chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stomach disturbance; minor inflammation on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach disturbance) and VACCINATION SITE INFLAMMATION (minor inflammation on the left arm) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE INFLAMMATION (minor inflammation on the left arm). On 12-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach disturbance). At the time of the report, ABDOMINAL DISCOMFORT (stomach disturbance) had resolved and VACCINATION SITE INFLAMMATION (minor inflammation on the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Presented with worsening covid symptoms; initial + covid 2 weeks prior; CXR: bilat PNA; Labs: D-dimer 1.23; CRP 8.08, Ferritin 268; Tx: Maxipime, Decadron, Lovenox; No remdesivir due to out of range; Initially on 2 LPM O2, up to 5 LPM during visit, back down to 2LPM at d/c; home with O2
The day following the vaccine patient developed a dry, unproductive cough. The cough was often and uncontrolled. Could not stop. It lasted for a month and then finally dissipated.  Patient did visit his physician and she thought maybe it could be allergies, but also said that she could also believe that this was a side effect of the vaccine.  After receiving the third dose, the same cough occurred again beginning the following morning. After it happening twice it seemed less coincidental and more related.
2-3 hours after PCV 7 vaccine, pt had swelling of lips, rash on face, apparent difficulty swallowing. No respiratory compromise. This event was immediately preceded by eating peanut butter. Treated with prednisolane and Benadryl.
This case involves a 77-year-old male patient who was accidently given MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Off label use). The patient past medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included ECULIZUMAB (SOLIRIS). On 21-Oct-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6920AA and expiry date: 15-Apr-2022) (Frequency once) via intramuscular route in the left arm for prophylactic vaccination. It was reported "The clinic reported that a dose of MENACTRA was accidently given to a 77-year-old male but with further research it was discovered the consumer was prescribed the MENACTRA due to being prescribed an upcoming therapy that needed the vaccination. The clinic reported that the consumer is needing to have a series of 2-doses of Menactra due to starting the therapy Soliris (eculizumab); that the MENACTRA was prescribed to be given 8-weeks apart; that the Nephrologist prescribed the Menactra and the Soliris (eculizumab); that the Soliris (eculizumab) will be performed with the nephrologist; that the clinic reached out to the nephrologist and confirmed the need for the MENACTRA; and that the consumer is now planning to get the second dose at his pharmacy". It was a case of actual medication error due to Off label use in unapproved age group (same day latency). At the time of report no adverse event was reported.
Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that, the vial was initially stored in the refrigerator on 01-Dec-2021 and vials did not undergo any temperature excursions. No concomitant medication were reported.  No treatment medication were reported.
tingling with pins and needles feeling all through arms, legs, face; nausea; dizziness sight; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on the left arm on 21Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included "Celtics disease", allergies to gluten and negative COVID-19 test nasal swab on 10Oct2020. Concomitant medication included birth control and prenatal vitamin. Patient did not have COVID prior to vaccination and was not pregnant. Vaccination was received in the hospital and no other vaccine was received four weeks prior. On 21Jan2021 16:00, the patient reported nausea, dizziness sight and chills were normal then she had tingling with pins and needles feeling all through arms, legs, face. She still had prickling feeling in arms and her left foot was tingling and it had been four days later. The adverse events pins and needles reportedly resulted in disability or permanent damage. Patient has been tested for COVID post-vaccination on an unspecified date with unknown results. Treatment was received for the events. Outcome of the events was not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of prickling feeling in arms and her left foot tingling cannot be excluded, considering the plausible temporal relationship. 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
Started getting flu-like symptoms (fever, sweating, chills body aches) and severe arm pain around midnight   after the shot. Severe enough he considered going to ER. Stayed home. Flu like symptoms resolved after 24 hours but arm pain continued. Pain in arm so severe he could hardly lift it and had very little range of motion. Went to physical therapy and saw ortho doc beginning of January. Range of motion almost back now (1/14) but still not all the way. This was the first time receiving HIGH dose flu shot and patient attributes complications to vaccine. Ortho did MRI and said there was a small tear in the rotator cuff. No fluid build up or bursae.  Doctor did NOT attribute tear in rotator cuff to vaccine administration. We do not administer vaccines that high in the arm. Patient was also told he had arthritis in shoulder.
