chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a red rash on the arm; itchy; warm to the touch; nauseous; painful/the pain returned and was worse; Hard to lift her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to lift her arm), VACCINATION SITE WARMTH (warm to the touch), NAUSEA (nauseous), VACCINATION SITE PAIN (painful/the pain returned and was worse) and VACCINATION SITE RASH (had a red rash on the arm) in a 43-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 reaction.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to lift her arm) and VACCINATION SITE PAIN (painful/the pain returned and was worse). On 15-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch) and NAUSEA (nauseous). On 16-Apr-2021, the patient experienced VACCINATION SITE RASH (had a red rash on the arm) and VACCINATION SITE PRURITUS (itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to lift her arm), VACCINATION SITE WARMTH (warm to the touch), NAUSEA (nauseous), VACCINATION SITE PAIN (painful/the pain returned and was worse), VACCINATION SITE RASH (had a red rash on the arm) and VACCINATION SITE PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported   Reporter did not allow further contact
rt arm;no fever,chills;no tenderness @ site;3 large inflamed axillary nodes;given anti-inflammatory by MD
Low grade fever T-max 99.6F lasted about 12 hrs. broke with Tylenol. L arm soreness - improving but still ongoing (today day 4) after injection.  Additionally have injection site reaction - red tender firm lump at left arm approx 2-3cm - slowly improving but still present. Now being more itchy. No drainage.
Received seasonal influenza immunization 11-09. He states had flu-like symptoms week prior to Christmas - fever and respiratory symptoms. 12/25/09 He noted tingling in arms and hand and numbness in his feet. Also noted symmetrical weakness in legs and upper extremities with decreased grip. Around 1/1/10 developed upper/lower extremity myalgias.
Accidentally received a YF-VAX mixed with sterile water instead of sodium chloride/wrong diluent administered with no reported adverse event; Initial information received on 27-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who accidentally received a yf-vax mixed with sterile water instead of sodium chloride/wrong diluent administered with no reported adverse event while receiving vaccine yellow fever vaccine [YF-VAX].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect yellow fever vaccine unknown formulation and strength lot number not reported via unknown route in unknown administration site for Immunization.  On an unknown date it was reported that a patient accidentally received a YF-VAX mixed with Sterile water instead of Sodium Chloride /wrong diluent administered with no reported adverse event (product preparation error) (unknown latency) following the administration of yellow fever vaccine. Action taken: Not applicable  Corrective treatment: Not applicable  Outcome: Unknown     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 guidelines. 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.
swelling left arm; it still hurts in the spot where she received the vaccine; low grade fever; shivering; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 15th May 2019, less than a day after receiving Shingrix, the patient experienced low grade fever and shivering. On an unknown date, the patient experienced swelling arm and injection site pain. On an unknown date, the outcome of the low grade fever, shivering, swelling arm and injection site pain were recovered/resolved.   It was unknown if the reporter considered the low grade fever, shivering, swelling arm and injection site pain to be related to Shingrix. Additional details were providded as follows: The patient received dose of Shingrix in the left arm. In the evening of day of vaccination, the patient experienced low grade fever and shivering, and lasted for approximately 3 days before resolving. The patient stated that, when she lift her left arm, it still hurts in the spot where, received the vaccine. For the tolerance of 2nd dose, refer case US2019AMR145250
no additional adverse effects; she is over 45 years of age and was administered the first dose of the vaccine; This spontaneous report as received from a consumer refers to a 55-year-old patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication.     The consumer reported that she is over 45 year old  and on 04-MAR-2020,she was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).No additional adverse effects reported.
Patient complained of feeling anxious with a rapid heart rate immediately after immunization.  Patient checked out by EMS, began feeling better shortly thereafter.  Patient advised to call 911 or go to the nearest emergency room for any additional issues as needed.  Also advised to sign up for v-safe.  Patient left site stating he felt better.
On night of vax adm 7MAY91 pt became fussy, excessive crying & t105R- fever started 9PM 102; APAP given;
patient received TENIVAC rather than ADACEL with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from Nurse via Medical Information (Reference number- 00787288) and transmitted to Sanofi on 27-Sep-2021.  This case involves a 28-year-old male patient who received a 0.5 mL (total, once) dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6669AA, expiry date 15-May-2022) via intramuscular route in the right deltoid on 27-Sep-2021 for prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to wrong vaccine administered (latency was on same day).  At the time of report, no adverse event reported.  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 guidelines. 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.
Event: Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture's guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient's guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient's guardian
9-10-11 Developed redness, discomfort at injection site (L) deltoid. Clindamycin 150 1 PO TID x 7 days. Dx cellulitis.
