chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received the second dose of the vaccine by SubQ injection instead of IM; Sore arm; A spontaneous report was received from a 72 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported received the second dose of the vaccine by SubQ injection instead of IM and developed sore arm.  The patient's medical history and concomitant medications were not provided.  On 21-JAN-2021, the patient received her first of two planned doses of mRNA-1273 (batch number: 032L20A) intramuscularly for the prophylaxis of COVID-19 infection.  On 01-MAR-2021, the patient received her second of two planned doses of mRNA-1273 (batch number: 014M20A) subcutaneously for the prophylaxis of COVID-19 infection.  On 01-MAR-2021, the patient received the second dose of vaccine subcutaneously instead of intramuscularly and developed sore arm.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of received the second dose of the vaccine by SubQ injection instead of IM was considered resolved and the outcome of sore arm was unknown.; Reporter's Comments: This report refers to a case of Incorrect route of product administration for mRNA-1273 (lot# 014M20A). Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-031572:Crosslinked case: Same reporter/different patient (husband) US-MODERNATX, INC.-MOD-2021-032594:Crosslinked case: Same reporter (Wife case (2nd dose)
This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 87-year-old female patient who received FLUARIX QUADRIVALENT. Previously administered products included Flu vaccine (without issue). Concurrent medical conditions included blood cholesterol increased. Concomitant products included ADVAIR, azelastine, Aspirin, CLARITIN, omeprazole and Pravastatin. On 3rd October 2016, the patient received the 1st dose of FLUARIX QUADRIVALENT .5 ml. On 6th October 2016, 3 days after receiving FLUARIX QUADRIVALENT, the patient experienced cellulitis (serious criteria GSK medically significant), erythema, skin discoloration, swelling and pain in arm. The patient was treated with Antibiotic. On an unknown date, the outcome of the cellulitis, erythema, skin discoloration, swelling and pain in arm were recovering/resolving. The reporter considered the cellulitis, erythema, skin discoloration, swelling and pain in arm to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: This case was previously reported to a doctor. The patient received previous flu vaccine in the past without any issue. The patient received the suspect vaccine in her left arm. On 6th October 2016, the patient developed swelling, which was like fluid filled, red, and sore area about 4 inches below the injection site, but not directly under it. The patient stated that it was black and blue and sore, but she denies hitting her arm or the injection itself being uncomfortable. The patient stated she did go back to the pharmacy and was also seen at an urgent care, who prescribed an antibiotic for concern of a potential cellulitis developing. The patient noted it does appear to be improving at this point. The patient did not know what else could be the cause of events besides the vaccine.
The day after vaccination and for several days afterwards had cough/congestion/fatigue/fever and cough.  Was tested for flu and covid both negative.  Chest X-ray mega rice for pneumonia.  Treated with steroids and antibiotic and inhaler .    After second vaccine similar symptoms but worse and chest pain.
Pt recvd vax in AM. That night around 7 PM he developed a swollen neck and itching. He has eczema. He was given APGC (a homeopathic med).
Vaccine liquid spilled from syringe during administration; Vaccine liquid spilled from syringe during administration; A spontaneous report was received from a pharmacist concerning a 74-years-old, female patient who experienced vaccine liquid spilled from syringe during administration.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 17 Feb 2021, prior to the onset of the symptoms, the patient received their planned dose of mRNA-1273 [Lot number 023M20A] for prophylaxis of COVID-19 infection.   On 17 Feb 2021, the pharmacist reported that some of the vaccine spilled from the syringe during administration. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The event vaccine liquid spilled from syringe during administration was considered recovered/resolved on 17 Feb 2021.; Reporter's Comments: This report refers to a case of Vaccine underdose and syringe connection issues for mRNA-1273 [Lot number 023M20A]  with no associated AEs.
Pt recv'd vax on 4/29/99. When mother was putting child to sleep she noticed the child was not breathing. She blew in child's face & he resumed respirations. Child cont to be lethargic,weak,& crying for 45 mins. Came to ER & dxed w/ poss
Diarrhea; Vomiting; Chills; Dry heaving; This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Shingrix. On 4th April 2022, 3 days after receiving Shingrix, the patient experienced chills and dry heaves. On 5th April 2022, the patient experienced vomiting. On 6th April 2022, the patient experienced diarrhea. On 5th April 2022, the outcome of the chills, dry heaves and vomiting were recovered/resolved. On an unknown date, the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the chills, dry heaves, vomiting and diarrhea to be related to Shingrix.     Additional Information: GSK Receipt Date: 6-APR-2022 Reporter's Comment: The patient self-reported that, after vaccination she experienced chills and dry heaving. The patient stated that continuing to experienced dry heaving that later progressed to vomiting after eating. On 6th April 2022, 6 days later, the patient experienced diarrhea. The reporter did not consent to follow-up.
