopericarditis.
This is a spontaneous case, initially received from a consumer on 14-Feb-2018, concerning a 01-year-old male infant patient. The patient did not have any medical history and was not taking any concomitant medication. On 13-Feb-2018, the 01-year-old (under 4 years of age) patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: anterolateral thigh, batch number and expiry date: not reported) (explicitly coded as inappropriate age at vaccine administration). The patient did not experienced any adverse event after the vaccination. the reporter assessed the event as non-serious. Non-significant follow up received on 28-Feb-2018: As per the reporter, batch number and expiry date of the suspect vaccine were not available. Non-significant case correction received with IRD 14-Feb-2018: The narrative was corrected.
Information has been received from a consumer concerning her 13 month old son who on 08-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was reported that the patient has chickenpox since vaccination and it was not improving. The consumer reported that her son never had a cold, fever or any symptoms of any illness before the vaccination. Unspecified medical attention was sought. A product quality complaint was not involved. No further information is expected.
Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007321A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
dose on 25Feb2020, not yet received second; adult dose administered to 12 year old; adult dose administered to 12 year old; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 14-year-old female patient who received HAV (Havrix adult) (batch number K4YAL, expiry date 17th June 2022) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis.   On 25th February 2020, the patient received the 1st dose of Havrix adult. On an unknown date, the patient received the 2nd dose of Havrix. On 25th February 2020, unknown after receiving Havrix adult and not applicable after receiving Havrix, the patient experienced overdose and adult product administered to child. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the overdose, adult product administered to child and incomplete course of vaccination were unknown.  Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose of Havrix. The reporter stated that, an adult dose of Havrix was administered to 12 year old patient, which led to overdose and adult product administered to child. Till the time of reporting, the patient did not receive second/ booster dose of Havrix series, which led to incomplete course of vaccination. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022032554:FU1 - Deleted
11-12 midnight I got chills, very Bad headache, very Bad. Body ache, sniffles. I felt like I was getting flu covid again   I had temp of 99 I slept 13 hrs. next day. Body aches 99 Temp.
Symptoms were first noted 12/24/2020. She had the Pfizer Covid vaccine at about 6pm. At about 10 pm she had mild chest tightness. It persisted for >24. hours. She also had injection site soreness. She was tired for a day. If she talked a lot or got angry, she found it a little difficult to breathe. (Her mother was in the hospital and she had been talking a lot.) She did not have any other symptoms. She reports she was not stressed when she had the vaccine: her mother?s stressful problem started in January. The patient?s symptom severity is rated as: ?mild,? ?not very severe.? If she did not talk, she did not feel anything. The SECOND DOSE was given at my office. The Covid vaccine was administered and the patient was observed for two hours. This was from Pfizer-Biontech Lot EL3246, expiring 4/2021. She had some chest tightness and was given an albuterol nebulizer treatment. Her symptoms resolved and she was discharged to home. I phoned her the next day. She had mild dyspnea the day after the vaccination that resolved that night. She did not have a fever, but did have local soreness, fatigue, body ache, and a headache, for which she took Tylenol.  She did see her primary care physician and they discussed the patient?s anxiety due to her mother?s poor health. An EKG will be done.
Severe fever (104.8), chills and muscle aches (severe). Fever dropped to 102 with Tylenol. Lasted throughout the night of injection and the next day. Fever began to fall in afternoon, stayed around 101 through Friday AM (vaccine received Wednesday afternoon). After Friday AM, no fever. Still had fatigue. Arm of injection very painful, sore to the touch.
tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable other HCP. A 5-decade-old female patient (in her 40's) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated they have a female patient in her 40s who received the first dose of the Pfizer covid vaccine on 06Feb2021 and tested positive for Covid, she was in the hospital for it. The reporter wanted to know about the second dose, can she still get Pfizer covid vaccine; if not, can she get J&J vaccine. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unknown date. The outcome of the event was unknown.  The information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported  COVID-19 cannot be ruled out in terms of drug ineffective.
