chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional, for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female patient with no pertinent medical history and allergic to latex and DEMEROL who on 21-APR-2010 was vaccinated with her first 0.5 ml IM dose of GARDASIL (lot# 663559/1178Y). Concomitant therapy included vitamins (unspecified) and LO/OVRAL. On 21-APR-2010 the patient was seen in Family Planning and a urine pregnancy test was performed which was positive. The patient's LMP was 17-MAR-2010 and her EDD was 22-Dec-2010. Follow up information has been received via telephone call from a registered nurse, who reported that the patient had been "into see them" on 28-OCT-2010 (no reason was provided). The registered nurse reported that the patient had delivered on 14-SEP-2010 and the baby had been in the Neonatal Intensive Care Unit (NICU) (WAES # 1004USA03561B1). At the time of the report the gestational age of the baby at birth was unknown. Upon internal review premature labour was considered to be an other important medical event. Additional information has been requested.
Hospitalized 1/16/22-1/19/22 Admitted 12/29/22 for Covid PNA Weakness, SOB, tachycardic, hypoxia, PNA, elevated troponin, resp. failure, sepsis
Feels a little achy; left arm became sore again; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Feels a little achy) and VACCINATION SITE PAIN (left arm became sore again) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (left arm became sore again). On 11-Mar-2021, the patient experienced PAIN (Feels a little achy). At the time of the report, PAIN (Feels a little achy) and VACCINATION SITE PAIN (left arm became sore again) outcome was unknown.            No concomitant medications reported.  No treatment medications reported.   This case was linked to MOD-2021-041019 (Patient Link).
Blood clots on my legs; tired; This is a spontaneous report from a contactable consumer (the patient).   A 30-year-old patient of an unspecified gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number ER8737), via an unspecified route of administration, on 07Apr2021 at 12:30 (at the age of 30 years old) as a single dose in he left arm  for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient has no known allergies. The patient's concomitant medications were not reported. The patient had received no other vaccines within fourteen days prior to vaccination. The patient experienced "blood clots on my legs" on 07Apr2021 at 17:00 with outcome of unknown, and "feeling drained and tired for two weeks now" begining on 07Apr2021 at 17:00 with outcome of unknown. The patient has not been tested for COVID-19 since the vaccination .
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received SHINGRIX. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (see case US2018GSK091903). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm and chills. On an unknown date, the outcome of the pan in arm was unknown and the outcome of the chills was recovered/resolved. It was unknown if the reporter considered the pain in arm and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional originally called to report that some of the SHINGRIX liquid leaked out from the needle during administration to a patient. Maladministration was taken prior (see case- US2018084274). After the health care professional was transferred about if that dose that leaked out needed to be repeated for that patient, the health care professional mentioned that himself, had gotten 2 doses of SHINGRIX. He was 60 years old male who got the first dose of SHINGRIX and said he had a lot of arm pain that he could barely lift his arm. (see case-US2018GSK091903). Then he got the 2nd dose of SHINGRIX 2 months later and again experienced arm pain (but not quite as bad as the first dose) and then also said had chills the night he got the 2nd dose of SHINGRIX. He said the chills only lasted that night. No further information was provided. This case has been linked with US2018084274 and US2018GSK091903, reported by the same reporter.
Use Error Narrative: Merck & Co. Inc Lot \# 1085X. Expired 05/31/2009. Symptoms Erythema
Redness & swelling after inj. given & cont >4d after inj. while pt on AUGMENTIN for puncture injury 4/23/2009.
IMMS GIVEN IN RIGHT DELT, ARM IS SWOLLEN, RED AND WARM TO TOUCH. CHILD NOT USING IT AT THIS TIME.