flulaval on October 18th 2023 and 2nd dose on October 30th (less than 4 weeks gap; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 12-month-old patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLULAVAL QUADRIVALENT).   On 30-OCT-2023, the patient received the 2nd dose of FluLaval Quadrivalent 2023-2024 season. On 30-OCT-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced drug dose administration interval too short (Verbatim: flulaval on October 18th 2023 and 2nd dose on October 30th (less than 4 weeks gap). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-NOV-2023 The pharmacist asked about what was the next step. The patient received 2nd dose of Flulaval earlier than recommended interval (less than 4 weeks gap as per schedule), which led to shortening of vaccination schedule. The reporter did not consent to follow-up.
This spontaneous report was received from a healthcare worker (medical assistant) and refers to two patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot# K020189, expiration date 11-SEP-2016, exact doses and route of administration were not reported). It was reported that the vaccines had 2 temperature excursions. No adverse symptoms were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Information has been received from a physician concerning a 23 year old white male with no pertinent medical history and no drug reactions/allergies, who in May 2007, was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) in another country. There was no concomitant medication. In May 2007, the patient developed fever, right sided parotitis and headache. Another physician diagnosed the patient as having Mumps. The outcome is reported as recovered two weeks after onset date reported by the patient. No further information is available. There were no lab diagnostics studies performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Received report from PCP that client has redness, swelling, and heat to injection site.  Mother of client reported reaction started the day of injection and got progressively worst. First sought medical treatment on 09/22/2004.  Mother returned to MD's office today for worsening symptoms.  Child treated with Keflex 250mg/5cc po TIDx5days on first visit of 09/22/2004.
Janssen COVID-19 vaccine was administered past the beyond use date. The vaccine vial was originally punctured at 8:15 am on 6/8/2021, but vaccine from this vial was withdrawn and administered at 2pm on 6/9/2021.
After the patient received the vaccine, he sat down in a chair for observation and less than 5-10minutes he slumped and dropped to the floor. the patient is able to respond to questions and felt very weak. he felt very thirsty and we gave him water drink. he slowly recovered while partially lying in the floor and being supported. when medics came in he was already able to sit in the chair and  refused to go with the ambulance. he rested more and finally went out of the pharmacy.
Dose 1 vaccination administered at 12.30pm on 1/18/2021 on RIGHT ARM. Felt arm pain and swelling 1 hour after getting vaccinated on day 1 with slight nausea and uneasy feeling till about 5 hours after vaccination. That feeling and nausea stopped, followed by chills and tiredness by late evening on day 1. No medication taken.   On day 2 (1/19/2021) morning felt better with tiredness and chills resolved on its own. However, pain and swelling on right arm increased and persisted till day 3 and then started to reduce drastically from then on.  On day 4, 5, 6 & 7 (1/21/2021- 1/24/2021) felt back to my normal self again. No arm pain. On the night of day 8 (1/25/2021), felt pain on right arm again 2 inches below the injection site. Day 9 (1/26/2021) morning, noticed red colored skin rash about 3 inches wide and 4 inches in length located 2 inches below injection site. Rash was painful and slightly itchy.  Today is day 10 (1/27/2021, and rash still persists.
Headache, low-grade fever (less than 100.5)- treated with 2 500 mg Acetaminophen 3 times. Treatment was successful, but symptoms returned after 6 hours. Symptoms were gone upon waking the next day (3/1/2021).
one other person had a nosebleed too; This is a spontaneous report from a contactable consumer or other non-HCP. A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose number unknown, single for COVID-19 immunization. Vaccination facility type was reported as Pharmacy/drug store. Patient medical history and concomitant medications were not reported. The pharmacy said they did not think that was a reaction, but they thought it was odd because one other person had a nosebleed too. The outcome of the events was unknown.   No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Severe pain and swelling to left arm, fever of 102, general malaise, nausea
swelling left arm, shoulder and hand; swelling left arm, shoulder and hand; pain in right breast but moved to left breast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), JOINT SWELLING (non-serious), outcome "unknown" and all described as "swelling left arm, shoulder and hand"; BREAST PAIN (non-serious), outcome "unknown", described as "pain in right breast but moved to left breast".  Additional information: Patient had 1st Covid vaccine last Friday. Having side effects and would like to talk to someone about them. Having swelling left arm, shoulder and hand. Also had pain in right breast but moved to left breast.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
H/o varicella vaccine given 6/21/06 to Left arm. C/o left arm redness, reddened area one inch in diameter, tender to touch, and warm to touch and mild rash. Dx'd chickenpox mild.