p/ pt recv vax 3/25//98 pt 4 days later exp 6-10 lesions on back. described as ``flat & not fluid filled'', pt sibling devel a ``chickenpox like rash''
Painful arm after injection, lymph node under right arm was quite large,  lymph nodes right side back of my head were swollen , low grade fever for one day , arm was swollen along with lymph nodes until Wednesday (4 days) after shot. Swelling down and pain gone, red blotches remain which were warm to touch and  today, - May  4th, I still have some red blotches that itch occasionally but not warm.
joint aches; Chest pain; body aches; fatigue; general not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 31Mar2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for immunisation. The patient's relevant medical history included: "allergy related asthma" (unspecified if ongoing), notes: since she was a child. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 01Apr2023, outcome "not recovered", described as "body aches"; FATIGUE (non-serious) with onset 01Apr2023, outcome "not recovered"; MALAISE (non-serious) with onset 01Apr2023, outcome "not recovered", described as "general not feeling well"; CHEST PAIN (non-serious) with onset 05Apr2023, outcome "not recovered"; ARTHRALGIA (non-serious) with onset 05Apr2023, outcome "not recovered", described as "joint aches". The events "body aches", "joint aches", "fatigue", "general not feeling well" and "chest pain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, arthralgia. Therapeutic measures were not taken as a result of fatigue, malaise, chest pain. Additional information: the patient had asthma and used an inhaler and allergist and primary care doctor thought that she should get pneumococcal 20-val conj vac (dipht CRM197 protein). She had the vaccine on 31Mar2023 ever since then had body aches, joint aches, fatigue and just like the general not feeling well since had it for 2 weeks. Went to the doctor. Had blood work done that was normal. She didn't read anything about side effects lasting more than 2-3 days. The patient had this for two weeks. Did not know if other people have reported this same problem. Had chest pain that went with the joint aches. For the body and joint aches, the patient took TYLENOL. When the patient took TYLENOL, the joint aches were a little better and then they got worse again. The fatigue had been pretty much consistent (was persisting).  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
PT reported on 10/27/06 that within 10 minutes after receiving vaccine she felt glands in neck felt hugh and later joints ached and felt like hot burning needles in them. Joints felt like on pins and needles. Then night of 10/26/06 had fever of 99 with spike of 103 with nausea. Reported had hugh sweat during night and woke up feeling better. 10/27/06 14:45 at time of report pt reported feeling fine.
Received Pfizer 5-11 monovalent. Should have received Pfizer 5-11 Bivalent.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 24-SEP-2014 the patient was vaccinated with VARIVAX (Merck) (dose, units, route of administration, anatomical location, lot# and expiry date were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
53 yo male Hx COPD, bilat lobectomy 2015 x2; 56 py smoker, hx scarlet fever who received PPS23 vaccine at 14:30 on 30 June, 2016 and presented to ER at 20:30 with SVT, which was converted with adenosine and carotid sinus massage. Per chart review his WBC in ER was 14, ABS neuts 10.9; CXR WNL. the following day he experienced severe erythema, edema pain (no pruritus), from his shoulder to below elbow, was again seen in ER, and treated with septra and KEFLEX for cellulitis, which resolved in 2-3 days. ER WBC 13.7 ABS neuts 11.4. blood cultures neg; lactic acid, CMP WNL.
no adverse symptoms; First dose received in november 2018 and second dose in december 8 2019; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, allergies/drug reactions and concomitant medications were not reported. On an unknown date in November 2018, the patient was vaccinated with first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 08-DEC-2019, the patient received second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (Inappropriate schedule of product administration). No adverse symptoms reported. No product quality complaint was involved.
Information has been received from a pharmacist concerning a patient with chronic obstructive pulmonary disease (COPD) who on 26-OCT-2010 was vaccinated with single injection of PNEUMOVAX 23 (lot# 667418/0978Z). Subsequently the patient experienced fever, rash, headache, nausea and vomiting. The patient experienced these side effects for 3 to 4 days after the initial injection. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Client stated shortness of breath.  Paramedics assessed client and client was transported to Hospital.
This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not provided. On 31-MAR-2015, the patient was vaccinated with expired dose of MMR II, lot # J003623, expiry date 22-MAR-2015, 0.5 milliliter (ml), subcutaneously, for an unknown indication. No symptoms reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No other details were provided. Additional information is not expected.