On Aug 10th patient reported to our institution that he was dx with RSD/complex regional pain syndrome (affecting sympathetic nervous system) in June 2012 after having symptoms since March 2012. Symptoms include chronic pain, inability to use L arm, shaking/jerking of the torso, breathlessness r/t shaking, poor short term memory and concentration. Pt is experiencing out of control anxiety/worry, irritability, sleeplessness and isolation, stress appears to exacerbate symptoms. On Aug 12th during another visit. Left arm swelled up after tetanus shot in March. Having jerking movements in his left arm, torso. Gets pinprick esp in his finger tips, pain can be at 8/10, all day. Cold water hurts him, hot water helps. The jerking is worse when standing or sitting, gets better when lying down. Applying for chronic disability... Relates the following chronology: 1) 3/8/12 received tetanus shot. Had redness and some swelling at the site, but not enough to seek help. 2) 3/28/12 had blood draw. Reports after this an explosion of pain and swelling in his left arm. 3) 4/17/12 went to urgent care and referred to emergency room for severe swelling and pain of left upper arm. Given antibiotics. (First time he sought medical care). 4) 4/16/12 - began evaluation through his private sector physician with MRI, EMG, and eventually to current diagnosis of Reflex Sympathetic Dystrophy, with symptoms of severe pain, swelling, sensitivity, and persistent jerking of arm and torso. Upon further follow up, Jan 2013 patient communicated following. Clinic, where he was told that his tremors or involuntary movements are originating in his peripheral nervous system, not his brain, and are due to his Reflex Sympathetic Dystrophy, in his left arm and shoulder, that had its onset following a tetanus vaccination, with possible exacerbation by subsequent venipuncture in the same upper extremity, in March of 2012. He was told that he does not have Multiple Sclerosis or Parkinson's Disease.
gave the last two doses after the six hours of vaccine viability time; A spontaneous report was received from a healthcare professional concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and the person that was giving the doses gave the last two doses after the six hours of vaccine viability time (expired product administered).   The patients' medical history was not provided. Concomitant product use was not provided.  On an undisclosed date, the patient received a dose of mRNA-1273 (batch number unknown) for prophylaxis of COVID-19 infection.   The reporter stated that they punctured the vial but the person that was giving the doses gave the last two doses after the six hours of vaccine viability time.  Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was unknown.  The event, gave the last two doses after the six hours of vaccine viability time, was considered recovered/resolved on an unknown date.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (batch number unknown) with no associated AEs.
Information has been received from a nurse concerning a female between the ages of 11 to 13 who in February 2007, was vaccinated with a first dose of Gardasil (lot # unknown) IM. In February 2007, the patient experienced a missed period for the first dose. On an unspecified date the patient was vaccinated with a second dose of Gardasil IM and experienced a missed period for the second dose. Medical attention was sought. The nurse was not concerned because at this age, many patient's menstrual periods are irregular anyway. The patient does plan, or may have already received her third and last vaccination. No further information was provided. At the time of reporting the patient has recovered on an unspecified date. Additional information has been requested.
Within 12 hrs child developed rectal temperature of 104.4 and began with tremors of the whole body, especially of the lower extremities. No previous history of reactions to any vaccines. Temp returned to normal with Motrin and Tylenol within the next 8 hrs. To ER for Dr review within 18 hrs of shot given.
Pt received vaccine on 11/13/17, about 30 mins after administration noticed swelling, redness and pain. Came back to clinic on 11/14/17 area of swelling/redness was 12x12 with numbness from her left hand to her mid forearm. Pt was advised to ice area and was prescribed naproxen.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site discomfort in a 72-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 12th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th June 2018, immediately after receiving SHINGRIX, the patient experienced injection site discomfort. On 15th June 2018, the patient experienced injection site warmth, injection site swelling, injection site itching and injection site erythema. The patient was treated with TYLENOL and BENADRYL. On an unknown date, the outcome of the injection site discomfort and injection site erythema were recovering/resolving and the outcome of the injection site warmth was not recovered/not resolved and the outcome of the injection site swelling and injection site itching were recovered/resolved. The reporter considered the injection site discomfort, injection site warmth, injection site swelling, injection site itching and injection site erythema to be probably related to SHINGRIX. Additional details were provided as follows: The health care professional reported at 13:15, the patient experienced discomfort when receiving the SHINGRIX injection on left deltoid. The patient experienced itching, redness, swelling, and warmth around the injection site beginning 3 days after receiving the SHINGRIX. The swelling around the injection site had gotten worse from June 15th to 17th June 2018. The health care professional recommended ice and TYLENOL. The health care professional had called the patient back and the patient notified him that her symptoms had improved greatly after taking only BENADRYL. The itching had resolved and there was almost no more redness.
Almost 2 weeks after my vaccine, the area around the injection site became sensitive and warm to the touch, almost like a sunburn. Checking online, it looks like a classic case of "COVID arm". Did not use anything to treat, it's annoying but not severe.
