chrisvoncsefalvay/vaers-outcomes huggingface dataset:
their arm is red and a little swollen at the injection site; it has been sore; their arm is red and a little swollen at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (their arm is red and a little swollen at the injection site), VACCINATION SITE PAIN (it has been sore) and VACCINATION SITE SWELLING (their arm is red and a little swollen at the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced VACCINATION SITE ERYTHEMA (their arm is red and a little swollen at the injection site), VACCINATION SITE PAIN (it has been sore) and VACCINATION SITE SWELLING (their arm is red and a little swollen at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (their arm is red and a little swollen at the injection site), VACCINATION SITE PAIN (it has been sore) and VACCINATION SITE SWELLING (their arm is red and a little swollen at the injection site) outcome was unknown.            patient reports that they got their Booster shot on Wednesday and that their arm is red and a little swollen at the injection site and that it has been sore, and that didn't happened with the first two doses of the Moderna covid19 vaccine. Also they notice redness the day that is calling Moderna.   No concomitant drug was reported.  No treatment drug was reported.
Patient has history of vaccine/needle phobia and fainting after vaccine administration and was nervous at the time of covid19 vaccine administration.  After discussion with the patient, patient decided she was willing to have immunization administered.   About 10 seconds after administration, the patient began hyperventilating, turned pale and fainted.  Patient was sitting down at the time of fainting and no injury was reported.  Patient was administered 0.3mg epi-pen once about 10 seconds after passing out and 911 was called.  After about 5 seconds after administration, patient regained consciousness and continued hyperventilating.  about 30 seconds later, patient slowly began to breath normally.  Emergency services came in shortly after and patient stated feeling "a little better."  I (pharmacist) called pt about 3 hours after even and patient was home and described feeling pleasant.  pt stated she did not required hospitalization and went home after EMS check up.
Patient had received the bivalent booster rather than the first dose in the monovalent series. patient went to a different facility in order to get a J&J shot and the mistake was caught.
Breakthrough case admission after third dose Moderna 3/4/21 Lot#023M20A Moderna 4/1/21 Lot# 011A21A Pfizer 11/16/21 Lot#32030BD
Had DTaP left thigh. 1-2 days later, developed redness and swelling of thigh; redness was posterior to injection site. Cleared after 1 day.
pt devel inc weakness in limbs w/paresthesias in distal extremities;devel difficulty walking; diffuse aching of limbs;some degree of imbalance;lost wt;sleeping excessively;reflexes absent;impression was the pt has GBS;
Raised red dotted and blotchy rash covering entire torso and chest, back. Rash itchy and warm. Started 24-36 hours after first vaccine does and grew in size over the course of several days. Instructed to take course of Benadryl and other antihistamines.
Within an hour of injection arm was very uncomfortable shoulder to wrist with throbbing pain which continued for 2 days.  Today is day 10 and arm continues to have approximately a 3" area of redness around the injection site and are is still sore as if bruised.  I can touch that area without pain but any pressure is still uncomfortable.  Redness seems to be getting worse instead of better.  Need to know if I should not get the 2nd dose understanding that reactions are more intense on the 2nd dose.
Sudden hearing loss; Tinnitus. ENT doctor prescribed Prednisone for 2 weeks (80mg per day for the first week, then a progressively decreasing dose for the second week).
Ever since completing my second COVID vaccination and then the booster, my immunity seems depressed.  I never was one to get sick as evidenced by perfect attendance at previous jobs but I now get sick every 4 weeks with something and causes me to miss work, seek medication attention, and use either persciption antibiotics and/or OTC medications.  Additionally, one week after the first shot, I got a cold.  And then again one week after the second shot, I got another cold.  And then, every four weeks after that I was sick even getting hand foot and mouth disease as an adult with a 103 fever. I had about a 2 month respite from illness and then I got the booster shot.  Two weeks after that shot, I got influenza A.  I've never had the flu in my life and had the flu shot.  Four weeks after that, leading to present day, I now have bronchitis, strep throat and an ear infection.
This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a 75-year-old female patient who received SHINGRIX (batch number A5X5B, expiry date 7th March 2021) for prophylaxis. On 4th October 2018, the patient received SHINGRIX (intramuscular) .5 ml. In October 2018, less than a day after receiving SHINGRIX, the patient experienced facial swelling, general body pain and eye swelling. On an unknown date, the outcome of the facial swelling, general body pain and eye swelling were not recovered/not resolved. It was unknown if the reporter considered the facial swelling, general body pain and eye swelling to be related to SHINGRIX. Additional information received as follows: The pharmacist reported that the patient developed swollen face, achy body and swollen eyes overnight.
swelling & redness from inject site (rt arm) to elbow, to around arm almost completely-painful but able to move arm;
With the 1st  dose of Pfizer vaccine (lot EL9269 IMRA) I had acute onset of A-fib that lasted for 24 hours.  I continued to take my heart medication sotalol. With the 2nd dose of vaccine, a few days later I had shortness of breath and difficulty getting a full breath.  About 2 and 1/2 weeks later, it was not getting better, so I went to the ER.   At the hospital, they took blood work, EKG,  MRI of the chest which all came back negative for heart attack and my lungs are clear.  I was discharged with instructions to see an allergist.  I went to see an allergist and was prescribed an albuterol inhaler and a steroid inhaler which I did not use.   It took about 1 more week for my breathing to be back to normal and cleared up on its own.
