chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Little heavy arm; Redness in the injection site; Swollen in the injection site; Little itch; A Spontaneous report was received from consumer concerning 84-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced sore and little heavy arm, redness, and swollen in the injection site, little itch.  The patient's medical history, and concomitant medications are unknown.  On 12 Jan 2021, the patient received her first dose of two planned doses of COVID-19 Vaccine (mRNA-1273) intramuscularly for prophylaxis of COVID-19 infection On 20 Jan 2021 patient started experiencing sore arm, as reported redness and swollen in the injection site.  No laboratory tests were provided.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event is unknown.
Employee stated that she developed a rash on neck, chest, arm, and back.  Had palpations. Was told to take Benadryl which resolved symptoms.  @ weeks later had a repeat of the rash and again took Benadryl.   Employee advised that she could not have second vaccine due to the reaction
injection site is still hard, red, and swollen. site has become itchy in the last day or so. vaccine was administered 9 days ago.  no treatment
On the same day following the vaccine patient was having trouble moving the arm that received the injection. She is not sure of the exact time it started but knows it wasn't immediately following the shot. The next day patient woke up and arm felt better but a bruise at least 6 inches in circumference was located below the injection site. The bruise is not painful or bothersome to the patient.
Felt dizzy, vision started to black out, slight nausea, stumbled backwards then forwards & knelt down.
COVID-19 TEST POSITIVE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 11-JUL-2021, the subject experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000185972.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Herpes outbreak on the 12 day after getting the first Pfizer dose. The outbreak is the same as usual, but I have been taking antiviral medication  for a full year and have had no outbreaks during that time.
The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 11-Aug-2022; No adverse event; Administered Moderna COVID-19 Vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 11-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis. No Medical History information was reported. On 11-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 11-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 11-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 11-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 11-Aug-2022). No concomitant medications were reported.  The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. The vial did not undergo any temperature excursions. No treatment details were reported.
51 year  old received Moderna vaccine at 4:49.  Pt complains of itching and tingling sensation of the lips and throat at 4:59 PM.   At 5:02PM, pt received Benadryl 25mg po .x1.  Refused Epinephrine.   At 5:16 PM pt informed me that the itching is resolving.   5:50PM   V/S B/P 117/77, Pulse=74,  RR=18, O2 sat = 98%,  Temp = 95.4.   Pt resolving 5:52 PM.  pt discharged.  Advised to continue with Benadryl  otc  for itching.  If symptoms continues pt will report to nearest E.R.
pt recvd vax & exp h/a; allergist determines that pt is allergic to yeast & devel h/a due to engerix-B; according to allergist, no further Engerix-B should be given to pt;
This case was initially reported by a healthcare professional (also subject's grandmother), via a GSK sales representative, that described the occurrence of swollen thigh (injection site) in a female subject aged between 4 and 6 years old who was vaccinated with KINRIX, (GlaxoSmithKline).  On an unspecified date in the last week of September 2008, the subject received an unspecified dose of KINRIX (.5 ml, unknown, left thigh).  Immediately after vaccination with KINRIX, the subject experienced swollen thigh (injection site) described as entire thigh swelling, injection site pain and injection site burning.  At the time of initial reporting, the outcome of the events was unspecified.  The healthcare professional considered the events were probably related to vaccination with KINRIX.  Follow-up was received by the healthcare professional (also the subject's grandmother).  The subject, a 4-year-old female, received the "primary" dose of KINRIX on 25 September 2008.  Immediately after vaccination with KINRIX, on 25 September 2008, the subject experienced swollen thigh (injection site) described as entire thigh swelling, infection site pain and injection site burning.  The events resolved on 07 October 2008.  The healthcare professional identified KINRIX as the suspect product.
Headache, nausea, chills just one day. The next day and continuing everyday since, an outbreak of cold sores.
swelling; numbness in face; swelling of right eyelid; urticarial rash to right upper abdomen; This spontaneous case was reported by a physician and describes the occurrence of SWELLING (swelling), HYPOAESTHESIA (numbness in face), SWELLING OF EYELID (swelling of right eyelid) and URTICARIA (urticarial rash to right upper abdomen) 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.    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 SWELLING (swelling), HYPOAESTHESIA (numbness in face), SWELLING OF EYELID (swelling of right eyelid) and URTICARIA (urticarial rash to right upper abdomen). At the time of the report, SWELLING (swelling), HYPOAESTHESIA (numbness in face), SWELLING OF EYELID (swelling of right eyelid) and URTICARIA (urticarial rash to right upper abdomen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
At the time of first dose of the vaccine which was on September 2, 2021 I was 31 weeks pregnant. At the time of my second dose I was 34 weeks pregnant. On October 29th 2021 I went into labor at 39 weeks and was admitted to the hospital for a stay from October 29th- November 2, @021
Stiffness, massive headache, fever, N/V diarrhea, palpitation (chest pain and shoulder pain, febrile 101). Generalize malaise and chills.