Complain of erythema progressing to small blisters.  Patient site of DTaP done two days ago.  Mom states it was improving.  Skin: firm red swollen area with small vesicles at injection site.  Assessment: adverse drug reaction.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 27-MAY-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number, dose and route were unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 27-JUL-2016, the patient was vaccinated with a dose of PNEUMOVAX 10 single DS, 0.5 mLVls 10SDV, (lot number L035882, with an expiration date of 19-APR-2017) (route and anatomical location were not reported) that was improperly stored. The lowest temperature excursion was of 34 degrees Fahrenheit (F) for a total of 176 hours. No adverse effects were reported. The type of excursion was refrigerator and the vaccine status in excursion. Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
This child had elevated temp, and hives 4 hours after the vaccines. Child was taken to the ER.
At 7-10 minutes after injection face and ears felt hot. At 30 minutes after had mild dizziness and tightness/wheezing in chest.
Initial report was received from a health care professional on 14 October 2011. A 13-year-old female patient had received an intramuscular injection of FLUZONE, lot number UT481AA (site of administration not reported) on 11 October 2011. The patient developed headache, blurry vision, and vomiting after the vaccine on the next day. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient received two doses of Adacel 13 months apart, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via Global Medical Information (Reference number- 00683679) and transmitted to Sanofi on 15-Jul-2021.  This case involves a 12 year old female patient who received two doses of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] 13 months apart (Inappropriate schedule of product administration)  The patient's past vaccination(s) included ADACEL on 17-JUN-2020, MENACTRA in 2020 and GARDASIL in 2020 for prophylactic vaccination.  Medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) (lot: U6920AB, expiry date:15-Apr-2022) for prophylactic vaccination.  On 14-Jul-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6900AA, expiry date: 18-Nov-2022) via unknown route in the right arm for prophylactic vaccination.  It was a case of an actual medication error due to Drug dose administration interval too short (latency: same day)  No adverse event was reported.  It was reported "Caller reports that a patient received ADACEL, MENACTRA & GARDASIL in 2020 and they received the same vaccines yesterday. Is there anything we should informed the parents about? Caller stated that she had to disconnected but will call us back. Health care professional (HCP) requested guidance on how to proceed when a patient received two doses of Adacel, approximately 13 months apart. She stated that the patient was vaccinated with Adacel on June 17, 2020, and received a dose of Adacel yesterday, July 14, 2021"  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 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.
the vial had been open for more than 24h; A patient was administered a dose from a vial that had been open for more 24h; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was administered a dose from a vial that had been open for more 24h) and PRODUCT STORAGE ERROR (the vial had been open for more than 24h) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2022 at 9:50 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was administered a dose from a vial that had been open for more 24h). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial had been open for more than 24h). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was administered a dose from a vial that had been open for more 24h) and PRODUCT STORAGE ERROR (the vial had been open for more than 24h) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported. It was reported that there were no other AEs as a result of this misadministration. 1 dose expired after the 12h. On Monday 6 Jun 2022 the vial was initially stored in the refrigerator.  On 9 June 2022 9:30 am vial was first punctured.  The vial was stored post puncture in a fridge.  The vial did not  undergo any temperature excursions. The vial was exposed to room temperature range for 15 mins before administration.
Severe body aches, chills, lethargy,  and sore arm  the morning after shot.   No fever but at multiple times through out the day the only way I could get warm is during napping under an electric blanket.  My body felt like it was having difficulty regulating body temperature.  Some mental confusion too.  After sleeping for 11 hours I awoke the following morning and felt normal.