sore arm; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received first dose of BNT162B2, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient asked if she can get the second dose of the Pfizer covid-19 vaccine while taking tofacitinib citrate (XELJANZ). She forgot to ask for the first dose and she already got it. She received the first dose of the Pfizer covid-19 vaccine and experiencing a sore arm that lasted a couple of days. The patient recovered from sore arm on an unspecified date.   Information on the lot/batch number has been requested.
full body aches; fatigue; This is a spontaneous report from a contactable nurse through a Pfizer sales representative. This nurse reported similar events for two patients. This is second of two reports.   A 16-years-old patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA) on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, 24 hours after the vaccination, the patient experienced full body aches and fatigue. Clinical outcome of the adverse events was unknown at time of this report.   No follow-up attempts are needed, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020322822 same reporter, product, AE and different patient
Information has been received from a physician concerning a female who on 05-NOV-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  The physician reported that on 12-NOV-2007, the patient presented to the office with shingles and pain.  The patient was informed she had a "bad case" of shingles and was placed on prednisone.  At the time of this report, the patient's shingles persisted as she remained uncomfortable.  Additional information has been requested.
After feeling totally fine for about 6 days, the injection site started feeling itchy and irritated. I thought it was just a sore muscle so I was rubbing it for a while, before I noticed that it had kind of a hard lump and was swelling. The next day (today) the discomfort continued and the injection site got a bit pink and warm to the touch.
mom brought pt for #2 hep b & reported about 2wk p/vax pt had a rash;no other sx stated;
I have had 3 moderna shots before this, last one 12/2/21. So I was not sure how to answer the dose questions. I started to feel nauseous around 5:30 pm on Saturday. I started throwing up around 8:30 pm and it continued until about 4:00 am. I threw up about 10 times, then diarrhea started and I was doing both at the same time. It really felt like food poisoning. But everything that I had eaten that day, was something that I had already had. (Opened box of hot pockets, etc.)  Fever got up to 100. I was exhausted. Sunday throughout the day, I just stayed in bed, but I didn't throw up or poop anymore. I went to work Monday and felt great.
It feels like my left ear is draining; This spontaneous case was reported by a consumer and describes the occurrence of OTORRHOEA (It feels like my left ear is draining) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Bell's palsy in 2017 and Pregnant in 2017.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced OTORRHOEA (It feels like my left ear is draining). At the time of the report, OTORRHOEA (It feels like my left ear is draining) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Date of Service 9/13/2021 patient was given Moderna vaccine in error, Mom and provider were both notified. Mom will have patient get the series of Pfizer vaccine.  Medical assistant was educated on age requirement for Moderna vaccine.
COVID VACCINE BY JANSSEN LOT# 1808982 EXP JUNE 23/2021  IN ADDITION TO REGULAR SIDE EFFECTS - PAIN AT INJECTION SITE, FEELING UNWELL, HOT AND COLD CHILDS, TIRED, NAUSEA - THE PTNT ALSO HAS CHEST PAIN AND VOMITING.  PHARMACIST ADVISED PTNT TO GO TO ER - PTNT WAS RELEASED UNCER FATHER CARE.  ADVERSE EFFECTS AND SYMTPONS IMPROVED AND WERE GONE BY DAY 5.
Patient woke the next day with 2inch by 2inch red, raised, warm welt at the injection site. Patient denied fever or respiratory concerns. Site was itchy as well. Patient applied ice. Reaction lasted 3 to 4 days.
Cellulitis of left upper limb. Redness, pain, swelling. Tender red induration at site of injection 2x4cm.
Hives after receiving the modern vaccine; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives after receiving the modern vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 URTICARIA (Hives after receiving the modern vaccine). At the time of the report, URTICARIA (Hives after receiving the modern vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications reported.    This case was linked to MOD-2021-035672 (Patient Link).
I had my vaccination on 04/04/2021. Immediately I felt dizzy. They had me go wait and monitor me for reactions. My vision started to spin. It did dissipate and I drove home. The dizziness lasted the one day.
Superficial skin reaction occurred the day after administration of vaccine (PENTACEL).  0 treatment.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female patient with no medical history and no drug reactions/allergies who was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number not reported) on 21-JUN-2010, and the third dose (lot number not reported) on 17-DEC-2010. There was no concomitant medication. The patient was subsequently determined to be pregnant on 04-JAN-2011. Urine pregnancy test performed on 04-JAN-2011. The patient sought unspecified medical attention. The patient's outcome was unknown. The follow-up information has been received from a licensed practitioner nurse concerning the patient who was vaccinated with a dose of GARDASIL. The nurse reported that the patient had a spontaneous abortion in January 2011. The patient's outcome for spontaneous abortion was unknown. Upon internal review, spontaneous abortion was considered to be an other important medical event. Additional information has been requested.