Patient is a 17y/o that was inadvertently vaccinated with Moderna vaccine on 2/5/2021. Administration error giving  Moderna vaccine to a patient <18y/o was detected on 3/3/2021 when the patient returned for her second dose. Patient was then given Pfizer vaccine instead because this is authorized for patients 16yrs and older. This was also an administration error due to a mixed dose series.
fatigue, joint pain, muscle aches, mucus/irritated throat, headache, night sweats, breathing problems, chest pain started 10/30/21 and still occurring on 11/26/21
Localized redness in the size of a football, soreness, and pain localized to area of injection, lasted for about 4 to 5 days. Pt was advised to take Benadryl.
Rash slight tenderness, small knot, tenderness, and warm to touch at injection site Narrative:
during the day male patient received Infanrix and a the same time Pentacel (DTaP-IPV-Hib).; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 6-month-old male patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis and PENTACEL for prophylaxis.   On 24th May 2021, the patient received Infanrix, Infanrix Pre-Filled Syringe Device and PENTACEL. On 24th May 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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 details were provided as follows: The nurse stated that during the day the patient received Infanrix and at the same time Pentacel (DTaP-IPV-Hib), which led to overdose. The reporter consented to follow up.
sore arm; injections site reactions  / swelling; injections site reactions / area of redness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th March 2020, the patient received the 2nd dose of Shingrix. On 11th March 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had injection site pain, area of redness and swelling was described as the size of the palm of his hand. The injections site reactions resolved within 2 days.  The reporter did not consent to follow up.
11 days post injection.  Redness at injection site 3 inches in diameter, red bumps within redness area, area warmer that surrounding skin, occasional itching.
Dizziness, nauseated, headache, and fatigue a few hours after injection.  I went to sleep. I woke at 4am to notice pain, red and swollen injection site which has gotten larger every day. Today, it is about a 3 inch circle. The injection site is now itchy. It has faded a little, not as red. It is still raised/swollen.
Seen in ER for febrile seizure lasting approx 6 minutes (limbs rigid). Hx of previous seizure with fever at 18 months and NL EEG at that time.
Severe pain in left shoulder; Pain in left hip; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 08Mar2021 at 13:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included malignant neoplasm of rectum and finished chemo for cancer in Jun2020. The patient did not have allergies to medications, food or other products. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN) all for unknown indications from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Mar2021, the same day of vaccination,  the patient experienced, severe pain in her left shoulder and left hip and the pain was so intense she couldn't move properly and could not lay on left side for about 4 weeks from first shot. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe pain in her left shoulder and left hip was recovering at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 05Apr2021 at 13:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Dizzy, pale, faintish, pulsating on (R) eye, shakiness, nausea, headaches, cold temperature, normal temp taken by school nurse. Pt had to be picked up from school 10:45 AM.
Received the COVID19 vaccine 2 weeks ago, and the next day started to have dizziness/lightheadedness and palpitations. It was the worst the first 2-3 days after the vaccine. It has improved somewhat, but is still not fully resolved and my improvement seems to have pleatued in the past few days. It is not debilitating nor a deterrent for me getting my 2nd dose, but I felt compelled to report my symptoms as I don't see dizziness and palpitations listed as a possible side effect.
Patient felt light headed and dizzy and passed out briefly following administration of vaccine. Patient had history of passing out during vaccination and blood draws. Patient felt sweaty and turned white. His color returned after a minute, I talked to his mother who was there during the incident. Did not eat or drink the morning of vaccine. I checked his pulse and blood pressure and it was 129/72 and pulse of 78. We gave him some water and orange juice. He felt much better. Then his mom bought him some muffins. He sat and ate for about 30 minutes and left feeling back to normal.
On March 11, 2021, approximately 2 weeks after my second Moderna vaccination I began experiencing frequent headaches and brain fog. The migraines cause dizziness, sensitivity to light and sound and occasional nausea.  My head seems extremely foggy at times and I have difficulty with memory. I have been prescribed Ubrelvy to treat these migraines, but they continue to happen frequently. I went for an MRI and complete panel of blood work as prescribed by my primary, all coming back completely normal. These headaches are very painful!
Pt. had Pneumovax and influenza shot both in the right deltoid.  Same day redness, pain, and swelling.  Pt. put ice on it and took ibuprofen, no better.  2 days after the shots, pt. felt hot and cold, had generalized aches, appeared pale, had nausea, and sweating.  In the office, pt. appeared pale, BP 96/68. pulse 112, temp 101.6 F.  No stridor/wheeze.  Area of erythema on right deltoid was 10cm circular, warm, raised.  Pt. was given liquid Benadryl, and liquid Motrin.  After 15 minutes, pt. feeling better, less nausea, BP improved to 108/68, pt. tolerating sips of water.  Total observation for 45 minutes.  Pt. ambulated out of office feeling somewhat better.  VS stable.  Instructed to continue liquid Benadryl and Motrin at home every 6 hours for generalized hives reaction.