approx 4 hrs p/the vax pt had 2 apnea spells; pt is on apnea monitor because was premature; spells lasted for 24 hrs; pt went to sleep respirations would get shallow & monitor would go off; no fever;
Information has been received from a registered nurse concerning an adult pt who in approx Feb 2006 was vaccinated IM with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650302/1039P). Subsequently the pt developed an injection site reaction to included redness, swelling and pain at the injection site. Unspecified medical attention was sought. At the time of the report the pt was recovering. Additional information has been requested.
Intermittent chest pain, most noticeably when lying down and while sleeping. Feeling of heavy heart beats. No signs of shortness of breath.
After vaccination, patient started to slump in chair. Patient placed on floor and vomited.  Skin cool and clammy.  SPO2 92%. Heart rate- 127. Patient monitored. Stated felt better within a few minutes. SpO2 100%. Heart rate- 92.
At site of injection left thigh, a red swollen lesion measuring 3.5 cm x 3 cm with 3 pustules. 12 days after immunization, told to use Aveeno anti-itch cream.
joint pain in shoulder-radiated down arm-all the way to hand-& on back-shoulder blade muscle-lasted over 6wk slowly dissipating-MD consulted said shot given too high & too close to joint;not allerg rxn-no redness;
Swollen joints for 48+ Hours after each dose headache  Muscle and nerve spasms
heavy menstrual bleeding (menorrhagia), bleeding between cycles (polymenorrhea), painful menstrual cycles
No adverse events following first dose on 3/19/2021 except soreness at injection site.  The second dose hit me hard the day after on 4/20/2021 when I woke up.  I felt flat, difficult focusing, no energy, headache, really bad back pain , chills, and low grade avg . 100.4 fever.  In bed for the night.  Took Ibuprofen and using heating pad for back.
Patient reported to pharmacy that she thinks she is allergic to acidic food items now, like spaghetti sauce, oranges, dill pickles, orange juice  Patient says she cannot eat those items ever since shot without having excessive itching.
Prolonged febrile seizure > 30 minutes lifesquad to ER, seizures meds, infant transferred to Children's ER, admitted to ICU.  03/26/2007 MR received for a 2 day hospital stay following transfer from local facility to pediatric hospital.  Infant had a 1 day hx. of tactile fever, mild congestion, and decreased activity.  Pt. noted by mom to have whole body shaking of generalized tonic/clonic type. Seizure activity >30 minutes. Initially treated at primary facility with Diastat and Ativan with subsequent apnea resulting in intubation .   PE:  ETT in place.  Skin slightly mottled. Cool extremities. Intermittant 4 extremity twitches and shivers.  Babinski decreased. Otherwise WNL.  Txd with antibiotics, NS fluid bolus for decreased perfusion with good results, Phosphenytoin for seizure control.  No further seizure activity observed.  Extubated and weaned to RA without difficulty. Initial Assessment:  Febrile Seizure likely 2' to MMR vaccine. Final DX: New Onset Seizure.
Within 20 minutes of vaccine administration, the pt had hives on neck, trunk, groin and thighs with a feeling of itching in mouth as well. He saw his provider within 60-90 minutes of 1st symptoms. He was given Zyrtec po.
Information has been received from a 61 year old female consumer with hypertension, fibromyalgia and chronic fatigue syndrome who on 03/10/2003 was vaccinated with a third dose of pneumococcal vaccine 23 polyvalent.  Concomitant therapy included levothyroxine Na (SYNTROID), valsartan (DIOVAN), amlodipine besylate (NORVASC), omeprazole (PRILOSEC), estrogens, conjugated (PREMARIN), acetaminophen (+) propoxyphene napsylate (DARVOCET-N) and diazepam (VALIUM). Subsequently, the patient reported that her arm swelled from the injection site to her elbow.  She reported that she has been weak and tired "ever since".  No additional patient information was provided.  Unspecified medical attention was sought.  Additional information has been requested. 02/18/2010 On 27-MAY-2008 at 1600, the patient received a fourth dose of PNEUMOVAX. On that same evening she developed aches and swelling on the left arm at the injection site. The next day, it was red around the swelling area and very sore. She also soad that she had melanoma prior to PNEUMOVAX and it came back to the left arm after her 2nd dose of PNEUMOVAC. Unspecified medical attention was sought. No laboratory diagnositc studies wer performed. At the time of this report, the patient had not recovered.  Additional information has been requested.
chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4229574-00 (Abbvie).  A 51 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Jul2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 08Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19". The action taken for adalimumab was unknown.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter considered "covid-19" related to bnt162b2. The reporter's causality for the event(s) of COVID with HUMIRA (ADALIMUMAB) was no reasonable possibility. Event abate after stopping drug was NA. The reporter's causality for the event(s) of COVID with HUMIRA (ADALIMUMAB) was no reasonable possibility.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out.
Patient has complained of internal itching continuously since the vaccine. No rash or anything on the skin just extreme itching.
Patient received less than .1ml in arm before the syringe got stuck and vaccinator was not able to finish the dose  patient was revaccinated with full dose as it was less then 1/2 of the amount received in the 1st attempt in opposite arm
The day following my second dose of Pfizer, I had nausea, high fevers, chills etc. At approximately 11:20 PM, I was woken abruptly by a rapid heart beat, palpitations, lightheadedness, shortness of breath, tremors, chronic chest pain that radiated down my left arm followed by tingling and cramping in arms and legs and what almost felt like surges of adrenaline in my chest that would not go away. After that day, these issues have been consistent and worsening over time and would last an entire day, everyday causing loss of sleep and loss of appetite. Fainting has occurred twice within this time frame along with these symptoms. It is now February 18th, 2022 and still dealing with these issues.
Stye formed in patient's left eye, visited a clinic and received Erthromycin Ophthalmic Ointment.  The next day a stye formed in patient's right eye.  To date stye's and related symptoms have stabilized but not healed.
On 6/11/99, the pt experienced an allergic reaction consisting of hives on the forehead. The pt sought unspecified medical treatment. The physician stated it was due to something he ate.
Pt received vaccine ~9am.  Was not observed to initially have any s/s of reaction.  ~1045am patient went in to restroom, was dizzy/flush.  Vaccine clinic staff were alerted, who them laid the patient on the ground and elevated feet.  Staff felt for a pulse and found one.  Patient was awake, but slow to respond to commands.  Patient was transferred to the ED for evaluation where they were given diphenhydramine 25mg IV once, famotidine 20mg IV once, and methylprednisolone 125mg IV once.
SOB, swelling-eyelids & lips;flushed from neck up;coughing;in ER 4hr;
Patient had a new onset seizure that lasted for nearly 1 hour.  The seizure occurred at day care after the patient had a breath holding spell.  The patient went rigid, had doll's eyes, and his eyes were fixed.  No tonic/clonic activity was present.  The patient received 4 doses of lorazepam 0.1mg IV push a few minutes apart.  The patient began to come out of the seizure after the last two doses.  Patient had an EEG done that was read as normal.  He was started on phenobarbital 25mg BID.  The patient had a little trouble walking during his hospital stay, which was considered to be a fairly normal manifestation after a prolonged seizure.  The patient had received the seasonal influenza vaccine on 10/08/2009. 11/2/09 DC summary and hospital records received for dates 10/12/09 to 10/14/09. DX: prolonged seizure. Presented to ER with acute onset of seizure. Entire duration lasting 1 1/2hrs. No clonic tonic activity, (+)rigid, (+)eyes fixed. Flu vax 3 days prior. Pt medicated in ER and admitted. On d/c date developed rash on abdomen, d/c in stable condition. ICD9 codes 780.39, 782.1, 786.9
She also felt pain; Felt like whole body was stabbing me; She also got a fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (She also felt pain), MYALGIA (Felt like whole body was stabbing me) and PYREXIA (She also got a fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040AZIA) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included PREDNISONE and SALBUTAMOL (VENTOLIN [SALBUTAMOL]) for Asthma.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN (She also felt pain), MYALGIA (Felt like whole body was stabbing me) and PYREXIA (She also got a fever). On 19-Mar-2021, PAIN (She also felt pain), MYALGIA (Felt like whole body was stabbing me) and PYREXIA (She also got a fever) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment details were reported.   This case was linked to MOD-2021-358713 (Patient Link).