Major increase of  tinnitus and substantial decrease in taste from date of shot 2/6/21 which continues
a 6 months old female patient was not administered DTap-IPV portion of Pentacel and she only received ActHIB portion diluted by sterile water from another manufacture diluent, no AE; Initial information received on 15-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a six month old female patient who received a 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: UJ148ABA and Exp. Date: 03-Feb-2021) via an intramuscular route in an unknown administration site for prophylactic vaccination on 20-Jun-2020, where DTap-IPV portion of vaccine was not administered and the Act-HIB portion was administered by diluted with sterile water from another manufacture's diluent from Merck (product preparation issue).  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), HEPATITIS B VACCINE and ROTAVIRUS VACCINE for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique.  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 holders 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.
per pediatric team, the child sat with grandmother for 15-30 minutes in lobby to evaluate for reaction after injection received at 1339 PM on 3/23/22. Grandmother/child stayed in the clinic for other reasons unknown. Child still in clinic at 252 PM, collapsed in front of staff with a seizure lasting over 15 minutes. EMS called and child transferred to Emergency room with grandmother. unknown outcome. ER of choice unknown per EMS transport.
Nausea, dizziness, foggy feeling, chills, elevated temp and significant large local redness, pain, itching and pinching at site of injection on left arm, numbness and tingling in fingers.
my arm started to ache that night, slowly travelling down my arm and into my hand; my arm started to ache that night, slowly travelling down my arm and into my hand; This is a spontaneous report from a non-contactable consumer, the patient. An elderly female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 06Jan2021 as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medication taken within two weeks of vaccination was unknown. It was unknown whether  patient received any other vaccines within four weeks prior to the vaccination. The patient reported that the only side effect was her arm started to ache that night, slowly travelling down her arm and into her hand", in Jan2021. It was gone when she awoke in the morning. The events were reported as non-serious. The patient did not receive any treatment for her arm started to ache that night, slowly travelling down her arm and into her hand. The clinical outcome of "her arm started to ache that night, slowly travelling down her arm and into her hand" was recovered on an unspecified date in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Continual decrease in range of motion in should/arm that received injection. Frequent spasm type pain. Noticeable loss of strength in arm. Increasing occurrences of "popping" noises below shoulder accompanied with short bursts of pain toward, but not reaching the elbow.  Increasing pain when trying to put on a shirt or jacket in injected arm. Inability to sleep on left side due to deltoid muscle pain.
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 25-OCT-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Child received vaccines at 1600 3/23/06 and was brought to ER 3/24/06 with possible focal seizure and fever.  05/17/2007 MR received for 2 night hospitalization 3/24-26/2006 for an episode of shaking of the right arm and leg, perioral cyanosis, and lip smacking which lasted 10-15 minutes.  The child was febrile on admission at T=101'F. Mild cough and congestion. PMH: none. NKDA PE: WNL Discharge DX:  Focal seizure. 5 more ER visits included in record for seizure activity, febrile and non-febrile.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: SEVERE NOSE BLEED THAT LASTED ABOUT 5-10 MINUTES
Swelling on arm; itching; larger wheal on arm the size of sand dollar; Initial information was received on 07-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves patient(unknown demographics) who experienced swelling on arm(peripheral swelling), itching (pruritus) and larger wheal on arm the size of sand dollar(urticaria), while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, concomitant therapy, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and other dosing details were not reported) via an unknown route at an unknown administration site.  On an unknown date, the patient developed non-serious swelling on arm (peripheral swelling), itching (pruritus) and larger wheal on arm the size of sand dollar(urticaria) Unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Detail of laboratory data were not reported.  Final diagnosis were peripheral swelling, pruritus and urticaria.  It was not reported if the patient received any corrective treatment.  On an unknown date, the outcome of the events was reported as Unknown.  Information on the batch number was requested.
patient developed moderately severe myalgias out of the blue; Very mild soreness for a day; Initial information received on 27-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 77 years old male patient who moderately developed severe myalgias out of the blue (myalgia) and very mild soreness for a day (pain), while he received vaccines BCG VACCINE and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect BCG VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed moderately severe myalgias out of the blue (myalgia) and very mild soreness for a day (pain) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and BCG VACCINE.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for both events.  There will be no information available on the batch number for this case.
Patient presented 3/11/12 with itching, red rash at injection site. (Dark red rash of 1.5", light red rash of 6" diameter). Counseled to use hydrocortisone & BENADRYL.
On 4/30/21 the patient contacted JCHD to report symptoms experienced after receiving the second dose of Moderna 4/22. She reported on 4/23 she experienced a fever of 102.1, resting HR 120.  Very weak.  Saturday into Sunday (4/24-4/25) she developed blisters on her nose into her nose and her lips.  Feels it may be cold sores.  She is a MS patient and did speak with her physician about getting the vaccine.
Patient reported a dry throat and tingling lips soon after administration.  Patient had history of anaphylaxis, and stated that these symptoms did not feel the same. Patient had no difficulty breathing nor swelling of the face. Patient was monitored for worsening of symptoms. Symptoms eventually subsided and patient returned home. Patient instructed to seek medical care if symptoms returned.