Hive around vaccination site 1 week !Raised red area(hive) that was itchy and warm to touch.Local reaction only
Left eye puffiness, left eye paresthesia Tx benadryl, solumedrol, head ct scan
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 63-year-old female patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, fever and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site swelling and fever were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site swelling and fever to be related to SHINGRIX. Additional information was reported as follows: The healthcare professional reported that the patient was administered with SHINGRIX vaccine via the subcutaneous route, led to incorrect route of drug administration. Due to the administration error, the patient had bouts of fever and swelling at the injection site.  The healthcare professional was advised that adverse events could be higher or more prominent due to the incorrect route of administration. Adverse events had all resolved.
unable to use arm; stuttered speech; very traumatizing; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (unable to use arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced LIMB DISCOMFORT (unable to use arm) (seriousness criterion disability) and DYSPHEMIA (stuttered speech). On an unknown date, the patient experienced INJURY (very traumatizing). On 15-Mar-2021, LIMB DISCOMFORT (unable to use arm) and DYSPHEMIA (stuttered speech) had resolved. At the time of the report, INJURY (very traumatizing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       There was no concomitant list provided.  Treatment included as PCP visit, emergency Room visit, CAT Scan Based on the current information and the temporal association between the use of the product and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Based on the current information and the temporal association between the use of the product and the start date of the event a causal relationship cannot be excluded.
arm presented redness / at site of injection; swelling at site of injection; headaches that are very bad; feeling tired; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of shingrix on an unknown date).   On 14th February 2021, the patient received the 2nd dose of Shingrix. On 14th February 2021, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, headache and tiredness. On an unknown date, the outcome of the injection site erythema, injection site swelling, headache and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, headache and tiredness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had her second dose of Shingrix and her arm presented redness and swelling at site of injection. She had been getting headaches that were very bad and she was feeling tired. The patient called to get recommendations regarding her symptoms. The consent for follow-up was not requested by involuntary omission of the agent.
This person developed full body rash from neck to waist in 1/17/21 afetr receiving vaccine 1/15/21. He took Allgra and rash dissipated by 1/18/21
It affects both my eyes . My eyes was blood red the 1st and and I made the connection when I took the 2nd one and the left eyes was the same blood red and I lost a tooth that now the dentist said I hv to pay 6k to have the surgery done
at injection site: heat, itchiness, redness, hardness, looks like bruising  nothing to go to the ER about but still noticeable.   experiencing it most of the day.
102 Fever, Sweats, Chills, all joints on fire and in pain, headache, nausea, swollen lymph nodes in neck.  Took several days to feel better.   After I felt better I ate shrimp on 2-13 and 2-17 and had a reaction to the shrimp on 2-17 which required a doctor visit and complete bloodwork analysis which showed allergy to shrimp and a high titer which could be an auto immune disorder.  Since then I have logged foods and have determined I have  reactions when something has MSG or Maltodextrin.  I have dry back of my throat, a feeling that I have a lump in my throat,  eyes seem a little dry,  the headache has not gone away.  Pressure on the top of my head and my forehead.  Tingling and on fire in hands wrists, forearms, shins and ankles.  I have an appointment with a Rheumatologist on March 30.
Vaccine was administered to patient.  He had a history of fear of needles, fainting, etc.  Approximately 5 minutes after administration, patient did faint with possible seizure activity.  Paramedics were called.  No further adverse events were observed.  Patient was conversational and walked out on his own power.
Information has been received from a health professional ("medical assistant") concerning an approximately 51 year old female who, on an unspecified date, was vaccinated with a dose of Pneumovax 23 (Lot# 651437/0899F).  Concomitant vaccination included a dose of influenza virus vaccine (unspecified).  Subsequently the patient developed bad swelling of the right shoulder at the injection site.  The medical assistant noted the patient was "in bad condition."  The patient was seen in the emergency room but not admitted to the hospital.  It was also reported that the patient recovered (date not reported).  Additional information has been requested.
4/1/2021-CLIENT CALLED TO REPORT ADVERSE SYMTPOMS THE DAY OF HIS VACCINE INCLUDING, PAIN, PRESSURE AND SMALL PRINT VISION LOSS IN BOTH EYES, PAIN AND TREMOR IN LEFT THUMB AND PAINFUL KNEE JOINTS. CONTACTED DR., WHO RECOMMENDED FOLLOW UP,  BUT CLIENT DECIDED TO WAIT AS IMPROVEMENT. 4/1/2021- OPTHOMOLOGY APPOINTMENT.  PAIN, PRESSURE AND VISION CONTINUES TO IMPROVED.  CAN READ SMALL PRINT AGAIN, BUT NOT AS CLEAR.  LEFT THUMB CONTINUES TO TREMOR, KNEE JOINTS IMPROVED.