Fever, fatigue, headache, weakness, muscle pain, chills, feeling unwell, behavioral changes.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient treated with Paxlovid (anti-viral) for COVID-19 treatment from 03Jan2023 to 07Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient received Pfizer COVID Vaccine for first dose on 4/6/2021 and received Moderna COVID vaccine on second dose. Patient and patient's son (Caregiver) were notified immediately of this event. Supervising provider, Patient's PCP, and consulting primary care physician were made aware of this event and advised patient be monitored for 30 minutes post vaccination for any side effects or reactions. Patient was also evaluated by PCP post vaccination for further evaluation and additional follow-up if needed.
PT FELT SO DIZZY AND STARTED BREATHING WITH DIFFUCLTY ALMOST FAINTED, CALLED 911, PT HAD A SEVERE DROP IN HER BLOOD PRESSURE AND WAS TRANSFERED TO ER TO HAVE SOME IV FLUIDS
This spontaneous report as received from a pharmacist via company representative and refers to a patient of unknown age. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. On an unknown date, it was reported that the patient was vaccinated with PNEUMOVAX 23 injection (dose, frequency were not provided) for preventing pneumonia. On an unknown date, the patient experienced diarrhea for three days. No product quality compliant (PQC) was involved. Many of the fields were marked, unknown by reporter, because the caller did not have the information to answer the questions within this report. No further adverse event information was there to report. The outcome of diarrhoea was reported as recovered. The reporter did not report the causal relation of event with respect to PNEUMOVAX 23.
5 MINUTES AFTER RECEIVING COVID MODERNA VACCINE, CLIENT LOOKED DOWN AT HIS LEFT ARM AND SAW RED WELTS APPEARING FROM NEAR VACCINE SITE AND STOPPING AT HIS LEFT FOREARM. THE RED WELTS ALSO APPEARED ON HIS RIGHT ARM STOPPING AT HIS RIGHT FOREARM.  BLOOD PRESSURE TAKEN BY NURSE AND BP WAS ELEVATED. TREATMENT GIVEN AT THIS TIME WAS 50MG BENEDRYL PO. PATIENT WAS OBSERVED BY NURSE FOR 15 MINUTES. PATIENT DID NOT WANT TO STAY LONGER THAN THE STANDARD 15 MINUTE WAIT. BY THEN THE RED WELTS ON HIS LEFT ARM WERE FADING AND BP MORE NORMAL. RED WELTS STILL ON HIS RIGHT ARM. PATIENT STATED HE FELT FINE AND WAS READY TO GO HOME NOW.
Approximately 30 to 60 minutes, post vax, pt developed itching/numbness of tongue and mouth, progressing to throat. Mother, a nurse, gave one dose of Benadryl, with slow resolution of symptoms. Mother applied cream to injection site before immunization.
Patient woke up in the morning after her vaccine, her arm was swollen and red all the way to her elbow, and her arm was painful and heavy and tingling. This continued until the following day with the tingling and swelling. The arm is still red and it is hot to the touch and is extremely itchy. Benadryl helps with the itching.
Extreme lethargy with bouts of nausea. The lethargy lasted a full week where she was unable to cook a meal with out sitting down to rest her eyes.
Information has been received from a 61 year old male patient with hypertension, type 2 diabetes mellitus, hypercholesterolaemia, drug hypersensitivity and sulfonamide allergy who in May 2008, was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included DIOVAN, NORVASC, metformin, CLARINEX and ezetimibe (plus) simvastatin (MSD). It was reported that "two weeks ago", approximately on 04-AUG-2009, the patient was diagnosed with shingles. The patient was evaluated by his physician and was advised to use topical Calamine Lotion. Unspecified blood test was performed on an unknown date (results not provided). The patient also stated that the lesions were "almost completely crusted over" at the time of the report. The patient was recovering at the time of reporting. Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2008, the patient was vaccinated with ZOSTAVAX, (lot number and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. Later in 2008 (previously reported as 04-AUG-2009), the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested. Sender's Comments: Merck 0908USA02991: Mfr number.
Injection site pain and soreness starting immediately (of course). Mild nausea starting about 3 hours after injection. Severe chills 17-20 hours after injection. Nausea and vomiting about 19-20 hours after injection. General malaise feeling, tiredness, and moderate headache lasting up to ~26 hours after injection (but that could've just been because I didn't sleep and was dehydrated).
Red blotchy rash at vaccine area. Rash is slightly raised but not itchy. Rash is several spots over an approximate 2 inch by 1.5 inch area, largest spot is the size of a dime.