I did not have a reaction to the vaccine. I started with symptoms 09/19/2022 of a severe headache, fever, cold symptoms, cough, runny nose and foggy head. I tested positive for COVID-19 with a home test on 09/20/2022. I had a telehealth visit with my doctor on 09/20/2022 and was prescribed PAXLOVID. By the third day I started to feel much better. I tested COVID-19 negative on 09/27/2022. On 10/03/2022 I rebound and tested positive for COVID-19. This time I work up with a runny nose without a fever for a couple of days. I didn't take anything for the symptoms this time. I test negative for COVID-19 on 10/14/2022.
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. The patient had thyroid disorder reported as medical history. No information about medical history, drug reactions and allergies was specified. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (unspecified lot# and expiration date, dose and route not specified), dose 1. Concomitant medications included SYNTHROID. The healthcare worker reported that she "thinks" that she reported to Merck "about 5 or 6 years ago" that patient developed an adverse reaction (fever and redness and swelling at the injection site) after receiving PNEUMOVAX 23. Unable to find original service request. She states that she remembers reporting this to Merck "years ago" and requesting a lot# check because two other unspecified patients at that time also developed an adverse reaction to the same unspecified lot #. She requested that someone from safety contact her back as soon as possible with information in regards to if there is a report about this patient, from "5 or 6 years ago". She states that she can be reached at her phone number. The healthcare worker also reported that on 17-SEP-2014, this patient received a dose of PNEUMOVAX 23 (lot#J015868 and expiration: 25-FEB-2014, dose and route not specified) (healthcare worker thinks that this is the patient's second dose). And, a "couple of hours later" after receiving PNEUMOVAX 23, she developed a fever and redness and swelling at the injection site. The healthcare worker also reports that the patient is the wife of the physician so the physician examined the reaction on 17-SEP-2014 (the patient sought medical attention). The healthcare worker states that the physician said that the swelling has "spread" since an unspecified date and looks like cellulitis. There was no product quality complaint. The outcome of the events is unknown. The causality of the events was not specified by the reporter. Additional information has been requested.
Two hours after having a MCV vaccine my son got rash all over his body  (very small dots) and very itchy.
Information has been received from a physician concerning a pt who was vaccinated with varicella vaccine. subsequently the pt experienced a full blown chicken pox . Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
@1330 Pt was vaccinated on the gurney as a precaution d/t hx of syncope in the past. Pt was doing well.    @1340 Increased HOB. Fluids provided. Tol PO intake well.    @1350 Sitting on high fowlers position. Tol well. Denies any dizziness or any nausea. Encouraged to increased fluid intake and to finish water in the bottle. Pt agreed and finished water in bottle. HR 60 RR18 Hx of bradycardia   @1355 RN stood pt up and ambulated. Tol well. Per RN, pt denies any symptoms.    @1405 Sat pt in chair. Pt stated that he doesn't feel 100% right. Pt then had a syncopal episode, which lasted for about a minute. Transferred patient to gurney via two person assist. Placed on supine.    @1410 VS 140/80 (101) 63 95% RA 16. Resp even and unlabored. No s/sx of distress noted. No SOB noted. Pt is fluttering eyes but not spontaneously opening eyes. Pain stimuli applied, pt woke up.    @1415 VS 114/62 55 18 99% Pt is fully awake and talking. GCS 15. Placed on semi fowlers position. Pt complained of being dizzy. Pt stated that he was dizzy and nausea. Pt then complained of L chest pain 5/10 tightness. Made pt aware that nurse will have to send pt in the ED. Pt refused. Wants to wait 5 minutes to reassess situation.    @1420 Pt stated that his CP was resolved. Orthostatic BP done. Supine 123/73 (87) 58 97% Sitting 150/74 (99) 69 99% with dizziness and nausea. Made pt aware that he is positive orthostatics and might need to have additional fluid resuscitation that we cant offer while in the vaccination clinic. Encourage pt to go to the ED for further care and management since his symptoms are not better. Pt agreed. Called team alert and ED.    @1430 Gave report to RN from team alert and took pt to ED.
Heart palpitations that persisted for over 5 days after the initial vaccine.; Minor shortness of breath.; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the arm left on 29Mar2021 at 17:00 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have allergies to medications, food, or other products. Concomitant medications included cannabis sativa [marijuana] (MANUFACTURER UNKNOWN) started on an unspecified date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 at 22:00, the patient experienced heart palpitations that persisted for over 5 days after the initial vaccine and minor shortness of breath. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events heart palpitations that persisted for over 5 days after the initial vaccine and minor shortness of breath was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.