a dose from the recalled batch was meant to be administrated; pharmacy dispensed a dose from the recall batch; This case was reported by a pharmacist via call center representative and described the occurrence of recalled drug administered in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 9lh3y, expiry date 7th February 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On 6th April 2021, unknown after receiving Shingrix, the patient experienced drug dispensing error. On an unknown date, the patient experienced recalled drug administered. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The pharmacist reported that their pharmacy dispensed a dose of Shingrix on 6th April 2021 from the recall batch, which led to recalled drug administered and drug dispensing error.  The vaccine was meant to be administrated to a male patient but the facility was unaware of the date of the administration. No further events were reported.  The reporter consented to follow up. This case was linked with US2021202999 and US2021203000, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021202999:same reporter US-GLAXOSMITHKLINE-US2021203000:same reporter
This spontaneous report was received from a nurse regarding a 3-year patient of an unknown gender. The patients' concurrent conditions and medical history were not provided. On 14-JAN-2019, the patient was vaccinated with an improperly stored PROQUAD (route of administration and dose were not reported) for prophylaxis (lots # and expiration dates: R020676, 15-JAN-2020; R020816, 16-JAN-2020; R020677, 15-JAN-2020; R020814, 16-JAN-2020), however, it was unknown which specific lot the patient received. A sterile diluent was used to reconstitute the vaccines was properly stored. No adverse effects were reported. The vaccines were exposure to a temperature excursion of 9°C to 25°C (9.2°C) during 2 hours which was called by a data logger. There was not previous temperature excursion. This is one of the several reports received from the same reported.; Sender's Comments:  US-009507513-1901USA005742: US-009507513-1901USA005741: US-009507513-1901USA005740: US-009507513-1901USA005743: US-009507513-1901USA005573:
No adverse events were witnessed yet. I forgot to dilute the Pfizer 5-11years old covid vaccine before administering the 0.2ml dose. I let the mom know and advised her to check with the pediatrician.
Patient 4 years of age, received / a dose of Bexsero by mistake; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB26AB, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th June 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 7th June 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 was provided as follows: The licensed practical nurse reported that, the patient received a dose of Bexsero at an age of 4 years old  by mistake, which led to inappropriate age at vaccine administration. The reporter did not consent to follow up. As per sales data sheet reported batch number was changed from AVXB268V to ABXB26AB.
Vaccines given in left arm while mom held patient.  Patient cried briefly after vaccines were given but was easily consolable.  Mom and patient left shortly after and returned about ten minutes later with the patient stating that her chest felt "tight" and that it was difficult for her to breathe.  I checked her pulse ox, it was 97% and called the doctor.  Gave Benadryl as per doctor's orders.  Called 911 and took patient to treatment room.
Severe chills, fever, body aches, muscle pain, joint pain, severe headache, fatigue, cough, loss of appetite, unable to sleep, hives, extremely sore arm; Lasted for 48 hours, still experiencing hives
2 days after vaccination, patient had upper lip swelling, swelling of the top gums in mouth, itchiness, and a rash on both wrists. He took prednisone, Benadryl, and Pecpid and this resolved.  Then, 3 days after this (5 days after vaccination), the patient had right eye swelling.  He took prednisone and Claritin and this resolved.
chills; off and on; This is a spontaneous report from a contactable female consumer (patient herself) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 28Feb2021 and first dose was on 04Feb2021 via unspecified route of administration both as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced chills, off and on. Patient chills were elevated when she had taken Tylenol, as a therapeutic measure. Patient stated that she had an appointment with HCP tomorrow and would like to know anyone else had reported the same symptoms. Outcome of the events was unknown.    Information regarding batch/lot number has been requested.
Woke up this AM and had notable numbness on the right side of my face. Including the tongue and throat. Had pain in the right ear and temporal mandibular joint 4/10. As I was consuming my breakfast I bit my lip. It was then that I noted my face on the right was not moving much. No marked facial droop, but when I smiled the right side was not moving as much as the left.
Information has been received from a physician concerning a 21 year old female on antibiotics for condition unspecified, and pertinent medical history and drug reactions/allergies unspecified who on approximately 29-JAN-2007 was vaccinated with first dose of Gardasil (lot # not reported) IM. Concomitant suspect therapy included Antimicrobial (unspecified). The physician reported that the patient sought medical attention (called the office) to report that she had hives (on approximately 25-JAN-2007). The patient had been on antibiotics for a couple of days prior to receiving Gardasil. The physician felt the hives may be related more to the antibiotics than the vaccine. The outcome of the hives was unspecified. no further information was available at the time of reporting. Additional information has been requested.
Right after the 4th vaccine was administered he became pale and appeared to have passed out . No reported eye rolling, but he appeared to shake before the episode. he swiftly jumped up after the incident and ran to the sink reporting he would vomit. He was sat down and given a drink of water. After 15-20 minutes of rest, he was re-evaluated.  Pallor improved and he reported he felt better.  Presentation appears to be consistent with a vasovagal response to the pain, and he was already anxious and nervous about vaccines."
I had a strange side effect- 02/06/2021, it hurt a little bit, Injection in left upper arm, the following day I had pain in right arm where I had first dose and the left arm pain had reduced. It lasted a couple of days. At some point around the second dose I started having jabbing pain in right hip.
Pt experience growing pain at lower abdomen/groin area 5 days after the 2nd dose Moderna... linger for 4-6 weeks. Patient just inform the pharmacy today 6/11 upon picking up his medication that the PCP ordered. PCP will do a full work up to make sure it's not something else. Pt claims that he's a healthy person, no illness. MD prescribed him temporary Medrol to calm down the system. I inform the patient to take the med, closely follow up with his PCP, & do a full work up to find the uderlying cause.