5 after booster, I started to feel like I had bad allergies. I had Rhinitis and conjunctivitis. It felt like a bad head cold. I did a home test and it came back positive. I went to the doctors and it was confirmed with a PCR test.  The next three days I ran a fever, my joints and muscles while on Paxlovid. Three days after the medication, I still felt sick and it lasted for about 16 days. My head still feels congested and I developed a sinus infection to which I am now on antibiotics.
Case number PHEH2014US018794, is an initial spontaneous report from a nurse received on 17 Sep 2014. This report refers to 33 months and 22 days old female patient. Past medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1412201) intramuscularly from a multiple dose vial (MDV) on 16 Sep 2014. No adverse event was reported following this maladministration (inappropriate age at vaccine administration).
Information has been received from a physician concerning a female "who fainted after receiving a dose of GARDASIL". Lot number was not available. The patient sought unspecified medical attention. The outcome was unknown. Additional information has been requested.
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 70-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 15-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250795, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805523 was crossed linked to original cases 201804863 due to same reporter.
When I woke up on day 2 after receiving my 2nd dose of the vaccine, I immediately noticed a ringing in my ears.  It has remained constant ever since.
Client reported to the health dept on 9/23/03 that he had begun to experience vertigo within 24hrs after recieving theYellow fever vaccineon 9/15/03. Client reported that he had not experienced fever,but had experienced gastrointestional problems on Wednesday 9/17/03 and on 9/21 and 9/22/2003.
muscle pain; headaches; swollen glands; the arm where the vaccine was injected could not be lifted and I still have difficulty lifting it; stiff neck; pain it causes in my back, legs, neck; lack of strength making it difficult for me to sleep; lack of strength making it difficult for me to sleep; The levels my doctor sees for the CReactive protein QT test have doubled.; 4 days with fever; This is a spontaneous report from a contactable consumer (patient herself). A 56-year-old female patient received BNT162b2 (BNT162b2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection) via an unspecified route of administration on 07-APR-2021 11:30 (Lot number: GW0151, Expiry date: Unknown) as 2nd dose, single dose for COVID-19 immunisation. Medical history included Ankylosing Spondylitis, Hypothyroidism, uveitis. The patient previously received first dose of BNT162b2 on 07-MAR-2021 11:45 (Lot number: EN6207, Expiry date was unknown) for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient was not diagnosed with COVID 19 since the vaccination. Concomitant medications included levothyroxine sodium (SYNTHYROID), folic acid (MANUFACTURER UNKNOWN), methotrexate and adalimumab (HUMIRA) for an unknown indication. On 08-APR-2021 09:30(after 21 hours) experienced fever and on an unknown date muscle pain, headaches, swollen glands, the arm where the vaccine was injected could not be lifted and still have difficulty lifting it, stiff neck, pain it causes in her back, legs, neck, lack of strength making it difficult for me to sleep, lack of strength making it difficult for me to sleep, the levels her doctor seen for the C-Reactive protein QT test have doubled. The patient visited doctor and told him that since she received the vaccine her body was not the same and the pain do not stop. The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included C-Reactive protein QT test have doubled on 12Apr2021 was 7500 and on 26Apr2021 was 8510. Therapeutic measures were taken for the events with Medrol-Valium-Mobic. The outcome of the event fever was not recovered and rest of the events was unknown.   Follow-up attempts are possible. Further information is expected.
Expired dose given 12 hours after expiration. Vaccine never left out long the 1 minutes to draw up the dose. No complaint of any adverse reactions form the patient. Patientt notified and offered to repeat the dose.
Arm was sore for 2 days following injection but went away. 1 week after injection arm was itch and red around injection site (large red circle). Also felt very hard & warm around injection site. Noticed yesterday (4/14) 1 week after injection and side effect still occurring today.
This spontaneous report as received from a nurse refers to a female patient who is currently 4 years old. Information regarding patient's medical history, concurrent conditions, concomitant medications, drug reactions, allergies and past therapies were not reported. On an unspecified dates, the patient was vaccinated with two doses of improperly PROQUAD lot # N015623, expiry date: 15-NOV-2018, lot #N024564, expiry date: 06-MAR-2019 for prophylaxis whose dose and route of administration were not reported. It was reported that vaccine was reconstituted with the sterile diluent (MERCK) lot # L030305, Expiry date: 08-APR-2018 also reported as "30-APR-2018" was stored in proper conditions. The PROQUAD was subjected to a temperature excursion of 6 degree F to 14 degree F (5.9 degree F) for a time frame of 18 minutes which was noted from a data logger. There were no previous temperature excursions. No adverse effect reported. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1804USA001618.
Fever, Chills, body ache, fatigue, Extreme pain and heat at injection site. The body aches and fatigue lasted 3 days. The arm/shoulder pain is still a continuing problem.  On three different days, the shoulder pain has been debilitating.