Mom report " blistered" rash appeared over a duration of 30 mins. Rash lasted for approx 1 wk , Did not form scabs. Was diagnosed by ER attending as having chicken pox
Big swollen bump on her arm right away; Lump immediately formed; This is a spontaneous report from a contactable pharmacist. A 70-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (lot# AL3605, Exp date Jul2021, NDC 0005197102), via an unspecified route of administration in the arm, on an unspecified date, at single dose, for immunisation. Medical history included high cholesterol and type 2 diabetes mellitus. Concomitant medications were not reported. The patient previously took Pneumovax for immunisation and experienced mass and peripheral swelling. The patient experienced big swollen bump on her arm right away and lump immediately formed both on an unspecified date immediately after vaccination. Outcome of the events was unknown. It was reported that same happened with Pneumovax but not so soon after giving it.
Moderna COVID-19 Vaccine EUA  I had a rash on upper back and neck (hives) that were itchy and red that lasted 1 week starting the day after vaccine. I also had a few canker sores develop beginning 2 days after vaccine that last about 5 days. It's typical for me to develop canker sores when ill or under stress so that may have been a normal response my body had to vaccine.
Severe vomiting, spinning, sweating first day. Told to take Zofran and Dramamine on Friday. Monday, still vertigo symptoms, went to Dr who referred to ER. They diagnosed w vertigo and told him to see ENT. They said inner ear issue and to do PT. Still today is very foggy.
Nausea/Vomitting/Rigors = 1343 9/10 duration aprox 2 hrs Fever/Chills/Itchy/Myalgia/Pain at injection site = 9/11 Swollen Lymph Node = 9/12
This case was reported by a consumer via call center representative and described the occurrence of fainting in a 18-year-old female patient who received BEXSERO for prophylaxis. In April 2019, the patient received the 1st dose of BEXSERO. In April 2019, 5 min after receiving BEXSERO, the patient experienced fainting (serious criteria GSK medically significant) and sinus tachycardia. On an unknown date, the outcome of the fainting and sinus tachycardia were unknown. It was unknown if the reporter considered the fainting and sinus tachycardia to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient received BEXSERO and experienced a blood draw and fainted and had since had 10 new episodes of sinus tachycardia with heart rates up to 198 lasting around 20 minutes. The patient had been in the emergency room twice for this and they were unable to figure out why this presented immediately after the vaccination. The reporter asked any information on this as a possible side effect of the BEXSERO.
Patient reported deceased to public health today. Date of death: 7/15/2021.   Sister of patient reports that case reported chest pain while at home walking on his treadmill, he then had to lie down and sister asked him if he was having pain and wanted ambulance called. Reports that patient declined 911 call. Sister then reports that patient had what looked like a seizure, but then went completely unresponsive, so she initiated CPR and called 911. Reports that CPR and 911 response was not successful and patient passed away.
Narrative:  Patient received three doses of COVID 19 Moderna vaccine Jan/Feb/Aug 2021. The patient presented to the ED on 1 Jun 2022 with cough, shortness of breath, fever, and malaise. The patient was admitted to the hospital with sepsis and covid pneumonia. The patient was treated with remdesivir and dexamethasone. The patient was discharged on 5 June on antibiotics for bacterial pneumonia in stable condition. Reported per EUA.
Patient administered a vaccine on 2/9, that expired on 1/30/2023.  There were no adverse symptoms reported by patient. Pt to be recalled to be -re-immunized per CDC recommendation, as discussed with representative at GSK.
Patient with known fear of needles reported lightheadedness and fainted after receiving her vaccine.  She was seated at the time, and was guided from chair to floor by her husband.  She did not sustain any trauma and did not lose consciousness.  After several minutes, she transferred independently to a chair and remained under observation for 30 minutes. She reported all symptoms resolved, she left the clinic independently
Tinnitus - began the evening of the 2nd vaccine and has not gone away Reported to family doctor Referred to ENT specialist
This is a spontaneous case, initially received from other non-health professional on 16-Oct-2018, concerning a 66-year-old, elderly, female patient. The patient's current conditions included unspecified gastrointestinal disorder, hypertension, reflux and atrial fibrillation. The patient's concomitant medications included XARELTO, NORVASC and NEXIUM. On 25-Oct-2018, the patient was administered FLUAD (TIV), dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm [deltoid], NDC: 70461-0018-03, batch number and expiry date: not reported). On the same day, immediately after vaccination, the patient experienced sharp pain going from injection site down into her arm to her wrist. The patient stated it was in the nerve. As the night progressed, it became harder for the patient to lift her arm. It subsided and came back and worsened. It was reported that the pain did not stop and kept hurting. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.